[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

                               __________

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             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

                              ----------                              

                               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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.''
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                           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.]

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