[Senate Hearing 117-920]
[From the U.S. Government Publishing Office]
S. Hrg. 117-920
DEPARTMENT OF DEFENSE SUPPORT TO THE
COVID-19 RESPONSE
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HEARING
BEFORE THE
COMMITTEE ON ARMED SERVICES
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
FEBRUARY 25, 2021
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Printed for the use of the Committee on Armed Services
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
59-451 PDF WASHINGTON : 2025
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COMMITTEE ON ARMED SERVICES
JACK REED, Rhode Island, Chairman JAMES M. INHOFE, Oklahoma
JEANNE SHAHEEN, New Hampshire ROGER F. WICKER, Mississippi
KIRSTEN E. GILLIBRAND, New York DEB FISCHER, Nebraska
RICHARD BLUMENTHAL, Connecticut TOM COTTON, Arkansas
MAZIE K. HIRONO, Hawaii MIKE ROUNDS, South Dakota
TIM KAINE, Virginia JONI ERNST, Iowa
ANGUS S. KING, Jr., Maine THOM TILLIS, North Carolina
ELIZABETH WARREN, Massachusetts DAN SULLIVAN, Alaska
GARY C. PETERS, Michigan KEVIN CRAMER, North Dakota
JOE MANCHIN III, West Virginia RICK SCOTT, Florida
TAMMY DUCKWORTH, Illinois MARSHA BLACKBURN, Tennessee
JACKY ROSEN, Nevada JOSH HAWLEY, Missouri
MARK KELLY, Arizona TOMMY TUBERVILLE, Alabama
Elizabeth L. King, Staff Director
John D. Wason, Minority Staff Director
(ii)
C O N T E N T S
_________________________________________________________________
FEBRUARY 25, 2021
Page
Department of Defense Support to the COVID-19 Response........... 1
Member Statements
Statement of Senator Jack Reed................................... 1
Statement of Senator James M. Inhofe............................. 3
Witness Statements
Salesses, Robert G., Performing the Duties of Assistant Secretary 4
of Defense for Homeland Defense and Global Security.
Cummings, Stacy A., Performing the Duties of Under Secretary of 6
Defense for Acquisition and Sustainment.
Perna, General Gustave P., Chief Operating Officer, Federal 17
COVID-19 Response for Vaccine and Therapeutics.
Questions for the Record......................................... 54
(iii)
DEPARTMENT OF DEFENSE SUPPORT TO THE COVID-19 RESPONSE
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THURSDAY, FEBRUARY 25, 2021
United States Senate,
Committee on Armed Services,
Washington, DC.
The Committee met, pursuant to notice, at 9:31 a.m. in room
SD-G50, Dirksen Senate Office Building, Senator Jack Reed
(Chairman of the Committee) presiding.
Committee Members present: Senators Reed, Shaheen,
Gillibrand, Blumenthal, Hirono, Kaine, King, Warren, Peters,
Manchin, Duckworth, Rosen, Kelly, Inhofe, Fischer, Cotton,
Rounds, Ernst, Tillis, Cramer, Scott, Blackburn, Hawley, and
Tuberville.
OPENING STATEMENT OF SENATOR JACK REED
Chairman Reed. Good morning. Today the Committee is holding
this hearing to receive testimony on the Defense Department's
role in the Federal response to the COVID-19 crisis. Our
witnesses are Ms. Stacy Cummings, who is performing the duties
of the Under Secretary of Defense for Acquisition and
Sustainment; Mr. Robert Salesses, who is performing the duties
of the Assistant Secretary of Defense for Homeland Defense and
Global Security; and General Gus Perna, who is the Chief
Operating Officer for the Federal COVID-19 Response for
Vaccines and Therapeutics the organization was formerly known
as Operation Warp Speed.
I want to welcome our witnesses and thank them, not only
for appearing today but for their tireless work in helping our
nation address this terrible pandemic.
America recently passed a grim milestone, over 500,000
recorded deaths from COVID-19. The impact of these losses is
tragic and immeasurable. Yet recent developments and trends
offer a glimmer of hope. The Centers for Disease Control and
Prevention (CDC) reports that the daily number of new cases has
declined approximately 70 percent from their peak in mid-
January. Positivity rates for testing are down, and the rate of
hospitalizations and the number of new deaths are decreasing.
More than 65 million vaccines have been administered and
the daily vaccination average is now over 1.6 million doses.
However, more needs to be done. The goal remains to accelerate
vaccination efforts nationwide and scale up our ability to get
shots to the people who need them. This requires transparency,
clear communication, and accountability at every level of
government.
The Department of Defense's support to civil authorities
has been critical for delivering help to pandemic-stricken
Americans and their communities. The Committee is interested in
hearing about the Department of Defense's contributions to the
whole-of-government response to the COVID-19 crisis, and what
more the Department can to do help get this pandemic under
control and allow Americans to return to normalcy.
The public-private partnership, originally known as
Operation Warp Speed, mobilized the Defense Department's
extensive contracting capabilities to accelerate efforts to
develop and produce COVID-19 vaccines. The Department's
contracting capabilities include in-depth experience managing
large-dollar contracting with drug manufacturers through the
Department of Defense's (DOD's) Joint Program Executive Office
for Chemical, Radiological, Biological, and Nuclear Defense.
This office has overseen billions of dollars in contracts for
various aspects of the response, including helping to support
research activities, conduct clinical trials, increase the
production of tests, and manufacture hundreds of millions of
additional vaccine doses. General Perna, the Committee is
interested in knowing more about this element of your effort
and what we can do to further aid the necessary research on,
and production of, COVID-19 vaccines.
The Office of the Under Secretary for Acquisition and
Sustainment has helped lead efforts by the Defense Department's
acquisition workforce to support the interagency COVID-19
response efforts. Ms. Cummings, I would appreciate if you could
tell us about the Defense Department's role in that effort, as
well as actions by the Department to support the defense
industrial base during this economically challenging time. We
are particularly interested in the use of the Defense
Production Act and other acquisition authorities, and whether
those authorities need to be enhanced or adjusted to support
this important work. The ability to improve the rollout of the
vaccine across the nation will depend critically on the
government's ability to procure the vaccines and the associated
equipment needed to administer millions of doses. We are
depending on the DOD acquisition workforce to help make sure
that this is done as quickly as possible.
The Department has also responded to requests for support
from the states and the Federal Emergency Management Agency by
deploying significant military personnel, from both the
National Guard and Active Duty units. Missions being conducted
by more than 28,000 National Guard members across the country
include giving vaccinations and providing medical treatment.
Earlier this week, the Department announced the deployment
of a second Army Vaccination Support Team, consisting of
approximately 140 personnel, to Texas to support the COVID-19
response and assist in vaccination efforts, and additional
Vaccination Support Teams are being readied. Mr. Salesses,
these missions are critically important for getting shots in
the arms of Americans, but these deployments must also have an
impact on readiness, and I am hoping you can give us
information on that topic.
Finally, the Committee is concerned about the impact of the
pandemic on the health and safety of our Defense Department
personnel and operations. The Department reports that it has
administered nearly 1 million vaccines to DOD personnel,
including both first and second doses. At the same time,
however, it is reported that nearly one-third of servicemembers
are opting not to voluntarily receive the COVID-19 vaccine. Mr.
Salesses, I hope you can address the Department's vaccination
policies and plans, the latest transmission rates of the virus
among military personnel, and how the Department's response is
impacting our military operations at home and abroad.
Thank you again to our witnesses for appearing this
morning, and I look forward to your testimony, and let me
recognize the ranking member, Senator Inhofe. Thank you.
STATEMENT OF SENATOR JAMES M. INHOFE
Senator Inhofe. Well, thank you, Mr. Chairman. I think that
we all know this is something that has not been precedented and
we have never experienced it before. It is one of the most
trying periods in our nation's history, and we mourn the loss
of over 500,000 Americans. We are thinking of the thousands of
Americans who are infected every day and for those who still
suffer from the disease's long-term effects. Speaking of long-
term effects, we are devastated by the continued closure of the
schools and the shutdowns of businesses. The pandemic created
unprecedented challenges for Federal, state, and local
governments.
The Defense Department played a vital role in the pandemic
response from the beginning, starting by assisting HHS and
Housing in housing Americans who had been evacuated from China.
In the months that followed, over 47,000 guardsmen, including
hundreds from my state of Oklahoma, mobilized to staff testing
centers and delivery of food, and provided medical support. The
Army Corps of Engineers constructed 38 new alternative care
facilities around the country, adding over 17,000 hospital beds
to handle the surge of patients. DOD partnered with HHS in
Operation Warp Speed, promising to deliver a safe and effective
vaccine by 2021, and they did.
Many doubted that the vaccine could be discovered so
quickly. For example, when the previous administration
announced plans of having the vaccine by the end of the year,
an NBC News fact check said he would need a miracle to be
right. We are talking about the Trump Administration. He would
need a miracle to be right. But by the end of 2020, the Trump
Administration's effort paid off and we had the miracle. Simple
as that. I do not know why people are not talking about that
right now. We had two safe and extremely effective vaccines
that were discovered, and we have got another one that is
coming on, it is my understanding, this weekend.
As the National Institutes of Health Director, Francis
Collins, who was an Obama appointee, recently remarked,
Operation Warp Speed, quote, ``was an effort that many of us
were not initially convinced was going to be necessary. The
Trump Administration's success in record time,'' in his words,
and this is Francis Collins making this statement, he said,
``it was just breathtaking.''
So thanks to you, General Perna, and your team. You know, I
have watched this happen. When you first announced, it was back
in the summertime, and we had a hearing right after that, you
said Warp Speed--I never did understand where ``Warp Speed''
came from. It was not my idea. It was not Jack's idea. But
anyway, it was a success, a huge success. Especially remarkable
is how the Operation Warp Speed has revolutionized our previous
way of doing things. Under your leadership, General Perna--and
I believe it was your leadership--we are seeing vaccines move
from the conveyor belt to the supplier to the American families
in just days. This has never happened before. I am heartened by
this program, that there is certainly more work to be done. We
understand that. But I hope we will learn, in this hearing,
about DOD's efforts to accelerate vaccine production and
administration.
I want to conclude by thanking our three witnesses, each of
whom oversees a vital part of the response effort and the
thousands of men and women in uniform who have served admirably
during this incredibly difficult period.
Let me just add one thing, which is probably not germane to
this. We had a hearing yesterday, and I heard from--it was
classified--but I am not at all satisfied that we need to have
all of these resources out there now. We have all of these
individuals that are here, the Guard. This is not their job.
This is not what they are trained for. This is not what they
are capable of doing, and all the barbed wire, I think it has
seen its day. So let me just voice, as an opinion that you may
agree or disagree with.
Thank you, Mr. Chair.
Chairman Reed. Thank you, Senator Inhofe, and now let me
recognize the witnesses. We will begin with Mr. Salesses, and
that is not because you are from Rhode Island. It is the proper
way to begin. Go ahead, please.
STATEMENT OF ROBERT G. SALESSES, PERFORMING THE DUTIES OF
ASSISTANT SECRETARY OF DEFENSE FOR HOMELAND DEFENSE AND GLOBAL
SECURITY
Mr. Salesses. Thank you, Senator. Chairman Reed, Ranking
Member Inhofe, distinguished Members of the Committee, thank
you for the opportunity to testify before you today on the
Department of Defense's response to the COVID-19 pandemic.
The COVID-19 pandemic has posed an unprecedented challenge
on our nation. Since the start, DOD has protected its people,
supported the national response, and ensured the readiness of
the force to meet its national security missions. To protect
DOD personnel from the pandemic, DOD implemented measures that
contain and mitigate the effects on the force, including force
health protection guidance, restriction of movement orders,
social distancing, mask-wearing, telework on an unprecedented
scale, testing, and contact tracing.
DOD has also established their tiered vaccination plan,
following CDC guidance tailored to DOD's unique requirements.
As of 23 February, DOD has administered over 1 million doses of
vaccine.
DOD's support for the national response to the COVID
pandemic has evolved over the last 13 months. DOD assistance
began in late January 2020, supporting the repatriation of U.S.
citizens and U.S. persons to the United States. In support of
the State Department, U.S. Transportation Command (USTRANSCOM)
facilitated a safe return of more than 4,500 Americans. In
support of HHS, U.S. Northern Command (USNORTHCOM) and Indo-
Pacific Command (INDOPACOM) and the Military Departments aided
in the quarantine of more than 3,000 individuals on 13 DOD
installations.
As the pandemic spread over the late winter/early spring of
2020, hospitalizations increased rapidly, and state and local
demand rose for both medical facilities and medical providers.
HHS and Federal Emergency Management Agency (FEMA) turned to
DOD to help meet this demand. NORTHCOM deployed over 15,000 DOD
personnel, including 5,000 Active Duty and Reserve medical
professionals, to ten states and multiple locations within
those states. Indo-PACOM provided similar support in Hawaii,
Guam, and the Northern Mariana Islands. The U.S. Army Corps of
Engineers designed and constructed 38 alternate care
facilities, providing additional medical bed capacity in
multiple states, up to 16,000 beds.
Working with FEMA, DOD also authorized National Guard
personnel to carry out FEMA COVID-19 mission assignments in
title 32 status. More than 47,000 National Guard personnel
supported testing, emergency medical care, medical sheltering,
public health, communications, transportation, logistics, and
first responder support.
The National Guard is also supporting state vaccine efforts
in 43 states, at over 350 sites, and have administered over 1
million doses of vaccine.
DOD also played a critical role in strengthening the
national supply chain for medical resources and Personal
Protective Equipment (PPE) in short supply. With DOD
assistance, FEMA and HHS established the Supply Chain Task
Force in late March of 2020, to accelerate acquisition, expand
production by generating new capacity, and allocate key
resources and supplies to priority hotspots around the nation.
In late March of 2020, DOD also established the COVID Joint
Acquisition Task Force to serve as the DOD nexus for supporting
Federal acquisition and logistics needs to restock the
strategic national stockpile and expand the domestic industrial
base for medical supplies and equipment.
Building on decades of work studying infectious disease in
the Department, such as Ebola and the coronaviruses, DOD
experts helped genetically sequence COVID-19 and establish the
first treatment protocol for remdesivir in the spring. Further,
DARPA-funded projects helped lay the groundwork for rapid
development of RNA COVID-19 vaccines, produced by Moderna and
AstraZeneca.
The Joint DOD-HHS Vaccine Task Force, established in May of
2020, accelerated the development, manufacturing, and
distribution of COVID vaccine in record time.
As Secretary Austin made clear in his day one message to
the Department, DOD must move further and faster to help
counter the COVID-19 pandemic. To that end, DOD, with FEMA,
have developed plans to support vaccine centers able to
administer up to 6,000 vaccines a day. DOD is actively
supporting California, Texas, New York, and New Jersey with
over 1,000 personnel, at the newly established vaccine centers.
FEMA has also provided mission assignments to DOD to
support sites in Florida, Pennsylvania, and the U.S. Virgin
Islands, with several other states making final arrangements
for DOD support.
Going forward, DOD is actively implementing President
Biden's national strategy, executive orders, and national
security policy memorandums, and it is committed to executing
the President's and Secretary Austin's direction to defeat
COVID-19 pandemic, defense the force against COVID-19, while
protecting our nation.
Chairman Reed, Ranking Member Inhofe, distinguished Members
of the Committee, thank you for the opportunity to testify
before you today. I appreciate the critical role and the
support Congress provides in ensuring the Department is
prepared to face every challenge at home and abroad.
Chairman Reed. Well, thank you very much. Let me now
recognize Ms. Cummings. Ms. Cummings?
STATEMENT OF STACY A. CUMMINGS, PERFORMING THE DUTIES OF UNDER
SECRETARY OF DEFENSE FOR ACQUISITION AND SUSTAINMENT
Ms. Cummings. Thank you. Chairman Reed, Ranking Member
Inhofe, and distinguished members of the Senate Armed Services
Committee, thank you for the opportunity to testify today to
showcase the accomplishments of the Defense Acquisition and
Logistics workforce in response to the COVID-19 global
pandemic.
DOD has played a vital role supporting the interagency to
acquire and deliver medical resources, to include PPE and to
establish and strengthen the domestic medical industrial base.
Leveraging various acquisition tools, to include the Defense
Production Act, the DOD executed contracts and agreements
valued at over $30 billion in support of the national response.
This include over $3 billion in direct assisted acquisition to
procure and deliver medical items and PPE requested by FEMA and
HHS. Additionally, through 34 awards, valued at $1.8 billion,
we have established and expanded domestic PPE and medical
supply chains in partnership with HHS. We also coordinated the
shipment and delivery of COVID-19 test kits, needles, and
syringes from abroad through the U.S. Transportation Command.
The CARES Act provided $1 billion in Defense Production Act
Title III funding to prevent, prepare for, and respond to the
coronavirus. As documented in the Department's spend plan, we
allocated $213 million to increase production capacity for
critical health resources, targeting N95 respirators and COVID-
19 testing capacity; $687 million was allocated to mitigate
financial impacts to companies within the defense industrial
base to ensure the survival of national security-critical
capabilities; and $1 million allocated to establish a loan
program in partnership with the U.S. International Development
Finance Corporation.
The defense industrial base is the nexus of national and
economic security. With congressional support, the DOD took
immediate steps to mitigate the impact of COVID-19 on the
defense industrial base, beginning with frequent and meaningful
engagement with industry and a series of formal issuances to
ensure DOD contracting officers and industry partners had the
information and tools they needed to sustain mission-critical
operations.
Our resulting implementation approach was incorporated
across 46 policy documents, focusing on three broad areas:
First, allowing companies to continue to work safely; Second,
providing liquidity to the defense industrial base; and Third,
implementing legislation, such as Section 3610 of the CARES
Act, to ensure complete spending transparency.
I would also like to note that like their commercial
counterparts, the organic industrial base experienced financial
and production challenges that would have had negative long-
term impacts to military readiness had Congress and the
Department not intervened. The Department undertook actions to
restore production operations to normal levels, and the organic
industrial base continues to manage and stabilize depot-level
production, due in large part to a $1.5 billion cash infusion
to the defense working capital fund.
I am incredibly proud of the Department's response to this
national emergency and of the dedicated individuals who have
worked so hard on behalf of the American people. I am grateful
for the transparency and dialogue with professional staff
members of the defense committees, and I thank you for your
support and the opportunity to testify before you today. I look
forward to answering your questions.
[The joint prepared statement of Ms. Stacy Cummings and Mr.
Robert G. Salesses follows:]
Joint Prepared Statement by Ms. Stacy Cummings and Mr. Robert G.
Salesses
introduction
Chairman Reed, Ranking Member Inhofe, distinguished Members of the
Committee: Thank you for the opportunity to testify before you today on
the Department of Defense's (DOD's) response to the coronavirus disease
2019 (COVID-19) pandemic. We are honored to be here in the company of
General Gustave Perna, DOD's lead for the Vaccine Task Force (formerly
``Operation Warp Speed'').
As President Biden's ``National Strategy for the COVID-19 Response
and Pandemic Preparedness'' states: ``The federal government cannot
solve this crisis alone. Full implementation of the National Strategy
for COVID-19 will require sustained, coordinated, and complementary
efforts of the American people, as well as groups across the country,
including State, local, territorial, and Tribal governments; health
care providers; businesses; manufacturers critical to the supply chain,
communities of color, and unions.'' DOD is a critical part of the
Federal response, but DOD's efforts rely greatly on partnerships. DOD's
provision of key medical and non-medical capabilities, personnel, and
supplies to support the States, the District of Columbia, U.S.
territories, or international partners, was only possible because of
strong, mutually supporting partnerships with our interagency partners.
The COVID-19 pandemic has posed an unprecedented challenge to our
nation. In the face of this tremendous challenge, Secretary Austin
stressed the need for DOD to defeat the COVID-19 pandemic and defend
the force against COVID-19, while protecting our nation. In this fight,
DOD is fully committed to achieving the seven goals of the National
Strategy for the COVID-19 Response and Pandemic Preparedness, as well
as, carrying out President Biden's direction, that were provided in:
Executive Order (E.O.) 13987, ``Organizing and Mobilizing the United
States Government To Provide a Unified and Effective Response To Combat
COVID-19 and To Provide United States Leadership on Global Health and
Security,'' E.O. 13991, ``Protecting the Federal Workforce and
Requiring Mask-Wearing,'' President Biden's ``Memorandum to Extend
Federal Support to Governors' Use of the National Guard to Respond to
COVID-19 and to Increase Reimbursement and Other Assistance Provided to
States,'' and the other Executive Orders and Presidential memoranda
related to COVID-19.
unprecedented incident
The COVID-19 pandemic is the greatest public health challenges our
nation has faced in over 100 years, since the 1918 influenza pandemic.
Domestically, most disasters or emergencies either affect a single
State or region within the United States In contrast, COVID-19 not only
affected the entire United States, but the entire world. (Historically
speaking, no President has ever before declared a major disaster for
all States, territories, and the District of Columbia.) Additionally,
typical incident responses last 1 to 3 weeks and then transition to
recovery, whereas the COVID-19 response has been ongoing for more than
one year. Uniquely, the need to stop the spread of the virus eliminated
an entire tier of the national response system (i.e., interstate mutual
aid and assistance). Furthermore, when most incidents occur, responders
are able to focus on saving and protecting lives, followed by a
transition to recovery. Instead, COVID-19 is a persistent incident that
only ebbs and flows in intensity without allowing for a true recovery
phase of operations yet.
The response to COVID-19 is distinct from previous disease
outbreaks, with the exception of the 1918 influenza pandemic, because
of the disability and death caused by the virus, the ease of
transmission, and its impact on an interconnected world. In many
countries, including the United States, the virus placed unprecedented
stress on the capacity of civilian healthcare systems. As of February
23, 2021, there were nearly 28 million confirmed COVID-19 cases and
more than 500,000 deaths in the United States--more lives than those
lost in World War II. \1\ Vaccination efforts have begun and are
steadily expanding, with more than 44 million people in the U.S. having
received at least one dose. \2\
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\1\ CDC COVID Data https://covid.cdc.gov/covid-data-tracker/
index.html#datatracker-home, As of February 18, 2021.
\2\ CDC COVID Data, https://covid.cdc.gov/covid-data-tracker/
index.html#vaccinations, As of February 18, 2021.
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In comparison to the general U.S. population, DOD Service members
have not been as significantly affected by COVID-19. As of February 22,
2021, there have been more than 159,000 cases of COVID-19 and 22 deaths
due to COVID-19 among DOD's military population. \3\ Across DOD's total
population (military, civilian, dependent, and contractor), there have
been more than 237,000 cases of COVID-19 and 281 deaths. \4\ The age-
adjusted mortality rate among military personnel has been lower than
that for the general population. The virus has nonetheless had
widespread impacts on the force, including delaying non-emergency
medical treatments, military training (especially collective training),
military exercises with allies and partners, and by complicating
recruitment and initial entry training. As is the case with our
civilian counterparts, impacts on family life of our force has been
disruptive to readiness as well. Persistent physical and mental health
effects of COVID-19 are being studied now, with early results
suggesting long-term effects, meaning the virus also has the potential
to impose additional costs to the force. \5\
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\3\ DOD, Coronavirus: DOD Response, As of February 17, 2021:
https://www.defense.gov/Explore/Spotlight/Coronavirus//./
\4\ DOD, Coronavirus: DOD Response, As of February 17, 2021:
https://www.defense.gov/Explore/Spotlight/Coronavirus//./
\5\ i, Luming, Fangyong Li, Frank Fortunati, and John H. Krystal.
``Association of a Prior Psychiatric Diagnosis With Mortality Among
Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
Infection.'' JAMA network open 3, no. 9 (2020): e2023282-e2023282; Li,
Sophie, Joanne Beames, Jill Newby, Kate Maston, Helen Christensen, and
Aliza Werner-Seidler. ``The impact of COVID-19 on the lives and mental
health of Australian adolescents.'' medRxiv (2020), As of November 2,
2020: https://www.medrxiv.org/content/10.1101/2020.09.07.20190124v1;
UNCLASSIFIED; Chen, Qiongni, Mining Liang, Yamin Li, Jincai Guo,
Dongxue Fei, Ling Wang, Li He et al. ``Mental health care for medical
staff in China during the COVID-19 outbreak.'' The Lancet Psychiatry 7,
no. 4 (2020): e15-e16; https://www.thelancet.com/journals/lanpsy/
article/PIIS2215-0366(20)30462-4/fulltext.
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protecting dod personnel
DOD took aggressive actions early in the pandemic to protect DOD
personnel. As COVID-19 spread, the U.S. Centers for Disease Control and
Prevention (CDC) began recommending cloth mask use, physical
distancing, avoiding crowds, and washing hands as key mitigation
strategies to help control the spread of the virus. DOD was doing these
things from the start of the pandemic as a way to protect the force and
maintain readiness. Over the course of the pandemic, DOD developed and
implemented several measures to contain and mitigate effects on the
force. These included: issuing force health protection (FHP) guidance
(DOD issued the first FHP guidance on January 30, 2020); strategically
issuing restriction of movement (ROM) orders; requiring social
distancing and mask wearing; instituting telework on an unprecedented
scale; employing testing and contact tracing; and implementing sentinel
surveillance programs in coordination with DOD's influenza sentinel
surveillance program, along with serologic surveillance through the
Department's HIV testing program. Collectively, these mitigation
efforts were critical to informing DOD senior leadership and allowing
leaders to make appropriate risk-based decisions enabling DOD to
protect the force, continue operations, and maintain readiness.
Early in the pandemic, DOD experienced the same shortages in
testing supplies as the rest of the nation due to the just-in-time
supply chain. Therefore, the Department initially prioritized testing
for those who presented with symptoms of the disease. Early global
shortages of testing equipment and supplies made it difficult for DOD
to conduct a broader range of screening and regular surveillance
testing to accurately estimate infection rates among DOD populations
and quickly isolate infected persons. Early testing supply limitations
made testing, contact tracing, and isolation less robust than DOD
pandemic plans would otherwise have been. To coordinate demand for
testing supplies, DOD and the U.S. Department of Health and Human
Services (HHS) created the Diagnostic and Testing Task Force, which
streamlined procurement efforts and developed algorithms derived from
U.S. Food and Drug Administration (FDA) and CDC guidance to help ensure
evidence-based use of new testing options as they became available.
In April 2020, the Department established a four-tiered COVID-19
testing program that would enable DOD to test a wider segment of the
military population, in addition to prioritizing testing across the
force for those presenting with symptoms or who had close contacts with
infected persons. \6\ Tier 1 testing was designated for those forces
involved in critical national capabilities such as strategic deterrence
or nuclear deterrence; Tier 2 was for fielded forces around the world;
Tier 3 was for forces being forward-deployed or those redeploying; and
Tier 4 was for all other forces.
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\6\ Garmone, Jim, ``DOD Starts Tiered COVID-19 Testing Process to
Ensure Safety,'' DOD News, April 22, 2020.
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DOD's testing capabilities have increased dramatically over time.
As of February 17, 2021, DOD had conducted more than 2.6 million tests
for DOD personnel over the course of the pandemic. Moreover, as of
early January 2021, DOD was conducting more than 15,000 tests per day.
DOD's testing strategy continues to evolve as new diagnostics become
available, supply chains change, and new guidance is released on how
best to employ COVID tests to execute its full testing strategy. The
increased testing capability and the four-tiered testing system have
been important tools that enabled DOD to maintain readiness, protect
the force, and safeguard the communities where we live and work.
DOD views testing as one of several complementary foundational
public health measures, including contact tracing, which must be used
in concert to limit the spread of the virus and to improve DOD's
overall force availability. To that end, Secretary Austin released
guidance across the Department to make mask wearing mandatory in any
room or area where more than one individual is present. DOD is now also
undertaking a thorough review of all COVID-related guidance documents,
to include a full review of workplace safety guidelines, in order to
maximize our effectiveness in stopping the spread of COVID-19.
support to the national and international response
Overview of National Response
COVID-19 involved unprecedented support to all 50 States, 3
territorial authorities, and the District of Columbia. Since January
27, 2020, the Department of Defense has received 374 Federal Emergency
Management Agency (FEMA) Mission Assignments and 47 Requests for
Assistance from other Federal Departments and Agencies in response to
the COVID-19 pandemic. To date, the total FEMA obligation amount for
DOD support is in excess of $3.4 billion, provided on a reimbursable
basis pursuant to the Stafford Act. More than 62,100 military
personnel, including National Guard (NG) personnel from all 50 States,
3 territories, and the District of Columbia, have been involved in
supporting COVID-19 relief operations. Military personnel have
augmented medical staff at hospitals, nursing homes, and assisted
living facilities; delivered food to hard-hit communities; supported
logistics efforts to supply medical equipment; built alternate care
facilities; conducted community-based medical screening; conducted
laboratory testing; provided installation support; and assisted with
fatality management among other tasks. \7\
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\7\ See National Conference of State Legislatures, ``National Guard
Assists Response to the COVID-19 Pandemic,'' NCSL homepage, April 28,
2020.
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Repatriation Efforts
Beginning in late January 2020, U.S. embassies and consulates
around the globe assisted U.S. citizens and U.S. persons in returning
to the United States. \8\ After an initial State Department charter
flight in January 2020, two flights arrived on February 5, 2020, at
Travis Air Force Base (AFB) and Marine Corps Air Station (MCAS)
Miramar, and on February 7, flights arrived at MCAS Miramar and Joint
Base (JB) San Antonio-Lackland. HHS requested DOD to provide lodging at
five sites, initially: March Air Reserve Base (ARB), Travis AFB,
Miramar MCAS, JB San Antonio-Lackland, and Camp Ashland. By the end of
this effort, U.S. Transportation Command (USTRANSCOM), in support of
the State Department, facilitated the safe return of more than 4,500
Americans, and U.S. Northern Command (USNORTHCOM) and the Military
Departments provided housing at 13 military installations in order to
quarantine more than 3,000 individuals from China and two cruise ships
in response to multiple HHS requests. The support ended on April 4,
2020, and was provided on a reimbursable basis pursuant to the Economy
Act. Installations were also used as support bases for DOD and FEMA
responders and logistics.
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\8\ https://www.gao.gov/reports/GAO-20-701/
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Medical Surge Support
By the end of March 2020, COVID-19 infections began materializing
in key hotspots around the nation, first in Washington, New York, and
California, then quickly spreading across the country. Hospitalizations
from COVID-19 began to increase rapidly, creating concerns about
insufficient medical capacity to treat the rising number of patients,
and a subsequent demand from States and local governments for both
medical facilities and medical providers. In accordance with the
National Response Framework, HHS and FEMA turned to DOD to help meet
this demand. In response, DOD deployed two Navy hospital ships, several
Navy Expeditionary Medical Facilities, Army Combat Hospital Centers,
Army Reserve Urban Augmentation Medical Task Forces, and Air Forces
Expeditionary Medical Support units to provide surge medical support on
ships, at alternate care facilities (ACFs), and in civilian hospitals
and nursing homes. Additionally, 38 ACFs were designed and constructed
by the U.S.
Army Corps of Engineers (USACE) to provide additional capacity. At
the peak of this demand, USNORTHCOM deployed almost 15,000 DOD
personnel, including almost 5,000 Active Duty and Reserve medical
professionals (approximately 580 doctors, 1,190 nurses, 130 respiratory
therapists, 180 mid-level providers, and 3,200 support services), to 10
different States and multiple locations within some States. Meanwhile,
U.S. Indo-Pacific Command provided similar support in Hawaii, Guam, and
the Commonwealth of the Northern Mariana Islands.
National Guard Support to the States
Beginning in March 2020, but extending throughout 2020 and into
2021, FEMA requested that DOD authorize NG personnel from 52 States and
territories \9\ to support COVID-19 response efforts. The Secretary of
Defense authorized title 32 duty status--funded by the Federal
Government but under State command and control, to support these
mission assignments. \10\ Due to the pervasive nature of the pandemic
and its economic consequences, President Biden in his ``Memorandum to
Extend Federal Support to Governors' Use of the National Guard to
Respond to COVID-19 and to Increase Reimbursement and Other Assistance
Provided to States'' authorized a 100-percent Federal cost-share to the
States and territories under the Stafford Act, extended the support
through September 30, 2021, directed FEMA to reimburse DOD fully for
the cost of pay and allowances for FEMA mission assignments to DOD
related to NG support, and directed the Secretary of Defense to
maximize the use of title 32 to support the States and territories.
Under this arrangement, States retain command and control of their NG
personnel for their COVID-19 response, while FEMA covers the costs of
such support. At the peak of such authorizations, more than 47,000
National Guard personnel supported community-based testing, emergency
medical care, medical sheltering, communicating health and safety
information to the public, transportation, logistics, and first
responder support. As of February 23, 2021, approximately 28,900
National Guard personnel were supporting the COVID-19 response in 49
States (excluding Wyoming) and three U.S. territories.
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\9\ Wyoming has yet to request support from FEMA for the use of
their National Guard, and the District of Columbia National Guard
always operates in title 32 when supporting the District of Columbia.
\10\ Section 502(f) of Title 32, U.S. Code, authorizes the
President or the Secretary of Defense to request the Governors order to
duty their NG personnel to conduct operations or missions for DOD.
Operations or missions conducted in a title 32 duty status are under
the command and control of the Governors with funding provided by DOD.
DODI 3025.22, ``The Use of the National Guard for Defense Support of
Civil Authorities,'' establishes policy for the use of the NG for DSCA
missions, which requires another Federal Department to request DOD
support. In this case, FEMA requested that DOD support the States and
territories and fully reimbursed DOD for the pay and allowances and
other costs associated with the use of NG personnel in title 32 status.
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Supply Chain and Acquisition Support
DOD also played a critical role in strengthening the supply chain
for medical resources and protective equipment, which were in
critically short supply at the beginning of this pandemic. COVID-19
created urgent demand for personal protective equipment, or PPE, such
as masks, gloves, and gowns, as well as medical equipment, such as
ventilators and respirators, all of which are necessary to protect
medical personnel and to treat patients. Initially, the global demand
for these items far outstripped the available supply, due in part to
the just-in-time global supply chain. The U.S. depends on the global
supply chain for PPE and some medical equipment necessary to respond to
COVID-19, making it difficult to expand production capacity within the
United States or use Defense Production Act (DPA) authorities to
prioritize domestic COVID-19-related requirements and expand the
industrial base to manufacture critical supplies. \11\ The national
supply chain, including the supply chain for the Strategic National
Stockpile, or SNS, was unable to meet the exponential increase in
demand as a result of the global pandemic. In recognition of this need,
the DOD mobilized its acquisition and logistics workforce to respond
quickly and professionally to support HHS and FEMA and meet this
National need.
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\11\ Senate Homeland Security and Governmental Affairs Committee,
``Evaluating the Federal Government's Procurement and Distribution
Strategies in Response to the COVID-19 Pandemic,'' June 9, 2020,
https://www.hsgac.senate.gov/evaluating-the-federal-governments-
procurement-and-distribution-strategies-in- response-to-the-covid-19-
pandemic.
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FEMA and HHS established the Supply Chain Task Force (SCTF), led by
Rear Admiral John Polowczyk, to focus on reducing the medical supply-
chain-capacity gap both to satisfy demand and to relieve pressure on
medical supply capacity. This organization was led and heavily
supported by DOD personnel who had expertise in supply-chain management
and logistics that were detailed to FEMA. The identified medical supply
chain constraints underscored a need to accelerate acquisition and
expand production to generate new capacity and allocate resources to
ensure that supplies were prioritized to hotspots. The SCTF also worked
with commercial distributors to facilitate the rapid distribution of
critical resources. A key example of this partnership in action is
Project Air Bridge. Working with the State Department and other
partners, FEMA created Project Air Bridge to reduce the time it takes
for U.S. medical supply distributors to receive PPE and other critical
supplies into the country for their respective customers. USTRANSCOM
supported this effort and delivered into the private sector supply
chain nearly 1.5 million N95 respirators, 937 million gloves, 112.7
million surgical masks, 39.4 million surgical gowns, more than 2.4
million thermometers, more than 2.5 million face shields, 1.4 million
coveralls, 109,000 stethoscopes, 370,000 oxygen masks, and more than
160,000 cannulas.
To facilitate the U.S. Government's urgent medical resource
acquisition efforts, DOD established the COVID-19 Joint Acquisition
Task Force, or JATF, on March 25, 2020. The JATF was responsible for
creating processes that enabled HHS and FEMA to quickly and effectively
access DOD acquisition workforce, expertise, and authorities in support
of the U.S Government's COVID-19 response. The JATF's goals were to
bring analytic, program management, and contracting expertise from the
Services and DOD Agencies to quickly respond to demand from FEMA and
HHS; utilize DOD's supply chain expertise to forecast gaps and identify
opportunities for industrial base expansion; and prioritize solutions
from industry to connect suppliers to FEMA or HHS requirements. Nearly
300 DOD acquisition and supply chain experts responded to this call for
support to enable FEMA and HHS to rapidly scale and modify their
acquisition efforts, both for procurement of supplies and to expand
domestic industrial capacity.
DOD initially provided full-service acquisition support across the
Government by establishing product teams in areas where DOD anticipated
HHS needs, material shortage, or an industrial base constraint that
would require action. DOD acquisition experts conducted the necessary
medical industrial base analysis and brought issues highlighted by this
analysis to a joint FEMA-HHS decision-making body for direction. As
HHS's analytic capacity increased and response efforts stabilized,
DOD's interagency acquisition support evolved from full-service to
streamlined support responding to HHS requirements and priorities.
In response to HHS' most critical needs, DOD played a key role
supporting the immediate response to the national health emergency by
replenishing the SNS while supporting an expanded domestic industrial
base. Leveraging the Defense acquisition workforce's supply chain
expertise, including its understanding of U.S. reliance on foreign
suppliers and the associated impact on producing at scale, HHS expanded
both the depth and breadth of the SNS. DOD assisted HHS in replenishing
the SNS with a goal of holding a stock level of 90-days based on surge
demand for critical medical supplies and PPE while identifying areas of
investment that reduce our reliance on foreign suppliers.
DOD has a long history of supporting the national response in
support of FEMA and other interagency partners. The Defense Logistics
Agency (DLA) has a standing arrangement with FEMA to acquire goods and
services during disasters and other incidents, and has been a
significant contributor to the pandemic response. DLA executed new
orders to restock the SNS and deliver critical COVID-19 related medical
supplies and test kits across the nation to support nursing homes,
assisted living facilities, and schools and universities. DLA used its
contracting and logistics expertise to assist FEMA and HHS in their
support to States and territories for the COVID-19 response. As of
February 16, 2021, DLA executed more than 27,000 contract actions,
obligating more than $3.2 billion in critical medical resources for the
Whole-of-Government response, including nearly $800 million to
replenish the SNS. These procurements include 168 million rapid antigen
tests, 8.9 billion gloves, 54 million N95 respirators, 201 million
surgical masks, 111 million gowns, and 5,800 ventilators.
With the passing of the CARES ACT, the Congress recognized that the
National response to a global pandemic would require industrial
manufacturing capacity to enable long-term domestic viability for
critical medical resources and PPE. Based on HHS's requirements, the
DOD leveraged innovative acquisition strategies to expand domestic
production of critical medical supplies such as ventilators, N95
respirators and filter media, surgical masks, screening and diagnostics
equipment, medical gloves and gowns, pharmaceuticals and other
therapeutics, and vaccine injection devices.
Recognizing the critical role the Defense Acquisition Workforce has
played in the response and recovery, DOD realized the structure and
processes developed in operationalizing the JATF needed to be formally
codified and sustained in preparation for future national emergencies.
Accordingly, on October 13, 2020, DOD formally established the Defense
Assisted Acquisition (DA2) Cell, nested within the Joint Rapid
Acquisition Cell (JRAC) to provide an enduring resource for future
interagency assisted acquisition requirements.
In support of HHS, the U.S. Government's single agency leading the
COVID-19 public health response efforts, DOD continues to support
industrial base expansion efforts. Facilitated by DA2 (and previously
JATF) the DOD has awarded 34 contracts to date, valued at $1.8 billion,
to expand the domestic health and medical resources industrial base.
The Defense Acquisition Workforce continues to actively respond to HHS
requirements to expand domestic production for Testing and Diagnostics,
PPE, and to mitigate constraints in the medical supply chain.
On behalf of HHS, DOD has also coordinated the shipment of over 878
thousand pounds of COVID Test Kits and the delivery of over 55 million
needles and syringes to the United States from China through United
States Transportation Command.
support to the defense industrial base
Defense Production Act
The DPA provides broad authorities to meet U.S. defense, essential
civilian, and homeland security requirements. There are three distinct
DPA authorities: Title I, Title III, and Title VII. DPA Title I
authorities may be utilized to prioritize federal contracts over all
other orders; control distribution of scarce materials within the
civilian economy; allocate scarce materials against federal or private
contracts; and prevent hoarding of scarce materials. DPA Title III
provides incentives to industry to develop, maintain, modernize, and
expand production capacity or critical technologies. These incentives
include loans/loan guarantees, purchases/purchase commitments, and
grants and subsidies. DPA Title VII authorities contain mandatory
survey authority for any U.S. registered business entity; antitrust
immunity for industry to develop and implement national emergency
preparedness plans; the Committee on Foreign Investment in the United
States (CFIUS); and Civilian Executive Reserve, called into federal
service during a national emergency.
DPA Title I, III, and VII authorities were heavily leveraged during
the national response to the COVID-19 pandemic. Through DPA Title I,
FEMA, HHS, and other federal partners placed priority rated orders for
health and medical resources to respond to COVID-19, including PPE and
ventilators. The DPA Title III Program was appropriated $1 billion to
the
DPA Purchases account via the CARES Act in order to ``prevent,
prepare for, and respond to the coronavirus.'' Of the $1 billion
appropriated to the DPA Title III Program, $213 million was allocated
to increasing production capacity for critical health resources,
including N95 respirators and testing consumables; $687 million was
allocated to mitigating financial impacts to companies within the DIB
and ensuring the survival of critical capabilities; and $100 million
was allocated to establishing a Federal Credit Line Program with U.S.
International Development Finance Corporation (DFC). The expenditures
have protected U.S. workers and ensured that essential elements of the
industrial base survived COVID.
Through DPA Title VII, DOD, the U.S Treasury Department and other
interagency partners have maintained a watchful eye on opportunistic
foreign investment in critical infrastructure sectors, and FEMA
established a voluntary agreement for enhanced coordination and
cooperation with private sector manufacturers, distributors, and
industry representatives to provide critical healthcare resources to
respond to the pandemic.
DPA Title III Loans through the U.S. International Development Finance
Corporation
E.O. 13922, issued on May 19, 2020, delegated authority under
section 302 of the DPA to the U.S. International Development Finance
Corporation (DFC) in order to establish a Federal Credit Line Program.
To enable execution of E.O.13922, DOD allocated to the DFC $100 million
of the $1 billion provided under the CARES Act for domestic production
of strategic resources needed to respond to the COVID-19 outbreak, and
to strengthen any relevant domestic supply chains. The DFC has over
fifty years of experience operating federal lending programs in
emerging markets, with specific expertise in manufacturing lending.
Responsibility for the management and execution of the loan program is
shared by DFC and DOD. To note, the DFC has setup a specific COVID-19
lending team to focus on this program in order to not interfere with
its Congressional mandates for international development finance.
Applications are screened by an interagency panel consisting of
representatives from DFC, DOD, HHS, the U.S. Department of State, the
U.S. Department of Commerce, and the Executive Office of the President.
DFC loans will help create, maintain, protect, expand, and restore
domestic industrial base capabilities supporting the national response
and recovery to the COVID-19 outbreak, as well as improve the
resiliency of domestic supply chains. DFC is actively evaluating 19 key
pandemic response projects for a total of $2.9 billion dollars. To
date, DFC has approved three loans worth $1.4 billion that increase
manufacturing capacity for COVID-19 vaccine vials, development, and
testing.
Mitigating Impacts on the Defense Industrial Base
Since the onset of COVID-19 the Office of Industrial Policy has
hosted calls with key DOD stakeholders and the leaders of more than
fifteen Associations representing over three million businesses. The
goal of these industry calls has been to establish a high level channel
of communication to address the numerous issues created within the
defense industrial base due to the pandemic. These calls have created a
vital link to partner businesses and lead to unique ways of solving
problems jointly.
The Office of Small Business Programs launched the Defense Small
Business Webinar series in April 2020 to help small businesses in the
defense industrial base remain strong and resilient throughout COVID.
In 2020, DOD OSBP held 7 webinars, reaching over 4,000 participants.
The Department has diligently implemented acquisition-specific
language of the CARES Act. In addition, my office has issued necessary
guidance and direction to the DOD contracting workforce to acquire
COVID-related supplies and services in the most expeditious way. The
Department also ensured our guidance was informed by frequent and
meaningful engagement with industry, both through recurring meetings
and open engagements to seek industry input to key policy initiatives.
The goal of our guidance was to ensure a healthy DIB in the face of the
COVID 19 crisis. Our implementation approach and related policies
outlined in some forty-six policy documents have focused on three
areas: 1) Allowing companies to continue to work (while maintaining
workplace safety); 2) Providing liquidity to the DIB; and 3)
Implementing legislation in a way that provides complete spending
transparency.
Allowing Companies to Continue to Work
From the onset of the pandemic, the Department worked to ensure the
DIB, within the parameters of public health guidance established by the
Centers for Disease Control, could continue to perform safely in an
effort to limit both the impact on national security and resulting cost
and schedule impacts to our readiness and modernization efforts. On
March 19, 2020, the Department of Homeland Security (DHS) published a
memo designating the DIB as critical national infrastructure. Following
this designation, the Under Secretary of Defense for Acquisition and
Sustainment and the Office of Defense Pricing and Contracting (DPC)
immediately published guidance leveraging the DHS designation to ensure
the DIB could continue to work. DPC issued guidance highlighting
telework for both government and contractor staff to enable continued
performance despite facility closures or other COVID-19-related
impacts.
Providing Liquidity to the Industrial Base
On March 20, 2020, DPC issued a Class Deviation to increase the
progress payment rates in the Defense Federal Acquisition Regulation
Supplement (DFARS) to 90 percent for large business concerns and 95
percent for small business concerns. This action addressed the number
one issue the DIB identified--liquidity or cash flow from prime
contractors down through their supply chains to small businesses. This
move was critical in enabling the DIB to continue working throughout
the national emergency. In addition to DOD direct payments to vendors,
many primes have passed these payments down to 2nd and 3rd tier
suppliers, providing liquidity at all levels. As of January 31, 2021,
this action has infused an estimated $4 billion in cash to all levels
of the DIB. Primes have assisted suppliers by accelerating payments,
restructuring performance based payment schedules, and employing other
favorable payment terms.
Support to the Organic Industrial Base
Like their counterparts in the Defense Industrial Base, the Organic
Industrial Base experienced similar financial and production challenges
that would have negative long-term impacts to readiness if both
Congress and the Department had not intervened. During the height of
the pandemic, individual depot, arsenals, and shipyards experienced a
range of employee non-availability extending to full closures of
production plant operations. But, across the Organic Industrial Base,
the Services took aggressive actions to protect and support their
workforces. In addition to providing the appropriate PPE, depots,
arsenals, and shipyards conducted routine health screening, applied
staggered shift-changes and flexible production scheduling, and
instituted disciplined workspace cleaning and social distancing
standards. In coordination with their customer commands, this
combination of actions has restored production operations to normal
levels as the organic industrial base continues to manage and stabilize
depot-level production. To mitigate the financial losses incurred
during the pandemic caused by reduced demand, delayed materiel
inductions, and lower productivity, the Defense Committees generously
granted $1.45B of Defense appropriations for transfer into the Defense
Working Capital Fund Components. This cash infusion was critical to
stabilizing out-year labor rates of the organic depots and to
preserving the Military Services' buying power for organic sustainment.
This was also essential to ensuring that commercial vendor deliveries
and payments were met and contracts were awarded with sufficient lead-
time to meet demands and to avoid draining cash balances below
acceptable levels.
Implementing Legislation
Section 3610 of the CARES Act allows agencies to reimburse
contractors for payment associated with the preservation of workforces
prevented from working due to COVID-19 facility closures or other
restrictions. In addition to increasing progress payment rates, the
Department moved swiftly to implement this legislation and provided
extensive guidance (to include reimbursement checklists) to the DOD
contracting community. In issuing this guidance, we took into
consideration industry input. Our implementation approach and paid
leave reimbursement guidance provide a framework for contracting
officers to assess any claimed, allowable paid leave cost, including
sick leave, that a contractor or their subcontractors provide to keep
their employees in a ready state, where they are unable to perform due
to facility closure or other COVID related impacts.
It is important to note that Section 3610 authorized, but did not
appropriate, the funds needed to make these reimbursements. As a
result, the Department has only reimbursed approximately $50 million to
84 separate companies to date. While the Department may be able to use
other appropriated funds to reimburse contractors, the cost for 3610 is
beyond the Department's resourced ability to do so without jeopardizing
modernization or readiness. The Department estimates the aggregate
potential Section 3610 Paid Leave costs to the DIB is $4.25 billion as
of December 1, 2020. This estimate is based on Rough Order of Magnitude
estimates (ROMs), which include both incurred and estimated costs for
Section 3610 Paid Leave, as provided by our top twenty-one vendors
based on total obligations.
In addition to paid leave costs under Section 3610, industry has
incurred and will continue to incur other COVID-19-related costs. The
Department has issued extensive guidance to enable reimbursement, to
include a checklist designed to reimburse these costs. If the
Department receives a supplemental appropriation for these costs, we
would prefer to negotiate settlements with major defense contractors at
a corporate level to avoid opening individual contracts, which may
result in higher costs and significant administrative burden. These
other COVID-19-related costs include such items as the purchase of
medical PPE, increased cleaning and sterilization costs, health
screenings, reconfiguration of production facilities and adjustment to
work schedules to implement public health guidance on social
distancing, and the costs associated with schedule delays emanating
from their supply chain. As with Section 3610, the Department does not
have the funding to cover these costs. The Department estimates the
impact of these other COVID-19-related costs to the DIB are $6.5
billion as of December 1, 2020. As with the paid leave costs, this cost
estimate is based on the industry provided ROMs, which include both
incurred and estimated costs through fiscal year 2023. This results in
a total impact of $10.8 billion to the DIB for both categories of cost.
With an appropriation, the Department could reimburse these costs and
maintain our readiness levels and planned modernization efforts in
support of the National Defense Strategy. Without an appropriation, the
Department would need to absorb these COVID-related costs through
reductions in planned modernization programs and reduced readiness
levels.
Development of Vaccines and Therapeutics
For decades, DOD laboratories have studied infectious diseases of
military importance, including HIV/AIDS, Ebola, and coronaviruses such
as Middle East Respiratory Syndrome (MERS). In January 2020, DOD began
research and development (R&D) on diagnostics, therapeutics, and
vaccines for SARS-CoV-2, the strain of coronavirus that causes COVID-
19.
The U.S. Army Medical Directorate-Armed Forces Research Institute
of Medical Sciences led important initiatives to sequence COVID-19 in
order to find its genetic ``fingerprint.'' Scientists used this
identification information to develop tests and proposed treatments as
early as January 2020, and later to help track the transmission chain
as the virus evolved over time. The Defense Health Program Medical R&D
funds provided the initial infusion required to support early COVID-19
research efforts. Some of these funds were allocated to the Joint
Program Executive Office for Chemical, Biological, Radiological, and
Nuclear Defense (JPEO-CBRND) and became an important source of funding
for early initiatives such as the development of testing and
therapeutics in February and March. \12\ One of the early successes was
the deployment of high-speed COVID-19 testing equipment to Fort
Jackson, South Carolina, that would turn around tests in a day and
isolate potentially infected recruits quickly, preventing further
transmission while allowing training to safely continue. Ongoing
research efforts proved useful for the COVID-19 response, which
resulted in publication of Clinical Practice Guidelines developed by
the Uniformed Services University of the Health Sciences and the
Defense Health Agency (DHA). Additionally, based on these research
efforts, JPEO-CBRND worked to achieve FDA Emergency Use Authorization
for the BioFire diagnostic test on March 23, 2020. The U.S. Army
Medical Research and Development Command (USAMRDC) established the
first U.S. treatment protocol for Remdesivir on March 17, 2020; and
JPEO-CBRND developed antibody treatments to be used by DOD and the
larger national response effort.
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\12\ https://www.jpeocbrnd.osd.mil/coronavirus
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Additionally, in 2011, the Defense Advanced Research Projects
Agency (DARPA) began focusing research specifically on efforts to
reduce the timelines for safe development and employment of vaccines
and antibodies. DARPA's Pandemic Prevention Platform (P3) program,
launched in 2017, focuses on rapid discovery, characterization,
production, testing, and delivery of efficacious DNA- and RNA-encoded
medical countermeasures against infectious disease. \13\ The
foundational technology was pioneered by DARPA under its Autonomous
Diagnostics to Enable Prevention and Therapeutics (ADEPT) program,
which began in 2011. ADEPT funded programs to research how the body
could produce antibodies against a new biological threat. These DARPA
programs funded projects that laid the groundwork for the development
of RNA COVID-19 vaccines produced by Moderna and AstraZeneca, and
COVID-19 therapeutics manufactured by Eli-Lilly.
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\13\ https://www.darpa.mil/news-events/2020-11-10
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*ERR14*DOD and HHS Vaccine Task Force
The joint DOD and HHS Vaccine Task Force was established in May
2020. The Task Force includes the U.S. Department of Agriculture, the
Department of Energy, the Department of Veterans Affairs, and several
private sector companies. The purpose of this partnership is to
facilitate, at an unprecedented pace, the development, manufacturing,
and distribution of COVID-19 countermeasures. The Task Force
coordinates existing HHS-wide efforts, including the National
Institutes of Health (NIH) Accelerating COVID-19 Therapeutic
Interventions and Vaccines (ACTIV) partnership for vaccine and
therapeutic development, NIH's Rapid Acceleration of Diagnostics (RADx)
initiative for diagnostic development, and work by the Biomedical
Advanced Research and Development Authority, under the office of the
Assistant Secretary for Preparedness and Response. There are three core
areas where the Vaccine Task Force has been accelerating the timeframe
for countermeasures, including a vaccine, reaching the American public:
1) Development; 2) Manufacturing; and 3) Distribution. The vaccine task
force effort is accelerating distribution, now at approximately 78.2
million vaccine doses, 59.6 million of which have been administered.
The task force expects to deliver the initial target of 300 million
vaccine regimens to States by the end of June 2021.
DOD's Vaccination Efforts
DOD established a tiered vaccination administration schema that
follows CDC guidance for determining priority groups, modified for
unique DOD requirements. As of February 20, 2021, DOD has received over
one million total doses of the Pfizer and Moderna vaccines, each of
which received an Emergency Use Authorization from the FDA. DOD is in
the expanded distribution phase with vaccine administration occurring
at 332 locations worldwide. Due to less demanding supply chain and
storage requirements for the Moderna vaccine, only the Moderna vaccine
is being used at sites outside the United States. As of February 20,
2021, DHA has administered approximately 990,000 of those doses. More
than 670,000 personnel have been partially vaccinated, and more than
318,000 have been fully vaccinated (i.e., having received 2 doses). As
of February 20, 2021, 18.3 percent of military personnel have been
vaccinated with the first dose, and 9 percent have been fully
vaccinated.
Support to the National Vaccine Program
As Secretary Austin made clear in his Day One message to the force,
the Department must move further and faster to contribute to the
Federal Government's efforts to counter the COVID-19 pandemic. One such
initiative to meet the Secretary's guidance is planning and resourcing
support to FEMA in order to support State and territory vaccination
efforts. DOD, in collaboration with FEMA, has developed plans to
support vaccine centers that could administer up to 6,000 vaccines per
day. This enhanced vaccination support will be provided directly to
FEMA to support existing state-run centers or to FEMA's new federally
supported, state-run centers. DOD is actively supporting New Jersey,
California, Texas, and New York with over 1,000 personnel at their
state-run vaccine centers. FEMA has provided mission assignments for
DOD to support additional sites in Florida, Pennsylvania, and the U.S.
Virgin Islands, totaling over 800 personnel. DOD expects to receive
additional requirements from FEMA to support other States and
territories in the near future.
International Response Efforts
During the COVID-19 pandemic, the Department of Defense supported
U.S. allies and partners through the provision and transport of life-
saving medical equipment, PPE, and humanitarian aid. As of February 15,
2021, DOD had provided more than $209 million in assistance to 143
countries to aid testing, diagnostic support, infection control, PPE
procurement, contact tracing, and more. DOD's assistance spanned the
areas of responsibility for all six Geographic Combatant Commands
(GCCs). The first phase of DOD's assistance, from March 2020 until May
2020, focused on supporting countries' immediate response to the
pandemic by providing locally procured PPE, medical supplies and
equipment, and testing supplies. The second phase of DOD's assistance
started in June 2020 and focused on capacity building to support mid-
to longer-term pandemic and infectious disease preparedness and
response capabilities. For example, DOD has provided subject matter
expert support to the African Union and the Africa CDC, and has
procured 71 field hospitals, diagnostic laboratory equipment, 477
ventilators, and 29 isolation clinics/pods. DOD's Humanitarian
Assistance and Foreign Disaster
Relief activities are funded by Overseas Humanitarian, Disaster,
and Civic Aid (OHDACA) appropriation funds. \14\ The advantage of
OHDACA is that use of such funds allows DOD to effectuate a transfer of
equipment, materials, or expertise, and thus can provide an immediate
boost to a partner nation's capacity. \15\ Throughout the COVID-19
pandemic, GCCs leveraged OHDACA funds and existing global health assets
to undertake ``minimal cost projects,'' which are humanitarian
assistance efforts costing up to $15,000, without higher-level
approval. \16\ The minimal cost project cap was eventually increased to
$75,000.
---------------------------------------------------------------------------
\14\ Defense Security Cooperation Agency, ``Security Assistance
Management Manual, Chapter 12: Overseas Humanitarian, Disaster, and
Civic Aid (OHDACA)''; Assistant Secretary of Defense for Special
Operations/Low-Intensity Conflict and Interdependent Capabilities,
Policy Guidance for DOD Overseas Humanitarian Assistance Program (HAP),
November 2009.
\15\ Garamone, 2020.
\16\ Defense Security Cooperation Agency, ``Security Assistance
Management Manual, Chapter 12: Overseas Humanitarian, Disaster, and
Civic Aid (OHDACA).''
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Priorities Going Forward
DOD remains focused on the national vaccination efforts including
production, distribution, and administration of COVID-19 vaccines to
support the States through FEMA. To protect DOD personnel and safeguard
DOD's national defense mission, the Department is continuing to expand
its internal vaccine program and refine its vaccination analytics,
improving DOD bio-surveillance (through implementation of DOD Directive
6420.02 ``DOD Biosurveillance'' published September 17, 2020) and
testing capabilities, exploring new treatments and testing capabilities
through its research and development programs, and continually is
refining its school and installation policies for force health
protection. The Department is also actively implementing President
Biden's guidance, publishing consolidated guidance for COVID-19 at the
Department and Service levels, implementing lessons learned from the
pandemic, and updating the Global Campaign Plan for Pandemic Influenza
and Infectious Disease. Finally, the Department is ensuring it is
postured to support the Administration's Global Health Security agenda.
conclusion
In conclusion, DOD remains committed to fulfilling Secretary
Austin's direction to defeat the COVID-19 pandemic and defend the force
against COVID-19, while protecting our nation.
Chairman Reed, Ranking Member Inhofe, distinguished members of the
Committee, thank you for your support to the Department and the
opportunity to testify before the Committee. We appreciate the critical
role Congress plays in ensuring that the Department is prepared to face
every challenge at home and abroad. We are also grateful for the
transparency and open dialogue afforded by professional staff members
from the pandemic's onset, especially their engagement at weekly
touchpoints that was invaluable to the nations and our efforts. We
especially thank the men and women of the Department of Defense--
military and civilian, Active, Guard, and Reserve--and their families
for all that they do every day to protect the people of our nation and
to keep our nation safe and secure.
Chairman Reed. Thank you very much, and let me join Senator
Inhofe in commending you, General Perna, for your extraordinary
work over the many months. You are recognized now. Thank you.
STATEMENT OF GENERAL GUSTAVE P. PERNA, CHIEF OPERATING OFFICER,
FEDERAL COVID-19 RESPONSE FOR VACCINE AND THERAPEUTICS
General Perna. Chairman Reed, Ranking Member Inhofe,
distinguished Members of the Committee, thank you for the
opportunity and true honor to testify before you today on the
vaccines and therapeutics operation under COVID-19 response.
Over the past nine months, I have had the privilege to co-
lead the operation with Dr. Moncef Slaoui and now Dr. David
Kessler. Our mission was to accelerate development,
manufacturing, and delivery of vaccines and therapeutics to our
nation.
I know you agree with me when I say this virus attacked our
nation. It attacked our way of life, and it impacted every
American. But it became obvious that our nation had never
fought this type of enemy before, and that there was no single
government or private organization that had the capacity,
capability, or expertise to execute the mission of defeating
this virus.
We also lacked unity of command and effort to develop,
manufacture, and distribute the vaccines to the entire American
population, much less at the scale and speed required to defeat
this pandemic. Thus, the reason for Operation Warp Speed and
our strategy of whole-of-America approach. We approached this
mission with the urgency, resolve, and steadfast determination
our nation deserves, and as we were fighting a near-peer
competitor in a large combat operation, we gave it everything,
every day.
We operationalized our effort through three key tenets.
First, all of our decisions were rooted in science and data. We
refused to sacrifice safety for speed. Second, we are
leveraging all resources available to scale up domestic
manufacturing and assessing every contract for use with the
Defense Production Act authorities. Finally, we built our
distribution strategy on existing vaccine infrastructure, a
tested network that could expand to new requirements, refined
by the professionals at the CDC, and almost virtually
flawlessly executed by private industry.
Through unprecedented collaboration from our best public
and private experts and science, logistics, manufacturing, and
security, our nation rose to the challenge. Because of our
whole-of-America approach and the collective efforts of the
Federal, state, and local governments, private industry, and
the health care community, today I can report that we have
developed two safe and effective vaccines and three safe and
effective therapeutics authorized for use. There will be more
soon.
We steadily increased our manufacturing capacity that will
result in enough doses available to all Americans by this
summer, and we have delivered more than 90 million doses of
vaccine to date across 50 states and 8 territories, to the
right locations, in the right conditions, in near flawless
execution.
Those are our nation's accomplishments, and all Americans
can be proud of how far we have come in a short amount of time.
More importantly, Americans can have hope and optimism that we
are on the offense and we will defeat this virus. We will win.
We have a lot of work in front of us, and we will not rest
until every American has access to vaccine and therapeutics. We
continue to learn and we continue to get better every day,
constantly improving our processes, remaining agile and
adaptive to the challenges and obstacles in front of us. Like
we do in every combat situation, we always assess ourselves,
the environment, and the enemy, and we adjust accordingly.
I am incredibly proud of the small team of 100 DOD
servicemembers and civilians who have selflessly served in the
background of this operation for the past nine months, and will
continue to do so until the mission is complete. Through the
pandemic and changing environment, our team remains 100 percent
committed and focused on executing the mission asked of us. We
took an oath to support and defend our nation, and every single
day we bring intensity and vigor to get this job done.
Your congressional support and advocacy have been pivotal
to accomplishing those milestones that we have achieved so far
and those that we will achieve. Thank you for your support, and
I look forward to your questions.
[The prepared statement of General Gustave F. Perna
follows:]
Prepared Statement by General Gustave F. Perna
introduction
Chairman Reed, Ranking Member Inhofe, distinguished Members of the
Committee: Thank you for the opportunity to testify before you today on
the Vaccines and Therapeutics Operation supporting the federal
coronavirus (COVID-19) response. I am grateful and deeply humbled to be
here with you and my fellow witnesses. Over the past nine months, I
have had the privilege to co-lead the operation with Doctor David
Kessler, and with Doctor Moncef Slaoui as chief adviser, to accelerate
the development, manufacturing and delivery of vaccines and
therapeutics for our Nation. Your Congressional support and advocacy
has been pivotal to accomplishing each milestone that we have reached.
Our mission has been clear: save lives by distributing safe and
effective countermeasures to the American public. Today, I am proud to
say that vaccines and therapeutics developed through this effort are
the direct result of the greatest public-private partnership in modern
times. This has been a whole-of-America approach and a nonstop effort
by the finest scientists, logisticians and medical professionals, in
partnership with expert professionals from private industry, who all
came together with a singular focus.
federal partnership
Operation Warp Speed was formalized on May 15, 2020, as a
collaboration between the Department of Health and Human Services (HHS)
and the Department of Defense (DOD) aimed at defeating the COVID-19
pandemic through accelerating the development, manufacturing, and
delivery of vaccines and therapeutics. Our goal was to provide
strategic leadership and guidance to identify the most promising
vaccine and therapeutic candidates and enable expeditious, parallel
execution of the necessary steps to manufacture doses at large scale
and gain approval or authorization of safe products by the Food and
Drug Administration (FDA).
The Operation was founded on the premise that fundamentally
restructuring the way the federal government typically supports product
development and vaccine distribution would speed the delivery of
lifesaving vaccines to the American people. With no blueprint,
organizational chart or historical precedent in the context of a global
pandemic, this partnership grew out of an acknowledged need to
fundamentally restructure the way the U.S. Government typically
supports product development and vaccine distribution. The initiative
was premised on setting a ``stretch goal'' for vaccine development and
availability for the American population--one that initially seemed
impossible, but in the end was achieved in record time.
We drew upon the experience and expertise of the National
Institutes of Health (NIH), Centers for Disease Control and Prevention
(CDC), Biomedical Advanced Research and Development Authority (BARDA),
and Department of Defense (DOD), including the Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense and
the Defense Advanced Research Projects Agency. Our experts engaged with
all critical aspects of medical countermeasure research, development,
manufacturing and distribution.
The initiative set ambitious objectives: deliver tens of millions
of doses of FDA approved or authorized, safe and effective COVID-19
vaccines for use by the end of 2020, with enough supply to vaccinate
300 million Americans across the U.S. by mid-2021. The pace and scope
of such a vaccine effort were unprecedented. In comparison, the 2014
West African Ebola virus epidemic spurred rapid vaccine development.
While preclinical data existed before the outbreak, the effort still
took 12 months to progress from phase 1 first-in-human trials to phase
3 efficacy trials. Our goal focused on compressing this timeline even
more. COVID-19 vaccine development began in 2020 with phase 1 clinical
studies in March and the first phase 3 clinical trials in July. The
objectives were based on advances in vaccine platform technology,
improved understanding of safe and efficacious vaccine design, and
similarities between the SARS-CoV-1 and SARS-CoV-2 disease mechanisms.
vaccine development
To date, our research and development efforts have already led to
FDA's issuing Emergency Use Authorizations (EUAs) for two vaccines
which both demonstrated nearly 95 percent efficacy, with additional
vaccines likely to follow soon.
Vaccine candidates were selected based on four criteria. Candidates
were required to have robust preclinical data or early-stage clinical
trial data supporting their potential for safety and efficacy.
Candidates had to have the potential, with acceleration support, to
enter large phase 3 field efficacy trials as quickly as possible,
amidst continued active transmission of the virus, to deliver efficacy
outcomes in a matter of months. Candidates had to be based on vaccine-
platform technologies permitting fast and effective manufacturing, and
their developers had to demonstrate the industrial process scalability,
yields, and consistency necessary to reliably produce more than 100
million doses by mid-2021. Finally, candidates had to use one of four
vaccine-platform technologies that were deemed the most likely to yield
a safe and effective vaccine against COVID-19: the mRNA platform; the
replication-defective live-vector platform; the recombinant-subunit-
adjuvant protein platform; or the attenuated replicating live-vector
platform. \1\
---------------------------------------------------------------------------
\1\ Slaoui M, Hepburn M. Developing Safe and Effective Covid
Vaccines--Operation Warp Speed's Strategy and Approach. N Engl J Med.
2020 Oct 29;383(18):1701-1703. doi: 10.1056/NEJMp2027405. Epub 2020 Aug
26. PMID: 32846056.
---------------------------------------------------------------------------
The development strategy relied on a few key principles. First, the
team sought to build a diverse project portfolio that included two
vaccine candidates based on each of the four platform technologies.
Such diversification mitigated the risk of failure due to safety,
efficacy, industrial manufacturability, or scheduling factors.
Furthermore, it permitted selection of the best vaccine platform for
each subpopulation at risk for contracting or transmitting COVID-19,
including older adults, frontline and essential workers, young adults,
and pediatric populations. In addition, advancing six vaccines in
parallel increased the chances of delivering 300 million doses in the
first half of 2021.
Second, the team sought to accelerate vaccine program development
without compromising safety, efficacy, or product quality. Clinical
development, process development, and manufacturing scale-up was
substantially accelerated by initiating all efforts streams, fully
resourced, in parallel. Doing so required the federal government taking
on substantial financial risk, as compared with the conventional
sequential development approach. Phase 3 trial sizes were maximized
(30,000 to 50,000 participants each) and trial-site locations were
optimized by consulting daily epidemiologic and disease-forecasting
models to ensure the fastest path to efficacy. Such large trials also
increased the safety data set for each candidate vaccine.
With heavy, up-front federal investment, companies were able to
conduct clinical operations and site preparation for phase 3 efficacy
trials even as they filed their Investigational New Drug application
(IND) for their phase 1 studies, thereby ensuring immediate initiation
of phase 3 when the FDA approved them to do so. To permit appropriate
comparisons among the vaccine candidates and to optimize vaccine
utilization after approval by the FDA, the phase 3 trial end points and
assay readouts were harmonized for consistency through a collaborative
effort involving the National Institute of Allergy and Infectious
Diseases (NIAID), the Coronavirus Prevention Network, and the sponsor
companies. An unprecedented effort, all candidates agreed to harmonized
critical trials with common endpoints and data sharing.
Finally, the federal government funded private industry to enable
their development and large-scale manufacturing while their vaccines
were in preclinical or very early clinical stages, instead of the usual
lengthy process where companies wait until FDA approval before
beginning full scale manufacturing. We assessed the U.S. domestic
manufacturing capacity, identified choke points, and invested
throughout the supply chain to increase availability and output of key
enablers such as supplies, raw materials, and equipment. To ensure that
industrial processes were set, running, and validated for FDA
inspection when phase 3 trials ended, the federal government funded
construction or refurbishing of various manufacturing facilities,
equipment fitting, staff hiring and training, raw-material sourcing,
technology transfer and validation, bulk product processing into vials,
and acquisition of ample vials, syringes, and needles for each vaccine
candidate. These decisions to support manufacturing prior to FDA
approval resulted in millions of vaccine doses available for
distribution to the American people within 24 hours of FDA Emergency
Use Authorization (EUA). This strategy accelerated vaccine development
without curtailing the critical steps required by sound science and
regulatory standards.
therapeutics
The operation simultaneously launched therapeutics efforts in May
2020. The intent was to accelerate the clinical development and
manufacturing scale-up of the candidates that were most likely to have
a broad public health impact to complement vaccines. This was
accomplished through a two-pronged approach that built on existing
agency efforts, focusing on treatment candidates to: 1) attack the
virus; and 2) manage complications. \2\
---------------------------------------------------------------------------
\2\ Slaoui M, Greene SE, Woodcock J. Bridging the Gap at Warp
Speed--Delivering Options for Preventing and Treating Covid-19. N Engl
J Med. 2020 November 12;383(20):1899-1901. doi: 10.1056/NEJMp2028535.
Epub 2020 September 15. PMID: 32931679.
---------------------------------------------------------------------------
The therapeutics research team, in conjunction with multiple
agencies and 12 therapeutics manufacturers, assessed more than 50
potential drug compounds to accelerate product development and
manufacturing. To date, these public-private partnerships resulted in
three EUAs for monoclonal antibody treatments from the FDA. The first
two received their authorization before the end of 2020. These
treatments were found to decrease mortality and the risk of
hospitalization by 70 percent in high-risk patients. Currently, the FDA
is considering a fourth application for use of an authorized monoclonal
antibody treatment. This application would allow use for both
preventing spread of COVID-19 and the treatment of hospitalized
patients. There are ongoing clinical trials for five additional
therapeutics candidates, which include small molecule antiviral, immune
modulators, and additional monoclonal antibodies.
Our manufacturing at-risk strategy allowed us to allocate and
distribute 80,000 doses of monoclonal antibodies within 48 hours of FDA
authorization. The operation partnered with the HHS Assistant Secretary
for Preparedness and Response (ASPR) for the successful allocation,
distribution and administration of therapeutics. To date, 850,000
courses of therapeutics have shipped to over 5,000 locations across the
country. The U.S. healthcare system has treated between 300,000 and
470,000 high-risk COVID-19 patients with mild-to-moderate symptoms,
potentially preventing up to 22,000 hospitalizations and potentially
9,000 deaths since November.
Between January 1 and November 21, 2020, the average Medicare fee-
for-service payment for patients hospitalized with COVID-19 was $23,558
for claims received by December 18, 2020. Using this value, monoclonal
antibody treatment has helped to avoid $518 million dollars in hospital
costs. We have purchased an additional 2.35 million doses of monoclonal
antibodies with options to purchase 2.85 million more doses, based on
need. To ensure the widest, fair and equitable administration of
monoclonal antibodies, the operation established seven pilot programs
to expand distribution to Long-Term Care Facilities, home infusion
programs, Federally Qualified Health Centers (FQHCs), and dialysis
centers.
In addition to partnering with pharmaceutical manufacturers, the
operation successfully accelerated COVID-19 Convalescent Plasma (CCP).
This treatment received an FDA EUA for treatment of hospitalized
patients with COVID-19 in August of 2020. (That EUA was subsequently
limited to high-titer CCP (CCP with high levels of COVID-19
antibodies).) The previous May of that same year, the U.S. Government
assigned a $460 million contract with America's Blood Center and the
American Red Cross for the collection and storage of CCP. To date, the
operation has collected more than 740,000 units of CCP and distributed
more than 569,000 units for use in the direct transfusions to
hospitalized patients. CCP with high titers has the potential to reduce
the severity and shorten the length of the COVID-19 illness in
hospitalized patients when administered early in the disease course.
The clinical strategy for therapeutics included the design and
launch of U.S. Government-funded platform clinical trials in
partnership with the NIH. The team supported NIH's public-private
partnership known as ``Accelerating COVID-19 Therapeutic Interventions
and Vaccines'' (ACTIV). This initiative, coordinated by the Foundation
for the National Institutes of Health, brought together the biomedical
resources from 20 pharmaceutical companies, multiple government
agencies, academic institutions, and non-profit organizations. The
ACTIV trials currently include seven rigorous master protocols that
covered the full spectrum of COVID-19 positive patient populations
requiring treatment: outpatient, inpatient, and convalescent.
Overall, therapeutics efforts include significant financial
investment, trial oversight, and logistical support, such as
contracting, site set-up, mobile infusion centers, and drug
acquisitions.
from the factory to the frontlines
Early in the planning phase, the team developed a distribution
strategy to achieve the principal purpose and objective to deliver safe
and effective doses of vaccine to the American people. Successful
implementation of the National COVID-19 vaccination program required
precise coordination across federal, state, local, tribal, and
territorial governments and among many public and private partners. The
plan to deliver vaccines leveraged major distributors, distribution
networks, customer bases, and infrastructure to distribute and
administer COVID-19 vaccine in a three-phased structure. \3\
---------------------------------------------------------------------------
\3\ HHS/DOD: From the Factory to the Frontlines, As of September
16, 2020: https://www.hhs.gov/sites/default/files/strategy-for-
distributing-covid-19-vaccine.pdf
---------------------------------------------------------------------------
Operation leadership provided unity of effort to a whole-of-America
approach for vaccine manufacturing and distribution. Contracting,
acquisition, legal and program management experts responsibly and
conscientiously coordinated, executed and oversaw the award of more
than $31 billion in contracts, along with the related Defense
Production Act (DPA) authorities, assuring the best value for U.S.
taxpayer dollars. Since May 2020, the U.S. Government has contracted
for 1.2 billion doses of vaccine with options to secure more, and
issued 18 DPA priority ratings for physical plant enhancements, raw
materials, supplies and countermeasures.
Military logistics experts closely managed the supply chain and
embedded in manufacturing plants to scale up manufacturing and maximize
industrial best practices, resulting in more than 20 million doses
delivered by the end of 2020, and hundreds of millions projected in 1st
quarter 2021.
Assuring a ready supply chain included securing more than 1 billion
needles and syringes for America's vaccination efforts. The operation
developed and contracted for ancillary kits, securing all necessary
supplies to administer vaccines--including syringes, needles, alcohol
prep pads, face masks, face shields, and diluent or adjuvant if
required--and coordinated distribution concurrently with the vaccines
to administration sites at no cost to providers.
Synchronizing and integrating data was a critical effort for the
operation. No single federal system existed to provide visibility of
vaccine distribution and administration across the entire operation.
The Tiberius platform was conceived and developed as a decision support
tool for federal and state leaders, allowing unprecedented oversight
and planning capabilities. Protecting the personal identification
information of patients, data from hundreds of separate systems now
provide full visibility of the vaccine operation--from supply and
allocations through delivery to administration. To ensure the federal
government could accurately and appropriately track vaccine
administration information, Data Use Agreements were developed and
coordinated with all 64 jurisdictions and the five federal entities.
Operation leadership initiated a series of reviews and exercises
with CDC and the states to rehearse distribution plans, setting a goal
of commencing vaccine distribution within 24 hours of an FDA EUA. These
weekly sessions allowed the various government and industry partners
involved in the effort to define roles and responsibilities,
synchronize movements, identify gaps, and plan for potential challenges
at every stage of the distribution process. Beginning distribution of
vaccines within 24 hours of authorization was not only an achievable
metric, it reflected the responsible and appropriate urgency of
delivering vaccines to the American people during a pandemic where
thousands of lives were and are being lost every day. Notably, delivery
of both Pfizer and Moderna vaccines began within 24 hours of
authorization, and to date, more than 75 million vaccine doses and
850,000 courses of therapeutics have been delivered to the right
locations at the right time and in the right quantities and conditions,
through nine winter storms, with above a 99 percent success rate.
To oversee distribution, the operation organized, managed and
staffed an inter- and intra-agency Vaccine Operations Center, with
liaisons from multiple industry and government agencies, that
coordinated and tracked the movement of the vaccines--facilitating all
cold chain requirements including dry ice refills, supplemental
handling kits and temperature monitoring capabilities, from the
manufacturer to distribution centers and finally to more than 30,000
administration sites to date.
A robust Security and Assurance effort developed physical,
information, cyber, and personnel security measures to protect the
vaccines and therapeutics operation. The operation's Security and
Assurance team developed a security plan to support the U.S. Government
production and distribution of supplies, diagnostics, therapeutics and
vaccines. The team worked closely with more than 30 partners, including
the Department of Justice, FBI, Cybersecurity and Infrastructure
Security Agency from the Department of Homeland Security, Defense
Digital Services, U.S. Marshals Service, law enforcement and industry,
nationwide as part of a robust physical and cybersecurity effort to
safeguard vaccines.
While vaccine administration was outside the scope of the
operation's mission, leadership worked closely with the CDC to enable
the ultimate goal of shots in arms. Military officers embedded
alongside CDC representatives in Atlanta to form regional teams in a
Vaccine Coordination Center that continues to remain in daily contact
with the 64 jurisdictions' state health officials. In September, the
CDC published an interim playbook for jurisdictions that provided
initial guidance for states to commence planning. In the months that
followed, regional teams worked closely with each jurisdiction to
refine their plans, at times deploying strike teams to provide on-site
support and capability.
Together with the jurisdictions and the CDC, the operation enrolled
more than 119,000 COVID-19 vaccination providers across the 50 states,
eight territories and six metropolitan cities, and five federal
entities. To care for one of the nation's most vulnerable populations
in Long-Term Care Facilities (LTCF), the operation conceived, developed
and executed a federal partnership with CVS, Walgreens, and Manage
Health Care Associates to administer vaccines at 70,000 sites across
the nation. This federal LTCF partnership eased the burden on states to
manage and coordinate vaccinating our most vulnerable population group.
By mid-February, CVS and Walgreens had completed first-dose clinics in
more than 60,000 facilities.
The operation also worked with the CDC to create a federal retail
pharmacy partnership to capitalize on the 40,000 chain and independent
brick-and-mortar pharmacy locations across the nation where Americans
primarily receive their vaccines. Through the partnership, initiated in
November, states were able to transfer allocations to retail sites to
assist them with vaccination efforts as a bridging strategy to the full
program launch which occurred this month.
Whether at a doctor's office, retail pharmacy, federally qualified
health center or hospital, the operation continues to work to ensure
hundreds of thousands of sites will be available as supply increases so
that no American is forced to travel far for their vaccination.
conclusion
In closing, the pandemic has led to unprecedented partnering across
industry, academia, the DOD and other federal agencies to deliver
lifesaving measures to the American people. As a career Soldier I swore
an oath to defend our Constitution against all enemies. I am proud to
state that the DOD stands ready to defend our Nation against all
adversaries, including this virus which is impacting our way of life.
For the past nine months, a team of 100 Service members and DOD
Civilians have dedicated themselves to defeating the enemy. DOD's
contribution to the federal COVID-19 response, while unprecedented, has
been monumental to moving our nation past this pandemic.
I appreciate the support of Congress in our work to develop,
manufacture, and deliver vaccines and therapeutics to our nation. We
look forward to continuing to partner with Congress and working
together as the country continues to open safely again. Thank you for
the opportunity to testify today and we look forward to your questions.
Chairman Reed. Thank you very much, sir. With some Senators
attending remotely, I wanted to let everyone know how the
hearing will run. Since it is impossible to know exactly when
our colleagues who will be joining via the computer arrive, we
will not be following our standard Early Bird timing rule.
Instead, we will handle the order of questions by seniority,
alternating sides until we have gone through everyone. Once we
reach the end, if there anyone we missed we will start back at
the top of the list and continue until everyone has had their
turn. We will do the standard five-minute rounds, and I ask my
colleagues on their computers to please keep an eye on the
clock, which you should see on your screen.
Finally, to allow for everyone to be heard, whether in the
room or on a computer, I ask all colleagues to please mute your
microphone when not speaking. Thank you very much.
I have a question I would like to address to the whole
panel, beginning with Ms. Cummings, and then a final question
for General Perna. Basically, Ms. Cummings, what do you think
are the greatest challenges in your area of responsibility, and
what resources and/or policy changes do you feel you need?
Ms. Cummings. Thank you for that question, Chairman Reed.
So throughout the opportunity for the DOD to participate in the
national response we have done so in support of our colleagues
at HHS. We leveraged many, many authorities, including the
Economy Act, which allowed HHS to use their authority and
funding and share that with the DOD, as well as the Defense
Production Act.
There are certainly flexibilities that the CARES Act
provided to the DOD under the Defense Production Act in that
authority for the way that we spent our title III funding. So
additional flexibilities in the Defense Production Act, we
would be happy to work with your staff to talk more about how
we might be able to work together to do that.
Chairman Reed. Thank you very much. Mr. Salesses.
Mr. Salesses. Sorry, Chairman. My view is that we need to
continue our aggressive mitigation efforts--mask-wearing,
social distancing, all of those types of things--continue to
increase our testing capacity and our contact tracing
capabilities, and thirdly, get the vaccine.
Chairman Reed. Well, thank you very much. General Perna,
your comments about the challenges you face and the resources
or policy changes you would need.
General Perna. Chairman, as I mentioned, you know, we have
never done this as a nation before.
Chairman Reed. Is your microphone on, sir?
General Perna. I apologize, Chairman.
Chairman Reed. That is okay.
General Perna. I am trainable.
[Laughter.]
General Perna. Chairman, as I talked about in my opening
comments, we have never faced these challenges before. I think
the success that we achieved by coming together at the Federal
level, HHS and the Department of Defense, invoking the
partnership with industry, academia, and then bringing the
state and local governments into play from the beginning, early
on planning and then execution and remaining flexible and
adaptable to our challenges has been our greatest success to
date.
Now clearly we could not have done what we have done so far
if we did not have the backbone that was already established in
the work by our great scientists to develop and have the
capability to bring vaccines rapidly into place, and we must
continue to sustain that research and support to that end.
Second, the use of the DPA has been immeasurable in our
ability to manage supply chain for materials, consumables, and
equipment, as well as production, to ensure that we have
capability to deliver the vaccines.
Then the last part--and therapeutics. Then the last part, I
will say, I would be remiss if I did not thank, publicly, the
heroic work that currently Pfizer, Moderna, McKesson, FedEx,
and UPS are doing to distribute the vaccine. It is their
infrastructure, their leadership, their workforce, and their
ability to handle the vaccine. When many people thought we
could not manage the cold chain, these leaders and
organizations did so, and it is leading to our success.
Chairman Reed. Well, thank you very much, and since you
have been so instrument in everything that has gone on and been
performed, I would say heroically, and I thank you very much.
Just looking ahead, what do you think the way ahead is for
the COVID response? We have looked back at what we have done.
Looking ahead, give us an idea of what you think might happen.
General Perna. Chairman, I would coach us all collectively
not to continue in the same thought process. In other words, we
created solutions for one purpose and we are just going to
continue to exercise. We must take a moment and truly
understand what are the potential future requirements, and
hence the purpose of what might need to be done. For example--
and truly a White House policy decision that will lead to
everything else. You know, what is the role going to be in
helping the rest of the world after we take care of the United
States with vaccines? What will be the requirement for booster
shots, if any, or shots required for mutation support? What
will be the decision about how much manufacturing and supply
chain capability do we want inside of the country?
Once we determine, and not limited to those questions, then
we must really understand how we are going to go about that.
What is the organization that must do that? Is it going to be a
specified, organization in place, or will we create an
organization, and then what will we do to resource it, man it,
prioritize it, and support it, is the way we need to look at
the future?
Chairman Reed. Thank you very much. Indeed, thank you all
for your testimony, and your hours and hours of dedicated
service to the country at a critical moment. Thank you.
Senator Inhofe, please.
Senator Inhofe. Thank you, Mr. Chairman. I think, General
Perna, you pretty much cleared this up in your opening
statement, and yet people are still--I think a lot of them in
the media are saying that they claim that there is no plan for
distribution after it was approved.
Now I know this is not true, but is there anything that you
did not cover in your opening statement, real briefly, to
counter this, because that is a statement that--they have got
to quit talking like that.
General Perna. So, Senator, thank you, and as you and I
have discussed many times, there was --
Senator Inhofe. Yeah. Talk about what that plan was first
and how that was changed or has been improved since December.
General Perna. Sure. So initial plans, you know, in support
of the directive-specified mission, develop, manufacture, and
deliver vaccines were very elaborate and well defined as we had
to figure out what were the vaccines that we were going to
pursue for development, take it down from many possibilities
down to six. We had to look at the manufacturing capacity in
the country and abroad, to make sure that we had capability and
capacity. We did very detailed work and analysis to ensure that
we had both drug substance, development of the product, and
drug product, which is the eventual fill finish. We had to make
sure that space existed and that we had priority, and we had to
execute it in a very precise manner to that end.
Then we had to manage and plan for the product coming off
of the conveyor built. Normal, usual execution, when we make
influenza vaccine, it is an order. The country orders vaccine,
the pharmaceutical companies produce it, and then they deliver
it. In this case, what we did is we were manufacturing it. We
started six months ago, so that we would get through the
process and have vaccines available as early as December.
Senator Inhofe. Okay. General, I agree with that and I
think that it was best said, as I mentioned in my opening
statement, by Francis Collins, who was an Obama appointee, that
it was just breathtaking the miracle that took place. Now I put
it in that category, and I appreciate that response, but we are
running out of time.
General Perna. I apologize.
Mr. Wittmann. Ms. Cummings, I want to ask you. Something I
found out, and I was surprised to find this out, and I believe
it came from HHS, that 80 percent of our needle and syringe
supply has come from China. Is that correct, and then, what are
we going to do to try to get back on top of this?
Ms. Cummings. That is correct, and we have assisted HHS
with transportation to get those needles and syringes into the
United States to support the delivery of vaccines. We have an
opportunity to leverage both the authorities of the Defense
Production Act but also the authorities of the Economy Act to
invest in syringes and needles. We have actually invested in
some innovative technology for vaccine delivery to increase the
domestic production here in the United States, so that those
capabilities can be made here.
Senator Inhofe. So you are aware of this and are addressing
this problem. It was a surprise to me to hear this. Do you feel
you are on the road to resolving that problem?
Ms. Cummings. We are on the road to seeking solutions to
that problem. We have made some investments to date, and I
think that there are more investments to be made in the future.
Senator Inhofe. That is good. Good work.
The last thing I wanted to bring up, because this is a
thing that I have a hard time understanding why it is true. But
so many people are reluctant to use the vaccine. The figure
that I would use, in a recent study, is one out of three
Americans, American adults, said that they definitely, or
probably, will not get the vaccine when it becomes available.
That is a shocker to me, because, first of all, it is not just
them. It is others that are affected by their willingness to
get the vaccine.
So I would like to ask you, or any of the witnesses, what
are we doing right now to try to educate people as to why it is
necessary to have this vaccine?
Mr. Salesses. Senator, I can talk about what the Defense
Department is doing. More broadly, I think some of the things
that we are doing would be helpful. There is a lot of
misinformation out there about the vaccine. The vaccine is
safe, as General Perna has pointed out, as many have pointed
out. I think that what we need to do is ensure that we have the
right level of education and awareness that goes on out there.
From a DOD perspective, obviously we use our military chain of
command, and the opportunity to educate and train people and to
clear up those misconceptions can be very helpful. We have seen
that happen in the Defense Department. We have only been at
this for about 60 days, but where we have seen vaccine rates a
little bit lower acceptance rates, the commands are getting
involved, providing education forums, having the opportunity to
have town halls and those types of things, but provide that
insight.
Senator Inhofe. That is good, and last week I think it was
stated that one-third of servicemembers are opting out, and so
I am glad you are addressing that, because we are concerned
about the whole public, but definitely our servicemembers.
Thank you, Mr. Chairman.
Chairman Reed. Thank you, Senator Inhofe. Senator Shaheen,
please.
Senator Shaheen. Thank you, Mr. Chairman, and let me echo
the chairman and ranking member's thanks to each of you for all
of your effort over the last year.
I want to pick up on Senator Inhofe's question about
syringes, Ms. Cummings, because I just want to point out we
have a company in New Hampshire, Smiths Medical that has been
producing syringes. They have had a contract with Biomedical
Advanced Research and Development Authority (BARDA), which I
appreciate is not in your purview. But they need some certainty
in order to address their supply chain concerns, and right now
they are waiting to hear from the Department about whether they
are going to have a continued contract.
We have a lot of companies out there, as you all know so
well, who really want to help in this effort, but they cannot
make the expenditures unless they have some certainty that what
they are producing is going to be needed. One of the areas
where I think the DPA has been very helpful has been with the
personal protective equipment. Again, we have two companies in
New Hampshire, Lydall, which is producing N95 mask materials,
and American Performance Polymers, which is producing non-latex
rubber gloves. Again, it has been the contract with DOD that
has allowed both of them to expand in a way that is going to be
able to produce what we need to help with our PPE supply.
So I guess one question I would have for you--I assume this
is for you, Ms. Cumming--is to follow up, is there more that
Congress needs to do with the Defense Production Act to make
sure that you have the capacity you need to do the contracts
with the companies so they can produce what we need to address
this pandemic?
Ms. Cummings. So, Senator, I agree that a common theme that
we heard throughout the pandemic from the industrial base, the
medical and PPE industrial base, is this lack of long-term,
consistent demand. There are tools available in the Defense
Production Act in order to create guarantees for future
procurement. Those guarantees need to come with funding, and so
the Defense Production Act has the authority. It needs to have
the associated appropriation that is long-term in nature, which
the DPA Title III is long-term in nature. So that is a great
tool.
We have other tools under the CARES Act and other
appropriations from HHS where we have been able to make similar
type investments as the DPA Title III. We have been using an
authority the Congress gave to DOD called Commercial Solutions
Openings, which gives us the opportunity to very quickly find
those unique companies, especially commercial companies that we
do not usually work within the Department, and be able to
engage them to be able to make those strategic investments. We
would like to continue to do that in partnership and support of
HHS.
Senator Shaheen. Well, thank you. As I said, I think we all
know there are a lot of companies that are really interested in
helping.
I had a conversation--Senator Rounds and I had a
conversation late last fall with former Assistant Secretary
Jordan Gillis about Defense Logistics Agency's (DLA's) cash
posture. One concern was that they had had a significant
reduction in their obligation authority which was affecting
their ability to contract. Can you talk about that and whether
that has been cleared up, and are you comfortable that DLA has
what it needs?
Ms. Cummings. I am actually watching that very closely. I
get a bi-weekly report on their cash position. We work with the
Comptroller to make sure they have everything they need to
remain solvent and have the obligation authority to support
both DOD needs and the vast amount of HHS and FEMA needs that
they are meeting. Right now we are good in our operating
position, but I will let you know if that changes.
Senator Shaheen. Thank you. I think that goes along with
the point you made about appropriations. There also needs to be
some certainty in appropriations, and I appreciate that, and I
think that is something where this Committee needs to reinforce
the importance of that.
I do not know who this question is for, but I know that
last night President Biden announced a new effort to deliver 25
million masks to the nation's most vulnerable populations,
through both DOD and the Department of Health and Human
Services, and that the plan is to make those masks available
beginning in March into May.
So has the Department met and talked about how they are
going to deal with this distribution of the masks and what we
need to do to support that effort?
Mr. Salesses. Senator, normally something like that would
be managed by FEMA. We could be asked, though, to support that.
A good organization to provide that kind of support would be
the National Guard, to get that out. So I imagine that as the
plan is being developed we will be part of that, and we will be
working closely with FEMA, the state and local authorities, to
make sure that we can maximize the distribution of those masks
for those communities.
Senator Shaheen. If there are companies who would like to
help engage in this effort and fill this need, is there a
contact person? Should they go through FEMA? Should they go
through DOD? Should they go through HHS?
Ms. Cummings. The DOD is working closely with HHS. There
will be a request for proposals through the Defense Logistics
Agency. We will be following our normal processes to ensure
that the masks are made in America, by Americans, and we will
support the distribution as well. Thank you.
Senator Shaheen. Great. Thank you all very much.
Chairman Reed. Thank you, Senator Shaheen. Senator Cotton
via WebEx. Senator Cotton?
Senator Cotton. Thank you, Mr. Chairman. Thank you to all
of our witnesses for appearing. I want to commend you and the
Department for your great efforts over these last 12 months. I
specifically want to commend General Perna for his leadership
of Operation Warp Speed, which has helped develop these
vaccines in record times, and I think you have us on the cusp
of turning the corner on this virus.
Ms. Cummings, the Defense Production Act was originally
passed 70 years ago to ensure the availability of industrial
resources to meet the Department's needs, and Congress has
updated it several times over the years, and we continue to
believe it is an effective tool that can be used to mitigate
risk to the industrial base.
Based on the Department's experience using those
authorities during the pandemic to address both medical and
defense industrial base issues, are there any changes to the
legislation that could help the Department or other Federal
agencies use it more effectively in the future, that you would
like this Committee to consider?
Ms. Cummings. When the pandemic began and we were looking
at the opportunity under the Defense Production Act Title III,
we looked at whether or not other Executive branch agencies,
via the Economy Act, could actually transfer funding into our
Defense Production Act Title III account. We learned that that
was not authorized, and so that is definitely a flexibility
that I think would be useful, to be able to expand the use of
Defense Production Act to execute the authorities of other
Executive branch departments.
The Defense Production Act, to your point, is extremely
valuable, and the authorization to be able to, through
contracts across multiple Executive branch agencies, prioritize
the delivery of those items rests across not just the
Department of Defense but also other Executive branch agencies.
For example, HHS has the authority to rate health resources,
whereas in DOD we have the authority to rate contracts that are
related to defense authorities. Thank you.
Senator Cotton. Thank you. Another question for you, Ms.
Cummings, from an acquisitions perspective, has the pandemic
broadened the Department's perspective on what it considers as
critical for national security, for instance, things like N95
masks now, versus where you might have been a year ago? Are
there areas where we are not self-sufficient in any new
perspective that we should be?
Ms. Cummings. So thank you, Senator. Yes, we realized early
on that our dependence on a global supply chain became a
national security risk when those lines of transportation were
cut. I am pleased to say that in the Department, to meet our
departmental needs, we actually have very good processes in
place to stockpile or to have war stock or programs, so that we
did not find ourselves in a situation where we were not
prepared to be able to support our medical community with the
items that they needed.
Now there are still critical PPE items that we need to
continue to work on onshoring, such as nitrile gloves. Those
are only made, almost exclusively only made outside of the
United States. But it was not just medical supply chains. Also,
our national security supply chains, the defense industrial
base, we have identified, in our Industrial Capabilities
Report, which we published in January, other fragile supply
chains that we intend to work with the interagency to ensure
that we are coming up with solutions to onshore and support the
long-term sustainability of those supply chains domestically.
Senator Cotton. Good. Thank you. I think it is really vital
that we look at it through this new perspective and that we
identify places where our supply chains that are entirely
offshore and that we try to get them at least back to the
United States, and that we are not relying on solely committed
sourced products out of China, and secondarily out of Taiwan,
and third, out of any country within missile range of Mainland
China.
Finally, General Perna, I want to direct this to you, since
you are still wearing the uniform. You had a long career of
serving with soldiers and leading soldiers. There have been
some concerning reports in the news about vaccine decline rates
among servicemembers. Can you give us thoughts on why that is
and what we can do to make sure all of our servicemembers are
getting vaccinated as soon as the vaccine is available to them?
General Perna. Senator, I think that I would just reassure
my teammates, the soldiers, sailors, airmen, marines, and coast
guardsmen that served that we have the greatest scientists in
the world that worked on these vaccines. Our pharmaceutical
companies are the best in the world. Then our FDA is the gold
standard for regulatory oversight in the world, and that I have
100 percent confidence in the vaccine, and I said so to my own
parents, to that end. I would encourage all soldiers, sailors,
airmen, marines, coast guardsmen, to include my sons, who serve
in the Navy, and their families, to get the vaccine.
Senator Cotton. Good. Thanks, General. I add my voice to
that statement. I urge them all to get the vaccine as soon as
possible. Thank you.
Chairman Reed. Thank you very much, Senator Cotton, and let
me recognize Senator Gillibrand via WebEx.
Senator Gillibrand. Thank you. Thank you both for being
here, and thank you Mr. Chairman.
Just to drill down a little bit on the questions that
Senator Cotton asked, as well as Senator Shaheen, it has been
reported that the Trump administration did not leave a reserve
in the national vaccine stockpile for when President Biden took
office, so we appear to be trying to ramp up production as fast
as possible. But in recent weeks it appears the daily
administration of vaccines has been stalled.
Where is the bottleneck in the system, and what can the DOD
do to facilitate an increased distribution of vaccines?
General Perna. Senator, this is General Perna, and I will
start, if that is okay. Initially, when the vaccine came off
the conveyor belts--and I apologize for using that term, a very
delicate process--we knew that the volume was going to be low.
It is the way that the vaccines are manufactured and the
process that they have to do to ramp up accordingly. We knew
that it would increase. After every batch that they run they
would get better at it, and so as we executed the distribution,
we planned according to that end.
We knew that as it increased we needed to be able to expand
the distribution, and that is why the capability and capacity
of private industry was utilized to do so, and I will pause.
Senator Gillibrand. Thank you. Ms. Cummings, on April 5,
2020, your predecessor, Ms. Ellen Lord, issued a memo, changed
the delegation of authority for use of other transactions for
prototype projects in response to COVID disease 2019, which is
geared, basically, towards increasing contracting with small
and medium-sized firms, rather than big defense contractors.
Other transaction authority can empower the DOD to move faster,
be more flexible in acquisitions, and develop solutions via
working with non-traditional, non-defense contractors across
the whole of industry and science.
Nevertheless, there has been recent criticism that this
authority is not being used to the fullest extent. Rick Dunn,
the general counsel of DARPA, recently wrote, ``The deficiency
of education and understanding on the transaction authority
among DOD lawyers, program managers, contracting personnel, and
financial managers is a profound handicap that has led to the
slow embrace of this program.''
Are you willing to engage with business leaders in order to
cut out the stovepiping and increase the use of other
transaction authorities, and particularly to increase the
number of minority-owned businesses that we contract with?
Ms. Cummings. Thank you Senator for that question. We
absolutely value the contribution of small business to the
defense industrial base, and what we found during the
contracting actions and other agreements such as OTAs is that
we were seeing an expansion in the participation of small
businesses, and I believe even more than 40 percent of the
contracts that we have been tracking specifically, in response
to COVID, have gone to small businesses.
But yes, I will commit to working with the defense
acquisition workforce, as well as the Defense Acquisition
University and the service acquisition executives to look to
expand the knowledge and understanding across all of the
different parts of the workforce, to include contracts and
legal. Thank you.
Senator Gillibrand. Then just to continue the line of
questioning that Senator Cotton started, GAO previously
reported that DOD plans to use about $687 million of the $1
billion in CARES Act Defense Production Act funding to mitigate
COVID-related problems in the defense industrial base. As of
January 2021, DOD has already awarded 37 projects valued at
approximately $663 million.
Please provide some specific examples of the benefits that
the Department has already realized through Defense Production
Act investments, and how much additional Defense Production Act
funding does DOD need to mitigate its highest priority defense
industrial base risk over the next two years?
Ms. Cummings. Sure. Thank you, and I would be happy to
take, for the record, some specific outcomes of some of the
awards that I am about to talk about.
But we made significant investments under DPA Title III in
industrial capability to sustain businesses that would
otherwise have been either fragile or have gone out of
business, based on the impacts of COVID in the area of
aircraft. So that would be materials to support aircraft
production, as well as aircraft engine production, ship-
building, space, soldier systems to include textiles,
electronics, and materials, and hypersonics. But again, I am
happy to come back to you or your staff with specifics on the
benefits we have seen from those investments to date.
Senator Gillibrand. Thank you, and I am out of time, but I
would like to submit for the record some specific questions
about the shortcomings of child care for military
servicemembers. We have seen it across the board, in non-
military child care centers as well. Last I checked there was
one slot for every eight kids that needed it, and I think that
is also a huge problem with the military because they have had
to close their child care centers. But I will submit those for
the record.
Thank you, Mr. Chairman.
Chairman Reed. Thank you, Senator Gillibrand. Before I
recognize Senator Rounds via WebEx, just to clarify a point. I
believe that DOD requires 17 immunizations. They can mandate it
but they cannot mandate without informed consent an emergency
FDA vaccine, which is the current status. Once it becomes fully
approved by FDA then the Department of Defense can mandate the
vaccine. Is that accurate, General Perna, or whoever is most --
General Perna. We did research on that, Chairman, and that
is a true statement.
Chairman Reed. Thank you very much. Senator Rounds, please.
Senator Rounds. Thank you, Mr. Chairman. First of all, good
morning to all of you, and I want to take this time to just
thank you very much for your service to our country and for
providing your expert testimony on the Department of Defense's
impact on the nation's COVID-19 response to this Committee
today.
I would like to begin with a question for Ms. Cummings.
During the very worst periods of uncertainty at the beginning
of the COVID-19 crisis, we struggled mightily to increase the
N95 mask production. It seems to me that there was a high
degree of confusion within DOD with respect to the DPA
framework, to include leadership, processes, and situational
awareness.
Your contributions at that time, and former Under Secretary
Lord's daily involvement, were absolutely crucial to overcoming
bureaucratic hurdles and significant delays, and I thank you
for that.
I am curious to know what your lessons learned are from
that period, and what you recommend to fix the process so that
when we need to use the DPA it will be a more effective tool
for rapidly providing capacity during national emergencies.
Ms. Cummings. Thank you, Senator. Yes, I was, myself,
personally involved in the decision and the activities in
coordination with HHS to make strategic investments in the
capacity for making N95 respirators here in the U.S. I think
one of the major lessons learned, that we had in the Department
of Defense, was that we did not have those strategic
relationships within the acquisition community, to the
acquisition community at HHS and FEMA that would have been
valuable at day one of the pandemic.
Because of that we created, instead of the task force,
which is what we established that I led beginning in March, we
transitioned that to a permanent office. That permanent office
is part of our Joint Rapid Acquisition cell, and the goal of
that office and the mission of that office is to maintain
relationships across the executive branch so that when there is
an emergency, whether it is a national, regional, local
emergency, that we have the relationships and we have the
agreements, interagency agreements, in place to quickly respond
to that requirement, without having to re-establish or newly
establish those relationships, and, frankly, all of the
Memorandums of Understanding (MOUs) and paperwork associated
with moving money or moving requirements from one agency to
another.
Senator Rounds. I just remember that it was a bureaucratic
nightmare, and it took direct intervention in order to work our
way to it, and I thank you for that.
I would like to continue on with Ms. Cummings. How much
money from the administration's COVID-19 package is DOD
anticipating to devote to the title III program for both
domestic production for the supply chain and for end products,
such as PPE, vaccines, and other critical medical products? Do
you think this is going to be sufficient to address the most
pressing and anticipated requirements that your office is
tracking?
Ms. Cummings. I think--am I understanding your question to
be the proposal, the supplemental package that includes $10
billion in DPA Title III funding for medical resources?
Senator Rounds. I am curious what your current status is.
Ms. Cummings. Oh, okay. So the current status is, we had,
in the CARES Act, $1 billion in DPA Title III funding. We
balanced that account between both medical resources, which we
allocated $213 million to. We dedicated $100 million towards a
loan program, and so that is in order to support subsidies so
we can make loans. Then the third was $687 million for the
defense industrial base.
We have obligated almost that entire account with the
exception of the $100 million that is a set-aside for subsidy.
That stays in our account, again, to subsidize a larger loan
amount. But we did balance that between the defense industrial
base and the medical industrial base.
But because we were able to move funding from HHS to DOD,
we have thus far been able to meet every requirement given to
us from HHS to expand N95 respirators, supply chains related to
ventilators and surgical masks, as well as testing capacity, to
include point of care and at-home testing kids.
Senator Rounds. I think the point I would make is that the
resources that you were provided, you have basically expanded
or utilized at this time. If we want to continue with the
program it is critical that we talk about specific targeted
needs that would be available for your use.
Ms. Cummings. Correct.
Senator Rounds. Thank you. Thank you, Mr. Chairman.
Chairman Reed. Thank you, Senator Rounds. Let me recognize
Senator Blumenthal.
Senator Blumenthal. Thanks very much, Mr. Chairman. I would
like to first of all thank you for your service. The ranking
member, Senator Inhofe, referred to the miracle of our
discovery and distribution of the vaccine, but as one of the
great American scientists once said--and I cannot remember who
it was--"Great inventions and innovations are 1 percent
inspiration and 99 percent perspiration.'' I know a lot of your
hard work and, equally so, the hard work at Pfizer and
Moderna--I know particularly Pfizer because I have talked to
some of the scientists and managers there--was necessary to
bring this vaccine to the American people and to people around
the world. So we owe you a great debt of gratitude.
I want to thank you, General Perna, for your work,
particular and for our conversation about the really herculean
steps that you are taking to make this vaccine available on a
mass level, through many, many more outlets and places of
vaccination around the country, which I know is essential to
make the vaccine real for people, getting it into their arms.
Let me focus for the moment on the question that Senator
Reed asked, in terms of our military men and women. Is it a
regulation or a statute that bars the Pentagon from mandating
vaccines? I know that it is under Emergency Use Authorization
right now, and if it was given final approval it could be
mandated, but that takes five, ten years. We do not know how
long. So is there a specific legal provision that forbids
mandatory vaccination, when it has received only Emergency Use
Authorization?
Mr. Salesses. Senator, the Emergency Use Authorization is
voluntary. As you point out, I believe it is a statute, sir
that does not provide for it to be mandatory. Actually,
somebody just handed me the statute so I can read it to you, if
you would like, the number here, sir. It is Emergency Use
Authorization, it is 1107A that talks about the Emergency Use
Authorization. So it is a statute and that is why it is
voluntary, sir.
Senator Blumenthal. Let me ask you, are there some groups
that have been more receptive than others within the military?
Mr. Salesses. What we are finding is we have been at this
for about 60 days, and we have a vaccine tiering system that we
are using. So, for example, in that first tier is our health
care professionals, and if the population for that health care
professionals is about 300,000, what we are seeing is over 60
percent taking the vaccine. We are able to track who takes the
vaccine. The remainder of the individual in that tiering that
are not taking the vaccine, there may be a number of reasons
why they are not taking the vaccine. They may have gotten a
shot somewhere else, or they may not want to take the vaccine.
We are working through that collectively right now to make the
determination of what those numbers accurately are. We do track
who has taken it, but again, those populations that we have in
the tiering system, that is how we are reviewing that.
Senator Blumenthal. Isn't it available to the entire force,
everybody who wants it?
Mr. Salesses. It will be, sir, but we start with a tier,
because the way the vaccine is being distributed, you can only
get so much supply. So we started with our health care workers.
Now we are working through our essential mission
responsibilities, and then we will continue to work through
that process. It will be available to everyone in the Defense
Department that wants to take the vaccine.
Senator Blumenthal. So are you saying that so far, within
our United States armed services, the vaccine has been made
available only to health care workers?
Mr. Salesses. No, sir that is not what I am saying. What I
am saying, that was the first tier. It is a tiered system. As
we work through the tiers, then we have essential, like
strategic forces, our military forces, those types of folks. We
work through the system, the tiered system, to the last tier,
which is our normal folks that are available for the vaccine,
our regular forces. We also look at, in the tiering system, at
those that have health conditions. Over 65 is another
condition. So as we work through that tier we make the vaccine
available.
Senator Blumenthal. Well, my time has expired, but I would
like to know how many, and in what categories, have received,
actually received the vaccine. I understand that you are
working through--I think that was your term--the essential
workers, forces. I would like to know who that is, how many
have actually received the vaccine, and what the next tiers
are. I would think this vaccine should be made available to all
men and women in uniform.
Mr. Salesses. It will be, sir.
Senator Blumenthal. Well, it will be, but why hasn't it
been already?
Mr. Salesses. Because the vaccine supply is coming--it is
coming in, in different increments, and we are vaccinating
based on the priorities. We have already vaccinated --
Senator Blumenthal. But shouldn't all of our men and women
in uniform be a priority?
Mr. Salesses. They are, sir, and they will get the vaccine.
Senator Blumenthal. Okay. I apologize, Mr. Chairman, but I
will look forward to getting more information.
Mr. Salesses. Yes, sir.
Chairman Reed. Thank you, Senator Blumenthal. Let me
recognize Senator Ernst.
Senator Ernst. Thank you, Mr. Chair, and thank you to our
witnesses today. This has been an extraordinary effort, and I
think you can say that all of us are very proud of the
accomplishments of those serving in the DOD when it comes to
Operation Warp Speed, so thank you General very much for your
leadership in that area.
It really has been quite a success, and we have been able
to provide an effective vaccine now to the American people in
less than a year, and all Iowans are very thankful for that.
Just to go over some of the things that the Department of
Defense has done and undertaken since the beginning of this
pandemic, a range of actions to support the defense industrial
base, which includes establishing a Joint Acquisition Task
Force to prioritize and increase production capacity of needed
medical resources, investing in industrial based expansion,
executing the CARES Act and Defense Production Act Title III
supplemental funding, and accelerating progress payments to
contractors, and we could go on and on and on. Just an
extraordinary effort across the board.
Another part of this, the players that I like to recognize
all the time, are our wonderful National Guardsmen that are out
there participating in efforts to support our communities. So
we have over 28,000 National Guardsmen that have been activated
or mobilized. They are out there in support of FEMA and other
various partners across 46 of our states and 3 territories, and
so what they are doing, they are supporting the vaccination
missions and other medical support missions.
So, Mr. Salesses, at what point does the National Guard and
the Defense Department complete this mission and then pass the
operation over to civil authorities?
Mr. Salesses. Senator, I do not know the exact time frame
in which the mission will be complete. Obviously, we have got a
lot to finish, as a nation, with the great work that you have
already point out that the Guard is doing every day around the
country. As we also know, we had 47,000 National Guard members
on duty at the peak of this, and now with the 28,000, 29,000,
they have done extraordinary work.
I suspect that they will be there until we have vaccinated
everybody and we have provided the support that we need to
within the communities. They continue to do great work around
the country, and I think we are going to continue to rely on
them to do that.
As you know, the President has authorized 100 percent
reimbursement through the end of September, which is very
helpful to the National Guard in executing this mission. So I
think we should plan for at least through the end of September,
and we will see what happens after that.
Senator Ernst. So the Department of Defense has started
talking about kind of the need to transition then, we are just
not sure of the date.
Mr. Salesses. Again, Senator, it will be up to what the
governors need, really, with the National Guard. So I would
look to the governors in each of the states and how they want
to continue to use the National Guard in that effort, and what
additional Federal requirements or Federal assistance may be
needed. We are going to work closely with FEMA and with the
states, the governors, and the National Guard Bureau to make
sure that we are capable of continuing to provide the support
that is necessary to the states.
Senator Ernst. Yeah, thank you, sir. I really appreciate
that, and I have seen our guardsmen out and about at various
test Iowa sites, and I know in many of the states are helping
with the vaccine distribution, and they are just very important
players to us.
The initial vaccine from Pfizer received an Emergency Use
Authorization on December 11, 2020, after determination was
made that it was effective at preventing COVID-19. Again, this
was the most efficient and fastest vaccine approval in the
history of the United States, and again, such incredible work.
With the vaccinations that have been approved, of course
there has been a number of confusing statements and issues with
the vaccine distribution when it comes to what is considered a
fair allocation. So I know in the state of Iowa we have had
issues understanding that formula. Senator Grassley and I had
sent a letter not long ago asking for clarity on what formula
was being used to determine what allocation our states were
receiving.
So, General Perna, if you could shed some light on that and
maybe explain what formula is being utilized so that we know
that every state is receiving a ``fair allocation'' of the
vaccines.
General Perna. Senator, it is an algorithm. It is based on
population, fair and equitable to all. The population is total
population based on the census from 2018. It is reduced by the
number of adolescents in the state, so 18 and above is the
total number that we go against. Then the percentage of that
population to the percentage of available vaccine being
distributed that week is the algorithm that runs. It is
strictly a mathematical problem.
Senator Ernst. Okay. So just to make it clear for everyone,
it is based on that algorithm. There are not other
considerations, outside influences, that determine the
allocation. Correct?
General Perna. Absolutely. No, you are correct 100 percent.
Senator Ernst. Okay. Thank you very much to our witnesses
today and your extraordinary efforts. We really do appreciate
it. Thank you. Thank you Mr. Chair.
Chairman Reed. Thank you, Senator Ernst. Let me recognize,
via WebEx, Senator Hirono.
Senator Hirono. Thank you, Mr. Chairman. Thank you all for
being here.
General Perna, Operation Warp Speed's goal or mission was
to develop, manufacture, and distribute the vaccine, and yes,
it was extraordinary, the development of these vaccines in such
a short period of time. We are still involved in the
distribution, and, of course, the manufacture of it.
So under the Biden administration, General Perna, has the
DOD's involvement, engagement increased with regard to getting
this pandemic under control, and if so, can you just briefly
describe what additional things you are doing?
General Perna. Senator, if I may address what they have
done with the actual distribution of the vaccine and support of
administration and then pass it to my colleagues, with your
permission. DOD has been, as stated earlier, Secretary Austin
was clear in his guidance that the Department of Defense was
going to be a part of the solution, not only to what they
contributed to Operation Warp Speed but now down in support of
the governors and local authorities.
So FEMA, they are working with FEMA on mass vaccination
sites. DOD is assisting with soldiers. They are also
supporting, down through the Federally Qualified Health Centers
and community vaccination centers with support.
With that I would have to pass to my colleague, Senator.
Senator Hirono. Thank you. So obviously your role, DOD's
role has definitely increased under the Biden administration.
That is what I heard you say. So does somebody else want to
give me a short response?
Mr. Salesses. Yes, Senator, it has increased. Obviously,
the Federal vaccine centers that General Perna just alluded to,
we have established one in California, Texas, and getting ready
to establish other ones in Florida and Pennsylvania. These are
what we call Type 1 centers. They are able to provide 6,000
shots a day. Secretary Austin was out in California yesterday,
at our first site in L.A., where they are providing those 6,000
shots. We have got 4,000 military personnel prepared to support
these sites, and we will be working very closely with FEMA and
the states going forward in where those sites will be
established.
Senator Hirono. Thank you. I think that is very much going
to be necessary because if we are looking at vaccinating a
population of some 225 million, that includes 18 million
veterans and over 1 million active and DOD, it is going to
require all hands on deck, I would say.
By the way, as the Johnson & Johnson vaccine becomes
available, is there going to be a push to distribute those one-
dose vaccines more than the Pfizer and Moderna vaccines? Is
there anybody who can respond to that question?
General Perna. Senator, it will be the same pro rata
approach based on the White House priorities. I have been given
guidance to distribute to jurisdictions, to Federal pharmacy
programs, as well as to FEMA and the Federally Qualified Health
Centers. So --
Senator Hirono. I think--excuse me. I am sorry, General. My
time is running out. My question really--it was probably not
clearly stated what it was--is there going to be more Johnson &
Johnson vaccines made available, because those are just one
dose that do not require the kind of refrigeration that the
Pfizer vaccine needs. So you would think that having more of a
one-dose vaccine is a more efficient way of vaccinating as many
people as we can. Is that going to happen?
General Perna. Absolutely. We have already contracted for,
and we will receive, 100 million doses through the month of
June, and we are working with the company for what does the
future look like for additional doses.
Senator Hirono. Question for Ms. Cummings. Under the
American Rescue Plan, if passed, that includes $10 billion in
Defense Production Act funding, which the DOD will need to
manage. My question is, what would this funding go for, Ms.
Cummings? Ten billion, that is a lot more than the $1.4 billion
or so, or the $3 billion that DOD has administered before.
Ms. Cummings. It is indeed, and my understanding is that
that would be specifically for medical resources, to include
expanding production capacity in the United States for
vaccines, vaccine delivery, test capacity, PPE. We would take
our lead from HHS and be in a supporting role, and so we would
look to HHS and the White House to provide us with specific
requirements. We would provide, through our executive agent,
which is the Air Force, as well as supplemental contracting
assistance throughout the Department in order to meet those
requirements. But again, we would take our lead from HHS as the
requirer of health resources, and that is how we would execute
that, should appropriations be made available.
Senator Hirono. Thank you. I think--okay, I still have 25
seconds left. For General Perna, due to weather conditions the
number of vaccines that Hawaii was expecting to get, they did
not receive it. Close to 40,000 vaccine doses were supposed to
come to Hawaii, but due to weather conditions on the Mainland
only about 10,000 of those doses came. So are there things that
you are doing to ensure that there is as little delay as
possible due to weather conditions in distributing the vaccine
to places such as Hawaii and Alaska?
General Perna. So, Senator, absolutely. We completed
delivery of all backlog last night, throughout the country, and
we will finish the final delivery of this week's vaccines by
Friday. So we are caught up to that end.
Senator Hirono. We appreciate all you can do to catch up as
quickly as possible, because you do not have control over the
weather, and, by the way, I hope you are getting enough doses
to Guam and American Samoa.
General Perna. We are treating them fair and equitably, and
I am personally watching the territories to ensure that.
Senator Hirono. Thank you.
Chairman Reed. Thank you, Senator Hirono. Let me now
recognize Senator Tillis, please.
Senator Tillis. Thank you, Mr. Chair, and thank you all for
being here. Mr. Salesses, I think I will start with you, just
to follow on to a line of questions that Senator Blumenthal
had. It is your goal to vaccinate everybody in the DOD,
correct? The only reason you are not doing it today is you do
not have a vaccine for every arm that needs it. Is that
correct?
Mr. Salesses. That is correct.
Senator Tillis. Over what period of time do you think,
based on the current production capability and maybe some
assumptions you can make about the Johnson & Johnson vaccine,
over what period of time do you think that you could have
provided the vaccine to everybody who was willing to take it?
Mr. Salesses. I think it would be late summer, Senator.
Senator Tillis. Late summer. Yeah. The reason I was asking
that question, I think it is fair to say that there are more
people willing to take the vaccine than there are vaccines to
give. One thing I want to make sure of is we do not start
focusing attention on vaccine hesitancy until we reach a point
to where we have a supply where there is no demand.
Mr. Salesses. Can I provide a clarifying comment, Senator,
if you do not mind?
Senator Tillis. Yeah.
Mr. Salesses. As General Perna pointed out, with the 50
states and 4 territories, there are actually 64 what we call
micro plants. One of those plants is DOD, one is VA. We all fit
into that plant so we get our portion of the vaccine
distribution.
Senator Tillis. Yeah.
Mr. Salesses. That is how it works, and then we --
Senator Tillis. Yeah. I just wanted to make it very clear
that there is no reduction in priority. It is more a matter of
supply and demand right now, and that I have confidence you are
working on it.
General Perna, thank you so much. I think you should be
very proud of the work that you have led. I am kind of curious,
because we rightfully, with the once-in-the-last-century
pandemic of this nature, have shifted attention over and made
sure that manufacturing priorities and everything was in place
to get the plumbing and get the vaccine out. Have you all been
tracking any other therapeutics, like flu vaccines or other
therapies that were dependent upon the same supply chain base
and manufacturing base to understand vulnerabilities there, and
how are we working to mitigate that? Is that a part of the
problem we are trying to solve or is that another problem that
we have to focus on?
General Perna. So, Senator, the way that we have been
looking at it is that we apply DPA and prioritization for
everything we are doing for the COVID vaccine, as I tell the
team we have to be offensive and defensive, because we do not
want to distract from any of the other life-saving drugs that
are necessary for the American citizens.
So we manage it on both sides, and that is how I am able to
do it to ensure that COVID vaccine continues to be produced in
a timely manner but yet does not disrupt any other life-saving
materials.
Senator Tillis. So we do not think that any of the other
courses of medications are suffering any critical shortages at
this point?
General Perna. Not at this time, but, you know, it depends
on how long we are going to keep going, of course, and the
impact. It would be both for materials to produce as well as
the actual materials that are needed to produce, right. So it
is a combination of both.
Senator Tillis. Thank you very much. This could be for Mr.
Salesses or Ms. Cummings. I think that we made the right
decision in a crisis to really look to the DOD to lead versus a
whole-of-government approach that could have taken us a year to
figure out how for everybody to operate efficiently. But the
question that I have is, now that we have created a real-life
scenario with this pandemic response, what work in the future
will we do to potentially vertically integrate the whole-of-
government so that when we execute the next time maybe it is a
little bit less of a demand on the DOD and a better execution
for the whole-of-government? Either of you, or General Perna,
if you have comments.
Mr. Salesses. Senator, I will start and turn it over to my
colleagues. The Department has done extraordinary things, as
you pointed out, supporting the other Federal departments and
agencies, and, in turn, state and local authorities. We have a
mission to do that, the defense support of civil authorities?
mission. It went beyond the scope of providing military
support, as you well know, to where we worked the acquisition
piece in different areas. We provided supply chain support, all
of that.
I think as we go forward the Department recognizes that we
will be called upon in these types of events to assist, but
part of that will be also potentially increasing the capacity
and capabilities of our Federal partner, whether it is HHS or
FEMA, and contracting has a big role in how we deal with many
of these emergencies around the nation. So as we look to that
in the future, having the ability to leverage the private
sector through our contracting capability, whatever Federal
department or agency that is, and harnessing the ability of the
private sector to deal with some of these crises that we go
through in the nation would be very helpful.
Senator Tillis. Yeah, I think that an after-action--I want
to make sure you are getting shots in arms and beat this
pandemic, but I think an after-action on how we have a
contemporary example of a pandemic response of this kind, that
there is something to learn from that. It may be instructive to
things that we should consider in the NDAA.
I am not going to take any more time except to say I am
going to submit some questions for the record related to
reimbursement from civil authorities and some general questions
on the impact on readiness as we have focused so many resources
on the COVID response. Thank you all for the great work.
Chairman Reed. Thank you, Senator Tillis. Let me recognize
Senator Kaine.
Senator Kaine. Thank you, Mr. Chair and Ranking Member
Inhofe and to our witnesses. I am very much about giving credit
where credit is due and I am going to get to that in a minute.
But I think any hearing about COVID has to start with this--it
has been a catastrophe. It has been an absolute catastrophe for
this country. I think the COVID response in the United States
will probably go down as the worst failure of domestic
governance in the history of the United States. There have been
some failures on the foreign policy and national security side.
This is a domestic governance failure. Death toll now in excess
of 500,000. The only two sort of singular events with higher
death tolls in the history of the United States were the Civil
War, at 620,000, Spanish flu at about 675,000. More Americans
have died in the last year than in the entire World War II or
Vietnam War or Korean War.
Dr. Fauci said the other day that the U.S. has handled this
worse than just about any other nation. There is no reason that
a nation with the technical expertise, resources, research
institutions, health care professionals that the United States
has should have suffered this way.
The scale of suffering has been intense. Everyone in this
room knows people who have been sick of COVID or died of COVID.
I know nine people who have died of COVID. Last time I checked,
the entire nation of Taiwan--the entire nation of Taiwan, very
close to China, only had nine COVID deaths.
This has been an atrocity, not only in the scale of
American history one of the deadliest events in the scale of
American history but compared to other nations. Let's not
compare to communist nations or nations that can tell their
citizens to get in line and they will. Let's just compare it to
other industrialized democracies. The excess deaths experienced
by the United States, compared to other comparable nations, is
shameful, is absolutely shameful.
It began with the perpetration of a big lie by a President
with the biggest microphone on the planet--this will go away,
it is not a problem, anti-science messaging--and if we have
ever learned how powerful a leader can be, those lies
perpetrated at the beginning of this pandemic demonstrate the
power of leadership and the power of a microphone that the
President of the United States has.
There has been spectacular work. General Perna, you and the
Warp Speed team that I will give the Trump administration huge
credit for, and I am going to come back to that in a second.
The development of vaccine has really been remarkable. The work
of our health care professionals, the scale and death and
illness that they have seen and had to deal with day in and day
out, everywhere from big-city hospitals to tiny rural health
clinics has been brutal, and I think we need to do everything
we can to keep our healers healthy. Our guardsmen and women, I
have seen guardsmen and women at testing sites, and then at
food banks, and now at vaccination sites, doing some amazing
work.
We have to thank and celebrate some tremendous heroism
during this time, but I think any discussion of COVID has to
begin with the recognition that this has been an absolutely
disastrous moment in the history of this country. Johns Hopkins
said this nation was the best-prepared nation in the world to
deal with a pandemic, and they were right. But from lies
perpetrated, to the CDC mistakes, and the development of a
testing protocol rejecting the World Health Organization test
protocol and then developing one that was faulty, we have to
get ahold of this. If we are not willing to begin with that
sense of humility about our failures, then we will not be ready
for the next one.
I have colleagues now, Mr. Chair, who are asking about a 9/
11-style commission to analyze the events on January 6th. We
need a 9/11 commission to look at why the U.S. fell down on the
job. That is what we need the commission about, because there
will be another pandemic, and we have to be willing to look
ourselves in the mirror and ask what went wrong, and then make
a commitment to what needs to go better. I believe the DOD has
some significant expertise to offer.
General Perna, just one question for you. President
Eisenhower used to say a lot of battles get lost because of
logistics. You might have all the capacity in the world but if
you cannot get at the last tactical mile then you lose a lot of
battles. I think some of the distribution challenges--the
development of the vaccine, I mean, has really been miraculous,
as Ranking Member Inhofe said. But I think some of the
distribution and logistical challenges will have significant
lessons for us. One of the reasons that you were put in the
spot you are in is because you are a logistics expert. Can you
just share some kind of, you know, thinking for us down the
road about the logistical challenges and things you have
learned along the way that can inform us if we do a commission
to try to figure out how to better deal with this in the
future? Thank you.
General Perna. Senator, quickly. Yes, and I appreciate the
opportunity to be a part of that because of the expertise that
I brought. It was clear that the industrial base was capable of
delivering the vaccine from factory down to the jurisdictions.
Quite frankly, really remarkably proud. Went to all 64
jurisdictions simultaneously. We did have to ramp up,
exponentially, the ability to distribute to the total number of
locations. We went from a registration of roughly 7,000 places
to deliver the vaccine to over 130,000. Then we had to match
what was available to the priority of execution, initially
long-term health care facilities and frontline medical, so we
were precisioned in delivery.
Now, as vaccine becomes available, it is about expanding it
to the breadth and the depth, bringing it into mass vaccination
sites and then the local pharmacies, over 40,000 of them
registered. We can deliver to their front doors, and that is
what will bring us success as the vaccine increases in volume
in March, April, and May.
Senator Kaine. We will keep relying on that expertise,
General Perna. Thank you. Thank you, Mr. Chairman.
Chairman Reed. Thank you, Senator Kaine. Let me recognize
Senator Cramer.
Senator Cramer. Thank you, Mr. Chairman, and thank all of
you for your service and for being with us today. Let me start
out also by thanking the Department of Defense for a heroic
effort and a great job. General Perna, when I think about the
contribution, the obvious contribution, I guess, and maybe I
would not have thought of it at the beginning that the
expertise of the military brings to Operation Warp Speed, just
thank you so much.
I join Senator Kaine and Senator Ernst and the others who
have pointed out that but for our National Guard I am not sure
where many states would have been. In North Dakota, they are,
along with our frontline health care workers, the unsung heroes
who brought a level of expertise and logistics that provided
efficiency and productivity to everything from standing up
temporary hospitals to certainly the testing, and now to
vaccine distribution. So thank you to all of you for that.
I want to ask you, General Perna, specifically about
vaccine manufacturing, and I want to be able to be part of the
solution perhaps. It is my understanding that a lot of the
messenger RNA vaccines use raw materials that are developed at
Aldevron in Fargo, North Dakota. Aldevron is both the most
advanced and has the largest capacity of any DNA plasmid
company in the world.
For several months the company has been trying its darndest
to get a meaningful meeting with somebody from Operation Warp
Speed. I have tried to facilitate that. We have been largely
unsuccessful, with some progress recently. On January 19,
Aldevron finally sent a letter to Carlo de Notaristefani.
Obviously you work closely with him at Operation Warp Speed. It
is my understanding that they finally received a return call
within the last week. That has taken way too long.
But I think that there has been a tendency to overlook some
of midsized, maybe Midwestern problem-solvers, and as we build
a domestic supply chain--which I commend you and the whole-of-
government for doing, we need to do that, certainly COVID-19
has exposed some frailties in our supply chain, not just of
pharmaceuticals but lots of things, food supply and others. But
I do not want to leave out a problem-solver that could help
solve the problem.
Now, I am not an expert, obviously, but you are, and you
have people who are. Aldevron is, and they have people who are.
I guess my ask of you would be today, General, first of all,
have you seen the letter, the one I referenced from Aldevron on
January 19th?
General Perna. No.
Senator Cramer. I am going to leave it here, and before you
leave here I am going to make sure that you have a copy of it.
I want to know if--well, would you just commit to me to
personally take a few minutes, and believe me, it is not lost
on me that you have other things to do. But I would love the
commitment that you would take some time to look at that make a
call and spend some time familiarizing yourself with this
fantastic company in Fargo.
General Perna. Senator, you have my commitment. I will
personally call and talk.
Senator Cramer. I very much appreciate that, and as I
said--and hopefully you will be inspired to send a team to
Fargo.
General Perna. Not in the winter.
Senator Cramer. You have not been there if you have not
been there in the winter, General. But anyway, whatever works
we are grateful for that.
Again, let's shore up our own supply chain, and I want to
be part of that solution. With that I will yield.
Chairman Reed. Thank you very much, Senator Cramer, and I
have been to Fargo in the winter.
Let me recognize Senator King via WebEx.
Senator King. Well, thank you very much, Mr. Chairman, and
first, I want to begin by acknowledging former chair Inhofe,
because these hearings really started last March. It was the
only committee that I serve on that was really actively engaged
in determining the role of what was going on, and I remember
having hearings from quarantine and various places around the
country when this was just getting started. So I want to
acknowledge Chairman Inhofe's leadership for getting us engaged
in this process at the very earliest stage.
I also want to recognize, goodness knows I have had my
major differences with the prior President, but setting in
motion Operation Warp Speed was an important initiative, and it
has been amazingly successful. The standard I use with my
staff, whenever they say, ``It will take a year to get this
done,'' I always say, ``Don't forget, Eisenhower retook Europe
in 11 months.'' General Perna, you beat that extraordinary
deadline, under very, very difficult circumstances, so I really
think that has to be acknowledged. There are plenty of other
failures to be discussed, as Senator Kaine mentioned, but I
think it is appropriate to recognize success when we see it, in
the development of the vaccine.
The question I am interested in is the distribution, and,
General Perna, my principal question is, where are the current
bottlenecks? Is it manufacturing? Is it syringes? Is it the
middle mile? Is it health care professionals at the end of the
line? What can we do now to try to address whatever bottlenecks
are remaining to get these shots into the arms of hundreds of
millions of Americans?
General Perna. Senator, just for reference, we purchased,
and being delivered every day, all the syringes and needles and
all accessories necessary for administration of the vaccine, so
that is not a shortfall, and they are delivered accordingly.
Currently, it is the volume of supply that we have access
to. With that said, I will tell you it is increasing very
rapidly. When we started in December, we were shipping roughly
4 million doses a week. As of this week, we are averaging 15
million doses a week, and come mid-March, maybe about 21 March,
we will be shipping as much as 30 million doses.
We knew that the ability for manufacturing to meet the
requirement would have to scale accordingly, and they are
getting there quickly, and as hopefully we add Janssen to the
portfolio this weekend, and then in the future AstraZeneca and
Novavax we will have even more for distribution. It is the
supply that is the holdup. Over.
Senator King. So there are no doses sitting somewhere in
warehouses, waiting to be distributed. It is the supply at the
very first stage, but the remainder of the distribution
network, even down to the health care professionals and
individuals sites and individual states, that is scaled up, you
believe, sufficiently.
General Perna. I am 100 percent confident in that the state
and local governments have done an exceptional job. As I
alluded to earlier, we have increased provider accessibility
from roughly 7,000 locations to over 130,000 across the entire
country. So our ability to deliver and then administer is equal
to the amount of supply that is available.
Senator King. Well, I want to end with a question to Ms.
Cummings, and really it is a reiteration of Senator Cotton's
question. I think this goes for both of you. One of the most
effective things about the military is the after-action review,
and, of course, we are in the middle of the action right now.
But to the extent you can assess, Ms. Cummings, problems in the
Defense Production Act, for example--authorities, timing, how
it actually is executed--that would be very helpful to us. The
same thing for you, General, in terms of distribution, are
there authorities, are there elements of the effectuation of
your work that can be improved by changes in statute and things
that we can do to help?
So I hope both of you will supply us, after this hearing,
with any written suggestions you have for authority changes or
other things that we can do, based on the now extensive
experience you have dealing with this catastrophic situation.
With that I want to thank all of our witnesses today, as
all of us have, for really extraordinary work, and we want to
be sure that we support you in every way possible to complete
this work and end this terrible chapter in American history.
Thank you, Mr. Chairman.
Chairman Reed. Well, thank you, Senator King. Let me
recognize, via WebEx, Senator Blackburn.
Senator Blackburn. Thank you so much. I appreciate that,
and, General Perna, I want to thank you for your time yesterday
to talk through some of these issues. There has been a lot of
conversation around the issue of red tape and things that are
getting in the way, so I want to go to the other side. Are you
all really compiling best practices and beginning to say, going
forward, or if we have another situation, if there is another
pandemic, these are going to be the methods that we will move
forward with best practices?
General Perna. Senator, absolutely. We are being agile and
adaptive to what is facing us now. We do not want to fight the
plan. We want to fight the enemy and execute accordingly. We
have a very rigorous and detailed process to capture our after-
action review comments and recommendations. Over.
Senator Blackburn. Well, thank you for that, and I think it
is important as we look at bringing the J&J vaccine online and
picking up the pace, as we are getting vaccinations, those
shots into arms, for our Active Duty, for our veterans. I think
it is just so important that these best practices evolve and be
put into place.
Yesterday, in our conversation, you mentioned FedEx, and
they are a Tennessee treasure, and we are so pleased to have
them participating in such an aggressive way. I think that the
relationship between DOD, FedEx, and other government entities
really shows that a public-private partnership and highlighting
the strength of that approach, of a public-private partnership,
can go a long way in tackling some of these complex issues. We
know that you are going to continue to work in that regard.
We also talked a little bit about our Tennessee National
Guard and the good work that they are doing. They are certainly
leading the Nation in supported static vaccination sites, with
560 personnel at 60 sites. As each state or metro area is
responsible for its own internal distribution of the vaccine,
there have been variations from jurisdiction to jurisdiction.
So given this flexibility, in your opinion, how have the
diverse approaches to distribution enabled or hampered the
ability of Americans to receive the vaccine, and then there
again, what are the best practices and the lessons learned in
this regard?
General Perna. Senator, you know, it is not lost on you. As
we discussed, you know, the flu vaccine is a pull, so every
year we order, you know, throughout the jurisdictions and then
pharmaceutical companies manufacture and distribute directly to
them. What we have been doing with the COVID vaccine is we
produced, and as it comes available we are distributing it
simultaneously throughout the country. You can see great
successes in many of the jurisdictions because of the detailed
planning, execution, support by the National Guard, et cetera,
and those lessons we are capturing holistically so that we
continue to not only share today in jurisdictions but that we
get it ready for the future.
Because, you know, what we do believe is if there is
another pandemic it will be the same type of situation, where
we will have to push the vaccine upon availability. We want to
get into this routine and normalize it. Thank you.
Senator Blackburn. Thank you. Ms. Cummings, I wanted to
talk with you for just a couple of minutes about supply chain
and the defense industrial base. There are some of us that were
at the White House yesterday, working on the supply chain issue
writ large, whether it is pharmaceuticals or semiconductor
chips.
I would like for you to speak briefly to what you are doing
to maintain the supply chain integrity with the ongoing
resource strain that you have, and really what keeps you up at
night in regards to that supply chain.
Ms. Cummings. So thank you for that question, Senator. I
would call out the Industrial Capabilities Report that our
office released earlier this year that does look at fragility
in the defense industrial base. I would agree, working in the
interagency on the pharmaceutical industrial base, onshoring
those precursors and active pharmaceutical ingredients (APIs)
is critically important to both national and economic security.
As far as the companies that make up the defense industrial
base, we took actions very early on to increase progress
payments. Through that process, we were able to infuse about $4
billion into the defense industrial base, funding they would
have received anyway, but we pushed that earlier so that they
could push those progress payments, our primes, down to our
second- and third-tier, mid-level and small businesses.
We had a lot of success in helping to sustain the defense
industrial base and mitigate those impacts that COVID would
have on those critical supply chains. So thank you.
Senator Blackburn. Thank you. I yield back my time.
Chairman Reed. Thank you very much, Senator Blackburn. Let
me recognize Senator Warren via WebEx.
Senator Warren. So thank you, Mr. Chairman, and thank you
for being here, General.
Last October, Senator Hirono and I requested a hearing on
DOD's role in developing and distributing COVID-19 vaccines,
and I am fully glad that this is one of the first topics that
you are addressing as chairman, so thank you very much that,
Chairman Reed.
I asked for this hearing because the Federal vaccine
effort, called Operation Warp Speed by President Trump, was
characterized by ethical conflicts and mismanagement. One of my
biggest concerns is lack of transparency. Operation Warp Speed
(OWS) issued billions of dollars' worth of vaccine contracts,
but with too little accountability on that. Last year, DOD
issued $6 billion in contracts to a defense contractor,
Advanced Technologies International, Inc. This company then
issued subcontracts to various pharmaceutical firms in an
arrangement called other transactions authorities that allowed
pharma to bypass regulatory requirements and limited
disclosures.
So, General Perna, what is the rationale for this
subcontracting process other than to reduce transparency and
avoid regulatory and ethics requirements?
General Perna. Senator, I cannot speak broadly, and I will
defer to my colleague here at the table. But for OWS in the
work that we have done, we have worked really hard to remain
transparent in coordination with the Government Accountability
Office (GAO), and to make sure that everything we are doing is
legally, ethically, and morally correct. We provided all of our
contracts to them so that they can be a part and help us see
ourselves and work our way forward.
Senator Warren. I appreciate that, General, and I
appreciate the need to move quickly. But I think that
transparency, giving up transparency, particularly when
billions of dollars of taxpayer money is involved, is not the
right approach.
So let me just ask you, moving forward, will DOD commit to
procurement transparency on our Federal vaccine efforts?
General Perna. Senator, I apologize but I cannot commit for
DOD. I would have to go to my colleagues.
Ms. Cummings. Senator, this is Stacy Cummings from
Acquisitions and Sustainment. We do send a monthly report to
Defense Committee staff that I will make sure that your staff
has a copy of. What I can commit to is that we will continue to
be transparent in how we are spending both DOD funds as well as
interagency funds.
The other transaction authority is a tool that helps us
move quickly. It is not meant to, in any way, stop us from
being transparent. I would be happy to come and brief you or
your staff on other transaction authorities and the benefits. I
am happy to do that at your convenience.
Senator Warren. Well, I appreciate you saying that you want
to be transparent, but just saying you are going to continue
the current level of transparency is just simply not good
enough. You know, the structure of the contracts are part of
the problem. The terms in these contracts were bad too.
Public interest groups had to fight OWS to release its
contracts, and when it did it became clear that the Trump
administration had sold out the American public. Key contracts,
including the contractors with Pfizer and Johnson & Johnson
excluded critical taxpayer pricing protections. One expert
described these contracts as giving away the store.
So let me ask the question another way, based on what we
know. I will go back to you, General Perna. It seems to me that
DOD should serve the American taxpayers, not massive
pharmaceutical companies. So moving forward, will you commit to
writing and developing vaccine contracts that protect the
American people instead of pharmaceutical executives?
General Perna. You have my 100 percent commitment to that
end.
Senator Warren. Good. I am very glad to hear that. You
know, given the massive taxpayer investment and public health
interest in COVID-19 therapeutics and vaccines and other
medical products, the American people deserve to know that the
Federal Government is using their tax dollars to develop
medical products as quickly as possible and at the very best
possible price, not to line the pockets of wealthy companies by
cutting corners in consumer protection or pricing or quality.
So I recognize, General Perna that you may have been
limited by the previous administration in many respect, but I
am noting for the record, here and now, that you have committed
to do a good deal more, and I will hold you to that commitment.
Thank you very much. Thank you, Mr. Chairman.
Chairman Reed. Thank you, Senator Warren. Let me recognize
Senator Hawley.
Senator Hawley. Thank you, Mr. Chairman, and thank you all
for being here and for answering our questions today.
Mr. Salesses, could I just start with you. I have heard
from constituents in my state, which is Missouri that the
Department of Defense is not releasing information about the
number of servicemembers on a given installation who have been
vaccinated. Is that correct, to your knowledge?
Mr. Salesses. I do not know exactly what is being released
in Missouri. We do keep track of the servicemembers that have
been vaccinated, so we do have that information, if you would
like that, Senator.
Senator Hawley. Would the Department consider--do you think
the Department should consider releasing this information so
the states and local communities have a better sense of who has
been vaccinated, and what the vaccination rates are around
these installations?
Mr. Salesses. I think that is reasonable. I think what we
are talking about is releasing--when we vaccinate somebody we
share that information with CDC, which can share that with the
public health individuals in the state to make that available
to them. So I will look into that, Senator.
Senator Hawley. Great. I appreciate that. Thank you very
much.
General, let me ask you, Senator Tillis, I think, asked a
somewhat similar question but let me just--I think this is
important so let me just come back to it. What, in your
estimation, are the most important steps that we can take to
ensure that civilian agencies lead responses in future public
crises with the Department supporting, of course, but in a way
where the civilians are leading the response so the Department
can stay focused on its vital mission, which is defense?
General Perna. Senator, I think the keyword I would tell
you is being able to operationalize to effects. Right now, my
assessment, albeit not very experienced in this world, because
I have been in the Army for 38-plus years, is that very, very
good policy and defining, you know, how things ought to be, but
executing is a shortfall.
So how do you operationalize to the effects that you want
is the reform, I think, that will be necessary in your
assessments when you look at these organizations to do
something similar in a potential future pandemic.
Senator Hawley. Do you have anything to add to that, Mr.
Salesses?
Mr. Salesses. Senator, I do. Most of the organizations
obviously are regulatory organizations. The U.S. military and
the Department of Defense have tremendous operational
capability. I think going forward there will always be that
partnership where the Defense Department will partner with our
Federal partners in support of state and local authorities.
I do think that there are opportunities for other Federal
departments and agencies, particularly as you see the
acquisition business that we are in now. There may be the
opportunity in the future to have that kind of contracting
capability. Because what we are doing, really, is leveraging
the private sector here in the nation to respond to this crisis
in a lot of ways. So how we do that going forward as a Federal
Government, across the Federal Government, will be very
important.
Senator Hawley. Very good. Let me ask you while I have you
still, Mr. Salesses, how COVID has affected the Department's
operations around the world, and I am particularly interested,
have we seen any sustained impacts in operational tempo, and
particularly in INDOPACOM, our pacing theater?
Mr. Salesses. So, Senator, as you know the Department every
day tracks the readiness of the Department, and I want to state
unequivocally that we are prepared to meet every mission that
we have in the Defense Department. Now, with that, obviously we
have learned a lot, how to adapt and how to operate in the
COVID environment, and we are using that. Our accessions, we
are meeting our accessions right now. Our follow-on MOS
schools, service schools, all of those things are full-up. We
are using virtual type of capability to make sure that we can
continue the education programs that we need to for our
military members. Our training, our exercises, obviously some
of that has been curtailed. But we are finding ways to adapt
and make sure that we are maximizing both the individual and
collective training that we need to execute to ensure that we
can meet our missions, and we are monitoring this very closely
as we go forward.
Senator Hawley. Good. Very good. Thank you.
Ms. Cummings, can I just ask you, has the Department's
response--how has the Department's response, I should say, to
COVID impacted the pace of modernization, and then any other
priorities in the acquisition and sustainment space?
Ms. Cummings. So thank you for that question. We have had
to adapt to telework. That is one thing. Program offices are
very used to being all together in one place. We have had to
adapt to that, and I think we have done a fantastic job doing
that.
When I initiated the Joint Acquisition Task Force to assist
HHS in assisted acquisition, we never met our teammates. All of
our work was done on the phone. We created policies so that we
could do things electronically that previously all required
paper, actual pen and ink, to get contracts signed. So we put a
lot of different policies in place for us, on the government
side, and we also created flexibilities for our industry
partners so they could continue to meet our needs.
There are some things that did have to get pushed back.
Section 3610, for example, of the CARES Act gave us the ability
to reimburse contractors for paid leave due to COVID. We did
not receive an appropriation for that, and so there are some
things in the future that could impact modernization, and we
are working through that to better understand it and be able to
share that information. Thank you.
Senator Hawley. Very good. Thank you for that. Thank you
all for your testimony and your tremendous service. Thank you,
Mr. Chairman.
Chairman Reed. Thank you, Senator Hawley. Let me now
recognize Senator Peters.
Senator Peters. Thank you, Mr. Chairman, and to each of our
witnesses thank you for being here today and thank you for the
work that you do each and every day. You certainly have a lot
on your plate and we appreciate your efforts.
I want to start off first to just say that I concur with
comments that Senator Kaine made earlier, broadly, about how we
have handled or not handled this pandemic up to this point. But
I want to particularly concur with the fact that we are going
to need to do a complete analysis of what happened, what went
well, what went bad, an after-action report, to get a sense of
how we deal with a future pandemic. We know it is not if there
will be pandemic, it is just when, and the unfortunate part
about that, according to many scientists and epidemiologists,
is that we are likely to see more of these, not fewer of them,
for a variety of reasons, complexity of the world, et cetera.
So we better get this right next time, as we go forward,
and that will be a commitment that I will be making, I am sure,
of Homeland Security and Government Affairs. As an oversight
committee, we plan to do a pretty in-depth investigation into
this, as well as other committees I am sure will be engaged,
and your continued input in that process will be appreciated
and essential for us to get the kinds of answers that we need.
General Perna, a question for you. You have talked about
the capacity that we have now to put injections in arms and
supply. We talked about the increase of supply. Right now we
have a situation where there is actually more capacity to
deliver vaccines than there is actual vaccines coming in. We
are seeing that in the state of Michigan right now. We can do a
whole lot more.
The good news is, as you mentioned, is the vaccine
production is increasing. I had the privilege of being with
President Biden last week in Michigan, at the Pfizer
manufacturing facility outside of Kalamazoo and Portage. We
take great pride in Michigan and we are making efforts and
making the vaccine in our state. When I was there they were
producing 5 million doses a week. I understand next week they
will be up to 10 million doses a week, and roughly 300 million
doses will be delivered, I believe, by July. That is about half
the American population will have doses available, and that is
just Pfizer. Then we have got Moderna and others that will be
coming online as well.
So we are going to get to the point where there is going to
be a whole lot more vaccine than there will be capacity to
actually put it in arms, so we have to align all that. What I
am finding is a problem that I am hearing from my folks is that
right now the visibility of when vaccines are actually coming
to them is not great. It is getting better, but I would like
you to talk about how it is going to get even better, so that
you know not just what you are going to get next week but what
you are going to get three weeks from now, and four weeks from
now, because it takes considerable planning to have that
capacity ramp up to match those vaccines coming in.
Then we are going to have to bring in even more capacity.
FEMA, as you mentioned, will be setting up Federal facilities.
We are hoping to get one of those in Michigan soon. Walk me
through, how are we going to make these align? How are we going
to have greater transparency? How are we going to make sure
these are more aligned so that we do not have a mismatch of too
much capacity, not enough vaccine, and then move from too much
vaccine and not enough capacity?
General Perna. Senator, I think, to start with,
communication from the White House to the governors on a weekly
basis has been very helpful to get the word out, and one of
their commitments was to put on Tiberius three-week projections
so that everybody could see what is coming their way. The rule
of thumb is we will never go backwards, so you will never
receive less than what you have received already, on a weekly
push, but always try to increase, but to give that
predictability.
We are working on, and I think we have good fidelity on
what we think the numbers are going to look like based on
Emergency Use Authorization for future companies and max
capacity, so that we know, for instance--and I have been to
Kalamazoo many times--that both Pfizer and Moderna will
probably hit their peak capacity around 21 March. So we know
that is roughly 24 million doses of vaccine the two companies
will produce on a weekly basis.
We know that Janssen will come, we believe, with Emergency
Use Authorization hopefully this weekend, and they will start
producing in a regular rhythm of 5 to 10 million doses a week,
so that we can project to everybody what we think the mass
volume is going to be pro rata, and we are working to
distribute that accordingly to all the states. I am in 100
percent agreement with you.
Senator Peters. Great. Well, I appreciate that. In my
remaining time I want to pick up on an issue related to defense
establishments, and the fact that recent surveys show that
about 60 percent of Americans are willing to take this vaccine
now, which, when we have these vaccines come in, we actually
have to make sure we have the capacity and Americans that want
it. Right now the demand exceeds supply, but that will change.
But my concern is that surveys show that--I think the most
recent one showed that the rate among military families is
about 33 percent. That is a real problem, and I am really
worried about communities that host defense facilities, that a
community could be doing a great job in getting 80 percent of
the folks vaccinated in the community, and yet folks on the
military base, in their communities, at 33 percent. That is
simply unacceptable. How are we going to change that? That
risks an entire community of military personnel who are going
into the community who are simply not vaccinated. How are we
going to address that?
Mr. Salesses. Senator, we know that the vaccine is safe. It
is the right thing to do. We are meeting all the time with our
leadership teams, at every level in the Defense Department, to
educate people and make sure that they know the value of the
vaccine and the importance of it. I believe that that
education--again, we have been at this for about 60 days--I
really believe that that will make a huge difference in the
continued emphasis by our leaders at every level in the Defense
Department will make sure that we improve upon that number.
Senator Peters. Having transparency in that data, so a
community knows, a previous question, is really important. The
community has to know what is happening at that base, with all
of those people there. So I hope that is a priority for you.
Mr. Salesses. Senator will we will.
Senator Peters. Great. Thank you. Thank you very much, Mr.
Chairman.
Chairman Reed. Thank you, Senator. Senator Tuberville,
please.
Senator Tuberville. Thank you, Mr. Chairman. Save the best
for last here I guess. I know it has been a long day. Thank you
for your efforts. Thank you for the miracle that you all pulled
off. I know you have heard some rhetoric here today that is a
little strong, but, hey, it is not against you. A lot of them
did not like our President, but that is fine. He got a lot
done, but you got a whole lot done.
You know, I was campaigning last year over the whole state
of Alabama, and I was telling people, everybody was asking
about, ``Coach, what do you think about this virus?'' And I
said, ``Well, I don't know but I will tell you this. China is
not going to come up with the answer. Russia? Europe? United
States of America is going to come up with the answer,'' and
you did. You worked hard at it. Most of you probably have not
slept a lot in the last year. Thank you for what you have done.
Some are saying, you know, it has been a disaster. A lot of
them in this building, 20 years ago, voted to send our
manufacturing to China. What the heck do they expect? We need
to get our medical supplies made in this country, and quit
putting the blame on other people. I hope you would agree with
that, because we have all gone through that.
I am proud of Alabama. We are making, in Huntsville,
Alabama, Rheem Corporation is making refrigeration for the
vaccine. In Auburn, where I live, we are making millions a
month of vials that are plastic, that are blowing glass into
the vials to store the vaccine, to be given out. I am proud for
what Alabama has done in a lot of the private sector. I hope
you have enough money. You know, we are out there right now
trying to spend money on bridges to nowhere, and tunnels, when
you need every dime you can get because our kids are not in
school and our people are not at work and they are scared to
death. But it is helping.
I was in Alabama last week, going to the military bases,
and the commanders there are saying, ``We are getting vaccine.
They are communicating,'' and that is all we ask, just
communicate, tell them what they are going to get. Fort Rucker
trains every vertical lift pilot in the country. For those of
you that do not know, it is helicopters. We need them trained.
They are in the air almost 24 hours, and for every pilot there
are about ten people on the ground waiting for it to land, to
maintain it, and put the fuel in it to continue to go, to
train. They are getting their vaccine, so I want to thank you
for that.
I just hope today you leave, knowing that things are
positive. In our state it is going down. We can see the light
at the end of the tunnel. We are not there yet. We need to
continue to social distance and do all the things we need to
do. But I just to end on a note that we want to thank you for
what you are doing. Let's say one thing. I have been in
recruiting all my life, and pretty much sales, being a football
coach, and marketing. We are going to get to the point where
people are not going to take this vaccine. We have gotten to
the point, some in Alabama, where at one point, three weeks
ago, 40 percent of the first responders were not taking it --40
percent. That cannot happen.
So I would just express upon you, and ask you your thoughts
about marketing. Sooner or later, we are going to have to go on
television, and we are going to have to get out there and have
people get in front of the camera, well-known people, people
that are average day workers, saying they have taken it and it
worked. We are going to need to do that, because we need this
country to get back to work, or we are going to lose our
country. It is not going to be all the mess that we have got
going on right now. It is going to be this virus that is going
to bring us to our knees. China is on the run. They are running
past us as fast as they can, and we need to get back to work,
and we need to get our eyes on other things.
So what are your thoughts, all three of you, thoughts on
marketing, probably starting in the very near future.
General Perna. Senator, I agree with you 100 percent, and I
know HHS and the CDC are developing and working that now, to
start expanding that as we go forward. So we believe, simply
said, it just needs to be a reflection of society saying that
they took the vaccine, so that others can see it, and that is
what they are working on now.
Mr. Salesses. Senator, I agree. It is building confidence,
and using the right people to reassure the public and make sure
that the American citizens know how important it is to take the
vaccine, not just for themselves but the others that they work
around--their families, co-workers, and those kinds of things.
Building that confidence with credibility is what will turn the
table on this.
Ms. Cummings. So I have worked for the Federal Government
my whole career so I am not a marketing expert. I can tell you
my husband and I actually participated in a vaccine trial, and
I think that the best way to give people confidence is that
they understand the process, the diligence that went behind the
trials, and that real people, real Americans, participate to
ensure it was safe and effective for them.
Senator Tuberville. I hear 75 percent of people have to
have a vaccination before we feel safe. Is that true or false?
General Perna. I cannot speak to that specifically,
Senator. I know it is something similar to that, but the
scientists would have to give you an update on that.
Senator Tuberville. Thank you. Thank you very much.
Chairman Reed. Thank you, Senator Tuberville. I want to
thank the panel for a very informative and thought-provoking
hearing. I particularly want to thank you for your individual
tireless efforts to deal with this crisis and to be innovative
and creative. It has been a very significant challenge and you
have met that challenge in many respects.
But I think we understand there is more work to be done. We
look forward to working with you to get that work done, not
only to defeat COVID but to prepare ourselves for other
pandemics that could be coming down the road.
So thank you again, and with that I will adjourn the
hearing.
General Perna. Thank you, Chairman.
Mr. Salesses. Thank you.
[Whereupon, at 11:43 a.m., the Committee adjourned.]
[Questions for the record with answers supplied follow:]
Questions Submitted by Senator Jack Reed
defense production act
1. Senator Reed. Ms. Cummings, based on the Department of Defense's
(DOD) experiences using the Defense Production Act (DPA) authorities
during the COVID pandemic to address both medical and defense
industrial base issues, are there any changes to the authority that
could help DOD and other Federal Agencies use it more effectively in
the future?
Ms. Cummings. Upon its initial adoption, the Defense Production Act
(DPA) was conceived as a mobilization and preparedness tool for a
military conflict. Since 1950, Congress has expanded and contracted
both the scope and authorities of the statute to cover non-defense
national emergencies. Historically, DPA has been used for a variety of
purposes, such as domestic aluminum production, workforce development,
and even the Trans-Alaskan pipeline.
Presidential Policy Directive-21 establishes agency leads across 16
critical infrastructure sectors, and Executive Order 13603 establishes
agencies of responsibility for certain resources under Title I of DPA.
DOD has relatively limited direct responsibilities, but as the DPA Fund
Manager, we execute Title III activities on behalf of all agencies. The
volume of that transaction activity has increased exponentially,
creating significant overhead responsibility for the Department.
DOD cannot execute its mission under Title III of DPA if non-
defense agencies are not effectively resourced and organized to assess
and determine their requirements within their areas of responsibility.
DPA is intended to support whole-of-nation preparedness and response to
a national emergency, and our non-defense agency partners are critical
to meeting that need.
During the COVID-19 response, the Department found other agencies
were unable to quickly transfer their appropriated funds to the
Defense-Wide//Defense Production Act Purchases account to execute
investments under Title III of DPA. For example, some Department of
Health and Human Services (HHS) funds allocated for medical response
needed DOD acquisition assistance. Since no direct transfer vehicle
existed, the Economy Act was used to transfer funds, which added 76
days to the process. It is essential that future appropriations acts
include the authority for non-defense agencies to transfer their funds
more expediently to DOD for DPA Title III execution.
Multiple administrations have chosen DPA Title III to mitigate a
myriad of industrial challenges. DPA's speed and efficiency can be
hindered by two requirements:
1. Non-delegation of Presidential Determinations (PD) (i.e., non-
delegation of authorities that were formerly delegated to USD(AT&L) or
SECDEF), and
2. The spending limit of $50 million per PD without Congressional
approval. These requirements limit the speed and flexibility with which
DOD can respond in peacetime and during periods of crisis.
2. Senator Reed. Ms. Cummings, the American Rescue Plan, if passed,
includes $10 billion in Defense Production Act funding, which DOD will
need to manage. To what extent is DOD adequately resourced to manage
this quantity of funding, including planning, prioritizing, executing,
and overseeing awarded projects?
Ms. Cummings. Upon the introduction of the American Rescue Plan,
the Office of the Deputy Assistant Secretary of Defense (ODASD) for
Industrial Policy, which oversees and executes the DPA Title III
program, began acquisition planning for these funds with their
counterparts at the Department of Health & Human Services (HHS). DOD is
working with its counterparts at OMB, HHS, and the Air Force Executive
Agent Program Office (EAPO) to determine the most effective path,
consistent with the underlying appropriation and fiscal laws, to assist
HHS with the execution of these funds.
3. Senator Reed. Ms. Cummings, to what extent has DOD begun
coordinating with the Department of Health and Human Services (HHS) and
Federal Emergency Management Agency (FEMA) on developing a strategy to
use any additional DPA funding provided in the American Rescue Plan?
Ms. Cummings. Acquisition planning between DOD and HHS for any
supplemental appropriations from the American Rescue Plan began upon
the introduction of the bill in the House of Representatives last
month. This acquisition plan is ongoing and pending final approval by
HHS and the Executive Office of the President.
expanding production of critical medical supplies
4. Senator Reed. Ms. Cummings, in testimony before the House Armed
Services Committee last June, you noted that at peak demand, the United
States would need about 100 million N95 respirators per month. You also
stated that with domestic production expansion efforts, U.S.
manufacturers would have the ability to produce over 1 billion N95
respirators annually by January 2021. To what extent have domestic
manufacturers met the mark of producing 1 billion N95 respirators
annually, and are we now able to meet U.S. demand through domestic
manufacturing sources?
Ms. Cummings. On behalf of the Department of Health and Human
Services (HHS), DOD initially awarded five contracts totaling $278.7
million to increase the domestic manufacturing capacity of N95
respirators an additional 834 million per year beyond base production.
On November 20, 2020, while in the process of final contract
negotiations, one of the manufacturers requested to withdraw from the
agreement, as the company had expanded its domestic monthly production
of N95 respirators by 12 million using private capital. After the
withdrawal, DOD's investments in N95 domestic production total $251.4
million and will increase production an additional 690 million per year
beyond base production. This industrial base expansion (IBX) will be
fully achieved by May 2021.
As the lead agency for the Federal COVID-19 response, HHS
determines the Nation's demand for health and medical resources.
However, DOD calculates demand for health and medical resources needed
to supply DOD personnel. While DOD demand signals for N95 respirators
and personal protective equipment (PPE) remain higher than pre-pandemic
levels, demand has lessened significantly when compared to the initial
spring and summer 2020 months. Stabilized demand, coupled with the
expanded industrial base, now allows production to keep pace with
immediate DOD medical demand while still reconstituting DOD
inventories. As of March 8, 2021, DOD has 83 million N95 respirators,
or six years' worth of respirators based on current forecasted demand,
in on-hand inventory.
5. Senator Reed. Ms. Cummings, in materials provided to Committee
in support of this hearing, you reported that industrial expansion
projects managed by the Department of Defense have significantly
increased the domestic production capacity of key medical supplies,
including surgical masks, gloves, swabs, and test kits. To what extent
are we now able to meet U.S. demand for these items through domestic
manufacturing sources?
Ms. Cummings. I would refer this question to the Department of
Health and Human Services.
6. Senator Reed. Ms. Cummings, what are the critical medical
supplies for which we are still heavily reliant on foreign sources?
Ms. Cummings. Our pharmaceutical industry is still heavily reliant
on foreign sources for the key starting materials that support active
pharmaceutical ingredients. While research is ongoing, the Food and
Drug Administration (FDA) estimates that approximately 80 percent of
active pharmaceutical ingredients are supported by off-shore
manufacturing.
Additionally, the DOD is aware of the Nation's outsized reliance on
foreign sources for Nitrile Gloves. To address this reliance, HHS
requested DOD issue an Area of Interest under the Commercial Solutions
Opening for gloves and awards to expand glove production in the U.S.
are expected within the month.
I would refer this question to the Department of Health and Human
Services for more details.
department of defense acquisition assistance to health and human
services, federal emergency management agency, and other federal
agencies
7. Senator Reed. Ms. Cummings, throughout the pandemic, DOD has
provided acquisition assistance to other Federal Agencies in the form
of market research, supply chain management, contract award and
administration, logistics advice, and other acquisition expertise. Can
you quantify how much support DOD has provided to other agencies during
the pandemic, such as in terms of number of contracts awarded, dollars
obligated, or DOD labor hours expended?
Ms. Cummings. Over the past year the DOD, in support of the Whole
of Government COVID-19 response, executed approximately $26 billion to
acquire the necessary vaccines, therapeutics, diagnostics, consumables,
PPE, and other enablers required for pandemic response.
8. Senator Reed. Ms. Cummings, to what extent has providing this
high level of interagency acquisition support adversely affected DOD's
ability to award and administer its own contracts?
Ms. Cummings. To date, no planned DOD activities have been delayed,
cancelled, or reduced due to interagency COVID-19 support. The
pandemic's slowing of the global economy allowed the Department to
dynamically respond with surge support to meet the Whole of Government
need and minimize adverse effects to DOD contracts. DOD has been
reimbursed for contracting activities as authorized under the Economy
Act.
9. Senator Reed. Ms. Cummings, what challenges has DOD encountered
in awarding and administering COVID-related contracts on behalf of
other agencies?
Ms. Cummings. DOD has faced challenges moving funding from HHS to
DOD, especially with funding appropriated in the Coronavirus Response
and Relief Supplemental Appropriations (CRRS) Act, which included
language about real property that previous appropriations did not. HHS'
and DOD's Offices of General Counsel carefully reviewed the CRRS real
property language and reached consensus about its implications for IBX
contracts. Funds have begun moving and DOD anticipates awarding IBX
contracts using CRRS funds in the coming weeks.
10. Senator Reed. Ms. Cummings, our understanding is that DOD and
the Department of Health and Human Services (HHS) agreed to transition
COVID-related acquisition activities from DOD to HHS by the end of
January 2021. What is the current status of these transition efforts,
and is DOD continuing to administer existing contracts and/or award new
ones on behalf of HHS?
Ms. Cummings. DOD and HHS agreed to transition responsibility for
COVID-19 contracting and industrial base management from DOD to HHS as
soon as awards resulting from outstanding Commercial Solutions Openings
(CSOs) are made. DOD continues to support HHS with acquisition
assistance past the previously agreed date of January 31, 2021, for
several reasons. A delay in funding transfer for the gloves and point-
of-care testing Commercial Solutions Opening (CSO) delayed contract
awards. Following this CSO, HHS requested DOD publish an additional CSO
for testing and diagnostics supply chain constraints. While DOD intends
to transition contracting efforts to HHS following these awards, the
Memorandum of Understanding allows for additional support to the
Nation's fight against COVID-19, should HHS request it.
cares act section 3610
11. Senator Reed. Ms. Cummings, you mentioned in your testimony
that if the Department does not receive supplemental appropriations to
fund reimbursements made under CARES Act section 3610, certain
modernization efforts may have to be delayed. What is the Department's
current cost estimate for CARES Act section 3610 reimbursements?
Ms. Cummings. The current cost estimate for the CARES Act section
3610 Paid Leave reimbursements is $7.1 billion. This includes actual
costs incurred to date and projected costs through September 30, 2021.
Separate from CARES Act section 3610 paid leave costs, the Department
estimates an additional $6.55 billion in Other COVID Related Costs that
have been and will continue to be incurred by the defense industry in
order to continue performance through the pandemic (e.g. purchase of
personal protective equipment, increased cleaning, health screening &
procedures, prime contractor and supplier impacts to alter shifts/
production processes to achieve social distancing). In total, the
Department estimates COVID impacts amount to $13.6 billion that could
impact modernization efforts.
12. Senator Reed. Ms. Cummings, what methodology and data sources
did the Department use to arrive at its current estimate of CARES Act
section 3610 costs?
Ms. Cummings. On October 27, 2020, the Honorable Ellen Lord
requested the major defense contractors each submit a COVID-19 Rough
Order of Magnitude (ROM) estimate of actual incurred and projected
costs. On December 1, 2020, we received ROM estimates from 21 major
defense contractors that collectively represent 46.6 percent of the
Department's fiscal year 2020 contract obligations. It is important to
note, that at the time industry prepared their ROM estimates, Section
3610 Paid Leave was only authorized through December 11, 2020. We
extrapolated this input to project the impact on the remaining 53.4
percent of defense contractors to arrive at an original total estimated
cost for Section 3610 Paid Leave of $4.25 billion.
Because Section 4015 of the American Rescue Plan extended the
Section 3610 authority through September 30, 2021, we updated our
estimate to account for the extended period of authority. The
Department assumed the same contractors that submitted ROMs for the
first 72 days in fiscal year 2021 (October 1, 2020 through December 11,
2020) would continue to incur those costs for the remainder of the
fiscal year. However, the Department recognized that paid leave costs
would decrease over time as vaccine distribution continues to increase
throughout fiscal year 2021. Therefore, using Center for Disease
Control (CDC) vaccine metrics, the Department projected the ROM
estimate over the remainder of the fiscal year, while incorporating
decrements each month to account for planned vaccine distribution,
resulting in a growing numbers of fully vaccinated adults over time.
Using this methodology, versus a straight line extension of the ROM
costs, our revised estimate of Section 3610 Paid Leave costs is $7.1
billion.
department of defense contract financing support to the defense
industrial base
13. Senator Reed. Ms. Cummings, in an effort to provide additional
cash flow to both prime contractors and small businesses, DOD increased
the rate of progress payments and authorized the use of advance
payments in certain situations. What is your current estimate of the
increased amount of contract financing that DOD provided to contractors
under the higher progress payment rates?
Ms. Cummings. As of March 31, 2021, the estimated amount attributed
to the progress payment rate increase is $4.6 billion.
14. Senator Reed. Ms. Cummings, in how many instances did DOD
authorize the use of advance payments and what was the value of those
payments?
Ms. Cummings. Based on data received from the Components as of
April 6, 2021, there have been 21 instances of advance payments
totaling approximately $712 million.
15. Senator Reed. Ms. Cummings, how did the Department ensure that
prime contractors who received higher rates of progress payments or
advance payments in turn provided those funds, as appropriate, to their
subcontractors and lower tier suppliers?
Ms. Cummings. Acquisition regulations stipulate that the progress
payment rate in the subcontract is the customary rate used by the
contracting agency (FAR 52.232-16(j)(6)).
Even though there is no privacy of contract between DOD and its
prime contractor's lower tiered vendors, the Department conferred with
major primes to encourage flow down of the increased progress payment
rate throughout the supply chain. Upon issuance of the class deviation
increasing the progress payment rate in March 2020, representatives
from industry associations were briefed on the implementation
procedures and the government's expectations that financing would be
flowed down to suppliers. Furthermore, through triweekly phone calls
with industry associations and major prime contractors and other
regularly-established forums, Department representatives communicated
DOD's desire for increased prime contract financing to be flowed down
to suppliers. DCMA prepared 1,798 contracting modifications to swiftly
implement the class deviation in eligible contracts they administered.
DCMA Contract Note 20-11, accompanying modifications increasing the
progress payment rate explicitly stated, ``[t]his deviation is
applicable to all subcontracts; therefore, should be flowed down to the
prime contractor's subcontractors as well.''
With respect to advance payments, the contracts covering the
majority of the dollars included a requirement for the prime contractor
to provide notification to specific subcontractors of their opportunity
to receive a proportional share of the advance payment.
16. Senator Reed. Ms. Cummings, how did it track and audit the
provision of funds to subcontractors and lower tier suppliers?
Ms. Cummings. In December 2020, the Department received responses
from 21 major prime contractors to obtain COVID ROM information. As
part of this data call, the Department asked primes to provide how
payment and financing terms were modified to assist subcontractors,
including small businesses. Eleven companies indicated they provided
additional financing or accelerated payments to suppliers.
With respect to advance payments based on information to date,
contracts include a requirement for the prime to provide a monthly
update on how it spends the advance payments received. The
administrative office in partnership with the buying activities has
been following up with the company to ensure its understanding of how
funds have been utilized and the company has provided information on
which suppliers received advance payments.
Finally, as part of the on-going DOD Contract Finance Study, the
Department is examining its policy in the area of flow-down to
suppliers.
17. Senator Reed. Ms. Cummings, please discuss the extent to which
the Department has made use of section 891 of the National Defense
Authorization Act for Fiscal Year 2021 and any challenges encountered.
Ms. Cummings. The Department has not made use of the authority from
section 891 of the Fiscal Year 2021 NDAA but is in the process of
developing a class deviation to implement this authority. At this
juncture, there are no known challenges.
defense logistics agency
18. Senator Reed. Ms. Cummings, during the COVID-19 pandemic, the
Defense Logistics Agency (DLA) closed monitored the health of the
suppliers with which it worked, including collecting data on closures,
furloughs, and sub-tier supplier issues. However, DLA officials
reported that they were constrained in their ability to provide
financial assistance to suppliers in distress because of rules and
regulations associated with being a Working Capital Fund. Please
discuss the extent to which DLA was able to provide financial
assistance to suppliers during COVID (such as through advance
purchases) and how being a Working Capital Fund affected DLA's ability
to provide assistance.
Ms. Cummings. DLA's longstanding relationships with industrial
partners facilitated an extensive communications network to manage and
assist response to the COVID-19 crisis. DLA quickly initiated weekly
conference calls with key suppliers to share vital information and
discuss critical financial and logistics issues created by the
pandemic.
While we maintain open communications, DLA is limited in what it
can do in terms of direct financial assistance. Working capital funds
are designed to provide support to customers with purchases based on
anticipated customer demand. Working capital funds operate on a
revolving fund concept, meaning, procurement orders placed with
suppliers ultimately must have customer demand that follows close
behind to reimburse the fund, sustain a minimum cash balance and infuse
liquidity back into the working capital fund to continue operations.
Placing advance purchases with suppliers above and beyond anticipated
customer demand requires appropriated funds. Otherwise, the working
capital fund runs the risk of becoming insolvent, which may result in
an Anti-Deficiency Act violation. Similarly, DLA would like to
accelerate payments to small suppliers, as a form of financial
assistance, but given dampened customer demand (due to COVID-19) and
associated negative impacts this has had on cash, DLA was not able to
accelerate payments. Similar to the inventory augmentation issue, DLA
could accelerate payment as a form of financial assistance if
appropriated funds were made available for this purpose.
19. Senator Reed. Ms. Cummings, in the absence of making advance
purchases, what tools does DLA have at its disposal to support
vulnerable suppliers?
Ms. Cummings. DLA operates as a working capital funded organization
and buys to requirements. This ``bona fide'' need rule prohibits DLA
from generating additional business for the purposes of stimulating an
industrial base.
Specific to the CARES Act, DLA secured $22M in Title III funds made
available through the Industrial Base Council, to support fragile
Clothing and Textile vendors negatively impacted by COVID-19 to invest
in production capacity improvements and facility modifications (for
safer workplace conditions in a COVID-19 environment).
Like others, DLA is actively engaged in CARES Act 3610
Implementation, however, the Agency has not received a significant
number of requests for relief under this Act from suppliers. Support to
impacted suppliers has mainly taken the form of contract modifications
to delivery dates.
In general, the tools available to support vulnerable suppliers can
be categorized by authority, contracting techniques, and funding types.
These tools are always available if circumstances warrant and are not
limited to the conditions caused by the COVID-19 pandemic.
Regarding authority, FAR Part 6.302-3 allows Contracting Officers
to limit competition when necessary to ``keep vital facilities or
suppliers in business or make them available in the event of a national
emergency'' and other circumstances necessitating the availability and
sustainability of critical capabilities.
The contracting techniques that may be used include contract
modifications, incremental performance payments, advanced payments, as
well as awarding contracts or reducing delivery schedules to a
supplier's minimum sustaining rate to allow the supplier to retain work
force, right-size in a planned fashion, and operate at a more stable
lower volume. Such techniques are exercised based on Contracting
Officer discretion on a contract-by-contract basis, in accordance with
applicable laws and regulation.
Appropriated dollars allow DLA to fund industrial solutions that
can reduce the vendor's risk to remain viable and to provide increased
surge capability. This can be done by funding a supplier's fixed costs
(with full financial disclosure and analysis) to ensure the supplier
may break even for a production line or capability. Appropriated
dollars also allow for DLA to establish material buffers with the
vendor to increase their ability to respond. These types of industrial
solutions are executed at various levels within each DLA supply chain
using the DLA Warstopper Program.
__________
Questions Submitted by Senator Jeanne Shaheen
t-cell testing
20. Senator Shaheen. General Perna, certainly, a person's medical
decisions are theirs and theirs alone and the government cannot in any
way coerce a decision to be vaccinated. But, given the national
security implications of a depleted force, we need to consider every
avenue to encourage vaccination, amongst Active Duty and Reserve
troops. One possible way to do that is to give soldiers a better
understanding of their personal vulnerability to the virus. T cells and
antibodies are two arms of the immune system that provide insights into
disease activity and an individual's personal immunity. Antibodies are
more commonly used to measure immune responses to infections; however,
since antibody responses are not always generated, and have been shown
to wane within 2 to 3 months of COVID-19 infection, they only provide a
partial picture of a person's risk profile. As the Department of
Defense grapples with the issue of vaccine hesitancy among Active Duty
and Reserve troops, wouldn't it make sense to have a full picture of a
soldier's immune response?
General Perna. Defer to OSD P&R.
OSD P&R. We understand that encouraging vaccination is key to
opening up the nation and protecting servicemembers and other
beneficiaries. The DOD CVTF maintains close relations with the Centers
for Disease Control and Prevention (CDC) and incorporates relevant
guidance into COVID-19 response strategies. The CDC's current guidance
does not recommend the use of COVID-19 antibody testing to ``assess for
immunity to COVID-19 following COVID-19 vaccination or to assess the
need for vaccination in an unvaccinated person.'' It is also unknown
what degree of immunity will be provided from subsequent infections or
the impact emerging viral variants will have. This guidance is the same
case for T-cell immune response. The CDC recommends serologic tests for
seroprevalance studies to estimate cumulative incidence of infection
(or vaccination) of a population. The DHA Armed Forces Health
Surveillance Division with assistance of U.S. Army Medical Research
Institute of Infectious Diseases (USAMRIID) has been performing
seroprevalance studies using the DOD Serum Repository which houses
serum samples from servicemembers to capture this information.
21. Senator Shaheen. General Perna, could those risk profiles be
another tool we have to encourage vaccination?
General Perna. Defer to OSD P&R.
OSD P&R. Yes, the high risk profiles could be another tool to
encourage vaccinations. With this data, DOD eligible personnel can see
those who have been vaccinated with the Janssen and mRNA (Pfizer and
Moderna) vaccines do significantly reduce severe COVID disease and
hospitalizations in vaccine recipients. It is exciting to learn that
these vaccines may also decrease transmission to others who have yet to
receive vaccine. Therefore, medical experts at the American Medical
Association and the CDC both say that you should take the vaccine that
is available when it's your turn to be vaccinated. None of the COVID-19
vaccines contain the live virus that causes COVID-19, so a COVID-19
vaccine cannot make you sick with COVID-19. While recipients may
experience side effects, these are indications that your body is
building protection against COVID-19 and they should go away after a
few days.
polymerase chain reaction test manufacturers
22. Senator Shaheen. General Perna and Ms. Cummings, despite
receiving significant amounts of funding from the National Institutes
of Health to support the science necessary to create their 15-minute
saliva polymerase chain reaction test, I have heard concerns from
manufacturers that have not been successful in securing money from the
Department of Defense (DOD) to support their manufacturing costs. Was
there a manufacturing scale-up, and if so, what was the Department's
decision making?
General Perna. I defer to Ms. Cummings.
Ms. Cummings. The Department of Health and Human Services (HHS), as
the lead agency for the Federal COVID-19 response, determines the
Nation's health and medical resource requirements, including for novel
technology. While DOD has executed multiple Commercial Solutions
Openings and awards on behalf of HHS for innovative commercial items
and technologies, including for testing and diagnostics capabilities,
HHS makes all award determinations. As of May 25, 2021, DOD had
invested $1.4 billion across 19 actions on behalf of HHS in testing and
diagnostics capabilities.
23. Senator Shaheen. General Perna and Ms. Cummings, is the
Department factoring in the capabilities of the platforms, their
ability to be used to detect multiple variants or their portability for
DOD needs?
General Perna. Defer to Ms. Cummings.
Ms. Cummings. The Defense Health Agency (DHA) factored in the
capabilities of the current technology receiving FDA Emergency Use
Authorizations (EUAs). These evaluations were performed on every EUA
testing platform which came to market and was considered for DHA use.
The test was evaluated by the scientific community to ensure the test
platform would provide a relatively reliable result. With regards to
detecting multiple variants, I defer to General Perna and his team as
USD(A&S) does not have insight into the capabilities of the platforms
to detect multiple variants, but no individual EUA addressed this
capability until variants were identified by the medical and scientific
community. Once variants were identified, the manufactures reevaluated
their test(s) and provided feedback on their ability to identify the
COVID-19 Virus, regardless of the variant.
cares act section 3610
24. Senator Shaheen. Ms. Cummings, section 3610 of the CARES Act
allows Federal Agencies to use their funds to reimburse contractors for
paid leave made to employees who are unable to access their worksites
and unable to telework. This was designed to help defense, NASA
(National Aeronautics and Space Administration), and other contractors
access their facilities and maintain their workforces even during
disruptions. This provision expires on March 31, 2021. This means that
even where contracting officers have the resources to provide this
assistance, they will no longer have the legal authority to do so. Does
the Department support extending this provision?
Ms. Cummings. Section 4015 of the American Rescue Plan Act of 2021
(Pub. L. 117-2), enacted on March 11, 2021, extended the end date of
the period through September 30, 2021. Defense Pricing and Contracting
implemented this extended period of authority via Defense Federal
Acquisition Regulation Supplement (DFARS) class deviation on March 23,
2021.
__________
Questions Submitted by Senator Kirsten Gillibrand
child development centers
25. Senator Gillibrand. General Perna, many servicemembers rely on
Child Development Centers (CDC) for childcare so they can focus on the
mission. Due to the risk of the pandemic, many of the CDCs were shut
down and have not provided care since last March. What is the
Department doing to reopen the CDCs safely?
General Perna. Defer to P&R.
OSD P&R. The DOD views child care as a workforce enabler that
directly impacts the readiness and efficiency of the Force. The
Department and the Military Services are focused on ensuring that DOD
Child Development Programs support family's needs, and throughout the
pandemic, installation commanders worked tirelessly to keep child
development centers open.
DOD Child Development Programs are uniquely suited to quickly
respond to safeguards designed to limit exposure to the COVID-19 virus.
Standard daily protocols are already in practice to ensure the health
and safety of children and staff. In concert with Public Health
Officials, local installation commanders implemented risk mitigation
measures, and adjusted facility operational capacity focused on
providing child care to mission essential personnel. Additional risk
mitigation practices included: use of face coverings by all adults;
optional use of face coverings by children over the age of 2; rigorous
handwashing and social distancing practices; increased daily
disinfecting and sanitation procedures; and wellness checks, to include
temperature checks and health questionnaires for all individuals
entering the facility.
At the height of the Pandemic (March to June 2020), some
installation child development programs were required to close due to
installation public health requirements, community public health
requirements, and host nation requirements. OCONUS installations were
the most significantly impacted due to host nation COVID-19
restrictions and requirements.
The Department experienced challenges maintaining our operations at
some installations between March and July 2020. In April 2020, 65 of
the 211 installation child development were closed. By September 2020,
significant progress towards opening the centers was made, and 208 of
our 211 installation child development programs were open to provide
service. Since January 2021, at least one child development center at
each installation has remained open. As of 29 April 2021, child
development centers are operating at 77 percent of the pre-COVID
capacity; capacity is improving each week. The Department continues to
monitor installation child development program capacity.
26. Senator Gillibrand. General Perna, what specific precautions
are being taken to mitigate the spread of the virus at CDCs?
General Perna. Defer to P&R.
OSD P&R. DOD Child Development Programs are uniquely suited to
quickly respond to safeguards designed to limit exposure to the COVID-
19 virus. Standard daily protocols are already in practice to ensure
the health and safety of children and staff. All DOD Child Development
Programs comply with Centers for Disease Control and Prevention,
American Academy of Pediatrics, and DOD guidelines and directives, in
close coordination with installation commanders and public health
officials, to ensure employees and children are protected to the
greatest extent possible. Maintaining vigilance by having staff,
children and visitors practice personal hygiene, complete wellness
checks upon entering the facility, and wear masks, while also reducing
capacity to allow for social distancing are just a few of the
protective measures taken. In addition, programs teach, practice, and
promote handwashing and sanitation practices for both staff and
children and are regularly inspected to ensure compliance.
27. Senator Gillibrand. General Perna, are CDC employees being
prioritized for the vaccine?
General Perna. Defer to P&R.
OSD P&R. CDC employees fall into the Department's overall category
of Other Essential Workers which immediately follows the highest
priority for the COVID-19 vaccine. All CDC employees are encouraged to
receive COVID vaccinations.
28. Senator Gillibrand. General Perna, how has the lack of child
care and schools being closed affected force readiness?
General Perna. Defer to P&R.
OSD P&R. Throughout the pandemic, DOD schools, the Military
Services, and installation commanders worked tirelessly to keep DOD
schools and child development centers open to the maximum extent
possible; the impact to force readiness has been minimal. The leaders
of both, the CDCs and DOD schools, work closely with installation
commanders to maximize the availability to service members while
ensuring CDC and school environments strictly adhere to COVID-19
protocols. Since January 2021, at least one child development center at
each installation has remained open. As of 29 April 2021, child
development centers are operating at 77 percent of the pre-COVID
capacity; capacity is improving each week. The Department continues to
monitor installation child development program capacity.
__________
Questions Submitted by Senator Richard Blumenthal
current outbreaks among military personnel
29. Senator Blumenthal. Mr. Salesses, underway ships continue to
present an unusual challenge as the Department of Defense adapts to the
pandemic environment, and I understand the USS Theodore Roosevelt is
experiencing another outbreak. How is the Department of Defense
addressing the specific challenges of underway ships?
Mr. Salesses. In addition to implementing health protection
measures recommended by the Centers for Disease Control and Prevention
(CDC), the Department has implemented numerous measures to protect the
health of the Force from the risk of coronavirus disease 2019 (COVID-
19), including: force health protection guidance to mitigate the risk
of contracting or spreading COVID-19 (e.g., face coverings and masks,
social distancing, restriction of movement, and travel restrictions);
giving commanders the authorities they need to make necessary decisions
and take necessary precautions to protect their Service members because
the effects of COVID-19 are unique to every situation and every
location; pre-deployment screening; excluding personnel from deployment
in accordance with CDC guidance (e.g., symptomatic personnel and
asymptomatic personnel with potential exposure to COVID-19); testing
and contact tracing; and implementing sentinel surveillance programs in
coordination with the Department of Defense's (DOD's) influenza
sentinel surveillance program, along with serologic surveillance
through DOD's HIV testing program; and a tiered vaccination
administration schema that follows CDC guidance for determining
priority groups, modified for unique DOD requirements.
Based on lessons learned, the Navy has also issued standardized
operational guidance, providing data-driven risk mitigation measures
for commanders to use to increase the probability of a COVID-19-free
and mission-ready crew.
vaccinating active duty personnel
30. Senator Blumenthal. Mr. Salesses, how is the Department
ensuring the delivery of COVID-19 vaccines to all military
installations and assets, including underway ships, so that any
military personnel who want a vaccine can get one?
Mr. Salesses. The Secretary of Defense authorized the Department,
subject to any guidance issued by the President, to provide vaccines to
servicemembers and other eligible DOD health care beneficiaries, as
well as selected other-than-U.S. Forces (OTUSF) populations, such as
DOD civilian employees and specified contractor employees.
DOD is in the expanded distribution phase of the vaccine
prioritization schema, with vaccine administration occurring at 332
locations worldwide. Due to less demanding supply chain and storage
requirements for the Moderna vaccine, only the Moderna vaccine is being
used at sites outside the United States.
As of February 25, 2021, DOD had ordered 1,326,205 vaccine doses
(669,825 doses of the Pfizer vaccine and 656,200 doses of the Moderna
vaccine). Of the doses ordered, 1,187,625 have been delivered to DOD
and 1,087,625 have been administered by DOD.
31. Senator Blumenthal. Mr. Salesses, how is the Department
prioritizing Active Duty personnel to ensure that all of our
servicemembers are given the opportunity to get vaccinated as soon as
possible?
Mr. Salesses. The DOD population tiers are established in the DOD
vaccine prioritization schema, available at https://www.defense.gov/
Portals/1/Spotlight/2020/coronavirus/vaccine-availability/Schema-Mar-
2021.pdf, and as indicated below:
Tier 1a--All healthcare providers, healthcare support personnel,
and emergency services and public safety personnel; healthcare and
support personnel at Military Medical Treatment Facility outpatient
clinics and ambulatory care facilities; and military, civilian, and
contractor personnel, students, and other hospital non-clinical staff
authorized to receive vaccinations from DOD and who support patient
care and are at heightened rise of exposure to individuals who have
contracted COVID-19.
Tier 1b--Critical national capabilities; personnel forward-deployed
to austere environments; personnel preparing to deploy to locations
outside the United States; authorized persons 75 years of age or older;
and frontline essential workers.
Tier 1c--All persons aged 65 years through 74 years-old; Persons16
years-old through 64 years-old who are at increased risk for severe
illness as defined by CDC; Persons deployed or on temporary duty travel
for more than 30 days outside of the United States; and essential
workers not previously included in Tiers 1a or 1b.
Tier 2--All persons aged 16 years or older not previously
identified for vaccination.
32. Senator Blumenthal. Mr. Salesses, what are the ``tiers'' of
Active Duty personnel and their prioritization for COVID-19
vaccination?
Mr. Salesses. Please refer to the response to question #31 for a
description of the DOD population tiers.
33. Senator Blumenthal. Mr. Salesses, how many Active Duty
personnel have been vaccinated in each tier?
Mr. Salesses. As of February 25, 2021, the total numbers of
eligible individuals (including active duty personnel) who have been
vaccinated are as follows:
Tier 1a/1b: 578,951 (50.5 percent of eligible personnel)
Tier 1c: 299,843 (24.4 percent of eligible personnel)
Tier 2: 1,207,475 (26.4 percent of eligible personnel)
34. Senator Blumenthal. Mr. Salesses, what tiers have yet to be
vaccinated and when will they be given the opportunity to get the
vaccine?
Mr. Salesses. Personnel in all tiers have been vaccinated. As of
February 25, 2021, the total numbers of eligible individuals (including
active duty personnel) who have been vaccinated are as follows:
Uniformed personnel in Tier 1a/1b (578,951), Tier 1c
(299,843), and Tier 2 (1,207,475) were vaccinated.
DOD civilian/contractor personnel in Tier 1a/1b
(243,155), Tier 1c (15,322), and Tier 2 (1,115,702) were vaccinated.
Other eligible personnel in Tier 1a/1b (324,164), Tier 1c
(913,290), and Tier 2 (2,246,508) were vaccinated.
department of defense support for covid-19 vaccine distribution
35. Senator Blumenthal. General Perna, what are you doing to ensure
that vaccine distribution to States is predictable, so that they can
adequately plan for first and second doses of the vaccine, where
applicable?
General Perna. Predictability of vaccine distribution primarily
comes from standardizing the timing of vaccine allocation and ordering
cap increase cadence. This cadence reflects the timing of when
allocations will be entered in Tiberius each week, and when ordering
cap increases will occur thereby enabling jurisdictions, federal
entities, Federal Emergency Management Agency (FEMA), Health Resources
and Services Administration (HRSA), and federal retail pharmacy
programs to place orders in the Center for Disease Control (CDC)
Vaccine Tracking System (VTrckS). This cadence accounts for increases
for first and second doses separately for awardees to clearly
understand when each dose ordering cap increase will occur. The
operation monitors the effect the cadence has on ordering and
deliveries and adjust it periodically as necessary. Lastly, on a weekly
basis we provide projected allocations covering a three-week period for
jurisdictions to plan with.
36. Senator Blumenthal. General Perna, how are you communicating
with States on the delivery of vaccine doses, to ensure they are
prepared to receive and administer the vaccines?
General Perna. The operation utilizes a variety of methods to
provide key updates on weekly allocations to jurisdictions. Vaccine
doses are only shipped to provider locations based upon orders entered
into VTrckS which have been validated by the jurisdictions. Unordered
vaccine doses are not shipped to jurisdictions. E-mails, generated by
Pfizer and our central distributor McKesson, are sent to receiving
locations as the orders are packed and shipped from the distribution
centers. These e-mail notifications contain the carrier tracking
information for the shipments, which deliver within 24 hours the vast
majority of the time.
37. Senator Blumenthal. General Perna, what measures are you taking
to be prepared to distribute any vaccine candidates that are approved
in the future?
General Perna. The operation began preparation to distribute any
OWS-related vaccine candidate that may receive FDA approval when the
CDC established the central distribution contract with McKesson. This
contract accounts for potential distribution of all remaining types and
potential quantities of the remaining vaccine candidates. The operation
continues to take other prudent steps leading up to submission for EUA
of those vaccine candidates, including conducting mock bulk product
shipments from manufacturing locations to our central distribution
locations, and end-to-end ordering tests to ensure our ability to call
forward product into our central distribution network.
38. Senator Blumenthal. General Perna, how is the Department
supporting and expanding the number of entities that are distributing
vaccines, such as local pharmacies?
General Perna. The federal retail pharmacy program (FRPP) which
launched on November 12, 2021 operationalizes 21 national pharmacy
partners and networks of independent pharmacies with over 50,000 brick-
and-mortar locations across the nation. As of March 16, 2021,
approximately 14M doses to over 17,000 retail pharmacy stores have been
delivered through the FRPP. The program will continue to expand as
additional doses become available.
global cooperation
39. Senator Blumenthal. General Perna, has the Department and
broader government effort been cooperating with any global partners or
consulting international researchers in the continued efforts to get
vaccinations to the American people?
General Perna. The operation has been cooperating with global
partners since the beginning, most notably the United Kingdom and
Mexico in order to share mutual progress in vaccine development and
lessons learned. Mexico and South Africa are also included in some of
our clinical trials. We defer to the Department of Defense on Military
cooperation efforts and the Department of State, United States Agency
for International Development (USAID) and the National Security Council
(NSC) on broader government international cooperative efforts.
40. Senator Blumenthal. General Perna, what adjustments has the
Federal Government made to respond to the emergence of various new
strains of COVID-19?
General Perna. The Federal Government is working with our vaccine
partners to develop vaccines and therapeutics to prevent or treat
infections caused by variant strains. Several of our vaccine partners
are already testing booster and/or bivalent candidates that contain
Messenger RNA (mRNA), Deoxyribonucleic acid (DNA), or protein from
variant strains, including the strains from the United Kingdom and
South Africa. In fact, Moderna and National Institute of Allergy and
Infectious Diseases (NIAID) announced on March 10, 2021 that they have
dosed the first participants in its clinical trial to evaluate a
variant booster as well as a multivalent booster that contains both the
original vaccine and the variant candidate.
The Federal Government also established the SARS-CoV-2 Interagency
Working Group (SIG) that is tasked with coordinating the response to
emerging SARS-CoV-2 variant viruses. The SIG is comprised of experts
from NIAID, Office of the Assistant Secretary Preparedness and Response
(ASPR), Biomedical Advanced Research and Development Authority (BARDA),
and CDC who use global surveillance, bioinformatics and modeling,
immune assays, and preclinical and clinical studies to define variants
of concern and provide recommendations for mitigation.
defense industrial base challenges
41. Senator Blumenthal. Ms. Cummings, how is the Department of
Defense supporting the smaller subcontractors that are critical to the
defense industrial base throughout the pandemic?
Ms. Cummings. Since the onset of the COVID-19 pandemic, the DOD has
acted swiftly and decisively to increase cash flow to the Defense
Industrial Base (DIB) to ensure its economic viability and ability to
continue to support the Department's mission in the short- and long-
term.
On March 20, 2020, DOD issued Class Deviation 2020-0010 to increase
the progress payment rates in the Defense Federal Acquisition
Regulation Supplement (DFARS) to 90 percent for large business concerns
and 95 percent for small business concerns. This action addressed the
number one critical issue the DIB identified which was liquidity or
cash flow to prime contractors and down through their supply chain
which includes small businesses.
By doing so, the DOD has enabled the DIB as part of the United
States' critical infrastructure, to continue operating throughout this
national emergency. The major primes have committed to promptly flowing
payments received to suppliers, and in many cases, use their company
funds to assist financial at risk suppliers. Also, the major primes are
in regular communication with their suppliers, to include small
businesses, to monitor financial issues and needs.
As of January 31, 2021, this action has infused an estimated $4.6
billion in cash to all levels of the DIB.
DOD also shared resources and information specific to small
businesses from the U.S. Small Business Administration (SBA) with its
stakeholders, such as:
The SBA website, which is designed to support small businesses
during the pandemic.
SBA's Disaster Assistance in Response to COVID-19: The
Economic Injury Disaster Loan (EIDL) process for economic support,
which includes contact information for the SBA's Disaster Assistance
Customer Service Center.
SBA's Small Business Guidance and Loan Resources related
to COVID-19 webpage, which provides information on topics such as the
Economic Injury Disaster Loan (EIDL) Program, Guidance for Businesses
and Employers, SBA Products and Resources, Government Contracting, and
Local Assistance.
SBA's Disaster Loan Assistance Program describing which
disaster areas were eligible, the application process, and how to check
application status.
The Paycheck Protection Program (PPP): A loan designed to
provide a direct incentive for small businesses affected by the COVID-
19 pandemic to keep their workers on the payroll.
SBA's Federal Contracting Guidance for Small Businesses
Impacted by COVID-19, which addresses COVID-19 contracting
opportunities for small businesses, under a current Federal contract,
experiencing difficulties related to the COVID-19 pandemic and program
flexibilities during COVID-19.
__________
Questions Submitted by Senator Mazie Hirono
challenges related to distribution of vaccines
42. Senator Hirono. General Perna, individual states are leading on
vaccine distribution and administration efforts at the local level.
What efforts is the Federal Government taking to share the lessons
learned and best practices of each state to increase efficiency across
the entire country?
General Perna. The operation works closely with jurisdictions,
federal entities, and various stakeholders to identify lessons learned
and share best practices. These matters are discussed in a variety of
forums including weekly regional discussions, CDC-hosted ``office
hours'' that focus on specific topics of interest such as distribution,
immunization information systems and all awardees calls with state,
local, and tribal health officials. These forums offer the opportunity
to provide key updates, solicit feedback, share best practices with all
jurisdictions and federal entities. Moreover, the operation, continues
to work closely with the CDC and Department of Health and Human
Services (HHS) - to ensure the successful distribution of safe and
effective vaccines to the American public.
supply chain challenges
43. Senator Hirono. Ms. Cummings, last year, former Secretary Ellen
Lord said that she expected the largest Department of Defense
acquisition programs to see 3-month delays due to the impact of COVID-
19. Which specific acquisition programs have been impacted by supply
chain delays?
Ms. Cummings. The following list provides the 16 Major Defense
Acquisition Programs (MDAPs) that have experienced a delay of 3 or more
months due to the COVID-19 pandemic (March 2020 to March 2021). Of the
16 MDAPs below, 5 have fully recovered.
Background:
COVID-19 impacts against MDAPs from March 2020 to March 2021
COVID-19 Delays--5 MDAPs experienced a 3-month delay but have
recovered (Name, Delay (Months)):
------------------------------------------------------------------------
MDAP Months Delayed
------------------------------------------------------------------------
Common Infrared Countermeasure 3
------------------------------------------------------------------------
DDG 1000 Zumwalt-class Destroyer* 6
------------------------------------------------------------------------
Guided Multiple Launch Rocket System/Guided 3
Multiple Launch Rocket System Alternative
Warhead
------------------------------------------------------------------------
Military Global Positioning System (GPS) User 6
Equipment Inc. 1
------------------------------------------------------------------------
Trident II (D-5) Sea-Launched Ballistic 5
Missile UGM 133A**
------------------------------------------------------------------------
*DCMA administers only a portion of the DDG 1000 program and has
stopped reporting as of March 2021.
**Only the Fire Control and Navigation Segments of the TRIDENT II
Missile program have experienced delays.
Current COVID-19 Delays (As of 19 March 2021) - Eleven (11) MDAPs
are experiencing a three (3) or more month delay (Name, Delay
(Months)):
------------------------------------------------------------------------
MDAP Months Delayed
------------------------------------------------------------------------
AH-64E New Build 9
------------------------------------------------------------------------
AH-64E Remanufacture 7
------------------------------------------------------------------------
Armored Multi-Purpose Vehicle (AMPV)*** 5
------------------------------------------------------------------------
AWACS BLK 40/45 Upgrade 3
------------------------------------------------------------------------
F-35 3
------------------------------------------------------------------------
Infrared Search and Track (IRST) 3
------------------------------------------------------------------------
Improved Turbine Engine Program (ITEP) 3
------------------------------------------------------------------------
MQ-25 Stingray 6
------------------------------------------------------------------------
Next Generation Operational Control System 6
(OCX)
------------------------------------------------------------------------
SM-6 Missile 8
------------------------------------------------------------------------
Weather System Follow-on (WFS) 3.4
------------------------------------------------------------------------
*** The contractor has identified a 3 to 5-month COVID delay, but DCMA
believes most of this delay is due to pre-COVID issues.
44. Senator Hirono. Ms. Cummings, what actions are you taking to
support small businesses in the defense industrial base as they face
short term and long term impacts of COVID-19?
Ms. Cummings. Since the onset of the COVID-19 pandemic, the DOD has
acted swiftly and decisively to increase cash flow to the Defense
Industrial Base (DIB) to insure its economic viability and ability to
continue to support the Department's mission in the short- and long-
term.
On March 20, 2020, DOD issued Class Deviation 2020-0010 to increase
the progress payment rates in the Defense Federal Acquisition
Regulation Supplement (DFARS) to 90 percent for large business concerns
and 95 percent for small business concerns. This action addressed the
number one critical issue the DIB identified which was liquidity or
cash flow to prime contractors and down through their supply chain
which includes small businesses.
By doing so, the DOD has enabled the DIB as part of the United
States' critical infrastructure, to continue operating throughout this
national emergency. The major primes have committed to promptly flowing
payments received to suppliers, and in many cases, use their company
funds to assist financial at risk suppliers. Also, the major primes are
in regular communication with their suppliers, to include small
businesses, to monitor financial issues and needs.
As of January 31, 2021, this action has infused an estimated $4
billion in cash to all levels of the DIB.
DOD also shared resources and information specific to small
businesses from the U.S. Small Business Administration (SBA) with its
stakeholders, such as:
The SBA website, which is designed to support small
businesses during the pandemic.
SBA's Disaster Assistance in Response to COVID-19: the
Economic Injury Disaster Loan (EIDL) process for economic support,
which includes contact information for the SBA's Disaster Assistance
Customer Service Center.
SBA's Small Business Guidance and Loan Resources related
to COVID-19 webpage, which provides information on topics such as the
Economic Injury Disaster Loan (EIDL) Program, Guidance for Businesses
and Employers, SBA Products and Resources, Government Contracting, and
Local Assistance.
SBA's Disaster Loan Assistance Program describing which
disaster areas were eligible, the application process, and how to check
application status.
The Paycheck Protection Program (PPP): A loan designed to
provide a direct incentive for small businesses affected by the COVID-
19 pandemic to keep their workers on the payroll.
SBA's Federal Contracting Guidance for Small Businesses
Impacted by COVID-19, which addresses COVID-19 contracting
opportunities for small businesses, under a current Federal contract,
experiencing difficulties related to the COVID-19 pandemic and program
flexibilities during COVID-19.
__________
Questions Submitted by Senator Joe Manchin III
national guard covid support
45. Senator Manchin. General Perna, is there sufficient manpower
deployed to allow us to support COVID response to every State and
Territory as requested with the recent increase in vaccine production?
General Perna. The Department of Health and Human Services (HHS) is
the lead Federal agency, and the Federal Emergency Management Agency
(FEMA) is the lead Federal coordinating agency, for the whole-of-nation
response to the COVID-19 pandemic. DOD continues to work closely with
HHS and FEMA to ensure that DOD is providing the capabilities and
resources necessary to help our nation in its fight against the COVID-
19 pandemic.
46. Senator Manchin. General Perna, how do our States make it known
to you that they need additional support?
General Perna. Consistent with the National Response Framework,
States and territories identify their support needs to FEMA.
47. Senator Manchin. General Perna, at what point is the Guard
manpower overtaxed if there were a simultaneous threat that required
their employment while continuing to support their current COVID
mission?
General Perna. National Guard support in the whole-of-nation COVID-
19 response has been voluntary for the Service members and requires the
consent of applicable State governors. State governors have managed the
use of their National Guard forces to support the whole-of-nation
COVID-19 response and responses to another 48 major disasters (e.g..,
fires, hurricanes, floods, severe storms, and tornados) without
overtaxing National Guard manpower.
throwing politics out of our response
48. Senator Manchin. General Perna, Ms. Cummings, Mr. Salesses,
what has been the largest issues you've dealt with in responding to the
pandemic?
General Perna. The most pressing issues that the operation has
faced during the pandemic included: 1) supply chain vulnerabilities for
raw materials, specialized equipment, and consumables, 2) changing
epidemiology impacted conduct of the Phase 3 clinical trials; and 3)
difficult recruitment of sufficient experienced manufacturing personnel
due to the rapid expansion of domestic manufacturing capacity.
Ms. Cummings. At the beginning of the pandemic, the DOD acquisition
workforce did not have strategic relationships with the acquisition
communities at HHS and the Federal Emergency Management Agency.
Building these partnerships required a significant time and labor
investment. In response to this challenge, we have created a permanent
office within the DOD, the Defense Assisted Acquisition Cell (DA2), to
proactively maintain relationships across the executive branch so that
we are prepared to quickly respond to the Nation's future urgent
requirements. DA2 will coordinate future requests from the interagency
for Defense acquisition assistance and determine which acquisition
authorities and resources across the Military Departments, Services,
and Components are best suited to support the requests.
Mr. Salesses. The COVID-19 pandemic is the greatest public health
challenge our nation has faced in more than 100 years, since the 1918
influenza pandemic. Domestically, most disasters or emergencies either
affect a single State or region within the United States. In contrast,
COVID-19 not only affected the entire United States, but the entire
world. This created an unprecedented demand signal for DOD support.
The response to the COVID-19 pandemic, like most disaster or
emergency responses, focuses principally on saving and sustaining
lives; however, most responses are carried out in the aftermath of a
disaster or emergency, whereas the COVID-19 pandemic is ongoing and
evolving.
Unlike most typical disasters and emergencies, even as DOD supports
the whole-of-nation response to COVID-19, we also have to mitigate the
risks posed by this public health emergency to our people and our
ability to carry out our national defense missions.
49. Senator Manchin. General Perna, Ms. Cummings, Mr. Salesses,
what institutional changes does Congress need to make within our
Federal Agencies to prevent those issues in the future?
General Perna. Since the beginning of this pandemic, we have
learned where the nation has gaps in pandemic preparedness and
response. No organization was singularly structured to oversee a
national pandemic response from beginning to end. In order to inform
requirements for future pandemic response, a commission to examine
federal agencies' ability to operationalize the government response is
needed. For example, the Blue Ribbon Commission on Defense Management
known as the ``Packard Commission'' led to the Goldwater Nichols
Defense Reorganization Act of 1986 setting forth extensive reforms
within the Department.
Ms. Cummings. DOD is collecting lessons-learned across the
Department to institutionalize the best-practices from COVID-19
response. This work will remain a continuous learning and improvement
process as opportunities are identified.
Mr. Salesses. As the pandemic is still ongoing, I recommend we
remain focused on the whole-of-nation response to save and sustain
lives. When the risk of the pandemic has passed, or sufficiently
diminished, a data-driven and comprehensive after-action review may
identify important institutional changes, some of which may require the
assistance of Congress.
vaccine doses
50. Senator Manchin. General Perna, Ms. Cummings, how are you
ensuring that states can accurately plan for vaccine clinics when the
Pfizer vial unreliably provides 6 doses?
General Perna. Since January 19, 2021, federally funded ancillary
kits shipped to the jurisdictions and federal entities are equipped
with 80 percent Low Dead Volume (LDV) and 20 percent standard syringes
to withdraw six doses of vaccine from every Pfizer vial. Jurisdictions
are also provided a five percent overage in every kit to account for
any possible contingency.
Ms. Cummings. I defer to Gen. Perna as the Chief Operating Officer
of the federal COVID-19 response for vaccine and therapeutics.
51. Senator Manchin. General Perna, Ms. Cummings, are you ensuring
all vials of Pfizer's vaccine are shipped with the correct syringe to
draw the extra dose?
General Perna. Yes. Refer to question #50.
Ms. Cummings. The White House COVID-19 Response Team/Operation Warp
Speed is the Federal government's lead on this effort, and I defer to
General Perna to provide a response.
lessons learned in procurement
52. Senator Manchin. Ms. Cummings, why has it taken us over a year
to get full capacity production with our industrial base in light of
enacting the Defense Production Act (DPA) which is supposed to provide
rapid and innovative solutions?
Ms. Cummings. The COVID-19 pandemic exposed a number of
shortcomings in U.S. supply chains for medical resources.
Over the course of many years, key portions of the medical
resources industrial base shifted overseas, following access to cheap
sources of labor, raw materials, and broader industry trends towards
globalized supply chains and logistics networks. This atrophy of the
medical resources industrial base is not that dissimilar to similar
trends in the defense industrial base.
With the onset of COVID-19, global markets underwent massive and
rapid change. Demand for healthcare goods and services skyrocketed
across the globe, and as many nations imposed limits on exports of
healthcare goods and travel, immediately-available global supply also
became severely constrained.
In response, major industrialized nations, including the United
State, initiated supply-side investments to increase production for
healthcare products (e.g., personal protective equipment). These
investments rippled up and across global supply chains, not only for
the raw materials consumed in the manufacture of healthcare products,
but also for engineering talent and industrial equipment to produce
these materials and assemble end items.
The Federal Government's activities under the Defense Production
Act entered into this hyper competitive marketplace from a standing
start. As such, it should be expected--however extremely painful--that
full industrial mobilization would not occur until several months after
the declaration of a national emergency.
53. Senator Manchin. Ms. Cummings, what actual steps is the
Department taking to change the institutionalized thought on
procurement to eliminate this lack of support to a dire and immediate
requirement?
Ms. Cummings. DOD is collecting lessons-learned across the
Department to institutionalize the best-practices from COVID-19
response (e.g., agile acquisition activities). This work will remain a
continuous learning and improvement process as opportunities are
identified.
defense production act
54. Senator Manchin. General Perna, Ms. Cummings, Mr. Salesses, are
you looking to utilize recently closed or closing domestic
manufacturing plants to increase the supply of medicines and medical
supplies through the DPA?
General Perna. Currently, the operation has no plans to utilize
closed or closing domestic plants for increasing supplies.
Ms. Cummings. DOD receives DPA requirements for health resources
from the Department of Health & Human Services (HHS). To the extent
that HHS determines that there is such a need and that action under DPA
is the most practical and expedient path to achieve the need, DOD has
the tools to fund investment in idle manufacturing plants to increase
supply.
Mr. Salesses. I defer to Ms. Cummings or General Perna.
55. Senator Manchin. General Perna, Ms. Cummings, Mr. Salesses, how
might a State contact you if they have a facility they feel could be
used under DPA authorities?
General Perna. States should contact the Office of the Assistant
Secretary for Preparedness and Response within Department of Health and
Human Services with any facility proposals.
Ms. Cummings. Information on our Defense Production Act programs is
available at the website for the Deputy Assistant Secretary of Defense
for Industrial Policy (https://www.businessdefense.gov/DPA-Title-III/
Contact/). This website also has additional resources for businesses
unique to COVID-19 response (additional resources for businesses unique
to COVID-19 response (additional resources for businesses unique to
COVID-19 response (
Mr. Salesses. I defer to Ms. Cummings.
johnson & johnson vaccine
56. Senator Manchin. General Perna, will considerations of this
vaccine's storage and dosage characteristics be taken into account when
selecting where it will be distributed?
General Perna. Vaccines regardless of manufacturer are allocated
equally to 64 jurisdictions and 5 federal entities based upon an
established pro-rata based formula. Distribution internal to a
jurisdiction or federal entities is done at the discretion of each
jurisdiction.
57. Senator Manchin. General Perna, can you tell me why
constituents in West Virginia should accept this vaccine when the
Moderna and Pfizer vaccines have efficacy rates near 94 percent vice 72
percent?
General Perna. I understand public health experts and scientists
uniformly agree that the best vaccine for anyone to get is the one they
can get first. While the efficacy rates for Pfizer, Moderna and Johnson
and Johnson vaccines vary, they are all equally effective against
severe illness, hospitalization and death, which is most crucial to us
all in surviving this pandemic.
__________
Questions Submitted by Senator Jacky Rosen
medical supply production
58. Senator Rosen. General Perna, Ms. Cummings, Mr. Salesses, it is
clear just how important it is to have a whole of government, national
strategy to combat the COVID-19 pandemic. The Defense Production Act
(DPA) is a critical tool the current administration has started to use
to combat the pandemic over the past month. The DPA is necessary not
only to ensure that we have the right supplies ready at the right time
and in the right locations, but also to give the stability needed for
our small manufacturers who want to adjust what they produce to help
the national effort. And the DPA also plays a direct role in supporting
our frontline health care workers. Hospitals in Nevada are still
operating under emergency conditions for personal protective equipment
(PPE) use due to supply shortages. I haven't heard of any that have
been able to return to pre-pandemic standards for use of N95 masks. Do
we have a clear understanding of domestic production and what is being
done within the Department of Defense to focus on research for next
generation PPE--including masks that are effective, more durable,
easier to sanitize for effective reuse, and more comfortable when worn
for longer periods of time?
General Perna. Defer to Mr. Salesses/Ms. Cummings
Ms. Cummings. Upon the introduction of the American Rescue Plan,
the Office of the Deputy Assistant Secretary of Defense (ODASD) for
Industrial Policy, which oversees and executes the DPA Title III
program, began acquisition planning for these funds with their
counterparts at the Department of Health & Human Services (HHS). DOD is
working with its counterparts at OMB, HHS, and the Air Force Executive
Agent Program Office (EAPO) to determine the most effective path,
consistent with the underlying appropriation and fiscal laws, to assist
HHS with the execution of these funds.
Mr. Salesses. I defer to Ms. Cummings.
59. Senator Rosen. General Perna, Ms. Cummings, Mr. Salesses, what
can you tell us about current Department of Defense (DOD) investment in
materials engineering for medical purposes and efforts to focus on
solutions for the current pandemic?
General Perna. Defer to Mr. Salesses/Ms. Cummings.
Ms. Cummings. DOD has deployed DPA investments and other HHS funds,
under the Economy Act, to support domestic production of fabrics,
rubber, and other raw materials necessary for the production of medical
resources to respond to COVID-19.
Mr. Salesses. I defer to Ms. Cummings.
60. Senator Rosen. General Perna, Ms. Cummings, Mr. Salesses,
getting vaccines out to our communities remains our number one priority
and absolutely critical. Is the DPA being used to ramp up equipment
needed to ensure the vaccine can reach our country's more remote rural
and frontier areas?
General Perna. The Defense Production Act (DPA) is not currently
being used for this purpose. We have no identified equipment
requirements in excess of what is already on-hand within jurisdictions
or available to them needed to reach remote and rural areas.
Ms. Cummings. Upon the introduction of the American Rescue Plan,
the Office of the Deputy Assistant Secretary of Defense (ODASD) for
Industrial Policy, which oversees and executes the DPA Title III
program, began acquisition planning for these funds with their
counterparts at the Department of Health & Human Services (HHS). DOD is
working with its counterparts at OMB, HHS, and the Air Force Executive
Agent Program Office (EAPO) to determine the most effective path,
consistent with the underlying appropriation and fiscal laws, to assist
HHS with the execution of these funds.
Mr. Salesses. I defer to Ms. Cummings and General Perna.
61. Senator Rosen. General Perna, Ms. Cummings, Mr. Salesses, some
towns in Nevada don't have health centers or even pharmacies. Do we
have enough mobile clinics, generators, and specialized freezers that
can transported, and how is the DPA being used to fill in these gaps?
General Perna. The Defense Production Act is not currently being
leveraged for mobile clinics, generators or specialized freezers.
Ms. Cummings. Upon the introduction of the American Rescue Plan,
the Office of the Deputy Assistant Secretary of Defense (ODASD) for
Industrial Policy, which oversees and executes the DPA Title III
program, began acquisition planning for these funds with their
counterparts at the Department of Health & Human Services (HHS). DOD is
working with its counterparts at OMB, HHS, and the Air Force Executive
Agent Program Office (EAPO) to determine the most effective path,
consistent with the underlying appropriation and fiscal laws, to assist
HHS with the execution of these funds.
Mr. Salesses. The Federal Government is providing support for
community vaccination centers, with Federal personnel on the ground at
community vaccination centers and mobile sites. The Federal Government
is also supporting mobile vaccination pop-up clinics in high-risk
communities, including in rural areas.
62. Senator Rosen. Ms. Cummings, as we work on vaccine
distribution, we must not forget about those who will still become
seriously ill in the meantime and need effective treatment. I'd like to
hear more about the use of the Defense Production Act as it relates to
ensuring all needed supplies and materials for not just vaccines but
also anticipated new therapeutics to ensure rapid deployment as they
become available. What materials need to be ramped up for therapeutics
that are different from vaccines?
Ms. Cummings. Upon the introduction of the American Rescue Plan,
the Office of the Deputy Assistant Secretary of Defense (ODASD) for
Industrial Policy, which oversees and executes the DPA Title III
program, began acquisition planning for these funds with their
counterparts at the Department of Health & Human Services (HHS). DOD is
working with its counterparts at OMB, HHS, and the Air Force Executive
Agent Program Office (EAPO) to determine the most effective path,
consistent with the underlying appropriation and fiscal laws, to assist
HHS with the execution of these funds.
Separate from the $10 billion, DOD is aware that the American
Rescue Plan also would appropriate even greater resources to HHS for
testing and contact tracing, vaccine manufacture and purchases, and
several other areas. DOD intends to coordinate its assisted acquisition
support to HHS, to ensure that there is complementarity in the
execution of American Rescue Plan Act funds.
medical and logistics personnel support
63. Senator Rosen. General Perna, Ms. Cummings, Mr. Salesses, the
support from DOD, and especially from our National Guard
servicemembers, has been absolutely critical to improving response to
the pandemic on the ground. In Nevada, we have a significant shortage
of medical providers and the National Guard has been helping to fill in
with pandemic response. In 2020, the Nevada Guard provided support for
administering over a million COVID tests, delivered nearly 15 million
critical PPE items, and brought nearly 3 million meals to families in
need. They are currently playing a critical role in getting Nevadans
vaccinated. We will continue to have a need for support from the
Department of Defense for both logistics and personnel. As members of
the military and their families get vaccinated, once military
installations are covered, are there plans to leverage the capacity of
the staff on base to help with vaccination clinics in the communities
where they are located?
General Perna. Defer to Mr. Salesses/Ms. Cummings.
Ms. Cummings. As the staffing of the Department's vaccination
support efforts is outside of my jurisdiction, I defer to the Office of
Personnel & Readiness/Defense Health Agency to discuss any future
community support plans.
Mr. Salesses. DOD provides support to our nation's fight against
the COVID-19 pandemic based on the requests of lead Federal agencies
such as FEMA, consistent with the law and mindful of DOD's own mission
requirements.
DOD is fully supporting FEMA-led community vaccination centers and
mobile sites. DOD continues to work closely with FEMA to ensure that
States receive the Federal assistance they require.
64. Senator Rosen. Mr. Salesses, the pandemic has deepened already
significant medical workforce shortages in Nevada and around the
country. The University of Nevada, Las Vegas School of Medicine has a
strong partnership with Nellis Air Force Base to train physicians
through a residency program. We have a dire need for increasing our
medical workforce--from medical assistants on up, and a significant
need for getting people impacted by the pandemic economically back into
good paying jobs, which may require some retraining. Can you speak
about how else partnerships between DOD facilities and civilian
institutions could be strengthened and leveraged to rapidly train a
workforce--including EMTs, medics, and technicians able to administer
vaccines--to meet the current and projected needs of the pandemic?
Mr. Salesses. The primary objective of DOD's partnerships with
civilian hospitals is to ensure the operational readiness of DOD
medical personnel. These programs give DOD medical personnel the
opportunity to maintain proficiency and sustain their medical skills by
working alongside civilian counterparts. DOD also has a number of
programs focused on training and educating the future DOD workforce.
Leveraging Reserve Component medical personnel is one potential
approach to meeting both DOD's requirements and civilian community
needs.
cybersecurity at the department of defense during the covid-19 pandemic
65. Senator Rosen. Mr. Salesses, DOD, like so many other employers,
has undergone a dramatic shift to telework due to the COVID-19
pandemic. As a former computer programmer and systems analyst, I
understand what an enormous and complex undertaking it is for the
Department to make this transition. In the capital region alone, DOD
has directed 60 percent of the Pentagon workforce to telework. While
DOD succeeded in rapidly activating employee accounts on its remote
work system, we know that malicious cyber actors are exploiting
vulnerabilities in both government and private sector networks
resulting from the transition to remote work. Without the proper
cybersecurity measures, the DOD workforce and networks are at a greater
risk of cyberattacks. What specific cybersecurity measures and cyber
hygiene protocols has DOD put in place to protect DOD personnel, data,
and our national security throughout the past year as you have shifted
to an increased telework posture, what gaps remain, and how can
Congress best support you and your mission?
Mr. Salesses. To mitigate the increased cybersecurity risk
associated with the expanded telework environment, DOD: issued
government-furnished mobile devices to conduct unclassified and
classified telework; expanded secure video-conferencing services; and
increased safe file sharing with milDrive and DOD Secure Access File
Exchange (SAFE) - two cloud-based solutions that permit secure and
convenient access to large files from diverse locations. DOD also
increased virtual private network capacity to protect communications.
DOD introduced the Commercial Virtual Remote (CVR) environment, which
augmented Microsoft's Teams capability with DOD-specific security
controls to support the greatly increased remote workforce securely. In
June, DOD will transition from CVR to the Defense Enterprise Office
Solution, which will be hosted in an impact level five environment to
harden further DOD's cyber-attack surface from adversaries. The move to
telework is accelerating DOD's move to micro-segmentation and zero
trust. DOD also published multiple guides to highlight, for its users,
cybersecurity best practices in the telework environment.
DOD appreciates Congress's continued support of our remote
teleworking workforce, which is contributing to DOD's ability to carry
out DOD's critical missions. DOD will continue to keep you apprised if
additional support from Congress is needed.
66. Senator Rosen. General Perna, how is DOD working to protect its
cyber networks and assets, particularly as they relate to COVID-19
testing and vaccination efforts?
General Perna. (CUI) In support of the cybersecurity pillar of the
Federal COVID Response Security and Assurance line of effort, DOD,
primarily through our DOD cyber partners, conducts activities pursuant
to the authorities assigned to it under E.O. 12333, Sec 1.7(c) (and
related policies and procedures). First, DOD defends its own networks,
systems, and information from malicious cyber activity and is prepared
to defend, when directed, those networks and systems operated by non-
DOD Defense Critical Infrastructure (DCI) and Defense Industrial Base
(DIB) entities which include organizations mobilized to support DOD-
affiliated COVID-19 testing and vaccination efforts. Second, DOD works
to preempt, defeat, or deter malicious cyber activity targeting U.S.
critical infrastructure that could cause a significant cyber incident
regardless of whether that incident would impact DOD's warfighting
readiness or capability, such as in the healthcare and public health
sectors. Third, DOD works with U.S. allies and partners to strengthen
cyber capacity and increase bi-directional information sharing in order
to advance our mutual interests including combatting COVID-19.
67. Senator Rosen. General Perna, specifically, how is the Defense
Health Agency ensuring COVID-19 testing and vaccination data among DOD
personnel are secure?
General Perna. The electronic health record and medical readiness
systems documenting testing and vaccination data of DOD personnel are
subject to rigorous, standardized security policies. The DHA workforce
is required to operate in compliance with those policies and their
corresponding procedures to ensure personally identifiable information
(PII) and protected health information.
(PHI) is safeguarded and available only to those with a verified
need to know. Protections in place to secure electronic healthcare data
of DOD personnel, including COVID-19 testing and vaccination data,
include use of multi-factor authentication (i.e., common access card
and complex password) to access MHS clinical work stations; configuring
systems to lock automatically to prevent unauthorized access;
encryption of PII and PHI being transmitted between systems; limiting
access to PII and PHI through management and annual verification of
user access and privileges for clinical information systems; and
routine reviews of clinical information system user activity logs.
Further, these clinical information systems are routinely scanned for
system vulnerabilities and patched as needed in accordance with
requirements of DODI 8510.01, Risk Management Framework.
68. General Perna, how is DOD collaborating with the Cybersecurity
and Infrastructure Security Agency, or CISA, to ensure the
cybersecurity of COVID-19 vaccine distribution and logistical
considerations?
General Perna. (CUI) The Cybersecurity and Infrastructure Security
Agency (CISA) has been an integral partner in our Security and
Assurance line of effort. DOD coordinates and deconflicts on
cybersecurity with several interagency partners including FBI, DHS
CISA, HHS. These activities include providing indications and warnings
via standard dissemination channels of foreign cyber threat actors
planning or executing malicious cyber activities against entities
critical to the U.S. Government's COVID-19 response efforts. This
assistance comes in the form of finished intelligence reports and
threat briefings to customers supporting Federal COVID Response across
DOD, HHS, and other USG departments and agencies. DOD's interagency
partners, CISA and the FBI, then leverage this information under their
respective authorities to provide guidance and support directly to
elements of the private sector, including healthcare. CISA uses the
information to publish advisories and alerts to stakeholders and deploy
a variety of services to increase awareness and monitoring
capabilities.
__________
Questions Submitted by Senator Tom Cotton
commercial solutions support
69. Senator Cotton. Ms. Cummings, the Department of Defense (DOD)
held several recent commercial solutions opportunities (CSO)
competitions to support the manufacturing scale-up for diagnostics and
other COVID-related industries. Awards seem to have been concentrated
on a small handful of companies receiving $100 million plus awards. Can
you explain the funding award decision-making process for the recent
CSOs the DOD has executed to support manufacturing scale-up for
critical biomedical industries?
Ms. Cummings. To date, 12 companies have been awarded contracts
through CSO competitions. Of the 12, only one received an award in
excess of $100 million. The other 11 awards ranged between $3.5 million
and $32.7 million. In the coming months, we anticipate awarding up to
an additional 10 contracts, all being competitive contracts with the
majority being less than $100 million.
Although DOD has executed contracts on behalf of HHS, HHS
determines the health and medical resource requirements sought through
the competitions and makes the award decisions for company submissions
to the CSOs. These requirements support the overall national response,
which HHS takes into consideration when selecting efforts that will
support increasing the overall national capacity of critical health and
medical resources.
70. Senator Cotton. Ms. Cummings, what avenues do small-to-medium
sized companies have to compete for manufacturing support of critical
COVID-related biomedical products?
Ms. Cummings. Existing avenues for small- to medium-sized companies
to compete for manufacturing support of critical COVID-related
biomedical products are through set asides for small businesses when
market research shows that two or more small businesses are capable of
fulfilling a requirement or based on capabilities of small businesses
or other than small businesses.
During the pandemic response, the Defense Logistics Agency (DLA)
and DOD identified opportunities to increase and maximize the
participation of domestic firms that can supply personal protective
equipment (PPE). DOD hosted PPE information days that brought together
more than 500 domestic PPE producers, suppliers, and key consumers. In
addition, across the U.S. government, two-thirds of all fiscal year
2020 COVID-19 related funding went to medical Research and Development,
parts of which went to two small companies, vaccine manufacturer
Moderna and Richmond-based Phlow Corp., for generic medicines and
pharmaceutical ingredients. The second largest category by obligation
was PPE.
DLA also developed ``tiered'' acquisition strategies, which
established an order of preference for PPE sourcing (from fully
domestic sources, to semi-domestic sources, to foreign sources as a
last resort). This tiered acquisition strategy supports the entire
domestic industrial base, including small-to medium-sized businesses,
and allows companies with partial domestic supply chains to bridge the
current supply gap for domestic PPE.
In addition, small-to medium-sized companies may also compete for
Defense Production Act (DPA) Title III funds through the DPA Title III
Program's Funding Opportunity Announcement (FOA), which is posted on
beta.sam.gov and links to the Program website (https://
www.businessdefense.gov/Programs/DPA-Title-III/). The DPA Title III FOA
allows industry to submit white papers through the open FOA, as well as
for government to issue requests for proposals through the FOA with
Calls. The FOA also provides industry with information on expected
project deliverables, eligibility, white paper or proposal submission
requirements, and general evaluation criteria. The FOA was utilized by
both medical and DIB companies throughout the execution of the CARES
Act appropriated funds. Approximately 40 percent of CARES Act
appropriated funds went to small businesses.
When Congress passed the CARES Act, DOD worked closely with
Executive and Legislative Branch stakeholders to utilize the special
authorities granted in the legislation to balance the needs of both the
medical care community and the Defense Industrial Base (DIB) impacted
by COVID. Those Congressional authorities enabled DOD to support
production of essential medical items and investments in capacity
expansion for the medical industry.
Following initial investment, DOD, in coordination with the
Department of Health and Human Services (HHS) and the Federal Emergency
Management Agency (FEMA) leveraged the DPA Title III funds to mitigate
adverse COVID impacts to the DIB. DOD was able to provide vital
contracting support to expand domestic production of medical resources,
leveraging HHS funding that Congress had provided for the purpose.
Those medical resources included drugs and biologicals, surgical
instruments, equipment and supplies, hospital and surgical clothing,
related special purpose items and other product service code items. As
of March 15, 2021, DOD COVID-19 obligations in the medical category was
$17.7 billion, of which $7.1 billion went to small businesses.
Finally, as of today, the DOD has expended approximately $22.29
billion to help support the federal COVID-19 response, with $8.77
billion, or roughly 39.37 percent, flowing to small businesses. $16.8
billion of those funds have been expended on medical-related supplies,
with $7.1 billion, or roughly 42.26 percent, going to small businesses.
71. Senator Cotton. Ms. Cummings, can you please provide for the
record a list of awards, including dollar amount and recipient,
executed by the DOD to support the COVID-related supply chains since
March 2020?
Ms. Cummings. From March 13, 2020, through March 8, 2021, the
Department awarded 29,647 new contracts, other transaction agreements,
and financial assistance awards in support of COVID-19 to 2,506
recipients, totaling over $47 billion in value. These awards,
summarized in the table below, do not include modifications to existing
contracts. A summary of the award count and dollar amounts by recipient
can be found in the attached file labeled QFR71 Atch-COVID Recipient
Summary for 13Mar20-08Mar21.
----------------------------------------------------------------------------------------------------------------
Number of New Number of
Awards Total $ Value Total Obligations Recipients
----------------------------------------------------------------------------------------------------------------
Contracts 29,444 42,309,969,868 $22,303,221,686 2,316
----------------------------------------------------------------------------------------------------------------
Other Transactions 119 $3,634,383,554 $3,990,328,535 112
----------------------------------------------------------------------------------------------------------------
Financial Assistance 84 $1,331,814,390 $1,230,773,710 78
----------------------------------------------------------------------------------------------------------------
Total New Awards 29,647 $47,276,167,812 $27,524,323,931 2,506
----------------------------------------------------------------------------------------------------------------
__________
Questions Submitted by Senator Thom Tillis
military readiness
72. Senator Tillis. Mr. Salesses, when examining and responding to
requests for assistance (RFAs) during the COVID-19 response, to what
extent have you factored impacts on readiness and training?
Mr. Salesses. One of the six factors DOD uses when considering
requests for assistance is ``readiness''; specifically, what impact
will providing the requested support have on the Department of
Defense's ability to perform its other primary missions.
department of defense reimbursement
73. Senator Tillis. General Perna, Ms. Cummings, Mr. Salesses, how
have decisions been made regarding reimbursement of the support that
the Department of Defense has provided to civil authorities?
General Perna. Defer to Mr. Salesses/Ms. Cummings.
Ms. Cummings. During the COVID-19 response, DOD has leveraged the
Economy Act to transfer funds from HHS to DOD for contract award and
administration. DOD expects reimbursement of $46.3 million in
acquisition support for past awards and efforts currently in-process,
$20.2 million of which has been reimbursed as of April 7, 2021.
Mr. Salesses. Decisions have been made in compliance with the law.
DOD support provided pursuant to the Stafford Act or the Economy Act is
provided on a reimbursable basis.
74. Senator Tillis. General Perna, Ms. Cummings, Mr. Salesses, has
there been any change under the Biden administration versus the Trump
administration?
General Perna. Since mid-January the operation has expanded the
network of federally supported administration sites and began working
closely with FEMA and Federally Qualified Health Centers (FQHCs).
Ms. Cummings. There have not been changes to the reimbursement
policy under the Biden administration.
Mr. Salesses. Perhaps the most important change is Federal
Government support for community vaccination centers, mobile sites, and
mobile vaccination pop-up clinics, which is increasing the rate of
vaccination dramatically.
department of defense supply chain management
75. Senator Tillis. General Perna, while I understand and
appreciate the critical importance of surging resources to COVID-19
manufacturing programs to defeat the virus and end the pandemic, it has
come to my attention that companies across the industry are facing
supply issues that are constraining their manufacturing capacity. These
products are in jeopardy due to the impact of ``COVID-19 rated
orders,'' which are diverting many types of supplies, materials, and
manufacturing lines to COVID-19 vaccine and therapeutic programs.
We must not lose sight of the short and long term impacts, ranging
from patients losing access to medically necessary treatments, to
broader public health efforts like meeting flu vaccine supply for
upcoming flu season.
What are you doing to mitigate these access issues for both
individual patients and public health efforts at large, while also
enabling the continuity of the important COVID-19 programs already
underway?
General Perna. The operation is currently assessing the impact of
the COVID-19 rated orders on other lifesaving/life-enhancing
therapeutics and the Seasonal Flu Vaccine. Priorities across the
industry remain (1) Health Resources Priority and Allocations (HRPAS)
and Defense Priorities and Allocations Systems (DPAS) Rated Orders (2)
Other COVID non-rated orders and life-saving therapeutics (3) life-
enhancing therapeutics, and (4) All others (e.g., seasonal flu
vaccine). We remain postured to use HRPAS/DPAS to support the U.S.
requirements for each of these priorities, as directed by White House
policy.
__________
Questions Submitted by Senator Dan Sullivan
critical minerals in national defense stockpile
76. Senator Sullivan. Ms. Cummings, the COVID-19 pandemic has
highlighted a number of serious supply chain issues, to include an
issue I've been focused on, which is critical minerals and rare earth
elements. In fact I held a hearing in the Readiness and Management
Support Subcommittee on in October 2020, with former-Under Secretary
Ellen Lord on supply chain security. In the hearing she committed to
work with this committee on improvements and restructuring to the
National Defense Stockpile and Defense Production Act Title III
authorities in support of securing Department of Defense (DOD)
industrial base supply chains. These efforts have continued under your
leadership at the Defense Industrial Policy office, with your staff
working on technical drafting assistance with my staff. Will you commit
to continue to make this a priority going forward, and expeditiously
complete review of the technical drafting assistance your staff is
completing?
Ms. Cummings. Yes, the Department will continue to work with you
and your staff on technical drafting assistance related to critical
minerals and rare earth elements.
department of defense and veterans affairs data sharing
77. Senator Sullivan. General Perna, the Department of Defense
(DOD) under your leadership, in partnership with the State of Alaska's
Department of Health and Social Services (DHSS), has done an incredible
job distributing vaccines across Alaska. In fact, Alaska currently
leads the Nation in COVID-19 per capita vaccination rates. That said,
DHSS has expressed some concern that there is a lack of data sharing
between the DOD and the State of Alaska. What is the DOD's policy on
data sharing with State government agencies, and how do you think it
can be improved?
General Perna. Defer to Mr. Salesses.
Mr. Salesses. DOD reports vaccination information directly to CDC,
not to the state. This problem was recognized by the CDC and they have
developed a website that provides information on vaccine administration
by State that includes all the various venues including ``Federal
Entities'' (includes DOD, VA, Indian Health Service, and Bureau of
Prisons). States may be able to see limited information in Tiberius,
but DOD is not directly/routinely providing states with DOD data.
Individual MTFs can give total numbers, but not numbers by tier nor
acceptance rate. On 2 April the CDC addressed limitations on
jurisdiction visibility, which is impacted not only by Federal Entities
but FEMA/Coronavirus Vaccine Centers, pharmacy administration, etc.
Currently, DOD does post data Monday, Wednesday, and Friday on the
website Defense.gov on the Coronavirus Spotlight Page by DOD Service
and DOD Civilians of Total Delivered, Total Administered, and Percent
Utilization. Local units may release numbers of vaccines delivered and
vaccines administered. However, local units are not cleared to release
vaccination numbers by population tier or group or discuss ``rates'' of
``acceptance.''
78. Senator Sullivan. General Perna, is the DOD able to expand data
sharing with states to the patient level rather than just the aggregate
level?
General Perna. Defer to Mr. Salesses.
Mr. Salesses. See response to question #77.
department of defense healthcare workforce
79. Senator Sullivan. General Perna, the Department of Defense has
been a critical part of the Government's response to the COVID-19
pandemic, from delivering healthcare to infected individuals to
distributing vaccines across the country. In your personal opinion,
what expertise shortfalls need to be addressed prior to another event
in which the DOD is again called upon to provide civil support at the
scale of the COVID-19 pandemic response?
General Perna. Expertise was not the shortfall at the time of
Operation Warp Speed's (OWS) origin. Requisite expertise in scientific
research and development and medical countermeasure production existed
in HHS. Necessary program management, acquisition and contract
management, logistics plans, operations and security assurance
expertise existed in DOD. OWS was able to leverage the best of HHS,
DOD, industry and academia in our whole-of-America approach. An
organizational structure with clear pandemic response mandate,
reporting chain, authorities and resources did not exist. For example,
the Blue Ribbon Commission on Defense Management known as the ``Packard
Commission'' led to the Goldwater Nichols Defense Reorganization Act of
1986 setting forth extensive reforms within the Department.
__________
Questions Submitted by Senator Marsha Blackburn
response to covid-19 ``attack on the u.s.''
80. Senator Blackburn. General Perna, when the United States goes
to large-scale war, many exceptional public initiatives support that
effort. Are there programs aimed at increasing economic output,
incentivizing domestic investment, curtailing certain activities, and
stonewalling foreign influence that you would recommend to supplement
the pandemic response effort if envisioned as ``fighting a near peer
competitor,'' as characterized in your testimony?
General Perna. Operation leadership provided unity of effort to a
whole-of-America approach for vaccine manufacturing and distribution.
No single federal organization existed to plan and execute vaccine
distribution and administration across the entire operation. The
historic unprecedented partnering across industry, academia, the DOD
and other federal agencies should serve as a foundation for future
national pandemic response and preparedness. In order to inform
requirements for future pandemic response, a commission to examine
federal agencies' ability to operationalize the government response is
needed.
supply chain integrity
81. Senator Blackburn. Ms. Cummings, a concerning amount of our
needle and syringe supply comes from China. I am of the understanding
that you are ``on the road to seeking solutions to this problem.''
Please share your progress to date and any resourcing shortfalls you
may have.
Ms. Cummings. DOD is supporting investments in needle and syringe
production on behalf of HHS's Biomedical Advanced Research and
Development Activity (BARDA) to decrease reliance on China for the
critical medical supplies required for vaccination.
The DOD awarded three Technology Investment Agreements (TIAs) to
expand domestic capacity for production of needles and syringes on
behalf of the Department of Health and Human Services in 2020.
Collectively, these investments will enable domestic syringe production
capacity by approximately 890M units per year.
DOD invested $138 million on behalf of and in coordination with HHS
in the domestic production of prefilled syringes using Blow-Fill-Seal
aseptic plastics manufacturing technology. The new production
capability will help significantly decrease the United States'
dependence on offshore supply chains and its reliance on older
technologies with much longer production lead times. Additionally, in
coordination with the U.S. International Development Finance
Corporation (DFC), the Department recently issued a letter of interest
to ApiJect Systems, Corp. to further expand domestic syringe
production.
defense production act authorities
82. Senator Blackburn. Ms. Cummings, in executing its Defense
Production Act authorities, has your office recognized any emerging
technologies which greatly enhance our production and distribution
efforts (for example, additive manufacturing)?
Ms. Cummings. Through a partnership via the Office of the
Undersecretary of Defense for Research and Engineering, we explored
additive manufacturing and 3D printing, developing an open source
sharing website for approved PPE designs.
department of defense vaccination support missions
83. Senator Blackburn. Mr. Salesses, I understand Type-1 and Type-2
Vaccination Support Teams/Centers to essentially be mega-vaccination
sites staffed by Active Duty Department of Defense personnel. As more
of these appear to be coming on line, how do we prioritize where they
are stood up, and is there any consideration being given to augmenting
manpower with the National Guard?
Mr. Salesses. It would be more accurate to say that the FEMA-
established community vaccination centers are supported by active-duty
military personnel. DOD supports FEMA, which is working with the States
to determine where community vaccination centers may be needed.
janssen/johnson & johnson vaccine
84. Senator Blackburn. General Perna, as the Johnson & Johnson's
vaccine is a 1- versus 2-shot candidate, is there an inherent
logistical efficiency in scaled production and distribution of this
particular candidate?
General Perna. According to CDC Implementation Guidelines ``The one
dose Johnson & Johnson/ COVID-19 vaccine can be transported and stored
at two to eight degrees Celsius. These product characteristics may be
amenable to use in mobile clinics or sites that do not have freezer
capacity necessary for storing the mRNA COVID-19 vaccines. The single-
dose vaccine might be desirable for people who want or need to complete
their immunization schedule quickly or who might have difficulty
returning for a second dose. In addition, a single dose vaccine may be
desirable for mobile populations or populations with high turnover,
such as homeless shelters or correctional facilities.''
85. Senator Blackburn. General Perna, can we target a particular
population group with this 1-shot candidate in such a way that makes
greatest economic sense (i.e. servicemembers returning from overseas
deployments, or rural communities)?
General Perna. The 64 jurisdictions and federal entities play a
crucial role in partnering to accomplish this historic effort. The
operation enables jurisdictions and federal entities plans to
distribute to their population. The operation defers to CDC guidance
and jurisdictions administration plans for actual implementation.
contracting authority
86. Senator Blackburn. Ms. Cummings, according to GAO-21-265, 55
percent of COVID contracts have been awarded non-competitively and
using Other Transaction Authorities (OTA). Why would this engender
concerns about reduced transparency and accountability?
Ms. Cummings. GAO's 21-265 report makes 13 recommendations to
federal agencies about ways to improve the ongoing response and
recovery efforts related to public health, the economy, and program
integrity. While none of the report recommendations were directed to
the Department of Defense (DOD), we are mindful of the concerns about
transparency and accountability when using OTA to respond to the COVID-
19 pandemic. The Department has successfully used OTAs for COVID-19
requirements, and understands the value of competition to drive
innovation and affordability. While the GAO found 55 percent of FAR
contracts were non-competitive, and the overall Department competition
rate is just over 50 percent on FAR based contracts, over three-
quarters of DOD OTA obligations for fiscal year 2020 were competitively
awarded.
The Department rapidly awarded competitive OTAs to meet the
immediate needs of HHS to supply the nation with PPE. The DOD continues
our efforts to expand OTA reporting formats to improve transparency and
accountability.
87. Senator Blackburn. Ms. Cummings, please provide an example of a
pre-COVID-19 OTA and why using such authority is justified in said
example?
Ms. Cummings. One pre-COVID-19 OTA example is the Air Force Air
Operations Center (AOC) Pathfinder Program that purposefully structured
its acquisition strategy to leverage the flexible and innovative
processes and procedures in an OTA. The initial project executed a
proof of concept designed to implement a modern, dynamic web-based
application to schedule air refueling operations, which replaced an
antiquated handwritten-whiteboard-on-the-wall system. The AOC
Pathfinder Program awarded a Prototype OTA to build software
applications that allowed faster integration of user feedback into
future iterations. The Air Force leveraged the Prototype OTA to solve a
capability gap through a scalable software development and production
platform to enable continuous integration, delivery and operation of
new applications. This application resulted in fuel savings of
approximately $200,000 per day based on more efficient use of available
assets.
In this example, the collaboration led to a tailored problem
statement that provided an opportunity for companies to leverage
commercial best practices to deploy software originally conceived under
a traditional waterfall development approach into an agile software
development process. The Air Force declared success after executing
this methodology to develop and deploy four unique applications, and
awarded a non-competitive follow-on Production OTA, as permitted under
the OT statute at 2371b(f), for the scaling and employment of the
initial prototype methodology and platform licenses across additional
Air Force software development teams and throughout the geographically
dispersed AOCs. The OT authorities granted the Department were rapidly
and effectively used to solve an air refueling operations challenge,
employing leading edge software solutions that both optimized usage of
our tanker fleet and cut Air Force fuel costs.
Finally, the DOD has also supported immediate COVID-19 interagency
requests from HHS for acquisition assistance through rapid award of
several OTAs. For example, the Department awarded a non-competitive OTA
to AstraZeneca Pharmaceuticals for $1.209 billion to provide for COVID-
19 vaccine development. Additionally, the DOD awarded a non-competitive
OTA to Ology Bioservices Inc., for COVID-19 Prototype Medical
Countermeasures (MCM) Manufacturing Capability to provide vaccine/
therapeutics development and manufacturing for $130.6 million. While in
some cases the Department had to use other than full and open
competition in response to critical COVID requirements, as noted
earlier, over three quarters of OTA actions are competitive.
[all]