[Senate Hearing 117-175]
[From the U.S. Government Publishing Office]
EXAMINING OUR COVID 19 RESPONSE:
AN UPDATE FROM FEDERAL OFFICIALS
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE COVID-19 RESPONSE, FOCUSING ON AN UPDATE FROM FEDERAL
OFFICIALS
__________
MARCH 18, 2021
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
46-775PDF WASHINGTON : 2022
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont RICHARD BURR, North Carolina,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
JACKY ROSEN, Nevada ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
TOMMY TUBERVILLE, Alabama
JERRY MORAN, Kansas
Evan T. Schatz, Staff Director
David P. Cleary, Republican Staff Director
John Righter, Deputy Staff Director
C O N T E N T S
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STATEMENTS
THURSDAY, MARCH 18, 2021
Page
Committee Members
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor,
and Pensions, Opening statement................................ 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State
of North Carolina, Opening statement........................... 3
Witnesses
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 7
Prepared statement........................................... 9
Kessler, David, M.D., Chief Science Officer, COVID Response,
United States Department of Health and Human Services,
Washington, DC................................................. 14
Prepared statement........................................... 15
Marks, Peter, M.D., Ph.D., Director, Center for Biologics
Evaluation and Research, United States Food and Drug
Administration, Silver Spring, MD.............................. 16
Prepared statement........................................... 18
Walensky, Rochelle, M.D., MPH, Director, United States Centers
for Disease Control and Prevention, Atlanta, GA................ 24
Prepared statement........................................... 25
QUESTIONS AND ANSWERS
Response by Anthony Fauci, M.D., to questions of:
Senator Hickenlooper......................................... 67
Senator Burr................................................. 69
Senator Murkowski............................................ 70
Response by David Kessler, M.D., to questions of:
Senator Murray............................................... 72
Senator Hickenlooper......................................... 73
Senator Lujan................................................ 73
Senator Burr................................................. 74
Senator Murkowski............................................ 75
Senator Braun................................................ 76
Senator Marshall............................................. 76
Senator Tuberville........................................... 77
Response by Peter Marks, M.D., Ph.D., to questions of:
Senator Hickenlooper......................................... 78
Senator Burr................................................. 79
Senator Paul................................................. 81
Senator Murkowski............................................ 82
Response by Rochelle Walensky, M.D., MPH, to questions of:
Senator Smith................................................ 84
Senator Burr................................................. 84
Senator Murkowski............................................ 85
Senator Braun................................................ 86
Senator Tuberville........................................... 87
EXAMINING OUR COVID-19 RESPONSE:
AN UPDATE FROM FEDERAL OFFICIALS
----------
Thursday, March 18, 2021
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:08 a.m., in
Room 216, Hart Senate Office Building, Hon. Patty Murray, Chair
of the Committee, presiding.
Present: Senators Murray [presiding], Casey, Baldwin,
Murphy, Kaine, Hassan, Smith, Rosen, Lujan, Burr, Collins,
Cassidy, Murkowski, Braun, Marshall, Romney, Tuberville, and
Moran.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. The Senate Health, Education,
Labor, and Pensions Committee will please come to order. Today
we are holding a hearing on the Federal response to the COVID-
19 pandemic with Administration officials at the forefront of
these efforts. Ranking Member and I will each have an opening
statement and then I will introduce our witnesses, Doctors
Fauci, Walensky, Kessler, and Marks. I appreciate each one of
you being here today, and I expect to be hearing from you often
as we continue to work to end this pandemic. After the
witnesses give their testimony, Senators will each have five
minutes for a round of questions.
Before we begin, I again want to work through the COVID-19
safety protocols that are in place. We will follow the advice
of the Attending Physician and the Sergeant-at-Arms in
conducting this hearing. Committee Members are seated at least
six feet apart. Some Senators are participating by video
conference. And while we are unable to have the hearing fully
open to the public or media for in-person attendance, live
video is available on our Committee website at help.senate.gov.
And if you are in need of accommodations, including closed
captioning, you can reach out to the Committee or the Office of
Congressional Accessibility Services. We are all very grateful
to everyone, including our Clerks, who have worked very hard to
get this set up and help everyone stay safe and healthy.
Thank you to all of them. We have seen a lot of change, and
recently change for the better, since this Committee had its
first COVID-19 hearing with Federal officials over a year ago.
The difference between how President Biden has been handling
the crisis and how former President Trump refused to is
staggering when it comes to public health guidance. Former
President Trump spread misinformation about masks, refused to
wear them, but one of President Biden's first acts as President
was to call on all Americans to wear masks and keep each other
safe. When it comes to listening to the experts, former
President Trump consistently interfered with their work.
President Biden has empowered them to lead a science based
response to this pandemic. When it comes to testing, former
President Trump was concerned that testing too many people
would make him look bad, while President Biden is concerned
that not testing enough will leave people at risk and let new
variants of this virus spread undetected. When it comes to
getting vaccines into arms, Trump administration's approach on
distribution was essentially giving vaccines to states, call it
mission accomplished. The Biden administration is directing
vaccines to pharmacies through a partnership reaching over
40,000 locations, to community health centers through a program
they have expanded to 950 total locations, and to patients by
standing up to Federal vaccine--standing up Federal vaccination
sites, which it announced last week it will double.
The result, recently, my home State of Washington
administered its 2 millionth vaccine. Our Country administered
its 100 millionth vaccine. We saw the first day without a
thousand COVID-19 deaths in our Country since November. And
President Biden announced he will direct all states, tribes,
and territories to make all people 18 and over eligible to be
vaccinated no later than May 1st. Well, we aren't through this
pandemic yet, we are finally on the right track and we can see
the light at the end of the tunnel, but we are going to have to
keep pushing to make sure we get there.
That is why the American rescue plan makes investments in
testing, contract tracing, and sequencing so we can identify
new variants of it and slow the spread, investments in vaccines
so we can distribute and administer them quickly, widely and
equitably, fight misinformation, promote vaccine confidence,
and engage trusted partners in communities, investments to
recruit and train 100,000 new public health workers for those
efforts, and investments to address inequities that have made
this pandemic more deadly for communities of color, to address
mental health, behavioral health, and substance abuse
challenges that this pandemic has worsened, to support home and
community based services that help people with disabilities and
older Americans, and to support community health centers which
continue to be a lifeline to so many hard hit and hard to reach
communities.
Now we must work to make sure these investments have the
impact we need them to in order to bring an end to this
pandemic. And for this to happen, we need to fight vaccine
hesitancy. While over half of people now say they will get
vaccinated compared to around a third at the end of December,
that is still far too low. And as we promote vaccines, we also
have to ensure equity and get vaccines and information to
communities of color, rural communities, people with
disabilities, people who don't speak English, and people who do
not have access to the Internet. The Biden administration's
plan to develop a federally run website showing vaccine
locations and a 1-800 number to help those without Internet are
a promising start, as are efforts being spearheaded by
community groups like the Pacific Islander Community
Association in Washington State, which I talked about in our
last hearing.
But we have to keep our focus on this because this pandemic
will not truly be over for anyone until we can vaccinate
everyone that we can. And even when we are all safe from COVID-
19, our work to recover will not be over. We have to rebuild
our Country stronger and fairer. And that work needs to start
with building a stronger and fairer public health
infrastructure, which is why I introduced the Public Health
Infrastructure Saves Lives Act last week. But it can't end
there. And that is why Ranking Member Burr and I, along with
the Members of this Committee, are focused around the need to
learn the lessons of this pandemic and take action so nothing
like this ever happens again. Together, I hope to work with
Ranking Member Burr and Members of this Committee to hold a set
of hearings, talk with experts, and stakeholders, and work
across the aisle with our colleagues over the next few months
to consider the many lessons of this pandemic and draft
bipartisan legislation to act on those lessons.
I know we will have different views on this Committee about
what that means, but I also know we share a common goal, to
keep our families and communities safe from future pandemics
and public health threats. And I am hopeful that we will find
common ground when it comes to what we can do to address the
need for a strong public health system, the painful health
inequities that hurt communities of color, the way this
pandemic was exacerbated by a lack of paid leave for every
worker and affordable child care for working families, the
importance of protecting schools and workers and more.
We all want to make sure we learn from this moment in our
history because we owe it to every American who has suffered or
who is grieving after this year to make sure we never find
ourselves here again. With that in mind, I would like to thank
all of our witnesses today for joining us. I look forward to
hearing from each of you about the issues we face as we work to
end this pandemic. And with that, I will turn it over to
Ranking Member Senator Burr for his opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Thank you, Madam Chair, and welcome to Dr.
Kessler, Dr. Marks, and Dr. Walensky. It is great to see all of
you. Continuity will be critical as we work through the lessons
learned from the COVID-19 pandemic and move into the next phase
of our response and hopefully our recovery. This hearing is
meant to take stock of our Federal COVID-19 response. But I
think it is now time to talk about where we are going in the
next 30, 60, and 90 days and beyond. America needs to reopen
our schools. We need to reopen our businesses.
We need to open up to global commerce, a much more
challenging thing. The actions taken by each of your officers
affect these goals. Some of you are new to the response and
some of you have been in the fight for the last year alongside
Members of this Committee. My request of each of you, however,
is the same. This pandemic has shown us very clearly how we can
better prepare for the next threat, and that it is being a
better partner to the private sector is one of the things at
the top of the list. Dr. Walensky, I am going to start with you
because you have the hardest job, I think, ahead of you. The
bottom line is there is a clear and compelling need for
significant reform at the CDC. Your agency is responsible for
communicating to the American people, based on facts, how to
return to some form of normalcy.
But the guidance documents coming out of CDC have been two
steps behind the data. All I am asking is for CDC
communications to be fast and transparent. Tell the American
people what we know, when we know it, and when we don't, so
that they can make the best decisions for themselves and their
families. As I mentioned, your best tool to keep pace with
science is the private sector. Last week during the Committee's
COVID hearing, I said that CDC can no longer be in charge of
all testing in early days of novel threats. Let me be blunt,
CDC's go alone mentality of the past on testing was arrogant
and it was wrong. Let me propose a solution based upon the
success that Dr. Hahn at the FDA led last year. Lean on your
private sector partners, commercial labs, academic centers,
large scale test makers like Beedi and Roche to rapidly develop
diagnostics that serve as one great asset during an outbreak of
an emerging infectious disease.
The same is true of the surveillance system. Last week, Dr.
Jha from Brown University's Public Health School said, we need,
``a new approach'' to our surveillance. We discussed leveraging
data sets like weather patterns and mobility information
alongside traditional dedensified testing and patient data from
health care providers. We need a layered surveillance system in
partnership with the private sector, states, and local public
health experts to get a true picture of the threats on the
ground. The COVID relief packages have given CDC billions of
dollars to modernize these systems. CDC must not hoard that
money for yourselves. Instead use these funds to identify
technologies that better equip us. I implore you to not build
internal systems that only become obsolete before they even get
up and running. Dr. Fauci, welcome back. You are everywhere
these days. You and I have worked on these issues together for
two decades. A lot of what we built together worked.
The NIH recognized the importance of technology, leveraging
existing clinical trials and research networks, extending
partnerships with the private sector through the NIH foundation
and other avenues, establishing programs like RADx in
partnership with BARDA to cast the widest net possible for
novel technologies and testing. Now, the challenge will be for
your center, along with the other institutes and centers at
NIH, to maintain this pace and to apply to the next challenge
or set of health care challenges in the future.
I am reminded this morning, as I read yesterday's article
on Ebola breakout, that it seems that the strain of Ebola in
this breakout might have been dormant for five years. That,
yes, this is about what we know, but this is about what we
don't know as well. Voices at the NIH will be important to
determine how we can expand, solidify, and maintain this
public, private approach to the biggest health care issues
facing our Country. Dr. Marks, this is where you and your
efforts at CBER come in. I can't think of another medical
products center at FDA that will see more of the technologies
that will benefit America's patients in the next decade. The
COVID vaccine comes through CBER for review, but so do cell and
gene therapies. Many of them relying on new platforms that can
be used for multiple devastating diseases and diagnosis. The
pandemic, I believe, has altered the model at FDA and the
agency should not go back to its historical approach. Dr. Hahn
used his emergency authorities exactly as we envisioned the FDA
using them.
In my mind, he, you and the dedicated professionals at the
FDA are the unsung heroes of the Federal response. The EUA
standard calls for the benefit to outweigh the risk, and we can
adjust these authorizations as we learn during a response. This
is how the statute is designed to work. Now, as the makers of
these products, vaccines, tests, the treatments apply for full
approval, the agency should take this opportunity to use real
world information to inform their review. And I hope that you
take advantage of the unique opportunity you have had. Each
medical product center at FDA can apply their practices during
the pandemic to the applications that come across their
reviewers' desk. We can accelerate development to the benefit
of patients here in the United States and more importantly
around the world for more than just COVID, but for cancer,
diabetes, and more. Stacking clinical trials, receiving rolling
sets of data, coordinating with our global colleagues have been
available tools at the agency for a long time. I urge you to
continue to use these as you have over the past 12 months.
Dr. Kessler, David, it has been a long time. Much of what
we have implemented, we didn't even talk about when you were
FDA Commissioner. I don't think it was a lack of vision. I
think it was yet developed future technologies. You were
serving as FDA Commissioner when our first conversation about
pandemic preparedness began though. Now, you are in a position
to help use those authorities to their fullest extent.
Operation Warp Speed or the new name, the Operation--did I get
that right? Has used NIH expertise in early research, BARDA's
contracting, advanced development and manufacturing
capabilities, and the DOD's logistic muscle to achieve
scientific breakthroughs that can rescue the world from this
virus.
The Operation Speed was a huge success, and I am glad that
you are planning on building on that success going forward. In
the next few months, this project will have made available
vaccines for all eligible Americans in record time without
cutting any safety or efficacy corners at the FDA. The
operation showed us where our gaps in countermeasure
development exist. We need ways to rapidly identify candidates
for tests, treatments, antivirals, and vaccines. This is an
area primed for partnership with academia and especially the
private sector. We also learned that our manufacturing
capabilities came up short. But we saw a remarkable thing when
private sector drug makers partnered with their competitors to
make vaccines.
It is my hope that you are willing to work with my office
to address the gaps that we found during the establishment of
the operation and to uphold many pieces that worked for the
future. Now, one year into the pandemic, even as the vaccine
offers hope that a return to normal will continue and speed up,
the offices and responsibilities that each of you hold, I
believe, will become more challenging. Not only will you be
required to maintain the pace and urgency of our current
response, but to begin to change the architecture of our public
health agencies.
The novel coronavirus has irreversibly altered our ability
as the Federal Government to interact with innovators that
bring real solutions to the greatest health care challenges in
generations. Do not take this moment for granted. Strengthen
the relationships and partnerships that have been established
during this response. Take stock of the needs that still exist
and how partnerships like these can help us all to address
them.
My staff and I are in the midst of a review with the same
goal and my office is available to each of you at any time for
us to work together on these efforts. I thank you for your
willingness to serve at such a difficult time for our Country.
I look forward to working with each of you to reopen our
Country and memorialize what we have learned along the way.
Thank you, Madam Chair.
The Chair. Thank you, Ranking Member Burr. I will now
introduce today's witnesses. I am pleased to start by welcoming
back Dr. Anthony Fauci, who has been a trusted voice and a
guiding hand throughout the COVID-19 pandemic, and who now
serves as Chief Medical Adviser on President Biden's COVID-19
response team.
Dr. Fauci, thank you for the work that you have done and
continue to do to help us all get through this pandemic. Dr.
Fauci was appointed Director of the National Institute of
Allergy and Infectious Diseases in 1984 and has led that
institute ever since. Over the years, he has advised six
Presidents through deadly global health crises like HIV and
AIDS, Zika, Ebola, and now COVID. Dr. Fauci received his M.D.
from Cornell University and completed his residency at the New
York Cornell Hospital Medical Center, now called the Weill
Cornell Medical Center. He has been recognized with the
National Medal of Science and the Presidential Medal of
Freedom, among many others. Dr. Fauci, welcome and thank you
for joining us again today.
Dr. Rochelle Walensky is the Director of the Centers for
Disease Control and Prevention and Administrator of the Agency
for Toxic Substances and Disease Registry. Prior to her
appointment in January, Dr. Walensky was the Chief of the
Division of Infectious Diseases at Massachusetts General
Hospital and a Professor of Medicine at Harvard Medical School.
Dr. Walensky has worked throughout her career to help advance
the national and global response to HIV and AIDS and is also an
expert on the testing and treatment of deadly viruses. During
the COVID-19 pandemic, she has conducted crucial research on
vaccine delivery and helped develop strategies to support
underserved communities. Dr. Walensky received her M.D. from
Johns Hopkins School of Medicine, trained in internal medicine
at Johns Hopkins Hospital, became a fellow in the Massachusetts
General Hospital and Brigham and Women's Hospital Infectious
Diseases Fellowship program, and earned an MPH in Clinical
Effectiveness from the Harvard School of Public Health. Dr.
Walensky, congratulations on your appointment as Director. We
are glad to have you here for what I am sure will be the first
of many productive conversations with the Committee in your new
role. Thank you.
Next, I want to introduce Dr. David Kessler. He is the
Chief Science Officer of the Biden administration's COVID-19
response. In this role, Dr. Kessler is focused on crucial
issues such as vaccine review and approval and the logistics of
manufacturing millions more doses of vaccine. He has been
instrumental in helping reach President Biden's goal of 100
million vaccinations in 100 days. Congratulations on that,
doctor. He brings to his role a wealth of experience from his
time serving as Commissioner of Food and Drugs under Presidents
George H.W. Bush and President Bill Clinton, and from his work
on a range of public health issues like HIV, AIDS, tobacco
regulation, and helping Americans improve their nutritional
habits. Dr. Kessler completed his J.D. at University of Chicago
Law School, received his M.D. from Harvard Medical School, and
completed his residency in Pediatrics at Johns Hopkins
Hospital. Dr. Kessler, I am glad to have you with us today.
Dr. Peter Marks is the Director of the Center for Biologics
Evaluation and Research for the Food and Drug Administration.
It is a position he assumed in 2016, after serving as Deputy
Director of the Center for several years. He has helped lead
the center through the approval of several groundbreaking
treatments, including the first CAR T-cell therapy for advanced
cancer, the first gene therapies, and the first Ebola vaccine.
Dr. Marks has played a critical role in the development of
guidance for vaccine manufacturers and the authorization of
COVID-19 vaccines. Dr. Marks received his M.D. and his Ph.D. in
cell and molecular biology at New York University, and
completed an internal medicine residency in hematology and
oncology college fellowship at the Brigham and Women's
Hospital.
After completing his training, Dr. Marks worked as a
Clinician Scientist and later as Clinical Director of
Hematology for Brigham and Women's Hospital, and later managed
the adult leukemia service at Yale University and served as the
Chief Clinical Officer of the Yale New Haven Hospital Cancer
Center. Dr. Marks, we are very glad to have you with us today.
With that, we will begin our testimony. Dr. Fauci, I will
start with you.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, BETHESDA, MD
Dr. Fauci. Madam Chair, Ranking Member, Members of the
Committee, thank you for giving me the opportunity to discuss
with you the role of the National Institute of Allergy and
Infectious Diseases and research addressing COVID-19. I think
we have some slides, so if we could show them. If not, I will
go without them. Next slide. The NIAID's strategic plan has
four major components to it, improving fundamental knowledge of
the virus, developing diagnostics and assays, characterizing
and testing therapeutics, and finally developing safe and
effective vaccines.
If I could have the next slide. The first that we will
discuss--no back one, back one sorry. The first I will discuss
is the characterization and testing of therapeutics. Next
slide. When one thinks about therapeutics--next slide. When one
thinks about therapeutics for COVID-19, one thinks of first,
early to moderate disease and next moderate to advanced
disease. In the first category, there are a number of
interventions that have been approved either by the FDA, such
as remdesivir, or have received emergency use authorization
from the FDA, including monoclonal antibodies from Lilly and
Regeneron.
In addition, convalescent plasma has received an EUA. If
you move on to moderate or advanced disease, the standard of
care now is dexamethasone, which in a randomized placebo
controlled trial, has clearly shown a diminution in the overall
mortality, over 28 days, in patients with advanced disease,
including those requiring the mechanical ventilation as well as
high flow oxygen. Next slide. However, the future of
therapeutics we feel strongly lies in the identification of
vulnerable targets in the SARS-COVID-2 replication cycle, and
to design drugs to specifically inhibit those vulnerable
targets. This has been a strategy that has been successful to a
great degree with HIV drugs as well as the curative drugs for
hepatitis C.
Next slide, the development of safe and effective
vaccines--next. Although we have done very, very quickly with
regard to the development of a vaccine, the work on a vaccine
started literally decades before the January recognition that
we were dealing with a new virus. And I refer specifically to
the role of NIH, particularly the Vaccine Research Center, and
our large number of grantees and contractors who for decades
were doing basic preclinical and clinical research to develop
new vaccine platforms, including the messenger-RNA, which has
been so successful. In addition, at the Vaccine Research
Center, the groundbreaking work of the stabilization of the
pre-fusion spiked protein, which has served as the immunogen
for five out of the six vaccines that are currently being
tested under the auspices of the United States. And finally, we
pivoted our extensive NIAID domestic and international clinical
trials networks that have previously been established for HIV
and influenza and have used them in the extensive clinical
trials for COVID-19.
This slide shows the three platforms and six companies that
have now been used successfully to develop the three vaccines
that currently have an EUA with a very high degree of efficacy
and a good safety profile, as well as two others that are on
the way. Next slide. This slide is a prototype of what has
happened with multiple vaccine candidates. It is an
extraordinary reflection of scientific advances. On January
10th, the sequence of the virus was known. 65 days later, a
Phase 1 trial was started. On July 27th, two of the vaccines
went into Phase 3 trial, and in an extraordinary feat, 11
months later, less than 1 year, there was vaccines that had
shown to be highly efficacious with a good safety profile. This
is something that is unprecedented in the history of
vaccinology and really is a reflection of not only the
fundamental basic science advances, but extraordinary
partnerships between the Government and the private sector.
On this final slide, although this is all good news, there
still are challenges ahead, particularly with regard to the
variants that have now become very familiar to us. They are
mutational changes in the virus strains that challenge us both
from the standpoint of spreading more rapidly, having a greater
degree of pathogenesis, and even evading some of our monoclonal
antibodies. But we can counter that in two ways. One, by
vaccination, maintaining the immune response against wild type,
either by continuing to get a good quarter of vaccinations or
boosting potentially in the future.
Also, and finally, as always, to continue to implement the
public health measures in the forms of masks, distance,
avoiding congregate settings, and washing hands. I will stop
there and be happy to answer questions later, Madam Chair.
Thank you.
[The prepared statement of Dr. Fauci follows:]
prepared statement of anthony s. fauci
Madam Chair, Ranking Member Burr, and Members of the Committee:
Thank you for the opportunity to discuss the role of the National
Institute of Allergy and Infectious Diseases (NIAID) in the research
response to coronavirus disease 2019 (COVID-19) and its etiologic
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Within the Department of Health and Human Services (HHS) and the
National Institutes of Health (NIH), NIAID is responsible for
conducting and supporting basic and clinical research on emerging and
re-emerging infectious diseases, including COVID-19. As the Director of
NIAID and the Chief Medical Advisor to the President, I am pleased to
discuss NIAID's research addressing this pandemic.
COVID-19 is a once-in-a-lifetime global infectious disease pandemic
requiring an unprecedented public-private research effort. NIAID plays
a central and important role in the public health response to COVID-19.
NIAID has capitalized on decades of investment in fundamental basic
research, including groundbreaking structure-based vaccine design at
the NIAID's Vaccine Research Center (VRC); engaged domestic and
international research infrastructure; and leveraged highly productive
partnerships with industry and longstanding relationships with
community partners. NIAID utilized its existing domestic and
international clinical trials infrastructure, originally established to
conduct research on HIV and influenza, and worked with partners in the
public and private sectors to establish the COVID-19 Prevention Network
(CoVPN). CoVPN has supported multiple COVID-19 vaccine candidates to
progress in record time from concept to authorization for emergency use
by the U.S. Food and Drug Administration (FDA). NIAID initiated
clinical trials with creative and adaptive designs, allowing the
evaluation of multiple new and existing therapeutics for use against
COVID-19. Several of these trials demonstrated safety and efficacy of
COVID-19 therapeutics and helped support authorization by the FDA.
These successes have helped slow the progression of the pandemic. Cases
are decreasing, and the administration of FDA-authorized vaccines is
increasing rapidly.
While we are cautiously optimistic about the future, we know that
many challenges remain; we must continue to employ the proven public
health measures that have brought us to where we are today. One of the
most concerning developments of the ongoing pandemic is the detection
of genetic variants of SARS-CoV-2, some of which appear to be more
transmissible than the original virus and less responsive to certain
therapeutic agents and vaccine formulations. So far, scientific
evidence suggests that the COVID-19 vaccines distributed in the United
States under FDA Emergency Use Authorization (EUA) continue to be
effective against these variants, but we must remain vigilant. NIAID is
rapidly conducting research to better understand these emerging
variants of SARS-CoV-2, how they interact with the immune system, and
their implications for COVID-19 therapeutic and vaccine formulations.
We also know that our fellow Americans in underserved and minority
communities have been disproportionally affected by this pandemic.
NIAID is committed to working directly with these communities and
partnering with other agencies in the Federal Government, and with
industry, and academia, to ensure that individuals in underserved and
vulnerable communities are not left behind as we move forward toward
defeating COVID-19. NIAID also recognizes that while many infections
with SARS-CoV-2 resolve after a relatively short time, some individuals
continue to suffer longer-term effects even after the virus has been
eliminated from the body. NIAID is supporting collaborative efforts to
study outcomes in patients across all ages, genders, and co-morbid
conditions, who have experienced a wide range of severity of original
disease, to identify and characterize these post-acute sequelae of
SARS-CoV-2 infection (PASC) and develop effective strategies to address
them.
Developing Vaccines and Therapies to Prevent COVID-19
Sustained investments by NIAID in structure-based vaccine design
and coronavirus research over the years prior to the emergence of SARS-
CoV-2 have enabled the unprecedented pace of COVID-19 vaccine
development. Long before the pandemic, NIAID VRC scientists and their
collaborators made the critical scientific discovery of how to
stabilize in a highly immunogenic form viral proteins that are
important for infection, including the spike protein of the Middle East
respiratory syndrome coronavirus (MERS-CoV), using a mutation known as
S2P. This key finding has facilitated the design of vaccine candidates
that generate robust immune responses against coronaviruses and other
viruses of public health importance such as respiratory syncytial
virus. As soon as the sequence of SARS-CoV-2 was made available, VRC
researchers were able to rapidly generate a stabilized SARS-CoV-2 spike
protein for use in COVID-19 vaccine development. This crucial
breakthrough in structure-based vaccine design for coronaviruses has
led to the development of safe and effective COVID-19 vaccines across a
range of vaccine platforms.
Five candidate COVID-19 vaccines have entered Phase 3 clinical
trials in the United States thus far, and three subsequently have
received an EUA from the FDA. Clinical trials to test COVID-19 vaccine
candidates in pediatric populations are ongoing. On December 11, 2020,
based on data from a Pfizer-supported Phase 3 clinical trial, an
investigational vaccine developed by Pfizer and BioNTech became the
first to receive an EUA from the FDA for the prevention of COVID-19 in
individuals 16 years of age and older. NIAID has helped to advance four
additional COVID-19 vaccine candidates through support for research on
the foundational biology underlying the vaccine concepts as well as for
clinical testing through the CoVPN. Two of these vaccine candidates
have received EUAs.
Utilizing the CoVPN, NIAID is participating in the implementation
of harmonized protocols to test investigational vaccines and preventive
interventions against SARS-CoV-2. These protocols were developed in
collaboration with the Accelerating COVID-19 Therapeutic Interventions
and Vaccines (ACTIV) public-private partnership, vaccine manufacturers,
and the Biomedical Advanced Research and Development Authority (BARDA).
NIAID also supports the underlying critical infrastructure for these
clinical trials such as a common Data and Safety Monitoring Board
(DSMB), an independent group that reviews data from the trials to
ensure the ongoing safety of study volunteers and to determine whether
efficacy has been achieved. The CoVPN has enrolled thousands of
volunteers across the United States and internationally in clinical
trials testing multiple investigational vaccines and monoclonal
antibodies intended to protect people from COVID-19. The CoVPN also has
developed an extensive community engagement framework to reach out to
the minority communities disproportionally affected by COVID-19; to
better understand their interest in, and concerns about, research
participation; and to partner with them to ensure that their vital
input is reflected in the conduct of the study.
To further address the critical challenges of participation in
clinical trials as well as vaccine acceptance and vaccine hesitancy,
NIH established the Community Engagement Alliance Against COVID-19
Disparities (CEAL) initiative, led by the National Heart, Lung, and
Blood Institute (NHLBI) and the National Institute on Minority Health
and Health Disparities. CEAL brings together trusted community leaders
to serve as champions who share information about the importance of
participating in COVID-19 research and communicate data on the safety
and efficacy of authorized COVID-19 vaccines.
mRNA-1273 (Moderna)
As part of a longstanding collaboration, the NIAID VRC worked with
the biotechnology company Moderna, Inc., to develop a vaccine candidate
designated as mRNA-1273, which uses a messenger RNA (mRNA) vaccine
platform to express the stabilized SARS-CoV-2 spike protein.
Early clinical trials demonstrated that mRNA-1273 was generally
well tolerated and induced robust neutralizing antibody responses in
healthy adults. NIAID and BARDA then began working with Moderna on a
Phase 3 clinical trial utilizing the CoVPN that showed that mRNA-1273
was 94.1 percent efficacious in preventing symptomatic COVID-19. On
December 18, 2020, after a thorough review of comprehensive data on
mRNA-1273, the FDA issued an EUA of the mRNA-1273 vaccine for
prevention of COVID-19 in individuals 18 years of age and older.
Ad26.COV2.S (Janssen/Johnson & Johnson)
Decades of NIAID support for basic, pre-clinical, and clinical
research on adenovirus (Ad)-based HIV vaccines underpin the development
by Janssen/Johnson & Johnson of a coronavirus vaccine based on the
Ad26-vector, known as Ad26.COV2.S or JNJ-78436735. NIAID is supporting
a Phase 3 clinical trial of Ad26.COV2.S through the CoVPN and has
provided immunological testing of the candidate using NIAID-funded core
laboratory infrastructure. In late January 2021, Janssen/Johnson &
Johnson released an interim analysis of the Phase 3 clinical trial
indicating that the one-dose vaccine candidate was 66 percent effective
overall at preventing moderate to severe/critical COVID-19 occurring at
least 28 days after vaccination and 85 percent effective overall in
preventing severe/critical COVID-19 across several geographical
regions, including areas where emerging viral variants predominate. In
the United States, the efficacy against moderate to severe/critical
disease 28 days after vaccination was 72 percent. On February 27, 2021,
the FDA issued an EUA for Ad26.COV2.S for prevention of COVID-19 in
individuals 18 years of age and older.
Other COVID-19 Vaccine Candidates
NIAID, through the CoVPN, is supporting Phase 3 clinical trials of
COVID-19 vaccine candidates from AstraZeneca (AZD1222) and Novavax
(NVX-CoV2373). AstraZeneca's AZD1222 COVID-19 vaccine candidate uses a
chimpanzee adenovirus-vectored vaccine approach developed by
researchers at the University of Oxford in collaboration with
scientists at NIAID's Rocky Mountain Laboratories. AstraZeneca has
reported promising results from their international Phase 3 clinical
trial of AZD1222; data from the U.S. trial of AZD1222 are pending.
Monoclonal Antibodies to Prevent COVID-19
NIAID scientists, collaborating with Regeneron Pharmaceuticals and
Eli Lilly and Company, also initiated two Phase 3 clinical trials to
evaluate whether their investigational monoclonal antibodies, known as
REGEN-COV and bamlanivimab respectively, can prevent infection or
symptomatic disease in people at high risk of exposure due to their
living or working conditions. Each company recently reported promising
initial results, and further analysis of the data from the trials is
ongoing.
Identifying Therapeutics to Treat COVID-19
Safe and effective therapeutics are urgently needed to treat
patients with COVID-19. NIAID launched a multicenter, randomized
placebo-controlled clinical trial, the Adaptive COVID-19 Treatment
Trial (ACTT), to evaluate the safety and efficacy of multiple
investigational therapeutics for COVID-19. ACTT-1 examined the
antiviral drug remdesivir for treatment of severe COVID-19 in
hospitalized adults. Based on positive data from ACTT-1, the FDA
approved the use of remdesivir for treatment in adults and children 12
years of age and older and weighing at least 40 kg hospitalized due to
COVID-19. ACTT-2 evaluated the anti-inflammatory drug baricitinib in
combination with remdesivir, and based on favorable data from ACTT-2,
the FDA issued an EUA for the use of baricitinib in combination with
remdesivir for treatment of adults and children older than 2 years
hospitalized with COVID-19 and requiring supplemental oxygen, invasive
mechanical ventilation, or extracorporeal membrane oxygenation. ACTT-3
is currently evaluating treatment of patients hospitalized with COVID-
19 with remdesivir plus interferon beta-1a, which is used to treat
individuals with multiple sclerosis. ACTT-4 is currently enrolling
adults hospitalized with COVID-19 to assess baricitinib plus remdesivir
versus the glucocorticoid dexamethasone plus remdesivir.
NIAID, in collaboration with other NIH Institutes, also launched
two clinical trials as part of the ACTIV partnership, which utilizes
master protocols allowing the addition of other investigational
therapeutics as the trials continue. The two studies, ACTIV-2 and
ACTIV-3, initially evaluated the use of the monoclonal antibody
bamlanivimab to treat COVID-19 in outpatient and inpatient settings,
respectively. Bamlanivimab was discovered by the company AbCellera in
collaboration with the NIAID VRC and developed by Eli Lilly.
Bamlanivimab received an FDA EUA in November 2020 for treatment of
mild-to-moderate COVID-19 in patients with high risk for COVID-19
disease progression, based on data from a Lilly sponsored Phase 2
clinical trial. ACTIV-2, which is focused on outpatients, has since
been expanded to evaluate a combination monoclonal antibody therapy,
BRII-196 and BRII-198, as well as three investigational therapeutics:
SNG001, an inhalable beta interferon; AZD7442, an investigational long-
acting antibody combination; and camostat mesilate, an orally
administered molecule that may block SARS-CoV-2 from entering cells.
ACTIV-3 currently is evaluating the AZD7442 monoclonal antibody
combination in hospitalized patients. In addition, NIAID launched a
Phase 3 trial called, ``Inpatient Treatment with Anti-Coronavirus
Immunoglobulin,'' or ITAC, to evaluate hyperimmune intravenous
immunoglobulin for treatment of COVID-19 in hospitalized adults. NIAID
also began a Phase 3 CoVPN trial of an Eli Lilly combination therapy,
bamlanivimab and etesevimab, for treatment of mild to moderate COVID-
19.
NIAID also announced the ACTIV-5/Big Effect Trial (BET), which is
designed to streamline the identification of experimental COVID-19
therapeutics that demonstrate the most promise. BET, an adaptive Phase
2 clinical trial, compares different investigational therapies to a
common control arm to identify treatments with relatively large effects
as promising candidates for further study in large-scale trials. BET
initially is evaluating two therapeutics: risankizumab, an
immunomodulatory monoclonal antibody developed by Boehringer Ingelheim
and AbbVie, which is FDA-approved for the treatment of severe plaque
psoriasis; and lenzilumab, an investigational immunomodulatory
monoclonal antibody developed by Humanigen.
The NIH also has established the COVID-19 Treatment Guidelines
Panel to provide recommendations to health care providers regarding
specific COVID-19 treatments based on the best available science. The
Guidelines also address considerations for special populations,
including pregnant women and children. Each Treatment Guidelines
section is developed by a working group of Panel members with expertise
in the area addressed in the specific section; these members conduct
systematic, comprehensive reviews of relevant information and
scientific literature. The Panel comprises representatives of NIH and
five other Federal agencies along with representatives of nine
professional organizations, academic experts, and treating physicians
including providers from high COVID-19 incidence areas, and community
representatives. The Panel meets regularly to evaluate possible
treatment options for COVID-19 and update the Treatment Guidelines as
new clinical evidence emerges.
Responding to Emerging Variants of SARS-CoV-2
NIAID is fully engaged in efforts to mitigate the potential impact
of emerging variants of SARS-CoV-2. NIH, including NIAID, participates
in the SARS-CoV-2 Interagency Group (SIG), which works to detect and
characterize these new variants and to develop and adapt
countermeasures to address them. The SIG was established by HHS to
facilitate coordination among NIH, the Centers for Disease Control and
Prevention (CDC), FDA, BARDA, the Department of Defense (DOD), and the
U.S. Department of Agriculture (USDA) to detect and address SARS-CoV-2
variants as they emerge. NIH, CDC, and DOD are assessing whether
vaccine-induced immunity, or natural immunity from prior infection, can
be effective in combating the variants. NIH, BARDA, and DOD also are
determining the efficacy of certain authorized therapeutics against
emerging variants in cells and in animal models. In addition, NIAID is
collaborating with vaccine manufacturers on key areas of research to
investigate whether vaccines designed for the original strain of SARS-
CoV-2 could maintain efficacy against emerging variants. NIAID also
plans to test new vaccine formulations designed specifically to protect
against certain variants that show early indications of reduced
sensitivity to existing countermeasures.
NIAID, the National Human Genome Research Institute, and the
National Library of Medicine are participating in the SARS-CoV-2
Sequencing for Public Health Emergency Response, Epidemiology, and
Surveillance (SPHERES) initiative. SPHERES is a national genomics
consortium led by CDC that helps to coordinate SARS-CoV-2 sequencing
across the United States. NIAID is working with partners to identify,
monitor, and calculate the frequency of current variations in the SARS-
CoV-2 genome to help predict emerging variants. NIAID also facilitates
the use of cutting-edge modeling and structural biology tools to
understand how variants might affect interactions between the virus and
the immune system or COVID-19 therapeutics. NIAID scientists are
helping to inform our understanding of transmissibility of the variants
by studying their stability in the environment of infected individuals
and their ability to grow in human lung cells. These efforts add to a
growing body of knowledge about SARS-CoV-2 variants and our ability to
combat them.
Understanding the Immunology and Pathogenesis of COVID-19
NIH is supporting studies to understand the incidence of SARS-CoV-2
infection in specific populations, including children, as well as
certain aspects of the clinical course of infection, including
thromboses, strokes, heart attacks, and other sequelae of infection.
NIAID is working with partners to delineate biological and immune
pathways responsible for the varied manifestations of COVID-19. NIAID
also will examine the quality and durability of the immune response to
SARS-CoV-2; this information may be leveraged to develop novel SARS-
CoV-2 therapeutics or vaccines.
NIAID, along with FDA, is supporting a National Cancer Institute
(NCI) effort to determine the sensitivity and specificity of certain
SARS-CoV-2 serological tests, which can detect antibodies indicative of
a prior exposure to SARS-CoV-2. NCI and NIAID also are working to
establish a collaborative network to increase national capacity for
high-quality serological testing with rapid return-of-results to
subjects. These efforts include the use of serological testing to
support clinical trials of convalescent serum and the establishment of
registries for seroprotection studies. NIAID, NCI, the National Center
for Advancing Translational Sciences, and the National Institute of
Biomedical Imaging and Bioengineering are partnering on a study, called
the Serological Sciences Network or SeroNet, to investigate whether
adults in the United States without a confirmed history of SARS-CoV-2
infection have antibodies to the virus, thus indicating prior
infection. The study is evaluating the durability of the immune
response and aspects of the immune response that contribute to
protection against COVID-19.
NIAID scientists are participating in leadership of the COVID Human
Genetic Effort, an international consortium of hospitals and genetic
sequencing hubs that aim to discover genetic factors conferring
resistance to SARS-CoV-2 infection or predisposing to severe COVID-19
disease. The consortium has identified a subgroup of patients with
severe COVID-19 that have ineffective immune responses to SARS-CoV-2,
some of whom have identifiable mutations in key immune pathways. NIAID
also supports efforts to understand the rare but extremely serious
multisystem inflammatory syndrome in children (MIS-C) that has been
associated with SARS-CoV-2 infection in children and adolescents. NIAID
hosted a virtual workshop on MIS-C with scientists and clinicians from
academia, NIH, FDA, and industry, and a report of the workshop
recommendations was published on November 2, 2020. NIAID also supports
the Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM)
to evaluate acute and long-term clinical and immunological effects of
MIS-C and SARS-CoV-2 infection in children. In addition, NIAID is
collaborating with Children's National Medical Center to follow 1,000
children with a history of SARS-CoV-2 infection, including those with
MIS-C, to determine long-term effects of the illness. NIAID is
participating in a trans-NIH effort to coordinate MIS-C research led by
NHLBI and the Eunice Kennedy Shriver National Institute of Child Health
and Human Development. This centralized effort, the Collaboration to
Assess Risk and Identify Long-term Outcomes for Children with COVID
(CARING for Children with COVID), will permit data to be shared across
studies to determine the spectrum of illness and predict long-term
consequences of infection.
Monitoring the Long-term Effects of COVID-19
Many people who have had COVID-19 report continued symptoms as they
transition from the acute to post-acute phases of the disease, and we
continue to learn more about the duration and manifestations of COVID-
19 as we hear from these patients. In December 2020, NIAID hosted a
Workshop on Post-Acute Sequelae of COVID-19 with clinicians,
immunologists, virologists, and members of the patient community to
present existing data, identify key knowledge gaps, and explore
different perspectives on this heterogeneous condition. Subsequently,
NIH announced a trans-NIH effort to address PASC, including targeted
funding for research in this critical area. The NIH PASC Initiative
will complement ongoing NIAID studies to better understand the various
post-acute manifestations of COVID-19 in various populations.
NIAID intramural scientists initiated the Longitudinal Study of
COVID-19 Sequelae and Immunity to better understand PASC and determine
whether people who have recovered from acute SARS-CoV-2 infection
develop an immune response to SARS-CoV-2 that provides protection
against reinfection. NIAID-supported investigators also have
established the Immunophenotyping Assessment in a COVID-19 Cohort
(IMPACC) to determine how immunological markers correspond to, or may
even predict, the clinical severity of COVID-19. Since May 1, 2020,
IMPACC researchers have collected detailed clinical data along with
blood and respiratory samples from 1,800 hospitalized COVID-19 patients
of diverse race and ethnicity at approximately 20 hospitals nationwide.
The cohort will be followed during hospitalization and up to one year
after discharge to assess their functional and immunologic recovery.
Conclusion
NIAID continues to expand efforts to elucidate the biology,
pathogenesis and clinical manifestations of SARS-CoV-2 infection,
including emerging variants, and to employ this knowledge to develop
safe and effective interventions to diagnose, treat, and prevent SARS-
CoV-2 infection and COVID-19. NIAID is focused on developing safe and
effective SARS-CoV-2 vaccines and therapeutics and sensitive, specific,
and rapid point-of-care molecular diagnostic and serological tests.
NIAID also is conducting early stage research on candidate vaccines
that could protect against multiple strains of coronaviruses. These
efforts will improve our response to the current pandemic and bolster
our preparedness for the next, inevitable viral disease outbreak.
______
The Chair. Thank you, Dr. Fauci. We will turn to Dr.
Kessler.
STATEMENT OF DAVID KESSLER, M.D., CHIEF SCIENCE OFFICER, COVID
RESPONSE, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Dr. Kessler. Chair Murray, Ranking Member Burr,
distinguished Members of the Committee, I am Dr. David Kessler,
and I am honored to be serving as the Chief Scientific Officer
of the COVID-19 response. 40 years ago, I had the privilege of
sitting in those seats behind you as the most junior member of
the staff of this Committee led by Senator Hatch and Senator
Kennedy. Thank you for having me back and for the opportunity
to testify before you today.
Senator Burr. David, would you make sure that microphone is
on or could you pull it just a little bit closer? There you go.
Dr. Kessler. Today, the United States is in a very special
position with three authorized vaccines for the prevention of
COVID-19. I want to acknowledge the significant work of those
who came before, who worked tirelessly to make this happen. If
I can have the first slide, please. As you can see from that
slide, when we get it up, we now have enough vaccine available
for all American adults by May 31st.
When we first arrived at the President's direction, the
operation, building on the work of our predecessors at BARDA,
DOD, NIAID, FDA, CDC, HHS and the private sector, we made
additional purchases of the Pfizer and Moderna vaccines, making
300 million doses of each available by July 31st. Working with
Pfizer and Moderna, we were able to get each company to agree
to deliver 200 million doses each. That is 200 million regimens
each by the end of May. Then we also worked with Johnson and
Johnson to help accelerate their delivery of 100 million doses
by the end of May. To provide additional vaccine availability,
we worked to forge an historic manufacturing collaboration
between Johnson and Johnson and Merck. I want to update you, if
I may, on three critical initiatives. First, as a pediatrician,
we need to carefully evaluate data on the safety and
effectiveness of the vaccines in adolescents and children.
We are currently supporting multiple clinical trials to
help us understand vaccine safety and immunogenicity in
pediatric populations, which is a high priority for us. Second,
we are also working to address questions about variance. While
the current vaccines have proven highly effective, we are also
supporting studies on variants and efforts to reduce the next
iteration of these vaccines. We will remain vigilant and pursue
options to protect Americans if the need arises.
Finally, we are planning for a potential boost dose of
vaccines if they are needed. We are studying the durability of
existing vaccines and their ability to maintain an
immunological response. As with other vaccines, a subsequent
dose may be needed. There are many options that we can consider
for booster doses. We are studying potential booster doses and
planning now to have sufficient vaccine available, if
necessary. I look forward to working with Members of this
Committee as we address the issues that I have highlighted.
Thank you for the opportunity to testify today and I look
forward to your questions.
[The prepared statement of Dr. Kessler follows:]
prepared statement of david a. kessler
Chair Murray, Ranking Member Burr, distinguished Members of the
Committee, I am Dr. David Kessler, and I am honored to be serving as
the Chief Scientific Officer for the COVID-19 Response. I had the
privilege of sitting in those seats behind you forty years ago, as a
junior member of the Committee Staff when this Committee was led by
Senator Hatch and Senator Kennedy. Thank you for having me back and for
the opportunity to testify before you today, provide this update, and
discuss our planned actions and priorities going forward.
Today, the United States is in a special position, with three
vaccines authorized for the prevention of COVID-19. I am pleased to
report that we are sending out more than 20 million doses each week,
which has resulted in more than 27 percent of adults having their first
dose, and more than 15 percent of all adults being fully vaccinated.
I want to acknowledge up front the important work that was done to
bring a vaccine to the American people in record time. We are grateful
for these efforts, including the contributions of Moncef Slaoui. As we
advance new plans to deliver vaccines and therapeutics, I have the
great privilege of working closely with General Gustave Perna and his
team from the Department of Defense (DoD), as well as my colleagues
from the Department of Health and Human Services (HHS) who are also
appearing before you today.
It is important for Members of this Committee to know that today,
there is one COVID-19 Response team that is coordinated throughout all
levels of government. We are all part of that team. I have served in
government before and I can tell you that this is an extraordinary
level of coordination, focus, and commitment across government.
I pledge to work with all Members of this Committee and Congress as
we advance our COVID-19 Response efforts to bring COVID-19 under
control.
Today, I am here to share with you the latest information on
vaccine supply and production and to discuss some of the challenges we
need to address.
One of the first tasks that we undertook, when Pfizer and Moderna
supplied the only two authorized vaccines, was to make 300 million
doses of each available by July 31st of this year. Working with each
company, we were then able to get them to agree to deliver 200 million
doses each by the end of May.
Johnson & Johnson received an Emergency Use Authorization (EUA) for
its COVID-19 vaccine from the U.S. Food and Drug Administration (FDA)
on February 27, 2021. Soon after, we worked with Johnson & Johnson to
accelerate their delivery of 100 million doses also by the end of May.
Based on these commitments, President Biden announced that we would
have enough vaccine available for all adults in the United States by
May 31, 2021.
In addition, we helped forge a historic manufacturing collaboration
between Johnson & Johnson and Merck to expand production of the Johnson
& Johnson COVID-19 vaccine. The collaboration will increase manufacture
of vaccine substance, as well as fill-finish capacity. President Biden
recently announced that the United States plans to purchase another 100
million doses of the Johnson & Johnson vaccine.
While Moderna, Pfizer, and Johnson & Johnson have made combined
commitments to provide enough vaccine for all American adults, these
doses are not yet in hand and still need to be produced. I have worked
throughout my career on drug regulation and I know that quality in the
manufacturing of these vaccines is essential. There is a very strong
government team supporting the efforts to produce these vaccines,
working with the manufacturers to provide operational and logistical
assistance to help them achieve these goals.
As President Biden has stated, there is a difference between simply
having a vaccine supply and getting shots in arms. I am privileged to
work with colleagues on the COVID-19 Response who coordinate efforts
with state and local partners to deliver and administer those doses. We
have provided Federal support for over 600 community vaccination
centers, with Federal personnel on the ground at more than 200
community vaccination centers and mobile sites. We have also launched a
program to directly send doses to 21 pharmacy companies, now including
over 14,000 stores, and over 25 percent of doses were administered in
high-risk communities. In addition, we have launched a program to
directly send vaccine to community health centers, with the initial
phase to reach 250 centers, and the second phase to reach up to 700
additional centers. We stood up 19 high-volume, federally run sites
that combined have a capacity to administer nearly 70,000 shots per day
and which have already administered over one million shots in some of
America's most disadvantaged neighborhoods. Sixty percent of doses
administered at these federally run sites have gone to minorities.
Underlying all of these efforts is an unwavering commitment to vaccine
equity. We are committed to providing all Americans with equal access
to these important vaccines.
Today, I want to provide specific updates on three topics that we
know are vitally important to the overall effort to bring COVID-19
under control in America.
First, as a pediatrician, I know it is essential that we carefully
evaluate data on the safety and effectiveness of the vaccines in
adolescents and children. We are currently supporting multiple clinical
trials in adolescents and children, including clinical trials with
messenger RNA (mRNA), adenovirus, and recombinant protein vaccine
platforms. Those studies will help us understand vaccine safety and
immunogenicity in pediatric populations, which is a high priority for
us. We expect to have that data in the coming months and they will be
carefully reviewed by the Food and Drug Administration (FDA) and the
Centers for Disease Control and Prevention (CDC), which, as it normally
does, will rely on the recommendations of its Advisory Committee on
Immunization Practices (ACIP).
In addition, we are confronting new and emerging variants. Over the
last several months, we have witnessed an increasing prevalence in
viral variants that have raised questions about how effective current
vaccines will be in the future. Through our own funding of additional
studies and close collaboration with developers that have funded
independent trials, we have been able to get, and to continue to
obtain, critical insight into this situation. While the current
vaccines have proven highly effective, we continue to plan for the
future. To that end, and as my colleagues will describe further, we
have begun partnering with product developers to support efforts to
produce the next iteration of these vaccines. We will remain vigilant
and pursue options to protect Americans if the need arises.
The third issue I want to address today is our planning around the
questions of if and when Americans who have been vaccinated might need
a booster dose. In collaboration with my colleagues testifying today,
we are studying the durability of the existing vaccines to continue to
mount an effective immunological response. Preliminary data show that
neutralizing antibodies persist for some time after the second dose of
an mRNA vaccine with a relatively slow decline over time. As with other
vaccines, such as the influenza vaccines, a subsequent dose may be
important to provide continued protection against the wild-type strain
but also may be critical to maintain protection against variants. The
good news is that there are many potential options that we can consider
for potential booster doses. We are evaluating and expanding studies to
determine which options would be effective to achieve ongoing
protection. As you can imagine there are numerous potential
combinations of vaccine doses that might help protect Americans in the
future. Therefore, we are also planning now to make sure we have
sufficient vaccine available to support this potential need.
I look forward to working with Members of this Committee as we
address the issues I have highlighted. Thank you for the opportunity to
testify today on our recent COVID-19 Response actions.
______
The Chair. Thank you, Dr. Kessler. We will turn to Dr.
Marks.
STATEMENT OF PETER MARKS, M.D., PH.D., DIRECTOR, CENTER FOR
BIOLOGICS EVALUATION AND RESEARCH, UNITED STATES FOOD AND DRUG
ADMINISTRATION, SILVER SPRING, MD
Dr. Marks. Chair Murray, Ranking Member Burr, distinguished
Members of the Committee, I am Peter Marks, Director of the
Center for Biologics Evaluation and Research at the U.S. Food
and Drug Administration. Thank you for the opportunity to
testify before you today to describe the agency's COVID-19
response efforts. All of our efforts are in close coordination
and collaboration with our partners across the Federal
Government to help ensure the development, authorization, or
licensure and availability of safe and effective medical
products to address the COVID-19 public health emergency.
While my testimony will focus on FDA's work regarding
COVID-19 vaccines, I want to note at the outset that this is in
the context of the breadth of work that we are doing across the
agency to address the pandemic, including our work on
therapeutics and diagnostics. With the urgency called for
during this pandemic, FDA, through our transparent scientific
review process, has provided Emergency Use Authorization, or
EUA for short, for three COVID-19 vaccines.
In doing so, we have relied upon the agency's rigorous
standards for safety, effectiveness, and manufacturing quality.
Though there may be some differences in the results obtained
using these three COVID-19 vaccines, it should be noted that
they were not compared in a head to head clinical trial. All
three were found by FDA and its external advisory committee to
exceed the standards for an EUA that we articulated in
guidance, and importantly, all did an excellent job in
preventing hospitalization and death from COVID-19. Following
vaccine authorization or approval, FDA works with manufacturers
to help ensure continued supply and availability of these
critical medical products. The agency does this by promptly
reviewing proposed technical or manufacturing changes and
monitoring the continued quality of these products.
For example, FDA recently reviewed the data submitted by
Pfizer to allow undiluted frozen vials of the Pfizer-BioNTech
vaccine to be transported and stored at conventional
temperatures commonly found in pharmaceutical freezers for up
to two weeks. This will help ease the burden of procuring
ultra-cold storage equipment for vaccination sites and should
help to get vaccines to more places. FDA also plays an integral
role in the monitoring of the safety of authorized COVID-19
vaccines. FDA is doing so in collaboration with the Centers for
Disease Control and Prevention, the Center for Medicare and
Medicaid Services, Department of Veterans Affairs, and other
academic and large non-Governmental health care data systems.
In addition, FDA actively participates in ongoing
international pharmacovigilance efforts, including those
organized by the International Coalition of Medicines
Regulatory Authorities and the World Health Organization. These
efforts are in addition to the pharmacovigilance efforts being
undertaken by the individual manufacturers of the authorized
vaccines. Given the importance of passive and active safety
monitoring, a coordinated and overlapping approach using state
of the art technology has been implemented. These systems can
also potentially be leveraged to assess safety in specific
populations and assess vaccine effectiveness including against
emerging variants. The emergence of such virus variants raises
new concerns about the performance of the authorized COVID-19
vaccines, as well as therapeutics and diagnostics. Just last
month, FDA issued three new guidances and an update to our
vaccine EUA guidance to address the emergence of SARS-COVID-2
variants.
By issuing these, we want the American public to know that
we are using every tool at our disposal to fight this pandemic,
including pivoting as the virus adapts. These guidances will
help manufacturers develop medical products to provide
healthcare providers with the best available diagnostics,
therapeutics, and vaccines to fight this virus even as variants
emerge. We remain committed to getting these lifesaving
products to the front lines. In closing, I would like to stress
that having three vaccines authorized by FDA only one year
after the declaration of the pandemic is a tremendous
achievement and a testament to the dedication of a multitude of
partners. And these include FDA's career scientists and
physicians who have been working tirelessly to conduct
comprehensive and rigorous evaluation of the data submitted for
vaccines to prevent COVID-19.
All of those working at the agency are also grateful to be
able to contribute immeasurably toward bringing this pandemic
to an end. Thank you and I look forward to responding to your
questions.
[The prepared statement of Dr. Marks follows:]
prepared statement of peter marks
Chair Murray, Ranking Member Burr, distinguished Members of the
Committee, I am Dr. Peter Marks, Director of the Center for Biologics
Evaluation and Research (CBER) at the U.S. Food and Drug Administration
(FDA or the Agency). Thank you for the opportunity to testify before
you today to describe FDA's response efforts. All of our efforts are in
close coordination and collaboration with our partners, both within the
Department of Health and Human Services (HHS) and across the Federal
Government, to help ensure the development, authorization, licensure,
and availability of critical, safe, and effective medical products to
address the coronavirus disease 2019 (COVID-19) public health
emergency.
While my testimony will focus on FDA's work regarding COVID-19
vaccines, I want to note at the outset that this is in the context of
the breadth of work FDA is doing across the Agency to address this
pandemic, including our efforts on diagnostics and therapeutics.
With the urgency called for during this pandemic, FDA, through our
transparent scientific review process, has provided Emergency Use
Authorization (EUA) for three COVID-19 vaccines. In doing so, we have
relied upon the Agency's rigorous standards for safety, effectiveness,
and manufacturing quality. Vaccine development is a highly de-risked
process that generally proceeds sequentially through the various stages
of clinical development, and manufacturing scale-up only takes place
when it is very clear that the vaccine is safe and effective and is on
track for regulatory approval. These vaccines were developed without
cutting corners or sacrificing our standards. Intensive interactions
between FDA and manufacturers eliminated the time between different
studies in the clinical development process; allowed seamless movement
between the different phases of clinical trials; and simultaneously
proceeded with manufacturing scale-up before it was clear whether the
vaccine would be shown to be safe and effective. For the three vaccines
authorized to date, our EUA process not only included a thorough
evaluation of the data by the Agency's career staff, but also included
input from independent scientific and public health experts through our
public advisory committee process. Throughout this process, FDA took
additional steps to facilitate transparency, such as posting sponsor
and FDA briefing documents and key decisional memoranda.
The three authorizations make available COVID-19 vaccines in the
United States that have shown clear and compelling efficacy in large,
well-designed phase 3 trials and that meet rigorous standards for
safety and effectiveness. Vaccines will help us in the fight against
this pandemic, which has claimed over half a million lives here in the
United States alone. All the COVID-19 vaccines that FDA has authorized
for emergency use have surpassed the standard of being at least 50
percent more effective than placebo in preventing COVID-19, which was
the standard recommended in our June 2020 guidance document,
Development and Licensure of Vaccines to Prevent COVID-19. \1\ A
vaccine with at least 50 percent efficacy would have a significant
impact on disease, both at the individual and societal level.
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\1\ https://www.fda.gov/media/139638/download.
As part of our continued efforts to be transparent and educate the
public, we have a wealth of information on our website about the COVID-
19 vaccines. \2\ The information includes fact sheets with important
information such as dosing instructions; information about the benefits
and risks of each vaccine; and topical Questions and Answers developed
by FDA for each vaccine.
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\2\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions.
It is also important to highlight that, as part of the EUA, we are
requiring the manufacturers and vaccination providers to report serious
adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and
cases of COVID-19 that result in hospitalization or death to the
Vaccine Adverse Event Reporting System (VAERS), a national vaccine
safety surveillance program jointly run by FDA and the Centers for
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Disease Control and Prevention (CDC).
At this time, data are not available to make a determination about
how long the vaccines will provide protection, nor are we certain that
the vaccines prevent transmission of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) from person to person.
Finally, manufacturers whose COVID-19 vaccines have been authorized
for emergency use are expected to continue their clinical trials in
order to obtain additional safety and effectiveness information and
pursue licensure (approval) through the submission of a Biologics
License Application (BLA).
FDA's Role Working With COVID-19 Vaccine Manufacturers
FDA plays a critical role in the development and authorization or
licensure of vaccines, spanning the entire product lifecycle. The
Agency provides scientific and regulatory advice to industry,
researchers, and other stakeholders across the vaccine development
spectrum. Interactions with product developers begin long before any
formal regulatory submission is made and continue throughout
development under FDA's investigational new drug application process.
FDA is committed to working with all manufacturers developing products
to prevent or treat COVID-19 and has had numerous interactions with
COVID-19 vaccine manufacturers studying these products and seeking
emergency use authorization.
FDA makes use of all available regulatory tools and expedited
programs, as appropriate, to help advance products critical for public
health, from product development to when a product application is
submitted to FDA for our evaluation of safety and effectiveness to
support approval.
Following approval of a BLA or authorization of an EUA request, the
Agency uses real-world data to monitor the safety of vaccines through
both passive and active post-market surveillance. Passive surveillance
involves the submission of adverse event reports by patients,
providers, and manufacturers to FDA. The Agency also performs active
post-market surveillance of vaccines through various data bases,
including FDA's Sentinel system.
FDA works with manufacturers of approved or authorized products to
help ensure continued supply and availability of critical medical
products. The Agency does this by promptly reviewing proposed technical
or manufacturing changes and monitoring the continued quality of these
products. For example, CBER recently reviewed data submitted by Pfizer
to FDA to allow undiluted frozen vials of the Pfizer-BioNTech COVID-19
vaccine to be transported and stored at conventional temperatures
commonly found in pharmaceutical freezers for up to two weeks. This
will help ease the burden of procuring ultra-low cold storage equipment
for vaccination sites and should help get vaccine to more sites.
FDA is committed to providing timely scientific and regulatory
advice to support rapid COVID-19 response efforts. To assist
manufacturers with the development of COVID-19 vaccines, provide
recommendations, and outline FDA's expectations, the Agency issued
specific COVID-19 vaccine guidances. In June 2020, FDA issued guidance
titled Development and Licensure of Vaccines to Prevent COVID-19. In
October 2020, FDA issued guidance titled Emergency Use Authorization
for Vaccines to Prevent COVID-19 and updated it in February 2021. \3\
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\3\ https://www.fda.gov/media/142749/download.
During the COVID-19 public health emergency, FDA is utilizing all
available tools and sources of information to support regulatory
decisions on applications or EUA requests that include manufacturing
sites where FDA's ability to inspect facilities is impacted due to
COVID-19. During this interim period, we are using additional tools,
where available, to determine the need for an onsite inspection and to
support the application assessment, such as reviewing a firm's previous
compliance history, and requesting records in advance of or in lieu of
onsite inspections or voluntarily from facilities and sites. Following
notice by a sponsor of intent to submit an EUA request, FDA will
continue to work with the sponsor regarding resolution of any necessary
manufacturing site issues resulting from a site visit or other
information submitted. FDA will assess current good manufacturing
practices (CGMP) or CGMP compliance for each manufacturing site using
all available tools and information.
The EUA Process for COVID-19 Vaccines
A determination by the HHS Secretary issued on February 4, 2020,
declared that there is a public health emergency that has significant
potential to affect national security or the health and security of
U.S. citizens living abroad. Declarations were issued stating that
circumstances exist justifying the authorization of emergency use of
unapproved products. These declarations permitted FDA to issue EUAs to
allow unapproved medical products or unapproved uses of approved
medical products to be used in an emergency to diagnose, treat, or
prevent COVID-19 when there are no adequate, approved, and available
alternatives.
The issuance of an EUA is different than an FDA approval
(licensure) of a vaccine, in that a vaccine available under an EUA is
not approved. In determining whether to issue an EUA for a vaccine, FDA
evaluates the available evidence to determine whether the product may
be effective, and assesses any known or potential risks and any known
or potential benefits. If there is evidence that convinces us that the
vaccine may be effective and the benefit-risk assessment is favorable,
it is made available during the public health emergency. Once a
manufacturer submits an EUA request for a COVID-19 vaccine to FDA, the
Agency evaluates the request and determines whether the relevant
statutory criteria are met, taking into account the totality of the
scientific evidence about the vaccine that is available to FDA.
The EUA requires fact sheets that provide important information,
including dosing instructions and information about the benefits and
risks of the COVID-19 vaccines, be made available to vaccination
providers and vaccine recipients.
Each of the manufacturers of FDA-authorized COVID-19 vaccines
submitted a pharmacovigilance plan to FDA describing their commitment
to monitor the safety of their vaccines. The pharmacovigilance plans
include plans to complete longer-term safety followup for participants
enrolled in ongoing clinical trials. The pharmacovigilance plans also
include other activities aimed at monitoring the safety profile of the
COVID-19 vaccines and ensuring that any safety concerns are identified
and evaluated in a timely manner. FDA also expects manufacturers whose
COVID-19 vaccines are authorized under an EUA to continue their
clinical trials to obtain additional safety and effectiveness
information and pursue approval (licensure).
Specific details about each of the authorized vaccines are provided
below.
PFIZER COVID-19 VACCINE
On December 11, 2020, FDA issued the first EUA for a vaccine for
the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years
of age and older. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine
to be distributed in the United States.
The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA),
which is genetic material. The vaccine contains a small piece of the
SARS-CoV-2 virus' mRNA that instructs cells in the body to make the
virus' distinctive ``spike'' protein. When a person receives this
vaccine, their body produces copies of the spike protein, which does
not cause disease, but triggers the immune system to produce an immune
response against SARS-CoV-2.
FDA Evaluation of Available Safety Data
The Pfizer BioNTech COVID-19 Vaccine is administered as a series of
two doses, three weeks apart. The available safety data to support the
EUA include 37,586 participants enrolled in an ongoing randomized,
placebo-controlled international study, the majority of whom are U.S.
participants. These participants, 18,801 of whom received the vaccine
and 18,785 of whom received saline placebo, were followed for a median
of two months after receiving the second dose. The most commonly
reported side effects, which typically lasted several days, were pain
at the injectionsite, tiredness, headache, muscle pain, chills, joint
pain, and fever. Of note, more people experienced these side effects
after the second dose than after the first dose, so it is important for
vaccination providers and recipients to expect that there may be some
side effects after either dose, but more after the second dose.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the Pfizer BioNTech EUA include
an analysis of 36,523 participants in the ongoing randomized, placebo-
controlled international study, the majority of whom are U.S.
participants, who did not have evidence of SARS-CoV-2 infection through
seven days after the second dose. Among these participants, 18,198
received the vaccine and 18,325 received placebo. The vaccine was 95
percent effective in preventing COVID-19 disease among these clinical
trial participants with eight COVID-19 cases in the vaccine group and
162 in the placebo group. Of these 170 COVID-19 cases, one in the
vaccine group and three in the placebo group were classified as severe.
MODERNA COVID-19 VACCINE
On December 18, 2020, FDA issued an EUA for the second vaccine for
the prevention of COVID-19 caused by SARS-CoV-2. The EUA allows the
Moderna COVID-19 Vaccine to be distributed in the U.S for use in
individuals 18 years of age and older.
Like the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19
Vaccine contains a small piece of the SARS-CoV-2 virus' mRNA that
instructs cells in the body to make the virus' distinctive ``spike''
protein. After a person receives this vaccine, their body produces
copies of the spike protein, which does not cause disease, but triggers
the immune system to produce an immune response against SARS-CoV-2.
FDA Evaluation of Available Safety Data
The Moderna COVID-19 Vaccine is administered as a series of two
doses, one month apart. The available safety data to support the EUA
include an analysis of 30,351 participants enrolled in an ongoing
randomized, placebo-controlled study conducted in the U.S. These
participants, 15,185 of whom received the vaccine and 15,166 of whom
received saline placebo, were followed for a median of more than two
months after receiving the second dose. The most commonly reported side
effects, which typically lasted several days, were pain at the
injectionsite, tiredness, headache, muscle pain, chills, joint pain,
swollen lymph nodes in the same arm as the injection, nausea and
vomiting, and fever. Of note, more people experienced these side
effects after the second dose than after the first dose, so it is
important for vaccination providers and recipients to expect that there
may be some side effects after either dose, but more after the second
dose.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the Moderna COVID-19 EUA include
an analysis of 28,207 participants in the ongoing randomized, placebo-
controlled U.S. study who did not have evidence of SARS-CoV-2 infection
prior to the first dose of vaccine. Among these participants, 14,134
received the vaccine and 14,073 received placebo. The vaccine was 94.1
percent effective in preventing COVID-19 disease among these clinical
trial participants with 11 cases of COVID-19 in the vaccine group and
185 in the placebo group. At the time of the analysis of these 196
COVID-19 cases, none in the vaccine group and 30 in the placebo group
were classified as severe. After the analysis of these 196 cases was
completed, one severe case in the vaccine group was identified and was
awaiting confirmation at the time the EUA was issued.
JANSSEN (JOHNSON & JOHNSON) COVID-19 VACCINE
On February 27, 2021, FDA issued an EUA for the third vaccine for
the prevention of COVID-19 caused by SARS-CoV-2. The EUA allows the
Janssen COVID-19 Vaccine to be distributed in the United States for use
in individuals 18 years of age and older.
The Janssen COVID-19 Vaccine is manufactured using a specific type
of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to
deliver a piece of the DNA, or genetic material, that is used to make
the distinctive ``spike'' protein of the SARS-CoV-2 virus. While
adenoviruses are a group of viruses that are relatively common, Ad26,
which can cause cold symptoms and pink eye, has been modified for the
vaccine so that it cannot replicate in the human body or cause illness.
After a person receives this vaccine, the body can temporarily make the
spike protein, which does not cause disease, but triggers the immune
system to produce an immune response against SARS-CoV-2.
FDA Evaluation of Available Safety Data
The Janssen COVID-19 Vaccine is administered as a single dose. The
available safety data to support the EUA include an analysis of 43,783
participants enrolled in an ongoing randomized, placebo-controlled
study being conducted in South Africa, certain countries in South
America, Mexico, and the United States. The participants, 21,895 of
whom received the vaccine and 21,888 of whom received saline placebo,
were followed for a median of eight weeks after vaccination. The most
commonly reported side effects were pain at the injectionsite,
headache, fatigue, muscle aches, and nausea. Most of these side effects
were mild to moderate in severity and lasted one to two days.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the Janssen EUA include an
analysis of 39,321 participants in the ongoing randomized, placebo-
controlled study being conducted in South Africa, certain countries in
South America, Mexico, and the United States who did not have evidence
of SARS-CoV-2 infection prior to receiving the vaccine. Among these
participants, 19,630 received the vaccine and 19,691 received saline
placebo. Overall, the vaccine was approximately 67 percent effective in
preventing moderate to severe/critical COVID-19 occurring at least 14
days after vaccination and 66 percent effective in preventing moderate
to severe/critical COVID-19 occurring at least 28 days after
vaccination.
Additionally, the vaccine was approximately 77 percent effective in
preventing severe/critical COVID-19 occurring at least 14 days after
vaccination and 85 percent effective in preventing severe/critical
COVID-19 occurring at least 28 days after vaccination.
There were 116 cases of COVID-19 in the vaccine group that occurred
at least 14 days after vaccination, and 348 cases of COVID-19 in the
placebo group during this time period. There were 66 cases of COVID-19
in the vaccine group that occurred at least 28 days after vaccination
and 193 cases of COVID-19 in the placebo group during this time period.
Starting 14 days after vaccination, there were 14 severe/critical cases
in the vaccinated group versus 60 in the placebo group, and starting 28
days after vaccination, there were five severe/critical in the vaccine
group versus 34 cases in the placebo group. In this trial, no
individuals receiving the vaccine required hospitalization or died
starting 28 days after the vaccine compared to 16 individuals receiving
placebo.
COVID-19 VACCINE SAFETY SURVEILLANCE
CBER is monitoring the safety of authorized COVID-19 vaccines
through both passive and active safety surveillance systems. CBER is
doing so in collaboration with CDC, the Center for Medicare & Medicaid
Services (CMS), the Department of Veterans Affairs, and other academic
and large non-government healthcare data systems. In addition, CBER
participates actively in ongoing international pharmacovigilance
efforts, including those organized by the International Coalition of
Medicines Regulatory Authorities and the World Health Organization.
These efforts are in addition to the pharmacovigilance efforts being
undertaken by the individual manufacturers for authorized vaccines. A
coordinated and overlapping approach using state-of-the-art
technologies has been implemented.
Passive Surveillance
Passive surveillance is defined as unsolicited reports of adverse
events that are sent to a central data base or health authority. In the
United States, these are received and entered into the Vaccine Adverse
Event Reporting System (VAERS), a national vaccine safety monitoring
system co-managed by FDA and CDC. In the current pandemic, these
reports are being used in conjunction with other vaccine safety systems
to monitor the occurrence of certain adverse events including serious
adverse events, as providers of COVID-19 vaccines are required to
report these to VAERS. FDA efforts complement those of the v-safe text-
based monitoring system for adverse events that CDC has implemented. An
example of the work done with passive safety surveillance during the
current pandemic has been the evaluation of severe allergic reactions
following vaccination with the authorized mRNA-based COVID-19 vaccines.
Through this work, we have come to understand that these reactions are
quite rare, happening in fewer than five in one million vaccine doses
administered.
Active Surveillance
Active surveillance involves proactively obtaining and rapidly
analyzing information occurring in millions of individuals recorded in
large healthcare data systems to verify safety signals identified
through passive surveillance or to detect additional safety signals
that may not have been reported as adverse events to passive
surveillance systems. FDA is conducting active surveillance using the
Sentinel BEST (Biologics Effectiveness and Safety) System and the CMS
system, and is also collaborating with other Federal and non-Federal
partners.
BEST
To elaborate further, the BEST system, which is part of the
Sentinel initiative, comprises large-scale claims data, electronic
health records (EHR), and linked claims-EHR data bases with a data lag
of approximately three months. The system makes use of multiple data
sources and enables rapid queries to detect or evaluate adverse events
as well as studies to answer specific safety questions for vaccines.
The linked claims-EHR data base makes it possible to study the safety
of vaccines in sub-populations with pre-existing conditions or in
pregnant women. The major partners for BEST currently are Acumen, IBM
Federal HealthCare, IQVIA, and Columbia University and many affiliated
partners such as MedStar Health, BlueCross BlueShield of America, the
Observational Health Data Sciences and Informatics, OneFlorida,
University of California, and several others.
Using BEST, CBER plans to monitor about 15 adverse events that have
been identified with the deployment of previous vaccines but have yet
to be associated with a safety concern for an authorized COVID-19
vaccine at this time. CBER further plans to use the BEST system to
conduct more in-depth analyses should a safety concern be identified
from sources such as VAERS.
Collaboration with CMS
CBER has worked over the past several years with CMS to develop
capabilities for routine and time-sensitive assessments of the safety
of vaccines for people 65 years of age and older using the Medicare
Claims data base. Because it was already in place, having demonstrated
its use for the evaluation of influenza vaccine safety and efficacy,
this system was immediately put into use for COVID-19 vaccine
surveillance to monitor for adverse events.
During the current pandemic, FDA, CMS, and CDC have already used
the Medicare data to publish a study showing that frailty,
comorbidities, and race/ethnicity were strong risk factors of COVID-19
hospitalization and death among the U.S. elderly.
In summary, in collaboration and coordination with several
different partners, CBER has assembled passive and active surveillance
systems that can detect and refine safety findings with the recently
authorized COVID-19 vaccines in a relatively rapid manner. These
systems can also potentially be leveraged to assess safety in specific
subpopulations and to assess vaccine effectiveness, including against
emerging variants.
NEXT STEPS
The emergence of the virus variants raises new concerns about the
performance of these authorized vaccines, as well as therapeutics and
diagnostics that FDA has authorized for COVID-19. In February 2021, FDA
issued two new guidances and an update to its vaccine EUA guidance to
address the emergence of SARS-CoV-2 variants of concern. \4\ By issuing
these guidances, we want the American public to know that we are using
every tool in our medical toolbox to fight this pandemic, including
pivoting as the virus adapts. These guidances will help manufacturers
to develop medical products to provide health care providers with the
best available diagnostics, therapeutics, and vaccines to fight this
virus--even as variants emerge. We remain committed to getting these
life-saving products to the frontlines.
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\4\ https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-
industry-fda-staff-and-other-stakeholders.
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CONCLUSION
The process FDA uses to evaluate the safety and effectiveness of
medical products is respected worldwide and commonly referred to as the
``gold standard.'' Because of a well-established history, the Agency's
review processes are globally recognized as the most rigorous and
accurate.
Having three vaccines authorized that meet the FDA's expectations
for safety and effectiveness only one year after the declaration of the
pandemic is a tremendous achievement and a testament to the dedication
of developers and FDA's career scientists and physicians, many of whom
have been working tirelessly to conduct comprehensive and rigorous
evaluations of the data submitted for vaccines to prevent COVID-19. The
Agency is very proud of these efforts, and we hope that the vaccines
will help bring this pandemic to an end.
______
The Chair. Thank you, Dr. Marks. We will turn to Dr.
Walensky.
STATEMENT OF ROCHELLE WALENSKY, M.D., M.P.H., DIRECTOR, UNITED
STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Walensky. Thank you, Chair Murray and Ranking Member
Burr, for your invitation to talk with you today and for your
leadership during the U.S. response to COVID-19. I have had the
honor of being the Director of the Centers for Disease Control
and Prevention for two months. Taking on this role in the
middle of a pandemic has presented no shortage of challenges.
And I am so grateful for the guidance of the dedicated staff at
CDC and the deep expertise they bring.
CDC staff continue to work tirelessly to respond to the
COVID-19 pandemic, and I am committed to supporting their
efforts to ensure that science and evidence drive our path
forward. Last week we crossed the one-year mark since WHO
declared COVID-19 a global pandemic. I want to take a moment to
recognize the more than 500,000 American lives lost during the
past year. That is half a million mothers, fathers, sisters,
brothers, grandparents, and children who have died because of
this virus. Every loss is felt by grieving families, by friends
unable to say goodbye, and by communities that have been
devastated by this pandemic. While we have recently seen
reductions in cases and deaths, we must remain cautious.
The average daily death rate is still tragically still more
than twice the rate seen last September. We are in a race to
stop transmission, and the emergence of variants that spread
more easily has made us even more challenging. I am committed
to closely monitoring the proliferation of these variants in
this Country and around the world. We are doing that by rapidly
scaling up genomic sequencing and we are well on our way to
25,000 samples per week. As we monitor disease transmission and
variants, we are getting vaccines into arms quickly, safely,
and as equitably as possible. Having three vaccines that you
just heard about that are highly effective at preventing
serious illness, hospitalization, and death will help us end
this pandemic. As of March 17th, more than 113 million doses of
COVID-19 vaccine have been administered, over 73 million people
have received at least one dose, including 40 million who are
fully vaccinated. This is a remarkable accomplishment, and yet
we have so much more to do.
CDC is working in coordination with national, state,
tribal, local, Governmental, and non-Governmental partners to
build trust in the vaccines, the vaccinator, and the
vaccination system. Instrumental to this work is addressing
barriers to vaccinations in communities of color and
disproportionately affected groups. COVID-19 has highlighted
long standing systemic health disparities and health equity
must be a cornerstone of our public health work. CDC is
committed to expanding evidence based approaches to reduce
disparities and COVID-19 cases, hospitalizations and deaths,
prioritizing equity in vaccine distribution and expanding a
diverse workforce. This is not our first emergency. Since 2009,
the U.S. has faced four significant emerging infectious disease
threats, the H1N1 influenza pandemic, Ebola, Zika, and now
COVID-19.
While urgency demanded rapid and unique approaches in
response to each of these threats, none resulted in the
necessary sustained investments for public health
infrastructure. This lack of preparation continues to present
significant challenges in our ongoing fight on COVID-19. If we
don't act with permanent fixes, these challenges will continue
to exist when the next public health threat emerges. I would
like to leave you with four points today. First, CDC is leading
with science and will continue to be the public health
resource, scientific resource for the American public and for
our international partners.
Second, we are expanding the reach of lifesaving vaccines
and improving vaccine confidence. To end this pandemic, we must
also maintain proven effective prevention measures, masks, and
hygiene, and physical distance. Third, health equity must be at
the intersection of everything we do in public health, and I am
committed to doing that as CDC Director. And we must work
toward sustainable investments in public health infrastructure
to be better prepared for whatever comes next. I look forward
to working together to address both the immediate challenges
ahead and the deficiencies in our public health infrastructure
that left our Country vulnerable to this pandemic.
We will get through this pandemic and I look forward to
working with you to support CDC and address our public health
challenges at home and abroad. Thank you again for the
invitation to testify today and I look forward to answering
your questions.
[The prepared statement of Dr. Walensky follows:]
prepared statement of rochelle p. walensky
Madam Chair Murray, Ranking Member Burr, and distinguished Members
of the Committee. It is an honor to appear before you today to discuss
the Centers for Disease Control and Prevention's (CDC) ongoing response
to the COVID-19 pandemic. I am grateful for this opportunity to address
this Committee as well as for your partnership and leadership in
responding to COVID-19.
It is my privilege to represent CDC. CDC is America's health
protection agency. We work 24/7 to prevent illness, save lives, and
protect America from threats to our health, safety, and security. CDC
is proud of its key role in preparedness and response to public health
concerns here in the U.S. and abroad. Addressing infectious diseases
and pandemics, like COVID-19, is central to our mission. CDC's
expertise lies in our ability to study emerging pathogens like SARS-
CoV-2, to understand how they are transmitted, and to translate that
knowledge into timely public health action. By deploying experts on the
ground to support our state, Tribal, local, and territorial partners,
we translate science into guidance that protects individuals,
communities, and populations. In our work with other Federal agencies
we ensure the safe and appropriate use of medical countermeasures,
including vaccines, and collaborate with the academic sector to further
our understanding of new diseases.
I've had the honor of being the Director of this agency for just
under two months, and it is clear to me that all of this work is done
by expert staff with great dedication to, and pride in, their work.
They work tirelessly to respond to the COVID-19 pandemic, and I am
committed to making sure that their efforts to conduct and analyze the
data allow science to drive our path forward.
CDC Efforts to Date
As you are aware, COVID-19 cases have decreased from their highest
points in December and early January. As of March 12th, the weekly
average number of cases has decreased by 11 percent over the previous
week's average. The number of deaths has also fallen, with an 19
percent change over the same period.
We are hopeful. And, still, we must remain cautious. The average
daily case rate is still more than twice the rate seen last September
before cases started rising through the fall.
It goes without saying, we have been tested over the past year. It
has been an extraordinarily difficult time for the United States. And I
want to take a moment to recognize the more than 500,000 Americans,
half a million mothers, fathers, sisters, brothers, wives, husbands,
grandparents, and children, who have died because of the pandemic.
Every loss is felt. By grieving families, by friends who are unable to
say goodbye because of hospital mitigation strategies, by communities
devastated by the disparate impact of this virus.
As hard as this has been, we can still persevere. If we can just
stay the course a little longer and maintain evidence-based mitigation
measures, while vaccinations continue to ramp up, we can prevent a lot
of disease and save a lot of lives.
Right now, we are in a race to stop transmission. Variants of this
virus that have slight genetic differences from the initial strain have
emerged and available data suggest some are more transmissible. CDC is
taking steps to expand sequence surveillance across the U.S. to improve
our understanding about the impact of these variants on vaccine
effectiveness, severity of disease, transmission, and mortality.
We must continue to use every tool we have to fight this virus:
wearing masks, social distancing, handwashing, and administering
vaccines.
The scale of this unprecedented public health emergency requires
unprecedented action--at CDC, more than 8,500 CDC personnel have been
part of our COVID-19 response, both at CDC headquarters and in the
field. More than 1,500 staff have taken part in over 3,000 deployments
to nearly 300 cities across the U.S. and around the world.
CDC is working to ensure that public health decisions are based on
the highest-quality scientific information.
Since the start of the pandemic, over 200 COVID-19 studies have
been published in the Morbidity and Mortality Weekly Report (MMWR) on
topics ranging from health disparities exacerbated during the pandemic,
to mitigation strategies to prevent spread, to emergence of new
variants, and CDC has produced more than 5,000 documents to provide
information and guidance for government agencies, businesses, and the
public.
The new resources provided by President Biden's American Rescue
Plan will further scale up the public health efforts needed to contain
the virus, through six critical priorities:
a strengthened national vaccination program,
increased testing to protect at-risk populations,
expansion of the public health workforce,
protection for vulnerable populations,
a commitment to U.S. leadership in the global
response, and
enhanced surveillance to identify emerging strains.
Now I want to take a moment to give you a more in-depth update on
some key areas for the COVID-19 response.
Variants
COVID-19 has brought to the forefront how interconnected we are as
a global community and the importance of our international scientific
relationships.
In the fall of 2020, several SARS-CoV-2 variants emerged, some of
which appear to spread more easily than others. An increase in viral
transmission could reverse the progress we've made and the downward
trend in COVID-19 cases that we have seen since early January. We are
at risk, once again, of overtaxing an overwhelmed health system.
Furthermore, there is concern with how well the variants are
neutralized by antibodies elicited through prior infection or
vaccination. The emergence of variants is, of course, concerning, and
it underscores the critical need for genomic surveillance and increased
vigilance in the implementation of public health mitigation measures.
In anticipation of these ongoing threats, the Department of Health
and Human Services (HHS) established the SARS-CoV-2 Interagency Group
to improve coordination across the CDC, National Institutes of Health,
Food and Drug Administration (FDA), Biomedical Advanced Research and
Development Authority, United States Department of Agriculture, and
Department of Defense. This interagency group is focused on the rapid
characterization of the emerging variants of concern and is actively
monitoring the potential impact on critical SARS-CoV-2 countermeasures
including vaccines, therapeutics, and diagnostics.
Of the emerging variants, three have captured our attention and
have the highest risk to the public health: B.1.1.7, B.1.351, and P.1.
The B.1.1.7 variant, originally identified in the United Kingdom,
was first identified in the United States on December 29, 2020. As of
March 15, 2021, CDC is reporting 4,500 cases in 50 jurisdictions that
are attributed to the B.1.1.7 variant. As of March 10, data from CDC
national surveillance showed that B.1.1.7 viruses represented 7 percent
of the viruses circulating for the week ending February 27th, but the
current trajectory suggests that the B.1.1.7 variant may now account
for as much as 25-30 percent of US viruses. The prevalence of B.1.1.7
is expected to continue to increase as a proportion of all cases.
Importantly, variant proportions are dynamic and are not the same in
all parts of the country.
The B.1.351 variant, first identified in South Africa, and the P.1
variant, first identified in Brazil, have also been identified in the
United States. CDC is reporting 81 B.1.351 cases in 20 jurisdictions
and 15 P.1. cases in nine jurisdictions.
New data from a collaboration between CDC and Emory University
suggest that antibodies generated against previous infection or
vaccination with the Moderna vaccine are able to neutralize the B.1.1.7
variant but have reduced neutralization against the B.1.351 variant. It
is unclear what impact this will have on the real-world effectiveness
of current vaccines against the B.1.351 variant, and efforts are
ongoing to better understand the impact of the variants on medical
countermeasures. CDC has been acting on multiple fronts to increase
surveillance in the United States to detect variants of SARS-CoV-2.
At CDC, we're contracting with several large commercial diagnostic
laboratories to get viral sequence data from around the country. These
laboratories are currently providing data on about 6,000 virus samples
per week and will expand to capture 25,000 samples per week, with
support from the funding the Administration announced last month and
resources provided by the American Rescue Plan Act. In addition, public
health laboratories around the country are sending CDC samples from 750
cases each week. These samples will allow us to both get the viral
sequences and isolate the viruses so that we can do additional
laboratory testing to better understand virulence, transmissibility and
the potential impacts on diagnostic tests, therapeutics, and vaccines.
Moreover, U.S. state and local public health laboratories are also
sequencing 4,000 specimens per week and using the data to better
understand the local epidemiology and to control outbreaks. In
addition, U.S. academic institutions and industry are also sequencing
another 4,000 viruses per week. These efforts are coordinated through
CDC's SPHERES collaboration, which is a new national genomics
consortium to coordinate large-scale SARS-CoV-2 sequencing across the
country. In all, the U.S. is currently sequencing about 4 percent of
the roughly 400,000 weekly cases. These partnerships with commercial
labs, state and local health departments, and academic and research
institutions will continue to grow and the amount of sequencing will
increase in coming weeks especially with the investment in sequencing
included in the American Rescue Plan.
Each new variant can present different challenges. But each can be
stopped by the same methods: rigorous and increased compliance with
public health mitigation strategies such as vaccination, physical
distancing, use of masks, hand hygiene, and isolation and quarantine.
Health Equity
COVID-19 has highlighted long-standing systemic health and social
inequities. Data repeatedly show the disproportionate impact of COVID-
19 on racial and ethnic minority populations, as well as other
population groups such as people living in rural or frontier areas,
people experiencing homelessness, essential and frontline workers,
people with disabilities, people with substance use disorders, people
who are incarcerated, and non-U.S.-born persons. Inequities in social
determinants of health, such as poverty, housing, and healthcare
access, have influenced a wide range of health and quality-of-life
outcomes for these groups experiencing disproportionate impacts.
These factors and others are associated with more COVID-19 cases,
hospitalizations, and deaths. Not surprisingly, they intersect with
higher rates of some medical conditions in these same populations that
increase one's risk of severe illness from COVID-19.
Health equity must be a cornerstone of our public health work. We
need the best possible data to identify the challenges and measure our
progress as we implement solutions. While we have seen big improvements
over the last year, we know that there are still critical gaps in these
data. For example, race and ethnicity data continue to be missing from
approximately half of the laboratory tests reported to CDC. Progress
has been slow because there are many data requisition forms and data
interfaces in the data exchange pathway that have to be updated. This
pandemic response has illustrated the long-standing need for
improvements in the public health data network. Congress has been
supportive of CDC and has responded to our partners' concerns about our
antiquated data systems by providing resources to CDC for the data
modernization initiative, the first comprehensive strategy to modernize
data, technology, and workforce capabilities--together and at once. CDC
is collaborating with our partners in the field to improve data
collection and sharing.
CDC is committed to addressing these gaps, not only for the COVID-
19 response, but for all public health data. And as we do this work, we
will simultaneously take action on what we know--that these disparities
exist and that they are unacceptable.
CDC's Chief Health Equity Officer has been leading our Health
Equity Strategy to accelerate progress in reducing COVID-19
disparities. The strategy commits to expanding evidence-based
approaches to reduce disparities in COVID-19 hospitalizations and
deaths; increase testing, contact tracing, isolation options, and
healthcare in populations at increased risk for COVID-19; prioritize
equity in distribution and administration of COVID-19 vaccines; reduce
stigma and bias; and expand a diverse workforce. We are engaging with
community-based organizations and diverse leaders to conduct outreach
that is culturally and linguistically responsive and make strides for
populations at increased risk of getting sick and dying from COVID-19
To operationalize the Health Equity Strategy, CDC is supporting
activities and interventions with organizations across multiple
sectors, including community-and faith-based organizations that have
been able to provide more insight about the challenges and needs of the
populations of focus. They have also helped us to reach these
populations with tailored prevention messages about COVID-19. With
their guidance, CDC has developed toolkits and other resources to
address the unique needs of, and to help, communities that have been
disproportionately impacted by COVID-19.
For example, CDC is providing funding for the Southern Alliance to
address COVID-19 among non-Hispanic Blacks and/or African Americans
living in the southeast region of the United States. The goal of this
project is to enlist established and trusted community members to
encourage the adoption of COVID-19 preventive and community mitigation
strategies. These include improving chronic disease management, COVID-
19 testing, facilitating contact tracing, promoting face covering and
social distancing, and identifying mental health issues associated with
COVID-19.
CDC is also funding the National Center for Farmworker Health to
enhance coordination among a national network of agricultural worker-
serving organizations and to strengthen their outreach capacity to
address the ongoing COVID-19 threat to agricultural communities. With a
focus on addressing COVID-19 educational needs among farmworkers, using
materials in their native language, the National Center for Farmworker
Health is encouraging vaccination, collaborating with other state and
local organizations to facilitate farmworkers' access to the vaccines
and other prevention resources, and finding and sharing replicable
promising practices that support agricultural workers and employers
during the pandemic and that may prevent COVID-19 outbreaks in rural
communities.
CDC has also led and supported initiatives to reduce the spread of
COVID-19 in Tribal communities. We know that clean water is essential
to meeting basic health needs--and in the context of the pandemic,
necessary to ensure handwashing and hygiene. CDC led a survey of all
110 Navajo Chapters to identify those with the lowest level of water
access and the highest COVID-19 infection rates. CDC and the Indian
Health Service partnered with the Navajo Tribal Utility Authority and
the Navajo Engineering and Construction Authority to install new water
access points for 59 Navajo Chapters with the greatest needs.
Another example of CDC efforts to support critical and underserved
populations is CDC's funding of the University of Minnesota's National
Resource Center for Refugees, Immigrants, and Migrants (NRC-RIM), which
provides assistance and resources to state and local health departments
working with refugee, immigrant, and migrant communities that have been
disproportionately affected by COVID-19. Their work provides health
departments with toolkits to improve communication, community
engagement, case investigation, contact tracing, and testing in these
populations. The resource center also provides a centralized location
for resources related to COVID-19 vaccines, which are accessible in
multiple languages and tailored to refugee, immigrant, and migrant
communities.
CDC has directed its COVID-19 funding toward activities and
programs that will help lay the foundation for long-term improvements
in health equity. As we expand our testing and mitigation efforts
through the American Rescue Plan, we also will be focused on
prioritizing increased access to testing in the communities hardest hit
by the pandemic and expanding screening testing in at-risk populations.
CDC remains focused on this goal and dedicated to working as a partner
with others.
Vaccines
Vaccination is a critical tool in bringing this unprecedented
pandemic to an end. In the year since COVID-19 infections were first
identified, the FDA has issued Emergency Use Authorizations (EUA) for
three vaccines that meet the expectations for safety and effectiveness
for emergency use that are being distributed and administered as we
speak. We should all take a moment and acknowledge that this is a
remarkable accomplishment. When someone asks me which of these vaccines
is the best vaccine to take, my answer is simple: take whichever
vaccine you are offered. Each vaccine--Johnson & Johnson/Janssen,
Moderna, and Pfizer--is very effective at preventing serious illness,
hospitalization, and death from COVID-19.
Building on long-standing relationships with state and local
partners, CDC has worked tirelessly to ensure that we are getting
vaccines into arms as quickly, safely, and equitably as possible. As of
March 15, over 135 million doses have been delivered, and more than 109
million doses of COVID-19 vaccine have been administered in just 13
weeks. This is a whole-of-society effort, and it is inspiring to see
people across government, business, and communities coming together to
complete this important lifesaving task.
I would like to touch on four core areas that drive CDC's vaccine
work: safety, confidence, access, and equity. Vaccines are rigorously
studied during clinical trials and there is a vast network of safety
systems that monitor vaccines once they are in use and safety protocols
to monitor people when they receive the vaccine. It is important that
we continually deliver the message that these vaccines are safe.
Strong confidence in vaccines within communities leads to more
people getting vaccinated, and to fewer COVID-19 illnesses,
hospitalizations, and deaths. CDC is working in coordination with
national, state, tribal, and local governmental and non-governmental
partners to build trust in the vaccine, the vaccinator, and the
vaccination system. We will continue to work with these critical
partners to address barriers to vaccinations, including in communities
of color and disproportionally affected groups.
In January 2021, CDC awarded $3 billion from the 2021 Coronavirus
Response and Relief Supplemental Appropriations Act to state, local,
and territorial health departments to ensure broad-based distribution,
access, and vaccine coverage nationwide. CDC requires that at least 10
percent of these funds be directed to vaccinating high-risk and
underserved populations.
In order to enhance vaccine uptake among underserved communities of
color and to build trust and confidence in the vaccine itself, CDC has
developed a comprehensive program of approximately 20 national
organizations that support hundreds of local and community-based
organizations to improve both COVID-19 and influenza vaccination
coverage among racial and ethnic groups who have historically had, and
continue to experience, health disparities.
Also critical to prioritizing equity in vaccine distribution is
improving access to underserved communities and disproportionately
affected populations who have historically had less access to
healthcare. To that end, CDC is working closely with the Federal
Emergency Management Agency (FEMA) and other Federal partners to get
vaccines to communities that may have limited healthcare access. This
includes coordination with FEMA around their Community Vaccination
Centers and partnering with the Health Resources and Services
Administration (HRSA) to launch a program to directly allocate COVID-19
vaccines in select HRSA-funded health centers. Both approaches will
help ensure that our Nation's underserved communities and
disproportionally affected populations are equitably vaccinated.
The Federal Retail Pharmacy Program (RPP) is another important
component in the work CDC is doing to provide greater access to COVID-
19 vaccines to communities of color and other underserved populations.
CDC is partnering with 21 national pharmacy organizations and
independent pharmacy networks that represent over 40,000 locations
nationwide to ensure that the public has access to COVID-19 vaccines in
a familiar setting. Almost 90 percent of Americans live within 5 miles
of a retail pharmacy. Earlier this month, the RPP began to prioritize
vaccinating teachers, school staff and childcare workers. Pharmacies
have also been critical to vaccinating residents and staff in long-term
care settings. Currently, there are over 14,000 pharmacy locations
participating in the program nationwide--an increase of over 10,000
since the program began, including 4,000 new locations in just the past
week--that have received nearly 14 million doses of vaccine, increasing
access to COVID-19 vaccination across the country while decreasing the
burden on state, local, and territorial health departments.
Health equity remains a cornerstone of CDC's vaccination efforts,
and we need the best possible data to both identify the challenges and
measure our progress as we implement solutions. At the end of February,
CDC hosted a virtual National Forum on COVID-19 Vaccine. The Forum
focused on vaccine confidence, data to drive vaccine implementation,
and equity in vaccine distribution. We gathered over 13,000 people from
6,700 organizations, from every state, Washington DC, nearly all
territories and 197 Tribes or tribal organizations--excited to learn,
teach, and bring back to their communities a renewed enthusiasm for the
massive task ahead and the urgent need to administer COVID-19 vaccines
as efficiently and equitably as we can. They each provided critical
feedback, which we are actively incorporating into our plans.
Looking to the future, we are optimistic that, in collaboration
with our state, Tribal, local, and territorial partners, we have built
a vaccine implementation infrastructure that will expand vaccination
coverage to allow our communities to resume some aspects of a normal
life. Active investigations will continue to determine how much
vaccines reduce asymptomatic infection and transmission, how long
vaccine protection lasts, and to what extent vaccines protect against
emerging SARS-CoV-2 variants. Last week, CDC released new guidelines
for fully vaccinated people, and we look forward to revising this
guidance as the science develops and as more of the population is
protected through vaccination.
Schools
Since becoming the director of the CDC, I have stressed the
importance of getting children back to school for in-person learning.
The safest way to open schools is to ensure that there is as little
disease as possible in the community. The lower the amount of disease
in the community, the less likely it is that cases will be introduced
into the school environment. This means that all community members,
students, families, teachers, and school staff should take actions to
protect themselves and the community where they live, work, learn, play
and worship.
CDC recommends that, among community institutions, schools should
be the first to open and the last to close. Because of the benefits of
in-person learning and the key support services schools offer, it is
critical for K-12 schools to open, and stay open, as safely and as soon
as possible. This is especially true in low-resourced communities,
which may include large representations of racial and ethnic minority
groups and students with disabilities. CDC began working on guidance,
resources, and tools for safe school reopening in March 2020 when the
first schools closed. As CDC learned more about COVID-19, we
continually updated our guidance, resources, and tools for schools,
parents, teachers, and other staff.
In February of this year, CDC released new science-based resources
and tools to help schools safely reopen and stay open for in-person
learning. Specifically, CDC conducted an in-depth review of the science
and released the Science Brief: Transmission of SARS-CoV-2 in K-12
Schools, \1\ which informed CDC's Operational Strategy for K-12 Schools
through Phased Mitigation. \2\ In developing the K-12 Operational
Strategy, CDC gathered input from school superintendents, school
officers and nurses, national associations with a focus on education,
organizations that represent elected officials, and others. These new
resources complement CDC's existing guidance and tools for K-12
schools, including a toolkit to assess risks and implement prevention
strategies to reduce the spread of SARS-CoV-2 in schools, a quick guide
to assist teachers in modifying the layout of their classroom in a way
that reduces the risk of virus spread, and updated materials about
ventilation strategies in school and child-care settings. CDC will
continue to collaborate closely with our colleagues at the U.S.
Department of Education to make sure that all schools have access to
the latest understanding and guidance.
---------------------------------------------------------------------------
\1\ https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-
research/transmission-k-12-schools.html.
\2\ https://www.cdc.gov/coronavirus/2019-ncov/community/schools-
childcare/operation-strategy.html.
Evidence indicates that many K-12 schools that have implemented
prevention strategies to reduce the spread of SARS-CoV-2 consistently
and correctly have been able to safely open for in-person instruction
and remain open. The K-12 Operational Strategy outlines options for all
schools--at any level of community transmission--to provide either full
or hybrid in-person instruction through strict adherence to prevention
strategies. Regardless of the level of SARS-CoV-2 spread in the
community, CDC recommends using a combination of five key strategies to
reduce the spread of SARS-CoV-2 in schools and help protect teachers,
students, and staff. These strategies are universal and include the
correct use of masks, physical distancing, handwashing and respiratory
etiquette, cleaning and maintaining healthy facilities, proper
ventilation, and contact tracing, in combination with isolation and
quarantine, in collaboration with the health department. We also point
to the added layers of prevention to be gained from regular testing and
---------------------------------------------------------------------------
vaccination.
Universal and correct use of masks and physical distancing are two
prevention strategies that are most essential to reducing SARS-CoV-2
transmission, but a layered approach that uses all five of these
strategies will provide the greatest level of protection.
Teachers and school staff hold jobs critical to the continued
functioning of our communities and our society, and are at potential
occupational risk of exposure to SARS-CoV-2. We must treat in-person
learning like the essential service that it is and get teachers,
childcare workers, and other school staff vaccinated as soon as
possible. Vaccination for teachers, staff, and among surrounding
communities is one of the several layers of prevention strategies to
reduce SARS-CoV-2 transmission in schools outlined in our K-12
Operational Strategy. CDC is committed to working with our Federal,
state, and local partners to achieve President Biden's goal, in
accordance with the HHS Secretarial directive related to making
educators eligible along with other priority groups , to provide a
first dose of the vaccine to every educator, school staff member, and
childcare worker by the end of March.
SARS-CoV-2 is still a relatively new pathogen, and we are learning
more about it and how it impacts different people and communities all
the time. CDC's K-12 Operational Strategy presents recommendations
based on the best-available evidence at the time of release. As science
and data on SARS-CoV-2 and COVID-19 continue to evolve, we will update
our guidance and recommendations to reflect new evidence. CDC stands
committed to providing the best, most current data and scientific
understanding available to protect the health, safety, and well-being
of our communities, including our students, teachers, and school staff.
Looking to the Future
I want to highlight that I'm cognizant that over the last 12 years,
the United States has faced four significant emerging infectious
disease threats--the H1N1 influenza pandemic, Ebola, Zika, and COVID-
19. While urgency demanded rapid and unique responses to each of these
threats, none resulted in the sustained improvements and investments
needed in our Nation's public health infrastructure.
This lack of preparation continues to present significant
challenges in our ongoing fight to tackle COVID-19. These experiences
have proven that public health emergencies and, specifically,
infectious disease threats are here to stay.
Looking to the future, I want to work within the Administration and
with you to address long-standing vulnerabilities in our core public
health infrastructure, including data, workforce, laboratory, domestic
preparedness, and global health security.
To avoid the substantial economic costs associated with both large-
scale emergencies and chronic public health concerns, we must be
willing to make investments in our public health system. We also must
offer up our technical expertise to support efforts to advance global
health security.
Conclusion
In closing, I want to emphasize that, while we must remain vigilant
and continue to use every tool we have to fight this virus, there are
reasons to be hopeful. I am optimistic that we are moving in the right
direction. I am looking forward to seeing more kids in school, more
families able to connect with one another safely, and our Nation
beginning to move forward and heal. We are committed to continuing to
advance the science around COVID-19; moving more vaccines into more
communities--especially those communities most at-risk for COVID-19
infection--and working to improve health equity.
The next few months will be critical, and we need everyone to
continue to wear masks properly, practice social distancing and
handwashing, and get vaccinated. I recognize that everyone is fatigued
after a very long year. It is as critical as ever to continue these
lifesaving efforts.
I look forward to working together to address both the immediate
challenges ahead in our fight against COVID-19, along with the
weaknesses in our public health infrastructure that left our country
vulnerable to this pandemic. CDC is grateful for your support.
We will continue to work tirelessly to ensure the health of this
Nation and the world. Together, we will get through this pandemic and
work to continue building a sustainable and resilient public health
system that can respond effectively to emerging threats and to the
ongoing public health needs of every American. Thank you again for the
invitation to testify today and I look forward to answering your
questions.
______
The Chair. Thank you, Dr. Walensky. We will now begin a
round of five minute questions of our witnesses. I want to
thank you all again for being here today. I ask my colleagues
to keep track of your clocks, stay within those five minutes.
Dr. Fauci, we have spent over a year responding to the biggest
public health crisis in a century. Since you last testified
before this Committee, lifesaving therapeutics and vaccines
have reached patients with increasing speed and saved lives.
However, we must do--all do more to end this pandemic and
build back stronger and fairer. The majority of the people in
this Country are not yet vaccinated, and the variants are
continuing to threaten our progress. As the nature of this
pandemic and the virus itself changes, our response has to
change too. What is the biggest challenge ahead in our response
to this pandemic?
Dr. Fauci. Right now, the biggest challenge--excuse me,
right now, the biggest challenge, I think, is multifaceted. One
is the staying ahead of this virus itself. We are doing a good
job now, up to 2 to 3 million vaccinations per day. The more we
get vaccinated, literally every day that goes by and more and
more people get vaccinated, we can stay ahead of what I would
consider a race between our ability to vaccinate people and the
emergence of variants. We have variants that are well-
established, like the 117.
Luckily, as Dr. Kessler has mentioned, the vaccine does
very well against it. But there are other variants that, in
fact, when you look at the antibodies induced by the vaccine
and the capability of essentially fighting against these
variants, they are diminished by anywhere from two to five or
six fold. Fortunately for us, the response to the vaccine has
been so robust that there still has been enough cushion that
you likely would maybe not necessarily prevent infection, but
certainly prevent severe disease resulting in hospitalizations
and deaths.
The challenge is to stay ahead of the variance. The other
is to make sure, and it looks like we are doing a good job and
it is getting better and better every day, of getting
accessibility and implementation of getting the vaccine into
people's arms, particularly making sure that we do it not only
quantitatively, but with equity. Equity with regard to
underserved populations. And there is a lot of activity right
now that is focusing on making that happen. Thank you.
The Chair. Thank you. I have been really encouraged to hear
good news about ramping up vaccine supply in the coming weeks.
But I want to ask about what the Administration is doing to
make sure people trust the safety of COVID-19 vaccines. We have
to overcome skepticism about the science as well as active
disinformation campaigns and false rumors. So I want to ask Dr.
Walensky and Dr. Kessler, how are you working to debunk
misinformation about vaccine safety and encourage people to get
vaccinated? Dr. Walensky, I will start with you.
Dr. Walensky. Thank you for that. I think we need to
understand exactly the reasons for vaccine--for lack of vaccine
confidence, and we need to address them at the local level. We
are working very closely with our state, local health
departments. Resources from the American Rescue Plan will help
in that regard toward education. We need to address vaccine
hesitancy with regard to its roots. Is it because it is not
convenient? Is it because people are not deeming it safe? Is it
because they felt that it could happen too fast, or they are
worried about side effects?
They need to hear this information from trusted messengers.
We have been working last week or two weeks ago, we had a
vaccine forum. Over 13,000 people sharing ideas of how they are
addressing at the local community. And we are continuing in
those efforts. We have vaccine confidence consults where we
have people who are able to call in and get advice, receive
toolkits as to how they can promote vaccine confidence. Thank
you.
The Chair. Thank you. Dr. Kessler.
Dr. Kessler. Madam Chair, we will have as a Country,
through the hard work of this Committee and everyone who has
come before, we will have within 90 days, in essence, quadruple
our vaccine supply. I believe that we are going to be shifting
from a supply issue to a demand issue pretty soon. Just as a
pediatrician, I have dealt with the issue of vaccine hesitancy
in children. And I think it is very important that we
understand that the American people look to their health
professionals for guidance.
We are approaching 100 million shots in arms. That is a
remarkable number. And I think that one of the most important
things that we can all do is to when we look at those 100
million shots in arms, look at the remarkable, knock wood,
safety profile. Things can happen. We are ever vigilant. That
is the job of my former agency and Dr. Marks. But I think that
to date, we can sit here in front of the American public and
say these are very safe vaccines.
The Chair. Thank you very much. I will turn it over to
Senator Burr for his questions.
Senator Burr. Thank you, Madam Chair. Tony, I will start
with you and I will just work my way down. You and other
experts have suggested that we need to get 60 percent to 70
percent of the population vaccinated to achieve herd immunity.
If the numbers are higher now, can we reach the number without
vaccination of children under 18, which is roughly 140 million
Americans?
Dr. Fauci. Senator Burr, I would like to maybe backtrack a
bit and say I think we should be careful about wedding
ourselves to this concept of herd immunity because we really do
not know precisely, for this particular virus, what that is. I
have been saying lately calculation, and it is purely an
estimate, of 70 to 85 percent of the population. If it is that,
we would probably have to get more children.
I believe as we get high school students vaccinated in the
fall, we will be able to reach that. But let me just emphasize
that comment. As was said in my response to Chair Murray, that
every day we get 2 to 3 more million and we get closer and
closer to where we want to be, we don't really know what that
magical point of herd immunity is, but we do know that if we
get the overwhelming population vaccinated, we are going to be
in good shape. And you are right in your question, we
ultimately would like to get and have to get children into that
mix.
Senator Burr. David, we can both agree that Operation Warp
Speed is a success story of American innovation and ingenuity.
What do you see as the biggest challenge that we face over the
next 30, 60, 90 and beyond?
Dr. Kessler. The next 30 days, 60 days?
Senator Burr. 30, 60, and 90 and beyond.
Dr. Kessler. But let's take the first 30, 60. I think it is
what the Chair raised, vaccine hesitancy. I think we are going
to have to make sure that people understand how important being
vaccinated is and what the safety profile is. I wasn't
convinced when I started, but I am convinced now that, as Dr.
Fauci said, we are in a race against these variants.
The most important thing we can do currently as citizens is
to step up, not for us, but for our families and for our fellow
citizens to become vaccinated. I think, Senator, I mean, in
your opening comments, I think you hit the nail on the head. I
think there are many things we can do to learn the lessons over
the last year. I think it is a phenomenal story, but I think
there are lessons to learn, and I look very much forward to
working with you and your staff to doing that.
Senator Burr. Thank you for that. Peter, FDA now has
experience evaluating the messenger or any platform, and a
baseline understanding of the technology. What steps will FDA
take to make sure that the technology does not have to go
through approval again, but new indications would? If you look
at our annual flu process, we use the same technology, but with
a different formulation on an annual basis and that is sort of
an expedited process. Can we expect to see over time a similar
type of approach to messenger-RNA platform and the clinical
requirements only for the new indications?
Dr. Marks. Thank you for that question, Senator Burr. So I
think we can say that is the case over the course of time. For
the first couple of changes that might be made for variants, we
probably will have to go through having some clinical studies,
but they won't be clinical outcome studies. They will be ones
where we look at the immune response. It is possible that once
we understand how these perform, that we won't actually even
need studies and people will be able to do like what we do for
influenza. Ultimately, the place we would like to get to is,
really understanding which pathogens go with which platforms,
because it turns out that the mRNA platform seems to be very
good for certain pathogens, but it may not be good for others.
Just as the vesicular stomatitis virus platform that was
used for the Ebola vaccine seems to be very good for certain
pathogens, but not for others. So we need to be able to do the
science to understand that matching, and that in the future
will hopefully expedite this even further to rely on these
platforms that we understand.
Senator Burr. Madam Chair, quick question for CDC, if I
could have the indulgence of the Chair. Rochelle, can you
understand why the American people were somewhat baffled when
it took three months for CDC to issue guidance on what
vaccinated Americans should do, precautions they should take,
things that they could forget they had been told? You said we
are leaning on the science and the science certainly suggested
something. Is that the norm in the future that it is going to
be delayed like that or do you see that being expedited in the
future?
Dr. Walensky. Thank you for that question. We are working
and looking at the science as it emerges and evaluating the
science in real time. Our CDC guidance on what to do when you
are vaccinated came when less than 10 percent of the American
public was vaccinated. During a time of emerging variants and
emerging science around those variants, and during a time when
we were looking to see whether vaccinated people could actually
transmit disease. So we needed to see what that science was
before we were able to provide those--before we were able to
provide that guidance.
We are working in real time as additional science emerges
to update that guidance as, in fact, more people get
vaccinated. May I just return to the question of herd immunity?
And I just want to make sure folks understand the concept of
herd immunity is an epidemiologic term that is one over one
minus R0. R0 is the transmissibility of the virus and that
actually turns out to be a moving target as we have different
variants. So as we think even conceptually about herd immunity,
I think we need to understand that as we have more
transmissible variants, our target for herd immunity may
change. As well when we look at children, if they actually are
not as transmissible to the young children, that in fact we may
not have to vaccinate at the same level young children. I
believe that children should be vaccinated, but I just want to
make sure we understand the target.
Senator Burr. Thank you, Chair.
The Chair. Thank you very much.
Senator Baldwin.
Senator Baldwin. Thank you, Chair Murray. It seems to me,
and certainly I have heard testimony from our witnesses today,
that one of the most significant threats to the progress we are
making in this pandemic is the emergence of variants and
mutations that could possibly elude the treatments that have
been developed and the vaccines that are being deployed.
Fortunately, the American Rescue Plan contains--provides $1.75
billion for CDC to ramp and scale up efforts on genomic
sequencing and surveillance. I was a proud champion of this
provision because I think it is so important that we know what
possible threats to our progress exist. Dr. Walensky, can you
describe how the CDC will use this $1.75 billion to combat
emerging mutations and variants of the coronavirus? And also
give us a sense of how many of the positive test samples ought
to be sequenced in order to really have a firm grasp on the
emergence of variants?
Dr. Walensky. Thank you so much, Senator, and thank you for
all of your support in getting us resources to be able to do
so. The initial $200 million that was given to the CDC to scale
up to sequencing, we are now doing somewhere between 10,000 and
14,000 sequences a week and that is in collaboration with
commercial labs, that is in collaboration with public health
labs, with academia. The additional $1.75 billion is in fact
essential to help fund jurisdictions for next genome sequencing
capacity. Not all jurisdictions have this capacity and we
really do need to be able to scale this up across the Country.
We actually need to be able to scale up our own surge
capacity within the CDC for sequencing infrastructure, for
clear, competent labs, for having scientific computing and IT
in CDC so that we can use that infrastructure for when the next
surge arises. We need to develop a workforce so that people
understand how to do genomic epidemiology. That is not standard
education. That is not what people standardly know. And so we
need to develop that workforce, and then we need to bolster
exactly what is being done already because we are only at
14,000 right now.
We really would like to be up at the 25,000 range. Of
course, the number of sequences you do very much depends on the
number of virus--the amount of cases that we have circulating.
And so we would like to be up to around 25,000, somewhere in
the 5 to 10 percent of the amount of cases that we have. Thank
you.
Senator Baldwin. Thank you. As Government looks to invest
in supply chain resiliency using funds provided by Congress for
COVID response and pandemic preparedness, we know one thing to
be true, that we can no longer afford to have an inadequate
domestic vaccine supply chain. While the delivery method will
always be vaccine dependent, there are certain supplies that it
seems to me would make sense to have advanced purchase of and
sufficient stockpiles of, things like vials, stopper syringes,
needle caps.
Manufacturers must be able to rapidly surge production for
a future pandemic without doing long term damage to their broad
customer base. So, Dr. Marks, can you describe some of the
early obstacles that FDA faced as a result of our overreliance
on foreign manufacturers of critical medical supplies? And what
role do you think our national stockpile system could play in
helping to maintain search capacity for American made critical
medical supplies, including those needed for vaccinations?
Dr. Marks. I may defer some of the stockpile question to
Dr. Kessler, but I will say that there clearly was a critical
shortage of vials and other manufacturing equipment to be able
to move ahead and rapidly produce vaccines. I think that was
part of what was overcome by a cooperative effort between
industry and Government partners early on in this pandemic to
try to pick up the pace on that. But I think a key piece of
learning for the future is that we have to start to rely on
more advanced manufacturing technologies, things that allow us
to scale up production not just for drugs and biologics, but
also for devices so that we can move more quickly.
Dr. Kessler. Senator, if I could----
Senator Baldwin. Please, go ahead.
Dr. Kessler. Senator, if I could just add there is a team,
a very dedicated team at DOD, BARDA, HHS, who spend their days
and have been doing this for months, sourcing the globe for
supplies. In the Rescue Plan, there is a specific provision
that will enhance our ability to make sure going forward things
like lipids that are key ingredients, that we will have
adequate supplies prior to the time we need them.
Senator Baldwin. Chair Murray, with your indulgence, I
would just like to formally request that our Committee receive
a briefing on the state of the strategic national stockpiles
and that the Administration provide Members with detailed
breakdowns of supply chains associated with the current
approved vaccine candidates, including manufacturing locations.
And that would be classified if necessary. I know some of the
information regarding the national stockpiles is sensitive.
The Chair. Thank you. We will do that. Thank you very much.
Senator Baldwin. Thank you.
The Chair. Senator Paul.
Senator Paul. Dr. Fauci, in a recent British study, David
Wiley and others found that no symptomatic infections from
COVID-19 after following 2,800 patients for several months. In
fact, there have been no reports of significant numbers of
infections after acquiring COVID-19 naturally. Shane Crotty, a
virologist at La Jolla Institute for Immunology concludes from
his experiments that the amount of immune memory gained from
natural infection would likely prevent the vast majority of
people from getting hospitalized disease, severe disease for
many years. In this study, which was published in Science, Dr.
Crotty showed that antibody levels stayed relatively constant
with only modest declines over six to eight months.
Dr. Crotty reported that notably memory B-cells specific
for the spiked protein, or RBD, were detected in almost all
COVID-19 cases with no apparent half-life at five to eight
months after infection. In other words, Dr. Crotty found
significant evidence of long term immunity after COVID
infection. Furthermore, Dr. Crotty noted, B-cell memory to some
other infections has been observed for as long as 60 plus years
after smallpox vaccination or even 90 years after a natural
infection with influenza. There was a woman who got the Spanish
flu who still showed immunity 90 years later. So rather than
being pessimistic toward people gaining immunity after they
have had COVID or had a vaccine, studies argue for significant
optimism.
In fact, there have been no scientific studies arguing or
proving that infection with COVID does not create immunity.
There have been no studies showing significant numbers of
infections. Of the 30 million Americans who have had COVID,
only a handful of infections have been discovered. In fact, The
New York Times reported last fall more than 38 million people
at the time worldwide had been infected with the coronavirus.
And as of that date, fewer than five of these cases had been
confirmed by scientists to be reinfections.
Scientists interviewed for the article concluded, in most
cases, a second bout with the virus produced milder symptoms or
none at all. Given that no scientific studies have shown
significant numbers of infections of patients previously
infected or previously vaccinated, what specific studies do you
cite to argue that the public should be wearing masks well into
2022?
Dr. Fauci. I am not sure I understand the connection of
what you are saying about masks and reinfection. We are talking
about people who have never been infected before----
Senator Paul. You are telling everybody to wear a mask,
whether they have had an infection or a vaccine. What I am
saying is they have immunity, and everybody agrees they have
immunity. What studies do you have that people that have had
the vaccine or have had the infection are spreading the
infection? If we are not spreading the infection, isn't it just
theater?
Dr. Fauci. No, it is not----
Senator Paul. If you have had a vaccine and you are wearing
two masks, isn't that theater?
Dr. Fauci. No, it is not. Here we go again with the
theater. Let's get down to the facts, Okay? The studies that
you quote from Crotty and Setit look at in-vitro examination of
memory immunity, which in their paper, they specifically say
this does not necessarily pertain to the actual protection. It
is in-vitro.
Senator Paul. What can you point to that shows reinfection?
There are no studies that show----
Dr. Fauci. Let me finish the response to your question, if
you please. The other thing is that when you talk about the
infection and you don't keep in the concept of variance, that
is an entirely different ballgame. That is a good reason for a
mask. In the South African study conducted by Jay and Jay, they
found that people who were infected with wild type and were
exposed to the variant in South Africa, the 351, it was as if
they had never been infected before. They had no protection. So
when you talk about reinfection, you have got to make sure you
are talking about wild type. I agree with you that you very
likely would have protection from wild type for at least 6
months if you are infected. But we in our Country now have
variants that are circulating----
Senator Paul. What study shows significant reinfection,
hospitalization, and death after either a natural infection or
the vaccine? It doesn't exist. There is no evidence that there
are significant infections after vaccine. In fact, I don't
think we have a hospitalization in the United States after the
two-week period after the second vaccination. We don't have a
death in the United States.
Dr. Fauci. You are not hearing what I am saying about
variants. We are talking about wild type versus variants. Now
we----
Senator Paul. What proof is there that there are
significant infections with hospitalizations and deaths from
the variants? None in our Country, zero.
Dr. Fauci. Well, because we don't have a prevalence of a
variant yet. We are having one--can I finish? We are having 117
that is becoming more dominant.
Senator Paul. But you are talking about conjecture. You are
making policy based on conjecture. You have the conjecture that
we are going to get variants----
Dr. Fauci. No, it isn't based on conjecture.
Senator Paul. You want people to wear masks for another
couple of years. You have been vaccinated and you parade around
in two masks for show.
Dr. Fauci. No.
Senator Paul. You can't get it again. There is almost--
there is virtually 0 percent chance you are going to get it.
And yet you are telling people that have had the vaccine, who
have immunity--you are defying everything we know about
immunity by telling people to wear masks who have been
vaccinated. Instead, you should be saying there is no science
to say we are going to have a problem from the large number of
people to vaccinate. You want to get rid of vaccine hesitancy,
telling people to wear their mask after they get the vaccine--
you want people to get the vaccine, give them a reward instead
of telling them the nanny state is going to be there for three
more years and you got to wear a mask forever. People don't
want to hear it. There is no science behind it.
Dr. Fauci. Well, let me just state for the record that
masks are not theater. Masks are protective. And we----
Senator Paul. As immunity, they are theater. If you already
have immunity, you are wearing a mask to give comfort to
others. You are not wearing a mask because of any science.
Dr. Fauci. I totally disagree with you.
The Chair. Dr. Fauci, if you could respond so that we could
understand the difference between the virus itself and the
variance and the reason for a mask.
Dr. Fauci. I am sorry, ma'am, I can't----
The Chair. If you could respond to the question so that we
could all understand the difference between the vaccine in
controlling the wild type versus the variants that are out
there and the reason for wearing a mask. I would appreciate it.
Dr. Fauci. Yes, I mean, yes. First of all, when you have a
variant, you have an immunity that you get with convalescent
sera and the same sort of thing. If I vaccinate you or me
against a wild type, you get a certain level of antibody that
specific for a particular viral strain. If there is a
circulating variant, you don't necessarily have it. You have
some spillover immunity, to be sure, but you diminish by
anywhere from two to eight fold the protection.
The point I am saying is that there are variants now
circulating. The point that Senator Paul was making was that if
you look at wild type only, there is some clear-cut credence to
what he is saying. But we are living right now in a situation
where we are having a dominance of 117, which was the original
UK. We have a very troublesome variant in New York City, a 526.
We have got two variants in California, a 42749. And we have a
number of others. So we are not dealing with a static situation
of the same virus. That was the only point I am making.
The Chair. Thank you very much. Thank you.
Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair. Dr.
Fauci, thank you for setting an example over the course of the
last year for Americans. You have made it clear that masks
saved lives. And the example that you have set that has not
been followed by other leaders in this Country has made a
difference, has kept tens, if not hundreds of thousands of
Americans from contracting this disease. Thank you.
I wanted to turn to the question of the massive contracts
that we have signed with vaccine makers and to talk a little
bit about the path forward. Pfizer reported about $9,6 billion
in profit last year. Moderna, a very small company before
entering the vaccine market, their Chief Executive owns shares
that are probably now worth about $5 billion. Thank goodness
for these companies. They have done remarkable work in a short
period of time. They have saved lives. At the same time, we
want to make sure that we are making wise use of taxpayer
dollars. And so I am going to direct this question to Dr.
Kessler and others can weigh in.
Dr. Kessler, do you sort of understand what the difference
is between AstraZeneca and Johnson & Johnson, who have said
that they are pursuing a nonprofit model in developing the
vaccine versus Pfizer and Moderna, who I assume because they
have not made the same statement, are pursuing a for profit
model. Help me understand what the difference is between those
two.
Dr. Kessler. Senator, all those are good questions, and you
have every right to be confused because it is very confusing. I
lived very much in the 1990's. We worked on HIV when I was at
FDA and chaired the Elizabeth Glaser Pediatric AIDS Foundation.
So we cared a lot about getting drugs in that instance to the
world. And that led to something called tiered pricing. And you
will see that there are multiple numbers. I mean, there is this
number that is cost and there is cost plus, there is a not for
profit cost, and all those have very honestly different
definitions.
I think the most important thing to stress right now, and I
have been no defender of the pharmaceutical industry and
certainly not on pricing, I mean, over my career, but I think
the fact is that this Committee, the Congress, you allowed the
Administration to go at risk, right? And we bought different
vaccines, the Administration bought different vaccines,
regardless of even whether they worked and, at the best price.
And the reality is, thank God for that, because we are in a
very fortunate position today. I am sure with hindsight, there
are a lot of legitimate questions and we have to do better at
understanding these prices. And I pledge to you, we will do
that. It is not an easy answer.
Senator Murphy. Let me just because I have got a minute
left, let me just ask two quick follow-up questions. On an
earnings call last month when asked about profit margins for
the vaccine, the Chief Financial Officer at Pfizer suggested
that the company is going to, ``get more on price'' after what
he called the pandemic pricing environment. One analyst
projected that the company could make vaccine prices three to
four times higher than they are today. Do you believe that we
have the ability to keep vaccine prices at a point that is
favorable for the American taxpayers? And then what do you
think about making these contracts disclosable so that--it is
sort of hard for the American public or, outside groups to do
oversight when they can't see the contracts.
Dr. Kessler. I can tell you, Senator, the President
believes very firmly, in making sure that there are affordable
medicines and vaccines, and we will work very hard. It is my
understanding that the contracts are publicly available, albeit
with redactions. I am happy to work with you to even improve on
that.
Senator Murphy. Great. I appreciate it. I know this
Administration has a commitment to getting the best value.
Obviously, the priority is getting shots in people's arms. And
so let's not let the perfect be the enemy of the good. At the
same time, hearing that we might be looking at three to four
times the amount of price as we move into booster shots or
childhood immunizations, certainly should be something we
should all pay attention to. Appreciate it. Thank you, Madam
Chair.
The Chair. Thank you.
Senator Collins.
Senator Collins. Dr. Walensky, the CDC school reopening
guidance has been at odds with what many public health experts
are recommending. When we discussed this issue recently, I
really detected a lack of a sense of urgency on your part to
reopen schools. Let me just share a little bit with everyone
here what the public health experts are saying. In USA Today,
four prominent experts said the recent school reopening
guidance released by CDC is an example of fears influencing and
resulting in misinterpretation of science and harmful policy.
The American Academy of Pediatricians cautioned against strict
adherence to six feet of distancing, if that forces students to
enter remote learning. And Dr. Jha who testified before it just
last week said in an interview that the guidance, ``didn't feel
to most of us in the public health world as particularly well
grounded in evidence and science.'' Maine's own CDC Director
made the point to me that children are less likely to contract
COVID in schools than they are in other settings.
Dr. Jha also said that we were focusing on the wrong
things. We should be focusing on mask wearing, ventilation. And
he said, it did not mention three feet versus six feet. It did
not mention deep cleaning of surfaces. There is a lot that is
going on that has gotten us distracted. We can keep teachers
safe. We can keep kids safe. We can open schools and we have
the ability to do that now. In the meantime, the negative
effects on our children continue to grow. And I am not just
talking about the lost learning. I am talking about social
development. I am talking about behavioral problems, stress on
the children, on their parents.
A hospital administrator told me just yesterday that they
are having children dropped off at the emergency room with
behavioral problems and the grandparents or the parent who
brought them just driving away, just leaving them there. We
have got to get the schools reopened. And you have presented no
timeline at all for doing that. And the CDC recommendations,
particularly on physical distancing of at least six feet, are
just not in sync with what most public health experts are
recommending. So I would like to know what you are going to do,
and when, to get our schools reopened.
Dr. Walensky. Thank you for that question. Thank you for
the conversation we had. And I am very sorry you--it appeared
like it wasn't urgent to me. I am the mother of three, one of
whom has been home for this entire year. This is an urgent
issue. I understand the mental health challenges. I understand
the educational challenge. There is food insecurity. This is
urgent. Please don't get me wrong. This is urgent.
There was a study out of Wisconsin that demonstrated in
schools that in a time of high disease prevalence, that if
there was 92 percent mask wearing and dedensification of
classrooms, somewhere between 11 and 20 students, we could get
students back to school safely. There is also a similar study
from Georgia that showed without masking and without the proper
mitigation strategies, there were outbreaks in nine elementary
schools. So our guidance was intended to lean in. We
specifically articulated as it was released that schools that
were doing well, and were open, we wanted to keep open.
As we released this guidance several weeks ago, it was
intended for schools to lean in--for schools that were clamped
shut to use this guidance to decide what mitigation strategies
they needed to do, recognizing that the MNWR that we reported
several weeks ago, 60 percent of students were wearing masks in
classrooms. We needed to get those numbers up if this was going
to be done safely, and this was the roadmap to do so. On the
question of three feet and six feet, we looked for science to
determine what was the proper distance on the question of three
feet and six feet.
At the time, you may recall, there were about 250,000 cases
per day and much of our communities were in a very high rates
of community spread. We agree on the science that the spread
was happening less so in the schools than in the community. But
if mask wearing was not happening, we were seeing breakouts and
we had science for that. Just last Thursday, I believe, there
was a study out of SID from Massachusetts in a place where
there was about 100 percent mask wearing that three feet and
six feet yielded the same amount of infections.
That was the first study we had seen that looked at three
feet versus six feet. Indeed, because six feet has been such a
challenge, science has leaned in, and there are now emerging
studies on the question between three feet and six feet. I am
aware of several that will be released in the next several
days, and we are actively looking at our guidance to update it
to address that science. Thank you.
Senator Collins. You need to do it now. And I agree with
you on mask wearing, but I really wish that you would look at
this testimony and what these public health experts are saying.
Thank you.
The Chair. Thank you, Senator Collins.
Senator Kaine.
Senator Kaine. Thank you, Madam Chair and Ranking Member,
and thanks to the witnesses. I generally don't like to respond
to a colleague after the colleague has left the room because it
doesn't seem kosher. But the public is watching this hearing.
And I want to just get into this mask issue just briefly. I
have had COVID, and I have been vaccinated and I wear a mask. I
wore a mask to make other people feel safer, even if there
weren't variants. I went to my grocery store during senior hour
when there aren't a lot of people there and my grocery clerk
who cannot telecommute is petrified about getting COVID. So she
is petrified about getting COVID and she stands eight hours a
day, a few feet away from people down the line, and she is
petrified. She doesn't want to take COVID home to her child in
the small apartment where they live. She doesn't want to take
COVID home to her mother, who also lives in that small
apartment with her. And many, 30 million Americans have had
COVID. That is the reported cases, so say it is double. I would
say it is 60 million.
Hundreds of millions of Americans have not had COVID and
they are afraid of getting it because they have seen 500,000
people die and they have seen a whole lot of people suffer and
they have seen people lose their jobs and lose their income and
lose their business. There are people in this room who haven't
had COVID. It makes people around you feel a little bit safer,
it makes my grocery store clerk feel a little bit safer if
people she is standing a few feet from every day are wearing a
masks. And if that is so hard to understand, is it so hard for
us to do? We don't care about these workers? I mean, if she saw
me come through with no mask, she would be afraid.
I could say, well, look, I have been vaccinated and I have
had COVID. Well, maybe she isn't reading the science about what
that means. It is just such a minor thing to do, to try to
protect the hundreds of millions of Americans who are deathly
afraid of getting COVID. That is a reasonable fear, and this is
a reasonable step that we can take to try to bring down the
fear level that people legitimately have. So I have two issues
that I just want to put on the table, and I would love any of
you to address them in there kind of long term issues. There
will be a day when a President will say the public health
emergency is over. There will continue to be a very long tail
of consequences on people's mental health, seeing death, seeing
illness, losing their jobs, losing income, isolation, that will
be a long consequence.
Many Members of the Committee have worked together on this
already, but we think we have more to do. Second, many
Americans who have had COVID will have continuing symptoms. I
have these weird neurological symptoms a year later. They are
not debilitating. They are not painful, but they are weird, and
they are 24/7. Many people have symptoms that are more serious
heart impairment, respiratory impairment, impairment of mental
functioning, fatigue challenges.
How should we as a community, how should we as a Nation,
how should the institutions you work for be thinking, planning,
investing in these two long term sets of consequences, mental
health and the physical needs of the COVID long symptoms?
Dr. Fauci. Let me address the one that you mentioned about
the persistence of post COVID sequelae, which is a really
serious and real issue. It is not imaginary. It varies from
person to person. The NIH, with the generosity of the Congress,
has invested $1.15 billion in collaboration with the CDC and
other agencies. And looking at the scope of this real
phenomenon, the sequelae, what the ultimate pathogenesis is--
because we don't know what the mechanisms are. You mentioned a
weird neurological symptom. We are not really quite sure what
that is. And we are putting together a large cohort studies to
be able to find out what the incidence of it is, what the
variability, what the range of organ system dysfunctions are,
and what the underlying pathogenic mechanisms.
It is really very puzzling, Senator, because it is
different than if someone is in ICU and has long damage and you
have a pulmonary function abnormality, so you have a
cardiomyopathy and you have a stroke volume that is down. It is
different than that. It is people who recover, have the virus
no longer there, and have a persistent of things like chronic
fatigue, muscle aches, temperature dysregulation, funny kind of
neurological issues that they can't explain. That is what we
are really focusing on in cohorts of tens of thousands of
people. So we are looking at that seriously.
Dr. Walensky. Maybe I will just chime in on the mental
health side and say that we are working--first of all, we need
to collect the data. We need to understand in real time what
the impacts of this are. We need to work with our state and
local health departments to ensure that the resources that they
have can be disseminated to their local jurisdictions. That we
have toolkits on culturally sensitive prevention strategies for
prevention of depression, toolkits for mental health resources
to provide.
We need to get those disseminated into the local
jurisdictions. And then we are working to do the science to,
and cohort studies, exactly, as Dr. Fauci noted, on both the
mental health issues as well as on the long haul issues.
The Chair. Thank you very much.
Senator Cassidy.
Senator Cassidy. Thank you all. Doctors Kessler and Fauci,
all generous in your comments of the previous administration's
effort without specifically saying them, so thank you for that.
I have to admit, the Chairwoman's opening comments would have
imagined that Operation Warp Speed was a Biden administration
initiative. Obviously, it was not. But all due credit to the
current administration. They are making great strides. I
appreciate that. And Dr. Walensky, I just also want to point
out as we speak of equity, the Kaiser Family Foundation, the
COVID-19 vaccine tracker, shows that the greatest hesitancy for
vaccination right now is among those in the rural areas and
Republicans. For some reason, when people speak about equity
and the need for special outreach, those folks never come up.
I know that you are aware of that, but I just want to say
that for the record. Frank Luntz just recently did a survey
group and found that if you present them with facts over and
over again, they will be persuaded, but they need to be spoken
to by trusted folks. Somebody mentioned that earlier. Just to
say that. And I am not scolding, I am just pointing that out
because that is the need. Dr. Fauci, always enjoy your
comments.
Dr. Kessler, we have spoken before. It is kind of a mixed
message here, that we know that we need to test in children,
but we also know that the incidence among children is going to
be so low that it could be difficult to have an outcomes based
result. Again if the incidence in the community is so low,
nobody is getting infected anyway, how do you compare a vaccine
versus a placebo group? Second, and that begs the question, we
do need that kind of surrogate marker, those T-cells and those
B-cell markers that would correlate with immunity.
I am struck that there is a letter to the New England
Journal of Medicine in which it says that antibody response and
seropositive persons after a single dose of the mRNA vaccine
and showing that antibody titers after a single dose than those
previously infected shoots up much more than those who have
never been who are naive, so to speak, never before been
infected. A second dose does not improve that. It just stays
flat. Where are we in establishing a surrogate marker that
could be used to see if children are immunized related to that?
Where are we in establishing that if you have been
previously infected, granted variants or a wild card, but if we
have a shortage of vaccine worldwide, it would be very
important in Asia and Africa, Mexico, to know that if someone
was previously infected at the most, they would need one more
dose of vaccine. It seems like we are being fairly conservative
about this. When will we have some answers? And I am not
scolding, I am just asking. Dr. Fauci?
Dr. Fauci. Thank you for that question, Senator Cassidy.
You make a very good point. And we will get what you are
referring to is a correlate of immunity, the surrogate marker.
And right now we are collecting data from the trials that we
did in adults in which we clearly showed a high degree of
efficacy that is associated with a very high degree of
neutralizing antibodies, measuring also T-cell responses, but
mostly neutralizing antibodies. When we get a firm correlate of
immunity, I think we are going to be able to answer the
question you say about what sort of surrogate marker that we
could tell that someone is actually protected. And I think in
the next couple of months, at the latest, we are going to get
that data.
Senator Cassidy. Let me ask because you said correlate.
Already, you correlate as an association the increase in
antibody titer and some sort of proliferation of the T-cells.
Presumably these are neutralizing antibodies similar to those
used in the monoclonal antibodies. So what additional
information do we need? Because obviously, the sooner we know
this, the better.
We are probably--I have been infected, I have been
vaccinated. I really don't think I needed the vaccine, but my
wife told me not to come home unless I took it. So I guess the
question is, but we could have given that vaccine to somebody
else. So when do we think we will have it and what is going to
be in addition to that which we already know?
Dr. Fauci. Again, another very good question, Senator
Cassidy. In the long run, the real proof of the pudding is when
the level of antibody goes down below a certain level. If you
still have protection, that means that isn't a direct
correlation with the height of the antibody level. We know
now----
Senator Cassidy. That is not necessarily true though. If I
may in all due respect, what you really want to know is if
there is anamnestic memory, as if you are reexposed to the
vaccine, and within that window period, your vaccine rises back
to a protective level. It seems like that would be fairly
easily done with the folks who are infected now and maybe their
antibody titer has fallen off.
Dr. Fauci. No, you are quite correct. And in fact, the
example that you gave is a really excellent example of people
who have been infected, and even if you look at them and they
don't have necessarily a very high level of antibodies,
multiple months later, when you vaccinate them, their level
goes up 100 fold as opposed to 10 fold. It is just
extraordinary, which means they have many more competent memory
B-cells than they do have a level of circulating antibody.
Senator Cassidy. But that is what always happens. I guess I
am asking, since we know that is the case and you already see
evidence of it, it does seem like there is a great hesitancy to
admit, if you will, that this could be protective when we know
the same thing is true of other viruses. That your antibody
titer falling to zero does not mean that you are not protected.
Your memory B-cells will quickly proliferate. And again, this
has such implications for how we use our vaccine now. If you
could answer this, and then I will yield back because I am over
time.
Dr. Fauci. No, yet again you are making good points,
Senator Cassidy, but since this is a virus for which we don't
have previous experience, it is a bit risky to make a direct
extrapolation, for example, to influenza or others. It is
certainly conceivable that it will match what we have seen with
other viruses, but we don't know that as a definite scientific
fact yet.
Senator Cassidy. Okay, I yield back. Thank you.
The Chair. Thank you, Senator Cassidy.
Senator Hassan.
Senator Hassan. Well, thank you, Madam Chair and Ranking
Member Burr, for having this hearing. Thank you to all of our
witnesses for your extraordinary hard work and for your
commitment to helping us get through this pandemic and beyond.
I also want to just take a minute to thank Senator Kaine for
the remarks he just made about the importance of mask wearing
at this moment in time as we continue to combat the pandemic.
As somebody with a highly vulnerable family member who is cared
for by a woman who is 80 years old, I have been holding my
breath throughout this and the fear is real.
I am very grateful to you, Senator, for your comments. Dr.
Kessler, earlier this month, I led a group of my colleagues in
writing a letter to the Departments of Health and Human
Services and Justice to urge them to address serious barriers
for individuals with disabilities in the COVID-19 vaccine
distribution process. This letter followed reports from
constituents in my home State of New Hampshire that they could
not access the vaccine registration website using a screen
reader, which is a crucial tool for people with vision loss.
Ensuring that individuals with disabilities and other
vulnerable communities can easily register for appointments and
access vaccination sites is essential for an equitable
distribution of the vaccine. So, Dr. Kessler, how will the
Federal Government partner with states to improve access to the
COVID-19 vaccine for individuals with disabilities and older
adults?
Dr. Kessler. Senator, absolutely key points. And no doubt
we can do better on that. I think we have all been frustrated
getting appointments, people staying up throughout the night,
refreshing their computers, trying to get appointments. What we
have been trying to do is to increase the number of access
points, increase the number of vaccinators. As you have heard,
we are going to increase not only the number--we are increasing
the number of appointments, the vaccinators, the number of
sites, but also working on the information systems. This was a
mad dash at getting this out. And what you see is just very
real, but there is a real commitment at the state level, at the
Federal level to improving those information systems and the
ease of use, right. And we have to do better.
Senator Hassan. Yes, I appreciate that. I just also want to
point out that it is a civil rights issue. The Americans with
Disabilities Act does apply here. And it is really critically
important that whether it is a telephone system that somebody
who has a hearing impairment can use, or screen that somebody
with a visual impairment can use, or a vaccination site where
somebody who might have difficulty being exposed to bright
lights or a lot of noise for long periods of time has space to
be. These are all requirements under the law for access.
It is--another time we will have another discussion about
how far the health care system has to go in this kind of
accessibility generally. But for vaccinations right now, it is
an issue we are hearing about a lot from constituents. So I
just wanted to bring that to everybody's attention. Let me move
on to another question for Dr. Kessler and Dr. Fauci.
As vaccinations continue to ramp up across the Country, you
have both mentioned the possibility that we will need to
develop booster shots to ensure long term protection from
COVID-19 and respond to existing and future variants of the
virus. Are there additional steps we should be taking now in
order to ensure that Americans will have timely access to any
necessary COVID-19 boosters and make sure that they will
understand the importance of taking them, including when the
current public health emergency declaration ends? Maybe Dr.
Kessler and then Dr. Fauci.
Dr. Kessler. First, we are looking at the data. We know, at
least for some of the vaccines, that there appears to be
durability at the six-month point. The reason I use the six-
month point is because that is how long the first people have
been immunized. So we are continuing to monitor that. And I
think what we see, I mean the good news is that durability
seems to exist. There is a slow decline and there is some
variability between individuals. So we can sit here today and
tell you when, and definitely there will be boosts.
But I think we have to plan for it. And I think at some
point, like my colleagues, I think it is--it may be more likely
than not that at some point we will need to boost with the
durability. But it depends on a number of questions. So we need
to make sure that we have enough vaccines in the cupboard,
right, that are ready to go when we need to do that. And we are
doing that planning, Senator.
Senator Hassan. Dr. Fauci, do you want to--I know I am a
little over time, but if you could briefly comment.
Dr. Fauci. Yes. I agree completely with Dr. Kessler. But
let me just add one thing that adds into the mix of
variability, is that there is a considerable degree of
variability across the population in the responsiveness to the
original vaccine. Remember, we have a lot of people in this
Country who have underlying conditions. Many people are on
drugs for autoimmune diseases, cancers and things. They get
vaccinated. Their level of antibody may not be as high or even
multifold lower than an otherwise normal, healthy young person.
That person would likely need to be boosted well before the
others.
As Dr. Kessler said, there is a considerable amount of
variability. What we need to find out is what is the minimum
cutoff? Where is the point where absolutely you have got to
start giving boosters? And I think we don't know that yet. We
just have to follow people long enough to know when the level
of antibody goes way down, because if a healthy person may hang
up there for months and months and months, somebody who is on
chemotherapy for cancer or glucocorticoids for an autoimmune
disease may come way down. That is the point.
Senator Hassan. Thank you. Thank you, Madam----
Dr. Walensky. If I may, Senator, may I just chime in and
let you know that CDC does have active, on your prior question,
active toolkits and playbooks for folks with disabilities. We
are working with our local partners and jurisdictions to make
sure that these vaccine sites have equitable access, there is
access to another round. So I just want to let you know those
resources are available.
The Chair. Thank you very much.
Senator Murkowski.
Senator Murkowski. Madam Chairman, thank you. To our
witnesses, thank you so very much. It is not very often that
Alaska makes the news in the good news category when it comes
to health and our statistics, but we are No. 1. We have moved
out early in terms of the vaccination of Alaskans. Right now,
it is 18.9 percent that are fully vaccinated, 28 percent have
received their first vaccine. We have some communities that are
approaching 90 percent vaccination. So we are pretty, pretty
proud of that.
The rest of the Country is looking at the model as to how
we were able to do it, open it up to everybody over 16. So I
think you are looking at that. You don't perhaps need to follow
the model of us delivering the vaccine to the clinics by way of
snow machine with a sled in back. But the model is good, and it
is one that has demonstrated how quickly we can move out. The
vaccine guidance and the vaccines shots in arms has given us a
kind of ray of hope here. Spring is coming, vaccines are
getting in arms, and people are feeling better.
But the economy is still struggling. And the guidance that
seems to be coming is not perhaps consistent with what we are
seeing on the ground and this is what Alaskans are sharing with
me. We have a significant tourist industry. We welcome people
to come up. We want them to be safe. We are going to encourage
all of the continuing protocols. But we have been struggling in
trying to get the economy back on track. When 60 percent of
your tourists that come to the State of Alaska come by cruise
ship, we have got a conditional no sale order or conditional
sale order in place. It is effectively a no sale order. Dr.
Walensky, we have had an opportunity to speak with folks on
your team. Alaskans aren't pushing to say don't send people our
way if it is not safe, don't use this if it is not safe.
But what they are asking for is some kind of guidance in
terms of timeline. It is the timeline so that you can know to
plan. Do we go ahead and the hundreds of small businesses that
are reliant on these tourists coming up, do they open up or do
they acknowledge that this is going to be the second season in
a year where they will have nothing and effectively no weather
to shutter their operations now.
When we are talking about health impacts, we all want to
make sure that we are following the guidance and the science
and all that comes with that. But there is also this
recognition of the economic impact. Certainty is helpful. We
haven't had much certainty with this virus, and it has been
challenging.
Can you give me any kind of guidance to give Alaskans in
terms of what we might be able to expect with where this
guidance is in the process? When you say later, does that mean
at the end of 2021? Does it mean in three months? Does it mean
in one month? What kind of guidance can you provide when it
comes to the CDC's order as it relates to the conditional sale
order?
Dr. Walensky. Thank you for that question. Yes. So first of
all, I understand the economic impact of the no sale, or the no
sale, the conditional sale and the travel. And so we don't take
that lightly. We have provided technical assistance on the
conditional sale where we have provided a four phase strategy
for how we could get sale open. We are in phase one of that,
moving toward phase two. This is an interagency decision. It is
not a decision solely up to the CDC. So this it would be--I
would be remiss if I was able to do that by myself, because the
decision is not solely up to us.
Senator Murkowski. Second phase, going to that second
phase. Can you give me some indicator in terms of a timeline
there?
Dr. Walensky. I can't simply because I don't believe it is
solely in our jurisdiction to address. It is not necessarily
CDC.
Senator Murkowski. Who else is part of the decisionmaking
process then beyond CDC?
Dr. Walensky. I believe Department of Transportation, OMB,
there are numerous others that are making these decisions.
Senator Murkowski. I want to follow-up with you, and I know
we have an opportunity for that later and I will look forward
to that. But again, you need to--CDC's role is to work through
the health safety. We understand and we respect that, but just
trying to gain some sense as to timing. Quick question for you
with regards to vaccine hesitancy. We have got Alaskans
vaccinated, they are ready to go.
Understand that, Okay, we got to keep masks on. We have to
continue social distancing. There is still the issue of whether
or not the guidance for the schools is going to allow kids to
get back in. One of the things that I am hearing from folks is
why am I even going to bother getting the vaccine if after I am
fully vaccinated everything is still the same?
I am told that it is not safe to be on an airplane or on a
cruise ship. If I am exposed to someone who has the virus, I
still have to quarantine, maybe not for as long a period. How
much of the guidance that we have in place, and to Senator
Burr's point about how long it takes to get that clear
guidance. To Senator Collins' point about the school guidance
and the reopening, is that contributing to the hesitancy that
we are seeing?
Dr. Walensky. Thank you for that question. I think there
are a lot of reasons for vaccine confidence. We articulated
some of those earlier, convenience, speed at which this
happened, and personal, concerns about side effects and
whatnot. I do think as more people are vaccinated, we are
working--I know we are working to move forward on that
guidance. The initial guidance was put forward with just 9
percent of the population vaccinated. That allowed actually for
a small gatherings in people's homes, for grandparents to hug
their grandchildren even if they were unvaccinated.
There has been since nursing home guidance so that we can
visit our loved ones in long term care facilities. One of the
things that has been challenging with travel is that, as I
think as people are aware, last Friday was the busiest travel
day of the season--since COVID-19 was declared a pandemic in
March 2020, 1.3 million people traveling through our airports.
This just at a time when we have 50--still 50,000 cases a day
and we know our variants have traveled through these airports.
We know that travel is a time when people, not necessarily
in flight itself, but travel is a time when people bring these
variants home, bring these variants to other places. So we are
balancing the fact that vaccinated people will likely travel
with unvaccinated people. There is travel happening. We had
surges after July 4th. We had surges after Labor Day. We had
certain surges after the Christmas holiday. And we want to just
make sure we are doing it safely. We are actively reviewing it
right now.
Senator Murkowski. I am well over my time, Madam Chair.
Thank you.
The Chair. Thank you.
Senator Casey.
Senator Casey. Chair Murray, thank you very much. I want to
thank the witnesses not only for appearing, but especially for
your service to the Country. I will start--I just, I think I
have two questions. I will start the first one with Dr. Kessler
and Dr. Walensky. And this comes right from home. Local
communities are asking, and frankly asking me and I am sure
others, to ask this question. And here is the predicate for it,
as vaccine production increases dramatically in the coming
months, and that is good news, and the venues in which people
are vaccinated increase, it is critical that every stakeholder
in the distribution and administration process have access to
the information, the data that they need.
At the state and local level, that includes getting data
from the Federal Government, not just about the vaccines
allocated to that jurisdiction directly, but information about
vaccines that will be flowing to that jurisdiction through some
of the direct Federal partnerships like the Program for
federally Qualified Health Centers and the Retail Pharmacy
Partnership. So here is a question for Dr. Kessler and Dr.
Walensky, will you commit to ensuring transparency of this
information to assist state and local leaders in making
decisions about the vaccine campaigns within their
jurisdiction?
Dr. Walensky. I am happy to start with that. Thank you,
Senator. The operation is responsible for how vaccines are
allocated. Those vaccines are allocated directly to the states.
I have been on weekly Governors calls where we have provided
the Governors a three-week timeline for how many vaccines they
can expect this week and two weeks after this week. That is the
first thing that has happened during this Administration so
that we have been able to give Governors a line of sight so
that they can plan three weeks ahead of time. There is also
allocation to Federal agencies, Department of Defense, the VA,
Bureau of Prisons, and FEMA. And then there is allocations that
go directly to federally qualified health centers and the
Federal Reserve Retail Pharmacy Program. Those decisions are
made after extensive deliberation and discussion. They are made
by the operation, but those discussions happen at all levels of
HHS. Thank you.
Senator Casey. Dr. Kessler, anything you wanted to add on
this?
Dr. Kessler. Senator, the answer is yes, we commit to that
transparency. As Dr. Walensky said, the Administration is
giving three weeks, looking ahead three weeks. The reason why
it is only three weeks is the realization that vaccine is being
made real time. It is coming off the line and they are
projections. We have every confidence that we will have enough
vaccines. But it is a very human, when you are dealing with a
very human process, biologics have to be made very carefully.
So we are making projections three weeks ahead of time, but we
want to be fully transparent on what we see coming and we are
trying to do that.
Senator Casey. Thank you, doctor. I guess my last question.
I will try to, in the remaining time, ask this question of Dr.
Fauci, if others wanted to chime in, we have time. But this is
really just projecting the biggest challenge you think we face,
the most urgent, the most difficult. I realize they can be
multiple and at the same time.
But Dr. Fauci, when you look forward just down the road a
few months in terms of just the public health challenge we
have, how would you rank or itemize the challenges that we
face? Are you more concerned about the impact of variants or
the struggle to get people vaccinated or is it both? Or do you
have some other worries that I haven't articulated? I know
others may have spoken of this earlier, but I would like to get
your view.
Dr. Fauci. Thank you for the for the question. There are a
couple of things that concern me. Probably the one that is the
most prominent is my concern that we will declare victory
prematurely. If you look at the dynamics of the outbreak, it is
a very, very high peak that we had following the holiday season
that was expected to have a peak, but not that high. It really
went up to 300,000 to 400,000 new cases a day at one point. It
is coming down sharply now, but we seem to be plateauing at a
level that is unacceptably high, around 50,000 or so cases a
day.
This is what has happened in previous surges where you come
to a plateau at a high level and then you start to surge.
Europe is generally about three to four weeks ahead of us in
the dynamics of their outbreak and what they saw a little while
ago was a plateauing of their decrement. They were coming down
nicely and then they plateaued. And just as you might have
predicted, then one started to go up. In a couple of weeks ago,
they had a 9 percent increase.
Now they have about a 5 percent increase. I am concerned
that if we pull back in our enthusiasm for the fact that
vaccines are rolling out and things look good, if we pull back
prematurely, we may trigger another surge and that would really
set us back in all the things that we are trying to do.
The Chair. Thank you, Senator Casey.
Senator Casey. Thank you.
The Chair. Senator Braun.
Senator Braun. Thank you, Madam Chair. My questions are
going to be for Dr. Fauci and Dr. Marks. It is going to be two
questions. One, you can sense the frustration from Senator
Paul, Cassidy, Murkowski, many of us, because we know we don't
have complete data. We know we have got to stay disciplined
before we get this thing under control. But in kind of a top
level way that I am looking at it, we have got to get the herd
immunity through natural infection or vaccination.
I want to make sure that you can take that and vaccinations
and come up with herd immunity. If the conferred immunity is
going to be about as good with a vaccination versus getting the
infection, I am taking 30 million as the number of cases
tested. I would like your opinion on how many completed
vaccinations there have been and then the big variable, how
many untested cases to get to that 250 million. And would like
your opinion on those numbers, because when you can give us a
little bit of certainty or idea on that, it gives us hope, like
Senator Paul said, to maybe stay tough and get through it.
Second question would be, if vaccinations aren't as
effective as we want them to be due to a cascade of variance,
then do we need to turn our attention to therapeutics if this
is going to be something we battle with over the long haul?
Dr. Fauci. Thank you for that question. I want to just
hearken back to what I had said some time ago to Senator Burr
and some of the comments that Dr. Walensky had made about this
magical terminology of herd immunity. We could get to where you
and Senator Murkowski and others want to get without
necessarily reaching this arbitrary percentage, because as Dr.
Walensky said, it is going to really depend on a number of
things because it depends on what the R0 of the virus is.
If you have variants that come in, they will modify it.
There are a lot of things that modify it. I like to look at it
in a different way. I would like to look at it in that every
day we get 2 to 3 million more people vaccinated. We also still
get people infected.
If you look at the number of people that are protected, we
don't necessarily have to reach 85 percent of the population to
get to the things that you were asking for about your
businesses in Alaska and about schools being open the way
Senator Collins had said. We can approach that in a real,
meaningful way before we get to this magical number.
Senator Braun. How many cases do you think there are
untested out there? Because to me, that is a big plug in
variable. I am reading four to five--is it four to five or is
it closer to two or three? And if we have no idea, that is the
biggest variable, when you get to that point, where you get to
what you are talking about. What do you do in your modeling?
How many untested cases do you plug into the model you are
using?
Dr. Fauci. No, see there really is no model right now for
herd immunity. It is purely an estimate. The only--take measles
for a second. We absolutely know what the level of herd
immunity is for measles, because we have had multiple instances
where when you went below a certain level of protection in the
community, you had outbreaks. It is a highly transmissible
virus. The vaccine is excellent, 98 percent effective. When you
get down below 90 percent of the population being immune, when
you get into the 80's, you get the kind of outbreaks that we
saw in the New York City metropolitan area. We don't know that
yet for coronavirus. We just don't know what it is yet.
Senator Braun. I understand that. And what about if it
seems to be an elusive thing to get through vaccinations and
natural infection, where do we start putting more emphasis on
therapeutics?
Dr. Marks. Maybe I will chime in. There is a fundamental
difference between measles and COVID-19. Measles is a virus
that does not vary with time the way that COVID-19 is varying.
And the reason for having this issue of needing to have the
best immunity you can and potentially vaccinating people who
have already had COVID-19 is to get to high enough antibody
levels to make sure that as these new variants come along, we
are not basically decimated by yet another version of COVID-19
coming across the population. So it is essentially doing it
right the first time to prevent another set of closures.
Senator Braun. Which has a lot of kind of uncertainty,
timeline, indefinite. And I think that is a tough thing I think
you guys have to contend with. Let's get to the question of
then therapeutics versus vaccines, because isn't that the way
we finally hammered AIDS was with the therapy, because a
vaccine was never----
Dr. Marks. For a global pandemic like we have here, I think
we really have to probably--I am going to defer to Dr.
Walensky, who is more expert than I am. But I think vaccination
is probably, and don't get me wrong, we need better
therapeutics, you are absolutely right.
Senator Braun. Or natural infection, right?
Dr. Marks. I think we would like to avoid natural
infections because I think as was already mentioned at this
hearing, we have this COVID long haul syndrome. So I probably
prefer not to have those people have those long term effects.
So we would like to prevent natural infection by providing
immunity through vaccination.
Senator Braun. You want to add anything?
Dr. Fauci. I agree completely that the idea of treatment as
prevention as we have with HIV doesn't work because you are
dealing with an acute syndrome that lasts just literally for a
few weeks. Virological, you may have persistence of symptoms.
Treatment is important because you don't want people to get
ill. And we have had 530,000 plus deaths. You can avoid that
with good treatment. But the dynamics of an outbreak absolutely
is going to depend upon the vaccine.
The Chair. Thank you. Thank you very much. And I would just
like to note that Dr. Fauci does need to leave at 12:15 p.m. so
we are going to try and get through as many as we can.
Dr.--Senator Smith.
Senator Smith. Thank you very much, Madam Chair. I think
you almost promoted me to doctor, but sure.
[Laughter.].
Senator Smith. I want to thank our panelists for being with
us today. And as I have been listening to the testimony and
also the questions that are being asked, I am thinking about a
conversation I had yesterday with the folks at Hennepin Health
Care, which is a safety net health system in Minnesota, level
one trauma center in Minneapolis. And one of the things that
one of the caregivers said really has stuck with me. He said,
we are just so worried here as we continue to grapple with the
impacts of COVID in this community that the world is going to
move on.
As Dr. Fauci and others have said, we are still seeing
somewhere in the neighborhood of about 50,000 cases or more of
COVID a day and 1,200 daily deaths. So I think it is important
that we stay vigilant and keep our focus. And, of course, also
look to where the good news is. And I think we can do both of
those things. Dr. Walensky, I want to ask you about something
around vaccine distribution. This is a bright spot. So tribal
nations in Minnesota have done an exceptional job in
distributing the COVID-19 vaccine.
Here is just one example. The White Earth Nation in
Northwestern Minnesota partnered with Bannermen County to
distribute the vaccine and has now, this county, one of the
highest vaccination rates in the whole state. And what they did
is they had--they established a joint task force with the
county, help to streamline vaccine distribution, and manage the
supply in order to get the vaccine out. And today, White Earth
Reservation, where, of course, there is a mix of native and
non-native people living and is a sovereign nation, so they set
their own guidelines about who can be vaccinated, today because
of this close collaboration and the partnership that they have,
they have been able to--anyone who is over 18, who lives on
White Earth reservation, has been able to be vaccinated.
Another example is the Boise for Mobile Vaccination Clinic,
which is they have brought this as--another Northern Minnesota
Ojibway tribe, they have brought their mobile vaccination unit
to tribal members in Duluth and Minneapolis, those who don't
live on tribal lands. So, Dr. Walensky, could you just comment
on why you think this is working and what this can teach us
about addressing the challenges that we see around the Country
in getting equitable distribution of vaccines?
Dr. Walensky. Thank you so much for that question, Senator.
I think, as I mentioned, several weeks ago we had a vaccine
forum where we brought people together to talk about their best
practices, lessons learned, how they have been able to
distribute. We had over 100 tribal participants and I don't
know if those were specific examples that were given, but those
are among the examples where we can say this is trusted
partners, this is community engagement, this is people getting
the message from people they know, places that they trust. This
is part of why we want to engage at not necessarily only the
state level, or we need to get that down to the local level.
People don't necessarily want to hear from me that they
should be getting their vaccine. They want to hear it from
their local pharmacist. They want to hear it from their tribe
members to say, we have all been doing this together. They may
actually need to have it not just be convenient, but be able to
revisit it and say, well, maybe I am not ready today. But it
turns out tomorrow I have noticed that five of my friends, five
of my community members have gotten it and then they are
willing to engage.
I think these are important lessons that we need to be--
that we are learning, and that we need to replicate those
lessons and not just the tribes, but in other areas around the
Country as well as rural areas around the Country.
Senator Smith. Thank you. I really, I couldn't agree more
with that. I think one of the things that is important about
this is that we sometimes think that what we are experiencing
is vaccine hesitancy, when actually what we are experiencing is
a lack of access and especially a lack of access from trusted
providers. So I think it is important. Dr. Fauci, I want to try
to get this question into you quickly.
The Minneapolis Star Tribune recently reported that
Minnesotans are using websites or vaccine shopping, so they are
trying to figure out what is the best brand and then shopping
around for that and trying to figure out the benefits of one
vaccine versus another. Dr. Fauci, what would be your message
to people who are trying to compare the efficacy of these
different vaccines as they are making decisions about how to
move forward? What would you tell them?
Dr. Fauci. Yes, thank you for bringing that up, because
that really is an important issue. We have three highly
efficacious vaccines with a good safety profile. I think it is
not appropriate, understandable, but not really appropriate to
be shopping around to see which one you could get because you
are making a guess of which one is better. The only way you
know, if one is better than the other is to do a head to head
comparison in a clinical trial.
My advice when people ask me is that what is the most
important thing is to get vaccinated as quickly as possible
when your turn comes up to get a vaccine. Which particular
candidate you get is really not nearly as relevant as getting
it as soon as you can. So if you go into a clinic and they have
any of the one of the three available, I would just take it
rather than waiting maybe a few weeks to a month for something
that you think might be better. All three or highly
efficacious.
Senator Smith. Thank you so much. Thank you, Madam Chair.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. Thank you, Madam Chair. Leadership is
what America is now looking for. They are looking for a strong,
consistent, honest voice from the NIH, from the CDC, the FDA
and from the White House. And frankly, Dr. Fauci, a Nation is
turning its lonely eyes to you for leadership. Let's talk about
schools for a second. I think you all know and agree with me,
our schools, our youth are in a mental health crisis. Our youth
are suffering from increased instances of suicide, substance
abuse, overdoses, depression, a true epidemic.
This was very predictable for all of us from the health
care field that when we closed down schools without the social
interaction, we would see increased mental health crisis.
Totally predictable. Let's talk about the science of viruses
for just a second. As a private practice OBGYN for 25 years, I
would tell you that viruses are predictably unpredictable. That
how they impact a nonpregnant versus a pregnant woman certainly
is different. And what I feel like when I try to listen very
hard to you all is that this little science we do have is being
presented as dogma, as gospel.
We know it is not. It is anecdotal at best. All I have
heard so far today is basically anecdotal experiences. When it
comes to schools, we need to hear a stronger voice from you
all, from leadership. We need to hear a stronger voice, not a
wishy washy voice. And Dr. Fauci, I would ask you, do you agree
with me that the benefits outweigh the risk of getting children
back in school? Will you tell America we need to get our kids
back to school?
Dr. Fauci. Yes. I have said that repetitively, as you know.
You have obviously been following what I have been saying. I
have been saying the most important thing we need to do is to
try as best as possible to get our children back to school
safely. And that is exactly what I have been saying over and
over again right in this room in previous hearings. I think the
Chair has heard me say that----
Senator Marshall. Based on everything we know about the
virus, the epidemic we have now, do you feel the benefits
outweigh the risk of getting children into schools across
America?
Dr. Fauci. Well, if you listen to the CDC's
recommendations, that is exactly what they are saying. They are
talking about the benefits versus the risk. And as you know,
their guidelines, they are trying to get people to follow
guidelines that will get the children back to school with the
minimum risk.
Senator Marshall. I was hoping a yes or no answer, but I
will move on to mask one masks. One mask, two masks, oh me, oh
my. President Biden recently said that we should all wear masks
until everyone is vaccinated. That is probably the worst thing
that could have been said for compliance. So many people have
said, why would I go get a vaccine when the President says we
have to keep wearing masks until everyone is vaccinated? We
Americans feel like the goal line keeps moving, and I
understand your fear of different variants and all those
different things going on here, but where is the science that
clearly shows wearing mask is helpful after you have had the
vaccines? And for the sake of time, I need to move on.
But I have heard the question asked already and I have
heard anecdotal evidence. But I would love to have you all send
me the studies that show that it is absolutely beneficial to
wear a mask after you have been vaccinated or if you have had
the virus. And we all want to know, where is the goal line?
When can we stop moving masks? I want to talk about the border,
though. That is what I am really concerned about.
I just visited the border, my third trip. There is
certainly a humanitarian crisis, and I am sure anyone that has
been down there would agree with me. That is a national
security crisis, but I want to talk about the health care
crisis going on there. When I went down with a group of
physicians three years ago or so, I was concerned about just
the doctors, the nurses being overwhelmed. I was concerned
about tuberculosis, hepatitis, scabies, sexually transmitted
diseases and other communicable diseases. But now, based upon
what we know, the incidence of COVID is 5 to 25 percent of the
people coming across the border. And then what I see is they
take a group of folks, 50 to 60 people, they put them on one
bus, then they do a couple of exams and they all put them in
some type of a dorm setting.
If they all didn't have the virus, they soon will. And then
we let them go out into the public. That just seems
hypocritical. The application that you are talking about for
when we can let ships come to Alaska, and the concern about
variance from South Africa, that just seems hypocritical to me.
While I respect completely where you are coming from, it seems
like it is a double standard. Dr. Fauci, are you comfortable
with what we are doing on the border from an ID standpoint?
Dr. Fauci. The reason I would have to hedge on that,
because I am not really very deeply familiar with the details
of what is going on at the border, and that is perfectly honest
with you, Dr. Marshall. I really am not familiar enough with
the situation at the border to be able to make a comment. If I
was, I would.
Senator Marshall. Whose job is it to know that?
Dr. Walensky. I can chime in and say that I am aware that
at CBP sites there is overcrowding and that we need to, from an
infectious disease standpoint, from a COVID standpoint, we need
to dedensify what is happening at CBP. We have been working
closely with ORR as children leave CBP and move to the ORR
sites to work toward getting them screened and tested, which is
why they have, what percent positivity they have there. Those
ORR sites are much improved compared to the CBP sites with
regard to how those children are cared for, who is caring for
them, and we are providing technical guidance on those ORR
sites to work to make sure that they are as safe as possible
using mitigation strategies----
Senator Marshall. But do you see the hypocrisy in what we
are doing to America? We are saying that I can't have a
barbecue with my entire family on the July 4th. I can't have
Easter service worship together. But we are going to let people
come across the border in mass numbers and just release them
into--does that not seem hypocritical?
Dr. Walensky. I think there are two different situations,
and we have to handle in two different ways. And we have
guidance and strategies for how we are providing technical
guidance for the challenges that are occurring in the density
at the border. And then we are trying to keep the public safe
using the evidence based strategies there. Thank you.
Senator Marshall. Thank you. I yield back.
The Chair. Thank you very much.
Senator Rosen.
Senator Rosen. Thank you, Chair Murray and Ranking Member
Burr. I really would like to thank all of the doctors for being
here, for their tireless service to our Nation, for their
information, for their hard work and studying. And I would like
to just make this other comment that most of us here do
understand that data takes time, good data takes time.
Coronavirus is a new virus. It hasn't been around that long. We
haven't collected all the data to show us what the trends or
variants may be. It is, of course, evolving. And that good data
that will help us do the predictions that epidemiologists and
doctors like yourselves helped to do will be there, it is just
a matter of time.
I appreciate how quickly you are working on that. But we
also have to keep focused, I believe, on treatment options as
we have more variants. And of course, people will continue to
contract the disease. And we want to--we know vaccinations need
to go up, but we want to reduce the deaths if you do contract
the disease. 5,100 Nevadans have already, over 5,100 have
already died from COVID. I don't want to see that going up. And
so I have introduced bipartisan legislation to hopefully track
a diverse set of COVID patients, long term, longitudinal study
and report those findings on a regular basis.
Dr. Fauci, I really appreciated so much the conversations
we have had in the past. Talk about monoclonal antibodies,
other antivirals. We know both have helped. Like I said, people
are still dying. So is it an issue of patients not having
access to some of these? And what can you maybe tell us about
what is in the pipeline for therapeutics for those who
unfortunately will, may still contract the disease?
Dr. Fauci. I had outlined, and I will briefly repeat it, in
my opening statement that we have therapeutics for people with
early disease, the difficulty logistically is that getting
people early enough to make it work. Monoclonal antibodies
clearly work in the setting of getting people before they enter
the hospital and before they develop advanced symptoms. Every
study that has looked at monoclonal antibodies after a person
has advanced disease in the hospital has shown no benefit.
We do have good drugs for advanced disease, particularly
the state of the art of using dexamethasone with advanced
individuals. We have a number of others under emergency use
authorization. But getting to the point that I think you are
suggesting, Senator, is that the real endgame for this is to
develop targeted antiviral drugs, very similar to what we did
so successfully with antiretrovirals for HIV and for curative
therapies for hepatitis C.
We are now beginning to be investing a considerable amount
of resources in doing that. We have a couple of candidates now
that look good that actually had been developed previously that
we are putting into Phase 1, 2, and 2a and 2b trials. So you
are absolutely correct. We need to do better on therapy, and
the strategy for the future is to direct antiviral therapies
that are similar to what we did with HIV. Thanks.
Senator Rosen. I would like to build on that then, because
we hear about the long haulers or the long term effects of
COVID-19. We see people really suffering from this. We know
about 30 percent of all COVID patients really continue to
suffer from some form of ill-defined symptoms, prolonged
fatigue, brain fog, as some people are calling that. It may
render folks unable to go to work. It puts them at risk for
continued social isolation and other kinds of issues that may
certainly decrease their immune system. And so, we have to be
sure that we don't deny benefits to these folks who have the
long haul symptoms, but what can you tell me about Dr. Fauci,
about NIH, how you are evaluating these troubling long term
health consequences? And are there treatments available? What
is in the pipeline there for those that are continuing to
suffer? Some people's sense of smell. I have heard rancid
smell. Now they get their smell back, but everything smells
sour or rotten. What are you doing?
Dr. Fauci. We have initiated a major program to the tune of
$1.15 billion that we are doing at the NIH, also in
collaboration with the CDC, and following cohorts of
individuals to determine the incidence, the prevalence, how
long these symptoms last. We have some studies say they go out
up to eight months or longer.
You asked a very relevant question. What about treatment of
them? It is very difficult to devise a therapeutic regimen when
you don't know what the underlying pathogenic mechanism of the
disease is. And that is the real stumbling block here and why
we are intensively studying these individuals, because although
it is an absolutely real phenomenon, we don't have any
pathogenic mechanisms right now that we are certain of that has
a commonality among all of them. We will find that out. And
when we do, then we will be able to devise hopefully
appropriate and effective therapies.
Senator Rosen. Thank you. Again, appreciate everything you
are doing. Madam Chair, I yield back.
Senator Burr. Thank you, Senator Rosen.
Coach Tuberville.
Senator Tuberville. Thank you, Senator Burr. Thank you very
much. Thank you all for your service. Kind of reminds me of my
old job, 40 years coach in college football, sitting there
listening to armchair quarterbacks. Everybody has got the right
idea of how to run your job. Thank you for what you are doing,
because this Country and I guess 340 million people are
counting on you all and several billion that are not in this
Country. So it is very important and, it just brings to the
fact where we are in this Country.
On the campaign trail for the last two years, I keep
telling people, this is really the last year that, everybody
thinks they are going to come up with a vaccine. Americans are
going to come up with this vaccine because that is what we do.
But we need leadership. Dr. Fauci, you are the Tom Brady of the
COVID team. You have had good days and you had bad days, and we
thank you for what you have done. We just need leadership from
you and consistency. Everybody that I talk to, they understand
where you are coming from but sometimes we change in midstream.
Coaches can't do that. You got to say what you believe in.
We just ask you to, just be firm with us, tell us. You had
people in here today, Senator Rand, talking about the mask.
Tell us what you believe because we know very little about it.
The American people don't know anything about it. Dr. Walensky,
you got a tough job in front of you. And thank you for taking
it on, really. Again, this is not a Republican or Democrat
disease. This is a worldwide disease. And our kids are hurting,
I will say that. Our kids are hurting. I have had friends that
have died. I have had people go out of business.
We got to get this Country back open as soon as we can. I
mean, we can't drag their feet much longer, but we can't put
people in harm's way either. We really can't. So thank you for
what you are doing. I will reiterate what Mr. Marshall said,
Senator Marshall said about people in Alabama can't understand
why we are letting people in when we know some of them have the
coronavirus. We are in a loving Country. We like everybody. My
God, we put our lives on the line, our Country on the line, our
businesses and everything else on the line for the last year.
And for some reason, the White House continues to let people in
with this virus.
It is just mind boggling to us that pay taxes, everybody
that pays taxes, that--we will help them. This isn't the time.
This is not the time to do it. And I think it is your, you
guys' job is to go up there and say, listen, what are we doing?
We can't do this anymore. We have got to get the people back to
work and kids back in school and go back to church and get back
to normal life. And we just got a double standard here right
now that--it just amazes me. But again, I don't have any
questions. Thank you for what you are doing.
We are looking up to you all and tell us what to do. Please
tell us what to do and how to get through this, because we have
a lot of people in trouble, mentally in trouble, not just
physically but mentally. Thank you very much. Thank you, Chair.
Dr. Fauci. Senator, can I make a comment just in response
to something that you said it is really very important. When
you have a static situation that doesn't change, when you do
change your mind, then you are flip flopping. But would you
have an evolving situation when the scientific evidence and
data roll out and you learn more things in March that you
didn't know in February, that you didn't know in January, that
is the reason why you may hear us saying things that seem to be
different from one month to another, because you make a
decision, you make a policy, you make a recommendation based on
what is going on and the data at the time. So I just wanted to
say that because you make a very good point. when you were
talking about consistency. We try to be consistent, but we have
to be consistent with the data as it exists.
Senator Tuberville. The game plan changes then?
Dr. Fauci. You bet. If you are playing against the zone or
you are playing against a man to man, it is different.
Senator Tuberville. You are exactly right. You are exactly
right. But when you do change it, sell it and stick with it. I
mean, that is what we are all counting on.
Dr. Fauci. Thank you.
Senator Tuberville. We are counting on you all. Thank you.
Dr. Fauci. Appreciate it, sir.
Senator Burr. Senator Moran.
Senator Moran. Gentlemen, ma'am, thank you for being here.
Thank you for your service to our Nation. Dr. Marks, it is nice
to see you all. See you and the FDA in the appropriations
process. And Dr. Kessler, thank you for your help in regard to
helping us with the care for veterans. And we have--we are
working to pass legislation passed the Senate last night with a
conversation we had in our hearing about spouses and caregivers
for veterans. So that issue that I raised with you is
progressing. And Dr. Fauci, I didn't have enough of you in the
appropriations process, so I joined the HELP Committee.
Dr. Fauci. Great to see you.
Senator Moran. Thank you very much. Let me just ask you a
question and then I think I will visit with Dr. Walensky. It is
going to be a bit outside of COVID-19, all that is related. So
you better than anyone know the resources that NIH has devoted
to combating COVID-19, the research and the response. I would
like to be reassured that despite that important work, that the
other things that are important to America that are led by NIH
research are not suffering. So how would you--how do you see
the overall picture at NIH during this time of COVID-19?
Dr. Fauci. I think I would not be totally frank with you if
I told you that things are just exactly the way they were prior
to COVID, Senator. There has been a diminution of activity in
some areas for the simple reason that a lot of the clinical
center, for example, is not going at full capacity for reasons
that relate to the outbreak itself. As far as our grantees on
the outside, we are continuing the same sort of support for all
the other diseases that I know you are interested in cancer,
heart disease, diabetes, Alzheimer's, Parkinson's, all of those
are going well.
But I think across the Country, the same way that other
areas of our society have been dampened down a bit by this
outbreak, I think some of the research endeavor, by the very
nature of when you shut down, you shut down a lot of things,
including accessibility, for example, of certain types of
approach. But I want to give you my absolute promise, and I am
sure that Dr. Collins, where he here would tell you the same
thing, we give you our absolute commitment that we will do
everything we can to make sure that nothing important slips in
the other areas of research.
Senator Moran. It is a matter of saving lives with COVID
and outside. There are other afflictions and diseases that
Americans are afflicted with. Let me turn to the CDC, Dr.
Walensky, it seems important to me, I mean, I have heard the--
well I have three hearings going on this morning at the same
time. I have heard most of the testimony and responses to
questions. And I certainly am a promoter and proponent of
people being vaccinated.
I think that the CDC could be helpful if there are
guidelines for instructions and suggestions for those who have
been vaccinated were current and consistent and timely. So what
is it that CDC would tell someone today that their behavior or
conduct can change or what their behavior or conduct should be
following vaccination?
Dr. Walensky. Thank you for that question, Senator. About a
week ago, we released our first guidance on the first step on
what you can do if vaccinated, and that included things like
small visits in your home, visits with other vaccinated people
unmasked and undistanced, so that you could dine with other
vaccinated people in your home. You can also visit with
unvaccinated people as long as people in their home don't have
risk, high risk of severe disease. So that is we are still
looking at data regarding whether people who are vaccinated can
be asymptomatically infected and potentially transmit to other
people. In that case, we wouldn't want you to be living with
somebody who was immunocompromised, on chemotherapy and
whatnot, because we would worry about severe disease in that
household.
We have also released guidance on the fact that you don't
have to quarantine if you have been exposed and you are
vaccinated. So the quarantine has gone away with regard to
people who are being vaccinated. We are revisiting what we
should do regarding travel for those who are vaccinated, and
that should be coming forward soon. That is going to likely be
the next step in this regard. I want to remind people that we
have now 12 percent of the population fully vaccinated, 39.9
million people. The initial guidance was released when we had 9
percent of people vaccinated.
As more and more people are getting vaccinated, as we are
getting more and more data about the implications of
vaccination with regard to asymptomatic infection and potential
transmission, those guidelines will continue to emerge as you
are requesting.
Senator Moran. Let me suggest in the two-seconds that I
have left, that I had left five seconds ago, that I would ask
you to be concerned, this is true for every agency here as it
is represented here, a rumor in today's social media world, a
rumor about a problem with a vaccine, a consequence which could
be false, but it is easy for fear to spread among Americans,
you need to be prepared with the science and medicine to
respond quickly to put down a rumor. And I hope that is the
case in all of your circumstances.
Senator Burr. Thank you, Senator Moran.
Senator Lujan.
Senator Lujan. Thank you so very much, Chair. I really
appreciate that. Dr. Fauci, before I get to my questions, just
wanted to ask you, does wearing masks stop the spread of COVID?
Or help prevent the spread of COVID?
Dr. Fauci. I am sorry, sir, I didn't hear your question.
Senator Lujan. Dr. Fauci, does wearing masks help stop the
spread of COVID?
Dr. Fauci. Absolutely.
Senator Lujan. Should people keep wearing masks?
Dr. Fauci. Absolutely.
Senator Lujan. I think there is a reason, Dr. Fauci, that
even physicians, when they are in surgery and practicing, that
they wear face coverings because it stops the spread of
infection. And I think it is important. I just wanted to make
sure that we gave you time to clarify that after some of the
previous questions that have been asked today. Dr. Fauci, first
to each and every one of our panelists including yourself,
thank you for what you have been doing to save people's lives
and to defeat COVID-19. There are a couple areas where I do
have some concerns, and it is based on some of the data.
According to the CDC, Native American and Latino
populations living in the United States are more than twice as
likely to die of COVID-19 and more than three times as likely
to be hospitalized as their white counterparts. Despite this
data showing us that communities of color in the United States
have been hit the hardest by this pandemic, Latino and Black
people are receiving a smaller share of vaccines compared to
the larger population.
On February 19, Dr. Fauci, you said that that racial
disparity was very disturbing. And I appreciate that. Given the
recent polling that there is little difference between racial
groups in terms of how much they want a vaccine, how can the
Federal Government and will the Federal Government increase
access to vaccine in Latino, Native American and Black
communities?
Dr. Fauci. This is a major initiative, Senator, that the
Administration, the President himself is very serious about,
and it has to do with any of a number of things that are being
put in place to allow equity and easy accessibility.
For example, community vaccine centers in areas that are
demographically represented by minority communities, community
health centers, the same thing, having pharmacies that are
stocked with vaccines in areas where there are representation
of minorities to a high degree, to have mobile units to go out
into the community, particularly in those areas that are
underserved, and to increase the number of vaccinators, people
who can put vaccine into people's arms, be they military, be
they retired physicians, nurses, and healthcare providers.
This is a high, high priority for the Administration to
include equity into a vaccine program.
Senator Lujan. Appreciate that response. And while I do
have some concerns and questions surrounding the decisions that
were made by HRSA with the initial 250 sites that were
identified, including the first 25, I appreciate the expansion
of those sites to 750, which has expanded more sites in New
Mexico, including in rural communities. With that being said,
Dr. Fauci, I believe that the CDC social vulnerability index, a
measure that takes into account racial and socioeconomic
factors and also rural communities, would be a useful index to
allocate a certain percentage of vaccine doses to address these
disparities.
The State of New Mexico has designated 25 percent of
vaccine doses based on SVI. And I know it was announced last
month that FEMA has partnered with CDC to launch vaccination
sites based on their SVI. Yes or no, do you agree that using
SVI as a measure in allocating vaccine doses could potentially
help address vaccine disparities?
Dr. Fauci. I think it would, Senator. I would probably ask
Dr. Walensky since it is a CDC issue, if you have any comments
on that.
Dr. Walensky. Yes, we are using that. We are using SVI as a
mechanism by which to include FEMA sites. We actually look, in
collaboration with FEMA, look at both census data to make sure
we are getting large populations as well as SVI. We have a
benchmark SVI. We are also looking at the SVI data for
distribution. We know we have work to do in this area. And
while we are looking at the data, we also know we don't need
the data in order to improve because we know we have
improvements to make.
Senator Lujan. I raise my concerns about HRSA's initial
decision with the first 250 sites that were announced, the
rollout of the first 25, and the first 250 in New Mexico, which
is a large geographical state that has many challenges, was
only identified with one center. Dr. Kessler and Dr. Walensky,
can I get your commitment today that future programs focusing
on vaccine equity will serve not only underserved communities
in urban centers, but also those in rural regions as well?
Dr. Walensky. Maybe I will just chime in here and say that
I was really pleased yesterday when CDC announced $2.25 billion
in funding to go toward testing in areas that needed more with
regard to health equity. This was the first time that we have
been able to directly give 19 percent of that funding
specifically to rural jurisdictions. And so that effort is
intended to reduce disparities, increase testing, increase
mitigation strategies and education, and actually leave a
workforce capacity in those areas.
Senator Lujan. Can I get your commitment that future
programs will make that commitment to rural regions as well?
Dr. Kessler. Senator, the answer is yes, absolutely.
Senator Lujan. Thank you. I appreciate that. That is what I
was looking for. I very much appreciate the explanation there.
Thank you very much, Chair, and I yield back my time.
The Chair. Thank you, Senator Lujan.
Senator Burr, do you have any additional questions?
Senator Burr. Thank you, Senator Murray. Guys, we are at
the end. I do want to make some comments to sort of tie
together much of what we have heard today. Senator Kaine said
about a reference to a woman, maybe she didn't read the
science. Well, I have got to tell you something, you already
know most Americans don't read the science. And if they do,
they are like me. They don't understand the data.
I think there is a lesson to that, and that is that when we
put out guidance, when we make suggestions, you can reference
to the science, but you have to say it in a way that the
American people understand it. So it is not just the guidance
that we need, it is an explanation in a common sense way as to
why that is the guidance today so that they can apply that to
their own lives.
Two, Senator Murray said something really important, that
we need to do everything we can to raise the confidence of the
American people to take the vaccine. To you, Dr. Walensky,
guidance contributes to that. To Dr. Fauci, where he here, a
simple pitch of if you take the vaccine, the data shows us you
won't die and you won't go to the hospital. That is the most
compelling argument to make to the American people today that I
can think of. But we don't use plain words like that. We come
up with something that is a way to expand it, that references
something versus something that the American people will
understand.
Now, these are my comments. I hope the vaccine policy will
change in the not too distant future with the appropriate focus
on geographical underserved needed areas. Where the policy is,
we are going to stick the next person in line. Now that we have
addressed long term care facility, congregate care, the most at
risk, I fear, David, that in the not too distant future, we are
going to be sitting there with vaccines and no arms to stick
based upon the inability of the American people to sort through
this or the frustration of staying up all night to try to get
your reservation at CVS, and you finally say, I am just going
to wait until it opens wide open.
I may be wrong, but what if I am right. And I just implore
all of you to begin to think through, at what point do we pivot
where we say to the American people, if you are over 17, then
the vaccine is available to you, you are going to--might have
to go stand in line. You might have to get a reservation. But I
remember the day I walked into a hospital that their specialty
was bypass surgery. And when they explained to me that the
first two surgeries in the morning actually spent the night in
the hospital the night before, I was bewildered at this and I
said, why?
They said, because if we if they don't show up on time for
their preop, then we miss two surgery windows, and those
surgery windows are our profit. We break even that day if we
miss those two. Well, if we miss that next person in line, if
we have to wait five minutes to stick that person, we haven't
maximized the limitations that we have of people, professionals
that can load that syringe and stick it in the arm. And I think
that is going to become more and more a concern.
Lastly--well, this first. With what we know today, our goal
of everybody who would like a vaccine by the end of May, I
think it is fairly easy to say to the American people, next
fall, schools should open, and they should all be in person. I
think it is fairly easy to say by the time we get to summer,
Americans should fly, and they should feel comfortable on an
airplane. I think we should be able to tell people to plan
their summer vacations. I think we should say next Thanksgiving
and Christmas plan to spend it with your families, both
immediate and extended. We have to accept the fact that our
goal right now is to be fully vaccinated then.
Dr. Walensky, I am not saying travel to Germany or travel
wherever, because we are at the mercy of their vaccination
schedule as to when we open it up, but let me just say to you,
providing some certainty for next Thanksgiving, next Christmas,
next school year, even if the CDC policy or the Administration
policy is not that we are going to open all schools today, we
can sort of lean out over our skis and say, but if everything
goes like we have got it designed, we can open in the fall, we
can open in person, and there are a lot of parents out there
that will be relieved and teachers are on notice and students
are on notice. Last thing, I recognize the fact that a year ago
when the pandemic hit, businesses altered what they did and how
they did it.
Schools altered what they did and how they did it.
Government altered what they did and how they did it. Congress
altered what we did and how we did it. The one thing that did
not change at your agencies was the responsibility for
everybody to show up to do their job. For a year, we have been
relying on the health care professionals that work for you,
with you, and beside you to do their job. If not, we would not
be here a year later with three vaccines. We would not be here
with an ample supply of syringes and all the accompanying
devices and PPE that is needed to carry out the most massive
vaccination program that the world has ever seen. We wouldn't
be in a position where we could be talking about, let's look
around the corner and see how we prepare and what we learn from
this.
I ask you all to go back to the people that work with you
and for you and thank them on behalf of this Committee and this
Congress, because without them, we would not have the ability
to have hope that this could soon be over, and we wouldn't have
a commitment that we could explore how to make sure this
doesn't happen again. So I thank each of you for your
testimony. And I thank you for your indulgence, Madam Chair.
The Chair. Thank you, Senator Burr. And what Senator Burr
just said, I think, is probably the most important thing we
have said to all of you in this Committee hearing. Thank you to
all of your staff, to everyone who has been working really hard
on this, and I appreciate all that they are doing. So thank you
for bringing that up. I just have two additional questions and
we will close the hearing.
First of all, Dr. Marks, I wanted to ask you, for a year
now, your team has been working around the clock and making
sure vaccines and therapeutics are being developed and are safe
and effective, and we are all grateful for that, but an
important phase of this work is making sure that vaccines are
safe for our children. And I know vaccine manufacturers have
now begun work on clinical trials in pediatric populations. Can
you update us quickly on what FDA is doing to authorize or
approve vaccines and therapeutics for children?
Dr. Marks. Thanks very much for that question. So all of
the manufacturers of the three currently authorized vaccines
have plans. Either they have clinical trials ongoing or about
to start trials in children. There are already trials very
advanced in the adolescent age group that is 12 and over. And
so there is hope, I think, as Dr. Fauci said, that we will be
able to get that population vaccinated for the fall for junior
high and high school students. And for the younger children, we
do this step program of the trials.
We will look at the older young children and then move
down. And that is to make sure that we don't injure any
children as we are looking at the vaccines. We have to make
sure that every step is safe, and we don't skip any steps
because obviously the safety of our children is paramount. So I
think we have a good program in place. We are working with the
operation to make sure that program really will move through.
And the hope would be that by, toward the end of this year, we
will have data in the younger children.
The Chair. Okay, very good. Thank you very much. And Dr.
Walensky, this pandemic, as has been especially deadly for
communities of color and has exasperated longstanding health
inequities. Recent CDC data shows that Black and Latino people
are more likely to die from COVID-19 compared to white people.
In order to address these disparities effectively, we need to
collect complete, reliable data that fully reveals the scope of
the problem.
Unfortunately, we are still dealing with incomplete race
and ethnicity data when it comes to COVID-19, especially in
regard to vaccinations. And even when we do collect data, it
often doesn't break out in important groups like Native
Hawaiian or Pacific Islanders. I wanted to ask you, what is the
CDC doing to streamline data reporting and make sure it
includes information on race and ethnicity from the states and
other entities?
Dr. Walensky. Thank you for that question. I think there
are numerous components there. First of all, I think we need to
realize that we know we have a problem before we collect the
data. So we are actually actively working toward resolution of
some of these issues even without seeing the data. We know that
access to vaccines is more among the white community than in
the communities that have been hit hardest hit. So we need to
act before we even see the data. But we need data as well. We
are a data driven organization and we need to see where the
data are.
When I came in, there were at least seven or eight states,
I believe, that actually their data use agreements didn't allow
them to report data to us, that was in racial and ethnic
divide. So we have been working closely with those states to
make sure that we can resolve those data use agreement so that
we can actually get those data. Once we get them, though, that
is not actually the only challenge, because, in fact, patients
don't want to report. And so we have, a, we have providers who
don't ask the question. Many of these states data forms say
unknown. And so we get, the race and ethnicity data, it is
checked off, but it says unknown, and that is not particularly
helpful. So we are working with a lot of states to ensure that
we can maybe get rid of that slot so that people have to report
it.
We are working to try and encourage people to report their
race and ethnicity data. One way that we have been able to do
this is through the electronic case reporting forms. So those
reporting forms and we have been scaling this up over the last
several months actually can link the test positivity with their
medical record in Cerner or Epic, which actually report the
race and ethnicity data. So we are working hard, and I think
this is going to be a key component of data monitorization.
The Chair. Okay, thank you very much for that explanation.
That ends our hearing today. And I really want to thank all of
our colleagues and our witnesses, Doctors Fauci, Walensky,
Kessler, and Marks for a really thoughtful discussion.
I think everybody wants you to say it is going to be over
tomorrow and nobody can predict that. And I know you are all
working really hard to make sure we have the best scientific,
informative information that we can to make good decisions
about ourselves and our entire Nation. For any Senators who
wish to ask additional questions, questions for the record will
be due in 10 business days, on Thursday, April 1st, at 5 p.m.
The hearing record will also remain open until then for
Members who wish to submit additional materials for the record.
And this Committee will next meet on Wednesday, March 24th in
Dirksen 430 at 10 a.m. for a hearing on the nomination of
Cynthia Marten to serve as Deputy Secretary of Education. Thank
you again to our witnesses. The Committee stands adjourned.
QUESTIONS AND ANSWERS
Responses by Dr. Anthony Fauci to Questions of Senator Hickenlooper,
Senator Burr, and Senator Murkowski
senator hickenlooper
Question 1. In the year-end omnibus package $40 million was
appropriated through the National Institute of Allergy and Infectious
Diseases (NIAID) for Regional Biocontainment Laboratories (RBLs).
Colorado State University is the location of one of twelve labs
nationwide and is located furthest west geographically in the country.
Unfortunately, the funding included last year is the first Federal
funds that these labs have received since 2010. These important labs
conduct research on dangerous pathogens and develop new vaccines and
treatments for emerging infectious diseases. Given the enormous
challenge we face as we recover from COVID and prevent against further
pandemics, consistent support for these labs is urgently needed.
Would you commit to working with me and the Committee to ensure
that these twelve facilities receive regular Federal support?
Answer. The National Institute of Allergy and Infectious Diseases
(NIAID) is committed to conducting and supporting research on emerging
and re-emerging infectious diseases. The twelve U.S. Regional
Biocontainment Laboratories (RBLs) were constructed with NIAID support
to enhance the research infrastructure required to safely and securely
conduct research on biodefense and emerging and re-emerging infectious
disease pathogens. Since their construction, the RBLs have received
support from Federal grants and contracts awarded on a competitive
basis to fund investigators conducting research within the facilities
as well as fees charged to outside entities, which may themselves be
recipients of funding from the National Institutes of Health (NIH).
NIAID will continue to support highly meritorious biomedical research
in biocontainment laboratories, including the RBLs, which are essential
for the development of novel diagnostics, therapeutics, and vaccines
for emerging and re-emerging infectious diseases.
Question 2. BioMARC is a non-profit infectious disease research and
development facility that is part of Colorado State University and was
established with funding from NIH. The facility is currently working on
a COVID-19 vaccine candidate using a platform manufacturing technology
developed at CSU. They received funding from the NIH to work on the
development of the manufacturing method and testing of the vaccine
candidate. They were recently told by the National Institutes for
Allergy and Infectious Diseases (NIAID) that there may not be funding
for future testing of this vaccine.
Given that COVID continues to mutate, stopping funding for the
development of additional vaccine candidates seems short sighted.
Would you commit to work with me and our Committee to ensure that
vaccine candidates like BioMARC's continue to get the proper funding
needed to advance them and keep our communities protected?
Answer. NIAID conducts and supports basic and applied research to
better understand, diagnose, treat, and ultimately prevent infectious
diseases such as COVID-19. NIAID remains committed to supporting a wide
range of highly meritorious extramural research through the standard,
competitive NIH peer review process. This includes research related to
vaccine development for SARS-CoV-2, the virus that causes COVID-19. In
addition, NIAID provides a broad range of preclinical services to the
research community to fill gaps in the vaccine development pipeline and
facilitate the development of vaccine candidates.
Colorado State University was awarded a contract through NIAID's
Omnibus Broad Agency Announcement solicitation in 2020 to develop a
SARS-CoV-2 vaccine using novel viral inactivation technology. In
addition, the Biomedical Advanced Research and Development Authority
(BARDA) made an award to Colorado State University for the same
technology, and the agencies collectively determined complementary
funding. BioMARC's vaccine candidate is in preclinical development and
may provide a vaccine platform for use in future infectious disease
outbreaks.
NIAID plays a central and important role in the public health
response to COVID-19 and is supporting the development and evaluation
of several vaccine candidates. Five candidate COVID-19 vaccines have
entered Phase 3 clinical trials in the United States thus far, and
three subsequently received Emergency Use Authorizations (EUAs) from
the U.S. Food and Drug Administration (FDA). NIAID has helped to
advance four of these COVID-19 vaccine candidates through support for
research on the foundational biology underlying the vaccine concepts,
as well as for clinical testing through the COVID-19 Prevention Network
(CoVPN). Two of these vaccine candidates from Moderna, Inc., and
Johnson & Johnson/Janssen have received EUAs. In addition, NIAID is
conducting a Phase 1 clinical trial of an investigational vaccine,
developed by Moderna based on its authorized COVID-19 vaccine, designed
specifically to target the B.1.351 SARS-CoV-2 variant first detected in
South Africa. NIAID also is supporting research to develop a SARS-CoV-2
vaccine that is broadly protective against emerging SARS-CoV-2 variants
and is testing strategies to achieve the ultimate goal of developing a
universal coronavirus vaccine.
The Administration and NIAID are committed to working with the
Committee and others in Congress to support the development and
clinical evaluation of investigational COVID-19 vaccines, including
vaccine candidates designed to target SARS-CoV-2 variants should they
be needed, and ultimately a universal coronavirus vaccine. NIAID will
continue to provide funding and resources to the research community to
advance the development of COVID-19 candidate vaccines.
senator burr
Question 1. I have long advocated for improved coordination within
our medical countermeasures enterprise and mechanisms that enable us to
rapidly develop countermeasures by screening drugs, biologics, and
platform technologies to determine potential utility against novel
threats. Efforts like the Rapid Acceleration of Diagnostics (RADx)
Initiative and the work of the Biomedical Advanced Research and
Development Authority and other partners during the COVID-19 response
have demonstrated that this type of rapid, coordinated screening and
development work is possible.
Question 1(a). How should we institutionalize these mechanisms and
related lessons learned from the COVID-19 response so we do not have to
start from scratch the next time a novel threat emerges?
Answer. Throughout the COVID-19 pandemic, the NIAID has leveraged
highly productive partnerships with industry, academia, and the public-
sector; and made use of longstanding relationships with community
partners to facilitate the biomedical research response by engaging
existing domestic and international research infrastructure. NIAID also
is an integral partner in the whole-of-government approach that began
under Operation Warp Speed and has continued under the current
Department of Health and Human Services (HHS) and Department of Defense
(DOD) Countermeasure Acceleration Group (CAG) partnership to promote
the development of safe and effective COVID-19 medical countermeasures.
This effort led to the identification of safe and effective
therapeutics for the treatment of COVID-19, as well as multiple COVID-
19 vaccine candidates progressing in record time from concept to EUA
from the FDA.
Early in the COVID-19 pandemic, the NIH initiated the Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private
partnership to advance a coordinated research strategy for prioritizing
and speeding development of the most promising treatment and vaccine
candidates. Coordinated by the Foundation for the NIH, ACTIV brought
together NIH and other HHS organizations, including the BARDA, Centers
for Disease Control and Prevention (CDC), and FDA; other government
agencies including the DOD and Department of Veterans Affairs; the
European Medicines Agency; and representatives from academia,
philanthropic organizations, and numerous biopharmaceutical companies.
In addition, NIAID established the CoVPN by leveraging four
existing NIAID-funded clinical trials networks in cooperation with the
DOD. The CoVPN enrolled thousands of volunteers in large-scale clinical
trials to test a variety of investigational vaccines and monoclonal
antibodies intended to protect people from COVID-19. The CoVPN also
participated in harmonized protocols developed in collaboration with
the ACTIV public-private partnership, vaccine manufacturers, and BARDA.
NIH also is partnering with BARDA, CDC, FDA, and the Defense
Advanced Research Projects Agency (DARPA) on the Rapid Acceleration of
Diagnostics (RADx \S*ERR17*M\)*ERR17* initiative to speed innovation in
the development, commercialization, authorization, and implementation
of technologies to test for SARS-CoV-2, the virus that causes COVID-19
disease. On March 31, 2021, CDC, in collaboration with NIH, launched an
initiative in Pitt County, North Carolina, and Chattanooga/Hamilton
County, Tennessee, to provide residents with access to free, rapid
antigen tests supplied by the RADx initiative that can be administered
at home three times a week for one month.
NIH and CDC plan to expand the at-home testing initiative to other
communities as well. NIH and CDC will be evaluating whether frequent
self-administered SARS-CoV-2 testing helps residents reduce community
transmission of SARS-CoV-2. The development of innovative, at-home
SARS-CoV-2 diagnostics also may inform the development of rapid
diagnostic tests for other emerging and re-emerging infectious disease
threats.
Efforts to develop COVID-19 medical countermeasures also
capitalized on decades of NIAID investment in basic research and
pandemic preparedness efforts, which focused on pathogen-specific work,
platform-based technologies, and prototype-pathogen efforts. NIAID-
supported research has advanced the development of ``plug and play''
platform technologies, such as the messenger RNA (mRNA) platform that
enabled COVID-19 vaccine candidate development to occur at an
unprecedented pace. In addition, NIAID prototype pathogen efforts--in
which scientists study and develop vaccine candidates for
representatives from a family of pathogens with pandemic potential--
also can shorten the time needed to create investigational vaccines
using platform-based methods. In the course of research on the Middle
East respiratory syndrome coronavirus (MERS-CoV) and other
coronaviruses, NIAID Vaccine Research Center researchers and their
collaborators discovered a technique to modify and stabilize a key
coronavirus protein--known as the spike protein--for use in vaccine
development. When the novel SARS-CoV-2 virus emerged, scientists were
able to adapt these modifications and stabilize the spike protein of
SARS-CoV-2, a close relative of MERS-CoV. Ultimately, this technology
was used in all three of the COVID-19 vaccines currently authorized
under an EUA from the FDA. These investments in basic research will
enable NIAID to prepare for the next inevitable infectious disease
outbreak.
HHS, DOD, and other Federal partners continue to collaborate to
support the research response to COVID-19. Lessons learned from the
COVID-19 pandemic will inform our efforts to prepare for--and respond
to--subsequent infectious disease threats.
Question 1(b). What steps are you and others involved in the
medical countermeasures enterprise taking to bolster the enterprise,
including tests, therapeutics, and vaccines so that the Federal
Government continues to effectively coordinate after this pandemic
ends?
Answer. As discussed in response to question 1.a., the Federal
response to the COVID-19 pandemic has strengthened existing
partnerships and coordination mechanisms, as well as established new
partnerships that will inform the response to future infectious disease
pandemics. The coordinated efforts through the RADx initiative, ACTIV,
and the CoVPN allowed us to leverage the intrinsic strengths from
public and private sector partners to achieve an unprecedented level of
scientific achievement in the midst of perhaps the most challenging
public health crisis of our lifetime. It should be noted that these
efforts would not have been possible without the longstanding Public
Health Emergency Medical Countermeasures Enterprise (PHEMCE) structure.
The existing relationships developed through the PHEMCE and the
understanding of the capabilities, portfolios, and expertise of the
constituent partners facilitated by previous work under PHEMCE allowed
for Operation Warp Speed to be quickly established, staffed, and
implemented and for the continued work under the current CAG
partnership.
When the COVID-19 pandemic ends, lessons learned from our
experiences with RADx, ACTIV, and the CoVPN will continue to help
inform efforts to address other emerging and re-emerging infectious
diseases. NIH and NIAID will continue to work with HHS Operating
Divisions and other Federal agencies to research and develop safe and
effective diagnostic tests, therapeutics, and vaccines for COVID-19.
NIH and NIAID will participate in collaborative efforts to identify the
actions that were most effective in responding to the COVID-19
pandemic, which may result in new initiatives, strategic plans, and/or
formal assessments of pandemic preparedness. NIAID is committed to
ensuring that the biomedical research enterprise is poised to respond
rapidly to the next, inevitable infectious disease threat.
senator murkowski
Question 1. Dr. Fauci, I understand that the Pfizer and Moderna
vaccines are about 95 percent effective in preventing ``symptomatic
COVID-19'' and that Moderna's vaccine is 66 to 85 percent effective in
preventing ``moderate to severe/critical COVID-19 infections''. Can you
explain the distinction between these two values? I understand that
your advice has been to get whichever vaccine we're offered, but for
Americans that would like an apples to apples comparison between the
vaccines, is that information available?
Answer. Efforts by Federal agencies, as well as partners in
academia and industry, to develop COVID-19 vaccines that meet rigorous
standards for safety and effectiveness have been remarkably successful.
The three COVID-19 vaccines currently available under FDA EUAs were
shown to provide a high level of protection against severe disease,
hospitalization, and death in large-scale Phase 3 clinical trials.
NIAID supported the trials for two vaccine candidates, developed by
Moderna, Inc., and Johnson & Johnson/Janssen, through the CoVPN. These
vaccine candidates were evaluated for safety and efficacy in separate
clinical trials, and the results from these trials should not be
directly compared because the trials were conducted in different
geographic regions where different variants were known to be
circulating and at different points in time with varying incidence of
COVID-19. As noted in the question, the trials also compared different
endpoints that were defined by the trial sponsors. These endpoints
provided valuable information on the safety and efficacy of the
candidate vaccines which ultimately informed FDA's assessment of the
data and their decision to issue EUAs.
The FDA has stated that a COVID-19 vaccine with at least 50 percent
efficacy against symptomatic SARS-CoV-2 infection would have a
substantial impact on COVID-19 disease, both at the individual and
societal level. All three of the COVID-19 vaccines available under an
EUA have significantly exceeded FDA's 50 percent threshold.
In order to contain the spread of SARS-CoV-2, it is important that
individuals become vaccinated--as soon as they are eligible--with one
of the COVID-19 vaccines currently authorized. Each of the available
vaccines provides significant protection from severe COVID-19 disease
and death. In addition, the clinical trials are ongoing and accruing
additional data pertaining to safety and effectiveness, and
observational data is emerging that further demonstrates the high level
of efficacy of these vaccines in ``real-world'' conditions. As we
accelerate vaccination efforts, we must also continue to follow the
public health measures outlined by the CDC to limit the spread of SARS-
CoV-2.
Question 2. Dr. Fauci, do scientists have enough data to understand
exactly where the COVID-19 variants are and to what degree? If not,
what more must the Federal Government, state public health agencies,
and health practitioners do to ensure that we can track and protect
ourselves from these variants that exist or may exist in the future?
Answer. A concerning development of the ongoing pandemic is the
detection of SARS-CoV-2 variants, some of which appear to be more
transmissible than the original virus. Additional data is needed to
fully understand the location and prevalence of SARS-CoV-2 variants,
and extensive efforts to expand and improve our ability to detect where
and to what degree these variants are circulating are underway through
Federal efforts led by the CDC. The Biden administration recently
announced plans to invest $1.7 billion from the American Rescue Plan to
expand CDC-led efforts to help states and other jurisdictions more
effectively combat these viral variants. This funding will help to
bolster the ongoing Federal Government's efforts to track and protect
from SARS-CoV-2 variants described below.
NIAID is participating in the SARS-CoV-2 Sequencing for Public
Health Emergency Response, Epidemiology, and Surveillance (SPHERES)
initiative. SPHERES is a national genomics consortium led by CDC that
includes State Public Health Laboratories, academic institutions, and
other partners and helps to coordinate SARS-CoV-2 sequencing across the
United States. Information on the proportion of SARS-CoV-2 variants
circulating in the United States can be found on the following CDC
website: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
Further, NIAID has established relationships with international
partners through the Centers of Excellence for Influenza Research and
Response, Centers for Research in Emerging Infection Diseases, Genomic
Centers for Infectious Diseases, and intramural programs that support
sequencing and ultimately offer insights into SARS-CoV-2 variants that
emerge globally. This ensures that the United States will be well-
positioned to assist partnering countries, as well as anticipate
variants prior to their detection in the United States.
NIAID also is fully engaged in efforts to mitigate the potential
impact of emerging variants of SARS-CoV-2. NIH, including NIAID,
participates in the SARS-CoV-2 Interagency Group (SIG), which works to
identify and characterize the potential impact of viral variants on
medical countermeasures and public health control efforts. The SIG is
developing a robust response to provide the evidence needed for rapid
decisionmaking in the face of a constantly evolving variant landscape.
The SIG was established by HHS to facilitate coordination among NIH,
CDC, FDA, BARDA, DOD, and the U.S. Department of Agriculture to detect
and address SARS-CoV-2 variants as they emerge. In addition, NIAID is
working with partners to identify, monitor, and calculate the frequency
of current variations in the SARS-CoV-2 genome to help predict emerging
variants.
A critical component to protecting against SARS-CoV-2 variants is
understanding how variants might affect interactions between the virus
and the immune system and their implications for COVID-19 therapeutics
and vaccines. To advance this knowledge, NIAID is rapidly conducting
research to better understand the impact of viral variants using
cutting-edge modeling, structural biology tools, and in vitro and in
vivo testing. NIAID scientists also are helping to inform our
understanding of transmissibility of the variants by studying their
stability in the environment and their ability to grow in human lung
cells. These efforts add to a growing body of knowledge about SARS-CoV-
2 variants and our ability to combat them.
While the emergence of SARS-CoV-2 variants that are more
transmissible has made efforts to contain the spread of SARS-CoV-2 more
challenging, current scientific evidence suggests that the COVID-19
vaccines available in the United States under EUAs continue to be
effective against SARS-CoV-2 variants. Given this, it is important that
individuals become vaccinated when they are eligible with one of the
COVID-19 vaccines currently available under EUAs, as well as continue
to follow the public health measures outlined by the CDC.
Question 3. Do you anticipate that Americans will need to get
vaccinated against COVID every year, as we do against the flu? If so,
do you anticipate that such vaccines will be as easy to get as flu
vaccines are now, through our workplaces, doctors' offices, and
pharmacies? What are the barriers to achieving that?
Answer. All vaccines available in the United States after
authorization by FDA meet rigorous standards for safety and
effectiveness. The durability of COVID-19 vaccine effectiveness is not
yet known, and it is possible that periodic boosting and/or changes in
vaccine composition may be necessary. NIAID is conducting and
supporting research that will help understand the immune response to
vaccines to inform whether boosters are needed, and to develop broadly
effective coronavirus vaccines and variant-specific vaccines if needed.
NIAID defers to FDA and CDC on questions regarding vaccine approval and
access.
NIAID is supporting research to monitor the duration of protection
provided by current COVID-19 vaccination regimens. In addition,
encouraging data on the durability of immune responses to the mRNA
COVID-19 vaccines recently have been released by Moderna and Pfizer/
BioNTech. Six months after vaccination, immune responses to the Moderna
COVID-19 vaccine remained robust, and the Pfizer/BioNTech vaccine
maintained 91.3 percent vaccine efficacy against COVID-19 after 6
months. We likely will have enough data by late Summer or early Fall
2021 to better assess the need for a booster dose of these COVID-19
vaccines.
Out of an abundance of caution, NIAID also is supporting the
evaluation of candidate vaccines against SARS-CoV-2 variants. NIAID
currently is supporting a Phase 1 clinical trial to test the safety and
efficacy of the vaccine candidate mRNA-1273.351, which was developed by
Moderna and designed to protect against the B.1.351 SARS-CoV-2 variant.
A BARDA-supported Phase 2a trial of mRNA-1273.351 also is underway to
evaluate the safety and efficacy of this vaccine candidate as a booster
in individuals who already received two Moderna COVID-19 vaccine doses.
In addition, investigators at the NIAID Vaccine Research Center are
collaborating with Moderna to evaluate mRNA-1273.351 in animal models.
NIAID also is supporting research to develop a SARS-CoV-2 vaccine
that is broadly protective against emerging SARS-CoV-2 variants and is
testing strategies to achieve the ultimate goal of a universal
coronavirus vaccine. On March 25, 2021, NIAID launched a Phase 1
clinical trial in healthy adults to assess the safety and
immunogenicity of second-generation COVID-19 vaccine candidates
developed by Gritstone Oncology, Inc. Gritstone's COVID-19 vaccine
candidates utilize a strategy aimed at inducing both neutralizing
antibodies and T cell responses to elicit a broad immune response.
This approach could provide protection against emerging SARS-CoV-2
variants by targeting several viral antigens, all of which are highly
conserved among viral strains. NIAID also is conducting early stage
research on the development of pan-coronavirus vaccines designed to
provide broad protective immunity against multiple coronaviruses,
including SARS-CoV-2 and others with pandemic potential.
______
Responses by Dr. Kessler to Questions of Senator Murray, Senator
Hickenlooper, Senator Lujan, Senator Burr, Senator Murkowski, Senator
Braun, Senator Marshall, and Senator Tuberville
senator murray
Question 1. Given the critical role that BARDA plays in the
advanced research, development, manufacturing, production and
procurement of diagnostics, vaccines, and therapeutics against COVID-
19, we are aware that BARDA has failed to invest in the advanced
research and development of therapeutics to date. Can you explain why
BARDA has not invested in the research and development of therapeutics
for COVID-19 especially given the continuing loss of life and the
threat of variants? The American Rescue Plan provided $6.05 billion for
research, development, manufacturing, production and purchase of
vaccines, therapeutics and ancillary medical products for COVID-19 or
any disease with potential for creating a pandemic. How much of this
funding that was appropriated to the HHS Secretary will be provided to
BARDA for the advanced research and development of therapeutics for
COVID-19?
Answer. Therapeutics are an important element of the COVID-19
response. Since February 2020, BARDA has obligated more than $10
billion for the development and purchase of 14 therapeutics.
Investments include: development of Regeneron's monoclonal antibody
therapy; early discovery work for AstraZeneca's prophylactic monoclonal
antibodies; two Phase 3 trials testing anti-IL-6 monoclonal antibodies
as a treatment for hospitalized COVID-19 cases; a Phase 2 screening
trial for two immune modulators with Genentech; early investments in
hyperimmune globulin development with Grifols and Emergent; antiviral
screening and therapeutic development efforts with Janssen; and, as of
March 18, 2021, 1.7 million courses of an investigational antiviral
treatment, molnupiravir (MK-4482) from Merck, if granted emergency use
authorization (EUA) or approval from the U.S. Food and Drug
Administration (FDA).
Since May 2020, BARDA has been an integral part of the Operation
leadership and colleagues at the Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to
identify promising candidates that may be close to receiving Emergency
Use Authorization (EUA) from the FDA. If new candidates are a strategic
fit for the existing portfolio, those products are considered for
potential funding through the Operation.
senator hickenlooper
Question 1. We are learning that for COVID-19, many key areas for
vaccine and therapeutic development, as well as increasing U.S.
manufacturing capabilities for better domestic resilience, have been on
hold for many months, including funding for the product development
group at BARDA. What is the plan to release the funds that have already
been allocated for these purposes?
Answer. BARDA is working closely with other parts of HHS and the
Administration to ensure that the Nation has the vaccines and
therapeutics needed to provide Americans as much protection from COVID-
19 as is feasible. Funds are available for obligation consistent with
agreed-upon plans.
senator lujan
Question 1. At the onset of this pandemic, we all quickly realized
the vulnerabilities in the existing Strategic National Stockpile (SNS).
Since then, the SNS has entered into short-term public-private
partnership contracts to leverage the capabilities of the distribution
industry to ensure a continuously replenishing inventory system.
Contracts such as these strive to ensure that health systems and
physicians have access to necessary drugs, medical devices, and
protective equipment subject to surge demand due to the COVID-19
pandemic.
As the Administration prioritizes policies to avoid future
shortages of critical goods, as evidenced by the recent 100-day supply
chain review executive order, how can public-private partnerships with
the SNS improve preparedness to address future demand-driven shortages
caused by pandemics, national emergencies, and any other unforeseen
challenges?
Answer. Public-private partnerships are critical for the success of
the Strategic National Stockpile (SNS). The relationships SNS has
cultivated with industry partners provides the SNS real-time visibility
of market capacity, allowing better decisionmaking in support of
preparedness planning and response operations. These partnerships
improve the resiliency of the SNS through:
Improved monitoring of commercial supply chain
inventory and performance;
Improved access to personal protective equipment
(PPE);
Improved public access to MCMs;
Improved coordination of the timing and quantity of
release of SNS assets to best support a response; and,
Education on challenges associated with over-ordering
or hoarding of needed materiel during a public health incident.
During the COVID-19 pandemic, SNS built upon these relationships by
partnering with Strategic Marketplace Initiative (SMI). SMI is a group
of medical distributors and providers committed to driving meaningful
improvements in supply chain agility, efficiency, and resilience.
To improve future response operations, throughout the COVID
response, the SNS has captured lessons learned and is now working to
incorporate changes and improvements. Going forward, the SNS will
continue to coordinate and partner with industry partners. The supply
chain is dependent on close coordination and communication between all
partners. Early identification of stress points, challenges, limited
supply, etc. helps to mitigate the lasting impact.
Question 2. While increasing medical supplies is important, we need
to ensure that all Federal acquisition procedures ensure that health
care providers receive the quality materials and supplies they need to
keep patients and personnel safe. Last year, there were reports that
the Indian Health Services purchased $3 million of potentially
substandard respirator masks and then distributed those masks without
proper quality screening to Navajo Nation hospitals in New Mexico and
Arizona. Why is it important for the Federal Government to regularly
review their acquisition contracts and audit their inventory to protect
patients and providers?
Answer. Regular reviews of government contracts are important and
are performed to ensure government needs are adequately defined, that
appropriate contract terms are included, and that contract
administration is done properly. In addition, regular inventory audits
are important and are done to ensure adequate supplies are on hand and
to ensure orders are placed timely for re-supply.
senator burr
Question 1. President Biden recently announced that 90 percent of
the adult U.S. population will be eligible for the COVID-19 vaccine and
90 percent will have a vaccination site within 5 miles of their home by
April 19th. The Administration plans to accomplish this goal by
doubling the number of COVID-19 vaccine doses available through retail
pharmacies, expanding the Federal Retail Pharmacy program, and adding
another twelve mass vaccination sites to the federally run mass
vaccinationsite program. \1\ Recent news reports indicate, however,
that federally run mass vaccination sites have been less efficient in
administering COVID-19 vaccine doses than other types of sites, such as
retail pharmacies. \2\ While announcing that 90 percent of adults will
be eligible for the vaccine in just a few weeks, our ability to keep
Americans safe and reopen our economy is contingent on our ability to
get shots in arms.
---------------------------------------------------------------------------
\1\ https://www.whitehouse.gov/briefing-room/statements-releases/
2021/03/29/fact-sheet-president-biden-announces-90-of-the-adult-u-s-
population-will-be-eligible-for-vaccination-and-90-will-have-a-
vaccinationsite-within-5-miles-of-home-by-april-19/.
\2\ Erin Banco, ``Biden Admin Remakes Vaccination Strategy after
Mass Vaccination Sites Fizzle,'' Politico Pro.
Question 1(a). What criteria were considered when deciding to
expand the mass vaccination site program compared to other distribution
---------------------------------------------------------------------------
channels that have been more effective?
Answer. HHS has worked with our government partners in a whole-of-
government response to vaccine all eligible Americans. As of March
2021, we have provided Federal support for 1,800 community vaccination
centers and mobile sites across the Country. In addition to mass
vaccination sites, we have also launched the Federal Retail Pharmacy
Program, a collaboration between Federal Government, states, and
territories, and to 21 national pharmacy networks to expand access to
vaccines for the American public, with over 40 percent of locations in
highest need neighborhoods. We increased the number of pharmacies
providing vaccines to nearly 40,000. In addition, we have launched a
program to directly send vaccine to community health centers, currently
reaching over 750 centers who have ordered nearly 6 million COVID-19
vaccine doses for over 2,000 sites. HHS also launched a Rural Health
Clinic program and announced expanded COVID-19 Testing and Mitigation
funding for small rural facilities and critical access hospitals--to
mitigate the spread of the virus in ways tailored to local rural
communities.
Question 1(b). About half of supermarket pharmacies that are
participating in the Federal Retail Pharmacy Program have not received
COVID-19 vaccines to administer. Will all participating supermarket
pharmacies be receiving COVID-19 doses through this expanded initiative
announced on March 29, 2021?
Answer. The Federal Retail Pharmacy program supports more than
40,000 pharmacies. The program works to ensure that nearly all enrolled
pharmacies receive COVID-19 vaccine doses.
Question 1(c). During the HELP Committee hearing on March 25, one
witness discussed a collaboration in North Carolina between Atrium
Health, Honeywell, and other partners that resulted in one of the most
successful mass vaccination efforts in the Nation to date. This
demonstrates that mass vaccination sites can be effectively run without
direct Federal support. How is the Administration working with states,
local governments, and the private sector to share information about
these innovative approaches and encourage more of these types of
partnerships?
Answer. States and communities are considering a variety of
approaches to increase COVID-19 vaccine uptake that involve innovative
partnership across sectors. CDC shares information, including through
toolkits, to support states and communities in putting together events
to improve vaccine confidence. Jurisdictions are also leading efforts
using local public-private partnerships to conduct outreach and host
vaccine clinics.
Question 1(d). How is the Administration working with states and
local governments to support their efforts to reach underserved
communities, including rural communities, to increase vaccine uptake
for the newly eligible over the next few weeks?
Answer. Thanks to the American Rescue Plan, the White House
announced HHS will invest nearly $10 billion to expand access to
vaccines and better serve communities of color, rural areas, low-income
populations, and other under-resourced communities in the COVID-19
response.
The Health Resources and Services Administration (HRSA) will
support Rural Health Clinics (RHCs) to increase the availability of
COVID-19 vaccines in rural communities and expand outreach to build
vaccine confidence. Working in partnership with the Centers for Disease
Control and Prevention (CDC), HRSA is inviting Medicare-certified RHCs
to join the new Rural Health Clinic COVID-19 Vaccine Distribution
(RHCVD) Program to directly receive Federal allocations of vaccines.
HRSA and CDC will continue to enroll interested RHCs to receive COVID-
19 vaccines, the allocation for which is separate from jurisdictions'
weekly allocations.
In addition, through the Rural Health Clinic Vaccine Confidence
(RHCVC) Program, HRSA will make nearly $100 million available in grants
to eligible RHCs nationwide to address health equity gaps by offering
support and resources to medically underserved rural communities where
COVID-19 vaccine uptake lags in comparison to more populated areas.
HRSA will fund all eligible RHCs that apply. The RHCVC Program is the
first targeted RHC grant since the passage of the Rural Health Clinic
Service Act in 1977. RHCs will be able to use the funds to increase
vaccine confidence, improve health care in rural areas, and reinforce
key messages about prevention and treatment of COVID-19 and other
infectious diseases.
HRSA and CDC launched the Health Center COVID-19 Vaccine Program to
ensure our Nation's medically underserved communities and those
disproportionally affected by COVID-19 are equitably vaccinated. The
program provides a direct supply of COVID-19 vaccines to HRSA Health
Center Program-funded health centers and Health Center Program look-
alikes in addition to COVID-19 vaccines that health centers might
receive through their states. This program started on February 9th with
an initial cohort of 25 health centers, and expanded in less than two
months to include all HRSA Health Center Program-funded health centers
and LALs on April 6, increasing its reach to 1,470 health centers
nationwide.
Health Center Program-funded health centers and Health Center
Program look-alikes have administered more than 10 million COVID-19
vaccine doses nationwide--with 61 percent provided to racial and ethnic
minorities. Community health centers, which largely serve the Nation's
underserved and most vulnerable communities, have been central to
President Biden's commitment to ensuring equity and access in the
COVID-19 response and vaccination program.
On March 15, 2021 CDC announced plans to launch a new grant program
starting in June 2021 called Reducing Racial and Ethnic Disparities in
Adult Immunization. This program of about 20 national organizations
supports hundreds of local and community-based organizations to improve
both COVID-19 and flu vaccination coverage among racial and ethnic
minority groups. In addition to funding support, the new program
creates opportunities for partners to collaborate with and learn from
one another through a learning community. Additionally, CDC is helping
state, territorial, and local health departments, as well as community-
based organizations, to deploy COVID-19 relief funding in a community-
driven way through guides that support the design and implementation of
activities to increase vaccine confidence and access. CDC will also
engage organizations in a social media strategy to detect, assess,
address, and intervene in vaccine-related misinformation circulating
throughout communities.
senator murkowski
Question 1. Do you anticipate that Americans will need to get
vaccinated against COVID every year, as we do against the flu? If so,
do you anticipate that such vaccines will be as easy to get as flu
vaccines are now, through our workplaces, doctors' offices, and
pharmacies? What are the barriers to achieving that?
Answer. Based on current clinical considerations, a patient is
considered fully vaccinated 2 weeks after a 2-dose mRNA COVID-19
vaccine series or 2 weeks after a single dose of Johnson & Johnson
(J&J) COVID-19 Vaccine. The need for COVID-19 booster doses has not
been established yet. No additional doses are recommended at this time.
CDC has launched several vaccine effectiveness studies that will
evaluate how well COVID-19 vaccines are working in real-world
conditions, and additional studies are underway as vaccines are
administered across the United States among different groups. Since
vaccination of priority groups with COVID-19 vaccines has only begun in
the last 4 months with eligibility expanding to additional people in
the last 2 months, data to determine vaccine effectiveness are being
collected and published in an ongoing manner. As data on vaccine
effectiveness become available, CDC will provide regular updates with
that information.
Primary care providers (PCPs) play an influential role in building
confidence in and improving access to vaccines; however, currently
fewer than 5 percent of all COVID-19 vaccine doses have been
administered by PCPs. CDC has developed guidance for expanding vaccine
distribution (from existing jurisdiction vaccine allocations) to PCPs
and increasing PCP enrollment for COVID-19 vaccine administration. This
involves identifying priority PCPs in communities with the highest
Social Vulnerability Index (SVI) scores and allocating vaccines to
those PCPs and expanding community outreach. States and local health
departments will also continue to leverage existing partnerships with
pediatricians and primary care providers through established
immunization programs to administer COVID-19 vaccines to eligible
populations.
senator braun
Concerning Vaccine Distribution
As COVID-19 vaccine distribution has ramped up in the Biden
administration, it seems there has not been enough of an effort to
leverage major distributors or key regional distributors in the
process.
Question 1. What efforts, if any, have been made to leverage other
distributors to date?
Question 2. Also, why have other distributors not been leveraged
for vaccine distribution, or even distribution planning, to date?
Answer to both questions: COVID-19 vaccine distribution utilized
existing infrastructure to ensure that vaccine could be ordered,
delivered, and administered to combat the ongoing pandemic in line with
the urgency of this effort. As the COVID-19 vaccination effort
continues, we will continue to monitor distribution processes.
senator marshall
Question 1. BARDA has played a critical role in the development of
vaccines, therapeutics and diagnostics. Focusing on vaccines, BARDA
made initial investments in multiple technologies since it was unknown
which technology would prove successful. The investments were based on
technologies that had clinical data from other diseases showing safety
of their technology and also had a robust or licensed manufacturing
process that was scalable. BARDA's previous investments have also
accelerated COVID-19 vaccine development. BARDA invested in Moderna for
their Zika vaccine and these investments provided clinical data and
improved the manufacturing process that is currently being used. BARDA
invested in Janssen and has had a partnership since 2015 to develop
their viral vector technology for Ebola, currently licensed in the EU.
The same technology is being used for their COVID vaccine. The early
investments made by BARDA provided the foundation for the vaccine
portfolio currently supported by BARDA and JPEO. BARDA has supported
clinical studies, scale up of manufacturing and validation and large-
scale manufacturing of vaccines being distributed.
Question 1(a). Will the Biden administration continue to support
ongoing projects and contracts BARDA established last year?
Answer. Yes, the Administration plans to support the investments
made previously by BARDA in the fight against COVID-19. The parallel
development, manufacturing, and regulatory review processes critical to
the successful development of multiple COVID-19 vaccines and
therapeutics have seen extraordinary success because of the dedicated
scientists and researchers who reviewed both the vaccine and
therapeutic candidate portfolios to ensure that Federal investment was
leveraged behind the most promising candidates.
Question 1(b). How will BARDA continue to both respond to the
current pandemic as well as prepare for future pandemics that could be
bacterial in nature, pandemic influenza or other emerging infectious
diseases?
Answer. As of March 18, 2021, BARDA has obligated more than $32
billion to support 7 vaccines, 42 diagnostics (21 with EUA shipping
over 120M tests to testing centers), 13 therapeutics, 12 rapidly
deployable capabilities, and numerous other supporting programs. BARDA
has supplied 945,000 treatment courses of 3 monoclonal antibody
products (bamlanivimab monotherapy, bamlanivimab etesevimab and
casirivimab imdevimab) that have achieved EUA to treatment sites across
the US. BARDA has also provided access to our Clinical Trials Network
for support of the ACTIV trials. BARDA has and will continue to limit
the impact of supply chain shortages, including ancillary supplies like
needles and syringes, as the USG prepares for the fall. The fact that
not one, but three vaccines are available in a little over a year from
the start of the pandemic is an amazing feat.
Going forward, BARDA will continue to develop its COVID-19 vaccine
portfolio. This includes procuring additional doses of vaccine as
needed for pediatric populations as well as to address waning immunity
and/or strain changes. BARDA will continue to support vaccines that
have not yet received EUA based on funding availability and
determination of need. Finally, BARDA will continue to support clinical
trials in adolescents and pediatrics to further expand the number of
individuals that can be vaccinated.
BARDA is always at the forefront of critical efforts during
epidemics or pandemics. This was shown in the response to H1N1, Ebola
in 2014/2015, Zika, Ebola in 2018-2020 and now COVID. The funds
provided to BARDA lead to results. For example, during the Ebola
responses, BARDA investments and collaboration with industry,
interagency colleagues, and the WHO, BARDA has supported the first
licensed Ebola vaccine (ERVEBO), two licensed Ebola therapeutics
(Inmazeb, first licensed therapeutic and Ebanga the second licensed
therapeutic that transitioned from NIAID), and the first FDA cleared
rapid diagnostic (OraQuick). The BARDA model has proven successful. As
shown with the COVID-19 response, early investments have the potential
to reduce the lead time to develop a medical countermeasure.
senator tuberville
Vaccine Distribution
Question 1. In Alabama, almost 1,200 providers are enrolled in the
Federal program to distribute vaccines. Unfortunately, only around 40
of these providers in the state actually have the freezer capacity to
store and distribute Pfizer vaccines.
Question 1(a). What can the Administration do to account for the
storage compatibility of different states' distribution capacity,
especially when it comes to urban vs. rural states?
Answer. The US Food and Drug Administration (FDA) has amended the
Pfizer-BioNTech COVID-19 Emergency Use Authorization (EUA) to include a
new Pfizer 450-dose order configuration, and changes in storage
temperatures should decrease the need for dry ice and make storage of
the Pfizer vaccine more manageable for sites.
Question 2. The Alabama Department of Public Health (ADPH) has also
struggled with transparency from the Federal level as they continue to
be left in the dark in terms of how many vaccines to expect each week
and what the breakdown of each vaccine type will be. Without knowing
these factors in advance, it's impossible to appropriately plan and
broadcast which categories of individuals will be able to receive the
vaccine in the next phase of distribution.
Question 2(a). Now that the J&J vaccine is being distributed along
with Moderna and Pfizer candidates, what can the Administration do to
increase transparency when it comes to the amount and breakdown of
upcoming shipments?
Answer. The Federal Government has made specific amounts of FDA-
authorized COVID-19 vaccine doses available to states and jurisdictions
on a weekly basis. CDC provides detailed information on their website,
available at: https://www.hhs.gov/coronavirus/covid-19-vaccines/
distribution/index.html.
Question 3. Two of Alabama's 17 federally Qualified Health Centers
(FQHCs) have yet to be invited to participate in the Federal vaccine
program, though they very much would like to be involved.
Question 3(a). What can be done to include such facilities that
have capacity and desire to be included in the Federal program without
Federal outreach?
Answer. The Health Center COVID-19 Vaccine Program is a
collaboration between HRSA and CDC, which provides a direct allocation
of COVID-19 vaccines to HRSA Health Center Program-funded health
centers in addition to COVID-19 vaccines that health centers might
receive through their states. This program started on February 9 with
an initial cohort of 25 health centers, and expanded in less than two
months to invite all HRSA Health Center Program-funded health centers
and look-alikes on April 6, increasing its reach to 1,470 health
centers nationwide.
To participate in the Health Center COVID-19 Vaccine Program and
place orders, health centers must have completed their Readiness
Assessment and Conditions of Participation Agreement. They also need to
have completed additional steps with both CDC and HRSA prior to
ordering vaccines through an online portal, the VTrcks Provider Order
Portal (VPoP). Additional details regarding these steps are posted on
HRSA's website in the Vaccine Program Community landing page.
COVID-19 Treatments
Question 4. A constituent of mine, Dr. Timothy Taylor (MD Chief
Medical Officer, MainStreet Family Urgent Care; Birmingham, AL)
recently participated in an HHS webinar where he spoke about the
positive role of monoclonal antibodies for COVID treatment across his
clinics in Alabama including the original pilot site in Pelham. One of
the keys to their positive outcomes is the ability to conduct rapid
testing which allows medical professionals to present the option of
COVID treatments to patients. So far, they had not seen any adverse
incidents, and the clinical trial data for these products indicate that
they are effective in preventing death and hospitalization. I
understand that infusions have been somewhat complicated, but they are
being done in Alabama and they prevent death and hospitalization. With
many of the treatments and therapeutics, early intervention greatly
increases the likelihood of positive outcomes. I hope the
Administration understands the urgency for getting patients who test
positive for COVID into treatments that will keep them out of the
hospital. Investing in infusion centers and temporary sites coupled
with expanded access to rapid testing has the potential to reduce
hospitalization and death. Congress has provided billions in funds for
testing and treatments.
Question 4(a). What is the Administration doing to integrate
testing and treatment?
Answer. Rapid testing is critical to mitigating the spread and
impact of COVID-19. The Federal Government has made tremendous progress
in historic speed to develop and support the manufacturing of
monoclonal antibody therapeutics. ASPR conducted external outreach
efforts to major laboratories including Quest, LabCorp, PWN, Aegis to
connect patient test results with information and resources about
monoclonal antibody therapeutics. In all efforts, ASPR ensured that
product reached those in the greatest need and in the most equitable
way possible, These outreach efforts are reaching up to 14.4 million
people per month.
Since May 2020, ASPR has hosted weekly calls for state and
territorial health officials as well as national health care and
medical organizations and associations to provide current information
regarding the allocation, distribution, and drug administration
surrounding the COVID-19 monoclonal antibody therapeutics available to
help combat the pandemic. ASPR also hosts a weekly virtual office call
session which provides an opportunity for individuals to ask questions
or raise topics of concerns pursuant to the distribution and/or drug
administration of COVID-19 monoclonal antibody therapies. These weekly
virtual office call sessions are open to all state, local, tribal and
territorial health officials, health care providers and other
monoclonal antibody therapeutics administration sites of care. This
call also serves as an informal opportunity to share relevant best
practices, lessons learned, and discuss challenges or concerns with
peers. HHS/ASPR is currently conducting five separate pilot programs to
reach underserved populations and establish much needed infusionsites.
We are currently assessing means to tie positive test results for those
patients who meet eligibility requirements with infusion centers across
the Nation.
______
Responses by Dr. Peter Marks to Questions of Senator Hickenlooper,
Senator Burr, Senator Paul, and Senator Murkowski
senator hickenlooper
Question 1. As we continue to scale up access to vaccines, we also
know that effective treatments play a critical role in reducing
hospitalizations, serious disease, and deaths among those who become
infected. We have a few such treatments right now, but we will soon
have the first oral agents to treat COVID.
How do we expedite access to these new treatments for the American
people, and in particular, ensure that vulnerable populations like
Medicare Part D beneficiaries have access to new oral therapies that
will first be approved under an Emergency Use Authorization (EUA)?
Answer. We defer this question to the Centers for Medicare and
Medicaid Services, who did not appear as a witness at the hearing.
senator burr
Question 1. FDA provided guidance on the type of data needed to
establish efficacy against new and emerging COVID-19 variants, which
included non-inferiority requirements for supplemental applications for
previously authorized COVID-19 vaccines.
Question 1(a). What type of data is FDA requiring to demonstrate
immunologic comparability?
Question 1(b). Are there multiple methods to demonstrate
immunologic comparability or immunogenicity that could be compared to
authorized vaccines? If so, how will you work with manufacturers to
ensure appropriate flexibility regarding methods to demonstrate
immunogenicity or immunologic comparability?
Answer. FDA has been communicating with vaccine manufacturers to
provide information and scientific advice as they evaluate the ability
of their vaccines to protect against SARS-CoV-2 variants.
In February 2021, FDA issued an update to its October 2020 vaccine
EUA guidance to address the emergence of SARS-CoV-2 variants. \1\ The
updated guidance outlines FDA's scientific recommendations for data
needed to amend emergency use authorizations for COVID-19 vaccines to
allow for use of modified vaccines to address SARS-CoV-2 variants. For
example, FDA expects that manufacturing information will remain
generally the same for an authorized vaccine and a modified vaccine
candidate from the same manufacturer. For clinical data, the guidance
recommends that a determination of effectiveness be supported by data
from clinical immunogenicity studies, which would compare the immune
response to the virus variant induced by the modified vaccine to the
immune response to the ``prototype'' virus induced to the authorized
vaccine. At this time all the authorized COVID-19 vaccines express the
SARS-CoV-2 ``spike'' or S-protein, and while an immune marker(s)
protective of protection has not been established, it is thought that
neutralizing antibody to the S-protein is a major component of the
vaccine protective response. The guidance explains that the
immunogenicity parameter of interest is an assessment of virus
neutralizing antibody levels.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/emergency-use-authorization-vaccines-prevent-covid-
19.
Manufacturers are encouraged to study the modified vaccine in both
naive (non-vaccinated) individuals and in individuals previously
---------------------------------------------------------------------------
vaccinated with the authorized vaccine.
Additionally, the guidance outlines FDA's recommendations for
assessments of safety to support an EUA for a modified vaccine.
Finally, the guidance states that further discussions will be necessary
to decide whether in the future, modified COVID-19 vaccines may be
authorized without the need for clinical studies.
Question 2. What requirements, if any, are manufacturers of
authorized COVID-19 vaccines required to meet in order to receive FDA
approval to use additional contract manufacturers to expand
manufacturing capacity?
Answer. For all vaccine manufacturers, including contract
manufacturers used to expand manufacturing capacity, sufficient data
should be submitted to support drug substance (DS) and drug product
(DP) manufacturing to ensure the quality and consistency of the vaccine
product that is produced. Evidence should be provided that all DS and
DP manufacturing sites, including testing sites, are adequately
qualified/validated to ensure that the equipment and process meets all
predetermined specifications, intended purposes, and that the
production process is controlled and operates with quality oversight
consistent with current good manufacturing practice (CGMP)
requirements. If more than one manufacturing facility is used to
produce DS and DP, data should be provided to support the consistency
of vaccine quality between manufacturing sites (See FDA guidance,
Emergency Use Authorization for Vaccines to Prevent COVID-19, for more
information).
Facility information should be submitted to demonstrate that the
facilities are of suitable size and adequately designed to prevent
contamination, cross-contamination, and mix-ups (See FDA guidance,
Emergency Use Authorization for Vaccines to Prevent COVID-19, \2\ for
more information).
---------------------------------------------------------------------------
\2\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/emergency-use-authorization-vaccines-prevent-covid-
19.
Part of FDA's evaluation of a request for emergency use
authorization (EUA) for COVID-19 vaccines and drugs includes evaluation
of the chemistry, manufacturing, and controls and facility information.
FDA expects manufacturers to submit sufficient data to ensure the
quality and consistency of the product. FDA uses all available tools
and information, including site visits, and previous compliance
history, to assess compliance with CGMP requirements. As part of the
authorization, FDA may include several conditions of authorization
related to the manufacture of the product. For example, as a condition
of authorization for each COVID 19 vaccine, the Letter of Authorization
stated ``No changes will be implemented to the description of the
product, manufacturing process, facilities, or equipment without
notification to and concurrence by the Agency.'' FDA must concur with
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the proposed changes.
Question 3. What is the average time it takes for FDA to approve a
contract manufacturing facility to manufacture an authorized COVID-19
vaccine? Does FDA have the authority to approve a contract
manufacturing facility prior to, or at the same time as, authorizing a
vaccine?
Answer. FDA's scientific and regulatory advice to vaccine
developers, as well as FDA's evaluation to determine the safety and
effectiveness of vaccines, are among the most robust in the world.
FDA approval of a facility, irrespective of whether it is a
contract manufacturing facility, and when it is approved, is dependent
on the adequacy of the data and information submitted to FDA. The time
between the submission to FDA and the authorization allows the FDA to
thoroughly evaluate the product and facility data and information
submitted in the EUA request and may also include further requests for
information. The amount of data submitted to FDA typically includes
thousands of pages of data and technical information that are analyzed
and evaluated by FDA career staff with specific expertise.
Once a product is authorized, no changes can be implemented to the
description of the product, manufacturing process, facilities, or
equipment without notification to and concurrence by the Agency. If a
contract manufacturing facility has been described as a facility to be
utilized for manufacturing of the product under the EUA at the time of
the authorization request, it may be possible for the contract
manufacturing facility to be authorized as part of the authorization.
Question 4. How many drug or biological product inspections have
been delayed due to COVID-19? By what date will FDA have acted on all
delayed inspections?
Answer. Throughout the COVID-19 pandemic, FDA has continued to
complete foreign and domestic inspections determined to be critical to
our public health mission, and also conducted prioritized domestic
inspections where and when it was safe to do so.
The prioritized inspections include those associated with product
application goal dates (pre-approval, pre-market or pre-license
inspections) that FDA determined to be necessary to support an
application decision, as well as for-cause compliance follow-up
inspections. If these did not meet mission-critical criteria they were
still prioritized and were conducted (if domestic) when and where it
was safe to travel. Sometimes this resulted in delays relative to goal
dates and scheduled follow-up. If the inspection was to be conducted at
a foreign facility and did not meet mission-critical criteria, it was
not conducted and would be considered to be ``delayed.''
As of March 2021, a total of 58 drug or biological product
application approval decisions have been delayed because FDA could not
conduct an inspection. Of these 58 delayed applications, six have been
determined to be mission critical. FDA plans to complete inspections in
support of these six mission-critical drug and biological product
applications by the end of the fiscal year (September 2021).
Regarding delayed compliance follow-up target dates for some for-
cause inspections, FDA plans and publicly tracks follow-up to
compliance actions related to a prior domestic inspection that was
classified as ``official action indicated'' (OAI). In fiscal year 2020,
eight human drug OAI follow-up inspections were delayed due to COVID-
19. These eight inspections carried over to the fiscal year 2021 OAI
follow-up target.
Most inspections that have been postponed due to the pandemic are
routine surveillance inspections that are planned for each fiscal year,
based on established drug and biological product inspection risk
factors. These inspections do not meet the criteria FDA has employed to
identify mission-critical inspections and are not otherwise
prioritized. In fiscal year 2020, FDA postponed approximately 650 drug
and biological product surveillance inspections, as well as many
additional inspections in other regulated commodity programs. As of
March 2021, FDA has 1,124 drug and biological product surveillance
inspections remaining to be conducted by the end of the fiscal year
(September 2021), including 857 human drug, 157 animal drug, and 110
biological product surveillance inspections.
FDA recognizes that addressing the large number of postponed
surveillance inspections will be challenging and given the continued
uncertainties and travel restrictions posed by the COVID-19 pandemic it
is difficult to determine when this can be accomplished. To confront
the inventory of postponed inspections while continuing to conduct
mission-critical inspectional work, FDA will use additional
prioritization strategies, employ alternative and remote tools, and
take an overall flexible and strategic approach to optimize FDA
oversight of the products we regulate. FDA has released the
``Resiliency Roadmap for FDA Inspectional Oversight'' \3\ that
describes the effect of the pandemic on our inspectional activities for
each regulated commodity as well as FDA's detailed plan for resuming a
more consistent state of operations employing these strategies, using
base, best, and worst-case scenarios.
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\3\ https://www.fda.gov/media/148197/download.
Question 5. FDA received $500 million in the American Rescue Plan
Act of 2021, Public Law 117-2. How much of this funding will be spent
to address the backlog of drug inspections? Please include a timeline
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for this resource spend.
Answer. The American Rescue Plan Act of 2021 (Public Law 117-2)
appropriated FDA $500 million to respond to emerging variants, ensure
that COVID-19 tests, therapeutics, and vaccines continue to be safe and
effective, conduct critical inspections, and prepare for the next
challenge by accelerating work in areas such as advanced manufacturing
and supply chain monitoring. Of the $500 million appropriated, FDA's
spend plan reflects approximately $73.5 million to address inspections
delayed due to the COVID-19 public health emergency. This total
includes $38.3 million supporting FDA's Center for Drug Evaluation and
Research (CDER) Pandemic Recovery: Medical Product Inspections and
$35.1 million supporting FDA's Office of Regulatory Affairs (ORA)'s
COVID-19 recovery activities, including inspectional modernization,
preparing to adjust staffing and bringing on staff to conduct
inspections delayed due to COVID-19 public health emergency. Of the
amount dedicated for inspectional work, FDA intends to obligate
approximately 17 percent in fiscal year 2021, 42 percent in fiscal year
2022, 21 percent in fiscal year 2023, 14 percent in fiscal year 2024,
and 6 percent in fiscal year 2025.
senator paul
Dr. Marks: FDA should be commended for their pro-active approach to
COVID-19 vaccine development. The agency's focus on flexibility and
speed--while maintaining rigorous safety standards--has resulted in
three COVID-19 vaccines receiving emergency use authorization in just
over a year. We will need to develop next-generation COVID-19 vaccines
moving forward, with a focus on single-dose vaccines that do not
require cold-chain storage and can be rapidly manufactured. I believe
FDA should continue to use a flexible approach to vaccine clinical
trials.
Question 1. How will FDA approach clinical trial design for next
generation COVID-19 vaccines, given the challenges of enrolling trial
participants and testing against vaccines which have already received
an EUA?
Answer. A COVID-19 vaccine that has been approved or authorized for
emergency use by FDA could serve as the control treatment in a study
designed to evaluate efficacy with non-inferiority hypothesis testing,
as inclusion of placebo control groups could be considered unethical.
Clinical development programs for COVID-19 vaccines might be expedited
by adaptive and/or seamless clinical trial designs that allow for
selection between vaccine candidates and dosing regimens and for more
rapid progression through the usual phases of clinical development. In
addition, once additional understanding of SARS-CoV-2 immunology is
acquired regarding vaccine immune responses that might be reasonably
likely to predict protection against COVID-19, accelerated approval of
a COVID-19 vaccine (pursuant to section 506 of the FD&C Act (21 U.S.C.
356) and 21 CFR 601.40) may be considered if an applicant provides
sufficient data and information to meet the applicable legal
requirements. For a COVID-19 vaccine, it may be possible to approve a
product under these provisions based on adequate and well-controlled
clinical trials establishing an effect of the product on a surrogate
endpoint (e.g., immune response) that is reasonably likely to predict
clinical benefit. This would allow the conduct of a trial of much
smaller size than one requiring a clinical efficacy endpoint.
Question 2. What steps should FDA take to ensure clinical trials of
next generation COVID-19 vaccines can be conducted in the United
States? Should manufacturers consider conducting clinical trials in
other countries if it is not feasible to enroll them in the United
States?
Answer. For the three currently authorized COVID-19 vaccines, the
clinical trials did include U.S. sites. The development of drugs and
vaccines has become an increasingly global enterprise. Foreign clinical
trials of a vaccine demonstrating safety and efficacy may be
acceptable; however, FDA may ask for bridging studies looking at
immunogenicity to ensure that the U.S. population has a similar immune
response to the population in which the vaccine showed efficacy.
Question 3. As you know, most clinical trial subjects must commit
to not taking a different COVID-19 vaccine for up to a year. Do you
believe FDA should allow flexibility for trial sponsors to modify this
requirement?
Answer. Clinical studies of vaccines are conducted to establish the
safety and effectiveness of the vaccine. Enrolled participants are
often requested to continue in the clinical study for several months
after completion of the vaccination series. During the entire clinical
study participants are monitored for safety and occurrence of the
disease which the vaccine is designed to prevent. Participants are
informed about the study follow-up times and procedures as part of the
informed consent process. Participants can withdraw consent at any
time. FDA's guidance (Emergency Use Authorization for Vaccines to
Prevent COVID-19) \4\ recognized that if a COVID-19 vaccine became
available under an EUA that study participants (either placebo
recipients in the study that supported the EUA or those in a study of
another product) may choose to withdraw and encouraged EUA applicants
to consider how to continue follow-up of study participants stating:
``An EUA request should include strategies that will be implemented to
ensure that ongoing clinical trials of the vaccine are able to assess
long-term safety and efficacy (including evaluating for vaccine-
associated enhanced respiratory disease as well as decreased
effectiveness as immunity wanes over time) in sufficient numbers of
subjects to support vaccine licensure. These strategies should address
how ongoing trials will handle loss of follow-up information for study
participants who choose to withdraw from the study in order to receive
the vaccine under an EUA.''
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\4\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/emergency-use-authorization-vaccines-prevent-covid-
19.
Question 4. What other steps will FDA take to ensure rapid
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development of new vaccines?
Answer. Having three vaccines authorized that meet the FDA's
expectations for safety and effectiveness only one year after the
declaration of the pandemic is a tremendous achievement and a testament
to the dedication of developers and FDA's career scientists and
physicians, many of whom have been working tirelessly to conduct
comprehensive and rigorous evaluations of the data submitted for
vaccines to prevent COVID-19. FDA remains committed to providing timely
scientific and regulatory advice to support the development of COVID-19
vaccines that meet FDA's expectations for safety, effectiveness, and
quality. The guidance documents that FDA released to assist
manufacturers with the development of COVID-19 vaccines remain in
effect and are a scientific and regulatory resource for industry,
providing recommendations and outline FDA's expectations. Specifically,
in June 2020, FDA issued guidance titled Development and Licensure of
Vaccines to Prevent COVID-19. \5\ In October 2020, FDA issued guidance
titled Emergency Use Authorization for Vaccines to Prevent COVID-19 and
updated it in February 2021. \6\
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\5\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/development-and-licensure-vaccines-prevent-covid-19.
\6\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/emergency-use-authorization-vaccines-prevent-covid-
19.
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senator murkowski
Question 1. Dr. Marks, you testified that the FDA is gathering data
on serious adverse events from the various vaccines currently in use.
You also stated that severe allergic reactions occur ``in fewer than
five in one million vaccine doses administered''. Yet, I am concerned
that many Americans may be refusing to get vaccinated because of rumors
that people have died after receiving a vaccine, or that after-effects
can make people feel seriously ill. What can you tell the American
people about these concerns that would help them feel more confident
about getting vaccinated? And where can Americans go, such as on FDA's
website, to find authoritative data from the various vaccine safety
monitoring efforts that are underway?
Answer. FDA has implemented a coordinated and overlapping approach
for continuous safety monitoring of COVID-19 vaccines using state-of
the art technologies. Specifically, the Agency's monitoring following
authorization of the COVID-19 vaccines uses a multi-pronged approach
including: (1) Spontaneous reporting (or passive surveillance) using
the Vaccine Adverse Event Reporting System (VAERS) consisting of safety
reports submitted by healthcare providers, patients, parents and other
members of the public, combined with (2) Active Surveillance, using
large population-based healthcare datasets. These latter healthcare
data systems offer a higher likelihood of detecting rare adverse events
because they capture medical data on millions of Americans, cover
diverse subpopulations (i.e., pregnant women, elderly, and patients
with comorbidities) and can provide a longer duration of follow-up when
compared to the prelicensure clinical studies. Together, these provide
a greater margin of safety for COVID-19 vaccines. Information on COVID-
19 vaccine reporting systems is available here: https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/reporting-systems.html.
FDA utilizes a variety of methods for evaluating COVID-19 vaccine
VAERS reports such as review of individual reports, aggregate analysis
of reports, generating a case series when indicated and close
collaboration with CDC's Immunization Safety Office (ISO). It may also
include a comparison of VAERS reporting rates with background rates of
disease or reporting rates of other vaccines. The goal of continuous
monitoring is to quickly identify any specific safety concerns that may
arise, to carefully evaluate and estimate the magnitude of the safety
concern, and if warranted, for FDA to take regulatory action to
mitigate the risk.
While many people have no effects from vaccination, information on
the safety of COVID-19 vaccines, including commonly reported events
such as fatigue, fever, muscle pain, and chills, is available here
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-
vaccines.html.
Many of these efforts are in collaboration with the Centers for
Disease Control and Prevention (CDC), the Center for Medicare and
Medicaid Services (CMS), the Department of Veterans Affairs (VA), and
other academic and large non-government healthcare data systems.
CBER also participates actively in ongoing international
pharmacovigilance efforts, including those organized by the
International Coalition of Medicines Regulatory Authorities (ICMRA) and
the World Health Organization (WHO).
This is all in addition to the pharmacovigilance efforts being
undertaken by the individual manufacturers for authorized vaccines.
CBER is also monitoring the effectiveness of COVID-19 vaccines on
several fronts to determine the duration of protection, effectiveness
by each dose, effectiveness if the second dose is delayed, and
effectiveness against variants. Please visit the following sites for
more information:
FDA's website: https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-disease-2019-covid-19/
covid-19-vaccines.
CDC website: https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety.html.
Finally, we do want to acknowledge the pause that was recommended
for use of the Janssen COVID-19 Vaccine (sometimes called the Johnson
and Johnson COVID-19 vaccine). The pause was recommended on April 13
and lifted on April 23, 2021, after initial reports of six cases of a
rare and severe type of blood clot in individuals following
administration of the Janssen COVID-19 Vaccine. During the pause,
medical and scientific teams at the FDA and CDC examined available data
to assess the risk of thrombosis involving the cerebral venous sinuses,
or CVST (large blood vessels in the brain), and other sites in the body
(including but not limited to the large blood vessels of the abdomen
and the veins of the legs) along with thrombocytopenia, or low blood
platelet counts. The teams at FDA and CDC also conducted extensive
outreach to providers and clinicians to ensure they were made aware of
the potential for these adverse events and could properly manage and
recognize these events due to the unique treatment required for these
blood clots and low platelets, also known as thrombosis-
thrombocytopenia syndrome (TTS).
FDA and CDC will continue with these efforts to closely monitor the
safety of COVID-19 vaccines and will be sure to inform your office of
relevant updates.
Question 2. Do you anticipate that Americans will need to get
vaccinated against COVID every year, as we do against the flu? If so,
do you anticipate that such vaccines will be as easy to get as flu
vaccines are now, through our workplaces, doctors' offices, and
pharmacies? What are the barriers to achieving that?
Answer. At this time, it is too early to tell if yearly COVID-19
vaccination will be necessary. The duration of protection with the
current vaccines appears to be at least 6 to 9 months and may be a year
or more. Vaccine manufacturers and others have expressed intent to
evaluate whether COVID-19 vaccines can safely be given at the same time
as the influenza vaccine. If the two vaccines can be administered
together, that would simplify things and allow routine vaccination
against both viruses to be administered through the same mechanisms now
used for influenza.
______
Responses by Dr. Walensky to Questions of Senator Smith, Senator Burr,
Senator Murkowski, Senator Braun, and Senator Tuberville
senator smith
Question 1. The timing of adolescent and pediatric eligibility for
the COVID-19 vaccine could impact routine immunization. Back to school
season is a time when children and adolescents ensure their vaccination
schedules are up to date for the upcoming school year, but current CDC
recommendations indicate that no other vaccine should be administered
within 14 days before or after COVID-19 vaccination.
Question 1(a). What steps is the CDC taking to ensure adolescents
receive their routine vaccinations ahead of COVID-19 eligibility to
prevent further declines in adolescent immunization rates?
Answer. The Centers for Disease Control and Prevention (CDC)
announced a Call to Action that outlines efforts needed to get children
caught up on vaccinations so that they can safely return to in-person
learning. COVID-19 has disrupted both in-person learning and routine
well-child visits for many children over the last year. While families
followed public health warnings about going out, an unfortunate result
was many missed routine vaccinations. During the COVID-19 outbreak, CDC
and the American Academy of Pediatrics (AAP) recommend every child
continues to receive routine vaccinations.
As vaccine manufacturers begin to seek Emergency Use Authorization
for COVID-19 vaccines in adolescents, the Advisory Committee on
Immunization Practices (ACIP) will review considerations for co-
administration and potential policy options will be discussed.
A multipronged approach is needed to promote optimal access and
uptake of COVID-19 vaccination among adolescents, including through
pediatric primary care providers, health departments, pharmacies, and
school-based clinics. Pediatric primary care providers are trusted
sources of vaccine information and vaccination for families. Thus, it
is important to continue to encourage pediatric providers to enroll to
become a COVID-19 vaccine provider. CDC will work with immunization
awardees and other partners to provide support and materials for
adolescent COVID-19 vaccination.
senator burr
Question 1. The American Rescue Plan Act provided $1.75 billion to
support genomic sequencing, analytics, and disease surveillance. In
addition, the Administration previously announced it would allocate
$200 million to the Centers for Disease Control and Prevention (CDC) to
scale up public health surveillance. Along with supporting capacity
building and modernization of data systems within public health
departments, it is critically important to form partnerships with the
private sector and academic institutions so that existing capacities
and capabilities can be appropriately leveraged.
Question 1(a). How does CDC plan to spend this nearly $2 billion in
funding for sequencing and surveillance?
Answer. In the American Rescue Plan Act of 2021 (ARPA), Congress
provided $1.75 billion to strengthen and expand the workforce and
activities related to genomic sequencing, analytics, and disease
surveillance. These funds are being used to increase partnerships with
commercial laboratories, state and local health departments, and
academic institutions for sequencing. Prior to the congressional
appropriations, the Administration allocated CDC with $192 million
allowing CDC to contract with commercial laboratories for sequencing.
Question 1(b). Does CDC plan to leverage the private sector and
academic institutions and encourage state and local health departments
in this effort? If so, how? If not, why not?
Answer. CDC will engage all three sectors to implement the ARPA
component of genomic sequencing. CDC has contracted with nine
commercial laboratories, among the largest in the United States,
capable of obtaining positive specimens across the Nation for
sequencing. These laboratories were chosen due to their large volume of
SARS-CoV-2 diagnostic testing, geographic reach, and ability to
sequence positive specimens.
For seven years, CDC's Advanced Molecular Detection (AMD) program
has worked with state and local health departments to develop their
capacity for sequencing and bioinformatics. All state public health
laboratories have next-generation sequencing capacity, and several
laboratories have CDC-supported regional bioinformaticians that can
assist states without that capacity. During the pandemic, CDC awarded
Paycheck Protection Program and Health Care Enhancement Act-and other
COVID-related funds to support state and local health departments for
sequencing of SARS-CoV-2. Going forward, CDC plans to use ARPA funds to
facilitate the consolidation of state and local capacities to develop a
national, cloud-based bioinformatics infrastructure to accelerate
collaboration and response capacity.
The AMD program has supported collaborations between academia and
public health since the beginning of the program. In late 2020, the
agency awarded seven contracts to academic programs across the US to
support genomic surveillance, and the agency will shortly award another
ten contracts. After the pandemic, CDC intends to use ARPA funds to
expand its network of centers of excellence, which represents CDC's
partnerships with academic institutions and public health agencies.
senator murkowski
Question 1. Dr. Walensky, can you commit to providing clarification
to the Coast Guard that this mask order does not apply to fishing
vessels, as the regulatory definition of ``conveyance'' clearly shows?
Answer. The Order issued on January 29, 2021, requires wearing
masks that completely cover both the nose and mouth while on any
commercial conveyance entering, traveling within, or departing the
United States, including commercial maritime vessels. This Order also
requires that individuals wear masks while at transportation hubs in
the United States such as seaports.
Commercial maritime vessels involve the movement of people from
different geographic areas in settings with inevitable close contact.
Like other close-contact environments, maritime vessels may facilitate
the transmission of respiratory viruses from person to person through
exposure to respiratory droplets or contact with contaminated surfaces.
CDC posted responses to frequently asked questions for maritime
environments on the Requirement for Face Masks on Public Transportation
Conveyances and at Transportation Hubs webpage.
The Order exempts persons from the requirement to wear a mask for
whom wearing a mask would create a risk to workplace health, safety, or
job duty as determined by the relevant workplace safety guidelines or
Federal regulations. However, as stated in current CDC guidance, the
exemption only applies while the person is performing that duty. For
more information on best mitigation practices for maritime environments
please visit Interim Guidance for Ships on Managing Suspected or
Confirmed Cases of Coronavirus Disease 2019 (COVID-19) Quarantine CDC.
Certain maritime conveyances are exempted from the Order. These
are:
Private maritime conveyances operated solely for
personal, non-commercial use (e.g., personal watercraft),
When the operator is the sole occupant on board the
maritime conveyance,
Mobile offshore drilling units and platforms, to
include floating and fixed Outer Continental Shelf facilities
as defined in 33 CFR 140.10, and
Certain maritime conveyances excluded from the
definition of vessels under 42 CFR 70.1:
Y Fishing boats including those used for shell-
fishing*;
Y Tugs which operate only locally in specific harbors
and adjacent waters**;
Y Barges without means of self-propulsion;
Y Construction-equipment boats and dredges; and
Y Sand and gravel dredging and handling boats.
* Fishing vessels, fish processing vessels, and
fish tender vessels as defined under 46 U.S.C
Sec. 2101 do not fall under this exemption--
including shell-fishing vessels. A ``fishing
boat'' is an auxiliary craft as defined under
46 U.S.C Sec. 4502(k) carried on board a
fishing vessel.
** Tugs which operate only locally in specific
harbors and adjacent waters means tug vessels
operating exclusively within a worksite and
that have been issued a worksite exemption by
the U.S. Coast Guard.
Question 2. Dr. Walensky, you testified that ``Vaccination for
teachers, staff, and among surrounding communities is one of the
several layers of prevention strategies to reduce SARS-CoV-2
transmission in schools.'' Others have said that vaccinating teachers
is not required for safe school re-opening. Can you please provide some
guidance to Governors and school leaders about the necessity for
teacher vaccinations so that schools may reopen in a way that is safe?
Answer. Vaccines are an important tool to help stop the COVID-19
pandemic. Teachers and school staff hold jobs critical to the continued
functioning of society and are at potential occupational risk of
exposure to SARS-CoV-2. Vaccinating teachers and staff provides one
layer of prevention and protection. Strategies that minimize barriers
to access vaccination for teachers and other frontline essential
workers, such as vaccine clinics at or close to the place of work, are
optimal.
On March 2, President Biden directed all states to make teachers,
school staff, and childcare workers eligible for vaccination and
prioritized vaccinations for them within the Federal Retail Pharmacy
Program during the month of March.
CDC published the COVID-19 Vaccine Toolkit for School Settings and
Childcare Programs to provide COVID-19 vaccine information to staff in
schools and childcare programs. The toolkit includes customizable
content for school leadership and childcare program directors and a
letter that parents can send to community schools or childcare programs
to encourage review and use of the toolkit materials.
Implementation of layered prevention strategies will need to
continue until we better understand potential transmission among people
who received a COVID-19 vaccine and there is more vaccination coverage
in the community. In addition, vaccines are not yet authorized for use
in children under 16 years old. For these reasons, even after teachers
and staff are vaccinated, schools need to continue prevention measures
for the foreseeable future, including requiring masks in schools and
physical distancing.
Question 3. Do you anticipate that Americans will need to get
vaccinated against COVID every year, as we do against the flu? If so,
do you anticipate that such vaccines will be as easy to get as flu
vaccines are now, through our workplaces, doctors' offices, and
pharmacies? What are the barriers to achieving that?
Answer. Based on current clinical considerations, a patient is
considered fully vaccinated two weeks after a two-dose mRNA COVID-19
vaccine series or two weeks after a single dose of Johnson & Johnson
(J&J) Janssen COVID-19 Vaccine. The need for and timing for COVID-19
booster doses have not been established yet. No additional doses are
recommended at this time.
CDC has launched several vaccine effectiveness studies that will
evaluate how well COVID-19 vaccines are working in real-world
conditions, and additional studies are underway as vaccines are
administered across the United States among different groups. Since
vaccination of priority groups with COVID-19 vaccines has only begun in
the last 4 months with eligibility expanding to additional people in
the last 2 months, data to determine vaccine effectiveness are being
collected and published in an ongoing manner. As data on vaccine
effectiveness become available, CDC will provide regular updates with
that information.
Primary care providers (PCPs) play an influential role in building
confidence in and improving access to vaccines; however, currently less
than 5 percent of all COVID-19 vaccine doses have been administered by
PCPs. As vaccine supply increases, CDC is developing guidance for
expanding vaccine distribution (from existing jurisdiction vaccine
allocations) to PCPs and increasing PCP enrollment for COVID-19 vaccine
administration. This involves identifying priority PCPs in communities
with the highest Social Vulnerability Index (SVI) scores and allocating
vaccines to those PCPs and expanding community outreach. States and
local health departments will also continue to leverage existing
partnerships with pediatricians and primary care providers through
established immunization programs to administer COVID-19 vaccines to
eligible populations.
senator braun
Concerning Testing Capacity
As attention has been drawn to vaccine development and now
distribution, it's critically important that we ensure that testing for
COVID-19 and variants are adequate, especially in rural areas. Proper
testing is critical to the reopening of businesses, schools, and
workplaces.
Question 1. What is your assessment of our testing capacity and
infrastructure, especially in the context of emerging variants?
Answer. The HHS Testing and Diagnostics Work Group (TDWG) estimates
that the United States manufactured approximately 187 million COVID-19
tests (NAAT and antigen diagnostic testing) in March 2021. Current test
production exceeds throughput and specimen submissions for testing. At
commercial laboratories, we estimate that 73 percent of capacity is
currently unused. At public health laboratories, this percentage is
currently 61 percent. These laboratories employ mainly Nucleic Acid
Amplification Tests (NAAT). To date, there have not been significant
signals that either NAAT or antigen test performance is diminished by
emerging variants. Therefore, our assessment is that test supply meets
demand, and should there be a rapid rise in cases due to emerging
variants, available supply is anticipated to be sufficient. We are
shifting focus more toward testing capacity and infrastructure,
including training a qualified workforce and establishing laboratory
networks with a focus on underserved populations.
Question 2. If there are gaps, how are you working to address them?
Answer. HHS Testing and Diagnostics Workgroup does not forecast
that there will be substantial gaps in testing supply, assuming that
there is no large second wave with or without a variant. Test
production is predicted to increase and is expected to reach over 250
million tests produced per month by June 2021. This increase is due in
part to a variety in USG investments in the supply chain for testing
supply components, kits, and the launch of additional testing programs.
For example, several testing programs for school testing and testing
among underserved populations and those in congregate settings are
currently in planning stages and are scheduled to come online starting
in May 2021.
senator tuberville
School Reopening
Question 1. Late last month, you appeared at a White House COVID-19
update briefing where you urged states not to reopen too soon,
suggesting that ``now is not the time'' to ease up on restrictions. Our
public education system has been destroyed and our kids are already #37
in the world in math. We don't have much time.
Question 1(a). Will you ever advocate or recommend for states to
reopen?
Question 1(b). What would have to happen for you to take such a
step?
Answer. CDC maintains that schools can safely reopen for in-person
instruction, as long as layered prevention strategies are in-place.
Additionally, CDC recognizes it is critical for schools to open as
safely and as quickly as possible, and remain open, to achieve the
benefits of in-person learning and to ensure provision of key support
services for students, families, and staff. CDC's guidance for schools,
the Operational Strategy for K-12 Schools through Phased Prevention,
presents a pathway for schools to provide in-person instruction safely
and states that K-12 schools should be the last settings to close after
all other prevention measures in the community have been employed, and
the first to reopen when they can do so safely. Evidence suggests that
many K-12 schools that have strictly implemented prevention strategies
have been able to do just that, safely open for in-person instruction
and remain open.
CDC reviews the evolving evidence on spread of COVID-19 in schools
and uses new science to inform our guidance. The preponderance of
evidence indicates that there is limited COVID-19 transmission in U.S.
schools that require proper mask use along with other prevention
strategies. In March 2021, CDC updated its guidelines to reflect this
new evidence. This update provides more options for schools to reopen
for in-person instruction for more students, provided that correct and
consistent mask use and other prevention strategies are in place.
It is important to recognize that different parts of the U.S. are
experiencing different levels of COVID-19 spread. CDC is partnering
with states and local communities to help with their plans to control
the spread of the virus that causes COVID-19, and has released a series
of decision support tools to assist in making reopening decisions
within schools, workplaces, and other community settings.
Border Crisis
Question 2. According to interviews with senior administration
officials, the Federal Government does not have a centralized system
for tracking or responding to COVID-19 cases among the surge of
migrants crossing our southern border.
Question 2(a). Without having a decent understanding of the number
of positive cases crossing into the country, how can the Federal
Government prevent potential outbreaks in packed detention facilities?
Answer. CDC developed Interim Considerations for SARS-CoV-2 Testing
in Correctional and Detention Facilities (https://www.cdc.gov/
coronavirus/2019-ncov/community/correction-detention/testing.html) to
assist administrators of correctional and detention facilities, law
enforcement agencies that have custodial authority over detained
populations (i.e., U.S. Immigration and Customs Enforcement [ICE] and
U.S Marshals Service), and their respective jurisdiction health
departments, in preparing for potential introduction, prevention,
spread, and mitigation of SARS-CoV-2, the virus that causes COVID-19,
in their facilities.
Question 2(b). How can the Administration prevent these potential
hot spots from spreading into the wider U.S. population?
Answer. To help mitigate the continued risks of introduction,
transmission, and spread of COVID-19, including emerging variants,
among Customs and Border Protection (CBP) personnel, noncitizens in the
ports of entry and Border Patrol stations, and people in surrounding
communities, CDC's Order suspending the right to introduce noncitizens
into the United States from countries where a quarantinable
communicable disease exists remains in effect.
To reduce the risk of an outbreak, CDC has provided recommendations
directly to HHS Administration for Children and Families' Office of
Refugee Resettlement (ORR) and has deployed staff to the Emergency
Intake Sites to ensure that public health recommendations for COVID-19
and other communicable diseases are being properly implemented.
Question 3. In January, CDC issued guidance requiring anyone,
including U.S. citizens, flying into the U.S. possess a negative COVID
test conducted within three days of their departure.
Question 3(a). Can the CDC please explain the discrepancy in
guidance between the what is required of travelers entering the U.S. by
plane and of those entering the U.S. at the land border?
Answer. CDC's Order requiring air passengers to present a negative
COVID-19 test result or documentation of recovery from COVID-19 before
boarding an international flight to the United States was made to help
slow the spread of the virus as vaccinations are rolled out to the
American public. While the testing does not eliminate all risk, when
combined with a period of staying at home and everyday precautions like
wearing masks and social distancing, it can make travel safer,
healthier, and more responsible by reducing spread in confined spaces
like planes, indoors in airports, and at destinations.
Other border measures like the Department of Homeland Security's
(DHS's) limitation to nonessential travel on land borders and ferries,
and CDC's Order that decompresses the number of people housed in
congregate border settings, can also reduce the number of people who
could expose or be exposed to others on the land borders. CDC continues
to recommend precautions like wearing masks and social distancing for
these populations. CDC will continue to work with partners and evaluate
data related to vaccines, travel, and variants to inform decisions on
border health measures.
______
[Whereupon, at 12:48 p.m., the hearing was adjourned.]