[Senate Hearing 117-386]
[From the U.S. Government Publishing Office]
S. Hrg. 117-386
ADDRESSING NEW VARIANTS:
A FEDERAL PERSPECTIVE ON THE COVID 19 RESPONSE
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE, FOCUSING ON
ADDRESSING NEW VARIANTS
__________
JANUARY 11, 2022
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
48-897 PDF WASHINGTON : 2023
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont RICHARD BURR, North Carolina,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
JACKY ROSEN, Nevada ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
TOMMY TUBERVILLE, Alabama
JERRY MORAN, Kansas
Evan T. Schatz, Staff Director
David P. Cleary, Republican Staff Director
John Righter, Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, JANUARY 11, 2022
Page
Committee Members
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor,
and Pensions, Opening statement................................ 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State
of North Carolina, Opening statement........................... 4
Witnesses
Walensky, Rochelle, M.D., M.P.H., Director, United States Centers
for Disease Control and Prevention, Atlanta, GA................ 8
Prepared statement........................................... 10
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 14
Prepared statement........................................... 16
Woodcock, Janet, M.D., Acting Commissioner, United States Food
and Drug Administration, Silver Spring, MD..................... 24
Prepared statement........................................... 25
O'Connell, Dawn, Assistant Secretary for Preparedness and
Response, United States Department of Health and Human
Services, Washington, DC....................................... 42
Prepared statement........................................... 44
QUESTIONS AND ANSWERS
Response by Rochelle Walensky to questions of:
Hon. Robert P. Casey, Jr..................................... 102
Hon. Maggie Hassan........................................... 103
Hon. Ben Ray Lujan........................................... 104
Hon. Bill Cassidy............................................ 107
Hon. Mike Braun.............................................. 109
Hon. Tim Scott............................................... 110
Hon. Tommy Tuberville........................................ 116
Response by Anthony Fauci to questions of:
Hon. Robert P. Casey, Jr..................................... 123
Hon. Maggie Hassan........................................... 126
Hon. Ben Ray Lujan........................................... 127
Hon. Rand Paul............................................... 128
Hon. Bill Cassidy............................................ 131
Hon. Mike Braun.............................................. 134
Hon. Tim Scott............................................... 135
Hon. Tommy Tuberville........................................ 135
Response by Janet Woodcock to questions of:
Hon. Robert P. Casey, Jr..................................... 142
Hon. Tina Smith.............................................. 144
Hon. Richard Burr............................................ 151
Hon. Bill Cassidy............................................ 154
Hon. Mike Braun.............................................. 154
Hon. Tim Scott............................................... 155
Hon. Tommy Tuberville........................................ 157
Hon. Maggie Hassan........................................... 158
Response by Dawn O'Connell to questions of:
Hon. Robert P. Casey, Jr..................................... 159
Hon. Tammy Baldwin........................................... 161
Hon. Maggie Hassan........................................... 163
Hon. Tina Smith.............................................. 163
Hon. Ben Ray Lujan........................................... 165
Hon. Richard Burr............................................ 165
Hon. Bill Cassidy............................................ 166
Hon. Tim Scott............................................... 167
Hon. Tommy Tuberville........................................ 170
ADDRESSING NEW VARIANTS:
A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE
----------
Tuesday, January 11, 2022
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room G50, Dirksen Senate Office Building, Hon. Patty Murray,
Chair of the Committee, presiding.
Present: Senators Murray [presiding], Casey, Baldwin,
Murphy, Kaine, Hassan, Smith, Rosen, Hickenlooper, Burr, Paul,
Collins, Murkowski, Braun, Marshall, Scott, Romney, Tuberville,
and Moran.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. The Senate Health, Education,
Labor and Pensions Committee will please come to order. Today
we are holding a hearing with members of the President's COVID-
19 response team on the pandemic and our efforts to address new
variants like Omicron. After the witnesses give their
testimony, Senators will each have 5 minutes for a round of
questions. And while we were unable to have this hearing fully
opened to the public or media--is my mic working?
While we are unable to have the hearing fully open to the
public or media for in-person attendance, live video is
available on our Committee website at help.senate.gov. And if
you are in need of accommodations, including closed captioning,
you can reach out to the Committee or the Office of
Congressional Accessibility Services. I want to start this
morning by recognizing the difficult moment we are in with this
pandemic.
The Omicron variant has caused an unprecedented number of
infections across the country over the past month. Thanks to
the hard work of so many, we have new tools to address the
threat caused by this new variant, including vaccines,
boosters, and high quality masks. But the sheer number of
infections is inputting an enormous strain on hospitals, health
care workers, schools, families, and communities across the
country. We all need to do our part to address this new
challenge by getting vaccinated and boosted and wearing high
quality masks.
That is why we are having this hearing in a larger hearing
room where we can be socially distanced, limiting the number of
people who are here in this hearing room, and taking additional
measures such as wearing masks. I will be wearing my mask
during the entire hearing and would respectfully request others
in the room today do the same.
As always, I appreciate the work from the staff of the
Sergeant-at-Arms, the Architect of the Capitol, and our
Committee Clerk and his staff to make this hearing as safe as
possible. Nearly 2 years into this pandemic, people are
exhausted after all we have been through, and even as the Delta
strain is still circulating, we are all alarmed by how quickly
Omicron has spread and anxious about what is next.
People back in my home State of Washington and across the
country are frustrated and worried about the course of this
pandemic and its persistent challenges, like how hard it still
is to get a test. I have heard from so many people who are
waiting in long lines and going from pharmacy to pharmacy,
trying to find a test, or who are giving up on getting tested
because tests are unavailable or cost too much. I have also
heard from people who have found the communication about new
isolation and quarantine guidance confusing and frustrating.
They are trying to keep themselves and their families safe as
this pandemic evolves and we continue to learn more.
But I am hearing more and more questions like, what kind of
tests should I get? When should I get tested? Why can't I find
a test? Do I need to isolate 10 days, 5 days, or even at all?
Testing, in particular, is a huge concern for parents who are
starting 2022 exhausted from the last 2 years and worried about
schools staying open safely this year. I know what a struggle
it is for parents scrambling to figure out childcare when they
have got to go to work, or how tough it is for kids to keep up
with classwork while transitioning back and forth from in-
person to online learning.
While most schools are still safely open for in-person
learning and we all want to make sure they stay that way, we
know schools are struggling with this, especially as Omicron
creates new challenges. I am hearing from schools in my States
that they are worried they will have to shut down again if they
can't get the support for testing they need, or they have staff
shortages because of staff who are ill. Nobody wants that.
Based on what we now know about this virus and the tools we
have to fight it, schools should be able to stay open safely if
they have tests, masks, ventilation, and people are vaccinated.
Hospital and health care providers are worried too. They have
been stretched too thin after two exhausting years, and now
Omicron is causing the worst surge in cases and
hospitalizations yet. Because while it may be less severe in
most cases, especially for those who are vaccinated and
boosted, it is so much more contagious, meaning we are still
seeing high rates of hospitalization overall.
We also have to protect children who are too young to get
vaccinated and people with health conditions and disabilities
that put them at high risk. Back in my State, hospitals are
asking our State leaders to declare a crisis for our medical
facilities. I have heard from health care providers in
Washington who have been well over their staffed bed capacity
for several days and are pausing nonessential procedures.
Families are wondering whether they can get care for non-
COVID related conditions and alarmed by how long ER wait times
are getting. Health care providers are concerned about how we
continue to keep health care workers safe, and also address the
fatigue and burnout and mental health challenges that they
face. These are not new challenges. I have been raising many of
these concerns since the earliest days of the pandemic, so I am
frustrated we are still behind on issues as important to
families as testing and supporting schools.
That is not to say we have not made progress, it is just
clear we haven't made enough. But even though we aren't where
we need to be yet, we are not back at the starting line when it
comes to COVID-19 either. We have safe and effective vaccines
for everyone ages five and up. We have booster shots available
for those 12 and up. More and more people are getting their
shots each day. The Administration is also working to help get
the world vaccinated to end this pandemic and has already
pledged over a billion vaccine doses to that effort. We have
new life saving therapeutics.
We have additional resources Congress passed in the
American Rescue Plan, which can help increase our testing
capacity, protect workers, and give schools the support they
need to stay safely open. And we have an Administration that is
focused on following the science, facing this pandemic head on,
and addressing the frustration people are feeling. That is
crucial at this moment when the path forward requires steady
leadership and clear communication about the challenges we are
still facing and the work ahead to tackle them.
President Biden has said plainly that he shares families'
frustration around testing, and he wants to make sure schools
stay safely open. And he has announced steps to address these
challenges by making 500 million tests available free of
charge, ordering over 200 million courses of antivirals,
expanding manufacturing to be able to make hundreds of millions
of tests a month, providing schools with guidance on how to
test to stay protocols which can help keep students in the
classroom, standing up more testing and vaccinationsites across
the country, and providing medical personnel to struggling
areas.
I expect to hear more detail on those efforts today, along
with what other steps the Administration plans to take, and I
will be watching closely as they are implemented. But I also
want to be clear, when we talk about these problems, we have to
be focused on solutions. You can't just say our schools must
stay open if you don't vote to provide additional resources
schools need to do so.
You can't just say the latest health guidance is confusing
and not call out the blatant misinformation that has come from
so many members of the Republican Party. We are not going to
get out of this crisis by treating each challenge as a
political opportunity. We are going to get through it by being
honest about what we are facing and clear about what we are
going to do about it. And as we continue working to get through
this pandemic, it is important we also look at what we can do
to prevent future health crises.
That is exactly why Senator Burr and I have been working in
a bipartisan way over the last several months on legislation to
learn from and improve on our pandemic response, like
strengthening our supply chain for medical products, updating
old and incompatible public health data systems, modernizing
the process for developing tests, fighting misinformation,
addressing root causes of health inequities and more. We will
be unveiling a discussion draft soon, and I look forward to
working with all of our colleagues to finalize and pass this
important package. In the meantime, we will continue working to
address the pandemic at hand.
People across the country are worried this will be another
year of uncertainty, uncertainty for their work, their schools,
and their everyday lives. But there is no reason it should be.
People should be able to make plans for the future without
fearing that everything they are looking forward to, or even
the everyday things they used to take for granted, will be
upended by this virus.
We all want that, and we have the tools we need to get us
there. We have the tools to get everyone tested quickly,
easily, and for free, to keep schools safely open during the
Omicron surge and beyond, to keep workers, especially our
health care workers, safe and healthy in the workplace. We have
the tools to mitigate this virus, to protect those at high risk
like seniors or kids who were too young to get vaccinated and
people with other health conditions, to get people back to
their friends and their lives, and to give families back some
certainty and stability.
We can do all this now thanks to the incredibly hard work
on the part of health care providers and scientists, parents
and teachers, workers, and our witnesses who are here with us
today. So what I hope to hear from this Administration at this
hearing is what are you doing right now to make sure every
American can make use of that progress they have worked so hard
for. What can my constituents expect to see improved this week
and the week after?
We have come a long way since the start of this pandemic,
and I look forward to hearing from each of you today about what
you are going to do to build on what we know, bring this virus
under control, and bring certainty and stability back to
families who are burnt out after 2 years of fighting this
pandemic. Thank you. And with that, I will turn it over to
Ranking Member Burr for his opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Madam Chairman, thank you. And before my
opening statement, I hope the Chair will indulge with me for
just a second since this is a hearing on preparation. I want to
help my good friend, Senator Kaine, as he gets ready for his
weekly travels.
I want to make sure that he has got an orange for his car,
that he has got a Dr. Pepper, and I provided a Lumbee blanket
to make sure that things are three things you have got in your
car regardless of what you run into on I-95, and I will have my
staff bring them over to you.
The Chair. I hope you provide those for everyone has to be
used to say to our kids in the classroom, do you have a piece
of gum for everyone?
[Laughter.]
Senator Burr. Well, in his particular case, I think he is
the only one that makes that trip on a weekly basis. Tim, we
are sorry you had to spend 27 hours, but you are now qualified
to be the Secretary of Transportation if you are looking for a
second job.
[Laughter.]
Senator Kaine. Thank you. It is sad when a career in the
Senate's most notable highlight is my long commute, but----
[Laughter.]
Senator Burr. Madam Chairman, thank you for holding this
hearing. To our witnesses, welcome back. Today is going to be a
tough hearing, but the American people deserve accountability
and transparency. I appreciate that all of you have cleared
your schedules to allow multiple rounds of questions today.
Next week marks 1 year of this Administration. It also marks 2
years since the first COVID case was confirmed. President Biden
said in his first, second, and third priorities would be
bringing us out of COVID pandemic and that his team would shut
down the virus.
This Administration was lucky. It started off on day one
with the tools to change the trajectory of COVID response.
Operation Warp Speed worked with the private sector to bring us
groundbreaking vaccines and treatments in record time.
Although we had a very bumpy start with testing early in
the pandemic, we successfully built some strong partnerships
with the private sector to support the development and
manufacturing of more tests. State and local leaders were
rising to the challenge of testing and vaccinating their
citizens. There was reason for hope.
Instead, now, a full year later, here is where we are. More
than 830,000 deaths caused by COVID, the majority of which
occurred under this Administration, despite having many tools
and significant resources from Congress, including $80 billion
plus for testing. A variant now spreading out of control across
the country with places like Washington, DC. seeing a
staggering increase in case counts over the holidays, and now
my State of North Carolina is following suit with a 319 percent
increase as of yesterday.
Over the holidays, when Americans were instructed to do the
responsible thing and get tests before they see loved ones,
there were no tests on the shelves or online, and hours long
lines were the norm at testing sites across the country. The
testing situation was worse when many sought tests to safely
return to work or to school. And the most vulnerable Americans
who contracted the virus could not get the treatments designed
to help because they were now in short supply.
This Administration has time and again squandered its
opportunities and made worse in the decisions you have made on
testing and treatment, and most crucially in communications
with the American people. The American people are right to be
confused. It seems like you all don't talk among yourself. Some
examples. Last August, the President announced that boosters
would be available to all vaxxed by the week of September 20th.
The three of you here today signed that statement, but neither
the FDA nor the CDC had yet approved boosters when the
President made the promise.
When you went to your advisory panels with a predetermined
outcome already made, those independent experts pushed back and
ultimately had to be overridden to meet the President's goal on
boosters. I know the data shows that boosters are necessary. I
am boosted. I want everybody to get vaccinated and booster. The
facts about the value of vaccines and booster are crystal
clear. But the way this Administration rolled out boosters was
a disaster. You created skepticism and mass confusion.
Example two, last summer the President dramatically
announced that CDC recommendations changed so that vaccinated
Americans didn't need to wear a mask indoors, implying that the
worst of the pandemic was behind us, even as the Delta variant
was exploding in India. Only after Delta hit America did CDC
begin to take it seriously and the Administration had to change
course.
Example three, last week Dr. Fauci said that the CDC was
going to update its guidance on quarantine. He left the
American people with the impression that CDC guidance was going
to include some testing component to reduce the quarantine to 5
days. But when CDC did update its guidance, there wasn't a
testing requirement. Again, I am not questioning the science. I
am glad you refrained from testing mandates, but I am
questioning your communication strategies.
It is no wonder the American--it is no wonder that the
American people are confused. When the President announced on
December 21st that 500 million tests were going to be
purchased, he left out that the contract wasn't going to be
signed for weeks and it would take even longer for those tests
to be--to materialize. Immediately, other experts and medical
professionals were asking what the value of just 1.5 tests per
person was when CDC's own guidance said that you need multiple
at home tests to be assured of the results.
Yesterday, the Administration mandated that insurers now
cover the 170 million Americans that are covered by private
insurance. They must cover up to eight tests per person per
month. That would be 16 billion tests. And we have 500 million
today that are aspirationally going to be contracted for. It is
still unclear when these tests will be available, how to get
them, whether any more are on their way.
But it is especially frustrating that the White House press
Secretary had previously mocked the very idea of doing what the
President later announced in a sarcastic and withering tone
when this was first proposed. She had four questions, whether
we should just send one to every American, then what happens,
how much does it cost, what happens after that? Those are all
good questions that remain unanswered by the Administration. My
final example, though, there are many to choose from, happened
last week too.
The White House press Secretary, a repeat offender in poor
communications was asked about boosters. The press Secretary
said, and I quote, ``they can get boosted now, regardless of
what CDC guidance is, whether you just approved for a booster,
or you have been approved for weeks.'' ``Regardless of what CDC
guidance is,'' from the White House podium. And then I was
amazed when I got home on Sunday, and I had this letter from
the Centers for Medicare and Medicaid Services telling me as a
Medicare beneficiary, that I am eligible to get a free vaccine
booster.
Five months after the President announced we are going to
have boosters, we are--this is the first communication from CMS
that I have gotten as a Medicare beneficiary in the 2-years of
COVID and all of a sudden I get a request to get a booster.
When a Republican Governor, or a Senator, including some on
this Committee, suggests concerns about CDC guidance, Twitter
and MSNBC can't react fast enough with scorn and anger. So it
can't come as a surprise that there is confusion and anger when
the White House says to ignore CDC guidance.
I tell my staff, as I have repeatedly said to you all in
all previous hearings, to look 30, 60, 90 days ahead. Look 6
months ahead. Look abroad. See what is happening in Asia,
Europe, Israel, Africa, UK, and elsewhere around the world.
What do we need to anticipate? In our hearing on July 20th, and
I warned that Delta would be--would not be our last variant.
And I pleaded with each of you to have a plan in place for the
next mutation of the virus. So why was the vice President
surprised that Omicron came to our shores?
Well, I will say it is very clear--very clearly, so the
Administration does not yet again say they are surprised,
viruses change, viruses mutate. There will be more variants.
They will come to America, period, end of sentence. I don't
understand why after tens of billions of Federal dollars being
appropriated, this Administration has failed to ensure that the
Americans have the tests they need.
I don't understand why suddenly it is okay to take into
account the economic and job impact of your guidance and
recommendations. You shortened quarantine guidance because too
many people would be out of work. Was that because of science
or was it because you now know that lockdown, shutdowns, and
school closures come with a significant downside impact?
You ask the American people to trust you. Quite frankly,
you have lost their trust. Rather than attempting to gain their
trust back, the Administration chooses to litigate mandate
requirements for employers with over 100 employees. I have
asked before, what is the plan? Never gotten a response. Very
seldom do I get a letter responded to by this Administration.
The Administration has not responded to my letters. Maybe folks
at the White House don't think they need to respond to
Republican Senators.
I think my record shows, I am approaching all of this as I
have for the last 20 years. I am trying to help. I love this
country, love its people, and I know we can do better than we
have done. I know we have to do better. Maybe I am wrong about
this. Maybe you will tell me where I got it wrong. Instead, I
am hoping that you will understand that my criticism comes from
a place of concern because the communication efforts are a mess
and have only made things worse.
Now, I admit it. I am at the end of my rope. I think you
will see today that most of my colleagues are as well. I have
tried to give my best advice and share what we hear and what we
see because no one is paying attention to the message from this
Administration right now. Maybe today you respond to my request
to learn what the plan is.
Hopefully, you will take this challenge to rebuild the
trust, not just with me, not just with my colleagues, but with
the American people we all serve. What do you change in
inflection to restore the confidence with the American people
that there is a strategy for testing, for treatments, for
fixing your communication strategy, because if you don't,
things are going to get worse before they get better? Madam
Chairman, I yield back.
The Chair. Thank you, Senator Burr. We will now introduce
today's witnesses. Dr. Rochelle Walensky is the Director of the
Centers for Disease Control and Prevention and the
Administrator of the Agency for Toxic Substances and Disease
Registry.
Dr. Anthony Fauci is the Director of the National Institute
of Allergy and Infectious Diseases and the Chief Medical
Adviser on President Biden's COVID-19 response team. Dr. Janet
Woodcock is the Acting Commissioner of the Food and Drug
Administration.
Dawn O'Connell is the Assistant Secretary for Preparedness
and Response. And Director Walensky, Director Fauci, Acting
Commissioner Woodcock, and Assistant Secretary O'Connell, I
want to thank you all for joining us today. We all look forward
to your testimony. And we will begin with Dr. Walensky on your
opening statement.
STATEMENT OF ROCHELLE WALENSKY, M.D., M.P.H., DIRECTOR, UNITED
STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Walensky. Good morning. Chair Murray, Ranking Member
Burr, Members of the Senate HELP Committee, I appreciate the
opportunity to join you to provide an update on the COVID-19
pandemic and the impact of the Omicron variant. It has been
just over 2 years since we were first alerted to the emergence
of SARS-CoV-2 in China.
Since that time, CDC has worked with our partner agencies
and you and Congress to make--take remarkable action to protect
the health and safety of Americans. Omicron is now the dominant
variant in the United States, driving case counts to
unprecedented heights here in the United States and around the
world.
Despite the increases in cases, there are promising
emerging data from South Africa and the United Kingdom that
hospitalization rates for people infected with Omicron are
lower compared with prior variants. These data seem consistent
with what we are seeing so far in the United States.
However, despite a potential decrease in severity, the
substantial number of absolute cases is resulting in
hospitalization increases across all age groups, including
children aged zero to four. The emergence of the Omicron
variant again emphasizes the importance of vaccinations and
boosters, which decrease the risk of infection, severe disease,
and death caused by COVID-19.
Just last week, we made important progress toward
increasing booster coverage through key--four key actions.
First, we expanded eligibility of booster doses to those 12 to
15 years old. Second, CDC strengthens its booster
recommendation for adolescents, now recommending that
adolescents aged 12 to 17 years old should receive a booster
shot 5 months after their initial Pfizer-BioNTech vaccine
series. Third, we recommended that moderately or severely
immunocompromised 5 to 11 year olds receive an additional
primary dose of vaccine 28 days after their second shot.
Fourth, we shortened the recommended time between a primary
mRNA series and a booster dose from 6 months to 5 months. Each
action increases access to vaccines and booster doses at a time
when protection is critical. As we continue to monitor this
rapidly evolving virus, we are working quickly to adapt with
it.
Over the holidays, CDC updated our quarantine and isolation
guidance, first for health care workers, and then for the
general public. I know this update has resulted in numerous
questions, so I would like to take a moment to walk through it
now.
For people who tested positive for COVID-19, CDC recommends
isolation for 5 days. If you are asymptomatic or if your
symptoms are resolving, for example, you are without a fever
for 24 hours, you no longer need to isolate. However, you
should continue to wear a well-fitting mask at all times when
around others, including at home and in public for an
additional 5 days. We recommend that you avoid activities where
you are unable to wear a mask and that you avoid travel for the
full 10 days.
In addition, CDC changed the recommended duration of
quarantine. And quarantine is what you do after you are
exposed. People who are not up to date on recommended COVID-19
vaccines should quarantine for 5 days if they come in contact
with someone with COVID-19. People who do not develop symptoms
by day five should get tested. If you test positive, you should
begin isolation.
People who test negative may end quarantine and should
continue to wear a well-fitting mask when around others for an
additional 5 days. These recommendations are consistent with
over 100 studies collected over the past 2 years, indicating
that people are most infectious during their first few days of
infection and significantly less infectious 6 to 10 days after
infection. A core part of CDC's mission is to translate science
into recommendations for best practices and real world
circumstances.
Over the holidays, we saw the growing surge of Omicron and
took swift science based action to address the very real
possibility of staffing shortages in hospitals and in other
essential areas of the workforce, including schools,
pharmacies, public safety, public labs, grocery stores, and
other sites, where shortages could have and have proven to have
dire public health consequences. This is the right guidance for
what we currently know about transmission and the real world
circumstances we currently face.
As we will learn more, we will continue to update
accordingly. Omicron is likely not to be the last curveball
this virus throws at us, but we have the tools to prevent
further spread of this virus. This means for everyone five and
older, please get vaccinated. For those 12 and older, get your
booster shot.
Please continue to adhere to the multi-layer prevention
measures, including masking, and yes, washing your hands. Thank
you, and I look forward to your questions.
[The prepared statement of Dr. Walensky follows:]
prepared statement of rochelle walensky
Chair Murray, Ranking Member Burr, and distinguished Members of the
Committee:
It is an honor to appear before you today to discuss the Centers
for Disease Control and Prevention's (CDC) ongoing response to the
COVID-19 pandemic. It is my privilege to represent CDC, America's
health protection agency. Since launching an agency-wide response to
the COVID-19 pandemic nearly 2 years ago, CDC has learned more every
day about this novel pathogen, how it spreads, and how it affects
people and communities. We are committed to continuing to work to
provide science-based guidance about how we can best protect ourselves
and our communities as the virus and the pandemic evolves.
Update on Omicron
On November 24, 2021, South Africa reported the identification of a
new SARS-CoV-2 variant, B.1.1.529 (Omicron), to the World Health
Organization (WHO). Omicron was first detected in specimens collected
on November 11, 2021, in Botswana and on November 14, 2021, in South
Africa. South Africa has since also detected Omicron in specimens
collected on November 8, 2021. As of January 4, 2022, Omicron has been
detected in 144 countries around the world, including the U.S., where
cases have been confirmed in most states and territories. CDC estimates
that for the week ending January 8th, the national proportion of
lineages designated as Omicron to be 98.3 percent with a 95 percent
prediction interval of 96.9-99.1 percent. The national proportion of
lineages designated as Delta is predicted to be 1.7 percent with a 95
percent prediction interval of 0.9-3 percent.
Data are emerging on how easily Omicron may spread, the severity of
illness it causes, and how well available vaccines and therapeutics
work against it. The variant has many concerning spike protein
substitutions, some of which are known from other SARS-CoV-2 variants
to be associated with reduced effectiveness of available
countermeasures, including vaccines and therapeutics. The rapid growth
rate in Omicron infections is believed to result from a combination of
increased transmissibility and the ability to evade immunity conferred
by past infection or vaccination (i.e., immune evasion).
At present, early data suggest Omicron infection might be less
severe than infection with prior variants; however, reliable data on
clinical severity remain limited. Even if the proportion of infections
associated with severe outcomes is lower than with previous variants,
given the increase in number of infections, the absolute number of
people with severe outcomes could be substantial. In addition, demand
for ambulatory care, supportive care for treatment of mild cases, and
infection control requirements, including quarantining/isolation of
exposed/infected workforce could also stress the healthcare system.
These stresses likely will be in addition to the ongoing Delta variant
infections and a rising burden of illness caused by other respiratory
pathogens, such as influenza, which have begun circulating at greater
frequencies.
CDC is working hard with domestic and international partners to
better understand how easily Omicron might be transmitted and the
effectiveness of currently authorized, cleared, or approved medical
countermeasures, such as vaccines and therapeutics, against this
variant. In addition, we are working, together with FDA, to ensure that
diagnostic tests and variant genomic sequencing accurately measure the
spread of Omicron. We continue to monitor and evaluate vaccine
effectiveness data from the U.S. Initial data from international
partners suggest vaccine effectiveness against infection is
significantly reduced; those data also suggest that a booster does
provide increased protection against infection, and importantly further
decreases the risk of severe disease, including hospitalization, and
death from COVID-19. CDC continues to strongly encourage COVID-19
vaccination for everyone 5 years of age and older and boosters for
everyone 12 years of age and older. In January 2022, CDC updated its
recommendation for when many people can receive a booster shot,
shortening the interval from 6 months to 5 months for people who
received a Pfizer-BioNTech or Moderna COVID-19 vaccines as their
primary series. In addition, CDC recommended that moderately or
severely immunocompromised 11-year-olds receive an additional primary
dose of vaccine 28 days after their second shot. Scientists are also
working to determine how well existing treatments for COVID-19 work for
Omicron infections. Based on the changed genetic make-up of Omicron,
some treatments are likely to remain effective, while others may be
less effective.
With the growing number of COVID-19 cases from the Omicron variant,
and consistent with current understanding of the disease trajectory, on
December 23, 2021, CDC released updated guidance for isolation and
quarantine for healthcare workers, decreasing their isolation time
after infection with COVID-19. Healthcare workers with COVID-19 who are
asymptomatic and not immunocompromised can return to work after 7 days
with a negative test. If health care personnel test positive at day 5-
7, they can return to work 10 days after their initial test, as long as
symptoms have improved and at least 24 hours have passed since last
fever without the use of fever-reducing medications. Additionally, CDC
released an update to guidance for contingency and crisis management in
the setting of significant healthcare worker shortages. Healthcare
workers who have received all recommended COVID-19 vaccine doses,
including a booster, do not need to quarantine at home following high-
risk exposures, as long as they remain fully compliant with masking
requirements. These updates provide healthcare facilities with the
strategies to limit the effects of staff shortages caused by COVID-19
on patient care.
On December 27, 2021, CDC updated and shortened the recommended
isolation and quarantine time for the general population. It is
important to note that this guidance does not supersede the guidance
for health care workers or guidance from state or local public health
jurisdictions. CDC shortened the recommended time for isolation from 10
days for people with COVID-19 to 5 days, if asymptomatic or improved
and fever-free for at least 24 hours, followed by 5 additional days of
wearing a well-fitting mask both at home and in public when around
others. The change is motivated by science demonstrating that the
majority of SARS-CoV-2 transmission occurs early in the course of
illness, generally in the 1-2 days prior to onset of symptoms and the
2-3 days after. Additionally, CDC changed the recommended quarantine
period for those exposed to COVID-19. For people who are unvaccinated
or are more than 5 months out from their second mRNA dose (or more than
2 months after the J&J vaccine) and not yet boosted, CDC now recommends
quarantine for 5 days followed by strict mask use for an additional 5
days. Alternatively, if a 5-day quarantine is not feasible, it is
imperative that an exposed person properly wear a well-fitting mask at
all times when around others for 10 days after exposure. Individuals
who have received their booster shot do not need to quarantine
following an exposure, but should properly wear a mask for 10 days
after the exposure. For all those exposed, best practice would also
include either an antigen test or nucleic acid amplification test
(NAAT) for SARS-CoV-2 at day 5 after exposure. If symptoms occur,
individuals should immediately quarantine until a negative test
confirms symptoms are not attributable to COVID-19.
On January 6, 2022, CDC reduced isolation and quarantine periods in
school settings to align with current CDC recommendations for isolation
and quarantine. CDC recommends that students, teachers, and staff who
are asked to quarantine, including those who are not fully up to date
on recommended vaccinations, should not go to school or school events
in-person during their quarantine period unless they are participating
in a school sponsored ``test-to-stay'' program.
Schools may consider Test to Stay as an option for keeping
asymptomatic school-associated close contacts in the classroom as an
alternative to traditional quarantine at home. This includes people who
are a school-associated close contact, are not up to date on
recommended vaccinations, do not test positive for SARS-CoV-2, and have
no symptoms. Test to Stay combines contact tracing and serial testing
that is repeated at least twice during the 5-to-7-day period post-
exposure to allow asymptomatic school-associated close contacts who are
not up to date on recommended vaccinations and do not test positive to
continue in-person learning. Outside of the school setting, quarantine
recommendations would still apply.
New data about the virologic, epidemiologic, and clinical
characteristics of the Omicron variant are rapidly emerging. CDC will
continue to actively monitor for and respond to this variant, and we
will continue to work diligently with state, local, and global public
health officials, and industry partners to learn more, monitor the
spread of Omicron, and inform the public.
Testing
On December 2, the White House announced new steps to ensure that
Americans have access to no-cost self-testing. CDC is working on
multiple fronts to expand access to testing, in support of this aim.
CDC has awarded approximately $30 billion to public health departments
to support activities, including testing, through the Epidemiology and
Laboratory Capacity cooperative agreement. For schools, CDC has
provided $10 billion to states to support COVID-19 screening testing
(i.e., testing of asymptomatic persons in order to identify unknown
cases of the disease and avoid further transmission) for teachers,
staff, and students to assist schools in staying safely open for in-
person instruction. More than 23.5 million tests were conducted in
schools between April 2021 and November 2021.
CDC also supports Operation Expanded Testing, which provides no-
cost screening testing for schools, underserved populations, child care
settings, and congregate settings. The program is available to all
states and territories and can be tailored to each site's testing
needs. Three federally funded contractors (coordination hubs) provide
testing materials, supplies, and results reporting at no direct cost to
recipients through a hub and spoke model.
The Increased Community Access to Testing (ICATT) program is
another testing initiative jointly managed by CDC and other agencies
with three primary objectives: working with pharmacies to ensure
equitable access to COVID-19 diagnostics, establishing surge testing
sites to provide infection control to populations at elevated risk for
SARS-CoV-2 transmission, and establishing community testing sites to
increase access to COVID-19 testing in under--resourced communities. In
October 2021, ICATT reached its goal of establishing 10,000 community
testing sites and plans to double that number in 2022 to 20,000 sites.
At the community level, CDC is supporting the HHS Office of the
Assistant Secretary for Preparedness and Response (ASPR) and other
agencies with the distribution of tests to Community Health Centers,
food banks, and rural clinics that receive grants from the Health
Resources and Services Administration (HRSA). Support includes the
provision of updated self-testing guidance and materials to accompany
test distribution to ensure the public is educated about the use of
these tests and how to handle positive results. These materials are
publicly available on CDC's website.
Together, these actions will help Americans access the tests they
need to help them stop the spread of COVID-19.
Genomic Sequencing and Surveillance
Viruses are constantly changing, and this includes SARS-CoV-2.
Currently, the only way to definitively determine if an infection was
caused by Omicron is by genomic sequencing. Genomic sequencing allows
scientists to identify and monitor how SARS-CoV-2 changes over time,
understand how these changes affect the characteristics of the virus,
and use this information to better evaluate how it might impact health.
Building on years of investments, CDC has intensified efforts to
vastly expand genomic sequencing capacity at both the Federal and state
levels over the past year. In addition to direct support to public
health laboratories, CDC provides support to academic institutions to
conduct genomic surveillance research in collaboration with public
health agencies and augments sequencing capacity through contracts with
commercial diagnostic laboratories to support the national genomic
surveillance system. Collectively, CDC's national genomic surveillance
efforts can reliably detect very low levels of variants, even variants
that account for as little as 0.1 percent of all COVID-19 cases,
circulating in the U.S. with high confidence.
The CDC Advanced Molecular Detection program established the SARS-
CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and
Surveillance (SPHERES) to coordinate SARS-CoV-2 sequencing. The SPHERES
collaboration includes scientists from clinical and public health
laboratories, academic institutions, and the private sector. The
SPHERES consortium is led by CDC's Advanced Molecular Detection (AMD)
program, which over the past 6 years has invested in Federal, state,
and local public health laboratories to expand the use of pathogen
genomics and other advanced laboratory technologies to strengthen
infectious disease surveillance and outbreak response.
On November 28, 2021, in partnership with U.S. public health
laboratories and the Association of Public Health Laboratories, CDC
rapidly activated enhanced surveillance for specimens with specific
characteristics indicating a possible case of Omicron. The agency
requested that public health laboratories send these specimens to CDC
as quickly as possible to accelerate the confirmation of Omicron cases
and to enable subsequent virological characterization. This led to the
rapid identification of the first cases of Omicron in the U.S. CDC
began detecting Omicron through its routine baseline genomic
surveillance on December 5, 2021. CDC and other Federal agencies
continue to work with international partners to learn more about
variants circulating globally and will continue to monitor all data
sources closely to identify cases of Omicron in the U.S.
The rapid detection of Omicron in the U.S. reflects the work that
CDC and partners have done over the course of the pandemic to build
local capacity, enhance communication and information exchange, and
advance new technologies. CDC continues to accelerate this work, as it
is essential to the Nation's ability to rapidly detect and respond to
emerging threats.
Travel Screening
As of December 6, 2021, all air travelers, regardless of
citizenship or vaccination status, are required to show a negative pre-
departure COVID-19 viral test administered no more than 1 day before
travel, or documentation of having recovered from COVID-19 in the past
90 days, before they board their flight to the U.S. CDC continues to
recommend that all travelers get a COVID-19 viral test 3-5 days after
arrival, and that unvaccinated travelers quarantine for 5 days after
travel. CDC's December 2021 amended air travel order strengthens
already robust protocols in place for international travel, including
requirements for most foreign travelers to be fully vaccinated before
travel to the U.S.
This new 1-day testing requirement will help to protect travelers
and the health and safety of American communities from COVID-19. In
light of concerns and unknowns regarding Omicron, these measures will
bring an additional layer of public health security and give us time to
ramp up surveillance, continue our messaging about the need for
vaccination and boosters, encourage non-pharmaceutical interventions
like mask-wearing and distancing, and continue to learn more about this
emerging variant and its capabilities. Both the U.S. Government and the
airline industry are committed to making this process as seamless as
possible for the traveling public.
In addition, CDC is collaborating with commercial partners on SARS-
CoV-2 surveillance programs that involve voluntary testing of arriving
international travelers at some of the busiest airports in the U.S.
Arriving international air travelers are offered pooled testing
conducted in the airport and offered at-home kits to be used 3-5 days
after arrival. Participants and their respective health departments are
notified of positive test results. Some positive samples are sequenced,
enabling detection of novel SARS-CoV-2 variants among travelers
entering the U.S.
Vaccination Efforts
The recent emergence of the Omicron variant further emphasizes the
importance of vaccination, boosters, and prevention efforts needed to
protect against COVID-19. As of January 6, 2022, nearly66.3 percent of
the U.S. population over the age of 5 have completed a primary
vaccination series, and approximately 35.3 percent of the eligible
population has received their booster dose, indicating there is still
more work to be done. Even as we learn more about the Omicron variant,
vaccination remains the best public health measure to protect from
disease, slow the spread of SARS-CoV-2, and reduce the likelihood of
new variants emerging. Scientists are currently investigating Omicron,
including how well vaccinated people will be protected against
infection, hospitalization, and death. CDC recommends that everyone 5
years and older protect themselves from COVID-19 by getting vaccinated.
On November 29, CDC strengthened its recommendation on booster
doses for individuals who are 18 years and older. Data from clinical
trials showed that a booster shot increased immune response in trial
participants. With an increased immune response, people have improved
protection against COVID-19. For the Pfizer-BioNTech and J&J/Janssen
vaccines, clinical trials also showed that a booster shot helped
prevent symptomatic COVID-19. CDC recommends that everyone ages 12
years and older should get a booster shot 5 months after vaccination
with an initial Pfizer-BioNTech or Moderna series, or 2 months after
the J&J/Janssen vaccine. CDC recommends clinical preference for
individuals to receive an mRNA COVID-19 vaccine over Johnson &
Johnson's COVID-19 vaccine for primary and booster vaccination due to
risk of rare, but serious adverse events. In addition, CDC recommends
that moderately or severely immunocompromised 5 years of age and older
receive an additional primary dose of vaccine 28 days after their
second shot.
Global Efforts
CDC works closely with public health authorities around the world,
including Ministries of Health. CDC also supports critical multilateral
partners, including WHO, Africa CDC and UNICEF. CDC's support to other
nations includes a range of activities to strengthen capacity to
prevent, detect, and respond to local COVID-19 cases. These efforts
help provide timelier and more accurate data to inform public health
decisionmaking, strengthen the public health workforce globally,
mitigate COVID-19 transmission across borders, and minimize disruptions
to essential health services. CDC's international collaborations and
support for special investigations contribute to the scientific
understanding of COVID-19 and address crucial unknowns regarding
clinical severity, extent and pathways of transmission, and infection.
In addition, CDC is working with global partners and over 50 low-
and middle-income countries to support planning, implementation, and
evaluation of COVID-19 vaccination programs, including vaccine safety
programs. We are currently developing plans to extend additional
support to countries that are unable to effectively manage and
distribute donated vaccines. CDC is also supporting countries'
development of timely, high-quality data on vaccine delivery and safety
and providing technical assistance and personnel to Gavi, COVAX, and
WHO to assist with the development and implementation of strategies to
distribute vaccines and implement vaccine programs.
Of particular importance related to detection of and response to
the Omicron variant and in addition to ongoing efforts, CDC is building
on a strong foundation of decades of work to augment laboratory
capacity in partnership with ministries of health around the world. CDC
also has participated in partnerships to develop sequencing capacity in
southern Africa.
Conclusion
Although we are still learning about Omicron, we have been fighting
COVID-19 for the last 2 years, and we know what people can do to
protect themselves. Until we know more about the risks of Omicron, it
is especially important to use all tools we have available to protect
ourselves and our communities. If you are not yet vaccinated now is the
time. If you are eligible, please get your booster. In areas of high
and substantial transmission, regardless of vaccination status, wear a
mask in indoor public places. Remember, where possible, to stay 6 feet
away from people and avoid crowds and poorly ventilated areas. If you
are experiencing symptoms or have been exposed to someone with COVID-
19, get tested and stay home.
Last, we also must continue to focus on how we can better prepare
for the future. Recent investments in public health have increased
surveillance and sequencing capabilities that have proven effective to
quickly identify Omicron here and around the world. We must make
investments now to make sure we maintain and address the long-standing
vulnerabilities in our public health system. I am committed to working
with Congress to find common ground to support our public health system
and make meaningful strides toward achieving health security for all
Americans now and into the future.
______
The Chair. Thank you.
Dr. Fauci.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, BETHESDA, MD
Dr. Fauci. Madam Chair, Ranking Member Burr, Members of the
Committee, thank you for giving me the opportunity to discuss
with you the role of the National Institute of Allergy and
Infectious Diseases in the conduct and support of research
addressing our Nation's response to COVID-19. In our most
recent hearing before this Committee on November the 4th, I
discussed the importance of booster shots to enhance immunity
against the Delta variant that wanes over time.
Indeed, booster shots have dramatically reconstituted the
waning immunity and has increased protection over and above the
original level afforded by the primary vaccine regimen. Today
we are faced with a different challenge, a new variant called
Omicron that has rapidly spread throughout the world, including
a massive, unprecedented surge in the United States.
This variant possesses a large number of mutations that are
associated with an increased efficiency of transmission, immune
evasion from certain monoclonal antibodies, convalescent
plasma, and antibodies induced by our current vaccines. Thus
far, data from our own laboratories at NIAID, as well as from
laboratories throughout the world, have indicated that vaccine
induced antibodies lose a considerable amount of potency in
neutralizing the Omicron variant.
Although this is of obvious concern, the encouraging news
is that a third shot boost of an mRNA vaccine significantly
reconstitutes and enhances the ability of antibodies from
boosted individuals to neutralize the Omicron variant, strongly
suggesting that boosters will play a major role in protecting
our population, at least from severe disease, in the context of
the ongoing massive surge of the Omicron variant that we are
currently experiencing, underscoring why it is so important for
the unvaccinated to get vaccinated and for those who are
already vaccinated to obtain the booster shot.
Therapies in general are an important part of our
armamentarium against COVID. In this regard, the NIH has been
heavily involved in the development and, or clinical testing of
several effective monoclonal antibodies against SARS-CoV-2.
However, we have ascertained that certain of the authorized
monoclonal antibodies are negatively impacted by the Omicron
variant. Direct antiviral therapies also are an extremely
important tool in the fight against COVID-19.
Importantly, it appears that the mutations expressed by the
Omicron variant do not interfere with the oral antiviral drugs
Paxlovid and Molnupiravir that NIH funded investigators played
an early role in developing and that have recently received
emergency use authorization from the FDA. Nor do they appear to
interfere with the FDA fully approved drug remdesivir shown by
NIH sponsored studies to be highly effective in preventing
severe disease.
Looking ahead in the context of the inevitable continual
emergence of new variants, the importance of developing a pan-
coronavirus vaccine, namely one that would be effective against
all SARS-CoV-2 variants and ultimately against all
coronaviruses, becomes even more apparent. My colleagues and I
recently published a paper in the New England Journal of
Medicine emphasizing the urgent need for such an effort. In
this regard, we have made significant progress in that
direction.
We have identified antibodies that neutralize multiple
different coronaviruses, and in addition, NIAID has issued new
awards to fund pan-coronavirus vaccines at four academic
institutions. These awards will fund multidisciplinary,
collaborative teams to conduct research focused on coronavirus
virology, immunology, immunogen design, and innovative vaccine
and adjuvant platforms, as well as technologies to discover,
design, and develop a pan-coronavirus vaccine candidates.
Finally, I would like to close by looking forward to how we
might best enhance our preparedness for what inevitably will be
the emergence of future pandemics. The NIAID will play an
important role in the multibillion dollar all of Government
plan for pandemic preparedness.
Our mission is the rapid development and implementation of
successful countermeasures against several prototype pathogen
families of viruses that threaten the health and safety, not
only of our Nation, but of the entire world. Thank you for your
attention, and I would be happy to answer your questions
following the presentations.
[The prepared statement of Dr. Fauci follows:]
prepared statement of anthony fauci
Madam Chair, Ranking Member Burr, and Members of the Committee:
Thank you for the opportunity to discuss the role of the National
Institute of Allergy and Infectious Diseases (NIAID) in the research
response to coronavirus disease 2019 (COVID-19) and its etiologic
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Within the Department of Health and Human Services (HHS) and the
National Institutes of Health (NIH), NIAID is responsible for
conducting and supporting basic and clinical research on emerging and
re-emerging infectious diseases, including COVID-19. As the Director of
NIAID and the Chief Medical Advisor to the President, I am pleased to
discuss NIAID's research addressing this once-in-a-lifetime global
infectious disease pandemic.
The public health response to COVID-19 has required an
unprecedented global public-private research effort. NIAID has played a
central and important role in this response. NIAID capitalized on
decades of fundamental basic research, including groundbreaking
structure-based vaccine design at the NIAID Vaccine Research Center
(VRC), to facilitate the rapid development of COVID-19 vaccines. NIAID
also initiated clinical trials with creative and adaptive designs,
allowing the evaluation of the safety and efficacy of multiple new and
existing therapeutics for the treatment of COVID-19, which has helped
support authorization of some of these products by the U.S. Food and
Drug Administration (FDA). In addition, NIAID has engaged domestic and
international clinical research infrastructure and leveraged highly
productive partnerships in the public and private sectors to support
multiple COVID-19 vaccine candidates to progress in record time from
concept to Emergency Use Authorization (EUA) by FDA. Use of these
vaccines throughout the world will continue to play a critical role in
reducing the threat of COVID-19 in the United States and globally.
One of the most concerning developments of the ongoing pandemic has
been the spread of SARS-CoV-2 variants, including the newly described
Omicron variant. The Omicron variant is highly transmissible and is now
the predominant variant in much of the United States. Early data
suggest that the severity of disease caused by infection with the
Omicron variant is lower compared to previous variants. However, the
increased transmissibility of Omicron and the large number of new
infections may lead to substantial numbers of hospitalizations and
deaths, particularly among unvaccinated individuals at highest risk.
The emergence of the Omicron variant makes it critical that we continue
to vaccinate as many people as we can, as quickly as possible,
including with booster doses.
The COVID-19 vaccines authorized or approved in the United States
appear to remain effective against severe disease for most individuals,
despite data showing waning of vaccine-and infection-induced immunity.
While antibodies generated by the primary COVID-19 vaccine series do
not neutralize the Omicron variant as well as prior variants,
laboratory studies show that booster doses of COVID-19 vaccines induce
high levels of antibodies against the Omicron variant. Early clinical
data also show that booster doses of vaccines restore levels of
immunity such that people are, at least initially, well-protected
against the Omicron variant, particularly against severe disease.
Further research to assess immune protection against Omicron is
underway, including studies of the durability of protection offered by
COVID-19 vaccination and boosters. NIAID efforts to enhance the
protection afforded by COVID-19 vaccines and understand the effects of
SARS-CoV-2 variants on immunity will help to address the Omicron
variant and any future variants that may emerge.
Responding to Emerging Variants of SARS-CoV-2
NIH, including NIAID, participates in the HHS-established SARS-CoV-
2 Interagency Group, along with the Centers for Disease Control and
Prevention (CDC), FDA, Biomedical Advanced Research and Development
Authority (BARDA), Department of Defense (DOD), and U.S. Department of
Agriculture to track variants in real time and address the potential
impact of emerging variants on critical SARS-CoV-2 countermeasures
including vaccines, therapeutics, and diagnostics. Active monitoring of
variants has allowed the U.S. Government to optimally deploy
therapeutics to treat COVID-19 patients. NIH, CDC, and DOD are
assessing the extent to which vaccine-induced immunity or post-
infection immunity prevent infection by variants. NIH, BARDA, and DOD
also are assessing the efficacy of authorized and candidate
therapeutics against emerging variants in cell lines and animal models.
NIAID and our collaborators have rapidly assessed vaccines,
monoclonal antibodies, and antiviral drugs to assess their
effectiveness against the Omicron variant. Research suggests that
although effectiveness of certain monoclonal antibodies against Omicron
has been markedly diminished, one of the three monoclonal antibodies
authorized for COVID-19 treatment retains its effectiveness against the
Omicron variant. A monoclonal antibody authorized for pre-exposure
prophylaxis (prevention) in high-risk people also retains its
effectiveness. In addition, antiviral drugs used to treat COVID-19
appear to be effective against the Omicron variant.
NIAID also is supporting the development of next-generation
vaccines that could provide protection against emerging SARS-CoV-2
variants by targeting several viral antigens, all of which are highly
conserved among viral strains. On March 25, 2021, NIAID launched a
Phase 1 clinical trial in healthy adults to assess the safety and
immunogenicity of second-generation COVID-19 vaccine candidates
developed by Gritstone Oncology, Inc. Gritstone's COVID-19 vaccine
candidates utilize a strategy aimed at inducing both neutralizing
antibodies and T cell responses to elicit a broad immune response
against conserved viral antigens. NIAID also is conducting early stage
research on pan-coronavirus vaccines designed to provide broad
protective immunity against multiple coronaviruses, especially SARS-
CoV-2 and other viruses with pandemic potential. In 2021, NIAID
announced awards to four academic institutions to conduct research to
develop vaccines to protect against multiple types of coronaviruses and
viral variants.
NIAID, the National Human Genome Research Institute, and the
National Library of Medicine are participating in the SARS-CoV-2
Sequencing for Public Health Emergency Response, Epidemiology, and
Surveillance (SPHERES) initiative. SPHERES is a national genomics
consortium led by CDC that helps to coordinate SARS-CoV-2 sequencing
across the United States. NIAID is working with partners to identify,
monitor, and calculate the frequency of current variations in the SARS-
CoV-2 genome to help predict emerging variants. NIAID also facilitates
the use of cutting-edge modeling and structural biology tools to
understand how variants might affect interactions between the virus and
the immune system or COVID-19 therapeutics. These efforts add to our
knowledge about SARS-CoV-2 variants and our ability to combat them.
Developing Vaccines to Prevent COVID-19
Sustained domestic and international research investments by NIAID
prior to the emergence of SARS-CoV-2 enabled the unprecedented pace of
COVID-19 vaccine development. Two activities in particular predate
successful COVID-19 vaccines: the development of versatile vaccine
platforms and the adaptation of structural biology tools to design
specific proteins (immunogens) that powerfully stimulate the immune
system. Long before the pandemic, NIAID VRC scientists and their
collaborators made the critical scientific discovery of how to
stabilize--in a highly immunogenic form--viral proteins that are
important for infection. These included the spike protein of Middle
East respiratory syndrome coronavirus (MERS-CoV), which was stabilized
using a double mutation known as S2P. This strategy facilitated the
design of vaccine candidates that generate robust immune responses not
only against coronaviruses but also other viruses of public health
importance such as respiratory syncytial virus. As soon as the sequence
of SARS-CoV-2 was made available in January 2020, VRC researchers
rapidly generated a stabilized SARS-CoV-2 spike protein for use in
COVID-19 vaccine development. This crucial breakthrough in structure-
based vaccine design led to the development of safe and effective
COVID-19 vaccine candidates, several now authorized or approved by the
FDA, across a range of vaccine platforms.
Six candidate COVID-19 vaccines have been assessed in completed or
ongoing large-scale Phase 3 clinical trials in the United States.
Clinical trials assessing COVID-19 vaccine candidates in certain
pediatric populations have been completed or are still ongoing. On
August 23, 2021, a candidate vaccine developed by Pfizer and BioNTech
became the first to be approved by the FDA for the prevention of COVID-
19 in individuals 16 years of age and older. The vaccine also is
authorized for emergency use and is available under the EUA as a two-
dose primary series for individuals 5 years of age and older, as a
third primary series dose for individuals 5 years of age and older who
have been determined to have certain kinds of immunocompromise, and as
a single booster dose for individuals 12 years of age and older 5
months after completing a primary series of the Pfizer/BioNTech COVID-
19 vaccine. The Pfizer/BioNTech COVID-19 vaccine also is authorized for
use as a heterologous single booster dose following completion of
primary vaccination with a different available COVID-19 vaccine. The
Pfizer/BioNTech vaccine is one of six COVID-19 vaccine candidates NIAID
has helped advance through support for the fundamental research
underlying the vaccine concepts, as well as for clinical testing. Two
additional vaccine candidates, from Moderna, Inc., and Johnson &
Johnson/Janssen, are available under an FDA EUA.
mRNA-1273 (Moderna)
As part of a longstanding collaboration, the NIAID VRC collaborated
with the biotechnology company Moderna to develop a vaccine candidate
designated mRNA-1273, which uses a messenger RNA (mRNA) vaccine
platform to express the stabilized SARS-CoV-2 spike protein. After
promising results in early clinical trials, NIAID and BARDA began
working with Moderna on a Phase 3 clinical trial. NIAID scientists and
their collaborators published updated results from this trial
indicating that the vaccine had 93.2 percent efficacy in preventing
COVID-19 illness, 98.2 percent efficacy in preventing severe disease,
and 63 percent efficacy in preventing asymptomatic infection.
Importantly, the efficacy of mRNA-1273 in preventing COVID-19 4 months
or more after the second dose was maintained at greater than 90
percent. In addition, in observational studies in ``real-world''
conditions in broader segments of the population, mRNA--based vaccines
continue to display high levels of effectiveness.
FDA has authorized mRNA-1273 for emergency use for prevention of
COVID-19 in individuals 18 years of age and older as a two-dose primary
series, as a third primary series dose for individuals 18 years of age
and older who have been determined to have certain kinds of
immunocompromise, and as a single booster dose in people 18 years of
age and older 5 months after completing a primary series of the
vaccine. mRNA-1273 also is authorized for use as a heterologous single
booster dose for individuals 18 years of age and older following
completion of primary vaccination with a different available COVID
vaccine.
Ad26.COV2.S (Johnson & Johnson/Janssen)
Decades of NIAID support for basic, preclinical, and clinical
research on adenovirus (Ad)-based HIV vaccines underpin the development
by Johnson & Johnson/Janssen of a coronavirus vaccine candidate based
on the Ad26-vector. The vaccine is known as Ad26.COV2.S or JNJ-
78436735. NIAID has supported a Phase 3 clinical trial of Ad26.COV2.S
and has provided immunological testing of the candidate using NIAID-
funded core laboratory infrastructure. As reported in the New England
Journal of Medicine, the one-dose vaccine candidate was 66 percent
efficacious overall at preventing moderate to severe/critical COVID-19
occurring at least 28 days after vaccination and 85 percent efficacious
overall in preventing severe/critical COVID-19 in the Phase 3 trial
across several geographical regions, including areas where viral
variants predominated. In the United States, the efficacy against
moderate to severe/critical disease 28 days after vaccination with
Ad26.COV2.S was 72 percent. FDA has authorized Ad26.COV2.S for
emergency use for prevention of COVID-19 in individuals 18 years of age
and older as a single primary vaccination dose and as a single booster
dose for individuals 18 years of age and older 2 months after
completing primary vaccination with the vaccine.
Ensuring Protection with COVID-19 Vaccine Boosters
FDA-authorized and FDA-approved COVID-19 vaccines have maintained
remarkable effectiveness in preventing severe COVID-19. However,
protection against mild and moderate disease begins to decrease over
time following the primary vaccine series; this effect is seen with
both the Delta and Omicron variants circulating in the United States.
As noted, the Omicron variant appears to be more transmissible than
previous variants and more apt to evade immunity. Individuals who
receive a booster dose of a COVID-19 vaccine have markedly higher
levels of antibodies against SARS-CoV-2 variants compared to levels in
individuals who received just the primary regimen, and early clinical
data still being evaluated suggest these boosted individuals are, at
least initially, well-protected against the current Delta and Omicron
variants, particularly against severe disease.
FDA amended the EUAs for the Moderna and Johnson & Johnson/Janssen
COVID-19 vaccines, respectively, to allow for use of a single booster
dose for individuals 18 years of age and older. FDA also amended the
EUA for the Pfizer/BioNTech COVID-19 vaccine to allow for the use of a
single booster dose for individuals 12 years of age and older. CDC
recommends receiving a booster dose of the COVID-19 vaccine at least 5
after completion of the primary series of the Pfizer/BioNTech and
Moderna COVID-19 vaccines, and at least 2 months after completion of
the single-dose primary regimen of the Johnson & Johnson/Janssen COVID-
19 vaccine.
NIAID has initiated several studies to specifically address the
Omicron variant and has several more in planning stages. For example,
NIAID is testing the impact of a higher dose of the Moderna vaccine as
a booster. In addition, the NIAID VRC is conducting preclinical testing
of an Omicron-specific booster candidate (mRNA-1273.529) and of mixed
(bivalent) booster candidates (mRNA-1273 plus a Beta variant-specific
booster) against the Omicron variant. NIAID also plans to examine
whether individuals who received boosters--either mRNA-1273 or
investigational COVID-19 vaccine boosters designed to incorporate
mutations found in emerging variants--generate antibodies that can bind
to and neutralize the Omicron variant.
NIAID is leading a study in fully vaccinated individuals to assess
the safety and immune responses following boosting with a COVID-19
vaccine different than the one used for the initial vaccination (``mix
and match''). This trial includes a booster candidate (mRNA-1273.211)
that incorporates several mutations that are present in the Omicron
variant. NIAID released early data from this trial demonstrating that
administering the Pfizer, Moderna, or Johnson & Johnson/Janssen COVID-
19 vaccines at least 12 weeks after individuals received a different
vaccine regimen effectively enhanced the immune response to SARS-CoV-2.
Additionally, no safety concerns were identified. The results of this
trial were made available to FDA during FDA's decisionmaking process to
authorize the use of heterologous, or ``mix and match,'' booster dosing
in eligible individuals following completion of primary vaccination
with a different available COVID-19 vaccine for persons 18 years of age
and older.
NIAID is supporting additional preclinical and clinical research to
assess the durability of immunity induced by COVID-19 vaccines, as well
as the effect of COVID-19 vaccine boosters.
On April 23, 2021, NIAID launched an observational study at the NIH
Clinical Center assessing how people with immune system deficiencies or
dysregulations respond to COVID-19 vaccination. NIAID investigators
also will gather information about COVID-19 illness in these
individuals. This study will inform decisionmaking about COVID-19
vaccination in people with immune deficiencies and dysregulation
conditions. In August 2021, NIAID launched multiple additional studies
to assess and enhance the immune response to COVID-19 vaccines in
immunocompromised individuals with autoimmune diseases as well as solid
organ transplant recipients. This effort features a study with a
multicenter, adaptive design to assess the immune responses to an
additional dose of the COVID-19 vaccine in immunocompromised
individuals. Data from this research will inform future considerations
of additional doses of COVID-19 vaccines for these populations. CDC has
made a recommendation, after review of the available scientific data,
that people with moderately to severely compromised immune systems
receive an additional dose of mRNA COVID-19 vaccine at least 28 days
after a second dose of Pfizer/BioNTech COVID-19 vaccine or Moderna
COVID-19 vaccine.
Clinical Trials of COVID-19 Vaccine Candidates in Special Populations
To effectively end the COVID-19 pandemic, it will be important to
vaccinate as many people as possible, including those in special
populations, such as pregnant and lactating women and children. Many
pregnant and lactating women already have received the available COVID-
19 vaccines. Data from these individuals demonstrate no safety concerns
for pregnant women or their babies. In addition, protective antibodies
against SARS-CoV-2 have been detected in babies born to pregnant women
who received mRNA COVID-19 vaccines. On June 23, 2021, NIAID launched
an observational study, MOMI-VAX, to evaluate the immune responses
generated by COVID-19 vaccines administered to individuals during
pregnancy or up to 2 months postpartum. The study also will assess
vaccine safety and evaluate the transfer of vaccine-induced antibodies
to infants across the placenta and through breast milk.
Efforts to evaluate COVID-19 vaccines in pediatric and other
special populations are ongoing. This includes KidCOVE, a Phase 2/3
study launched by Moderna, in collaboration with NIAID and BARDA, to
evaluate the safety and efficacy of mRNA-1273 in children ages 6 months
to less than 12 years. This study is in addition to Moderna's ongoing
TeenCOVE study of mRNA-1273 in adolescents between the ages of 12 and
17. Pfizer also is evaluating their vaccine candidate in children
younger than age 5, including a three-dose primary series. Other
vaccine developers have begun, or are planning to begin, trials to test
their vaccine candidates in children, adolescents, and other special
populations.
Other COVID-19 Vaccine Candidates
NIAID also is supporting Phase 3 clinical trials of COVID-19
vaccine candidates from AstraZeneca (AZD1222) and Novavax (NVX-
CoV2373). FDA has not yet authorized either of these vaccine candidates
for emergency use.
Understanding the Nature of Immunity to SARS-CoV-2
NIAID is conducting and supporting research to enhance our
knowledge of immunity against SARS-CoV-2 and to identify components of
the immune response that provide protection against COVID-19. NIAID
also is examining the quality and durability of the immune response to
SARS-CoV-2, generating information that may be leveraged to develop
novel SARS-CoV-2 therapeutics or vaccines and inform public health
measures.
Data on infection-induced immunity from natural infection with
SARS-CoV-2, including studies by NIAID scientists and NIAID-supported
researchers, clearly demonstrate that most individuals generate a
protective immune response to COVID-19 after infection. However,
uncertainty surrounds several variables that can affect the generation
of a protective immune response to SARS-CoV-2 following either
infection or vaccination. Variables affecting the immune response
include the age of the individual; their immune status; the medical
treatments they have received; the impact of SARS-CoV-2 variants; and
the impact of the severity of initial infection and time since
infection, if applicable. Given that COVID-19 vaccination after
infection with SARS-CoV-2 is safe and markedly enhances immune
responses, COVID-19 vaccination is recommended for eligible individuals
regardless of history of symptomatic or asymptomatic SARS-CoV-2
infection. NIAID continues to support research to understand immune
responses to SARS-CoV-2 infection and/or COVID-19 vaccination,
including projects investigating the durability of immune responses;
whether immunity differs in certain populations; and how SARS-CoV-2
variants may affect immunity.
NIAID also is supporting research to improve understanding of the
role of T cells in protection against COVID-19 and COVID-19 disease
progression. NIAID supported a collaborative longitudinal study by
researchers at Emory University and the Fred Hutchinson Cancer Research
Center that demonstrated that SARS-CoV-2-specific T cells were
detectable for up to 8 months in patients after mild to moderate COVID-
19. NIAID also supported two separate studies examining T cell
responses in recovered COVID-19 patients and individuals vaccinated
against COVID-19. They found robust immune responses to the original
strain as well as multiple variants of SARS-CoV-2 in both groups.
Additional work by NIAID researchers and grantees showed that most
individuals with existing T cell responses against SARS-CoV-2 should
generate a T cell response against the Omicron variant, and that SARS-
CoV-2 has thus far not evolved extensive T cell escape mutations. Other
work from NIAID-supported investigators has shown that vaccine-induced
T cell responses recognize the Omicron variant. In another NIH-
supported study, researchers uncovered features of T cells that
distinguish fatal from non-fatal cases of severe COVID-19, which could
lead to new treatments for this disease. However, it is important to
note that although we are learning important information about T cell
responses in SARS-CoV-2 infected and vaccinated individuals, we still
do not know the extent to which T cell responses mediate protection
against COVID-19.
To help prepare for future pandemic threats, the NIAID VRC has
established the Pandemic Response Repository through Microbial/Immune
Surveillance and Epidemiology (PREMISE) program. The program will use
data from the measurement of T and B cell immune responses to inform
the discovery and development of diagnostic, prophylactic, and
therapeutic countermeasures and accelerate the global response to
pandemic threats. NIAID anticipates the research conducted by PREMISE
will advance our knowledge of immune response to vaccination and
infection and help inform the response to future pandemic threats.
Identifying Therapeutics to Treat COVID-19
Safe and effective therapeutics are urgently needed to treat
patients with COVID-19. NIAID has worked quickly from the earliest days
of the pandemic to evaluate promising therapeutics for COVID-19 in
rigorous, randomized, controlled clinical trials. COVID-19 therapeutics
that inhibit essential viral processes or address the host response to
COVID-19 are expected to maintain their effectiveness against emerging
variants, such as the Omicron variant. As noted above, some monoclonal
antibodies appear to be ineffective against Omicron, while others
maintain their activity. NIAID is conducting and supporting additional
research to determine how Omicron and other variants impact the
effectiveness of monoclonal antibodies and other therapeutics as well
as working to develop new drugs.
The Adaptive COVID-19 Treatment Trial
Early in the outbreak, NIAID launched a multicenter, randomized
placebo-controlled clinical trial, the Adaptive COVID-19 Treatment
Trial (ACTT), to evaluate the safety and efficacy of multiple
investigational therapeutics for COVID-19. ACTT-1 examined the
antiviral drug remdesivir for treatment of severe COVID-19 in
hospitalized adults. Based on positive data from ACTT-1, the FDA
approved the use of remdesivir for treatment in adults and children 12
years of age and older and weighing at least 40 kg hospitalized due to
COVID-19. ACTT-2 evaluated the anti-inflammatory drug baricitinib in
combination with remdesivir, and based on favorable data from ACTT-2,
the FDA issued an EUA for the use of baricitinib in combination with
remdesivir for treatment of adults and children older than 2 years
hospitalized with COVID-19 and requiring supplemental oxygen, invasive
mechanical ventilation, or extracorporeal membrane oxygenation. The FDA
subsequently revised the EUA for baricitinib to remove the requirement
that baricitinib be administered in combination with remdesivir. ACTT-3
evaluated the treatment of hospitalized COVID-19 patients with
remdesivir plus interferon beta-1a, which is used to treat individuals
with multiple sclerosis, and found no clinical benefit from the
addition of interferon beta-1a. ACTT-4 assessed baricitinib plus
remdesivir versus the glucocorticoid dexamethasone plus remdesivir in
adults hospitalized with COVID-19 and requiring oxygen, showing that
these two regimens led to similar outcomes.
The ACTIV Public-Private Partnership
NIAID, in collaboration with other NIH Institutes, also launched
two clinical trials as part of the ACTIV partnership, which utilizes
master protocols allowing the addition of other investigational
therapeutics as the trials continue. ACTIV-2 and ACTIV-3 initially
evaluated the use of the monoclonal antibody bamlanivimab to treat
COVID-19 in outpatient and inpatient settings, respectively. ACTIV-2,
which is focused on outpatients, has been expanded and is currently
evaluating two investigational therapeutics: SAB-185, a fully human
polyclonal antibody produced in cattle, and SNG001, an inhalable beta
interferon. After completing the Phase 2 portion of the ACTIV-2 trial,
AstraZeneca is independently pursuing a Phase 3 trial of their
investigational long-acting monoclonal antibody combination, AZD7442.
Brii Biosciences announced a rolling EUA submission for their
combination monoclonal antibody therapy, BRII-196 plus BRII-198, based
on promising results from ACTIV-2 for the treatment of COVID-19. Among
patients at high risk of clinical progression, those receiving BRII-196
plus BRII-198 had 178 percent decreased risk in hospitalization and
death. On September 24, 2021, SAB Biotherapeutics announced the
graduation of SAB-185 into Phase 3 efficacy studies in ACTIV-2.
ACTIV-3 currently is evaluating the AZD7442 monoclonal antibody
combination and PF-07304814, a protease inhibitor, in hospitalized
patients. PF-07304814 inhibits a critical part of the replication
process of SARS-CoV-2. On April 22, 2021, NIAID and the National Heart,
Lung, and Blood Institute (NHLBI) launched a new trial, known as ACTIV-
3 Critical Care, to test Zyesami and remdesivir (alone and in
combination), for their safety and efficacy in hospitalized COVID-19
patients who are experiencing acute respiratory distress syndrome, a
life-threatening condition. Zyesami is a synthetic version of
vasoactive intestinal peptide, which is made naturally in the human
body and appears to have lung-protective antiviral and anti-
inflammatory effects.
Three monoclonal antibody therapies currently have FDA EUAs for the
treatment of COVID-19 in outpatients. Due to concerns of variant
resistance to monoclonal antibody therapies, the FDA now includes
information on the susceptibility of SARS-CoV-2 variants to various
monoclonal antibodies in its fact sheets for health care providers.
NIAID-supported scientists and collaborators are evaluating the
potential impact of emerging SARS-CoV-2 variants on the efficacy of
monoclonal antibodies. NIAID and BARDA have shared their expertise with
FDA as FDA has modified EUAs for monoclonal therapies regarding the
testing of these products against variants and the conduct of
independent assessments of potency against variants as they emerge.
Additional NIAID-supported Therapeutics Activities
NIAID also launched the ACTIV-5/Big Effect Trial (BET), which is
designed to streamline the identification of experimental COVID-19
therapeutics that demonstrate the most promise. BET, an adaptive Phase
2 clinical trial, compares different investigational therapeutics to a
common control arm to identify treatments with relatively large effects
as promising candidates for further study in large-scale trials. BET
initially evaluated two therapeutics: risankizumab, an immunomodulatory
monoclonal antibody developed by Boehringer Ingelheim and AbbVie that
is FDA-approved for the treatment of severe plaque psoriasis; and
lenzilumab, an investigational immunomodulatory monoclonal antibody
developed by Humanigen. Recently, a third therapeutic was added:
danicopan, an oral drug that inhibits a key inflammatory pathway and
was originally designed to treat a rare but serious disorder called
Paroxysmal Nocturnal Hemoglobinuria.
NIAID, in collaboration with the DOD Defense Threat Reduction
Agency, supported basic research and product development for the oral
antiviral drug molnupiravir. Merck and Ridgeback Biotherapeutics
announced clinical data from their Phase 3 trial which showed that
molnupiravir reduced the risk of hospitalization or death by
approximately 30 percent in at risk, non-hospitalized adult patients
with mild-to-moderate COVID-19. In December 2021, FDA authorized the
use of molnupiravir for the treatment of mild-to-moderate COVID-19 in
adults who are at high risk for progression to severe COVID-19 and for
whom alternative COVID-19 treatment options authorized by the FDA are
not accessible or clinically appropriate. NIAID also provided support
for the development of Paxlovid, an oral antiviral candidate developed
by Pfizer. In a Pfizer-supported Phase 2/3 clinical trial, a course of
Paxlovid given within the first 3 days of symptoms reduced the risk of
COVID-19-related hospitalization or death by 89 percent among non-
hospitalized adults with COVID-19 at high risk of progressing to severe
illness. In December 2021, FDA authorized the use of Paxlovid for the
treatment of mild-to-moderate COVID-19 in adults and pediatric patients
12 years of age and older weighing at least 40 kilograms who are at
risk for progressing to severe COVID-19 and/or hospitalization.
NIH has launched the Antiviral Program for Pandemics, an NIH-BARDA
collaboration that aims to develop safe and effective antivirals to
treat and prevent SARS-CoV-2 infection. The program will build
sustainable platforms for targeted drug discovery and development of
antivirals directly targeting viruses with pandemic potential. As part
of this effort, NIAID will establish Antiviral Drug Discovery Centers
for Pathogens of Pandemic Concern. These multidisciplinary research
centers will create platforms that will target coronaviruses and
additional RNA viruses with pandemic potential, helping to better
prepare the Nation for future viral threats. Oral drug candidates for
broad use in outpatient settings are the primary focus of this effort.
NIH also has established the COVID-19 Treatment Guidelines Panel to
provide recommendations to health care providers regarding specific
COVID-19 treatments based on the best available science. The Guidelines
address considerations for hospitalized and non-hospitalized patients
as well as special populations, including pregnant women and children.
Each Treatment Guidelines section is developed by a working group of
Panel members with expertise in the area addressed in the specific
section; these members conduct systematic, comprehensive reviews of
relevant information and scientific literature. The Panel comprises
representatives of NIH and five other Federal agencies along with
representatives of 11 professional organizations, academic experts, and
treating physicians including providers from high COVID-19 incidence
areas, and community representatives. The Panel meets regularly to
evaluate possible treatment options for COVID-19 and update the
Treatment Guidelines as new clinical evidence emerges.
Understanding the Incidence and Pathogenesis of COVID-19
NIH is supporting studies to understand the incidence of SARS-CoV-2
infection in specific populations, including children, as well as
certain aspects of the clinical course of infection, including
thromboses, strokes, heart attacks, and other sequelae of infection.
NIAID also is working with partners to delineate biological and immune
pathways responsible for the varied manifestations of COVID-19.
Early in the pandemic, the intramural research programs of NIAID,
the National Cancer Institute, the National Center for Advancing
Translational Sciences, and the National Institute of Biomedical
Imaging and Bioengineering partnered to rapidly deploy the SARS-CoV-2
Pandemic Serosurvey. The study investigated whether adults in the
United States without a confirmed history of SARS-CoV-2 infection have
antibodies to the virus, thus indicating prior infection. Findings from
the first time point of this longitudinal study suggest that the
prevalence of COVID-19 may have exceeded the number of cases medically
diagnosed by an additional 16.8 million infections through mid-July
2020. Continued analysis of the 1-year follow-up data from the study
will be important in better understanding mortality rates, prevalence
of immunity, and the impact SARS-CoV-2 has had on various communities
in the United States.
NIAID scientists are participating in leadership of the COVID Human
Genetic Effort, an international consortium of hospitals and genetic
sequencing hubs that aims to discover genetic factors conferring
resistance to SARS-CoV-2 infection or predisposing to severe COVID-19.
The consortium identified a subgroup of patients with severe COVID-19
that have ineffective immune responses to SARS-CoV-2, some of whom have
mutations in key immune pathways.
NIAID also is engaged in efforts to understand the rare, but
extremely serious, multisystem inflammatory syndrome in children (MIS-
C) that has been associated with SARS-CoV-2 infection in children and
adolescents. NIAID supports the Pediatric Research Immune Network on
SARS-CoV-2 and MIS-C (PRISM) to evaluate acute and long-term clinical
and immunological effects of MIS-C and SARS-CoV-2 infection in
children. In addition, NIAID is collaborating with Children's National
Medical Center to follow 1,000 children with a history of SARS-CoV-2
infection, including those with MIS-C, to determine long-term effects
of the illness. NIAID is participating in a trans-NIH effort to
coordinate MIS-C research led by NHLBI and the Eunice Kennedy Shriver
National Institute of Child Health and Human Development. This
centralized effort, the Collaboration to Assess Risk and Identify Long-
term Outcomes for Children with COVID (CARING for Children with COVID),
will permit data to be shared across studies to determine the spectrum
of illness and predict long-term consequences of infection.
Addressing the Long-term Effects of COVID-19
Many people who have had COVID-19 experience continued symptoms or
other sequelae as they transition from the acute to post-acute phases
of the disease, and we continue to learn more about the duration and
manifestations of COVID-19 as we hear from these patients.
NIH has announced the Researching COVID to Enhance Recovery
(RECOVER) Initiative, a trans-NIH effort to address PASC, including
targeted funding for research in this critical area. The NIH RECOVER
Initiative will complement ongoing NIAID studies to better understand
the various post-acute manifestations of COVID-19 in various
populations. On June 10, 2021, NIH announced awards to New York
University (NYU) to build the RECOVER research consortium, harmonize
and coordinate data within the consortium, and develop methods for
monitoring protocols; and to Massachusetts General Hospital to provide
statistical analyses and coordinate data standardization, access, and
sharing among RECOVER projects. On September 15, 2021, NIH announced,
through NHLBI and the National Institute of Neurological Disorders and
Stroke, awards to NYU to develop the RECOVER Cohort with funding from
the American Rescue Plan Act of 2021 (P.L. 117-2). NYU is engaging more
than 100 researchers at more than 30 institutions to build a diverse
national study population and support large-scale studies on the long-
term effects of COVID-19.
NIAID intramural scientists initiated the Longitudinal Study of
COVID-19 Sequelae and Immunity to better understand PASC and determine
the extent to which people who have recovered from acute SARS-CoV-2
infection develop an immune response that provides protection against
reinfection. NIAID-supported investigators also have established the
Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC) to determine
how immunological markers correspond to, or may even predict, the
clinical severity of COVID-19. Since May 1, 2020, IMPACC researchers
have collected detailed clinical data along with blood and respiratory
samples from more than 1,200 hospitalized COVID-19 patients of diverse
race and ethnicity at approximately 20 hospitals nationwide. The cohort
will be followed during hospitalization and up to 1 year after
discharge to assess their functional and immunologic recovery.
Conclusion
NIAID continues to expand efforts to elucidate the biology,
pathogenesis, and clinical manifestations of SARS-CoV-2 infection,
including emerging variants such as Delta and Omicron, and to employ
this knowledge to develop safe and effective interventions to diagnose,
treat, and prevent SARS-CoV-2 infection and COVID-19. NIAID is focused
on developing safe and effective SARS-CoV-2 vaccines and therapeutics
and sensitive, specific, rapid point-of-care molecular diagnostic and
serological tests. NIAID also is conducting early stage research on
candidate vaccines that could protect against multiple strains of
coronaviruses. All these efforts will improve our response to the
current pandemic and bolster our preparedness for the next, inevitable
viral disease outbreak.
______
The Chair. Thank you.
Dr. Woodcock.
STATEMENT OF JANET WOODCOCK, M.D., ACTING COMMISSIONER, UNITED
STATES FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. Woodcock. Good morning, Chair Murray, Ranking Member
Burr, and Members of the Committee. Thank you for the
opportunity to testify. FDA's thousands of employees remain
steadfast in fighting this pandemic.
Our work continued during the holiday season and led to
critical advancements in combating the virus. The agency has
been closely monitoring the potential impact of the Omicron
variant on the currently available vaccines, diagnostics, and
therapeutics. I will provide a brief update and actions the
agency has taken in these three areas since I last testified
before this Committee.
First, regarding vaccines. The currently authorized and
approved vaccines remain highly effective at preventing serious
outcomes associated with COVID-19 infection, including
hospitalization and death. Additionally, data evaluated by the
FDA suggests that an additional booster shot following the
completion of primary vaccination series provides further
protection against these outcomes.
Following these data, FDA updated the Pfizer-BioNTech and
Moderna vaccine EUAs to shorten the time between completion of
a primary series and a booster dose to at least 5 months rather
than 6 months. FDA also updated the Pfizer-BioNTech EUA, so is
now available for a primary series in children 5--ages 5 and
older, and for the use of a booster dose in all individuals 12
through 15 years of age after completion of primary
vaccination, as you have already heard from Dr. Walensky as the
CDC followed up on this.
The agency also authorized the Pfizer vaccine for a third
primary series dose for certain immunocompromised children that
are 5 through 11. These vaccines have met FDA's rigorous
standards, and the bottom line is getting vaccinated or
receiving a booster with one of the currently available
vaccines is the best thing the public can do right now to
protect themselves and those they care about. It is not too
late to get vaccinated or get boosted.
Second, diagnostic tests, which are another key line of
defense in this pandemic. Increasing access to accurate, rapid
at home tests continues to be a priority for FDA. Since I last
testified, the agency has authorized four additional over-the-
counter at home tests, bringing the total number to 15, and the
agency continues to prioritize the review of these type of
tests. We also partnered with the NIH to establish ITAP, which
streamlines validation and authorization of antigen tests with
potential for large scale manufacturing.
We expect shorter review times for such EUA request due to
our partnership with ITAP. In fact, the first two tests that
participated in this program were authorized in 2 days or less
from the time FDA received the final data. So this is a very
good model for Government assistance of diagnostic
manufacturers. In this new program, ITAP will prioritize new
over-the-counter test submissions that could be manufactured at
significant scale to accelerate the availability of high
quality, accurate, and reliable tests for the public as quickly
as possible.
Third, as new variants continue to emerge, it is crucial to
expand the country's arsenals of COVID-19 therapeutics,
especially for those unable to get vaccinated or who can't
respond to vaccination. Since I last testified, three
therapeutics have been authorized for use in the treatment of
COVID-19 for emergency use. The first of these EUAs, Evusheld,
was authorized for the prevention of COVID-19.
The other two therapies, Paxlovid and Molnupiravir, as you
heard from Dr. Fauci, are the first authorized treatments for
COVID-19 in the form of a pill that can be taken orally, which
is a major step in the fight against this global pandemic.
These authorizations provide new tools to combat COVID-19 at a
crucial time, and it should make antiviral therapy more
accessible to people at high risk for progression.
Now, while these are important tools, they are not a
substitute for vaccination and people for whom vaccination is
recommended, and I continue to urge the public to get
vaccinated if eligible. And fourth, we continue our mission of
protecting the public from fraudulent medical products.
Since March, we have refused admission of more than 23,000
lines of FDA regulated products that were trying to get into
the country illegally. And finally, I want to assure the public
the FDA is committed to continue to use every tool in our
toolbox to fight this pandemic with the best available
diagnostics, lifesaving therapeutics, and vaccines.
Thank you, and I look forward to your questions.
[The prepared statement of Dr. Woodcock follows:]
prepared statement of janet woodcock
Introduction
Chair Murray, Ranking Member Burr, distinguished Members of the
Committee, I am Dr. Janet Woodcock, Acting Commissioner of the U.S.
Food and Drug Administration (FDA or the Agency). Thank you for the
opportunity to testify before you today to describe FDA's coronavirus
disease 2019 (COVID-19) response efforts. All of our efforts are in
close coordination and collaboration with our partners, both within the
Department of Health and Human Services (HHS) and across the Federal
Government, to help ensure the development, authorization, licensure,
approval, and availability of critical, safe, and effective medical
products to address the COVID-19 public health emergency.
I want to note that this testimony is just a snapshot of some of
our extensive work and is in the context of efforts across the Agency
to address this pandemic. There are thousands of FDA employees who have
been working on COVID-19 response efforts non-stop since the start of
the pandemic. I want to commend and recognize their efforts and thank
them for their dedication and service. I also want to thank all FDA
employees who have continued to work on the myriad issues the Agency is
responsible for that do not directly involve COVID-19.
From the beginning of this public health emergency, FDA has taken
an active leadership role in the all-of-government response to the
COVID-19 pandemic, inspired by the resiliency of the American people
and our great innovators. FDA stood up an internal cross-agency group
that continues to ensure we are doing everything possible to protect
the American public, help ensure the safety, efficacy, and quality of
FDA-regulated medical products, and provide the industries we regulate
with the guidance and tools to do the same. We continue to focus on
facilitating the development and availability of medical
countermeasures to diagnose, treat, and prevent COVID-19, surveilling
the medical product and food supply chains for potential shortages or
disruptions, and helping to mitigate such impacts, as necessary to
protect the public health.
This includes working to quickly address any potential impacts of
the new omicron variant. FDA is working as quickly as possible to
evaluate the potential impact of this variant on the currently
available diagnostics, therapeutics and vaccines. We are closely
monitoring the situation and are committed to communicating with the
public as we learn more. Just a couple weeks ago we updated the SARS-
CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share new
information on the omicron variant and its impact on antigen diagnostic
tests. FDA is committed to continuing to use every tool in our toolbox
to fight this pandemic, including pivoting as the virus adapts, to arm
ourselves with the best available diagnostics, and life-saving
therapeutics and vaccines to fight this virus.
At this time, the current vaccines remain highly effective at
preventing serious clinical outcomes associated with a COVID-19
infection, including hospitalization and death. Additionally, currently
available data from our international partners and vaccine
manufacturers that has been evaluated by the Agency, suggests that an
additional booster shot following the completion of a primary
vaccination provides further protection.
Getting vaccinated or receiving a booster with one of the currently
available vaccines is the best thing Americans can do right now, in
addition to standard precautions like wearing a mask, to help protect
themselves and their families.
Biologics, Including Vaccines
FDA's Center for Biologics Evaluation and Research (CBER) continues
to use every tool available to help facilitate the development and
availability of vaccines and other biological products to combat the
COVID-19 pandemic expeditiously and safely.
CBER is working on multiple fronts to address the COVID-19
pandemic, including:
Helping to facilitate expedited clinical trials for
vaccines and certain therapeutic biological products that hold
promise to prevent or treat COVID-19 by providing timely
interactions, scientific advice, and recommendations for
individual sponsors and through issuance of guidance documents;
Supporting product development and facilitating the
scaling up of manufacturing capacity for high priority products
to treat COVID-19 and conducting timely reviews;
Expediting the review of Emergency Use Authorization
(EUA) requests and Biologics License Applications (BLAs) for
vaccines and other critical medical products to address COVID-
19, including the evaluation of booster doses of COVID-19
vaccines and the use of COVID-19 vaccines in certain pediatric
populations;
Helping to ensure an adequate and safe blood supply;
and
Providing information to healthcare providers and
researchers to help them submit expanded access investigational
new drug application (IND) requests to permit the use of CBER-
regulated investigational products for patients with COVID-19.
CBER's work on COVID-19 vaccines, as discussed below, has made a
tremendous difference in addressing the pandemic by facilitating the
availability of COVID-19 vaccines, that meet the Agency's rigorous
standards, as expeditiously as possible. Through our transparent
scientific evaluation process, FDA has issued EUAs for three COVID-19
vaccines and has approved one vaccine for use in individuals 16 years
of age and older. In doing so, we have relied upon the Agency's
rigorous standards for safety, effectiveness, and manufacturing
quality. These COVID-19 vaccines were developed without cutting corners
or compromising our regulatory and scientific standards. Intensive
interactions between FDA and manufacturers minimized the time between
different studies in the clinical development process; allowed seamless
movement throughout the different phases of clinical trials; and
simultaneously facilitated manufacturers proceeding with manufacturing
scale-up before it was clear whether the safety and effectiveness data
for a vaccine would support an EUA, allowing for quicker access to
products once FDA reviewed the data and found the products met the
Agency's rigorous standards for authorization or approval.
For the approved vaccine, as well as those that have been
authorized for emergency use, our process included a thorough
evaluation of the data by the Agency's career staff. We also solicited
input from independent scientific and public health experts through our
public advisory committee meetings for the COVID-19 vaccines that we
have authorized. Throughout our scientific and regulatory process, FDA
took additional steps to facilitate transparency, such as posting
sponsor and FDA briefing documents and key decisional memoranda.
The COVID-19 vaccines that are available in the United States have
shown clear and compelling efficacy in large, well-designed phase 3
trials. These vaccines are helping the country in the fight against
this pandemic and have met FDA's rigorous standards for safety and
effectiveness to support either EUA or approval. All the COVID-19
vaccines that FDA has authorized for emergency use have far surpassed
being at least 50 percent more effective than a placebo in preventing
COVID-19, which was recommended in our June 2020 guidance document,
Development and Licensure of Vaccines to Prevent COVID-19. \1\ A
vaccine with at least 50 percent efficacy, we noted, would have a
significant impact on disease, both at the individual and societal
level. The vaccines are approved or authorized to prevent COVID-19, and
have been shown to significantly reduce the associated serious
outcomes, including hospitalization and death.
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\1\ https://www.fda.gov/media/139638/download
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During this past year, we have continued to make great strides with
regard to COVID-19 vaccines. As part of our continued efforts to be
transparent and educate the public, we have a wealth of information on
our website about the COVID-19 vaccines available for use in the United
States. The information includes fact sheets for healthcare providers
(vaccination providers) and fact sheets for vaccine recipients and
caregivers in multiple languages, with important information such as
dosing instructions; information about the benefits and risks of each
vaccine; and topical Questions and Answers developed by FDA for the
approved vaccine and each authorized vaccine. \2\
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\2\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently asked-questions
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It is also important to highlight that, as part of each EUA or
approval, manufacturers and vaccination providers are required to
report serious adverse events, cases of Multisystem Inflammatory
Syndrome (MIS), and cases of COVID-19 that result in hospitalization or
death to the Vaccine Adverse Event Reporting System (VAERS), a national
vaccine safety surveillance program jointly run by FDA and the Centers
for Disease Control and Prevention (CDC).
COVID-19 vaccine safety is a top priority for the Federal
Government, and we take all reports of health problems following COVID-
19 vaccination very seriously. FDA and CDC have implemented a
coordinated and overlapping approach for continuous safety monitoring
of all COVID-19 vaccines using state-of the art technologies.
Specifically, the Agency's monitoring following authorization of the
COVID-19 vaccines uses a multi-pronged approach including: 1) passive
surveillance using VAERS consisting of safety reports submitted by
healthcare providers (providers in the CDC COVID-19 Vaccination Program
are required to report adverse events following COVID-19 vaccination to
VAERS), patients, parents and other members of the public, combined
with 2) active surveillance, using large population-based healthcare
datasets. These latter healthcare data systems offer a higher
likelihood of detecting rare adverse events because they capture
medical data on millions of Americans, cover diverse subpopulations
(i.e., pregnant women, elderly, and patients with comorbidities) and
can provide a longer duration of follow-up when compared to the
prelicensure clinical studies. In addition, COVID-19 vaccine recipients
are encouraged to enroll in CDC's v-safe After Vaccination Health
Checker smartphone-based tool that uses text messaging and web surveys
to check-in with vaccine recipients over time after they receive a
COVID-19 vaccine. Through v-safe, they can quickly tell CDC if they
have any side effects after getting a COVID-19 vaccine. Together, the
passive and active safety surveillance provide a coordinated and
overlapping approach to vaccine safety monitoring for COVID-19
vaccines.
On August 23, 2021, FDA announced the first approval of a COVID-19
vaccine. The vaccine previously known as the Pfizer-BioNTech COVID-19
Vaccine was approved and is now marketed as Comirnaty, for the
prevention of COVID-19 in individuals 16 years of age and older.
Comirnaty has the same formulation as the originally authorized Pfizer-
BioNTech COVID-19 Vaccine. Since the approval of Comirnaty, the Pfizer-
BioNTech COVID-19 Vaccine has continued to be available under an EUA,
including for the two-dose primary series in individuals 12 through 15
years of age and as a third primary series dose for individuals 5 years
of age and older who have been determined to have certain kinds of
immunocompromised conditions. While millions of people have already
safely received COVID-19 vaccines, we recognize that for some, the FDA
approval of a vaccine may now instill additional confidence to get
vaccinated. To be clear, the American public should feel confident in
receiving any of the available vaccines.
On September 22, 2021, FDA amended the EUA for the Pfizer-BioNTech
COVID-19 Vaccine to allow for use of a single booster dose, to be
administered at least 6 months after completion of the primary series
in the following groups: individuals 65 years of age and older,
individuals 18 through 64 years of age at high risk of severe COVID-19,
and individuals 18 through 64 years of age whose frequent institutional
or occupational exposure puts them at high risk of serious
complications of COVID-19 including severe COVID-19.
On October 20, 2021, FDA further amended the EUA to clarify that a
single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may also be
administered at least 6 months after completion of the primary series
to individuals 18 through 64 years of age with frequent institutional
or occupational exposure to severe acute respiratory syndrome
coronavirus 2(SARS-CoV-2).
On October 20, 2021, FDA also amended the Moderna COVID-19 Vaccine
EUA to include use of a single booster dose at least 6 months after
completion of the primary series in the following groups: individuals
65 years of age and older, and those 18-64 years of age at high-risk of
severe COVID-19 or with frequent institutional or occupational exposure
to SARS-CoV2. The Agency also amended the Janssen EUA to include the
use of a single booster dose of the Janssen (Johnson & Johnson) COVID-
19 Vaccine, administered at least 2 months after completion of the
single-dose primary regimen to individuals 18 years of age and older.
As of this announcement, all three COVID-19 vaccines had been
authorized for a booster dose, but with varying eligibility.
Additionally, FDA authorized the use of heterologous, or ``mix and
match,'' booster dosing in eligible individuals following completion of
primary vaccination with a different available COVID-19 vaccine.
On October 29, 2021, the FDA authorized the emergency use of the
Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to
include children 5 through 11 years of age. The authorization was based
on the FDA's thorough and transparent evaluation of the data that
included input from independent advisory committee experts who
overwhelmingly voted in favor of making the vaccine available to
children in this age group. We are confident in the safety,
effectiveness and manufacturing data behind this authorization. As part
of our commitment to transparency around our decisionmaking, which
included a public advisory committee meeting, we have posted documents
supporting our decision. We hope this information gives parents the
confidence they need to have their children vaccinated.
On the same day, FDA also authorized a manufacturing change for the
vaccine to include a formulation that uses a different buffer; buffers
help maintain a vaccine's pH (a measure of how acidic or alkaline a
solution is) and stability. This authorization is for two
presentations: one for individuals 12 years of age and older and one
for individuals 5 through 11 years of age. This new formulation is more
stable at refrigerated temperatures for longer periods of time,
permitting greater flexibility for vaccination providers. The new
formulation of the vaccine developed by Pfizer Inc. contains Tris
buffer, a commonly used buffer in a variety of other FDA-approved
vaccines and other biologics, including products for use in children.
FDA evaluated manufacturing data to support the use of Pfizer-BioNTech
COVID-19 Vaccine containing Tris buffer and concluded it does not
present safety or effectiveness concerns. FDA has since approved this
new Tris formulation as part of the Comirnaty BLA.
On November 19, 2021, FDA amended the EUA for both the Moderna and
Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster
dose for all individuals 18 years of age and older 6 months after
completion of primary vaccination with any FDA-authorized or approved
COVID-19 vaccine. On December 9, 2021, FDA amended the EUA for the
Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single
booster dose for administration to individuals 16 and 17 years of age
at least 6 months after completion of primary vaccination with the
Pfizer-BioNTech COVID-19 Vaccine.
On January 3, 2022, FDA amended the EUA for the Pfizer-BioNTech
COVID-19 Vaccine to expand the use of a single booster dose to include
use in all individuals 12 through 15 years of age after completion of
primary vaccination and authorized a third primary series dose for
certain immunocompromised children 5 through 11 years of age.
Additionally, FDA authorized the shortening of the time between the
completion of primary vaccination of the Pfizer-BioNTech COVID-19
Vaccine and a booster dose to at least 5 months. Last Friday, January
7, 2022, FDA also amended the EUA for the Moderna COVID-19 Vaccine to
shorten the time between the completion of a primary series of the
vaccine and a booster dose to at least 5 months for individuals 18
years of age and older.
At this time FDA is closely monitoring the emergence of the Omicron
variant in order to determine what, if anything, needs to be changed in
the composition of COVID-19 vaccines moving forward to best protect the
population. The Agency has already issued COVID-19 vaccine-specific
guidance to address the emergence and potential future emergence of
variants of SARS-CoV-2, the virus that causes COVID-19.
Figure 1
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This pandemic is dynamic and evolving, with new data continuously
emerging about vaccine safety and effectiveness. As we obtain more data
about the safety and effectiveness of COVID-19 vaccines, including the
use of a booster dose, we will continue to evaluate the rapidly
changing science and keep the public informed.
At this time, it is clear that the approved or authorized vaccines
reduce the risk of severe illness; however, data are not yet available
to make a determination about how long they will provide protection.
Additionally, although we do not yet know the full range of SARS-CoV-2
variants that each of the vaccines will protect against, there is
evidence that the available vaccines protect against disease caused by
variants circulating in the United States.
Finally, manufacturers whose COVID-19 vaccines have been authorized
for emergency use are expected to continue their clinical trials in
order to obtain additional safety and effectiveness information and
pursue licensure (approval).
To date, having three authorized vaccines and one approved vaccine
that meet FDA's expectations for safety and effectiveness at this point
of the COVID-19 pandemic is a tremendous achievement and a testament to
the dedication of vaccine developers and FDA's career scientists and
physicians. We are highly engaged in ensuring that all COVID-19
vaccines meet the high quality that the American public expects and
deserves. The Agency is very proud of these efforts, and we believe
that the vaccines will help bring this pandemic to an end.
In addition to its work on COVID-19 vaccines, CBER also has been
actively involved in reviewing data related to COVID-19 convalescent
plasma and on December 28, 2021, the FDA updated the EUA for COVID-19
convalescent plasma. The update limits the authorization to the use of
COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2
antibodies for the treatment of COVID-19 in patients with
immunosuppressive disease or who are receiving immunosuppressive
treatment. These patients may be treated in outpatient or inpatient
settings. Additionally, to help assure the manufacture of high titer
COVID-19 convalescent plasma, the update to the EUA revises acceptable
tests and increases qualifying result cutoffs to be used for
manufacturing COVID-19 convalescent plasma with high titers of anti-
SARS-CoV-2 antibodies.
Drug Products
Since the beginning of the COVID-19 pandemic, FDA's Center for Drug
Evaluation and Research (CDER) has been working tirelessly to
facilitate the development and availability of therapeutics for use by
patients, physicians, and health systems as expeditiously and safely as
possible. FDA accelerated the development and publication of guidance
and other information for industry and researchers on developing COVID-
19-related treatments. Further, on March 31, 2020, FDA announced the
creation of an emergency review and development program for possible
therapies for COVID-19, the Coronavirus Treatment Acceleration Program,
or ``CTAP.'' The primary goal of CTAP is to help accelerate the
development of therapeutics for patients and consumers. The Agency has
supported the program by reassigning staff and working continuously to
review requests from companies and researchers who are working to
develop therapies. Under CTAP, FDA is using every available authority
and regulatory flexibility to facilitate the development of safe and
effective products to treat patients with COVID-19. As of November 30,
2021, there are more than 670 drug development programs in the planning
stages and the Agency has reviewed more than 470 trials of potential
therapies for COVID-19. These include antivirals, immunomodulators,
neutralizing antibodies, cell and gene therapies, and combinations of
these products. The diversity of therapeutic approaches being
investigated is important because it rapidly expands our understanding
of the effect of different categories of potential treatments.
Figures 2 & 3
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As of December 31, 2021, FDA has approved one drug to treat COVID-
19 and 14 therapeutics are currently authorized for emergency use. On
December 8, 2021, FDA issued an EUA for AstraZeneca's Evusheld
(tixagevimab co-packaged with cilgavimab and administered together) for
the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults
and pediatric individuals (12 years of age and older weighing at least
40 kilograms [about 88 pounds]).
On December 22, 2021 FDA issued an EUA for the first oral
antiviral, Paxlovid, manufactured by Pfizer. Paxlovid (nirmatrelvir
tablets and ritonavir tablets, co-packaged for oral use) is authorized
for the treatment of mild-to-moderate coronavirus disease (COVID-19) in
adults and pediatric patients (12 years of age and older weighing at
least 40 kilograms or about 88 pounds) with positive results of direct
SARS-CoV-2 testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death.
On December 23, 2021, FDA issued an EUA for another oral antiviral,
molnupiravir, manufactured by Merck. Molnupiravir is authorized for the
treatment of mild-to-moderate coronavirus disease (COVID-19) in adults
with positive results of direct SARS-CoV-2 viral testing, and who are
at high risk for progression to severe COVID-19, including
hospitalization or death, and for whom alternative COVID-19 treatment
options authorized by the FDA are not accessible or clinically
appropriate.
Both Paxlovid and Molnupiravir are available by prescription only.
In considering EUA requests for therapeutics, we promptly and
carefully evaluate the totality of the scientific evidence to determine
whether the statutory criteria for issuance under section 564 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3)
are met. Among other criteria, this evaluation considers whether the
product may be effective for its proposed authorized uses, and whether
the product's known and potential benefits outweigh its risks.
Our goal is to be as transparent as possible about the scientific
basis for recommending that a drug or biological product be authorized
for emergency use under section 564 of the FD&C Act or for recommending
that an EUA be revised or revoked. For example, last month, FDA held a
meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to
discuss Merck and Ridgeback's request for an EUA for molnupiravir, an
investigational antiviral drug to treat COVID-19. The advisory
committee discussed the available data supporting the use of
molnupiravir to treat mild-to-moderate COVID-19 in adults who have
tested positive for COVID-19, and who are at high risk for progression
to severe COVID-19, including hospitalization or death. The meeting was
scheduled as soon as possible following the submission of the EUA
request by the company. FDA thoroughly evaluated the data and
information submitted in the EUA request before the meeting and engaged
in a robust public discussion with the advisory committee members.
FDA continues to work closely with manufacturers to mitigate and
prevent shortages as the COVID-19 pandemic evolves. For example, the
Agency has issued four EUAs to authorize the emergency use of certain
therapeutic products intended to treat serious or life-threatening
diseases or conditions (e.g., Acute Kidney Injury, Acute Respiratory
Distress Syndrome) caused by COVID-19 after determining that sufficient
FDA-approved alternatives to these products were not available to fully
meet the emergency need. This has helped to alleviate shortages of some
therapies that are essential for the care of critically ill COVID-19
patients. FDA is working with manufacturers to increase supplies to
meet current demand by expediting review of applications. In addition,
the Agency has prioritized the review of generic drug applications for
potential treatments and supportive therapies for patients with COVID-
19, such as sedatives used in ventilated patients, anticoagulants, and
pulmonary medications. In June 2021, FDA reached a milestone of
approving 1,000 original and supplemental generic drug applications
since the start of the pandemic to help in the treatment of patients
with COVID-19. This supports FDA's everyday mission of improving access
to safe, effective, high-quality treatment options, especially during
the COVID-19 pandemic.
Medical Devices
FDA's Center for Devices and Radiological Health's work to support
access to medical devices for the COVID-19 pandemic began in January
2020--before the Public Health Emergency (PHE) was declared in the U.S.
and 2 months before the pandemic was declared worldwide--due to the
immediate need for COVID-19 tests and testing supplies, collection
kits, personal protective equipment (PPE), and other devices. The need
for medical devices to respond to the COVID-19 pandemic has far
exceeded what we experienced in any prior PHE. The first EUAs issued
for the COVID-19 PHE were for medical devices, and the volume of EUA
requests quickly surpassed (by two orders of magnitude) that of any
prior PHE or other situation. Since January 2020, FDA has received over
7,500 EUA requests and Pre EUA (PEUA) submissions for devices. Further,
the emergency use requests included submissions for devices that FDA's
Center for Devices and Radiological Health (CDRH) had never received
EUA requests for during prior PHEs. This included ventilators and novel
devices such as extracorporeal blood purification devices, as well as
novel indications for devices such as continuous renal replacement
therapy devices. Since the start of the pandemic, FDA has issued EUAs
or granted marketing authorization to nearly 2,000 medical devices for
COVID-19-related uses. In addition, FDA rigorously monitors safety
signals and medical device reports, using the information to publish 23
letters to healthcare providers and 9 safety communications. FDA
completed other pivotal work activities such as addressing supply chain
shortages and counterfeit products related to COVID-19.
Diagnostic tests are the first line of defense in an outbreak, and
FDA plays an important role to ensure these work through the EUA
review. The EUA process expedites access to appropriately accurate
diagnostic tests during emergencies, when information gaps and false
results may adversely affect individual patient care and public health
decisionmaking. Through this process, molecular diagnostic tests are
able to be developed, validated, authorized, and deployed within weeks
rather than several months to over a year, as is typical for test
development and traditional premarket submissions. The Agency employed
its EUA authorities to facilitate availability of tests in six previous
emergencies. Careful review of tests is critical because false test
results can adversely impact the Nation's response. In PHEs, FDA is
generally open to receiving and reviewing EUA requests for tests from
any developer, including commercial kit manufacturers and laboratories,
for tests that address the public health need.
FDA sought to facilitate COVID-19 test evaluation and authorization
through the development and availability of templates for EUA requests.
The templates provide recommendations for test validation and a fill-
in-the-blank form to streamline the paperwork and make it easier for
developers to provide information in support of a request for an EUA.
Since providing the first template in January 2020, FDA has been in
daily contact with test developers to answer questions and help them
through the EUA process. This has proved to be a helpful tool for many.
FDA had as many as ten posted templates and continues to update, add,
combine, and remove templates as the science evolves and as necessary
to support developers of COVID-19 tests. As of October 8, 2021, these
templates have received over 556,635 hits from those visiting FDA's
website. FDA also supported test developers through establishment of a
dedicated mailbox, 24-7 toll-free hotline that ran until July 2020, the
posting of over 100 frequently asked questions on our website, and by
hosting 74 weekly virtual town halls for test developers. The Agency
has worked with over 1,000 test developers since January 2020.
The Agency prioritizes review of EUA requests for at-home rapid
antigen tests and is actively engaging with test developers to increase
their availability. The Agency first discussed this prioritization in
the Spring of 2020, during one of its weekly virtual Town Halls on
COVID-19 tests, due to their potential impact on test accessibility and
public health. To further encourage such test development, on July 29,
2020, FDA posted a template for at-home diagnostic tests. This template
includes recommendations for validating over-the-counter (OTC) tests
for screening asymptomatic individuals with general performance
expectations that are lower than for lab-based tests. The Agency
recognizes the benefits of increased availability of OTC tests, and
these recommendations have helped to increase OTC screening test
availability, particularly rapid antigen tests.
Throughout the pandemic, FDA has also monitored evolving
circumstances and growing scientific knowledge and made adjustments
when appropriate to help streamline and expedite the path to market for
these and other tests as much as possible while assuring they are
supported by sound science. In March 2021, FDA obtained results from an
NIH-sponsored study that supported further streamlining of FDA's at-
home test recommendations. Based on these data, on March 16, 2021, FDA
issued an EUA that provides a streamlined path to authorize tests with
at least 80 percent sensitivity in symptomatic individuals, with
sensitivity falling in a range as low as 70 percent in certain
circumstances, for developers to offer their test for OTC serial
screening without additional data collection. Multiple tests were
authorized under this approach within weeks.
FDA authorized the first at-home test on November 17, 2020. At-home
tests, also referred to as self-tests, are those that can be performed
by a lay user at home, or in other settings, with a self-collected
sample. In Fall 2021, the Agency added home tests from ACON
Laboratories, Celltrion Diatrust, iHealth, and InBios International to
the growing list of home tests authorized in the U.S. Two of the FDA's
recent authorizations alone may result in up to 400 million more at-
home tests available monthly to American consumers by early 2022, based
on projections by the manufacturers and dependent on Federal subsidies.
As of December 31, 2021, FDA has authorized 15 distinct at-home COVID-
19 tests.
FDA further streamlined the process for manufacturers developing
over-the-counter at-home tests on October 25, 2021, by facilitating at-
home single-use testing for symptomatic individuals for tests currently
authorized only for serial testing. Developers of certain tests may
request authorization to add single-use testing for symptomatic
individuals without submitting additional data. For example, right now
when people go to a pharmacy to buy an at-home test, they are sold in
two-packs. This change would allow tests authorized for single use to
be sold in singles, meaning more individual tests for sale potentially
at a lower price.
On November 15, 2021, FDA published an update to its Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency that
describes our review priorities based on the current needs of the
pandemic. Going forward the FDA generally intends to focus its review
on EUA requests for the following types of tests:
At-home and point-of-care (POC) diagnostic tests for
use with or without a prescription and that can be manufactured
in high volumes;
Certain high-volume, lab-based molecular diagnostic
tests (and home collection kits for use with such tests) that
expand testing capacity or accessibility such as through
pooling of specimens to increase throughput, testing specimens
collected at home and shipped to the lab, screening
asymptomatic individuals or detecting multiple different
respiratory viruses at once;
Certain lab-based and POC high volume antibody tests
that can measure the amount of antibodies (fully quantitative
antibody tests) or the amount of neutralizing antibodies; and
Tests for which the request is from, or supported by,
a U.S. Government stakeholder, such as the Biomedical Advanced
Research and Development Authority or the National Institutes
of Health's Rapid Acceleration of Diagnostics (RADx)
initiative.
These priorities help developers focus their prospective efforts
where they are most needed, and reduce inefficient use of developer and
FDA time on tests with less public health impact. Ultimately, we
anticipate we will receive EUA requests only for those tests identified
in the guidance for which the public health need is greatest, and we
will be able to focus our attention on the review of such tests.
FDA also worked with NIH to establish an Independent Test
Assessment Program (ITAP) to streamline validation and authorization of
antigen tests with potential for large-scale manufacturing. This
program is an extension of the RADx program which has already supported
development of several authorized tests, including the first at-home
OTC COVID-19 test. ITAP goes further to conduct studies on over-the-
counter tests and work with companies to help them provide complete,
high quality submissions for FDA review. ITAP is conducting independent
laboratory and clinical evaluations using protocols developed jointly
with FDA. FDA uses information from these evaluations in deciding
whether to grant EUAs. On December 24, FDA authorized the first at home
COVID-19 test where validation data were gathered through ITAP and the
second followed shortly after on December 29. We expect to continue
shorter review times for such EUA requests due to our partnership with
ITAP in establishing the evaluation program to address our regulatory
needs.
Going forward, FDA continues to take steps to increase access to
reliable, accurate rapid antigen tests. This includes continuing to
prioritize review of EUA requests for at-home antigen tests, and
increasing staffing on the antigen test review team as resources
permit. FDA is actively working to increase the pipeline of at-home
tests by engaging with companies to obtain data that can be used to
support their EUA, working with developers with authorized POC tests to
expand their authorization for at-home use, continuing support of ITAP
and engagement with RADx and international regulators, and conducting
targeted outreach to manufacturers of home tests in non-U.S. markets.
Because of these various efforts, as of December 31, 2021, FDA has
authorized over 400 tests and sample collection devices for SARS-CoV-2.
As noted in Figure 4 below, these include 290 molecular tests and
sample collection devices, 87 antibody and other immune response tests,
and 43 antigen tests. Among these are 16 authorizations for diagnostic
tests that can be run at home without a prescription (three molecular
and 13 antigen authorizations). We have also authorized 33 tests for
serial screening programs (24 antigen and nine molecular). The volume
and variety of authorized tests is a testament to FDA's support of
innovative test design and our commitment to public health. FDA will
continue to adapt to address public health needs and increase access to
tests for consumers, including at-home diagnostic tests, adopting an
approach that is grounded in sound science.
Figure 4
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In addition to these efforts, FDA has been actively monitoring for
the possible emergence of SARS-CoV-2 variants since early in the
pandemic and has worked with test developers when a new variant (or
mutation) emerges that could impact test performance. FDA also works
with test developers, who are required to monitor their authorized test
for the impact of viral mutations. As the FDA's or the developer's
analysis identifies tests whose performance could be impacted by SARS-
CoV-2 viral mutations, these tests are added to FDA's SARS-CoV-2 Viral
Mutations: Impact on COVID-19 Tests webpage. This includes posting the
latest information on the omicron variant and testing implications as
they become available. FDA also works with other agencies and divisions
in HHS, such as NIH, as we monitor tests for potential effects of
genetic variation on test performance on an ongoing basis.
Since early 2020, FDA has adopted agile, interactive, and
innovative approaches to review EUA requests for all types of devices.
For example, FDA developed the umbrella EUA approach to efficiently
authorize multiple devices of the same type falling within the scope of
authorization and meeting the statutory criteria for issuance. The
Agency has also issued 28 guidance documents (including 21 revisions)
outlining policies to help expand the availability of medical devices
needed in response to COVID-19. For example, developers of certain
tests offered their tests, upon validation and notification to FDA,
prior to issuance of an EUA during Agency review of the EUA request.
Further, FDA made several improvements to our EUA review processes to
make the most efficient use of our resources, including a front-end
triage process to identify devices that would have the greatest impact
on the public health. These improvements incorporate the latest
information on device availability and shortages, prioritizing novel or
critical devices not yet available on the market or those that would
address significant device shortages.
Given the magnitude of the COVID-19 PHE, the FDA recognizes that
continued flexibility, while still providing necessary oversight, will
be appropriate to facilitate an orderly and transparent transition back
to the eventual resumption of normal operations. In December 2021, FDA
issued draft guidance for public comment to help manufacturers begin to
plan a future return to normal operations, including a proposed phased-
in transition period and recommendations relating to submitting
marketing submissions. The Agency hopes that providing additional
transparency on our current thinking now will facilitate advance
planning for an orderly transition to normal operations after the
public health emergency with fewer supply disruptions for device
manufacturers, healthcare providers, and patients.
At the beginning of the pandemic, when there were relatively few
diagnostic tests authorized, FDA's priority was to rapidly increase the
availability of tests. For medical devices, review times have increased
over time as the number of EUA requests and Pre-Emergency Use
Authorization (PEUA) submissions for medical devices have increased to
unprecedented levels. This is demonstrated in the tables we have
provided with review times for IVD EUA requests over time, and
submission volume for IVD EUA requests over time (see Figures 5 & 6
below). At the beginning of the pandemic, FDA was authorizing tests and
other devices in as little as 1 or 2 days upon receipt of complete data
packages. Congress has provided critical, one-time funding that FDA has
used to leverage contractors from outside organizations, to provide
technical expertise to supplement our review staff in the review of EUA
requests and other marketing submissions. These personnel are
authorized to work alongside full-time employees, integrated into our
internal review teams to help with the massive workload for tests,
ventilators, PPE, and other devices, but the workload has continued to
greatly exceed capacity even with the additional support.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Please note that FDA's actions have reduced the review times for
tests from a peak average of 90 days for EUA requests received in
September 2020 to approximately 35 days for those received since
February 2021.
FDA has authorized a wide variety of other medical devices for use
in combating the pandemic, including a wide range of PPE, ventilators,
and other therapeutic devices. As of December 31, 2021, FDA has
authorized 269 PPE devices, including 51 surgical masks, 205 filtering
facepiece respirators (FFRs), and issued 13 EUAs for face shields and
other barriers intended to protect the user from bodily fluids, liquid
splashes, or potentially infectious materials. See Figure 7. In
addition to issuing EUAs, FDA has also cleared, through its premarket
notification pathway, over 500 PPE 510(k)'s, which not only support the
response to this pandemic but also future PHEs as well.
Figure 7
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
FDA recognizes that medical devices, particularly tests, will
continue to play an important role in the next phase of the pandemic
response. The Agency is continuing to monitor its policies, the
marketplace, and national needs, and will continue to adapt as the
circumstances of the evolving pandemic warrant.
Human and Animal Food (Center for Food Safety and Applied Nutrition and
Center for Veterinary Medicine)
Throughout the pandemic, FDA has worked with Federal, state, and
local partners, as well as industry, to help ensure a safe and adequate
food supply for both people and animals.
While there is no evidence to show that SARS-CoV-2 is likely to be
transmitted by food, some components of the food system are
experiencing challenges and supply chain imbalances. We saw this at the
outset of the pandemic with the dramatic shift in where people were
eating, and most recently, we are seeing that the broad supply chain
issues impacting so many commodities are also impacting food. Overall,
food production and manufacturing in the U.S. has been remarkably
resilient, but we continue to monitor the food supply chain systems
closely to efficiently and promptly identify supply chain challenges
and apply mitigation strategies when necessary.
In response to the pandemic, FDA's Foods Program developed 21
Forward, a food supply chain data management tool, to help identify
where risks for interruptions in the continuity of the food supply may
be greatest. As part of 21 Forward, FDA conducted targeted outreach to
the food industry to offer additional resources and technical
assistance in addressing challenges.
FDA also recognizes that food supply chain continuity and worker
safety are two sides of the same coin. Thus, a robust food supply
depends on the safety and health of the Nation's food and agricultural
workforce. Along with our Federal, state, and local partners, we have
provided best practices for food and agricultural workers, industry,
and consumers on how to stay safe, and help ensure the continuity of
operations in the food and agriculture critical infrastructure sector
during the pandemic.
In collaboration with HHS, CDC, Health Resources and Services
Administration (HRSA) and U.S. Department of Agriculture (USDA), data
from 21 Forward on the estimated numbers and distribution of food and
agricultural workers have been made available to assist states with
their vaccine distribution efforts for workers in the food and
agriculture sectors, including migratory and seasonal agricultural
workers. Now, FDA is using the information from 21 Forward to help
identify and react to supply chain challenges and elevate as needed to
the appropriate agencies or other entities. In addition, FDA has worked
with its Federal partners to provide both COVID-19 and flu vaccination
encouragement messages for the food industry.
FDA's Coordinated Outbreak Response and Evaluation team has been
working throughout the pandemic looking for signs of foodborne illness
outbreaks and initiating responses as needed. FDA's Center for
Veterinary Medicine is monitoring the animal food supply and initiating
needed foodborne illness and natural disaster responses. In terms of
inspectional work, FDA's Office of Regulatory Affairs (ORA)
investigators continue to conduct mission-critical inspections
domestically and abroad, including inspections and investigations in
response to foodborne outbreaks, as they have done throughout the
pandemic. FDA resumed standard operations for domestic surveillance
inspections in July 2021. FDA continues to screen every line of every
shipment of imported food entering the U.S. utilizing our Predictive
Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT)
tool. We adjusted the algorithm in PREDICT to place increased scrutiny
on shipments from facilities where foreign surveillance inspections
have been postponed. FDA has made greater use of our Foreign Supplier
Verification Program (FSVP) regulation to oversee compliance with FDA
Food Safety Modernization Act (FSMA) requirements. The shift to remote
FSVP inspections, along with other tools utilized by the foods program,
has been critical to ensuring the safety of human and animal food from
foreign suppliers during the COVID-19 pandemic. Since March 2020, FDA
has conducted approximately 2,982 FSVP inspections, which represents a
95 percent increase in inspections (1,527) over the 18 months prior to
the pandemic. Additionally, FDA continues to identify human and animal
foods that are unsafe, misbranded, or may cause a serious health
concern for the public at the border with over 10,481 lines being
refused admission since March 2020.
In July 2020, FDA announced the New Era of Smarter Food Safety
Blueprint outlining the Agency's plans over the next decade to create a
more digital, traceable, and safer food system. The Agency has learned
from its response to the pandemic that there is an accelerated need for
certain goals in this blueprint, especially those involving supply
chain continuity and resilience, modernized inspectional approaches,
strengthening food safety infrastructures with regulatory partners, and
the safety of foods ordered by consumers online. The number of
consumers ordering food online has been steadily increasing over the
years, but it has skyrocketed during the COVID-19 pandemic. FDA
recently hosted a virtual Summit on E-Commerce to help the Agency
improve its understanding of how human and animal foods are sold
through e-commerce models and to identify courses of action for
addressing potential food safety vulnerabilities, including those that
may arise in the ``last mile'' of delivery.
Inspections, Compliance, and Protecting the Medical Supply Chain
Similar to their work protecting the food supply, import
investigators have been onsite protecting the medical supply chain at
our ports of entry, courier facilities, and the international mail
facilities (IMFs) throughout the pandemic with uninterrupted support
from ORA's laboratories. Through continued vigilance, FDA has prevented
unsafe and unproven pharmaceuticals and other medical products from
entering the country. Since March 2020, with the cooperation of and in
coordination with the U.S. Customs and Border Protection (CBP), FDA has
received and destroyed almost 85,500 products, totaling over 15,050,242
capsules, tablets, and other dosage forms of unapproved drugs.
Since March 2020, FDA has maintained the same level of screening
for imported products as pre-pandemic and refused approximately 121,759
lines of imported violative medical products. However, FDA has focused
examinations on COVID-19 relief supplies to ensure compliant products
are expedited while maintaining our commitment to refusing imported
medical products that are unsafe, misbranded, unapproved, counterfeit,
or may cause serious illness or injury to the public. In fact, our
import investigators have evaluated donations of shipments destined for
the Federal Emergency Management Agency (FEMA) and met the first
vaccines (Pfizer Belgium) on their arrival into the United States in
December 2020 to ensure proper transport, storage, and reconciliation
of products, and also assisted with expediting the importation of other
compliant vaccine-related shipments as well as other COVID-19
necessities.
Despite generally pausing domestic and foreign surveillance
inspections in March 2020 to safeguard the health and well-being of our
staff, as well as employees at facilities we inspect, our investigators
continued to conduct mission critical inspections both domestically and
abroad to ensure FDA-regulated industries were meeting applicable FDA
requirements. In July 2020, FDA resumed prioritized domestic
inspections. To arm our investigators with the most reliable and
accurate information, FDA developed a rating system to assist in
determining when and where it was safest to conduct prioritized
domestic inspections until we resumed standard inspectional operations
for domestic surveillance inspections in July 2021.
On May 5, 2021, FDA issued a report titled, ``Resiliency Roadmap
for FDA Inspectional Oversight,'' \3\ outlining the Agency's
inspectional activities during the COVID-19 pandemic and its detailed
plan to move toward a more consistent state of operations, including
FDA's priorities related to this work going forward. The report was
updated on November 22, 2021. \4\
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\3\ https://www.fda.gov/media/148197/download
\4\ https://www.fda.gov/media/154293/download
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The report described our oversight work during the pandemic and
outlined the inspectional activities that the Agency had postponed due
to travel restrictions or inability to ensure the safety of our
workforce or the workforces within the industries the Agency regulates.
The report also outlined the number of mission-critical inspections FDA
completed during that time, such as inspections of facilities for which
there was a drug shortage, inspections needed for the approval of novel
drugs or drugs related to the potential treatment of COVID-19, support
of pre-market and pre-license applications, and response to foodborne
disease outbreaks or other food safety risks such as food contaminated
with pathogens.
Additionally, the Resiliency Roadmap outlines FDA's continued,
successful use of alternative tools and approaches where inspections
are not feasible, including remote assessments (e.g. requests to
regulated establishments to remotely view records) and remote
interactive evaluations that include remote livestreaming video of
operations, teleconferences, or screen sharing, and leveraging
information from trusted regulatory partners. For example, FDA made
over 1,300 requests to human and animal drug and biological product
manufacturers to remotely view records, to support on-time regulatory
decision actions. Our review of records requested under section
704(a)(4) of the Federal Food, Drug, and Cosmetic Act supported more
than 300 approval recommendations for new or abbreviated drug
applications, as well as support for authorization decisions for EUA
requests, potentially allowing new products to come to market and
provide access to lower cost generic drugs to patients more quickly
than may have otherwise been possible.
Notably, FDA's bioresearch monitoring program staff have conducted
more than 130 remote assessments that were directly used in application
decisions. \5\ The new tool was incentivized for and supported by
industry and continues to provide the Agency with valuable information
to assist with risk-based targeting for inspections. FDA recognizes
that remote approaches do not replace physical onsite inspections, and
that there are situations where only an onsite inspection is
appropriate, based on risk and history of compliance with FDA
regulations.
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\5\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/remote-interactive-evaluations-drug-manufacturing-
and-bioresearch-monitoring-facilities-during-covid
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The Resiliency Roadmap further outlined the ongoing steps the
Agency is taking to resume standard operational levels of inspection
activities, including how it intends to prioritize domestic and foreign
inspections that could not be performed during the pandemic. On July 1,
2021, FDA transitioned to standard operations for domestic surveillance
inspections and other prioritized operational work through the end of
September 2021. As noted in the updated November 2021 report, FDA has
exceeded the goals for completing domestic surveillance inspections
that were detailed in the May Resiliency Roadmap. We also exceeded our
performance goal related to following up on previous inspections
classified as official action indicated (OAI). Additionally, of the
more than 13,500 applications for medical product approval or
authorization received between March 2020 and September 2021, only 68
applications had been delayed due to the inability to conduct
inspections--the vast majority of these applications are not deemed
mission-critical. From the time FDA first issued the Resiliency Roadmap
in May to September 2021, the FDA has been able to make decisions on
nearly half of the 68 applications.
When planning surveillance inspections, the Agency is prioritizing
higher-risk establishments. For example, a sterile manufacturing site
that has not been previously inspected and is making narrow therapeutic
index drugs would likely be deemed a higher risk than a site that had a
well know inspectional and compliance history that is making over-the-
counter solid oral dosage form drugs. This means that postponed
inspections will be prioritized based on risk and conducted over a
longer period of time, ultimately increasing the amount of time between
inspections of certain lower-risk facilities in order to focus on
products that present the greatest risk to public health.
The Agency launched a multi-year modernization effort in July 2021
to further transform our data enterprise platforms and cross-program
interoperability infrastructure to better support innovation related to
its regulatory oversight role. This includes adopting technology to
support regulatory assessments to improve our remote receipt, review,
and analysis of industry data and records, and improve remote
interactions with industry entities to be easier, more efficient, more
consistent, and more secure. This modernization effort includes a
review of inspectional approaches using next-generation assessment
technologies and improvements. FDA established an Agency-wide
Inspectional Affairs Council (FIAC) that provides coordination of
inspection approaches and assessment processes. The Agency intends to
share more information on these efforts as this work progresses. FDA
will continue to leverage and maximize every available tool and
resource to meet its regulatory oversight responsibilities, while
achieving optimal public health outcomes.
Compliance and Enforcement
FDA exercises its regulatory authority by, among other things,
issuing warning letters and by pursuing civil and criminal enforcement
actions against firms and individuals who do not comply with regulatory
requirements, including those distributing unapproved products with
false or misleading claims that the products prevent, treat, mitigate,
diagnose, or cure COVID-19. In March 2020, FDA launched Operation Quack
Hack, which leverages the Agency's expertise and advanced analytics to
protect consumers from fraudulent medical products, including unproven
cures, illegitimate test kits, and substandard or counterfeit
respirators. FDA has sent hundreds of abuse complaints to domain name
registrars and internet marketplaces. The Agency also has sent more
than 260 warning letters to sellers of unproven products claiming to
treat or cure COVID-19. Working with the Department of Justice (DOJ),
FDA has sought and obtained preliminary injunctions that require
defendants to halt the sale of unproven products claiming to treat or
prevent COVID-19, including one product, ``Miracle Mineral Solution,''
that, when used as directed, is equivalent to industrial bleach. In
addition, since the start of the COVID-19 pandemic, FDA has issued 17
warning letters to owners and/or operators of illicit internet pharmacy
websites that offer for sale unapproved and misbranded drugs purported
to treat COVID-19 to U.S. consumers.
In addition, ORA's Office of Criminal Investigations (OCI), working
with other Federal and local law enforcement agencies, has conducted
criminal investigations involving unproven COVID-19-related products.
In one such example, OCI investigated a physician who attempted to
profit from the pandemic by marketing and selling an unproven COVID-19
treatment. The physician marketed and sold treatment kits--which
included hydroxychloroquine--as a cure for COVID-19. In July 2021, the
physician pleaded guilty to, among other things, trying to smuggle
hydroxychloroquine into the United States to sell in his COVID-19
``treatment kits.'' In another case, OCI investigated an individual who
attempted to import approximately 1,000 unlawful COVID-19 test kits
from China, which were intercepted at a FedEx facility in Memphis,
Tennessee. As a result of OCI's investigation, the individual pleaded
guilty in October 2021 to a felony smuggling charge. OCI also has
conducted criminal investigations to bring to justice those who tamper
with COVID-19 vaccines. For example, OCI investigated a hospital
pharmacist who tampered with COVID-19 vaccine doses at a Wisconsin
hospital where he worked. On two successive nights, the pharmacist
purposefully removed a box of COVID-19 vaccine vials from the
hospital's refrigeration unit intending to render the vaccines inert
and no longer effective. Before the full extent of his conduct was
discovered, 57 people received doses of the vaccine from these vials.
In January 2021, the pharmacist pleaded guilty to two counts of
attempting to tamper with consumer products with reckless disregard for
the risk that another person will be placed in danger of death or
bodily injury. He has been sentenced to 3 years imprisonment, followed
by 3 years of supervised release, and he must pay approximately $83,800
in restitution to the hospital.
In addition, FDA investigators remain on the front lines at ports
of entry, quickly examining, reviewing, and sampling import entries,
and refusing admission of violative products where appropriate. We
protect the supply chain in two equally critical ways: first, we help
ensure safe products are coming in; and second, that illegal,
dangerous, and fraudulent products do not get into the country. These
efforts include partnering with U.S. Customs and Border Protection
(CBP) in establishing satellite laboratories at selected International
Mail Facilities (IMFs) with scientists using state-of-the-art screening
tools to rapidly identify unapproved, counterfeit and illicit products.
In March 2020, OCI, with the help of domestic law enforcement
partners and foreign counterparts in the United Kingdom, led the
investigation of fraudulent COVID-19 ``treatment kits'' that were
falsely declared as ``water treatment.'' Import examination of these
shipments found misbranded ``kits'' intended to treat COVID-19. As a
result of this investigation, a British national was charged and
arrested for shipping mislabeled and unapproved products. In May 2020,
FDA worked with CBP to intercept several shipments of counterfeit
facemasks, with the result that they were refused and destroyed before
entering U.S. commerce.
FDA also has taken steps to address hand sanitizer products that
pose safety concerns, such as products that do not meet the required
ethanol or isopropanol levels or that contain or may contain toxic
ingredients like methanol or 1-propanol. FDA has tested several hundred
products using field-based and laboratory-based tools and found more
than a hundred violative products. FDA also has taken steps to help
ensure that these dangerous or subpotent products do not enter domestic
commerce, including coordinating with CBP to identify such products,
and we have listed products made by more than 65 manufacturers on
import alert. FDA also placed all alcohol-based hand sanitizers from
Mexico on a countrywide import alert to help stop products from
entering the U.S. that appear to be in violation until the Agency is
able to review the products. That action marked the first time the FDA
has issued a countrywide import alert for any category of drug product.
Medical Product Supply Chain
FDA monitors and responds to worldwide demand and supply chain
disruptions for medical products caused by the COVID-19 pandemic. \6\
We work closely with manufacturers, within our current resources and
authorities, to help ensure they continue to notify the Agency of any
permanent discontinuance or interruption of drug (human and animal),
biological product, and device manufacturing in a timely manner and, as
noted in FDA's Fiscal Year (FY) 2022 budget, we are working to better
position the Agency and our health care system to assure a strong
domestic supply chain in future emergencies. \7\
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\6\ https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-
supply chain-review-report.pdf
\7\ FDA Fiscal Year 2022 Justification of Estimates for
Appropriations Committees (https://www.fda.gov/media/149616/download)
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This is especially important as the COVID-19 pandemic has exposed
major vulnerabilities in the supply chain that FDA continues to face as
it works to help ensure access to the treatments and devices that
patients and healthcare providers need.
In addition to our usual communications with drug manufacturers, we
work closely with healthcare and pharmacy systems, hospitals,
providers, and others on the frontlines of COVID-19 patient care to
identify problems with access to critical care drugs used to treat
COVID-19.
FDA understands the significant impact shortages can have on
patient care and we are using our authorities to help prevent and
alleviate disruptions. When we identify a shortage, we react swiftly to
help mitigate the impact to U.S. patients and health care
professionals, and quickly share that information with the public.
Restoring and increasing the supply of approved drugs has been the
agency's priority. In addition, where necessary, FDA has issued
temporary policies during the COVID-19 emergency to respond to reports
from hospitals of increased demand and interruptions in supply, some of
which have not resulted in a drug shortage but caused concern about
continuing access to drugs to support hospitalized patients with COVID-
19. We issued temporary policies for outsourcing facilities registered
with FDA and pharmacists in state-licensed pharmacies or Federal
facilities, regarding the compounding of certain drugs used for
hospitalized patients with COVID-19. The Agency has published guidances
to help applicants and manufacturers provide FDA with timely and
informative notifications about changes in the production of certain
human drugs, including biological products, and certain animal drugs.
We urged the timely submission of these notifications, which may assist
in our efforts to prevent or mitigate shortages of such products. In
addition, section 503B(a)(2)(A) of the FD&C Act permits outsourcing
facilities to use bulk drug substances to compound drug products that
appear on the drug shortage list in effect under section 506E of the
FD&C Act at the time of compounding, distribution, and dispensing, when
all conditions of section 503B are met.
Our experience with COVID-19 demonstrates that a strong domestic
supply chain depends on a resilient supply chain for medical devices as
well. Indeed, multiple entities across both the public and private
sector collectively have important roles to play in strengthening the
domestic medical device supply chain. FDA can play a critical role in
identifying and preventing shortages for devices, because the Agency
not only reviews and authorizes these products, but has unique,
collaborative relationships that allow direct engagement with device
manufacturers, patients, distributors, healthcare organizations, and
other stakeholders. Even before the pandemic hit the U.S., there were
disruptions in the supply chain due to higher demand for devices in
other nations where COVID-19 was already prevalent and shutdowns in
locations from which supplies were sourced. As a result, FDA began
shortage mitigation activities for medical devices in January 2020
before the PHE was declared in the U.S., and 2 months before a pandemic
was declared worldwide. At that time, the Agency did not have any
dedicated funding or explicit authority regarding prevention or
mitigation of medical device or animal drug shortages. The Agency
lacked dedicated staff necessary to mitigate supply chain disruptions
and/or shortages. Nevertheless, the Agency took several actions to
rapidly respond to supply chain needs, including reassigning over 130
staff to perform shortages work across CDRH and contacting over 1,000
manufacturing facilities in 12 countries in just a few weeks' time to
get as much information as possible about critical devices. However,
because the Agency lacked any explicit shortages authority at this
time, only about one-third of facilities that were contacted responded
even in part to CDRH requests because response was voluntary. This lack
of explicit authority, staff and supply chain information significantly
hampered our efforts to mitigate and prevent shortages at the outset of
the pandemic.
On March 27, 2020, the CARES Act was signed into law. The CARES Act
gave FDA, for the first time, authority related to device shortages
(see section 506J of the FD&C Act). The enactment of the CARES Act at
the height of the initial pandemic response gave some authority to help
prevent or mitigate medical device shortages during the public health
emergency. Specifically, section 506J of the FD&C Act requires
manufacturers to notify FDA of a permanent discontinuance in or
interruptions in the manufacture of certain devices that are likely to
lead to a meaningful disruption in supply of that device in the United
States during, or in advance of, a public health emergency. Section
506J also requires FDA to maintain a publicly available list of devices
the Agency has determined to be in shortage, as well as devices that
have been discontinued. The Agency is also directed to, as it deems
appropriate, prioritize and expedite inspections and review of
premarket submissions to help alleviate the supply chain constraint.
Since receiving this new authority, during the pandemic response,
FDA has among other actions:
issued guidance on submitting notifications to FDA
during the COVID-19PHE and updated the guidance to provide
better assistance based on stakeholder feedback;
published a list of device types it has determined to
be in shortage at this time, as well as a list of devices for
which we have been notified by manufacturers the device has
been permanently discontinued;
created the infrastructure around receiving,
processing, and analyzing notifications to determine devices
that are in shortage and publicly post a list of the devices
that FDA has determined to be in shortage;
worked with manufacturers to plan for an expedited
device premarket submission, which allows us to increase device
availability for products that are most needed.
In addition to the implementation of the new device shortages
authorities, FDA has conducted horizon scanning to assess demand for
devices needed to respond to the pandemic, including PPE, ventilators,
diagnostic supplies, infusion pumps, and non-contact infrared
thermometers; and established a rapid response team, working with field
personnel to address fraudulent imports. The Agency has likewise worked
to prevent and mitigate shortages of testing supplies. For example, FDA
collaborated with U.S. Cotton, one of the world's largest manufacturers
of cotton swabs, to develop and produce a polyester-based Q-tip-type
swab for testing. FDA also collaborated with laboratories and clinical
investigators validating potential alternative sources of control
materials, transport media, and swabs. As individual developers
validated these alternative components, FDA requested their permission
to share their findings publicly so that others could benefit, and we
posted these alternatives on our website. In this way, FDA has been
serving as a clearinghouse for scientific information that the entire
community can leverage to mitigate shortages and increase testing
capacity. FDA continues to post this information on a rolling basis on
an FAQ website so that labs have access to the latest information
regarding alternative controls, transport media, extraction,
instruments, and swabs.
FDA continues to work to implement and operationalize the new
device shortage authority and utilizing one time funding from COVID
supplementals, stand up a new state-of-the-art Resilient Supply chain
and Shortages Prevention Program (RSCSPP). Medical device shortages not
only put patients in harm's way but also jeopardize our health care
workers on the front lines, during PHEs like the COVID-19 pandemic and
every day in our health care system. Moreover, device shortages
disproportionately affect at-risk populations and exacerbate health
disparities. For these reasons, FDA continues to do all it can within
its current authorities and resources to mitigate shortages and supply
chain interruptions for COVID-19 and within the U.S. health care system
generally.
Congress has acknowledged the importance of FDA's work on shortages
in our health care system and we want to continue working with this
Committee and others to make sure FDA has the resources and authorities
needed to ensure U.S. patients and health care providers have the
medical products they need each day. To ensure the U.S. is properly
prepared now, and in the future, we must take action to secure our
medical device supply chain, including related materials, parts, and
components. The FDA recognizes that this will take resources and
expanded authority.
Conclusion
FDA continues to advance its mission to protect and promote public
health by helping to ensure the safety of human and animal food, and
the safety and effectiveness of medical products. We take our public
health mandate very seriously and will continue to work each day to
help end this pandemic. We continue to communicate with the American
public and make regulatory decisions based on data and sound science. I
look forward to continuing to work with the Committee on these efforts
and thank you again for the opportunity to testify today.
______
The Chair. Thank you.
Assistant Secretary O'Connell.
STATEMENT OF DAWN O'CONNELL, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, UNITED STATES DEPARTMENT OF HEALTH
AND HUMAN SERVICES, WASHINGTON, DC
Ms. O'Connell. Chair Murray, Ranking Member Burr, and
distinguished Members of the Committee, it is an honor to
testify before you today on efforts within ASPR to respond to
the pandemic since the emergence of the Omicron variant. When
Omicron first emerged, as we have done with each new variant,
we immediately evaluated its impact on our current vaccines,
therapeutics, and diagnostics, and adjusted our response
accordingly. Data suggests that our current vaccine doses with
a boost confer protection against Omicron.
As a result, we have continued distributing the three
authorized and approved vaccines. Over 600 million doses of
vaccine have been developed and delivered since the start of
the pandemic. We have ample supply of both primary and booster
doses, contributing to more than 200 million Americans now
being fully vaccinated. However, we have had to make
adjustments to our therapeutics supply in light of Omicron.
Two of our workhorse monoclonal therapies, one from Lilly,
the other from Regeneron, are not as effective against Omicron.
As a result, we have increased our supply of GSK's monoclonal,
which is effective. We continue to purchase all that we can
from GSK, though this supply is still limited. We are on track
to have 250,000 courses available this month. A force
monoclonal by AstraZeneca is targeted for immunocompromised
individuals at high risk and is taken prior to exposure to
prevent infection.
It has retained effectiveness against Omicron, and we will
have made nearly half a million courses available through the
end of this month. All four monoclonal that are currently
available for States and jurisdictions to order free of charge
on a weekly basis to treat either Omicron or Delta infections.
Also, we now have antivirals by Pfizer and Merck that are
effective against Omicron and are being delivered to States
free of charge every other week. We have procured 3.1 million
courses of Merck that are now available.
Last week, we doubled our commitment to order 20 million
courses of Pfizer's product. We have 265,000 courses available
through this month and anticipate delivering the first 10
million courses to States by mid-summer. We remain in frequent
communication with States and territorial health officials on
the distribution of therapeutic products and continue to focus
on ensuring these lifesaving therapies are available to
Americans across the country. The dramatic rise in cases due to
Omicron has put a significant strain on our testing capacity.
Despite significant effort and investment, there is more work
to do, and we are working every day and night with
manufacturers to increase the availability of tests.
As soon as we saw the dramatic increase in cases in South
Africa and Europe, we reached out to test manufacturers to
understand their surge capacity and supply chain constraints.
We are engaging daily with the lab test providers to mitigate
any supply chain constraints with their sub-tier suppliers. We
are also working with the commercial and public health labs to
prioritize their needs.
We continue to use the Defense Production Act's authorities
when needed. To further increase test availability, we are
procuring 500 million rapid tests to distribute to American
households. As a requirement of this procurement, none of these
tests can interfere with what is available in the current
commercial market so as not to diminish what consumers are able
to access now.
We are currently shipping 2.8 million tests to long term
care facilities per week, as we have throughout the pandemic.
We continue to work to send 50 million rapid tests to federally
qualified health centers and food banks, with 7 million having
shipped so far. And we will keep working around the clock with
manufacturers and our Government partners to increase and
sustain the number of tests available now and in the future.
Finally, in addition to vaccines, therapeutics, and
testing, ASPR continues to provide on the ground support to
States and communities in need. Since July 40, National
Disaster Medical System teams, nearly 880 team members have
deployed to 19 separate States and the Commonwealth of the
Northern Mariana Islands to support a range of functions,
including hospital augmentation and decompression, setting up
medical overflow centers for patients, and mortuary support.
We continue to send supplies as requested from the
Strategic National Stockpile, including 300 ventilators to six
jurisdictions since the emergence of our Omicron. We are
grateful for the support from this Committee and Congress, and
I look forward to answering your questions.
[The prepared statement of Ms. O'Connell follows:]
prepared statement of dawn o'connell
Chair Murray, Ranking Member Burr, and distinguished Members of the
Committee, it is an honor to testify before you today on efforts within
the U.S. Department of Health and Human Services (HHS) Office of the
Assistant Secretary for Preparedness and Response (ASPR) to respond to
the current pandemic, restore and strengthen our capabilities, and
prepare for future health emergencies. I am grateful for this
opportunity to address this Committee and appreciate your continued
support.
Update on ASPR's COVID-19 Response Effort
As we enter the third year of the pandemic, we continue to apply a
whole of government approach to protect Americans from COVID-19. At the
direction of Secretary Becerra and in my role as ASPR, I am responsible
for leading HHS' COVID-19 response coordination. In this role, I work
closely with my fellow panelists on all facets of the Department's
response, however, for the purposes of this testimony, I will focus my
update on the work for which the ASPR organization is chiefly
responsible.
HHS Coordination Operations and Response Element (HCORE)
The vaccines and therapeutics available to us today are the result
of an unprecedented partnership between HHS and the Department of
Defense, through the Countermeasures Acceleration Group (CAG),
previously known as Operation Warp Speed. Together this team, has
helped develop and deliver over 600 million doses of vaccine and 3.9
million treatment courses to protect the American people from COVID-19.
On December 31, 2021, our Memorandum of Understanding with DOD
expired and on January 1, 2022, we successfully completed the planned
transition of this work to the recently established HHS Coordination
Operations and Response Element, or HCORE. HCORE institutionalizes the
efforts previously led by the CAG within ASPR. It will allow us to
build on the progress to date, retain expertise and skills, and
continue providing the necessary tools to the American people to
respond to the COVID-19 pandemic.
Since my last appearance before the Committee, HCORE continues to
lead, in partnership with CDC, the rollout and distribution of the
Pfizer, Moderna, and Johnson & Johnson vaccines and boosters. While the
data suggests that primary doses of vaccine confer reduced levels of
protection against Omicron, we know that boosters strengthen protection
significantly. These vaccines are being administered widely at 90,000
locations around the country, and ample supply is available in the
field to meet the needs for both booster and primary series
vaccinations. Additionally, the introduction of vaccines for children
ages 5 through 11 has resulted in over 6.7 million doses delivered for
this population. Significant work with the state, Federal, territorial,
and pharmacy partners continues to ensure that there is ample vaccine
available at locations where young children are likely to receive their
vaccines.
In addition to vaccines HCORE continues to purchase and distribute
to states and jurisdictions a wide variety of treatments including
monoclonal antibodies and oral antivirals. In total, we have bought
nearly 30 million treatment courses for patients with COVID-19.
Some of these therapies may be less effective against Omicron,
however. The new variant is predicted to have markedly reduced
susceptibility to two of the monoclonal antibody treatments we have
purchased (Lilly's bamlanivimab/etesevimab and Regeneron's REGEN-COV).
However, two of the monoclonal antibody treatments we have procured are
expected to retain activity against Omicron--GSK's Sotrovimab and
AstraZeneca's EVUSHELD. We are increasing our supply of the GSK
monoclonal to 1 million courses over the next few months and are on
track to have more than 250,000 courses available in January.
AstraZeneca's monoclonal is a pre-exposure therapy which is targeted
for immunocompromised individuals at high risk. We will have more than
half a million courses on hand in January.
In addition to these monoclonal antibody treatments, the newly
authorized oral antiviral pills developed by Merck and Pfizer are
expected to retain activity against Omicron and HCORE is distributing
doses to all states and jurisdictions. More than 360,000 courses were
delivered to dispensing sites in December--with a total of about 3
million courses of the Merck antiviral and more than 265,000 of the
Pfizer antiviral on the way in January. The Administration recently
announced plans to double the Pfizer antiviral order from 10 million to
20 million treatment courses.
Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA)
continues to leverage the supplemental appropriations provided by
Congress to support the development of vaccines, therapeutics, and
diagnostics to end the COVID-19 pandemic. BARDA has awarded contracts
for 78 medical countermeasure projects to aid the COVID-19 response to
date. All of these contract awards are listed on
medicalcountermeasures.gov in detail and include 16 therapeutics, 55
diagnostics, and seven vaccine candidates. Notably, BARDA has placed
1.5 billion doses of vaccine under contract (including a combination of
adult primary, booster, and pediatric doses), distributed over 3.3
million doses of monoclonal antibodies, and shipped more than 182
million diagnostic kits.
BARDA also supports research on expanding eligibility for the
current authorized and approved vaccines as well as the continued
development of vaccine candidates that have not yet been authorized or
approved. This ongoing work on vaccines is critical as we begin to look
for next generation vaccines that are easier to store, ship, administer
and may prove more durable than the current authorized and approved
vaccines.
BARDA's work on therapeutics is critical as we seek to balance the
ease of administration with the benefits of the treatment. For example,
many of the available monoclonal antibodies are administered by
infusion which must be done in clinical settings. BARDA's collaboration
with industry on developing oral antivirals offer an important
alternative to monoclonal antibodies. As a result, there are now two
antivirals available under EUA for the prehospital treatment of
patients at high risk for progression to severe COVID-19.
BARDA continues to play an important role in the development of
diagnostic tests that expand beyond central labs to point of care and
at home solutions. This includes contracts for three molecular and two
antigen point of care and home use tests and for two molecular and five
antigen point of care only tests. In addition, BARDA has funded six
manufacturing capacity expansion efforts to increase domestic testing
capacity.
Strategic National Stockpile and Medical Supply Chain
The pandemic has severely strained our public health and medical
supply chains. As this Committee is well aware, the medical supply
chain ecosystem is complex, with different private sector players and
market dynamics across multiple domains of medical equipment and
supplies. Many vital products and their raw materials are primarily
made overseas, and practices like ``just in time'' inventory management
resulted in difficulty accelerating manufacturing when demand surged
last spring. This created significant and devastating challenges for
States and healthcare systems that required access to these key
supplies.
Over the course of the COVID-19 response, the SNS has worked to
backstop States' medical supply needs at an accelerated pace. Since the
beginning of the pandemic, the SNS has deployed more than 250 million
items to aid the national response including Personal Protective
Equipment (PPE), ventilators, Federal Medical Stations, and
pharmaceuticals. In particular, the SNS deployed almost 3,000
ventilators to 17 jurisdictions between July and October 2021, to
respond to the Delta variant case surge. The SNS has deployed more than
300 ventilators and High Flow Nasal Cannula to six jurisdictions since
Omicron emerged.
I highlighted in my testimony in July that ASPR continues to work
to replenish SNS inventory to levels at or above pre-COVID-19 amounts
to ensure we are prepared for any subsequent wave of additional cases
and to do so to the extent possible with domestically manufactured
supplies and equipment. As of December 29, 2021, the SNS has utilized
approximately $12 billion from COVID-19 supplemental appropriations
provided by Congress to have in its inventory approximately: 747
million N95 respirators (59 times pre-pandemic levels); 274 million
surgical and procedure face masks (8.5 times pre-pandemic levels); 19.6
million face shields (two times pre-pandemic levels); 59.6 million
gowns and coveralls (12.5 times pre-pandemic levels); 4 billion gloves
(240 times pre-pandemic levels); and 158,000 ventilators (10 times pre-
pandemic levels). SNS has also made investments to ensure there is
capacity to make these critical supplies.
In addition, to better identify and understand baseline issues
during the COVID-19 response and improve future response operations, we
supported three meetings with Tribal representatives to determine if
changes or updates are needed regarding how federally recognized Tribal
governments request SNS support. These listening sessions were in
collaboration with the Indian Health Service (IHS), the Centers for
Disease Control and Prevention (CDC)/Division of State and Local
Readiness, and the HHS/Office of Intergovernmental and External Affairs
(IEA). The SNS team continues to engage other key state and local
leaders and organizations as it seeks input on how to improve access to
the stockpile.
While replenishing the SNS is essential, it is also critical to
address the root cause of why supply chains were so strained in the
first place. ASPR is taking on this work as well since ensuring a safe
and consistent public health supply chain for medical materials,
ingredients, and supplies is critical for any national response to
public health emergencies.
Throughout the COVID-19 response, ASPR has leveraged the
authorities delegated to the Secretary under the Defense Production Act
(DPA) to issue 66 priority ratings for U.S. Government (USG) contracts
for health resources, eight priority ratings for USG contracts for
industrial expansion, three priority ratings for non-USG contracts to
support the production of resins for both diagnostics and infusion
pumps, and the manufacture of closed suction catheters for treatment of
patients with COVID-19--all to ensure private sector partners making
life-saving products are able to acquire the raw materials, components,
and products requisite to deliver for the response.
Also under the DPA, ASPR is strengthening the industrial base to
secure and develop domestic capacity, retool and expand industry
machinery, scale production facilities, train workforces, and
ultimately infuse the supply chain and marketplace with products the
U.S. needs to contain further pandemic waves. ASPR continues to invest
in critical funding in expanding domestic manufacturing including
investments in manufacturing PPE, testing consumables, vaccine raw
material, vaccine vials, at home and point of care tests, and testing
raw materials. Each of these domestic manufacturing initiatives meets
current, as well as future COVID-19 needs, and seeks to create or
sustain high-value domestic jobs.
All of these investments, and the industrial base overall, require
dedicated and persistent management and engagement. As such, my intent
is to institutionalize this mission in ASPR. I am working to integrate
and organize supply chain situational awareness and industrial
analysis, domestic industrial base expansion, and supply chain
logistics into a new office within ASPR. Bringing these pieces together
will strengthen our industry partnerships and support our work to
establish and maintain resilient supply chains. I ask for your support
as we work to address this effort and would be happy to provide future
briefings on this effort as needed.
As you are likely aware, several groups outside of ASPR are
reviewing the SNS as well as other Federal stockpiles. Specifically,
the HHS Inspector General (IG) is completing a 3-year SNS review. The
IG began the review when the SNS transitioned from CDC to ASPR in 2018
but shifted the review slightly in 2020 with the onset of the COVID-19
pandemic to review holdings, requirements, and available resources to
meet needs.
In addition, the National Academies (NAS) has reviewed at our
request the Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE), the interagency group of experts that advise, among other
things, what should go into the SNS. The full report is available via
the NAS website: https://www.nap.edu/read/26373/chapter/1. We are
reviewing the findings in the National Academies report to determine
how to strengthen both the PHEMCE and the SNS. Restoring and rebuilding
the SNS is one of my priorities and I look forward to reviewing both of
these reports and incorporating their findings or recommendations into
the strategic work we are undertaking to rebuild and restore the
stockpile and realign it with the PHEMCE. I would be happy to discuss
both of these reports with this Committee once both are released and
made public. As chair of the PHEMCE, I plan to incorporate lessons
learned from the COVID-19 response into future PHEMCE planning. I'm
pleased to report that we will relaunch the PHEMCE next month.
Healthcare System Preparedness
Next, I want to share more about ASPR's work to prepare our
healthcare system to surge to meet the demands of those being treated
for COVID-19, without compromising day-to-day healthcare needs.
Through ASPR's Hospital Preparedness Program (HPP), ASPR has
invested $350 million from supplemental appropriations in the National
Special Pathogen System (NSPS). These investments span the 62 HPP
funding recipients, their associated 55 Special Pathogen Treatment
Center sub-recipients, 10 Regional Ebola and Special Pathogen Treatment
Centers (RESPTC) recipients, the National Ebola Training and Education
Center (NETEC) (a consortium of three academic medical centers), and 53
hospital associations, while leveraging and amplifying technical
guidance from the CDC. These components work together to provide a
coordinated, national approach to preparing healthcare systems to surge
for public health and medical emergencies.
We also continue to support our Regional Disaster Health Response
System (RDHRS) demonstrationsites. The goal of the RDHRS is to link
together existing health systems to address health care preparedness
challenges, establish best practices, expand access to specialty
clinical care, and increase medical surge capacity at the regional
level. As I mentioned in my November 2021 statement, a fourth RDHRS
demonstrationsite was established at Emory University. With this award,
we now have demonstrationsites based at Massachusetts General Hospital,
Nebraska Medical Center, and Denver Health and Hospital Authority. The
ultimate goal of this system is to support a more coordinated,
comprehensive, and capable health care disaster response system able to
respond to health security threats.
As part of our COVID-19 pandemic response, the National Special
Pathogen System coordinated national expertise, regional capabilities,
and state and local healthcare capacities across the public and private
sectors to support an effective pandemic response. Looking ahead, I
look forward to examining ways to strengthen investments like these in
preparedness to ensure the healthcare system is ready to surge for
future public health and medical incidents.
Further, if a public health or healthcare system becomes
overwhelmed with patients, States can request National Disaster Medical
System (NDMS) personnel to provide additional support. Since July 2021,
forty National Disaster Medical System teams nearly 880 team members
were deployed to support sites in 19 separate states and the
Commonwealth of the Northern Mariana Islands (CNMI). There is currently
an NDMS team in New York and Missouri. For these deployments, NDMS
personnel support a range of functions including hospital augmentation
and decompression, setting up medical overflow centers for patients,
and mortuary support. As we learn more about Omicron, and if additional
needs are identified, we will continue to make resources available to
states and communities to respond.
Of note, this critical system requires a renewal of its direct
hiring authority, which was set to expire on September 30, but was
extended as part of the continuing resolution. NDMS has utilized this
authority to bring on additional personnel over 1,000 personnel hired
to date and will continue to utilize the expedited authority, if
extended by Congress, to continue to enhance the force.
Testing
In addition to the Industrial Base Expansion efforts I mentioned
previously, ASPR continues to support COVID-19 testing for the Nation.
The HHS Testing and Diagnostics Working Group (TDWG) mission was
established early in the pandemic to increase testing capacity through
interagency coordination and partnerships with industry and state,
tribal, local, and territorial public health agencies. TDWG was created
as part of the Federal response to COVID-19 in March 2020, residing
with Operation Warp Speed temporarily, and then established under the
Office of the Assistant Secretary of Health (OASH) leadership and was
located in the Joint Coordination Cell (JCC) run by the U.S. Coast
Guard. In March 2021, when the JCC was officially stood down, TDWG's
administrative and contracting support were moved to ASPR.
While there is more work to do to increase the supply of rapid
tests, we have significantly increased our country's testing capacity
over the past several months. In fall 2021, ASPR invested $3 billion to
accelerate the production of rapid tests and expand capacity. As a
result, we have quadrupled the number of rapid at home-tests available
since we made those investments in September. To further increase
testing supply, ASPR, is leading the Administration's procurement of
500 million Over-the-Counter (OTC) tests, an investment of over $3
billion, with plans for initial tests to be available this month. ASPR
has also shipped over 40 million rapid antigen tests and 2.3 million
point-of-care PCR tests to our most vulnerable populations, including
nursing homes, federally qualified health centers, and long-term care
facilities since May 2021. In addition to the purchase and distribution
of these tests, ASPR continues to work with manufacturers, companies,
and laboratories to identify and proactively address any supply issues.
Conclusion
Thank you again for inviting me to testify before you on efforts
within ASPR to support the COVID-19 response. I look forward to
answering your questions and working with my team at ASPR and our
colleagues across HHS to end the COVID-19 pandemic.
______
The Chair. Thank you to all of our witnesses. We will now
begin a round of 5 minute questions of our witnesses, and I
again ask my colleagues to keep track of your clock and stay
within those 5 minutes. As the Omicron variant of COVID-19
continues to spread at an alarming rate, people are looking for
clear, straightforward guidance on how to protect themselves
and those around them.
It is really critical that we reduce the infection rates so
we can relieve pressure on our health care workers, protect
people with disabilities and older Americans, young kids and
anyone else who has been disproportionately impacted by COVID-
19.
However, I have heard from so many people who find the
latest CDC isolation and quarantine guidance confusing and hard
to interpret. So, Dr. Walensky, can you please clearly explain
CDC's latest guidance on what people need to do to protect
themselves and others if they are exposed to or contract COVID-
19? And let me start with vaccinated people. What is your
guidance to them?
Dr. Walensky. Thank you, Chair Murray, for the opportunity
to clarify. Maybe if I could just rewind the clock to just
before the holidays, where we were hearing from hospitals that
they were--their staff were going out and that they were in a
real crunch in terms of beds. They had plenty of beds, but they
didn't have staff to staff them.
ICU beds were starting to close. So immediately we worked
toward our updated health care worker guidance, but when we did
so, we recognized that we were going to have challenges and
that this Omicron surge that we were about to face was
threatening many other places of our health care----
The Chair. I appreciate the background, but I just want to
know straight forward if someone is exposed to or has COVID-19
and they are vaccinated, what do they do?
Dr. Walensky. If they are exposed to COVID-19 and they are
completely boosted, they should--they do not need to stay home,
but they should get a test at day five. If they have COVID, our
guidance is--does not distinguish between your vaccination
status, and our science has demonstrated that you are maximally
infectious 2 days before and two to 3 days after.
By 5 days after your symptoms, if you are feeling better,
if your fever is better, if you are cough and sore throat are
better, then on day six you can go out, but you have to wear a
mask, you have to wear a mask reliably and you should not go to
places you can't wear a mask. You probably shouldn't go and
visit Grandma. You shouldn't get on an airplane.
The Chair. For vaccinated. What about unvaccinated?
Dr. Walensky. Same for unvaccinated for isolation. So
isolation being those who have had disease--who have disease.
The Chair. Well, let me just say, nearly 2 years ago, when
this Committee first started having Congressional hearings on
COVID-19, the very first thing I asked was where are the tests?
And we have made progress since then, and we are now producing
300 million rapid at home tests each month, along with ramping
up our lab based testing.
But I am disappointed, as I said, by the testing challenges
that we are facing. Tests are hard to find. They are costly.
People are unable to find the at-home tests in pharmacies,
online. They are waiting in long lines, and often after that,
waiting days for results. So it is ineffective at the end of
the day.
Ms. O'Connell, I want to ask you, what are you doing to
address the frustrations and challenges we are hearing about
COVID testing?
Ms. O'Connell. Chair Murray, thank you so much for this
very important question. Testing remains a critical priority
for this Administration. When we saw the unprecedented cases of
Omicron sweep into South Africa and Europe, we immediately
reached out to our manufacturers to understand any supply
constraints they had and to evaluate their surge capacity.
We have also met daily with them to make sure that they
have what they need from their suppliers and have used the
Defense Production Act authorities 12 times throughout this
pandemic in support of testing needs. Most recently in the last
few weeks for two tests, we were able to unlock supplies and
manufacturing capacity. We continue to invest in rapid, over-
the-counter tests, which are in high demand.
In the fall we invested $3 billion to increase
manufacturing line staffing and to commit to those
manufacturing lines for 13 months. As a result, we went from
50--46 million tests, over the counter tests available in
October, to the 300 million, Chair Murray, that you just
mentioned that are available now. But that is not enough. We
are continuing to bring tests to the American people.
As a result, the President has announced, and we are in the
process of procuring the 500 million tests, which every
American household will be able to order and have shipped
directly to their house. We have completed four contracts so
far, have secured 50 million tests, and are in the process of
securing the additional tests over the next several days.
The U.S. Postal Service has agreed to do the distribution,
and the U.S. Digital Services is going to help with the
website. We anticipate the first tests going out at the end of
this month, with the remaining tests going out over the next 60
days.
The Chair. Okay, I am out of time, but I do want to just
say this, I am hearing from so many schools that are having
trouble staying open. They want to stay open. Part of it is
they have staff that are sick. That is understandable. But a
big part of it is they don't have access to the safety measures
like masks and testing supplies. What do I tell them about
where they go to get that?
Ms. O'Connell. Chair Murray, thank you. Having--schools
having enough supply, testing supplies to stay open as a
critical priority for us. We have invested $10 billion of the
American Rescue Plan given to States to support and stand up
testing programs. We have also invested $60--$650 million in a
program called Operation Expanded Testing, which set up
regional hubs of labs that schools could contract with to run
their testing programs.
But that doesn't work if there aren't tests available, so
ASPR is working directly with States to match additional
manufacturing capacity with States that need it. Not only that,
we are in the process within ASPR of looking at our contracts
to see if we have any additional capacity, and we will commit
to sending that capacity to the school programs.
The Chair. Senator Burr.
Senator Burr. Thank you, Madam Chairman. Let me just cut to
the chase. Dr. Fauci, you said CDC was going to update its
guidance and include antigen testing or suggested that it
would. Dr. Walensky and CDC came out with the guidance that
didn't include it. Was that part of the communications plan to
start with and they diverted it, or was that something you just
chose to inject?
Dr. Fauci. Thank you for that question, Senator Burr. In
discussions about the real gray zone, which Dr. Walensky
described about after the 5-days where you have a considerable
diminution in the likelihood of being transmitting, we had been
in discussions about what the role of antigen testing would be.
As a matter of fact, when Dr. Walensky came out with the
final guidelines, they include that if you have a test
available, you may take a test. So at the end of the day, we
were quite in concordance with our views.
Senator Burr. Well, I think the Chair and I share this, we
found it very confusing, and I think the American people found
it confusing, and I don't see it lightly when I say not too
many people in America listening to what comes out of
Washington, whether it is Congress or out of the Administration
as it relates to COVID.
The President makes an announcement, Ms. McConnell, of 500
million at home test. Is this the first time that you have
thought about purchasing at home test or have you tried to
before and it was rejected?
Ms. O'Connell. Thank you, Ranking Member Burr. This is the
first time the Administration has committed to purchasing tests
to send to the American households.
Senator Burr. So is that ASPR or is that DOD? Because of
all the notifications of contracts signed, I have seen them
from DOD. I haven't seen them from HHS.
Ms. O'Connell. Thank you for that question, Ranking Member
Burr. We use--we have a relationship with DOD for assisted
acquisitions, so ASPR will request that DOD put out a
solicitation or manage a contract on our behalf.
They are able to do it extraordinarily quickly. And we have
had an MOU in place with DOD for this work that will run
through June 2023. We have used this relationship to purchase
vaccines and therapeutics, and we are now using it for testing.
Senator Burr. So the best I can find, you mentioned 50
million doses having been contracted. I can identify 27 million
out of two companies, Medea and Atlantic Trading. Neither one
of them are manufacturers of test, and I believe the third one,
Revival, is not a manufacturer of test.
Medea actually came to fame with the importation of vodka
and tying cell phones to vodka. And like a lot of other
companies, they got the PPE business in 2020 with some nominal
FEMA contracts. Why should we have any confidence in these
contracts if in fact we are dealing with companies that don't
manufacture anything? And can you assure me that the tests that
are coming in are not coming from China?
Ms. O'Connell. Thank you, Ranking Member Burr. Absolutely,
these tests--what we initially did to be able to access tests
for the initial shipments that will go toward the end of
January, we worked with warehouses to see where additional
tests were stored and assessed that additional capacity and are
bringing that capacity to bear for these initial tests that are
going out, which is why you are seeing contracts with
warehouses and not with test manufacturers.
Senator Burr. So is what you are telling me, they have got
50 million tests in warehouses in the United States, and all we
did was access that inventory?
Ms. O'Connell. That is my understanding.
Senator Burr. Well, will you confirm your understanding?
This is a very, very important piece, when you have got
companies that don't manufacture tests and all of a sudden we
are giving them $190 million contract for about 14 million home
tests and their expertise is importation of vodka.
I encourage you to look through the list of people that we
are signing up with. Are you aware that some of the larger test
manufacturers in 2021 shut down lines because of the lack of
purchases for at home test?
Ms. O'Connell. One of the things we did in the fall was a
$3 billion investment that we made was to turn lines on and to
commit to those lines for 13 months so they wouldn't be turned
off again.
Senator Burr. Dr. Woodcock, let me just--last question,
Chair. Of the 15 tests that you have currently approved for
over the counter, how many detect Omicron?
Dr. Woodcock. We are still working on that, but we believe
all of them detect Omicron. We simply feel they are somewhat
less sensitive than they were to some of the previous variants.
Senator Burr. Of the 50 million tests that the ASPR has
contracted for, how many of those tests detect Omicron?
Dr. Woodcock. I don't know which tests they are. We can get
back to you on that.
Senator Burr. So you haven't consulted with what we are
purchasing on the $500 million, and they haven't consulted with
FDA to figure out whether the tests they are buying actually
detect Omicron.
Dr. Woodcock. I believe they have. I simply don't have that
list.
Senator Burr. Okay. I think thank the Chair.
The Chair. Senator Kaine.
Senator Kaine. Thank you. Thank you, Chair Murray and to
the witnesses. Dr Fauci, can you provide us a general breakdown
of what percentage of hospitalized individuals are vaccinated
versus unvaccinated, and what percentage of COVID deaths are
among vaccinated or unvaccinated individuals?
Dr. Fauci. Thank you for that question, Senator Kaine. One
of the ways to answer that question would be to look at people
who are in the hospital and take a look at if you are
vaccinated versus unvaccinated.
If you look at vaccinated versus unvaccinated, there is
about a 10 times greater chance that you be infected if you
were unvaccinated, about a 17 times greater chance that you
would be hospitalized if you were unvaccinated, and about a 20
times likelihood that you would be--that you would be dead if
you were unvaccinated.
When you look at every parameter, 10 times, 17 times, 20
times infection, hospitalization, death.
Senator Kaine. Thank you, Dr. Fauci. Ms. O'Connell, I want
to ask you a question about vaccine--additional vaccine
development. The current vaccines against COVID, as was
indicated by Dr. Fauci's answer, have been very successful in
reducing deaths, severity of illnesses, and hospital
admissions.
However, they have had more limited success in preventing
forward transmission from vaccinated individuals after
breakthrough cases, and the existing vaccines are not as
durable as vaccines in other areas, so we need booster shots to
continue to protect against the virus.
Is the Administration considering supporting the
development of additional vaccines that might be able to
address the gaps in the current vaccines' capabilities?
Ms. O'Connell. Senator Kaine, thank you so much for that
question. Yes, absolutely. I think we all see the need for next
generation vaccines. We are also looking for next generation
antivirals and therapeutics as well.
We are in the process of working with Dr. Fauci's team to
develop a unified NIH, BARDA research agenda and budget to
address these issues, to identify candidates that might already
be in the pipeline, to help support the research into
candidates that are just starting in the pipeline, just so we
can accelerate the availability of the next generation vaccines
and therapeutics.
Senator Kaine. Thank you for that answer. Dr. Walensky, I
would like to ask you a question about access to testing, and
in particular, what is the CDC doing to make sure that testing
capacity is robust in rural America and also among community
health centers in disadvantaged parts of the country?
Dr. Walensky. Thank you, Senator Kaine. So we have this
program, increased community access to testing, in
collaboration with ASPR as well. This is a program that has
collaborated with FEMA to increase surge testing just over the
holidays.
We have increased testing, Federal testing sites for PCR,
12 Federal testing sites doing thousands of tests over the
holiday. We also work with pharmacies in collaboration with
pharmacies, and in that stead, we are able to map where the
pharmacies are and their social vulnerability index, and we can
actually put PCR tests in areas of High Social Vulnerability
Index through all of our pharmacy partners, CVS, Walgreens,
Rite Aid, and whatnot.
Then we actually put tests in our community centers as
well. So really a broad stretch in order to be able to get
access to testing, especially among those most vulnerable. And
then, of course, as ASPR O'Connell mentioned, $10 billion for
testing supplies to our schools and working closely with our
schools in peer to peer support, in technical support, to allow
those tests to be used well in those school settings. Thank
you.
Senator Kaine. Thank you for that answer. And Dr. Fauci,
one more question for you. I ask a version of this question
every time we have this panel before us. What is the NIH doing
right now, or what is the current status of NIH research to
better understand long COVID, to look at symptoms and potential
treatments?
Dr. Fauci. There are several levels of activity going on.
Some news since we spoke last. I had mentioned to you, Senator,
that in fact, there was a $1.15 billion program for studying
long COVID that is now developing cohorts to look at various
incidences, prevalence, pathogenesis, and potential
interventions.
There have been a number of awards that have been given.
Most recently in September, there was an additional $470
million funding supported through the American Rescue Plan,
engaging about 100 researchers from 30 institutions to get
individuals together.
One of the things that is really interesting that we are
seeing right now is that when you look at individuals who have
these symptoms that go on, as you know and have experienced
yourself, for a considerable period of time, a recent study
that is in the preprint stage, so it hasn't been peer reviewed,
has some very interesting information that needs to be
validated and verified.
It was an autopsy study in people who had varying levels of
COVID, from relatively mildly symptomatic to moderately
symptomatic individuals who actually died, and when they looked
at the spread of what was not necessarily replication competent
virus, but was PCRable virus, which means you could have
nucleotides that were there, there was, it seems to be a
persistence in multiple organ systems, indicating that even if
you clear the virus, one of the possibilities.
I have to emphasize possibility because it needs to be
validated, is that you don't completely clear the fragments of
the virus and you have continual stimulation, not that you are
infectious or that you are going to infect anybody else, but
that it is still generating perhaps an aberrant response in
your immune system.
I underscore again, it is preliminary, it is in the pre-
print stage, and it needs to be peer reviewed, but that is some
of the information we are starting to gather.
Senator Kaine. Thank you very much for that answer. Thank
you, Chair Murray.
The Chair. Senator Paul.
Senator Paul. Dr. Fauci, the idea that a Government
official like yourself would claim unilaterally to represent
science, that any criticism of you would be considered a
criticism of science itself is quite dangerous. Central
planning, whether it be of the economy or of science, is risky
because of the fallibility of the planner.
It would not be so catastrophic if the planner were simply
one physician in Peoria. Then, the mistakes would only affect
that physicians' patients, the people who chose that physician.
But when the planner is a Government official like yourself who
rules by mandate, the errors are compounded and become much
more harmful.
A planner who believes he is the science leads to an
arrogance that justifies in his mind using Government resources
to smear and to destroy the reputations of other scientists who
disagree with him. In an email exchanged with Dr. Collins, you
conspired, and I quote here directly from the email, ``to
create a quick and devastating published takedown of three
prominent epidemiologist from Harvard, Oxford and Stanford.''
Apparently, there is a lot of fringe epidemiologists at
Harvard, Oxford, and Stanford. And you quote in the email that
they, or from Dr. Collins and you agree, that they are fringe.
And immediately there is this takedown effort. A published
takedown, though doesn't exactly conjure up the image of a
dispassionate scientist.
Instead of engaging them on the merits, you and Dr. Collins
sought to smear them as fringe and take them down, and not in
journals, in lay press. This is not only antithetical to the
scientific method, it is the epitome of cheap politics, and it
is reprehensible, Dr. Fauci. Do you really think it is
appropriate to use your $420,000 salary to attack scientists
that disagree with you?
Dr. Fauci. The email you are referring to was an email of
Dr. Collins to me. If you look at the email----
Senator Paul. That you responded to and hurried up and
said, I can do it, I can do it, we got something in wire----
Dr. Fauci. No, no, I think in usual fashion, Senator, you
are distorting everything about me.
Senator Paul. Did you ever object to Dr. Collins's
characterization of them as fringe? Did you write back to Dr.
Collins, no, they are not fringe, they are esteemed scientists,
and it would be beneath me to do that?
Dr. Fauci. I did not----
Senator Paul. You responded to him that you would do it,
and you immediately got an article and sent it back to him, and
said, hey, look, I got him, I nailed him in Wired of all
scientific publications.
Dr. Fauci. That is not what went on. There you go again.
You just do the same thing every hearing.
Senator Paul. That was your response--that was your
response? And this wasn't the only time. So your desire to take
down people----
Dr. Fauci [continuing]. you are incorrect--as usual,
Senator, you are incorrect with almost everything said----
Senator Paul. Well, no, you deny, you deny, but the emails
tell the truth of this.
Dr. Fauci. No.
Senator Paul. This wasn't the only time your desire to take
down those who disagree with you didn't stop with Harvard,
Oxford, and Stanford. You conspired with Peter Daszak, who you
communicated with privately, and other members of the
scientific community that wrote opinion pieces for Nature.
Five of them signed a paper for Nature, an opinion piece.
17 signed a paper that called it conspiracy theory, the idea
that the virus could have originated in the lab. Do you think
words like conspiracy theory should be in a scientific paper?
Dr. Fauci. Senator, I never used that word when I was
referring to it. You are distorting virtually everything----
Senator Paul. Did you communicate with the five scientists
who wrote the opinion piece in Nature, where they were
describing, oh, there is no way this could come from the lab?
Dr. Fauci. That was not me----
Senator Paul. Did you talk with any of those scientists--?
Dr. Fauci. See, but you keep distorting the truth. It is
stunning how you do that----
Senator Paul. Did you--talk to any of the scientists
privately who wrote the opinion----
Dr. Fauci. Yes.
Senator Paul. You did. What were they telling you
privately?
Dr. Fauci. Well, let me explain. You know, you are going
back to that original discussion when I brought together a
group of people to look at every possibility with an open mind.
So not only are you distorting it, you are completely turning
it around as much as you usually do.
Senator Paul. Well, most of the scientists who came to you
privately, did they come to you privately and say no way this
came from the lab or was their initial impression, Dr. Gary and
others that were involved, was their initial impression
actually that it looked very suspicious for a virus that came
from lab.
Dr. Fauci. You know, Senator, we are here at a Committee to
look at a virus now that has killed almost 900,000 people. And
the purpose of the Committee was to try and get things out, how
we can help to get the American public. And you keep coming
back to personal attacks on me that have absolutely no
relevance to reality.
Senator Paul. Do you think anybody has had more influence
on our response to this than you have?
Dr. Fauci. Madam Chair, can I----
Senator Paul. Do you think it is a great success what has
happened so far? Do you think the lockdowns were good for our
kids? Do you think we slowed down the death rate?
More people have died now under President Biden than did
under President Trump. You are the one responsible. You are the
architect. You are the lead architect for the response from the
Government, and now 800,000 people have died.
Dr. Fauci. Right.
Senator Paul. Do you think it is a winning success what you
have advocated for Government?
Dr. Fauci. Senator, first of all, if you look at everything
that I said, you accuse me of in a monolithic way telling
people what they need to do. Everything that I said has been in
support of the CDC guidelines, wear a mask, get boosted, get
vaccinated----
Senator Paul. You have advocated to make it coercive and
done through force----
Dr. Fauci. Take everything that I have said----
Senator Paul. You have advocated it be done by mandate. You
have advocated that you are infallible opinion be dictated by
law.
Dr. Fauci. Right. So again, Madam Chair, I would like just
a couple of minutes because this happens all the time. You
personally attack me and with absolutely not a shred of
evidence of anything you say. So I would like to make something
clear to the Committee. He is doing this for political reasons.
What you need to do is--he said in front of this Committee----
Senator Paul. Do you think your takedown of three prominent
epidemiologists was not political?
Dr. Fauci. You don't want me to finish----
Senator Paul. That was my question.
Dr. Fauci [continuing]. because you know what I am going to
say.
Senator Paul. That was the question.
The Chair. Senator----
Senator Paul [continuing]. were you political in taking
down these three prominent epidemiologists?
The Chair. Senator Paul, if you would, please, I am going
to allow this--Dr. Fauci to respond. We have a number of
Senators who would like to ask questions, and I would like him
to be able to respond. Please do so.
Dr. Fauci. The last time we had a Committee or the time
before, he was accusing me of being responsible for the death
of 5, 4 to 5 million people, which is really irresponsible, and
I say, why is he doing that? There are two reasons why that is
really bad. The first is it distracts from what we are all
trying to do here today, is get our arms around the epidemic
and the pandemic that we are dealing with, not something
imaginary.
No. 2, what happens when he gets out and accuses me of
things that are completely untrue is that all of a sudden that
kindles the crazies out there and I have life--threats upon my
life, harassment of my family and my children with obscene
phone calls because people are lying about me.
Now, I guess you could say, well, that is the way it goes.
I can take the hit. Well, it makes a difference because as some
of you may know, just about three or 4 weeks ago, on December
21st, a person was arrested who was on their way from
Sacramento to Washington, DC. at a speed stop in Iowa, and they
asked, the police to ask him where he was going and he was
going to Washington, DC to kill Dr. Fauci, and they found in
his car an AR-15 and multiple magazines of ammunition because
he thinks that maybe I am killing people.
I ask myself, why would the Senator want to do this? So go
to Rand Paul website and you see fire Dr. Fauci with a little
box that says, contribute here you, can do $5, $10, $20, $100.
So you are making a catastrophic epidemic for your political
gain. So the only thing----
Senator Paul. You have politically attacked your
colleagues, and in a politically reprehensible way, you have
attacked their reputations. You won't defend it. No, going to
argue it. You will just simply turn around the attack.
The Chair. We are going to continue this hearing. We have a
number of questions.
Dr. Fauci. Just one more minute, if I----
The Chair. Dr. Fauci, I really appreciate your response,
but we do have a number of questions from Senators, and we do
have a second round and I am being asked to make sure that
everybody has their time, so thank you.
Dr. Fauci. Thank you very much for allowing me, Madam
Chair.
The Chair. We will move to Senator Murphy.
Senator Murphy. Thank you, Madam Chair. Dr. Fauci, thank
you. Thank you, first of all, for what you do. You shouldn't
have to put your life at risk. You shouldn't have put your
family's life at risk to simply stand up and do your job to try
to protect my constituents from a pandemic disease. And thank
you for calling out this agenda for what it is, an attempt to
score political points, to build a political power base around
the denial of science and around personal attacks on you and
your family.
On social media I follow many of President Trump's advisers
and family members and they make us sport out of attacking you
personally in some of the most vicious, hateful, ugly ways that
are possible. They do it because it gets clicks. They don't do
it because they are legitimately engaged in a honest debate
about the science revolving--surrounding COVID. Those people
attack you because it gains them political followers.
I appreciate the fact that you are willing to stand up for
yourself and for your colleagues who have been dragged into the
political muck, not because those that followed President Trump
are interested in an honest, science based debate about how to
attack COVID, but because they see political opportunity.
Thank you, Dr. Fauci, for your work, for the panel's work,
and for sticking up for yourself, which is not always easy. Dr.
Walensky, I want to take my time to just do a little bit of an
update on best practices for schools. I know we talk about this
a lot here, but you know part of what I think is frustrating
for a lot of parents is that the guidance they are getting from
the schools changes.
I get it, educators are sort of adjusting as the variant
changes, as technology changes but what has changed since the
last time, has there been any change since the last time you
were here about what you were recommending for schools to stay
open? And I appreciate what you said in the last hearing is
that schools should be the first places to open and the last
places to close.
Man, as the parent of two public school kids, I couldn't
agree more. The trauma on these kids during this pandemic has
been significant, and the data tells us that especially for
poor kids and kids of color, distance learning just doesn't
work.
I am grateful that I have got a Governor who has gone to
extraordinary lengths to make sure that the Federal dollars are
used to keep schools open. But anything new that you can share
with us about what you are recommending for schools to stay
open for the rest of the year?
Dr. Walensky. Thank you, Senator Murphy. And in fact, that
you took the words right out of my mouth. Schools should be the
first places to open and the last places to close. We had a
Delta surge in the fall, and 99 percent of our schools were
safely open. And one of the things that is majorly different
between September 2021 and today is we have pediatric
vaccinations.
We have vaccines that are available for every child over
the age of five. And the children who are in the hospital now
are largely those who are unvaccinated. So first and foremost,
one of the most important things that has changed is we should
be getting our children and our teenagers vaccinated. And if
our teenagers are eligible, we have boosters available for our
teenagers as well.
We saw through the Delta surge that we were able to keep
our children safely in school before we had vaccines. So now
today, what do we have for our children? We have vaccines, of
course, that we can use. We have school testing programs.
We have new science that demonstrates tests to say. This is
where a child might be exposed in the classroom, but if they
are exposed, they don't have to stay home in quarantine. They
can test every other day or twice a week and stay in the
classroom safely. And what that has demonstrated is hundreds of
thousands of person days of children in school rather than at
home.
We have new science that has demonstrated the value of
masking, 3.5 times increased risk of school outbreaks if you
are masking--if you are unmasked in schools versus if you are
masking in schools. And just this week we updated our K-12
guidance so that it is consistent with our isolation and
quarantine guidance for the general public so that people can
come back to school after isolation after 5 days.
Senator Murphy. Thank you, Dr. Walensky, for that and for
your commitment to keeping our schools open. Final quick
question for you, Ms. O'Connell. Talking about in-home tests,
obviously, a lot of focus on in-home tests today, but these are
antigen tests. There are some interesting research going on
about the ability to make PCR tests available at home.
There are companies all over the country, including one in
Connecticut, that believe that with some additional investment
to bring those tests to scale, we could get PCR tests into
families hands at home for a cost that is at or below what we
are currently charging, or companies are currently charging for
antigen tests. Is that a possibility?
Ms. O'Connell. Senator Murphy, thank you. We share your
interest, of course, in seeing as many tests available for the
American people as quickly as possible. And at BARDA, have
worked very closely with several of the manufacturers that you
mentioned for these at home PCR tests.
We have contracted with one of them and have reached 5
million per month manufacturing capacity in contract with them
and continue to look at the others in ways that we can support
them.
I would also like to say NIH colleagues in a program called
RADx, the rapid acceleration of diagnostics, are working very
closely with many of these companies as well as they go through
the development stages. So we remain very committed to the work
that these companies are doing and look forward to partnering
with them as they begin to bring these products forward.
The Chair. Thank you.
Senator Collins.
Senator Collins. Thank you. Ms. O'Connell, over the past 2
years, Congress has appropriated $82.6 billion specifically for
testing. In addition, we have given the Department flexibility
to use other sources of funding.
Yet, as you have heard repeatedly today, our frustrated
constituents cannot find rapid tests when they need them. This
testing crisis appears to have been entirely preventable, as is
evidenced by the availability, the widespread availability of
rapid tests in Europe, for example. The fact is that it appears
the Administration simply failed to anticipate our testing
needs.
As the former Assistant Secretary of Health recently
pointed out, a lack of Federal orders for tests between January
and September 2021 caused the manufacturers to reduce their
lines and lay workers, including at Abbott facilities in the
State of Maine where 400 workers were laid off.
As a Member of the Appropriations Committee, I share the
concerns that have been expressed by Senators Burr and Blunt. I
don't believe that we are in the position that we are in now
due to a lack of funding, but rather a lack of planning. My
question to you is, has any of this funding, as close to $83
billion that was supposed to be used for testing, been diverted
for other purposes?
Ms. O'Connell. Senator Collins, thank you for this
question. Testing remains a priority for this Administration.
And all the work we have done on testing has been to promote
the priorities of expanding the number of testing sites
available, expanding the type of tests that are available for
use in the United States, expanding the supply of tests in the
United States, and lowering the cost of tests.
We used the $47 billion that came in the American Rescue
Plan. $10 billion of that went to schools through the States to
set up the school testing programs. $8.3 billion has gone to
community testing sites, including for the uninsured and at the
community health centers and the pharmacy program Dr. Walensky
mentioned.
$5 billion has gone to procure tests and supplies, and an
additional $4.5 billion will go toward this 500 million that we
are in the process of procuring. $29 billion has gone directly
to States from previous supplementals for them to build and
promote testing programs within their jurisdictions. The
testing money, as you recall, was for testing, contact tracing,
and mitigation efforts, and some of that, the funds have been
used for mitigation efforts.
For example, when children are crossing the border one of
the responsibilities that we have within HHS is to make sure
that anyone who has--that the children that are unaccompanied
are cared for, and we used some of the funds to test those
children and then to separate them from COVID negative children
at the border.
Senator Collins. Was--I am going to repeat my question
because you did not answer it. Has any of that money been used
for non-testing related purposes at the border?
Ms. O'Connell. For the mitigation purposes as well, which
the legislation allowed the funding to be used for.
Senator Collins. I will follow-up with you because I don't
feel like I am getting an answer. Dr. Fauci, just last week,
the President once again said that COVID-19 is a pandemic of
the unvaccinated. And let me make very clear that I have been
encouraged vaccinations. I believe in them.
But contracting--contradicting the President's statement,
in Maine our largest health system reported that absences of
vaccinated staff caused by COVID-19 last week was at the
highest point since vaccines became available. It has increased
by four fold.
Does the message that COVID is a pandemic of the
unvaccinated still hold true with the emergence of Omicron? And
do you agree with the New York Times, which has twice reported
that while the COVID vaccine is critical in preventing
hospitalizations and death, it is less effective against the
Omicron variant?
Dr. Fauci. Thank you for that question, Senator. Yes,
indeed there is no doubt that the Omicron variant, when you
look at the protection against symptomatic disease and
asymptomatic infection, it dramatically goes down to about 30
percent.
What maintains itself, it goes up to about 70--it is about
70 percent against severe disease. When you boost, when you
boost, what happens is you get a rather significant
reconstitution of the protection, particularly against
hospitalization. So if you were to say that Omicron or even
COVID-19 as it is, is really a pandemic, when you are talking
about a pandemic that causes serious disease, there is no doubt
that there is an extraordinary divergence of risk between
vaccinated and unvaccinated person.
In response to the question just a bit ago when I said
that, if you look at vaccinated versus unvaccinated, there is a
17 times greater chance of being hospitalized and a 20 times
greater chance of dying if you are unvaccinated versus
vaccinated.
The Chair. Thank you.
Senator Hassan.
Senator Hassan. Thank you, Madam Chair and Ranking Member
Burr, and thank you to all of our witnesses for being here
today and for your ongoing work. I deeply appreciate it. Dr.
Fauci, I want to start with a couple of questions for you.
We need to make sure that individuals who become seriously
ill with COVID-19 can receive treatment, and that doctors have
clear guidelines on the effectiveness of each treatment for the
latest variant.
You touched on this in your opening statement, but I would
like you to just expand a little bit on this. In light of
Omicron, how is the Administration evaluating new COVID-19
treatments and monitoring the effectiveness of existing
treatments?
Dr. Fauci. Thank you for that question, Senator. There are
a number of studies that have been conducted and that are being
conducted right now, and they have to do with studies that NIH
sponsored, one of which is the adaptive COVID-19 treatment
trials, or ACTT, which in fact have been from the very
beginning as early as February 2020, was the basis for the FDA
approval of the antiviral remdesivir.
Other of those studies, particularly those on monoclonal
antibodies, showed several of them in the clinical trials to be
effective at first against Delta. We know now that a couple of
them, except for one, has now lost some of its effectiveness.
There is another group of studies called Activ and there
are six of those, and that stands for accelerating COVID-19
therapeutic interventions and vaccines, and the whole gamut of
oral, IV monoclonal antibodies, direct antivirals. And as I
mentioned in my opening statement, antivirals like Paxlovid and
Molnupiravir, the original research had been done in the early
trials by the NIH.
But importantly in direct answer to how we know what to
use, the NIH has put together a guidelines panel made up of 48
highly qualified clinicians and individuals with experience in
COVID-19 to give a prioritization of what you do if you are
infected and with advanced disease in the hospital, as well as
what you do as an outpatient, and they have fairly clearly
delineated in the guidelines, which is easily accessible by
just going to the NIH website and going to nih.gov and then
guidelines panel, and people can get a good idea, clinicians
throughout the country and the world, of how to use these
antivirals. Thank you.
Senator Hassan. Thank you. I want to follow-up, I am
grateful that the Administration heeded my call to send FEMA
teams to New Hampshire to help administer COVID-19 treatments.
However, the teams were delayed in arriving and are
scheduled to stay only for a short period of time. So, Dr.
Fauci, what additional personnel and support is the
Administration planning to provide to New Hampshire and other
States to help treat COVID-19 patients in the most effective
way possible?
Dr. Fauci. Well, there are several things, perhaps
Assistant Secretary O'Connell can answer, but I can start off
by saying that there are surge teams right now, at least 60
surge teams that have been deployed to help those areas that
have difficulty because of the surge and the fewer volume of
cases to be able to handle them with regard to everything from
hospitalizations to treatment and other implementations.
Senator Hassan. I appreciate that Assistant Secretary
O'Connell is in a good position to follow-up, and I would like
to follow-up after the hearing, but I did want to ask one other
question to Dr. Walensky.
We have long had problems with accurate State vaccination
data in New Hampshire. It has come to light that the CDC's data
on New Hampshire's vaccination rates is also inaccurate.
Apparently, the CDC can't consistently distinguish in its data
between first doses of the vaccine and boosters, and as a
result, the agency incorrectly records boosters as first doses,
artificially raising the vaccination rate.
The CDC's data is inaccurate for other States as well. We
have been looking at this for other States too. So what steps
is the CDC taking to resolve these data inaccuracies, and when
will the CDC have accurate data for New Hampshire?
Dr. Walensky. Thank you, Senator. This is a really
important question. So CDC is the compiler of the data, and we
rely on the State immunization services to provide CDC the data
at the State level. Now, among the challenges with these
accuracy is that if people don't bring in their card, they are
counted as a first dose when in fact their card would have been
a third dose.
We rely on the States to work to reconcile any differences
if a person put in a middle initial on one card, but not on
another. And we are working closely with every single State to
increase their accuracy.
We are encouraging people to bring their cards because that
also increases the accuracy. We recognize this challenge, and
we are working State by State, including in New Hampshire, to
reconcile these inaccuracies to get them more accurate in our
comprehensive reporting of every State.
Senator Hassan. Well, I appreciate that very much. Thank
you, Madam Chair. I will just say that what I am hearing you
say to the general public is it is really important to help
with the accuracy of data by keeping your car, taking a photo
of your card, making sure that you are sharing all your
information at the site where you are getting a vaccine or
booster shot.
Dr. Walensky. Very helpful. Yes. Thank you very much.
Senator Hassan. Thank you.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. President Biden inherited a vaccine, a
distribution plan, trillions of dollars in funding, but
unfortunately, this Administration has chosen to put all its
eggs in one basket, prioritized unconstitutional vaccine
mandates and testing.
Yet comparing 2021 to 2022, COVID infections have increased
72 percent and deaths increased 27 percent. This we know, if
you look at this data, your current plan is not working. The
current plan is not working, we need therapeutics at warp
speed. Ms. O'Connell, who is responsible for this failure?
Ms. O'Connell. Senator Marshall, thank you for that
question. We are making six therapies available to the American
people free of charge.
Senator Marshall. Who is responsible for the failure?
Ms. O'Connell. Senator Marshall, we continue to make
therapies available at warp speed to the American people.
Senator Marshall. The Biden administration has allocated
over $80 billion for testing and only $15 billion on
therapeutics. It is obvious that your plan has failed. We can't
keep throwing good money after bad money. This is insanity. We
have to admit our mistakes and go a different direction. Ms.
O'Connell, would you commit to an Operation Warp Speed for
therapeutics?
Ms. O'Connell. Senator Marshall, thank you. Therapeutics
are part of Operation Warp Speed. And that is how we have the
six therapies that we are currently making available to States
free of charge.
Senator Marshall. They will be available after Delta has
already been come and gone and also after, of course, Omicron
will be said and done as well. Dr. Fauci, 59 percent of
Americans and 81 percent of Republicans do not have a favorable
opinion of you. Frankly, honestly, you have lost your
reputation.
The American people don't trust the words coming out of
your mouth. Every day you appear on TV, you do more damage than
good when it comes to educating the public on COVID. Suppose
you were leading a team in an effort to try to get people to
stop smoking cigarettes, but every time your spokesperson goes
on television, over half the Nation goes out and buys a pack of
Marlboros, wouldn't you stop that person from appearing on
national television?
Dr. Fauci. Once again, Senator Marshall, I believe that is
a real distortion of the reality. If you look at everything
that I have said on TV, it is to validate, encourage, and get
people to abide by the recommendations of the Centers for
Disease Control and Prevention. Look at everything I have ever
said----
Senator Marshall. Dr. Fauci--but perception is reality. And
you are hurting the team right now. You are hurting the team
right now. Dr. Fauci, you previously told this Committee under
oath that NIH and NIAID have never funded gain of function
research with the EcoHealth Alliance. However, a report from
the Department of Defense Inspector General released yesterday
States that EcoHealth Alliance opposed DARPA in 2018, seeking
funding to conduct gain of function research on bat-borne
coronaviruses.
This proposal, named Project DEFUSE, was rejected by DARPA
because the project didn't address the current researcher's
potential to violate the gain of function moratorium. ``The
proposal does not mention or assess potential risk of gain of
function research.'' That is a direct quote from the DARPA
rejection letter.
The same proposal rejected by DARPA for gain of function
potential was not rejected by NIAID under your leadership. You
funded Project DEFUSE and its research that took place at the
Wuhan Institute of Virology. Why did you tell the Committee
that your agency has never funded gain of function research?
Why did your agency award this grant, despite it being
rejected by DARPA due to its concerns about violating the
moratorium that was in place? And finally, will you commit
today to release all records fully unredacted by the end of
this week so Congress and the American people can know the
truth about NIH's role in the origins of COVID-19?
Senator Marshall. So again, Senator, it really pains me to
have to just point out to the American public how absolutely
incorrect you are. What came out last night on Project Veritas
was a grant that was submitted to DARPA. Then it distorted and
said we funded the grant.
We have never seen that grant and we have never funded that
grant. So once again, you are completely and unequivocally
incorrect, when you joined the DARPA proposal was a grant that
we never saw, and we did not fund. So you are incorrect.
Senator Marshall. Our social media will have all the
supporting documents and we will be entering into the record as
well.
Dr. Fauci. Senator, you are backing down on this. Why don't
we go and look at the very tossed statement? They were talking
about a grant that was submitted to DARPA----
Senator Marshall. Are you saying this is not--are you
saying that this was viral gain of function research?
Dr. Fauci. I am telling you that you are saying----
Senator Marshall. Are you saying that this was not viral
gain of function research?
Dr. Fauci. By the definition that you were very well
aware----
Senator Marshall. The--definition is just legalese to get
away and allow you to do the viral gain of function.
Dr. Fauci. This is what I am talking about, Senator----
The Chair. Senator Marshall, please allow the witness to
respond.
Dr. Fauci. Senator, we know and misinformation that the
guide rails for what can be done or not were not established by
me, they were established by a 3-year process led by the Office
of Science and Technology Policy of the White House----
Senator Marshall. And decided by you in a secret meeting at
the White House in December 2019.
Dr. Fauci. Senator, that is incorrect, and this refers
exactly to what I was talking about in response to Senator Rand
Paul. You are incorrect completely, and every time I try to
explain----
Senator Marshall. You are saying you are incorrect, but the
facts are on my side. So why--would you not commit to sharing
everything, open, unredacted with this Congress?
The Chair. Senator Marshall----
Dr. Fauci. So here is an example----
The Chair. Dr. Fauci--this hearing is critically important
to the American people. There are millions of people infected
with the COVID virus. It is impacting every part of our
economy. Every family is asking for answers to critical
questions.
Both sides of the aisle have asked tough questions, but we
are not going to allow this Committee hearing to be another
personal attack that undermines our ability to deal with this
terrible virus that is impacting so many people. I will then
turn to Senator Smith. Thank you.
Dr. Fauci. Thank you, Senator.
Senator Smith. Thank you. Thank you, Chair Murray, and
well, I will just let that go. So as we move into the third
year of the COVID-19 response, it seems to me that our strategy
is shifting. We are shifting from a goal of trying to get to
zero COVID cases to eradicating the virus. And our goal is
really much more about minimizing the damage of this pandemic.
You and I have talked about this, Dr. Fauci, as well as with
Dr. Walensky. So we need, of course, to minimize
hospitalizations and deaths caused by COVID.
We do that through vaccines and through therapies. And we
also need to minimize the COVID damage by understanding how to
keep kids in school, how to keep businesses open, and how to
protect against the damage that is caused by social isolation
and burnout and other stresses that injures our mental health.
It seems to me that while--this is happening while COVID
continues to seriously stress our health care system, and while
we still have people in this country, including sadly, some
Members of Congress who continue to spread misinformation and
lies about the pandemic. So it seems like we have to be
realistic that these cycles of the pandemic, until it becomes
endemic, are going to continue. We are going to probably
continue to see some unpredictable variants arise.
Madam Chair, I just want to say that I hope that this
Committee can find some time to discuss these issues as they
relate to global vaccine strategy, because this is going to be
crucial to our work to protect Americans' health as we go
forward since we are not an island.
But let me ask, I am very interested in how we think about
like the data that is important for Americans to keep in their
minds as they are trying to measure relative risk. Last week,
public health experts published some interesting articles that
suggested that we should maybe think about incorporating COVID-
19 data into aggregate risk for all respiratory viruses that
are circulating, including the flu and RSV, and that maybe this
data, if we could look at it in real time from medical
facilities and ERs and so forth, testing facilities and private
homes even, and would give us a better picture of what is
happening.
Let me ask Dr. Walensky and Dr. Fauci, if you could talk a
little bit, I want to understand about this--I want to
understand how you think about this question of relative risk,
how we should be transitioning in what we consider from daily
case counts, for example, to looking at other data and
particularly how you evaluate this idea of looking at all
respiratory illnesses in one basket.
Dr. Walensky. Yes, Senator Smith, this is such a critically
important question. Thank you for raising this. So we have to
do two things simultaneously. Right now, we are dealing with an
Omicron surge where we have the most number of cases we have
ever had in a day in this country.
We have to get out of this Omicron surge. But in the
meantime, we have to look down the field and we have to
understand what is this going to look like when we are not in a
surge? How do we deal with endemic disease? And what don't we
start looking at with regard to endemic disease?
You are absolutely right. We need to think about the
severity of that disease because now with 62 percent of
Americans vaccinated, some of that disease is not as severe as
it was. That is the success of our vaccines. We have to look
critically at hospital capacity. What can our hospitals handle,
because if people are coming in with COVID or have hospital
staff are out with COVID that is a really important measure
that we are going to look at. And one of the things we probably
still are going to examine, although perhaps with less import,
is the actual number of the cases.
Why that is important in general is because it generally
foreshadows what is coming into the hospital. So knowing that
and understanding what that might mean for the future of
hospitalizations, future of severity, future of capacity, and
all of those are things that we are looking at right now. But
one of the things that you critically mentioned was our efforts
in data modernization.
How do we take the efforts that we have had so far with
COVID and increase them, continue to keep the pedal to the
metal as it were? When we started here, we were not collecting
racial and ethnicity data. We didn't have a way to link in a
personal--with personal identifiers removed, electronic health
records with our testing records. We had 187 hospital systems
who could do that.
Now we have 10,000. So what we really need to do is scale
up our data modernization efforts and do it, as you say, not
just for COVID, but--and not just for other respiratory
diseases like flu, RSV, as you note, but for all diseases.
We are looking at doing this for maternal mortality, for
sickle cell disease, for opioid injury, for many, many diseases
and this is going to be the power of our data modernization
efforts and I am really grateful for resources from Congress to
be able to leverage those. Thank you.
Senator Smith. Thank you. Madam Chair, I believe I am out
of time, but I will have other questions if we have a second
round.
The Chair. We will have a second round.
Senator Tuberville.
Senator Tuberville. Thank you, Madam Chair. Thank you for
being here today. You know, this Administration has been in
charge of the Federal COVID response for a year. I have to say
I don't think it has been a job well done. Our Federal
Government not only sets the tone and the guidance for how
millions of Americans should be handling COVID, we set the
standard for the world.
Our information has to be correct. I continue to hear that
we need to follow the science and I agree. But we have to yet
hear the clarity from this Administration. We are conflicting
guidance across the board. In order to be effective, guidance
has to be understood and implemented by the average American,
but most Americans can't make heads or tails of anything coming
out of this Administration.
We are all, all of us, are failing this test. One thing I
do know is that when we finally toward the end of this thing,
Congress is going to have an investigation. We all know that.
We have heard that the FDA and President Biden say 55 years
will be needed to share data related to a lot of those
decisions. But we will have to investigate. This group will
have to investigate and have the information before 2076.
Heck, most of us won't be here in 2076. This investigation
will look into what--who had authority to make decisions. I
know there are more people making decisions behind the scenes.
So what I would like to know is I am just concerned how badly
the response has been. It is handled--President Biden has
handled this in his first year. We have heard all the pluses
and minuses.
This Administration took office with three successful
vaccines and numerous effective therapeutics and basically
drove the response into a ditch. At times, it doesn't seem like
anyone is in charge. You started the year by dismantling
Operation Warp Speed, canceling contracts of monoclonal
antibodies, underinvesting in testing, and we spent billions in
that, first with Delta now on Omicron, people can't find a
test.
I am getting text as we speak sitting here, where do I get
a test. We spent billions on this. You know, if we can't find a
test and test positive, they can't get treatment. Monoclonal
antibodies are rationed. Antiviral pills are months away.
I just got a simple question, of all of you up there and
whoever wants to answer this, if you have a problem in your
coordinates, who do you go to? Who is the head coach of this
virus that you have to go to, whether it is an Administration,
whether it is one of you? Dr. Fauci, who do we go to?
Dr. Fauci. The person who is in charge of that is Jeff
Zients----
Senator Tuberville. At the White House?
Dr. Fauci. At the White House. And we meet very, very
regularly, the entire medical team as well as others going over
all of the data, going over what the strategies are, going over
what the issues are, what the problems are, what we have done
right, what we have done wrong. We examine literally
continually, sir,.
Senator Tuberville. Has he done a good job?
Dr. Fauci. You know, I think given the circumstances that
we are in right now, I believe he has done a very good job. I
really do this. This is an extraordinary virus, the likes of
which we have not seen even close to in well over 100 years. It
is a very wily virus. It is fooled everybody all the time from
the time it first came into Delta to now Omicron. Very
unpredictable and we are doing the best we possibly can.
Senator Tuberville. Yes. Dr. Walensky, it has been reported
by some virologists and scientists that this year around 170
people have died from taking the regular flu vaccine. The
Vaccine Advisory Adverse Reporting System reported that the
number of people dying after or following the COVID vaccine is
actually in the thousands.
Now this is what I am hearing. I will give you a chance to
refute that or confirm it here. You know, is this true? Are we
having that many people die after taking one of these vaccines?
Dr. Walensky. Senator Tuberville, thank you for that
question. The Vaccine Adverse Event Reporting System is a
mandatory system of any adverse event that happens after being
vaccinated.
If you get hit by a car tragically after getting
vaccinated, that gets reported in the vaccine adverse reporting
system, VAERS system. So the vaccines are incredibly safe. They
protect us against Omicron, they protect us against Delta, they
protect us against COVID. They don't protect us against every
other form of mortality out there.
Senator Tuberville. Do we keep numbers of people that died
following taking a COVID test--from taking this vaccine? Do we
have any idea? I am just asking.
Dr. Walensky. I am sorry, those who have died after taking
a COVID test?
Senator Tuberville. Following taking the vaccine. Is there
any number or count? Do we keep records on that from----
Dr. Walensky. Absolutely, yes. I couldn't give you the
absolutely number off the top of my head, but our staff could
absolutely get back in touch with you. We collect this data.
Senator Tuberville. Do you know, Dr. Fauci? Do you have any
clue on that?
Dr. Fauci. About how many died----
Senator Tuberville. 100?
Dr. Fauci. I don't know the number, but I think it is
really important for----
Senator Tuberville. Microphone, microphone.
Dr. Fauci. I am sorry, I don't have a number, but I think
part of the confusion is that when you do a reporting, if you
get vaccinated and you walk out and get hit by a car, that is
considered a death--I mean, that is the thing that gets
confusing, that everything that happens after the vaccination,
even if you die of something completely obviously unrelated, it
is considered a death. So if I had metastatic cancer, got
vaccinated and died 2 weeks later that is a death that gets
counted.
Senator Tuberville. I understand that.
Dr. Walensky. And every one of those is adjudicated.
Senator Tuberville. Yes. And one quick question before we
get through here, I am in rural Alabama, but I get one of these
home tests. I test positive. I have--asymptomatic. What do I
do? People call--what do I do? I don't have a doctor. What do I
do?
Dr. Walensky. Thank you. So you are asymptomatic? You are
asymptomatic, no symptoms, feel well?
Senator Tuberville. Yes.
Dr. Walensky. You stay home for 5 days and the next 5 days,
if you continue to be asymptomatic, you can go out, wear a
mask. Don't go traveling. Don't go to gyms----
Senator Tuberville. If I get real sick, then what do I do?
Dr. Walensky. Then--well, first you go and call your
physician. And in fact, I tell you, call your physician
regardless, but call your physician, call your provider. If you
are continuing to have symptoms, then you stay home until your
symptoms are resolved.
Senator Tuberville. No therapeutics?
Dr. Walensky. Well, that is where I would say call your
physician and see if you are eligible for therapeutics.
Senator Tuberville. A lot of these people don't have
physicians. They have got a drug store.
The Chair. Senator, we do need to move on.
Senator Tuberville. Thank you.
The Chair. Thank you.
Senator Rosen.
Senator Rosen. Thank you, Madam Chair. Thank you, Ranking
Member Burr. This hearing is so very important. I really want
to thank all of the witnesses here for testifying today, for
your continued work. Thank you so much as we combat this
pandemic in real time, in real time.
First, I just want to want to echo the concerns my
colleagues have raised about access to testing, both in-person
PCR tests and the at home rapid test. We do know that home test
kits are scarce. Americans are standing in extremely long lines
to get a COVID test, and hospital emergency Departments in my
home State of Nevada have seen a significant increase in people
coming solely for tests because there just aren't enough
alternatives.
This is just really only adding to the stress, as again, I
can say speak to Nevada on our health systems. Nevada has been
expanding our testing options but increased Federal support on
the ground in addition to home testing, we feel is absolutely
critical. And in the future, the Federal response must be more
proactive in this space.
I am a little bit concerned about the testing keeping up
with the variants because we are--this is all happening in real
time. COVID is evolving. You don't know which strain may become
the dominant strain. And so we want to ensure just in addition
to the effectiveness of the vaccines and therapeutics that the
testing accuracy must also keep up.
Dr. Fauci, with some recent reports about the current
variant settling more in the throat than in the nose for some
patients, what are we doing with the development and deployment
of rapid at home tests based on saliva versus a nasal swab?
Then, Dr. Woodcock, how rapidly do you think of the over-
the-counter testing can be delivered, approved--looked at
approved, delivered to the American public to make sure that
they are less anxious?
Dr. Fauci. Thank you for that question, Senator. Yes, there
have been recent reports that in fact the sensitivity and the
ability to detect in a swab of the throat versus the nose of
pharynx, at least with omicron, that is the preliminary report.
I think it needs to be validated and verified. If the data
were strong enough, then we--the company, whatever, who makes
that will likely go to the FDA to ask to change the indication
because the emergency use authorization is for a nasal swab.
If the data, the scientific data indicate that is better to
get an oral or other swab, they would present that to the FDA.
So I would leave that to Dr. Woodcock to answer the rest of
that question.
Senator Rosen. Thank you.
Dr. Woodcock. Certainly. Well, we can act very rapidly. But
first, I would like to say people should not use swabs that are
designed as nasal swabs and try to swab their throat. They may
stab themselves, Okay. That would not be good.
What we need to do is have tests that see whether the
throat swab, as Dr. Fauci said, could provide more sensitivity.
We do know the tests are picking up omicron, but right now with
less sensitivity than they did some of the other variants.
As far as time, as I said, after the ITAP program does the
testing at NIH, FDA has been able to approve--authorize within
a day or two of getting those data. However, the companies
would have to change the test configuration to accommodate the
swab, the larger swab that you would use in the throat, and
that is probably what would take the most time, as well as
seeing whether that was better.
Senator Rosen. To continue with that point, as we have seen
with some of the testing, the reagents or the materials that it
really takes to use the test, is there the ability for people
to return a test that may no longer work?
Can those agents, any of that be recycled or upcycled if
they are returned to the company unopened? Like, how can--how
do we not dispose them and not get some recyclability out of
that? Is that possible in some way?
Dr. Woodcock. We can get back to you on those parameters.
Would be happy to do that.
Senator Rosen. Thank you, I appreciate that. I would like
to talk a little bit again, people are talking about the public
health data. You know, we are noting about all the daily
statistics, noting about some of the statistics about possibly
deaths, and so positive or negative, critical--this data is
critical even for us to make our decisions as far as what we
fund.
Sometimes there is no choice to say that we shouldn't
include home testing in the daily statistics because they might
not be reliable. So Dr. Walensky, to build on some of that
testing and the statistics that you need to do your job, that
all of us need to do our job, how is the CDC working with the
State, local health, our hospitals to be sure that the
voluntary self-reporting guidance, it is going to be accurate
and give us the kind of statistics we need going forward?
Dr. Walensky. Yes, thank you for that question, Senator. So
we are routinely reporting PCR tests. That is what is routinely
reported from the State and that is what our updated statistics
are. There are--there is passive reporting that occurs with
rapid tests, but I also want to--understand, the importance of
rapid tests, at home tests for people to be empowered to use
these rapid tests to do the right thing.
Regardless of whether we can count them, generally they
tend to be people who have milder symptoms. They might have
been vaccinated, have a runny nose, and they decide to go and
get a rapid test and do the test at home. Less important is
counting that case than it is that person stay home, isolate,
do the right thing, and not be forward transmitting.
I think that many of these tests have different purposes.
But one of the really important purposes of these rapid tests,
even if we don't count them, is to empower the public to do the
right thing through this pandemic.
The Chair. Thank you.
Senator Rosen. Thank you very much.
The Chair. Senator Romney.
Senator Romney. Thank you. Thank you, Madam Chairman. Just
a couple of thoughts. One, it has been 2 hours since we have
been here. As one of the people at the low level here--out in
the hinterlands. Just a couple of thoughts. One, I think it
would be helpful if, and please excuse me for this comment, if
the Chair and Ranking Member limited their opening comments to
the 5-minutes, just like you expect those folks to limit their
comments to 5 minutes.
We didn't get started till 25 minutes after asking these
folks their questions. I do want to note also that in this
process, as I am sure you who are testifying here today
recognize, that some of what we do is performing, and so what
we do is to become informed. And I do both from time to time,
so I am not just in one camp or the other in that regard, but I
do want to point out how much I personally and I believe the
great majority of the people in our country respect you
individually and professionally for the work that you do. You
are scientists, not politicians.
Nevertheless, you are being made subject to the political
whims of various political individuals and that comes at a high
cost, which unfortunately I fear will lead some to not want to
participate in helping our Government make scientific choices.
But I very deeply appreciate your commitment to the American
people and your desire to do things as well as we possibly know
how to do. That doesn't mean they will be done perfectly. That
doesn't mean you won't make mistakes. Doesn't mean there won't
be changes from time to time.
Sometimes as data comes in that is different than what you
had anticipated, and sometimes just because you were wrong. I
mean, it is the nature of being a human being. That is where we
are. I think unfortunately, the Administration was wrong in not
building testing capacity at a time when we all thought COVID
was kind of going away.
I remember the summer and the fall, going into a grocery
store--excuse me, into a drugstore and seeing two rapid tests
on the shelf, and those things stayed there for days. No one
was interested in buying a rapid test. And apparently the
Administration didn't think that it should be aggressively
building rapid tests.
Omicron came along, cut people by surprise, and we were
obviously badly mistaken, the Administration was, and we are
suffering in part because of that. Let me ask with regards to
Paxlovid. Ms. O'Connell, is that being subject to Warp Speed?
My understanding is that Paxlovid is far superior to other
oral antivirals. Should we not be much more aggressively
producing that and getting that out so that it can be
prescribed?
Dr. Walensky. Thank you, Senator Romney. We are in active
conversations with Pfizer about how to increase their time
limits. It is my understanding, and the scientists on the panel
can feel free to jump in, is that the process required in order
to generate this particular antiviral is months-long. It is a
chemical process.
It is one that is very, very hard to accelerate. What we
have been able to do is to find additional doses to work with
Pfizer to try to unlock additional capacity, where they can
find it. And we are continuing to do that actively.
Senator Romney. Thank you. Dr. Walensky, good to see you
again. I appreciate the chance we had to speak earlier this
week or last week rather. As I have looked on the CDC's COVID
tracker report, I note the data goes through November 20th and
I remember my days in business, if we didn't have daily
information, we couldn't make good decisions.
I wonder, do we need to invest in either developing a new
sub-agency or a task force to get basically immediate data,
daily data so we know what is going on. And that is not just
for the public that is for those of you who are making those
decisions. Do we need do a much better job moving faster
getting data?
Dr. Walensky. Senator, first of all, let me thank you for
your earlier comments. But also to comment on our COVID data
tracker, I think you are speaking to the seven--I am sorry, the
27 jurisdictions that we now compile data, that allows those
jurisdictions to report together their testing data, their
cases data, their immunizations data, their age data, as well
as their death data.
It is over two-thirds of the country that we do, and we
update that about once a month, and it is about three or 4
weeks in a year. So mid-January, we will be having data through
the end of December, and it simply does take that long for our
jurisdictions to compile those data.
Of course, our death data are generally lagging. It takes a
while for those to get reported and adjudicated. So we are now
updating those are about 6 weeks in a year and that is in--we
are working hard to keep those in real time.
Senator Romney. Yes, I know retailers like Zara, for
instance, they apparently get data and correlate it daily. So I
would hope we could find a way to increase the speed with which
we get that data. I know my time is up. If I could just going
to make a comment, and that is that I think it would be helpful
if people knew when they should get tested, when it is called
for, because I think a lot of individuals, myself included, get
tested when there is no indication that I need to get tested,
other than just want to make sure I am not sick.
There is huge demand for tests which are in short supply,
in part because of that. And No. 2, when you say when people
have been exposed, please let us know what it means to be
exposed. We are in a room right now. I am sure someone here has
Omicron.
Are we all exposed and therefore need to get tested? What
does it mean to be exposed and when do we need to get tested?
And I know--I wanted to ask that of Dr. Fauci. I can't do that
given my time. Those are topics I would love to have elaborate
on that. Thank you.
The Chair. Senator Romney, I think that is a question we
all want answered, and I will give Dr. Fauci the opportunity to
respond to that.
Senator Romney. Dr. Fauci.
Dr. Fauci. Well, the CDC guidelines make that very clear,
and it is if you are exposed to an individual with known--if
you are in a period of 15 minutes at a time or a total of 15
minutes over a 24 hour period, in a situation where you come
into close contact, perhaps Dr. Walensky could expand on that,
but that is the fundamental core of the CDC guidelines.
Dr. Walensky. That is exactly right in terms of the
definition of exposure. In terms of who should get tested, you
should get tested if you have symptoms of COVID-19. If you do a
rapid at home test and you continue to have symptoms and that
test is negative, you should do another test or get a PCR.
You should get tested within 5 days of your exposure or
after 5 days of your exposure with the definition that Dr.
Fauci mentioned. And we are testing through tests to stay and
other mechanisms as well.
Many reasons to test, but really, most importantly, if you
are exposed, if you have symptoms, and also if you are going
into a setting where you might be seeing an immunocompromised
person, somebody who is vulnerable, not able to be--to take a
vaccine.
The Chair. Thank you very much.
Senator Casey.
Senator Casey. Chair Murray, thank you very much for this
hearing. And I want to start by commending the public service
of all of the members of the panel, Dr. Walensky, Dr. Fauci,
Dr. Woodcock, and Assistant Secretary O'Connell. This is
difficult work, and we appreciate your public service.
In particular, I want to reiterate statements I think I had
to make before in light of Dr. Fauci's commendable public
service, not just in the middle of this pandemic, throughout
the pandemic, but also for decades. I think I speak for a lot
of people back home and across the country that not only have
confidence in your integrity, but also your work in public
health, and so we are grateful for that. Let me start with a
question for Dr. Walensky.
Doctor, I am quoting from a statement you made on Friday on
television in the context of a question about COVID-19 deaths.
And I will quote two sentences. One is, ``the overwhelming
number of deaths, over 75 percent occurred in people who had at
least four co-morbidities. So really, these are people who were
unwell to begin with and, yes, really encouraging the news in
the context of Omicron.''
Now, this statement, and I know it was part of a broader
interview, caused great concern. I know from my work as a
Senator for years that you and your team at CDC, whether it is
your, the policy or the work that you do, that policy and that
work are both focused on ensuring that all Americans receive
the best possible treatment and protection.
This is especially important for older adults and people
with disabilities who may need additional supports and
protections. So context is important in an interview like this.
So please explain what point you were making, that is No. 1,
the point you were making. And second, outline CDC's commitment
to protecting older adults and people with disabilities as we
continue to address the pandemic.
Dr. Walensky. Senator Casey, I am really grateful for the
opportunity to explain this. And to step back, that interview
on Friday, I recently spoke to a study on the high level of
protection against vaccines. It was a pre-taped interview and
much of it was cut and that phrase was taken out of context, as
you note.
The study was a cohort of 1.2 million people who were
vaccinated and 36 people passed, demonstrating their remarkable
effectiveness of our vaccines. But no less tragic is the 36
people who passed because of COVID-19, and that many of them
had comorbidities, comorbidities that I have spent my career
taking care of, comorbidities that just prior to coming to the
CDC, we saw time and time again disproportionately impacting
people with COVID-19 and the hospitals that I cared for
patients.
What are we doing at CDC given the critical importance?
Well, we have toolkits for COVID-19 for patients with
disabilities. We have accessible materials that are available
in braille and in American sign language so that people with
disabilities, in easier to read and understand language, so
that people with disabilities can access our materials. We have
improved data collection systems on our COVID data tracker. You
can track vaccination status by disability.
We have worked with States to make sure that those are
reporting. And the more funding partners in our public health
partners to do more for patients with disability. And if
anything, this issue on Friday has redoubled our commitment to
continuing to make sure that we have access for people with
disabilities. Thank you for allowing me to clarify.
Senator Casey. Well, I appreciate that, and I appreciate
the time it took to respond. I would also suggest and maybe
even ask you to spend some time meeting with leaders from both
the disability and aging communities to walk through what you
just walk through and even expand beyond that.
Dr. Walensky. We are already planning. Thank you.
Senator Casey. Thanks very much. I want to turn now to
vaccine development for children. The recent setbacks in
vaccine trials for children under five is of great concern. So
many parents are exhausted from this pandemic.
I know we can't change the outcome of the trials, but we
can take steps to reassure parents that their young children
will still get vaccinated as soon as possible. Dr. Fauci, Dr.
Woodcock, if you could briefly talk about these trials and
any--anything you can tell us about speeding up the development
of safe and effective vaccines for children under five.
Dr. Fauci. Thank you for that question. Senator, I will
take a quick shot at it and then pass it over to Dr. Woodcock.
The situation that I believe the public needs to understand is
that the trials from children from 6 months to 4 years was
broken up into two groups. It was 6 months to 24 months, 24
months to 4 years.
In the dosage that was used, the individual, the children,
the younger group, the trial met the end point of
noninferiority, comparing it to what would be the standard of
what would be success. However, for the middle group, the 24
months to 4 year group, they did not meet that standard of
noninferiority.
Because of that, it was felt that this likely will be a
three dose vaccination for children in that group, so the
trials are being done now as quickly as possible to see if they
can get that data to have a uniform dose and a uniform regimen.
But I will pass it over to Dr. Woodcock.
Dr. Woodcock. Yes, well, of course, I can't say a lot, but
we are working very closely with the manufacturers of vaccines
on accelerating and making sure that vaccines are available for
the youngest children.
Senator Casey. Thank you very much.
The Chair. Thank you.
Senator Murkowski.
Senator Murkowski. Thank you, Chairman--Madam Chairman. It
says a lot about 2021 when the most appreciated gift under the
Christmas tree in our family was COVID kits for everybody. I am
still getting thank yous for those. Dr. Walensky, there has
been a lot of discussion here today about the--some of the
confusion with guidance and just some very clear asks to tell
us what that is.
A question that I am going to forward to you from a teacher
is, if the teacher is fully vaccinated, boosted, tests positive
for COVID, but after they test positive, they feel pretty fine,
there is no fever, there is no nothing, after 5 days, can that
teacher return to school without testing negative just so long
as that individual wears a mask?
Dr. Walensky. Yes. Thank you, Senator.
Senator Murkowski. Great. That is exactly what I needed to
know. I am going to be having a meeting, a zoom meeting later
this afternoon with several different Alaska based companies
that have more than 100 employees. They are quite concerned
about the mandate that requires testing of unvaccinated
employees.
We all know that this is under litigation now, and things
may change on that. But right now their real concern is, if
this goes into place and we are required to ensure that these
unvaccinated individuals receive testing, right now testing all
around the State is in limited supply. The front page of the
Anchorage Daily News shows the line of cars that are waiting to
get there their PCR tests.
You can't find the at home tests available in the stores
now. It is becoming harder and harder. And then again, if you
really do have a mandate in place, it is going to require this.
So I know that the question has been asked about what more is
being done. I know we have heard the extraordinary Federal
resources that have gone that way, but the facts on the ground
remain that we are in an extraordinarily short supply of
testing, whether it is the at home kits or whether it is the
ability to get the testing that you need.
It is cold back home right now and my hearts go out to
those workers who are working in the outdoor drive in where
they have to go out when it is 20 below as it is in Fairbanks.
That is more of a statement rather than a question there, but I
think it is important for folks to realize that we are still in
a very difficult place when it comes to accessibility.
Dr. Walensky, this is a question for you, and you and I
have had many conversations last year about the specific impact
of conditional sail orders as it relates to the cruise
industry. That industry was effectively shut down or all of
2020, and we were able to salvage a bit of it as things relax
last year.
But in fairness, the industry itself has undertaken
extraordinary precautions as one industry to make sure that
people are protected from this virus. So the question to me--to
you is, I want to make sure that Alaskan communities and
businesses can have a season this coming year. And right now
people are making their decisions as to whether or not to book
a trip to Alaska for the summer or not.
I understand the conditional sail order is set to expire in
a few days in recognition that the companies have practices
that adhere to or even exceed the guidance in the orders. So I
guess I would like some assurance from you that they can count
on that, that this is clear guidance and messaging to those
within the industries and to those who are counting on being
able to have a season is coming summer.
Dr. Walensky. Yes, thank you, Senator. And I think the
conditional sails order and the fact that the industry has
stepped up and is now interested in doing and exceeding, as you
note, the compliance with the sail order without the order even
necessarily needing to be in place is a real testimony to how
well that has worked and how we work collaboratively with the
industry.
What I can say is that just over the last 2 weeks with
Omicron, we have seen a 30 fold increase in cases on ships
during this season because of Omicron. So while I anticipate
that with ships following conditional sail order, we still will
continue to follow--do the oversight and watch and do all the
technical assistance and support in every single way.
We anticipate that this order will not be renewed and that
the cruise ship industries will continue to understand that
this is a really safe practice for those industries. What I
can't predict is what the summer will bring.
Senator Murkowski. I understand that, but for right now,
you expect this guidance to stay in place.
Dr. Walensky. That is my anticipation.
Senator Murkowski. Thank you. Thank you, Madam Chair.
The Chair. Thank you.
Senator Hickenlooper.
Senator Hickenlooper. Now it is on. Thank you, Madam Chair
and Ranking Member Chair, right. First, I want to reiterate a
little bit about what Senator Romney said. You know, I was the
odd one out, I was--worked as a scientist for a number of
years, then I was a Mayor of a big city and was pretty much the
only scientist among all the Mayors. I was a Governor and
pretty much the only scientists around Governors. And now I am
one of the only scientists among Senators and I recognize from
that long list of experience the frustration that you must feel
having to put up with the attacks and assaults when you are out
there trying to do your job. It is something that each of you
have committed to, the service of society.
I just want you to know that I appreciate how difficult
science is, it is not perfect, and when you combine that with
the complexity of dealing with any large bureaucracy, I am not
making apologies, these are just like just like any--well, we
are having a war against this virus, and just like in any
wartime situation, mistakes have serious consequences, but I
appreciate more than I can say how much work you all have done.
I don't think anyone here thinks you are not trying your
very best all the time. Really appreciate that. Dr. Fauci, I
think one of the problems we haven't gotten far enough on is
innovation, and how do we stimulate innovation to go faster and
better? How do we increase not just the breadth of our
vaccines, but the durability so that as we get the next wave--I
am not sure how many letters there are in the Greek alphabet,
but I know there is going to be another one?
In that process, because I think we are, this country is
known for innovation, it is one of the tools that we have that
we know work. I am hoping that you can take the opportunity to
be a little bit optimistic and feel that you are not going to
be judged and held accountable because I think people want to
hear that we are going to come through and begin to look at
some of these things successfully.
Dr. Fauci. Well, thank you very much, Senator, for your
original kind comments. And I will answer your question now. As
a scientist, that there are fundamental basic issues that are
discovery, that once you get the discovery, then you could do
the implementation of that discovery--we were very fortunate in
that the basic research and clinical research investments that
had been made literally for decades prior to the new revelation
that we had a very threatening virus among us was the reason
why we were able to use new platform technologies as well as
immunogen designed to get highly successful and safe vaccines.
That same thing is going on right now. It isn't well known
because it isn't front page yet. And as a scientist, when you
are doing your basic research, it is only until you get the
result that people really understand what you have been doing.
There is a lot of investment not only in improving the
vaccines that we have for COVID, for SARS-CoV-2, but a lot of
work, as I mentioned in my opening statement, about looking at
using the tools of fundamental, basic, and applied science to
develop next generation of vaccines, particularly universal
coronavirus vaccines, or at least universal SARS-CoV-2
vaccines, so we won't be chasing after the next variant. That
we will be able to have a vaccine that has the capability of
responding to every iteration of a variant.
There is a lot of work going on with that right now. But
again, when you are doing basic research, as you can appreciate
as well more than anyone that usually isn't very well
recognized by the public.
Senator Hickenlooper. Point made. In terms of testing, a
parallel thought, Dr. Woodcock, maybe you can address this, but
the testing now by the time it gets the retail is somewhere in
the $15 to $20 range, maybe as high as $22 or $23 in some
places.
Is there the prospect of--because I keep reading about
different approaches to testing, that we might find a way to
do--reduce the cost of testing down to service instead of $15
could be $0.15 cents, or at least for the chemical side of it?
I realize then you have got a manufacturer and put it in cases
and packaging. Maybe you can provide a little optimism on that.
Dr. Woodcock. Sure. Well, I believe the RADx program, which
Congress provided funding for quite some time ago, is really
cutting edge, and they have a sort of a shark tank approach.
They are really looking for innovation.
They are--they provide assistance to developers, and I
really believe that is promising, that we will come up with
additional technologies that are easier to manufacture and
actually easier for people to use and cheaper.
Senator Hickenlooper. Great. Thank you, and I have
obviously more questions, but I will yield the floor back--for
now.
The Chair. Thank you.
Senator Braun.
Senator Braun. Thank you, Madam Chair. Reading the paper
last night, lead editorial in The Washington Post, and I about
dropped it when I read the first paragraph. In the title of the
editorial is, living with COVID. ``Quite understandably, the
coronavirus pandemic at first was a dire emergency, but it
can't be one forever. The crisis will have to shift to a
manageable health threat without massive disruption and
overwhelming anxiety. President Biden has been fighting the
virus as an emergency in his first year, but a shift must come
before too long.'' Never thought I would read anything like
that in a place like Washington Post, but I think it reflects
where we are at in the journey.
Generally when you wrestle with something of this magnitude
where it has dominated the conversation for now 2 years and you
are still seeing results similar to, if not worse, from when we
started, it would beg the question, do we need to take a
different approach? It has been very top-down, been put in
place, I think understandably, by the agencies that would be
most pertinent.
But when you look at the results, you look at the fact that
a third of the country, for whatever reason, is not going to
get vaccinated. You got a mandate that now is going to force
the hand. And when you get someplace like The Washington Post
saying that we have got to take a different approach, I am
wondering, do we have it within our constitution here, when we
have been brought in for so long that this is the way it has
got to be?
Listening to Senator Casey earlier, made a very good point,
everybody talks about data, paying attention to the data, and
when this is so ravaged such a small percentage so
significantly of a population with comorbidities that are
elderly, it just keeps saying, why don't we change the
approach?
You don't want to have the legacy of being a country in
disruption and full of anxiety. And kind of what I am hearing
here today, I am not sensing that we are going to see a real
change in approach, and even more so, doubling down on what now
for 2 years has arguably not gotten us in a place where we feel
better about it, where we are not drowning in anxiety. And I am
going to pose the question to Dr. Woodcock.
You have been involved in Federal health care in one way or
another for a long time, Acting Commissioner at the FDA.
Normally, a Board of Directors, a CEO would be fired as a CEO,
No. 1, a Board of Directors would be questioned in terms of how
good they are, meaning maybe us here in the Senate, to where
you are not directing for something other than what we have
had, which in my opinion, would be decentralizing it, providing
the information to the American public to make their own best
decisions.
Dr. Woodcock, do you think that is sensible? Do you think
The Washington Post makes sense? And are you willing to change
up there on this panel to reflect accordingly?
Dr. Woodcock. Well, I think that we are talking about a
natural disaster, and you can fire your Board of Directors
because your factory was devastated by a hurricane or tornado
or a wildfire, but I don't know whether that would improve this
situation. I think right now we need to focus on continuity of
operations for hospitals and other essential services as this
variant sweeps through the population.
I don't think that will last a really long time, but that
is what--where I think we are right now. So I don't think prior
approaches reflect what is going on right now. I think it is
hard to process what is actually happening right now, which is
most people are going to get COVID, alright.
What we need to do is make sure that hospitals can still
function, transportation other essential services are not
disrupted while this happens. I think after that will be a good
time to reassess how we are approaching this pandemic.
Senator Braun. I am out of time, but I think if you want to
regain the trust of the American public, you probably need to
look at a total revamp on what we do in terms of how we contend
with it over the next year or so, or I think you are going to
get more forceful editorials from places that you would never
imagine. If you keep doing the same thing, generating the same
results, that isn't the formula for success in any endeavor.
The Chair. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Madam Chair. And I want to
thank all of our witnesses today. And I also want to just
underscore the preface that our colleague, Senator Romney, gave
to his questioning. I like the way he described it, sometimes
we come to perform, sometimes we come to be informed.
I guess I would just speculate a little bit beyond that if
there were to be a true tit for tat on the performance angle,
there is any number of areas we could go. I reflect on
proposals for ultraviolet light and drinking bleach and
drinking hydroxychloroquine. We could go there, but it is not
constructive.
I am going to be constructive in my questions, and I just
urge my colleagues to do that. We are all in this together, and
we have a duty to act responsibly in that fashion. And again,
thank you to our witnesses. Dr. Walensky, I am going to start
with you on a topic that I bring up frequently when you are in
our presence, and that is the tools we have now to sequence, do
genomic sequences to better understand variants, to better
track variants.
I know that there has been much investment in that. I would
like to hear what tools that we have in place now that we
didn't before and what you see the future of this genomic
sequencing is, especially as this Committee looks at pandemic
preparation for future potential pandemics.
Dr. Walensky. Thank you, Senator Baldwin, and for your
championing our ability to ramp up our genomic sequencing
efforts and the resources from the American Rescue Plan. Once
that $1.7 billion really did allow us to detect Omicron
swiftly.
Maybe I will just tell you the story of what happened with
Omicron, and that as we heard about this variant that was
coming from South Africa and we didn't know if it was here yet,
but we did know it had this unique footprint of the S-gene
target failure on PCR.
What we did immediately after hearing about this is to
enhance surveillance for this footprint and do enhanced
sequencing so that any sequence that had this footprint--I
shouldn't say any. Many sequences that had this footprint, we
were specifically looking for this Omicron variant.
Within days, we found it. So within 3 days, I think that we
started doing this enhanced surveillance, and then within days
we had tens, forties. By about 4 days later, by December 5th is
when we started detecting it in our background genomic
sequencing. So that background genomic sequencing now does tens
of thousands of sequences a week. It is a collaboration with
academic partners, industry commercial labs, CDC labs, public
health partners to do tens of thousands of sequences a week.
What we do is we look at the number of cases that are out
there, and our goal is to detect a variant that is present at
0.1 percent with 99 percent confidence, so that we see the menu
of variants that are out there. We are enthusiastic about this
program.
We are intending to ramp up this program for potentially
other viruses with the potential to do so there, for other
foodborne outbreaks, as well as for wastewater investigation.
We have the capacity to do that there as well. So again, thank
you for championing this effort, which truly did allow us to
detect Omicron in real record speed. Thank you.
Senator Baldwin. Thank you. Next, Assistant Secretary
O'Connell, when we last met in this Committee, I asked you for
a commitment that a significant portion of the $10 billion for
the Defense Production Act funding that I helped secure as part
of the American Rescue Plan be invested in the raw materials
needed to make N95 masks here in America.
The alarming spread of Omicron has made the need for N95
even more clear, and yet ASPR has not spent any of this
American Rescue Plan funding on the raw material needed to make
N95s in America, while it has invested $3.1 billion on other
priorities, primarily using prior supplemental funding.
The FDA reports now that 60 percent of the KN95 masks that
are being imported from China are fake, and Americans still
can't go to a local pharmacy and purchase an American made N95.
So President Biden has now personally urged Americans to
upgrade the quality of the masks they wear.
I want to know when the American people will be able to buy
an American made N95 mask that they know will protect them, and
when we can expect ASPR to invest the American Rescue Plan
funding into the raw materials necessary.
Ms. O'Connell. Senator Baldwin, thank you for that
question. You can buy an N95 mask manufactured in America now.
We have 737 millions of those in the Strategic National
Stockpile. We are also in the process, this month, we hope, to
award--or next month as contracts go, to award an agreement for
warm based manufacturing of N95 masks.
What we are asking the vendors to return to us as part of
the proposal is their ability to manage 141 million masks a
month at a surge capacity and to be able to maintain that
manufacturing at a 20 to 30 percent rate in times where demand
is not as high.
We are very invested in N95 masks being made available, and
we will continue to look, and I appreciate your support in
getting us the American Rescue Plan dollars that we are
currently investing. And we will continue to look at the right
ways to invest that and have really appreciated the
conversations you and I have had around that.
The Chair. Thank you very much. I appreciate the witnesses
have been here well over two and a half hours. We are going to
have a second round of questions. So I am going to recess for
10 minutes to allow a break for our witnesses. We will
reconvene at 12.45 p.m.
[Recess.]
The Chair. This Committee will reconvene. And before I
start, I do want to make clear that this Committee will conduct
itself with decorum and respect, and if I do hear personal
attacks, I will gavel, and we will move on to the next
questions. And I want to thank the Committee Members and
witnesses.
I also am going to be very strict with the 5-minute rule as
we have moved way past our time here and we need to move on. So
with that, I look forward to the next round of questions so we
can get to the essential work of addressing this pandemic,
which has upended so many lives and that continues to threaten
the public health. And we will begin with Senator Baldwin.
Senator Baldwin. Thank you, Madam Chair. Dr. Walensky,
during our last hearing, we discussed the critical need for my
Bio-Preparedness Workforce Act legislation that I introduced
with Senators Collins, Rosen, and Murkowski to strengthen our
outbreak response workforce so that we can better prepare for
the next pandemic.
This legislation would address the serious workforce
shortages and recruitment challenges that you mentioned by
establishing a new loan repayment program focused on
encouraging students to pursue careers as clinicians and bio
preparedness health professionals.
As this Committee assembles a package of policies to
respond to the next pandemic, it is important to remember that
without people, there is no preparedness. In the midst of the
Omicron surge, it has never been clearer that we need a robust
and capable workforce to fully respond to public health
emergencies.
The Bio Preparedness Workforce Act would go a long way
toward that goal. So Dr. Walensky, as an infectious disease
physician and public health leader, can you share more about
how a strong clinical and public health workforce is key to
responding to outbreaks, and how legislation like the Bio
Preparedness Workforce Act is important to prepare for the
future--for future public health emergencies?
Dr. Walensky. Yes. Thank you, Senator. There is so much
here. So first, let me just say there has been a recent study
that had demonstrated that our public health workforce is now
down about 80,000 jobs. So just to give you a sense of massive
public health workforce--that is not physicians who are
actually doing the work on the ground, right, in the hospitals.
This is a public health workforce down 80,000 jobs.
We saw through this pandemic the challenges in sort of the
volume of people who are doing public health work, but also
where they were located and their experience. We need an up
skilled public health workforce.
For example, we need people to do those genomic sequences.
We need genomic epidemiologists. We need people who are
diverse, as diverse as the communities they serve. We also need
to make sure that they are compensated and have the right
salaries, and as you say, have loan repayment for their work.
To give folks a sense, the infectious disease physicians
are among the lowest paying physicians in hospitals. They don't
do procedures. And by virtue of not doing procedures, there is
not a large incentive from a financial standpoint to continue
to go into infectious diseases, which are the bread and butter
of what outbreak investigation and clinical does.
There have been many resources that we are moving forward
to expand our public health workforce. Public Health AmeriCorps
is a big piece of that. And that is something that we are
working on and really grateful to resources from Congress to be
able to do so.
But there is a vital need now to expand our public health
workforce in laboratory capacity, in genomic surveillance, in
disease outbreak investigation, and a workforce that is
upskilled and as diverse as the communities we serve. Thank
you.
Senator Baldwin. Thank you. We all know that vaccines
remain the best way to protect yourself against existing
variants of COVID-19. And I have been encouraged by the FDA's
work to authorize vaccines for the public.
But parents continue to be concerned that we don't have a
vaccine for their kids as Omicron surges. Dr. Woodcock, can you
provide an update on where we are in examination of the
authorization of COVID-19 vaccines for children under five?
Dr. Woodcock. Certainly. As Dr. Fauci said earlier, there
were--one of the companies, Pfizer had done trials. There were
other trials going on. There were probably complications with
the dose in the slightly older of the younger children, perhaps
indicating that a third dose, as Dr. Fauci said, might be
needed to the primary regimen.
FDA is working with the company very closely. Trials are
ongoing. I too have heard from many, many parents of the
youngest children. They have other children in school. They may
have immunocompromised individuals in their household, and
there are people who really want to get this vaccine, so--one
of the vaccines and get the children vaccinated.
We are working very intensely on this right now, and we are
working, of course, with NIH and with the companies.
Senator Baldwin. Thank you. I yield back.
The Chair. Thank you.
Senator Paul.
Senator Paul. Dr. Fauci, it is disappointing for you to
suggest that people who dare to question you are responsible
somehow for violent threats. Realize that by attacking me you
are attacking the one Member who actually has suffered from
violent attacks. I was at the ballfield the day Steve Scalise
almost died.
I was 10 feet away from a staffer who was shot in the leg.
We had over 160 rounds of semiautomatic weapons fired at us,
ammunition. So for you to somehow suggest that somehow I or
people who dare to oppose you are responsible for a threat that
is insulting. The person who shot at us and almost killed Steve
Scalise was a rabid supporter of Bernie Sanders.
But the one thing you will find if you look at the record
is not one of us accused Bernie Sanders of being responsible
for that. So this is the kind of ignorant sort of personal
attacks that you have engaged in.
You engaged in these attacks with fellow scientists. Not
only was it three scientists from Harvard, Oxford, and Stanford
that you chose to malign, 50,000 scientists and medical doctors
signed this petition. And what they wanted was something that
most Americans think is pretty reasonable, is a different kind
of approach. Instead of saying that everyone is the same and
everyone should get the same treatment, and everybody ought to
just get vaccinated, what it did is it said that the death rate
for this disease is extraordinary in the risk being different
according to ages.
If you look at an 80 year old, it is at least a thousand
times greater death rate than it is for a 10 year old. So
wouldn't we want to say that well, we are going to assess the
risks of each individual and have the treatment according to
that? Or would we just simply say everyone should be
vaccinated? The death rate for kids under 18 is about one in a
million, a little bit less than the chance of being struck by
lightning.
We don't yet know fully whether or not kids who have
already had COVID might be at risk for some of the side effects
of the vaccine. It still needs to be explored. But for a kid
under 18 who has already had COVID, the death rate of about one
in a million, even if you haven't had a disease, even if you
haven't had COVID, it is about one in a million.
It is extraordinarily uncommon for a child to die. If you
have already had the disease, it is probably a great deal less
than that. Many Americans wonder why you steadfastly refused
and worked with others to try to hide any kind of knowledge of
natural immunity and how it would affect our decisionmaking.
For example you have a 10 year old kid and his mom comes
up, and all of a sudden he gets myocarditis from the vaccine
and dies. Admittedly, a rare complication. But what are you
going to tell her when she says, well, he had COVID 3 months
ago, I mean, why would you force me to vaccinate my kid? Why
would you force me to vaccinate my kid without even checking to
see whether he is already immune?
Now, the idea of natural immunity is the idea upon which
vaccines are based. We have believed in, and all of medicine is
based on the idea of acquiring natural immunity. People often
respond and say, but you don't know how long it will last.
Well, we don't know how long vaccines will last and that
doesn't make us anti-vaccine. We do know that the vaccines are
waning very quickly in potency.
We do know that the vaccine against Omicron really isn't
preventing transmission. You have noticed that the debate has
shifted, and the debate is now talking about trying to prevent
hospitalizations and death. And I agree with those statistics.
I think it is a good idea if you are at risk to be vaccinated.
I have always been pro-vaccine. I am just simply against
authoritarianism and against mandates.
The anger that has developed with you, Dr. Fauci, is that
you don't want to give us advice, you want to tell us what to
do. You think you are the science and that anybody responds to
you, how dare you, how dare you criticize science, as if you
somehow our science. That kind of arrogance, that hubris is
really--that is where the anger is coming toward you.
If you were one doctor among hundreds of doctors in the
Government who gave advice, I don't think anybody--people might
object to your advice, but there wouldn't be such a degree of
anger. But you are so certain that you are right, they are not
willing to hear anyone else.
Three epidemiologists, of which you are not even an
epidemiologist, but three epidemiologists prominent in their
field, Oxford, Stanford, and Harvard, you maligned them. You
spoke openly with Dr. Collins, and you did not disagree that
let's paint them as fringe. You went after them and said, we
will do a public takedown, not in science or Nature, or Lancet,
in Wired, in the Nation, a left wing publication.
You have engaged in base politics. You will wonder why
there is so much anger? You are not an objective scientist. You
have lost that long ago. And so many of the things that people
want, it is like, they say they want to know why you are
forcing their children to be vaccinated when 95 percent of
people at risk have been vaccinated.
Over 95 percent of people over 65, it is huge voluntary
success. And yet you won't rest until you force every child to
get this. So yes, there is a great deal of dissatisfaction with
you and many people want you to go, but nobody wishes you
violence.
The Chair. Senator Paul, your time has expired. I will use
one time of my remaining 5 minutes to allow Senator Fauci to
respond.
Dr. Fauci. Thank you very much----
The Chair. Dr. Fauci.
Senator Paul. Thank you, Dr. Murray----
[Laughter.]
The Chair. No, no.
Dr. Fauci. So first of all, Senator, again, at a hearing
such as this, where there are almost 900,000 people in this
country have died from this outbreak, you have chosen to just
personal attacks on me that go back to multiple hearings.
Again, just for the record, for people to check, I have
never said take people down in that email. It was an email that
was sent to me see, and again----
Senator Paul. You agreed with Dr. Collins in the email.
The Chair. Senator Paul, this is my time.
Dr. Fauci. You know, you personally attacked me and the
things that you do are incorrect and proven incorrect. You have
publicly accused me at a hearing of being responsible for the
deaths of 5 million people when there is not a single, single
shred of evidence that anything that was done with the NIH had
anything to do with COVID-19. You talk about things like gain
of function----
The Chair. Dr. Fauci, I am going to let you respond
continually, but I think you have responded, and I appreciate--
--
Dr. Fauci. Okay, I appreciate the time. Thank you very
much, Madam Chair. But I just want to say I am actually stunned
by the amount of misinformation. The only thing I have ever
done, and this will take 20 seconds. If you look at the things
I have said, they have been to support the recommendations of
the CDC, of their advisory committees, and of the FDA.
I have told people that it is important to get vaccinated,
to get boosted, to wear a mask, and to be prudent. That is the
only thing I said. I haven't dictated anything that is only a
monolith with me. It is always public health practices. And
anybody goes back over any record of me, they know that.
The Chair. Thank you and I will retain the balance of my
time. Thank you very much.
Senator Casey.
Senator Casey. Thank you, Chair Murray. I want to start
with Dr. Walensky. Doctor, as the CDC has been working with my
staff on an outstanding nursing home vaccine data request. I
would appreciate it if you and your team would continue to work
with me and with our team at the Aging Committee to resolve
this matter.
Dr. Walensky. Yes, thank you, Senator, I am aware of that
matter, and we are committed to continuing to that work with
you. Thank you.
Senator Casey. Thank you. Let me turn to a matter for
Health and Human Services. Assistant Secretary O'Connell, you
know that our Nation's long term care facilities were ground
zero during the first year of COVID-19. 200,000 residents and
workers, when we add up the number of residents plus the number
of workers who died, it gets to 200,000 over these 2 years.
However, nursing home deaths have declined, declined
dramatically thanks to the safety and effectiveness of the
vaccines. It is a credit to the Administration that 90 percent
of nursing home residents and 80 percent of workers have been
vaccinated. We know that infections are on the rise right now,
though, in nursing homes, raising safety concerns and putting
additional pressures on workers who have been stretched thin.
For instance, we know the pandemic has worsened existing
staffing shortages and turnover issues. So we also know at the
same time that the rescue plan the Democrats passed in March
helped to fill the staffing gap with a $500 million initiative
for strike teams based upon legislation that I was leading
recently.
These strike teams provide medical personnel and other
supports that help nursing homes get through the surges like
the one that we are seeing right now. On the 22d of December of
last year, I along with three of my colleagues sent a letter to
Secretary Becerra asking how Health and Human Services was
protecting nursing home residents and workers in the current
COVID-19 surge, including the distribution of booster shots.
What is HHS doing to ensure nursing homes have the support
they need to protect residents and workers who care for those
residents?
Ms. O'Connell. Senator Casey, thank you so much for your
question. We share your concern for nursing home staff and long
term care facility residents and have continued to do all we
can to make sure they have access to boosts.
We have worked with pharmacies to bring in vaccination
clinics, bring those to the long term care facilities and
skilled nursing facilities so that vaccines are available on
the ground and the residents don't have to travel or access the
vaccines on their own.
In addition, ASPR has been sending since the beginning of
the pandemic or since the beginning that these tests were
available, 2.8 million tests per week to long term care
facilities across the country. We know how important it is that
they are able to surveil any disease in their facilities and
having access to these tests is one of the ways they can stay
on top of where they are.
We share your concern, and we will look forward to
responding to your letter.
Senator Casey. Thanks very much.
The Chair. Senator Burr.
Senator Burr. Thank you, Madam Chairman. Ms. Woodcock, I
know you said a while ago that you are excited about what RADx
accomplished, and I think we all are. But FDA issued revised
guidance stating that it would focus its review efforts on at
home testing and point of care COVID test applications from
developers, with the capacity to manufacture more than 500,000
tests per week within 3 months of being authorized.
Why did the FDA move the goalpost at this particular time
and suggest to companies that can't ramp up to that
manufacturing that they are not going to get an accelerated EUA
pathway?
Dr. Woodcock. Well, because of what some of the Members
have been discussing over the last several hours that we have
an urgent need for high volume, home based tests, and we have a
queue--we have done, moved heaven and earth to get as many done
as possible.
We have approved, authorized over 400 different kinds of
tasks or test collection devices during this pandemic. But as
far as what the queue is a priority, we are prioritizing the
highest volume and just putting them to the front so that we
can get home test kits into the hands of people.
Senator Burr. I get what you are doing. My question is
this, what does this say to the innovative company that is out
there that doesn't have the manufacturing capacity, and without
us marrying them to a large manufacturing capacity, it is
basically saying don't innovate because you are not going to
get consideration under the EUA if you don't have a
manufacturing capacity 500,000 tests a week.
Dr. Woodcock. It says these are prioritized. It doesn't say
we won't get to the others.
Senator Burr. Well, get to the others. I mean this there is
all--a sense of urgency here. I just think that might have been
thought of before we did this. Let me go to you, Ms. O'Connell.
I am really challenged on this procurement of 500 million
tests, as you can tell.
I don't understand why there has not been a release that
came out of ASPR or BARDA publicly announcing here is how many
we have contracted, that I have got to find it somewhere in a
DOD contract that a very limited amount of people go to,
certainly not one that I regularly looked at.
But based on what of your contracts, we have got 13.6
million tests costing $190 million. I think that is from the
vodka distributor. When I break that down, that is about $14 a
test. Now, CMS just put out a new rule that mandated that
insurers must cover up to eight tests per person per week--per
month for a family of four, that is 32 tests, and that they can
reimburse at $12.
Now, if I am a manufacturer and I am under a $12
reimbursement or I can go over here and I can sell directly to
the Federal Government and get $14, I am probably going to sell
to the Federal Government to get $14. Where am I wrong?
Ms. O'Connell. Thank you, Senator Burr. We continue to work
to access the tests that will be distributed as part of the 500
million and the tests that you are referring to.
First of all, DOD by tradition has put out, whenever we
have done and assisted acquisitions with them, they put out
within the first 24 hours of that contract going out an
announcement that the contract has gone out.
That is what you are seeing and that has been the rigor. It
has been what--the way DOD has approached us through our entire
relationship. We are continuing to----
Senator Burr. Why would ASPR not putting out a similar
public statement?
Ms. O'Connell. We would be happy to and thank you, Senator.
I will go back and talk to the communications team and see if
there is a companion press release that makes sense for us to
put out.
Senator Burr. Well, I am not sure you addressed my concern,
which is it is more profitable to sell to the Federal
Government than it is to put it on retail based on the
reimbursements that this Administration has now required of
insurers. I hope you will think about that. This is alarming to
me.
As we have all displayed, there are no tests out there.
There are no tests on the shelves of Walgreens, CVS that people
can go in, buy, and take home, and do it. So it makes it even
more confusing CDC's policy that if you want to take a test, go
ahead and take it. It is not required, but you can take it. You
can't get it.
Dr. Fauci, just very quickly. South African data suggests
that Omicron may have an ability to build immunity to Delta.
Delta does not have an immunity--it does not build an immunity
to Omicron. Have you got any comments on that? Cyprus announced
a Deltacron variant. Are you worried about that?
We have been about 3 weeks behind Israel throughout this
whole thing. And even though we have seen South African data go
up and go back down very quickly, Israel epidemiologists just
this week said they expect that for the next 2 weeks, they will
see a doubling of the infections in Israel, meaning they are
not following the same timeline that we saw in South Africa.
How should we interpret that for the U.S.?
Dr. Fauci. Okay, thank you very much for those questions,
Senator. With regard to the cross-protection, I think it is too
early to tell because you are dealing with multiple population
demography of people who have been previously infected,
vaccinated, or what have you.
It seems pretty clear that if you get infected with
Omicron, you are going to get good protection against Omicron,
but also good protection against some of the other spillover.
So we really yet to have seen, and I think the basis of your
question is a reasonable one. If we wind up getting infected
with Omicron at a very, very low level of pathogenicity, is
that going to be sort of almost like a live attenuated vaccine?
I don't think we can say that right now. We really have to
see how things spread out when we see how that affairs in the
next variant. So there will be invariably another variant. We
are going to have to take a look at whether or not there is
going to be any protection there. That is the first thing. With
regard to the Deltacron, this new variant, right now, even
though it has got a bunch of mutations that people look at, it
is not something that at least the WHO has looked at this
carefully, feels that has to be something that is of great
concern, but we always keep our eye on it to make sure.
When you say it is not of a great concern now--the one
encouraging thing about it is that it has been around for a
while. It isn't something that just popped up, and yet Omicron
completely outstripped it, as did Delta. So it doesn't look
like it has the capability of being transmissible enough to be
a problem.
Nonetheless, we still keep an eye out on it. With regard to
Israel, I mean, I am not--I am sorry. I forgot your question
about Israel. Could you repeat it?
The Chair. We are way over time here.
Senator Burr. They are on about 3 weeks in front of us but
yet their experience is not up and down drastically. Like South
Africa, data begins to show, they went up, and now it looks
like over the next 2 week, their epidemiologists say it is
going to double and maybe double again before they hope it
comes down. What should we expect?
Dr. Fauci. Yes, I think it is a bit--that is a great
question, Senator. But what it really reflects is that when you
have an outbreak of a particular variant, how high it goes up,
when it peaks and comes down is a reflection of what the status
is in your country.
Because if you look at what you saw in South Africa, they
were almost free of Delta when they got Omicron. So Omicron--so
it had the unfettered capability of going way up and way down.
When you talk about what happened in Israel that is a different
population. It is a mostly vaccinated population, so they are
likely going to see breakthrough infections.
In the United States, we have such a large country with
such differences in vaccinations versus infections, etcetera,
that we believe we will see it peak, and we will see it come
down. But it is very difficult to predict whether it is going
to be a sharp decrease or whether it is going to do this.
Our own feeling, and I believe that Dr. Walensky feels the
same way as I do, that it is going to vary depending upon where
in the country you are, how much infection you had previously,
what at the level of vaccination is. So we may see a peak up
and down in some regions of the country and a pickup and doing
this in other regions of the country. Thank you.
The Chair. Thank you very much.
Senator Smith.
Senator Smith. Thank you, Madam Chair. I would like to ask
a question of Dr. Walensky, if I could. I think we all know
that Americans need better access to rapid testing, and this is
a big deal for us in terms of trying to figure out what are our
health risks, how do we protect ourselves, and how do we also
go about our lives?
I think that we are making headway here, that we have a
long way to go. Dr. Walensky, I would like you to talk about
this issue of how we should be or not collecting and analyzing
the data from rapid home tests. Should we be incorporating this
data into like should be trying to capture that data? Is this
important for local communities as they are trying to make
decisions about masking and other public health strategies that
they want to deploy?
Should we be thinking of the data from rapid tests as a
tool for individual risk assessment or as an important tool for
population level understanding of what is happening? How do you
see that?
Dr. Walensky. Yes, thank you so much, Senator Smith. So we
have been using the PCR test, not the rapid tests, the lab
tests, the molecular tests to really capture our case counts
and really get a good view of where we are in terms of the
epidemiology, anticipating what was going to be coming into the
hospitals. But the tests are a really important valuable tool
for people to empower themselves, their own health, to not
expose themselves to other people, to get some information
about their own health.
If an individual were to test positive, if they are feeling
unwell, they should certainly consult with a health care
provider, consult with a pharmacist, and your health
Department. But if you are feeling well, then use that rapid
test to say, okay, my test was positive, I need to stay home
and isolate, protect myself from the community, protect myself
or the community from me, and protect me--my loved ones so that
they don't get infected themselves.
I think that it is less about the absolute case count of
understanding whether you have asymptomatic infection, or a
runny nose and your rapid test was positive, than it is really
about empowering you to do the right thing and not be forward
transmitting.
Senator Smith. Could you talk a little bit about what other
countries are doing. Are other countries in trying to
incorporate this rapid testing data into their population
metrics--how is that working in other places around the world?
Dr. Walensky. Some countries are, and some countries
aren't. London and UK have been doing more reporting of rapid
testing, but they too are saying that they are missing I think
somewhere around 40 percent, I would have to confirm that
number, but they too, well they capture more than we have tried
to. They also agree that they are missing some as well.
Senator Smith. Okay. Thank you very much. Madam Chair, I am
going to cede back the rest of my time. I just want to
acknowledge something I think has been going on here today that
I think just deserves being called out.
Dr. Fauci has been the target of a concerted and
coordinated campaign of disinformation and distortion and
personal attacks, and then he is being blamed for all of this
hatred and anger that has been generated against him.
I think we just need to be honest here that this is being
done by some members of the Republican Party that are using it
for fundraising. I am not saying that is happening by members
of this--I am just saying that is happening. It was just
pointed out to me that somebody sent out earlier in 2021, a
Fauci for prison email.
I just think it is important that we--I have to call this
out, and I think it is important that we see it and we have to
try to rise above this kind of behavior. Our Committee here
should be focusing on these kinds of nitty gritty policy
questions, and we are not always going to agree.
I have never heard Dr. Fauci, or Dr. Walensky, for that
matter, declare themselves to be invincible. I certainly am
not. But that should not mean that an individual's career,
public servants are subjected to this kind of abuse. Thank you,
Madam Chair.
The Chair. Thank you.
Senator Collins.
Senator Collins. Ms. O'Connell, I want to follow-up on my
previous questions to you because I don't feel, frankly, that I
got answers. I asked you specifically how much money was
diverted from the testing budget to deal with the surge of
people, including unaccompanied minors, illegally crossing the
Southern border, and how much money was diverted out of the
funds allocated for the strategic stockpile?
Ms. O'Connell. Thank you, Senator Collins. Again, all of
the funds, as they were appropriated to the American Rescue
Plan, were for testing, contact tracing, and mitigation
efforts.
Of those funds, funds were used to test unaccompanied
children at the border and then to mitigate the COVID positive
cases so they wouldn't enter the community and spread COVID,
which was a use of the funds that was allowed under the
testing, contact tracing, and mitigation requirements.
Senator Collins. Well, you are still not answering my
question on the amount of money that was used to deal with the
crisis at the Southern border, so I will tell you that our
staff's investigation found that $850 million out of the
testing budget and another $850 million out of the allocation
for the stockpile were instead used to deal with the crisis at
the Southern border. Do those numbers sound right to you?
Ms. O'Connell. Senator, I will be happy to take that back
and discuss that with our finance team to make sure that those
numbers are the same numbers that they are tracking.
Senator Collins. Well, I have to say that it is interesting
to me that you knew all of the numbers, and I commend you for
this, that we are going to community programs, to schools,
etcetera, but you can't tell me how much was reallocated to
deal with the crisis at the Southern border, a crisis that we
are it right under control, we would have these funds for the
purposes that they were intended. Let me ask you further, what
do you mean when you say mitigation as applied to the Southern
border and the surge, the unprecedented surge of people
crossing?
Ms. O'Connell. Thank you. One of the important things that
we needed to do when we identified a COVID positive
unaccompanied child was to make sure, for example, they didn't
ride on the same bus to a shelter with a COVID negative child.
So there were additional costs for transportation to keep the
children separate to mitigate spread as the statute allowed us
to spend those funds.
In addition, within the shelters, it was necessary to set
up a separate room where COVID positive unaccompanied children
would reside so they wouldn't interact with their COVID
negative children. And that required additional resources in
those shelters in order to keep them separate.
When the children entered the community with their
sponsors, they were not bringing COVID into the communities.
Senator Collins. Well, I will tell you, having visited the
Southern border in late March, testing was being done, but
people had been there for weeks at a time with no testing, and
there were people, adults who were released into the community
with no testing.
The fact remains that if we had the Southern border under
control, we would be using the $850 million designated for
testing to buy more rapid tests. We would be using the money
out of the stockpile, the $850 million for the purposes for
which it was intended.
I think that this is a problem that has contributed to the
shortage of testing, the uncontrolled crisis at the border, and
I also am perplexed by the lack of Federal orders for tests
between January and September 2021, which I know from my
experience in Maine caused the major manufacturer, Abbott, to
lay off 400 workers that were producing those tests because it
lacked the Federal orders. That makes no sense to me and seems
very shortsighted. Thank you.
The Chair. Thank you, Senator.
Senator Hickenlooper.
Senator Hickenlooper. Great. Thank you, Madam Chair. Again,
thank each of you for your public service. Dr. Walensky, I
wanted to talk to you just for a moment about genomic
sequencing. Even before COVID-19 appeared, Colorado made a
genomic sequencing of diseases a high priority, and we are now,
I think, one of the leading States in detecting changes as they
evolve and COVID-19.
We test about 15 percent of all positive COVID tests. I
think that is still one of the highest rates in the country.
And we also monitor wastewater for community detection. So, Dr.
Walensky, how would we or how can we expand genomics
surveillance and expand those capabilities in order to try to
stay ahead of existing but also future threats, COVID-19 or
otherwise? How do we close the gap between the states that are
heavily sequencing and following this and those that aren't?
Dr. Walensky. Yes. Thank you for that and for your
leadership in Colorado in genomic sequencing. As I have
mentioned we need to have both numbers and breadth and
geographic distribution in order to get a real good view of
what is happening genomic--in genomic sequencing.
We need to sample from State labs, so we get samples from
every single lab. We also get samples from commercial labs,
which gives us a lot of volume. We have partnerships now with
19, I believe, academic medical centers in order to do so. And
what we do and power our genomic sequencing is so that we are
able to detect a sequence that is present in less than 0.1
percent.
We scale up and based on the number of cases that we have,
we scale up or scale down our genomic sequencing so we can
detect it. And what we were able to do with Omicron is when we
saw the footprint of the S-gene target failure in PCR, a
similar footprint as Alpha, we were able to do targeted
enhanced surveillance of sequences that actually had that
initial footprint and able to identify sequences even before
they reach that 0.1 percent threshold.
As you said, we can scale this up in wastewater. We are
able to potentially scale it up for purposes of antimicrobial
resistance, for foodborne outbreaks, and many other things,
which we are really looking forward to doing now that we have
established this incredible capacity.
Senator Hickenlooper. Right. Great. Perfect. Ms. O'Connell,
I want to ask you a question in terms of the, we have talked a
lot about the distribution of tests and whether it is schools
or workplaces, hospitals, and we have talked about how at this
moment we don't have enough tests out there and we are not
getting results quickly enough.
In terms of the distribution of tests on a national level,
we are still obviously working on a system, I know the
Administration is hard at work on this, but some States like
Colorado already have systems in place where tests are being
mailed directly to people in their home.
I guess, I am not--I don't know, is the Federal Government
working with States like Colorado and trying to look at those
systems already in place, and how do we integrate the Federal
system with those States?
Ms. O'Connell. Absolutely. Thank you, Senator. That is
terrific what Colorado is doing. We have invested $29 billion
with the State so they could set up such testing programs
however they saw fit. And we are seeing States like Colorado
use those funds to be able to do exactly what we are hoping to
do on a national level. We are in the process, as we have
talked about today, setting this up, working with the U.S.
Postal Service.
As the Federal Government, we will allow American
households to order and have them delivered to their house as
well. I imagine that we will--these will be in addition to what
Colorado is able to provide. And we want to have as many tests,
of course, available to all Americans as possible.
If Colorado is already doing it that is terrific. I am sure
we will learn some lessons from the experiences you have had in
your State and apply those to this national initiative.
Senator Hickenlooper. Great. Thank you on that. And then
just real quickly, Dr. Fauci, we have heard from Dr. Walensky,
who was just talking about how you integrate the aggregation of
large amounts of data, and we have had a discussion about
Israel versus South Africa, and it really is a question of how
do we take--my question is, is how do we take information from
global sources and learn from those countries who are ahead of
us on the curve, make sure that we are learning from their
experiences. And I think how can we do a better job working
with our international partners to make sure that we are
prepared for the next Greek letter?
Dr. Fauci. Yes. Well, thank you very much. Excellent
question, and we are just actually doing that. Every week to 10
days, I have a long phone call with Chris Whitty and Patrick
Vallance, who are the two leading medical and scientific
advisers to the Prime Minister of England to get a feel of what
is going on there. We have regular phone calls with our Israeli
colleagues.
Every Saturday or Sunday morning, depending upon what it
is, Dr. Walensky and I and others are on the phone with our
South African colleagues. So we are in literally constant
communication with them.
Senator Hickenlooper. Great. Thank you. I yield back.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. The American people my family, all of our
families, are struggling as this pandemic continues to drag on
with no end in sight. The words I hear every day, multiple
times each day, continue to resonate and echo in my mind as I
said here, words like I am tired, confused, burnout, scared,
and frustrated. The list goes on.
What is making the situation worse are the officials
leading our Nation's COVID response going on national
television and contradicting each other. And of course, some
Supreme Court justices are spreading misinformation as well.
Dr. Walensky, this past week, you recommended asymptomatic
people be able to return to work after 5 days. But Dr. Fauci
ambiguously corrected you on national television and suggested
folks needed a test before return.
How does that make you feel when Dr. Fauci or someone like
Justice Sotomayor upstages a previous statement or policies of
yours, blatantly contradicts and undermined your guidance, or
offers false claims that cause more confusion for the American
people?
Dr. Walensky. Thank you, Senator. I have the great honor of
leading the agency of 12,000 public health servants in this
country, and we work collaboratively with tens of thousands of
public health officials around the country to provide guidance.
I also get to work with a COVID-19 task force that is full
of a multidisciplinary group of people with diverse expertise,
from immunology to drug regulation to epidemiology. This
science is moving really quickly, and I know you will
appreciate that it is moving fast, and it is changing. And our
responsibility----
Senator Marshall. Right. You are not answering my question.
Dr. Walensky [continuing]. is to convey that science.
Senator Marshall. I will move on. The FDA has recently set
up protocols for monoclonal antibodies and antiviral
pharmaceuticals to be prioritized based upon race. Dr. Woodcock
has the CDC or FDA getting multiple regression analysis on race
to see if indeed it is an independent factor for increased
morbidity and mortality. And if it has, don't you think zip
code would actually be more predictive?
Wouldn't it make sense to prioritize these antivirals and
testing, for that matter, to senior citizens and those with
significant comorbidities regardless of race, especially if the
multiple regression analysis proves my opinion? Dr. Woodcock.
Dr. Woodcock. What FDA did was to recommend if, you know
that people at high risk would be candidates for these
products.
Senator Marshall. Did you do a multiple regression analysis
on this independent factor?
Dr. Woodcock. We did not.
Senator Marshall. Okay.
Dr. Woodcock. We did not. We don't make those kind of
recommendations. We make----
Senator Marshall. But you can do studies, right? The FDA
and CDC can do studies to see if it is truly an independent
factor, or if not truly that the issue should be about your
comorbidities and your age. So Dr. Fauci, according to Forbes,
you have an annual salary in 2020 was $430,000.
You oversee over $5 billion in Federal research grants. As
the highest paid employee in the entire Federal Government, yes
or no, would you be willing to submit to Congress and the
public a financial disclosure that includes your past and
current investments?
After all, your colleague, Dr. Walensky, and every Member
of Congress submits a financial disclosure that includes their
investments.
[Technical problems.]
Dr. Fauci. I don't understand why you are asking me that
question. My financial disclosure is public knowledge and has
been so for the last 37 years or so, 35 years----
Senator Marshall. The big tech giants are doing an
incredible job of keeping it from being public. We will
continue to look for it. Where would we find it?
Dr. Fauci. All you have to do is ask for it. You are so
misinformed, it is extraordinary.
Senator Marshall. Why am I misinformed? This is a huge
issue. Wouldn't you agree with me that you have a--you see
things before Members of Congress would see them, so that there
is an air of appearance that maybe some shenanigans are going
on. You know, I don't think that is--I assume that is not the
case.
Dr. Fauci [continuing]. are you talking about the case? My
financial disclosures are public knowledge and have been so.
You are getting amazingly wrong information.
Senator Marshall. So what--I cannot find them. Our office
cannot find them. Where would they be if they are public
knowledge, where?
Dr. Fauci. It is totally accessible to you if you want it.
Senator Marshall. For the public, is it accessible for the
public?
Dr. Fauci. Through the public to the public. You are
totally incorrect.
Senator Marshall. Well, we look forward to reviewing it.
The Chair. Senator Marshall, Dr. Fauci has answered you it
is public information, and he is happy to give it to you if you
were to ask.
Senator Moran.
Senator Moran. Chairwoman, thank you. I know this has been
talked about, I have watched a bit of the hearing from my
office this morning and into this afternoon, but would you
highlight for me--I suppose this is for Dr. Woodcock. Lots of
funding. I think adequate funding. Certainly knowledge about
winter months would bring an increase in cases. What is the
challenge in not being better prepared for access to testing,
in home and elsewhere? And how soon will that change?
Dr. Woodcock. I don't think that is--I think that is a
question for Assistant Secretary O'Connell. But I would tell
you, FDA has approved or authorized over 400 tests or
collection systems just for COVID. We have approved, authorized
15 over-the-counter tests, but it is capacity that we are
talking about here, production capacity.
Senator Moran. So there is no--what you were telling me,
Dr. Woodcock, is there is no problem with the FDA approval of
tests, it is the manufacturing process and the supply chain?
Dr. Woodcock. We could do more with more resources. We have
authorized over 2,000 different device products, including the
400 test related products in 2 years. So that is an incredible
increase in the workload, and we really appreciate the funding
that Congress has provided.
However, the test manufacturers, many of them give us
incomplete results. We have to go back and forth with them. The
ITAP program that we are doing with NIH for home testing, I
think we will improve that tremendously. That is a big advance
forward. But there is also the matter of production capacity
with this huge surge and so many more people becoming infected.
Senator Moran. Is there a separate FDA results process in
which the test is read and determine positive or negative,
there is no challenges there in that process?
Dr. Woodcock. That is what the ITAP program over--NIH is
doing. They are actually doing the laboratory and clinical
testing for the manufacturers, and then they send us the data.
And so it is standardized, and it is a panel and that really
accelerates our ability to get these authorized very quickly.
As I said earlier, we have authorized them within 2 days of
getting the data from the ITAP program. So it is that--that is
a tremendous set up that I think is really beneficial where we
have standardized testing by scientists in the Government and
that enables the manufacturers to get their products through
very fast.
Senator Moran. Thank you.
Ms. O'Connell.
Ms. O'Connell. Thank you, Senator. And just to pick up
where Dr. Woodcock left off, once those tests are authorized,
ASPR reaches out to the manufacturers to make sure that we are
optimizing the manufacturing capability.
That part is sort of a seamless process that we have. But
all of the work we are doing and testing in this Administration
is in service of four priorities. One, to expand the number of
testing sites that are available.
Two, to expand the number of tests that are available, that
is the part that I am working on, to increase capacity. Three,
the kinds of tests that are available. That is the part Dr.
Woodcock just discussed. And then to help lower the cost of
tests.
Senator Moran. Is there is there a problem--I don't know
whether the testing devices are manufactured domestically. Do
we have another challenge of the importation of tests, as we
did with masks, gowns, and gloves?
Ms. O'Connell. We continue to look for tests wherever we
can find them, and we have encouraged actually some test
manufacturers that are approved in Europe to apply for FDA
approval here in the United States. So I do anticipate we will
have some importation of tests at some point. But we have used
the Defense Production Act authorities 12 times to support the
domestic manufacture of tests and to priority rate those orders
so we can increase the supplies and manufacturing capacity here
in the U.S..
Senator Moran. In the third of a minute that I have left,
we have changed, I think, our view on masks recently and we are
emphasizing N95s. Is there any intentions to--is there a plan
to manufacture additional 95 masks so there are more available?
Is there a way to make them more comfortable? I will leave
that--that is the crux of my question.
Ms. O'Connell. We continue to support the manufacture of
N95 masks. We have 737 million in the Strategic National
Stockpile, all sourced from 12 domestic manufacturers. So we
are continuing to support that. We are also in the process of
putting out an agreement for warm based manufacturing.
We are able to keep this capacity that we currently have
going even when demand diminishes. So that is all underway
right now. As far as fit and style and how they work, I am sure
colleagues at the table are probably have various pieces of
their programs that might be participating to that effort and
consulting with the manufacturers on how that will work. Thank
you.
The Chair. Thank you.
Senator Tuberville.
Senator Tuberville. Thank you very much. Just very quickly
I know there is plenty of misinformation on both sides when it
comes to COVID but I would say the fear mongering on the left
is and I will give you a couple of questions here about this,
has made matters much worse.
Dr. Fauci, I just want to ask you this from my constituents
back in Alabama. Ivermectin. Forty year drug. Now my
constituents read this, they hear about it. This 40 year drug,
they call it a wonder drug. It is about a nickel of tablet. It
has done wonders, supposedly in India and several other places.
Then you have this new antiviral pill that were coming out
and my constituents think, this thing is going to cost about
$500, $600, $700 each. Could you give me a rundown on the
difference in those two, what you think about them?
Get it on record here, so I can tell my people back home,
this is what Dr. Fauci says.
Dr. Fauci. Yes. So Paxlovid, the drug from Pfizer has shown
in a randomized, placebo controlled trial to be highly
effective to the point of 89 percent, almost 90 percent.
Senator Tuberville. What is it called?
Dr. Fauci. Paxlovid.
Senator Tuberville. Okay.
Dr. Fauci. It is made by Pfizer and has been shown in a
very well controlled, randomized, placebo controlled trial that
if you take that drug compared to the placebo within the first
three to 5 days within the first 3 days, you have about an 89
percent chance of preventing you from going to the hospital or
dying. There were no deaths in the Paxlovid group, and there
were several deaths in the placebo group. That is Paxlovid.
Ivermectin has had non-controlled trials suggesting that it
might be effective, mostly anecdotal. The CDC--excuse me, the
NIH guidelines panel have looked at that data and felt is not
sufficient evidence to say that it works, or it doesn't. The
WHO recommends strongly against it and suggests that it might
actually be harmful.
The NIH active studies are doing a whole bunch of studies
with ivermectin, as well as others to try and settle it once
and for all, to prevent people from taking it if it doesn't
work, because it could be toxic. So there is a world of
difference between ivermectin and Paxlovid.
Senator Tuberville. But this is a 40 year drug. And we are
talking about one that is just now coming on the market. So we
actually know that much about this Pfizer drug. I wish they
would come up with a lot easier names----
Dr. Fauci. Yes, they always do that. They fool me too with
the names, coach. But it is what it is. The fact is, I think it
is kind of a mis comparison to say one is a 40 year drug and
one is a drug that was just discovered.
It was just discovered, but it was shown in a very well
controlled clinical trial to be highly effective. Even though
ivermectin is a good drug for some parasites, it has not been
shown in a well-controlled, placebo controlled trial to be
effective in COVID.
Senator Tuberville. Okay. Thank you. Dr. Walensky, I don't
know if anybody has asked this question. I just want to get
cleared up. Our Supreme Court justice last week, looking into
the situation with the mandate, Justice Sotomayor said there is
100,000 children that are sick as we speak with Omicron, and a
lot of them are serious and in the hospital. Is that true or
false?
Dr. Walensky. I don't have the number of children in the
hospital right now. It is likely less than 100,000.
Senator Tuberville. Yes. And Justice Breyer said that if we
continue to delay this ruling, that we are going to have
750,000 more that are not vaccinated infected a day. I mean,
does that make sense to you?
Dr. Walensky. What I can't tell you is our children between
the ages of zero and four, one of the only places where our
hospitalization rates are currently rising, and that children
who are in the hospital are generally unvaccinated, not
uniformly, but generally unvaccinated. And that is true for not
just our 0 to 4 who are obviously ineligible, but also true for
5 to 11 year olds, as well as our 12 to 17 year olds.
Senator Tuberville. Thank you. Well, thank you all for
being here today. Thank you very much. Thank you, Madam Chair.
The Chair. Thank you so much. I have one final question for
Ms. O'Connell and Dr. Walensky, and that is regarding
education. In the past, we have seen school districts that
serve a significant number of students of color or those in low
income or rural areas that are facing great challenges in
accessing resources they need to serve our students.
How is the Federal Government working now to make sure that
States are equitably distributing tests and necessary resources
like masks to all school districts, particularly those that
serve predominantly students from families with low income,
students of color, or rural students? And Ms. O'Connell, I will
start with you.
Ms. O'Connell. Thank you, Chair Murray. Equity is woven
into all of the work that we are doing in this response. It is
something that we remain focused on, including making sure that
schools across all States are able to access the tools and
resources that they need. We gave $10 billion, as you know,
from the American Rescue Plan, for schools to be able to set up
their funding programs--we are also--testing programs.
We have also made it possible through Operation Expanded
Testing, which Dr. Walensky can talk more about, where we have
regional hubs, where schools can contract directly with labs to
run their programs for them. That was designed for schools that
might not otherwise have resources to be able to manage a
testing program on their own. In addition, we are making tests
available through the federally qualified health centers and
rural health centers. And we have done that with masks as well
earlier in the year.
The Chair. Thank you.
Dr. Walensky.
Dr. Walensky. Yes, and maybe I will just pick up exactly
where ASPR O'Connell has put down. So our ICATT program, our
increase community access to testing program, does place tests
in pharmacies in socially vulnerable--social vulnerability
indices that are high. That is by design.
Tests in federally qualified health care centers and
community centers, just as the Assistant Secretary mentioned.
We also continue to support screening tests at no cost to
childcare centers, K-12 schools, and congregate settings
through exactly the program that the ASPR mentioned, Operation
Expanded Testing.
We prioritized high schools that have and all schools that
have high social vulnerability, and we have own website now
that is active where you can enroll.
The Chair. Okay, thank you. Senator Burr, I understand you
have two additional questions.
Senator Burr [continuing]. questions, if I could, Madam
Chair. This is for Dr. Woodcock and Ms. O'Connell. It is my
understanding that prior to Omicron, BARDA informed some
therapeutic manufacturers that they would no longer be
supporting additional work on new therapies because there is no
longer an unmet need which may impact whether and how FDA
prioritizes reviewing such therapies. Did BARDA and FDA change
course on this policy once the Omicron variant was discovered
in November?
Ms. O'Connell. BARDA's decision to put that notification
out was in light of the fact that the therapeutics development
was moved over to Operation Warp Speed and BARDA was supporting
the therapies that were being developed through the Warp Speed
effort. So it was a way of combining the funding that was
available to be able to move the therapies through faster.
BARDA never stopped supporting therapy work. But I will let Dr.
Woodcock----
Dr. Woodcock. Yes, there is--we still regard, there is an
extreme unmet medical need for therapeutics at most stages of
the disease, particularly the late stages where we still don't
have interventions and so people are dying in the late stage of
disease, getting into the ICU, going on the ventilator.
Of course, we have had have 670 INDs that we have been--
clinical protocols that are ongoing, to my knowledge. So robust
development is still ongoing in the therapeutic area.
Senator Burr. So how much--how much funding has BARDA
allocated to therapeutics this year and how much is left to
spend?
Ms. O'Connell. I will have to go back and check that. On
the actual development, we have spent a lot of funds this year
on the procurement of the therapeutics that have already been
developed but would be more than happy to bring that number to
you and your staff.
Senator Burr. And this is, I am talking about the
development end of it. There is a firm belief out there that
BARDA went to the industry and said, we are not supporting this
anymore. They didn't say this got moved over to Operation Warp
Speed, which by the way doesn't exist anymore.
But they said, BARDA said we are not supporting
therapeutics because there is not an unmet need. That is what
the industry heard. I would love for you to clarify that for
me. Last thing, Dr. Woodcock, since we did discuss the point of
care and at home testing. I just had them come up with the
chart that FDA put out not long ago. So let me just, and you
are probably familiar with it, one is molecular, one is
antigen, and one is serology.
For the molecular and the antigen point, if you test yes
for point of care or at home, that kicks you to the right. The
next box is high manufacturing capacity. If your answer is no
there, it kicks you down to an FDA intends to decline box.
There is no option. So if you are not a high manufacturing
test, then FDA is going to decline to review. Boy, I got to
tell you, I think this is a huge mistake.
Now if you tell me that you have got a couple of hundred
tests that fall into the high manufacturing capacity right now
at the FDA, where you have got the luxury of being able to kick
out new innovative companies that haven't solved their
manufacturing yet, by all means, tell me that is the case, that
there are a couple hundred.
Right now, Ms. O' Connell was struggling to buy 500 million
test, where 47, maybe 50 million there, that leaves another 450
million to purchase. And we are going to distributors trying to
buy their inventory, not to manufacturers trying to buy their
capacity. Something is not right here, guys, on testing. And I
will tell you, the current Administration's Chief of Staff got
it right in 2020 March, and he said testing is broken, testing
is broken, testing is broken. I just say to all of you right
now, testing is broken.
Ms. O'Connell, I think the responsibility falls to the
ASPR. I wrote the law. If--in the case of CDC, they were the
delay to begin with, but to acquire testing, that falls in your
lane. And I, for the life of me can't figure out after $82
billion, except for somebody sitting down and saying, well, we
just don't need those tests, we don't need to buy them, how you
could let Abbott close two lines because there wasn't any
business.
These are some of the most premier manufacturers in the
world that we have let get out of the mass manufacturing of
home test business. If I am wrong, tell me I am. I respect all
four of you in a huge way. But I also express my disapproval
very quickly and that is what I am doing today. Anything you
want to add to that? Ms. O'Connell.
Ms. O'Connell. Please. Thank you, Ranking Member Burr. Let
me just clarify, of course, that the initial contracts you are
speaking of toward the 500 million were the available inventory
that these distributors had. These the distributor contracts.
The manufacturer contracts are currently being worked. You
will see that capacity come on quickly. We just haven't been
able to land the contracts, to draft the contracts as quickly
as the distributors, but they are coming.
Senator Burr. My suggestion in the future is that when you
guys huddle inside the COVID team, try to get the
Administration to refrain from making these proclamations until
we have got the product, until we know who we are negotiating
with. We are now 3 weeks since the President said we are going
to buy 500 million test.
We have 50 million currently contracted. I don't know how
long it is going to take to get the rest of the contracts. This
is not dissimilar to when we went out and said we are going to
booster everybody in America, yet we rolled it out with just
people over 60 to start with and then we started moving down.
And now we are begging people to get boosted, which is where we
should have been on day one because we had the product
available.
But listen, you guys have a tough job. And I don't know of
anything else Congress can do than try to create the statutory
framework that you can work in to do your job, which exists, or
provide the funding to allow you to acquire. Those are the only
two things we can do other than bitch and gripe when it doesn't
happen as quickly as we would like. But Tony, I really respect
you and I am sorry you and your family went through what you
are going through.
But please understand, we go through that every time we go
home with millions of people in North Carolina, millions that
believe the bad information that is out there, millions of
people that have a loved one in the hospital but there is no
monoclonal form to take, millions of people who are
unvaccinated, probably wish today they had gotten vaccinated,
probably wish they had gotten boosted. But they are now in the
ICU and their wife or husband, or daughter is calling us and
saying, what do I do?
We are here to support. What you need, tell us. But don't
think that we are just going to sit here and print money
without a full accountability of where it has gone. And I hope
the Secretary is listening to that conversation today. Senator
Blunt and I said give us a full audited accounting of the $82
billion and will entertain additional funding for testing. That
was 10 days ago.
I am not sure when we are going to get it or if we are
going to get it, but it is conditional, and this is the most
powerful person on the other side of the Appropriations, and I
think she knows I am serious on this one.
There has got to be accountability on the money and the way
it is spent. Thank you for being here. Thank you, Madam Chair.
The Chair. Thank you. I want to thank, truly thank all of
our witnesses today, Dr. Walensky. Dr. Fauci, Dr. Woodcock,
Assistant Secretary O'Connell. We all know this is a very
difficult, challenging, changing time and you have all been
through it for a long time. I think you do understand the
frustration.
I am sure you all have it as well as where we are. We all
want to find solutions and we stand at your back to be able to
provide those. But thank you so much for answering all our
questions. This is a really important conversation about the
threat of the new COVID variant, or whatever the next one is,
and about the path forward for our pandemic response, and we
really do appreciate all the work you and all the people in
your agencies do.
For any Senators who wish to ask additional questions,
questions for the record will be due in 10 business days,
January 26 at 5.00 p.m.
With that, the Committee does stand adjourned.
QUESTIONS AND ANSWERS
Response by Rochelle Walensky to Questions of Senator Casey, Senator
Hassan, Senator Lujan, Senator Cassidy, Senator Braun, Senator Scott,
and Senator Tuberville
SENATOR CASEY
Question 1. At the hearing, I asked how the Federal
Government is working with vaccine manufacturers to speed the
development of a safe and effective vaccine for children under
age five. Understanding that the Pfizer trial for children 24
months to 5 years old did not meet its endpoint, my follow-up
questions are, how did we get here and what's next? Please
describe, generally, the following----
Question 1(a). How vaccine developers make decisions about
dose size, quantity and spacing in age deescalation trials;
Answer 1. CDC defers to FDA.
Question 2. What type of indicators a vaccine manufacturer
might consider when determining whether and how to change the
dose size, quantity or spacing if primary endpoints are not
met; and
Answer 2. CDC defers to FDA.
Question 3. Whether the emergence of a viral variant could
affect the efficacy of a vaccine in children differently than
it would affect the efficacy of the same vaccine in adults.
Answer 3. CDC defers to FDA.
Question 4. Furthermore, could you please provide an update
on current Federal goals and investments relating to the
development of vaccines to protect children under age five from
COVID-19, including grants, contracts or other funding awarded
to vaccine developers; and what information is currently being
provided to vaccine developers regarding current or planned
opportunities for collaboration between the Federal Government
and vaccine developers, including the extent to which BARDA
will conduct TechWatch/CoronaWatch meetings and the extent to
which FDA will accept applications for emergency use
authorization.
Answer 4. CDC defers to FDA and ASPR.
Question 5. Finally, could you describe current thinking
across your agencies regarding the circumstances under which
your efforts would expand to include the development of
additional or next generation vaccines and therapeutics for
COVID-19?
Answer 5. CDC defers to NIH and ASPR.
SENATOR HASSAN
Question 1. Individuals with autoimmune diseases are at
higher risk of severe COVID-19 symptoms and death.
Additionally, some of the medicines these patients may take can
alter vaccine effectiveness. Does the CDC plan to put out
guidance regarding the interaction between COVID-19 vaccines
and treatments and immunosuppressant medications to help
patients with autoimmune diseases and their providers?
Answer 1. Some people with immunocompromising conditions or
people who take immunosuppressive medications or therapies are
at increased risk for severe COVID-19. CDC's Interim Clinical
Considerations for Use of COVID-19 Vaccines includes
information for healthcare providers regarding COVID-19
vaccination in moderately or severely immunocompromised people.
Immunocompromised people ages 5 years and older should receive
a primary COVID-19 vaccine series as soon as possible; for
those 18 years and older, mRNA COVID-19 vaccines are preferred
over the Janssen COVID-19 Vaccine. The current Food and Drug
Administration (FDA) approved or FDA authorized COVID-19
vaccines are not live vaccines and therefore can be safely
administered to immunocompromised people. Moderately or
severely immunocompromised people may not mount a protective
immune response after initial vaccination and, furthermore,
their protection by primary vaccination may wane over time
making them susceptible to severe SARS-CoV-2 infection. The
Advisory Committee on Immunization Practices (ACIP) and CDC
have made age-specific recommendations for an additional
primary dose and a booster dose for this population. Evusheld
is a combination of two long-acting monoclonal antibodies that
is authorized for emergency use as pre-exposure prophylaxis for
persons who are moderately to severely immunocompromised or
unable to get vaccinated.
SENATOR LUJAN
Question 1. Americans are confused about how to best
protect themselves and their communities from the spread of
COVID. In New Mexico, trusted health messengers such as
hospitals are struggling to convey updated guidance to the
patients they serve. As new guidance comes out, the burden
falls on providers to disseminate this information in a way
that reflects the diversity of racial and ethnic, regional, and
political identities present in the state of New Mexico.
Hospitals, already stretched thin, still have non-urgent, non-
symptomatic people showing up because these patients simply do
not know where to turn. The American people need clear
guidance, presented in a format that leave no doubt as to the
official recommendations. What can you do in your role as a
public health official to ensure that public health guidance is
communicated clearly and effectively?
Answer 1. CDC recognizes that we can always make
improvements as an agency and are committed to ensuring that
our public health messaging and communication efforts are
effective and accessible to providers and patients alike. As
the science and our understanding of COVID-19 evolves, we are
actively working to disseminate the latest public health data
and guidance as quickly as possible. CDC continues to reach out
to healthcare providers and has hosted over 50 Clinician
Outreach and Communication Activity (COCA) calls and sent over
20 Health Alert Network notices. CDC has connected with
numerous partner organizations, working with them to better
understand the needs of the people they serve, including
organizations serving people at increased risk of serious
illness or death from COVID-19. These audience-specific
outreach efforts are in addition to providing accessible
information via the web, social media, and news media briefings
and interviews. Since the emergence of the virus, CDC has
worked very closely with state, tribal, local, and territorial
(STLT) health departments and public health partner
organizations. We have heard that people want to hear from us
directly, to that end we have instituted CDC briefings with CDC
scientists and subject matter experts in order to convey the
latest recommendations to the public. In addition, I have
personally conducted over 80 White House press briefings on
COVID-19 in just this past year, as part of our engagement
efforts.
CDC is working to ensure the agency is communicating across
government, the scientific community, and the medical community
in order to provide real-time updates and guidance that are
both feasible and realistic to implement. As we strive to move
us forward on this path out of the pandemic, we see it as our
mission to restore public trust in science.
Question 2. We know that this virus mutates and presents
new challenges, that our understanding of the virus continues
to grow, and that sometimes new information can alter
recommendations or even change the public's understanding of
the virus in terms of public health messaging. What lessons
have you learned from the most recent guidance change? How can
the CDC improve?
Answer 2. Our scientific understanding has changed
frequently during this pandemic it has evolved and even with 2
years of data, research, and experience, there are things we do
not know or do not understand completely. Despite this, we
continue to work to communicate what we know, what we recommend
based on what we know, and what steps we are taking to learn
more.
Because science is continually evolving, we are committed
to bringing that information to the public in real time. That
means we must update our guidance to ensure that
recommendations are understandable and actionable so that
people can implement them.
When we communicate guidance during a dynamic, evolving
public health situation, we need to be clear that our guidance
is based on our best understanding at the time and that, as we
learn more, our recommendations may change.
Question 3. Studies have found that minds are most changed
during personal conversations with trusted sources like
clinicians or loved ones. Among the CDC's recommended
strategies are developing a corps of vaccine Ambassadors. How
do we scale up our ability to engage in conversations in a
supportive, empathetic, and non-judgmental way?
Answer 3. Vaccinate with Confidence is the strategic
framework of the CDC to strengthen vaccine confidence and
prevent outbreaks of vaccine-preventable diseases in the United
States. Strong confidence in COVID-19 vaccines within
communities leads to more adults, adolescents, and children
getting vaccinated. High vaccine coverage rates reduce the
number of COVID-19 illnesses, hospitalizations, and deaths. One
of CDC's strategies within the Vaccinate with Confidence
framework focuses on engaging communities and individuals in a
sustainable, equitable, and inclusive way--using two-way
communication to listen, build trust, and increase
collaboration. CDC works with health departments and national
partners to engage communities around vaccine confidence and
service delivery strategies to meet community needs. Also, CDC
collaborates with trusted messengers within the community to
tailor and share culturally relevant messages and materials.
CDC provides information on how to tailor COVID-19 vaccine
information to help those, including vaccine Ambassadors,
understand their audience and create messages that resonate.
Question 4. How can a corps of vaccine Ambassadors combat
public health misinformation that proliferates on social media?
Answer 4. Vaccine Ambassadors play a key role for public
health in validating the credibility of messages and
effectively delivering messages and strategies within their
community. They can address mis-and disinformation by working
with jurisdictional communications staff to take questions on
social media, share accurate information, and post shareable
graphics and content. Many of the tools are available on CDC
and HHS websites.
Question 5. How can we be prepared to counteract
misinformation and vaccine hesitancy early in future pandemics
or other public health emergencies that require vaccinations?
Answer 5. Monitoring misinformation through social
listening is a key strategy to quickly identify and address
misinformation about COVID-19 vaccines. This includes
identifying trending inaccurate information, which, if not
addressed, can lead to the spread of misinformation.
Catching misinformation early can help develop and get out
accurate information to address concerns and questions ahead of
time and close information gaps before they are filled with
inaccurate information.
CDC created the Insights Unit to use an evidence-based
approach, leverage socio-behavioral and epidemiological
insights, and execute a plan to reduce and prevent the spread
and harm of misinformation and promote accurate, credible
information. Limited tools exist to address misinformation and
traditional risk communication and social media outreach
approaches are not sufficient because they are inherently
reactive approaches.
Identifying misinformation before it spreads and developing
programmatic and communications approaches to address it is
critical to prevent and manage misinformation in future
pandemics and public health emergencies.
The Insights Unit generates the COVID-19 State of Vaccine
Confidence Insights Reports which identify the public's
questions, concerns, frustrations and circulating
misinformation. The results are used to identify how CDC and
partners can take action against the information gaps and
misinformation.
Misinformation is not unique to COVID-19, and as technology
makes communication easier, misinformation will continue to be
a problem. The lessons learned from the COVID-19 pandemic can
be expanded to other disease areas of vaccine hesitancy.
Question 6. In thinking about education and messaging, what
changes would you all advise for these same leaders on the
media platforms to use to make vaccination messages resonate
with those who may still be hesitant about taking the COVID-19
vaccine?
Answer 6. Vaccinate with Confidence is the strategic
framework of the CDC to strengthen vaccine confidence and
prevent outbreaks of vaccine-preventable diseases in the United
States. Strong confidence in COVID-19 vaccines within
communities leads to more adults, adolescents, and children
getting vaccinated--which leads to fewer COVID-19 illnesses,
hospitalizations, and deaths.
CDC's Vaccinate with Confidence strategy is built on three
pillars:
Answer 1. Build trust: Share clear, complete, and accurate
messages about COVID-19 vaccines, and take visible actions to
build trust in the vaccine, the vaccinator, and the vaccination
system.
Answer 2. Empower healthcare personnel: Promote confidence
among healthcare personnel in their decision to get vaccinated
and to recommend vaccination to their patients.
Answer 3. Engage communities and individuals: Engage
communities in a sustainable, equitable, and inclusive way-
using two-way communication to listen, build trust, and
increase collaboration.
Answer 4. CDC is working in coordination with national,
state, and local governmental and non-governmental partners
using strategies to build trust in the vaccine, the vaccinator,
and the vaccination system.
SENATOR CASSIDY
Question 1. The U.S. is in the middle of flu season, which
has the potential to add additional burden to already-stressed
health care systems due to the ongoing pandemic.
LWhat steps is HHS taking to ensure the
availability of appropriate diagnostics and treatment
options to address the potential dual threats of COVID
and influenza, including through shoring up the
Strategic National Stockpile?
Answer 1. CDC defers to ASPR.
LBeyond testing and preventative steps like
vaccination, what steps has HHS taken to proactively
treat vulnerable populations like the elderly or others
who may be at risk for and are likely to spread
communicable diseases like COVID and the flu?
Answer 1(a) The COVID-19 pandemic has reinforced the
importance of healthcare infection prevention and control in
keeping Americans-especially our most vulnerable populations in
nursing homes and hospitals safe and healthy. CDC has worked
with the Healthcare Infection Control Practices Advisory
Committee (HICPAC), a Federal advisory committee appointed to
provide advice and guidance to HHS and CDC regarding the
practice of infection prevention and control (IPC) and
strategies for surveillance, prevention, and control of
healthcare-associated infections, antimicrobial resistance and
related events in United States healthcare settings, to develop
general guidelines for preventing transmission of infectious
diseases, including respiratory diseases like influenza.
In addition to those guidelines developed with HICPAC, CDC
works closely with the Centers for Medicare & Medicaid Services
and the long-term care (LTC) community to support
implementation of best practices and provides tools and
resources to protect residents and staff from infectious
diseases, including COVID-19 and influenza. In order to monitor
and track infections including healthcare-associated infections
(HAI) and COVID-19 activities in LTC settings, CDC has utilized
the National Healthcare Safety Network (NHSN) LTC Facilities
Component (LTCFC) to track infections and infection prevention
process measures and also to identify problems and improve
care. This includes tracking healthcare personnel (HCP)
influenza vaccination status, COVID-19 vaccination status for
both residents and HCP. Additionally, CDC funds state HAI
programs that work directly with LTC facilities to keep
residents and staff safe. It was the relationships that these
programs had built over many years that allowed for quick
responses and support to many outbreaks in LTCFs.
CDC has also developed educational materials for LTCFs,
including trainings such as the National Nursing Home Training
Series and the Nursing Home Infection Preventionist Training
Course. While the use of CDC's Infection Control Assessment and
Response Program (ICAR) infection control assessment tools has
been recently used mostly to improve IPC activities as part of
the COVID-19 response, these tools were developed for use in
assessing IPC programs at healthcare facilities for any
infectious disease. CDC has developed setting specific guidance
and assessment tools, including for long term care facilities,
in both English and Spanish.
CDC is using American Rescue Plan (ARP) funding to expand
efforts that protect Americans from COVID-19 infections and
other emerging infectious diseases across healthcare settings,
specifically long-term care facilities and nursing homes. For
example, over the next 3 years, CDC will issue awards totaling
$1.25 billion to 64 state, local, and territorial health
departments to support this work. Initial awards totaling $885
million were made in October 2021 to 64 health department
jurisdictions, including $500 million to support state-based
COVID-19 nursing home and other long-term care strike teams.
The state-based nursing home and other long-term care strike
teams will allow state, local, and territorial jurisdictions to
provide surge capacity to facilities for clinical services;
address staffing shortages at facilities; and strengthen
infection prevention and control activities to prevent, detect,
and contain outbreaks of COVID-19, including support for COVID-
19 vaccine boosters. This builds on previous CDC investments in
health departments to improve patient safety through the
Antibiotic Resistance (AR) Solutions Initiative and Prevention
and Public Health Fund established by the Patient Protection
and Affordable Care Act of 2010 (ACA).
HHS is working with other Federal agencies, health
departments, healthcare providers, professional organizations,
and public health partners to increase vaccine uptake and
promote the use of boosters in residents and staff in LTCFs.
The Federal Government is committed to ensuring that residents
and staff in these facilities have access to COVID-19 vaccines
to receive primary series and booster shots. All LTC settings
that request assistance accessing COVID-19 vaccines for their
residents and staff will receive the support they need. Many
LTC providers have already identified strategies and
partnerships to obtain and administer COVID-19 vaccines for
residents and staff. These include working with established LTC
partners and retail pharmacy partners and coordinating with
state and local health departments.
Question 2. Health systems in Louisiana have been
overwhelmed by successive waves of COVID variants. These health
systems could have been better prepared for these growing
variant trends if they had access to better national and
regional dashboards monitoring variants of concern. What are
you all at the CDC, FDA, NIH, and HHS doing to make sure health
providers are armed with the best data to respond appropriately
to the next COVID variant or pandemic? Second, how are you all
harnessing the speed and innovation of the private sector to
help predict, prevent, and mitigate future COVID-19 variants or
other pathogens of concern?
Answer 2. CDC is building on lessons learned from
responding to COVID-19 variants to determine how to gather and
report data on variants of concern, particularly the
application of genomic sequencing. CDC is evaluating sources
from the data pipeline to determine which prove most useful in
responding to an emerging variant of concern. These findings
will inform response to future variants.
National SARS-CoV-2 Strain Surveillance (NS3) is
implemented in partnership with state and local public health
laboratories and the Association of Public Health Laboratories
(APHL). State public health laboratories provide to CDC, on a
weekly basis, confirmed, de-identified, diagnostic specimens
that, ideally, represent a variety of demographic and clinical
characteristics and geographic locations. The program provides
a comprehensive and population-based surveillance system for
national monitoring to track virus evolution over time and
identify emerging variants that may affect the performance of
diagnostics, therapeutics, or vaccines, or that impact the
transmissibility of SARS-CoV-2 or severity of COVID-19.
In addition to the NS3 program, CDC contracted with large
commercial diagnostic laboratories to sequence specimens from
across the United States. These contracts provide consistent
access to SARS-CoV-2 sequence data across the country to
supplement existing public health sequencing efforts. The
proportion of variants in a population are calculated
nationally, by HHS region, and by jurisdiction and are
available on CDC's COVID Data Tracker.
SENATOR BRAUN
Question 1. Over 62 percent of Americans are fully
vaccinated against COVID-19. Yet, the rate of positive COVID-19
cases reported in the U.S. has increased six fold from early
December to early January. The spike in cases is likely due to
the contagious nature of the variant.
LWhy is the CDC not tracking the number of
individuals who have been diagnosed with a breakthrough
infections after having received a COVID-19 vaccine?
Answer 1. As part of ongoing efforts to understand how
COVID-19 vaccines are working, CDC monitors rates of COVID-19
cases, hospitalizations, and deaths in vaccinated
(breakthroughs) and unvaccinated persons. CDC now monitors
rates of COVID-19 cases and deaths using data from
jurisdictions that routinely link case surveillance data with
records from immunization information systems (IIS) to identify
the vaccination status of all reported COVID-19 cases. This
approach provides more complete information on breakthrough
cases and a better understanding of the impact of vaccines than
was available previously. These data are updated monthly on the
COVID Data Tracker.
As of December 2021, 27 jurisdictions, representing all 10
HHS regions and more than 50 percent of the United States, can
link their case, death, and vaccine data and are voluntarily
sharing these data with CDC. Jurisdictions report these
breakthrough data to CDC in multiple ways. Interoperable
information systems that enable linkage of data is a core goal
of CDC's Data Modernization Initiative.
CDC uses COVID-NET, a population-based surveillance system
of COVID-19-associated hospitalizations from a network of 250
acute-care hospitals in 14 states, to monitor rates of COVID-
19-associated hospitalizations by vaccination status. These
data are also updated monthly and shared with the public on the
COVID Data Tracker. Previous data on breakthrough cases were
reported in an MMWR that summarized data from January--April,
2021. Follow-up analysis of breakthrough surveillance data on
hospitalizations and deaths reported during January-September
2021 has shown that characteristics of people with severe
COVID-19 following vaccination were similar to people at risk
for severe COVID-19 in general, including older age. Notably,
historical breakthrough data were reported as case counts which
was useful during initial vaccine introduction, but challenging
to interpret because of limited completeness and
representativeness, as well as a lack of denominator data for
calculating rates and making direct comparisons with
unvaccinated persons to contextualize trends.
Additionally of note, the Federal Government lacks the
authority to compel reporting of key hospital and case data
elements, including vaccination status. While robust systems
have been set up to capture and analyze voluntary reporting of
breakthrough cases as described above, significant gaps remain
in the data that is needed to detect adverse events and monitor
vaccine effectiveness for COVID-19. This has been particularly
challenging for real-world observational vaccine effectiveness
studies because it is not possible to identify a cohort of
individuals that we know are unvaccinated. It is challenging to
directly compare vaccinated individuals and unvaccinated
individuals. Therefore, Federal authority to require reporting
of public health data, such as vaccination status associated
with case and hospital data, would provide a more complete
national picture of the COVID-19 outbreak and allow for better
tracking of breakthrough infections. A Federal public health
authority would benefit all levels of public health and provide
better data to inform decisionmakers.
SENATOR SCOTT
Omicron Status
Question 1. Dr. Walensky--Of omicron hospitalizations, what
percentage are ICU cases and what percentage are on
ventilators? How do those percentages compare to the previous 2
variants?
Answer 1. CDC is currently working to determine this
information and expects to publish an upcoming paper in CDC's
Morbidity and Mortality Weekly Report.
Question 1(a). Doesn't this and other available data
suggest that the omicron variant is less severe than the
previous 2 variants?
Answer 1(a) Omicron infection generally causes less severe
disease than infection with prior variants. Preliminary data
suggest that Omicron may cause more mild disease, although some
people may still have severe disease, need hospitalization, and
could die from the infection with this variant. Even if only a
small percentage of people with Omicron infection need
hospitalization, the large volume of cases could overwhelm the
healthcare system.
Question 2. Dr. Walensky--What is the difference between
someone hospitalized with COVID and someone hospitalized
because of COVID?
Answer 2. Some data sources of hospitalization allow us to
distinguish when patients are hospitalized with COVID, and when
they are hospitalized for (or because) of COVID. However,
making this distinction with the data may not always be clear.
We are currently exploring the available data, including
primary and secondary diagnoses codes, as well as data on
medications such as remdesivir and dexamethasone, to determine
how to make this distinction.
In the Coronavirus Disease 2019-Associated Hospitalization
Surveillance Network (COVID-NET), we have the ability to
examine primary reason for admission on a sample of
hospitalized cases. In an analysis (on a preprint server and
not yet peer-reviewed) among adults aged 18 years who were
hospitalized with laboratory-confirmed SARS-CoV-2 infection
from January-July 2021, 716 (11.7 percent) of 6,115
hospitalizations had a primary reason for admission other than
COVID-19 related illness. In a recent study of children aged 18
years hospitalized with laboratory-confirmed SARS-CoV-2
infection during July 1-December 1, 2021, 81.3 percent of 1,703
COVID-19-associated hospitalizations in children were likely
related to COVID-19. This proportion is similar to a prior
published analysis using the same data source that found
children aged 18 years hospitalized with laboratory-confirmed
SARS-CoV-2 infection during March 2020-May 2021, approximately
718 (23 percent) of 3,106 had a primary reason for admission of
Ob/labor and delivery, inpatient surgery or procedures,
psychiatric admission needing acute medical care, trauma or had
``other'' reason for admission with no symptoms of COVID-19 on
admission. The remaining 77 percent had a primary reason for
admission likely related to COVID-19.
We have historically avoided making strong claims that
these hospitalizations are not related to COVID-19, as COVID-
NET was designed to conduct rapid surveillance of COVID-19-
associated hospitalizations and not to carefully adjudicate the
reason for admission for each hospitalization. Determining the
primary reason for admission to a hospital can be complex, and
multiple factors can influence the decision to seek care or be
admitted, including COVID-19 status. Levels of community
incidence of COVID-19 and population vaccination coverage can
also have an impact. Additionally, patients who test positive
for SARS-CoV-2 infection may develop symptomatic illness after
admission, which may influence the course of their
hospitalization, and this would not necessarily be captured in
the patient's primary reason for admission.
Question 2(a)1. Is the data currently being collected
sophisticated enough to differentiate?
Answer 2(a) CDC Response: Data used to examine this
question do not include distinguishing details needed to
differentiate between patients being hospitalized with COVID-19
or because of COVID-19. To examine this question other
accompanying information from the discharge, claim or
electronic health record must be leveraged. CDC continues to
examine data from multiple hospitalization data sources, to
better understand trends in COVID-19 related hospitalizations.
Question 2(b)1. How long does it take to publish this
differential?
Answer 2(b) CDC Response: Data available for
hospitalizations come from multiple sources; some of which
cannot distinguish ``with'' and ``for''. Analysis of the
various datasets is ongoing.
The process of identifying claims where hospitalization
occurred ``with'' COVID-19 is not readily available or apparent
through query of available data. Data are reported by the
process of utilizing electronic health record data to identify
an incidental COVID-19 case is complex.
Question 2(c). Given continuous updates to guidance, is
this lag in reporting problematic when crafting guidance that
is commensurate with the actual risk posed by a variant of
concern?
Answer 2(c) CDC Response: CDC guidance is based on the best
available data at the time. CDC uses a combination of available
sources including hospital data and epidemiological studies to
inform guidance during fluctuating conditions of a response.
Prevalent Hospitalizations of Patients with Confirmed COVID-19
are published on COVID Data Tracker within a 2-3-day lag. CDC
has also published Disease Severity Among Hospitalized Patients
on COVID Data Tracker. The disease severity metrics are the
percentage of hospitalized COVID-19 patients who were admitted
to the intensive care unit (ICU), received invasive mechanical
ventilation (IMV), or died. These data, from three healthcare
data sources, show downward trends in ICU admission, invasive
mechanical ventilation, and mortality among hospitalized
patients over the course of the pandemic.
Testing
Question 1. Dr. Walensky--Can T-cell testing be used to
measure the U.S.' progress toward herd immunity?
Answer 1. CDC defers to FDA.
LCan T-cell testing complement antibody
testing to inform efforts against COVID-19 variants
that might evade vaccines or allow for reinfection?
Answer 1(a) CDC defers to FDA.
LIf so, how can we ensure physicians have
access to tools-like T-cell testing-they need to make
appropriate clinical decisions in treating patients?
Answer 1(b) CDC defers to FDA.
Vaccinations & Treatments
Question 1. Dr. Walensky--Can monoclonal antibody
treatments be used to prevent COVID infection?
Answer 1. CDC Response: Anti-SARS-CoV-2 monoclonal
antibodies (mAbs) have shown evidence of clinical benefit in
treating SARS-CoV-2 infection, however, some have reduced
effectiveness against Omicron. Some anti-SARS-CoV-2 mAbs have
shown evidence of clinical benefit as post-exposure prophylaxis
after a potential exposure to SARS-CoV-2, like in a household
setting or during SARS-CoV-2 outbreaks in skilled nursing or
other long term care facilities. Other anti-SARS-CoV-2 mAbs
have shown evidence of reducing the risk of infection when used
as pre-exposure prophylaxis. The FDA has issued an emergency
use authorization for tixagevimab plus cilgavimab (Evusheld),
an investigational medicine used in adults and children ages 12
years and older. Evusheld consists of 2 monoclonal antibodies
provided together to help prevent infection with the virus that
causes COVID-19. A healthcare provider gives Evusheld as two
separate consecutive intramuscular (IM) injections at a
doctor's office or healthcare facility. If an individual is
moderately or severely immunocompromised or severely allergic
to COVID-19 vaccines, they may be eligible for Evusheld.
School Closures
Question 1. When discussing children and the omicron case
surge on MSNBC, President Biden's chief medical advisor, Dr.
Fauci, pointed out that pediatric hospitalizations are much
lower on a percentage basis than adults, especially when
compared with the elderly. He went on to state: ``But the other
important thing is that if you look at the children who are
hospitalized, many of them are hospitalized with COVID as
opposed to because of COVID. And what we mean by that--if a
child goes into the hospital, they automatically get tested for
COVID and they get counted as a COVID-hospitalized individual
when, in fact, they may go in for a broken leg or appendicitis
or something like that. So it's over-counting the number of
children who are, quote, `hospitalized with COVID,' as opposed
to because of COVID.''
Question 1(a). Dr. Walensky--Do you agree with Dr. Fauci's
assessment?
Answer 1. In the Coronavirus Disease 2019-Associated
Hospitalization Surveillance Network (COVID-NET), we have the
ability to examine primary reason for admission on a sample of
hospitalized cases.
In an analysis (on a preprint server and not yet peer-
reviewed) among adults aged 18 years who were hospitalized with
laboratory-confirmed SARS-CoV-2 infection from January-July
2021, 716 (11.7 percent) of 6,115 hospitalizations had a
primary reason for admission other than COVID-19 related
illness. In a recent study of children aged 18 years
hospitalized with laboratory-confirmed SARS-CoV-2 infection
during July 1-December 1, 2021, 81.3 percent of 1,703 COVID-19-
associated hospitalizations in children were likely related to
COVID-19. This proportion is similar to a prior published
analysis using the same data source that found children aged 18
years hospitalized with laboratory-confirmed SARS-CoV-2
infection during March 2020-May 2021, approximately 718 (23
percent) of 3,106 had a primary reason for admission of Ob/
labor and delivery, inpatient surgery or procedures,
psychiatric admission needing acute medical care, trauma or had
``other'' reason for admission with no symptoms of COVID-19 on
admission. The remaining 77 percent had a primary reason for
admission likely related to COVID-19.
We have historically avoided making strong claims that
these hospitalizations are not related to COVID-19, as COVID-
NET was designed to conduct rapid surveillance of COVID-19-
associated hospitalizations and not to carefully adjudicate the
reason for admission for each hospitalization. Determining the
primary reason for admission to a hospital can be complex, and
multiple factors can influence the decision to seek care or be
admitted, including COVID-19 status. Levels of community
incidence of COVID-19 and population vaccination coverage can
also have an impact. Additionally, patients who test positive
for SARS-CoV-2 infection may develop symptomatic illness after
admission, which may influence the course of their
hospitalization, and this would not necessarily be captured in
the patient's primary reason for admission.
Question 2. CDC published in its March 19, 2021 Morbidity
and Mortality Weekly Report that ``changes in modes of
instruction have presented psychosocial stressors to children
and parents that can increase risks to mental health and well-
being and might exacerbate educational and health
disparities.''
Question 2(a). Dr. Walensky--Does virtual learning present
more risks than in-person learning related to child and
parental mental and emotional health in addition to healthy
behaviors like physical activity which can impact individuals
over a lifespan?
Answer 2. Findings from a nationwide study of 1,290 parents
of children ages 5-12 conducted from October 8-November 13,
2020 and published in March 19, 2021 MMWR ``Association of
Children's Mode of School Instruction with Child and Parent
Experiences and Well-Being During the COVID-19 Pandemic--COVID
Experiences Survey, United States, October 8-November 13,
2020'', suggest children not receiving full-time, in-person
instruction and their parents might experience increased risk
for negative mental/emotional and physical health outcomes.
Specifically:
LParents of children receiving virtual-only or
combined instruction more frequently reported that
their child's mental/emotional health worsened during
the pandemic and that their time outside, time in-
person with friends, and physical activity decreased.
LParents of children receiving virtual-only
instruction more frequently reported their own
distress, difficulty sleeping, loss of work, concern
about job stability, conflict between work and
providing childcare, and childcare challenges than did
parents whose children were receiving in-person only
instruction.
LChildren receiving in-person instruction and
their parents reported the lowest prevalence of
negative indicators of child and parent well-being.
LParents whose children attended school in-
person only were less likely to report challenges with
employment and childcare.
Answer 1. CDC recognizes the need for a comprehensive,
coordinated, multidisciplinary approach to promoting student
mental health and well-being, especially given the potentially
broad impact of school closures on student mental health.
Schools have the infrastructure to provide critical support
to youth and families, including opportunities to engage in
academic, social, mental health, and physical health services,
and mental health promotion activities, all of which can buffer
stress and lessen negative outcomes. Many students and staff
have been adversely impacted by the pandemic. While mental
health services are necessary, this alone is not sufficient to
promote mental health and well-being.
Question 2. We have witnessed the damaging impacts school
closures have had on student achievement, mental health, and
even physical health. I believe parents, in consultation with
their child's doctor, not teachers' unions know what's best for
their child.
LDr. Walensky--Should teachers' unions have a
role in crafting health guidance?
Question 2(a). Should teachers' unions be pushing policies
that directly contradict CDC guidance on in-person learning and
have damaging impacts on child development?
Answer 2. When developing guidance and recommendations, CDC
often engages with organizations and groups that are impacted.
The agency does so to ensure recommendations are comprehensive,
address the stakeholder needs and concerns, and are feasible to
implement. These informative and helpful interactions result in
beneficial feedback for final revisions to promote clarity,
completeness, and usability.
For the development of the school guidance, CDC had close
engagement with the U.S. Department of Education and sought
input from a variety of organizations and stakeholders-
including public health and education organizations to discuss
experiences, challenges, and lessons learned in implementing
prevention strategies for infectious diseases in K-12 schools
CDC Guidance
Question 1. The CDC in 2018 published a Crisis and
Emergency Risk Communications pamphlet which stresses the need
to ``be first, be right, be credible.'' Unfortunately, we've
seen anything but. We've seen statements made anonymously or on
background. We've seen pronouncements made in anger and
frustration regarding factors outside of the Administration's
control. We need timely, accurate, clear guidance instead of
mixed messages and paternalistic attitudes.
LDr. Walensky--How is CDC working to restore
and broaden public trust?
Answer 1. CDC's mission is to protect the American public
from threats to their health. The American public should know
that CDC is comprised of dedicated and compassionate scientific
professionals who are working long hours every day to serve and
protect them. At CDC, we are striving to advance science and
communicate our findings and recommendations in the least
confusing and most effective manner.
The dedicated experts at CDC have been responding to this
pandemic since the early days of 2020 and have done their best
to communicate with the American people openly and clearly
about this public health emergency. When we haven't met our own
standards for clear and open communication, we've worked to
provide additional information quickly. And when we have heard
from scientific colleagues, policymakers, and the public that
we can do better, we have listened and made changes. President
Biden's commitment to leading with science and truth and
treating each other with respect and kindness can help CDC
regain its reputation and credibility, but we have a lot of
ground to make up and restoring public trust is going to take
time.
The virus that causes COVID-19 has challenged and humbled
us, teaching us even more about modern threats to the public's
health-like global interconnectedness and the spread of
misinformation. These threats compound the risks posed by novel
infectious diseases. And while everyone has worked as hard as
they can with the best of intentions, there have been missteps
and the spotlight has been shone on the weaknesses in our
country's public health system. CDC alone cannot strengthen
this system, prepare for future emergencies, and rebuild trust
in public health. Our success in doing these things-which are
critical to our health and safety as a nation-depends on state
and local public health, governments, businesses, communities,
and many others working together.
Question 2T1. What is the Agency doing to address a process
that has, so far, produced confusing and sometimes conflicting
guidance that appears to be consistently behind the curve
instead of ahead of it?
Answer 2. As the science and our understanding of COVID-19
evolves, CDC is actively working to disseminate the latest
public health data and guidance as quickly as possible. To
provide unified guidance, CDC is collaborating across
government and across the scientific and medical community to
stay ahead of the virus, stop the spread of infection, keep
people out of the hospital, and save as many lives as possible.
SENATOR TUBERVILLE
COVID and Vaccinations
Question 1. In March 2021, you stated ``vaccinated people
do not carry the virus, don't get sick.'' Do you stand by this
statement?
Answer 1. The immunity provided by vaccine and prior
infection are both high but not complete. Multiple studies have
shown that antibody titers correlate with protection at a
population level, but protective titers at the individual level
remain unknown. As described in greater detail in CDC's COVID-
19 Vaccine and Vaccination Science Brief, studies have
demonstrated waning of both antibody titers and vaccine
effectiveness against infection over time, especially among
older populations. Decreased vaccine effectiveness may reflect
a combination of waning antibody titers and decreased
neutralizing capacity in the setting of widespread circulation
of variants with partial immune escape.
Question 2. In July 2021, you stated ``99.5 percent of
deaths from COVID-19 in the United States were in unvaccinated
people'' and Dr. Fauci also stated 99.2 percent of deaths in
June were unvaccinated. Is this still accurate?
Answer 2. As part of ongoing efforts to understand how
COVID-19 vaccines are working, CDC monitors rates of COVID-19
cases, hospitalizations, and deaths in vaccinated
(breakthroughs) and unvaccinated persons. CDC monitors rates of
COVID-19 cases and deaths using data from 30 jurisdictions
representing all 10 HHS regions and 70 percent of the U.S.
population that routinely link case surveillance data with
records from immunization information systems (IIS) and vital
registration to identify the vaccination status of all reported
COVID-19 cases and deaths. This approach provides more complete
information on breakthrough cases and deaths and a better
understanding of the impact of vaccines than was available
previously. These data are updated monthly on the COVID Data
Tracker.
CDC also uses COVID-NET, a population-based surveillance
system of COVID-19-associated hospitalizations from a network
of 250 acute-care hospitals in 14 states, to monitor rates of
COVID-19-associated hospitalizations by vaccination status.
These data are also updated monthly and shared with the public
on the COVID Data Tracker.
While people had become accustomed to following counts of
breakthrough infections, the public health impact of case
counts is difficult to interpret without knowing the underlying
burden of community transmission or the proportion of the
population that has been vaccinated. Reporting rates based on
comprehensive capture of information on vaccination status
provides more accurate information about breakthrough
infections, including patterns over time and across age groups,
vaccine types, and receipt of booster doses and direct
comparisons with unvaccinated persons to contextualize trends.
An MMWR published in September 2021 demonstrated that
incidence rate ratios are more stable and directly related to
vaccine effectiveness (VE), while the percentage of vaccinated
people among COVID-19 cases rises with either increasing
vaccination coverage or decreasing VE, complicating
interpretation of this metric. Interpretation of the proportion
of vaccinated people among hospitalized and fatal cases may be
further complicated by older people and people with
comorbidities having higher risks of severe COVID-19 outcomes
and higher vaccination coverage.
Question 3. Dr. Walensky, you have stated this is a
pandemic of the unvaccinated. Is that still accurate?
Answer 3. Vaccines greatly reduce the risk of the most
severe outcomes for those who are sickened with COVID-19,
including the risk of severe illness and death among people who
are fully vaccinated. Vaccine effectiveness against
hospitalizations has remained relatively high over time,
although it tends to be slightly lower forder adultsd
for people with weakened immune systems.
Question 4. Many countries as well as cities like San
Francisco and New York City have high vaccination rates and
mask and vaccine mandates but have recorded some of the highest
levels of COVID-19 infections ever in December 2021 and January
2022.
Question 4(a). Why are these cities experiencing COVID-
19 outbreaks?
Answer 4. The Omicron variant was first clinically
identified in the United States on December 1, 2021 and spread
rapidly. By late December, it became the predominant strain,
and by mid-January it represented 99.5 percent of sequenced
specimens in the United States (1). The Omicron variant has
been shown to be more transmissible and less virulent than
previously circulating variants.
Question 4(b). Please provide data to confirm that mask
and vaccine mandates are effective at reducing the
spread of COVID-19.
Answer 4(b) COVID-19 vaccination helps protect adults and
children ages 5 years and older from getting sick or severely
ill with COVID-19 and helps protect those around them. CDC
tracks state-issued vaccination requirements by requirement
type (e.g., a vaccination requirement with no test-out option
versus those that allow recurring testing in lieu of
vaccination), exemption types allowed, documentation required
to apply for an exemption, and groups to which the vaccination
requirement applies (e.g., school workers, government workers,
healthcare workers, as well as others).
Vaccination requirements have increased vaccination rates
by 20+ percentage points to over 90 percent in many
organizations. An analysis of health care systems, educational
institutions, public-sector agencies, and private businesses
shows that organizations with vaccination requirements have
seen their vaccination rates increase by more than 20 percent
and have routinely seen their share of fully vaccinated workers
rise above 90 percent. That is substantially higher than
broader working-age vaccination rates for Americans aged 18 to
64.
Question 5. What percentage of Americans have had COVID-19?
Answer 5. As of January 11, 2022, more than 62.6 million
cases of COVID-19 have been reported in the U.S. However, case
surveillance data do not represent the true burden of COVID-19
in the United States. The number of cases also includes
reinfections and therefore does not equal the number of people
who have had COVID-19. Many people infected, even if
symptomatic, do not seek medical care or get tested. In these
situations, data cannot be extracted from medical records. Data
can also be limited if people are unavailable or unwilling to
provide information.
Most of the case reports captured by health departments are
based on laboratory reports that might contain limited patient
information. Because of the volume of cases, most health
departments are unable to obtain additional information on
every case. As a result, many case reports are missing data on
patient demographics, symptoms, underlying health conditions,
characteristics of hospitalizations such as ventilator use, and
other factors such as travel history. Because of missing data,
analyses of these data elements are likely an underestimate of
the true occurrence.
Question 6. What percentage of children under 18 have had
COVID-19?
Answer 6. As of January 11, 2022, there are 8,968,092
cumulative COVID-19 cases among children aged 0-17 years, as
shown on the CDC COVID Data Tracker Note that this number does
not represent the number of unique individuals with infection
as it also includes reinfections. Case based surveillance of
SARS-COV-2 also likely underestimates the prevalence of
infections.
Question 7. For the most recent week, what percentage of
COVID-19 infections are breakthrough cases in vaccinated and
boosted individuals?
Answer 7. As part of ongoing efforts to understand how
COVID-19 vaccines are working, CDC monitors rates of COVID-19
cases, hospitalizations, and deaths in unvaccinated and
vaccinated persons, including people who received booster
doses. Data are published monthly on CDC's COVID Data Tracker.
Unvaccinated adults had 5 times the risk of testing positive
for COVID-19 in December 2021, compared to fully vaccinated
adults with additional or booster doses. Although changes
occurred in December related to the emergence of the Omicron
variant, monthly rate ratios are more stable than weekly and
are therefore preferred for monitoring.
Question 8. For the most recent week, what percentage of
hospitalizations and deaths are vaccinated/boosted individuals?
Answer 8. As part of ongoing efforts to understand how
COVID-19 vaccines are working, CDC monitors rates of COVID-19
cases, hospitalizations, and deaths in unvaccinated and
vaccinated persons, including people who received booster
doses. On a monthly basis, CDC publishes rates of
hospitalizations and deaths by vaccination status on COVID Data
Tracker. During December 2021, unvaccinated adults had 41 times
the risk of dying from COVID-19-associated death compared to
fully vaccinated persons with additional or booster doses.
COVID-19-associated hospitalizations were 45 times higher in
unvaccinated adults ages 50-64 years and 51 time higher in
unvaccinated adults ages 65 years and older, compared with
fully vaccinated persons with additional or booster doses in
each age group during December 2021.
Question 9. Has the Federal response to COVID-19 been
successful?
L(a) Please explain.
L(b) If not, please explain what should have
been done differently.
Answer 9. As of January 2022, more than 900,000 people have
died in this country alone from COVID-19. Others have been
sickened, lost time with their family and loved ones, missed
work and school, and developed post-COVID conditions. These
losses are an incalculable tragedy, for every person who has
personally experienced them and for our country and our world.
The entire Federal Government is committed to preventing as
many deaths as we can while minimizing the negative effects
COVID-19 has on the health and well-being of our society. We
have developed safe, effective vaccines and administered more
than 545 million doses as of January 2022. The Federal response
has developed treatments for COVID-19 and are working to ensure
everyone, particularly those at highest risk of severe illness,
has access to these treatments. We have enhanced existing
public health data and surveillance systems and stood up new
ones to monitor the spread of this virus, so that we can more
quickly detect and respond to case surges, increased healthcare
system burden, and the emergence of new variants. We've worked
to reopen schools safely and to keep them open because schools
are so critical to the well-being of children, families, and
communities. Most recently, we have further scaled up testing
capacity, making millions of at-home self-tests available to
America households free of charge, and we've worked with
pharmacy and health center partners to distribute free masks
across the country.
Question 10. Will you commit to doing a cost-benefit
analysis of the COVID-19 response?
Answer 10. An effective public health response requires
global, Federal, state, territorial, tribal, and local public
health partners to be independently strong, yet closely
coordinated. This pandemic has continued to reinforce how
interconnected we all are and why it is critical to support
surveillance and response capacity abroad, as we make public
health investments at home.
I will continue to prioritize support for the improvement
of core public health capabilities across public health
partners through flexible and consistent funding to support
surveillance capabilities, data modernization, laboratory
capacity, and workforce development.
Question 11. Please provide specific examples where your
agency has utilized real world evidence in regards to COVID-19
or treatments for COVID-19.
Answer 11. The clinical spectrum of SARS-CoV-2 infection
includes asymptomatic or pre-symptomatic infection and mild,
moderate, severe, and critical illness. CDC provides
considerations for healthcare providers regarding the clinical
management and treatment of COVID-19 stratified by whether the
patient has mild or moderate illness that often can be managed
in the outpatient setting, or severe or critical illness that
requires hospitalization. CDC recommends clinicians refer to
the recommendations in the National Institutes of Health (NIH)
COVID-19 Treatment Guidelines, recommendations and information
contained within FDA websites and EUAs for treatment, and the
Infectious Diseases Society of America Guidelines on the
Treatment and Management of Patients with COVID-19. These
recommendations and those from CDC are based on scientific
evidence and expert opinion and are regularly updated as more
data become available. CDC defers additional questions on
treatments available to FDA and NIH.
Question 12. Do you believe schools and universities should
be requiring students to be vaccinated and boosted in order to
be enrolled or attend school?
Answer 12. Ensuring students can safely attend school in-
person is a priority and being up to date on vaccines is the
most effective way to do so. CDC is working with state public
health partners to reach school districts and universities
across the country to continue to demonstrate the importance of
implementing layered prevention strategies in schools,
including vaccination and screening testing.
Vaccine Adverse Event Reporting System (VAERS)
Question 1. It's been reported by some virologists and
scientists that this year, around 170 people died from taking
the flu vaccine. The Vaccine Adverse Event Reporting System
(VAERS) reports that the number of people dying after taking
the COVID vaccine is actually in the thousands--maybe as many
as 20,000 people. I understand that VAERS reports deaths
``after taking'' the vaccine as opposed to ``from'' the
vaccine, however, these numbers are startling.
Question 1(a) What do we know about how many people
might have died as a direct relation to taking the
COVID vaccine?
Answer 1. CDC scientists have conducted detailed reviews of
Thrombosis with thrombocytopenia syndrome (TTS) cases following
receipt of the J&J/Janssen COVID-19 vaccine and have identified
nine deaths causally associated with J&J/Janssen COVID-19
vaccination. CDC and FDA continue to review deaths following
COVID-19 vaccination reported to VAERS--including death
certificates, autopsy reports, and available medical records--
and provide updated information to healthcare providers and the
public as it becomes available. With the exception of the nine
deaths from TTS following the J&J Janssen COVID-19 vaccine,
there is no evidence to suggest that COVID-19 vaccines are
causing or contributing to deaths. In fact, CDC published an
analysis that showed that during December 2020-July 2021,
COVID-19 vaccine recipients had lower rates of non-COVID-19
mortality than did unvaccinated persons after adjusting for
age, sex, race and ethnicity, and study site: (https://
www.cdc.gov/mmwr/volumes/70/wr/mm7043e2.htm).
Reports of death after COVID-19 vaccination are rare. FDA
requires healthcare providers to report any death after COVID-
19 vaccination to VAERS, even if it is unclear whether the
vaccine was the cause. Reports of adverse events to VAERS
following vaccination, including deaths, do not necessarily
mean that a vaccine caused a health problem. More than 539
million doses of COVID-19 vaccines were administered in the
United States from December 14, 2020, through December 14,
2021. During this time, VAERS received 10,688 preliminary
reports of death (0.0022 percent) among people who received a
COVID-19 vaccine.
Question 1(b) Why does VAERS report data this way?
Answer 1(b) CDC Response: VAERS serves as the Nation's
early warning system to monitor vaccine adverse events and
detect potential safety problems. As a passive surveillance
system, it relies on individuals to send in reports of their
experiences to CDC and FDA. CDC accepts all reports of adverse
events after vaccination from healthcare providers and
individuals to assess possible safety concerns related to
vaccines, including COVID-19 vaccines. FDA also requires
vaccine manufacturers to submit reports for any adverse events
following vaccinations to VAERS. These data are especially
useful for quickly detecting unusual or unexpected patterns of
adverse event reporting that might indicate a possible safety
concern (or ``signal'') with a vaccine.
When VAERS reports are received, they are reviewed,
processed, and coded. To better understand the circumstances
around a particular adverse event, VAERS staff from CDC and FDA
request follow-up medical records for reports that are
classified as ``serious.'' This includes adverse events
resulting in death, life-threatening illness, hospitalization
or prolongation of hospitalization, permanent disability, or
congenital anomaly/birth defect. FDA requires all healthcare
providers to report any death following COVID-19 vaccination to
VAERS and all reports of deaths are reviewed by CDC and FDA.
All adverse events reported in VAERS are then publicly posted
to the CDC WONDER data base, except for in very rare and
specific instances.
Question 1. Where can Americans find data about the actual
number of deaths from the COVID vaccine, as opposed to ``after
taking'' it?
Answer 1. This information is reported publicly on CDC's
website at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/
safety/adverse-events.html.
SENATOR HASSAN
Question 1. Children under age five are still not eligible
for a COVID-19 vaccine. Moderna reported earlier this month
that it expects to report trial data on its COVID-19 vaccine in
children ages 2 to 5 by March.
Question 1(a). Meanwhile, the number of children with
COVID-19 is surging in New Hampshire and across the country. As
of January 1, the hospitalization rate for children under age 5
reached 4 in 100,000 children-3 times higher than the same time
last year.
Question 1(b). What guidance are you providing to parents
of young children to keep them safe in the interim?
Answer 1. CDC recommends that all family members above the
age of 5 years old be vaccinated to help protect younger
children who are not yet eligible to be vaccinated. In
addition, CDC recommends the following strategies on our
website to help protect yourself and others from getting sick
with COVID-19: https://www.cdc.gov/coronavirus/2019-ncov/
prevent-getting-sick/prevention.html
SENATOR TUBERVILLE
Question 1. Does science still support a 90-day period
after an infection during which a person should be exempt from
testing requirements?
Answer 1. CDC continues to recommend that people who have
had a laboratory-confirmed SARS-CoV-2 infection within the past
90 days who have subsequently recovered and no longer have
COVID-19 symptoms do not need to quarantine following an
exposure. In addition, CDC continues to recommend that people
who develop symptoms consistent with COVID-19 isolate
immediately and get tested.
Currently, there are not enough data to support a change in
this recommendation. CDC will continue to monitor relevant data
and update public health recommendations and guidance on
quarantine and isolation for the general population as more
information becomes available.
Question 2. Why does our Federal Government not currently
recognize natural immunity, as other countries do?
Answer 2. Available evidence shows that fully vaccinated
individuals and those previously infected with SARS-CoV-2 each
have a low risk of subsequent infection for at least 6 months.
Data are presently insufficient to determine an antibody titer
threshold that indicates when an individual is protected from
infection. At this time, there is no FDA-authorized or approved
test that providers or the public can use to reliably determine
whether a person is protected from infection.
Multiple studies have shown that antibody titers correlate
with protection at a population level, but protective titers at
the individual level remain unknown. Whereas there is a wide
range in antibody titers in response to infection with SARS-
CoV-2, vaccination typically leads to a more consistent and
higher-titer initial antibody response. Substantial immunologic
evidence and a growing body of epidemiologic evidence indicate
that vaccination after infection significantly enhances
protection and further reduces risk of reinfection, which lays
the foundation for CDC recommendations.
------
Response by Anthony Fauci to Questions of Senator Casey, Senator
Hassan, Senator Lujan, Senator Paul, Senator Cassidy, Senator Braun,
Senator Scott, and Senator Tuberville
SENATOR CASEY
Question 1. At the hearing, I asked how the Federal
Government is working with vaccine manufacturers to speed the
development of a safe and effective vaccine for children under
age five. Understanding that the Pfizer trial for children 24
months to 5 years old did not meet its endpoint, my follow-up
questions are, how did we get here and what's next? Please
describe, generally, the following:
Question 1(a). How vaccine developers make decisions
about dose size, quantity and spacing in age de-
escalation trials;
Question 1(b). What type of indicators a vaccine
manufacturer might consider when determining whether
and how to change the dose size, quantity or spacing if
primary endpoints are not met; and
Question 1(c). Whether the emergence of a viral variant
could affect the efficacy of a vaccine in children
differently than it would affect the efficacy of the
same vaccine in adults.
Answer 1(a)(b)(c). NIAID defers to FDA and ASPR on the
above questions.
Question 1(d). Furthermore, could you please provide an
update on current Federal goals and investments
relating to the development of vaccines to protect
children under age five from COVID-19, including
grants, contracts or other funding awarded to vaccine
developers; and what information is currently being
provided to vaccine developers regarding current or
planned opportunities for collaboration between the
Federal Government and vaccine developers, including
the extent to which BARDA will conduct TechWatch/
CoronaWatch meetings and the extent to which FDA will
accept applications for emergency use authorization.
Answer 1(d). NIAID currently is supporting the evaluation
of existing coronavirus disease 2019 (COVID-19) vaccines and
novel COVID-19 vaccine approaches for potential use in young
children. Researchers supported by the National Institute of
Allergy and Infectious Diseases (NIAID), in collaboration with
the Biomedical Advanced Research and Development Authority
(BARDA) and Moderna, Inc., are evaluating the mRNA-1273 vaccine
in children 6 months to less than 12 years of age in a Phase 2/
3 clinical trial called KidCOVE. There are multiple trial sites
at the NIAID-supported Vaccine and Treatment Evaluation Units
(VTEUs). Moderna has indicated that it expects to report data
in March 2022 for children 2 years of age to less than 6 years
of age. In addition to the clinical evaluation of mRNA-1273,
NIAID intramural scientists are conducting early stage research
on an intranasal live-attenuated parainfluenza virus-vectored
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
vaccine approach, which is designed to protect infants and
young children against both human parainfluenza virus 3 and
SARS-CoV-2. NIAID also is supporting a study to identify
adjuvants that improve vaccine efficacy in very young children.
NIAID notes that the Pfizer-BioNTech COVID-19 Vaccine also
is being evaluated in children under 5 years of age; however,
NIAID is not involved in the trial. NIAID would defer to the
vaccine manufacturer to provide an update on the status of the
trial.
Question 1(e). Finally, could you describe current
thinking across your agencies regarding the
circumstances under which your efforts would expand to
include the development of additional or next-
generation vaccines and therapeutics for COVID-19?
Answer 1(e). NIAID is supporting research on next-
generation COVID-19 vaccines. On March 25, 2021, NIAID launched
a Phase 1 clinical trial in healthy adults to assess the safety
and immunogenicity of second-generation COVID-19 vaccine
candidates developed by Gritstone Oncology, Inc. Gritstone's
COVID-19 vaccine candidates utilize a strategy aimed at
inducing both neutralizing antibodies and T cell responses to
elicit a broad immune response. This approach could provide
protection against emerging SARS-CoV-2 variants by targeting
several viral antigens, all of which are highly conserved among
viral strains. In addition, NIAID is pursuing the development
of mucosal vaccine approaches that may stimulate greater
immunity in the upper respiratory tract. These candidates could
result in a much lower rate of breakthrough infection, broader
and more durable protection, and stronger reduction in disease
transmission than that observed with currently available COVID-
19 vaccines. One of these mucosal vaccine approaches is an
Adenovirus type 4 (Ad4)-based intranasal SARS-CoV-2 vaccine
candidate developed by NIAID researchers that currently is
undergoing preclinical testing.
Current COVID-19 vaccines approved or authorized by the
U.S. Food and Drug Administration (FDA) elicit robust immune
responses to the spike protein of SARS-CoV-2. NIAID Vaccine
Research Center investigators have created a nanoparticle-based
pan-coronavirus vaccine candidate designed to elicit antibodies
targeted to the spike protein of multiple different
coronaviruses. This mosaic nanoparticle-based approach--based
on the universal influenza vaccine concept known as FluMos--is
currently undergoing preclinical testing in an animal model.
NIAID-supported scientists also provided proof of principle
that self-assembling mosaic nanoparticles displaying receptor
binding domains of multiple coronaviruses in the Sarbecovirus
subgroup (including SARS-CoV-2) can induce protection in mice
when challenged with another Sarbecovirus. In addition, NIAID
intramural investigators are evaluating inactivated whole virus
vaccine candidates for a broadly protective beta-coronavirus
vaccine based on related efforts to develop a universal
influenza vaccine. NIAID also is supporting studies through its
vaccine adjuvant program to compare different classes of
adjuvants and identify the most efficacious vaccine
formulations. The identification of vaccine adjuvants that
promote cross-protective and durable immunity in vulnerable
populations would complement ongoing efforts to develop next-
generation coronavirus vaccines.
In late 2021, NIAID announced four awards to fund
multidisciplinary, collaborative teams that had submitted
highly meritorious applications to conduct research on
universal coronavirus vaccine candidates and help accelerate
pan-coronavirus vaccine development. The teams will incorporate
advances in coronavirus biology and immunology; immunogen
design; and innovative vaccine and adjuvant technologies to
discover, design, and develop vaccine candidates to protect
against multiple types of coronaviruses and viral variants. The
four awards are funded under the auspices of the Emergency
Awards Notice of Special Interest (NOSI) on Pan-Coronavirus
Vaccine Development Program Projects. A key goal of this NIAID
initiative is to develop multivalent vaccine platforms and
strategies suitable for use in vulnerable populations and to
understand vaccine-induced immune responses and efficacy
related to a person's age or sex. NIAID currently expects
additional awards will be issued in 2022 to highly meritorious
applications to support pan-coronavirus vaccine research from
additional institutions submitted in response to the NOSI.
The National Institutes of Health (NIH) also is supporting
research to identify and develop additional COVID-19
therapeutics. The NIH Accelerating COVID-19 Therapeutic
Interventions and Vaccines (ACTIV) public-private partnership
coordinates research strategies for prioritizing and speeding
development of the most promising treatments. The ACTIV public-
private partnership has evaluated hundreds of available
therapeutic agents with potential application for COVID-19,
prioritized the most promising candidates, designed and
harmonized adaptive master protocols for ACTIV clinical trials,
and selected numerous NIH-supported networks to launch these
clinical trials to test prioritized therapeutic candidates.
On a particular note, NIAID launched the ACTIV-5/Big Effect
Trial (BET), which is designed to streamline the identification
of experimental COVID-19 therapeutics that demonstrate the most
promise. BET, an adaptive Phase 2 clinical trial, compares
different investigational therapeutics to a common control arm
to identify treatments with relatively large effects as
promising candidates for further study in large-scale trials.
In addition, NIH has launched the Antiviral Program for
Pandemics, an NIH-BARDA collaboration that aims to develop safe
and effective antivirals to treat and prevent SARS-CoV-2
infection. The program will build sustainable platforms for
targeted drug discovery and development of antivirals directly
targeting viruses with pandemic potential. As part of this
effort, NIAID will establish Antiviral Drug Discovery Centers
for Pathogens of Pandemic Concern. These multidisciplinary
research centers will create platforms that will target
coronaviruses and additional RNA viruses with pandemic
potential, helping to better prepare the Nation for future
viral threats. Oral drug candidates for broad use in outpatient
settings are the primary focus of this effort.
NIAID will continue to conduct and support research to
identify and develop next-generation COVID-19 vaccines and
therapeutics. These efforts will improve our response to the
current pandemic and bolster our preparedness for the next
viral disease outbreak.
SENATOR HASSAN
Question 1. Children under age five are still not eligible
for a COVID-19 vaccine. Moderna reported earlier this month
that it expects to report trial data on its COVID-19 vaccine in
children ages 2 to 5 by March.
Meanwhile, the number of children with COVID-19 is surging
in New Hampshire and across the country. As of January 1, the
hospitalization rate for children under age 5 reached 4 in
100,000 children--3 times higher than the same time last year.
Question 1. At this point, when do you expect that
vaccinations will be available to children under age 5?
Answer 1. NIH defers to FDA.
Question 2. What guidance are you providing to parents
of young children to keep them safe in the interim?
Answer 2. NIH defers to CDC.
SENATOR LUJAN
Question 1. You stated recently in an interview that,
``scientists tend to talk in a different language than regular
people can understand. It's kind of a mismatch between those
who communicate and those who want to be communicated with not
talking the same language.'' What is the consequence of
scientists and regular people not speaking the same language?
How do you overcome that?
Answer 1. NIAID notes that the statements in Question 1
were not made by Dr. Fauci. The BuzzFeed News article
containing these quotes appears to cite a ``prominent scientist
who spoke with BuzzFeed News--but asked to remain anonymous due
to the sensitive nature of the questions''. NIAID does
appreciate the opportunity to reaffirm the importance of
conveying complex and rapidly evolving public health
information and research findings in a manner that is
accessible to non-scientists. The NIAID Director frequently
answers questions from non-scientists and has the opportunity
to assess where there may be confusion around the latest
research on COVID-19. One effort to overcome such confusion is
through the White House COVID-19 Response Team's public
briefings in which Administration officials help translate and
contextualize the latest research advances for non-scientists.
Question 2. There are differences between PCR and antigen
testing and the appropriate use for both. How has the public
been educated about the differences and appropriate uses? How
can it be done better?
Answer 2. The Centers for Disease Control and Prevention
(CDC) would be the most appropriate agency to elaborate upon
efforts to educate the public about COVID-19 testing.
The National Institute of Biomedical Imaging and
Bioengineering (NIBIB) at the NIH has overseen the Rapid
Acceleration of Diagnostics (RADx) Tech and Advanced Technology
Platforms programs, part of the overall RADx initiative. These
programs have supported development of technologies to increase
lab capacity for PCR tests, development of test supplies, and
development of new lab, point-of-care, and over-the-counter
test devices, including both PCR and antigen technologies.
NIBIB's focus is on the research and development of testing
technologies and information about the different types of tests
in development has been provided through the NIBIB website.
This includes descriptions of the tests and a list of tests
authorized for use by the FDA organized by type of test.
NIBIB also supported development of the When to Test
website to help guide individuals and families on COVID-19
testing. The Testing Impact Calculator also includes tools to
help organizations plan for and develop testing strategies.
This site includes additional resources on testing strategies
and obtaining supplies.
Additionally, NIBIB has issued press releases about the
awarding of contracts for development of tests and the NIBIB
Director has participated in numerous media interviews about
this project and the tests that were developed. Press releases
are listed on the news section of the NIBIB website.
NIBIB uses social media and e-newsletters to disseminate
this information to the public.
Question 3. Given the increased demand for N95 and KN95
masks, we have seen an increase in costs to the
consumer. New Mexicans hoping to protect themselves
face costs as steep as $6 per mask--a cost that is
simply out of reach for some of our most vulnerable
populations. What barriers are preventing the Federal
Government from providing N95 or KN95 masks to the
public free of charge?
Answer 1. NIH defers to ASPR.
SENATOR PAUL
Question 1. Did the NIH award a grant (available at https:/
/reporter.nih.gov/search/6Io2KK8sZEefzzm WqkIOyg/project-
details/8674931) on bat SARS-related coronaviruses to EcoHealth
Alliance with a subcontract to the Wuhan Institute of Virology?
Please answer yes or no.
Answer 1. Yes, the NIH award to EcoHealth Alliance (EHA)
included funds for a subaward to the Wuhan Institute of
Virology (WIV) and EHA then entered into an agreement with WIV.
Question 2. Was the NIH informed in a grant progress report
submitted in 2016 that the researchers constructed new SARS-
related coronaviruses (so-called ``chimeric SARS-related
coronaviruses'') that combined the spike gene of one SARS-
related coronavirus with the rest of the genetic information of
another SARS-related coronavirus, and that the resulting new
viruses infected human cells? Please answer yes or no.
Answer 2. No, NIH received a progress report in 2017
describing research testing whether spike proteins from
naturally occurring bat coronaviruses in China were capable of
binding to cultured human cells (HeLa) genetically engineered
to express the human ACE2 receptor. The presence of the human
receptor alone is not sufficient to drive human infection.
Question 3. Did the NlH inform EcoHealth Alliance in a
letter dated May 28, 2016, that ``[a]s per the funding pause
announcement, new USG funding may not be released for Gain of
Function (GoF) research projects that may be reasonably
anticipated to confer attributes to influenza, MERS, or SARS,
viruses such that the virus would have enhanced pathogenicity
and/or transmissibility in mammals via the respiratory route''
and that the grant ``appears to involve research covered under
the pause''? Please answer yes or no.
Answer 3. While the NIH did send a letter to EHA dated May
28, 2016; the language quoted above in Question 3 differs from
the language in the letter.
The relevant section from the May 28, 2016, letter is
included below. In particular, please note the letter to EHA
states ``new USG funding will not be released'' while Question
3 states ``new USG funding may not be released''
``Based upon information in the most recent progress
report, NIAID has determined that the above referenced grant
may include Gain of Function (GoF) research that is subject to
the U.S. Government funding pause (http://www.phe.gov/s3/
dualuse/Documents/gain-of-function.pdf), issued on October 17,
2014. The following specific aims appear to involve research
covered under the pause:
Aim 3: Testing predictions of CoV inter-species
transmission
As per the funding pause announcement, new USG funding will
not be released for GoF research projects that may be
reasonably anticipated to confer attributes to influenza, MERS,
or SARS viruses such that the virus would have enhanced
pathogenicity and/or transmissibility in mammals via the
respiratory route.''.
In addition, the letter clearly states that such a
determination of whether the research included projects subject
to the funding pause had not yet been made: ``Therefore, the
next non-competing segment of the award that starts June 1,
2016 cannot be released until a determination is reached based
on the receipt and review of the information requested below.''
Question 4. Did the NIH inform EcoHealth in 2016, under
``Special Terms and Conditions'' for continuation of the grant,
that ``should any of the MERS-like or SARS-like chimeras
generated under this grant show evidence of enhanced virus
growth greater than 1 log [10 times] over the parental backbone
strain you must stop all experiments with these viruses and
provide the NIAID Program Officer and Grants Management
Specialist, and Wuhan Institute of Virology Institutional
Biosafety Committee with the relevant data and information''?
Please answer yes or no.
Answer 4. Yes, in an abundance of caution and as an
appropriate biosafety measure, additional language was included
in the terms and conditions of the grant award to EHA. The
Special Terms and Conditions of the award state:
``No funds are provided and no funds can be used to support
gain-of-function research covered under the October 17, 2014
White House Announcement (NIH Guide Notice NOT-OD-15-011). Per
the letter dated July 7, 2016 to Mr. Aleksei Chmura at
EcoHealth Alliance, should any of the MERS-like or SARS-like
chimeras generated under this grant show evidence of enhanced
virus growth greater than 1 log over the parental backbone
strain you must stop all experiments with these viruses and
provide the NIAID Program Officer and Grants Management
Specialist, and Wuhan Institute of Virology Institutional
Biosafety Committee with the relevant data and information
related to these unanticipated outcomes.''
These measures would prompt a secondary review to determine
whether the research aims should be re-evaluated to determine
whether new biosafety measures should be enacted.
Question 5. Was the NIH informed in a progress report
submitted in 2018 that the researchers had found that their
novel, laboratory-generated chimeric SARS-related coronaviruses
exhibited increased pathogenicity and greater than 4-log
(greater than 10,000 times) enhanced viral growth in lungs of
so-called ``humanized mice'' (i.e., mice engineered to display
human receptors on lung cells)? Please answer yes or no.
Answer 5. NIH received a progress report in 2018 that
showed a figure presenting transient differences in weight loss
and viral load within the lungs of transgenic mice infected
with chimeric bat severe acute respiratory syndrome-related
coronaviruses (SARSr-CoVs). Note, however, that these findings
were not reported to be statistically significant in comparison
to mice infected with the parental backbone virus.
Question 6. Did the NIH continue to fund the grant, despite
the violation of the terms and conditions outlined on page S of
the 2016 grant Notice of Award (specifically, for failing
immediately to ``stop all experiments with these viruses and
provide the NIAID Program Officer and Grants Management
Specialist. .. with the relevant data and information'')?
Please answer yes or no.
Answer 6. NIH did not conclude that there was non-
compliance with the Special Terms and Conditions of the award
based on the figures presented in the 2018 progress report.
Question 7. Did the NIH award another 5-year grant in 2019
to EcoHealth Alliance with a subcontract to the Wuhan Institute
of Virology (available at https://reporter.nih.gov/search/
6lo2KK8sZEefzzmWqkIOyg/project-details/9819304) for research on
bat SARS-related coronaviruses, which proposed to continue and
expand the construction of new chimeric SARS-related
coronaviruses? Please answer yes or no.
Answer 7. NIH renewed the EHA grant in 2019 after the
renewal application underwent peer review and was found to be
highly meritorious. EHA has reported that no subcontract or
subaward agreement was reached with WIV under the renewal award
and EHA has reported that no funds from the renewal award were
sent to WIV.
Question 8. Did the NIH award the second 5-year grant
despite the fact that the 2018 grant proposal disclosed the
greater-than-I 0,000-times enhanced viral growth and enhanced
viral pathogenicity of the laboratory-generated chimeric SARS-
related coronaviruses? Please answer yes or no.
Answer 8. Please see answers to Questions 5 through 7.
Question 9. Did the NIH award the second 5-year grant
despite not having forwarded the grant proposal to the HHS
Potential Pandemic Pathogen Care and Oversight (P3CO) Committee
for risk-benefit review? Please answer yes or no.
Answer 9. NIAID awarded the grant after reviewing it in
accordance with the U.S. Department of Health and Human
Services Framework for Guiding Funding Decisions about Proposed
Research Involving Enhanced Potential Pandemic Pathogens (HHS
P3CO Framework). Only proposed research being considered for
funding and that has been determined by the funding agency as
reasonably anticipated to create, transfer, or use enhanced
potential pandemic pathogens (ePPPs) is subject to additional
HHS department-level review.
Question 10. Did Sections I and II of the HHS P3CO
Framework (available at https://www.phe.gov/s3/dualuse/
documents/p3co.pdf) require that NIH forward grant proposals to
the HHS Potential Pandemic Pathogen Care and Oversight (P3CO)
Committee for risk-benefit review whenever ``proposed research
is reasonably anticipated to create, transfer, or use enhanced
PPPs,'' where ``enhanced PPP is defined as a PPP resulting from
the enhancement of the transmissibility and/or virulence of a
pathogen''? Please answer yes or no.
Answer 10. Yes, Section II of the HHS P3CO Framework states
that ``proposed intramural and extramural life sciences
research that is being considered for funding and that has been
determined by the funding agency as reasonably anticipated to
create, transfer, or use enhanced PPPs is subject to additional
HHS department-level review.'' The HHS P3CO Framework defines a
PPP as:
``a pathogen that satisfies both of the following: 1.
It is likely highly transmissible and likely capable of
wide and uncontrollable spread in human populations;
and 2. It is likely highly virulent and likely to cause
significant morbidity and/or mortality in humans.''
NIAID, as the funding agency, reviewed the EHA grant in
accordance with the HHS P3CO Framework and determined that the
experiments to generate SARS-like or MERS-like chimeric
coronaviruses were not reasonably anticipated to create,
transfer, or use ePPPs and, therefore, were not subject to
additional HHS department-level review as delineated in the HHS
P3CO Framework.
Question 11. If you answered yes to any of the questions
above, are you prepared to retract your previous false
testimony before the U.S. Senate Committee on Health,
Education, Labor, and Pensions?
Answer 11. None of the responses to Questions 1 through 10
contradict testimony before the U.S. Senate Committee on
Health, Education, Labor, and Pensions.
SENATOR CASSIDY
Question 1. The U.S. is in the middle of flu season, which
has the potential to add additional burden to already-stressed
health care systems due to the ongoing pandemic.
Question 1(a). What steps is HHS taking to ensure the
availability of appropriate diagnostics and treatment
options to address the potential dual threats of COVID
and influenza, including through shoring up the
Strategic National Stockpile?
Question 1(b). Beyond testing and preventative steps
like vaccination, what steps has HHS taken to
proactively treat vulnerable populations like the
elderly or others who may be at risk for and are likely
to spread communicable diseases like COVID and the flu?
Answer 1. NIH defers to CDC.
Question 2. Health systems in Louisiana have been
overwhelmed by successive waves of COVID variants. These health
systems could have been better prepared for these growing
variant trends if they had access to better national and
regional dashboards monitoring variants of concern.
Question 2(a). What are you all at the CDC, FDA, NIH,
and HHS doing to make sure health providers are armed
with the best data to respond appropriately to the next
COVID variant or pandemic?
Answer 2. NIH defers to CDC.
Question 2(b). Second, how are you all harnessing the
speed and innovation of the private sector to help
predict, prevent, and mitigate future COVID-19 variants
or other pathogens of concern?
Answer 2. NIAID, the National Human Genome Research
Institute, and the National Library of Medicine are
participating in the SARS-CoV-2 Sequencing for Public
Health Emergency Response, Epidemiology, and
Surveillance (SPHERES) initiative. SPHERES is a
national genomics consortium led by CDC that helps to
coordinate SARS-CoV-2 sequencing across the United
States. NIAID is working with partners to identify,
monitor, and calculate the frequency of current
variations in the SARS-CoV-2 genome to help predict
emerging variants. NIAID also facilitates the use of
cutting-edge modeling and structural biology tools to
understand how variants might affect interactions
between the virus and the immune system or COVID-19
therapeutics. In addition, NIAID-supported scientists
are collaborating with vaccine manufacturers to assess
the impact of new variants of concern on their products
and to design and test new vaccines to help protect
against variant viruses. These efforts add to our
knowledge about SARS-CoV-2 variants and our ability to
combat them.
Question 3. Dr. Fauci: Many experts have expressed optimism
regarding how the Omicron variant might leave behind extremely
high levels of immunity, and the prospect of an end to this
pandemic is encouraging. However, with each new variant that
emerges, any gaps in population-level data on how our immune
systems respond--not just antibodies but also T-cells--limit
our ability to inform the policies on which public health
experts, public officials, providers, and patients depend.
Question 3(a). Given that questions about efficacy of
COVID-19 vaccines and the need for boosters can only be
answered by understanding both T-cells AND antibodies,
how do we ensure that T-cell analysis is fully included
in research decisions for vaccines and boosters going
forward?
Question 3(b). How can NIH ensure T-cell data is
incorporated into its ongoing research to combat the
pandemic, including the effectiveness of vaccines and
prior infection against new variants, including Omicron
and what might come next?
Answer 3(a)(b). NIAID continues to conduct and support
research to improve understanding of the role of T
cells in protection against COVID-19 and COVID-19
disease progression. NIAID supported a collaborative
longitudinal study by researchers at Emory University
and the Fred Hutchinson Cancer Research Center that
demonstrated that SARS-CoV-2-specific T cells were
detectable for up to 8 months in patients after mild to
moderate COVID-19. NIAID also supported two separate
studies examining T cell responses in recovered COVID-
19 patients and individuals vaccinated against COVID-
19. They found robust immune responses to the original
strain as well as multiple variants of SARS-CoV-2 in
both groups. Additional work by NIAID researchers and
grantees showed that most individuals with existing T
cell responses against SARS-CoV-2 should generate a T
cell response against the Omicron variant, and that
SARS-CoV-2 has thus far not evolved extensive T cell
escape mutations. Other work from NIAID-supported
investigators has shown that vaccine-induced T cell
responses recognize the Omicron variant. In another
NIH-supported study, researchers uncovered features of
T cells that distinguish fatal from non-fatal cases of
severe COVID-19, which could help harness knowledge of
T cells to inform new potential treatments for this
disease.
Question 3(c). How can NIH ensure T-cell data is fully
integrated into its RECOVER research initiative for
those suffering from prolonged symptoms following a
COVID infection?
Answer 3(c). Assessment of T-cell function after SARS-
CoV-2 infection may provide important clues to disease
mechanisms, diagnosis, and treatment of post-acute
sequelae of SARS-CoV-2 infection (PASC), including Long
COVID. In recognition of this, the NIH Researching
COVID to Enhance Recovery (RECOVER) Initiative includes
studies of the pathobiologic mechanisms underlying
PASC, including studies characterizing the cellular
immune response to SARS-CoV-2. Importantly, RECOVER
also includes collection, analysis, and biobanking of
serum and peripheral blood mononuclear cells (PBMC),
including T cells, from adult and pediatric study
participants during the course of the project. A
RECOVER Consortium group of experts is monitoring the
state of the science regarding immunologic responses to
SARS-CoV-2 infection and the best technical approaches
for characterizing those responses as well as
evaluating optimal approaches for cell-based assays for
the RECOVER serum and PBMC samples. RECOVER core
immunophenotyping laboratories will conduct the
recommended T-cell function assays utilizing the
biobanked specimens. These analyses will provide a
unique resource for correlation of PASC clinical
symptoms with deep clinical phenotyping in the RECOVER
cohorts as well as for studies by the broader research
community.
Question 3(d). How can NIH support efforts to integrate
T-cell data into vaccine, booster, and other public
health decisions at FDA and CDC?
Answer 3(d). NIAID investigators will continue to
integrate T cell data into vaccine and booster
research, including in clinical studies and pre-
clinical challenge studies for COVID-19 vaccine
candidates. For example, NIAID is supporting a Phase 1
clinical trial in healthy adults to assess the safety
and immunogenicity of COVID-19 vaccine candidates
developed by Gritstone Oncology, Inc., that utilize a
strategy aimed at inducing both neutralizing antibodies
and T cell responses to elicit a broad immune response
against conserved viral antigens. In addition, the
NIAID Vaccine Research Center has established the
Pandemic Response Repository through Microbial/Immune
Surveillance and Epidemiology (PREMISE) program. The
program will use data from the measurement of T and B
cell immune responses to inform the discovery and
development of diagnostic, prophylactic, and
therapeutic countermeasures and accelerate the global
response to pandemic threats. NIAID anticipates the
research conducted by PREMISE will advance our
knowledge of immune response to vaccination and
infection and help inform the response to future
pandemic threats.
NIAID also is leading a study in fully vaccinated
individuals to assess the safety and immune responses
(including T cell responses) following boosting with a
COVID-19 vaccine different than the one used for the
initial vaccination (``mix and match''). NIAID released
early data from this trial demonstrating that
administering the Pfizer, Moderna, or Johnson &
Johnson/Janssen COVID-19 vaccines at least 12 weeks
after individuals received a different vaccine regimen
effectively enhanced the immune response to SARS-CoV-2.
The results of this trial were made available to FDA
during FDA's decisionmaking process to authorize the
use of heterologous, or ``mix and match,'' booster
dosing in eligible individuals following completion of
primary vaccination with a different available COVID-19
vaccine for persons 18 years of age and older.
SENATOR BRAUN
Question 1. Your administration is explaining to the
American public that COVID tests will be ``free'' to everyone
covered by private insurance. Is this true? Will employer and
individual premiums be impacted by the cost of these tests?
Question 2. Over the past 2 years, businesses of all sizes
have faced innumerable challenges and significant disruptions.
To add to this, inflation is at its highest level since the
1980's and is having a significant impact on business
operations. How will adding significant costs to employers'
healthcare bills through the over-the-counter (OTC) testing
coverage requirement help bring down the costs of these tests
and help employers address their workforce and inflation
concerns?
Question 3. How does the new OTC testing coverage
requirement policy solve for the problem of the limited supply
of tests in the country, particularly with your administration
seemingly purchasing most of the current supply?
Answer 1,2,3. Thank you for your questions, these are best
addressed by the Centers for Medicare & Medicaid Services.
Question 4. Senior caregivers working across assisted
living and memory care communities have been instrumental in
successfully mitigating the spread of COVID-19 among the most
vulnerable populations in congregate care settings. Without the
Federal relief that other long-term care options, like nursing
homes, have received, nearly two-thirds of assisted living
communities have not experienced a single COVID-19 death due to
the outstanding efforts of frontline caregivers. However,
emerging variants mean that seniors in assisted living and
memory care remain extremely vulnerable despite high
vaccination rates.
T3Question 4(a). Dr. Fauci, as new Federal data shows
that 85 percent of reported breakthrough deaths were of
those 65 and older, and 80 percent of all COVID-19
deaths are individuals over age 65, should these
assisted living and memory care communities be
prioritized in the distribution of rapid tests, PPE,
and additional boosters?
Answer 4. Access to both rapid tests and personal
protective equipment is critical for assisted living
and memory care communities to carry out infection
prevention and control programs and remain vigilant
against COVID-19 among residents and staff. Older
adults are at high risk of developing severe COVID-19
disease and remaining up-to-date with all recommended
COVID-19 vaccine doses is essential to protect both
staff and residents against developing severe COVID-19.
It also is important for any visitors to these
facilities remain up to date with all recommended
COVID-19 vaccine doses. I continue to urge everyone,
especially those who are most vulnerable, to protect
themselves by getting vaccinated and boosted.
SENATOR SCOTT
Omicron Status
Question 1. Dr. Fauci, should we be employing a ``COVID
zero'' strategy or should our strategy be to minimize mortality
and social harm until we reach herd immunity?
Answer 1. I agree that our strategy should minimize
mortality and social harm by sustaining and building on the
progress we have made so far. As therapeutics to prevent
progression to severe COVID-19 are becoming more widely
available and a higher percentage of the population is
vaccinated and boosted, we should be able to return to some
degree of normality. It is important to note that the emergence
of new variants capable of evading currently available
therapeutics and/or vaccines is possible. Therefore, NIAID will
continue to conduct and support research to develop next-
generation COVID-19 vaccines and therapeutics in order to help
protect against novel SARS-CoV-2 variants.
SENATOR TUBERVILLE
Omicron Infection
Question 1. What information does the administration have
about the potential for someone to be reinfected with the
Omicron variant?
Answer 1. Reinfections with the Omicron variant in
individuals who already have recovered from an Omicron variant
infection are rare. If someone mounts a good immune response to
the initial infection, it is unlikely that they will be re-
infected with the same variant. Most reinfections occur in
people who have been infected with one variant, such as Delta
variant, and then are subsequently re-infected with a different
variant, such as Omicron variant. We also have to be prepared
for the possibility of another variant emerging that is so
different from existing variants that it eludes any protection
that individuals have acquired from vaccinations and/or prior
infections. NIAID will continue to conduct and support research
to develop next-generation COVID-19 vaccines and therapeutics
in order to help protect against novel SARS-CoV-2 variants.
Question 2. Does science still support a 90-day period
after an infection during which a person should be exempt from
testing requirements?
Answer 2. NIH defers to CDC.
Question 3. In a CNN appearance on January 11, 2022, you
said ``What the CDC has said and it gets misinterpreted they're
saying wearing any mask is better than no mask at all.'' Can
you provide the data that informed these remarks?
Answer 3. According to the CDC, loosely woven cloth
products provide the least protection compared to other types
of masks, layered finely woven products offer more protection,
well-fitting disposable surgical masks and KN95s offer even
more protection, and well-fitting NIOSH-approved respirators
(including N95s) offer the highest level of protection. For
additional information on studies informing CDC's public health
messaging on masks, please see the CDC's Science Brief:
Community Use of Masks to Control the Spread of SARS-CoV-2
(https://www.cdc.gov/coronavirus/2019-ncov/science/science-
briefs/masking-science-sars-cov2.html).
COVID and Vaccinations
Question 4. On May 16, 2021, you stated ``So even though
there are breakthrough questions with vaccinated people, almost
always the people are asymptomatic and the level of virus is
much lower in their nasopharynx, the top part of their throat
that lies behind the nose, than it is in someone who is
unvaccinated. When you get vaccinated, you not only protect
your own health and that of the family but also you contribute
to the community health by preventing the spread of the virus
throughout the community. In other words, you become a dead end
to the virus.'' Do you still agree with this statement?
Answer 4. The statement was accurate at the time it was
made. Since then, we have seen the emergence of SARS-CoV-2
variants--such Omicron--that remain highly transmissible even
in communities with a high level of vaccination. It is
important to note that COVID-19 vaccines and boosters protect
against severe disease, hospitalization, and death from known
variants of concern.
Question 5. In June 2021, President Biden stated ``[y]ou're
not going to get COVID if you have these vaccinations,'' and
``[i]f you're vaccinated, you're not going to be hospitalized,
you're not going to be in the ICU unit, and you're not going to
die.'' Do you agree with this statement?
Answer 5. Most individuals who are vaccinated and boosted
remain asymptomatic or have only mild symptoms following SARS-
CoV-2 infection. Booster doses remain remarkably effective
against the Omicron variant. COVID-19 vaccines and booster
shots can keep you out of the hospital and certainly can save
your life.
Question 6. In July 2021, Dr. Walensky stated ``99.5
percent of deaths from COVID-19 in the United States were in
unvaccinated people'' and you also stated 99.2 percent of
deaths in June were unvaccinated. Is this still accurate?
Answer 5,6. The statements were accurate at the time they
were made. NIAID would defer to the CDC to provide the most
recent data on the percentage of deaths from COVID-19 in the
United States that were unvaccinated people.
Question 7. In July 2021, former NIH Director Collins
stated 99 percent of people in a hospital were unvaccinated. Is
this still accurate?
Answer 7. Dr. Collins' statement was accurate at the time
it was made. NIAID would defer to the CDC to provide the most
recent data on the percentage of COVID-19 hospitalizations who
were unvaccinated.
Question 8. In August you stated that ``vaccines prevent
getting infected, prevent getting sick, prevent your
hospitalization.'' Is that statement still accurate?
Answer 8. COVID-19 vaccines and boosters protect against
severe disease, hospitalization, and death from known variants
of concern; however, vaccines may not be as effective in
preventing asymptomatic or mild infection with SARS-CoV-2
variants.
Question 9. Has the Federal response to COVID-19 been
successful?
Question 9(a). Please explain.
Answer 9,9(a). The public health response to COVID-19 has
required an unprecedented global public-private research
effort. NIAID has played a central and important role in this
response. NIAID capitalized on decades of fundamental basic
research, including groundbreaking structure-based vaccine
design at the NIAID Vaccine Research Center, to facilitate the
rapid development of COVID-19 vaccines. NIAID also initiated
clinical trials with creative and adaptive designs, allowing
the evaluation of the safety and efficacy of multiple new and
existing therapeutics for the treatment of COVID-19, which has
helped support authorization of some of these products by FDA.
In addition, NIAID has engaged domestic and international
clinical research infrastructure and leveraged highly
productive partnerships in the public and private sectors to
support multiple COVID-19 vaccine candidates to progress in
record time from concept to Emergency Use Authorization by FDA.
Use of these vaccines throughout the world will continue to
play a critical role in reducing the threat of COVID-19 in the
United States and globally.
Question 9(b)4. Please explain what should have been
done differently.
Answer 9(b). The emergence of novel SARS-CoV-2
variants, namely Delta and Omicron, has highlighted the
importance of vaccinating the rest of the world. The
United States is a world leader in these efforts;
however, we should continue to look at ways to
buildupon existing efforts to address global vaccine
disparities. Improving global COVID-19 vaccination
rates is one way that the Federal Government could help
limit the impact of additional SARS-CoV-2 variants.
Question 10. Please provide specific examples where your
agency has utilized real world evidence in regards to COVID-19
or treatments for COVID-19.
Answer 10. Randomized controlled clinical trials are the
gold standard and continue to be used to determine the safety
and efficacy of candidate COVID-19 vaccines and therapeutics.
Real-world evidence also continues to play an important role in
the public health response to COVID-19. Specifically, real-
world evidence from observational studies was used--when
available--to help prioritize which repurposed agents to
evaluate in the ACTIV-6 trial. Real-world evidence also has
helped inform recommendations of the NIH COVID-19 Treatment
Guidelines Panel, which aim to provide clinicians with
evidence-based recommendations on the management of COVID-19.
In addition, real-world evidence of vaccine effectiveness has
shown that COVID-19 booster doses reconstitute the waning
immune protection of the initial vaccine series. Booster doses
are especially effective in protecting against severe COVID-19
disease, hospitalization, and death. NIAID will continue to use
real-world evidence to help inform research on COVID-19 medical
countermeasures.
Question 11. A recent Kaiser study found increased
myocarditis risk in men 18-24 years old who have taken the
COVID-19 vaccine and some physicians have raised alarm over
recent sudden deaths in young athletes worldwide, particularly
soccer players. Yet, the Biden administration is pushing
booster shots amongst this and younger age groups. Are you
concerned that this administration's policy could be increasing
the risk of adverse events like myocarditis in individuals that
have minimal risk from COVID-19, many of whom are fully
vaccinated and have protection from a prior COVID infection?
Answer 11. Reports of myocarditis and pericarditis in
adolescents and young adults following COVID-19 vaccination are
rare. Unvaccinated adolescents and young adults are at higher
risk of developing myocarditis from SARS-CoV-2 infection
itself. The benefits of COVID-19 vaccination outweigh the
possible risk of myocarditis or pericarditis as most patients
who receive care respond well and feel better quickly. Patients
can usually return to their normal daily activities after their
symptoms improve. Vaccines and boosters continue to be the best
way protect individuals from severe COVID-19 disease.
Question 12. Do you believe schools and universities should
be requiring students to be vaccinated and boosted in order to
be enrolled or attend school?
Answer 12. The decision to require COVID-19 vaccines and
boosters (and other vaccines) to attend schools and
universities is made at the local level. I will continue to
encourage everyone who is eligible to protect themselves from
COVID-19 by getting vaccinated and boosted.
Natural Immunity
Question 13. In September 2021, when asked whether natural
immunity provided similar protection as a vaccine, you stated
you did not have a firm answer on that but needed to discuss
the durability of the response. In the roughly 4 months since
you made those comments, have you developed a firm answer?
Answer 13. Available evidence shows that vaccinated and
boosted individuals are at much lower risk of hospitalization
and death from COVID-19. Individuals previously infected with
SARS-CoV-2 are believed to have a low risk of subsequent
infection for at least 6 months. At this time, there is no FDA-
authorized or--approved test that health care providers or the
public can use to reliably determine whether a previously
infected person is protected from SARS-CoV-2 infection at any
given time. It also is important to note that the level of
protection from prior infections may not be the same for all
viral variants or in all individuals. Further, we now know that
vaccination enhances the protective immune response in
previously infected individuals.
Question 14. Why does our Federal Government not currently
recognize natural immunity, as other countries do?
Answer 14. NIH defers to CDC.
Early Treatments for COVID-19
Question 15. Please provide a complete list and funding
amount of studies funded by the Federal Government that have
examined early treatments for COVID-19.
Answer 15. NIH is only able to provide information about
projects funded by the NIH. You may wish to consult with HHS or
other agencies for information on studies not funded by NIH.
NIH sponsored a wide range of research activities during
Fiscal Year (FY) 2020 and fiscal year 2021 that related to
investigation of potential early treatments for coronavirus
disease 2019 (COVID-19) spanning both inpatient and outpatient
settings as well as early stage research where the modality was
not yet tested in humans. A total of 201 projects were funded,
representing a trans-NIH initiative involving multiple
Institutes, Centers and Offices (ICOs), led by NIAID. The
portfolio of NIH-funded COVID-19 early treatment projects
included a diverse range of research.
Through fiscal year 2021, $389 million in COVID-19
emergency supplemental and annual appropriations supported
grants, contracts, and other research agreements related to
early treatment research projects.
------------------------------------------------------------------------
Total FY 2020
Funding IC FY 2020 FY 2021 & FY 2021 No. of
Obligations Obligations Obligations Projects
------------------------------------------------------------------------
NIAID $193,394,653 $81,080,280 $274,474,933 110
------------------------------------------------------------------------
NHLBI $35,890,868 $10,684,487 $46,575,355 7
------------------------------------------------------------------------
NCATS $9,921,728 $24,330,995 $34,252,723 28
------------------------------------------------------------------------
NCI $13,596,274 $4,231,135 $17,827,409 31
------------------------------------------------------------------------
NIEHS $3,206,576 $5,152,543 $8,359,120 7
------------------------------------------------------------------------
NIBIB $1,366,290 $2,388,843 $3,755,133 8
------------------------------------------------------------------------
OD $2,070,470 $521,426 $2,591,896 6
------------------------------------------------------------------------
NICHD $1,079,400 $1,079,400 4
------------------------------------------------------------------------
Total $260,526,259 $128,389,709 $388,915969 201
------------------------------------------------------------------------
The COVID-19 early treatment-targeted projects examined the
full spectrum of research opportunities for suppression of
infection symptoms and improved health outcomes in both
inpatient and outpatient settings as well as early stage
research where the modality was not yet tested in humans. These
projects included investigation of a broad range of therapeutic
approaches, such as antiviral treatments, anti-inflammatory
medications, immunotherapeutics, convalescent plasma, dietary
supplements or vitamins, and repurposed drugs. Other projects
investigated the use of advanced technologies, such as
nanobodies.
----------------------------------------------------------------------------------------------------------------
Total FY 2020 & FY
Topic FY 2020 Obligations FY 2021 Obligations 2021 Obligations No. of Projects
----------------------------------------------------------------------------------------------------------------
Chloroquine and $8,083,110 $1,848,182 $9,931,292 7
Hydroxychloroquine
----------------------------------------------------------------------------------------------------------------
Other Investigational Products $149,945,138 $78,958,425 $228,903,564 147
----------------------------------------------------------------------------------------------------------------
Remdesivir $1,703,830 $760,184 $2,464,014 5
----------------------------------------------------------------------------------------------------------------
Vitamins and Other Repuposed $32,928,856 $11,868,302 $44,797,158 27
Drugs
----------------------------------------------------------------------------------------------------------------
Monoclonall Antibody/Biologic $67,019,048 $30,488,737 $97,507,785 10
----------------------------------------------------------------------------------------------------------------
Multiple $846,277 $4,465,879 $5,312,156 5
----------------------------------------------------------------------------------------------------------------
Total $260,526,259 $128,389,709 $388,915969 201
----------------------------------------------------------------------------------------------------------------
Projects in the Multiple category displayed in the table
above include grants for projects in which more than one
medication or therapeutic was evaluated for treatment
effectiveness, such as chloroquine, hydroxychloroquine and
remdesivir.
Projects in the Other Investigational Products category
encompassed different lines of inquiry, including the use of
high throughput screening (HTS) to identify whether metabolic
changes induced by COVID-19 could be blocked or reversed. Other
sample efforts include projects that supported development of
novel therapeutics that target the COVID-19 virus spike protein
or replication machinery. For example, one project examined
modified mRNA (modRNA) drugs to target COVID-19. Another
project identified potential drugs that could target the virus
spike protein through an approach called protein-catalyzed
capture (PCCs).
The projects funded within the Vitamins & Other Repurposed
Drugs research category involved varied approaches to discover
existing drugs or vitamins that could effectively block the
cellular mechanisms required for viral infection or block the
cellular response to infection that causes disease. One project
investigated the efficacy and use of dietary supplements sold
for weight loss, energy, sports performance, and immune
function in treating COVID-19 infection. For example, a
prevention study in health care workers evaluated the efficacy
of low versus moderate to high doses of Vitamin D.
Question 16. Why does the NIH-funded trial of ivermectin
not conclude until 2023?
Answer 16. Ivermectin is being studied in a clinical trial
known as ACTIV-6 (Accelerating COVID-19 Therapeutic
Interventions and Vaccines master protocol number 6), which
began recruiting participants on June 11, 2021. ACTIV-6 is a
clinical trial to test up to seven existing medications, at
varying doses, for adults with COVID-19 who have mild-to-
moderate symptoms. The ACTIV-6 study completion date of March
2023 listed on clinicaltrials.gov reflects when enrollment for
all ACTIV-6 drugs is anticipated to be complete. The `study
completion date' on clinicaltrials.gov does not reflect
completion dates for individual drugs/dosages tested. An
independent Data Safety and Monitoring Board is responsible for
periodic assessment of ACTIV-6 data and makes recommendations
related to the study protocol, individual drugs/dosages, and
continuation of the trial to the study team and trial sponsors
to maintain the safety of ACTIV-6 participants.
Ivermectin is being tested at two different dosages within
ACTIV-6. A study testing a lower dosage of ivermectin opened
for enrollment on June 11, 2021, and will close in February
2022, having met its enrollment goal. Results from the lower
dose ivermectin study are anticipated later this year, after a
period of participant follow-up and data analysis. All results
from ACTIV-6 will be made available to the public and also for
review by treatment guidelines committees, which span the
Federal Government, and public health organizations, for
potential development into guidelines and recommendations for
healthcare providers. A higher dose ivermectin study is
anticipated to start in February 2022 and will continue to
enroll participants over the next six to 8 months until
enrollment goals are met, with results expected in early 2023.
------
Response by Janet Woodcock to Questions of Senator Casey, Senator
Smith, Senator Burr, Senator Cassidy, Senator Braun, Senator Scott,
Senator Tuberville, and Senator Hassan
SENATOR CASEY
Question 1. At the hearing, I asked how the Federal
Government is working with vaccine manufacturers to speed the
development of a safe and effective vaccine for children under
age five. Understanding that the Pfizer trial for children 24
months to 5 years old did not meet its endpoint, my follow-up
questions are, how did we get here and what's next? Please
describe, generally, the following:
Question 1(a). How vaccine developers make decisions
about dose size, quantity and spacing in age de-
escalation trials;
Question 1(b). What type of indicators a vaccine
manufacturer might consider when determining whether
and how to change the dose size, quantity or spacing if
primary endpoints are not met; and
Question 1(c). Whether the emergence of a viral variant
could affect the efficacy of a vaccine in children
differently than it would affect the efficacy of the
same vaccine in adults.
Question 2. Furthermore, could you please provide an update
on current Federal goals and investments relating to the
development of vaccines to protect children under age five from
COVID-19, including grants, contracts or other funding awarded
to vaccine developers; and what information is currently being
provided to vaccine developers regarding current or planned
opportunities for collaboration between the Federal Government
and vaccine developers, including the extent to which BARDA
will conduct TechWatch/CoronaWatch meetings and the extent to
which FDA will accept applications for emergency use
authorization.
Question 3. Finally, could you describe current thinking
across your agencies regarding the circumstances under which
your efforts would expand to include the development of
additional or next-generation vaccines and therapeutics for
COVID-19?
Answer 1. As with all vaccines, the FDA requires that
COVID-19 vaccine developers provide sufficient data to the
Agency to evaluate the safety and effectiveness of the vaccine
for its intended use and population. Having a safe and
effective COVID-19 vaccine available for younger children is a
priority for FDA. The Agency will ensure the data support
effectiveness and safety before authorizing or approving a
COVID-19 vaccine for use in younger pediatric populations.
As background, dose finding studies are a part of vaccine
development where various dosages are tested in people in
randomized-controlled studies. These studies also provide some
initial safety information on common short-term side effects
and risks, the safety profile at the different dose levels, and
examine the relationship between the dose administered and the
immune response and the ability of a vaccine to generate an
immune response.
For some vaccines, including COVID-19 vaccines, age de-
escalation is a step-wise approach that is undertaken for
vaccine development in pediatric populations. With an age-de-
escalation approach in the pediatric population, clinical
trials may begin in adults and/or adolescents and proceed
downward in age, in a step-wise manner, as safety and
effectiveness data are accrued, sometimes including from post-
marketing use in a much larger number of children than
evaluated in clinical trials. COVID-19 vaccines may be
authorized for emergency use in pediatric populations,
depending on the available safety and effectiveness data and
benefit/risk considerations, which may be different for various
age groups.
Conducting clinical trials to determine an appropriate
vaccine dose in younger pediatric populations requires
additional investigation and study over that done in the
clinical trials for adults, including the evaluation of
different dosages to ensure that the vaccine dosage and the
schedule chosen for younger pediatric populations is optimal
before larger clinical studies in pediatric populations to
evaluate safety and effectiveness.
Acknowledging that COVID-19 affects all age groups, but
that the epidemiology and pathogenesis of COVID-19, and the
safety and effectiveness of COVID-19 vaccines, may be different
in children compared with adults, FDA generally expects that
pediatric trials would be initiated in specific age groups as
soon as available data support that the vaccine would confer a
prospect of direct benefit and acceptable risk to trial
participants (21 CFR 50.52).
This determination will be made in the context of specific
vaccine development programs and following discussion of study
design elements that ensure participant safety and compliance
with 21 CFR Part 50 Subpart D regulations providing additional
safeguards for children in clinical investigations. The
development of COVID-19 vaccines for pediatric populations is
addressed in our June 2020 Guidance for Industry, Development
and Licensure of Vaccines to Prevent COVID-19, which reflects
the advice FDA has been providing to vaccine developers since
the onset of the pandemic.
In June 2021, FDA convened its Vaccines and Related
Biological Products Advisory Committee (VRBPAC) to discuss
licensure and emergency use authorization of vaccines to
prevent COVID-19 for use in pediatric populations and
specifically to discuss approaches to evaluating safety and
effectiveness to help FDA advise COVID-19 vaccine manufacturers
to ensure that pediatric trials will be adequately designed to
support vaccine licensure (or emergency use authorization, when
relevant statutory criteria are met) in various age groups.
FDA has been working closely with vaccine manufacturers to
provide advice as data accrue about safety and effectiveness,
the latter of which may be comprised of immune response data or
the number of COVID-19 cases that occur, or a combination of
both, for their respective COVID-19 clinical trials in
pediatric populations. These data are accruing as the United
States experiences SARS-CoV-2 variant surges, such as Delta and
Omicron.
For the FDA-authorized COVID-19 vaccines and the
populations authorized for use, at this time, the available
evidence supports the effectiveness of the current vaccines,
including a single booster dose, in preventing COVID-19 and
serious outcomes that can occur, including hospitalization and
death.
With respect to the circumstances that would warrant next-
generation COVID-19 vaccines, the FDA has anticipated the
emergence of SARS-CoV-2 variants. FDA is prepared to work
closely with vaccine manufacturers to provide feedback in the
clinical development and, if applicable, the licensure or EUA
of vaccines that are tailored to a specific SARS-CoV-2 variant.
With respect to therapeutics, FDA is committed to working with
companies to evaluate and expeditiously address the potential
impact of emerging variants on existing therapies and
facilitate the development and availability of new therapies
that retain activity against such variants.
SENATOR SMITH
Question 1. Given the importance of ensuring we have
sufficient supply of accurate COVID-19 tests, can you explain
the Administration's plans to develop and increase access to
broad spectrum diagnostic tests, including molecular tests, to
increase our ability to detect current and future COVID-19
variants?
Answer 1. Since the start of the pandemic, the FDA has
adapted its regulatory approach to address the public's testing
needs and has been working closely with test developers to
adjust as those needs have changed. These efforts have helped
increase testing capacity and broaden public access to all
types of COVID-19 tests, including laboratory-based, point-of-
care, and over the counter (OTC) tests.
FDA sought to facilitate COVID-19 test evaluation and
authorization through the development and availability of
templates for EUA requests. The templates provide
recommendations for test validation and a fill-in-the-blank
form to streamline the paperwork and make it easier for
developers to provide information in support of a request for
an EUA. Since providing the first template in January 2020, FDA
has been in daily contact with test developers to answer
questions and help them through the EUA process. This has
proved to be a helpful tool for many. FDA has had as many as
ten posted templates and continues to update, add, combine, and
remove templates as the science evolves and as necessary to
support developers of COVID-19 tests.
FDA also supported test developers through establishment of
a dedicated mailbox, 24-7 toll-free hotline that ran until July
2020, the posting of over 100 frequently asked questions on our
website, and by hosting 78 weekly virtual town halls for test
developers. The Agency has worked with over 1,000 test
developers since January 2020.
Since its inception in April 2020, FDA has worked closely
with NIH on the Rapid Acceleration of Diagnostics (RADx)
initiative, which aims to speed the development, validation,
and commercialization of innovative point-of-care and home-
based tests, as well as improve clinical laboratory tests, that
can directly detect the virus. FDA meets regularly with RADx
Tech program staff and test developers to answer questions and
provide feedback on validation plans.
Additionally, in October 2021, the Administration launched
and invested in a program called the Independent Test
Assessment Program (ITAP), an innovative partnership between
the NIH and FDA, funded with resources from the American Rescue
Plan to further accelerate new products to market.
This initiative leverages the clinical and scientific
expertise of the FDA and the NIH to develop validation
protocols and the resources of the NIH to perform validation
testing to establish test performance, which enables FDA to
accelerate test manufacturers through the FDA review process
based on data provided by trusted partners through the NIH. The
first two successful candidates to come through this process
were authorized by FDA in the last week of 2021, which was
weeks, if not months, ahead of schedule. The ITAP program and
the FDA continue to prioritize new OTC test candidates which
have the potential for large-scale production capacity.
FDA prioritizes review of tests with the greatest public
health impact, including those that can be run in high volumes,
at the point-of-care, and at home. The Administration has also
proactively reached out to manufacturers with self-tests on the
international market (e.g., in the United Kingdom or Germany)
and asked them to submit their tests for FDA review.
To date, the FDA has authorized over 420 tests and sample
collection devices that provide a wide array of test options.
This includes POC tests, rapid at-home tests, multi-analyte
tests that detect both COVID-19 and flu, antigen, molecular,
and serology tests as well as tests for pooling, screening, and
serial screening.
FDA has been monitoring for viral mutations and their
impact on authorized molecular and antigen diagnostic tests
throughout the pandemic. FDA tracks the part of the viral
genome targeted by each authorized molecular test in a data
base, monitors global data bases for emerging variants, and
conducts in silico analyses to evaluate whether any of the
authorized test probes target a part of the viral genome that
has mutated.
If FDA identifies a potential impact on test performance,
FDA contacts the test developer and communicates with the
public. The first such communication took place on January 8,
2021, not long after variants began to emerge. FDA issued a
safety alert and Letter to Health Care Providers to caution
that the presence of viral genetic mutations in a patient
sample can potentially change the performance of a diagnostic
test.
At that time, FDA identified three authorized molecular
tests that may be impacted by genetic variants of SARS-CoV-2,
though the impact did not appear to be significant. FDA also
provided recommendations to address possible false negative
results for clinical laboratory staff and health care providers
who use molecular tests for the detection of SARS-CoV-2.
In January 2021, the RADx program established a Variant
Task Force (VTF) to monitor for emerging variants and study the
performance of COVID-19 tests with different variants. Most
recently, the VTF has been evaluating the performance of
antigen tests with patient samples that have the omicron
variant.
On February 22, 2021, FDA issued a guidance to provide test
developers information on evaluating the potential impact of
emerging and future viral genetic mutations on COVID-19 tests.
(See ``Policy for Evaluating Impact of Viral Mutations on
COVID-19 Tests''.) The guidance describes the FDA's activities
and provides recommendations to test developers, such as
considering the potential for future viral genetic mutations
when designing their test, and conducting their own routine
monitoring to evaluate the potential impact of new and emerging
viral genetic mutations, which may be the basis of viral
variants, on the performance of their tests.
In March 2021, FDA launched a website with information
regarding the impact of viral mutations on COVID-19 tests.
(Please see SARS-CoV-2 Viral Mutations: Impact on COVID-19
Tests (FDA.) The website includes a list of tests that are
impacted by viral mutations and provides test-specific analyses
of the impact on performance as well as recommendations for
clinical laboratory staff and health care providers using the
test. The website is updated regularly as new information
becomes available.
In September 2021, FDA revised EUAs for most tests to add
Conditions of Authorization requiring test developers to
conduct their own monitoring of their test in addition to the
monitoring done by FDA. These Conditions require test
developers to notify FDA if any viral mutations are found to
affect the performance of the test, perform and provide any
additional analyses requested by the FDA, and update labeling
with any risk mitigations identified by FDA regarding the
impact of viral mutations on test performance.
Question 2. Looking long-term, what steps should Congress
and the Administration take to improve development and supply
of broad spectrum diagnostics for future pandemics?
Answer 2. Ensuring the rapid development of diagnostic
tests in response to future public health emergencies (PHEs)
will require a coordinated national response across several
Federal agencies, as well as dedicated funding. FDA will play
an important role in these efforts so that it can help to
ensure tests used in emergencies are appropriately accurate and
reliable. Based on the Agency's experience, FDA has identified
the following Federal Government goals:
Establish More Effective Mechanisms for Sample Sharing During Outbreaks
to Facilitate Test Development/Validation
Access to clinical specimens is critical for the validation
of accurate and reliable tests. At the beginning of the COVID-
19 outbreak, clinical specimens were not available to the U.S.
Government or laboratories. Although developers could design
tests based on the published sequence of the virus, the lack of
clinical specimens made it challenging to validate these tests.
For example, the developers could use contrived specimens--
including synthetic contrived specimens--for validation, but
these contrived specimens may not have accurately characterized
the performance of the test if the test was not done properly.
Fifty-nine molecular tests for SARS-CoV-2 were authorized based
on validations with contrived transcripts before clinical
specimens or viral RNA were readily available. Of note, FDA
later found that validation with synthetic transcripts had not
accurately shown test performance. Looking forward, the U.S.
Government should work with international partners to establish
a plan for sharing clinical specimens as soon as a public
health threat emerges. This effort could be aided by having
appropriate international agreements in place in advance.
Establish Contracts to Pre-Position a Handful of Commercial Developers
Ready to Respond in an Outbreak
Following the MERS outbreak, South Korea established public
and private partnerships and invested approximately $25 million
in infectious disease diagnostic technology. As a result of
these investments and the expectations created through these
partnerships, a subset of South Korean commercial manufacturers
were well positioned to develop and manufacture tests quickly.
For example, two commercial manufacturers began developing
COVID-19 tests several weeks prior to the South Korean
government's request to do so. In the United States, there was
no such pre-positioning of test developers and manufacturers
for immediate response. In fact, hesitancy from some U.S.
commercial manufacturers was expressed based on unfavorable
experiences with prior outbreaks in which some test
manufacturers had significantly invested in tests that were not
ultimately needed.
Furthermore, the test platform installation base in
laboratories across the United States is heterogeneous, which
adds a layer of complexity to a rollout of widespread testing.
For example, molecular diagnostic tests are validated for use
only on specific polymerase chain reaction (PCR) machines from
specific vendors and are generally not interchangeable. The
laboratories therefore had to wait for an authorized test that
could be used on the platform they had available. The
installation base of any given platform is proprietary to the
vendor, which made it difficult for the U.S. Government to
ensure laboratories had access to tests they could run.
FDA reviewed EUA requests from all comers and was soon
flooded by thousands of requests. With tests for SARS-CoV-2,
the virus that causes COVID-19, FDA ultimately had to implement
a triage and prioritization process. In the fall of 2020, FDA
began to prioritize review of the tests that could either
increase testing accessibility (e.g., POC tests, home
collection tests, at-home tests) or significantly increase
testing capacity (e.g., tests that would reduce reliance on
test supplies, high throughput tests, widely distributed
tests). Looking forward, we believe the U.S. Government could
establish contracts to preposition a handful of commercial
developers to be ready to respond in an outbreak.
Ideal candidates would have a good track record with test
development and be capable of working fast and scaling
manufacturing operations quickly. These contracts should
consider the availability of platforms in laboratories across
the United States and ensure that tests will be available to
all the laboratories that need them. The government may wish to
develop test designs that could be implemented by preset
contract manufacturers, commercial manufacturers, and
laboratories performing the tests.
This pre-positioning of commercial developers and
commercial contract manufacturers would enable the country to
achieve a greater overall testing capacity with a smaller
number of tests. In a situation where these contracts were
prepositioned, FDA would have the enhanced capacity to ensure
these tests are accurate and reliable before they are used.
De-Risk Test and Incentivize Product Development, as was Done for
Covid-19 Vaccines
To encourage the development of diagnostic tests by
commercial manufacturers, the South Korean government
guaranteed both purchasing of minimum quantities of tests and
reimbursement once the tests were authorized for emergency use
by the MFDS, which is FDA's South Korean counterpart. This
process eliminated the risk that a test developer might lose
revenue from shifting manufacturing lines to tests for SARS
CoV-2. These types of steps to de-risk and incentivize product
development, although later taken for vaccine development, were
not taken early on by the U.S. Government for test development.
Instead, to incentivize development of tests, FDA issued
policies regarding developers offering certain tests prior to
an EUA while an EUA request was pending (and for certain
serology tests, without an EUA or submission of an EUA
request). These policies had tradeoffs; for example, FDA later
found that some poorly performing tests were being used. Of
particular note, FDA's experience with serology tests
underscores the importance of FDA reviewing tests used in a PHE
prior to such products entering the market based on sound
science. In the future, the government should consider de-
risking the financial investment needed to produce accurate and
reliable tests at scale. This effort could be focused on the
developers who are pre-positioned to produce tests at scale
when needed.
Establish a Centralized Clinical Validation Program
To complement the flexible policies that FDA put in place
for serology tests, FDA collaborated with the Centers for
Disease Control and Prevention (CDC) and the National
Institutes of Health (NIH) to establish a government capability
to evaluate the performance of serology tests. This was the
first time the Federal Government created a capability to
evaluate tests itself to inform regulatory decisions.
This was valuable in helping FDA deal with poorly
performing tests and ultimately for making decisions on EUA
requests. FDA's research into South Korea's response found that
the Korea Disease Control and Prevention Agency established a
testing capability in selected laboratories to conduct a
clinical evaluation of all molecular tests for which the
manufacturer sought an EUA. As a result, test developers in
South Korea did not have to find their own clinical specimens
or viral material to evaluate their tests, which likely
shortened the length of time needed to complete validation
studies to support EUA applications and increased the
government's confidence in each test's accuracy.
With respect to molecular tests, the traditional approach
of test developers conducting their own clinical evaluation of
their tests continued, as no independent testing capability
existed in the United States. Establishing the capacity within
or on behalf of the Federal Government to evaluate test
performance before outbreaks occur would permit an independent
evaluation to be quickly performed during an outbreak. This
established capacity would minimize the need for developers to
find patient specimens or other clinical samples to validate
their tests and would conserve specimens for validation. By
centralizing validation materials and providing this evaluation
for developers, the government could expedite the validation
and authorization of tests while increasing confidence in test
performance. The Federal Government should also consider the
utility of this approach for technologies used outside an
outbreak.
Collaborate With Laboratories and Commercial Developers on a Framework
for How to Conduct Appropriate Validations
FDA received thousands of pre-EUA and EUA requests for
tests for SARS-CoV-2, many of which came from developers
without prior experience with appropriate test validation. FDA
created templates to facilitate test validations and EUA
submissions; however, FDA encountered many cases of poor
validation and poor-quality submissions, which required the
Agency to expend even more resources. For example, in an
analysis of 125 EUA requests from laboratories for molecular
tests, FDA found that 79 requests had issues with the
validation. FDA saw similar problems with EUA requests from
commercial manufacturers, particularly those with less
experience in test development.
Going forward, FDA intends to work collaboratively with the
community on best practices and common approaches to validating
test design and performance. FDA could proactively create
validation protocols in collaboration with the test developer
community for commonly anticipated pathogens and sample types
before an outbreak; the Agency could then modify them as
necessary after an outbreak occurs. This proactive approach
would facilitate appropriate and faster validation.
Additionally, FDA believes a modern legislative framework for
all tests, regardless of who makes them, would facilitate a
more common understanding of validation prior to an outbreak
and would enhance the developer community's collaboration with
FDA during an outbreak.
Stockpile Testing Supplies
There were no testing supplies in the Strategic National
Stockpile, and by March 2020, laboratories were experiencing
shortages of supplies ranging from extraction reagents, to
swabs, to transport media. FDA worked to develop shortage
mitigation measures by seeking alternative products that could
adequately perform so that end users did not experience a
depletion of materials. For example, FDA proactively reached
out to platform developers with PCR instruments, which are used
to detect and amplify RNA and DNA sequences. FDA requested that
these developers validate the use of CDC's assay on their PCR
instruments, leveraging data from a prior authorization of
CDC's influenza panel to support the use of additional PCR
instruments and extraction kits.
In addition, FDA supported manufacturers who do not
typically produce medical supplies as part of their business
operations in altering their manufacturing to create products
usable for U.S. testing. For example, FDA collaborated with
U.S. Cotton, one of the world's largest manufacturers of cotton
swabs, to develop and produce a polyester-based Q-tip-type swab
for testing. FDA also collaborated with laboratories and
clinical investigators validating potential alternative sources
of control materials, transport media, and swabs, later posting
the results of these collaborations on the Agency's website.
Similarly, as individual developers validated alternative
components, FDA requested their permission to share their
findings publicly, on the Agency's website, so that others
could benefit. In this way, FDA shared scientific information
that the entire community could leverage to mitigate shortages
and increase testing capacity. Going forward, the Federal
Government should either maintain a stockpile of basic testing
supplies so that it does not need to seek out and validate so
many alternatives or use less optimal alternatives in a future
outbreak.
Provide Continuing Education on the Appropriate Use of Tests as the
Situation and Scientific Knowledge Evolve
During COVID-19, FDA saw examples of when the clinical
community relied on tests for uses that were outside their
authorization and not supported by science. For example, many
members of the community relied on serology tests for
diagnosis, or as measures of immunity, despite the lack of
evidence correlating an immune response to immunity from
infection. In another example, lower sensitivity tests were
used to screen asymptomatic individuals in whom infection may
have been harder to detect, if present at all. All members of
the clinical community should have an understanding of test
performance and how to use that information in patient care.
Tests should be accompanied by clear, standardized, and
comprehensible information on performance for clinicians and
patients. Training and continuing education can enhance
physicians' understanding of test performance, selection,
interpretation, and clinical usefulness. Ongoing education is
paramount in any PHE response as scientific knowledge evolves,
particularly given the misuse of serology tests for diagnosis,
the potential for false positive results when a single test is
used in populations with a low rate of infection, and the
perception of immunity. The national approach to testing needs
to be consistently updated and guided by sound science.
Invest in Novel Poc and At-Home Technologies
As the pandemic evolved, FDA saw a growing demand for tests
that could be performed outside of a traditional laboratory,
such as at the POC, in homes, in schools, and at other non-
healthcare settings. FDA developed templates for and authorized
tests that could be performed in these settings; however, most
such authorizations came many months into the pandemic. The
Federal Government should invest in the development of truly
novel technologies that can be used at the POC and in homes and
for multiple conditions--including potential advances such as
sequencing to provide mutation detection, breath analyzers, and
light-based devices--as long as they are accurate.
In fact, the first POC COVID-19 tests authorized by FDA
came from developers applying technologies that had already
been developed prior to COVID-19. Although it may be difficult
to predict diagnostic needs, it is generally easier to add a
new, specific target of analysis to an existing platform than
it is to create, validate, and manufacture an entirely new test
and testing platform. This especially applies to POC and at-
home tests as they often go through additional validation to
demonstrate accuracy and reliability in the hands of untrained
users. The Federal Government could use several mechanisms,
including competitions with prize awards and grants. FDA
believes that the establishment NIH's Independent Test
Assessment Program (ITAP) is critical for supporting these
efforts.
The goal of this program is to accelerate the availability
of more high-quality, accurate, and reliable OTC tests to the
public, as quickly as possible. If we invest in POC and at-home
testing technologies now, when a public health threat warrants
large-scale testing, the government would be able to move
swiftly to financially support modifications to detect the
target pathogen, ramp up large-scale production, and provide
guaranteed reimbursement for use of applicable and already FDA-
approved tests
SENATOR BURR
Question 1. On November 15, FDA issued revised guidance
stating it would focus its review efforts on at-home and point-
of-care COVID test applications from developers with the
capacity to manufacture more than 500,000 tests per week within
3 months of being authorized.
Question 1(a). How many test developers are able to
scale up to manufacture more than 100,000, but less
than 500,000 tests per week?
Question 1(b). Will FDA review their test under the EUA
pathway? If not, why not?
Question 1(c). Is FDA denying applications that cannot
meet the 500,000 tests per week manufacturing capacity
requirement?
Question 1(d). How does this policy account for
manufacturers developing tests at risk who have the
near term potential to reach the 500,000 capacity but
cannot scale up without authorization?
Answer 1. FDA has received over 5,000 EUA and PEUA requests
for IVDs since January 2020, and continues to receive over 100
EUA requests a month, mostly for IVDs. It is therefore critical
that we focus limited resources on those tests that will have
the greatest impact on the public health. There remains a
public health need for increased access to testing. This can
best be addressed by prioritizing review of tests such as at-
home and point-of-care diagnostic tests that can be produced in
high volumes.
The priorities outlined in our guidance of November 15,
2021 are based on our experience working with test developers
to respond to the pandemic for over 2 years. We took into
account both our review capacity as well as what we have seen
developers accomplish with respect to ease of use and
manufacturing capacity. When considering manufacturing
capacity, we generally consider the developer's projected
capabilities within 3 months of authorization. This allows
manufacturing scale up to take place post-authorization rather
than prior to authorization. FDA also reviews any EUA requests
for tests from or supported by a US government stakeholder,
regardless of the developer's manufacturing capacity. This
helps to ensure that tests that are part of a coordinated
response, such as the school and community testing programs,
are prioritized for review.
FDA does not have information on the number of test
developers able to scale up to manufacture more than 100,000,
but less than 500,000 tests per week. However, any developers
of tests that have not been prioritized by the Agency for EUA
may seek marketing authorization through traditional device
review pathways such as 510(k) notification or De Novo
classification.
Question 2. FDA has authorized over 400 COVID tests, and
has stated that some of these tests may not be as sensitive to
the Omicron variant. The more this virus shifts and drifts from
its original strain, the more difficult it may be for our tests
to detect. What is the FDA doing to work with manufacturers to
address the challenge that will come along with diagnosing and
detecting new variants of COVID-19?
Answer 2. FDA has been monitoring for viral mutations and
their impact on authorized molecular and antigen diagnostic
tests throughout the pandemic. FDA tracks the part of the viral
genome targeted by each authorized molecular test in a data
base, monitors global data bases for emerging variants, and
conducts in silico analyses to evaluate whether any of the
authorized test probes target a part of the viral genome that
has mutated. If FDA identifies a potential impact on test
performance, FDA contacts the test developer and communicates
with the public.
The first such communication took place on January 8, 2021,
not long after variants began to emerge. FDA issued a safety
alert and Letter to Health Care Providers to caution that the
presence of viral genetic mutations in a patient sample can
potentially change the performance of a diagnostic test. At
that time, FDA identified three authorized molecular tests that
may be impacted by genetic variants of SARS-CoV-2, though the
impact did not appear to be significant. FDA also provided
recommendations to address possible false negative results for
clinical laboratory staff and health care providers who use
molecular tests for the detection of SARS-CoV-2.
In January 2021, the RADx program established a Variant
Task Force (VTF) to monitor for emerging variants and study the
performance of COVID-19 tests with different variants. Most
recently, the VTF has been evaluating the performance of
antigen tests with patient samples that have the omicron
variant.
On February 22, 2021, FDA issued a guidance to provide test
developers information on evaluating the potential impact of
emerging and future viral genetic mutations on COVID-19 tests.
(See ``Policy for Evaluating Impact of Viral Mutations on
COVID-19 Tests''.) The guidance describes the FDA's activities
and provides recommendations to test developers, such as
considering the potential for future viral genetic mutations
when designing their test, and conducting their own routine
monitoring to evaluate the potential impact of new and emerging
viral genetic mutations, which may be the basis of viral
variants, on the performance of their tests.
In March 2021, FDA launched a website with information
regarding the impact of viral mutations on COVID-19 tests.
(Please see SARS-CoV-2 Viral Mutations: Impact on COVID-19
Tests (FDA.) The website includes a list of tests that are
impacted by viral mutations and provides test-specific analyses
of the impact on performance as well as recommendations for
clinical laboratory staff and health care providers using the
test. The website is updated regularly as new information
becomes available.
In September 2021, FDA revised EUAs for most tests to add
Conditions of Authorization requiring test developers to
conduct their own monitoring of their test in addition to the
monitoring done by FDA. These Conditions require test
developers to notify FDA if any viral mutations are found to
affect the performance of the test, perform and provide any
additional analyses requested by the FDA, and update labeling
with any risk mitigations identified by FDA regarding the
impact of viral mutations on test performance.
Question 3. What is the latest science on boosters for
recipients of the J&J vaccine? When will you have answers for
the millions of Americans that received this shot who are
interested in ensuring they continue to be protected against
Omicron and future variants?
Answer 3. FDA has authorized a single-dose primary
vaccination regimen for the Janssen COVID-19 Vaccine for
individuals 18 years of age and older. FDA has also authorized
a single Janssen COVID-19 Vaccine booster dose that may be
administered at least 2 months after primary vaccination with
the Janssen COVID-19 Vaccine. Additionally, FDA has authorized
use of either the Pfizer BioNTech COVID-19 Vaccine or the
Moderna COVID-19 Vaccine as a heterologous booster dose for
individuals who have received primary vaccination with the
Janssen COVID-19 Vaccine. The booster dose of either of the
mRNA vaccines may be administered at least 2 months after
completion of primary vaccination with the Janssen COVID-19
Vaccine.
Data published in a Morbidity and Mortality Weekly Report
by the CDC are reassuring in that for the mRNA COVID-19
vaccines, two doses and one booster dose, and for the Janssen
COVID-19 Vaccine, one dose and a booster dose, continue to
provide protection against severe COVID-19 and hospitalization
and death. Rates of COVID-19 cases were lowest among fully
vaccinated persons who had received a booster dose, compared
with fully vaccinated persons who had not received a booster
dose, and much lower than rates among unvaccinated persons
during October/November and also December 2021, when the
Omicron variant was circulating.
In addition, during December, unvaccinated people had
approximately 5 times the risk for developing COVID-19 compared
to vaccinated people who had received a booster dose of a
COVID-19 vaccine. A similar increase in risk was seen among
unvaccinated people compared to people who had received a
booster dose, irrespective of what vaccine people received for
primary vaccination.
Question 4. FDA has authorized vaccines for COVID-19 for
individuals and children ages 5 and up. When does FDA expect
that a vaccine for ages 2-4 will be available? What challenges
exist for clinical trials conducted for the 2-4 year old age
group, and how is FDA working to help address such challenges?
Answer 4. FDA recognizes the need for a safe and effective
vaccine for younger children, particularly given the rapid
spread of the Omicron variant, the notable rise in the number
of hospitalizations in young children with severe disease, and
the possibility that future variants could cause severe disease
in those who are unvaccinated.
It is important that the public recognize that, because
children are still growing and developing, it's critical that
thorough and robust clinical trials of adequate size are
undertaken to evaluate the safety and effectiveness of a COVID-
19 vaccine in pediatric populations. Children are not small
adults and issues that may be addressed in pediatric vaccine
clinical trials can include the appropriate dose and
administration schedule of vaccines already used for adults.
Conducting clinical trials to determine an appropriate
vaccine dose in younger pediatric populations requires
additional investigation and study over that done in the
clinical trials for adults including ensuring that the vaccine
dosage is safe and effective. FDA has been working closely with
vaccine manufacturers to provide advice as data accrue about
safety and effectiveness, the latter of which may be comprised
of immune response data or the number of COVID-19 cases that
occur, or a combination of both, for their respective COVID-19
clinical trials in pediatric populations. Once adequate data
are available, we plan to convene a meeting of our Vaccines and
Related Biological Products Advisory Committee to publicly
discuss the data.
SENATOR CASSIDY
Question 1. Second, how are you all harnessing the speed
and innovation of the private sector to help predict, prevent,
and mitigate future COVID-19 variants or other pathogens of
concern?
Answer 1. FDA continues to work with companies that are
developing additional medical products, researchers, and
manufacturers to help expedite the development and availability
of medical products such as additional vaccines,'monoclonal
antibodies, and other drugs to prevent or treat COVID-19?
SENATOR BRAUN
Question 1. Dr. Woodcock, we understand that, through the
National Institutes of Health Rapid Acceleration of
Diagnostics' Independent Test Assessment Program, companies
worked closely with the FDA to obtain Emergency Use
Authorization for rapid antigen tests. Diagnostic manufacturers
are producing millions of much-needed rapid antigen tests for
the American people. Can you discuss the future of this
program?
Answer 1. The Independent Test Assessment Program (ITAP)
will continue to be critical to streamlining validation and
authorization of antigen tests with potential for large-scale
manufacturing. FDA has already authorized three new OTC, at-
home COVID-19 tests that participated in this program one
manufactured by SD Biosensor and distributed by Roche, one
manufactured by Siemens (please see the following release for
more details: Two New Over-the-Counter At-Home COVID-19 Tests
Brought to U.S. Market Quickly by Biden-Harris administration
(HHS.gov), and a third manufactured by Maxim Biomedical.
This program is an extension of the RADx program which has
already supported development of dozens of authorized tests,
including the first over-the-counter COVID-19 test.
Organizations applying to ITAP will be evaluated for
participation based on several criteria. \1\ Prior to EUA
submission, ITAP supports independent laboratory and clinical
evaluations using protocols developed jointly with FDA.
---------------------------------------------------------------------------
\1\ https://www.poctrn.org/itap
---------------------------------------------------------------------------
We plan to continue to use the information from ITAP to
grant emergency use authorization when the science supports
doing so. We are already seeing shorter review times for such
EUA requests due to our partnership with ITAP in establishing
the evaluation program to address our regulatory needs. The
average FDA review time for a test evaluated under ITAP is less
than a week, and can be as short as 1 day.
This solution is based on our lessons learned earlier in
the pandemic. Namely, developers unfamiliar with the regulatory
process often provide incomplete or poor validation data that
is insufficient to support authorization. FDA interacts with
such developers to guide them in appropriate validation, but
this is inefficient for both parties and stretches out review
times. The establishment of ITAP is a targeted solution that
will continue to assist developers and streamline the FDA
review process, and ultimately accelerate the availability of
more high-quality, accurate and reliable over-the-counter tests
to the public.
Our experience with ITAP illustrates the value of an
independent government testing capability in bringing accurate
and reliable tests to market quickly. South Korea took this
approach with molecular diagnostics at the beginning of the
COVID-19 outbreak and was able to scale their national testing
capacity very quickly. In the Spring of 2020, we established an
evaluation program with NCI for serology tests which provided
valuable data to inform our regulatory decisions. As we have
noted in our perspective on lessons learned published in NEJM,
we should establish the capacity within or on behalf of the
Federal Government to evaluate test performance before
outbreaks occur so that independent evaluation can be performed
quickly during an outbreak.
SENATOR SCOTT
Treatments
Question 1. Dr. Woodcock what is the status of in-patient
therapeutics? Do we have effective treatments for those in the
ICU to prevent ventilator intubation or post-intubation to
accelerate recovery
Question 1(a). Are repurposed drugs being considered
and approved?
Answer 1. Currently, the following products are approved or
authorized for certain patients who are hospitalized:
LOral Paxlovid (ritonavir-boosted
nirmatrelvir) is authorized for the treatment of COVID-
19 among persons with mild to moderate symptoms who are
at high-risk for disease progression. In a clinical
trial, Paxlovid reduced the risk of hospitalization and
death by 89 percent in unvaccinated outpatients with
COVID-19 at higher risk of severe disease. Serious
adverse events are uncommon with Paxlovid treatment.
Paxlovid is given twice daily for 5 days, starting as
soon as possible and within 5 days of symptom onset,
and is approved for use in adult and pediatric patients
(12 years of age and older weighing at least 40kg).
LVeklury (remdesivir) is an approved drug
product that is indicated for the treatment of
coronavirus disease 2019 (COVID-19) in adults and
pediatric patients (12 years of age and older and
weighing at least 40 kg) with positive results of
direct severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) viral testing, who are:
Y LHospitalized, or
Y LNot hospitalized and have mild-to-moderate
COVID-19, and are at high risk for progression
to severe COVID-19, including hospitalization
or death;
LActemra (tocilizumab) is authorized for
emergency use for the treatment of COVID-19 in
hospitalized adults and pediatric patients (2 years of
age and older) who are receiving systemic
corticosteroids and require supplemental oxygen, non-
invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO);
LOlumiant (baricitinib) is authorized for
emergency use to treat COVID-19 in hospitalized adults
and pediatric patients 2 years of age or older
requiring supplemental oxygen, non-invasive or invasive
mechanical ventilation, or ECMO;
LCOVID-19 convalescent plasma with high titers
of anti-SARS-CoV-2 antibodies is authorized for
emergency use for the treatment of COVID-19 in patients
with immunosuppressive disease or receiving
immunosuppressive treatment, in either the outpatient
or inpatient setting.
Since early in the COVID-19 public health emergency, FDA
recognized the increased demand for certain products and
prioritized the review of generic drug applications for
potential treatments and supportive therapies for patients with
COVID-19, such as for heparin and dexamethasone.
With respect to additional products, including repurposed
drugs, being considered for emergency use authorization or
approval, we note that, consistent with Federal statutes and
FDA's implementing regulations concerning the confidentiality
of commercial information, and to protect the integrity of the
review process, FDA generally cannot disclose information about
unapproved products. FDA is committed to quickly and thoroughly
reviewing all submitted applications, including requests for
emergency use authorization, to speed patient access to
medicines to prevent or treat COVID-19 provided they meet the
agency's rigorous standards. Through the Coronavirus Treatment
Acceleration Program (CTAP), we continue to support research
and clinical trials that are testing new treatments for COVID-
19, including therapies intended to treat severe forms of the
disease, so that we gain valuable knowledge about their safety
and effectiveness.
SENATOR TUBERVILLE
Antibody Testing & Treatments
Question 1. On May 19, 2021, the FDA recommended against
antibody testing to determine a person's level of immunity.
a. How should people be aware of their level of
antibodies or need for a booster?
b. Do you believe people are receiving a booster when
they already have adequate protection from COVID-19?
Answer 1. The currently authorized SARS-CoV-2 antibody
tests should not be used to evaluate a person's level of
immunity or protection from COVID-19 at any time, including
after the person received a COVID-19 vaccine. Currently
authorized SARS-CoV-2 antibody tests have not been evaluated to
determine whether they can predict if a person is protected
against COVID-19. Furthermore, there is no specific level of a
particular antibody which has been shown to be associated with
protection against disease. The available data from the COVID-
19 clinical trials and ongoing assessment of the effectiveness
of the vaccines provides confidence that the vaccines protect
against COVID-19, including serious consequences that can occur
such as hospitalization and death.
Based on HHS's assessment of currently available data,
including during the surge of the circulation of Delta and
Omicron variants, a single booster dose of the currently
authorized vaccines after completion of primary vaccination is
recommended to provide protection against COVID-19. With this
in mind, individuals ages 12 years and older who have completed
primary vaccination may receive a single booster dose.
The FDA amended the emergency use authorization for the
Pfizer-BioNTech COVID-19 Vaccine to allow for a single booster
dose for people ages 12 years of age and older at least 5
months after completion of a primary series with the Pfizer-
BioNTech COVID-19 Vaccine or Comirnaty (COVID-19 Vaccine,
mRNA). Individuals 12 through 17 years of age should receive
only the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty (COVID-
19 Vaccine, mRNA) as their booster dose.
Individuals 18 years of age and older who completed a
primary series with the Pfizer-BioNTech COVID-19 Vaccine,
Comirnaty (COVID-19 Vaccine, mRNA), or the Moderna COVID-19
Vaccine, at least 5 months ago, may receive a single booster
dose of any of the currently authorized or approved COVID-19
vaccines. Individuals 18 years of age and older who completed
their primary vaccination with Janssen COVID-19 Vaccine at
least 2 months ago, may receive a single booster dose of any of
the currently authorized or approved COVID-19 vaccines.
Question 2. Please provide specific examples where your
agency has utilized real world evidence in regards to COVID-19
or treatments for COVID-19.
Answer 2. The following is an example of when FDA has
utilized real world evidence for a COVID-19 vaccine. FDA has
determined that the known and potential benefits of a single
booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide
continued protection against COVID-19 and the associated
serious consequences that can occur including hospitalization
and death, outweigh the known and potential risks in
individuals 12 through 15 years of age when given at least 5
months following primary series.
FDA reviewed real-world data from Israel, including safety
data from more than 6,300 individuals 12 through 15 years of
age who received a booster dose of the vaccine at least 5
months following completion of the primary two-dose vaccination
series. These additional data enabled the FDA to reassess the
benefits and risks of the use of a single booster dose in this
age group in the setting of the January 2022 surge in COVID-19
cases. The data showed that there were no new safety concerns
following a booster in this population, and in particular, that
no new cases of myocarditis or pericarditis were reported in
these individuals.
(Moved from the NIH set of QFRs)
SENATOR HASSAN
Children under age five are still not eligible for a COVID-
19 vaccine. Moderna reported earlier this month that it expects
to report trial data on its COVID-19 vaccine in children ages 2
to 5 by March.
Meanwhile, the number of children with COVID-19 is surging
in New Hampshire and across the country. As of January 1, the
hospitalization rate for children under age 5 reached 4 in
100,000 children--3 times higher than the same time last year.
Question 1. At this point, when do you expect that
vaccinations will be available to children under age 5?
Answer 1. FDA recognizes the need for a safe and effective
vaccine for younger children, particularly given the rapid
spread of the Omicron variant, the notable rise in the number
of hospitalizations in young children with severe disease, and
the possibility that future variants could cause severe disease
in those who are unvaccinated.
It is important that the public recognize that, because
children are still growing and developing, it's critical that
thorough and robust clinical trials of adequate size are
undertaken to evaluate the safety and effectiveness of a COVID-
19 vaccine in pediatric populations. Children are not small
adults and issues that may be addressed in pediatric vaccine
clinical trials can include the appropriate dose and
administration schedule of vaccines already used for adults.
Conducting clinical trials to determine an appropriate
vaccine dose in younger pediatric populations requires
additional investigation and study over that done in the
clinical trials for adults including ensuring that the vaccine
dosage is safe and effective. FDA has been working closely with
vaccine manufacturers to provide advice as data accrue about
safety and effectiveness, the latter of which may be comprised
of immune response data or the number of COVID-19 cases that
occur, or a combination of both, for their respective COVID-19
clinical trials in pediatric populations.
Once adequate data are available, we plan to convene a
meeting of our Vaccines and Related Biological Products
Advisory Committee to publicly discuss the data. For the
Pfizer-BioNTech COVID-19 Vaccine, we will provide an update on
timing for the advisory committee meeting once we receive and
evaluate additional data on the results of three doses
administered to children 6 months through 4 years of age from
the company's ongoing clinical trial.
------
Response by Dawn O'Connell to Questions of Senator Casey, Senator
Baldwin, Senator Hassan, Senator Smith, Senator Lujan, Senator Burr,
Senator Cassidy, Senator Scott, and Senator Tuberville
SENATOR CASEY
Question 1. At the hearing, I asked how the Federal
Government is working with vaccine manufacturers to speed the
development of a safe and effective vaccine for children under
age five. Understanding that the Pfizer trial for children 24
months to 5 years old did not meet its endpoint, my follow-up
questions are, how did we get here and what's next? Please
describe, generally, the following:
Question 1(a). How vaccine developers make decisions about
dose size, quantity and spacing in age de-escalation trials;
Answer 1,1(a). In general, vaccine developers typically do
a small, carefully planned `dose ranging' study for each new
age range. Based on the adult and non-clinical data, developers
may select a number of different dose levels to test.
Typically, the spacing between doses and number of doses is the
same as in the adult trials, at least initially, to allow for
bridging between the two populations. The safety and
immunogenicity data from these small trials is analyzed,
including comparing immunogenicity results with immunogenicity
results from the adult population, and based on the data, one
or two different dose levels may be selected for the larger,
confirmatory trials. If results from the small trial do not
identify a dose with a proper safety and immunogenicity
profile, a second small study might be conducted before moving
to larger trials. This follow-on study could include looking at
additional dosing regimens or looking at lower or higher dose
levels.
Question 1(b). What type of indicators a vaccine
manufacturer might consider when determining whether
and how to change the dose size, quantity or spacing if
primary endpoints are not met; and
Answer 1(b). As mentioned above, vaccine developers
typically do a small, carefully planned `dose ranging' study
for each new age range. Based on the adult and non-clinical
data, developers may select a number of different dose levels
to test. Typically, the spacing between doses and number of
doses is the same as in the adult trials, at least initially,
to allow for bridging between the two populations. The safety
and immunogenicity data from these small trials is analyzed,
including comparing immunogenicity results with immunogenicity
results from the adult population, and based on the data, one
or two different dose levels may be selected for the larger,
confirmatory trials. If results from the small trial do not
identify a dose with a proper safety and immunogenicity
profile, a second small study might be conducted before moving
to larger trials. This follow-on study could include looking at
additional dosing regimens or looking at lower or higher dose
levels.
Question 1(c). Whether the emergence of a viral variant
could affect the efficacy of a vaccine in children differently
than it would affect the efficacy of the same vaccine in
adults.
Answer 1(c). Emergence of a variant can potentially impact
vaccine effectiveness, and a vaccine may not work as well to
protect against disease caused by the variant for all. In
addition, it is not uncommon for a vaccine to have a different
level of efficacy for certain ages/populations as many factors
can play into this, including decreased immune response to some
vaccines as individuals age, the health status of the
individual, and the endpoint being assessed.
Question 2. Furthermore, could you please provide an update
on current Federal goals and investments relating to the
development of vaccines to protect children under age five from
COVID-19, including grants, contracts or other funding awarded
to vaccine developers; and what information is currently being
provided to vaccine developers regarding current or planned
opportunities for collaboration between the Federal Government
and vaccine developers, including the extent to which BARDA
will conduct TechWatch/CoronaWatch meetings and the extent to
which FDA will accept applications for emergency use
authorization.
Answer 2. From the beginning of the COVID-19 response, ASPR
has been committed to developing safe and effective vaccines
for all age ranges. When BARDA awarded the initial COVID-19
vaccine development contracts to Janssen and Moderna in the
early spring of 2020, funds were included to conduct trials in
all age ranges down to the youngest populations. Subsequent
product development and procurement contracts to Novavax,
Sanofi/GSK, and AstraZeneca included scope and funds to support
pediatric clinical trials. Similarly, advanced purchase
agreements with Pfizer included procurement of pediatric doses.
Over the last 2 years, ASPR/BARDA has and will continue to work
closely with each product developer to support development of
their vaccines for pediatric indications as early as is
appropriate (for example, once efficacy in adults has been
shown). This includes funding the majority of the Moderna
pediatric trial that just announced Phase III results, as well
as advanced purchase agreement of Pfizer pediatric vaccine to
support their pediatric development efforts, including advanced
purchase of the Pfizer-BioNTech COVID-19 Vaccine for children
ages 5 through 11 years that is currently authorized under EUA
and being widely distributed.
BARDA's TechWatch program remains open to all threat areas,
including COVID-19. Industry partners, including those
developing COVID-19 vaccines, are encouraged to request a
TechWatch meeting. This program continues to serve as a central
location for industry to engage interagency government partners
with potential funding opportunities. At this time, ASPR/BARDA
does not have sufficient funding to initiate development of
additional or next generation COVID-19 vaccines. Several
promising potential candidates and technologies for investment
have been identified and will be pursued if funding is
provided, with plans to develop vaccines with broader and/or
more durable protection.
Question 3. Finally, could you describe current thinking
across your agencies regarding the circumstances under which
your efforts would expand to include the development of
additional or next-generation vaccines and therapeutics for
COVID-19?
Answer 3. BARDA's TechWatch program remains open to all
threat areas, including COVID-19. Industry partners, including
those developing COVID-19 vaccines, are encouraged to request a
TechWatch meeting. This program continues to serve as a central
location for industry to engage interagency government partners
with potential funding opportunities. At this time, ASPR/BARDA
does not have sufficient funding to initiate development of
additional or next generation COVID-19 vaccines. Several
promising potential candidates and technologies for investment
have been identified and will be pursued if funding is
provided, with plans to develop vaccines with broader and/or
more durable protection.
Regarding therapeutics, the oral antivirals are recent
authorizations and allow for much easier administration and
improved patient access. One of the benefits of the oral
antivirals Paxlovid and molnupiravir is that they have much
broader activity against SARS-CoV-2 and its variants. In fact,
both Paxlovid and molnupiravir have activity against all SARS-
CoV-2 variants tested as of January 2022. Looking to the future
and the President's Pandemic Preparedness Plan, focusing on
broad acting antivirals with activity against many viruses, as
well as focusing on host-targeted therapeutics that are virus-
agnostic will be high priorities.
SENATOR BALDWIN
Question 1. The Omicron variant has made clear the critical
need for higher quality masks, such as N95. Further, I applaud
the Administration's efforts to begin distributing N95 masks to
the public.
Question 1(a). Masks that are currently being distributed
to the public came from the Strategic National Stockpile (SNS).
How is ASPR working to make sure that masks purchased to
replenish the stockpile following this distribution are made in
the United States, using raw materials from American
manufacturers?
Answer 1,1(a). The Administration is committed to procuring
domestically manufactured PPE in accordance with the
Infrastructure Investment and Jobs Act (IIJA). The Department
has relied on COVID-19 supplemental resources to support the
COVID-19 response. ASPR is currently validating COVID-19 PPE
stockpiling goals and assessing priorities to ensure the best
use of remaining supplemental funds, possibly including
investments geared toward creating or expanding domestic
capabilities to manufacture the raw materials and intermediates
needed for final manufacture of N95 masks.
Question 1(b). Please describe how ASPR intends to support
small domestic manufacturers in the process of replenishing the
SNS.
Answer 1(b). The SNS adheres to small business procurement
regulations. If a small business can meet the requirements of
the solicitation and is the best offeror for the requirement,
they will be selected.
Question 1(c). What is ASPR's plan to invest in domestic
manufacturers of the raw materials needed to make high-quality
PPE, including N95s, here in the United States?
Answer 1(c). ASPR is utilizing funding appropriated by
Congress via various COVID-19 supplemental appropriations to
invest in domestic manufacturing of PPE when possible. ASPR has
stood up an industrial-based expansion office and is working to
hire staff with specific expertise in this field to award
contracts to ensure preparedness for future public health
incidents.
Question 1(d). How will ASPR work to ensure that any
contracts for warm-base manufacturing capacity of PPE and its
raw materials support small businesses?
Answer 1(d). HHS adheres to small business procurement
regulations. If a small business can meet the requirements of
the solicitation and is the best offeror for the requirement,
they will be selected.
Question 1(e). Please provide an update on the status of
the RFI for medical-grade meltblown production.
Answer 1(e). The U.S. produces approximately 2 percent of
the man-made fiber (MMF) needed for PPE and other products used
domestically. During the ongoing COVID-19 response, we have
invested approximately $20.7 million in meltblown material
capacity expansion for use in N95 masks, surgical masks, and
ventilator filters. The chart below captures these investments.
----------------------------------------------------------------------------------------------------------------
Award Full Prod Source
Vendor City State Award Date Amount Capacity Increase Date Account
----------------------------------------------------------------------------------------------------------------
Hollingswort Floyd VA 5/19/2020 $1.9M Meltblown 3.1M 20-Dec DPA Title
h & Vose N95s/mo 27.5M III
Vent/mo
----------------------------------------------------------------------------------------------------------------
Lydall Strafford NH 6/19/2020 $13.5M Meltblown 100M 21-May HHS CARES
N95s/mo or 192M
surgical masks/mo
----------------------------------------------------------------------------------------------------------------
FyterTech Green Bay WI 7/24/2020 $2.75M Meltblown 60M Jan 2022 HHS CARES
Nonwovens N95s/mo or 170M
surgical masks/mo
----------------------------------------------------------------------------------------------------------------
Hollingswort Floyd VA 12/2/2020 $2.5M Meltblown 8.3M 22-Jan HHS CARES
h & Vose N95s/mo
----------------------------------------------------------------------------------------------------------------
We currently have a solicitation (https://sam.gov/opp/
0e037509432b491a80d789e5a4f34380/view) and are currently
reviewing offerors for MMF capacity and research and
development to support gown manufacturing.
SENATOR HASSAN
I'm grateful that the administration heeded my call to send
FEMA teams to New Hampshire to help administer COVID-19
treatments, as this assistance was essential to keeping our
health system functioning. However, there were delays in the
teams' arrival and limits to how long they were able to remain
in the state.
Question 1. What additional personnel and support is the
administration planning to provide to New Hampshire and other
states to help providers overwhelmed by the pandemic?
Answer 1. The Secretary of HHS, and by delegation the ASPR,
serves as the lead for Emergency Support Function No. 8 (ESF-8)
under the National Incident Response Framework. Utilizing an
established resource request process through the ASPR and FEMA
Regional Offices, state, local, tribal, and territorial
requests for Federal medical support for healthcare facilities
and needs related to the COVID-19 pandemic are evaluated and
resourced under that construct, to include deployment of
personnel for medical surge, vaccination, monoclonal antibody
administration, testing sites, and technical support. To
support the review of such requests, HHS conducts a call as
required with the other Federal partners supporting elements of
the medical response. On this ESF-8 Partner Call, the Federal
partners including NDMS, DoD, the VA, PHS Commissioned Corps,
and CDC, gather to discuss, coordinate, and determine
resourcing support decisions based on requests received from
states, tribes, and territories. As COVID-19 case counts and
other considerations change, the requests are reviewed in real-
time to determine the best allocation possible given limited
Federal resources. We will use this established process to
determine any additional support the Administration can offer
to New Hampshire and other states overwhelmed by the pandemic.
SENATOR SMITH
Question 1. Given the importance of ensuring we have
sufficient supply of accurate COVID-19 tests, can you explain
the Administration's plans to develop and increase access to
broad spectrum diagnostic tests, including molecular tests, to
increase our ability to detect current and future COVID-19
variants?
Answer 1. The Administration has been focused on testing
since day one and has four priority areas:
Answer 1(a). Increasing the number of testing sites and
programs for getting tested in the U.S., for example,
through the Increasing Community Access to Testing
(ICATT) program and federally Qualified Health Centers
(FQHCs);
Answer 1(b). Increasing the types of tests authorized
for use in the U.S., working closely with FDA;
Answer 1(c). Increasing the overall supply of tests;
and
Answer 1(d). Lowering or eliminating the costs of
testing, in coordination with CDC and CMS.
Advancing equity in access and use of tests is woven
throughout each of these key goals--from selecting the location
of Federal, free testing sites to the provision of free tests
to the uninsured to expanding lower-cost testing options more
generally. We continue to do everything we can to advance our
four priority areas, as quickly as we can.
FDA, in collaboration with other offices in HHS (CDC,
BARDA, NIBIB), is working to ensure that authorized tests can
detect all circulating SARS-CoV-2 variants. Most tests can
detect all high prevalence variants, but several tests have had
issues detecting specific circulating variants. In those cases,
FDA works with the manufacturers so that the manufacturers can
improve their tests quickly or remove them from the market.
Antigen tests are relatively low cost, are now widely
available to detect SARS-CoV-2 infections, and are essential to
ending the ongoing pandemic. However, molecular tests are
generally much higher performing and can be developed and
deployed for a new emerging disease much more rapidly than
antigen tests. Molecular tests can be developed that are
specific enough to differentiate a particular disease variant
from other circulating variants. New molecular testing
technologies that overcome some of the challenges associated
with centralized laboratory molecular testing have been in
development over the past 5 or so years and have become
available for use, with significant Federal investment, during
the COVID-19 pandemic. These new tests may be appropriate for
use in non-laboratory settings including doctors' offices and
nursing homes, and even as self-tests for some diseases like
COVID-19.
Question 2. Looking long-term, what steps should Congress
and the Administration take to improve development and supply
of broad spectrum diagnostics for the current and future
pandemics?
Answer 2. The Administration is working to support efforts
to make testing available more quickly, both for new emerging
diseases and emerging SARS-CoV-2 variants. Due to the shorter
development time for molecular test technologies, the
Administration is also supporting efforts to support investment
in domestic capabilities to manufacture newly emerging
molecular tests that are appropriate for use in non-laboratory
settings, including homes, making them much more widely
available. The Administration is also working on a revised
National Biodefense Strategy that will include broad objectives
and plans for future investments in this space. There is no
timeline for release of the revised NBS at this time.
SENATOR LUJAN
Question 1. Throughout the pandemic, state and Federal
policymakers have asked pharmacists to provide clinical
services to patients. Every state now authorizes licensed
pharmacists to order and administer vaccines, tests for COVID-
19 and other infectious diseases, and therapeutics to treat
COVID-19, but pharmacists' ability to perform these services
will expire with the public health emergency expiration. The
Secretary of Health and Human Services even used their
authority under the Public Readiness and Emergency Preparedness
(PREP) Act to ensure that all Americans could access these
services from their pharmacist. At least 38 states have
expanded their Medicaid coverage of clinical services provided
by pharmacists during the pandemic, and many commercial payers
cover clinical services provided by pharmacists. But I
understand that the Medicare program cannot cover clinical
services that Medicare beneficiaries want to receive from their
pharmacist. When Medicare beneficiaries need clinical services
from their pharmacist, does the Medicare program have the
authority it needs to pay for those services? If not, what
legislative change is necessary to ensure Medicare
beneficiaries have access to clinical services that their
pharmacist is licensed to provide?
Answer 1. This response is best addressed by the Centers
for Medicare & Medicaid Services.
SENATOR BURR
Question 1. The development of the first successful mRNA
vaccines is a clear success story from the COVID-19 pandemic.
However, this virus has, and likely will, continue to mutate,
which means that we must continue to support the development of
a variety of medical countermeasures, including those that
utilize different platforms or mechanisms of action. Operation
Warp Speed recognized this need and supported multiple vaccine
platforms and therapeutic candidates. In response to Omicron
and the continued threat of COVID-19, how is ASPR ensuring that
there are funding opportunities for innovators who have
products that might work better against the next SARS-CoV-2
variant or emerging infectious disease than the countermeasures
we have now?
Answer 1. Some of the vaccine technologies BARDA has
invested in during the COVID-19 response are considered readily
adaptable technologies which means they can be updated easily.
For example, a change in the sequence of an mRNA vaccine can
produce a vaccine targeted to a SARS-CoV-2 variant. All the
investments in the vaccine industrial base capacity expansion
support not only the current COVID-19 response efforts, but
also responses to variants as well as other future pandemic
response and preparedness efforts.
With respect to therapeutics, one of the benefits of the
oral antivirals Paxlovid and molnupiravir is that they have
much broader activity against SARS-CoV-2 and its variants. In
fact, both Paxlovid and molnupiravir have activity against all
SARS-CoV-2 variants tested as of January 2022.
Looking to the future and the American Pandemic
Preparedness Plan, focusing on broad acting antivirals with
activity against many viruses as well as focusing on host-
targeted therapeutics that are virus-agnostic will be high
priorities.
SENATOR CASSIDY
Question 1. The U.S. is in the middle of flu season, which
has the potential to add additional burden to already-stressed
health care systems due to the ongoing pandemic.
Question 1(a). What steps is HHS taking to ensure the
availability of appropriate diagnostics and treatment options
to address the potential dual threats of COVID and influenza,
including through shoring up the Strategic National Stockpile?
Answer 1,1(a) There are four FDA-approved influenza
antivirals drugs recommended by CDC for use against recently
circulating influenza viruses: oseltamivir, baloxavir-marboxil,
peramivir and zanamivir. Oseltamivir is the most widely used
oral antiviral for the treatment of influenza and is also
widely available in generic form with at least 10 different
manufacturers approved by FDA to provide drug on the U.S.
market. The broad manufacturing capacity ensures that even
large waves of influenza infections can be sufficiently covered
by the commercial market. In the event that demand for
influenza antivirals exceeds commercial capacity, HHS could
activate influenza antivirals that are stored in the SNS.
Early in the COVID-19 outbreak, ASPR/BARDA recognized the
negative impact that needing influenza testing would have on
national COVID-19 testing capacity during flu season. As such,
we began supporting the development of multiplexed panels to
test for both diseases in one testing operation. BARDA is
supporting the development and submission for review for 17
test panels for use in laboratory and limited testing resource
settings such as homes, nursing facilities, tribal clinics,
doctors' offices and temporary testing centers. Four of these
panels have received EUAs so far, with the remaining 13
awaiting FDA review of their submissions or finalizing test
development. BARDA is supporting most of these test panel
developments through the FDA's 510(k) clearance process.
Question 1(b). Beyond testing and preventative steps like
vaccination, what steps has HHS taken to proactively treat
vulnerable populations like the elderly or others who may be at
risk for and are likely to spread communicable diseases like
COVID and the flu?
Answer 1(b). ASPR proactively works with Federal and state,
local, tribal, and territorial (SLTT) partners to address the
access and functional needs of at-risk populations, including
older adults and others who may be more adversely affected by
or susceptible to infectious diseases such COVID-19 or flu
through developing tools, guidance, training, and programs to
support public health emergency preparedness and response
activities and engaging with Federal and proactively engaging
with stakeholders to disseminate and implement critical
information and best practices.
ASPR's At-Risk Individuals Program continues to monitor
emerging issues, oversee development of curriculum, and
disseminate and update promising practices including developing
a series of web-based trainings and capacity-building guidance
that address all-hazards planning including infectious disease
outbreaks. In addition, the HHS emPOWER Program is a mission-
critical partnership between ASPR and CMS. It provides Federal
data, mapping, and artificial intelligence tools, as well as
training and resources, to help communities nationwide protect
the health of at-risk Medicare beneficiaries, including 4.4
million individuals who live independently and rely on
electricity-dependent durable medical and assistive equipment
and devices, and or essential health care services. The HHS
emPOWER Program continues to grow and innovate, including
leveraging the program to develop the restricted HHS emPOWER
Program: COVID-19 At-Risk Medicare Populations suite of
datasets, geographic information systems, and dashboards tools
for SLTT partners to use in response and community mitigation
efforts.
Question 2. Health systems in Louisiana have been
overwhelmed by successive waves of COVID variants. These health
systems could have been better prepared for these growing
variant trends if they had access to better national and
regional dashboards monitoring variants of concern. What are
you all at the CDC, FDA, NIH, and HHS doing to make sure health
providers are armed with the best data to respond appropriately
to the next COVID variant or pandemic? Second, how are you all
harnessing the speed and innovation of the private sector to
help predict, prevent, and mitigate future COVID-19 variants or
other pathogens of concern?
Answer 2. ASPR has supported internal development data
governance strategies, building out modernized IT systems for
data sharing (HHS Protect, Tiberius and ASPR Ready), and has
coordinated closely with CDC and the Office of the National
Coordinator for Health Information Technology (ONC). Overall,
the engagement at the state/local level with healthcare
providers is through CDC.
SENATOR SCOTT
Question 1. Ms. O'Connell--How much COVID funding is still
left for testing and what is the plan for its investment?
Answer 1. As of the hearing date, the Federal Government
has invested $10 billion to support school testing; $8.3
billion on free community testing, testing for the uninsured,
rural clinics and hospitals; and $5 billion on test
procurement, distribution, and materials. As of the hearing
date, $4.4 billion remains available for future testing
efforts.
On efforts related to test procurement and distribution, we
have quadrupled the amount of at-home tests available since the
fall and have worked with test manufacturers and FDA to help
expedite development and review of at-home tests, which will
directly result in even more tests being available. In the
near-future, we will announce an initiative in which households
can place orders for tests, free of charge, and test kits will
be delivered via USPS. More information will be provided to
Congress as this initiative goes live.
We have also supported free testing sites at over 10,000
pharmacies throughout the country, over 10,000 state-and
locally run community sites offering free testing generally
with FEMA or CDC support--for a total of over 20,000 free
testing sites across the country today. As of the hearing date,
we are setting up surge testing sites in states to further
increase access. There are 17 sites up and running in New York
City, New Jersey, Pennsylvania and Washington, DC, with plans
for sites in more than a dozen additional states in the coming
couple of weeks.
Question 1(a). How many tests does the Federal Government
currently have and what is the distribution plan?
Answer 1(a). As of the date of this hearing, the Federal
Government had begun contracting for the tests to be provided
to the general public at no cost. As of the date of this
hearing, over 50 million tests were secured through four
initial letter contracts, and we will continue to award more in
the days ahead to get us to a goal of having 1 billion tests
available. Under the distribution plan, the tests would be
distributed through the U.S. Postal Service to households who
place orders in the system. As of the hearing date, final plans
were being set for the website as well as an automated help
number.
Question 1(b). How is distribution determined?
Answer 1(b). In the near-future, we will announce an
initiative in which households can place orders for tests, free
of charge. Under the distribution plan, the tests would be
distributed through the U.S. Postal Service to households who
place orders in the system.
Question 1(c). Given concerns regarding limited accuracy
and inability to detect early infection with antigen tests,
what action has the Administration taken to support increased
production and procurement of rapid, at-home molecular tests?
If none, why not and does the Administration plan to do so?
Answer 1(c). Testing continues to be a vital part of our
response. We've made significant progress in increasing testing
supply, availability, and affordability. As of the hearing
date, we went from zero over-the-counter tests in January 2021
to supporting the manufacturing of approximately 375 million
tests per month. We invested $3 billion to accelerate
production of rapid tests and expanded capacity, including
necessary components such as pipette tips and vials. We're also
standing up an office within ASPR to focus on making sure we
have the right mix of products, suppliers, and partnerships to
respond to public health emergencies and strengthen the
Nation's overall preparedness.
In January, President Biden announced a plan to make 1
billion free at-home tests available to the American people and
mail them directly to their homes via COVIDTests.gov.
Question 2. Ms. O'Connell--Recently, President Biden
mentioned that there is no Federal solution to defeating COVID-
19 and later said Americans need to adjust and prepare for
COVID to be a part of everyday life.
Question 2(a). How does the Administration view the role of
the Federal Government moving forward?
Answer 2,2(a). The President has been clear that we're
moving toward a time when COVID won't disrupt our daily lives--
a time when COVID won't be a constant crisis. Rather, it will
be something we can easily prevent and treat. In doing so, we
will rely on the powerful tools we've used to protect the
public from COVID-19--vaccines, treatments, and testing. As we
move toward that time, we're working closely with state
Governors, local public health officials, and other subject
matter experts on steps we should be taking to keep the country
moving forward.
Question 2(b). What are the protocols for hospitals
regarding overloading: what does the trigger look like
regarding National Guard or other supports?
Answer 2(b). The Secretary of HHS, and by delegation the
ASPR, serve as the lead for Emergency Support Function #8 (ESF-
8) under the Incident Response Framework. Requests for medical
support are evaluated and resourced under that construct. To
support the review of requests, HHS supports a daily call where
the other Federal partners supporting elements of the medical
response, including DoD, the VA, PHS Commissioned Corps, and
CDC, gather to discuss, coordinate, and determine resourcing
assignment decisions. As case counts and other considerations
change, the requests are reviewed in real-time to determine the
best allocation possible. Using this process, this team will
decide when to deploy a National Disaster Medical Services team
or DOD clinical response team to decompress an overwhelmed
hospital-factors for consideration include the number of cases,
the available beds, and the available staff in the hospital
setting.
Question 3. One of the things that we've learned in this
pandemic is that we have the best biopharma industry in the
world. It has been a truly unbelievable feat that America's
biopharmaceutical companies have been able to respond to an
unprecedented and evolving pandemic by delivering safe and
effective vaccines in essentially less than a year's time.
Additionally, we are seeing continued innovation in the COVID
space--antivirals, new medications designed to keep people off
ventilators, as well as continued promising research on
existing medications, all which will help us to continue to
expand our COVID-fighting capabilities. As a long term champion
for the strategic national stockpile and the advanced research
and preparation conducted by BARDA, I do worry that we may be
falling behind in our efforts to maintain the most up-to-date
and innovative repository to respond to the current and future
pandemics.
Question 3(a). Ms. O'Connell--What can be done to improve
partnerships with industry to allow for public-private
partnerships to manage and to provide certainty for production
needs and distribution of essential medical countermeasures?
Answer 3,3(a). HHS is committed to supporting our industry
partners, providing value-added services, expertise, and
funding to develop, manufacture and deliver medical
countermeasures that protect health and save lives in public
health emergencies. To help the country build manufacturing
capabilities needed to produce population-scale vaccines and
therapeutics, we issued a Request for Information (RFI) and
held a virtual Industry Day as part of our market research into
the capabilities needed, how those capabilities could be
sustained over time, and how best to build consortia that
engage more industry partners with large-scale manufacturing
experience. In addition, BARDA issued an RFI on domestic
vaccine manufacturing capabilities utilizing mRNA technology.
We will leverage all of the legislative authorities at our
disposal and available funding to build not just the capacity
but also the capability that the Nation needs. We look forward
to working with industry on this critical issue for national
security.
SENATOR TUBERVILLE
Question 1. The administration's declaration on December
21, 2021 that they would make 500 million test kits available
to be shipped to people's homes has made it more difficult for
companies to get shipments to help keep workplaces safe, as
there have been fewer tests available for private purchase.
Question 1(a). Can you provide a high-level roadmap to an
increase in EUA antigen test production?
Answer 1,1(a). Testing continues to be a vital part of our
response. We've made significant progress in increasing testing
supply, availability, and affordability. As of the hearing
date, we went from zero over-the-counter tests in January 2021
to supporting the manufacturing of approximately 375 million
tests per month. We invested $3 billion to accelerate
production of rapid tests and expanded capacity, including
necessary components such as pipette tips and vials. We're also
standing up an office within ASPR to focus on making sure we
have the right mix of products, suppliers, and partnerships to
respond to public health emergencies and strengthen the
Nation's overall preparedness.
In January, President Biden announced a plan to make 1
billion free at-home tests available to the American people and
mail them directly to their homes via COVIDTests.gov.
Question 1(b). Specifically, how much are vendors
increasing test manufacturing? In what quantity and by what
date?
Answer 1(b). In early 2021, we saw a decline in demand for
tests following the rollout of COVID vaccines and domestic
manufacturing capacity for rapid antigen tests significantly
exceeds current demand. Our industry partners have reached out
to us with concerns that active manufacturing lines risk being
shut down without orders from the Federal Government to
partially offset this imbalance. ASPR recognizes the importance
of keeping this critical infrastructure active given the large
supply/demand shifts created by the spread of recent--and
potentially subsequent--variants. As such, we are working in
tight coordination with our industry partners as we continue to
invest in procurement of tests to build a stockpile that will
be at the ready to respond to rapid demand surges and continue
to explore ways that we can ``warm base'' existing
manufacturing capacity so that tests are available if needed.
Question 2. Across the country, members of the health care
workforce have been fired for refusing to comply with COVID-19
vaccine mandates. Do you believe that these mandates have
contributed to labor shortages in hospitals and other health
care facilities?
Answer 2. The Office of the Assistant Secretary for
Preparedness and Response has worked tirelessly to support the
development and manufacturing of safe and effective COVID-19
vaccines. ASPR is committed to ending the pandemic and ensuring
Americans can live safe and healthy lives. ASPR can provide
resources, such as personnel from the National Disaster Medical
System (NDMS), to augment care if and when a medical system or
systems is in need of additional staff augmentation. The issue
of labor shortages is something outside of ASPR's role and
responsibility, but we stand by to support requests if and when
needed and have done so throughout the ongoing response.
Question 3. One of the things we've learned during this
pandemic is that America has the best biopharma industry in the
world. It was an almost unbelievable feat that America's
biopharmaceutical companies were able to respond to an
unprecedented and evolving pandemic by delivering safe and
effective vaccines in essentially less than a year's time.
We've also seen continued innovation in the COVID space-
antivirals, new medications designed to keep people off
ventilators, as well as promising research on existing
medications. All of these things will help us to further expand
our COVID-fighting capabilities for all variants. As a
supporter of the Strategic National Stockpile and the advanced
research and preparation conducted by BARDA, I worry that we
may be falling behind in our efforts to maintain the most up-
to-date and innovative repository to respond to the current and
future pandemics.
Question 3(a). What can be done to improve partnerships
with industry to allow public-private partnerships to manage
and to provide certainty for production needs and distribution
of essential medical countermeasures?
Answer 3,3(a). HHS is committed to supporting our industry
partners, providing value-added services, expertise, and
funding to develop, manufacture and deliver medical
countermeasures that protect health and save lives in public
health emergencies. To help the country build manufacturing
capabilities needed to produce population-scale vaccines and
therapeutics, we issued a Request for Information (RFI) and
held a virtual Industry Day as part of our market research into
the capabilities needed, how those capabilities could be
sustained over time, and how best to build consortia that
engage more industry partners with large-scale manufacturing
experience. In addition, BARDA issued an RFI on domestic
vaccine manufacturing capabilities utilizing mRNA technology.
We will leverage all of the legislative authorities at our
disposal and available funding to build not just the capacity
but also the capability that the Nation needs. We look forward
to working with industry on this critical issue for national
security.
(Moved from NIH QFRs)
SENATOR LUJAN
Question 1. Given the increased demand for N95 and KN95
masks, we have seen an increase in costs to the consumer. New
Mexicans hoping to protect themselves face costs as steep as $6
per mask-a cost that is simply out of reach for some of our
most vulnerable populations. What barriers are preventing the
Federal Government from providing N95 or KN95 masks to the
public free of charge?
Answer 1. In January, 2022, just before we testified before
this Committee, the Biden administration announced a plan to
deploy more than 400 million American-made, high-quality N95
masks from the Strategic National Stockpile (SNS) to retail
pharmacies and federally qualified health centers (FQHCs)
across the country. This effort represents the largest
deployment by the SNS to date, and it is also the largest
deployment of personal protective equipment (PPE) in U.S.
history. It will help ensure that Americans have access to
high-quality masks. Please note these masks were N95s as those
are the masks manufactured in the U.S.
------
[Whereupon, at 1:55 p.m., the hearing was adjourned.]
[all]