[Senate Hearing 117-195]
[From the U.S. Government Publishing Office]
S. Hrg. 117-195
THE PATH FORWARD:
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
FIRST SESSION
ON
EXAMINING A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE, FOCUSING ON
THE PATH FORWARD, AFTER RECEIVING TESTIMONY FROM ROCHELLE P. WALENSKY,
DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, ANTHONY S. FAUCI,
DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES,
NATIONAL INSTITUTES OF HEALTH, JANET WOODCOCK, ACTING COMMISSIONER OF
FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION, AND DAWN O'CONNELL,
ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, ALL OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES.
__________
JULY 20, 2021
__________
Printed for the use of the Committee on Health, Education, Labor, and Pensions
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
46-775PDF 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
----------
STATEMENTS
TUESDAY, JULY 20, 2021
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........................... 3
Witnesses
Walensky, Rochelle, M.D., MPH, Director, United States Centers
for Disease Control and Prevention, Atlanta, GA................ 6
Prepared statement........................................... 7
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 14
Prepared statement........................................... 15
Woodcock, Janet, M.D., Acting Commissioner, United States Food
and Drug Administration, Silver Spring, MD..................... 23
Prepared statement........................................... 24
O'Connell, Dawn, Assistant Secretary for Preparedness and
Response, United States Department of Health and Human
Services, Washington, DC....................................... 34
Prepared statement........................................... 36
QUESTIONS AND ANSWERS
Response by Rochelle Walensky, to questions of:
Senator Casey................................................ 70
Senator Baldwin.............................................. 72
Senator Hassan............................................... 72
Senator Burr................................................. 73
Senator Braun................................................ 75
Senator Tuberville........................................... 76
Response by Anthony Fauci, to questions of:
Senator Burr................................................. 78
Senator Braun................................................ 81
Senator Tuberville........................................... 82
Response by Janet Woodcock, to questions of:
Senator Burr................................................. 84
Senator Braun................................................ 86
Senator Scott................................................ 87
Senator Tuberville........................................... 91
Response by Dawn O'Connell, to questions of:
Senator Baldwin.............................................. 92
Senator Burr................................................. 93
Senator Braun................................................ 96
Senator Tuberville........................................... 96
THE PATH FORWARD:
A FEDERAL PERSPECTIVE
ON THE COVID-19 RESPONSE
----------
Tuesday, July 20, 2021
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
430, Dirksen Senate Office Building, Hon. Patty Murray, Chair
of the Committee, presiding.
Present: Senators Murray [presiding], Casey, Baldwin,
Kaine, Hassan, Smith, Rosen, Lujan, Hickenlooper, Burr, Paul,
Cassidy, Braun, Marshall, Romney, Tuberville, and Moran.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. Senate Health, Education, Labor,
and Pensions Committee will please come to order. Today we are
holding a hearing on our Federal response to the COVID-19
pandemic. Ranking Member Burr and I will each have an opening
statement and I will introduce our witnesses. After they give
their testimony, Senators will each have 5 minutes for a round
of questions.
While we are yet 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
anyone is in need of accommodations, including closed
captioning, please reach out to the Committee or the Office of
Congressional Accessibility Services.
We are at a point of great promise and peril in the fight
against COVID-19. While I am encouraged by the fact that two-
thirds of adults in our Country have received their first dose
of vaccine, I am alarmed by how the rate of vaccination has
been slowing, and how driven by the delta variant, rates of
COVID-19 cases and deaths are once again on the rise. Five
counties in my state currently have high levels of transmission
according to the Centers for Disease Control and Prevention.
For example, in Walla Walla County, cases are up in July from
June, and they were up in June from April and May.
Even though 99 percent of the COVID deaths nationwide last
month were among people who had not gotten vaccinated, we are
still seeing fear and misinformation hold people back, huge
disparities in vaccination rates among communities of color and
rural communities, skepticism about vaccines among some
religious and conservative communities, and slow uptake among
youth--young adults. Vaccines are safe, effective and free and
easy to get. We need to make sure people know that. And we also
need to make sure they understand. Choosing not to get
vaccinated doesn't just put themselves at risk, it puts the
people around them at risk and including people who are
immunocompromised like those fighting cancer and kids who are
not yet eligible for vaccines.
We also have to remember vaccinations are just one front of
this fight. Local health departments need the capacity to track
emerging outbreaks quickly through contract tracing sequence,
virus samples to identify variants, help isolate ill people,
and track vaccination progress. And more experts need to
evaluate the longevity of immunity, especially in the face of
new variants and the potential value of booster shots.
Researchers need to study the long term impacts of this
disease and how to treat long haul COVID-19 or PASC. And
perhaps most importantly, we as a Nation need to fully learn
the lessons of this pandemic and take action so we are never in
this situation again. That is why Senator Burr and I have been
working on bipartisan legislation and oversight to build the
world class public health and preparedness infrastructure our
people deserve. It is my hope that through this work, we will
not only address challenges we faced during this pandemic but
build on progress we saw in some states across the country.
In my home State of Washington, they worked to overcome
challenges with sharing critical COVID data among health
departments, labs, and hospitals to improve how data was used
to allocate critical medical supplies like respirators and
develop a more complete dashboard for demographic data that
broke out numbers, for example, for the Pacific Islander
community. Michigan created a task force on racial disparities
early on in the pandemic to ensure they were reaching
communities of color for testing and contact tracing.
Alaska literally employed every mode of transportation to
deliver vaccines to hard-to-reach communities. One of the
clearest lessons from this crisis is that you should have the
same protection from a pandemic, chronic disease, or public
health threat, regardless of where you live, who you are, or
what your income is. And one of the best ways of providing that
level of protection is through strong public health
infrastructure.
The stronger our health departments are at every level, the
more effectively they can work to use sequencing technology and
modern data systems to track the spread of diseases and monitor
the success of vaccination efforts, stand up testing and
contact tracing to stop disease outbreaks, develop science
based guidelines to address local needs, build partnerships in
hard to reach communities, and build trust as communicators and
fight misinformation. There is a saying in health care, an
ounce of prevention is worth a pound of cure. We need to have
that same mindset when it comes to public health. That is why I
have pushed for more funding for public health departments
throughout our COVID response packages.
It is why earlier this year I reintroduced legislation to
end the cycle of crisis and complacency in public health
funding by providing $4.5 billion in dedicated annual funding
and is why I am going to continue pushing for us to make these
critical investments. We all want this pandemic to end. And it
is clear, despite the incredible progress we have made in the
last few months, we still have a lot more work to do. But even
after we are through this crisis, our work won't be done. We
have to make sure we learn from this history and take action,
so we never repeat it.
This crisis has cost too much, has taken too many lives for
us to do anything less. I look forward to hearing from all of
our witnesses today. Thank you for being here. We want to hear
about our response to this pandemic so far, the path forward,
and how we better prepare for threats like this in the future.
With that, I will turn it over to Ranking Member Burr for his
opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Well, thank you, Madam Chair. I am pleased
that we are holding this hearing today. Our third panel with
members of the Administration, this Congress on COVID-19. To
our witnesses, welcome. Welcome back. Some of you are old hands
at this now and others are relatively new. Dr. Fauci, Dr.
Walensky, thank you for returning to the Committee for the
third time this year to discuss this pressing matter. Ms.,
O'Connell, welcome. This is your first hearing before the
Committee in your newly confirmed role as the ASPER.
I am glad that we are able to get you confirmed so quickly.
You have a lot of work in front of you and all of us,
Republicans and Democrats, are ready to help you and the fine
folks at ASPER get the job done. Dr. Woodcock, welcome back to
the HELP Committee. The FDA has benefited from your leadership,
and you are the right person at the helm as we continue to
grapple with the pandemic.
I hope that we will see you again at another hearing to
talk about the great things that you are doing at the FDA,
preferably a confirmation hearing. I look forward to hearing
from each of you on your perspectives of the current response
to COVID-19 and what we--where we should go from here. I have
spent the better part of my career in Congress working to
prepare our Country for the unthinkable and anticipating what
we may need to respond to it. These early efforts had the
support and leadership of many of my colleagues here now,
including Senator Collins, our Chair, Senator Murray, Senator
Casey have all been important partners on preparedness with me,
working to reauthorize PAHPRA and continue to keep a focus on
these items during peacetime. All of this effort was with the
hope that we would never have to act on the authorities we
provided. But it was also with an eye to what may be around the
corner. Each law we wrote was designed to build on the lessons
that we learned from each event, Zika, West Nile, SARS and the
anthrax attacks.
We tried to anticipate what we didn't think of last time
around so that we could be better prepared for when the big one
came. This Committee has been holding hearings on COVID-19
response since March 2020, at the very first hearing that
raised concerns with our ability to keep pace with the virus,
to track its whereabouts, and understand the impact it would
have on the lives of the American people. We have the
authorities needed, but we were and still are faced with many
unknowns.
Each step of the way, we need to look around the corner and
ask ourselves, what do we need to do today to keep us up with
the virus 30, 60, and 90 days from now? CDC estimated in mid-
June the delta virus, the variant accounted for more than 30
percent of all covered infections. As of mid-July, the cases
caused by delta variant may be approaching 60 percent of all
cases. The good news is the cases are down significantly since
the peak. The bad news is the delta virus--variant is surging
and vaccines have slowed because of hesitancy of resistance. I
can tell you that the next few weeks and months will require us
to answer some very difficult questions, especially as we work
toward the last few miles of administering the vaccine in this
country. COVID won't just go away.
We need all Americans who can get the vaccine to get the
vaccine. If you won't do it for yourself, do it for your
friends, your families, for your neighbors, and your local
community. Do it for your grandchildren so they can go back to
school. Do it for your grandparents so they can finally go out
and eat. Not only is a delta variant a concern, but we need to
look around the corner to the next mutation of the disease.
I would like to know if we are performing enough sequencing
to be able to quickly detect the presence of variants. And are
we tracking the right metrics to understand the shift and drift
of the virus so that we can see in real time what new variants
may mean for our response? Last week, one vaccine company
announced it was ready to file for FDA emergency use for
booster shot. Do we need booster shots, when do we need them?
What does this mean for a widely available vaccine? Israel
started offering booster shots last week.
I am worried that American leadership is no longer what it
once was when it comes to public health and other countries are
outpacing us. We have the same data as Israel. Why aren't we
making the same decisions? Messages from public health experts
won't be followed if Americans don't believe in the experts.
The White House has the power to shape messaging, but it
doesn't and shouldn't shape science in any administration. The
last Administration lost the attention and trust of the
American people with 2 hour press briefings. This
Administration shouldn't lose theirs for the sake of the
teachers' union. We need to know what we are being told by
experts is the unvarnished truth. Don't tell us what you don't
think we can handle. Don't tell us what the Administration
thinks we should hear. Level with us.
As we sit here today, we are just months away from flu
season. How do we get ready for the colder months ahead of us
and the flu and cold season that it will bring along with it?
Are the flu shots ready? Will we have enough? These questions
should have been thought about weeks ago as they are already on
our doorstep. The same is true for our legislative efforts and
the long term changes we need to make now. While lessons
learned from COVID response are top of our mind, the ASPER must
play a more prominent role managing the threat landscape in
peacetime and commanding the public health and medical response
during the emergencies with better coordination among Federal
agencies, better availability of data and public health
surveillance, stronger partnerships with innovators in the
private sector, building on the good work of BARDA, and
visibility into our supply chain for critical drug supplies,
which are also--which also need to be more sustainable.
The CDC must be reformed to become a more focused,
accountable, and transparent partner in public health and
public health preparedness and learn to adopt and leverage 21st
century technologies. The NIH should build on its ability to
accelerate basic research, leaning on its long expertise in
partnering with academia to better understand the pathogens
that pose the greatest risk and what tools we may have in the
research bench to combat them. And the FDA should build on the
great success that we have had, staying the more nimble and
creative agency it has become during the COVID-19 response.
This is especially important as the agency works to make
final its user fee agreements and transmit them to Congress for
our approval next year. Now is the time to anticipate what is
next. I encourage each of you, in this critical role that you
play to engage with this Committee to provide the insight into
the COVID response as you have over the last 18 months, but
more importantly, to look ahead. We have a window to update our
public health and medical preparedness policies, taking into
account the lessons learned from COVID-19 and this Committee
intends to act before the attention of Congress turns to other
matters.
It is hard to believe, but memories will fade. I have had
to fight to keep funding for pandemic and threat awareness too
many times to count. I hope to pass that baton onto one of my
colleagues to protect these important programs. But before I
leave, I feel a great responsibility to make things better in
one final bill.
I am glad that the Chair is an active and able partner in
that effort. I appreciate her commitment to this bipartisan
concern. And I think we have a real opportunity to make
improvements. This effort will be our focus going into the
fall.
We welcome your feedback, your insight, and most
importantly, your expertise. There is nothing more important
than the health and security of our Nation. With that, I thank
the Chair and I yield.
The Chair. Thank you, Senator. With that, I will introduce
today's witnesses. We will begin with Dr. Rochelle Walensky.
She is the Director of the Centers for Disease Control and
Prevention and the Administrator of the Agency for Toxic
Substances and Disease Registry. Dr. Walensky, welcome back.
Thank you for joining us.
Next, I would like to introduce Dr. Anthony Fauci, who is
the Director of the National Institute of Allergy and
Infectious Diseases and the Chief Medical Advisor in President
Biden's COVID-19 response team. Dr. Fauci, it is good to have
you back before the Committee. Thank you for joining us.
Our next witness is Dr. Janet Woodcock, the Acting
Commissioner of the Food and Drug Administration. Dr. Woodcock,
thank you for being here. I look forward to your testimony.
Finally, we have the Assistant Secretary for Preparedness and
Response, John O'Connell. It is good to see you, Assistant
Secretary O'Connell.
Thank you for joining us. I am pleased to welcome you back
to the Committee following your confirmation to this new role.
With that. Dr. Walensky, you may begin your opening statement.
STATEMENT OF ROCHELLE WALENSKY, M.D., MPH, DIRECTOR, UNITED
STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Walensky. Good morning. Chair Murray, Ranking Member
Burr, Members of the Senate Health Committee. I am honored to
join you today to provide an update on the COVID-19 pandemic
and our four priorities of CDC's ongoing response, tracking and
preventing further spread of COVID, creating access to and
confidence in vaccines, advancing health equity, and getting
our children back to school. The current data reveal two
divergent truths.
Since the epidemic peaked in January 2021, we have seen
large reductions in COVID-19 cases, hospitalizations, and
deaths. And these trends are a testament to the success of our
vaccination program and the tireless effort of professionals
from across health, business, and Government sectors who have
come together to respond.
On the other hand, our progress across the country is not
uniform. Vaccine coverage varies by state and by county.
Communities where people remain unvaccinated, are most
vulnerable and most likely to experience increase in case
counts. As of last week, nearly 50 percent of vaccine eligible
population in this country is now fully vaccinated. 160 million
people and still nearly two-thirds of counties in the United
States have vaccine coverage less than 40 percent.
In areas where vaccine coverage is low, cases and
hospitalizations are starting to climb again. Over the last
week, we have averaged 239 deaths per day, an increase of
nearly 48 percent over the prior week. Each death is tragic and
even more heartbreaking when we know that the majority of these
deaths could be prevented with a simple, safe, available
vaccine. Areas with limited vaccine coverage are allowing for
the emergence and rapid spread of the highly transmissible
delta variant. CDC has released estimates of variance across
the country and predicted the delta variant now represents 83
percent of sequenced cases.
This is a dramatic increase, up from 50 percent for the
week of July 3rd. In some parts of the country, the percentage
is even higher, particularly in areas of low vaccination rates.
To date, our data indicates that vaccines are available to
neutralize but circulating variants in the United States and
provide protection against severe disease, hospitalization, and
death. The message from CDC remains clear, the best way to
prevent the spread of COVID-19 variants is to prevent the
spread of disease. And vaccination is the most powerful tool we
have.
We must continue to expand vaccine coverage by building
trust and confidence in COVID-19 vaccines. And this is
particularly important in communities of color, rural
communities, and other population groups at risk. CDC is
engaging trusted community leaders to reinforce messages about
the safety, efficacy, and importance of vaccination. CDC
remains committed to ensuring all of our work advances health
equity. Thanks to supplemental resources, CDC has provided
additional support to health departments to address health
disparities and improve health equity among historically
underserved populations at elevated risk. That includes racial
and ethnic minority groups and people living in rural areas.
We are training and integrating community health workers
into care teams, collaborating with partner organizations to
improve vaccine access, and building vaccine confidence among
medically underserved communities and disproportionately
affected populations. As the Director of the CDC, it is my
priority to get our children back to school for safe in-person
learning. Earlier this month, the CDC released updated guidance
to reflect the latest science on COVID-19 and the widespread
availability of safe and effective vaccines for those ages 12
and over.
We continue to recommend that schools implement layered
prevention strategies to protect those who are not fully
vaccinated and encourage vaccination for those who are
eligible. Masks continue to be a critical part of these layered
prevention strategies. Working together, school administrators
and public health workers can carefully consider community
transmission rates, local vaccine coverage, and occurrence of
outbreaks when deciding what strategies are needed to help
prevent the spread of COVID-19 and safeguard in-person
education.
In summary, the overwhelming majority of deaths from COVID-
19 are now occurring in unvaccinated people. Vaccines are
widely available across the country, and the suffering and loss
is simply entirely preventable, nearly.
For our entire Nation to heal and move forward, we must do
all our part to get our Country vaccinated. 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 again 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. We work 24/7 to prevent illness,
save lives, and protect America from threats to health, safety, and
security. CDC is proud of its key role in preparedness and response to
public health concerns here in the United States and abroad.
CDC Efforts to Date
Since we last met, COVID-19 cases have decreased from the spring to
summer, and we have made tremendous strides in getting people
vaccinated, which has allowed many people to resume their daily
activities safely. We are hopeful and have made incredible progress
toward controlling this pandemic. However, many states and communities
continue to have low vaccination rates, and the threat of variants is
growing. We are now witnessing concerning increases in a number of
jurisdictions and given the threat of variants, including the increased
prevalence of the hyper-transmissible Delta variant, we must remain
diligent as we continue to fight this virus.
On June 23rd we officially passed the heart wrenching milestone of
over 600,000 deaths from COVID-19 in the United States. This tragic
reminder is a powerful motivator for us all to continue to push to
achieve higher vaccination rates and prevent the loss of as many more
of our loved ones as possible.
As of July 15, about 89 percent of the U.S. population 65 years and
older, 68 percent of those 18 years and older, 65 percent of those 12
years and older, and nearly 56 percent of the total U.S. population
received at least one dose of a COVID-19 vaccine. This is good news and
demonstrative of continued progress. These gains are thanks to the
tireless efforts of professionals from across the public health,
medical, business, and multisectoral levels of government who have come
together across the country to respond to this pandemic. However,
looking state-by-state and county-by-county, it is clear that
communities where people remain unvaccinated are communities that
remain vulnerable and, in many cases, are experiencing increased
numbers of cases. Preliminary data from a collection of states over the
last several months suggest the overwhelming majority of deaths from
COVID-19 in the United States have occurred in unvaccinated people. Any
suffering or death from COVID-19 is tragic. With vaccines available
across the country, the suffering and loss are nearly entirely
avoidable.
Currently, nearly two-thirds of counties in the United States have
vaccination coverage less than 40 percent. We are seeing increasing
rates of disease in different areas across the country, primarily in
counties with low vaccination coverage. As the Delta variant continues
to spread across the country, we expect to see increased transmission
in these communities unless we can vaccinate more people. Our
authorized vaccines provide protection against the variants circulating
in this country--including Delta. Vaccination is the key to protecting
these vulnerable individuals, families, and communities and preventing
severe disease, hospitalizations, and death from COVID-19. The scale of
this unprecedented public health emergency requires unprecedented
action--at CDC, 9,300 CDC personnel have been part of our COVID-19
response, both at CDC headquarters and in the field. About 1,700 staff
have taken part in over 3,600 deployments to more than 300 locations
across the United States and around the world.
As we well know and the world has learned from this pandemic, a
public health threat anywhere is a threat everywhere. To support the
prevention of international spread, CDC is working around the world
with global partners and many low-and middle-income countries to
support the planning, implementation, and evaluation of COVID-19
vaccine programs. We will continue working to facilitate lesson sharing
across countries to increase vaccine access to all, both here and
abroad. CDC is working to ensure that public health decisions are based
on the highest-quality scientific information. Since the start of the
pandemic, over 300 COVID-19 studies have been published in the
Morbidity and Mortality Weekly Report (MMWR) on topics ranging from
health disparities exacerbated during the pandemic, to prevention
strategies, including the safety and effectiveness of COVID-19
vaccines, to emergence of new variants. CDC has also produced more than
6,000 documents to provide information and guidance for government
agencies, businesses, and the public. CDC is actively studying the
epidemiology of post-COVID conditions (often referred to as long
COVID), including the prevalence, duration, and severity of symptoms
following acute SARS-CoV-2 infection, as well as risk factors for
developing post-COVID conditions. This work will help to establish a
more complete understanding of the natural history of SARS-CoV-2
infection and post-COVID conditions, which can inform healthcare
strategies, clinical decision-making, and the public health response to
this virus that will be required over the long term. A recent MMWR
article comparing patients who have had COVID-19 with cancer
rehabilitation patients and the general adult population found that
post-COVID patients had poorer physical health, more pain, and greater
difficulty with physical activities.
CDC has provided new guidance to assist healthcare professionals in
evaluating and caring for patients with post-COVID conditions.
Recognizing and confirming the impact that post-COVID conditions can
have on quality of life is important. The goal of managing post-COVID
conditions is to help patients function in the best way possible and
improve quality of life.
Now I want to take a moment to give you a more in-depth update on
some key areas for the COVID-19 response.
Variants
COVID-19 has brought to the forefront how interconnected we are as
a global community and the importance of our international scientific
relationships.
In the fall of 2020, several SARS-CoV-2 variants emerged, some of
which appear to spread more easily than others. The emergence of
variants is, of course, concerning, and it underscores the critical
need for genomic surveillance and increased vigilance in the
implementation of public health prevention measures.
We are monitoring dozens of variants and conducting ongoing and
comprehensive risk assessments through the SARS-CoV-2 Interagency Group
comprised of CDC, the National Institutes of Health (NIH), the Food and
Drug Administration (FDA), the Biomedical Advanced Research and
Development Authority (BARDA), the United States Department of
Agriculture, and the Department of Defense. We are also in consultation
with many of our international colleagues. Of the emerging variants,
four have captured our attention and have the highest risk to public
health: B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2
(Delta).
The Alpha variant, originally identified in the United Kingdom, was
first identified in the United States in December 2020, and quickly
became the predominant variant. However, based on CDC's most recent
data, the Delta variant is now predicted to be the predominant lineage
circulating in the United States. The Delta variant was originally
detected in India and the earliest known case in the United States was
in February 2021. According to CDC's Nowcast model for the two-week
period ending July 3, the national proportion of the Delta variant is
projected to be 51.7 percent of cases, with the Alpha variant being the
second-most predominant variant at 28.7 percent. The third most
prevalent variant in the United States is the Gamma variant, with a
projected national proportion of 8.9 percent for the two-week period
ending July 3. The fourth variant of concern, Beta, is projected to be
well below 1 percent.
Available data indicate that antibodies elicited shortly after
vaccination with the currently authorized vaccines are able to
neutralize the circulating variants, although some have a reduced
neutralization against the Beta and Gamma variants in laboratory
studies. A recent study from the United Kingdom indicated that the
Pfizer vaccine was 93 percent effective at preventing symptomatic
infection with the Alpha variant and 88 percent effective at preventing
symptomatic infection with the Delta variant, and a related study
indicated that the Pfizer vaccine was greater than 95 percent effective
at preventing hospitalization when infected with either the Alpha or
Delta variants. Based on preliminary data from a Johnson & Johnson
vaccine clinical trial in South Africa where the prevalence of the Beta
variant was estimated to be 95 percent, the vaccine was 64 percent
effective in preventing infection and 81.7 percent effective in
preventing severe disease. Additional data from among healthcare
workers in South Africa vaccinated with the Johnson & Johnson vaccine
demonstrate that 94 percent of breakthrough infections are mild, in a
setting with a high prevalence of the Delta variant. Studies are
currently underway to understand the impact on the real-world
effectiveness of current vaccines against variants and to better
understand the impact of the variants on medical countermeasures.
Since January 2021, CDC has dramatically built up our domestic
genomic surveillance platforms to monitor circulating variants. While
the decline in SARS-CoV-2 cases compared to the high peak this past
winter means that the number of specimens available for sequencing has
declined, CDC continues to generate enough sequences to detect emerging
variants through the National SARS-CoV-2 Strain Surveillance (NS3)
program and contracts with commercial diagnostic laboratories.
With the funding provided by the American Rescue Plan Act, we are
further investing in public health infrastructure to strengthen genomic
sequencing and bioinformatics capacity. We have issued 29 awards,
totaling approximately $37 million, as part of the SARS-CoV-2
Sequencing for Public Health Emergency Response, Epidemiology, and
Surveillance (SPHERES) Initiative. These awards are intended to fill
knowledge gaps and promote innovation in the U.S. response to the
COVID-19 pandemic, and will help integrate next-generation genomic
sequencing technologies with bioinformatics and epidemiology expertise
across the US public health system.
On July 1, to address low vaccination coverage and increasing cases
due to spread of the Delta variant in some communities, CDC, along with
other Federal partners, intensified our efforts to help states prevent,
detect, and respond to hotspots among the unvaccinated by launching
COVID-19 Surge Response Teams. With this interagency initiative, CDC
will participate in teams at-the-ready to deploy resources and
personnel to communities at higher risk for--or already experiencing--
outbreaks due to the spread of the Delta variant and under-vaccination.
In collaboration with state, tribal, local, and territorial health
department partners, interagency teams will define the needs on the
ground and work to address these gaps. The most important step we can
take to prevent these outbreaks is for everyone eligible to get
vaccinated, and we continue to work with communities across the country
on that goal.
Health Equity
Data continue to show the disproportionate impact of COVID-19 on
racial and ethnic minority populations, as well as other population
groups such as people living in rural or frontier areas, people
experiencing homelessness, essential and frontline workers, people with
disabilities, people with substance use disorders, people who are
incarcerated, and non-U.S.-born persons.
In June 2021, CDC began providing additional resources to health
departments to address COVID-19-related health disparities and advance
health equity among populations that are underserved and facing
conditions that place them at elevated risk, including racial and
ethnic minority groups and people living in rural areas. This funding
represents an investment by CDC--$2.25 billion over 2 years--to support
communities affected by COVID-19-related health disparities. CDC's new
National Initiative to Address COVID-19 Health Disparities Among
Populations at High-Risk and Underserved Communities, Including Racial
and Ethnic Minority Populations and Rural Communities, is providing
grants to local and state public health departments to work in
partnerships with members of the affected communities to improve
testing and contact tracing capabilities; develop innovative mitigation
and prevention resources and services; improve data collection and
reporting; build, leverage, and expand infrastructure support; and
collaborate with partners to advance health equity and address social
determinants of health as they relate to COVID-19.
Community Health Workers (CHW) have a demonstrated impact in the
communities they serve yet persistent barriers have left them
underutilized in addressing health disparities. In May 2020, CDC
announced $332 million dollars in CARES Act funding for a grant program
and evaluation to support Community Health Workers for COVID Response
and Resilient Communities. The program will support the training and
deployment of CHWs to bolster response efforts and strengthen community
resilience to fight COVID-19 by addressing existing health disparities.
CHWs are well-positioned to reach communities, especially those
disproportionately impacted by COVID-19. CHW interventions can improve
uptake and access to health care services, improve communication
between community members and health providers, reduce the need for
emergency and specialty services, and improve adherence to health
recommendations.
As of May 2021, CDC has released several publications examining
vaccination rates in certain population groups to monitor disparities
and track progress toward health equity. The first study, Demographic
and Social Factors Associated with COVID-19 Vaccination Initiation
Among Adults Aged 65 Years--United States, December 14, 2020-April 10,
2021, found that after the first 3.5 months of the U.S. COVID-19
vaccination program, 79.1 percent of adults aged 65 years had received
1 dose, with higher vaccination initiation among men. Counties with
lower vaccination initiation rates had higher percentages of older
adults with social vulnerabilities. The second study, Disparities in
COVID-19 Vaccination Coverage Between Urban and Rural Counties--United
States, December 14, 2020-April 10, 2021, found that COVID-19
vaccination coverage was lower in rural counties (38.9 percent) than in
urban counties (45.7 percent) and that disparities persisted among age
groups and by sex. A third study, Patterns in COVID-19 Vaccination
Coverage, by Social Vulnerability and Urbanicity--United States,
December 14, 2020-May 1, 2021, found disparities in county-level
vaccination coverage by social vulnerability have increased as vaccine
eligibility has expanded, especially in large fringe metropolitan
(areas surrounding large cities, e.g., suburban) and nonmetropolitan
counties. By May 1, 2021, vaccination coverage among adults was lower
among those living in counties with lower socioeconomic status and with
higher percentages of households with children, single parents, and
persons with disabilities.
Collectively, these findings highlight the need to continue
monitoring demographic and social factors affecting COVID-19 vaccine
access; to prioritize efforts to ensure equitable access to COVID-19
vaccine; to tailor public health messaging for local populations and
counties with high social vulnerability; and the need for public health
practitioners to collaborate with health care providers, pharmacies,
employers, faith leaders, and other community partners to identify and
address barriers to COVID-19 vaccination in rural areas.
While these data indicate additional work that lies ahead to
achieve greater vaccination rates in certain population groups, we know
there are communities that have been successful in their vaccination
efforts. In June 2021, as part of the National Month of Action, CDC
hosted a webinar as a call to action to increase the number of
vaccinated people in Black or African American and Hispanic or Latino
communities. The webinar highlighted organizations that have conducted
successful mass vaccination activities for Black or African American
and Hispanic or Latino people. These organizations shared their
successes, challenges, and strategies used to increase vaccine
education, awareness, and uptake with the nearly 500 participants from
public health, healthcare, clinical, and community organization
leadership. This effort is part of CDC's ongoing work to share best
practices around the country to help all communities achieve the
highest rates of vaccination possible.
To assist decision-makers and researchers, CDC also launched a
Health Equity page on our COVID Data Tracker. The page catalogs current
health equity-related data that align with populations and place-based
focus groups identified in CDC's COVID-19 Response Health Equity
Strategy.
Vaccines
Vaccination is a critical tool in bringing this unprecedented
pandemic to an end. As of May 10, every person aged 12 and over in
every state and territory is eligible to get vaccinated. CDC has
continued to improve accessibility by increasing distribution of
vaccines to medical offices. We have increased the number of medical
practices receiving vaccine by nearly 85 percent since early April and
now have over 10,000 medical practices served by primary care doctors,
administering vaccine alongside other routine medical care. The country
exceeded President Biden's goal of administering 200 million shots in
the first 100 days of his Administration. A CDC study \1\ reviewing
data from 2 months of early vaccinations among health care personnel
found that both Moderna and Pfizer vaccines were 94 percent effective
in preventing symptomatic SARS-CoV-2 infection, seven or more days
after the second dose. In addition, another CDC study \2\ found these
two vaccines were 94 percent effective against hospitalization among
fully vaccinated adults aged 65 years and older. These findings
demonstrate the high, real-world effectiveness of these vaccines.
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\1\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e2.htm's-
cid=mm7020e2-w.
\2\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm's-
cid=mm7018e1-w.
CDC will continue working with partners to monitor how well COVID-
19 vaccines work in real-word conditions through multiple studies
looking at vaccine effectiveness in various populations, locations, and
settings. Through these studies, CDC can obtain more representative,
scientifically valid, and complete information about vaccine
---------------------------------------------------------------------------
effectiveness, including factors associated with vaccine breakthrough.
Vaccinations are highly effective against severe disease including
hospitalizations and death, thus protecting even the limited number of
people who are vaccinated but still get COVID-19. A recent analysis led
by CDC published in the New England Journal of Medicine found that mRNA
COVID-19 vaccines show secondary benefits of vaccination for people who
were fully or partially vaccinated and still got COVID-19. Secondary
benefits included having shorter and milder illness and potentially
being less likely to spread the virus to others compared to
unvaccinated people with COVID-19.
COVID-19 vaccine safety is a top priority for the Federal
Government, and we take all reports of health problems following COVID-
19 vaccination seriously. Since April 2021, increased cases of
inflammation of the heart muscle, called myocarditis, or outer lining,
called pericarditis,--have been reported in the U.S. following mRNA
COVID-19 vaccination (Pfizer or Moderna). This is a rare condition and
reported cases have occurred predominantly in male adolescents and
young adults. Following a thorough safety review and meeting of CDC's
Advisory Committee on Immunization Practices, which found the benefits
of mRNA vaccination greatly outweighed the risks, CDC continues to
recommend COVID-19 vaccination for everyone 12 years of age and older,
given the risk of COVID-19 illness and related, possibly severe
complications. FDA and CDC also conducted extensive outreach to
providers and clinicians to ensure they were made aware of the
potential for these adverse events.
CDC and FDA are monitoring reports of Guillain-Barre Syndrome (GBS)
after receiving Johnson & Johnson's Janssen (J&J/Janssen) COVID-19
Vaccine. GBS is a neurological disorder in which the body's immune
system damages nerve cells, causing muscle weakness or in the most
severe cases paralysis. Reports of GBS after receipt of the J&J/Janssen
COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS)
are rare, but do likely indicate a small possible risk of this side
effect following this vaccine. Around 100 preliminary reports of GBS,
mostly in males, many aged 50 years and older, have been detected in
VAERS after 12.8 million doses of J&J/Janssen COVID-19 Vaccine
administered. Available data do not show a similar pattern with mRNA
vaccines (Pfizer-BioNTech and Moderna). On July 13, the FDA updated the
label of the Johnson & Johnson vaccine to add a new warning suggesting
an increased risk of Guillain-Barre Syndrome within 42 days following
vaccination. This issue will be discussed as part of an upcoming
meeting of CDC's Advisory Committee on Immunization Practices (ACIP)
later in July. The detection of rare complications, such as
myocarditis, thrombosis-thrombocytopenia syndrome (a rare and severe
type of blood clot), and GBS, is an important validation of the
sensitivity of vaccine safety monitoring systems to be able to pick up
even very small numbers of potential vaccine safety concerns.
Building on long-standing relationships with state and local
partners, CDC has worked tirelessly to ensure that we are getting
vaccines to people as quickly, safely, and equitably as possible. As of
July 16, 2021, about 389 million doses have been delivered, and more
than 336 million doses of COVID-19 vaccine have been administered.
About 79 percent of all Americans age 65 years and older were fully
vaccinated by this date, and about 68 percent of adult Americans had
received at least one vaccine. This is a whole-of-society effort, and
it is inspiring to see people across government, business, and
communities coming together to complete this important lifesaving task.
Strong confidence in vaccines within communities leads to more
people getting vaccinated, and to fewer COVID-19 illnesses,
hospitalizations, and deaths. CDC is working in coordination with
national, state, tribal, local, and territorial governmental and non-
governmental partners to build trust in the vaccine, the vaccinator,
and the vaccination system. We will continue to work with these
critical partners to address barriers to vaccinations, including in
communities of color and disproportionally affected groups. It is
important that we continually deliver the message that vaccines are
rigorously studied during clinical trials, and there is a vast network
of safety systems that monitor vaccines once they are in use and safety
protocols to monitor people when they receive the vaccine. In order to
address vaccine hesitancy, it is crucial to provide accurate scientific
messaging across all sectors and multiple platforms, using creative
communications approaches such as enlisting trusted community members
to help address concerns over COVID-19 vaccines. Listening to, and
patiently addressing concerns, including on an individual basis, is a
vital method that should be used to build confidence in vaccines.
Further supporting efforts to prioritize equity in our vaccine
strategy, in early April CDC awarded $3.15 billion directly to states,
territories, and some large cities to support local efforts to increase
vaccine access, uptake, and equity. The funding focused on reaching
communities hit hardest by the pandemic, including those with a high
Social Vulnerability Index, minority communities, and rural areas.
In order to enhance vaccine uptake among underserved communities of
color and to build trust and confidence in the authorized COVID-19
vaccines, CDC has developed a comprehensive program of approximately 20
national organizations that support hundreds of local and community-
based organizations to improve both COVID-19 and influenza vaccination
coverage among racial and ethnic groups who have historically had, and
continue to experience, health disparities. Jurisdictions are also
encouraged to consider factors such as the Social Vulnerability Index
and current administration rates in local communities when reaching out
to enroll providers. Guidance was disseminated to jurisdictions on
increasing the proportion of vaccines allocated to providers who are
located in socially vulnerable communities. In July, CDC added a new
Vaccination Equity tab to display Social Vulnerability Index and
vaccination coverage maps to the COVID Data Tracker. Improving access
to underserved communities and populations that have historically
experienced greater barriers to healthcare access is another critical
component to prioritizing equity in vaccine distribution. Improving
access also requires a multi-pronged approach. For example, CDC
partners with the Health Resources and Services Administration (HRSA)
to provide COVID-19 vaccinations and technical assistance to interested
HRSA-funded health centers, with the goal of bringing vaccines to
communities and improving access for populations disproportionately
impacted by COVID-19. As of June 29, roughly 7 million doses had been
distributed to 2,200 HRSA-funded health centers across the Nation.
The Federal Retail Pharmacy Program is integral to the work CDC is
doing to maximize access to COVID-19 vaccines in all communities,
including communities of color and other underserved populations, such
as rural communities. CDC partnered with 21 national pharmacy
organizations and independent pharmacy networks that represent over
40,000 locations nationwide--to ensure that the public has access to
COVID-19 vaccines in a familiar setting. Almost 90 percent of Americans
live within five miles of a retail pharmacy. These pharmacies continue
to reach out to communities, administering almost 3 million doses at
nearly 10,000 mobile pop-up clinics, with 58 percent of people
vaccinated by pharmacies in the last 2 weeks of June being in a
minority group.
On May 13th, CDC released new guidance for fully vaccinated people,
which said that, anyone who is fully vaccinated can resume activities--
indoor or outdoor--safely without a mask or physical distancing, except
where required by Federal, state, local, tribal, or territorial laws,
rules and regulations, including local business and workplace guidance.
This decision was based on three major scientific developments: (1) Our
vaccines working in the real world, with studies showing them to be >90
percent effective in the real-world settings in preventing mild and
severe disease, hospitalization, and death, (2) Our vaccines proving to
be effective against the SARS-CoV-2 variants currently circulating in
the country, and (3) Research showing that if you are vaccinated, you
are less likely to spread the virus. A growing body of evidence
suggests that fully vaccinated people are less likely to have
asymptomatic infection and to be able to transmit SARS-CoV-2 to others.
While we hope this was encouraging news for the country, we must remain
vigilant in our efforts to continue increasing vaccination if we want
to continue returning to normal. At this time, CDC sees no need to
change our fully vaccinated guidance; however we will continue to
monitor all indicators and data closely.
Schools
Since becoming the director of CDC, I have stressed the importance
of getting children back to school for in-person learning. The safest
way to open schools is to ensure that there is as little disease as
possible in the community. With the widespread availability of safe and
effective vaccines, we have seen reductions in COVID-19 cases,
hospitalizations, and deaths. If vaccination rates continue to increase
and community transmission rates decrease, the risk in schools is
expected to decrease as well.
CDC began working on guidance, resources, and tools for safe school
reopening in March 2020 when the first schools closed. As CDC learned
more about COVID-19, we continually updated our guidance, resources,
and tools for schools, parents, teachers, and other staff. Earlier this
month, CDC released updated guidance to help prevent the spread of
COVID-19 and safeguard in-person learning. CDC's Guidance for COVID-19
Prevention in K-12 Schools is now updated to reflect the latest science
on COVID-19, lessons learned from schools implementing COVID-19
prevention strategies, and the widespread availability of safe and
effective COVID-19 vaccines for those aged 12 years and older. Reports
suggest that limited in--person instruction during the pandemic may
have had a negative effect on learning for children and on the mental
and emotional well-being of both parents and children. In addition,
many K-12 schools globally implemented layered COVID-19 prevention
strategies during the 2020-2021 academic year. These schools'
experiences contributed to our knowledge of the nature of SARS-CoV-2
transmission in schools and informed updates to the K-12 guidance,
which emphasizes the importance of offering in-person learning in K-12
schools.
CDC recommends schools implement layered prevention strategies to
protect people who are not fully vaccinated, including students,
teachers, staff, and other members of their households. These
strategies include vaccination for children and adults ages 12 and up,
the correct use of masks, physical distancing, handwashing and
respiratory etiquette, cleaning and maintaining healthy facilities
(including proper ventilation), and contact tracing, in combination
with screening testing, isolation, and quarantine for those exposed and
not vaccinated. The guidance emphasizes the need for localities to
monitor community transmission, vaccination coverage, screening
testing, and occurrence of outbreaks to guide decisions on the level of
layered prevention strategies.
Mask use and physical distancing are two key prevention strategies
for reducing SARS-CoV-2 transmission, but a layered approach that uses
several strategies will provide the greatest level of protection.
Schools where not everyone is fully vaccinated should implement
physical distancing to the extent possible within their structures, in
addition to masking and other prevention strategies. If it is not
possible to maintain adequate physical distancing, it is especially
important that schools layer multiple other prevention strategies, such
as masking and screening testing, to help ensure that no students need
be excluded from in-person learning.
In April, CDC provided $10 billion to states and jurisdictions to
support COVID-19 screening testing for K-12 teachers, staff, and
students to assist schools in reopening safely for in-person
instruction. In May, CDC also awarded $500 million to jurisdictions to
expand the school-based public health workforce, including nurses and
other health personnel. Combined, we believe these resources will
provide substantial help to schools around the Nation as they open in
the fall.
SARS-CoV-2 is still a relatively new pathogen, and we are learning
more about it and how it impacts different people and communities all
the time. CDC's Guidance for COVID-19 Prevention in K-12 Schools
presents recommendations based on the best-available evidence at the
time of release. As science and data on SARS-CoV-2 and COVID-19
continue to evolve, we will update our guidance and recommendations to
reflect new evidence. CDC stands committed to providing the best, most
current data and scientific understanding available to protect the
health, safety, and well-being of our communities, including our
students, teachers, and school staff.
Conclusion
In closing, I want to emphasize that with increased vaccinations
nationwide, we can look forward to seeing more kids in school, more
families able to connect with one another safely, and our Nation
beginning to move forward and heal. But we have to ensure that we are
stamping out COVID-19 in all communities, not just some communities. We
cannot risk only keeping parts of the U.S. moving forward safely while
other parts of the country continue to see tragic numbers of cases and
deaths from COVID-19. This will require sustained efforts from all
stakeholders and across all levels of government and most importantly
individuals making the decision to get vaccinated to protect
themselves, their loved ones, and their communities.
We also must address the long-standing vulnerabilities in our
public health system and the conditions that led to disproportionate
burden of COVID-19 illness and death in some communities. The Fiscal
Year 2022 President's Budget Request includes an increase of nearly
$1.7 billion for CDC to invest across the public health system. This is
an important first step in building back a better public health system
that can deliver health security to all Americans.
______
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. Thank you very much, Madam Chair, Ranking Member
Burr, Members of the Committee. Thank you for giving me the
opportunity to discuss with you again the role of the National
Institute of Allergy and Infectious Diseases in the research
response addressing COVID-19. As I have mentioned to this
Committee on prior hearings, the strategic plan for research
for NIAID involves research on fundamental basic knowledge
regarding the virus to development of diagnostics,
therapeutics, and vaccines.
For the purposes of today's discussion and my presentation,
I would like to focus on three vaccines that you know have been
approved through the emergency use authorization for use in the
United States, and that is the two mRNA vaccines from Pfizer,
Biogenetic, and Moderna, and the J&J vaccine, which is a human
adenovirus vector vaccine. As I mentioned to this Committee on
prior hearings, the clinical trials that proved the
extraordinary efficaciousness of these vaccines to the tune of
93 and 94 percent are very, very clear right now.
What I would like to emphasize today is what has transpired
since the last hearing, and that is the accumulation of data on
the real world effectiveness of these vaccines. In a situation
we are confronted with a historic pandemic. And that is seen
not only in the United States, but also in the UK in the form
of England and Scotland, in Israel, Qatar, and other places.
When one looks at the data, and one good example is the
cohort study from Israel in which the mRNA vaccine used in that
population was highly effective in the real world beyond the
clinical trial, including among asymptomatic, early symptomatic
advanced disease, intensive care, and even deaths, and if one
looked across the cohort, you saw that it was effective in
essentially every age group from young individuals, middle
aged, and even the elderly. That is the good news. The sobering
news that you have already heard of is the fact that we are now
challenged with a very difficult and problematic variant
referred to as the delta variant. It has now been detected in
at least 90 plus countries throughout the world.
The reason it is so formidable is the fact that it has the
capability of transmitting efficiently from human to human in
an extraordinary manner, well beyond any of the other variants
that we have experienced up to now, which has led to its
becoming the dominant variant in this country. When I spoke to
you last time, it was about 1 to 3 percent of the variance in
the population. Right now it has gone to over 80 percent, and
in some regions of the country, as high as 90 percent. That is
the troubling news.
The fact is that, however, and the importance of
vaccination is that our vaccines that we are using in this
country are very effective against this variant, particularly,
I point out, to the situation regarding advanced disease
leading to hospitalizations and deaths where it is still well
in the 90 percent of effectiveness. I would like to close with
just one or two comments that we have been hearing about
regarding the situation of booster or an additional third dose
superimposed upon the double doses of the mRNA and the single
dose of the J&J.
Right now, we are doing studies to determine whether or not
we will need boosters to increase the durability of protection.
We don't want people to believe that when you are talking about
boosters, that means that the vaccines are not effective. They
are highly effective. We are talking about the durability of
that. And we are doing studies now to determine that.
In addition, there are individuals who are
immunosuppressed, people who are on cancer, chemotherapy, a
variety of other individuals, transplant individuals who may
actually need a boost as part of their initial regimen in the
sense of getting them up to the point where they are protected.
So in closing, I want to underscore what Dr. Walensky just said
a few moments ago, the extraordinary importance of getting as
many people vaccinated as we possibly can.
We have the tools to end this epidemic. It is up to us to
utilize those tools to the maximum. Thank you very much, Madam
Chair.
[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 pandemic.
COVID-19 is a once-in-a-lifetime global infectious disease pandemic
requiring an unprecedented public-private research effort. NIAID plays
a central and important role in the public health response to COVID-19.
NIAID has capitalized on decades of investment in fundamental basic
research, including groundbreaking structure-based vaccine design at
the NIAID Vaccine Research Center (VRC); engaged domestic and
international research infrastructure; and leveraged highly productive
partnerships with industry and longstanding relationships with
community partners. NIAID utilized its existing domestic and
international clinical trials infrastructure, originally established to
conduct research on HIV and influenza, and worked with partners in the
public and private sectors to establish the COVID-19 Prevention Network
(CoVPN). The CoVPN has supported multiple COVID-19 vaccine candidates
to progress in record time from concept to authorization for emergency
use by the U.S. Food and Drug Administration (FDA). NIAID also has
built on its longstanding relationships with community partners to
successfully conduct these crucial clinical trials. NIAID initiated
clinical trials with creative and adaptive designs, allowing the
evaluation of multiple new and existing therapeutics for use against
COVID-19. Several of these trials provided evidence of safety and
efficacy of COVID-19 therapeutics and helped support authorization by
the FDA.
These successes have helped slow the progression of the pandemic in
the United States. Currently, more than 67 percent of U.S. adults have
received at least one dose of a COVID-19 vaccine, and we must continue
to vaccinate as many people as we can, as quickly as possible. FDA-
authorized COVID-19 vaccines meet FDA's rigorous standards for safety
and efficacy. The high levels of vaccine efficacy observed in the
carefully controlled conditions of clinical trials have been
subsequently confirmed by their effectiveness in studies of vaccines
administered to broad segments of the public in the United States and
other countries. Vaccination and adherence to public health measures
are the proven interventions that will be particularly important as we
work to address the SARS-CoV-2 Delta (or B.1.617.2) variant and other
variants with increased transmissibility or pathogenicity that may
emerge.
While we are cautiously optimistic about the future, we know that
many challenges remain. One of the most concerning developments of the
ongoing pandemic is the spread of variants of SARS-CoV-2 such as the
Delta (B.1.617.2) variant. So far, scientific evidence suggests that
the COVID-19 vaccines distributed in the United States under FDA
Emergency Use Authorizations (EUA) continue to be effective against
severe disease caused by these variants, but we must remain vigilant.
NIAID is rapidly conducting research to better understand these
emerging variants, how they interact with the immune system, and their
implications for COVID-19 therapeutic and vaccine formulations.
We also know that our fellow Americans in underserved and minority
communities have been disproportionally affected by this pandemic.
NIAID is committed to continuing to work directly with these
communities and partnering with other agencies in the Federal
Government, and with industry and academia to ensure that nobody in
vulnerable communities is left behind as we move forward toward
defeating the COVID-19 pandemic. NIAID also recognizes that while many
individuals with SARS-CoV-2 infection fully recover after a relatively
short time period, some individuals suffer longer-term effects after
the initial phase of illness. NIAID is supporting collaborative efforts
to study COVID-19 outcomes in patients across all ages, genders, and
co-morbid conditions. These studies include people who experienced a
broad range of COVID-19 disease severity so we can identify and
characterize post-acute sequelae of SARS-CoV-2 infection (PASC) and
develop effective strategies to address them.
Developing Vaccines and Monoclonal Antibodies to Prevent COVID-19
Sustained research investments by NIAID in the years 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 key finding 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 for coronaviruses led to the development of safe and effective
COVID-19 vaccine candidates across a range of vaccine platforms.
Six candidate COVID-19 vaccines have been or are in the process of
being assessed in large-scale Phase 3 clinical trials in the United
States thus far, and three have received EUAs from the FDA. Clinical
trials to test COVID-19 vaccine candidates in pediatric populations are
ongoing. On December 11, 2020, based on data from a Pfizer-supported
Phase 3 clinical trial, an investigational vaccine developed by Pfizer
and BioNTech became the first to receive an EUA from the FDA for the
prevention of COVID-19. This vaccine is now authorized for emergency
use in individuals 12 years of age and older. NIAID has helped to
advance five additional COVID-19 vaccine candidates through support for
research on the foundational biology underlying the vaccine concepts,
as well as for clinical testing through the CoVPN. Two of these vaccine
candidates, those from Moderna, Inc., and Johnson & Johnson/Janssen,
have received EUAs.
Utilizing the CoVPN, NIAID is participating in the implementation
of harmonized protocols to test investigational vaccines and preventive
interventions against SARS-CoV-2. These protocols were developed in
collaboration with the Accelerating COVID-19 Therapeutic Interventions
and Vaccines (ACTIV) public-private partnership, vaccine manufacturers,
and the Biomedical Advanced Research and Development Authority (BARDA).
NIAID also supports the underlying critical infrastructure for these
clinical trials, such as a common Data and Safety Monitoring Board
(DSMB), an independent group that periodically reviews data from the
ongoing trials to ensure the safety of study volunteers and to
determine whether efficacy has been achieved. The CoVPN has enrolled
tens of thousands of volunteers across the United States and
internationally in clinical trials testing multiple investigational
vaccines and monoclonal antibodies intended to protect people from
COVID-19. The CoVPN also has developed an extensive community
engagement framework to reach out to the underserved and minority
communities disproportionally affected by COVID-19; to better
understand their interest in, and concerns about, research
participation; and to partner with them to ensure that their vital
input is reflected in the conduct of these clinical studies.
To further address the critical challenges of participation in
clinical trials as well as vaccine acceptance and vaccine hesitancy,
NIH established the Community Engagement Alliance Against COVID-19
Disparities (CEAL) initiative, led by the National Heart, Lung, and
Blood Institute (NHLBI) and the National Institute on Minority Health
and Health Disparities. CEAL brings together trusted community leaders
to serve as champions who share information about the importance of
participating in COVID-19 research and communicate data on the safety
and efficacy of authorized COVID-19 vaccines.
mRNA-1273 (Moderna)
As part of a longstanding collaboration, the NIAID VRC worked 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. Early
clinical trials demonstrated that mRNA-1273 was generally well
tolerated and induced robust immune responses in healthy adults. NIAID
and BARDA then began working with Moderna on a Phase 3 clinical trial
through the CoVPN that showed that mRNA-1273 was 94.1 percent
efficacious in preventing symptomatic COVID-19. On December 18, 2020,
after a thorough review of comprehensive data on mRNA-1273, the FDA
issued an EUA for the mRNA-1273 vaccine for prevention of COVID-19 in
individuals 18 years of age and older. In subsequent observational
studies under ``real-world'' conditions in broader segments of the
population, mRNA-based vaccines continue to display high levels of
effectiveness. For example, in an article published in Morbidity and
Mortality Weekly Report (MMWR), Centers for Disease Control and
Prevention (CDC) researchers and their collaborators showed that among
health care personnel, first responders, and other essential workers,
the mRNA-1273 and the Pfizer-BioNTech mRNA vaccine were 90 percent
effective against SARS-CoV-2 infections 14 or more days after receiving
a second dose. Other MMWR articles reported that these vaccines were 94
percent effective at preventing symptomatic COVID-19 among health care
personnel and reduced the risk of COVID-19 hospitalization by 94
percent among people 65 years of age and older. Recently, NIAID
scientists and their collaborators demonstrated that anti-SARS-CoV-2
antibodies persist for at least 6 months after the second dose of mRNA-
1273. On June 26, 2021, FDA updated the EUAs for the Moderna and Pfizer
COVID-19 vaccines to include information on the potential risks of
myocarditis and pericarditis, particularly following the second dose.
According to CDC, reports of myocarditis and pericarditis following
vaccination with mRNA COVID-19 vaccines are rare. Most patients who
received care have responded well to treatment and rest, and patients
usually can return to their normal daily activities after their
symptoms improve. Given the significant potential health risk of COVID-
19, the CDC continues to recommend that individuals ages 12 and older
be vaccinated with the relevant FDA-authorized COVID-19 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, known as Ad26.COV2.S or JNJ-78436735. NIAID is
supporting a Phase 3 clinical trial of Ad26.COV2.S through the CoVPN
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
effective overall at preventing moderate to severe/critical COVID-19
occurring at least 28 days after vaccination and 85 percent effective
overall in preventing severe/critical COVID-19 in the Phase 3 trial
across several geographical regions, including areas where emerging
viral variants predominate. In the United States, the efficacy against
moderate to severe/critical disease 28 days after vaccination with
Ad26.COV2.S was 72 percent. On February 27, 2021, the FDA issued an EUA
for Ad26.COV2.S for prevention of COVID-19 in individuals 18 years of
age and older. On April 13, 2021, out of an abundance of caution, the
FDA and CDC released a joint statement recommending a pause in the use
of Ad26.COV2.S in order to review extremely rare case reports of blood
clots in combination with low blood platelets after vaccine
administration. Medical and scientific teams at the FDA and CDC found
that available data suggest that the chance of this serious adverse
event occurring is very low. Following their thorough safety review--
and in accordance with recommendations from the CDC's Advisory
Committee on Immunization Practices--the FDA and CDC lifted the
recommended pause on the use of Ad26.COV2.S on April 23, 2021. On July
12, 2021, FDA announced revisions to the vaccine recipient and
caregivers and vaccination providers fact sheets for the Johnson &
Johnson/Janssen COVID-19 vaccine regarding a suggested increased risk
of Guillain-Barre syndrome during the 42 days following vaccination.
The chance of this occurring following vaccination appears to be very
low.
Other COVID-19 Vaccine Candidates
NIAID, through the CoVPN, is supporting Phase 3 clinical trials of
COVID-19 vaccine candidates from AstraZeneca (AZD1222) and Novavax
(NVX-CoV2373). AstraZeneca's AZD1222 COVID-19 vaccine candidate uses a
chimpanzee adenovirus-vectored vaccine approach developed by
researchers at the University of Oxford in collaboration with
scientists at NIAID's Rocky Mountain Laboratories. On March 25, 2021,
AstraZeneca announced an updated interim analysis of AZD1222 reporting
that the vaccine candidate was 76 percent effective at preventing
symptomatic COVID-19, including 85 percent effective in participants
aged 65 years and over. Importantly, the efficacy of AZD1222 against
severe COVID-19 disease was reported to be 100 percent. Novavax's NVX-
CoV2373 COVID-19 vaccine candidate uses a protein nanoparticle vaccine
approach. On June 14, 2021, Novavax announced that NVX-CoV2373
demonstrated 90.4 percent efficacy in preventing symptomatic COVID-19
and 100 percent protection against moderate and severe disease. In
addition, the company reported that NVX-CoV2373 showed 91 percent
efficacy in preventing symptomatic COVID-19 in people 65 years or
older, as well as those with certain comorbidities or those who were
identified as being likely to experience regular exposure to SARS-CoV-
2. FDA has not yet authorized either of these vaccine candidates.
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, children, and people
with immune deficiencies. More than 130,000 pregnant and lactating
women already have received the COVID-19 vaccines under FDA EUAs, and
early data are promising. These data do not demonstrate any safety
concerns for women who are pregnant 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. On March 16, 2021, Moderna, in
collaboration with NIAID and BARDA, announced the launch of KidCOVE, a
Phase 2/3 study 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. On May 10, 2021, the FDA expanded the EUA for
Pfizer's COVID-19 vaccine to include adolescents ages 12 to 15 years of
age, and Pfizer also is evaluating their vaccine candidate in younger
individuals. Other vaccine developers also have begun, or are planning
to begin, trials to test their vaccine candidates in children,
adolescents, and other special populations. 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
decision-making about COVID-19 vaccination in people with immune
deficiencies and dysregulation conditions.
Monoclonal Antibodies to Prevent COVID-19
NIAID, collaborating with Regeneron Pharmaceuticals and Eli Lilly
and Company, also initiated two Phase 3 clinical trials to evaluate
whether their investigational monoclonal antibodies, REGEN-COV and
bamlanivimab respectively, can prevent infection or symptomatic disease
in people at high risk of exposure due to their living or working
conditions. Regeneron reported in a preprint publication that REGEN-COV
prevented symptomatic and asymptomatic infection in household contacts
of individuals who had recently tested positive for SARS-CoV-2.
Bamlanivimab also was reported to prevent symptomatic and asymptomatic
infection in residents and staff of skilled nursing and assisted living
facilities, and these findings were published in the Journal of the
American Medical Association. FDA has not yet authorized the use of
either of these drugs for prevention of COVID-19. Clinical trials to
test the safety and efficacy of monoclonal antibody therapies for the
treatment of COVID-19 are being tested through the ACTIV partnership,
and these are discussed below.
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.
The Adaptive COVID-19 Treatment Trial
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. ACTT-3 currently
is evaluating treatment of hospitalized COVID-19 patients with
remdesivir plus interferon beta-1a, which is used to treat individuals
with multiple sclerosis. ACTT-4, a study assessing baricitinib plus
remdesivir versus the glucocorticoid dexamethasone plus remdesivir in
adults hospitalized with COVID-19, has closed to enrollment because the
study met pre-defined futility criteria.
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. The two studies, 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 since been
expanded to evaluate two combination monoclonal antibody therapies--
BRII-196 plus BRII-198 and BMS-986414 plus BMS-986413--as well as four
additional investigational therapeutics: SAB-185, a fully human
polyclonal antibody produced in cattle; SNG001, an inhalable beta
interferon; and AZD7442, an investigational long-acting monoclonal
antibody combination. Camostat mesilate, an orally administered drug
that may block SARS-CoV-2 from entering cells, was evaluated but
ultimately not included in ACTIV-2 efficacy studies, as it failed to
induce early changes in viral shedding or improvement in symptoms.
ACTIV-3 currently is evaluating the AZD7442 monoclonal antibody
combination, as well as the small molecule ensovibep, in hospitalized
patients. Ensovibep binds to several sites on the SARS-CoV-2 spike
protein, which may inhibit the virus's ability to infect human cells.
On April 22, 2021, NIAID and 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 in its fact
sheets for health care providers for each of these therapies. NIAID-
supported scientists and collaborators are evaluating the potential
impact of emerging SARS-CoV-2 variants on the efficacy of monoclonal
antibodies.
Additional NIAID-Supported Therapeutics Activities
On April 13, 2021, NIAID announced the launch of the COVID-19 anti-
CD14 Treatment Trial (CaTT) to evaluate the use of a monoclonal
antibody known as IC14 in adults hospitalized with COVID-19. IC14 works
by binding to and blocking a human protein called CD14 that is
associated with the development of severe inflammatory reactions in
some COVID-19 patients. In addition, NIAID completed a Phase 3 trial
called, ``Inpatient Treatment with Anti-Coronavirus Immunoglobulin,''
or ITAC, to evaluate hyperimmune intravenous immunoglobulin (hIVIG) for
treatment of COVID-19 in hospitalized adults. The study demonstrated
that hIVIG plus remdesivir was not superior to remdesivir alone.
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 therapies to a
common control arm to identify treatments with relatively large effects
as promising candidates for further study in large-scale trials. BET
initially is evaluating two therapeutics: risankizumab, an
immunomodulatory monoclonal antibody developed by Boehringer Ingelheim
and AbbVie, which is FDA-approved for the treatment of severe plaque
psoriasis; and lenzilumab, an investigational immunomodulatory
monoclonal antibody developed by Humanigen.
NIH recently launched the Antiviral Program for Pandemics, a
collaboration between NIH and BARDA that aims to develop safe and
effective antivirals to treat and prevent SARS-CoV-2 infection. The
program also 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 initially target coronaviruses, and then could be expanded to
other viruses with pandemic potential--helping to better prepare the
Nation for future viral threats.
The 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 also address considerations for 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 nine
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.
Responding to Emerging Variants of SARS-CoV-2
NIAID is fully engaged in efforts to mitigate the potential impact
of emerging variants of SARS-CoV-2. NIH, including NIAID, participates
in the HHS-established SARS-CoV-2 Interagency Group, along with CDC,
FDA, BARDA, the Department of Defense (DOD), and the U.S. Department of
Agriculture to address the potential impact of emerging variants on
critical SARS-CoV-2 countermeasures. NIH, CDC, and DOD are assessing
whether vaccine-induced immunity, or natural immunity from prior
infection, can be effective in combating the variants. NIH, BARDA, and
DOD also are determining the efficacy of certain authorized
therapeutics against emerging variants in cell lines in vitro and in
animal models.
NIAID is collaborating with vaccine manufacturers on key areas of
research to investigate whether vaccines designed for the original
strain of SARS-CoV-2 can maintain efficacy against emerging variants.
NIAID also is conducting and supporting comprehensive studies to
understand the ability of vaccine-induced antibodies to neutralize the
variant viruses. NIAID researchers have analyzed the immune responses
of individuals who recovered from COVID-19 prior to the emergence of
variants and demonstrated that their T cells--a key component of the
immune response to SARS-CoV-2--also were capable of recognizing the
three most widespread SARS-CoV-2 variants at the time, Alpha (also
known as B.1.1.7), Beta (B.1.351), and Gamma (P1). These findings,
published in Open Forum Infectious Diseases, shed new light on the role
of T cells in the development of immunity to SARS-CoV-2 and suggest
that these cells also may help protect against emerging variants of
concern. 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.
NIAID also plans to test new vaccine formulations that may protect
against certain variants that show early indications of reduced
sensitivity to existing countermeasures. On March 31, 2021, NIAID
launched a Phase 1 clinical trial of an investigational Moderna vaccine
based on its FDA-authorized COVID-19 vaccine, designed specifically to
target the Beta (B.1.351) SARS-CoV-2 variant first detected in South
Africa. NIAID and Moderna are evaluating this vaccine candidate as a
precautionary measure as we gain more data to confirm that current
vaccines provide an adequate degree of protection against currently
circulating SARS-CoV-2 variants. In addition, NIAID is leading a study
in fully vaccinated individuals to determine the safety and efficacy of
boosting with a COVID-19 vaccine different than the one used for the
initial vaccination. The results of this trial are intended to inform
public health policy decisions on the potential use of mixed vaccine
schedules should booster doses be needed.
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. NIAID scientists are
helping to inform our understanding of transmissibility of the variants
by studying their stability in the environment of infected individuals
and their ability to grow in human lung cells. These efforts add to a
growing body of knowledge about SARS-CoV-2 variants and our ability to
combat them.
Understanding the Immunology 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 is working with partners to delineate biological and immune
pathways responsible for the varied manifestations of COVID-19. NIAID
also will examine the quality and durability of the immune response to
SARS-CoV-2; this information may be leveraged to develop novel SARS-
CoV-2 therapeutics or vaccines and inform public health measures.
NIAID, along with FDA, is supporting a National Cancer Institute
(NCI) effort to determine the sensitivity and specificity of certain
SARS-CoV-2 serological tests, which can detect antibodies indicative of
a prior exposure to SARS-CoV-2. NCI and NIAID also are working to
establish a collaborative network to increase national capacity for
high-quality serological testing with rapid return-of-results to
subjects. These efforts include the use of serological testing to
support clinical trials of convalescent serum and the establishment of
registries for seroprotection studies.
Early in the pandemic, the intramural research programs of NIAID,
NCI, 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 in the
United States during the spring and summer of 2020 may have far
exceeded the number of cases medically diagnosed. Extrapolating from
analyses of blood samples from people who did not have a previously
diagnosed SARS-CoV-2 infection, along with socioeconomic, health, and
demographic data, the researchers estimate that there may have been an
additional 16.8 million undiagnosed SARS-CoV-2 infections through mid-
July 2020. Continued analysis of the one-year follow-up data from the
study will be very 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 aim to discover genetic factors conferring
resistance to SARS-CoV-2 infection or predisposing to severe COVID-19
disease. The consortium has identified a subgroup of patients with
severe COVID-19 that have ineffective immune responses to SARS-CoV-2,
some of whom have identifiable mutations in key immune pathways. NIAID
also supports 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
hosted a virtual workshop on MIS-C with scientists and clinicians from
academia, NIH, FDA, and industry, and a report of the workshop
recommendations was published on November 2, 2020. NIAID also 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.
Monitoring 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. In December
2020, NIAID hosted a Workshop on Post-Acute Sequelae of COVID-19 with
clinicians, immunologists, virologists, and members of the patient
community to present existing data, identify key knowledge gaps, and
explore different perspectives on this heterogeneous condition. A
report from this workshop highlighting the key scientific questions and
knowledge gaps regarding PASC was recently published in the Annals of
Internal Medicine. 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.
NIAID intramural scientists initiated the Longitudinal Study of
COVID-19 Sequelae and Immunity to better understand PASC and determine
whether people who have recovered from acute SARS-CoV-2 infection
develop an immune response to SARS-CoV-2 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 1st, 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, 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. Thanks for the opportunity
to be here today. I am going to provide a brief update of what
the agency has been doing in our COVID-19 response. But first,
I want to start by recognizing the thousands of FDA employees
who have really been working nonstop for the past year and a
half. I really commend their efforts and thank them for their
service to the country. It has been extraordinary.
From the earliest days of this public health emergency,
there was a need for reliable diagnostics, as we all know. We
began gauging developers in early January 2020. And as of last
week, FDA has authorized nearly 400 tests and sample collection
devices that provide a wide range of options for testing beyond
diagnostics. We have evaluated emergency use requests for
ventilators and novel devices such as continuous renal
replacement therapy products. We continue to review additional
submissions for COVID medical devices and rigorously monitor
safety signals and reports, including their performance against
variance for the products on the market.
This is in addition to addressing numerous device shortages
that occurred during the pandemic and working with our
Government partners to prevent counterfeit and substandard PPE
and other products from entering the United States because, of
course, people take opportunities to try to get substandard
products into the country. FDA has also supported development
and availability of COVID therapeutics as expeditiously as
possible. On March 31st, we announced the creation of an
emergency review and development program, the Coronavirus
Treatment Acceleration Program. We reassigned staff from other
areas to review the hundreds and hundreds of requests from
companies, scientists, and doctors who are working to develop
treatments as of June 30th.
We have reviewed more than 460 trials for potential COVID
therapies. These include antivirals, neutralizing antibodies,
cell and gene therapies, and combinations of these products.
The diversity of therapeutic approaches that are being
investigated is really critical to increasing our knowledge of
this disease in its different stages. And these efforts have
led to one approved drug therapy to treat COVID-19 and 10
therapeutics currently authorized for emergency use.
In addition, FDA issued EUA, as you know, for three COVID-
19 vaccines. These vaccines were authorized without cutting
corners or sacrificing our rigorous standards. Intensive
interactions between FDA and manufacturers minimize the time
between different ordinary phases of the clinical development
process and allowed for seamless movement through development,
manufacturing, and our rigorous scientific review.
Throughout the vaccine authorization process, we took steps
to facilitate transparency and trust by posting trial data,
putting out guidances on what our standards would be, key
decisional memoranda, and we held public advisory committee
meetings. These vaccines have met the standards and quality to
support an EUA and are helping, as you have heard, in our fight
against the pandemic. Our work did not end with the
authorization of these vaccines, though we have to share as
much information as we can with the public to help with trust
and transparency. We are also deeply involved with CDC on the
safety surveillance for the vaccines as they go into millions
of healthy people to understand what adverse events might be
related. And we continue to find that the known and potential
benefits of these vaccines far outweigh the known risks, even
as additional rare risks have been discovered.
All this is in addition to the critical work we do to
protect the Nation's food supply, which also came into some
jeopardy during this, and to interdict substandard medical
products at our ports of entry, courier facilities, and
international mail facilities. Since March 2020, with
coordination with Customs and Border Protection colleagues, we
have intercepted and destroyed almost 60,000 illegal and
unapproved medical products that were attempting to get into
the country.
FDA has also played a major role in investigating the
numerous shortages of medical products that have occurred
during the pandemic. Partnering with our sister agencies
represented here and far beyond, we have responded quickly and
decisively while maintaining our commitment to protecting the
health of the American people. We look forward to working with
the Committee to address further issues. Thank you.
[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,
and availability of critical, safe, and effective medical products to
address the COVID-19 public health emergency.
I want to note at the outset that this is just a snapshot of some
of our recent 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 non-stop for the past year-and-a-half. I want to commend
and recognize their efforts and thank them for their service.
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.
Biologics and Vaccines
FDA's Center for Biologics Evaluation and Research (CBER) uses
every tool available to help patients access promising biological
products while facilitating research to evaluate their safety and
efficacy as well as manufacturing efforts.
CBER is working on multiple fronts to address the COVID-19
pandemic, including:
Expediting 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 specific sponsors, and
generally through guidance documents;
Supporting product development and facilitating the
scaling up of manufacturing capacity for high priority products
to treat COVID-19;
Expediting the review of Emergency Use Authorization
(EUA) requests and Biologics License Applications (BLAs) for
critical medical products to address COVID-19;
Helping to ensure an adequate and safe blood supply;
and
Providing information to healthcare providers and
researchers to help them submit expanded access IND requests to
permit the use of investigational products for patients with
COVID-19.
Through our transparent scientific review process, FDA has issued
EUAs for three COVID-19 vaccines. In doing so, we have relied upon the
Agency's rigorous standards for safety, effectiveness, and
manufacturing quality. Development of a vaccine generally proceeds
sequentially through the various stages of clinical development;
ordinarily this process minimizes scientific and financial risk for the
manufacturer. Manufacturing scale-up only takes place when the data
support the safety and effectiveness of a vaccine and it is on track
for regulatory approval. These three COVID-19 vaccines were developed
without cutting corners or sacrificing our 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 EUA.
For the three vaccines authorized to date, our EUA process not only
included a thorough evaluation of the data by the Agency's career
staff, but also included input from independent scientific and public
health experts through our public advisory committee meetings.
Throughout this process, FDA took additional steps to facilitate
transparency, such as posting sponsor and FDA briefing documents and
key decisional memoranda.
The three authorizations make available COVID-19 vaccines in the
United States that have shown clear and compelling efficacy in large,
well-designed phase 3 trials. These vaccines have met rigorous
standards for safety and effectiveness to support EUA and are helping
us in the fight against this pandemic. All the COVID-19 vaccines that
FDA has authorized for emergency use are at least 50 percent effective
compared to placebo in preventing COVID-19, which is the expectation we
conveyed 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.
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\1\ https://www.fda.gov/media/139638/download.
As part of our continued efforts to be transparent and educate the
public, we have a wealth of information on our website about the
authorized COVID-19 vaccines. The information includes fact sheets for
healthcare providers (vaccination providers) and vaccine recipients and
caregivers, with important information such as dosing instructions;
information about the benefits and risks of each authorized vaccine;
and topical Questions and Answers developed by FDA for 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.
It is also important to highlight that, as part of each EUA, we are
requiring the manufacturers and vaccination providers 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
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Disease Control and Prevention (CDC).
These surveillance efforts have led the Agency to take steps to
proactively address emerging safety signals. In April, out of an
abundance of caution, FDA and CDC recommended a pause in the use of the
Janssen COVID-19 vaccine while we investigated reports of thrombosis
with thrombocytopenia syndrome. Later that month, after careful
evaluation of the data, FDA announced revisions to the vaccine
recipient fact sheet to include information about the risk of
thrombosis with thrombocytopenia, and the vaccination provider fact
sheet to include a warning about the risk of thrombosis with
thrombocytopenia syndrome. We concluded that the available data suggest
that the chance of this serious adverse event occurring is very low.
FDA and CDC determined that the recommended pause regarding the use of
the Janssen COVID-19 vaccine in the U.S. should be lifted and use of
the vaccine should resume. As with all of the COVID-19 vaccines, we
continue to closely monitor the safety of the Janssen COVID-19 Vaccine.
On June 25, FDA announced revisions to the vaccine recipient and
caregivers and vaccination provider fact sheets for the Moderna and
Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased
risks of myocarditis and pericarditis following vaccination. The chance
of these adverse events occurring following administration of either
the Moderna or Pfizer-BioNTech COVID-19 vaccine appears to be very low,
but the level of potential risk due to vaccination is still under
investigation. FDA and CDC are monitoring the reports, collecting more
information, and will follow-up to assess longer-term outcomes over
several months.
On July 12, FDA announced revisions to the vaccine recipient and
caregivers and vaccination providers fact sheets for the Janssen COVID-
19 vaccine regarding a suggested increased risk of Guillain-Barre
syndrome during the 42 days following vaccination. The chance of this
occurring following vaccination appears to be very low.
At this time, data are not yet available to make a determination
about how long these authorized vaccines will provide protection, nor
are we certain that the vaccines prevent transmission of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) from person to person.
Additionally, although we do not yet know the full range of SARS-CoV-2
variants that each of the authorized vaccines will protect against,
there is evidence that the current 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).
Having three vaccines authorized to date that meet FDA's
expectations for safety and effectiveness only 1 year after the
declaration of the COVID-19 pandemic is a tremendous achievement and a
testament to the dedication of developers and FDA's career scientists
and physicians. We are highly engaged in ensuring that all COVID-19
vaccines meet the high quality that Americans expect and deserve and
are also actively engaged in ensuring the safety of these vaccines
following deployment. FDA is also working with international partners
as part of multinational efforts to end this global pandemic. We have
provided guidance and technical assistance, and continue to share
information as we evaluate and release vaccine doses for use in other
countries. The Agency is very proud of these efforts, and we believe
that the vaccines will help bring this pandemic to an end.
Therapeutics
Since the beginning of the COVID-19 pandemic, FDA 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 has also 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, scientists, and doctors 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 June 30,
2021, there are more than 630 drug development programs in planning
stages and the Agency has reviewed more than 460 trials of potential
therapies for COVID-19. These include antivirals, immunodulators,
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.
FDA has approved one drug to treat COVID-19 and eleven therapeutics
are currently authorized for emergency use. 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 Federal Food, Drug and Cosmetic Act (21 U.S.C.
360bbb-3) or for recommending that an EUA be revised or revoked.
FDA also continues to work closely with manufacturers to mitigate
and prevent shortages as the COVID-19 pandemic evolves. For example,
the Agency has issued three 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 the FDA-approved alternatives to these products were not available
in sufficient quantities 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 also 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 antibiotics,
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
The need for medical devices to respond to the COVID-19 pandemic
has far exceeded what we experienced in any prior Public Health
Emergency (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.
Further, the emergency use requests included submissions for devices
that CDRH had never received EUA requests for during prior PHEs. This
included ventilators and novel devices such as continuous renal
replacement therapy devices. Since the start of the pandemic, FDA has
issued EUAs or granted full marketing authorization to almost 1,500
medical devices for COVID-19-related uses. In addition, FDA rigorously
monitored safety signals and medical device reports using the
information to publish 21 letters to healthcare providers and seven
safety communications, and 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 they work through EUA review. The
EUA pathway expedites access to accurate diagnostic tests during
emergencies, when information gaps and false results may adversely
affect individual patient care and public health decision-making. EUAs
enable molecular diagnostic tests 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 has employed its EUA authorities to
facilitate availability of tests in each PHE or threat situation since
2009, when the Secretary of HHS declared that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics.
In PHEs, FDA is generally open to receiving and reviewing EUA request
for tests from any developer, including commercial kit manufacturers
and laboratories.
FDA sought to facilitate COVID-19 test evaluation and authorization
through the development and availability of templates. 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 emergency use
authorization. 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 now made nine templates available for a variety of
test types. As of July 13, 2021, these nine templates have received
510,725 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 weekly virtual town
halls for test developers. The Agency has worked with over 1,000 test
developers since January 2020.
Since early 2020, FDA has adopted agile, interactive, and
innovative approaches to EUA review for all types of devices. For
example, FDA developed the umbrella EUA approach to efficiently
authorize multiple devices of the same type meeting the same criteria.
The Agency has also issued 28 guidance documents (including 17
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
establishing 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.
As of July 13, 2021, FDA has authorized 397 tests and sample
collection devices for SARS-CoV-2. As noted in the graphic below, these
include 282 molecular tests and sample collection devices, 85 antibody
and other immune response tests, and 30 antigen tests. Among these are
11 diagnostic tests that can be run at home (three molecular and eight
antigen tests), seven of which do not require a prescription. We have
also authorized 18 tests for serial screening programs (11 antigen and
seven molecular). The volume and variety of available tests is a
testament to FDA's support of innovative test design and our commitment
to public health.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
.epsFDA has authorized a wide variety of other medical devices for
use in combating the pandemic, including a wide range of personal
protective equipment (PPE), ventilators, and other therapeutic devices.
As of July 13, 2021, FDA has authorized 270 PPE devices including 39
surgical masks, and has authorized 205 filtering facepiece respirators
(FFRs), 13 systems for PPE decontamination or bioburden reduction at
the time there was a need for these types of devices due to PPE
shortages, \3\ and 13 EUAs for face shields and other barriers intended
to protect the user from bodily fluids, liquid splashes, or potentially
infectious materials (see related graphic below). In addition to
granting EUAs, FDA has also cleared, through its premarket notification
pathway, over 250 PPE 510(k)s.
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\3\ https://www.fda.gov/news-events/press-announcements/fda-brief-
fda-revokes-emergency-use-authorizations-certain-respirators-and-
decontamination-systems.
[GRAPHIC] [TIFF OMITTED] T6775.002
.epsFDA 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
Food security is national security. Thus, 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 SARS-CoV-2 is not transmitted by food, some components of the
food system experienced challenges and supply chain imbalances,
particularly at the outset of the pandemic. Overall, food production
and manufacturing in the U.S. has remained resilient. We continue to
monitor the food supply chain systems closely to efficiently and
promptly identify mitigation strategies when necessary. Early on, the
pandemic caused a significant shift in where consumers were buying
food. We took steps to provide temporary guidance to provide
flexibility in packaging and labeling requirements to help industry
redirect products manufactured for food service and institutional use
to retail grocery stores, or if needed to the animal food industry so
the food does not go to waste.
FDA also recognizes that food supply chain continuity and worker
safety are two sides of the same coin. Thus, a robust food supply is
dependent 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 and now as restaurants and
other retail establishments resume regular operations.
In response to the pandemic, FDA's Office of Food Policy and
Response, Center for Food Safety and Applied Nutrition, Office of
Regulatory Affairs, and Center for Veterinary Medicine developed 21
Forward, a food supply chain data management tool, to help identify
where risks for interruptions in the continuity of the food supply due
to COVID-19 transmission among workers may be greatest. As part of 21
Forward, FDA also conducted targeted outreach to the food industry to
offer additional resources and technical assistance in addressing
challenges.
In collaboration with HHS, CDC, and US Department of Agriculture
(USDA), data from 21 Forward 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.
FDA's Coordinated Outbreak Response and Evaluation team has been
working throughout the pandemic, is fully staffed, and on the job
looking for signs of foodborne illness outbreaks and initiating
responses as needed. FDA's Center for Veterinary Medicine is also
monitoring the animal food supply and initiating needed responses,
working closely with other veterinary diagnostic laboratories in its
Veterinary Laboratory Investigation and Response Network (VET-LIRN). In
terms of inspectional work, FDA investigators continue to conduct
mission-critical inspections domestically and abroad, including
inspections and investigations in response to foodborne outbreaks
during the pandemic. FDA transitioned to standard operations for
domestic surveillance inspections in July 2021. Additionally, our
import investigators and laboratory analysts continue to work on-site
by:
Staffing our ports of entry, helping to ensure the
efficient distribution and safety of the Nation's imported food
supply; and
Conducting examinations, sample collections, and
laboratory analyses of imported and domestic food to ensure the
safety of our Nation's food supply.
FDA continues to screen every line of every shipment of imported
food entering the United States 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 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 26, 2020,
FDA has conducted 1,888 FSVP inspections. Since March 2020, FDA has
refused approximately 8,469 lines of imported food products. FDA will
continue to target and refuse human and animal foods that are unsafe,
misbranded, or may cause a serious health concern for the public.
FDA continues to closely monitor the overall safety of the Nation's
food supply, in collaboration with CDC, USDA, U.S. Customs and Border
Protection (CBP) and our state and local partners, to protect consumers
from foods contaminated with pathogens.
One year ago, 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. We have learned from
our response as an Agency 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, and strengthening food safety infrastructures with
regulatory partners.
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. Through continued vigilance,
FDA has prevented unsafe and unauthorized pharmaceuticals and other
medical products from entering the country. Since March 2020, with the
cooperation of and in coordination with CBP, FDA has received and
destroyed almost 60,000 products, totaling over 11,093,868 capsules,
pieces, and tablets of illegal or unapproved drugs.
Since March 2020, FDA has refused approximately 94,725 lines of
imported violative medical products. We have maintained the same level
of pre-pandemic screening for imported 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 and domestic officers 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. Our officers also assisted with expediting
the importation of other compliant vaccine-related shipments.
Despite 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.
On May 5, 2021, FDA issued a report titled, ``Resiliency Roadmap
for FDA Inspectional Oversight,'' 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 outlines inspections that the Agency was unable to
complete during the past year 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 outlines 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.
Of note:
From March 2020 through March 2021, FDA conducted a
total of 821 mission-critical inspections, including 29 in
foreign countries.
Additionally, the Agency conducted a total of 777
prioritized domestic inspections since resumption of that work
in July 2020.
Of the more than 13,500 applications for medical
product approval or authorization received since March 2020,
only approximately 68 applications have been delayed due to the
inability to conduct inspections--and a majority of these
applications are not deemed mission-critical.
Additionally, the Resiliency Roadmap Report outlines FDA's
continued, successful use of alternative tools and approaches where
inspections were or are not currently feasible, including remote
interactive evaluations (e.g., remote livestreaming video of
operations, teleconferences, or screen sharing), making record requests
to regulated establishments, and leveraging information from trusted
regulatory partners. For example, FDA made over 1,300 record requests
to human and animal drug and biological product manufacturers, to
support on-time regulatory decision actions. In addition, since March
2020, FDA has added products from 18 firms to import alerts as subject
to detention without physical examination, based on records requests in
advance or in lieu of inspection that FDA submitted pursuant to section
704(a)(4) of the FD&C Act.
Notably, FDA's bioresearch monitoring program staff have conducted
more than 130 remote interactive evaluations that were directly used
for application decisions. \4\ 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 inspections, and that
there are situations where only an inspection is appropriate based on
risk and history of compliance with FDA regulations.
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\4\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/remote-interactive-evaluations-drug-manufacturing-and-
bioresearch-monitoring-facilities-during-covid.
The Resiliency Roadmap Report further outlines 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 were not performed during the pandemic.
The plan highlights a variety of possible scenarios given the continued
uncertainty of the trajectory of the ongoing COVID-19 pandemic. On July
1, FDA activated the base-case scenario (COVID response continues on
current trend) to transition to standard operations for domestic
inspections and other operational work, as detailed in the report.
Inspections considered critical to FDA's mission will remain the
primary focus. When planning routine surveillance inspections, the
Agency will prioritize higher-risk establishments. 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
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on products that present the greatest risk to public health.
The Agency will also soon begin a multi-year modernization effort
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 will include a
review of inspectional approaches using next-generation assessment
technologies and improvements. FDA is also establishing an Agency-wide
Inspectional Affairs Council that will provide for 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 inspectional responsibilities, while achieving
optimal public health outcomes.
Compliance and Enforcement
FDA exercises its regulatory authority by, among other things,
issuing warning letters and pursuing civil and criminal actions against
firms and individuals who do not comply with regulatory requirements,
including those selling 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 Agency 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 thousands of abuse complaints to domain name registrars and
internet marketplaces. The Agency also has sent more than 241 warning
letters to sellers of unproven COVID-19 products. Working with the
Department of Justice (DOJ), FDA has sought and obtained preliminary
injunctions that require defendants to halt the sale of fraudulent
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, FDA's Office of Criminal Investigations (OCI), working
with other Federal and local law enforcement agencies, investigated a
hospital pharmacist who tampered with COVID-19 vaccine doses at a
Wisconsin hospital where he worked. On two successive overnight shifts
at the hospital in late December 2020, the pharmacist purposefully
removed a box of COVID-19 vaccine vials manufactured by Moderna--which
must be stored at specific temperatures for specific time periods to
remain viable--from the hospital's refrigeration unit intending to
render the vaccines inert and no longer effective. The pharmacist
acknowledged that after leaving the vaccines out for several hours each
night, he returned them to the refrigerator to be used in the
hospital's vaccine clinic the following day. Before the full extent of
his conduct was discovered, 57 people received doses of the vaccine
from these vials. In January 2021, the pharmacist pled 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 where appropriate. We protect the supply chain
in two equally critical ways, by helping to ensure that (1) safe
products are coming in; and (2) illegal, dangerous, and fraudulent
products do not get into the country. These efforts include partnering
with CBP in establishing satellite laboratories at selected 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 SARS-CoV-2. As a
result of this investigation, a British national was charged and
arrested for shipping mislabeled and unapproved products. Subsequently,
in April 2020, FDA intercepted a bulk shipment of hydroxychloroquine
coming from China going to a physician in California. The physician was
thereafter charged with mail fraud and making a false statement
stemming from the allegations that he smuggled hydroxychloroquine from
China to make his own pills and concealed the shipment from CBP by mis-
declaring it as yam extract. In May 2020, FDA worked with CBP to
intercept several shipments of counterfeit facemasks, with the result
that they were refused and destroyed before getting into U.S. commerce.
More recently, FDA 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. Regarding the
latter, substantial methanol exposure can result in nausea, vomiting,
headache, blurred vision, permanent blindness, seizures, coma,
permanent damage to the nervous system or death. Ingesting 1-propanol
can cause central nervous system depression, which can result in death.
FDA has tested several hundred products using field-based and
laboratory-based tools, found more than a hundred violative products,
issued warnings to consumers not to use contaminated hand sanitizers,
and has taken steps to help ensure that these dangerous or subpotent
products do not enter domestic commerce. FDA has coordinated with CBP
to identify such products, and we have listed products made by more
than 40 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 United States 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. We
work closely with manufacturers 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 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. \5\
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In addition to our usual communication 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 current or emerging regional shortages of critical care drugs
used to treat COVID-19.
FDA understands the significant impact shortages can have on
patient care and is doing everything within our authorities to help
prevent and alleviate disruptions. When we identify a shortage, we
react swiftly to mitigate the impact to U.S. patients and health care
professionals, and quickly share that information with the public. For
example, 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 to
treat hospitalized patients with COVID-19 when approved drugs are not
available. The Agency has also published guidance to help applicants
and manufacturers provide FDA with timely and informative notifications
about changes in the production of certain drugs (including animal
drugs) and human biological products, and urging the submission of
these notifications, which may assist in our efforts to prevent or
mitigate shortages of such products.
The Agency quickly identified the need to help ensure widespread
access to hand sanitizers as demand spiked, while also continuing our
mission to ensure these products are not contaminated by removing
adulterated products from the market. FDA has published and continues
to update three guidance documents designed to help facilitate the
production of alcohol-based hand sanitizer in non-traditional settings
such as pharmacies or distilleries. The Agency has launched several
enforcement initiatives and import alerts to help stop adulterated and
subpotent hand sanitizer products from getting into U.S. distribution
channels.
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 the public and private sector
have important parts 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 also has unique, collaborative
relationships that allow direct engagement with device manufacturers,
patients, distributors, healthcare organizations and other
stakeholders. Even before the pandemic hit the United States, there
were already problems in the supply chain due to demand for devices in
other nations where COVID-19 was already prevalent. As a result, FDA
began shortage mitigation activities for medical devices in January
2020 before the PHE was declared in the U.S., and months before a
pandemic was declared worldwide. The Agency took several actions to
rapidly respond to supply chain needs, including reassigning 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.
In addition, 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 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.
Congress has acknowledged the importance of this work to our health
care system, and we want to continue working with this Committee and
others to ensure FDA has the resources and authorities needed to ensure
U.S. patients and health care providers have the products they need
each day, and especially during public health emergencies.
Conclusion
FDA continues to advance its mission to protect and promote public
health by ensuring 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 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, I am honored to testify
before you today regarding efforts within the Office of the
Assistant Secretary for Preparedness and Response to support
the ongoing response to COVID-19. First, let me thank you for
your support of my confirmation. It was just 6 weeks ago that I
was before you as a nominee, and it has been just over 3 weeks
since I was confirmed as the ASPER.
I am honored that you have entrusted me with this important
role, and I pledge to do everything I can to maintain your
trust and confidence in my abilities to lead this Office with
vision, precision, and transparency. While I continue to assess
ASPER's work, one thing is abundantly clear. The ASPER team is
working tirelessly to end this pandemic, and I am pleased to
share some examples of the work that they are leading. As you
know, the Strategic National Stockpile, or SNS, worked to
backstop states' medical supply needs when the pandemic
strained global supply chains.
The SNS has deployed more than 200 million items including
personal protective equipment or PPE, ventilators, Federal
medical stations, and pharmaceuticals. ASPER has invested
approximately $10 billion from COVID-19 supplementals to
replenish the SNS to levels at or above pre-COVID-19 amounts. A
new mission ASPER has taken on over the course of the pandemic
is securing the medical supply chain. This work is complex and
challenging and has forced our organization to stretch in new
ways. A secure and resilient medical supply chain is not only
necessary for our current COVID-19 response but will be
critical for any nationwide response that follows.
ASPER is investing in industrial base expansion efforts to
reduce supply chain vulnerabilities and generate a domestic
warm base for manufacturing that can be leveraged in a crisis.
So far, ASPER has supported efforts for domestic manufacturing
of PPE, active pharmaceutical ingredients, COVID-19 tests and
supplies such as reagents and resins.
In support of this work, ASPER is also leveraging the
authorities delegated to the secretary under the Defense
Production Act to ensure that private sector partners making
life saving products have the materials they need to deliver
their product. So far, ASPER has priority rated 55 contracts to
directly and indirectly support the COVID-19 response effort.
ASPER will continue to leverage all of the tools we have at
our disposal to ensure the supply chain is secure and that we
are never again in this situation we found ourselves in last
year. The national disaster medical system has completed nearly
5,400 mission assignments. The teams have brought surge
capacity to ICU and emergency rooms, established medical
overflow centers, provided mortuary support in places like New
York City, established sites to deliver therapeutics, and
operated Federal vaccination sites. They are currently standing
by to participate in surge teams being stood up by the
Administration to respond to recent hotspots.
The ASPER's Biomedical Advanced Research and Development
Authority, or BARDA, has supported over 65 medical
countermeasure projects for the COVID-19 response. Most
notably, BARDA led the vaccine development work for what was
then known as Operation Warp Speed and is now known as the
Countermeasures Acceleration Group and advanced the development
of the three vaccines currently authorized by the FDA.
This was done, as you know, at historic speed with less
than a year between the identification of the virus in the
authorization of the first vaccine. ASPER is also working with
HHS leadership and the Department of Defense to transition the
Countermeasures Acceleration Group to a long term sustainable
management structure within HHS. Dr. Robert Johnson, a senior
leader at BARDA, recently assumed the responsibilities as the
Chief Operating Officer of the mission.
I look forward to using this transition planning period as
an opportunity to evaluate gaps and bring in the additional
logistical capacity needed at ASPER and HHS to sustain the
enduring mission for as long as it is required. As we move
forward, I would like to build on this foundation to accelerate
and recalibrate the work where needed and continue to do all we
can to bring an end to the pandemic as quickly as possible.
Thank you again for inviting me to testify and allowing me
to share these examples of the work ASPER is leading on behalf
of the Administration wide COVID-19 response effort. 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 support the
ongoing response to COVID-19. I am grateful for this opportunity to
address this Committee and appreciate your continued support for the
ongoing response efforts.
When I first appeared before the Committee in early June as the
ASPR nominee, I shared my top three priorities for the office, which
are reflected in the Fiscal Year 2022 Budget request:
First, I wanted to ensure that ASPR has the resources and
support necessary to continue its critical COVID response work,
and help the Nation emerge quickly from the current pandemic.
This critical work is in addition to our normal preparedness
and response efforts for natural disasters, chemical,
biological, radiological, and nuclear incidents, and pandemic
influenza PI events.
Second, I wanted to restore and strengthen capacities that have
become strained during the COVID-19 pandemic. Specifically, I
wanted to ensure the Strategic National Stockpile (SNS) is
appropriately resourced, replenished, and ready to respond to
future challenges, and that the medical supply chain is
resilient and can support our country's needs.
Finally, I wanted the organization to increase readiness for
future public health emergencies by working with our colleagues
both inside the Department and across the interagency to
prepare for whatever manmade or naturally occurring threats may
come next.
A month into the job, these remain my top priorities. Every passing
day I am awed by the hard work and dedication of the ASPR team. It is
clear to me that they are working as hard now to end the pandemic as
they did when the outbreak first began. Today, I am pleased to share
with you an update on the tireless work they have been doing to respond
to COVID-19.
Update on ASPR's COVID-19 Response Effort
Countermeasures Acceleration Group
The response to the COVID-19 pandemic has required an unprecedented
whole of government approach. As you are familiar, HHS and the
Department of Defense (DoD) forged a partnership formerly called
Operation Warp Speed (OWS) that is now known as the Countermeasures
Acceleration Group (CAG). This partnership brought together the two
Departments to develop, manufacture, and deliver safe and effective
vaccines and therapeutics to the American people. ASPR has played a
significant leadership and coordination role on behalf of HHS in the
effort. This endeavor has delivered nearly 390 million vaccine doses
and over a million therapeutic doses to protect the American people
from COVID-19.
In addition, the President has committed to sharing 580 million
doses of vaccine with the world. This includes half-a-billion Pfizer
doses the United States will purchase and donate to 100 countries in
need--the largest-ever donation of COVID-19 vaccines by a single
country, and a commitment to share 80 million doses of our own surplus
U.S. supply. The CAG has delivered nearly 40 million vaccines to 25
countries, with millions more en route.
Now, work is underway to transition DoD's role in the CAG to HHS
for long term sustainability and management. Dr. Robert Johnson, the
Director of the Influenza and Emerging Infectious Diseases Division of
ASPR's Biomedical Advanced Research and Development Authority (BARDA),
assumed the responsibilities as the Chief Operating Officer of the CAG
earlier this month. Under Dr. Johnson's leadership, ASPR's role in the
response is more apparent than ever.
Biomedical Advanced Research and Development Authority
ASPR's BARDA has supported over 65 medical countermeasure projects
for the COVID-19 response. All of these contract awards are listed on
medicalcountermeasures.gov in detail and include 14 therapeutics, 48
diagnostics, and seven vaccine candidates. Notably, BARDA, as part of
the then-Operation Warp Speed, accelerated the availability of three
vaccines--Moderna, Pfizer, and Johnson & Johnson. This was done at
historic speed, with the novel virus identified and the first vaccine
authorized in under a year.
Looking forward, BARDA will leverage the supplemental
appropriations provided by Congress to continue its work as part of the
CAG to support the development of additional vaccines and therapeutics
to end the COVID-19 pandemic. There are still populations--like
children under the age of 12--that cannot yet receive the vaccine as we
complete careful clinical testing. It is critical that the work
continue to develop vaccines and to establish successful treatments for
those who do become infected. I look forward to working with this
Committee on specific plans toward this effort.
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 categories of medical equipment and supplies.
Many vital products are primarily made overseas, and practices like
``just in time'' inventory management resulted in difficulty surging
manufacturing when demand surged last spring. This created significant
and devastating challenges for states and healthcare systems that
needed 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. As of
June 15, 2021, the SNS deployed more than 200 million items to aid the
national response including Personal Protective Equipment (PPE),
ventilators, Federal Medical Stations, and pharmaceuticals. Now, ASPR
is working to replenish the SNS to levels at or above pre-COVID-19
amounts, so it is prepared for any subsequent wave of additional cases.
As of July 9, 2021, the SNS has utilized approximately $10 billion
from COVID-19 supplemental appropriations provided by Congress to
inventory approximately: 517 million N95 respirators (35 times pre-
pandemic levels); 272.5 million surgical and procedure face masks
(eight times pre-pandemic levels); 11.9 million face shields (two times
pre-pandemic levels); 22 million gowns and coveralls (five times pre-
pandemic levels); 524.7 million gloves (17 times pre-pandemic levels);
and 167,000 ventilators (10 times pre-pandemic levels).
While replenishing the SNS is essential, it is also critical to
address the root-causes 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 supply chain for medical materials, ingredients, and
supplies is critical for any national response to public health
emergencies.
To start, ASPR is leveraging the authorities delegated to the
Secretary under the Defense Production Act (DPA) to ensure that private
sector partners making life-saving products are able to acquire raw
materials, retool their machinery, scale their production facilities,
train their workforces, and ultimately deliver their product.
Throughout the COVID-19 response, ASPR has used the DPA authority to
issue 46 priority ratings for U.S. Government (USG) contracts for
health resources, eight priority ratings for USG contracts for
industrial expansion, 3 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. Going forward, ASPR will continue to build
capacity and partnerships with private industry toward the shared goal
of ending the COVID-19 pandemic.
In addition, ASPR is working to steward Congress's investment in
expanding the domestic industrial base. These industrial base expansion
(IBx) efforts seek to reduce supply chain vulnerabilities and generate
a domestic ``warm-base'' for manufacturing that can be leveraged in a
crisis. So far, ASPR has supported domestic manufacturing of PPE;
active pharmaceutical ingredient manufacturing capacity; and COVID-19
testing, including swabs, tests and kits, and supplies such as reagents
and resins. Each of these domestic manufacturing initatives meet
current, as well as future COVID-19 needs, and seek to create or
sustain high-value domestic jobs.
Healthcare System Preparedness
Finally, 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 health care needs.
Through ASPR's Hospital Preparedness Program (HPP), the only
Federal program that supports preparedness efforts within the
healthcare system, 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, and helped
leverage and amplify technical guidance from the Centers for Disease
Control and Prevention (CDC). These components work together to provide
a coordinated, national approach to preparing health care systems to
surge for public health and medical emergencies.
During the COVID-19 pandemic, the NSPS 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. During the
COVID-19 response, NDMS has completed nearly 5,400 mission assignments
so far, and counting. For these deployments, NDMS personnel supported
hospital augmentation including emergency room support; hospital
decompression; setting up medical overflow centers for patients and
mortuary support; establishing monoclonal antibody therapy sites; ICU
augmentation; and, operating Federal vaccine sites. With the aid of
NDMS personnel and resources, communities were able to continue to
provide care to those in need of medical assistance and treatment. NDMS
will continue to support such requests.
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 very much to all of our panelists
today. We will now begin a round of 5 minute questions of our
witnesses. I ask all of my colleagues, please keep track of
your clock. Stay within those 5 minutes. We do have votes
starting at 11:30 a.m. and we have many Members in attendance
today. My first question is for the whole panel.
We are at a pivotal point in this pandemic, and after weeks
of declining rates of cases and deaths, we are now seeing a
resurgence of COVID-19 in part due, as you mentioned, to the
circulation of variants. Vaccination rates are plateauing and
COVID fatigue is setting in around the country. So I want to
ask each of you, what is the one thing everyone can do to help
keep us from returning to the early days of this pandemic?
Dr. Walensky.
Dr. Walensky. Get vaccinated and get your neighbors
vaccinated.
Dr. Fauci.
[Technical problems.]
The Chair. Dr. Woodcock.
Dr. Woodcock. Couldn't say it better.
The Chair. Ms. O'Connell.
Ms. O'Connell. Get vaccinated.
The Chair. Thank you to all of you and I hope everyone
heard that. Dr. Fauci, the quick development of effective COVID
vaccines has been a real success story during this pandemic.
People are getting vaccinated. It is really key to everyone's
ability to return to normal lives. With the spread of variants,
as we all talked about, driving and increases in cases and
deaths now, I am encouraged to see public health experts and
vaccine developers are now considering the possible need for
boosters. You mentioned this a bit in your opening remarks, but
I want to ask you, how do you assess the duration of vaccine
efficacy and the impact of variants on that efficacy?
Dr. Fauci. Thank you very much, Madam Chair. There are two
ways that are actively being used now to assess the answer to
your question. One is there are correlates of immunity which
have been established. In other words, you have a level of
measurable laboratory, for example, neutralizing antibody,
which is the easiest to measure. There are also areas of
immunity that are more difficult to measure, like T-cell
responses. But the one that seems to be very well correlated is
the antibody level.
We know from studies, from the clinical trials, as well as
from animal studies that there is a baseline level below which
you go, you are much more vulnerable to getting a breakthrough
infection. So the first is laboratory data. The second is
watching and following cohorts of people to see if you have an
increase in breakthrough infections. We know, according to the
clinical trial, take for an example, the mRNA, they are 93 to
94 percent effective in preventing clinically recognizable
disease.
If you see a fall below that into the 80's or even
unfortunately hope it never happens into the 70's, then you
reached the point where the durability needs a boost. Those
studies are ongoing right now.
The Chair. We don't have any data about whether or not we
are seeing that?
Dr. Fauci. No, we don't. There are some preliminary data
that we have heard about from Pfizer, which studies that they
did in Israel and in their own studies, which seem to indicate
that there is waning immunity. We have a lot of cohorts that we
are following. The CDC is following at least 20 cohorts that
will be able to amplify on that data and give us much more of a
basis of making a decision.
The Chair. How will the Administration determine if booster
shots are needed?
Dr. Fauci. Just by those very studies. Just by the
following the cohort studies and we are waiting. We will be
maybe--perhaps Dr. Walensky would like to comment because she
has in her domain of the CDC a number of cohort studies that
will inform us. In the meantime, we at NIH are doing studies
now to determine when you give a booster, how high up do you
get it and what kind of a cushion do you get for antibody
responses?
The Chair. Okay.
Dr. Walensky.
Dr. Walensky. Yes. Thank you, Senator. We have numerous
cohort studies. They represent tens of thousands of people, and
they are represented across the United States. These include
data from 14,000 nursing home facilities, long term care
facilities. We have a heroes cohort that is essential workers
of over 5,000 people that are actually getting weekly PCR
testing. We have health care worker cohorts.
We have cohorts across the country where we are following
these data and really looking at it every several weeks to
understand what the vaccine efficacy is. And it is among that,
and the laboratory data will be the decisions that we use.
Fortunately, we are anticipating that this will wane and not
plummet. So as we see that waning, that will be our time for
action.
The Chair. Okay, thank you very much. We really appreciate
it. We will stay in touch on that. I will reserve the balance
of my time because there are many Members here.
Senator Burr.
Senator Burr. Thank you, Madam Chair. I have got to say,
the last exchange was, oh, my god, we haven't learned anything.
Let me just make this point. I remember early on in this when
the question of testing came up, the CDC said we do testing.
And CDC demanded to do the test and we lost weeks. And I am not
here to evaluate data. Tony, that is your job and Rochelle and
others. But to say we are going to make this decision based
upon the research we have got going on at CDC, based upon the
information that we have put out and only our research counts,
and to basically ignore the Israeli data or the Pfizer data--
and I am not suggesting that we are totally doing that.
I guess my question would be, is Israel giving us
transparency into their data? If you still lived in a world
when we didn't accept foreign data for applications, which FDA
has had the authority to do since 1996 when I changed the law,
but it took COVID to actually make that happen. So I realized
that we want accuracy. But do we really have to wait for CDC to
complete the data? Do you think you are going to come to a
different conclusion than Israel did? Share with me.
Dr. Walensky. Thank you for that question, Senator.
Absolutely not. We have to have collaboration across the globe
because this is a global problem. So we have already had two
conversations with Israel. We have data sharing from our
collaboration--from our cohorts as well as from theirs. We have
also been in discussions with the UK to see what data they have
because, of course, they are several weeks ahead of us in the
delta variants. So we intend to leverage all of the data we
have around the world to share liberally with other countries
and the hopes that they will share with us so that we can make
the proper decisions here in this country and around the world.
Senator Burr. Is there a reason to believe that the Israeli
data is flawed?
Dr. Walensky. I am sorry?
Senator Burr. Is there reason to believe the Israeli data
is flawed?
Dr. Walensky. Flawed, we are in discussions, epidemiologic
discussions. There are numerous cohorts in Israel, those in the
Ministry of Health, those in their health care systems. And we
have seen some of their data. They are actually continuing to
analyze the data. And so where we are in those active
epidemiologic conversations.
Senator Burr. My point is they have made a decision to do
booster's based upon their data. And we are saying we are still
going to work out through our research to determine. And that
is where you begin to lose the trust of the American people in
our health care experts. In April, the Biden administration
announced a $1 billion commitment for sequencing at CDC. To
date, only 844 cases from North Carolina have been sequenced,
according to CDC website. We had over a million cases. It seems
there is a major problem again at CDC. Let me just ask you, in
CDC's recent updated mask guidance for schools, says community
should use local outbreak data to make decisions.
Yet I would challenge you that if only 844 cases have been
sequenced, those local people don't have the data they need to
make that determination as to what the policies are going to be
at a local level. Would you agree?
Dr. Walensky. That discussion is based on cases, not based
on variance. So we are actually getting data from around the
country based on variance as well, based from the local health
departments within North Carolina and with all of the states,
as well as academic centers, and commercial labs. And the
recommendations for schools was based on test positivity and
positive cases, not necessarily based on variance.
Senator Burr. But shouldn't transparency by the local
health department about the variant in their community be
important to their decision as to what they do in the schools?
Dr. Walensky. Absolutely. And we have data by region for
variants that are posted on our website. They have been updated
this morning with 83 percent. So not only are we looking at
test positivity actually down to the county level, but variants
that come in as well from each of the individual states, from
the academic partners, from the labs.
Senator Burr. Dawn, I know you have only been there 3
weeks. What are your plans to address the pressure that the flu
is going to cause on the system?
Ms. O'Connell. Ranking Member, thank you for that question.
That has been something that we have been--the ASPER team has
been considering and planning for over the last several months.
There is now an interagency process set up by the White House
Supply Chain Coordinator that ASPER has been actively
participating in, working with manufacturers of both flu
vaccines and COVID vaccines to make sure that the supplies are
there so we have access to both vaccines as we head into the
fall.
But it is something that we will continue to monitor and
recalibrate if needed so we are sure that we can do both at the
same time. At this point, our planning assumption suggests that
we can, but I will continue to monitor that.
Senator Burr. Thank you. Thank you, Chair.
The Chair. Senator Kaine.
Senator Kaine. Thank you, Chair Murray and Ranking Member.
Thank you to the witnesses. I want to say a word about
disinformation and then have some questions. Former President
Trump was on television this weekend and he said one of the
reasons people won't get vaccinated is because, ``they don't
trust the election results.'' And when I heard that, I sort of
chuckled at that. I thought that was odd to be connecting a big
lie about the election to refusal to get vaccinated. But it
caused me to do something that I hadn't done, which is look at
the vaccination rates in all 51 states, including the District
of Columbia.
The CDC data from yesterday morning shows the following.
The 21 jurisdictions with the highest vaccination rates all
vote for Joe Biden. 25 of the 30 jurisdictions with the lowest
vaccination rates voted for Donald Trump. There is a difference
between causation and correlation. But possibly what the
President said on television on Sunday, there may be something
to it that repeated disinformation about the election is now
connecting in people's minds with this information about
willingness to take the vaccine.
It didn't have to be this way because one of the great
things about President Trump and the Trump administration
working with partners and funded by Congress was setting a
world record in terms of developing really super effective
vaccines in record time. President Trump had COVID in October.
He decided to get vaccinated in January. He didn't tout the
vaccination. It came out months later. But he could still tout
it, he could still say this is a Trump accomplishment and
encourage people in these states who are lagging behind the
national average to get vaccinated.
That won't solve all of the problem because there are many
reasons people don't get vaccinated. But I am now convinced, I
just came back from Latin America. In Latin America, they are
so thrilled at the U.S. donation of vaccines, and they view our
vaccines as state-of-the-art compared to the China and Russia
vaccines. And they appreciate that we are donating them rather
than charging them, which China and Russia are doing. So around
the world, people are beating a door down to try to get to U.S.
vaccines if they can. And here we have near universal
availability.
Again, I thought it was sort of comical, the President's
comments this past weekend. But as I look at the CDC data,
maybe it is not so comical, but it is incredibly serious. Dr.
Walensky, I wanted to ask you this question. I think you stated
in your opening testimony that the overwhelming majority of
deaths now are people who are not vaccinated. Now, when you say
overwhelming majority, are you talking about 60 percent, 80
percent, 95 percent, 99 percent? What is the statistic?
Ms. O'Connell. In a five-month study from January to May
and numerous states, five or six states, it was 99.5 percent.
Senator Kaine. Now, obviously, before the vaccine started,
it was 100 percent. 100 percent of people who died before we
were vaccinating were unvaccinated by definition. And since the
vaccine has begun to be deployed, 99.5 percent of people who
died are people who are unvaccinated. Those are very, very
powerful statistics. As the Administration has begun to say
this is now a pandemic of the unvaccinated. Dr. Walensky, I am
very concerned with a CDC press release, I guess, from last
week about overdose deaths in the last calendar year. A 29
percent increase in overdose deaths.
It appears to be connected to the isolation. Substance use
disorders is often a disorder of isolation. It appears to be
connected to the intense isolation of the last year. Can you
tell us what CDC and other partners are doing to look at this
and work together with us to try to combat the resurgence of a
scourge which we had seen some positive movement on in the last
few years?
Dr. Walensky. Yes, thank you, Senator. You know, there have
been two things in the last decades that have decreased life
expectancy in this country. One is COVID-19 and the second is
overdose. And so we are now seeing a collision of those two
things happening at the same time. And in fact, as you noted,
the report demonstrated a 29 percent increase in overdose
deaths a year over year.
We are actively working to not only study this issue and
not only study the overdose deaths, but the overdose
hospitalizations, to look at surveillance, to look at the
infectious diseases associated with injection drug use, to
promote certain services programs, naloxone programs, as well
as to provide services and toolkits around the country for not
just substance use disorders, but for mental health, Hear Her
Now campaigns--Hear Her Now campaigns for maternal mortality,
toolkits for suicide prevention for youth. Parental toolkits.
We are actively not only doing the surveillance and the
studying of this, but also the--in the communities for the
toolkits on the prevention side.
Senator Kaine. Right, thank you. I yield back, Chair
Murray.
The Chair. Thank you.
Senator Paul.
Senator Paul. Dr. Fauci, as you are aware, it is a crime to
lie to Congress. Section 1001 of the U.S. Criminal Code creates
a felony and a five-year penalty for lying to Congress. On your
last trip to our Committee on May 11, you stated that the NIH
has not ever and does not now fund gain of function research in
the U.S. Institute of Virology. And yet gain of function
research was done entirely in the Wuhan Institute by Dr. Xi and
was funded by the NIH.
I would like to ask unanimous consent to insert into the
record the human virology paper entitled, Discovery of A Rich
Gene Pool of Bats SARS Related Coronaviruses. Please deliver a
copy of the Journal article to Dr. Fauci. In this paper, Dr. Xi
credits the NIH and lists the actual number of the grant that
she was given by the NIH. In this paper she took two bat
coronavirus genes, spiked genes, and combined them with a SARS
related backbone to create new viruses that are not found in
nature.
These lab created viruses were then shown to replicate in
humans. These experiments combine genetic information from
different coronaviruses that infect animals but not humans to
create novel artificial viruses able to infect human cells.
Viruses that in nature only infect animals were manipulated in
the Wuhan Lab to gain the function of infecting humans.
This research fits the definition of the research that the
NIH said was subject to the pause in 2014 to 2017, a pause in
funding on gain of function. But the NIH failed to recognize
this defines in a way, and it never came under any scrutiny.
Dr. Richard Ebright, a molecular biologist from Rutgers,
described this research in Wuhan as, ``the Wuhan lab used NIH
funding to construct novel chimeric SARS related coronaviruses
able to infect human cells and laboratory animals.
This is high risk research that creates new potential
pandemic pathogens--potential pandemic pathogens that exist
only in the lab, not in nature. This research matches,'' these
are Dr. Ebright's words, ``this research matches, indeed
epitomizes the definition of gain of function research done
entirely in Wuhan,'' for which there was supposed to be a
Federal pause.
Dr. Fauci, knowing that it is a crime to lie to Congress,
do you wish to retract your statement of May 11th where you
claimed that the NIH never funded gain of function research in
Wuhan?
Dr. Fauci. Senator Paul, I have never lied--.
Senator Burr. Microphone.
The Chair. The Microphone.
Dr. Fauci. Senator Paul, I have never lied before the
Congress, and I do not retract that statement. This paper that
you were referring to was judged by qualified staff up and down
the chain as not being gain of function.
Senator Paul. What does--.
Dr. Fauci. Let me finish----
Senator Paul. You take an animal virus, and you increase
its transmissibility to humans. You are saying that is not gain
of function?
Dr. Fauci. That is correct. And Senator Paul, you do not
know what you are talking about, quite frankly. And I want to
say that officially. You do not know what you are talking
about. Okay, you get one person--can I answer your question?
Senator Paul. From the NIH definition of gain of function--
this is your definition that you guys wrote. It says that
scientific research that increases the transmissibility among
mammals is a gain of function. They took animal viruses that
only occur in animals, and they increased their
transmissibility to humans. How you can say that is not gain of
function.
Dr. Fauci. It is not.
Senator Paul. It is a dance, and you are dancing around
this because you are trying to obscure responsibility for 4
million people dying around the world from a pandemic.
The Chair. Let's let--Dr. Fauci.
Dr. Fauci. I have to--well, now you are getting into
something. If the point that you were making is that the grant
that was funded as a sub-award from Eco Health to Wuhan created
SARS-CoV-2, that is where you are getting. Let me finish.
Senator Paul. We don't know. We don't know if it did--but
all the evidence is pointing that it came from the lab, and
there will be responsibility for those who funded the lab,
including yourself.
Dr. Fauci. I totally resent--.
The Chair. This Committee will allow the witness to
respond.
Dr. Fauci. I totally resent the lie that you are now
propagating, Senator, because if you look at the viruses that
were used in the experiments, that were given in the annual
reports that were published in the literature, it is
molecularly impossible--.
Senator Paul. No one is saying those viruses caused it.
Dr. Fauci. It is molecularly--.
Senator Paul. No one is alleging that those viruses caused
the pandemic. What we are alleging is the gain of function
research was going on in that lab and NIH funded it.
Dr. Fauci. That is not----
Senator Paul. You can't get away from it. It meets your
definition, and you are obfuscating the truth.
Dr. Fauci. I am not obfuscating the truth, you are the one.
The Chair. Senator Paul, your time has expired, but I will
allow the witness to----
Dr. Fauci. Let me just finish. I want everyone to
understand that if you look at those viruses, and that is
judged by qualified virologists and evolutionary biologists,
those viruses are molecularly impossible to result in SARS-CoV-
2.
Senator Paul. No one is saying they are. No one is saying
those viruses caused the pandemic. We are saying they are going
to function viruses--.
Dr. Fauci. They are not--.
Senator Paul. Because they are animal viruses that became
more transmissible in human, and you funded it. Why won't you
admit the truth?
Dr. Fauci. You are implying----
The Chair. Senator Paul, your time has expired, and I will
allow witnesses who come before this Committee to respond.
Dr. Fauci. You are implying that what we did was
responsible for the deaths of individual--I totally resent
that--.
Senator Paul. It could have.
Dr. Fauci. If anybody is lying here, Senator, it is you.
The Chair. Senator Smith.
Senator Smith. Thank you, Dr. Fauci. And thanks to all of
our panelists for being here today. And thank you, Chair Murray
and Ranking Member Burr. I just want to say, Dr. Fauci, is
there anything more that you would like to say to counteract
these attacks on your integrity that we have all just
witnessed?
Dr. Fauci. Well, Senator, thank you. I don't think I have
anything further to say. This is a pattern that Senator Paul
has been doing now at multiple hearings based on no reality. He
is talking about gain of function. This has been evaluated
multiple times by qualified people to not fall under the gain
of function definition. I have not lied before Congress. I have
never lied, certainly not before Congress. Case closed.
Senator Smith. Thank you. So we are 6 months into this
pandemic, and I think we are at a critical moment. Two-thirds
of adults have received at least one dose of the vaccine. And
at the same time, we are seeing cases rising to about 41,000 a
day. As Dr. Walensky has said, we have an epidemic here of the
unvaccinated. And--but, of course, this continues to affect
every single one of us. So it seems to me that our actions and
messages in this moment are going to make a huge difference in
whether we move forward or backward, not only here in the
United States, but everywhere in the world.
Today, as I was walking into this Committee hearing, for
the first time in months, I saw a line of people waiting
outside of a pharmacy for testing and vaccines. And it made me
wonder whether the recent surge of the delta variant is getting
people's attention and moving them from indecision to action.
What a terrible way for this to happen. But--so I have a few
questions just I hope clear up some of the misinformation and
misunderstandings. Dr. Fauci, the COVID-19 vaccine protects
against the delta variant, is that correct?
Dr. Fauci. It protects against the clinically apparent
disease, and it protects extremely well against hospitalization
and death.
Senator Smith. Right. So if you are not vaccinated, given
how contagious the delta variant is, I mean, it is--would it be
fair to say you are almost--you are very likely to get this
variant. To get the COVID-19 variant, would you say?
Dr. Fauci. Well, certainly when you look at the capability
of this virus to transmit from people to people. I mean,
obviously you have to be in an environment in which the virus
is present. So if you are in it, for example--and I believe Dr.
Walensky mentioned that in her remarks. If you are in an area,
be it a state, a city, a county or what have you, well, you
have a high level of infection in the community and a very low
level of vaccinated people, the chances in that environment of
getting infected are reasonably high.
Senator Smith. Right. And how do you compare, how do you
think about the risks--the side effect risks of the COVID-19
vaccine compared to the risks of not being vaccinated? Because
this is, I think, what people are struggling with.
Dr. Fauci. Right. It refers to the risk benefit ratio of
getting a vaccination. And every time this has been evaluated,
not only with this vaccine, but with so many other vaccines,
there is no intervention that is without some time getting an
adverse event. I mean, I don't think I can think of one that
hasn't.
When you have that situation, you balance the rarity or the
uncommonness of a particular adverse event with the advantage
that you would get from protecting yourself against the actual
disease against which you are vaccinated. And thus far,
whenever this has come up about an adverse event, it has been
evaluated, perhaps even a warning has been given, but it is
always weighed on the part of saying that the benefit of the
protection of the vaccine outweighs the risk of the adverse
event.
Senator Smith. Thank you. Dr. Walensky I talk with public--
I have spoken with a lot of public health experts in Minnesota
who tell me that they are still challenged getting especially
younger adults who are eligible to be vaccinated, getting them
vaccinated. And part of it is the challenge, this perception
that COVID is just not that big a deal for younger people,
people who consider themselves healthy and have got a strong
immune system and so forth. So let me ask you this. Are there a
larger number of younger people getting hospitalized today
versus a year ago or 6 months ago?
Dr. Walensky. We have seen hospitalizations go up for every
age bracket recently as cases go up. Proportionally because
there are more cases now among younger people, we are seeing
more of those people in the hospital. They still get
hospitalized at a less frequent rate given unvaccinated than
elderly patients. But in fact, because there are more of them
now that we are seeing more of them in the hospital.
Senator Smith. Okay. So another good piece of advice there
to have, being aware of the risk, even if you are--even if you
see yourself as young and healthy.
Dr. Walensky. Absolutely.
Senator Smith. Thank you, Madam Chair.
The Chair. Thank you.
Senator Moran.
Senator Moran. Madam Chair, thank you. Thank you and
Senator Burr for today's hearing. Thank you for the witnesses
for being here. Let me start with Dr. Walensky, please. Doctor,
in May, the CDC announced new guidance for fully vaccinated
individuals, that they could resume activities without wearing
a mask or staying socially six feet apart.
At that time, the CDC further said that they would continue
to update guidance for travel as the science was developing and
they would need to collaborate with other agencies regarding a
face mask requirement. A month later, a number--me and a number
of my colleagues sent a letter to the CDC and the TSA asking
for an update regarding the mask requirement during travel.
While we had a response from TSA, we have not had it yet, a
response from CDC. And I wondered if you would tell me where
the CDC is in the process of updating the mask requirement for
fully vaccinated individuals while traveling.
Dr. Walensky. Thank you for that question, Senator.
Obviously, as you know, the discussion about masking on Federal
aviation and ships is an interagency process, not simply with
CDC. I will say a lot has changed since May 13th. As you heard
from Dr. Fauci, we now have a variant circulating in this
country that is at the time was less than 3 percent and is now
83 percent and much more transmissible.
We are continuing those conversations, working toward a
letter back to you. Thank you for your patience. And we will
continue to revisit that as we learn more about vaccine
efficacy, as we learn more about transmission in the context of
vaccination, and as we understand more about the delta variant.
Senator Moran. Are you expecting a change in the expiration
date of that continued requirement?
Dr. Walensky. I think we still have more looking to do with
that.
Senator Moran. Let me turn to Ms. O'Connell. Ms. O'Connell,
you are not the perfect witness from HHS for my statements or
questions, but you are my only witness from HHS for my
statements. It is a bit about the future, which you are fully
engaged in. We need a better response to public health
emergencies. And I want to talk about--in that regard, I want
to talk about the parameters of the provider relief fund. HHS,
in my view, is terribly slow in their release of guidance and
on how the funds could be utilized.
There has been a lot of confusion by health care providers.
They have been reluctant to spend the money. It is--we are
incapable of solving problems if the resources that we provide
to those who are in the health care field, they are not
utilized because they are fearful that they don't know what the
guidance is and therefore, if they make a mistake, they have
penalties at a later date.
I guess the question that could be for you, what is the
plan to get HHS to perform better or more quickly so that
providers have the necessary information and comfort level to
take the steps necessary to prevent the spread of the virus and
to care for the health care of Americans and others?
The part that doesn't necessarily involve you, but in hopes
that HHS is otherwise listening, there is about $24 billion
left unspent in the Provider Relief Fund and we have been
anxiously awaiting always with the answer that it is in the
works about assistance and care for facilities that care for
our senior populations. And there is still no answer in that
regard.
I don't know that you have a comment necessarily on that
part of my commentary, but again, I would utilize this as an
opportunity to try to get more certainty at HHS on the spending
of those dollars.
Ms. O'Connell. Senator Moran, thank you for your question,
for both parts of it, and I certainly appreciate how
frustrating it has probably been not to have the clarity that
you and your constituents have been seeking.
We will take the comments that you have made today and
bring them back to the secretary and other parts of HHS senior
leadership to make sure that we understand how important it is
that this money is moving quickly, and that the guidance comes
out expeditiously and that we can do all we can to support. I
mean, we really want to do all we can to support your
constituents.
It is helpful to know that this has been a problem, and I
look forward to working with you and your staff on it.
Senator Moran. If you can accomplish that, the purpose of
my comment will be satisfied. I would particularly ask that
someone from HHS respond to us about the provider relief fund
as it relates to senior care living circumstances.
Dr. Fauci, in the 24 seconds I have left, I will just ask a
quick question. What are the necessary steps--you have talked
about mental health. What are the necessary steps to mitigate a
mental health and drug overdose crisis? What should Congress
and American institutions be doing today for a future pandemic?
Dr. Fauci. Well, first of all, I think the lesson that we
have learned from this, and we would hope in good preparation
for what will inevitably be another challenge in the future,
can't predict when, is to realize the important mental health
impact that this outbreak has had, not only in the suffering
from the disease itself, but from the extraordinary disruption
of our society, which I think we are going to have to realize,
that even when we get this under control, the mental health
effects of this are going to be following this for months if
not years afterwards.
We can't forget that. When the outbreak is over, the mental
health effects are not going to be over. They are going to
linger. And that is what we really need to address.
The Chair. Thank you.
Senator Rosen.
Senator Rosen. Thank you, Chair Murray, Ranking Member
Burr, for holding this vitally important hearing today. And I
really want to thank all of the witnesses for helping to get
our Country vaccinated. It is so important to every person that
we know and love in our community and our personal lives that
we do everything we can to save them and protect them, and I
appreciate your hard work in this regard.
I just want to speak a little bit about vaccine outreach,
because our Country--we have made tremendous progress over the
past several months in making the vaccine available to most
individuals, to getting shots and arms. I have had the honor of
going to some of the vaccine sites, of course, clinics in my
home State of Nevada. Our health care heroes, they are pillars
of strength in our communities, showing up day after day to be
sure that everybody that wants a vaccine can get one.
We just can't lose ground. But unfortunately, Nevada is--
our cases are growing, and we seem to be getting to the top of
the list nobody wants to be in, in the cases of the delta
variant. I am extremely concerned about the lag in vaccination
rates. In fact, last week, especially a nursing home, Senator
Cortez Masto and I sent a letter to Secretary Basara to raise
concerns about the low reported vaccination rates in Nevada's
nursing homes. And we have to find a solution to protect those
most vulnerable who can't go out to a site and even their loved
ones couldn't take them.
Dr. Walensky, are there any plans for the CDC or in
coordination with other agencies to restart the pharmacy
partner program that sent teams directly to every nursing home,
perhaps, or every facility with less than a 90 percent
vaccination rate for residents and staff and I might even say
families of staff who they go home to?
Dr. Walensky. Thank you for that question, Senator Rosen.
And we recognize this challenge, and we are with you. And that,
in fact, we have 10 CDC people deployed to Nevada right now
working to assist. You know, part of the long term plan in
terms of working to vaccinate our long term care facilities,
not necessarily these staccato partnerships with the
pharmacies, but to have a longitudinal plan, because, in fact,
especially in our long term care facilities, there is quite a
bit of turnover of the patients.
We want to make sure that there is always vaccine
available. Many of these long term care facilities have access
to pharmacies, and we want to make sure that there is a vaccine
actually active in the pharmacies so that they can do
vaccination when patients come in. I agree with you and in fact
we need to work to get our staff vaccinated as well. In fact,
staff in some of these long term care facilities are 20 percent
less coverage than the facility members themselves--the
residents themselves.
We are working on confidence in those areas, but
specifically strike teams in with a long term care facilities
to assist in getting vaccine to those places that is not
reliant on a one time mass vaccination, but really has a
longitudinal plan to make sure vaccine can be available in the
long term.
Senator Rosen. Yes, and I would hope that you would include
the families of the staff, because oftentimes they have a high
turnover, too. They go home to their community and are just
going to keep putting out that fire over and over. But I would
like to switch now and talk a little bit about the research in
vaccines, because obviously we are discovering more about COVID
every single day.
I think for years to come, we are going to continue to
learn. And so now is the time to take those additional steps to
say--to see we don't look back and find gaps in data that could
have been prevented, those gaps could have been prevented if we
had acted sooner, speaking of longitudinal. And so data like
this could save lives. That is why I introduced the Ensuring
Understanding of COVID-19 to Protect Public Health Act. And it
is bipartisan legislation that requires long term those
longitudinal studies on a variety of COVID patient population
with regular public reporting.
For example, some of the recent research is showing that
COVID-19 vaccine may actually improve symptoms for some
patients with long haul COVID. So, Dr. Fauci, how do we--what
do we know about this so far and how common is the vaccine to
be a strong prevention tool, but also to work therapeutically
in this case? And what else should we be studying?
Dr. Fauci. Very good point, Senator. And there has been
anecdotal reports of people who have been infected, have
developed long COVID, and their symptoms have been improved
upon getting the SARS-CoV-2 vaccine. That has not been proven
under the scrutiny of a clinical trial.
Right now, we are looking at individuals who actually have
recovered and seeing if, in fact, vaccination does improve.
Right now, although the anecdotal cases suggest that I don't
think we can say anything definitively from a scientific
standpoint, but that is something that is being looked at.
Senator Rosen. Thank you. I see my time is up. Thank you.
The Chair. Thank you.
Senator Romney.
Senator Romney. Thank you, Madam Chair. And thank you to
the members of our panel today for being here responding to our
questions. Thank you also to the teams of people that you work
with. Their tireless work over the last year and a half is
something which many of us feel a great deal of gratitude for,
for that effort. As we try and understand vaccine hesitancy, I
am sure some of that is due to spurious conspiracy theories.
Perhaps and I don't know this, but social media may be
populated in part by enemies of our Country that are putting
out theories to try and get people not to take vaccines. But
there is also, I believe, another reason why some people who
are not prone to believe those conspiracies don't get
vaccinated, and that is because they don't know what the data
really suggests. And they wonder, Okay, is this really a good
thing for my 16 year old?
What are, the serious side effects of this vaccine for a 16
year old versus the probability of them getting very ill? And I
wonder, do we provide or is there a place where people can go
to find out what the data show for the side effects of vaccines
by age group and how many serious complications there are for
people of different ages and then compare that perhaps with the
serious implications of getting COVID? And I will ask first,
Dr. Walensky.
Dr. Walensky. Yes. Thank you very much, Senator Romney. In
fact, that is exactly what we are doing. So, one of the things
I think that is so important to understand is that when people
don't want to be vaccinated it's for a whole host of reasons.
And until you start talking to them about what is their reason,
is it, I can't take off work tomorrow and I may feel unwell, is
it because I don't understand these potential side effects for
my 6 year old?
We and CDC have what we call vaccine confidence consults.
So we have state departments, local health departments who can
call into us and say, these are the things that we are hearing
on the ground. What is the real data so that we can have
trusted messengers for providing that real data in real time to
people and making sure that their answers are--their questions
are answered and that we can empower the people who are the
trusted messengers on the ground with exactly those data.
Senator Romney. Is that information being collected? Are
doctors and hospitals actually collecting the data that shows
how many people are getting side effects by age group? Are you
getting accurate information that people can rely upon?
Because, again, I see on social media and some broadcasters a
sense that somehow this is being hidden, that the side effects
are being underplayed, that you have an incentive not to let
people know what the kind of side effects might be and the
seriousness of those side effects.
Dr. Walensky. The answer is absolutely. We have numerous
large scale mechanisms by which to collect these data. We have
the first ever V-safe monitoring program where people are--
given their vaccine, how did they do today? How are they doing
in a week? We have the Vaccine Adverse Event Reporting System.
That is a passive reporting system.
Everything gets reported, is supposed to get reported but
we recognize it is passive. Things may get missed. And then we
actually also have the vaccine safety data link, which is a
link of nine academic centers that were able to get real
vaccine data as well as their denominators, which is hard to
get in passive reporting so we can check numerators and
denominators there and give us real estimates. We are doing--we
are covering the gamut.
Senator Romney. The talk that Senator Burr described with
regards to getting a booster, the suggestion from Israel is it
makes sense. There are a number of us that would get in line to
get a booster. How long is it going to take before we are able
to get sufficient information to allow Americans who want to
get an additional vaccination to be able to do so? Are we
talking weeks, are we talking months? I mean, I guess given the
fact that this is being done overseas, can we not use the data
that has come from those places to allow people in this country
to get a third shot if they want to?
Dr. Woodcock. The agencies represented here are all
monitoring this extremely carefully. As you have heard, 95-99.5
percent of all people are being hospitalized now are
unvaccinated. So at the moment, the people that are getting
sick are the people who haven't been vaccinated.
Senator Romney. I understand but I am looking at the data
that is coming from Israel, and people who have double
vaccinations are still susceptible to the delta variant for
serious disease and death. And they are showing that if they
get a booster, that dramatically is reduced. Why should we not
allow people who are elderly or have other compromised
conditions to be able to get that booster?
Dr. Woodcock. Certainly. We are looking at all that.
Remember this vaccine right now, the vaccines that are under
emergency use authorization require an additional authorization
for a booster.
Senator Romney. How long is that going to take? That is a
question. We have people who want to get that booster, and I am
hearing that from people who are at risk and concerned. They
want to take that booster. They are willing to take the
additional risk of something that has not been--they have
already had two shots of it. They are saying, give me the
third, because I got this over a year ago. I got the
vaccination over a year ago. I want to get that protection. Why
can't they? And if--I understand, you won't let them yet. But
when will you let them?
Dr. Woodcock. Well, Pfizer, at least has announced that it
is going to submit to their EUA data, both Pfizer data and
Senator Burr's early point, other Israelis--other data that
they have available to potentially make the case for a booster.
So the FDA will be looking at that.
Senator Romney. I am sure you will. I don't like the
timeframe, frankly, given the fact that this is being done
elsewhere. My time is up so I will turn back to you, Chair.
The Chair. Dr. Woodcock, for clarification, Pfizer has not
requested FDA to approve a booster?
Dr. Woodcock. Well, of course, I can't talk about that, but
Pfizer has publicly announced that they are going to submit an
amendment to their EUA to request--for a booster dose.
The Chair. Thank you.
Senator Hassan.
Senator Hassan. Well, thank you, Chair Murray and Ranking
Member Burr. And thank you to all of our witnesses today for
the work you do. I want to just start to talk about a recent
news item. It is a deeply disturbing report detailing dangerous
inequities that USA Paralympians are facing at this year's
Tokyo Paralympics. Becca Myers is a six time Paralympic
medalist who won three golds in Rio 5 years ago. She is deaf,
blind, but in the past, that hasn't stopped her from competing
and winning at the highest levels.
This year, though, she and other athletes from Team USA who
experienced disabilities are being denied adequate access to
personal care assistants, reportedly due to COVID-19
restrictions. Individuals who experience disabilities should
not be forced to navigate the Tokyo Olympics without the
support that they need in the midst of a global pandemic. Becca
announced on Sunday that she is quitting the team because she
is being denied a, and this is her quote, ``reasonable and
essential accommodation'' that would enable her to compete.
This is an outrage and a preventable situation that should
never have gotten to this point. So I want the U.S. Olympic and
Paralympic Committee to work immediately to address this issue,
and I want them to ensure that all of our athletes are able to
compete safely at this summer's game, including by providing
them the basic supports that they need just to navigate the
world. So I do have a question though, Director Walensky,
because over the last year and a half, the CDC has provided
guidance on how to mitigate the risk of COVID-19 in various
activities, as well as special events, including sports.
I have a question that you all could answer in writing. You
can comment on it now if you would like. But what I am
interested in is your best guidance regarding COVID-19
mitigation, taking into account the needs of people with
disabilities. So if you would like to comment now you can or we
can just do it in writing.
Dr. Walensky. Maybe I will just comment and say I share
your concern. We have dedicated resources specifically to
disabled communities, especially those who are unable to come
out and get vaccinated. I think probably the details of
individual sports, which we can do by writing, but I just want
to echo your concerns.
Senator Hassan. I just want to be clear that for some
people with disabilities, the accommodation, the aid they need
is another human being. And it really needs to be seen as the
same kind of accommodations we would make in other situations.
So I appreciate having an ongoing discussion with you about it.
Now, I would like to turn to you, Ms. O'Connell. Last year,
many states, hospitals, and First Responders struggled to
acquire personal protective equipment, and the Federal
stockpile did not contain the supplies needed to fulfill their
requests for help. The stockpile also contained many expired
and unusable products, which further limited its effectiveness.
I recently introduced bipartisan legislation with Senator
Cassidy that would improve transparency into the stockpile,
authorized transfers of expiring products, and assist states in
establishing and maintaining their own stockpiles in order to
help avoid the kinds of challenges that we faced last year.
What steps are you taking to improve the stockpile, and
will you continue to work with us on this bipartisan
legislation to make further improvements?
Ms. O'Connell. Senator Hassan, thank you so much for your
question. This is a place where I intend to spend a lot of time
in my new role. I am pleased to report that ASPER has spent and
invested over $10 billion in supplemental funds to restock the
stockpile.
We currently have 35 times the number of N95 respirators we
had at the beginning of the pandemic. We have 17 times the
number of gloves, 8 times the number of masks, and of the N95
masks, all 12 contracts are with domestic manufacturers. So we
are beginning to see some progress.
Senator Hassan. Will you work with us on the bipartisan
legislation that Senator Cassidy and I have introduced?
Ms. O'Connell. I would look forward to. Thank you, Senator.
Senator Hassan. Thank you. Dr. Fauci, I have a question for
you about pediatric vaccines. Many parents and family members
are understandably eager for updates on the potential
availability of COVID-19 vaccine authorized for use for
children under 12. I am encouraged that clinical trials for
young children are underway, and I am hopeful that we will see
the same safety and efficacy that we have seen from previously
authorized COVID-19 vaccines. Doctor, when do you believe
parents and families can expect trials to yield the type of
data needed to pursue authorization for use in children under
12?
Dr. Fauci. Thank you for that question, Senator. From the
standpoint of the data that would be required to make a
decision, that very likely when you do the age de-escalation
studies, so we have gone from 12 to 9, 9 to 6, 6 to 2, and then
6 months to 2 years, likely by late fall, early winter, we will
have enough data. But that doesn't mean that then it is all of
a sudden going to be allowed to happen. That will be a
regulatory decision that the FDA will have to make.
Senator Hassan. Well, thank you. And I see that I am out of
time. I will follow-up with you in writing because I am also
interested in what you think we could do now to help boost
confidence and uptake for the pediatric population once the
approval is authorized.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. Thank you, Madam Chair. My first question
for Dr. Walensky. As a physician, we always want to be able to
know and discuss the benefits and risk of anything that we are
prescribing, including a vaccine. It is estimated that 40,
maybe 50 percent of children have already had the COVID virus.
What are the additional benefits to the vaccine to a child who
has already had the virus?
Dr. Walensky. I think it very much depends on what that
variant that child might have had, whether they could
potentially be infected or reinfected. And one thing I just
want to note with the children is I think we fall into this
flawed thinking of saying that only 400 of these 600,000 deaths
from COVID-19 have been in children. Children are not supposed
to die. And so 400 is a huge amount for a respiratory season.
Senator Marshall. Thank you. Dr. Woodcock, how many
children under the age of 18 without a preexisting condition, a
significant health condition, have died from COVID in this
country?
Dr. Woodcock. I don't--I don't have that at my fingertips.
I am sorry.
Senator Marshall. Dr. Walensky.
Dr. Walensky. Over 400
Senator Marshall. Without a pre-existing----
Dr. Walensky. That, I don't know.
Senator Marshall. The answer is probably zero. So I think
if you take a deep dive, most of the children that have died
had some type of underlying health condition. Dr. Fauci, in my
hand is a three dimensional printing of the COVID spike,
something that is certainly a scientific--just baffles me in so
many ways.
It is composed of two units, as you know. There is an S2
subunit and an S1. And I would like for you to talk about the
S2 subunit for a second. Can you explain the significance of
the furin cleavage side, the double arginine CGG codon, if you
would, and how that works clinically for us?
Dr. Fauci. Yes. Thank you for that question, Senator. The
furin cleavage site is a site of a set of amino acids, which is
at the point where the enzyme furin can cleave it so that the
virus can then bind to the receptor cell and then enter the
cell. So what is seen on a number of viruses, it has been seen
on the SARD-CoV-2 and it is also seen on other beta
coronaviruses. You asked also about the double CGG codon that
is a codon again, that is unusual, but it is also seen on a
number of beta coronaviruses. It is not a very common codon for
the amino acid in question, but it is seen in coronaviruses.
Senator Marshall. Dr. David Baltimore, a Nobel Laureate, I
will quote him here, ``when I first saw the furin cleavage side
in the viral sequence with this arginine codon I said to my
wife, it was the smoking gun for the origin of the virus. These
features make a powerful challenge to the idea of a natural
origin for SARS-2.'' And again, this is Nobel Laureate, Dr.
David Baltimore saying this. Would you agree or disagree with
Dr. Baltimore?
Dr. Fauci. Well, Dr. Baltimore, who is an extraordinarily
accomplished scientist, has backtracked on that statement, and
says, I wish I had not used the word smoking gun when it was
pointed out to him that actually this is seen in a number of
coronaviruses, including one of the common cold coronaviruses.
So I believe, if you would ask--.
Senator Marshall. You disagree with him?
Dr. Fauci. Well, I agree with his second statement where he
backtracked and said he wished he had not--.
Senator Marshall. You disagree with his first statement
though?
Dr. Fauci. He disagrees with his first statement.
Senator Marshall. Okay, not going to answer the question.
We also have the S1 subunit, and I refer to the timeline behind
me here that there was a moratorium placed for viral gain of
function in 2014. And I think you will agree with me that the
NIH funded research that led to this, an S1 spike that looks
very similar, if not exactly to what is on the COVID-19 spike.
Dr. Fauci. What are you referring to, Senator? Can you
please be more specific?
Senator Marshall. Yes. So I am talking about the S1 subunit
of the current COVID-19 spike.
Dr. Fauci. What about it? I mean, are you talking about an
experiment or are you talking about a paper that was published?
Senator Marshall. I am talking about viral research that
was done using NIH funding with the North Carolina lab and Dr.
Xi developed this S1 subunit spike that looks exactly like what
we have on the current COVID-19 spike. Is that not true?
Dr. Fauci. No, I am not sure exactly what you are referring
to. Are you referring to the paper of Baric and Xi in Nature
Immunology? Is that what you are referring--I need to know
specifically.
Senator Marshall. Yes, Dr. Baric and Xi printed studies on
this S1 unit that was basically the development of the key to
the door that was--specifically took the original SARS virus
and made it so it would bind to the human lung cells.
Dr. Fauci. No, there was gain--if you are referring,
Senator, to gain of function by the definition.
Senator Marshall. That is not my question. Would you agree
that the spike that was developed there is was also on the
current--
Dr. Fauci. Yes, but that is irrelevant to anything until
you have a context in which you are putting it. You are talking
about an S1 and a spike in what context? If you are talking
about a paper that was written by them.
Senator Marshall. But would you agree or disagree that it
is the same spike?
Dr. Fauci. I am not sure what you are talking about,
Senator. I am really not sure what you are talking about.
Senator Marshall. Okay, thank you.
Dr. Fauci. Alright.
The Chair. Thank you.
Senator Casey.
Senator Casey. Thank you, Chair Murray. And I want to thank
the panel for being here today and for your public service. A
challenging time for the country. I just wanted to make a
couple of statements at the top. Assistant Secretary O'Connell,
I was--I want to ask you a question, but just wanted to note on
page four and five of your testimony about the information
about the inventory that you have built up. We are happy to
read that. I won't go through it all.
Also the statement you made about ensuring, ``ensuring a
safe and consistent supply chain for medical materials,
ingredients and supplies is critical for any national response
to public health emergencies.'' I couldn't--we couldn't be, I
should say, more pleased with that kind of a focus, because we
are going to need that in the future. Dr. Walensky, there was
an earlier question, I think, by Senator Hassan talking about
nursing homes and nursing home workers in particular.
I want to ask you a question, because I have got a separate
question. But the lower vaccination rate for nursing home
workers is of concern. We are told by Federal data that there
are still 13 states with less than half, less than half of
nursing home workers have been vaccinated. So the message about
vaccinations couldn't be more important.
Last thing I would say, Dr. Fauci, in reference to the
questions by Senator Paul today and the accusation, I think it
is a widely shared view in both houses, in both parties that
the integrity that you bring to your work and the knowledge you
bring to your work on behalf of the Nation, that I think that
sentiment is a broad and deep reservoir, and it is very, very
much bipartisan. I want to ask you to comment on that.
But I wanted to--I have a question for Dr. Fauci and Dr.
Walensky about breakthrough infections. We know that even with
any--even with the great success of the vaccines, there is no
100 percent effectiveness. So I wanted to ask you about
breakthrough infections. I haven't seen, maybe it is available,
but I haven't seen information about either breakthrough
infections or enough information about cases of long COVID,
because--I assume because of a lack of data.
Dr. Walensky, I would ask you, what types of data is CDC
collecting to track breakthrough infections? And how are both
CDC and the National Institute of Allergy and Infectious
Diseases, Dr. Fauci, using data to monitor outcomes in patients
with breakthrough infections?
Dr. Walensky. Thank you, Senator. So there are different
ways that we are capturing these data. And I think all of them
fit together in a puzzle. One is passive surveillance where
folks give us data when they break through, the hospital
systems provide us data. They know that somebody is
hospitalized and has a history of vaccination. We want to know
about those cases to the extent possible. We would like to have
a sample of the virus so that we can understand the viral load,
so that we can sequence it, we can understand their symptoms
and their risks that potentially put them in that situation.
However, that is actually limited because it actually
doesn't give us the denominator. We don't know who else would
have been reporting or who we missed in that process. And in
order to do real effectiveness studies, we need to have both
the numerator of the cases as well as the denominator. So we
are doing many of those studies across the Nation. We do have
them geographically sampled. We have a long term care facility
study where we are getting data from over 14,000 long term care
facilities. We have a health worker study.
We have an essential worker study. That is 5,000 essential
workers that are being tested by PCR every single week. And we
have numerous other cohorts in 19 academic medical centers, 187
hospitals to monitor both the numerator, how many people are
breaking through, how serious is their infection, as well as
the denominator, how many people overall were vaccinated, so we
can get a really good window as to the breakthrough--the
percentage of people who are breaking through.
Senator Casey. Thank you.
Dr. Fauci.
Dr. Fauci. Well, thank you very much for your prior
comment, Senator. That is much appreciated. With regard to your
question, I think people need to appreciate when you talk about
breakthrough infections, that the original data from the
clinical trial, the efficacy data, was based on preventing
clinically apparent disease, not preventing infection such as
asymptomatic infection.
When you hear about a breakthrough infection, that doesn't
necessarily mean the vaccine is failing because it is still
holding true, particularly with regard to protection against
severe disease, leading to hospitalization and deaths.
As per your question, what are we doing? We will be
following for two-years the people who are in the clinical
trials, the 30,000 and 44,000 people, to be able to determine
just what percent now in the context of the delta variant are
actually breaking through, to determine if it is more than that
original that we saw or in the context of delta, if it is
actually much more.
Senator Casey. Thank you, Doctor. Thank you, Chair Murray.
The Chair. Thank you.
Senator Cassidy.
Senator Cassidy. Thank you all. I will ask--if I cut you
off, it is not--I am not being rude, I just got 5 minutes. Got
to hustle. Ms. O'Connell to follow-up on what Senator Hassan
said, thank you for replenishing the strategic national
stockpile. The one thing that troubled us is that there was no
first in, first out. There was no rotation of material before
it expired which was just dumped. What--just yes or no, have
inventory management systems been implemented to minimize the
wastage?
Ms. O'Connell. Thank you, Senator. Yes, we are looking at
that.
Senator Cassidy. Looking is a very vague term. If you are
one of my medical students on rounds, I would say, what does
that mean?
Ms. O'Connell. Well, one of the things we are pursuing is
the model of the vendor manage.
Senator Cassidy. Wonderful. Thank you. Second, related to
that, I am told there is a lot of vaccine that is about to
expire. So it is 6 months from being expired in a state which
is not completely using it. Unfortunately, my state, is among
those.
Ideally, from my perspective, we rotate that vaccine out to
the border for those who are coming across as undocumented or
down to Central America and Mexico, which is having these COVID
outbreaks. I am told there is contractual issues with that. But
is there any effort to rotate out soon to expire vaccine that
doesn't appear as if it is going to be used into a set in which
it could be used quite rapidly?
Dr. Woodcock. We have been working on this, and what we
have been advising the states is where they have repositories
to hold on to that vaccine because unlike most medical products
you are used to, we are making these stability determinations
on the fly.
Senator Cassidy. Dr. Woodcock, that is the news. You are
telling me that even if it goes beyond the expiration date,
that the vaccine can still be used?
Dr. Woodcock. No, I am saying we are telling people to hold
on to it, because when the additional stability--because we are
doing stability--the companies are doing stability on the fly
because we--
Senator Cassidy. I understand.
Dr. Woodcock. Yes, so we have extended the date once
already for one of the vaccines. We may be able to keep
extending as more stability--as there is longer stability
observed.
Senator Cassidy. But it still seems to me inevitably,
sooner or later, you are going to decide you have got to toss
it. Now, just an inventory management system. It seems wise to
be rotating that to a place where it would be taken up quickly
as opposed to a place where it is being taken up quite slowly.
Agree, disagree, and if you agree, any thoughts regarding that?
Dr. Woodcock. Well, that is really for probably ASPER to
talk about----
Senator Cassidy. Maybe for State Department.
Dr. Woodcock. Yes.
Senator Cassidy. Are there other contractual obstacles to
doing that? Because someone told me that the contracts with the
drug companies would not allow the transfer of the product to
another setting. We couldn't give it to Mexico, for example,
because it just has to be tossed. Do you know about that?
Dr. Woodcock. Well, they aren't FDA's contract so my
understanding is that it is possible under EUA to do exports
and that could be possible. So that--but we can get back to you
on that, because it really isn't an FDA issue.
Senator Cassidy. Sounds great. Next, as regards Dr. Fauci,
Walensky, it does seem to me this issue of Dr. Woodcock, of
whether or not we need a booster would be ascertainable by
whether or not we can see a response of antibody to re-
challenge within the window period is what, 4 days for the
virus between exposure and an onset of infection if the
antibodies after exposure to vaccine, if you will, mimicking an
infection, shoot up rapidly, we have got protection. Are any
studies taking place along these lines?
Dr. Woodcock. Yes, absolutely, both within the Government
and within the companies. And we certainly are--the Government
as a whole, the agencies involved are monitoring this very
carefully and we are sharing all the data. And we have heard
from----
Senator Cassidy. Now these are very simply done in very
short--and don't have a lot of timeframe. Obviously, the window
period is only 4 days. So, and I have asked about this before,
but it doesn't seem as if there are any answers. What is the
delay in knowing this? Because that would answer Senator
Romney's question as regards whether or not a booster is
required.
Dr. Woodcock. Well as Dr. Fauci said, there are two things
going on here. One is, when does immunity wane to the point
that you need to give a booster? Our populace is not just going
to--we can't just boost them all the time, right. We need to
boost them when it is appropriate.
Senator Cassidy. But isn't there a subset of people whom
you are following longitudinally that have negative antibodies?
Their antibodies are initially positive and now they have gone
on either very low or zero.
Dr. Woodcock. They are waning. I wouldn't say they are
negative. Obviously, Senator, Dr. Cassidy, there are going to
be people who don't respond to vaccination primarily because of
some immunocompromise. However, what is being followed is the
waning of humoral immunity, as Dr. Fauci described, over time.
But it is waning. It isn't vanished. And that is clear because
everybody who is getting hospitalized is unvaccinated and they
are being exposed to the delta variant. So the vaccination is
holding right now in the U.S.
Senator Cassidy. Good. I thank you all.
The Chair. Thank you.
Senator Lujan.
Senator Lujan. Thank you so much, Chair Murray, for this
important hearing, and to all of our witnesses for being here
today. While I am encouraged that data shows vaccine rates are
increasing across America, still less than half of Hispanics
have been vaccinated despite data showing that it is the least
vaccine hesitant group. Dr. Walensky, Federal investment in
community health centers increased Hispanic vaccination rates.
Yes or no, did this investment in this community save lives?
Dr. Walensky. I am grateful for your collaboration with
HRSA and the Federal qualified health centers, and I absolutely
think that being able to reach out to these communities has
saved their lives, some of their lives.
Senator Lujan. Dr. Walensky, additionally, when Hispanic
communities has received outreach in Spanish, it increased
vaccination rates. What is the plan to build on the success of
using culturally appropriate outreach and messaging to boost
Hispanic vaccination rates?
Dr. Walensky. I think we need to use culturally appropriate
messaging in all of our vaccination efforts. And not just in
our vaccination efforts, in all of our health care efforts. We
have--our vaccination toolkits are available in more than 20
languages. So it has to work within the vaccination of the
Hispanic community, but also many of our other harder to reach
communities.
Yes, we are continuing to do outreach by trusted messengers
in their own language and culturally sensitive ways. And in
fact, we are seeing that is working. We had a recent NWR in
North Carolina that demonstrated when we did this outreach, we
were able to reach Hispanic communities, increasing vaccination
rates from 8 to 19 percent.
Senator Lujan. Dr. Walensky, the next question I have is
along those lines. The Administration has enlisted Black owned
barbershops and beauty salons, as well as faith based community
outreach to promote the shots and even serve as vaccination
sites to increase Black vaccine rates. Which is important and I
applaud. Does the Administration have plans to employ similar
targeted outreach to the Hispanic community?
Dr. Walensky. The Administration is working to reach people
where they are and to understand the community by community,
what is it that community needs, to understand--to have trusted
messengers, whether it is in barbershops, whether it is in
faith based organizations, whether it is in grocery stores,
that is what we are working to do.
Senator Lujan. I would be interested if you could submit to
me or get to me what those plans are for outreach into the
Hispanic community, similar to the plans I just described. I
wish I could ask the panel similar questions about Native
American vaccination rates. IHS is not sharing the data, with
the exception of the good work that is happening in Alaska,
where Alaska is not depending on IHS to get vaccination rates.
We do not have state specific IHS data. Many officials have
told me they are going to fix this. It has not been fixed.
Please fix it. Let's get IHS on board. Let me ask each of you a
yes or no question, has disinformation on tech platforms
negatively impacted the response to the pandemic, Dr. Walensky?
Dr. Walensky. Yes. And in fact, it has propagated 70
percent more often.
Senator Lujan. Dr. Fauci.
Dr. Fauci. Yes, it has.
Senator Lujan. Dr. Woodcock.
Dr. Woodcock. Yes, absolutely.
Senator Lujan. Ms. O'Connell.
Ms. O'Connell. Yes, it has.
Senator Lujan. Assistant Secretary O'Connell, viruses don't
respect international borders, and for interconnected border
states like New Mexico, our physical and economic health
depends on international cooperation. I very much appreciate
the line of questioning from Dr. Cassidy. We need to do better
in this space and look for every available tool that exists to
make sure we are helping get vaccine out, especially into
neighboring countries across the Americas. What can the Federal
Government do to decrease COVID infections in border
communities?
Ms. O'Connell. Thank you, Senator, for that question. And,
I did want to follow-up on what Senator Cassidy asked and Dr.
Woodcock was responding to. It is a question of liability,
which is one of the things that we work through in these
contracts that need to be worked through when vaccines are
shared with other countries.
That is the contracting issue that can be an impediment.
But it is important, I think, that we offer tests and vaccines
where we can to prevent the spread of COVID in the border
communities.
Senator Lujan. I recently joined a CODEL to Latin America,
and one of the countries we visited in Ecuador, where I found
out that some of the vaccine formularies and samples have not
been made available to local regulators to approve the vaccine
anticipating if the United States can donate more vaccine or
there is more vaccine purchased.
Dr. Walensky and Dr. Woodcock--and I know my time is about
to expire. Maybe submit this into the record. How can the
Federal Government better coordinate internationally to ensure
that foreign regulatory bodies have the data and vaccine supply
so they can be approved locally? If you want to give me a quick
response so then I can follow-up into the record.
Dr. Woodcock. We have--we have collaborations with
regulators around the world through EKRA, which is the
International Medicines Group, Medicine Regulator Group, as
well as other ways. So we are actively reaching out to other
foreign regulatory authorities to give them information about
what we have done to review vaccines and what we know about
them.
Senator Lujan. Thank you. And I want to thank this trusted
panel. I certainly hope that we can stop the spread of
misinformation, that we can listen to the experts, and save
more people across America. Thank you for your commitment to
saving lives. I yield back.
The Chair. Thank you.
Senator Braun.
Senator Braun. Thank you, Madam Chair. Questions for Dr.
Fauci. I am a strong believer in First Amendment protections,
and we have obviously seen coming from the business world as
well, the tech industry carries so much clout. They are
monopolies as ones are defined. And when you have markets that
you control over 70, 80 percent, that is so much not only
economic power, but it is a lot of other power that goes along
with it. When you have any case where the Federal Government
gets in cahoots in any way with big companies like that, that
is almost unheard of.
Generally the Government would try to do something about
that. In February, Facebook included new criteria for removing
misinformation, and part of it was about the origination of the
COVID virus, which now has gone from what they were declaring
is misinformation to maybe the way we think it actually
occurred.
Facebook has said that they have made consultations with
leading health organizations. Was your organization, NIAID, one
of the leading health organizations Facebook consulted with
when deciding what speech to filter through?
Dr. Fauci. To my knowledge, Senator, that is not the case.
When you say consulting with my agency regarding what speech to
filter through, I don't ever recall or have ever heard of any
discussion about filtering speech.
Senator Braun. Did they consult with you on any topics, not
necessarily whether you would filter through it or not? Have
you been in contact with them to give them your personal
opinion on this or that?
Dr. Fauci. I don't know what you mean by this or that.
There was one communication or two perhaps with Mark Zuckerberg
in which he emailed me and wanted to know if there is anything
that he could do that I believe it was promoting vaccination or
making sure people do the right thing, wear a mask. But it was
mostly propagating a public health message. It had nothing to
do with the origins of the virus at all.
Senator Braun. Then do you, on a very frequent basis,
consult with him, either via email or do you have his cell
phone number, for instance?
Dr. Fauci. I have exchanged a few emails. You probably know
that because you are asking the question. About 10,000 pages of
my email have been FOIA'd. And in fact, there is an email
exchange or two between myself and Mr. Zuckerberg. I don't
recall--I can look it up right now and see if I have a cell
phone number. I am not sure I do.
Senator Braun. Well, you can get back to me on that. I am
guessing you might. My point is an entity like that, and we
have got 190 million users here in the U.S. and they are
getting into the fray on so many things. And they are the
classic example where there is too much concentration within
one entity. And in years past, we have done something about
that, not just let it kind of run its course. And we have never
had any of the big monopolies get involved with filtering or
censoring speech to boot.
Another question related to the White House, has recently
said that they are wanting to flag problematic posts. And
working for the President, would you be one that would try to
come up with whatever posts that are out there that need to be
flagged as misinformation?
Dr. Fauci. No, I have not at all been involved, even
indirectly, in that.
Senator Braun. Do you think there is a risk, even though
you haven't been involved, to the White House wanting to flag
stuff that they think is problematic, and then have that same
type of communication with entities like Facebook? Just your
opinion on that?
Dr. Fauci. No, actually, this is beyond my area of
expertise. I developed vaccines to save people's lives. I don't
get involved in flagging things, Senator. So, I am sorry.
Senator Braun. Let's then pivot to speaking of vaccines.
Dr. Fauci. Yes.
Senator Braun. When you entered grade school, there are
many vaccines that are mandated, and I think accepted over
time. Would you, and I would like Dr. Walensky to ask or answer
this as well, would you be for mandating ever a vaccine for
COVID-19 or any other variants as mandatory for getting into
grade school?
Dr. Walensky. I think first we need to see the data. I hope
they are efficacious. But first we need to see the data.
Understand the risk benefit. So I think that is premature at
this point.
Senator Braun. What data would you need beyond what we have
got to go to that next step of making that a mandate, along
with some of the others that have been so for a long time?
Senator Braun. We don't have--we don't have clinical trial
data in the grade school age population yet.
Senator Braun. I think that means for you that you might
considering further down.
Dr. Walensky. I think we need to see what the clinical
trial data to see the risk benefit and see the long term data.
Senator Braun. Dr. Fauci?
Dr. Fauci. I think the same thing. You have to make
decisions based on data. We don't have that data right now.
When we do, then we could address that decision.
Senator Braun. Thank you.
The Chair. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Madam Chair. So I have been
encouraged by this Administration's use of the Defense
Production Act to produce more pandemic supplies in the U.S.
And I was proud to be a part of the effort to secure $10
billion in the American Rescue Plan to increase the domestic
supply of PPP and other medical supplies. In 2020, the U.S. was
overly dependent on China, and we did not have sufficient
domestic sources of very critical PPE, which was exacerbated by
a shortage of raw materials.
When the pandemic hit, there was a bottleneck in the global
production of medical grade meltblown material that is
essential for N95 masks. Today, Wisconsin manufacturers have
the ability to provide the meltblowns to provide surge capacity
required to produce billions of N95 respirator masks. This type
of American manufacturing is exactly what we need to be
supporting.
Ms. O'Connell, I know that ASPER has used significant
funding to increase its inventory of supplies, but I am
concerned that if we don't focus some of our expenditures on
raw materials, we may remain dependent on China and other
countries. How is ASPER working to secure supplies of raw
materials like meltblown to make us better prepared for the
future?
Ms. O'Connell. Senator Baldwin, thank you so much for that
question and thank you for the work that you did to get that
$10 billion in the American Rescue Plan. We just recently had
released by OMB $2 billion of that $10, which is going to go
to, among other things, expanding manufacturing for raw
materials for vaccines. So that is one of the first efforts
that is going to--that money will be used for. It will also go
to make sure that we have enough fill-finish capacity, needles
and syringes, and it is just the start.
We are, of course, very anxious to get these contracts
awarded and moving. But it is the beginning of that $10 billion
going to exactly what you had hoped it would go to. Of course,
that is not enough. We have got more to go. But I just wanted
to share with you, that is where we are right now. We have also
spent, as I mentioned earlier, other supplemental funds on
producing, and in the U.S., gowns and other PPE.
We are continuing to do that domestic manufacturing. But we
do have this industrial base expansion for vaccine
manufacturing capacity right now.
Senator Baldwin. Okay, thank you. During this Committee's
last COVID-19 hearing, I asked about the Administration's
approach to reducing waste and better targeting vaccines,
including by reducing the number of doses in each vial and the
number of vials in each package. Experts believe that both of
these steps would significantly aid vaccination efforts as
doctors' offices and community organizations could more easily
give interested patient shots without worrying about spoiling
additional doses.
In that hearing, Dr. Kessler expressed the Administration's
strong desire and efforts to move forward on both of those
goals. But recent reporting suggests that this might no longer
be the case. Dr. Fauci, can you assure me that the
Administration is doing all it can to encourage the production
of smaller vials and smaller batches as soon as possible? And
what steps are being taken and what is your anticipated
timeline for changes like this?
Dr. Fauci. Well, thank you for that question, Senator. That
is not really in my area of activity. I believe that is more of
an FDA question.
Senator Baldwin. Well, Dr. Woodcock, please.
Dr. Woodcock. Certainly. And between ASPER and FDA, right.
Basically, to do that, we need to get the manufacturers to
change how they are manufacturing the drug and what the storage
conditions might be and things like that. And I think heroic
efforts are being made to try and get a vaccine--get vaccines
that don't require deep freezing storage conditions and that
could be then broken up into smaller groups and stored in, say,
a pediatrician's office refrigerator.
I mean, that is the idea here, that--so that pediatricians
and others could--primary care, at the pharmacy, at the nursing
home pharmacy, whatever, as new people come in, they could
vaccinate them without wasting large amounts of vaccine or
having to break into something in the deep freeze.
Those efforts are arduously going on. They are highly
technical, though, and they aren't simple. And I think the
Government and the manufacturers are both united in realizing
this is necessary.
Senator Baldwin. Thank you.
The Chair. Thank you.
Senator Tuberville.
Senator Tuberville. Thank you very much. Thank you for
being here today, testifying. Dr. Walensky, you have been in
your current post since January. You are in the top position,
and you surely have heard critiques of the job the CDC has done
so far in each--this Administration, even the last, you usually
learn from some things that happened in the past. What would
you say to those who look to the CDC and say that change is
needed, that perhaps the agency needs a bit of restructuring?
Dr. Walensky. Thank you for that question. Certainly
during--
Senator Tuberville. What would you do different?
Dr. Walensky. What would I do differently? You know,
certainly during the times of pandemic, I came in on January
20th. We had our pedal to the metal, shall we say, moving
forward to try and do everything that we could to get us out of
the pandemic. We have made a lot of progress. We have had to be
humble about what this virus can do. And a lot has changed just
in the last 6 months. We need a public health infrastructure in
this country that allows CDC and our state and local health
departments to be prepared for a pandemic.
In that process of restructuring, we need long term disease
diagnostic funding that isn't like a roller coaster that comes
with one pandemic and, or one infectious disease threat and
disappears when that threat is gone. We are going to be dealing
with this--when, God willing, everybody is vaccinated and
people are well and the pandemic is largely behind us, we have
long COVID, we will have boosters to be thinking about, we will
be dealing with mental health issues for a very long time to
come and we need the public health infrastructure to do so.
That would be my biggest--my biggest task and change.
Senator Tuberville. Thank you. Dr. Woodcock, FDA currently
has emergency use authorization for three COVID vaccines, but
they have not yet received the full FDA seal of approval. What
would you say to the vaccine hesitant people who don't feel
comfortable taking a vaccine that hasn't been fully FDA
approved?
Dr. Walensky. Well, first of all, I would say we did not
cut any corners in these 30,000 patient trials and these 44,000
patient trials and all the surveillance you have been hearing
about of potential rare side effects. So compared to other
vaccines they would be looking at, these have really gotten the
full court press as far as evaluation and study.
They have gone through the FDA process, and they have gone
to the ACIP, the CDC's advisory committee, and strongly
recommended that people take them. That said, it is public that
one of the companies put a marketing application before us and
we are going to do everything we can to review that in a timely
manner. But, of course, I can't say anything more about that.
Senator Tuberville. What kind of timeline, do you think,
that we will have full approval?
Dr. Walensky. That is the kind of thing I can't talk about.
Thank you.
Senator Tuberville. Thank you. Dr. Fauci, we have made this
way too political--this has been tough on the American people.
We all know that. Everybody has worked hard to try to get
through this. Politics has played a huge role in this. We have
all watched it from close and afar.
But I think people need a unifying message from all of us.
Because in my State of Alabama, we don't have everybody taking
a vaccine and we are having outbreaks as we speak. We have had
Operation Warp Speed General Perna here in a committee
hearing--not in this Committee, but in other committee. He took
a beating saying how poorly a job he did. And the American
people saw that.
A lot of people voted for Donald Trump and a lot of people
in the South, a lot of people in my state, and we have to have
a unified message. We can't be blaming this or that. We have
got to go North with this. We can't go South. We can't go the
other direction.
Dr. Fauci, can you understand unless this Administration
acknowledges the efforts of the last one, a large part of
Americans, they are going to continue to feel like nothing is
positive. They are not going to take the vaccine. You
understand what I am saying?
Dr. Fauci. I understand exactly what you are saying,
Senator. And thank you. That is a very appropriate question
that I would be pleased to answer. Having been present through
the last year, which was the year when COVID began, the last
year of the former Administration, I can tell you that no doubt
that the former Administration deserves a considerable amount
of credit for the effort that was put into Operation Warp Speed
that was able to allow not only the rapid development and
testing, but also the implementation of the vaccine.
There is no doubt in my mind, as someone who has been on
both sides of the fence, to say that is the case. But with
regard to a unifying message, if I might, sir, I think what we
need to appreciate is that we are dealing with a common enemy
and the common enemy is the virus. The virus doesn't know if
you are a Republican, Democrat or Independent. The virus just
knows that it makes people ill and it kills people.
We have an extraordinarily efficient tool against that
common enemy. And what I would hope the message would be, the
unifying message is let's all pull together and utilize that
tool, which is vaccination, to really crush that common enemy.
I think we have it within our capability to do it. And I would
hope that would be the message.
Senator Tuberville. Positive attitude plus effort equals
performance. And if we keep that positive attitude, we can get
through this thing. We just need to quit fighting in the media
and get everybody believing in the same thing. We are all on
the same team. Thank you very much.
The Chair. Thank you.
Senator Hickenlooper.
Senator Hickenlooper. Thank you, Madam Chair and Ranking
Member. Thank you, Coach. I appreciate that. The belief in the
positive attitude. As someone who was a part of many scientific
debates back in my salad days, it just--it makes--it increases
my respect beyond what I can say in words of how well you have
gone through the intense debate, because these are life and
death decisions you have to make oftentimes where there was
conflict among the science, and we were trying to get the facts
assembled and sorted and prioritized as quickly as we could.
Before I even ask any questions, just let me say that my
questions are always toward a unified future. But I want to
make sure I recognized how well you have each served your
Country under very difficult circumstances. So, and I don't
know, Dr. Fauci, how many of these types of hearings have you
been in so far?
Dr. Fauci.
[Technical problems.]
Senator Hickenlooper. Yes. So just to look at the intensity
by which you focus on the answers is remarkably impressive and
I want to express my gratitude and our gratitude. I guess first
with Dr. Walensky and Dr. Fauci together, we saw yesterday the
Pediatrics Academy talk about kids older than two wearing
masks. We know that kids 12 and older should be getting
vaccinated.
Well, just quickly, just to give you a platform to talk
about that unified message, what should schools be thinking
about and who should they be talking to get ready? Obviously,
the more kids we can get that are over 12 and older, the more
we get them vaccinated, there can be--they will be fully
protected by the time they get to school in the fall, if we
start now.
What does that message look like--would be a couple of--Dr.
Walensky why don't you start then Dr. Fauci can fill in.
Dr. Walensky. Thank you for that question, Senator. First
of all, I want to lean in and say I think it is critically
important that our schools be open for full in-person learning
in the fall. We have learned enough over the last year to
understand what we need to do to keep our children safe. And we
believe based on the science, that we can keep them safe in
those settings. How are we going to keep them safe?
The first and foremost is the best thing would be to have
everybody vaccinated who can be vaccinated. Surround
unvaccinated children who are no longer--who are not yet
eligible, with people who are vaccinated to protect them. So
that is the highest and most important thing. For those
children who are not able to be vaccinated, they can and should
wear a mask in those school settings. And we have said that in
our guidance.
I want to also comment on one other thing, and that is that
I think is critically important in the school year coming ahead
and that is the role of testing. Senator Burr has talked about
the importance of other viral syndromes, flu, influenza. We are
going to see upper respiratory infections in these schools in
the fall. These kids have not been in school.
They have not been with each other. And I am worried about
the upper respiratory infections. And we are going to have to
understand what is COVID and what is a simple cold among
children. So those are among the things that I am thinking
about. Thank you.
Senator Hickenlooper. Great. Thank you. Nothing to add?
Dr. Fauci. Nothing to add. That was a very good
explanation.
Senator Hickenlooper. You have become a good--an admirable
team. Dr. Woodcock, some of the FDA reports on--is it
pronounced Adulhelm? Biogen's new Alzheimer's drug I think are
very concerning. Last week, there was an expert panel convened
by the Institute for Clinical and Economic Review unanimously
concluded that it wasn't--it wasn't efficacious, it didn't
provide a benefit for patients with Alzheimer's and certainly
wasn't worth the price tag. And I know that I saw a couple--I
was researching or reading my briefs from my remarkable staff
last night that it could have been handled differently. How
specifically differently should the FDA have looked at this?
Dr. Woodcock. Well, a lot of the confusion is in some of
the controversy is simply what you said, this is an accelerated
approval. That means it was approved on a surrogate endpoint
that we believe is reasonably likely to predict clinical
benefit. So the conclusion that you just referred to is not
surprising, Okay, because they haven't definitively shown
benefit.
Now, Congress has urged us to use the accelerated approval
pathway for life threatening diseases that don't have any
effective therapy. Alzheimer's is one. I think part of the
issue was that it was brought to an advisory committee and
proposed for traditional approval, not on a surrogate endpoint.
The advisory committee more or less conclusively shut that
down. And so the agency went back and looked at all the data on
the surrogate endpoint, which is clearing out the Alzheimer's
plaque, the amyloid plaque from the brain.
They found that correlated with benefit, benefit meaning
slowing a decline of deterioration of thinking, right. And so
with Malta looking at other programs with other antibodies to
do the same thing, they concluded that this clearing out of a
plaque was reasonably likely to predict clinical benefit,
right. But not--doesn't definitively mean that there is a
clinical benefit. So I think with such a prevalence--it is very
common in cancer. It is well accepted.
That is how we approved HIV drugs from the very beginning,
alright. And that was a very big success story. That is how we
approve many drugs for rare diseases. But this is a common
disease and almost everyone probably in this room has had a
relative--.
The Chair. Dr. Woodcock, thank you. We do have votes called
and we have got to finish our hearing. So I appreciate the
response.
Dr. Woodcock. I am sorry.
The Chair. Thank you.
Senator Burr.
Senator Burr. Thank you, Madam Chair. Let me say, Dr.
Woodcock, I think the decision that FDA made relative to
surrogate endpoints is exactly that forward leaning approach
that we envision when we created that expedited pathway. And I
applaud the decision. I look back at HIV, who Tony Fauci was
very involved in, and had we not done similar things then, we
wouldn't have found the keys that unlock doors that we needed.
I want to turn to Dr. Walensky for just a second. I just
want to ask a quick follow-up on breakthrough. And Dr. Fauci, I
understood what you said about the NIH following the clinical
trials over a two-year period as it relates to breakthrough.
That is important. It is not important from a standpoint of
today and the decisions that we make. It is my understanding
that CDC is only tracking breakthroughs that result in
hospitalization. Is that accurate?
Dr. Walensky. No, it is not. So that is in passive
surveillance, which is, as I mentioned earlier, not the best
way to track these breakthroughs and one of the limitations of
our passive surveillance system, which is why we are collecting
longitudinal data in tens of thousands of people, some of whom
are getting PCRs so that we can check each test for
asymptomatic breakthroughs as well.
Senator Burr. Okay. I think it is extremely important that
we be as specific on breakthrough exposures. One of the last
tools that we have is, yes, you may get vaccinated, but you may
become infected, and you are going to have to prove the data
that says you probably won't go to the hospital, and you
certainly won't die. So without that data, you are in a very
weak situation. So I would encourage you to build that data
base. I am going to take a couple of minutes to make an
editorial, and it really gets to the heart of supply chain.
Ms. O'Connell, this is going to fall in your lap. And this
is something that the Chair and I and the Committee are going
to deal with. You talked about a warm base. I know the target
for what we want in the strategic national stockpile. Here is
the reality. Federal purchases are 4 percent of PPE. And for us
to set up a sustainable supply chain, it means that you have to
compete with dumping practices of China on N95 masks. You have
to compete with competition from around the world.
I think, I know Janet and Tony understand that the memory
span of a Member of Congress is about 18 to 36 months. After
that, we sort of forget about the last incident that we went
through and where we look at it and say, well, why are we
funding to keep the lights on in this N95 mask facility. We
don't need any more N95 masks. And the problem is that the 96
percent of the purchasers providers across the country have now
turned to the lowest cost competitor, which is probably not the
warm base facilities that we have got. We have got to come up
with a solution to this, and I want to work with you.
I want to work with the White House. Because I have gotten
to a point through a process of elimination as to what won't
work, faced with the realities of Congress's inability to
continue to fund indefinitely things that don't produce
something tangible. We have had to put BARDA on life support
three different times because members didn't see a need for it.
Thank God we were able to keep it resuscitated.
I am not sure that there is a way to do this without
creating an America's trading bloc, where we incorporate North
and South America together, where we incorporate the low cost,
low labor areas of Central America, where textile companies
already have a presence, where companies could move automatic
N95 masks, and not just warm base them, but actually let them
compete with China in the open marketplace and sell to the rest
of the world, and invite the EU and invite Australia and invite
Africa and India to be part of the America's trading bloc where
we can expand.
As Janet knows, we have had problems with Brazilians on
knocking off pharmaceutical manufacturing down there for years.
Let's turn them into a part of our inventory of assets where we
can turn to vaccine production down there, pharmaceutical
production down there, raw materials of South America.
If not, then show me something that is sustainable without
the condition of Congress coming in and funding at the tune of
hundreds of billions of dollars on an annual basis to keep that
supply chain for us as a purchaser of only 4 percent. Somehow
we have got to--we have got to present to the other 96 percent
a domestic manufacturing capability that makes them competitive
against China even with China's dumping practices.
I sort of lay that on the table. It won't be the first time
Tony has looked at me and said, you come up with something
crazy, but I am in the business of trying to find solutions
that are sustainable. And it will only happen if we think
outside the box on this. We thought outside the box with
surrogate endpoints and Janet, well down the road people don't
die of HIV. They extend their lives.
Maybe the keys we find are actually cures in the future,
mRNA technology platform, Tony. We may be curing cancer off of
that platform two, three, four years down the road. I wonder
what the person who didn't like mRNA for the vaccine for COVID
think when they have got prostate cancer and they have got a
cure on an mRNA platform? I think they are going to take it.
Everything is going in our favor, but this is absolutely
crucial to our assurance to the American people and to the
American economy and manufacturers that we are going to put
them somewhere, in a system that is sustainable for the future.
I thank you for listening to me and I thank the Chair. I yield
back.
The Chair. Thank you, Senator Burr. Appreciate that. That
will end our hearing for today. And I want to thank all of our
colleagues, our witnesses, Dr. Walensky, Dr. Fauci, Dr.
Woodcock, Ms. O'Connell, Assistant Secretary O'Connell, for
such a thoughtful discussion about our ongoing response to this
pandemic and the path forward.
With that, for any Senators who wish to ask additional
questions, questions for the record will be due in 10 business
days, August 3rd at 5 p.m. The hearing record will also remain
open until then for Members who wish to submit additional
material for the record.
The Committee will next meet tomorrow, July 21st, for an
executive session to consider the Family Violence Prevention
and Services Improvement Act of 2021 and the nominations of
Catherine Lhamon to be Assistant Secretary for Civil Rights at
the Department of Education, Lisa Brown to be General Counsel
of the Department of Education, Roberto Rodriguez be Assistant
Secretary for Planning, Evaluation and Policy Development at
the Department of Education, David Weil to serve as
Administrator of the Wage and Hour Division at the Department
of Labor, and Gwynne Wilcox and David Prouty to serve as
members of the National Labor Relations Board.
Again, thank you to all of our witnesses today. With that,
this Committee does stand adjourned.
QUESTIONS AND ANSWERS
Response by Dr. Rochelle Walensky to questions of Senator Casey,
Senator Baldwin, Senator Hassan, Senator Burr, Senator Braun, and
Senator Tuberville
Responses to the QFRs are accurate as of the date of the hearing.
senator casey
Question 1. Even as the vaccination campaign continues--whether it
is reaching people who thus far have been reluctant to get vaccinated,
or hopefully expanding the campaign soon to include younger children--
testing remains an important tool in our fight against COVID-19.
Especially given that younger children are not yet eligible for
vaccination, and with the rise of the Delta variant, testing continues
to be a pressing need to ensure that cases are caught early to break
the chain of transmission--or to rule out COVID-19 when someone is
showing symptoms that are common to different illnesses. How is CDC
working with local public health officials, health care providers,
employers and schools to support robust testing regimes, and what do
those recommendations look like currently?
Answer 1. CDC is actively engaging with our state, tribal, local
and territorial public health partners and with K-12 schools to support
implementation of robust testing programs. CDC guidance on testing can
be found here: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-
overview.html.
CDC has provided specific technical assistance (TA) on testing and/
or deployed teams to jurisdictions and school districts who have
requested assistance. Support is provided through technical assistance
calls, sharing of resources, and creating connections with their state
or local school testing teams at the health department or referrals to
other opportunities for Federal testing support, such as the HHS
Testing and Diagnostics Work Group.
CDC is also partnering with jurisdictions interested in exploring
various ways to expand access to testing and incentives to test in
populations they have identified as likely to benefit from additional
testing. This includes factors such as current proximity to testing
sites, area percent test positivity or case burden, and other factors
such as social vulnerability index scores. Pilot activities have
explored expanding testing in high density workplaces, using pop-up
testing in retail sites in the communities, and event-based testing
where testing is offered in conjunction with previously scheduled or
well-known events or gatherings. As an example, the Race to End COVID
project at the Talladega Superspeedway, sponsored by Talladega
Superspeedway, the Alabama National Guard, the U.S. Department of
Health and Human Services, the CDC Foundation, and the Alabama
Department of Public Health, offered an incentive to drive two laps
around the track behind a pace car to all participants who were tested
or vaccinated at the pop-up site hosted by the track. The lessons
learned from these pilots will be disseminated to inform other
jurisdictions who are seeking ways to expand testing availability and
desirability within their populations.
Starting in mid-May, one-on-one TA calls were held with 46 health
departments to discuss their testing plans for summer schools and
summer camps as well as their plans to offer screening testing to K-12
schools in their jurisdiction using CDC Epidemiology and Laboratory
Capacity (ELC) Reopening Schools cooperative agreement funds.
Question 2. Earlier this year, I sent a letter with Senator Wyden,
Senator Tim Scott, and Senator Crapo, calling on CDC to publicly
release data that have been provided to the Federal Government by CVS
and Walgreens in relation to the Long-Term Care Partnership (LTC
Partnership). The LTC Partnership data is the only real time accounting
of the COVID-19 vaccine rollout from the beginning, and experts have
testified to Congress that it is critical to understanding how the
distribution of vaccines proceeded, as well as the racial, economic and
geographic equity of the COVID-19 vaccine distribution. As the
bipartisan letter noted, releasing such information retrospectively
will help researchers and policymakers analyze issues such as the speed
and equity of vaccine distribution, and the vaccine's role in reducing
disease and death in nursing homes. One need look no further than your
agency for proof of the data's usefulness--CDC shared the LTC
Partnership data with states, and used the data for its own public-
facing research. Please provide me with all facility-level vaccination
data that has been transmitted to CDC by the LTC Partnership since
December 2020. Please provide these data no later than August 20, 2021.
Answer 2. CDC has been in communication with your staff regarding
this data request.
Question 3. There is concern that cases of influenza this coming
winter season will be significantly higher than last year. Is there an
opportunity to encourage increased uptake of both flu and COVID-19
vaccines in the coming months, and what would need to occur to make
that happen, in terms of patient and provider education, vaccine
distribution plans, etc.?
Answer 3. This influenza (flu) season, CDC will expand education
efforts to promote flu vaccination, including among groups of people
for whom vaccination is especially important, such as people with
underlying health conditions, pregnant women, children under 3, and
people within racial and ethnic minority groups, which typically have
lower vaccine uptake. CDC is investing an additional $150 million to
continue to build community engagement around COVID-19 and flu
vaccination among racial and ethnic minority groups.
In addition, CDC has planned outreach through social media, press
conferences, web page spotlights, radio media tours, op-eds, and other
publications. A digital campaign will launch to educate the public and
people who are at increased risk from influenza and COVID-19
complications about the importance of vaccination. Finally, CDC will
support a special campaign to inform the general population, with a
focus on Black/African American and Hispanic/Latino audiences, about
the importance of flu vaccination.
senator baldwin
Question 1. The CDC is updating its variant tracker once every 2
weeks. Please provide additional information regarding CDC's plan to
increase the frequency of this reporting, improve the granularity of
data provided, and work with state and local health departments to
enhance sequencing efforts on the ground.
Answer 1. CDC reports variant proportion data on two-week time
intervals with plans to increase frequency in the coming weeks. CDC
developed guidance for state and local public health laboratories to
``tag'' sequences submitted to public data bases that were generated
through state-level baseline genomic surveillance efforts. By tagging
these sequences, CDC can incorporate these sequence data into the
national analysis of variants. Integration of surveillance across the
U.S. maximizes the sequencing capacity, expertise, and available data
across the U.S. that is available to inform public health decision-
making.
To improve the detection, monitoring, and mitigation of COVID-19
variants, the American Rescue Plan invested $1.7 billion to help the
CDC, states, and other jurisdictions more effectively detect and track
variants by scaling genomic sequencing efforts. This one-time funding
is supporting CDC and state and local public health to increase the use
of sequencing in the U.S. public health system. The information from
sequencing allows CDC and state and local public health leaders to
respond to emerging infectious threats more effectively. Sequencing
technology is used not only to help in the detection and prevention of
COVID-19, but also with most other infectious disease threats. The CDC
Advanced Molecular Detection (AMD) program was established in 2014 and
has been funded by Congress at $30 million per year, to incorporate
sequencing and relevant technologies into public health and has been
applied to food safety, emerging infections, biosecurity, antimicrobial
resistance, and many other pathogens. CDC has also funded 29
universities to conduct genomic surveillance research in collaboration
with public health agencies. The studies are meant to provide deeper
insights into viral genomics and molecular epidemiology within the
various regions across the country.
senator hassan
Recently, deeply disturbing reports have been published detailing
dangerous inequities that USA Paralympians are facing at this year's
Tokyo Paralympics.
Becca Meyers is a six-time Paralympic medalist who won three golds
in Rio 5 years ago. She is deaf and blind, but in the past that hasn't
stopped her from competing--and winning--at the highest levels.
This year, though, she and other athletes from Team USA who
experience disabilities are being denied adequate access to personal
care assistants, reportedly due to COVID-19 restrictions.
Individuals who experience disabilities should not be forced to
navigate the Tokyo Olympics without the support they need in the midst
of a global pandemic.
Becca announced on Sunday that she is quitting the team because she
is being denied a, ``reasonable and essential accommodation'' that
would enable her to compete.
This is an outrage--and an entirely preventable situation.
The US Olympic & Paralympic Committee must work immediately to
address this issue, and ensure that all of our athletes are able to
compete safely at this summer's games--including by providing them the
basic supports they need to navigate the world.
Question 1. Director Walensky, over the last year and a half, the
CDC has provided guidance on how to mitigate the risk of COVID-19 in
various activities, as well as special events--including sports.
Understanding that the CDC does not have jurisdiction over specific
safety measures taken by the US Olympic & Paralympic Committee, can you
please explain how COVID-19 mitigation efforts take into account the
needs of people who experience disabilities?
Answer 1. We know that most people with disabilities are not more
likely to become infected with or have severe illness from COVID-19.
However, some people with disabilities might be more likely to get
infected or have severe illness because of underlying medical
conditions, residing in congregate living settings, or systemic health
and social inequities.
CDC is currently providing $93 million to the Administration for
Community Living (ACL) within HHS to administer grants to aging and
disability networks in every state and territory. These funds are
providing assistance to older adults and people with disabilities for
scheduling vaccine appointments, transportation to vaccine sites,
direct support services needed to attend vaccine appointments,
connection to in-home vaccination options, and education about the
importance of receiving the vaccine to older adults and people with
disabilities. This partnership is also providing an additional $5
million in funding to stand-up and maintain a new Disability
Information and Access Line (DIAL) to help people with disabilities
find vaccination locations in their communities, assist callers with
making vaccination appointments, and connect callers to local services.
CDC partners with state, territorial, local, tribal partners, and
community-serving organizations to support communities at higher risk
for COVID-19. For example, CDC is partnering with FEMA, CDC Foundation,
Georgia Tech Center for Inclusive Design and Innovation, University of
North Carolina Center for Literacy and Disability Studies, DeafLink,
and National Association of State Directors of Developmental
Disabilities Services, to provide COVID-19 guidance and resources for
people with disabilities and care providers. There is a need for
guidance and resources that are tailored for people with disabilities
and their care providers. This project aims to compile and develop
guidance and tools to help people with disabilities and those who
provide services or care for them make decisions, protect their health,
and communicate with their communities. The tools and guidance
developed in this project reflect what CDC has learned about the needs
of people with disabilities and care providers from partners and
listening sessions, projects, and research efforts. Following the
launch of the CDC Toolkit for People with Disabilities web page
(https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/
people-with-disabilities.html), we gathered feedback from partners
indicating a need for more information geared toward people with
disabilities related to vaccine access, accessible vaccination sites,
and accessible communications products/web resources to develop web
content, fact sheets and one-pagers, scheduling language, and a
promising practices document on vaccination access for people who have
challenges leaving their home. As a result, we began the integration of
information related to people with disabilities as well as social media
and web-based graphics that reflect varying disabilities throughout the
CDC sites instead of just on disability-related webpages.
Another collaborative project involving CDC Foundation and Georgia
Tech Center for Inclusive Design and Innovation is developing
accessible materials and culturally relevant messages for people with
disabilities. The project focuses on people with disabilities, as well
as caregivers of people with disabilities, and organizations serving
people with disabilities to deliver essential COVID-19 information. The
project helps to ensure that COVID-19 guidance is not only accessible
to people with disabilities, but also that it is culturally appropriate
and relevant to the challenges people with disabilities face during
emergency response situations such as COVID-19.
senator burr
Question 1. Is CDC tracking the number of individuals who got
vaccinated that were previously infected with COVID-19?
Answer 1. CDC uses seroprevalence surveys to estimate the
proportion of the population that has antibodies as a result of
vaccination, infection, or both. Both vaccination and infection result
in production of antibodies. By using a combination of antibody tests
and vaccine history, we can distinguish if someone has been infected,
vaccinated, or both.
CDC is working with national blood collection organizations to
estimate the number of vaccinated persons that were previously infected
based on vaccine history and antibody testing. We are analyzing these
data and working to publish soon.
CDC is modifying its national commercial laboratory survey to
capture similar information and hopes to implement this during the
upcoming months.
Question 2. If not, how is CDC estimating the actual level of
immunity--both natural immunity from having COVID-19 and the immunity
provided by vaccination--to get a full picture of the road ahead to
protect our communities?
Answer 2. CDC is currently estimating the level of immunity through
the seroprevalence studies described above. The type of antibodies
detected can determine if the person has antibodies because of past
infection or due to vaccination alone. In addition, CDC currently has a
manuscript in production that assessed SARS-CoV-2 seroprevalence
related to infection and vaccination in the US population.
Question 3. Is CDC tracking reinfection rates for those that have
been previously infected with COVID-19?
Answer 3. CDC is using several data sources to understand
reinfections including cohort studies, review of big data from
electronic health record systems, and by working with local
jurisdictions as they link cases over time. In terms of surveillance,
CDC is working closely with public health jurisdictions and the Council
of State and Territorial Epidemiologists (CSTE) to update the national
surveillance case definition of COVID-19 and enable states to count
repeat infections in the same individuals over time. This information
will be included in the approved position statement 21-ID-01 titled
``Update to the standardized surveillance case definition and national
notification for 2019 novel coronavirus disease (COVID-19).'' The rate
of reinfections depends on both the level of protection by previous
infection, for which there is increasing evidence, and the general rate
of infections in the population, which is highly variable. Unlike
ascertaining vaccine status, ascertaining prior infection status relies
on data systems linking multiple episodes in local jurisdictions or on
widespread sequencing.
Question 4. Can T-cell testing be used to gain better insight in to
how COVID-19 variants interact with immunity from previous infection or
vaccine?
Answer 4. SARS-CoV-2 T cell assays are very complex, and therefore
are not widely available. Individuals cannot obtain these tests from
health care providers. T cell studies can be performed in a research
setting. However, we do know that T cells contribute to immunity.
Preliminary studies indicate that vaccines generate T-cell immunity,
and it is maintained against variants. Ongoing studies are being
performed to understand T-cell immunity better.
Question 5. According to CDC, 74 percent of hospitalized or fatal
breakthrough infections occurred in individuals 65 and older. Is CDC
tracking how many of these individuals have other conditions that may
make them more susceptible to severe illness from COVID-19?
Answer 5. The best data for this come from the Coronavirus Disease
2019 (COVID-19)-Associated Hospitalization Surveillance Network (COVID-
NET), because it has more comprehensive and complete information on
underlying medical conditions among hospitalized patients.
COVID-NET is a population-based surveillance system that collects
data on laboratory-confirmed COVID-19-associated hospitalizations among
children and adults through a network of over 250 acute-care hospitals
in 14 states covering approximately 10 percent of the U.S. population.
Preliminary data from COVID-NET show, among all COVID-19-associated
hospitalizations, approximately 29 percent of all vaccinated cases are
immunocompromised compared to 11 percent of all unvaccinated cases.
Additionally, approximately 68 percent of vaccinated hospitalized cases
have 3 or more underlying medical conditions compared to 52 percent of
unvaccinated cases. For adults ages 65 years, 32 percent of all
vaccinated hospitalized cases are immunocompromised compared to 13
percent of unvaccinated hospitalized cases. For adults ages 65 years,
the proportion of vaccinated hospitalized cases (74 percent) is not
significantly different from the proportion seen in unvaccinated cases
(69 percent).
For national surveillance, 7,525 vaccine breakthrough infections
among people who were hospitalized or died were reported as of August
2, 2021. Of those, 2,895 (38 percent) had one or more of the following
conditions noted: pregnant, diabetes, renal disease, liver disease,
autoimmune disease, immunocompromised, or immunosuppressive medication.
However, another 3,352 (45 percent) were missing data regarding one or
more of these underlying conditions. In addition, national vaccine
breakthrough surveillance does not collect information on other
underlying medical conditions (e.g., obesity, cardiovascular disease,
or pulmonary disease) that have been associated with more severe COVID-
19 disease but are not presumed risk factors for a vaccine breakthrough
infection.
Of note, of the 7,525 reported vaccine breakthrough infections
among people who were hospitalized or died, 5,557 (74 percent) were
aged 65 years, including 3,704 (49 percent) who were aged 75 years.
Therefore, a large majority likely have one or more underlying medical
conditions that might reduce their response to vaccination and/or
increase their risk for severe COVID-19 disease.
The number of COVID-19 vaccine breakthrough infections reported to
CDC through national surveillance likely are an undercount of all SARS-
CoV-2 infections among fully vaccinated persons. National surveillance
relies on passive and voluntary reporting, and data might not be
complete or representative. These surveillance data are a snapshot and
help identify patterns and look for signals among vaccine breakthrough
cases.
Question 6. CDC stated that children who are eligible for the
COVID-19 vaccine can get their routine vaccinations at the same time as
their COVID-19 vaccine. Looking to the fall and a potential need for
boosters, can a person receive the flu shot and the COVID-19 shot at
the same time?
Answer 6. COVID-19 vaccine and other vaccines may be administered
on the same day, as well as any interval without respect to timing
(https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-
clinical-considerations.pdf). However, some additional guidance related
to co-administration of COVID-19 vaccines and influenza vaccines
specifically is under consideration for the upcoming Prevention and
Control of Seasonal Influenza With Vaccines: Recommendations of the
Advisory Committee on Immunization Practices (ACIP)--United States,
2021-2022 Influenza Season. CDC will provide a further update when
available.
senator braun
Question 1. Can you please provide specific updates on your plans
to ensure that nursing home staff and residents have sufficient point
of care molecular diagnostics and access to the most appropriate
prophylactics and treatments?
Answer 1. Long-term care facilities (LTCF), such as nursing homes,
are high-risk settings for residents, staff, volunteers, and visitors.
Case and death rates for LTCF staff and residents have declined sharply
since mid-December 2020 when vaccine rollout began. Recent outbreaks,
including those linked to variants and/or breakthrough cases, further
stress the need to vaccinate residents and staff, including vaccinating
new residents and staff given relatively high turnover in both
categories, and continue to implement appropriate infection prevention
and control (IPC) practices effectively and consistently.
More than 80 CDC teams have deployed to LTCFs to investigate
outbreaks, assess staff and supply shortages, and recommend IPC
measures. Additionally, CDC maintains guidance specifically for nursing
homes and long-term care facilities around IPC practices and the
appropriate use of testing which are both essential to quickly detect,
identify, and prevent the spread of SARS-CoV-2 infections in LTCFs.
CDC continues to provide resources and information on our website
and for patients and healthcare providers regarding the availability of
monoclonal antibody treatments and other COVID-19 therapeutics for
certain patients at high risk of disease progression.
CDC is working to rapidly characterize emerging variants to
understand the potential impacts on critical SARS-CoV-2 medical
countermeasures (e.g., vaccines, therapeutics, and diagnostics). CDC
provides updated information on variant classifications and definitions
as well as the national prevalence of variants of interest and concern.
These data and other clinical considerations are being used by the
Office of the Assistant Secretary for Preparedness and Response (ASPR)
within HHS and other Federal and state partners to inform decisions
regarding distribution and allocation of testing supplies, therapeutics
(i.e., monoclonal antibodies), and personal protective equipment (PPE)
supplies to help jurisdictions and their nursing homes. CDC continues
to update its information and resources as new science becomes
available. CDC also continues to work closely with the Centers for
Medicare & Medicaid Services (CMS) within HHS and jurisdictions to
provide technical assistance and support to nursing home facilities
across the U.S. through current CDC programs and those stood up as part
of the ongoing COVID-19 response. This also includes hosting webinars,
Clinician Outreach and Communication Activity (COCA) calls, and
engaging LTCF partners to provide the latest information.
Question 2. Due to mandatory lockdowns, limited doctor office,
clinics and emergency room visits, there has been a rapid decline in
routine health screenings such as HIV/AIDS. Your agency found that at
just one commercial laboratory system, comparing a six-month period in
2019 to 2020, they reported nearly 700,000 fewer HIV screening tests
completed and about 5,000 fewer confirmed HIV diagnoses. This is
reflective of what has happened across the country: HIV testing is
greatly reduced due to patients not accessing healthcare and health
departments moving resources to COVID.
Question 2(a). This is especially troublesome because as we know,
early detection and getting patients on a treatment plan is critical to
limiting the spread of HIV/AIDS. Will you commit to keeping this
Committee updated on HIV screening levels? Will you commit to
developing a plan to encourage Americans to visit their local
healthcare provider for routine screenings?
Answer 2. Yes, and thank you for asking this important question.
After an initial interruption of key HIV prevention activities due to
the pandemic, jurisdictions rapidly prioritized surveillance activities
and many scaled up self-testing and mobile HIV testing activities.
These innovations could help overcome longstanding barriers to
prevention by providing testing in locations beyond traditional testing
venues. Although overall HIV testing declined in 2020, 2021 HIV testing
year-to-date is back on track.
Answer 2(a). CDC will keep the Committee updated on progress
related to HIV screening and testing in the U.S. Through CDC's core HIV
programs and our role in the Department of Health and Human Services-
wide initiative, Ending the HIV Epidemic in the U.S., CDC is committed
to making testing accessible, convenient, and routine by scaling-up
self-testing, making HIV screening a regular part of health care, and
increasing testing in non-traditional settings, such as correctional
facilities and syringe services programs.
Question 3. Congress has provided a substantial amount of funding
for COVID testing--nearly $50 billion in the American Rescue Plan
alone, plus tens of billions of dollars more last year. A significant
amount of testing money appears to be unspent. This is concerning,
given that we are hitting a vaccine wall and cases are on the rise due
to the delta variant. We need to ensure that our capacity for testing
remains high going into the fall and winter.
Question 3(a). How much money remains for COVID testing from the
American Rescue Plan?
Question 3(b). How much money remains for COVID testing
appropriated in 2020?
Question 3(c). What is the Administration's plan for the remainder
of the COVID testing funds? How and when will this money be spent?
Answer 3(a), 3(b), 3(c). As of the end of July 2021, of the
approximately $95 billion identified by Congress across all COVID
supplemental appropriations for testing-related activities, all but
$17.5 billion had been allocated to support testing, contact tracing
and mitigation activities across HHS. HHS is in the process of
allocating the remaining balance for priority activities such as
increasing community access to testing and supporting domestic
manufacturing capacity of tests and enhancing testing capacity in
congregate settings.
In particular, as of the end of July 2021, the Centers for Disease
Control and Prevention awarded approximately $40 billion of the COVID
supplemental funding appropriated to HHS for broad testing, mitigation
and related activities, support for school testing and to address
testing-related health disparities in high-risk and underserved
communities to state, local, and territorial health departments. In
addition, CDC had plans in place for additional awards to targeted
settings. These funds support a range of activities, including:
enhancing testing and mitigation in targeted settings such as
correctional facilities, and among homeless populations; expanding the
Nation's disease intervention specialists; supporting infection
prevention and control; expanding the Nation's wastewater surveillance
system; and improving laboratory data and capacity.
senator tuberville
Question 1. What would you say to those who look at the CDC and say
that change is needed, that perhaps the agency needs restructuring?
Question 2. What areas or offices specifically do you think could
be restructured?
Answer 1 & 2. Thank you for the questions. The ability to respond
to a public health emergency requires a strong day-to-day public health
system, supported by infrastructure that is not highly segmented by
disease, condition, or activity. In addition to the COVID-19 pandemic,
over the past 24 months, CDC has also responded to diverse public
health threats from E-cigarette or Vaping Product Use-Associated Lung
Injuries (EVALI), Ebola, complex multi-state food-borne disease
outbreaks, wildfires, and hurricanes. Responding to the unique
characteristics of each of these public health emergencies has required
deep scientific expertise to deploy a specialized approach and called
for a robust public health system with world-class infrastructure
nationwide to stop disease at its source. Unfortunately, this recent
history has revealed the effects of an inadequate public health
infrastructure. Ongoing health disparities made us as a nation more
vulnerable to outbreaks, large-scale public health emergencies, and
pandemics as well as burdening large segments of our population with
chronic public health concerns. Additional investments in both domestic
and global public health and health security infrastructure are needed.
With investments requested in the fiscal year 2022 Budget, CDC will
begin to address mission-critical gaps in public health infrastructure
and capacity nationwide. Transitioning from sporadic influxes of
supplemental funding tied to a specific emergency to flexible funding
that can prevent another crisis will strengthen the current public
health system. Flexible, sustainable investments in infrastructure and
capacity are critical for saving lives and averting economic losses
caused by public health emergencies and chronic public health problems.
In fiscal year 2022, CDC will prioritize funding to rebuild the most
critical public health infrastructure needed to safeguard the Nation's
health and economic security.
Question 3. Isn't it important for CDC to track cases in order to
determine the effectiveness of the vaccine against COVID?
Answer 3. CDC has multiple surveillance systems and ongoing
research studies to monitor the performance of vaccines in preventing
infection, disease, hospitalization, and death. CDC also collects data
on breakthrough infections through outbreak investigations. Examples of
CDC's systems for monitoring performance of vaccines include: The
National Healthcare Safety Network (NHSN), HEROES/RECOVER, Influenza
and Other Viruses in the Acutely Ill (IVY), and the Coronavirus Disease
2019-Associated Hospitalization Surveillance Network (COVID-NET).
Question 4. Do you consider it misinformation for individuals to
share their stories of adverse events following vaccination?
Answer 4. Millions of people in the United States have received
COVID-19 vaccines under the most intense safety monitoring in U.S.
history. Communicating timely and transparent information to public
health officials, healthcare providers, and the public about the safety
of vaccines, including possible adverse events following vaccination,
continues to be a top priority for CDC. CDC's communication effort will
always be based on the scientific evidence and data that we have
gathered to-date through different sources, including analyzing our
vaccine safety monitoring data and vaccine safety clinical research.
CDC recommends that individuals who may have experienced an adverse
event following vaccination speak to their healthcare providers. CDC
also encourages anyone experiencing any possible adverse events
following vaccination to share this information through CDC and FDA's
vaccine safety monitoring system, Vaccine Adverse Event Reporting
System (VAERS). When individuals are administered COVID-19 vaccines,
they are also given information about the opportunity to register with
CDC's after-vaccination health checker service, called v-safe. Through
v-safe, vaccine recipients can quickly tell CDC if they have any side
effects after getting a COVID-19 vaccine.
Question 5. Can you provide the estimated number of reinfections in
COVID-recovered individuals, to the best of the CDC's understanding?
Answer 5. CDC is using several data sources to understand
reinfections including cohort studies, review of big data from
electronic health record systems, and by working with local
jurisdictions as they link cases over time. In terms of surveillance,
CDC is working closely with public health jurisdictions and the Council
of State and Territorial Epidemiologists (CSTE) to update the national
surveillance case definition of COVID-19 and enable states to count
repeat infections in the same individuals over time. This information
will be included in the approved position statement 21-ID-01 titled
``Update to the standardized surveillance case definition and national
notification for 2019 novel coronavirus disease (COVID-19).'' The rate
of reinfections depends on both the level of protection by previous
infection, for which there is increasing evidence, and the general rate
of infections in the population, which is highly variable. Unlike
ascertaining vaccine status, ascertaining prior infection status relies
on data systems linking multiple episodes in local jurisdictions or on
widespread sequencing.
Question 6. Can you explain the scientific differences between CDC
and WHO recommendations for masking children under 5 years old?
Answer 6. Out of an abundance of caution, CDC recommends masks for
children older than age two, carefully weighing the risks and benefits
of masking this age demographic. Conversely, most children older than 2
years old do not have any anatomic, physiologic, or developmental
limitations that should preclude them from wearing a mask safely and
effectively. Masks have been shown to be safe in children older than
age two. A cohort study among infants and young children in Italy found
that the use of facial masks was not associated with respiratory
distress or significant changes in oxygen saturation, including among
children age 24 months and younger. In addition, studies suggest that
masks are not likely to impact social development in children.
Additional research emerged during the ongoing COVID-19 pandemic
with strong and consistent evidence demonstrating the effectiveness of
mask use among children age 2 years and older in preventing SARS-CoV-2
transmission, especially when it is combined with multiple prevention
strategies.
Question 7. Can you provide the most recent estimate of the number
of COVID infections in children under 18 years old?
Answer 7. There were 3,757,699 cases aged 0-17 years during the
period, January 21, 2020--August 17, 2021, based on the aggregate case
surveillance system counts, accessed August 18, 2021.
Question 8. Are you aware of any ongoing studies into the
effectiveness of masking in children under 12 years old?
Answer 8. CDC regularly scans the published and pre-print
literature as well as other sources for research on this topic. CDC
uses this information to assess current guidance and whether any
amendments are warranted based on that new science. There are data from
studies of children, including children under 12 years old, that
demonstrate masking provides an additional layer of protection against
spread of infection in schools. These data are reviewed in this
document: https://www.cdc.gov/coronavirus/2019-ncov/science/science-
briefs/transmission-k-12-schools.html.
Question 9. Funds in part from NIH/NIAID helped build the 12
Regional Biocontainment Laboratories (RBLs) and 2 National
Biocontainment Laboratories (NBL) to support high consequence
infectious disease research after 9/11 and the anthrax scares in 2001.
However, unlike the NBL facilities, the RBL facilities received no
further direct support until last year when Congress provided enhanced
investment through NIH/NIAID, targeted specifically to RBL facilities,
one of which is at the University of Alabama at Birmingham (UAB) in my
state. Nevertheless, it seems as though the RBL infrastructure, most
importantly the highly trained staff these facilities maintain and
produce is something that falls within the purview of the HHS ASPR,
considering among other things the UAB RBL has had collaborations with
Altimmune and ImmunityBio for COVID19 vaccine development, and
supported BARDA contractors. This type of work strongly aligns with
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and
Sustaining Robust and Reliable Public Health Security Capabilities. The
RBL infrastructure and personnel is expensive to maintain and operate,
and perhaps should not solely rest on either the shoulders of the host
University or the NIH/NIAID.
Question 9(a). Therefore, is support from Assistant Secretary for
Preparedness and Response (ASPR) something under consideration?
Question 9(b). If not, why not, and if so what is needed to
facilitate that conversation?
Answer 9(a) & 9(b). CDC defers to our HHS colleagues from NIH and
ASPR.
______
Response by Dr. Anthony Fauci to questions of Senator Burr, Senator
Braun, and Senator Tuberville
Responses to the QFRs are accurate as of the date of the hearing.
senator burr
Question 1. Recent reports from the Administration have indicated
that, while we don't need a booster for the COVID-19 vaccine just yet,
we will likely need one in the near future.
Question 1(a). What does the data show us so far about the
durability of all three authorized vaccines, particularly against
circulating variants, such as Delta?
Answer 1(a). At this time, data indicate that all currently
authorized COVID-19 vaccines remain effective at preventing severe
disease and death from COVID-19, including from the Delta variant of
SARS-CoV-2 (also known as B.1.617.2). The National Institute of Allergy
and Infectious Diseases (NIAID) is supporting research to assess the
duration of protection provided by current COVID-19 vaccination
regimens and further quantify the protective effect of these vaccines
against variants of SARS-CoV-2. Moderna and Pfizer/BioNTech recently
reported that immune responses to their respective COVID-19 vaccines
remained robust 6 months following vaccination. Johnson & Johnson/
Janssen also reported that the durability of immune response from
vaccination with their COVID-19 vaccine lasts at least 8 months and
that the average neutralizing antibody levels were greater at 8 months
than at 29 days post-vaccination. In addition, data from both lab
studies and clinical effectiveness studies show the effectiveness of
all three authorized COVID-19 vaccines against the Delta variant,
particularly against hospitalization.
Question 1(b). What factors should be considered in determining if
or when a booster is needed? Should certain populations be considered
for a booster before others?
Answer 1(b). The National Institutes of Health (NIH), Centers for
Disease Control and Prevention (CDC), and U.S. Food and Drug
Administration (FDA) continue to engage in a science-based, rigorous
process to help evaluate whether the durability of immune protection
from currently authorized COVID-19 vaccines is waning and whether a
booster may become necessary. Current data indicate that all currently
authorized COVID-19 vaccines remain highly effective at preventing
severe disease and death from COVID-19, including against the Delta
variant, and as of the date of the hearing, the CDC and FDA have stated
that fully vaccinated people do not need a booster shot at this time.
Whether a booster is needed in the future will depend on multiple
factors, including the durability of immune protection, the emergence
of a SARS-CoV-2 variant that evades protection from currently
authorized vaccines, and the strength of immune responses elicited by
the initial vaccine regimen in certain populations. For example, data
indicate that some immunocompromised individuals, including solid organ
transplant recipients and individuals with cancer, have a weak response
to the standard vaccine regimen. Emerging data suggest that some of
these individuals are able to generate immune responses to an
additional dose of COVID-19 mRNA vaccines. Given these data,
immunocompromised individuals are likely to be considered for
additional doses of the COVID-19 vaccine before other populations.
NIH is conducting and planning studies to measure and enhance the
immune response to COVID-19 vaccines in immunocompromised individuals.
In April 2021, NIH scientists began two clinical trials to assess how
adults and adolescents with certain cancers or immune system
deficiencies respond to COVID-19 vaccination. These studies will
provide valuable information about the immune responses to COVID-19
vaccines in these individuals. NIAID also plans to launch two
additional trials in August 2021 that will assess immune responses to
an additional dose of a COVID-19 vaccine in patients taking
immunosuppressive medications. One of these trials will enroll
participants with one of five autoimmune diseases, and the other will
enroll kidney transplant recipients. Each study will enroll
participants who have absent or weak antibody responses after an
initial course of COVID-19 vaccination. NIAID also plans to launch an
additional study that will enroll other solid organ transplant
recipients who are receiving immunosuppressive medications. Results
from these studies will help us to better understand the immune
response to vaccination in immunocompromised individuals and identify
approaches to safely enhance their responses to vaccination. These
studies may also lead to evidence-based guidelines for safely enhancing
responses to COVID-19 vaccination in immunocompromised individuals.
Question 1(c). What is the status of studies looking at using
different types of vaccines together, such as administering doses of
both Moderna and Pfizer to someone or using an mRNA vaccine as a
potential booster for Johnson & Johnson?
Answer 1(c). It is possible that the use of mixed vaccine
regimens--in which an individual receives doses of more than one
vaccine type--may induce a broader immune response, resulting in
improved protection against COVID-19. NIAID currently is supporting
research to determine the effect of mixed vaccine regimens and on June
1, 2021, launched a study to determine the safety and efficacy of
boosting with a COVID-19 vaccine different than the one used for the
initial vaccination, such as the Johnson & Johnson/Janssen vaccine
followed by one dose of the Moderna COVID-19 vaccine. The study also
will evaluate immune responses against SARS-CoV-2 variants. Initial
results from this trial are expected in late summer 2021 and may inform
public health policy decisions on the potential use of mixed vaccine
schedules, should booster doses be needed.
NIH is committed to supporting further research into the use of
mixed vaccine regimens. NIAID also is studying the currently available
COVID-19 vaccines--which were designed to target the original strain of
SARS-CoV-2--to assess the durability of protection they provide against
SARS-CoV-2 variants.
Question 2. Given all of the work that we have put into identifying
and tracking these new variants as they emerge, once a new variant is
detected, how quickly can we determine--in days or weeks--whether our
vaccines will continue to protect us from severe illness due to COVID-
19?
Answer 2. As mentioned in the response to question 1, data indicate
that all currently authorized COVID-19 vaccines remain effective at
preventing severe disease and death from COVID-19, including against
known variants of SARS-CoV-2. Once a new SARS-CoV-2 variant of interest
or of concern is detected and scientists obtain a sample of the variant
or the genetic sequence of the variant, they can assess whether
antibodies from individuals who have recovered from COVID-19, or who
received a COVID-19 vaccine, can neutralize the variant virus. These
experiments, which provide an early indication of vaccine efficacy
against a new variant, can be performed in a matter of days. However,
the process of definitively determining the impact of a variant can
take months and can vary based on several factors, including how
widespread, transmissible, and/or pathogenic the variant is. NIAID is
fully engaged in efforts to rapidly mitigate the potential impact of
emerging variants of SARS-CoV-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. NIAID scientists are helping to inform our
understanding of transmissibility of the variants by studying their
stability in the environment and their ability to grow in human lung
cells. These efforts add to a growing body of knowledge about SARS-CoV-
2 variants and our ability to combat them.
As part of the ongoing COVID-19 response, NIAID is collaborating
with vaccine manufacturers on key areas of research to investigate
whether vaccines designed for the original strain of SARS-CoV-2
maintain efficacy against emerging variants. NIAID is conducting and
supporting comprehensive studies to understand the ability of vaccine-
induced antibodies to neutralize the variant viruses. In addition,
NIAID is supporting the development of additional COVID-19 candidate
vaccines that seek to induce a broader immune response. 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 known viral strains.
Question 3. The Regional and National Biocontainment Laboratories
were designed to facilitate NIAID-funded research to address
biothreats, including emerging infectious diseases. As you know, Duke
University is home to one of these regional biocontainment
laboratories, and you have previously highlighted some of their
promising research, including a pan-coronavirus vaccine candidate that
could potentially provide increased protection against SARS-CoV-2 and a
variety of other coronavirus infections.
Question 3(a). Could you expand on the role of the Regional and
National Biocontainment Laboratories in the development of medical
countermeasures for COVID-19 and other threats?
Answer 3(a). NIAID established the U.S. National Biocontainment
Laboratories (NBLs) and Regional Biocontainment Laboratories (RBLs) to
conduct research on biodefense and emerging infectious disease agents
and to be available and prepared to assist national, state, and local
public health efforts in the event of a bioterrorism or infectious
disease emergency. Biocontainment laboratories, including the NBLs and
RBLs, are essential for the development of medical countermeasures for
emerging and re-emerging infectious diseases.
The NBLs and RBLs offer unique resources for the research
community, including animal models, imaging services, and specialized
equipment. In the case of COVID-19, research that involves the use of
live SARS-CoV-2 is required to take place in high biocontainment
laboratories, such as the BSL-3 laboratories within the NBLs and RBLs.
The NBLs and RBLs were able to utilize their unique BSL-3 capacity to
assist with basic, translational, and clinical research on SARS-CoV-2
and COVID-19.
Over the past year, the NBLs and RBLs played a critical role in
helping to address the COVID-19 pandemic and have been utilized to
conduct research with clinical samples containing live SARS-CoV-2 to
advance the development of COVID-19 medical countermeasures. The NBLs
and RBLs also have been involved in a variety of pre-clinical research
activities to test novel vaccines and therapeutics for COVID-19 and to
explore the pathogenesis of, and immune responses to, SARS-CoV-2. This
research includes the development of new animal models for COVID-19
research and the analysis of SARS-CoV-2 variants of concern.
Question 3(b). How can these biocontainment laboratories be used in
future preparedness and response efforts?
Answer 3(b). As noted in the response to question 3(a), the NBLs
and RBLs facilitate the conduct of research that aims to prevent,
prepare for, and respond to emerging and re-emerging infectious
diseases. NIAID recently published a funding opportunity for facility
and building system upgrades for the RBLs, which will facilitate future
research efforts in these laboratories. NIAID will continue to support
highly meritorious biomedical research in biocontainment laboratories,
including at the NBLs and RBLs, to prepare for and respond to future
infectious disease threats.
senator braun
Question 1. Dr. Fauci, what steps are your agency taking to prepare
for the increased exposure to flu, COVID variants, and other
communicable diseases in nursing homes?
Answer 1. Older adults, and specifically those in nursing homes and
long-term care facilities, are often at higher risk for severe outcomes
from infectious diseases, and the Administration is committed to the
development and testing of medical countermeasures for this vulnerable
population. The Centers for Disease Control and Prevention (CDC), the
lead agency for public health, has released guidance on the prevention
and management of transmissible diseases in long-term care facilities,
including nursing homes. This includes specific detailed guidance for
COVID-19, influenza, and other communicable diseases. The National
Institute of Allergy and Infectious Diseases (NIAID) conducts and
supports basic, translational, and clinical research into infectious
diseases, including research into the prevention of infectious
diseases. This research encompasses studies in vulnerable populations,
such as older adults and individuals living in nursing homes.
Vaccines are the most effective public health tools for preventing
infectious diseases, and COVID-19 vaccines currently authorized by the
U.S. Food and Drug Administration (FDA) are well tolerated and
effective at preventing severe disease and death, including in older
adults. NIAID has played an integral role in the evaluation of COVID-19
vaccines. Early in the pandemic, NIAID supported a Phase 1 clinical
trial of Moderna, Inc.'s COVID-19 vaccine, mRNA-1273, which was
developed through a collaboration between scientists at the NIAID
Vaccine Research Center and Moderna. NIAID included individuals aged 55
and over in this trial to assess the safety and efficacy of mRNA-1273
in older adults. The data from this trial facilitated progression of
mRNA-1273 into more advanced clinical trials that ultimately led to the
emergency use authorization (EUA) of this vaccine by the FDA.
New viral threats will continue to emerge, and the development of
universal influenza vaccines and pan-coronavirus vaccines, which would
protect vaccinated individuals against multiple viruses in one shot,
can help us be better prepared for future infectious disease threats.
NIAID is leading efforts to develop universal influenza vaccines to
protect against multiple strains of seasonal and pandemic influenza
viruses. NIAID also is conducting early stage research on the
development of pan-coronavirus vaccines designed to provide broad
protective immunity against multiple coronaviruses, especially SARS-
CoV-2 and other viruses with pandemic potential. These vaccines
ultimately would be evaluated for use across the age spectrum,
including in older adults. NIAID also is investigating the use of
therapeutics for prevention of COVID-19 in older adults. In
collaboration with Eli Lilly and Company, NIAID initiated a Phase 3
clinical trial that demonstrated that the investigational monoclonal
antibody, bamlanivimab, could prevent symptomatic and asymptomatic
infection in residents and staff of skilled nursing and assisted living
facilities. In addition, NIAID is supporting the development of broad-
spectrum therapeutics, including antivirals and antimicrobials, that
can be used to treat infections, including in older adults.
NIAID also conducts and supports research into understanding how
the immune system changes as we age. On October 21, 2020, NIAID
announced a new funding opportunity announcement (FOA), ``Cohort
Studies To Improve Our Understanding of Influenza Immunity, Vaccine
Response and Effectiveness in Older Adults.'' This FOA will support
research to increase understanding of (1) factors that correlate with
protection against influenza in older individuals, (2) the impact of
influenza exposure and vaccination history on protective immune
responses, and (3) immunological mechanisms associated with vaccine
failure, including potential intra-seasonal waning of protection.
Moreover, this research may lead to the identification of risk factors
for severe outcomes associated with influenza infection. Ultimately,
this work will inform efforts to develop durable, broadly protective
influenza vaccines across the age spectrum of adults.
Question 2. COVID vaccines do not appear to be working as well in
immunocompromised individuals or individuals taking immunosuppressants.
Could antibody tests be used to greater effect in this population to
identify individuals who may need an additional vaccine dose?
Answer 2. Immunocompromised individuals are at an increased risk
for poor clinical outcomes from COVID-19. While data indicate that some
immunocompromised individuals have a weak response to the COVID-19
vaccines available under FDA EUAs, vaccines remain the most effective
tool that we have for preventing COVID-19. As of the date of the
hearing, the FDA does not recommend using currently authorized SARS-
CoV-2 antibody tests to evaluate a person's level of immunity or
protection from COVID-19, including whether an individual may need an
additional dose of the COVID-19 vaccine. Antibody tests have not been
evaluated to assess the level of protection provided by immune
responses to COVID-19 vaccination, including in immunocompromised
individuals.
NIH is conducting and planning studies to assess and enhance the
immune responses to COVID-19 vaccines in immunocompromised individuals.
In April 2021, NIH scientists began two clinical trials to assess how
adults and adolescents with certain cancers or immune system
deficiencies respond to COVID-19 vaccination. These studies will
provide valuable information about the immune responses to COVID-19
vaccines in these individuals. NIAID also plans to launch two
additional trials in August 2021 that will assess immune responses to
an additional dose of a COVID-19 vaccine in patients taking
immunosuppressive medications. One of the trials will enroll
participants with one of five autoimmune diseases, and the other will
enroll kidney transplant recipients. Each study will enroll
participants who have absent or weak antibody responses after an
initial course of COVID-19 vaccination. NIAID also plans to launch an
additional study that will enroll other solid organ transplant
recipients who are receiving immunosuppressive medications. Results
from these studies will help us to better understand the immune
responses to vaccination in immunocompromised individuals and identify
approaches to safely enhance their immune responses to vaccination.
These studies may lead to evidence-based guidelines for safely
enhancing responses to COVID-19 vaccination in immunocompromised
individuals.
Results from these studies will help us to better understand the
immune responses to vaccination in immunocompromised individuals and
may better inform the development of meaningful antibody tests or other
assessments of immune response to vaccination for this population.
senator tuberville
Vaccination of Children/Parental Consent
Question 1. Last November, the District of Columbia passed a bill
allowing children 11 years and older to get vaccinated without their
parents' consent. It's been proven that this virus has an insignificant
impact on children under the age of 15 or 16.
Question 1(a). Do you think minor children should be vaccinated
without the consent of their parents?
Answer 1 & 1(a). I cannot comment on legislation passed at the
local level. While it is true that young children and adolescents are
less likely to experience severe symptoms from COVID-19, a portion of
these individuals will still experience severe disease and
hospitalization. Additionally, children and adolescents who are
infected with SARS-CoV-2 can experience a rare, but extremely serious,
multisystem inflammatory syndrome in children (MIS-C). As the Delta
variant (also known as B.1.617.2), which appears to be more
transmissible, has become the dominant strain of SARS-CoV-2 in the
United States, it is critical that as many people as possible are
vaccinated against COVID-19. The U.S. Food and Drug Administration
(FDA) has authorized the Pfizer/BioNTech COVID-19 vaccine for use in
individuals 12 years old and older, and I would encourage everyone who
is eligible to receive the vaccine to do so as soon as they can.
COVID-19 Origins
Question 2. Did you have knowledge of safety concerns at the Wuhan
lab?
Question 2(a). If so, when did you become aware of those concerns?
Question 2(b). Was it before or after you said in May 2020 that the
virus was more likely to have emerged naturally?
Answer 2(a) & (b). NIAID was aware of interest on the part of the
Wuhan Institute of Virology (WIV) to obtain additional information and
trained staff as they prepared to begin research in a new
biocontainment level 4 (BSL-4) facility.
My own view, based on the studies I have reviewed and my prior
experience, is that it is most likely that SARS-CoV-2 infections in
people resulted from zoonotic transmission from animals to humans,
based on what occurred with two other coronaviruses--Severe Acute
Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome
(MERS)--and many other emerging diseases, as well as what is known
about the molecular makeup of SARS-CoV-2. The available scientific
evidence, including information about the sequence of the virus, does
not support the assertion that SARS-CoV-2 was engineered. This view is
consistent with an emerging consensus from world-renowned experts in
virology, genetics, and evolutionary biology based on currently
available data. However, as I have publicly stated, the possibility of
a laboratory accident exists. A laboratory accident could include
scenarios where a naturally occurring virus was unintentionally
released during research activities such as collection of animal
samples or examination of virus in a laboratory. I am in favor of a
full investigation into the origins of SARS-CoV-2, and I look forward
to the findings of the experts in the various disciplines relevant to
this discussion.
Question 3. What is your awareness of Dr. Baric's collaboration
with researchers at the Wuhan lab?
Answer 3. I am aware of collaborations between Dr. Ralph Baric from
the University of North Carolina and the WIV. Dr. Baric was listed as a
collaborator on a 2014 grant ``Understanding Risk of Bat Coronavirus
Emergence'' submitted by EcoHealth Alliance and also was listed as a
co-investigator on the corresponding 2019 grant renewal application.
Prior to the renewal, this grant had included subawards to the WIV.
Based on results published in peer-reviewed papers that include authors
from Dr. Baric's lab and the WIV, I also am aware that Dr. Baric has
collaborated with investigators from the WIV on basic coronavirus
research.
Question 4. At what point did you realize that more investigation
is necessary to determine the origins of the virus?
Answer 4. Since the beginning of the pandemic, I have been
supportive of a full investigation into the origins of SARS-CoV-2 by
qualified experts in the relevant fields.
Question 5. In May, President Biden asked the Intelligence
Community to review the origins of Covid-19. Biden also asked that this
effort include work by our National Labs and other agencies of our
government to augment the Intelligence Community's efforts. Have you
participated in this review?
Answer 5. The National Institutes of Health (NIH) is supporting and
cooperating with the President's call for a U.S. Intelligence Community
(IC) investigation and would refer you to the IC for additional
information about their review.
NIH Grants
Question 6. The HHS Office of Inspector General (OIG) is conducting
a review of NIH grants.
Question 6(a). Have you provided documentation to the OIG?
Question 6(b). Have you been interviewed as part of this review?
Answer 6(a) & (b). I am unable to specifically comment on any
ongoing oversight engagements; however, I will note that the NIH is
fully cooperating with the Department of Health and Human Services
(HHS) Office of Inspector General.
COVID-19 Vaccine Clinical Trials
Question 7. Members of your staff served as co-investigators on the
COVID-19 Vaccine clinical trials.
Question 7(a). Have they investigated every report of an adverse
event by a trial participant?
Question 7(b). If so, what does that investigation entail?
Question 7(c). Do they evaluate each participant reporting an
adverse event?
Answer 7(a), (b) & (c). Vaccine clinical trials are designed, in
part, to assess the safety of candidate vaccines, and all reported
adverse events are investigated by the trial sponsor. The National
Institute of Allergy and Infectious Diseases (NIAID) was the trial
sponsor for the Phase 1 clinical trial for the Moderna vaccine
candidate, and the study recorded all adverse events among the 120
enrollees, including capturing any symptoms, new medical conditions,
and laboratory abnormalities. While NIAID is supporting the underlying
critical infrastructure for other clinical trials for COVID-19 vaccines
through the COVID-19 Prevention Network (CoVPN), NIAID is not the trial
sponsor.
Clinical trial protocols include information surrounding the
definition and handling of adverse events. NIAID would note that most
of the trial sponsors for the Phase 3 clinical trials of the COVID-19
vaccines tested through the CoVPN have made the protocols for these
trials available online, including for Moderna's COVE trial, Johnson &
Johnson/Janssen's ENSEMLE trial, and Novavax's PREVENT-19 trial. The
protocol for Pfizer/BioNTech's Phase 3 clinical trial also is available
online. NIAID recommends contacting the trial sponsors for further
information on COVID-19 vaccine clinical trials.
Misinformation
Question 8. Are you involved in the administrations recently
revealed efforts to flag ``misinformation'' about COVID-19 for removal
by social media companies?
Answer 8. No, I am not involved in the described efforts.
Question 9. Do you consider it misinformation for individuals to
share their stories of adverse events following vaccination?
Answer 9. No. I encourage anyone who has experienced an adverse
event following vaccination to report it to the Centers for Disease
Control and Prevention and FDA Vaccine Adverse Event Reporting System
(VAERS), a national early warning system to detect possible safety
issues in vaccines.
Question 10. Funds in part from NIH/NIAID helped build the 12
Regional Biocontainment Laboratories (RBLs) and 2 National
Biocontainment Laboratories (NBL) to support high consequence
infectious disease research after 9/11 and the anthrax scares in 2001.
However, unlike the NBL facilities, the RBL facilities received no
further direct support until last year when Congress provided enhanced
investment through NIH/NIAID, targeted specifically to RBL facilities,
one of which is at the University of Alabama at Birmingham (UAB) in my
state. Nevertheless, it seems as though the RBL infrastructure, most
importantly the highly trained staff these facilities maintain and
produce is something that falls within the purview of the HHS ASPR,
considering among other things the UAB RBL has had collaborations with
Altimmune and ImmunityBio for COVID19 vaccine development, and
supported BARDA contractors. This type of work strongly aligns with
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and
Sustaining Robust and Reliable Public Health Security Capabilities. The
RBL infrastructure and personnel is expensive to maintain and operate,
and perhaps should not solely rest on either the shoulders of the host
University or the NIH/NIAID.
Question 10(a). Therefore, is support from Assistant Secretary for
Preparedness and Response (ASPR) something under consideration?
Question 10(b). If not, why not, and if so what is needed to
facilitate that conversation?
Answer 10(a) & (b). NIAID defers to the HHS Office of the Assistant
Secretary for Preparedness and Response to respond to this question.
______
Response by Dr. Janet Woodcock to questions of Senator Burr, Senator
Braun, Senator Scott and Senator Tuberville
Responses to the QFRs are accurate as of the date of the hearing.
senator burr
Question 1. Pfizer and Moderna have both submitted or begun to
submit applications for full, standard approval of their vaccines.
Given FDA's extensive knowledge and understanding of the vaccine data,
are the agency's review timelines going to be faster than a traditional
application? If not, why not?
Answer 1. FDA's review of a Biologics License Application (BLA) is
among the most comprehensive in the world. When a BLA is submitted, the
Agency evaluates the information supporting safety and effectiveness as
well as manufacturing data. FDA also inspects the facilities that are
involved in the manufacturing of the product to ensure that the
vaccines that are distributed meet rigorous quality standards.
FDA scientists are working around the clock and reviewing the
applications, which include hundreds of thousands of pages of data and
other information, as expeditiously as possible, in a thorough and
science-based manner.
Having safe and effective approved COVID-19 vaccines is a top
priority for HHS and FDA. We firmly believe that those eligible to
receive a vaccine under the existing EUAs should get their COVID-19
vaccine now.
As you know, FDA first issued an EUA for the use of the Pfizer-
BioNTech COVID-19 Vaccine in individuals 16 years of age and older on
December 11, 2020. Additionally, two other vaccines are currently
available under EUA for the prevention of COVID-19. On December 18,
2020, FDA issued an EUA for the use of the Moderna COVID-19 Vaccine,
and on February 27, 2021, FDA issued an EUA for the use of the Janssen
COVID-19 Vaccine. The Moderna and Janssen COVID-19 vaccines are
authorized for use in individuals 18 and older. For additional
information on COVID vaccines, please visit: https://www.fda.gov/
emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/
covid-19-vaccines.
Question 2. FDA has made great strides in supporting innovative
clinical trial designs. How do you plan to continue to advance
innovative clinical trial designs to expedite the development of novel
products, using the creativity and flexibilities exercised during the
pandemic response as a roadmap?
Answer 2. FDA has a long-standing commitment to supporting
innovation in clinical development programs to help bring safe and
effective drugs to patients more efficiently. Although the COVID-19
pandemic accelerated the use of innovative trial designs, FDA's policy
development in this area long preceded the current public health
emergency. FDA recognizes that there are emerging shifts in how
diseases are diagnosed, prevented, and treated, and in the development
of therapeutics. FDA is working on multiple fronts to provide guidance
on innovative approaches to drug development, such as complex,
innovative trial designs, master protocols, decentralized trials,
trials utilizing real world data and evidence (RWD/RWE), modelling, and
simulation. Our engagements with stakeholders have supported innovative
trial designs as part of the COVID-19 pandemic response. These designs
improve clinical trial efficiency and may optimize product development.
FDA continues to promote innovation in clinical trial design and
conduct, and to encourage the utilization of advanced technologies. The
agency is already working in many ways to facilitate pharmaceutical
development and improve the overall clinical trial enterprise. We are
also leveraging strong national and global partnerships in collectively
advancing scientific knowledge to ultimately benefit patients. We are
invested in advancing innovations, such as decentralized clinical
trials and the use of digital health tools that have the potential of
making clinical trials more efficient and may allow for wider
inclusivity of diverse populations. Further, recognizing the value of
innovative designs, FDA is committed to continuing the Complex
Innovative Designs Meeting Program, which provides applicants accepted
into the program with additional meetings with FDA to discuss proposed
innovative designs.
Question 3. What has FDA learned from its review of products made
using platform technologies, such as the mRNA and viral vector-based
platforms, during the response? How will FDA support the development of
products for other disease areas that leverage platform technologies?
Answer 3. FDA recognizes that, when scientifically appropriate,
certain products have begun sharing manufacturing platform
technologies, allowing certain information from one product to be
applicable to future products with similar production strategies. The
Agency is interested in finding ways to streamline the development and
review of such innovative technologies. Toward this end, FDA hopes to
find ways to best leverage knowledge gained from approved products that
rely on certain platform technologies and associated manufacturing
methods to be applied to subsequent products that a sponsor may
develop. As this is a novel area, FDA continues to work to determine
how to best leverage such platform technologies and looks forward to
working with Congress in this area.
Question 4. On July 8th, the FDA and CDC said that Americans who
have been fully vaccinated do not need boosters at this time. Pfizer
announced it would file for authorization of a booster with the FDA,
and the ACIP has stated that they cannot recommend booster shots for
specific groups of individuals without FDA action. What is the timeline
for determining whether to authorize a proposed booster, either for
certain populations or the general public?
Answer 4. At the time of the hearing, FDA was closely monitoring
data as it became available from studies administering a booster dose
of the authorized COVID-19 vaccines to immunocompromised individuals.
The Agency is collaborating with the Centers for Disease Control and
Prevention and continues to evaluate all potential solutions to this
growing question in the medical community. For more information and
updates, please see: https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
FDA understands the potential importance of booster vaccine doses
for control of this pandemic and will promptly review any data
submitted to the Agency regarding their use in a thorough and science-
based manner. Due to legal and regulatory restrictions, FDA generally
cannot discuss product submissions that may be under review, including
the timing of any potential FDA action to authorize or approve the use
of additional doses of COVID-19 vaccines. Please contact the vaccine
manufacturers directly regarding their plans to submit data for their
individual vaccines and the timing of such submissions.
senator braun
Question 1. FDA has authorized large numbers of COVID tests and
other products using emergency use authorizations. Without further
action from FDA, when the public health emergency comes to an end these
products will no longer be available for use.
Question 1(a). How does the FDA plan to transition products to full
approval or clearance? What will happen if the public health emergency
ends, and critical products have not received approval or clearance
from FDA?
Answer 1 & 1(a). On February 4, 2020, the Secretary of the
Department of Health and Human Services (HHS) determined, pursuant to
section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, \1\ that
there is a public health emergency that has a significant potential to
affect national security or the health and security of United States
citizens living abroad, and that involves the virus that causes COVID-
19. Pursuant to Section 564 of the FD&C Act, and on the basis of such
determination, the Secretary of HHS then declared that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostics for the detection and/or diagnosis of COVID-19 (February 4,
2020), personal respiratory protective devices (March 2, 2020), other
medical devices (March 24, 2020) for use during the COVID-19 outbreak,
and drugs and biological products during the COVID-19 pandemic (March
27, 2020). (Please note that a determination under section 319 of the
Public Health Service Act that a public health emergency exists, such
as the one issued on January 31, 2020, and subsequently renewed, is
insufficient to enable FDA to issue EUAs.)
---------------------------------------------------------------------------
\1\ https://www.fda.gov/regulatory-information/laws-enforced-fda/
Federal-food-drug-and-cosmetic-act-fdc-act.
The declarations under section 564 have enabled FDA to authorize
unapproved products and unapproved uses of approved or cleared products
when, based on the totality of the scientific evidence available, it is
reasonable to believe that the product may be effective in diagnosing,
treating, or preventing the disease or condition and the known and
potential benefits of the product's use outweigh the known and
potential risks, taking into consideration the material threat posed by
an emergency situation. Irrespective of the status of the public health
emergency declaration under section 319 of the Public Health Service
Act, FDA is empowered to authorize such uses until the Secretary
terminates the declaration of emergency or threat justifying emergency
use under section 564(b), the criteria for EUA issuance are no longer
met, or revocation is otherwise appropriate to protect the public
health. It may be the case that once the public health emergency
declaration under section 319 of the Public Health Service Act expires,
the benefit-risk justification for issuance of any particular EUA are
no longer met or revoking such use is otherwise appropriate. In some
instances, manufacturers of certain devices, especially nonconventional
manufacturers, may no longer wish to market or distribute these
products. In other instances, manufacturers may desire to transition to
full approval or clearance and the statute directs FDA to communicate
---------------------------------------------------------------------------
with manufacturers regarding such transition.
The Agency is required to periodically review the authorizations
made under section 564 of the FD&C Act. As part of that review, FDA
reviews the progress made toward approval, licensure, or clearance of
the products authorized. See section 564(g) of the FD&C Act and FDA's
guidance on Emergency Use of Medical Products and Related Authorities.
\2\ As outlined in FDA's guidance, Emergency Use Authorization for
Vaccines to Prevent COVID-19, it is FDA's expectation that, following
submission of an EUA request and issuance of an EUA, a sponsor would
continue to collect placebo-controlled data in any ongoing trials for
as long as feasible and would also work toward submission of a
Biologics License Application (BLA) as soon as possible. FDA's
recommendations regarding the safety and effectiveness data and
information are essential to ensure that clinical development of a
COVID-19 vaccine has progressed far enough that issuance of an EUA for
the vaccine would not interfere with the ability of an ongoing Phase 3
trial to demonstrate effectiveness of the vaccine to support licensure
and to continue safety assessments, including investigating the
potential for vaccine-associated enhanced respiratory disease (ERD).
The ability of a sponsor to accrue this information about a COVID-19
vaccine is critical to ongoing assessment of its benefits and risks.
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\2\ https://www.fda.gov/media/97321/download.
FDA is working on a transition plan for devices that have been
authorized under EUAs \3\ or that fall within enforcement policies \4\
issued during the COVID-19 public health emergency. FDA's intention is
to issue guidance in draft form and request public comment before
finalization and implementation. Transition plan draft guidance is on
CDRH's Fiscal Year 2021 ``A List,'' \5\ meaning that this is a
prioritized policy that FDA seeks to publish in a timely fashion. FDA
recognizes that it will take time for device manufacturers, healthcare
facilities, healthcare providers, patients, consumers, and FDA to adapt
and adjust from policies adopted and operations implemented during the
public health emergency to normal operations. One of the goals of
developing guidance on this topic is to have an orderly transition
process and to provide transparency around FDA's approach to that
transition. In addition, FDA is engaging in discussions with individual
companies that are interested in obtaining marketing clearance or
approval for their devices, and we encourage companies to initiate
those discussions. Note that this proactive engagement is an integral
part of FDA's transition plan. As we shift more resources toward
working with sponsors pursuing full marketing status and as more
devices achieve this status, there will be a smoother transition away
from reliance on products authorized for emergency use or that fall
within enforcement policies issued during the COVID-19 public health
emergency.
---------------------------------------------------------------------------
\3\ https://www.fda.gov/medical-devices/emergency-use-
authorizations-medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices.
\4\ https://www.fda.gov/medical-devices/emergency-situations-
medical-devices/coronavirus-covid19-and-medical-devices#guidance.
\5\ https://www.fda.gov/medical-devices/guidance-documents-
medical-devices-and-radiation-emitting-products/cdrh-proposed-
guidances-fiscal-year-2021-fy-2021.
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senator scott
Question 1. Dr. Woodcock, the COVID-19 pandemic has had a
disproportionate and devastating impact on communities of color.
Drivers of this disparate impact correlate directly to social
determinants of health, such as health and financial literacy,
transportation, housing conditions, employment, safety, and education.
I have expressed concerns at a number of hearings on the prevalence of
vaccine hesitancy among Black Americans, with a 2020 survey suggesting
that only 25 percent of Black adults planned to get vaccinated in the
event of a COVID-19 vaccine approval. The pandemic has exposed several
disparities that exist within the U.S. healthcare system. One such area
is the under-representation of communities of color in clinical trials.
Improving the diversity of participants in clinical trials continues to
be a challenge due to a number of obstacles, including a lack of racial
diversity in clinical trial investigators, community mistrust and
skepticism due to historic abuses of racial minorities used as test
subjects, as well as a lack of convenient and affordable transportation
to clinical trial sites. To improve health outcomes for those most at
risk, we must diversify our pool of participants. Our goal should be to
include participants from diverse ethnic backgrounds and income levels.
It is also imperative investigators make devices and software available
to participants in addition to allowing enrollees to participate from
diverse settings such as their home, local clinics, and, potentially,
skilled nursing facilities.
Question 1(a). Dr. Woodcock--You have praised the success of the
innovations made within clinical trial designs. What is your vision to
expand access to clinical trials and how do we get there?
Answer 1 & 1(a). Modernizing clinical trials is a priority for FDA
and the subject of significant policy work in which we are currently
engaged. We view modernizing clinical trial designs and conduct and
utilizing innovative technologies as an essential area to improve
efficiencies and to facilitate the development of drugs, biological
products, and devices.
Prior to the pandemic, the Agency was working on these areas, and
the current public health emergency further catalyzed these efforts.
There is a wide range of designs, tools, and methods that can be
utilized in this area. For example, decentralized clinical trials,
hybrid trials, trials embedded in healthcare settings, trials that
allow for seamless transition between phases, the use of digital health
technologies, and supporting efficient, risk-based, approaches to trial
conduct are all areas that FDA is currently working on or is planning
on addressing. We have recently announced that the Agency will be
issuing a draft guidance on the use of digital health technologies in
clinical investigations and another draft guidance on decentralized
clinical trial designs.
Question 1(i). What was done during the pandemic to ensure COVID-19
treatment and vaccine trials were clinically diverse?
Answer 1(i). FDA published guidance \6\ to encourage diversity in
clinical trials and make recommendations on how to help increase
diversity in trials.
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\6\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/enhancing-diversityclinical-trial-populations-
eligibility-criteria-enrollment-practices-and-trial.
Sponsors who have requested an Emergency Use Authorization have
provided numbers, including enrollment numbers about the diverse
populations, in the package submitted to FDA for consideration for
potential Emergency Use Authorization (EUA). We continue to strongly
encourage the companies to improve their enrollment diversity and we
provide recommendations on how to do so by leveraging messaging in
local communities, site selection, and other strategies to raise the
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proportion of minorities being enrolled.
With regard to COVID-19 vaccines, in the June 2020 guidance,
Development and Licensure of Vaccines to Prevent COVID-19, the Agency
encourages the inclusion of diverse populations, including those most
affected by COVID-19, in all phases of vaccine clinical development.
For the three vaccines that FDA has authorized for emergency use,
all clinical trials included members of racial or ethnic groups at
greater risk from COVID-19.
FDA, vaccine manufacturers, and other scientists are currently
working to try to understand how long the authorized vaccines will
provide protection for the prevention of COVID-19. Many studies are
well underway to evaluate how long protection from a COVID-19 vaccine
lasts and whether there is any variability based on age, race or
ethnicity, or comorbidities that disproportionately impact underserved
communities. These studies are currently being conducted by government
agencies, academia, and industry partners. Specifically, these studies
are longitudinal patient follow-up studies, which usually entail
measuring antibody titers in a cohort of individuals before and at
multiple times after vaccination, and identifying an association
between antibody responses below a certain antibody level threshold and
vaccine failure/infection. These studies may be designed to demonstrate
differences in various groups based on age, race and ethnicity, or
comorbidities.
Question 1. If successful, how can we implement these changes post-
pandemic?
Answer 1. Advancing innovative and inclusive clinical trials is a
key part of FDA's ongoing efforts that started prior to the pandemic
and will continue post-pandemic. FDA will continue to encourage the
inclusion of diverse populations in clinical trials and is committed to
continue to work on ensuring that best practices for enhancing
diversity in COVID-19 treatment and vaccine trials are sustained beyond
the pandemic. Because clinical trials provide a crucial base of
evidence for evaluating whether a medical product is safe and
effective, enrollment in clinical trials should reflect the diversity
of the population that will ultimately use the product. The opportunity
to participate in clinical research should be available to all eligible
patients who are impacted by the disease.
In November 2020, FDA issued a final guidance for industry titled,
Enhancing the Diversity of Clinical Trial Populations; Eligibility
Criteria, Enrollment Practices, and Trial Designs. \7\ This guidance
recommends approaches that sponsors of clinical trials to support a new
drug application or a biologics license application can take to broaden
eligibility criteria, when scientifically and clinically appropriate,
and to increase enrollment of underrepresented populations in their
clinical trials. FDA has also published several additional guidances
supporting clinical trial diversity, including, Collection of Race and
Ethnicities in Clinical Trials (2016); Pregnant Women: Scientific and
Ethical Considerations for Inclusion in Clinical Trials (2018);
Clinical Lactation Studies: Considerations for Study Design (2019);
Postapproval Pregnancy Safety Studies (2019); and Older Participants-
ICH E7.
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\7\ https://www.fda.gov/media/127712/download.
FDA remains committed to increasing the participation of racial and
ethnic minorities and other underrepresented populations in clinical
trials that test new medical products for all diseases and conditions
through issuing guidance, developing tools, and encouraging the use of
innovative trial designs. In addition, FDA is working on policies
pertaining to the use of decentralized trial designs and digital health
technologies. Decentralized clinical trials have the potential to
increase diversity of research participants by incorporating,
telemedicine and mobile/digital technologies to increase access to
under-represented populations and/or communities--rural or remote--that
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may not have access to major medical and research centers.
Moving forward, FDA will apply lessons learned from COVID-19 to
help support the participation of people in racial, ethnic, and other
minority groups in the clinical trials that test new medical products
through hosting public meetings, developing tools, and issuing guidance
documents.
Question 1(ii). What are some of the benefits to providing
technology to clinical trial participants? For example, mobile glucose
monitors or tablets and phones equipped with software to transmit
information back to clinical trial investigators.
Answer 1(ii). Digital health technologies are among the most
promising tools we have for advancing clinical trial innovation and
promoting diversity and inclusion. Including digital health
technologies in clinical trials may make trial participation less
burdensome for participants and expand access to trials by enabling
remote data collection and monitoring from the participant's home
instead of traveling to a clinical site. Additionally, providing
digital health technologies to participants may enhance a participant's
experience in a clinical trial by promoting engagement and more
seamless information sharing between trial participants and clinical
investigators. Some of these digital health technologies allow
continuous collection of data from trial participants, which could
allow round-the-clock monitoring of drug effects. This may improve our
ability to understand the safety and efficacy of new drugs in ways that
were not previously possible.
When digital health technologies are included in clinical trials,
however, FDA recognizes the crucial importance of maintaining both the
safety of trial participants and clinical trial integrity. To promote
both, the Agency promptly provided guidance during the COVID-19
pandemic titled Conduct of Clinical Trials of Medical Products during
COVID-19 Pandemic \8\ that included recommendations regarding the
remote collection of data in clinical trials.
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\8\ http://wcms-internet.fda.gov/media/136238/download.
In this guidance, FDA explains that sponsors planning to use remote
electronic assessments as part of a clinical investigation should use
appropriate technology and develop procedures for provision of
technology and technical support to trial participants, investigators,
and/or other trial personnel to facilitate those assessments. For
example, sponsors could develop a plan to accommodate trial
participants who are either already enrolled in a trial or may be
enrolled in a trial in the future, but who do not have access to
appropriate communication technology (e.g., cell phones or Internet),
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by providing trial participants with these services.
FDA encourages the use of digital health technologies in clinical
trials that are beneficial to study participants. The Agency issued
final guidance in November 2020, entitled Enhancing the Diversity of
Clinical Trial Populations--Eligibility Criteria, Enrollment Practices,
and Trial Designs Guidance for Industry. \9\ This guidance encourages
sponsors to think about reducing visit frequency, when appropriate, in
addition to considering whether flexibility in visit windows is
possible and whether electronic communications, such as phone, email,
social media platforms, or other digital health technology tools, can
replace site visits and provide investigators with real-time data.
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\9\ https://www.fda.gov/media/127712/download.
In the above-referenced guidances, FDA provides a few examples of
potential approaches, and encourages the development of other
approaches that can make trial participation less burdensome for
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participants and foster retention and inclusiveness.
Question 1. What statutes need to be changed to allow for this
exchange?
Answer 1. At this time, FDA has not identified statutory changes
that are necessary to facilitate the use of digital health technologies
in clinical trials. The Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act provide sufficient flexibility to enable use
of a broad spectrum of technologies when appropriate to a particular
development program. Sponsors are already utilizing digital health
technologies in clinical development programs, and FDA is working with
sponsors to help facilitate such use consistent with applicable
regulatory requirements.
Question 2. The role of the Food and Drug Administration (FDA) in
combatting the COVID-19 pandemic has been critical, and I'd like to
thank you for the agency's vital work to support the successful
delivery of three vaccines to the American people. You have testified
in the past before this Committee that no corners were cut in FDA's
evaluation of COVID-19 vaccines in authorizing them under Emergency Use
Authorization (EUA), meaning that the FDA's gold standard review for
evaluating the safety and efficacy of COVID-19 vaccines was met or
surpassed for the vaccines authorized in the United States. Looking to
future pandemic preparedness efforts and other biological threats,
whether naturally occurring, deliberate, or accidental, I would like to
better understand the EUA process--not just for vaccines, but also for
vaccine manufacturing. Vaccine manufacturers moved at unprecedented
speed to develop a product and its manufacturing process while
simultaneously scaling-up manufacturing capacity--all at a record-
breaking pace. These efforts took place in the middle of a pandemic in
an environment with serious supply chain constraints. While not
unexpected given the circumstances, our understanding is that there
have been a number of challenges with COVID vaccine and therapeutic
manufacturers--with media reports focused on a range of companies,
including some of the largest pharmaceutical companies in the world
(Merck, Lilly) and some smaller contract manufacturers (Emergent, Texas
A&M/Fujifilm DioSynth, Catalent). So, I think explaining the EUA
standard for the authorization of the product and the manufacturing
process will serve to assure the American public and the world that any
product authorized during a public health emergency by the FDA is
appropriate--both for the current pandemic and in preparation for the
next.
Question 2(a). Dr. Woodcock--Can you please briefly explain the
standards for granting an EUA for a vaccine candidate?
Answer 2 & 2(a). FDA may issue an EUA after FDA has determined that
the product that is the subject of an EUA request meets the statutory
requirements under section 564 of the FD&C Act. In determining whether
to issue an EUA for a vaccine, FDA evaluates the available evidence to
determine, among other things, whether it is reasonable to believe that
the vaccine may be effective in preventing COVID-19 and whether the
known and potential benefits of the vaccine, when used to prevent
COVID-19, outweigh any known and potential risks of the vaccine. Once a
manufacturer submits an EUA request for a COVID-19 vaccine, FDA
evaluates the request and determines whether the relevant statutory
criteria are met, taking into account the totality of the scientific
evidence about the vaccine that is available to the Agency. The FDA
guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19
\10\ provides more information about FDA's current recommendations
regarding the data and information needed to support the issuance of an
EUA under section 564 of the FD&C Act for an investigational vaccine to
prevent COVID-19, including chemistry, manufacturing, and controls
information; nonclinical data and information; and clinical data and
information, as well as administrative and regulatory information. \11\
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\10\ https://www.fda.gov/media/142749/download.
\11\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently-asked-
questions#biologics.
Question 2(i). Can you please explain the standards for authorizing
a bulk drug substance manufacturing facility as part of a product EUA
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in a public health emergency?
Answer 2(i). As stated in FDA's Guidance for Industry, Emergency
Use Authorization for Vaccines to Prevent COVID-19, FDA assesses
current good manufacturing practice (CGMP) compliance for each
manufacturing site using all available tools and information. FDA
expects manufacturers to submit sufficient data to ensure the quality
and consistency of their product, and FDA evaluates the chemistry,
manufacturing, and controls and facility information for the product.
FDA uses all available tools and information, including reviews, site
visits, inspections, EUA investigations, and previous compliance
history, and has utilized the authority under section 704(a)(4) of the
FD&C Act to request records and other information from foreign and
domestic establishments to assess compliance with CGMP requirements of
facilities that are intended to manufacture vaccines to prevent COVID-
19 under an EUA. FDA has also used establishment inspection information
from capable foreign regulatory authorities under the Pharmaceutical
Annex to the U.S. and European Union Mutual Recognition Agreement
(MRA), and the Pharmaceutical Annex to the U.S. and United Kingdom MRA,
as well as other confidentiality agreements and commitments.
FDA takes its responsibility for helping to ensure the quality of
manufacturing of vaccines and other medical products for use during
this pandemic very seriously. As outlined above, the Agency is using a
variety of tools to help ensure that products being produced in
different facilities meet the high-quality standards that Americans
have come to expect. It is important to note that even when companies
use contract manufacturing organizations, it is ultimately the
responsibility of the company that holds the EUA to ensure that the
required quality standards are met. No product can be distributed by
manufacturers until FDA authorizes its distribution from the facility
that is manufacturing it. FDA will continue to work with companies to
ensure that the quality standards it expects for products distributed
under an EUA are met, and will continue to work diligently to help
bring needed medical products in a timely manner to Americans during
this public health emergency.
Question 2(ii). Can you please explain the standards for
authorizing a fill/finish manufacturing facility as part of a product
EUA in a public health emergency?
Answer 2(ii). Please see the response to ``i'' above.
Question 3. Current data suggests high efficacy rates among the
vaccines for which Emergency Use Authorization was approved, good news
for the 85.7 percent of South Carolinian seniors who have received at
least one dose and the 77 percent of whom are fully vaccinated.
However, as the Delta variant remains extremely contagious and the
World Health Organization labeling the Lambda version a ``variant of
interest,'' the U.S. cannot remain idle as we work to return students
back into the classroom and more adults come back to work. Recently,
Pfizer announced it planned to submit COVID-19 booster shot data to the
FDA by mid-August 2021. American seniors, their families and
caregivers, and stakeholders remain interested in knowing what the
Federal Government plans to do regarding the possible authorization and
distribution of booster vaccines. This information is especially timely
since the first Americans, including South Carolinian long-term
facilities residents, received their initial vaccines in December 2020.
Question 3(a). Dr. Woodcock--What collaborations are occurring
between the Federal Government, vaccine developers, the states, long-
term care facilities, the senior community, and other interested
stakeholders regarding information about booster vaccines? When will
this information be made public?
Answer 3 & 3(a). The COVID-19 vaccines authorized in the United
States continue to be remarkably effective in reducing risk of severe
disease, hospitalization, and death, even against the widely
circulating Delta variant. Recognizing that many vaccines are
associated with a reduction in protection over time, and acknowledging
that additional vaccine doses could be needed to provide long lasting
protection, we have been analyzing the scientific data closely from the
United States and around the world to understand how long this
protection will last and how we might maximize it.
FDA understands the potential importance of booster vaccine doses
for control of this pandemic and will promptly review any data
submitted to the Agency regarding their use in a thorough and science-
based manner. Due to legal and regulatory restrictions, FDA cannot
discuss product submissions that may be under review, including the
timing of any potential FDA action to authorize the use of booster
doses of COVID-19 vaccines. Please contact the vaccine manufacturers
directly regarding their plans to submit data for their individual
vaccines and the timing of such submissions.
senator tuberville
Question 1. Funds in part from NIH/NIAID helped build the 12
Regional Biocontainment Laboratories (RBLs) and 2 National
Biocontainment Laboratories (NBL) to support high consequence
infectious disease research after 9/11 and the anthrax scares in 2001.
However, unlike the NBL facilities, the RBL facilities received no
further direct support until last year when Congress provided enhanced
investment through NIH/NIAID, targeted specifically to RBL facilities,
one of which is at the University of Alabama at Birmingham (UAB) in my
state. Nevertheless, it seems as though the RBL infrastructure, most
importantly the highly trained staff these facilities maintain and
produce is something that falls within the purview of the HHS ASPR,
considering among other things the UAB RBL has had collaborations with
Altimmune and ImmunityBio for COVID19 vaccine development, and
supported BARDA contractors. This type of work strongly aligns with
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and
Sustaining Robust and Reliable Public Health Security Capabilities. The
RBL infrastructure and personnel is expensive to maintain and operate,
and perhaps should not solely rest on either the shoulders of the host
University or the NIH/NIAID.
Question 1(a). Therefore, is support from Assistant Secretary for
Preparedness and Response (ASPR) something under consideration?
Question 1(b). If not, why not, and if so what is needed to
facilitate that conversation?
Answer 1(a) & (b). FDA defers to ASPR to respond to these
questions.
______
Response by Dawn O'Connell to questions of Senator Baldwin, Senator
Burr, Senator Braun, and Senator Tuberville
Responses to the QFRs are accurate as of the date of the hearing.
senator baldwin
Question 1. I was encouraged to hear Assistant Secretary
O'Connell's announcement that $2 billion of the $10 billion that I
secured in the American Rescue Plan for domestic manufacturing and
utilization of the DPA would be used to support vaccine industrial base
expansion for raw materials, consumables, fill/finish capacity,
needles, vials, and syringes. Please provide additional details on the
recipients of this funding, as well as any information that can be
shared regarding future obligations.
Answer 1. With $10 billion received for industrial base expansion,
ASPR has been establishing and maintaining domestic capacity for
vaccine production and administration, in addition to a number of other
efforts for PPE and pharmaceutical manufacturing. Specifically, ASPR is
executing an acquisition strategy to expand the capacities and surge
capabilities for high-speed, reliable sterile filling/packaging
operations, domestic conversion of bulk biological drug substance into
drug product for distribution, and investments in manufacturing
capacities to better avail raw materials and consumables that are
commonly used across the commercial sterile biologic products industry
for production, delivery and administration (e.g., nucleoside
triphosphates (NTPs), enzymes, resins, lipids, and needle and syringe
sets).
Question 2. How is the Administration utilizing this funding to
ensure that American companies that shifted and significantly expanded
production of raw materials to aid in our pandemic response receive
support? How is the Administration working to build on our pandemic
response to develop a public health industrial base with the capacity
to respond to crises and make us less reliant on China?
Answer 2. ASPR is leveraging the authorities delegated to the
Secretary under the Defense Production Act (DPA) to ensure that private
sector partners making life-saving products are able to acquire raw
materials, retool their machinery, scale their production facilities,
train their workforces, and ultimately deliver their product.
Throughout the COVID-19 response, ASPR has used the DPA authority to
issue 46 priority ratings for U.S. Government (USG) contracts for
health resources, 8 priority ratings for USG contracts for industrial
expansion, and 3 priority ratings of specific purchase orders for
companies manufacturing critical lifesaving health resources that have
been impacted by COVID-19 response demands. ASPR is also continuing to
build capacity and partnerships with private industry toward the shared
goal of ending the COVID-19 pandemic. ASPR is also working to support
efforts in expanding the domestic industrial base. These industrial
base expansion (IBx) efforts seek to reduce supply chain
vulnerabilities and generate a domestic ``warm-base'' for manufacturing
that can be leveraged in a crisis.
Supporting domestic vaccine development and manufacturing efforts,
BARDA has invested $1.256B in the advanced research and development of
Moderna's mRNA-1273 vaccine candidate, supporting clinical trials and
manufacturing scale up and validation. The investments in a mRNA
vaccine will support new vaccine production platforms in the future
that will improve the efficiency and reduce the timeline to develop
vaccines for other biodefense threats and emerging infectious diseases.
Platform technologies, such as the mRNA approach, can provide flexible
and rapid response and have many advantages with potential to
revolutionize the way vaccines and therapeutics are produced for known
and newly emerging threats.
Question 3. Will the Administration commit to using some of this
funding for the raw materials, including medical-grade meltblown,
needed to produce N95 and N99 masks so that we are not dependent on
countries like China for this material?
Answer 3. ASPR has invested over $20.5 million in several companies
to increase and sustain melt-blown fiber production in the U.S.,
producing enough raw material to manufacture the equivalent of
approximately 171 million N95 or 400 million surgical masks a month. In
addition, utilizing the $10 billion received via the American Rescue
Plan Act to support industrial base expansion, ASPR has been working to
establish and maintain domestic capacities for N95 manufacturing.
senator burr
Question 1. As we saw during the early stages of the COVID-19
response, quickly identifying and containing the spread of a new
pathogen is a significant challenge. In preparing for the next public
health threat, how is HHS taking into account additional capacity for
testing in health care facilities as a result of health systems'
investments in high throughput instruments during the COVID-19
response?
Answer 1. HHS monitors the testing supply chain through
collaboration with diagnostic manufacturers. Ten of the major
manufacturers send shipment data, install base data, and supply
projections on a regular basis. HHS integrates this data into HHS
Protect, a platform that overlays epidemiological data, hospital
clinical data, COVID-19 testing data, and other public health metrics.
Of the three main data reports, the install base data gives HHS
visibility into the locations and quantity and utilization of all the
high-throughput machines for a specific company. This information
allows HHS to monitor how additional capacity for testing has increased
since the beginning of the pandemic.
Question 2. T-cell testing adds a critical dimension to how we
measure immune response. How can these tests be used to inform both
individual clinical decisions and a population-based, public health
response, and what steps is HHS taking to include T-cell testing in
planning for future public health threats?
Answer 2. T cells are an important component of the immune response
to viruses, including SARS-CoV-2, the virus that causes COVID-19.
Existing T cell testing technologies available for widespread use can
be used to aid in identifying individuals with an adaptive T cell
immune response to a virus, indicating recent or prior infection. For
example, the T-Detect COVID Test, which was developed by Adaptive
Biotechnologies and received an emergency use authorization (EUA) from
the FDA, can help determine if a person previously had COVID-19. This
test may be useful for people who have exhibited symptoms previously
but have not tested positive for COVID-19 using a molecular or antigen
diagnostic test. At this time, the test has only been authorized to
detect prior infection by SARS-CoV-2, and cannot be used to indicate
the degree of protection induced by COVID-19 vaccination or infection.
It is important to note that antibody or serum-based commercial
assays are readily available to the public and are easier and less
expensive to perform than T cell assays. Antibody or serum-based tests
also are generally sufficient to indicate current or previous
infection/vaccination. Techniques to examine T cells are labor
intensive, relatively expensive, and require specialized equipment and
sample collection. Laboratories that perform the T-Detect test for
commercial purposes also must be specifically designated by the company
and have obtained specialized certification. For these reasons,
monitoring of T cell responses to COVID-19--or other infectious disease
threats--is only possible on a small scale at this time. Nonetheless,
scientific studies of T cells can provide important insights into
COVID-19 progression, protection against SARS-CoV-2 variants, and
durability of immunity. HHS, through the National Institute of Allergy
and Infectious Diseases (NIAID), is supporting research to improve
understanding of the role of T cells in protecting against COVID-19 as
well as in COVID-19 progression. These efforts may lead to improved T
cell tests and help support the public health response to COVID-19.
NIAID also conducts and supports basic and clinical immune
research, including on T cell responses, to improve understanding of
SARS-CoV-2. NIAID supported a collaborative longitudinal study by
researchers at Emory University and the Fred Hutchinson Cancer Research
Center that demonstrated that T cells were detectable for up to 8
months in patients after mild to moderate COVID-19. NIAID also
supported two separate studies--one led by researchers from NIAID and
Johns Hopkins Hospital and another by scientists from the La Jolla
Institute--that examined the T cell responses in recovered COVID-19
patients and individuals vaccinated against COVID-19 and found robust
immune responses to the original strain--as well as multiple variants--
of SARS-CoV-2 in both groups. 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.
NIAID also is funding a number of basic research studies that will
inform how T-cell based approaches could be incorporated into future
countermeasures. This includes assays that measure the magnitude of T
cell responses in individuals who receive the currently authorized
COVID-19 vaccines. Understanding how T cells respond to SARS-CoV-2
infection and vaccination may help improve protection afforded by
future vaccines. Additional monitoring of T cell responses to SARS-CoV-
2 may also improve our understanding of the extent and longevity of
immunological protection against SARS-CoV-2.
Question 3. Health systems have experienced a spike in cyber-
attacks during the pandemic. For example, Universal Health Services,
Inc. experienced a cybersecurity attack in September 2020, which forced
hospital systems offline for weeks. Pursuant to the 2020 National
Defense Authorization Act Section 9002, the ASPR was designated as the
sector risk management agency for the health care and public health
sector.
Question 3(a). What work does ASPR perform as the sector risk
management agency? Of this work, what proportion is specific to
cybersecurity?
Answer 3 & 3(a). This past year has been full of challenges, and
HHS has found ourselves responding to increased quantities and new
types of cyber-attacks against the Healthcare and Public Health Sector.
In ASPR, the Division of Critical Infrastructure Protection (CIP)
serves as the hub for HHS as the sector-specific agency. Based on
authorities included in the 2021 National Defense Authorization Act
(NDAA), CIP is now the focal point for HHS as the sector risk
management agency. The goal of sector risk management agencies is to
look at the entire sector--in this case, health care and public
health--for all hazards. CIP works closely with government and private
sector partners through the structure of the Critical Infrastructure
Partnership Advisory Council to identify and address risks across the
sector--working with hospitals, pharmacies, manufacturers,
distributors, health IT providers, insurance plans, and mass fatality
managers. Over the past 5 years, CIP has been focused on four main
areas of risks management:
1. Identifying risks at facilities across the sector in an
objective data driven manner through our Risk Identification
and Site Criticality Tool (RISC), currently in development of
an enhanced, web-based version. The RISC tool identifies cyber
risks alongside natural hazard and other manmade risks, unlike
many other tools used in the sector, thus promoting
conversation between IT security staff and emergency managers.
The tool was released 2 years ago and has been downloaded in
all 50 states and utilized by at least 1,400 individuals.
2. Monitoring supply chain challenges in the health sector,
including dependence on foreign sourcing and challenges of
just-in-time-distribution;
3. Overall mitigation of risks before, during, and after
disasters--with a focus on planning for and communicating
during responses, including Hurricane Maria and the WannaCry
and Petya/notPetya cyber incidents of 2017, wildfires,
hurricanes, and the COVID-19 pandemic; and
4. Coordinating with the White House, DHS, and the FBI to
enhance HHS' ability to identify and share cyber hygiene best
practices; promote sharing of cyber incident information;
engage in discussion and coordination with the private sector
on priority education, policy, and communications activities;
and exercise existing and new cyber plans among government and
private sector partners.
As cybersecurity is such a threat to the Healthcare and Public
Health Sector, CIP makes sure to incorporate that risk into a majority
of projects to both raise awareness and encourage all those involved in
the partnership to recognize their potential role in preventing or
responding to cyber incidents.
Question 3(b). How has ASPR been executing its cybersecurity
responsibilities as part of this role and/or how does ASPR plan to
execute these responsibilities? If the latter, what is ASPR's timeline
for putting into place this plan?
Answer 3(b). ASPR led the development of a ``strategy for public
health preparedness and response to address cybersecurity threats''
that was required by section 703(a)(1) of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019. This strategy was
delivered to the HELP Committee on August 2, 2021 by Secretary Becerra.
This strategy identifies duties, functions, preparedness and response
goals for which HHS is responsible for the Healthcare and Public Health
(HPH) Sector. It also includes strategies to address identified gaps
and strengthen public health emergency preparedness and response
capabilities.
ASPR will direct and monitor implementation of this strategy
through the CIP Division, relying on expertise and activity from many
HHS Operating and Staff Divisions, including the FDA for medical
devices, OCR for privacy and security, ONC for health IT, and OCIO for
the HC3 and 405d programs. ASPR also manages the Critical
Infrastructure Partnership Advisory Council Joint Cybersecurity Working
Group, with hundreds of members. The group bases its work on the
recommendations of the 2018 Healthcare Industry Cybersecurity Task
Force and is currently developing CY2022 joint priorities.
ASPR CIP has led the development of the HPH sector Incident
Response plan, which will be appended as an annex to the all hazard
plan. The plan describes the full spectrum of the USG response to HPH
cyber incidents, including coordination of tactical activities among
HHS, FBI and CISA; development of an assessment of the effect of cyber
incidents on delivery of care, on supply chains, and on system
integrity; engagement of ESF-8 as necessary; and development of post-
incident reporting and of after-action plans.
Question 3(c). How many FTEs and resources are dedicated to
cybersecurity at ASPR?
Answer 3(c). For the management of the Sector Risk management
Agencies (SRMA) role for external HPH Sector Cybersecurity (which
excludes internal HHS/ASPR IT security), ASPR has one dedicated staff
member supporting cybersecurity preparedness across the health care and
public health (HPH) sector, partial time of a second staffer and two
contractor positions currently waiting to be filled. In addition, ASPR
staff greatly leverage external resources of HHS, DHS, and the private
sector to ensure comprehensive risk management for the HPH Sector.
Specific activities include:
Co-chairing the Joint Cybersecurity Working Group
comprised of 15 subject-specific Task Groups and over 300
organizations represented;
Leading efforts of Federal, state, local, tribal and
territorial entities to develop and disseminate Sector-wide
recommendations and guidance to prepare and better secure the
sector from Cyber threats, to identify risks from cyber
threats, lead response efforts to HPH-wide cyber events, and
promote mitigation and resiliency strategies;
Collaborating with private sector and Federal, state,
local, territorial, and tribal partners to establish and lead
work groups to address recommendations made by the Healthcare
Industry Cybersecurity Task Force Report for improving
healthcare cybersecurity, released in June 2017;
Leading collaborative interagency and other HPH
sector efforts to identify emerging cyber risks in HPH,
including risks associated with emerging technologies such as
artificial intelligence and machine learning-based tools, as
well as risks associated with new care delivery models such as
telehealth;
Leading tracking and assessment efforts during the
Federal response to Cyber Incidents;
Developing and implementing mitigation strategies as
well as incident and after action reports to inform and advise
on future response operations; and,
Creating a bi-weekly bulletin on cybersecurity topics
that reaches approximately 3,000 subscribers. Topics discussed
in the bulletin include information pertinent to understanding
and mitigating cybersecurity risks across all critical
infrastructure sectors, identification and analysis of trends
in cyberattacks and vulnerabilities, best practices for general
cyberhygiene, and specific recommendations for addressing
significant cyber threats.
Question 3(d). How does ASPR coordinate with the Cybersecurity and
Infrastructure Security Agency and the Federal Bureau of
Investigations?
Response: One of the ways ASPR collaborates with CISA is by
promoting their tools and resources and sharing info that could help
our sector partners. ASPR serves as a conduit between the Healthcare
and Public Health (HPH) Sector and CISA. Confronting cybersecurity
threats requires contributions from across the Federal Government,
including CISA, the FBI's National Cyber Investigative Joint Task
Force, and other stakeholders. ASPR participates in weekly calls with
CISA colleagues and our health sector partners. ASPR also works closely
with CISA through the Federal Senior Leadership Council Roles and
Responsibilities work, through which we have negotiated mechanisms of
sharing information between SRMAs, CISA, and the FBI.
Question 3(e). Please describe ASPR's coordination with the health
care and public health sector specifically related to cybersecurity.
Answer 3(e). As described above, ASPR holds weekly calls with
sector partners to discuss cybersecurity threats. During these calls,
ASPR is able to provide both the specialized knowledge regarding
cybersecurity as well as sector-specific knowledge to assist partners
in preventing and responding to incidents like a ransomware attack.
ASPR is also able to create private sector partnerships that have a
Federal Advisory Committee Act (FACA) exemption so that we can meet
with the same private sector partners and request consensus advice and
recommendations from them in a closed setting. Last, ASPR holds joint
sector working groups with private sector and government sector
partners to identify topics to work on, analyze best practices, and
develop products to release to the private sector.
senator braun
Question 1. Can you please provide specific updates on your plans
to ensure that nursing home staff and residents have sufficient point
of care molecular diagnostics and access to the most appropriate
prophylactics and treatments?
Answer 1. You should be aware that HHS has and continues to
distribute approximately 3 million point of care tests to long term
care facilities on a weekly basis. In addition, HHS monitors the
testing supply chain through collaboration with diagnostic
manufacturers. Ten of the major manufacturers send shipment data,
install base data, and supply projections on a regular basis. HHS
integrates this data into HHS Protect, a platform that overlays
epidemiological data, hospital data, testing data, and other public
health metrics. Of the three main data reports, the install base data
gives HHS visibility into the locations and quantity of all the high-
throughput machines for a specific company. This information allows HHS
to monitor how additional capacity for testing has increased since the
beginning of the pandemic.
senator tuberville
Question 1. Funds in part from NIH/NIAID helped build the 12
Regional Biocontainment Laboratories (RBLs) and 2 National
Biocontainment Laboratories (NBL) to support high consequence
infectious disease research after 9/11 and the anthrax scares in 2001.
However, unlike the NBL facilities, the RBL facilities received no
further direct support until last year when Congress provided enhanced
investment through NIH/NIAID, targeted specifically to RBL facilities,
one of which is at the University of Alabama at Birmingham (UAB) in my
state. Nevertheless, it seems as though the RBL infrastructure, most
importantly the highly trained staff these facilities maintain and
produce is something that falls within the purview of the HHS ASPR,
considering among other things the UAB RBL has had collaborations with
Altimmune and ImmunityBio for COVID19 vaccine development, and
supported BARDA contractors. This type of work strongly aligns with
numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and
Sustaining Robust and Reliable Public Health Security Capabilities. The
RBL infrastructure and personnel is expensive to maintain and operate,
and perhaps should not solely rest on either the shoulders of the host
University or the NIH/NIAID.
Question 1(a). Therefore, is support from Assistant Secretary for
Preparedness and Response (ASPR) something under consideration?
Answer 1(a). NIAID provided funding in 2003 and 2005 for the
construction of National Biocontainment Laboratories (NBLs) and
Regional Biocontainment Laboratories (RBLs). The NBLs and RBLs are
designed to complement and support the research activities of NIAID-
funded biodefense and emerging infectious diseases research as well as
assist national, state, and local public health efforts. The NBLs and
RBLs achieve this mission by providing safe and secure state-of-the-art
BSL-3/4 laboratory space to the scientific community to advance
research on biodefense pathogens and emerging infectious diseases.
NIAID's mission to support the development of medical products to
counter bioterrorism and emerging and reemerging infectious diseases is
part of a larger national strategy that involves many agencies.
The majority of Federal oversight of U.S. BSL3/4 labs is done on
those conducting select agent research, and falls under the purview of
CDC and USDA through the Select Agent Program. Additional certification
and oversight responsibilities for BSL3/4 labs is handled at the level
of the institution. As such, NIH and ASPR oversight is generally
limited to oversight of funded research.
Question 1(b). If not, why not, and if so what is needed to
facilitate that conversation?
Answer 1(b). See response to 1(a).
______
[Whereupon, at 12:24 p.m., the hearing was adjourned.]