[Senate Hearing 117-185]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 117-185

                    AN UPDATE FROM FEDERAL OFFICIALS
                     ON EFFORTS TO COMBAT COVID	19

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                                   ON

         EXAMINING AN UPDATE FROM FEDERAL OFFICIALS ON EFFORTS 
                           TO COMBAT COVID-19
                               __________

                              MAY 11, 2021
                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
                                
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        Available via the World Wide Web: http://www.govinfo.gov
        
        
                              ___________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
46-765 PDF                 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

                         TUESDAY, MAY 11, 2021

                                                                   Page

                           Committee Members

Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, 
  and Pensions, Opening statement................................     1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State 
  of North Carolina, Opening statement...........................     3

                               Witnesses

Walensky, Rochelle, M.D., MPH, Director, United States Centers 
  for Disease Control and Prevention, Atlanta, GA................     6
    Prepared statement...........................................     7
Fauci, Anthony, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health, Bethesda, 
  MD.............................................................    15
    Prepared statement...........................................    17
Marks, Peter, M.D., Ph.D., Director, Center for Biologics 
  Evaluation and Research, United States Food and Drug 
  Administration, Silver Spring, MD..............................    23
    Prepared statement...........................................    25
Kessler, David, M.D., Chief Science Officer, COVID Response, 
  United States Department of Health and Human Services, 
  Washington, DC.................................................    30
    Prepared statement...........................................    31

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Collins, Hon. Susan:
    A Misleading C.D.C. Number By David Leonhardt, The New York 
      Times......................................................    71

 
                    AN UPDATE FROM FEDERAL OFFICIALS
                      ON EFFORTS TO COMBAT COVID-19

                              ----------                              


                         Tuesday, May 11, 2021

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:04 a.m., in 
room 106, Dirksen Senate Office Building, Hon. Patty Murray, 
Chair of the Committee, presiding.
    Present: Senators Murray [presiding], Casey, Baldwin, 
Murphy, Kaine, Hassan, Smith, Rosen, Hickenlooper, Burr, Paul, 
Collins, Cassidy, Murkowski, Braun, Marshall, 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 hearing the latest update from Federal 
officials about our efforts to fight the COVID-19 pandemic. 
Ranking Member Burr and I will each have an opening statement, 
and then I will introduce our witnesses, Doctors Walensky, 
Fauci, Marks, and Kessler.
    I am glad to have you all back before our Committee today, 
and I know we will continue to hear from you as we work to end 
this pandemic.
    After the witnesses give their testimony today, each 
senator will have 5 minutes for a round of questions.
    Before we begin, I want to again walk through the COVID-19 
safety protocols that are in place today. We will follow the 
advice of the Attending Physician and Sergeant at Arms in 
conducting this hearing. We are again grateful to all of our 
Clerks and everyone who has worked so hard to get this set up 
and help everyone stay safe and healthy.
    Committee Members are seated at least 6 feet apart, and 
some Senators are participating by videoconference. And while 
we are unable to have this 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.
    While we are not yet through this pandemic, it is clear we 
are making significant progress. We administered well over 200 
million COVID-19 vaccines in President Biden's first 100 days. 
Over half the adult population has gotten at least one dose; 
one-third of the Country is fully vaccinated. Schools, 
businesses, and communities are working to safely reopen. And, 
the Food and Drug Administration has now authorized vaccines 
for adolescents. So, we have come a long way in the last few 
months.
    But, even as we are encouraged by the progress so far, we 
are all keenly aware more work lies ahead. This pandemic has 
touched every community in our Country and every corner of the 
world. To truly end it, vaccines have to be just as widespread.
    While some progress is being made, for example in my home 
State of Washington, they have released a dashboard with 
vaccination data, the latest numbers from which show Washington 
State has vaccinated over five million people, and we are 
vaccinating around 50,000 more a day. The data also shows 
vaccinations are lagging in some areas, especially for Black, 
Latino, Tribal, and rural communities, and not just in my 
state, but across the Country.
    In some states, we are still lacking key data on 
demographic characteristics, including race and ethnicity. We 
have to address systemic inequities and tear down barriers that 
are making it harder for some people to get vaccines. Everyone 
must have the opportunity to get vaccinated regardless of race, 
zip code, disability, primary language, or internet access.
    We are also seeing vaccination rates slow. It is a reminder 
that making sure people can get vaccines is just half the 
battle. We need to make sure they do get them. To make that 
happen, we need to make sure people are getting reliable 
information about vaccines and hearing from voices they trust 
about why getting vaccinated is so important, not just to 
protect themselves, but to protect those around them and stop 
this disease from spreading or mutating into new deadly 
strains.
    I am glad the Biden administration is continuing to release 
funds from the American Rescue Plan to help address some of 
these challenges, including last week when they announced 
almost a billion dollars to strengthen our response in rural 
communities, and one-quarter of a billion dollars to develop 
and support a community-based workforce to help underserved 
groups get information about vaccines, schedule appointments, 
arrange transportation, and more.
    As we work to get our Nation vaccinated, we have to also 
acknowledge this is a global fight and do our part to lead on 
the world stage. The deadly outbreak in India is a 
heartbreaking reminder of what can happen when this virus 
spreads unchecked, when it mutates into more contagious, more 
deadly strains, and when it overwhelms healthcare systems. It 
is a reminder this pandemic will not fully be over for our 
Country until it is over for the world, which is why I am glad 
the Biden administration is sending medical support to India, 
sharing some of our excess doses globally, and even considering 
other steps to remove barriers to vaccines for countries that 
need them, including a targeted waiver of COVID-19 patent 
protections.
    These moves will not just save lives in India. They will 
ultimately save lives in Washington State, North Carolina, and 
across the Country. Because people get that when there is a 
fire down the street, it is in their best interest to put it 
out before it gets to their family's home, not to mention that 
helping your neighbor is always the right thing to do.
    I am also hearing from lots of people in my home state who 
really feel we cannot simply end this crisis and never look 
back. We have to learn from it. We have to be better prepared 
for the next public health emergency so that we are never again 
in a situation like this, which is why Ranking Member Burr and 
I plan to develop bipartisan legislation to address and build 
on lessons learned from the COVID-19 response; ensure robust 
public health and medical capacity to provide services to those 
most at risk; improve and supply the supply chain for critical 
medical supplies; tackle the health disparities that afflict so 
many of our communities; and strengthen the Nation's public 
health infrastructure and medical preparedness and response 
programs at every level.
    I look forward to having more hearings specific to that 
work soon and hearing what our witnesses today have to say on 
that subject, as well.
    As Federal officials on the front lines of this pandemic, 
you all have an important perspective into the progress we are 
making today, as well as the lessons we must learn for 
tomorrow.
    Now, 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. I am glad we are 
holding another hearing to update us on the status of COVID-19 
response. And, to our witnesses, thank you for the work you 
have done. More importantly, welcome back to the Committee.
    It has been almost 18 months since the initial reports of 
severe pneumonia in Wuhan, China surfaced. Since that time, we 
have tragically seen over a half million deaths in this Country 
from COVID-19. Government-backed shutdowns have jeopardized the 
livelihood of millions of Americans, and we have spent more 
taxpayer money than I could have ever imagined in response to 
this virus and the devastating effect it has had on our 
economy.
    But, now, more than ever, there is reason for hope. We are 
seeing the promise of vaccines and treatments in real time. A 
month ago, the case count in the United States was over 70,000 
new cases per day. Today, we are down to roughly 40,000 and 
headed south. The CDC is projecting continued declines in death 
and hospitalization rates.
    Because of Operation Warp Speed, Dr. Marks, Dr. Fauci, Dr. 
Hahn, and the FDA, we have fully vaccinated 115 million 
Americans, which is roughly 44 percent of adults, and delivered 
almost 330 million doses to states. Operation Warp Speed and 
BARDA spent more than $18 billion to make vaccines available to 
Americans, manufacturing vaccines at risk, and the American 
people are benefiting from that today. Manufacturers were able 
to produce vaccines, enough vaccines, that the United States is 
now able to help provide vaccines to countries in need, like 
India.
    Because of the collaborative efforts over the last year, we 
are ready to turn the corner. The partnerships developing in 
manufacturing the COVID-19 vaccines have been one of the 
biggest scientific success stories in generations. Industry 
answered the call at the start of the pandemic and partnered in 
an unprecedented way to bring us these live-saving products.
    Intellectual property is part of the reason we have these 
life-saving products today. If these protections are not in 
place for innovators of life-saving medicines, we will not have 
them for the next pandemic. It is that simple.
    We held a hearing on the threat of China taking 
intellectual property from U.S. research, and now the Biden 
administration has agreed just to hand it over. There is a way 
to support the manufacturing of vaccines globally and help 
countries in need without acting in bad faith against 
innovators who stepped up when the world needed them the most.
    It is the partnerships we are already seeing today that are 
saving lives, not silly ideas about socializing means of 
production. The action from the Biden administration to support 
waiving intellectual property rights will undermine the 
innovation we are relying on to bring this pandemic to an end 
and will leave us with a less-prepared future.
    I am encouraged that some of our European allies cautioned 
against this reckless action, and I hope the adults in the 
Biden administration will realize that what sounds good in a 
grad school ivory tower thesis paper does not make sense in the 
real world. You four are the adults in the room. I urge you to 
think about the real consequences if we just give away this 
science and this technology.
    The next part of our job is going to be the difficult part. 
I have been looking to Israel to help predict the challenges 
that we may be in store for in the U.S. since they are ahead of 
us on vaccination rates today. Israel was able to vaccinate 40 
percent of the adult population by the end of February. Their 
data shows that uptake stalled once they vaccinated about 60 
percent of the adult population. While there are differences 
between our countries, we have to use the information we have 
to best predict our road ahead.
    Every adult has the opportunity to be vaccinated, and 
supply is starting to exceed demand. In other words, we have 
more shots than we have arms to put it in. We need to address 
vaccine hesitancy, and it needs to be done now.
    I know this is the case in my state with recent reports 
from Wilmington, North Carolina that local officials are 
changing their approach as vaccine demands slow. We must paint 
a picture for the American people showing the benefits of both 
a vaccination and a reopening of our Country. This is a simple 
message for those in leadership positions.
    I got the vaccine. My wife got the vaccine. My sons got the 
vaccine. Their wives got the vaccine. I have encouraged all of 
my staff to take it as soon as it is available to them. And, I 
have gone through the last 24 hours with a real fear that I had 
a one-and-a-half year old grandson who might have had COVID. 
Fortunately, it all came back negative and he will hopefully 
leave the hospital sometime today.
    But, I would guess that everyone in this room is 
vaccinated, which means if we follow the CDC guidelines, we can 
dispense with masks and social distancing. Tomorrow, I hope 
that we are going to have a vaccine that is approved for kids 
over 12, and ones younger hopefully in the not-too-distant 
future.
    We must reassure Americans that COVID vaccines are safe. 
Vaccines save lives. I might have been naive when we started 
this, believing that staying out of the hospital and not dying 
might have been motivation enough to get people vaccinated. It 
clearly was not. And that is why we must reassure Americans 
that if you get a COVID vaccine, our lives can and will return 
to normal. But, we cannot assure, without painting that picture 
for them, what that looks like. Today's response is preparing 
us for tomorrow's threat.
    As Senator Murray said, we have launched a joint effort to 
strengthen our public health preparedness programs for the next 
threat, which we will inevitably face. That threat could be 
emerging today, or it could be a new virus, another curveball 
from Mother Nature, or the result of deliberate, manmade 
attacks on our Country.
    Our framework has always been flexible and it needs to stay 
that way. There will always be lessons that we learn from each 
response, and our threat landscape is constantly evolving. Our 
experience with this pandemic has made that even more clear.
    Senator Murray and I look forward to working with each of 
you and the Members of the Committee on this project to take 
stock of lessons learned and to actually put them into action.
    To our witnesses today, thank you for all you have done up 
to this point of the response, but know that the most 
challenging days may be the next several weeks and months ahead 
as we attempt to get to a vaccination level that changes the 
glidepath to one that is permanently in the decline.
    With that, I thank the Chair.
    The Chair. Thank you, Senator Burr, and I look forward to 
working with you on that, and I wish your grandson well.
    Senator Burr. Thank you.
    The Chair. I will now introduce today's witnesses.
    Dr. Rochelle Walensky is the Director of the Centers for 
Disease Control and Prevention and the Administrator of the 
Agency for Toxic Substances and Disease Registry.
    Dr. Walensky, welcome back. Thank you for joining us today.
    Next, I would like to introduce Dr. Anthony Fauci, who is 
the Director of the National Institute of Allergy and 
Infectious Diseases and the Chief Medical Advisor on President 
Biden's COVID-19 Response Team.
    Dr. Fauci, good to have you back before the Committee, as 
well. Thank you for joining us.
    Dr. Peter Marks is the Director of the Center for Biologics 
Evaluation and Research for the Food and Drug Administration.
    Dr. Marks, we are glad to have you here again, as well. 
Thank you.
    Finally, I would like to introduce Dr. David Kessler. Dr. 
Kessler is the Chief Science Officer of the Biden 
administration's COVID-19 Response Team.
    Dr. Kessler, glad to have you with us, as well.
    With that, we will begin our witness testimony. Dr. 
Walensky, we will begin with you for your opening statement.

  STATEMENT OF ROCHELLE WALENSKY, M.D., MPH, DIRECTOR, UNITED 
 STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Walensky. Thank you, Chair Murray, Ranking Member Burr, 
and Members of the Committee for the invitation to speak with 
you today.
    I last testified before this Committee less than 2 months 
ago. Since that time, the dedicated professionals at CDC have 
been working diligently to provide additional resources to 
states, localities, territories, and tribes thanks to support 
from Congress. We are updating our guidance based on the latest 
scientific evidence, and we are working with our partners 
around the Country and around the globe to reduce the burden of 
COVID-19.
    I am pleased to report that since January, we have seen a 
consistent downward trend with daily averages of new infections 
dropping 76 percent, hospitalizations down 71 percent, and 
reported deaths decreasing by 75 percent.
    This progress is also reflected in our data on the county-
level risk. Just a few months ago, 85 percent of all counties 
in the U.S. were experiencing high COVID-19 transmission rates 
and increased community risk. This morning, that is down to 33 
percent of counties.
    These trends give me hope. And, still, I continue to 
emphasize that we must remain diligent and committed to our 
surveillance and prevention efforts because the emergence of 
variants could set us back.
    With your help, CDC is using the $1.7 billion Congress 
provided to expand nationwide genomic sequencing efforts. Since 
January, we have dramatically increased sequence output from 
3,000 samples per week to approximately 35,000 samples per 
week.
    We are also keeping our commitment to prioritize health 
equity. Since March, we have announced a number of investments 
that center in health equity. These include $2.25 billion to 
address COVID-19-related health disparities and advance health 
equity among high-risk and underserved populations; $3 billion 
to strengthen vaccine confidence, with a focus on increasing 
uptake and equity in administration, particularly in 
communities hardest hit by the pandemic; $332 million in 
community health workers to support COVID-19 prevention and 
control; and $250 million to develop targeted strategies for 
vaccine education and outreach for uptake in specific 
communities.
    In addition, CDC continues to update our guidance as we 
learn more. This includes a recent update outlining levels of 
risk of activities for fully vaccinated and unvaccinated 
people. We will continue to update this guidance to be clear 
that vaccines are a means of returning to activities we stopped 
as a result of the pandemic.
    I am so proud to report the administration of more than 261 
million vaccine doses, including more than 133 million since I 
last testified before you in March. Over 84 percent of 
Americans age 65 and older, and over 58 percent of all adult 
Americans have now received at least one vaccine dose.
    With these cases trending down in the United States and 
more people getting vaccinated, we are cautiously optimistic. 
However, globally, the pandemic is more severe than ever. 
India's surge of cases is tragic and a reminder that the virus 
can rapidly outstrip our efforts to contain it if we are not 
careful. We will not end this pandemic without working hand in 
hand with countries around the globe to fight COVID-19.
    I want to take a moment to acknowledge that while we have 
made great progress over the last few months, more than 579,000 
people in the United States have died from COVID-19 during this 
pandemic. And just since I saw you in March, over 39,000 of our 
loved ones have died from COVID-19 in the United States. Every 
death is a stark reminder of why we must remain vigilant and 
focused to end this pandemic as quickly as possible.
    I want to close with a promise and an appeal to the 
American people. My promise is that CDC will continue to follow 
the science as our guide. And, my appeal is to implore everyone 
to get a COVID-19 vaccine as soon as possible as the fastest 
way to end this pandemic.
    But, even with this powerful tool, while we continue to 
have community transmission, we must also maintain public 
health measures we know will prevent the spread of this virus--
masks, hygiene, hand hygiene, and physical distancing.
    Finally, as we get through this pandemic, we must work 
together over the months and years ahead to build on the 
investments, partnerships, and innovations that we have created 
during this crisis. This includes achieving sustainable 
investments in public health infrastructure to be better 
prepared for whatever comes next. It is one way we can turn 
tragedy into lasting progress and improved health for all.
    Thank you again for the opportunity and invitation to 
testify today, and I look forward to answering your questions.
    [The prepared statement of Dr. Walensky follows:]
                prepared statement of rochelle walensky
    Chairman Murray, Ranking Member Burr, and distinguished Members of 
the Committee. It is an honor to appear before you again today to 
discuss the Centers for Disease Control and Prevention's (CDC) ongoing 
response to the COVID-19 pandemic. 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 health, safety, and security. CDC is 
proud of its key role in preparedness and response to public health 
concerns here in the United States and abroad. 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 over 4 
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
    While COVID-19 cases have recently decreased, COVID-19 transmission 
remains widespread across the Nation. We are hopeful. We have made 
significant progress in getting shots in arms. But, given that many 
people around the country are not yet fully vaccinated and given the 
threat of variants, we must remain cautious.

    It goes without saying, we have been tested over the past nearly 
year and a half. It has been an extraordinarily difficult time for the 
United States. And I want to take a moment to recognize the more than 
570,000 Americans--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. We also 
acknowledge the millions of others who have suffered with this disease 
and recognize there are so many who will require long-term care and 
support.

    As hard as this has been, we can still persevere. If we can just 
stay the course a little longer by strengthening and maintaining 
evidence-based prevention 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 
has expanded sequence surveillance across the United States 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 locations across the United States 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 250 COVID-19 studies have 
been published in the Morbidity and Mortality Weekly Report (MMWR) on 
topics ranging from health disparities exacerbated during the pandemic, 
to prevention strategies, to emergence of new variants. CDC has also 
produced more than 6,000 documents to provide information and guidance 
for government agencies, businesses, and the public. CDC is actively 
studying the epidemiology of post-COVID conditions (often referred to 
as long COVID), including the prevalence, duration, and severity of 
symptoms following acute SARS-CoV-2 infection, as well as risk factors 
for developing post-COVID conditions. This work will help to establish 
a more complete understanding of the natural history of SARS-CoV-2 
infection and post-COVID conditions, which can inform healthcare 
strategies, clinical decision-making, and the public health response to 
this virus that will be required over the long term. A recent MMWR 
article found that among 3,000 adults with COVID-19 who didn't require 
a hospital stay, two out of three returned for at least one outpatient 
visit within one to 6 months after COVID-19 diagnosis; many with 
recurring symptoms potentially related to COVID-19.

    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. There is also 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 prevention 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. This group is also 
engaging with international partners to improve global surveillance of 
variants and identify synergies in our collective assessment of the 
impact of variants globally.

    We are monitoring dozens of variants and conducting ongoing and 
comprehensive risk assessments through the SARS-CoV-2 Interagency Group 
and in consultation with our international colleagues. Of the emerging 
variants, five have captured our attention and have the highest risk to 
public health: B.1.1.7, B.1.351, B.1.427, B1.429, 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. Data 
from CDC national surveillance project that B.1.1.7 viruses represented 
72 percent of the viruses circulating for the two-week period ending 
April 24. The B.1.1.7 variant is the predominant strain of SARS-CoV-2 
in the country now and has likely continued 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. Data from CDC national surveillance project that B.1.351 
viruses represented approximately 0.6 percent of the circulating 
viruses, and the P.1 variant represented approximately 5.6 percent for 
the two-week period ending April 24. The proportion of cases attributed 
to the B.1.427 and B.1.429 variants, which were first identified in 
California, have decreased in recent weeks. According to data for the 
two-week period ending April 24, the combined prevalence of B.1.427 and 
B.1.429 is 2.6 percent.

    Available data suggest that antibodies elicited by vaccination with 
the currently authorized vaccines are able to neutralize the B.1.1.7 
variant but have reduced neutralization against the B.1.351 and P.1 
variants. Based on preliminary data from a Johnson & Johnson vaccine 
clinical trial in South Africa where the prevalence of the B.1.351 
variant was estimated to be 95 percent, the vaccine efficacy was 64 
percent and had 81.7 percent efficacy in preventing severe disease, and 
promising efficacy data have been released from the Pfizer clinical 
trial in South Africa. Studies are currently underway to understand the 
impact on the real-world effectiveness of current vaccines against the 
B.1.351 variant and other variants of concern. Efforts are ongoing to 
better understand the impact of the variants on medical 
countermeasures.

    Since January, CDC has dramatically built up our domestic genomic 
surveillance platforms to monitor circulating variants, increasing the 
Nation's sequencing output 75-fold, with over 36,000 specimens now 
sequenced weekly. With support from the funding the Administration 
announced in February as well as the resources provided by the American 
Rescue Plan Act, we're contracting with several large commercial 
diagnostic laboratories to get viral sequence data from around the 
country. These laboratories are providing data on over 22,000 virus 
samples per week. 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 approximately 7,000 
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 7,000 viruses per 
week. These efforts are coordinated through CDC's SPHERES 
collaboration, which is a national genomics consortium to coordinate 
large-scale SARS-CoV-2 sequencing across the country. In all, the 
United States is sequencing about 10 percent of the roughly 350,000 
weekly cases. These partnerships with commercial labs, state and local 
health departments, and academic and research institutions will 
continue to grow. We are on our way to sequencing an even higher 
percentage of cases, a tremendous accomplishment. CDC is working with 
state and local public health departments to use these sequencing data 
as part of their COVID-19 response strategy. CDC has also made 
significant strides to make our genomic surveillance data more 
accessible to the public through an interactive dashboard on our COVID 
Data Tracker website. This site is updated regularly with the 
prevalence of SARS-CoV-2 variants at the national, regional, and state 
levels.

    Each new variant can present different challenges. But each can be 
stopped by the same methods: rigorous and increased compliance with 
public health prevention 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. 
CDC's Chief Health Equity Officer has been leading implementation of 
our Health Equity Strategy to accelerate progress in reducing COVID-19 
disparities. The strategy outlines an approach to expand evidence-based 
approaches to reduce disparities in COVID-19 hospitalizations and 
deaths; increasing testing, contact tracing, isolation options, and 
healthcare access in populations at increased risk for COVID-19; 
prioritizing equity in distribution and administration of COVID-19 
vaccines; reducing stigma and bias; and expanding a diverse workforce, 
equipped to address the needs of a diverse population. We are engaging 
with community-based organizations and diverse leaders to conduct 
outreach that is culturally and linguistically responsive to the needs 
of 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 they serve. They have also helped us craft and convey 
tailored prevention messages about COVID-19 to these important 
populations across the country. 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.

    We know we need the best possible data to more clearly understand 
these 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 almost 40 percent of the 
COVID-19 cases reported to CDC. Progress has been slow because there 
are many data requisition forms and data interfaces in the data 
exchange pathway that must be updated. Moreover, public health data 
systems are not set up in a way that captures the underlying drivers 
for which race and ethnicity are markers. Those drivers include social 
determinants of health such as occupation, housing, education, access 
to healthcare and other factors that are the underlying causes for the 
disparities we see by race and ethnicity. There are multiple barriers 
to collecting some of these data elements, including at the state and 
individual level--including reticence to report income or other socio-
economic factors.

    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 
antiquated public health data systems by providing resources to CDC for 
the data modernization initiative, the first comprehensive strategy to 
modernize public health data, technology, and workforce capabilities--
together and at once. CDC is collaborating with our partners in the 
field to improve data collection and sharing.

    In the last few months, data continue to document ongoing health 
disparities. In February, CDC's National Center for Health Statistics 
(NCHS) released data that highlighted disparities in life expectancy 
between 2019 and 2020, demonstrating the impact of COVID-19 on Black 
and Hispanic/Latino communities. Additional CDC data \1\ released in 
February noted that racial and ethnic minority groups have experienced 
disparities in mental health and substance use disorder related to 
access to care, psychosocial stress, and social determinants of health, 
exacerbated by the pandemic. Hispanic/Latino adults reported a higher 
prevalence of psychosocial stress related to not having enough food or 
stable housing than did adults in other racial and ethnic groups. And 
more recently, in April, we published a report \2\ that found racial 
and ethnic disparities in hospitalization rates during the early months 
of the pandemic, with rates being highest for Hispanic or Latino 
patients, although these disparities generally declined later in 2020 
as the proportion of cases in White patients increased.
---------------------------------------------------------------------------
    \1\  https://www.cdc.gov/mmwr/volumes/70/wr/mm7005a3.htm?s-
cid=mm7005a3-w.
    \2\  https://www.cdc.gov/mmwr/volumes/70/wr/mm7015e2.htm?s-
cid=mm7015e2-w.

    While it is important to document these disparities, we do not need 
further documentation to take action, and we are making strides toward 
change using the data we have. These data compel us to do what we do 
best at CDC--to turn our research and science into policy and action to 
improve the health of all. CDC, in collaboration with other components 
of HHS, has made historic investments in the last month to address 
---------------------------------------------------------------------------
COVID-19 health disparities and promote health equity.

    In March, CDC announced plans to invest $2.25 billion over 2 years 
to address COVID-19 related health disparities and advance health 
equity among populations that are at high-risk and underserved, 
including racial and ethnic minority groups and people living in rural 
areas. This funding represents CDC's largest investment to date to 
support communities affected by COVID-19-related health disparities. 
CDC's new National Initiative to Address COVID-19 Health Disparities 
Among Populations at High-Risk and Underserved Communities, Including 
Racial and Ethnic Minority Populations and Rural Communities, will 
offer grants to public health departments to improve testing and 
contact tracing capabilities; develop innovative mitigation and 
prevention resources and services; improve data collection and 
reporting; build, leverage, and expand infrastructure support; and 
mobilize partners and collaborators to advance health equity and 
address social determinants of health as they relate to COVID-19.

    CDC is also investing $300 million over 3 years in jurisdictions 
for community health worker services to support COVID-19 prevention and 
control, and an additional $32 million for training, technical 
assistance, and evaluation related to this effort. This funding will be 
used to address disparities in access to COVID-19 related services, 
such as testing, contact tracing, and vaccinations, and it will help 
address factors that increase risk of severe COVID-19 illness. This 
effort will benefit populations with increased prevalence of COVID-19 
and disproportionately impacted by long-standing health disparities.

    Through this funding CDC is committed to addressing these gaps, not 
only for the COVID-19 response, but across public health. And as we do 
this work, we will simultaneously take action on what we know--that 
these disparities exist, and they are unacceptable; addressing them is 
critical in ensuring success against COVID-19 and future pandemics.
                                Vaccines
    Vaccination is a critical tool in bringing this unprecedented 
pandemic to an end. In the year since SARS-CoV-2 infections were first 
identified, the FDA has issued Emergency Use Authorizations for 
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 and appreciate how vaccine efficacy helps prevent 
serious illness, hospitalization, and death from COVID-19. As of April 
19, every person aged 16 and over in every state and territory is now 
eligible to get vaccinated, and 90 percent of Americans now have a 
vaccine site within 5 miles of their home. The country has exceeded 
President Biden's goal of administering 200 million shots in the first 
100 days of his Administration.

    A CDC study reviewing data from the first 3 months of vaccinations 
among health care personnel, first responders, and other frontline and 
essential workers found that both Moderna and Pfizer vaccines were 90 
percent effective in preventing COVID-19 infection, two or more weeks 
after full vaccination. In addition, another recent CDC study \3\ found 
these two vaccines were 94 percent effective against hospitalization 
among fully vaccinated adults aged 65 years and older. These findings 
demonstrate the high, real-world effectiveness of these vaccines.
---------------------------------------------------------------------------
    \3\  https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm?s-
cid=mm7018e1-w.

    COVID-19 vaccine safety is a top priority for the Federal 
Government, and we take all reports of health problems following COVID-
19 vaccination seriously. On April 23, following a thorough safety 
review, including two emergency meetings of the CDC's Advisory 
Committee on Immunization Practices, the FDA and CDC determined that 
the previously recommended pause regarding the use of the Janssen 
(Johnson & Johnson) COVID-19 Vaccine in the United States should be 
lifted and use of the vaccine should resume. The pause had been 
recommended after 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 (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. The identification of 
this rare complication is an important validation of the sensitivity of 
vaccine safety monitoring systems to be able to pick up even very small 
---------------------------------------------------------------------------
numbers of vaccine safety concerns.

    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 
May 6, about 325 million doses have been delivered, and more than 251 
million doses of COVID-19 vaccine have been administered. Over 70 
percent of all Americans age 65 years and older were fully vaccinated 
by this date, and about 57 percent of adult Americans had received at 
least one vaccine. This is a whole-of-society effort, and it is 
inspiring to see people across government, business, and communities 
coming together to complete this important lifesaving task.

    I would like to touch on four core areas that drive CDC's vaccine 
work: safety, confidence, access, and equity. As shown during the 
recent Janssen (Johnson & Johnson) vaccine pause, our commitment to 
safety remains paramount to our work. 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.

    Further supporting efforts to prioritize equity in our vaccine 
strategy, CDC announced an investment of $3.15 billion to support local 
efforts to increase vaccine access, uptake, and equity. In early April, 
these funds were awarded directly to states, territories, and some 
large cities, enabling them to support local health departments and 
community-based organizations in launching programs and initiatives 
intended to increase vaccine access, acceptance, and uptake. The 
funding will focus on reaching communities hit hardest by the pandemic, 
including those with a high social vulnerability index, minority 
communities, and rural areas.

    In order to enhance vaccine uptake among underserved communities of 
color and to build trust and confidence in the authorized COVID-19 
vaccines, CDC has developed a comprehensive program of approximately 20 
national organizations that support hundreds of local and community-
based organizations to improve both COVID-19 and influenza vaccination 
coverage among racial and ethnic groups who have historically had, and 
continue to experience, health disparities.

    Improving access to underserved communities and populations who 
have historically experienced greater barriers to healthcare access is 
another critical component to prioritizing equity in vaccine 
distribution. Improving access also requires a multi-pronged approach. 
To that end, CDC is working closely with the Federal Emergency 
Management Agency (FEMA) and the Health Resources and Services 
Administration (HRSA) on two critically important programs with the 
goal of bringing vaccines to communities and improving access for 
populations disproportionately impacted by COVID-19. CDC partners with 
FEMA on the implementation of their Community Vaccination Centers. CDC 
also partners with HRSA to support COVID-19 vaccinations in select 
HRSA-funded health centers.

    The Federal Retail Pharmacy Program is integral to the work CDC is 
doing to maximize access to COVID-19 vaccines in all communities, 
including communities of color and other underserved populations, such 
as rural communities. CDC is partnering with 21 national pharmacy 
organizations and independent pharmacy networks that represent over 
40,000 locations nationwide--including 45 percent in highest-need 
neighborhoods--to ensure that the public has access to COVID-19 
vaccines in a familiar setting. Almost 90 percent of Americans live 
within five miles of a retail pharmacy. The retail pharmacy program was 
also instrumental in attaining the goal of prioritizing Pre-K through 
12th grade educators, school staff, and childcare workers for COVID-19 
vaccination in the month of March. As a result of this effort, our 
estimates show that approximately 80 percent of these essential 
frontline workers across the United States received at least one shot 
in March and more than 2 million teachers, school staff, and childcare 
workers were vaccinated through the Federal Retail Pharmacy Program in 
March. More than 52 million doses of vaccine in total have been 
administered through this program.

    Last month, CDC also announced a new partnership with certain 
clinics to provide COVID-19 vaccinations to people receiving dialysis, 
as well as health care personnel working in these clinics. Dialysis 
patients are disproportionately affected by COVID-19 and are at high 
risk for severe illness and death from COVID-19. It is estimated that 
34 percent of people receiving dialysis are Black and 19 percent are 
Hispanic; and that 22 percent of staff in dialysis clinics are Black. 
People on dialysis who get COVID-19 have a 50 percent hospitalization 
rate and a 20 to 30 percent mortality rate. This effort is another 
important step in making sure that vaccines reach the most medically 
vulnerable communities and that prioritizing equity in vaccination 
continues to anchor our efforts to end the COVID-19 pandemic.

    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. CDC recently released updated guidelines 
for fully vaccinated people, providing guiding principles on how to 
assess their own risk for COVID-19 and determine what prevention 
measures, including masks, should be used. 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, \4\ which informed CDC's Operational Strategy for K-12 Schools 
through Phased Prevention. \5\ 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 
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. In March, CDC 
updated its school guidance reflecting the latest evidence to recommend 
that, with universal masking, students should maintain a distance of at 
least three feet in classroom settings. However, middle school students 
and high school students should be at least six feet apart in 
communities where transmission is high, if cohorting (or podding) is 
not possible. 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 guidance, as well as tools and best 
practices about how to apply this guidance.
---------------------------------------------------------------------------
    \4\  https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-
research/transmission-k-12-schools.html.
    \5\  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. 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 (including 
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.

    In April, CDC provided $10 billion to states and jurisdictions to 
support COVID-19 screening testing for K-12 teachers, staff, and 
students to assist schools in reopening safely for in-person 
instruction. In addition to ensuring diagnostic testing of symptomatic 
and exposed individuals, serial screening testing will help schools 
identify infected individuals without symptoms who may be contagious so 
that prompt action can be taken to prevent further transmission. With 
this funding, states can support the critical testing and testing 
supports schools need to implement screening testing programs. 
Recognizing that establishing a testing program is new for many 
schools, CDC and state and local health departments will support 
technical assistance to assist states and schools in standing up and 
implementing these programs. A recent article in CDC's MMWR found 
participation in a free, in-school COVID-19 testing program within Utah 
elementary schools was higher among students belonging to a racial or 
ethnic minority group and among students living in areas with higher 
rates of COVID-19. In-school testing could help reach underserved 
populations and reduce the spread of COVID-19 across the community.

    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
    As I've said before, 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 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 COVID-19 cases remain 
widespread, there are reasons to be hopeful. 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.

    Ending this pandemic requires more equitable access to affordable 
and timely testing, treatment, and vaccination. Looking forward, we 
will continue to take a health equity approach, not only in future 
emergency responses, but in everything we do at CDC. And even when this 
crisis is over, we will still need a strong public health system. The 
COVID-19 pandemic has illuminated long-standing inequalities in health 
among racial and ethnic minority groups; demonstrated the need for 
resilient, fast, and accurate data systems; and showed the essential 
role a robust, skilled, and diverse public health workforce plays in 
protecting Americans.

    The next few weeks and 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 cannot strengthen the public health infrastructure our Nation 
needs to combat public health emergencies--like pandemics and other 
infectious disease threats--overnight or in the middle of an emergency 
crisis. We must work together over the months and years ahead to 
reinforce the foundations, partnerships, modernizations, and 
innovations that we have initiated during this pandemic--ensuring 
robust public health systems continue to be grounded in science. It is 
one way we can turn tragedy into lasting progress and improved health 
outcomes for all. Thank you again for the invitation to testify today 
and I look forward to answering your questions.
                                 ______
                                 
    The Chair. Thank you.
    Dr. Fauci.

STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
  OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
                      HEALTH, BETHESDA, MD

    Dr. Fauci. Madam Chair, Ranking Member Burr, Members of the 
Committee, thank you for giving me the opportunity to discuss 
with you this morning the role of the National Institute of 
Allergy and Infectious Diseases and the NIH and research 
addressing the COVID-19 pandemic.
    As I had mentioned to this Committee during the last 
hearing that we attended, we have a strategic plan that has 
four major components--fundamental knowledge of the virus, 
diagnostics, therapeutics, and the development of safe and 
effective vaccines. For the purpose of today's discussion, I 
will focus on the issue of vaccines.
    We often get asked how it could be possible that the virus 
was discovered in January 2020 and we had doses of vaccine 
going into the arms of individuals, a vaccine that was highly 
efficacious and safe, 11 months later in December 2020. Well, 
the story behind that has been the decades of investment in 
basic and clinical, biomedical research that has led to our 
ability to accomplish this extraordinary feat.
    Just some examples. The basic preclinical and clinical 
research in developing vaccine platform technology, 
particularly the highly successful MRNA platform.
    In addition, scientists at the Vaccine Research Center at 
NIAID, as well as grantees and contracts--contractors 
throughout the Country developed the optimal immunogen, which 
is the confirmationally correct spike protein, which is used by 
virtually all the vaccines that are being tested right now.
    Finally, the utilization of a clinical trial network that 
we had set up decades ago for influenza and for HIV.
    When one thinks of efficacy, it really is what are the 
results of a clinical trial. Often, when you get into the real 
world, the effectiveness of vaccines falls short of the 
original efficacy. That is not at all the case with the 
vaccines for COVID-19 because the real-world effectiveness is 
even more impressive than the results of the clinical trial.
    One example, the University of Texas looked at 23,000 of 
their employees and found that the incidence of infection was 
0.05 percent, markedly lower than unvaccinated individuals.
    The CDC has multiple MMWRs reporting on various aspects of 
the real-world effectiveness. Importantly, a recent paper in 
The Lancet reported on the experience in Israel, which, as 
Senator Burr had mentioned, has done an extraordinary job of 
getting their citizens vaccinated. And, what we have seen is a 
remarkable diminution in the number of infections that reached 
a critical turning point when they reached a certain percentage 
of the individuals who were vaccinated.
    It was not only limited to Israel. Another recent paper in 
the country of Qatar showed a similar type of result in which, 
not only was the MRNA vaccine highly effective in over 300,000 
individuals tested in preventing the original wild-type virus, 
but it also had a very interesting capability of protecting 
against mild to moderate disease of a problematic variant from 
South Africa, the 351, and protected virtually 100 percent from 
severe disease, including hospitalization and death.
    When the President makes the goal of 70 percent of adults 
receiving at least one vaccine by the 4th of July, we believe 
that is an attainable goal. The reason we feel it is important 
is that I believe that we are about at that critical turning 
point when we get a certain percentage--we do not know exactly 
what it is, but clearly the majority of individuals in the 
Country vaccinated, we will see a sharp turning point and a 
marked diminution in cases.
    As I said the last time I testified before you, we are in a 
race between the vaccine and the virus, if left to its own 
devices will continue to surge. Based on experience thus far in 
this Country and globally, I feel confident that if we continue 
to vaccinate people at the rate that we are doing, that we will 
very soon have a situation where we will have so few infections 
in this Country, we will begin to return to normality that all 
of us desire so much.
    Thank you very much.
    [The prepared statement of Dr. Fauci follows:]
                  prepared statement of anthony fauci
    Madam Chair, Ranking Member Burr, and Members of the Committee:

    Thank you for the opportunity to discuss the role of the National 
Institute of Allergy and Infectious Diseases (NIAID) in the research 
response to coronavirus disease 2019 (COVID-19) and its etiologic 
agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 
Within the Department of Health and Human Services (HHS) and the 
National Institutes of Health (NIH), NIAID is responsible for 
conducting and supporting basic and clinical research on emerging and 
re-emerging infectious diseases, including COVID-19. As the Director of 
NIAID and the Chief Medical Advisor to the President, I am pleased to 
discuss NIAID's research addressing this pandemic.

    COVID-19 is a once-in-a-lifetime global infectious disease pandemic 
requiring an unprecedented public-private research effort. NIAID plays 
a central and important role in the public health response to COVID-19. 
NIAID has capitalized on decades of investment in fundamental basic 
research, including groundbreaking structure-based vaccine design at 
the NIAID Vaccine Research Center (VRC); engaged domestic and 
international research infrastructure; and leveraged highly productive 
partnerships with industry and longstanding relationships with 
community partners. NIAID utilized its existing domestic and 
international clinical trials infrastructure, originally established to 
conduct research on HIV and influenza, and worked with partners in the 
public and private sectors to establish the COVID-19 Prevention Network 
(CoVPN). The CoVPN has supported multiple COVID-19 vaccine candidates 
to progress in record time from concept to authorization for emergency 
use by the U.S. Food and Drug Administration (FDA). NIAID also has 
built on its longstanding relationships with community partners to 
successfully conduct these crucial clinical trials. NIAID initiated 
clinical trials with creative and adaptive designs, allowing the 
evaluation of multiple new and existing therapeutics for use against 
COVID-19. Several of these trials provided evidence of safety and 
efficacy of COVID-19 therapeutics and helped support authorization by 
the FDA.

    These successes have helped slow the progression of the pandemic in 
the United States. Currently, we are vaccinating approximately 2.5 
million people per day, and we must continue to vaccinate as many 
people as we can as quickly as possible. FDA-authorized COVID-19 
vaccines are safe and highly effective. The high levels of vaccine 
efficacy observed in the carefully controlled conditions of a clinical 
trial setting have been subsequently confirmed by their effectiveness 
in studies of vaccines administered to broad segments of the public. 
Vaccination and adherence to public health measures are the fundamental 
tools that will help us head off another COVID-19 surge.

    While we are cautiously optimistic about the future, we know that 
many challenges remain. One of the most concerning developments of the 
ongoing pandemic is the spread of genetic variants of SARS-CoV-2, some 
of which appear to be more transmissible than the original virus, more 
virulent, and/or 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 Authorizations (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 continuing to work directly with these 
communities, as well as 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 the COVID-19 pandemic. NIAID also 
recognizes that while many individuals with SARS-CoV-2 infection fully 
recover after a relatively short time period, some individuals suffer 
longer-term effects after the initial phase of illness and after the 
virus is cleared 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 broad 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 research investments by NIAID in the years prior to the 
emergence of SARS-CoV-2 enabled the unprecedented pace of COVID-19 
vaccine candidate development. Two activities predate successful COVID-
19 vaccines: the development of versatile vaccine platforms and the 
adaptation of structural biology tools to design agents (immunogens) 
that powerfully stimulate the immune system. Long before the pandemic, 
NIAID VRC scientists and their collaborators made the critical 
scientific discovery of how to stabilize in a highly immunogenic form 
viral proteins that are important for infection, including the spike 
protein of the Middle East respiratory syndrome coronavirus (MERS-CoV), 
using a double mutation known as S2P. This key finding 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 in January 2020, VRC researchers rapidly 
generated a stabilized SARS-CoV-2 spike protein for use in COVID-19 
vaccine development. This crucial breakthrough in structure-based 
vaccine design for coronaviruses has led to the development of safe and 
effective COVID-19 vaccine candidates across a range of vaccine 
platforms.

    Five candidate COVID-19 vaccines have been assessed in large-scale 
Phase 3 clinical trials in the United States thus far, and three have 
received EUAs from the FDA. Clinical trials to test COVID-19 vaccine 
candidates in pediatric populations are ongoing. On December 11, 2020, 
based on data from a Pfizer-supported Phase 3 clinical trial, an 
investigational vaccine developed by Pfizer and BioNTech became the 
first to receive an EUA from the FDA for the prevention of COVID-19 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, those from Moderna, Inc. and Johnson & Johnson/Janssen, 
have received EUAs.

    Utilizing the CoVPN, NIAID is participating in the implementation 
of harmonized protocols to test investigational vaccines and preventive 
interventions against SARS-CoV-2. These protocols were developed in 
collaboration with the Accelerating COVID-19 Therapeutic Interventions 
and Vaccines (ACTIV) public-private partnership, vaccine manufacturers, 
and the Biomedical Advanced Research and Development Authority (BARDA). 
NIAID also supports the underlying critical infrastructure for these 
clinical trials, such as a common Data and Safety Monitoring Board 
(DSMB), an independent group that periodically reviews data from the 
ongoing trials to ensure the safety of study volunteers and to 
determine whether efficacy has been achieved. The CoVPN has enrolled 
thousands of volunteers across the United States and internationally in 
clinical trials testing multiple investigational vaccines and 
monoclonal antibodies intended to protect people from COVID-19. The 
CoVPN also has developed an extensive community engagement framework to 
reach out to the underserved and minority communities disproportionally 
affected by COVID-19; to better understand their interest in, and 
concerns about, research participation; and to partner with them to 
ensure that their vital input is reflected in the conduct of these 
clinical studies.

    To further address the critical challenges of participation in 
clinical trials as well as vaccine acceptance and vaccine hesitancy, 
NIH established the Community Engagement Alliance Against COVID-19 
Disparities (CEAL) initiative, led by the National Heart, Lung, and 
Blood Institute (NHLBI) and the National Institute on Minority Health 
and Health Disparities. CEAL brings together trusted community leaders 
to serve as champions who share information about the importance of 
participating in COVID-19 research and communicate data on the safety 
and efficacy of authorized COVID-19 vaccines.
                          mRNA-1273 (Moderna)
    As part of a longstanding collaboration, the NIAID VRC worked with 
the biotechnology company Moderna to develop a vaccine candidate 
designated mRNA-1273, which uses a messenger RNA (mRNA) vaccine 
platform to express the stabilized SARS-CoV-2 spike protein. Early 
clinical trials demonstrated that mRNA-1273 was generally well 
tolerated and induced robust immune responses in healthy adults. NIAID 
and BARDA then began working with Moderna on a Phase 3 clinical trial 
through the CoVPN that showed that mRNA-1273 was 94.1 percent 
efficacious in preventing symptomatic COVID-19. On December 18, 2020, 
after a thorough review of comprehensive data on mRNA-1273, the FDA 
issued an EUA for the mRNA-1273 vaccine for prevention of COVID-19 in 
individuals 18 years of age and older. In subsequent observational 
studies under ``real-world'' conditions in broader segments of the 
population, mRNA-based vaccines continue to display a high level of 
effectiveness. In an article published in Morbidity and Mortality 
Weekly Report (MMWR), Centers for Disease Control and Prevention (CDC) 
researchers and their collaborators showed that among health care 
personnel, first responders, and other essential workers, the mRNA-1273 
and the Pfizer-BioNTech mRNA vaccine were 90 percent effective against 
SARS-CoV-2 infections 14 or more days after receiving a second dose. In 
another MMWR article, these vaccines reduced the risk of COVID-19 
hospitalization by 94 percent among people 65 years of age and older. 
Recently, NIAID scientists and their collaborators demonstrated that 
anti-SARS-CoV-2 antibodies persist for at least 6 months after the 
second dose of mRNA-1273.
                Ad26.COV2.S (Johnson & Johnson/Janssen)
    Decades of NIAID support for basic, preclinical, and clinical 
research on adenovirus (Ad)-based HIV vaccines underpin the development 
by Johnson & Johnson/Janssen of a coronavirus vaccine candidate based 
on the Ad26-vector, known as Ad26.COV2.S or JNJ-78436735. NIAID is 
supporting a Phase 3 clinical trial of Ad26.COV2.S through the CoVPN 
and has provided immunological testing of the candidate using NIAID-
funded core laboratory infrastructure. As reported in the New England 
Journal of Medicine, the one-dose vaccine candidate was 66 percent 
effective overall at preventing moderate to severe/critical COVID-19 
occurring at least 28 days after vaccination and 85 percent effective 
overall in preventing severe/critical COVID-19 in the Phase 3 trial 
across several geographical regions, including areas where emerging 
viral variants predominate. In the United States, the efficacy against 
moderate to severe/critical disease 28 days after vaccination with 
Ad26.COV2.S was 72 percent. On February 27, 2021, the FDA issued an EUA 
for Ad26.COV2.S for prevention of COVID-19 in individuals 18 years of 
age and older. On April 13, 2021, out of an abundance of caution, the 
FDA and CDC released a joint statement recommending a pause in the use 
of Ad26.COV2.S in order to review extremely rare case reports of blood 
clots after vaccine administration. Medical and scientific teams at the 
FDA and CDC found that available data suggest such blood clots are very 
rare events. Following their thorough safety review--and in accordance 
with recommendations from the CDC's Advisory Committee on Immunization 
Practices--the FDA and CDC lifted the recommended pause on the use of 
Ad26.COV2.S on April 23, 2021.
                   Other COVID-19 Vaccine Candidates
    NIAID, through the CoVPN, is supporting Phase 3 clinical trials of 
COVID-19 vaccine candidates from AstraZeneca (AZD1222) and Novavax 
(NVX-CoV2373). AstraZeneca's AZD1222 COVID-19 vaccine candidate uses a 
chimpanzee adenovirus-vectored vaccine approach developed by 
researchers at the University of Oxford in collaboration with 
scientists at NIAID's Rocky Mountain Laboratories. On March 25, 2021, 
AstraZeneca announced an updated interim analysis of AZD1222 reporting 
that the vaccine candidate was 76 percent effective at preventing 
symptomatic COVID-19, including 85 percent effective in participants 
aged 65 years and over. Importantly, the efficacy of AZD1222 against 
severe COVID-19 disease was reported to be 100 percent.
 Clinical Trials of COVID-19 Vaccine Candidates in Special Populations
    To effectively end the COVID-19 pandemic, it will be important to 
vaccinate as many people as possible, including those in special 
populations, such as pregnant and lactating women, children, and people 
with immune deficiencies. Tens of thousands of pregnant and lactating 
women already have received the COVID-19 vaccines under FDA EUAs, and 
available data indicate that these vaccines are safe and effective in 
these populations. In addition, protective antibodies against SARS-CoV-
2 have been detected in babies born to pregnant women who received mRNA 
COVID-19 vaccines. NIAID-supported investigators plan to continue to 
monitor the safety and further study the immune responses to these 
vaccine candidates in pregnant and lactating women. Efforts to evaluate 
COVID-19 vaccines in pediatric populations are ongoing. On March 16, 
2021, Moderna, in collaboration with NIAID and BARDA, announced the 
launch of KidCOVE, a Phase 2/3 study to evaluate the safety and 
efficacy of mRNA-1273 in children ages 6 months to less than 12 years. 
This study is in addition to Moderna's ongoing TeenCOVE study of mRNA-
1273 in adolescents between the ages of 12 and 17. Other vaccine 
developers also have begun, or are planning to begin, trials to test 
their vaccine candidates in children, adolescents, and other special 
populations. On April 23, 2021, NIAID launched an observational study 
at the NIH Clinical Center assessing how people with immune system 
deficiencies or dysregulations respond to COVID-19 vaccination. NIAID 
investigators also will gather information about COVID-19 illness in 
these individuals. This study will inform decision-making about COVID-
19 vaccination in people with immune deficiencies and dysregulation 
conditions.
               Monoclonal Antibodies to Prevent COVID-19
    NIAID scientists, collaborating with Regeneron Pharmaceuticals and 
Eli Lilly and Company, also initiated two Phase 3 clinical trials to 
evaluate whether their investigational monoclonal antibodies, REGEN-COV 
and bamlanivimab alone and in combination with etesevimab 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. These studies have 
completed enrollment and further analysis of the data from the trials 
is ongoing. Due to the sustained increase of SARS-CoV-2 viral variants 
that are resistant to bamlanivimab--when administered alone--the FDA 
revoked the EUA for bamlanivimab alone for the treatment of mild-to-
moderate COVID-19 on April 16, 2021. In light of these concerns of 
variant resistance, the use of bamlanivimab alone is no longer being 
pursued for the prevention of COVID-19. The FDA now includes 
information on the susceptibility of SARS-CoV-2 variants in its fact 
sheets for health care providers for each of the monoclonal antibody 
therapies currently available through an EUA (REGEN-COV and 
bamlanivimab in combination with etesevimab). In separate studies, 
NIAID-supported scientists and collaborators are evaluating the 
potential impact of emerging SARS-CoV-2 variants on the efficacy of 
monoclonal antibodies.
               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 hospitalized COVID-19 patients 
with remdesivir plus interferon beta-1a, which is used to treat 
individuals with multiple sclerosis. ACTT-4, a study assessing 
baricitinib plus remdesivir versus the glucocorticoid dexamethasone 
plus remdesivir in adults hospitalized with COVID-19, has closed to 
enrollment because the study met pre-defined futility criteria.

    NIAID, in collaboration with other NIH Institutes, also launched 
two clinical trials as part of the ACTIV partnership, which utilizes 
master protocols allowing the addition of other investigational 
therapeutics as the trials continue. The two studies, ACTIV-2 and 
ACTIV-3, initially evaluated the use of the monoclonal antibody 
bamlanivimab to treat COVID-19 in outpatient and inpatient settings, 
respectively. ACTIV-2, which is focused on outpatients, has since been 
expanded to evaluate a combination monoclonal antibody therapy, BRII-
196 and BRII-198, as well as four investigational therapeutics: SAB-
185, a fully human polyclonal antibody produced in cattle; SNG001, an 
inhalable beta interferon; AZD7442, an investigational long-acting 
antibody combination; and camostat mesilate, an orally administered 
drug that may block SARS-CoV-2 from entering cells. ACTIV-3 currently 
is evaluating the AZD7442 monoclonal antibody combination in 
hospitalized patients. On April 22, 2021, NIAID and NHLBI launched the 
ACTIV-3 Critical Care study to test Zyesami and remdesivir (alone and 
in combination), for their safety and efficacy in hospitalized COVID-19 
patients who are experiencing acute respiratory distress syndrome, a 
life-threatening condition. Zyesami is a synthetic version of 
vasoactive intestinal peptide, which is made naturally in the human 
body and appears to have lung-protective antiviral and anti-
inflammatory effects.

    On April 13, 2021, NIAID announced the launch of the COVID-19 anti-
CD14 Treatment Trial (CaTT) to evaluate the use of a monoclonal 
antibody known as IC14 in adults hospitalized with COVID-19. IC14 works 
by binding to and blocking a human protein called CD14 that is 
associated with the development of severe inflammatory reactions in 
some COVID-19 patients. In addition, NIAID completed a Phase 3 trial 
called, ``Inpatient Treatment with Anti-Coronavirus Immunoglobulin,'' 
or ITAC, to evaluate hyperimmune intravenous immunoglobulin (IVIG) for 
treatment of COVID-19 in hospitalized adults. The study demonstrated 
that IVIG plus remdesivir was not superior to remdesivir alone.

    NIAID also launched the ACTIV-5/Big Effect Trial (BET), which is 
designed to streamline the identification of experimental COVID-19 
therapeutics that demonstrate the most promise. BET, an adaptive Phase 
2 clinical trial, compares different investigational therapies to a 
common control arm to identify treatments with relatively large effects 
as promising candidates for further study in large-scale trials. BET 
initially is evaluating two therapeutics: risankizumab, an 
immunomodulatory monoclonal antibody developed by Boehringer Ingelheim 
and AbbVie, which is FDA-approved for the treatment of severe plaque 
psoriasis; and lenzilumab, an investigational immunomodulatory 
monoclonal antibody developed by Humanigen.

    The NIH also has established the COVID-19 Treatment Guidelines 
Panel to provide recommendations to health care providers regarding 
specific COVID-19 treatments based on the best available science. The 
Guidelines also address considerations for special populations, 
including pregnant women and children. Each Treatment Guidelines 
section is developed by a working group of Panel members with expertise 
in the area addressed in the specific section; these members conduct 
systematic, comprehensive reviews of relevant information and 
scientific literature. The Panel comprises representatives of NIH and 
five other Federal agencies along with representatives of nine 
professional organizations, academic experts, and treating physicians 
including providers from high COVID-19 incidence areas, and community 
representatives. The Panel meets regularly to evaluate possible 
treatment options for COVID-19 and update the Treatment Guidelines as 
new clinical evidence emerges.
             Responding to Emerging Variants of SARS-CoV-2
    NIAID is fully engaged in efforts to mitigate the potential impact 
of emerging variants of SARS-CoV-2. NIH, including NIAID, participates 
in the HHS-established SARS-CoV-2 Interagency Group, along with CDC, 
FDA, BARDA, the Department of Defense (DOD), and the U.S. Department of 
Agriculture to address the potential impact of emerging variants on 
critical SARS-CoV-2 countermeasures. NIH, CDC, and DOD are assessing 
whether vaccine-induced immunity, or natural immunity from prior 
infection, can be effective in combating the variants. NIH, BARDA, and 
DOD also are determining the efficacy of certain authorized 
therapeutics against emerging variants in cell lines in vitro and in 
animal models.

    NIAID is collaborating with vaccine manufacturers on key areas of 
research to investigate whether vaccines designed for the original 
strain of SARS-CoV-2 can maintain efficacy against emerging variants. 
NIAID also is conducting and supporting comprehensive studies to 
understand the ability of vaccine-induced antibodies to neutralize the 
variant viruses. NIAID researchers have analyzed the immune responses 
of individuals who recovered from COVID-19 prior to the emergence of 
variants and demonstrated that their T cells--a key component of the 
immune response to SARS-CoV-2--also were capable of recognizing the 
three most widespread SARS-CoV-2 variants, B.1.1.7, B.1.351, and P1. 
These findings, published in Open Forum Infectious Diseases, shed new 
light on the role of T cells in the development of immunity to SARS-
CoV-2 and suggest that these cells also may help protect against 
emerging variants of concern. On March 25, 2021, NIAID launched a Phase 
1 clinical trial in healthy adults to assess the safety and 
immunogenicity of second-generation COVID-19 vaccine candidates 
developed by Gritstone Oncology, Inc. Gritstone's COVID-19 vaccine 
candidates utilize a strategy aimed at inducing both neutralizing 
antibodies and T cell responses to elicit a broad immune response. This 
approach could provide protection against emerging SARS-CoV-2 variants 
by targeting several viral antigens, all of which are highly conserved 
among viral strains.

    NIAID also plans to test new vaccine formulations that may protect 
against certain variants that show early indications of reduced 
sensitivity to existing countermeasures. On March 31, 2021, NIAID 
launched a Phase 1 clinical trial of an investigational Moderna vaccine 
based on its FDA-authorized COVID-19 vaccine, designed specifically to 
target the B.1.351 SARS-CoV-2 variant first detected in South Africa. 
NIAID and Moderna are evaluating this vaccine candidate as a 
precautionary measure as we gain more data to confirm that current 
vaccines provide an adequate degree of protection against currently 
circulating SARS-CoV-2 variants.

    NIAID, the National Human Genome Research Institute, and the 
National Library of Medicine are participating in the SARS-CoV-2 
Sequencing for Public Health Emergency Response, Epidemiology, and 
Surveillance (SPHERES) initiative. SPHERES is a national genomics 
consortium led by CDC that helps to coordinate SARS-CoV-2 sequencing 
across the United States. NIAID is working with partners to identify, 
monitor, and calculate the frequency of current variations in the SARS-
CoV-2 genome to help predict emerging variants. NIAID also facilitates 
the use of cutting-edge modeling and structural biology tools to 
understand how variants might affect interactions between the virus and 
the immune system or COVID-19 therapeutics. NIAID scientists are 
helping to inform our understanding of transmissibility of the variants 
by studying their stability in the environment of infected individuals 
and their ability to grow in human lung cells. These efforts add to a 
growing body of knowledge about SARS-CoV-2 variants and our ability to 
combat them.
       Understanding the Immunology and Pathogenesis of COVID-19
    NIH is supporting studies to understand the incidence of SARS-CoV-2 
infection in specific populations, including children, as well as 
certain aspects of the clinical course of infection, including 
thromboses, strokes, heart attacks, and other sequelae of infection. 
NIAID is working with partners to delineate biological and immune 
pathways responsible for the varied manifestations of COVID-19. NIAID 
also will examine the quality and durability of the immune response to 
SARS-CoV-2; this information may be leveraged to develop novel SARS-
CoV-2 therapeutics or vaccines and inform public health measures.

    NIAID, along with FDA, is supporting a National Cancer Institute 
(NCI) effort to determine the sensitivity and specificity of certain 
SARS-CoV-2 serological tests, which can detect antibodies indicative of 
a prior exposure to SARS-CoV-2. NCI and NIAID also are working to 
establish a collaborative network to increase national capacity for 
high-quality serological testing with rapid return-of-results to 
subjects. These efforts include the use of serological testing to 
support clinical trials of convalescent serum and the establishment of 
registries for seroprotection studies. 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 experience continued symptoms or 
other sequelae as they transition from the acute to post-acute phases 
of the disease, and we continue to learn more about the duration and 
manifestations of COVID-19 as we hear from these patients. In December 
2020, NIAID hosted a Workshop on Post-Acute Sequelae of COVID-19 with 
clinicians, immunologists, virologists, and members of the patient 
community to present existing data, identify key knowledge gaps, and 
explore different perspectives on this heterogeneous condition. A 
report from this workshop highlighting the key scientific questions and 
knowledge gaps regarding PASC was recently published in the Annals of 
Internal Medicine. NIH has announced 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 more than 1,200 hospitalized COVID-
19 patients of diverse race and ethnicity at approximately 20 hospitals 
nationwide. The cohort will be followed during hospitalization and up 
to 1 year after discharge to assess their functional and immunologic 
recovery.
                               Conclusion
    NIAID continues to expand efforts to elucidate the biology, 
pathogenesis, and clinical manifestations of SARS-CoV-2 infection, 
including emerging variants, and to employ this knowledge to develop 
safe and effective interventions to diagnose, treat, and prevent SARS-
CoV-2 infection and COVID-19. NIAID is focused on developing safe and 
effective SARS-CoV-2 vaccines and therapeutics and sensitive, specific, 
rapid point-of-care molecular diagnostic and serological tests. NIAID 
also is conducting early stage research on candidate vaccines that 
could protect against multiple strains of coronaviruses. All of 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. 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, thank you for the opportunity to 
testify before you again to describe FDA's continued COVID-19 
response efforts, and particularly our efforts on vaccines.
    First, yesterday evening, the FDA announced the expansion 
of the emergency use authorization for the Pfizer-BioNTech 
COVID-19 vaccine to include adolescents down to age 12 years. 
We know that this is a big step for our Country as vaccinating 
a younger population can bring us closer to a sense of normalcy 
and to ending this pandemic.
    To look at the safety of the vaccine, the FDA evaluated a 
clinical trial of more than 2,000 adolescents age 12 through 
15. Half of the participants received the Pfizer-BioNTech 
vaccine, and half received a saline placebo. The side effects 
experienced by those age 12 through 15 were similar to those 
experienced by individuals age 16 and older.
    To look at effectiveness, the FDA evaluated data about how 
participants' immune systems responded to the vaccine, 
comparing 190 individuals, age 12 through 15, to 170, age 16 
through 25.
    The FDA also evaluated data on cases of COVID-19 among 
adolescents age 12 through 15, 7 days after the second dose of 
vaccine was given. And no cases of COVID-19 occurred among 
1,005 adolescents who received the vaccine, compared to 16 
cases in 978 placebo recipients, thus indicating the vaccine 
was completely effective in preventing COVID-19 in the trial 
that was symptomatic.
    Parents and guardians can rest assured that the Agency 
undertook a rigorous and thorough review of all available 
scientific data, as we have with all of our COVID-19 vaccine 
authorizations, and the CDC's Advisory Committee on 
Immunization Practices will next review the data tomorrow.
    Also, as we announced yesterday, we intend to convene a 
virtual meeting of the Vaccines and Related Biological Advisory 
Committee on June 10, 2021, during which we will provide a 
status update on our approach to emergency use authorization in 
individuals age 12 through 17 years of age. And, we will also 
discuss the data needed to support an emergency use 
authorization and a biologics license application in children 
less than age 12.
    Second, as COVID-19 vaccination expands into adolescents, 
we continue to work diligently with CDC and other partners on 
safety surveillance of the authorized vaccines. We are grateful 
to Congress for the American Rescue Plan funds, which are 
supporting expanded vaccine safety surveillance, among other 
critical priorities. We have seen that our safety surveillance 
systems are doing what they are supposed to do in detecting 
important adverse events.
    Recently, our surveillance systems detected a safety signal 
for rare blood clots and low blood platelets, known as 
thrombosis thrombocytopenia syndrome, with the Janssen or 
Johnson & Johnson COVID-19 vaccine. Following a brief pause 
taken to evaluate the situation and educate providers, based on 
the rare but increased risk of this adverse event, mainly in 
women age 18 through 50 years of age, FDA modified the fact 
sheet for healthcare providers to include a warning pertaining 
to the risk of thrombosis with thrombocytopenia, and the fact 
sheets for recipients and caregivers was also updated.
    We will continue to diligently monitor the safety of all of 
these vaccines.
    Third, the CDC and FDA are working closely together to 
track the emergence and the spread of COVID-19 variants. 
Currently available evidence suggests that the three available 
FDA-authorized vaccines adequately address COVID-19 variants 
circulating in the United States. However, we are working with 
manufacturers and government partners to plan the composition 
of the vaccine so that we can administer booster vaccinations 
if necessary of an appropriate composition.
    Fourth, the FDA recently completed an inspection of 
Emergent BioSolutions, the proposed manufacturing facility for 
the Janssen COVID-19 vaccine. At the close of the inspection of 
Emergent BioSolutions, FDA investigators cited several 
observations concerning whether the facility's practices met 
our regulatory requirements and standards. We are now working 
with Emergent BioSolutions to address the conditions 
identified. It has been made public that no product has been 
released from this facility for use in the United States, and 
we will not agree to the release of any product from this 
facility until we are truly confident that it meets our 
expectations for quality.
    Additionally, moving forward, the Agency is refining how to 
optimally evaluate the manufacturing quality during this and 
any future public health emergency. We are committed to 
maintaining the trust of the public in the vaccines and hope 
that every eligible individual will consider getting vaccinated 
to help end this pandemic.
    Thank you.
    [The prepared statement of Dr. Marks follows:]
                   prepared statement of peter marks
                              Introduction
    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 coronavirus disease 2019 (COVID-19) 
response efforts. All of our efforts are in close coordination and 
collaboration with our partners, both within the Department of Health 
and Human Services (HHS) and across the Federal Government, to help 
ensure the development, authorization, licensure, and availability of 
critical, safe, and effective medical products to address the COVID-19 
public health emergency.

    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 issued 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 the data support the safety and effectiveness of a vaccine and is 
on track for regulatory approval. These vaccines were developed without 
cutting corners or sacrificing our standards. Intensive interactions 
between FDA and manufacturers minimized the time between different 
studies in the clinical development process; allowed seamless movement 
throughout the different phases of clinical trials; and simultaneously 
proceeded with manufacturing scale-up before it was clear whether the 
safety and effectiveness data for a vaccine would support emergency use 
authorization.

    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 effectiveness in 
large, well-designed phase 3 trials and that meet rigorous standards 
for safety and effectiveness to support emergency use authorization. 
Vaccines are helping us in the fight against this pandemic, which has 
claimed almost 600,000 lives here in the United States alone. All the 
COVID-19 vaccines that FDA has authorized for emergency use have far 
surpassed being at least 50 percent more effective than placebo in 
preventing COVID-19, which was recommended in our June 2020 guidance 
document, Development and Licensure of Vaccines to Prevent COVID-19. 
\1\ A vaccine with at least 50 percent efficacy 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 
authorized COVID-19 vaccines. The information includes fact sheets for 
healthcare providers (vaccination providers) and vaccine recipients 
with important information such as dosing instructions; information 
about the benefits and risks of each authorized vaccine; and topical 
Questions and Answers developed by FDA for each authorized vaccine. \2\
---------------------------------------------------------------------------
    \2\  https://www.fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions.

    It is also important to highlight that, as part of each EUA, we are 
requiring the manufacturers and vaccination providers to report serious 
adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and 
cases of COVID-19 that result in hospitalization or death to the 
Vaccine Adverse Event Reporting System (VAERS), a national vaccine 
safety surveillance program jointly run by FDA and the Centers for 
---------------------------------------------------------------------------
Disease Control and Prevention (CDC).

    At this time, data are not available to make a determination about 
how long these authorized vaccines will provide protection, nor are we 
certain that the vaccines prevent transmission of severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) from person to person. 
Additionally, although we do not yet know the full range of SARS-CoV-2 
variants that each of the authorized vaccines will protect against, 
there is evidence that the current vaccines protect against disease 
caused by variants circulating in the United States.

    Finally, manufacturers whose COVID-19 vaccines have been authorized 
for emergency use are expected to continue their clinical trials in 
order to obtain additional safety and effectiveness information and 
pursue licensure (approval) 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 developing these vaccines 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, including vaccines, from early product development to when a 
product application is submitted to FDA for our evaluation of safety 
and effectiveness to support authorization or approval.

    Following approval of a BLA or issuance of an EUA request, the 
Agency uses real-world data to monitor the safety and effectiveness 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 through the Vaccine 
Adverse Event Reporting System (or VAERS). The Agency also performs 
active post-market surveillance of safety and effectiveness of vaccines 
through various data bases, including an FDA partnership with the 
Center for Medicare & Medicaid Services (CMS) to use Medicare data and 
use of the FDA's of BEST (Biologics Evaluation and Safety) 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.

    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 
scientific and regulatory advice, and outline FDA's expectations, the 
Agency issued specific COVID-19 vaccine guidances. In June 2020, FDA 
issued guidance titled Development and Licensure of Vaccines to Prevent 
COVID-19. In October 2020, FDA issued guidance titled Emergency Use 
Authorization for Vaccines to Prevent COVID-19 and updated it in 
February 2021. \3\
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    \3\  https://www.fda.gov/media/142749/download.

    During the COVID-19 public health emergency, FDA is utilizing all 
available tools and sources of information to support regulatory 
decisions on applications or EUA requests that include manufacturing 
sites where FDA's ability to inspect facilities is impacted due to 
COVID-19. During this interim period, we are using additional tools, 
where available, to determine the need for an onsite inspection and to 
support the application assessment, such as reviewing a firm's previous 
compliance history, and requesting records in advance of or in lieu of 
onsite inspections or voluntarily from facilities and sites. Following 
notice by a sponsor of intent to submit an EUA request, FDA will 
continue to work with the sponsor regarding resolution of any necessary 
manufacturing site issues resulting from a site visit or other 
information submitted. FDA will assess current good manufacturing 
practices (CGMP) or CGMP compliance for each manufacturing site using 
all available tools and information.
                 The EUA Process for COVID-19 Vaccines
    A determination by the previous 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 permit 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 may be 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 follow-up 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).

    FDA, CDC, Centers for Medicare & Medicaid Services (CMS), Veteran's 
Health Administration and Department of Defense are conducting post-
authorization safety and effectiveness monitoring in their surveillance 
systems including VAERS, CMS Medicare data, FDA BEST, the CDC Vaccine 
Safety Datalink and others.

    Specific updates about each of the authorized vaccines are provided 
below.
                        Pfizer COVID-19 Vaccine
    As Pfizer announced, FDA received the company's request to amend 
its emergency use authorization (EUA) to expand the authorized age 
range for its COVID-19 vaccine to include individuals 12 through 15 
years of age. Currently, the vaccine is authorized for emergency use to 
prevent COVID-19 in individuals ages 16 and older. While the Agency 
cannot predict how long its evaluation of the data and information will 
take, we will review the request as expeditiously as possible using a 
thorough and science-based approach. Based on an initial evaluation of 
the information submitted, at this time the Agency does not plan to 
hold a meeting of the Vaccines and Related Biological Products Advisory 
Committee (VRBPAC) pertaining to this request to amend the EUA for the 
Pfizer-BioNTech COVID-19 Vaccine. The original EUA request was 
discussed at a VRBPAC meeting in December 2020. The VRBPAC voted in 
favor of the determination that based on the totality of scientific 
evidence available, the benefits of the Pfizer-BioNTech COVID-19 
Vaccine outweigh its risks for use in individuals 16 years of age and 
older. After considering all the evidence, including the VRBPAC's 
advice, FDA issued an EUA for the Pfizer vaccine. As with all FDA-
authorized COVID-19 vaccines, we are committed to transparency with 
this EUA review process.
                        Moderna COVID-19 Vaccine
    On April 1, 2021, FDA announced two revisions regarding the number 
of doses per vial available for the Moderna COVID-19 Vaccine. The first 
revision clarifies the number of doses per vial for the vials that are 
available, in that the maximum number of extractable doses is 11, with 
a range of 10-11 doses. The second revision authorizes the availability 
of an additional multi-dose vial in which each vial contains a maximum 
of 15 doses, with a range of 13-15 doses that can potentially be 
extracted. The type of syringes and needles used to extract each dose 
affect the number of doses that can be extracted from the vials.

    Both of these revisions positively impact the supply of Moderna 
COVID-19 Vaccine, which will help provide more vaccine doses to 
communities and permit more people to be vaccinated. Ultimately, more 
vaccinations administered in a timely manner in the United States and 
around the world should help bring an end to the pandemic more rapidly.

    Depending on the type of syringes and needles used to extract each 
dose, there may not be sufficient volume to extract more than 10 doses 
from the vial containing a maximum of 11 doses or more than 13 doses 
from the vial containing a maximum of 15 doses.

    To support these changes to the EUA, FDA evaluated data showing the 
number of doses that could be extracted from the vials and on the fill 
volumes for both vials that were submitted by ModernaTX, Inc. The Fact 
Sheet for Healthcare Providers Administering Vaccine (Vaccination 
Providers) and Prescribing Information \4\ have been revised to reflect 
the new information and are intended to help frontline workers 
administering COVID-19 vaccines understand the number of doses that can 
potentially be extracted per vial.
---------------------------------------------------------------------------
    \4\  https://www.fda.gov/media/144637/download.
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              Janssen (Johnson & Johnson) COVID-19 Vaccine
    As part of our regulatory processes for reviewing all manufacturing 
facilities, FDA recently completed an inspection of Emergent 
BioSolutions, a proposed manufacturing facility for the Janssen COVID-
19 Vaccine. As Johnson & Johnson announced last month, FDA has not 
authorized this facility to manufacture or distribute any of the 
Janssen COVID-19 Vaccine or components and, to date, no COVID-19 
vaccine manufactured at this plant has been distributed for use in the 
U.S.

    FDA's inspections are thorough, and these assessments review the 
quality of manufacturing procedures, including records, staff training, 
facility operations, drug production and testing, and the systems in 
place to ensure product quality. At the close of the inspection of 
Emergent BioSolutions, FDA investigators cited a number of observations 
concerning whether the facility's practices met our regulatory 
requirements and standards. These observations are outlined in an 
inspection closeout report, also known as an ``FDA Form 483.'' \5\
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    \5\  https://www.fda.gov/media/147762/download.

    Typically, firms respond to the observations cited on an FDA Form 
483, and the Agency then works with a company to help identify a path 
---------------------------------------------------------------------------
forward to remedy the issues.

    Indeed, it is often in the public's best interest that FDA work 
with firms to quickly resolve inspectional observations to ensure that 
the public has access to medical products that meet the Agency's high 
standards for quality, safety, and effectiveness.

    In the case of Emergent BioSolutions, we are working with the 
company to address the conditions identified. At the Agency's request, 
Emergent BioSolutions has agreed to pause new production while it works 
with FDA to resolve potential quality issues. For the vaccines already 
manufactured, the products will undergo additional testing and will be 
thoroughly evaluated to ensure their quality before any potential 
distribution. We will not allow the release of any product until we are 
confident that it meets our expectations for quality.

    We have notified various health authorities regarding the findings 
we observed at the Emergent facility and are providing additional 
information as requested. FDA will continue to work closely with its 
international partners, as it has throughout the pandemic. 
Additionally, moving forward, the Agency is considering how best to 
further evaluate manufacturing quality during this and any future 
public health emergency.

    These manufacturing actions are unrelated to an ongoing evaluation 
by FDA and CDC of clinical reports of blood clots along with low levels 
of platelets that have occurred in some people after receiving the 
Janssen COVID-19 Vaccine, described further below.

    We are committed to ensuring that the COVID-19 vaccines given to 
the people of this Nation have met the Agency's high standards for 
quality, safety, and effectiveness. We know that every time a person, 
including members of our own families, receives a COVID-19 vaccine, 
they are putting their trust in us. We are committed to maintaining 
that trust.
                  COVID-19 Vaccine Safety Surveillance
    On April 13, 2021, FDA and CDC issued a joint statement, announcing 
that, out of more than 6.8 million doses administered as of that date, 
six reports of a rare and severe type of blood clot combined with low 
blood platelet levels occurring in people after receiving the Janssen 
COVID-19 Vaccine had been reported to VAERS. In these cases, a type of 
blood clot called cerebral venous sinus thrombosis (CVST) was seen in 
combination with low levels of blood platelets (thrombocytopenia). All 
six cases occurred among women between the ages of 18 and 48, and 
symptoms occurred 6 to 13 days after vaccination. Treatment of this 
specific type of blood clot is different from the treatment that might 
typically be administered. Usually, an anticoagulant drug called 
heparin is used to treat blood clots. In this circumstance, 
administration of heparin may be dangerous, and alternative treatments 
need to be given.

    Out of an abundance of caution, FDA and CDC recommended a pause in 
the use of the Janssen COVID-19 Vaccine while we investigated reports 
of these serious adverse events. This was important, in part, to help 
ensure that health care providers were made aware of the potential 
occurrence of these adverse events and could plan for proper 
recognition and clinical management due to the unique treatment 
required for thrombosis with thrombocytopenia syndrome.

    FDA and CDC have reviewed all of the available data, and CDC's 
Advisory Committee on Immunization Practices (ACIP) held emergency 
meetings to discuss the data on April 14 and April 23, 2021. Those 
data, plus the deliberations and recommendations of the ACIP, informed 
our assessment that the known and potential benefits of Janssen COVID-
19 Vaccine outweigh its known and potential risks in individuals 18 
years of age and older. We concluded that, at this time, the available 
data suggest that the chance of this serious adverse event occurring is 
very low. Thus, on April 23, 2021, FDA and CDC determined that the 
recommended pause regarding the use of the Janssen COVID-19 Vaccine in 
the U.S. should be lifted and use of the vaccine should resume. 
However, investigation into the level of potential excess risk due to 
COVID-19 vaccination is ongoing.

    The Fact Sheet for Healthcare Providers Administering Vaccine 
(Vaccination Providers) has been updated to include a Warning 
pertaining to the risk of thrombosis with thrombocytopenia. \6\ The 
Fact Sheet for Recipients and Caregivers has also been updated to 
include information about these serious adverse events.
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    \6\  https://www.fda.gov/media/146304/download.
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    FDA and CDC will continue to closely monitor the safety of these 
vaccines. We will continue to closely monitor the safety of the Janssen 
COVID-19 Vaccine.

    The pause in the use of this vaccine was an example of our 
extensive safety monitoring system working as it is designed to work--
identifying even this small number of cases.

    As of May 4, 2021, a total of 23 cases of thrombosis with 
thrombocytopenia following post-authorization use of Janssen COVID-19 
Vaccine were confirmed, involving cerebral venous sinuses and other 
sites in the body. These cases have been associated with three deaths. 
FDA anticipates these numbers will change over time as additional cases 
are reported and investigated.

    FDA continues to inform the public of these cases and has noted 
that a causal relationship with Janssen COVID-19 Vaccine is plausible 
for thrombosis with thrombocytopenia syndrome. 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. The 
outreach also provided information so that they could properly 
clinically 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). Specific risk factors 
for thrombosis with thrombocytopenia after vaccination continue to be 
investigated.

    As noted earlier, CBER is monitoring the safety of all authorized 
COVID-19 vaccines through both passive and active safety surveillance 
systems. CBER is doing so in collaboration with CDC, 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 COVID-19 vaccine manufacturers for authorized vaccines. A 
coordinated and overlapping approach using state-of-the-art 
technologies has been implemented.
                               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.

    Having three vaccines authorized to date that meet FDA's 
expectations for safety and effectiveness only 1 year after the 
declaration of the COVID-19 pandemic is a tremendous achievement and a 
testament to the dedication of developers and FDA's career scientists 
and physicians, many of whom have been working tirelessly to conduct 
comprehensive and rigorous evaluations of the data submitted for 
vaccines to prevent COVID-19. We are highly engaged in ensuring that 
all COVID-19 vaccines meet the high quality that Americans expect and 
deserve and are also actively engaged in ensuring the safety of these 
vaccines following deployment. 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. 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, thank you for the 
invitation to provide an update on our COVID-19 response.
    Allow me to succinctly set out what we are focused on 
today. First, we have delivered to date 330 million doses of 
vaccine in the United States and have administered over 260 
million of them. The most important thing we all need to do is 
to get a vaccine to everyone who wants to be vaccinated in the 
United States.
    The current vaccine supply exceeds demand. Nothing is more 
important than achieving the President's goal of having 70 
percent of adults with at least one shot before--by July 4. The 
long-term fate of many of our communities depends on getting 
people vaccinated.
    There are many reasons why many people have not yet been 
vaccinated. We need to recognize at the core for many is simply 
a fear of the unknown. All the data support the basic 
proposition that these vaccines are safe and effective. Getting 
vaccinated will prevent hospitalization and death.
    Second, the FDA took a significant step yesterday in the 
fight against COVID-19 by expanding the Pfizer EUA to 
adolescents ages 12 to 15. Pending the recommendation of the 
ACIP tomorrow, we plan to offer the Pfizer vaccine to all young 
people ages 12 to 15.
    Right now, the Pfizer vaccine is available at many local 
pharmacies and larger health clinics. We are working to make 
smaller trays available so that the Pfizer vaccine can be 
administered by more pediatricians, family doctors, and rural 
healthcare providers.
    By late fall, we expect to have data on the safety and 
effectiveness of vaccines for children under 12.
    Third, we are planning--and I underscore the word 
planning--to have booster doses available if necessary for the 
American people. Increased age, the natural waning of 
antibodies over time, and new variants all increase the 
probability that booster doses may be needed.
    Fourth, it is absolutely essential that we begin sharing 
doses made in the United States with the rest of the world. 
Supplying other nations with vaccines is not just the right 
thing to do for lifesaving, humanitarian purposes; it is also 
in the best interest of the United States to mitigate the risk 
of viral evolution.
    Fifth, we need to hasten our search for an antiviral. I am 
concerned that even after we finish vaccinating most of the 
people who want to be vaccinated by this summer, there will 
still be a significant number of cases and an unacceptable 
number of deaths. People who are immunosuppressed, who do not 
mount an immune response for a number of reasons, or choose not 
to be vaccinated will continue to be vulnerable, and we need 
options for them. The antibody treatments are one approach, but 
a simple oral antiviral can add to our armamentarium to bring 
this epidemic under control.
    Last, we need to build a program for vaccine preparedness 
for future pandemics. This will need to be done in partnership 
with the private sector and build on all the lessons we have 
learned to date.
    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 kessler
                              Introduction
    Chair Murray, Ranking Member Burr, and 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. Thank you 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 that have met our standards for safety and effectiveness and 
are authorized for the prevention of COVID-19. 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. I am 
pleased to report that more than 83 percent of people over the age of 
65 have received at least one dose and over 70 percent of them are 
fully vaccinated. As of April 19, 2021, every person aged 16 and over 
in every state and territory is now eligible to get vaccinated. The 
country has exceeded President Biden's goal of administering 200 
million shots in the first 100 days of his Administration.

    We are carefully monitoring the supply chain, raw materials and our 
manufacturing capacity for vaccines. I am pleased to report that our 
supply remains strong as we work toward achieving President Biden's 
goal of having 70 percent of adult Americans with at least one shot and 
160 million Americans fully vaccinated by July 4.

    We have provided Federal support and Federal personnel for over 
1,800 community vaccination centers and mobile sites across the 
country. 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. Today 90 percent of all Americans have a vaccination 
site within 5 miles of where they live. 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 just 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.

    I want to stress how important it is that our fellow citizens get 
vaccinated and that we help ease the minds of those who are considering 
getting vaccinated. We need to confront the reality of vaccine 
hesitancy. I have focused my career on studying drug safety. We can 
help people overcome their concerns about vaccines by being transparent 
with them about the safety of these products. When it comes to the mRNA 
vaccines, real world data show that they are more than 90 percent 
effective in preventing infection two or more weeks after the second 
dose, and that these vaccines have to date an excellent safety profile.

    I also want to emphasize that we are committed to helping other 
countries fight COVID-19, most recently India. We delivered 20,000 
treatment courses of the antiviral drug remdesivir to India to help 
treat hospitalized patients. We have redirected the United States' own 
order of AstraZeneca vaccine manufacturing supplies to India. This will 
allow India to make over 20 million doses of COVID-19 vaccine. We are 
also delivering critical supplies to help provide oxygen to patients 
and additional personal protective equipment for healthcare workers. 
Supplying other nations with vaccines and personal protective equipment 
(PPE) is not just the right thing to do for life-saving humanitarian 
purposes, it is also in the best interests of the United States to 
mitigate the risk of viral evolution. The best way to stop new variants 
from emerging is to prevent outbreaks that allow mutations to occur.

    Today, I want to provide updates on three topics that we know are 
vitally important to the overall effort to bring COVID-19 under control 
in America.

    First, we are developing plans to provide booster doses to 
Americans, if determined to be necessary later this year. We know that 
neutralizing antibodies persist for some time after the second dose of 
an mRNA vaccine, with a relatively slow decline over time. We are 
supporting research to determine who would benefit from booster doses 
and when these should be administered. We expect to have more 
information this summer about the potential benefits that a booster 
dose could provide, as well as the process and timing for regulatory 
review of these vaccines. We are also supporting research to evaluate 
the use of different combinations of booster doses, so that a person's 
booster dose might be from a different manufacturer than that person's 
initial vaccine regimen. As part of our plans, we will carefully 
evaluate whether we might need doses that are modified to address 
variants. As these efforts progress, we will work with manufacturers to 
make those doses available, as needed, to continue to protect Americans 
from COVID-19.

    Second, if the Food and Drug Administration (FDA) authorizes 
vaccines for adolescents between the ages of 12 and 15, we will make 
sure those adolescents have access. After a careful review of the data 
by FDA and the Centers for Disease Control and Prevention's (CDC's) 
Advisory Committee on Immunization Practices (ACIP), we plan to have 
about 20,000 pharmacy sites across the country ready to vaccinate 
adolescents. We will also work to get vaccines into the offices of 
pediatricians and family physicians so that parents and their children 
can talk to their doctor about vaccines and have an option of receiving 
their dose from a trusted provider.

    Finally, I want to talk about our work on therapeutics. Taking a 
whole of government approach, we have worked to accelerate the clinical 
development and manufacturing scale-up of therapeutic candidates most 
likely to have a broad public health impact to complement the vaccine 
effort, with successful therapies at sufficient quantities. There are 
two monoclonal antibody (mAb) treatments with emergency Use 
authorization (EUAs) currently available, Regeneron's cocktail 
(casirivimab and imdevimab) and Eli Lilly's combination treatment 
(bamlanivimab + etesevimab). We have procured almost 3 million 
monoclonal antibody doses that are being provided to the US healthcare 
system at no cost, with approximately 980,000 total doses shipped to 
5956 (suggest--almost 6000) provider sites. As of April, mAbs were 
being administered to approximately 1 out of 5 eligible high-risk 
patients. We continue to support efforts to increase awareness of 
treatments and expand infusionsites and services to help ensure fair 
and equitable administration of mAbs.

    Our efforts are also focused on the research and development of 
antiviral drugs, particularly small molecule oral antivirals to treat 
individuals who are not vaccinated or who might become infected after 
vaccination. These drugs could also help patients in the event of 
rapidly emerging variant strains. Monoclonal antibodies and other drugs 
in development target those at high risk of severe disease, but a safe 
and effective oral drug that demonstrates an endpoint of symptom 
resolution would be an important treatment option for Americans. We are 
committed to supporting research and development of antivirals for 
COVID-19.

    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 to all of our witnesses for being here 
today and your testimony.
    We will now begin a round of 5-minute questions of our 
witnesses, and I ask our colleagues to keep track of your clock 
and stay within those 5 minutes. We do have votes starting at 
11:30 today.
    Dr. Fauci, I am going to start with you. The surge of 
COVID-19 that is devastating India is a painful reminder, 
really, that we cannot end the pandemic here until we end it 
everywhere. And I am glad the Biden administration is leading 
that global fight by rejoining the World Health Organization 
and funding global vaccine efforts and committing to donate 60 
million AstraZeneca vaccines to other countries by July 4th. 
India's outbreak really underscores the need for a robust 
public health infrastructure in the U.S. to respond 
appropriately to this pandemic and future outbreaks, as well.
    I wanted to ask you today, Dr. Fauci, what can we learn 
from India's outbreak that we should apply to our response here 
in the U.S.?
    Dr. Fauci. Well, I think one of the important things is do 
not ever underestimate the situation. You know, the reason that 
India is in such dire straits now is that they had an original 
surge and made the incorrect assumption that they were finished 
with it. And what happened, they opened up prematurely and wind 
up having a surge right now that we are all very well aware of 
is extremely devastating. That is the first thing.
    The second thing is preparedness with regard to public 
health preparedness, which we, as a lesson learned for future 
pandemics, have to realize that we need to continue to buildup 
our local public health infrastructure. Which, over the last 
decades, we have let actually, in many respects, go into 
disarray, likely because of our successes in controlling so 
many diseases.
    The other lesson that is learned, Madam Chair, is that this 
is a global pandemic that requires a global response. And, we 
need to pay attention to the responsibility that we have, not 
only for our own Country, but to join with other countries to 
make sure that we have the access to interventions, 
particularly vaccines, throughout the world because if it 
continues to have dynamics of virus anywhere in the world, we 
have a threat here in the United States, particularly with 
variants. And, there is one variant in India that is also a new 
variant, number 617B617.
    Those are just a few of the lessons that I believe we can 
take from what is going on in India. Thank you.
    The Chair. Thank you.
    Dr. Marks, I am really encouraged by how the FDA has worked 
both quickly and carefully to get multiple COVID vaccines 
authorized. But, having said that, I am very concerned about 
the reports involving Emergent BioSolutions. You mentioned it 
in your remarks. It is a contractor that received $628 million 
to manufacture COVID vaccines, and I wanted to ask you to 
explain FDA's recent findings. Because after receiving reports 
of cross-contamination with another vaccine, FDA inspected the 
Emergent facility, as you said, and asked the contractor to 
pause manufacturing, and the cross-contaminated vaccine was not 
distributed for any use.
    But, Dr. Marks, what steps is FDA taking to make sure the 
quality, safety, and effectiveness of all COVID-19 vaccines?
    Dr. Marks. Chair Murray, thank you for that question. So, 
we are currently, for the Emergent facility, we are actively 
working with all of the parties involved to ensure that the 
facility's deficiencies are all remediated so that before they 
actually are able to release vaccine, it meets all of our 
quality standards that Americans deserve from vaccines.
    Also, as we move on to other facilities that may be 
producing vaccines, we will take the approach of using all of 
our inspectional tools to ensure that the quality of those is 
the highest nature. And, as with all of our biologics license 
applications, we, for the--generally, will be performing onsite 
inspections of those facilities to ensure the quality of those 
products.
    The Chair. Thank you. And I am really deeply concerned 
about what happened, and my expectation is in the future, 
nothing like that happens again.
    Dr. Walensky, in my last minute here, let me just ask you. 
The CDC says that while fewer children have been sick with 
COVID-19 compared to adults, children can be infected, get 
sick, and spread the virus. With the authorization of Pfizer 
yesterday for children 12 to 15, what would you say to parents 
who are considering getting their kids vaccinated now?
    Dr. Walensky. I would encourage all parents to get their 
children vaccinated. I know many parents are enthusiastic and 
have been texting me, cannot wait to get their children 
vaccinated. I recognize that there--some parents want to sort 
of see how it goes first. But, I am encouraging all parents to 
get their children vaccinated. Some parents will not want to be 
first.
    But, I am also encouraging children to ask for the vaccine. 
I have a 16-year old myself, and I can tell you he wanted to 
get the vaccine. He wants his life back. These kids want to go 
back to school. They want to go back to the things they love.
    The Chair. Thank you.
    Senator Burr.
    Senator Burr. Thank you, Chair.
    Dr. Kessler, we have shipped 2.7 million doses of 
AstraZeneca, I think, to Mexico. That is the only country we 
have shipped to. We have additional doses of AstraZeneca in 
inventory in this Country. We talked about July 4th exporting 
more. Why have we not taken the AstraZeneca, which is not 
approved for vaccination in the United States, why have we not 
mobilized that to other countries of the world today?
    Dr. Kessler. Senator, it is a very important question. We 
have shipped a total of four million doses to date, including 
to Mexico, and I believe 1.5 to Canada. We are ready to ship up 
to 60 million doses of AstraZeneca. But, as the Chair pointed 
out, and as my colleague, Dr. Marks, responded, there are 
issues with Emergent that are under review by the Food and Drug 
Administration. If and when those issues are resolved and we 
can say that these are quality doses, we will do just as you 
say.
    Senator Burr. Correct me if I am wrong. I did not think the 
Emergent Baltimore facility had anything to do with AstraZeneca 
production. Am I wrong, Dr. Marks?
    Dr. Marks. Senator Burr, no. The AstraZeneca vaccine was 
being produced in that facility, and the FDA feels it is 
imperative that before vaccine can be shipped to any other 
partner, it has to meet the quality standards that it would 
meet for any American, as well.
    Senator Burr. How long do you anticipate that testing the 
AstraZeneca vaccine that is currently manufactured would take 
to verify?
    Dr. Marks. We are working on that as quickly as we can. We 
understand the imperative here. There is a working group across 
our Office of Regulatory Affairs and our center and others at 
FDA that are working together to try to clear that--those doses 
as quickly as we can. I cannot give you an exact time, but we 
understand the imperative to be able to have them available so 
that Dr. Kessler can arrange for them to be shipped to those in 
need.
    Senator Burr. Okay. Dr. Kessler, one of the reasons we are 
as successful today is that partnerships have been leveraging 
vaccinations around the world, and over 275 partnerships have 
been created to scale up vaccine production and manufacturing.
    I guess I am asking you this. If we waive intellectual 
property in the United States, do we not stand the risk of 
affecting innovation in the future when, if we did it to scale 
up manufacturing capacity, the private sector has done that 
through partnerships already and that is the reason that we 
have been so successful? Should we not let the private sector 
continue to do something that--I think Dr. Fauci and I have 
said in the past, we never anticipated this. This is novel that 
they would have the relationship to do it. Why mess with a good 
thing?
    Dr. Kessler. I applaud the actions of the pharmaceutical 
industry. Senator, this is a once-in-a-century pandemic. I 
think we all recognize that extraordinary circumstances call 
for extraordinary measures. We know--and I agree with you, 
Senator--that a waiver alone will not result in the scale and 
speed we need to make enough vaccines to end the pandemic. That 
is why we will continue to ramp up our efforts working with the 
private sector and all possible partners to expand vaccine 
manufacturing and distribution around that, around the world. I 
mean, our job is to do, as you say, to increase that supply. 
That is what we are focused on. We want to make vaccines 
available to the world.
    Senator Burr. David, here is the reality. When Pfizer went 
to open up its Kansas plant to produce vaccine, it took them, I 
believe, 7 months to retool and to get everything done. This 
belief that you can export intellectual property and you are 
going to have a standup around the world instantaneously of 
vaccine production is a joke. Dr. Marks has already expressed 
concern over the backlogs for inspections and how long would it 
take for us to inspect foreign sites, if in fact there was a 
vaccine pool that found its way in and out of the United 
States.
    Let me just get this before my time runs out. Can anybody 
give me the number? There has been 33 million Americans 
infected with COVID that have actually tested positive. How 
many of that 33 million have then been vaccinated? Does anybody 
know what that number is?
    [Brief silence.]
    Senator Burr. Here is why I make the point, and here is why 
I think it is relevant. If we are looking at a certain number 
that we do not know exactly what it is, Dr. Fauci, that we want 
to get to, and we have vaccinated 115 million, it is important 
for us to know, of the counted vaccine number, how many of 
those already had protection because they were COVID-positive.
    If we are trying to reach a number--when the President says 
70 percent vaccination, if we get to 65 vaccinated and 5 
percent got COVID and they had protection, is that not like 
being at 70?
    I think one of the problems that--the goal post continues 
to be too far. And we now have the harder part of how do we 
take the 40 percent that are not real comfortable with getting 
vaccinated and at least have a shot at vaccinating 50 percent 
of that 40 percent. And, it may be that our number is higher 
today on the protected. I know it is. I do not think 33 million 
have all been vaccinated that were positive, but I think it is 
absolutely crucial that we figure out what that number is. I am 
not sure whose responsibility it is that we figure out what 
that number is and put that into our formula of how many 
Americans have protections.
    I thank the chair.
    The Chair. Thank you, Senator Burr.
    Senator Casey.
    Senator Casey. Chair Murray, thank you very much. And I 
want to thank our guests, Dr. Fauci, Dr. Kessler, Dr. Marks, 
and Dr. Walensky. I think I will have at least one question for 
Dr. Walensky and one for Dr. Marks.
    I am going to start with you, Dr. Walensky. I want to thank 
you for your leadership and the leadership of the CDC and your 
efforts to ensure that children and adolescents are up to date 
on vaccinations, particularly as students return to in-person 
learning.
    You and others have noted, there are over 11 million doses 
through the Vaccines for Children Program that have been 
missed. These missed doses could seriously and negatively 
impact efforts to protect children, their families, and 
communities from vaccine-preventable diseases and conditions. 
Of course, we are talking here about diseases other than COVID-
19.
    At the same time, with 12 to 15 year olds now able to get 
vaccinated against COVID-19, there is an even greater need to 
ensure parents are aware of all the vaccines, all the vaccines 
that children should receive in order to remain healthy. The 
Rescue Plan contains funding to build vaccine confidence, and 
specifically includes provisions to ensure funding is allocated 
toward increasing vaccination rates throughout the U.S.
    Here is the question, Doctor. In addition to the public 
awareness efforts that you and CDC have already undertaken, 
will the CDC be releasing the funding to both states and 
communities to ensure that children and adolescents are caught 
up on both routine and recommended vaccinations, particularly 
as children return to in-person learning?
    Dr. Walensky. Thank you, Senator, for that. You raise an 
issue that is near and dear to my heart and I am very worried 
about. More than 20 percent of our measles vaccines were not 
used this year. We have the same issue with meningococcal 
vaccines, and especially among our adolescents.
    Unfortunately, we actually do not have data on whether we 
can co-administer the COVID-19 vaccine and other routine 
immunizations and whether we get the same protection from the 
COVID-19 vaccines and the routine administration of other 
immunizations. That is one issue that the experts at ACIP are 
going to address tomorrow as to whether that can safely be done 
and that we could potentially get adequate protection.
    You are right. We need to, as we are putting forward these 
efforts in vaccine confidence for the COVID-19 vaccine, we need 
to take this outreach and make sure that we are breaching these 
communities and not only conveying the importance of getting 
the COVID-19 vaccine, but, if we are not able to co-administer 
them, to make sure we get back to these children and be able to 
administer the routine vaccines that they have lost before the 
school year.
    Senator Casey. In terms of the funding, though, that will 
be released? Do you have any sense of the timing of that?
    Dr. Walensky. I do not, but we can get back to you.
    Senator Casey. Okay. Thank you.
    Dr. Marks, I wanted to start with you regarding Pfizer. We 
have heard a lot this year about emergency use authorization, 
and we know that Pfizer has recently filed their application 
for full licensure of their COVID-19 vaccine. I think we get a 
lot of questions at home on a range of these issues, and, in 
particular, what does it mean? What does it mean? What does 
full licensure mean? One of the concerns that we have heard a 
lot about as the vaccines are provided, this emergency use 
authorization, but what is the next step for a vaccine? Can you 
explain what it means to get full licensure? That is question 
No. 1.
    Second, what additional information would a company need to 
submit beyond what was required just for so-called EUA?
    Dr. Marks. Senator, thanks very much for that question. The 
full licensure is something that a manufacturer submits with a 
full data package, which I will go into in a moment.
    But, I just want to go back to pick up on something that 
Dr. Fauci said. These COVID-19 vaccines, they were expedited 
not by cutting corners, but by going through a development plan 
in which kind of empty space, space that would have been 
normally just not stuff happening, was taken away. So, 
manufacturing was done while the clinical trials were done.
    The large clinical trial programs were of the size of 
normally licensed vaccines in the United States. The one place 
where we are a little bit short was the duration of safety 
follow-up. But, we are very confident from the amount of safety 
follow-up, at least a meeting of 2 months safety follow-up on 
this safety data set for the emergency use authorization, that 
the large majority of adverse events became apparent. So, we 
are very confident in recommending these vaccines for 
everyone--our families, all Americans.
    The difference that will happen with the biologics license 
application is that the manufacturers will be able to submit 
additional safety data, perhaps 6 months of safety data rather 
than just the median 2 months safety data. And, additionally, 
there are some technical things that will be there that many 
people may not care a lot about, but we do. That is, 
manufacturing conformance lots, the formal facilities 
inspections will occur, and additional ancillary studies will 
be put in that package.
    I think the main message to the American public is that for 
all intents and purposes, the vaccine that is being used is 
very close to what we would normally have in a biologics 
license application. There are some little things around the 
margins that will go into the biologics license application 
when we have a formal approval.
    Senator Casey. Thank you.
    Thank you, Chair Murray.
    The Chair. Senator Paul.
    Senator Paul. Dr. Fauci, we do not know whether the 
pandemic started in a lab in Wuhan or evolved naturally, but we 
should want to know. Three million people have died from this 
pandemic, and that should cause us to explore all 
possibilities.
    Instead, government authorities, self-interested in 
continuing gain-of-function research, say there is nothing to 
see here. Gain-of-function research, as is juicing up naturally 
occurring animal viruses to infect humans.
    To arrive at the truth, the U.S. Government should admit 
that the Wuhan Virology Institute was experimenting to enhance 
the coronavirus' ability to infect humans. Juicing up super 
viruses is not new. Scientists in the U.S. have long known how 
to mutate animal viruses to infect humans.
    For years, Dr. Ralph Baric, a virologist in the U.S., has 
been collaborating with Dr. Shi Zhengli of the Wuhan Virology 
Institute, sharing his discoveries about how to create super 
viruses. This gain-of-function research has been funded by the 
NIH. The collaboration between the U.S. and the Wuhan Virology 
Institute continues. Doctor Baric and Shi worked together to 
insert bat virus spike protein into the backbone of the deadly 
SARS virus and then used this manmade super virus to infect 
human airway cells.
    Think about that for a moment. The SARS virus had a 15 
percent mortality. We are fighting a pandemic that has about a 
1 percent mortality. Can you imagine if a SARS virus that has 
been juiced up and had viral proteins added to it, to the spike 
protein, if that were released accidentally?
    Dr. Fauci, do you still support funding of the--NIH funding 
of the lab in Wuhan?
    Dr. Fauci. Senator Paul, with all due respect, you are 
entirely and completely incorrect that the NIH has not ever and 
does not now fund gain-of-function research in the Wuhan 
Institute of Virology.
    Senator Paul. Do they fund Dr. Baric?
    Dr. Fauci. We do not fund gain----
    Senator Paul. Do you fund Dr. Baric's gain-of-function 
research?
    Dr. Fauci. Dr. Baric is not doing gain-of-function 
research. And, if it is, it is according to the guidelines, and 
it is being conducted in North Carolina, not----
    Senator Paul. You do not think----
    Dr. Fauci [continuing]. In China.
    Senator Paul [continuing]. Inserting a bad virus spike 
protein that he got from the Wuhan Institute into the SARS 
virus is gain-of-function?
    Dr. Fauci. That is not----
    Senator Paul. You would be in the minority because at least 
200 scientists have signed a statement from the Cambridge 
Working Group----
    Dr. Fauci. Yes.
    Senator Paul [continuing]. Saying that it is gain-of-
function.
    Dr. Fauci. Well, it is not. And, if you look at the grant 
and you look at the progress reports, it is not gain-of-
function, despite the fact that people Tweet that and----
    Senator Paul. Do you still----
    Dr. Fauci [continuing]. Write about it.
    Senator Paul [continuing]. Support sending money to the 
Wuhan Virology Institute?
    Dr. Fauci. We do not send money now to the Wuhan----
    Senator Paul. Do you support----
    Dr. Fauci [continuing]. Virology Institute.
    Senator Paul [continuing]. Sending money? We did, under 
your tutelage. We were sending it through EcoHealth. It was a 
sub-agency and a sub-grant. Do you support that the money from 
NIH that was going to the Wuhan Institute?
    Dr. Fauci. Let me explain to you why that was done. The 
SARS-CoV-1 originated in bats in China. It would have been 
irresponsible of us if we did not investigate the bat viruses 
and the serology to see who might have been----
    Senator Paul. Or perhaps it----
    Dr. Fauci [continuing]. Infected in China.
    Senator Paul [continuing]. Would be irresponsible to send 
it to the Chinese government that we may not be able to trust 
with this knowledge and with these incredibly dangerous 
viruses.
    Government scientists, like yourself, who favor gain-of-
function research----
    Dr. Fauci. I do not favor----
    Senator Paul [continuing]. Maintain----
    Dr. Fauci [continuing]. Gain-of-function research in China.
    Senator Paul [continuing]. That the disease arose 
naturally.
    Dr. Fauci. You are saying things that are not correct.
    Senator Paul. Government defenders of gain-of-function, 
such as yourself, say that COVID-19 mutations were random and 
not designed by man. But, interestingly, the technique that Dr. 
Baric developed forces mutations by serial passage through cell 
culture that the mutations appear to be natural. In fact, Dr. 
Baric named the technique the no-see-um technique because the 
mutations appear naturally.
    Nicholas Baker of the New York Magazine said nobody would 
know if the virus had been fabricated in a laboratory or grown 
in nature. Government authorities in the U.S., including 
yourself, unequivocally deny that COVID-19 could have escaped a 
lab. But, even Dr. Shi in Wuhan was not so sure.
    According to Nicholas Baker, Dr. Shi wondered, could this 
new virus have come from her own laboratory? She checked her 
records frantically and found no matches.
    That really took a load off my mind, she said. I had not 
slept for days.
    The director of the gain-of-function research in Wuhan 
could not sleep because she was terrified that it might be in 
her lab.
    Dr. Baric, an advocate of gain-of-function research, admits 
the main problem that the Institute of Virology has is the 
outbreak occurred in close proximity. What are the odds, Baric 
responded.
    Could you rule out a laboratory escape? The answer in this 
case is probably not.
    Will you, in front of this group, categorically say that 
the COVID-19 could not have occurred through serial passage in 
a laboratory?
    Dr. Fauci. I do not have any accounting of what the Chinese 
may have done, and I am fully in favor of any further 
investigation of what went on in China.
    However, I will repeat again, the NIH and NIAID 
categorically has not funded gain-of-function research to be 
conducted in the Wuhan Institute of Virology.
    Senator Paul. You do support it in the U.S. We have 11 labs 
doing it, and you have allowed it here. We have a committee to 
do it, but the committee is granted every exemption. You are 
fooling with Mother Nature here. You are allowing super viruses 
to be created with a 15 percent mortality. It is very dangerous 
and it was a huge mistake to share this with China, and it is a 
huge mistake to allow this to continue in the United States. 
And, we should be very careful to investigate where this virus 
came from.
    Dr. Fauci. I fully agree that you should investigate where 
the virus came from. But, again, we have not funded gain-of-
function research on this virus in the Wuhan Institute of 
Virology. No matter----
    Senator Paul. You are parsing words.
    Dr. Fauci [continuing]. How many times you say it, it did 
not happen.
    Senator Paul. There was research done with Dr. Shi and Dr. 
Baric. They have collaborated on gain-of-function research 
where they enhanced the SARS virus to infect human airway 
cells, and they did it by merging a new spike protein on it. 
That is gain-of-function. That was joint research between the 
Wuhan Institute and Dr. Baric. You cannot deny it.
    The Chair. Senator Paul, your time is expired.
    Dr. Fauci, I will let you respond to that. We need to move 
on.
    Dr. Fauci. Excuse me?
    The Chair. I will allow you to respond to that, and then we 
will move on.
    Dr. Fauci. Yes. I mean, I just wanted to say, we--I do not 
know how many times I can say it, Madam Chair. We did not fund 
gain-of-function research to be conducted in the Wuhan 
Institute of Virology.
    The Chair. Thank you.
    Senator Smith.
    Senator Smith. Thank you, Chair Murray. And thank you so 
much to our panelists for being here today.
    I want to just, following up on that exchange, just ask Dr. 
Fauci a question.
    Dr. Fauci, what is the impact of conspiracy theories 
pedaled by Senator Rand Paul and others on Americans' 
willingness to take this vaccine? A vaccine that, by all 
accounts, is remarkable for its safety and efficacy.
    Dr. Fauci. Well, conspiracy theories certainly are not 
helpful in what we are trying to do. I guess I can say that 
with some degree of confidence.
    Senator Smith. Well, I would agree. And I think, in this 
moment we are at a critical moment for our response to this 
pandemic. And, in only 14 months since we--this pandemic 
started, we are here today to acknowledge that we have 261 
million doses of vaccine in people's arms. We have over 58 
percent of Americans with at least one dose. I mean, this is an 
incredible and--an incredible accomplishment.
    We also know that we have more work to do, and it seems to 
me that we ought to be focused on that work. We have to make 
sure that our comprehensive strategy that you have been working 
on, Dr. Fauci, for a long time, and I am so grateful for the 
support that you are getting from the Biden-Harris 
administration. A comprehensive strategy that is around 
vaccinations, around surveillance testing, around treatment, 
social distancing and masks, and also centering our work around 
health equity. I mean, this is what we need to be really 
focused on, seems to me.
    I would like to ask Dr. Walensky a question about how we go 
about this question on this issue of getting people--getting 
vaccines into people's arms now.
    Vaccines--an acceptance of vaccines seem to be really a 
spectrum, from people that are gung-ho and ready to go to 
people who have a serious resistance to taking vaccines. And, 
we are seeing some learning, it seems to me, about what works.
    I have a great example of that in Duluth, Minnesota where 
public health nurses set up a pop-up vaccine clinic at the 
Duluth Transportation Center. And, Minnesotans, who were taking 
their bus home or going to pick up their children at childcare 
can go to that vaccine pop-up clinic, fill out their paperwork, 
and get their shot, all in one dose. So, it is breaking down 
some of the logistical challenges that a lot of Americans and 
Minnesotans still have, and they are finding just great 
success.
    There was a story on Minnesota Public Radio just in the 
last couple of days about a woman named Karen Moore, who was 
waiting to get a vaccine and hoping that she would be able to 
get it at a convenient location, and was able to do it all in 
one spot. And that made all the difference in the world to her 
in terms of overcoming her so-called vaccine hesitancy, which 
was not hesitancy. It was just the logistics challenges.
    Dr. Walensky, can you tell us a little bit about what the 
CDC is doing, working with states and localities, to deploy 
methods like we are seeing in Duluth, Minnesota to help people 
get easy access to vaccines?
    Dr. Walensky. Thank you so much, Senator. We have spent $3 
billion getting money to states and localities to advance these 
efforts in trying to get vaccines into people and to enrich 
vaccine confidence.
    I would invite all of you to take out your cell phones and 
to text GETVAX, 438829. You put in your zip code. You get a 
list of all the places where vaccines are available to you. You 
can do that by an 800 number, or you can go to vaccines.gov and 
type your zip code and find out which vaccines are available 
nearby to you.
    We are trying to make it--we are working to make it easy. 
We do have to do some of the pivoting, as you discussed, and 
ensure that----
    Places now have pop-up sites. They have mobile vaccination 
units; that we are reaching out to rural communities; that we 
are putting vaccines in federally qualified healthcare centers; 
that we have a We Can Do This campaign now, a campaign with 
5,000 community core members from everyone from NASCAR and NFL 
to Infectious Disease Society of America, to faith-based 
organizations, sending our messages, being the trusted 
messengers. And we are starting to see the effects of this 
work.
    Just this morning, CDC released new racial and equity data 
on how we are doing in reaching racial and ethnic minorities 
with vaccines. The bar graph now shows not just our overall 
progress, but what we have done in the last 2 weeks. And, in 
the last 2 weeks, we have been really successful in reaching 
racial and ethnic minorities in ways we had not up until this 
time.
    We have to do more. We recognize we have to do more. We 
have vaccine confidence consults that you can--locals and 
states can call the CDC and say, we are having a hard time 
reaching people in this community, what are the things that we 
can do.
    This is just a brief list of the many, many activities that 
we are engaged with every single day to get vaccines into 
people for--and to recognize that all hesitancy is not the same 
flavor. Some people, it is convenience. Some people want to 
understand the science more. Some people just need the time 
off.
    Senator Smith. Thank you so much.
    Thank you, Madam Chair. I want to just say I appreciate the 
work of the CDC and others to support the innovative and 
strategic efforts of states like mine to overcome some of those 
barriers. Thank you.
    Dr. Walensky. Thank you so much, Senator.
    The Chair. Senator Collins.
    Senator Collins. Thank you.
    Dr. Walensky, I used to have the utmost respect for the 
guidance from the CDC. I always considered the CDC to be the 
gold standard. I do not anymore, and I want to give you three 
examples where I think the conflicting, confusing guidance from 
your agency has undermined public confidence and contradicts 
the scientific guidance of many experts.
    The first has to do with school openings, an issue that we 
have talked about before. The New York Post reported that a 
powerful teachers' union, the AFT, successfully secured 
changes, verbatim, in draft guidance on school reopenings. This 
came about because of an outside group that did a FOIA request 
that revealed extensive interactions between the AFT and the 
CDC.
    This has been described by Dr. Monica Gandhi, a professor 
who has written extensively about the coronavirus, as very, 
very troubling. She is referring to the emails back and forth 
between the CDC and the AFT. And, she says, this is not how 
science-based guidance should work or be put together.
    My second example is from a New York Times story that 
appeared today. It talks about CDC guidelines on mask wearing, 
and it--where the CDC announced that less than 10 percent of 
COVID-19 transmission was occurring outdoors. The article 
points out that this is, quote, almost certainly misleading, 
and goes on to say, there is not a single documented COVID 
infection anywhere in the world from casual outdoor 
interactions, such as walking paths, someone on a street, or 
eating at a nearby table.
    The third example has to do with new guidance the CDC has 
issued for summer camps, and here are the reactions of two 
experts. One, a pediatric immunologist at Columbia referred to 
the recommendations as, quote, senseless. The editor-in-chief 
of the Journal of the American Medical Association Pediatrics 
called the guidance, quote, unfairly draconian.
    Here we have unnecessary barriers to reopening schools, 
exaggerating the risks of outdoor transmission, and unworkable 
restrictions on summer camps. Why does this matter? It matters 
because it undermines public confidence in your 
recommendations, in the recommendations that do make sense, in 
the recommendations that Americans should be following.
    I would like you to respond to why the CDC is not following 
the standard procedures, why it is having offline, secret 
negotiations with one stakeholder that was revealed only 
through reporting in a FOIA request, why it is exaggerating 
outdoor transmission. We know that masks make a big difference 
indoors. They do not outdoors.
    Dr. Walensky. Thank you for that question. Maybe if I could 
take each of your examples one by one.
    First, the school guidance. As a matter of practice, the 
CDC engages with stakeholders, with consumers who take our 
guidance, who use our guidance, before it is finalized so we 
can understand whether it addresses their needs. For our school 
guidance, we did that with 50 different stakeholders. Over 50, 
actually. I personally engaged with both parents and teachers 
and many different stakeholders to address what could be done 
to improve the draft guidance we had.
    One of those stakeholders recognized that in our guidance 
we had addressed what you do if you have immunocompromised 
children at risk of severe disease, but we had neglected in our 
draft to address what happens if you have immunocompromised 
teachers--teachers who are getting chemotherapy, who have 
immunocompromising diseases.
    The request was that we add some language for what happens 
if you have immunocompromised teachers and how they should 
behave in school. That is what we did. We used CDC-based 
science to make that addition, but the request was to address 
what happens if you have immunocompromised teachers. And that 
was an oversight in our initial draft, and we included a 
science-based response--or science-based language in our 
guidance.
    With regard to the New York Times piece this morning, there 
is a meta-analysis from Journal of Infectious Diseases that was 
published in November, I believe, where the topline result of 
all studies that were included in the systematic review said 
less than 10 percent of cases were transmitted outdoors. It is 
that meta-analysis that combined science from all sorts of--all 
different science from many different places. I think over 19 
studies were included. The topline result was less than 10 
percent, published in the Journal of Infectious Diseases, one 
of our top infectious disease journals. That is where that came 
from. It was a published study that synthesized studies from 
many places.
    With regard to camp, I have a 16-year old. Every day--every 
year, he comes home from camp and he writes the number of days 
until he returns to camp the next year. This year, it got to 
zero and I told him he was not going. I want our kids back in 
camp. We now have 38,000 new infections on average per day. 
Last May 11, it was 24,000, and we sent a lot of kids home and 
camps were closed. The camp guidance is intended to get our 
kids to camp and allow them to stay there.
    Thank you.
    Senator Collins. Madam Chair, I would just ask unanimous 
consent that the full New York Times story, dated today, be 
placed in the record because it answers--I realize I am out of 
time. It answers Dr. Walensky's response.
    The Chair. So ordered.

    [The information referred to can be found on page 70]

    The Chair. Senator Kaine.
    Senator Kaine. Thank you, Madam Chair, and thank you to the 
witnesses for your important testimony.
    Some of you have been before this Committee so often. I can 
remember the first time you were before us on January 24, 2020. 
And so much has happened since then and there is so much to 
talk about, but my colleagues have done a good job already in 
addressing many of my interests.
    At the last hearing that we had together, which I believe 
was in March, Dr. Fauci, I talked to you a little bit about 
long COVID. When the day comes where the President declares 
that the national emergency is over, there is still going to be 
at least two challenges: Long COVID, and then the mental health 
challenges that have resulted from a year of such loss.
    I want to ask Dr. Fauci and Dr. Walensky to dig into a 
little bit how you are using the funds that have been provided 
to deal with the long COVID issue for folks who are suffering 
symptoms after they have recovered from COVID.
    Dr. Fauci. Thank you very much for that question, Senator. 
This is really an important problem. The NIH has been given 
$1.15 billion to study this, and we are doing this in 
collaboration with CDC and other organizations.
    Long COVID is a real issue. Anywhere from 10 to, in one 
study, as high as 30 percent of individuals who recover from 
the acute manifestations of COVID-19, who have virologically no 
virus in them at all and they should be on the road to an 
uneventful recovery. But, unfortunately, what we have been able 
to find out now--and we are going to be putting together a 
number of cohort studies to determine the extent, the duration, 
any possible underlying pathogenesis, and any intervention.
    But, the symptoms are somewhat common. There is a 
commonality among them. It is extreme, sometimes debilitating 
fatigue; muscle aches; temperature dysregulation, you feel hot 
or cold; dysautonomia, which is related to that; unexplained 
rapid heartbeat, or tachycardia; neurological symptoms and what 
people refer to as brain fog, or the inability to focus or 
concentrate over an extended period of time.
    These are real symptoms, and they can last for a long time. 
We have people that we have followed now up to 9 months or 
longer where this occurs. It is a very important problem. We 
take it very seriously.
    We have a task force at the NIH. Multiple NIH institutes--
not only my own--Heart, Lung, and Blood, Neurology, and Mental 
Health, all of which are going to be looking at this over the 
next year or so because it is something that we really do feel 
we need to find out what is the underlying cause and what we 
can do about it.
    Senator Kaine. Thank you for that, Dr. Fauci. That is going 
to provide a lot of comfort to people who are grappling with 
these symptoms.
    Dr. Walensky, I want to shift to the second concern that I 
have. Again, we are not at a point yet where the emergency is 
over. And, yet, even when we are at that point, the mental 
health impact of this very, very challenging time on the 
American public and people all around the world is very 
significant.
    I have worked closely with colleagues, including Senator 
Cassidy, really to pinpoint mental health impact on frontline 
healthcare workers, whose experience of dealing with death and 
illness at such a massive scale, having to manage end-of-life 
conversations with people who would normally be having those 
conversations with their own family members. This is a real 
significant concern.
    My colleagues supported inclusion of provisions of the Dr. 
Lorna Breen Act in the recent work that we have done, and I 
understand that CDC and NIOSH are starting to focus on a public 
information campaign to frontline healthcare providers to 
reduce stigma to seeking mental health assistance should they 
need it.
    Could you talk a little bit about those efforts, and more 
broadly, the question of keeping our healers healthy?
    Dr. Walensky. Thank you very much for that question, 
Senator, and for the resources. I think it would be hard to 
overestimate the trauma that our healthcare providers, our 
frontline workers, have seen over this last year. Having been 
there before I was here, I can tell you, pulling up to 
driveways in your hospital that have morgues in the parking lot 
is really a striking thing to find.
    I am grateful for the resources. We are collaborating--
NIOSH is collaborating with our Injury Prevention Center within 
the CDC to create mechanisms and support tools to do outreach 
for our healthcare workers.
    I would also mention that we saw mental health challenges 
ahead of COVID-19, so these are not just mental health 
challenges because of COVID-19. Even among our youth, between 
2009 and 2019, before COVID ever started, we saw 40 percent 
increase in mental health challenges. So, we need this not just 
for our healthcare workers, but through--for the society at 
large.
    Senator Kaine. Thank you very much.
    Thanks, Chair Murray.
    The Chair. Thank you.
    Senator Cassidy.
    Senator Cassidy. Doctors, thank you all for being here. I 
approach you now kind of as a physician who has done research 
in vaccines as much as a--more so than I am approaching you as 
a Senator.
    I was struck--and, by the way, I am incredibly frustrated, 
and the American people are frustrated because they hear you 
are following science, but then they just have a sense that the 
lag time between the implementation of that and recommendations 
is far too long. It is not just the American people. I will put 
it this way. Not just the people in my state.
    Here is a Stat Article, CDC's Slow Cautious Messaging Seems 
Out of Step with the Moment.
    Want to Go Back to the Office? Don't Wait on the CDC. That 
is from the Wall Street Journal.
    The Liberals Who Can't Quit Lockdown from The Atlantic.
    First, I was struck when Senator Burr suggested that 
previous immunization actually confers immunity. Do any of you 
agree with that? Dr. Fauci?
    Dr. Fauci. Does previous immunization confer----
    Senator Cassidy. Does previous infection confer immunity?
    Dr. Fauci. It does. We do not know what the durability of 
it is, but----
    Senator Cassidy. Okay.
    Dr. Fauci [continuing]. It certainly does confer immunity.
    Senator Cassidy. Now, so, but we still recommend that they 
be vaccinated?
    Dr. Fauci. Yes, we do.
    Senator Cassidy. That seems out of step.
    Dr. Fauci. No, actually--actually, Senator, a study has 
shown very clearly that if you vaccinate someone who has 
previously gotten infected and recovered, the level of 
neutralizing antibodies and T cells are extraordinarily high 
not only against the wild type----
    Senator Cassidy. Let me----
    Dr. Fauci [continuing]. Virus, but also against----
    Senator Cassidy. Let me interrupt.
    Dr. Fauci [continuing]. The variants.
    Senator Cassidy. I am aware of that research. I pulled some 
of the research that refers to that.
    Dr. Fauci. Right.
    Senator Cassidy. My concern is that would happen if you had 
another infection. All the immunization does is mimic a pre-
existing infection. That is very well established with other 
viruses. No one has not established it for this virus. And, 
indeed, some of this research shows that within 4 days, which 
is the window period, if you will, for an infection to become 
an illness, those antibodies rise quite precipitously.
    But, we still recommend that they get two doses, even 
though the same literature shows that there is an increase in 
side effects when someone gets a second dose and they have been 
previous immunized. So--now, not life threatening, but, 
nonetheless, an increase in side effects. But, nowhere do I see 
a recommendation that, well, do not get the second dose because 
the literature shows that after one dose, you have topped out 
your immunologic response and you are at an increased risk with 
the second dose.
    Would anybody like to speak to that?
    Dr. Marks. There are studies ongoing to look at the first 
versus second dose. I agree with you, it is a very reasonable 
proposition for study. But, the purpose of immunizing somebody 
who has been infected previously is to develop higher antibody 
titers. Those high antibody titers are what is so critical in 
preventing a----
    Senator Cassidy. If I may, again, the studies of other 
viruses show--hopefully we have research showing here, but it 
appears to that a second--that a re-immunization merely mimics 
what would happen if somebody were exposed to the virus. All it 
does is kind of mimic that which would occur.
    Dr. Marks. Senator, this is a different virus. Each virus--
--
    Senator Cassidy. It is a different virus.
    Dr. Marks [continuing]. Has its unique----
    Senator Cassidy. Dr. Marks, is there research going to 
explore that which I am referring to? Because the research so 
far shows that within 4 days, you get a significant increase in 
antibody titer.
    Dr. Marks. There is research that has been done to show 
that after the vaccination, the nature of the immune response 
gives a sufficiently high titer antibodies that the post-----
    Senator Cassidy. That is with every virus.
    Dr. Marks [continuing]. Vaccination immune response----
    Senator Cassidy. That is with every virus. That is not 
unique to this.
    Dr. Marks. It is likely superior to natural infection in 
this case in preventing against some of these variants, and I 
think that is what Dr. Fauci was getting to.
    Senator Cassidy. I also point out that the vaccines 
themselves, and presumably the previous infection, is also 
effective against the variants.
    By the way, can people go back to work if they have been 
vaccinated and not wear a mask, assuming they are not 
immunocompromised?
    Dr. Walensky. We have about a third of people in this 
Country who are vaccinated. We have about a third of counties 
in this Country that still have over 100 cases per 100,000. We 
are working to review our guidance and to update our guidance. 
We have put out three different guidances.
    Senator Cassidy. I am sorry. Let me just ask again. If I am 
vaccinated and I have antibody and I am exposed to somebody 
else, what is my risk of coming down with symptomatic 
infection?
    Dr. Walensky. Five percent.
    Senator Cassidy. Five percent if I am--no, that is overall. 
Not if I have been vaccinated and if I have antibody. That is 
if I am vaccinated overall, correct. If I have antibody----
    Dr. Walensky. We do not have--I do not think we have data 
on what you are looking at. We did not check antibodies on 
everybody who was vaccinated.
    Senator Cassidy. But, we could.
    Dr. Walensky. We absolutely could, but----
    Senator Cassidy. Absolutely could.
    Dr. Walensky [continuing]. To date, we only have 
information about----
    Senator Cassidy. We do know that if we are in a--if we know 
that critical mass or if we know that herd immunity is 
somewhere north of 60 or 70 percent, if we go into a workplace 
where, within that workplace, there is 100 percent 
immunization, such as here, we have achieved herd immunity. 
Yes, there is somebody in here that may not be responding to 
the vaccine, but because everybody else has, they are 
protected. That is nowhere reflected. And right now, we have 
Federal agencies, which we have had employees not working for a 
year, because the union says that they have to have special 
workplace precautions for them to return to work. There is 
consequence to this kind of delay, as the Stat article shows, 
of the kind of updating of these recommendations.
    The American people are incredibly frustrated. And, as 
Senator Collins said, they are beginning to disregard what you 
say that is true because what you--so much of what you say is 
patently not true. I have to wear a mask when I am outside and 
the wind is blowing at 20 miles an hour. That has been changed, 
but it was only changed recently. They seek not to believe 
those things which are true. You have got to realize. You have 
got to be more real time.
    Let me finish with this. I think--I do not know if it was 
the Stat article or the New York Times that pointed on the HIV 
epidemic. The recommendations were much more kind of calibrated 
to real life. Listen, we know people are going to do this. If 
you are going to do it, please accept this recommendation.
    This is a blanket. Walk outside and wear a mask. You are 
vaccinated and everybody else in the room is vaccinated, but 
you are wearing a mask.
    The American people have just lost patience with us, with 
you guys. I just ask you just kind of be aware of their 
frustration and get a little real time into updating these 
things.
    I am sorry to be so frustrated. I respect you all and thank 
you for your service. I yield back.
    The Chair. Senator Baldwin.
    Senator Baldwin. Thank you, Madam Chair.
    Dr. Walensky, as I led the effort to ensure that the 
American Rescue Plan included funding for CDC's work to address 
variants of the coronavirus, specifically through genomic 
sequencing. I am really encouraged to hear from your testimony 
that we are now sequencing 10 percent of our Nation's weekly 
cases, and this is up from about--well, less than half of 1 
percent in February when I introduced my Tracking COVID-19 
Variants Act.
    A couple questions about what we are finding. Last month, 
the White House announced that it would provide initial funding 
to jurisdictions so that health departments could conduct, 
expand, and improve activities to sequence genomes and identify 
mutations of the coronavirus. I would like to have you describe 
how health departments are making use of this funding and how 
this investment will improve our response to future public 
health threats. But, also, any new variants that we should know 
about that--particularly anything troubling from the 
perspective of eluding the therapeutics and vaccinations that 
we have produced?
    Dr. Walensky. Thank you so much, Senator. I am--we are so 
grateful for those resources and our ability to scale up. As 
you note, we are now sequencing about 35,000 virus samples per 
week. That is a broad collaboration with commercial labs, with 
public health labs, with academic partners, and then with 
public health labs sending samples to CDC so we can address 
them more completely.
    In terms of moving forward, I am looking forward to 
bolstering the infrastructure to be able to do these sequences 
at the local level; to producing the infrastructure within CDC 
to be able to follow these in a pandemic-related way, not just 
for this pandemic, but for future public health threats; and 
then, further, to expand our ability and our workforce in 
genomic sequencing and analytics and bioinformatics to be able 
to not just address COVID-19, but these are longstanding things 
that we are going to need to address antimicrobial resistance 
and other infectious threats.
    Thank you.
    Senator Baldwin. Thank you. Last week, the Administration 
announced support for the waiver of intellectual property 
protections on COVID-19 vaccines to help end the pandemic. I 
believe that this news is the beginning of our work to restore 
America's public health leadership on the world stage. But, 
there is more to be done when it comes to addressing COVID-19 
worldwide.
    Dr. Fauci, can you explain how increases in new cases of 
COVID-19 worldwide threaten the progress that we have made here 
in the United States? And how can we avoid repeating history 
when it comes to combatting infectious diseases worldwide?
    Dr. Fauci. Thank you for that question, Senator. Yes, 
indeed, as we have said so often, and it is true, that a global 
pandemic requires a global response. And, even if we 
successfully vaccinate our population and get the level of 
infection down to a very low level, as long as there is a 
dynamic of infection spread throughout the world, any place in 
the world, there always is the danger that variants will be 
generated and ultimately will come to the United States because 
of the travel that we know makes no place in the world separate 
completely from any other place in the world.
    That is something that we really need to pay attention to, 
and it is for that reason that I keep saying, and many of my 
colleagues keep saying, we really do have a responsibility to 
the United States first. We do, for sure.
    But, we also need to take part in an effort, whatever 
effort, and it is going to be multifaceted effort, to make sure 
that the rest of the world contains the outbreak. And that 
could be from some of the things we are doing right now with 
India by giving them immediate help with oxygen and drugs and 
PPEs, but also to provide for the availability of doses of 
vaccine that we can make available to them. Not alone, not just 
the United States, but the rest of the developed world.
    Senator Baldwin. Thank you. One quick last question to Dr. 
Kessler. In its first few months, the Biden administration has 
surpassed every goal and expectation it has set in terms of 
getting shots in arms. Because of this effort, we are moving 
into the next phase of our vaccination effort in which the 
focus is less on mass vaccination sites and more about meeting 
folks where they are to get shots to hesitant and hard-to-reach 
individuals.
    As these vaccines come with certain logistical challenges 
and limitations, including cold storage and use-by 
requirements, as well as specific numbers of doses in each 
vial.
    As we shift to a more individualized effort, how will the 
Administration work to ensure that we are using our existing 
vaccine supplies effectively and maximizing the potential--and 
minimizing the potential for wasted doses?
    Dr. Kessler. Senator, a very, very important question. 
Because, as everyone on this Committee has recognized and has 
been part of this heroic effort, initially certain decisions 
were made on how to maximize the number of doses produced.
    The decision--in order to get the hundreds of millions of 
doses that we have already administered, we have had to make 
certain tradeoffs, and that is why you see the packaging the 
way it is, which is in a considerable number of doses, and we 
have to reduce that packaging.
    But, every day, Senator, I am in awe of the contributions 
that many of our local community health professionals, 
community leaders, ordinary citizens are taking to be able to 
bridge the barriers that people are having.
    I would like to get this eventually down into very small 
individual doses, but that is going to take time. And right 
now, we are going to do everything possible to speed that up.
    The Chair. Thank you.
    Senator Murkowski.
    Senator Murkowski. Thank you, Madam Chair. Thank you all 
for being here.
    A lot of frustration this morning, and I think, as Senator 
Cassidy mentioned, it kind of reflects the frustration that 
Americans have with where we are. We are all tired with COVID. 
We are done with COVID. But, as many have said, COVID is not 
yet done with us. But, how we are able to make sense of the 
guidance that comes out of CDC is critically important.
    Alaska was very early on in making sure that the vaccine 
was available to all very quickly, and, as a consequence, we 
are pretty proud of the fact that our numbers of vaccination 
were strong and we were No. 1 in the Country. But, when you 
start out first, you also then are the forerunner in 
demonstrating what it means to really see this vaccine 
hesitancy, and we are seeing that play out in different ways 
and different shapes.
    I appreciated your comments, Dr. Walensky, to Senator Smith 
about the ways that we can address the concerns that have been 
raised, whether it is where can I get the vaccine, is it safe, 
who do I look to for guidance.
    The State of Alaska did a survey that was released on 
Thursday that indicated that people are not looking to you all 
for guidance. They are not looking to our chief medical officer 
in the State of Alaska. They are looking to see what their 
friends and their neighbors do. They do not care what their 
Senator or the folks from CDC do. So, we have a lot more work 
to be doing with regards to that.
    I want to speak to my particular frustrations, which you 
have had the benefit of multiple conversations with me, and 
that is how we can get our tourist sector back to work for even 
a small sliver of the season.
    One point three million tourists come to the State of 
Alaska on a cruise ship. There were 48 tourists that came to 
Alaska on a cruise ship last year. And, right now, it does not 
look much better.
    We have been working back and forth with CDC, trying to 
deal with these--this conditional sail order. After many months 
of requests, we finally get to a place where we think we have 
some guidance out there. I just, at 11:30, got new information 
that the CDC's last traunch of guidance still requires 
additional guidance to be published. And, I say, yes, it is 
minor, but the fact of the matter is it is still yet one more 
gate that has to be gone through. Our reality is if you cannot 
get ships turned north now, there is no season, whether it is 
for 1 week or 1 month.
    I guess, Dr. Walensky, I am going to ask you one more time, 
can you give Alaskans any guidance at all with regards to the 
ability to finally get this guidance fully resolved? You have 
cruise lines that are saying, we are going to require everybody 
be vaccinated. All of our crews will be 100 percent vaccinated. 
We will require that those who want to sail on our ships this 
summer be vaccinated. Those in the communities who are 
welcoming them are also equally committed to the vaccine.
    Should I just tell folks back home do not even bother 
ramping up your seasonal operations because it is just not 
coming, we cannot get that guidance from the CDC?
    Dr. Walensky. First of all, Senator, let me congratulate 
you and Alaskans for getting vaccines into arms because you 
have been a role model in being able to do that.
    With regard to sail, I was here in March. We were waiting 
on 2A guidance. That 2A guidance of working with ports has 
since come. We have been now engaging, as I noted we do with 
schools, with our consumers, with our key stakeholders. We have 
had twice-weekly calls now with the cruise ship industry to 
understand what--how they are interpreting their guidance and 
what they need in order to be able to get boats back in the 
water. That is our goal for this season. Mid-summer was our 
goal.
    2A has been released. 2B has been released. Our guidance on 
how we get conditional--how we get trial voyages into the 
water, as well as Step 3 released, how you get conditional sail 
certificates. All three of those have been released.
    They have--we have been in this dialog with the industry so 
that we can understand what are the challenges in the current 
guidance that are hard to be met. And, we are actually having 
these conversations and then going back and addressing those 
challenges. We had a dear colleague's letter that went out 
after 2A, and we have others that are in the works.
    We are working with those in the industry to do our best to 
get ships back in the water this season, and we have actually 
agreed to a 5-day turnaround when those proposals come to us.
    Senator Murkowski. Well, it was news to me to, again, just 
see that there is yet another thing that has come up just this 
morning, so I would ask you to take a look at that.
    My time is expired here, but I must raise this fishing mask 
mandate. If you think about those mandates that really do not 
make sense, the fact that the Coast Guard is requiring, because 
they--it is Federal law out there that persons traveling on a 
conveyance or at a transportation hub wear a mask for the 
duration of their travel.
    I have fishermen, commercial fishermen, that are out there 
in the water. I have crabbers and salmon fishermen and cod 
fishermen that are trying to deal with a mask because they are 
concerned about failure to comply. This is more of a safety 
hazard than anything else. You are out on a boat. The winds are 
howling. Your mask is soggy wet.
    Tell me, tell me, how anybody thinks that this is a sane 
and a sound policy to do. So, I--we have a situation right now 
where the fishermen are more concerned about the liability in 
failing to have the mask on rather than prudent marine safety 
protocols. This is absolutely, absolutely a crazy policy.
    I just do not understand. I do not understand how we put 
our Coast Guard men and women in a situation where they know 
that safety is at issue, a broader safety issue, than the fear 
of transmission when you are outdoors, in the elements, and you 
are now being required to wear a mask. So, I would hope that 
the CDC would reconsider this quickly, quickly, quickly.
    Dr. Walensky. We are in the process of finalizing industry-
specific guidance for exactly this reason. Thank you.
    Senator Murkowski. Thank you.
    Thank you, Madam Chair.
    The Chair. Thank you. We will turn to Senators Murphy, 
Marshall, and Hassan. A vote has been called. I am going to go 
over to the floor and vote. Senator Burr will preside, and I 
will be back as quickly as possible. We will go to Senator 
Murphy.
    Senator Murphy. Thank you, Chair Murray. Thank you all for 
the fantastic work you do to protect the Country.
    Just a quick word on this frustration you are hearing 
regarding guidance from the CDC. I mean, listen, our witnesses 
today could sit here and claim that we have definitive 
information on risks or means of transmission or asymptomatic 
transmission, but they would not be telling the truth. We 
suffered through 4 years with a president who literally made 
things up about this virus; who simplified the story over and 
over and over again because he thought simplifying things and 
being definitive would make him look good, including giving 
free medical advice to Americans on what therapies they should 
take; making claims that the virus would disappear after a 
matter of weeks.
    That was not good for the Country. It did not help us fight 
this disease. We still have a lot to learn. And, so, I frankly 
appreciate the fact that we have leaders today who recognize 
that we still have gaps in information, who occasionally may 
err on the side of caution in order to save lives. And I share 
the frustration, but the frustration is rooted in the fact that 
we are still less than a year and a half into a virus that we 
are still beginning to understand.
    To that end, Dr. Walensky, on this question of outdoor 
transmission. So, Senator Collins was asking you about a paper 
you put out suggesting that it could be 10 percent of cases. 
There are other folks that say it could be 1 percent of cases. 
There are some epidemiologists who say that it could be .1 
percent of cases. That is a really important difference, and I 
assume the difference between 5 percent and .1 percent would 
likely educate decisions you would make about what 
recommendations you make to summer camps.
    How do we, on this question, close the gap in information 
that we have? Given that there are so many competing analyses 
out there of outdoor transmission, what do we do to try to make 
sure, especially heading into this summer, that we have the 
best information possible? How do we solve this problem?
    Dr. Walensky. Thank you, Senator, for that question. I 
think it is important for--to realize that we, at CDC, are 
responsible for putting out guidance for individuals, as well 
as for populations, for public health. We are responsible for 
putting out guidance for counties that have less than five 
cases per 100,000 and for counties that have greater than 100 
cases per 100,000, as well as for counties that have less than 
10 percent of people vaccinated and counties that have more 
than 50 percent of people vaccinated. Our guidance has to be 
science-based for all of these situations.
    In our last iteration of what vaccinated people can do, 
safely do, we did update our guidance not only for not wearing 
masks outdoors, but also for not wearing masks outdoors in 
certain settings for people who are unvaccinated. In those 
situations, we also said if people are gathered with other 
unvaccinated people dining with their masks off and close by, 
there may be a risk to that if they are dining close by.
    Certainly, this meta-analysis that was put forward that 
demonstrated the top line result of less than 10 percent 
transmission occurring outdoors was helpful scientific 
evidence, and we are following the science as it continues to 
emerge.
    I think it is also really important to recognize that now, 
with vaccination of 12 to 15 year olds, our summer camp 
guidance is probably going to have to change in those settings, 
and we plan to do so.
    Senator Murphy. Great.
    Dr. Kessler, question for you on booster shots. You have 
got--you included in your testimony an expectation that we may 
be in the business of purchasing and distributing booster 
shots, maybe as soon as later this year.
    I asked a question at the last hearing about the 
transparency of contracts with the companies that are supplying 
vaccines. I still think that we could do better in terms of 
letting the American public know and policymakers know about 
the financial terms of these contracts.
    But, what do we expect when it comes to contracting for 
booster shots? Are we going to go back to the same companies 
that provided the vaccine, or are we going to open that tender 
up to a broader set of companies? How do we expect the process 
of procuring booster shots to work, and how do we make sure 
that it adequately protects taxpayer dollars?
    Dr. Kessler. Senator, thanks for the question. Very 
important. We are in that process now. In order to plan, 
because that is really what we are doing, if we want a vaccine, 
let's say both the duration of immunity increasing age so there 
is less antibodies, and the variants, we have to take all of 
those things into consideration. And if we want vaccine end of 
the year, we have to do that now, and we are, in fact, in those 
negotiations.
    The best science to date--I mean, the data we have, and I 
do not want to get too technical, but the question is are we 
dealing with homologous boosts or heterologous boosts. 
Basically, are you going to boost with the same vaccine or are 
you going to--can you switch that out and do mix and match? And 
that requires data. We are collecting that data, and it is 
going to be the data that drives what we boost with.
    But, for planning purposes, I think the simplest and safest 
assumption--and I underline the word assumption--is that it may 
be for, at least the short term, the homologous boost with the 
same type of vaccine makes the most scientific sense. But, I 
need a couple of more months in order to give you definitive 
answer, but I have to plan now.
    Specifically to answer your question, we are dealing with 
the same companies because we want to continue with the safety 
and efficacy that we have seen in those vaccines. Down the 
road, that may change as we get other, for example, protein-
based vaccines available, Senator.
    Senator Murphy. I was just going to say this. I hope that 
this Committee is actively involved with the Administration on 
the construction of those contracts, to make sure that we are 
adequately protecting our taxpayers' investment.
    Thank you, Mr. Chairman.
    Senator Burr. [Presiding] Senator Braun.
    Senator Braun. Thank you, Senator Burr.
    Dr. Walensky, I think from the get-go, there has been an 
uncertainty of when we arrive at the moment when many of us 
feel that this is truly in the rearview mirror. And, from the 
early conversations I have had being on this Committee, it has 
always been interesting to understand, I think, if and when 
that comes with clarity, that is the only way I think we get 
true comfort back into the Country.
    Senator Murphy, others, have mentioned how things have 
changed, goal posts have moved. I think that is inherently 
confusing to people, especially ones that might have other 
reasons for not getting vaccinated, and I think that is so 
important that we get there, everyone vaccinated.
    My question is, I think, on the education side of it, more 
emphasis and resources need to be put into rural America, I 
think along with the logistics, that have seen some effort made 
there to improve it. I think it is inherently more difficult to 
get vaccines in the arms when it is spread out in areas like 
that.
    I would like you to zero in on it was 3 feet, or 6 feet and 
then 3 feet, indoors and outdoors. So many things have evolved. 
And I think with something as uncertain as this, it is natural 
to have that dynamic.
    Where in time, and does natural infection go along with 
vaccination to have some weight in that point in time where 
cases really start to fall off the chart?
    Dr. Walensky. Thank you so much for that--those questions, 
Senator. Maybe I will start briefly with the rural and say in 
our efforts over this last several weeks, resources have gone 
broadly to rural communities. We are now funding federally 
qualified healthcare centers, getting vaccines into areas in 
those centers. Over five million vaccine doses have been given 
through federally--FQHCs. So, we know we need to do that 
outreach, and that is part of this next chapter.
    In terms of the 6 versus 3 feet, I think from the school 
guidance--I know from the school guidance, the first iteration 
that was put out in February, the biggest challenge to getting 
children back to school was the 6 foot guidance. What happened 
soon thereafter is science emerged. And because 6 feet proved 
to be such a challenge, within a month, we had three studies 
that demonstrated that 3 feet and 6 feet were equivalent for 
younger children. And, so, it was based on the science. I would 
really like to say that we are in a static situation here and 
that the science is not changing, but we are changing our 
guidance with--as the science evolves and as the science 
emerges, and we have to remain humble to that science.
    With regard to your question regarding natural immunity, we 
have several challenges there. The CDC on its website has a map 
of presumed seroprevalence by state as to how much--how many 
people out there have antibodies. And, of course, we do not 
know all of the infection that has happened, right, because 
much of this infection has been asymptomatic.
    As Dr. Fauci has said, that prior infection likely confers 
some immunity. It might confer full immunity for some period of 
time.
    But, I will say that we are still learning and being humble 
here. This past week, our genomic surveillance data 
demonstrated that 72 percent of our sequences are now the B117 
variant. What do we know about how long prior infection will 
last with regard to new infection and a B117 variant if you are 
not vaccinated? We do not have all of those data yet. We are 
doing studies. We are evaluating it. But, I do think that we 
should continue to encourage vaccination of people who have had 
disease before.
    Senator Braun. Thank you.
    Dr. Fauci, the J&J vaccine, which I think for many people 
was a preference in terms of just being one shot and had a high 
efficacy rate to boot. Do you think it was a mistake in that we 
pulled it when statistically the rate of an incident was so, so 
low--lower than I think on many other drugs out there that 
seemingly have much higher side effect consequences? Was that a 
setback that put us in a place that has really hurt us, or have 
we recovered from it?
    Dr. Fauci. I do not believe it was a setback, Senator, and 
I think if it was, we certainly have recovered from it because 
we now know. When you ask people, there is a lot of people who 
really want to get a one-dose vaccine, who are waiting for the 
availability of this.
    What I do think it did that you do not fully appreciate is 
that it really underscored how seriously we take safety. 
Because to call a pause on an adverse event that, as you 
mentioned correctly is really quite rare, because at the time, 
there were six cases in about seven million people, which is 
less than one per million, which is really a very, very low 
amount.
    The FDA and the CDC looked at the data. They wanted to find 
out if there were any more. They wanted to alert the physicians 
who might be out there seeing patients about what is the proper 
way to treat them, because there is one general way to treat 
that people might use that would actually be contraindicated, 
namely with heparin.
    In the long run and the big picture, when all is said and 
done, I do not believe it was a setback. I think it really 
underscored how seriously we all take safety.
    Dr. Braun. How many vaccinations do we need to get fully in 
the arms to be at what the theoretical herd immunity would be 
and cases crash? Anybody?
    Dr. Fauci. Yes. I think that is going to be a difficult 
number to give because herd immunity as a concept means you get 
enough people vaccinated, enough people infected, so that you 
have a core of protected people that is a blanket of protection 
over even the vulnerables who cannot. The threshold of herd 
immunity is a number we do not know yet for this particular 
virus. We know it for measles, but we do not know yet what that 
is. We can----
    Senator Braun. I think that----
    Dr. Fauci [continuing]. Guess it is somewhere between----
    Senator Braun. That uncertainty is probably the thing that 
is going to be the hardest thing to grapple with to get this 
fully in the rearview mirror. So, thank you.
    Senator Burr. Thank you, Senator Braun.
    Senator Hassan.
    Senator Hassan. Well, thank you, Ranking Member Burr, and I 
thank the Chair for holding this hearing. And, really, thank 
you to all of our witnesses today for not only being here, but 
for your service.
    Before I get to a question, Dr. Walensky, I just want to 
second what Senator Murkowski said about getting the guidance 
to the fishing industry out as quickly as you can. I just met 
with my fishermen at the Yankee Fishermen's Co-op in New 
Hampshire this week, and we have boats of fishermen who are 
fully vaccinated who see the Coast Guard coming, telling them 
they have to keep their masks on. Not only is a wet mask 
dangerous out on the open water, but because of the noise, both 
the wind and the equipment, these guys are used to relying on 
kind of sign language on the boat. And with the mask on, they 
really cannot, and it is a real safety issue. So, I hope you 
will take this under advisement and get the guidance out as 
quickly as you can.
    Dr. Fauci, I wanted to follow-up a little bit. We have been 
talking about the very good news of the Pfizer authorization 
for 12 through 15 year olds, and it looks like they may be 
seeking at least emergency authorization for 2 to 11 year olds 
in September. And that is really welcome news, but many 
families are still looking for guidance about how to protect 
children under the age of 12 from the virus until a vaccine is 
authorized for them, especially as public health restrictions 
are being lifted around the Country. And I am hearing some from 
parents that the schools are mostly reopened, or hybrid 
reopened, but they are kind of nervous about sending their 
children to school.
    What advice do you have for families about what steps they 
can take to protect their children from the virus while we 
await FDA authorization for use of the vaccine for kids?
    Dr. Fauci. My recommendation, Senator, would be really to 
follow the CDC guidelines. I mean, what both--when the children 
are in the home with vaccinated individuals, the guidelines are 
clear what needs to be done. When they are outside, many things 
you can do without a mask outside. But, if you are not 
vaccinated and you are interacting with people outside of the 
home from different locations, you want to be careful and have 
the children have masks.
    I think a good following of the CDC guidelines, which, as 
Dr. Walensky says, continue to evolve in real time as they get 
more data. The guidelines get updated and upgraded. So, that 
would be my recommendation.
    One other thing that I think is important is that there is 
a lot of work that we are doing now in clinical trials to get 
vaccinations for children younger than 12. So, a bunch of 
companies, several of them, are doing what is called age de-
escalation studies where we are looking at children from 12 to 
9, 9 to 6, 6 to 2, and then 6 months to 2 years. We think by 
the time we get to the end of this year that we will have 
enough information to vaccinate children of any age.
    Senator Hassan. Well, that would be very welcomed news to a 
lot of parents.
    Dr. Fauci. Right.
    Senator Hassan. Thank you.
    Dr. Kessler, I want to follow-up on a line of questioning 
that Senator Murphy was following. We have heard encouraging 
news, certainly, that the protections from the COVID-19 
vaccines remain strong for at least 6 months and likely longer, 
but, also, that Americans will need booster shots, as you all--
may need booster shots, as you all just discussed. It is going 
to be really critical that these vaccines remain accessible and 
that their price reflects the large investments that American 
taxpayers made in the research and development of the 
technology.
    What steps should Congress take to ensure that COVID-19 
vaccines, including booster shots if needed, remain available 
to Americans even after the end of the public health emergency? 
And how can we ensure that pharmaceutical companies price these 
vaccines in a way that account for taxpayer investment?
    Dr. Kessler. Senator, a key question. Let me assure you 
that because of what this Committee has done and your 
colleagues on Appropriations, we do have the funds to purchase 
the next round, again, if, if they are necessary. So, we will 
be able to purchase the next round and to assure that if there 
are boosters, they are free, just as the last round. I think 
you raise a very good question.
    Beyond that, beyond 2022, I mean, I look to your guidance 
and your colleagues on at what point do you transition back to 
a commercial market. But, I think for this coming round, we are 
going to proceed as we have proceeded, and you have made those 
funds available.
    Senator Hassan. Well, I look forward to continuing the 
discussion. I see that I am almost out of time here, but I did 
want to just ask Dr. Walensky quickly. Can you speak to the 
importance of continued access to COVID-19 testing even as we 
work to distribute the vaccine and people are getting--we are 
building up our community and herd immunity?
    Dr. Walensky. Yes. Thank you very much for that question. 
First of all, we recognize that right now we have done an 
extraordinary job in getting vaccine to one-third of Americans, 
and yet two-thirds of Americans do not yet have vaccine. And, 
in fact, our young children will not have access to vaccine for 
the rest of this year. We have put out $10 billion toward 
states to be able to do testing programs within schools. Some 
higher ed have been able to successfully engage in this past 
semester through testing programs on their college campuses. We 
are going to need to continue testing through our long-term 
care facilities, as well as our correctional facilities, our 
dense industries. And, so, yes, I think there has to be a huge 
corner of what we are doing that is related to testing.
    Also, surveillance water testing, sewage testing, to look 
for outbreaks. So, we are doing a lot in the testing area. We 
are really grateful for the resources to be able to do so.
    Once we have vaccine in the majority of people, we are 
still going to have disease out there and we are going to need 
to rapidly be able to detect it. Thank you.
    Senator Hassan. Thank you very much.
    Thank you, Madam Chair.
    The Chair. [Presiding] Senator Marshall.
    Senator Marshall. Thank you, Madam Chair.
    Dr. Fauci, do you think it is possible that COVID-19 arose 
from a lab accident at a lab in Wuhan, and should it be fully 
investigated?
    Dr. Fauci. That possibility certainly exists, and I am 
totally in favor of a full investigation of whether that could 
have happened.
    Senator Marshall. Great. Is it possible COVID-19 is not 
naturally occurring?
    Dr. Fauci. Again, that is a possibility. I do not know if 
we are ever going to be able to prove that. But, you always 
need to open up and leave all possibilities, which is the 
reason why I and so many of my colleagues are very much in 
favor of what the WHO said, that they want to go back again and 
take another look in there and see what was going on in that 
lab.
    Senator Marshall. Will you commit to get this Committee all 
the records, anything to do with any type of viral experiments, 
say from 2013 to the present so we can review those?
    Dr. Fauci. Certainly. I would comply with any request of 
the Committee.
    Senator Marshall. Do you and others at NIH have a conflict 
of interest when determining if the labs and lab work you help 
fund should be investigated and how it is investigated?
    Dr. Fauci. No. I do not think it is a conflict of interest. 
We are very open and wanting to make sure that everything that 
has any question is looked into, at all. I have no problem with 
that.
    Senator Marshall. Okay. In 2013, President Obama placed a 
moratorium on viral gain-of-function studies with some 
loopholes, which you were able to use at certain times. I know 
we disagree--I do not know if we disagree. We can discuss what 
is viral gain-of-function and what is not. But, in 2017, you 
had a long process, and I assume it was you that decided to 
lift this moratorium, and during this review--my question is 
this.
    During the review, did you consider the risk of dual 
applications by military, terrorists, or other foreign actors?
    Dr. Fauci. I am not sure what you mean by that, Senator. 
Did I consider applications from dual actors?
    Senator Marshall. Yes. I will say it again. Did you 
consider the risk of dual application, that there might be 
other folks that would use some of the----
    Dr. Fauci. Sure.
    Senator Marshall [continuing]. Function of discoveries, 
that they might be used by a military----
    Dr. Fauci. Sure.
    Senator Marshall [continuing]. Terrorist, or other foreign 
actors?
    Dr. Fauci. Well, in any research that we do, we publish the 
research. It is available for anyone to use it in any manner in 
which they can. That is the modus operandi of the NIH. We fund 
research. The research is----
    Senator Marshall. Is there not a----
    Dr. Fauci [continuing]. Made public.
    Senator Marshall. Is there a national security 
consideration, though, in that type of decision with--thinking 
the viral gain-of-function could be more powerful than the 
nuclear weapons to----
    Dr. Fauci. No, but----
    Senator Marshall [continuing]. Share that information with 
a government----
    Dr. Fauci. Right.
    Senator Marshall [continuing]. Foreign actor may be 
considered--been like trying to do the Manhattan Project in 
nuclear energy, nuclear weapons, doing it with, say, Hitler or 
the Soviet Union?
    Dr. Fauci. I am not sure what you are getting at, Senator, 
but we do not fund research. We have committees that look at 
that to make sure that research that is of any potential danger 
is not funded. So, I am not exactly sure what your point is.
    Senator Marshall. My point is, is there national security 
implications with something as theoretically lethal as viral 
gain-of-function?
    Dr. Fauci. Sure, there is. That is why we have committees. 
We have a P3CO committee, which is the Potential Pathogen--
Pandemic Pathogen Care and Observation--and Oversight, excuse 
me. And that is a committee separate from the NIH that looks at 
these types of grants to see if they need to be funded. So, 
there is a considerable amount of oversight to make sure grants 
that are doing research that would obviously be of danger is 
not performed.
    Senator Marshall. When you make a decision to stop the 
moratorium on gain-of-function, was--were there national 
security advisors in the room? Was there State Department? Was 
there Defense Department? Who were those people that might have 
been part of that decision?
    Dr. Fauci. First of all, I did not make the decision to 
stop, to pause the gain-of-function. If one looks at what 
actually happened, we put a pause on, and I was the one that 
was very much in favor of that pause. In 2013----
    Senator Marshall. You are talking the 2013 pause?
    Dr. Fauci. In 2014----
    Senator Marshall. Okay.
    Dr. Fauci [continuing]. To 2017, the pause was lifted 
because we established a committee that looked at what we 
called P3CO.
    Senator Marshall. I am familiar with it.
    Dr. Fauci. Right. Exactly. And when that committee then was 
able to make decisions about granting, apart from the NIH so 
that we would not have any decision and it would be a 
decision----
    Senator Marshall. I have one last question I wanted to 
sneak in. I still do not know that you answered was there 
national security people in the room when you--when that 
process--someone made the decision. I think you led that 
decision, but we will come back to that.
    Here is my last question. If COVID-19 is indeed a product 
of lab manipulation, can you sit here and unequivocally say the 
viral studies that NIH funded--helped fund, could not be 
indirectly or directly related to this final COVID-19 virus?
    Dr. Fauci. Yes. Looking at the experiments that were done 
that we funded, there would not be that possibility.
    Senator Marshall. Unequivocally?
    Dr. Fauci. Well they are talking about a hybrid virus of a 
mouse virus that was adapted to a mouse that anyone that knows 
anything about virology would realize that is not something 
that would infect a human, much less be pathogenic and 
transmissible.
    Senator Marshall. But we helped make the mouse that had the 
HLA receptor that this COVID-19 was specific for, and you 
were--NIH was involved in the development of----
    Dr. Fauci. Yes.
    Senator Marshall [continuing]. Humanized mouse?
    Dr. Fauci. Yes, but as I mentioned in response to Senator 
Paul, the NIH and NIAID did not fund gain-of-function research 
to be conducted at the Wuhan Institute of Virology.
    Senator Marshall. But that is not my question. You know, 
the question is, could some of the--some of the funding you 
did--you can call it gain-of-function or not, developing the 
HLA receptor with the mouse. I am not sure if you are going to 
call that gain-of-function or not. Probably not.
    But, could some of the funding indirectly ended up to the 
contribution of this--of COVID-19?
    Dr. Fauci. I am not sure exactly where that question is 
going. You could do research on something as benign as looking 
at something that has nothing to do with it and it could 
indirectly, someday, somehow, be involved. So, if you want to 
trap me into saying yes or no, I am not going to play that 
game.
    Senator Marshall. But we need to look at that very deeply 
and consider exactly--that is why you committed earlier to make 
sharing all the viral----
    Dr. Fauci. I would be happy to share any information you 
would like with the Committee.
    Senator Marshall. Thank you so much. I yield back.
    The Chair. Thank you.
    Senator Rosen.
    [Brief silence.]
    The Chair. Senator Rosen, I believe you are on mute.
    [Brief silence.]
    The Chair. We are going to hold 1 second for Senator 
Rosen's mute function to work.
    [Brief silence.]
    The Chair. I believe they are trying to undo Senator 
Rosen's mute function from the studio.
    Senator Rosen, if you can just be patient with us for a 
minute while we get that fixed.
    I am going to go ahead and ask a question, and if--Senator 
Rosen, if you can just hold for just a minute.
    I wanted to ask Dr. Walensky. There are variant strains of 
COVID-19 that threaten to disrupt progress made toward ending 
the pandemic, and the CDC reports that the B117 variant is now 
the predominant strain in the United States. We need to know 
which variants are out there and how they are spreading and why 
they--and who they are spreading to, which is why we approved 
$1.75 billion in the American Rescue Plan to help CDC shore up 
its genomic sequencing and surveillance activities.
    Do you have enough data? Do you have the right data and the 
right data systems to be able to track these variants as they 
spread?
    Dr. Walensky. Thank you, Senator. We are--we have scaled up 
our sequencing dramatically, as I have noted, and every 2 weeks 
or so, we get an update on data and we look at the--where these 
sequences are. Just yesterday, I believe, we had the most 
recent update that demonstrated 72 percent of our cases are now 
B117. Six percent are now P1. And, we are grateful for the 
resources to be able to do so.
    Generally, our ballpark was to have 10 percent of viral 
sequences able--10 percent of all circulating virus to be able 
to be sequenced. And, so, with cases coming down and our 
sequencing rising up, we have been able to reach about that 10 
percent mark right now. That has required a lot of 
collaboration across government, across commercial labs, and 
whatnot.
    The function is a--and the impact of these, whether they 
are variants of concern, variants under investigation, how we 
understand these, is related to an interagency collaboration 
with BARDA, NIH, and CDC in terms of seeing how transmissible 
they are, as well as how well they function against monoclonal 
antibodies and our vaccines.
    The Chair. Thank you for that.
    Senator Rosen, do we have you back?
    Senator Rosen. I think we are back. Can you hear me now?
    The Chair. Yes, we do.
    Senator Rosen. Oh, very good. Sometimes that Zoom happens. 
There you go.
    Well, thank you, Chair Murray. I appreciate your patience. 
I appreciate you calling this hearing. It is extremely 
important. And, so, for you, for all the scientists, the 
medical personnel, the frontline workers, I am so grateful for 
what everyone has been doing to be sure that we can keep the 
American people, really, people around the world, safe, 
healthy, and informed.
    Dr. Fauci, when we last spoke in March, you shared that NIH 
had just launched a billion-dollar initiative to study the 
long-term effects of COVID-19 and identify potential prevention 
and treatment measures for the long-haulers. Because COVID-19, 
of course, is a novel virus, there are so many gaps in our 
research and unknowns for the people who have been affected and 
are still suffering. And that is why I introduced bipartisan 
legislation that will ensure that NIH will continue to be able 
to work with the CDC on comprehensive and longitudinal studies 
of a diverse group of COVID-19 patients. I know some of the 
research has already been done. It is going to go forward.
    You shared earlier some updates on long COVID. Could you 
speak to the research gaps that remain for learning more about 
the long-term effects, such as lung capacity, heart function, 
some of the things that people really seem to be struggling 
with once they have recovered from their initial symptoms?
    Dr. Fauci. Well, thank you very much for that question. 
Yes, we have initiated a series of studies, first of all, 
building up cohorts so that we can get enough individuals in 
the cohort to be able to do the kinds of studies that you are 
going to do.
    As I mentioned in response to a prior question, it is a 
multi-institute endeavor involving multiple NIH institutes with 
differences--different interests in different organ systems, 
just as you said. The National Institute of Heart, Lung, and 
Blood is one that is looking at some of the issues that you 
raised in your question, the National Institute of Neurological 
Diseases and Stroke, the National Institute of Mental Health, 
and my institute, the National Institute of Allergy and 
Infectious Diseases.
    We have also just now started the request for applications 
to be able to gather the cohorts and do those types of studies. 
So, there is a considerable amount of interest in this and a 
major commitment on the part of the NIH to study this 
thoroughly to fill in some of the gaps that still remain as to 
what the pathogenesis of this particular syndrome is because it 
is a real syndrome that is very troubling to a large number of 
patients.
    Senator Rosen. Thank you. I would like to move to the other 
part of this equation, which is the therapeutic research and 
development. Because even though people are getting vaccinated, 
of course, there are still people getting sick and there are 
people, like we said, still suffering chronic pain, chronic 
illness, as a result of COVID-19. And, so, we have to be sure 
that we have those tools to continue to treat any cases that 
come forward.
    Could you give us any updates about what therapeutics might 
be in the pipeline? And do you think is there a potential for 
any of these treatments to help some of the long haulers? You 
know, maybe it can treat acute and chronic illness as a result 
of this function of COVID?
    Dr. Fauci. Senator, it is an excellent question but it is 
almost impossible to talk about treatment when you do not know 
what the underlying pathogenesis is. So, that is the reason why 
the studies are starting off by gathering the cohorts and 
trying to find out if there is a mechanism for some of the 
symptomatology--the profound fatigue, the muscle aches, the 
temperature dysregulation, the sleep disorder, the brain fog, 
as they call it.
    We do not know exactly what the mechanism of this 
symptomatology is and, for that reason, it becomes very 
difficult to do anything other than symptomatic treatment for 
these individuals. That is why it is so important to do the 
studies that we are planning to do, so that hopefully when we 
understand the mechanisms, we will be able to have some 
therapeutic intervention.
    Senator Rosen. Well, thank you. I appreciate that because 
it is really going to be important moving forward. It is going 
to be important to our healthcare workers, to our surging of 
hospital capacities, and actually globally around the world.
    I just thank you for that. I look forward to reconnecting 
with you as we begin to see more results of this really 
important longitudinal research and the progress that it is 
making.
    Thank you, Madam Chair. I yield back.
    Dr. Fauci. Thank you.
    The Chair. Thank you very much.
    I wanted to ask, the pandemic's deadly impact on 
communities of color shows we have a long way to go to address 
systemic racism and health inequities in this Country. Black 
and Latino people are receiving vaccinations at 
disproportionately low rates, and some of the systems that are 
designed to make vaccinations easier, like online registration 
for appointments, have actually made it harder for some, like 
our native Hawaiian and Pacific Islander elders. Additionally, 
AAPI communities have experienced higher rates of 
discrimination and violence, as we know, since the start of 
this pandemic.
    Dr. Kessler, I wanted to ask you, how is the Federal 
Government working to decrease COVID-19-related health 
inequities?
    Dr. Kessler. Senator, thank you for the question. 
Enormously important. There is some at least initial good news. 
You know, we have seen that deaths are down dramatically since 
January, and we all know that they are down 80 percent among 
seniors. But, they also include--that drop includes a drop 
among Hispanics of 80 percent, and among African Americans of 
about 70 percent. And, in the past 2 weeks, 55 percent of the 
people vaccinated were White, but 45 percent were non-White. 
That compares to the general population that is about 60 
percent White and 40 percent non-White.
    We have much more to do, especially in the area of 
confidence. We do see that people's confidence in the vaccine 
is increasing. Black Americans' confidence increased by 24 
points since January, and Latino Americans' confidence 
increased by 22 points since January.
    But, outreach access is absolutely critical. These vaccines 
are free. Every adult in America is eligible in about 80,000 
locations. But, we have a lot more work to do, and we are 
keeping equity at the center of the response, and we will not 
leave anyone behind.
    The Chair. Okay. Thank you so much for that effort, and I 
appreciate it.
    Senator Burr, do you have any closing questions or 
comments?
    Senator Burr. Madam Chair, thank you. Yes, I do. I have a 
little bit of cleanup if I can.
    What I have been able to piece together since we started--
and this is to you Dr. Marks and maybe Dr. Kessler. BARDA 
signed a contract for $1.2 billion for 300 million doses of 
AstraZeneca vaccine. That is currently authorized in 70 
countries around the world; its manufacturing capacity in 15 
countries and 25 sites. In addition to the Baltimore Emergent 
facility, two sites in the U.S. manufacturing, in Ohio and New 
Mexico, of AstraZeneca vaccine.
    Here is my question. Of the stock that we currently have on 
hand, which I estimate to be about 60 million doses, is all of 
that being held because it came from Emergent? Or, in that 60 
million inventory that we have today, is some of that either 
foreign manufactured and/or Ohio or New Mexico and would not 
have to be held up because of the current inspection concerns 
at Baltimore?
    Dr. Kessler. Senator, I have been talking to AstraZeneca, 
even last night. I have been talking to them regularly over the 
last several weeks. I--to answer your question very 
specifically, the 60 million that you reference, all of that 
drug substance was made at Emergent.
    There is another facility at Catalent that manufactures 
drug substance, but we are not--we have not contracted and we 
are not involved, and that is for global.
    There are two other facilities, one in West Chester that 
you referenced, that is for drug product.
    But, everything that we have involvement in is that 60 that 
has been produced for that first initial hundred, and they 
stopped at 60 when--because of the problems at Emergent were--
are all being reviewed by our colleagues at FDA because of 
issues at Emergent.
    Senator Burr. Follow-up question. Of the over two million 
doses that went to Mexico, a million and a half doses that went 
to Canada, have there been any indications from those vaccines 
if they have--one, I assume they have been used. Is there any 
reason to believe that they are reporting any adverse effects?
    Dr. Marks. Senator Burr, no, and in--and those came from a 
time when that facility was not being used for more than one 
vaccine, to produce more than one vaccine, sir.
    Senator Burr. The fact that they produce not only AZ, but 
J&J, now makes them susceptible?
    Dr. Marks. It is a matter of public record that the problem 
that occurred at the facility involved a contamination event 
between two vaccines.
    Senator Burr. Okay.
    Dr. Marks. That was the issue that we are dealing with. 
But, I just should add that you have our commitment that we are 
going to work as quickly as we possibly can to get both 
clearance of the doses that are currently being held--because 
we do not have clearance of the safety of those doses yet--and 
also to get that plant back up and running in a manner that is 
fully consistent with what Americans expect from their 
pharmaceutical products.
    Senator Burr. Okay. This question, I am going to go to Dr. 
Fauci, Dr. Marks, and Dr. Walensky.
    What percentage of the employees in your institute, your 
center, or your agency, of your employees, has been vaccinated?
    Dr. Fauci. I am not 100 percent sure, Senator, but I think 
it is probably a little bit more than half. Probably around 60 
percent.
    Senator Burr. Dr. Marks.
    Dr. Marks. I cannot tell you the exact number, but it--it 
is probably in the same range. Some people vaccinated at our 
facility and others outside of the facility.
    Senator Burr. Dr. Walensky.
    Dr. Walensky. We are encouraging our employees to get 
vaccinated. We have been doing town halls and education 
seminars. We have--our staff have the option to report their 
vaccination status. But, as you understand, the Federal 
Government is not requiring it, so we do not know.
    Senator Burr. Okay. And, listen, you are the face of why 
people should get vaccinated, and no one--and promoting and 
confidently giving numbers, percentages, I think is really, 
really important as we go into this last part.
    Now, if you tell me that there is some statute that says 
you cannot require somebody to tell you, imagine being the 
parent of a school age kid who for generations has been 
required to have their kids vaccinated before they could start 
school. And, the fact that, even within our health 
organizations, we cannot require that of people, we are going 
to have tough decisions to make.
    Employers are going to make those decisions. There have 
been decisions already made by colleges around the Country that 
said if you are on faculty or you are a student, you are not 
coming next year if you are not vaccinated. Now, they have the 
ability to do that.
    These are tough questions with even tougher answers. But, 
if we are going to get that last mile coverage, we are going to 
have to start portraying that we are willing to do to ourselves 
what we are asking the American people to do.
    Dr. Walensky, I think it is safe to say that the 21st 
Century is something that the CDC has not totally entered, but 
I am confident that you are going to take them there, and 
especially as it relates to science and technology.
    My question is simple. Do you believe the CDC director 
should meet with private industry and innovators who have new 
technologies that can help modernize the CDC?
    Dr. Walensky. Thank you. I think I have an extraordinary 
opportunity as being the director of the CDC during this period 
of time. I think that much of what we are going to need to do 
in public health is going to take collaboration with academia, 
with government, with private sector, with non-profits. And I 
am looking forward to engaging in those in a transparent, open 
way so that we can have that dialog and create those 
collaborations.
    Senator Burr. Let me go back and ask you one more time. Do 
you believe that the CDC director should meet with private 
industry and innovators that have new technologies?
    Dr. Walensky. I believe that we should--I should be 
encouraging all of those collaborations, and I am relying on my 
senior leadership team, my subject matter experts, to engage in 
many of those conversations.
    Senator Burr. But not you?
    Dr. Walensky. If it is a subject matter where I am an 
expert, I would be happy to, absolutely.
    Senator Burr. I think in a question to your staff, they 
suggested that you could not, but I will revisit that through 
my staff to yours.
    I have to say that I am little bit confused on the issue of 
CDC guidance after hearing my colleagues, Senator Collins and 
Senator Cassidy, about exactly who is involved in content and 
language. So, I sent to CDC an oversight letter, and I got your 
response to it on 22 April, and I will just highlight a few 
things.
    CDC uses its emergency response clearance protocol to clear 
items during emergency responses. This emergency response 
clearance is applicable to all CDC-authored, CDC-branded 
information products with content related to an active or 
ongoing response, such as COVID-19 response.
    The clearance process consists of a series of formal 
reviews, approvals, by relevant CDC subject matter experts, 
SMEs, and Agency clearance officials. This typically consists 
of content, development, and review by CDC's relevant COVID-19 
Response Task Force or SMEs, followed by additional review 
coordinated by CDC's Joint Information Center.
    At no point, given the opportunity, did the letter mention 
anything about people outside of government. It could be 
parents. It could be the National Education Association. It 
basically said this all happens within government.
    Now, that is not what I heard my colleagues say as it 
related to the guidance on schools, that there was input 
provided by outside entities. And, as a matter of fact, I went 
ahead and pulled all the email chains that I think was accessed 
by the media outlets that made them write this story.
    I will just say that it is a little bit alarming because it 
is all done on a timeline, and it suggests that AFT 
leadership--not sure what the issue was they raised, but they 
certainly changed the language of the guidance because there is 
actually email that thanked them for the language that they 
provided.
    When you look at the timeline between that and White House 
announcement, one would have a hard time believing that 
everything went through a clearance process that was described 
in the oversight response letter to me. So, I would ask you 
clear it up for me, if you would.
    Dr. Walensky. Thank you. Thank you for that question. So, 
as I mentioned to Senator Collins, prior to our putting our 
guidance through a formal clearance process, we do an enormous 
amount of stakeholder engagement to ensure that the guidance 
can actually address the questions asked. In fact, I can tell 
you, on the other side, when I was a healthcare provider at 
Massachusetts General Hospital, I would frequently call my 
colleagues at the CDC and say, we need guidance on X, it needs 
to address X, Y, and Z.
    In the stakeholder engagement for the schools, we did 
outreach with over 50 organizations. We spoke to teachers. We 
spoke to parents. We spoke to superintendents. We spoke to many 
different stakeholders to understand what it is that they 
needed from our guidance.
    As I mentioned previously, in doing so, we recognized, in 
meeting with the teachers, that we had actually failed to 
comment on what happened if teachers were immunosuppressed, if 
teachers were undergoing chemotherapy, if they had a family 
member with a transplant at home, how we were going to engage 
and provide guidance to those. It was the CDC scientists that 
provided the guidance, that provided the science around what we 
should do. It was the request from teachers to say, you did not 
address this issue, and we had not.
    Senator Burr. The first contact by AFT with your staff was 
on February 1st, Monday, February 1st. And your staff person--
we were able to review a copy of the draft guidance or--excuse 
me.
    Troutner with the AFT. We were able to review draft 
guidance documents over the weekend. We are able to provide 
some initial feedback to several staff this morning about 
possible ways to strengthen the document.
    That is on February 1st in the morning. On February 2nd, 
your staff emailed to you that they had followed-up with 
suggested language on accommodations per exchange.
    On February 3rd at a White House press conference, you say 
schools can open, reopen without teachers being vaccinated.
    Would one reading this be concerned with this timeline and 
what the oversight letter told me was the protocol that you 
went through to have guidance signed off on?
    Dr. Walensky. In the February 3rd press--first of all, in 
the February 3rd press conference, that was before our guidance 
was released. That was speaking to science and studies that 
demonstrated that schools had effectively reopened without 
teachers being vaccinated and keeping students and children 
safe. February 3rd pre-dated our guidance release, which I 
believe was February 12th, although I would have to confirm.
    You may recall at the time that in the media I took quite a 
hit for commenting on that from teachers themselves. They were 
not happy with me at the time.
    Senator Burr. With the success of AFT, the NEA engages you, 
and you actually committed to do an NEA town hall meeting. Is 
that right?
    Dr. Walensky. We were engaging at the time with over 50 
organizations--teachers, superintendents, parents alike--at the 
time when our school guidance came out as a matter of practice 
and in an unbiased fashion.
    Senator Burr. Well, Madam Chair, I am going to ask that the 
letter and the emails be included as part of the record.
    The Chair. Without objection.
    [The information referred to follows:]
    Senator Burr. I want to make this observation, that I hope 
you can understand why Members express frustrations on 
guidance, that there is a chain of information that suggests 
people had a preferred access to not only advice, but actual 
language that went into the guidance.
    I know what your answer to my last question is going to be 
because I have stated it in one of the emails.
    Should CDC guidance suggest that all states should require 
teachers to be vaccinated?
    Dr. Walensky. I would encourage all teachers to be 
vaccinated. We spent the month of March providing vaccines 
through our Federal pharmacy programs and we got over 80 
percent of our teachers and educators vaccinated as a--through 
that process. So, I am certainly encouraging that all teachers 
be vaccinated.
    I think that the guidance with regard to mandatory 
vaccination in schools is going to have to be done at the local 
level.
    Senator Burr. Would you provide guidance that suggested to 
schools that they vaccinate teachers?
    Dr. Walensky. We have been encouraging vaccination of 
teachers----
    Senator Burr. All teachers.
    Dr. Walensky. We have been encouraging vaccination of all 
teachers, of all educators, of all parents, of all students.
    Senator Burr. Is that in guidance?
    Dr. Walensky. I would have to confirm because I do not know 
whether our most recent updated guidance for schools actually 
had widespread availability of vaccine.
    Senator Burr. Okay. The Chair has been awfully kind to me, 
and I am not trying to pick.
    As I said when I started, the next several months are going 
to be extremely tough at getting people vaccinated. I do not 
want any of us to lose focus on what the mission is out there. 
I know for all of you, I am stating the obvious, that we have 
to stay focused on vaccines.
    But, the confidence the American people have in you is a 
lot of what is going to make us successful. As Dr. Fauci and I 
have talked many times about, thank God we had in place an 
architecture that we perfected over the last 20 years that 
allowed things to happen organically, like EUAs and this type 
of thing.
    It was not because we experienced anything. We went through 
little red flags, H1N1, SARS, Ebola, where we looked at it and 
said, boy, if this had been the big one, what would we have 
changed, and collectively, we went through and changed them. We 
were much better prepared a year ago architecturally, and 80 
percent of what we did was following the statute that is out 
there and the authorities that were given to many of your 
institutes or agencies. Or, in Dr. Marks' case, to the FDA. 
And, I have to tell you that I believe what the FDA has 
accomplished, I never dreamed they could do.
    My goal now is to make sure we do not roll back. Because as 
we move into technology platforms, that is not something that 
is easy to go back and do clinical trials on again if you are 
just looking for a new indication. But, I have to tell you that 
I believe that schools going back in person in the fall is 
absolutely crucial to getting a majority of the parents who 
have yet to be vaccinated, vaccinated. And knowing that at 
least by the end of this month, if we are not already there, 
every adult that wants to be vaccinated can be vaccinated.
    It is time for us to start setting the stage and paint the 
picture for what the fall looks like; that people can go on 
vacation this year and they can eat in a restaurant, in the 
Outer Banks of North Carolina, preferably; that they can plan 
their summer vacation; hopefully, in a few more weeks or days, 
maybe they can go to camp; that in the fall, we expect every 
school to be in person, short of some drastic change in the 
infection glidepath; and next Thanksgiving, you ought to plan 
to have Thanksgiving with your family and extended family; and 
Christmas, you ought to be able to enjoy.
    If we paint that type of picture, I believe, David, we are 
going to get people vaccinated. But, if we continue to fail at 
the trust that they have in us making the calls that are 
appropriate at the time, feeling like they are influenced in 
any way, feeling like we are not out there where we need to be 
interpreting the science, we are going to fail, and we are 
going to fail for the American people. But, more importantly, 
we are going to fail for the world because the world right now 
is relying on us getting to that number and us providing the 
technology and the manufacturing capacity for them to be 
vaccinated. So, we have a big step ahead of us.
    I am delighted that all four of you are here today. I thank 
you for the work that you have done up to this point and, more 
importantly, for the work you are going to do in the future.
    I thank the Chair.
    The Chair. Thank you. That will end our hearing today.
    I want to thank all of our colleagues who are here. I 
especially want to thank all of our witnesses today. Thank you 
all, Doctors Walensky, Fauci, Marks, and Kessler, for joining 
us to update on this fight against this pandemic, and to tell 
you thank you to all of those who work for you and have been 
diligent and trying to make tough decisions in a difficult time 
to help protect all Americans. So, thank you very much to you 
and to all the people that work with you.
    For any Senators who wish to ask additional questions, 
questions for the record will be due in 10 business days, on 
Tuesday, May 25th, at 5 p.m. The hearing record will remain 
open until then for Members who wish to submit additional 
remarks and materials for the record.
    The Committee will next meet tomorrow, Wednesday, May 12th, 
to mark up the nominations of Jocelyn Samuels to be a member of 
the Equal Employment Opportunity Commission, Jennifer Abruzzo 
to serve as General Counsel of the National Labor Relations 
Board, and Seema Nanda to serve as Solicitor for the Department 
of Labor.
    With that, the Committee stands adjourned.

                          ADDITIONAL MATERIALS

                       A Misleading C.D.C. Number
                           By David Leonhardt
    The New York Times

    Published May 11, 2021

    When the Centers for Disease Control and Prevention released new 
guidelines last month for mask wearing, it announced that ``less than 
10 percent'' of Covid-19 transmission was occurring outdoors. Media 
organizations repeated the statistic, and it quickly became a standard 
description of the frequency of outdoor transmission.

    But the number is almost certainly misleading.

    It appears to be based partly on a misclassification of some Covid 
transmission that actually took place in enclosed spaces (as I explain 
below). An even bigger issue is the extreme caution of C.D.C. 
officials, who picked a benchmark--10 percent--so high that nobody 
could reasonably dispute it.

    That benchmark ``seems to be a huge exaggeration,'' as Dr. Muge 
Cevik, a virologist at the University of St. Andrews, said. In truth, 
the share of transmission that has occurred outdoors seems to be below 
1 percent and may be below 0.1 percent, multiple epidemiologists told 
me. The rare outdoor transmission that has happened almost all seems to 
have involved crowded places or close conversation.

    Saying that less than 10 percent of Covid transmission occurs 
outdoors is akin to saying that sharks attack fewer than 20,000 
swimmers a year. (The actual worldwide number is around 150.) It's both 
true and deceiving.

    This isn't just a gotcha math issue. It is an example of how the 
C.D.C. is struggling to communicate effectively, and leaving many 
people confused about what's truly risky. C.D.C. officials have placed 
such a high priority on caution that many Americans are bewildered by 
the agency's long list of recommendations. Zeynep Tufekci of the 
University of North Carolina, writing in The Atlantic, called those 
recommendations ``simultaneously too timid and too complicated.''

    They continue to treat outdoor transmission as a major risk. The 
C.D.C. says that unvaccinated people should wear masks in most outdoor 
settings and vaccinated people should wear them at ``large public 
venues''; summer camps should require children to wear masks virtually 
``at all times.''

    These recommendations would be more grounded in science if anywhere 
close to 10 percent of Covid transmission were occurring outdoors. But 
it is not. There is not a single documented Covid infection anywhere in 
the world from casual outdoor interactions, such as walking past 
someone on a street or eating at a nearby table.

    Today's newsletter will be a bit longer than usual, so I can 
explain how the C.D.C. ended up promoting a misleading number.
                         The Singapore Mystery
    If you read the academic research that the C.D.C. has cited in 
defense of the 10 percent benchmark, you will notice something strange. 
A very large share of supposed cases of outdoor transmission have 
occurred in a single setting: construction sites in Singapore.

    In one study, 95 of 10,926 worldwide instances of transmission are 
classified as outdoors; all 95 are from Singapore construction sites. 
In another study, four of 103 instances are classified as outdoors; 
again, all four are from Singapore construction sites.

    This obviously doesn't make much sense. It instead appears to be a 
misunderstanding that resembles the childhood game of telephone, in 
which a message gets garbled as it passes from one person to the next.

    The Singapore data originally comes from a government data base 
there. That data base does not categorize the construction site cases 
as outdoor transmission, Yap Wei Qiang, a spokesman for the Ministry of 
Health, told my colleague Shashank Bengali. ``We didn't classify it 
according to outdoors or indoors,'' Yap said. ``It could have been 
workplace transmission where it happens outdoors at the site, or it 
could also have happened indoors within the construction site.''

    As Shashank did further reporting, he discovered reasons to think 
that many of the infections may have occurred indoors. At some of the 
individual construction sites where Covid spread--like a complex for 
the financial firm UBS and a skyscraper project called Project Glory--
the concrete shells for the buildings were largely completed before the 
pandemic began. (This video of Project Glory was shot more than 4 
months before Singapore's first reported Covid case.)

    Because Singapore is hot year-round, the workers would have sought 
out the shade of enclosed spaces to hold meetings and eat lunch 
together, Alex Au of Transient Workers Count Too, an advocacy group, 
told Shashank. Electricians and plumbers would have worked in 
particularly close contact.
                         Are schools outdoors?
    How, then, did the Singapore cases get classified as they did?

    When academic researchers began collecting Covid data from around 
the world, many chose to define outdoors spaces very broadly. They 
deemed almost any setting that was a mix of outdoors and indoors to be 
outdoors.

    ``We had to settle on one classification for building sites,'' 
Quentin Leclerc, a French researcher and co-author of one of the papers 
analyzing Singapore, told me, ``and ultimately decided on a 
conservative outdoor definition.'' Another paper, published in the 
Journal of Infection and Public Health, counted only two settings as 
indoors: ``mass accommodation and residential facilities.'' It defined 
all of these settings as outdoors: ``workplace, health care, education, 
social events, travel, catering, leisure and shopping.''

    I understand why the researchers preferred a broad definition. They 
wanted to avoid missing instances of outdoor transmission and 
mistakenly suggesting that the outdoors was safer than it really was. 
But the approach had a big downside. It meant that the researchers 
counted many instances of indoors transmission as outdoors.

    Yet even with this approach, they found a minuscule share of total 
transmission to have occurred outdoors. In the paper with 95 supposedly 
outdoor cases from Singapore, those cases nonetheless made up less than 
1 percent of the total. A study from Ireland, which seems to have been 
more precise about the definition of outdoors, put the share of such 
transmission at 0.1 percent. A study of 7,324 cases from China found a 
single instance of outdoor transmission, involving a conversation 
between two people.

    ``I'm sure it's possible for transmission to occur outdoors in the 
right circumstances,'' Dr. Aaron Richterman of the University of 
Pennsylvania told me, ``but if we had to put a number on it, I would 
say much less than 1 percent.''
                     Britain's Scientific Approach
    I asked the C.D.C. how it could justify the 10 percent benchmark, 
and an official there sent this statement:

        There are limited data on outdoor transmission. The data we do 
        have supports the hypothesis that the risk of outdoor 
        transmission is low. 10 percent is a conservative estimate from 
        a recent systematic review of peer-reviewed papers. CDC cannot 
        provide the specific risk level for every activity in every 
        community and errs on the side of protection when it comes to 
        recommending steps to protect health. It is important for 
        people and communities to consider their own situations and 
        risks and to take appropriate steps to protect their health.

    Erring on the side of protection--by exaggerating the risks of 
outdoor transmission--may seem to have few downsides. But it has 
contributed to widespread public confusion about what really matters. 
Some Americans are ignoring the C.D.C.'s elaborate guidelines and 
ditching their masks, even indoors, while others continue to harass 
people who walk around outdoors without a mask.

    All the while, the scientific evidence points to a conclusion that 
is much simpler than the C.D.C.'s message: Masks make a huge difference 
indoors and rarely matter outdoors.

    The health authorities in Britain, notably, seem to have figured 
this out. They have been more aggressive about restricting indoor 
behavior, locking down many businesses again late last year and 
requiring masks indoors even as most of the country is vaccinated. 
Outdoors, however, masks remain rare.

    It certainly doesn't seem to be causing problems. Since January, 
daily Covid deaths in Britain have declined more than 99 percent.
                                 ______
                                 
    [Whereupon, the hearing was adjourned at 12:42 p.m.]

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