[Senate Hearing 116-527]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 116-527

                        VACCINES: SAVING LIVES,
                        ENSURING CONFIDENCE, AND
                        PROTECTING PUBLIC HEALTH

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

                                 HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                                   ON

EXAMINING VACCINES, FOCUSING ON SAVING LIVES, ENSURING CONFIDENCE, AND 
                        PROTECTING PUBLIC HEALTH

                               __________

                           SEPTEMBER 9, 2020

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
                                     
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky			ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine			TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana		CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas		        ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska			TIM KAINE, Virginia
TIM SCOTT, South Carolina		MAGGIE HASSAN, New Hampshire
MITT ROMNEY, Utah		        TINA SMITH, Minnesota
MIKE BRAUN, Indiana			DOUG JONES, Alabama
KELLY Loeffler, Georgia			JACKY ROSEN, Nevada

              David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                  Evan Schatz, Minority Staff Director
              John Righter, Minority Deputy Staff Director
                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                      WEDNESDAY, SEPTEMBER 9, 2020

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     5

                               Witnesses

Collins, Francis, M.D., Ph.D., Director, National Institutes of 
  Health, Bethesda, MD...........................................     8
    Prepared statement...........................................    10
Adams, Jerome M., VADM, M.D., MPH, Surgeon General of The United 
  States, United States Department of Health and Human Services, 
  Washington, DC.................................................    13
    Prepared statement...........................................    15

 
                        VACCINES: SAVING LIVES,
                        ENSURING CONFIDENCE, AND
                        PROTECTING PUBLIC HEALTH

                              ----------                              


                      Wednesday, September 9, 2020

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10 a.m., in room 
SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander, 
Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Murray, Enzi, 
Sanders, Burr, Casey, Paul, Baldwin, Collins, Warren, Cassidy, 
Kaine, Murkowski, Hassan, Romney, Smith, Jones, Rosen, Scott, 
Braun, and Loeffler.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. The Committee on Health, Education, Labor, 
and Pensions will please come to order. First, I would like to 
welcome everyone and go through some administrative matters 
that we do at the beginning of the hearing. We have done this 
after consulting with the attending physicians, Sergeant-at-
Arms, CDC, Health and Human Services. Individuals in the room 
are seated six feet apart so there is no room for the public to 
attend and the press is working as a pool. The hearing maybe 
watched gavel-to-gavel online.
    Both of our witnesses today, Dr. Collins and Surgeon 
General Adams are participating in person. Some Senators are in 
person, some are participating by video conference. The Office 
of Attending Physician has advised that Senators and witnesses 
may remove their masks to talk in the microphone since our 
chairs are six feet apart or more. So that is why my mask is 
off. I am more than six feet apart. When I am in the hall or 
when I am walking on the Senate floor, I wear my mask. So we 
are grateful to the Rules Committee, the Sergeant-at-Arms, the 
Press Gallery, the Architect of the Capitol, Chung Shek and 
Evan Griffis, all who have helped us maintain a safe 
environment for this hearing. I would like to say to that their 
votes have begun at 11:15 a.m., but we will continue the 
hearing so that all Senators will have a chance to participate. 
And if necessary, I will leave and I will ask someone else to 
preside during the time that I am voting and then I will come 
back.
    Senator Murray, and I will each have an opening statement. 
We will then turn to our witnesses who we thank for being with 
us. We would like to ask the witnesses to summarize their 
remarks in 5 minutes to leave more time for back and forth 
questions. I will ask each Senator, questions of 5 minutes or 
of up to 5 minutes. I have been reading, I was saying to 
Senator Tim Kaine and Maggie Hassan that I have been reading 
Guns, Germs, and Steel the book that Jared Diamond wrote that 
won a Pulitzer Prize in 1977. He wrote that there is nothing 
new about epidemics that cause mass deaths and social upheaval, 
and there is nothing new about where most of the infectious 
disease come from.
    Over the last 10,000 years, he says, humans have acquired 
most of our infectious diseases from animals. During most of 
history there were basically three ways to deal with these 
epidemics, one was to isolate the infected. Leper colonies, for 
example. Two, according to Jared Diamond, was that over 
thousands of years there have been genetic changes in human 
populations in response to infectious diseases that cause major 
outbreaks like small pox, but that didn't help the Native 
Americans who had no resistance when European settlers arrived 
here, wiping out 90 percent for example of a native tribes by 
handing them blankets with smallpox on it because the tribe had 
not previously been exposed to the virus. And then there is a 
third way that was most common throughout most of history and 
that was really to let it rip, let the virus run its course 
through the population until everyone had either been killed or 
recovered and develop some immunity. Diamond says that the 
Black Death killed about one third of Europe's population 
between 1347 and 1351.
    What is new about epidemics is modern medicine, including 
the ability to diagnose the disease and create treatments to 
make it easier to recover. But the true miracle of modern 
medicine is vaccines which can prevent humans from acquiring 
the disease at all. That is why today in all 50 states and the 
District of Columbia school children are required to take 
vaccinations for the following diseases, diphtheria, tetanus, 
the whooping cough, polio, measles, rubella and chickenpox 
before entering school. The vaccination will protect the child 
from getting the disease which in turn prevents the child from 
infecting someone else, a pattern that has caused these 
diseases eventually to disappear.
    Americans of my generation remember how polio terrified our 
parents in the early 1940's and 50's. Many saw their children 
die or be left depended on an iron lung to breathe for the rest 
of their lives. Of those who contracted polio, the lucky 
children were like Senator Mitch McConnell, the majority 
leader, who was left only with a limp. The disease terrified 
Americans until Dr. Jonas Salk developed the polio vaccine in 
the 1950's. After the vaccine was developed, the United States 
undertook a large-scale vaccination program and polio was 
declared eradicated from the United States in 1979. So the 
purpose of this hearing is to explore the remarkable progress 
that science is making toward a COVID-19 vaccine to remind 
parents to get their child vaccines and to encourage as many 
Americans as possible to get the flu vaccine this fall.
    First the progress toward a COVID vaccine. Dr. Collins, the 
Director of the National Institutes of Health, is here today to 
talk about that, research and development, Operation Warp-Speed 
which is working around the clock to develop manufacture and 
distribute a safe and effective vaccine to hundreds of millions 
of Americans. Some people incorrectly believe that warp speed 
means cutting corners, but it refers to the extraordinary 
investment in research, development, and manufacturing scale up 
for the COVID-19 vaccine. Perhaps most significantly the 
Biomedical Advanced Research and Development Authority, we call 
it BARDA, has taken up the unprecedented step to help speed up 
manufacturing for hundreds of millions of doses of the vaccine 
early in the process so they can be ready as soon as the new 
vaccines are approved by the Food and Drug Administration.
    In other words, they will be manufactured before they are 
approved, and if they are approved, they will be ready to 
distribute and if they are not approved, they will be thrown in 
the dumpster. Despite the speed with which scientists are 
developing this COVID-19 vaccine, Dr. Hahn, the Commissioner of 
FDA, said the Administration is not or his agency, ``is not 
skimping on its review of safety and efficacy. This is going to 
be a science, medicine data decision. This is not going to be a 
political decision,'' Dr. Hahn said. That means that if the FDA 
determines that a vaccine is not safe or effective after 
reviewing the science and clinical trial results, the vaccine 
will not be distributed.
    At the same time, CDC is working on a plan to distribute 
the vaccine as soon as they are authorized or approved, 
prioritizing vaccines for healthcare workers and vulnerable 
populations. CDC's plan will be a fair system informed by 
nonpartisan health experts from the National Academies of 
Science, Engineering and Medicine and the Advisory Commission 
on Immunization Practice. As inevitably happens, some have 
suggested, well, you are speeding up the vaccine because an 
election is coming and you have asked states to distribute it 
because an election is coming. Well, I was thinking this 
morning, what if Dr. Collins showed up and Dr. Adams saying 
well, it will be 5 years before we are going to get a vaccine. 
I think we probably throw them out of the room and ask the 
President to try to find some more effective people. Or what if 
we didn't ask states to get ready to distribute the vaccine and 
show that we hadn't learned our lesson from what happened with 
the H1N1 virus when the vaccine was ready, but the states 
weren't ready to distribute it. So we should move as rapidly as 
we can, both to develop the vaccine and to be prepared to 
distribute it.
    Why are some Americans saying they are not persuaded to 
take the vaccine? Well, there are three reasons. One is are 
they safe? Vaccines are approved and reviewed by the Food and 
Drug Administration. FDA can either license a vaccine or 
authorize it for use during a public health emergency and the 
FDA stringent approval process is the world's gold standard. 
The vaccines are routinely--that are given to children are 
specifically recommended by the advisory committee on 
immunization practices and outside group of health experts that 
look at all available scientific information about each 
vaccine. And the medical associations like the American Academy 
of Pediatrics ,the American Academy of Family Physicians work 
with that agency to develop these recommendations.
    In a 2015 article in Scientific American, Nina Fimeran 
writes, ``by age two, most children will receive almost 30 
shots designed to boost a child's natural defenses against 
disease yet the same time parents who take their children for 
those recommended vaccinations might be inundated with website 
and celebrity espoused rumors making false claims that shots 
are not necessary or cause autism.'' She continues, ``at best 
navigating this landscape can be confusing but when weighing 
the risk of encountering life-threatening disease against the 
benefits of receiving a vaccine, there is no contest. The vast 
majority of children do not experience anything worse than 
short-lived redness or itching at the spot of the injection.'' 
And then are they effective? According to CDC there is evidence 
that smallpox was ravaging humans as early as the 3rd century 
B.C.E.
    The disease killed three out of 10 people who were 
affected. Then in 1796 an English doctor named Edward Jenner 
saw that milkmaids who had gotten cowpox seemed to be immune 
from smallpox. So he scratched some pus from a cowpox blister 
on an eight-year-old boy and the boy became immune to smallpox. 
Jenner published his results in 1801 leading to the development 
of mankind's first ever vaccine and no one on earth has 
naturally acquired smallpox since 1977. It has been officially 
eradicated. Polio was one of the most dreaded childhood 
diseases. Following the introduction of vaccines, specifically 
the vaccine in 1955 and then another in 1963, the number of 
polio cases fell rapidly to less than 100 in the 1960's to 
fewer than 10 in the 1970's according to CDC.
    Thanks to a successful vaccination program, the United 
States has been polio-free since 1979. Diphtheria terrified 
patients in the 1920's but today there are only a few cases a 
year according to the AAP which attributes the change to 
vaccinations. And then there is, is the doctor's office safe? 
The panic has made some parents leery of the doctor's office, 
but analysis of patient records according to the Wall Street 
Journal, shows that the immunization rate for recommended 
routine childhood vaccines has declined about 40 percent from 
late February through mid-April. So for parents who are worried 
about taking the children to the doctor, the American Academy 
of Pediatrics says pediatricians are working to make their 
offices as safe as possible. They say they are among the safest 
places you can be. Don't be afraid to take your child to see 
your doctor.
    I started my statement with comments from Jared Diamond. I 
will end with a warning he wrote recently, on June 23rd this 
Committee held a hearing on preparing for the next pandemic. 
One member of the Committee asked, why would we worry about the 
next pandemic when we haven't even conquered this one yet? Well 
in a Wall Street Journal essay on May 23rd Jared Diamond 
provides an answer to that comment. He says that in this age of 
jet planes with millions of people carrying infections from one 
place to another overnight, the next pandemic could be next 
year and we would be wise to prepare for it. Congress tried to 
do that in response to the other new diseases that have emerged 
over the last 40 years. HIV/AIDS, SARS, MERS, Ebola, but good 
intentions often evaporated as the epidemics ended. As one 
example, in 2012 Congress created three manufacturing plants, 
so that when the next epidemic arrived we could introduce 
vaccines rapidly.
    Fortunately two of those plants are playing a role in 
manufacturing hundreds of millions of doses of vaccine for 
COVID-19. Senator Burr, and I took a virtual tour of one of 
them not long ago. However, there is still a need to improve 
and sustain these types of facilities so they are able to pivot 
more quickly to the next threat when it emerges. In a similar 
way, stockpiles were created and then stockpiles were depleted. 
Former HHS Secretary and Governor Mike Leavitt told this 
Committee that public health programs have been underfunded for 
the last 30 to 40 years. The Nation goes, he said, from panic 
to neglect to panic. Fortunately, thanks to an unprecedented 
effort by the private sector in our Government as well as 
scientists around the world, there is likely to be a COVID-19 
vaccine ready for the most vulnerable citizens by the end of 
the year and hundreds of millions of doses available in 2021. 
Some of the challenges apart from finding a vaccine are how to 
distribute it, whom should it go first, and how to persuade 
Americans that it is safe to take.
    But while we are in the midst of dealing with this 
pandemic, it would be wise to remember in any legislation that 
Congress passes this year to make sure that onshore 
manufacturing plants are functioning, stockpiles are full, 
public health is properly funded, and states have the right 
tools and resources. The reason to do that now while our eye is 
on the ball is at the next pandemic, as Jared Diamond wrote, 
could be next year.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman. 
And while you still have a few months left, well and a few more 
hearings, I do want to start off by saluting you for your many 
years of service to this country, including as Senator and 
Chairman of this Committee. I know my Democratic colleagues and 
I will miss you next year. On the topic of today's hearing. Mr. 
Chairman, our country is in the middle of a painful crisis.
    The COVID-19 pandemic has crowded hospital intensive care 
units. It has emptied schools. It has shuttered businesses. It 
has deepened damaging health disparities among Black, Latino, 
and tribal communities, people with low incomes and people with 
disabilities. It has ravaged prisons and nursing homes and 
other congregate care facilities. It has strained our economy, 
our mental health, and a lot more. It has claimed around 
190,000 lives so far and more each day. Unfortunately, instead 
of leading us in the war against this virus and fighting the 
pandemic, President Trump is fighting public health experts.
    Instead of supporting facts and science, he is supporting 
conspiracies. He has spread absurd false theories about FDA 
officials being deep state agents and CDC overstating the death 
toll. He has promoted unproven treatments and junk science. He 
has called for less testing, which he blamed for the rising 
number of COVID-19 cases, wrongly claimed kids aren't likely to 
get or transmit the virus, and has repeatedly insisted this 
will just all go away. The list of inaccuracies and outright 
lies at a time when truth is a matter and life and death goes 
on and on. And unfortunately, President Trump is not alone in 
his deeply flawed response.
    In July, after months of delay in an action, Republicans 
put forward a proposal that didn't even come close to 
addressing the harsh realities of this pandemic. Now, we are 
hearing their new plan is to force a vote on a proposal that 
does even less. I hope instead that Republicans will sit down 
with Democrats to work on a package that helps our economy and 
keeps our American families safe. A package that actually 
increases testing and access to healthcare, that actually 
supports our schools and addresses the child care crisis and 
actually protects workers, and most relevant to this hearing 
today helps make sure we get safe, effective, trusted vaccines 
that are widely and equitably distributed and administered.
    Vaccines have long been a critical public health tool, and 
even before this crisis, it was important that we encourage 
uptake of flu vaccines each year to keep people safe, to make 
sure vaccines are available and administered to kids across the 
Nation including through efforts like the Vaccines for Children 
program, and to build vaccine confidence while combating 
misinformation. But this pandemic has made these challenges 
more urgent than ever. So I am glad we do have Surgeon General 
Dr. Adams and NIH Director Dr. Collins here today to share 
their expertise, but I am also frustrated that despite my 
request to the Chairman, FDA Commissioner Dr. Hahn and CDC 
Director Dr. Redfield were not invited to testify today. Those 
agencies play a very critical role in developing and 
distributing vaccines and should be here today. Hearing from 
them is even more urgent in light of recent political 
interference. By waiting to bring them before the Committee, we 
are losing valuable time to avoid costly mistakes.
    In the past few weeks, we have not only watched President 
Trump directly promote conspiracies about FDA and CDC, we have 
also seen reports that he exerted political pressure on FDA to 
issue an emergency use authorization for convalescent plasma, 
and on CDC, which changed testing guidelines to be more 
restrictive with no justification and running counter to the 
consensus of public health experts from across the country. And 
these aren't the first reports of political interference. The 
Trump administration has previously promoted unproven 
treatments like hydroxychloroquine and blocked CDC guidelines 
for community reopening.
    Recently FDA Commissioner Hahn announced he was prepared to 
authorize a COVID-19 vaccine before Phase 3 trials were 
complete but without providing any guidance about when that 
would be appropriate. When it comes to a COVID-19 vaccine, we 
cannot allow President Trump to repeat his alarming pattern of 
putting politics ahead of science and public health. FDA 
scientists' efforts to ensure the safety and efficacy of 
vaccines must not be undermined by political meddling. CDC's 
role in distributing a vaccine and prioritizing who receives 
the first doses must not be supplanted by politicians or 
campaign strategists or corporate lobbyists.
    If we are going to begin to turn the page on this pandemic, 
people across the country must not have any doubt in this 
process or in the final product, which is why we need to hear 
directly and immediately from our public health agencies about 
how they will prevent political interference and why we need to 
push to the transparency required to hold this Administration 
accountable. We need the FDA to be transparent by issuing an 
official guidance with standards for granting any vaccine and 
emergency use authorization, including standards for the 
independent review of Phase 3 data by waiting for the 
completion of Phase 3 clinical trials before moving on any 
candidates and by committing to make public any data used to 
green-light a vaccine.
    We need transparency from CDC about how it plans to handle 
distribution, how its experts will drive the process despite 
the ill-advised decision to have the Department of Defense 
rather than CDC lead a lot of this effort and who will get 
priority when the first doses are available. We also need 
transparency on Operation Warp-Speeds contracts and how it is 
addressing any potential conflict of interest. In short, we 
need transparency from top to bottom. And of course in addition 
to transparency, we still need a comprehensive national vaccine 
plan, one of several steps I have called for in the vaccine 
white paper I put out on vaccine months ago. We have seen with 
testing how many problems the Trump administration caused by 
throwing up its hands and refusing to develop a plan and 
leaving our states to fend for themselves. Testing is an 
ongoing catastrophe and we cannot risk a repeat performance 
when it comes to vaccines.
    The Administration must develop an end-to-end national 
vaccine plan that addresses how we make sure vaccines are safe 
and effective, how we produce, distribute, and administer 
hundreds of millions of doses, how we alleviate rather than 
deepen the health disparities we know exist, and how we 
overcome barriers to access like cost and proximity to 
providers, and how we promote vaccine confidence and fight 
misinformation, especially when there is so much misinformation 
coming from the President of the United States. Developing and 
distributing safe, effective vaccines is a huge undertaking and 
one that cannot be accomplished without a strong science driven 
leadership from the Federal Government.
    I really am glad we have this opportunity to talk about the 
important challenges that lie ahead but there are many more 
questions we need to answer and so many more witnesses that we 
need to hear from. And I will absolutely keep pushing to make 
that happen. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray, and as usual, you 
are having some considerable effect. We have announced our next 
health hearing which will be in two weeks. Dr. Redfield from 
CDC will be a witness. Admiral Giroir will be here. Dr. Hahn, 
head of FDA will be here. And Dr. Anthony Fauci will be a 
witness. Today, we have two witnesses. We welcome them.
    Dr. Francis Collins is Director of the National Institutes 
of Health. He oversees the largest public funding of biomedical 
research in the world. He is a physician geneticist. Prior to 
becoming the NIH Director in 2009, he served as Director of the 
agency's National Human Genome Research Institute from 1993 to 
2008, and he led the International Human Genome Project. He is 
a member of the National Academy of Medicine, National Academy 
of Science and was awarded the Presidential medal of freedom 
and received the national medal of sciences. He is a graduate 
of Virginia and Yale, University of North Carolina School of 
Medicine, and he is the only National Institutes of Health 
Director I know who has ever played the guitar at the Bluebird 
Cafe in Nashville and played it pretty well I might say.
    Next, we hear from Vice Admiral Jerome Adams, Surgeon 
General of the United States. He oversees Public Health Service 
Commission Corps, a group of over 6,000 public health 
professionals working throughout the Federal Government for the 
advancement of public health. He previously served as the 
Indiana State Health Commissioner. He led that state's response 
to Ebola, HIV, and Zika.
    He was staffed anesthesiologist and assistant professor at 
the Indiana University School of Medicine. He has been at the 
University of Maryland Baltimore County where he obtained a 
degree, Masters from the University of California at Berkeley 
and MD from Indiana University where he completed his 
residency. Welcome to both witnesses. Dr. Collins, let's begin 
with you.


 STATEMENT OF FRANCIS COLLINS, M.D., PH.D., DIRECTOR, NATIONAL 
               INSTITUTES OF HEALTH, BETHESDA, MD

    Dr. Collins. Well, thank you very much and perhaps we could 
get the visuals up on the screen if that is possible. Chairman 
Alexander, Ranking Member Murray and distinguished Members of 
this Committee, thank you for inviting me to discuss Operation 
Warp-Speed and the importance of developing safe and effective 
vaccines. I am grateful for your long-standing support of NIH 
and for this opportunity to address how we are working 
tirelessly with other parts of the Government and with industry 
partners to prevent, diagnose, and treat the novel coronavirus, 
SARS COVID 2. Let me provide a metaphorical illustration of how 
vaccines work.
    Your immune system is like an antibody factory. Yes, you 
have a very sophisticated biotech company inside your body. 
When your body sees an invader like these three viruses, it 
designs an antibody, a y-shaped protein that can counter that 
specific threat. It may take a week or two for the factory to 
make that new product but then it keeps the blueprints on file 
for every antibody it has ever made. The goal of a vaccine 
therefore is to present a completely harmless part of the virus 
to your body, allowing your factory to work out an effective 
production strategy. Now, if at some time in the future the 
actual virus enters your body, your factory can quickly pull 
out the blueprints and ramp up production wiping out that virus 
before it has a chance to multiply and make you sick. For 
COVID-19, there are six vaccine candidates engaged in large-
scale U.S. trials.
    Each vaccine has already undergone rigorous testing in 
animals followed by Phase 1 safety testing and a small group of 
humans. For three of the six vaccines, we are already in Phase 
3 of testing, where the goal is to inject 30,000 volunteers 
located in areas where the virus is actively spreading. Half of 
the volunteers are injected with the vaccine and half placebo 
and nobody knows which is which. Over the next weeks, they are 
followed closely to see if infections occur. A successful 
vaccine should have many fewer cases of COVID-19 in those who 
got the actual vaccine versus those who got the placebo. We 
will also follow all of them for as long as two years to assess 
safety. We expect the other three candidates to enter Phase 3 
in the coming weeks and months. Now these six vaccines 
represent three different scientific approaches.
    Having this mix of strategies is the best insurance against 
some unexpected problem with safety or efficacy. We hope and 
expect that more than one of these will succeed. They all have 
one thing in common, the initiation of immune responses against 
the spike protein of the SARS COVID 2 virus and you have seen 
this picture so many times but that is the protein you want to 
raise that antibody against. We know that people who have 
survived COVID-19 make neutralizing antibodies to this spike. 
So we want the vaccine to do the same. Now, the first 
scientific approach is a very traditional method, recombinant 
protein technology. Basically, you purify the spike protein in 
the laboratory and you inject that purified protein and the 
antibody factory goes to work. The laboratory process to 
produce and purify the protein means that this approach, 
although tried and true, is on a bit lower trajectory than some 
of the other candidates but not much.
    Novavax plans to initiate their Phase 3 trial in mid-
October. Santa Fe and GSK announced their Phase 1 clinical 
trial last week. If results are positive, Phase 3 would start 
for them by the end of the year. The second scientific approach 
also uses a well-known vaccine technology, harnessing a 
harmless viral vector called an adenovirus and using it 
basically as a delivery truck. The adenovirus is modified by 
inserting a gene for the spike protein. Once the virus enters 
the individual cells, the spike protein is produced triggering 
an immune response. Phase 3 clinical trial of this approach was 
launched by AstraZeneca on August 31st, though it is now as of 
yesterday on clinical halt ,and a similar Phase 3 trial will be 
launched by Jansen later this month.
    Finally the newest platform technology is one that was 
developed at NIH using supplemental funds from the Ebola 
epidemic a few years ago. In this approach, which is now being 
pursued separately by Pfizer and by Moderna, a small, non-
infectious snippet of messenger RNA or mRNA from the genome of 
SARS COVID 2 is prepared. Injecting this mRNA, which codes for 
this spike protein, into muscle will spur a person's own cells 
to make that protein and then encourage the production of those 
protective antibodies against SARS COVID 2. Before I conclude, 
I want to address concerns about safety. This is foremost in 
all our minds. We cannot compromise here. The announcement 
yesterday about the AstraZeneca vaccine is a concrete example 
of how even a single case of an unexpected illness is 
sufficient to require a clinical halt for the trial in multiple 
countries. And that is what is happening. There are ways 
however that we have adopted in warp speed to move quickly 
while retaining those most rigorous scientific standards.
    I think you would want us to do that. People are dying. 
Delays that traditionally require many years for a vaccine to 
be developed had to be addressed. In some instances we have 
done that by carrying out steps in parallel that are 
traditionally done in sequence. We have eliminated downtime by 
moving into new phases before data from the previous phase is 
completely analyzed. We have, as the Chairman said, started to 
manufacture doses of all these vaccines before we know if they 
work, understanding that we are spending hundreds of millions 
of dollars for a vaccine doses that we may have to throw away 
if they don't work. But please hear me out, the rigor of the 
scientific evaluation on safety and efficacy will not be 
compromised.
    As a scientist, I am excited that the pace of discovery is 
allowing us to respond to this crisis in record time. As a 
physician, I am hopeful when I think of the millions of lives 
that have been saved from other diseases through vaccination 
and the millions more that we can save by developing a safe and 
effective vaccine for COVID-19. Thank you again for your 
support. I look forward to your questions.
    [The prepared statement of Dr. Collins follows:]
                prepared statement of francis s. collins
    Chairman Alexander, Ranking Member Murray and distinguished Members 
of this Committee thank you for inviting me to discuss the Department 
of Health and Human Services' (HHS) Operation Warp Speed (OWS) efforts 
and the importance of vaccination. I am grateful for this opportunity 
to address how the National Institutes of Health (NIH) is working 
tirelessly with other parts of the government, and with industry 
partners, to prevent, diagnose, and treat the novel coronavirus SARS-
CoV-2. We thank Congress for your continual partnership in response to 
COVID-19.

    I am also pleased to be here today to reinforce the importance 
vaccines play in protecting public health from childhood immunizations 
to the annual flu and pneumonia vaccines in keeping Americans safe and 
healthy. While our immediate focus has been on the development of a 
COVID-19 vaccine, we can't lose sight of the need to encourage the 
continued uptake of all vaccines by the American people.

    To accelerate the development and subsequent production of a 
vaccine for COVID-19, in mid-May, President Trump announced Operation 
Warp Speed (OWS). OWS aims to deliver up to 300 million doses of a safe 
and effective vaccine for COVID-19 in early 2021, as part of a broader 
strategy to accelerate the development, manufacturing, and distribution 
of COVID-19 vaccines, therapeutics, and diagnostics (collectively known 
as medical countermeasures). OWS is a partnership among components of 
HHS, including NIH, Centers for Disease Control and Prevention (CDC), 
U.S. Food and Drug Administration (FDA), and Biomedical Advanced 
Research and Development Authority (BARDA), and the Department of 
Defense (DoD), with the aim of a unified government approach to respond 
to the pandemic. OWS engages with private firms and other Federal 
agencies, including the Department of Agriculture, the Department of 
Energy, and the Department of Veterans Affairs. OWS coordinates with 
existing HHS-wide efforts, including the NIH's Accelerating COVID-19 
Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH's Rapid 
Acceleration of Diagnostics (RADx) initiative, and research activities 
by the National Institute of Allergy and Infectious Diseases (NIAID).

    NIH is the HHS agency leading the biomedical research response to 
COVID-19 and the novel coronavirus that causes the disease, SARS-CoV-2. 
We have done everything possible to unleash the most rapid and 
innovative approaches to address this global pandemic. The importance 
of studying the safety and efficacy of vaccine and therapeutic 
candidates during the critical clinical trial phases is now NIH's top 
priority. OWS has been selecting the most promising countermeasure 
candidates and providing coordinated government support. Protocols for 
the demonstration of safety and efficacy are being aligned, which 
allows the trials to proceed more quickly. The protocols for the trials 
are being overseen by the Federal Government, in contrast to 
traditional public-private partnerships, in which pharmaceutical 
companies are solely responsible for design and implementation of their 
own protocols. Rather than eliminating steps from traditional 
development timelines, steps are proceeding simultaneously. That 
includes starting manufacturing of a vaccine candidate at industrial 
scale well before the demonstration of vaccine efficacy and safety, as 
happens normally. This increases the financial risk in the event of 
non-optimal product performance, but not the product risk.

    It is important to highlight that none of the safety and efficacy 
assessments will be skipped or abbreviated. Efforts to shorten the 
timeline from bench to bedside, but still achieve a safe and effective 
vaccine, have been accomplished by eliminating down times and assuming 
the costs of at-risk manufacturing. Throughout the clinical trials, an 
independent data and safety monitoring board (DSMB) continues to 
monitor ongoing results to ensure study participant well-being and 
safety as well as study integrity. The critical final steps in clinical 
trials will be well-coordinated and done in parallel with 
manufacturing, but with NIH and industry providing the FDA with all of 
the critical safety and efficacy data necessary for sound scientific 
decisionmaking.

    NIH is deeply engaged in the vaccine trial program. NIAID recently 
established the COVID-19 Prevention Network (CoVPN) by leveraging four 
existing NIAID-funded clinical trials networks: the HIV Vaccine Trials 
Network (HVTN), the HIV Prevention Trials Network (HPTN), the 
Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS 
Clinical Trials Group (ACTG), in partnership with the DoD. The CoVPN is 
engaged in assisting enrollment of tens of thousands of volunteers in 
large-scale clinical trials testing a variety of investigational 
vaccines, monoclonal antibodies (mAb), and drugs intended to treat and 
protect people from COVID-19. The CoVPN is a functional unit of the OWS 
partnership led by HHS to invest in and coordinate the development, 
manufacture, and distribution of COVID-19 vaccines, therapeutics, and 
diagnostics. The CoVPN is participating in harmonized protocols, 
developed in collaboration with the ACTIV public-private partnership, 
vaccine manufacturers, and BARDA. The network will participate in 
numerous trials at more than 100 clinical trial sites across the United 
States and internationally. The CoVPN has developed an extensive 
community engagement framework to reach out to the diverse communities 
most affected by COVID-19; understand interest in, and concerns about, 
research participation; and partner with them to ensure their input is 
reflected in study implementation. The CoVPN plans to evaluate both 
therapeutic and vaccine candidates. While the long-term goal is to have 
a safe and effective vaccine, NIH is continuing its vital work on 
researching and evaluating all potential therapeutic approached against 
SARS-CoV-2.
               Identifying Therapeutics to Treat COVID-19
    NIH, in collaboration with the Foundation for the NIH, launched an 
innovative public-private partnership to speed up the development of 
COVID-19 therapeutics and vaccines. The ACTIV public-private 
partnership brings together stakeholders from across the U.S. 
Government, industry, and the European Medicines Agency to develop an 
international strategy for a coordinated research response to the 
COVID-19 pandemic. The ACTIV public-private partnership is led by an 
Executive Committee co-chaired by me and Dr. Paul Stoffels of Johnson & 
Johnson, and has engaged more than 100 experts from both sectors in a 
24/7 effort to prioritize therapeutic options. ACTIV has designed five 
adaptive master protocols for ACTIV clinical trials. These master 
protocols provide an efficient and coordinated evaluation of multiple 
investigational agents as they become available within the same 
clinical trial structure and across multiple study sites. Adaptive 
master protocols reduce administrative burden and cost, provide a 
flexible framework to identify rapidly drug candidates that work, and 
quickly move additional experimental agents into the trial.

    Effective therapeutics for COVID-19 are critically needed to treat 
patients who have been infected with SARS-CoV-2. NIH was engaged in 
this effort from the very beginning of the pandemic. On February 21, 
2020, NIAID launched a multicenter, randomized placebo-controlled 
clinical trial, the Adaptive COVID-19 Treatment Trial (ACTT), to 
evaluate the safety and efficacy of therapeutics for COVID-19, 
initially examining the antiviral drug remdesivir for treatment of 
severe COVID-19 in hospitalized adults (ACTT-1). An analysis of 
preliminary data from ACTT-1 indicated that those who received 
remdesivir had a 32 percent faster time to recovery, a median of 11 
days compared with 15 days for those who received placebo. These 
initial findings were published on May 22, 2020, in the New England 
Journal of Medicine. The adaptive design of this trial will enable the 
evaluation over time of additional promising therapies, such as the 
anti-inflammatory drug baricitinib. This drug was added to the second 
iteration of the study (ACTT-2); enrollment for ACTT-2 is now complete. 
The third iteration of the study (ACTT-3), announced by NIH on August 
6, 2020, is a randomized, controlled clinical trial to study the use of 
interferon beta-1a, which is typically used to treat individuals with 
multiple sclerosis.

    Monoclonal antibodies (mAbs) are another promising approach for the 
treatment of COVID-19. At least 21 companies are developing mAbs that 
target SARS-CoV-2 and several of them are already being studied in 
clinical trials. On August 4, 2020, NIH launched two clinical trials 
under the ACTIV-2 and ACTIV-3 master protocols. ACTIV-2, a Phase 2/3 
clinical trial, will evaluate potential therapeutics in study 
participants with mild to moderate COVID-19 who do not require 
hospitalization. The first stage of ACTIV-2 is looking at the potential 
of synthetic mAbs to treat the disease. The trial may also investigate 
other experimental therapeutics later under the same trial protocol. 
Another Phase 2/3 randomized, controlled trial known as ACTIV-3 will 
test mAb treatments in hospitalized patients. The initial stage of the 
ACTIV-3 clinical trial plans to enroll approximately 300 volunteers who 
have been hospitalized with mild to moderate COVID-19. ACTIV-3 will 
initially study the investigational mAb from Lilly, LY-CoV555, 
discovered by Abcellera Biologics in collaboration with NIAID's Vaccine 
Research Center (VRC).
  Developing Vaccines to Prevent SARS-CoV-2 Infection and/or COVID-19 
                                Disease
    A safe and effective vaccine for SARS-CoV-2 will be essential to 
stopping the spread of infection, reducing rates of morbidity and 
mortality, and preventing future outbreaks. It is among our best hopes 
for getting our country back to normal.

    NIAID has been supporting development of several SARS-CoV-2 vaccine 
candidates, including vaccines based on platform technologies that have 
shown promise against coronaviruses that cause SARS and MERS. As part 
of a longstanding collaboration, the NIAID VRC worked with 
biotechnology company Moderna, Inc., to develop a vaccine candidate 
using a messenger RNA (mRNA) vaccine platform expressing the SARS-CoV-2 
spike protein. On July 14, 2020, encouraging interim findings from the 
Phase 1 clinical trial were published in the New England Journal of 
Medicine. The investigational mRNA-1273 vaccine was generally well 
tolerated and induced robust neutralizing antibody responses in healthy 
adults in this interim analysis of data from the ongoing trial. On May 
29, 2020, a Phase 2 clinical trial, sponsored by Moderna, was initiated 
to further study the safety and immune response to the experimental 
mRNA vaccine. The Phase 2 study closed to enrollment on July 30, 2020, 
and is now in follow-up--no safety concerns have been identified. The 
Coalition for Epidemic Preparedness Innovations (CEPI) funded the 
manufacture of the vaccine candidate for the Phase 1 trial, and BARDA 
is supporting advanced development of the candidate.

    Scientists at NIAID's Rocky Mountain Laboratories (RML) in 
Hamilton, Montana, are collaborating with University of Oxford 
researchers to develop the SARS-CoV-2 chimpanzee adenovirus-vectored 
vaccine candidate AZD1222, formerly known as ChAdOx1. The University of 
Oxford has partnered with the pharmaceutical company AstraZeneca on 
this vaccine candidate, now in a Phase 3 clinical trial in the U.S. 
supported by NIAID and BARDA. BARDA has announced plans to support 
advanced development and production of AZD1222.

    In July, OWS committed to working with Novavax on their new COVID-
19 vaccine candidate after Phase 1 trials of this vaccine were done in 
Australia with promising results. A Phase 3 trial is expected to begin 
in the U.S. by the end of September. Janssen Pharmaceutical Companies 
of Johnson & Johnson have a viral vector COVID-19 vaccine candidate 
that has demonstrated protection in nonhuman primate models. OWS is 
working with this company and Phase 1 trials began on July 27, 2020, in 
the U.S. Depending on results from the early trials, a Phase 3 clinical 
trial is expected to begin this month. Additionally, Sanofi working 
with GSK developed a protein-based vaccine candidate that is currently 
in preclinical development. A Phase 1 trial is expected to begin this 
month with a goal of entering Phase 3 by the end of 2020.

    Lastly, Pfizer working with BioNTech developed an RNA vaccine 
candidate for COVID-19. Phase 3 trials for this vaccine began on July 
27, 2020. The RNA vaccines, developed by Pfizer in partnership with 
BioNTech, and by Moderna in partnership with NIAID, have already begun 
large scale manufacturing in order to be ready to distribute if the 
Phase 3 trials show promising results on the safety and efficacy of the 
vaccine candidates. OWS is working to refurbish manufacturing sites to 
scale up manufacturing for the other COVID-19 vaccine candidates in 
testing. The CoVPN at NIH is currently working to enroll thousands of 
volunteers in the clinical trials for vaccine candidates and preventive 
interventions. We continue to prioritize enrollment of racial and 
ethnic populations impacted disproportionately by this disease. It is 
critical that we continue to engage all communities in this effort with 
transparency and the highest standards of safety and ethics.

    The CoVPN developed a community engagement framework to assist 
researchers in reaching out to communities, and potential research 
volunteers. In order to have the trust of the community, NIH has 
prioritized open and transparent communication with participants, 
sharing the specific details involved in participating in the clinical 
trials for COVID-19 vaccine candidates or therapeutics and using their 
feedback to improve the trial designs. To facilitate outreach to key 
communities, the CoVPN established expert panels of 10-15 scientific 
experts from within those respective communities. NIH believes that by 
engaging communities early we can address any concerns about the 
treatments and vaccines in advance of potential distribution of FDA-
approved/licensed vaccines.
                    COVID-19 and Seasonal Influenza
    The fight against the COVID-19 pandemic may become more difficult 
as we enter the fall and winter ``flu season''. Each year influenza 
causes a surge in hospitalizations. This expected surge, in combination 
with COVID-19, is a serious concern for healthcare systems across the 
U.S. In addition to the expected surge in patient numbers, the clinical 
symptoms for influenza and SARS-CoV-2 can overlap, and an increase in 
influenza infections will require testing for SARS-CoV-2 in order to 
determine if the patient has COVID-19 or influenza. NIAID is currently 
supporting studies investigating the impact of seasonal influenza co-
circulation with SARS-CoV-2, and coinfections have already been 
observed in the Southern hemisphere. An increase in the vaccination 
rate for influenza will help to safeguard our healthcare systems 
against this surge, by reducing flu morbidity, to allow for COVID-19 
surge capacity in hospitals and reducing the number of sick individuals 
presenting to outpatient clinics. During the 2018-2019 fall and winter, 
the influenza vaccination rate for adults was 45.3 percent. It is 
imperative that we increase this vaccination rate to protect our 
healthcare systems. Last, it is important to remind the public that 
childhood vaccinations are another way we can protect our communities 
and healthcare systems from avoidable illnesses and deaths.
                               Conclusion
    The rigorous clinical testing required to establish vaccine safety 
and efficacy means that it may take some time for a licensed SARS-CoV-2 
vaccine to be available to the general public, but there is growing 
optimism that one or more of these vaccine candidates will prove safe 
and effective by late 2020 or early 2021.

    The NIH is the world's largest biomedical research funder, but we 
are also America's research engine. Right now, our funded scientists 
are working around the clock to find the best ways to diagnose, 
prevent, and treat COVID-19. We won't rest until this job is done.
                                 ______
                                 
    The Chairman. Thank you, Dr. Collins.
    Dr. Adams, welcome.

STATEMENT OF JEROME M. ADAMS, VADM, M.D., MPH, SURGEON GENERAL 
 OF THE UNITED STATES, UNITED STATES DEPARTMENT OF HEALTH AND 
                 HUMAN SERVICES, WASHINGTON, DC

    Dr. Adams. Well, good morning. And thank you Chairman 
Alexander, Ranking Member Murray and Committee Members for 
allowing me to address the importance of childhood and adult 
immunizations particularly in the context of COVID-19. My 
central message today is this, equitable vaccination of 
America's children and adults against preventable diseases is 
safe, smart good for the economy and critical in our fight 
against COVID-19.
    The science here is clear. Vaccines save lives and the U.S. 
vaccine supply is the safest in history and the safest in the 
world and they are at great value as every dollar invested in 
the measles vaccine, for instance, saved society up to twenty. 
This is because the vaccines actually prevent disease keeping 
people out of the hospital and clinic and keeping employees and 
parents in the workplace. Yet despite these benefits, less than 
half of adults get a yearly flu vaccine. Flu vaccines reduce a 
pregnant woman's risk of hospitalization by 40 percent and a 
newborn baby's risk by 72 percent. However, only half of all 
pregnant women get recommended flu and whooping cough 
vaccinations. And pregnant African Americans have even lower 
vaccination rates, a fact which may contribute to higher infant 
and maternal mortality. In fact, vaccination among ethnic and 
minority adults lags far behind already poor national averages.
    37 percent of Hispanics, Native Americans, and African 
Americans get their flu shots versus 48 percent of whites. 
Among adults, rates of pneumococcal vaccination exceed 70 
percent in whites but are just over 50 percent in Blacks and 
Hispanics, and these disparities persist for tetanus, zoster 
and Tdap as well. I want to move to childhood vaccinations and 
it is important to note that childhood vaccination rates remain 
high nationally, but one in ten parents refuse at least one 
childhood vaccine and almost a third delay a vaccine.
    We know that unvaccinated children are more likely to be 
uninsured to live below the poverty level and to live in rural 
areas. Unfortunately, the fear and access issues induced by 
COVID-19 has put millions of additional children and adults at 
risk for vaccine preventable diseases. So to ensure the 
benefits of vaccines for all Americans, we must acknowledge and 
address obstacles to vaccination and in particular those 
encountered by racial and ethnic minority communities. These 
obstacles, which I think are also opportunities, include public 
education and rebuttal of misinformation, addressing practical 
issues related to access, and increasing provider engagement 
and trust that the final decision point. Realizing the 
opportunities will not only save lives, prevent suffering and 
make wise use of resources now, but will further serve millions 
of Americans when we get a safe and effective COVID-19 vaccine. 
And with both COVID-19 and the flu circulating the fall, this 
will be in my opinion the most important flu season of our 
lifetimes.
    Less flu and fewer hospitalizations will help conserve 
precious healthcare resources. So let me be clear, the best way 
to prevent the flu is to get the flu vaccine and I hope all of 
you, all of you here today will get your flu vaccine early and 
publicly. That is why my COVID-19 prescription is twofold. 
First, we must all practice the three Ws, wash your hands, ware 
your mask, and watch your distance. And second, we must use 
every lever to ensure all ages, races, and ethnicities receive 
recommended vaccinations. In my written testimony, I outlined 
efforts underway across HHS to boost vaccination rates and I 
will finish by highlighting just a few. CDC works with 
providers through the Vaccines for Children or VFC and the 
section 317 immunization programs to provide over 80 million 
doses of vaccines annually, and they have increased their flu 
vaccine purchase 20 fold this year. You can find out where to 
get vaccinated using CDC's vaccinefinder.org.
    HHS recently launched Catch Up to Get Ahead, informing 
parents that it is important to and safe for their children to 
get vaccinated during COVID-19. The Catch Up to Get Ahead 
toolkit is available on vaccines.gov, and again, to Senators 
out there, I would encourage you to send your staff there 
because there are great printable documents and digital 
documents to help people understand that vaccines are safe and 
effective. Through a recent amendment to the Prep Act, HHS 
authorized licensed pharmacist to administer routine vaccines 
for children ages 3 through 18 during the COVID-19 pandemic, 
and breaking news that I just got the okay to tell you all 
about right before I came in, today HHS will be issuing 
guidance to expand access to safe and effective COVID-19 
vaccines when they are made available. State licensed 
pharmacists will now be able to administer COVID-19 
vaccinations to persons aged 3 and older.
    Office of Minority Health is working with Morehouse School 
of Medicine on a $40 million plan to help engage and inform 
racial and ethnic minority communities about COVID-19 on 
vaccinations. And then finally the Public Health Service 
Commissioned Corps, which I helped lead along with Admiral 
Giroir, works with underserved populations, including Indian 
Health Services and Bureau of Prisons, leading efforts to 
increase acceptance of and uptake of the flu vaccine. PHS 
officers are also working with racial and ethnic communities to 
engage them in culturally competent ways in to increase access 
through partnerships with states and federally qualified health 
centers. So I want to close with calls to action to again U.S. 
Senators, to your family, to your staff and to your 
constituents.
    No. 1, get your flu shot. Ideally before the end of 
October. We want everyone to get their flu shots by Halloween. 
Second, catch up on childhood and adult immunizations right 
now. Clinics and pharmacies around the country are safe, open, 
and ready to vaccinate. No. 3, stop COVID-19 in its tracks by 
practicing my three Ws, washing your hands, wearing your mask, 
and watching your distance. Fourth, use your bully pulpits to 
tweet, text, blog, and shout that vaccines are safe, effective, 
and more important now than ever. And then finally go to 
vaccines.gov for more information. And I just want to throw in 
a quick personal note.
    We are in the midst of a social justice movement the likes 
of which we haven't seen since the 60's in my lifetime. As 
Surgeon General of the United States, I want you to hear me say 
that achieving health equity is necessary to achieving social 
justice and vaccines are the quickest and the easiest way for 
minority and at-risk populations to protect their health. So 
now more than ever we need to help people understand vaccines 
are safe, vaccines are effective, vaccines are how we achieve 
health equity and social justice. Thank you and I look forward 
to your questions.
    [The prepared statement of Dr. Adams follows:]
                 prepared statement of jerome m. adams
                              INTRODUCTION
    Chairman Alexander, Ranking Member Murray and distinguished Members 
of the Committee, thank you for the opportunity to address the 
importance of immunizations in children and adults, particularly in the 
context of the COVID-19 pandemic, and the actions we are taking to 
ensure the health and safety of all Americans.

    I am grateful to you for focusing attention and action on this 
critical health issue. Getting children and adults immunized, 
protecting millions from preventable infections, is a battle we can 
win--and win now.

    I would like to start by clarifying terms often used in discussions 
on this topic. Vaccination refers to the act of introducing a vaccine 
into the body to produce immunity to a specific disease. Immunization 
is the process by which a person develops immunity through the act of 
vaccination. Though their meanings are different, they are often used 
interchangeably.

    I should also define a couple of other terms. Vaccine confidence is 
the trust that parents, patients, or healthcare professionals have in 
the safety and effectiveness of vaccines, and the processes and 
policies involved in vaccine development, licensure, manufacturing, and 
recommendations for use. Secretary Azar has declared that ``one of the 
most pressing public health challenges our country faces is vaccine 
hesitancy, driven in part by misinformation. Vaccine hesitancy refers 
to delay in acceptance or refusal of vaccines despite their 
availability and is different from the anti-vaccine movement according 
to researchers. \1\, \2\, \3\ Vaccine hesitancy, named one of the top 
10 global health threats in 2019 by the World Health Organization, is a 
product of complacency, inconvenience, and lack of confidence. \4\
---------------------------------------------------------------------------
    \1\ World Health Organization. Ten threats to global health in 
2019. https://www.who.int/emergencies/ten-threats-to-global-health-in-
2019.
    \2\ The National Academies of Sciences, Engineering, and Medicine. 
Vaccine Access and Hesitancy--The Public Health Importance of Vaccines. 
https://www.nationalacademies.org/news/2020/06/vaccine-access-and-
hesitancy-the-public-health-importance-of-vaccines.
    \3\ Natbony, J., & Genies, M. (2019). Vaccine Hesitancy and 
Refusal. Pediatrics in review, 40(Suppl 1), 22.
    \4\ World Health Organization. Addressing Vaccine Hesitancy. 
https://www.who.int/immunization/programmes-systems/vaccine-hesitancy/
en/.

    While I will describe the current status, benefits, challenges, and 
actions related to childhood and adult vaccinations, including that for 
seasonal influenza, I want to ground this discussion in the reality of 
COVID-19. The pandemic has affected every household and almost every 
facet of our lives and livelihoods. We are deep in the fight against 
the virus that causes COVID-19, and that fight may become more complex 
in the weeks and months ahead when it and the flu virus will most 
---------------------------------------------------------------------------
likely circulate together.

    We are confident that safe and effective vaccines will be developed 
for COVID-19. But they are not yet available. In the meantime, we rely 
on the heroic efforts of the frontline healthcare workers to treat 
those who become ill and dedicated public health workers to test the 
people who need to be tested and implement control and prevention 
practices that prevent further spread of the disease. In addition, I 
want to highlight the three things we can all do right now to protect 
ourselves and each other--washing our hands, wearing a mask, and 
watching our distance by maintaining at least 6 feet between others and 
avoiding large gatherings.

    One more action is critical. One of the most powerful acts that 
Americans of every age can take is to be up-to-date on their 
immunizations. Keeping up with recommended vaccinations is important 
for all age groups. Teens should be protected against meningitis and 
preventable cancers with recommended vaccinations. Adults need vaccines 
too to help them stay healthy and avoid diseases such as shingles, 
influenza, whooping cough, tetanus, and pneumococcal pneumonia. 
Children and adults with health conditions are particularly susceptible 
to diseases and there are vaccines specifically recommended for them. 
Missing or delaying vaccines puts our country at risk of having to 
fight outbreaks of preventable disease and could take precious 
resources away from the COVID-19 response in communities across 
America.

    As a physician, public health expert, parent, and the Nation's 
Doctor, I can confidently and unequivocally state that vaccines are 
safe, effective, and life-saving. The science is indisputable and the 
benefits are real. To help all Americans reap these benefits, we must 
ensure that they have the facts on vaccines, communicate vaccine 
confidence and overcome vaccine hesitancy, and make the case that, this 
year, more than ever, being current on recommended vaccinations is 
essential to preserve health, prevent disease, reduce the burden on the 
healthcare system, and restore our economy.
                        CHILDHOOD IMMUNIZATIONS
    Vaccinating babies according to the recommended immunization 
schedule ensures that they are protected against 14 serious childhood 
illnesses such as measles, meningitis, and whooping cough. \5\ The good 
news is that over 90 percent of parents choose to protect their 
children through vaccinations. \6\, \7\
---------------------------------------------------------------------------
    \5\ Centers for Disease Control and Prevention. Vaccinate Your Baby 
for Best Protection. https://www.cdc.gov/features/infantimmunization/
index.html.
    \6\ Centers for Disease Control and Prevention. Vaccination 
Coverage with Selected Vaccines and Exemption Rates Among Children in 
Kindergarten--United States, 2018-19 School Year. https://www.cdc.gov/
mmwr/volumes/68/wr/mm6841e1.htm?s-cid=mm6841e1-w.
    \7\ Centers for Disease Control and Prevention. Vaccination 
Coverage by Age 24 Months Among Children Born in 2015 and 2016--
National Immunization Survey-Child, United States, 2016-2018. https://
www.cdc.gov/mmwr/volumes/68/wr/mm6841e2.htm?s-cid=mm6841e2-w.

    However, in some communities in the United States, misinformation 
has contributed to parents choosing to delay or refuse vaccinations for 
their children. While overall vaccination rates remain high, nearly 12 
percent of parents refuse at least one recommended childhood vaccine, 
\8\ over 30 percent of parents delay one or more recommended childhood 
vaccines, \9\ and many parents are getting school immunization 
exemptions for personal, rather than health reasons.
---------------------------------------------------------------------------
    \8\ Freed GL, Clark SJ, Butchart AT, Singer DC, Davis MM. Parental 
vaccine safety concerns in 2009. Pediatrics.2010;125(4):654-9.
    \9\ Smith PJ, Humiston SG, Marcuse EK, Zhao Z, Dorell CG, Howes C, 
Hibbs B. Parental Delay or Refusal of Vaccine Doses, childhood 
vaccination coverage at 24 months of age and the health belief model. 
Public Health Rep.

    These trends tend to be concentrated in geographic pockets and in 
certain communities. For example, the large outbreaks of measles in and 
around New York City in 2018 and 2019 were concentrated among 
unvaccinated children. They began when a returning traveler who was 
infected with measles abroad exposed a community that did not have a 
communitywide or ``herd'' immunity. New York accounted for nearly 75 
percent of the 1,270 reported measles cases across 31 states in the 
United States in 2019, the most in a single year since 1992. \10\ As a 
result, our country nearly lost its status as a measles-eliminated 
country, an important public health milestone that was achieved in 
2000. \11\ More importantly, people, primarily children, suffered 
needlessly from a preventable disease.
---------------------------------------------------------------------------
    \10\ Centers for Disease Control and Prevention. Measles Cases and 
Outbreaks. https://www.cdc.gov/measles/cases-outbreaks.html.
    \11\ Centers for Disease Control and Prevention. Measles 
Elimination. https://www.cdc.gov/measles/elimination.html.

    What stopped the measles outbreak in New York was the community 
coming together with elected, religious, and other leaders speaking as 
one voice to connect public health messages and vaccination efforts 
with community members, including parents who had not vaccinated their 
children. This coalition spoke on how safe vaccines are and how they 
protect people, listened to concerns expressed by the parents of 
children and the community and dispelled myths and misinformation on 
vaccines, and made it possible for the children and the community to 
---------------------------------------------------------------------------
get vaccinated conveniently.

    In my role as Surgeon General, I was deployed to see some of these 
cases first hand and observed the vast disruption an outbreak can cause 
in a community. One example is the outbreaks in Washington State last 
year. I met with parents, clinicians, and public health experts to 
chart a path forward to tackle myths and misinformation surrounding 
vaccines and make informed decisions based on scientific evidence.

    First, parents must have time with trusted, well-informed, and 
caring providers who listen to their concerns and address their 
questions. Some providers I spoke with went beyond their clinic walls 
to share their advice, hosting ``ask the doctor'' sessions, often after 
normal business hours, that enabled non-judgmental conversations with 
parents. Some parents visited their healthcare professionals two or 
even three times before ultimately deciding to get their children 
vaccinated. With time, support, and compassion from their clinicians, 
these parents made the choice to protect their children with vaccines. 
There's an old saying--``people don't care how much you know until they 
know how much you care.'' This adage comes true when healthcare teams 
talk with parents about giving vaccines to their children.

    Second, start conversations on vaccines between parents and 
providers early. We need to talk to parents of infants and young 
children and with pregnant women, answer questions, and reduce vaccine 
hesitancy. We need to leverage available data and seek additional data 
on how to best communicate with African American, Latino/Latina, Asian 
American, Native American, and other racial and ethnic communities, 
cultures, socially or economically disenfranchised communities, and 
other close-knit communities subject to large outbreaks of measles in 
2019.

    Third, we have to further develop partnerships and work with 
trusted messengers to stop myths and contain the spread of 
misinformation on vaccines. We can do that by promoting trustworthy 
vaccine information to be disseminated by trusted voices through 
outlets to which people go to get information. We need to build and 
normalize a culture of immunization in healthcare practices, our 
schools, our workplaces, and our communities. To do that, we also need 
help from state and local policymakers who set the tone and advance 
policy decisions, and enable best public health practices such as 
immunization programs to protect us and our communities. Finally, we 
recognize the power of a communications campaign to reinforce social 
norms about vaccination, combat myths, and utilize tested and tailored 
messaging to respond to common questions and sharpen focus on personal 
and community benefits of vaccination.
                     IMMUNIZATIONS DURING PREGNANCY
    I mentioned earlier that we need to start the conversation on 
vaccines with parents early. It starts with expectant mothers and women 
who may become pregnant. They need to know the facts about vaccines and 
how vaccines protect them and their babies. However, only about half of 
pregnant women get the recommended flu and whooping cough vaccinations 
during pregnancy. African American and Latina women who are pregnant 
have even lower rates of these vaccinations. Those who do not get these 
vaccines are at risk for potentially serious complications during 
pregnancy.

    When pregnant women are immunized against flu and whooping cough 
vaccines, they pass on antibodies to the unborn baby, providing 
protection for several months after birth, until babies can safely be 
vaccinated. Newborns whose mothers did not receive flu or whooping 
cough vaccines are at risk for the diseases and complications including 
hospitalization and death.

    Pregnancy results in changes to women's respiratory and immune 
systems and doubles their risk for serious complications that require 
hospitalization if they get the flu. Pregnant women age 15 to 44 years 
account for 24 to 34 percent of hospitalizations due to flu each year 
in the United States. That disproportionate rate of hospitalizations 
for pregnant women with the flu is even more striking if we take into 
account that only 9 percent of women in this age group are pregnant.

    How effective are the flu and whooping cough vaccines for pregnant 
women? Research has shown that getting a flu vaccine reduces a pregnant 
woman's risk of hospitalization due to the flu by 40 percent, and their 
newborn babies' risk of hospitalization by 72 percent. The case for flu 
vaccination for pregnant women cannot be much stronger than this. 
Pregnant women should get the flu vaccine at any time during her 
pregnancy to protect her and her baby against serious complications 
from the flu.

    Whooping cough is a serious disease in babies, but they cannot get 
the vaccine until they're at least 2 months of age. Babies younger than 
2 months of age who get whooping cough require hospitalization 67 
percent of the time. Babies in this age group also make up 69 percent 
of deaths all caused by whooping cough. This is why the vaccine against 
whooping cough is recommended for pregnant women during her third 
trimester. The whooping cough vaccine prevents 78 percent of whooping 
cough in babies younger than 2 months of age.
                          ADULT IMMUNIZATIONS
    Vaccines are recommended not only for children and pregnant women, 
but for adults throughout their lifespan. Adults need to keep up-to-
date on their vaccines because immunity from childhood vaccines can 
wear off over time. Additionally, adults are at risk for different 
diseases because of their age, health conditions (like heart disease 
and diabetes), occupation, and other reasons. As it is for children, 
vaccination is one of the most effective, convenient and safest ways to 
prevent disease and stay healthy.

    In the United States, 140,000 to 710,000 flu-related 
hospitalizations and 12,000 to 56,000 deaths occur from flu-related 
illnesses each year--mostly among the elderly. Additionally, about 
320,000 people get pneumococcal pneumonia each year, resulting in 
150,000 hospitalizations and 5,000 deaths--again mostly among the 
elderly. Most of us know at least of someone who has had to endure the 
severe, unrelenting pain that accompanies shingles, long after the 
disease itself has cleared. Each year, 1 million people get shingles in 
the United States.

    There are vaccines for adults that can prevent these and other 
diseases that can cause serious illnesses, hospitalizations, and even 
death. Young adults should get the flu vaccine; the tetanus, 
diphtheria, and pertussis vaccine (Tdap); and, if they did not receive 
it before, the human papillomavirus (HPV) vaccine. Older adults should 
get the flu, Tdap, shingles, and pneumococcal vaccines. Other vaccines 
are indicated for adults with health conditions.

    Despite the benefits of these routine vaccinations, the vaccination 
coverage rates for adults are low. Only about 45 percent of adults age 
19 years or older receive the flu vaccine each year, with racial and 
ethnic minorities and younger adults having lower coverage rates. 
Pneumococcal vaccination coverage among adults age 19-64 years at 
increased risk for pneumococcal disease is about 25 percent and for 
those age 65 years or older is about 69 percent. Shingles vaccination 
rate is about 35 percent for adults age 60 years or older. The shingles 
vaccine is now recommended for adults age 50 years or older, so going 
forward, data on the shingles vaccination rate will change.

    Given these low vaccination coverage rates for adults, additional 
efforts to promote vaccines for adults are needed. Similar to efforts 
for children, trusted, well-informed, and caring providers need to 
listen to the concerns expressed by their adult patients, answer 
questions, and strongly recommend vaccines; have conversations on 
vaccines early and frequently; and actively work to stop myths and 
contain the spread of misinformation on vaccines. These efforts require 
time, energy, and resources. We need to better equip and enable our 
healthcare providers to do this critical preventive health work.
            IMMUNIZATION DURING THE EARLY COVID-19 PANDEMIC
    Unfortunately, but not surprisingly, the COVID-19 pandemic 
disrupted life-saving vaccinations at all levels, putting millions of 
children and adults at risk for vaccine-preventable diseases. Efforts 
to control the spread of COVID-19 during the early months of the 
pandemic resulted in providers closing their practices and patients 
canceling their appointments as communities were subject to social 
distancing, stay-at-home and other public health response measures.

    Early pandemic data on the Vaccines for Children (VFC) program--
CDC's over $4 billion program that supports a network of public and 
private health care providers to administer free vaccines to about half 
the children in the United States--painted an alarming picture. VFC 
providers across the country ordered 3 million fewer doses of vaccines 
compared to the same period in 2019 \12\. At the same time, there was a 
substantial decrease in childhood vaccine administration rates in eight 
large healthcare systems in the United States. When the vaccination 
status at milestone ages of children in Michigan was evaluated in the 
aftermath of the national public health emergency declaration in March 
2020, coverage rates for essentially all childhood vaccinations 
declined substantially compared to the same time period in previous 
years. Data indicate that vaccination coverage rates for adults were 
similarly adversely impacted.
---------------------------------------------------------------------------
    \12\ Santoli, J. M. (2020). Effects of the COVID-19 pandemic on 
routine pediatric vaccine ordering and administration--United States, 
2020. MMWR. Morbidity and Mortality Weekly Report, 69.

    Subsequent data suggest that vaccine ordering through the VFC 
program and vaccine administration rates have largely recovered from 
the declines in the early months of the pandemic but the backlog of 
vaccinations that have been delayed, particularly for adults, have not 
yet been resolved.
           IMMUNIZATION DURING THE UPCOMING INFLUENZA SEASON
    For the upcoming flu season, the viruses that cause COVID-19 and 
influenza will be inextricably linked. The question is how we can best 
prepare Americans to stay healthy from both threats. Although the world 
has changed over the last nine months due to COVID-19, one thing has 
not: getting the flu vaccine is the best way to prevent the flu.

    Everyone six months of age or older should receive a flu vaccine 
every year. We should do better to reach people with high risk for 
serious complications from the flu, such as older adults and those with 
health conditions, African American and Latino/Latina communities, and 
younger adults who have the lowest flu vaccination rates among adults.

    At least part of this lower participation is due to a reluctance 
and mistrust of vaccines and health systems. We need to do a better job 
of conveying the right message the right way. We need to be sensitive 
to the cultural norms of the diverse communities that comprise America 
and work with the trusted leaders and service providers in those 
communities to communicate that vaccines are safe and effective and 
that vaccines save lives. Again, we need to work with our communities 
to establish an expectation that children and adults are current in 
their vaccinations and that being up-to-date is the norm.

    The disparities in low uptake of flu and other vaccinations echo 
those we have observed with how COVID-19 has disproportionately 
impacted racial and ethnic minority communities. In recent data (August 
22), African Americans and Native Americans are hospitalized due to 
COVID-19 at four to five times the rate of whites. Hispanic Americans 
are hospitalized at three times the rate of whites. The reasons are 
many and are rooted in long-standing socioeconomic conditions that 
reduce resilience, opportunity, and health. These conditions make it 
harder for people of color to get and stay healthy.

    That is why it is imperative public health leaders, Members of 
Congress, Federal and state agencies, and communities all across the 
country, concentrate our efforts to ensure that the most vulnerable 
populations are protected from both the flu and other vaccine-
preventable diseases, in addition to COVID-19.

    While widespread vaccination for the flu each year is always 
important, we must aim for record-breaking vaccination rate for this 
upcoming season. Of course the flu vaccine does not protect against 
COVID-19, but the possibility of coming down with the flu amidst the 
COVID-19 pandemic is concerning. We should take advantage of all the 
tools available to protect ourselves, our families, and our 
communities. And getting the flu vaccine gives each of us one big tool 
to do that. As I described earlier, the flu vaccine can help us stay 
out of hospitals and reduce possible exposure to COVID-19, and help 
conserve healthcare resources that our healthcare professionals and 
healthcare systems desperately need.
                              PATH FORWARD
    This moment in our national and global lives is one of 
unprecedented challenge. It is also one of unparalleled opportunity. 
With will, intention, collaboration, and intelligent (data-informed) 
resourcing, we can close past gaps and break past records to vaccinate 
millions of Americans, across all age groups, genders, races, 
ethnicities, and geographies. We can protect and preserve health--and 
healthcare resources--if we work together now.

    Secretary Azar has declared that ``one of the most pressing public 
health challenges our country faces is vaccine hesitancy, driven in 
part by misinformation.'' \13\ Vaccination saves lives, but only if 
people trust that they are safe and effective, and agree to receive the 
vaccine. We must take responsibility to counter misinformation and 
ensure that every American understands the importance of vaccines 
throughout their lives.
---------------------------------------------------------------------------
    \13\ Youtube. Highlights of HHS Secretary Alex Azar's remarks to 
NVAC & commitment to vaccination. June 7, 2019. https://
www.youtube.com/watch?v=SpJHDl09SQs. Accessed September 10, 2019.

    The U.S. Department of Health and Human Services (HHS) is using a 
three-tiered approach to improve vaccine confidence through: (1) 
research and evaluation, (2) collaboration and partnerships, and (3) 
communication strategies and knowledge dissemination. We continue to 
look for opportunities to advance and promote vaccinations for all 
Americans and have championed vaccinations in a variety of ways. From 
the more traditional avenues like an op-ed in the New York Times and 
events in town halls, hospitals, and community centers across the 
Nation, to connecting with individuals on digital platforms and social 
media by hosting things like the #HHSVaxChat, we have strived to reach 
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people directly.

    Our efforts also include advancing research to better understand 
vaccine confidence as well as partnerships to help counter 
misinformation. The Department has a long history of working with 
external and trusted partners to counter misinformation online. Last 
year, in partnership with Twitter, the platform provided a resource box 
Vaccines.gov when a Twitter user searched for vaccines or immunization. 
This collaboration gave Twitter users direct access to accurate, 
science-based information on Vaccines.gov.

    On top of that, HHS has also made improvements to Vaccines.gov to 
make it mobile-friendly and increase both the ease of and access to 
information about vaccines, making it a go-to resource for common 
questions and a resource hub for others to communicate about the life-
saving value of vaccines.

    In addition, CDC developed Vaccinate with Confidence, a strategic 
framework to strengthen vaccine confidence and prevent outbreaks of 
vaccine-preventable diseases in the United States. Vaccinate with 
Confidence will strengthen public trust in vaccines by advancing three 
key priorities: protect communities, empower families, and stop myths.

    The HHS Office of Minority Health (OMH) recently announced funding 
of the National Infrastructure for Mitigating the Impact of COVID-19 
(NIMIC) Initiative. NIMIC seeks to develop and coordinate a strategic 
and structured national network of national, state/territorial/tribal 
and local public and community-based organizations that will mitigate 
the impact of COVID-19 on racial and ethnic minority, rural and 
socially vulnerable populations.

    The NIMIC initiative is a three-year cooperative agreement between 
OMH and the Morehouse School of Medicine to fight COVID-19 in racial 
and ethnic minority, rural and socially vulnerable communities. The 
Morehouse School of Medicine and OMH will lead the initiative to 
coordinate a strategic network to deliver COVID-19-related information 
to communities hardest hit by the pandemic. Though focused on COVID-19, 
this network will nurture community level connections, build trust, and 
enhance local capacity and infrastructure, generating benefits well 
beyond those related to the pandemic.

    The Office on Women's Health serves as a trusted resource for women 
and families, including recommendations for vaccinations during 
pregnancy and the most current updates about the health impacts of 
COVID-19.

    U.S Public Health Service Commissioned Corps officers are leading 
efforts to increase acceptance of and access to influenza vaccine, 
particularly in underserved and racial and ethnic minority communities. 
Officers are implementing innovative strategies to ensure that 
culturally competent messages on the importance of influenza 
vaccination reach these communities, while also increasing access 
through partnerships with states, federally qualified health centers, 
and Federal entities such as the Bureau of Prisons and the Indian 
Health Service.

    The Health Resources and Services Administration (HRSA) launched a 
social media campaign with the hashtag #WellChildWednesdays to 
encourage parents and stakeholders to maintain a regular schedule of 
well-child visits and immunizations. Every Wednesday for ten weeks, 
social media messages promoted the importance of immunizations and well 
child visits with pediatric providers. The Office of the Surgeon 
General, along with numerous HHS operating divisions and other 
national, state and local public health partners amplified the 10 HRSA 
posts, which reached more than 330,000 people and generated at least 
500 additional posts using the #WellChildWednesdays hashtag.

    The Administration on Children and Families supported distribution 
of HRSA's eNews messages (sent via tweet #WellChildWednesdays), 
including their message encouraging parents to bring their children to 
the doctor for vaccinations and extending their reach in the following 
ways:

          The Office of Child Care posted the message on its 
        website, and sent it to 4,450 stakeholders through the OCC 
        Announcements email blast.

          The Early Childhood Development Office sent the 
        message to its Federal partners' list serve of over 73 Federal 
        staff across multiple agencies.

          The Office of Head Start sent the message to over 
        1600 Head Start Grantees and conducted a webinar: Keeping Our 
        Children Well During COVID-19, which included information on 
        the early childhood vaccination schedule.

          Head Start can send messaging about vaccinations for 
        children and flu shots for parents/staff to 1,600 grantees, 
        250,000 staff and 1,000,000 children.

          The Children's Bureau will send communication to all 
        child welfare offices including foster parents and courts 
        regarding the importance of vaccination schedules including the 
        flu vaccine.

    Last month marked ``National Immunization Awareness Month,'' a time 
when our messaging is usually ramped up on the importance of 
vaccinations. This year, we launched Catch Up to Get Ahead, an effort 
to increase childhood immunization rates that fell so dramatically 
during the early months of the pandemic. The Catch Up to Get Ahead 
toolkit is available on vaccines.gov and includes talking points, 
safety protocols, payment information, and other helpful materials to 
help get children catchup on the vaccines that have been delayed by the 
COVID-19 pandemic.

    The effort focused on increasing vaccination opportunities, 
informing parents that it is important and safe for their children to 
get vaccinated during COVID-19. Its goals were to: (1) increase access 
to childhood vaccines by encouraging vaccination service providers to 
expand their service hours, (2) redouble communication efforts about 
vaccine safety and the importance of staying up-to-date on 
vaccinations, and (3) promote policies that reduce barriers to 
vaccinations. This was a coordinated HHS effort through my office, the 
Office of the Assistant Secretary for Health (including the Office of 
Infectious Disease and HIV/AIDS Policy, the Office on Women's Health, 
and the Regional Health Offices), the Office of Minority Health, CDC, 
the Health Resources and Services Administration, and the Indian Health 
Service.

    Lastly, on August 19, HHS issued a third amendment to the 
Declaration under the Public Readiness and Emergency Preparedness Act 
(PREP Act) to increase access to childhood vaccines by authorizing 
state-licensed pharmacists to administer all routinely recommended 
vaccines for children age 3 through 18 years during the COVID-19 
pandemic. The goal was to decrease the risk of vaccine-preventable 
disease outbreaks as children begin to return to daycare, preschool, 
and primary and secondary school across the United States. Looking 
ahead, when COVID-19 vaccines are licensed and recommended for use, the 
PREP Act will greatly increase the vaccines' access to children and 
adults in the United States.
                                CLOSING
    Our goal is to communicate the best available evidence to the 
public to help them stay safe and healthy. To protect children, adults, 
and pregnant women through vaccinations in the time of COVID-19, we 
offer the following recommendations, gleaned from experts across the 
Federal Government and healthcare systems.

    First, everyone should know that all vaccines including the flu 
vaccine can be delivered safely during the COVID-19 pandemic. 
Healthcare providers for children and adults should:

          Communicate with patients about how they can be 
        safely vaccinated during the pandemic;

          Follow infection control guidance to prevent the 
        spread of COVID-19;

          Assess the vaccination status of all patients at 
        every visit;

          Strongly recommend the vaccines they need;

          Administer recommended vaccines or refer patients to 
        a vaccination service provider such as a pharmacy or health 
        department (delay vaccination for people with suspected or 
        confirmed COVID-19);

          Ensure that vaccination records are maintained at the 
        patient's usual medical home;

          Implement effective strategies for catch-up 
        vaccinations such as patient reminder-recall; and

          Submit records of vaccines administered in the state 
        or local immunization information system.

    We're frequently asked when the best time to get the flu vaccine 
is. The timing of onset of the influenza season is unpredictable, and 
there are concerns that vaccine-induced immunity might wane over the 
course of a flu season if given too early in the season. To address 
this concern, Americans 6 months and older should get vaccinated for 
the flu during October or as soon as possible after October, as 
additional flu vaccine becomes available.

    We have all been deeply affected by the pandemic and there is much 
work to be done to mitigate the challenges we face as a result of 
COVID-19. Despite the challenges, I remain steadfast in my resolve to 
use our scars, losses, and lessons learned during COVID-19 as an 
opportunity to make our communities healthier, more resilient and more 
just. And increasing vaccination rates for children and adults is a key 
part of that opportunity.
                                 ______
                                 
    The Chairman. Thank you, Dr. Adams. We will now begin a 
round of 5 minute questions. I am going to ask Senators to 
try--and the witnesses to try to keep the questions and the 
answers within 5 minutes so all the Senators have a chance to 
participate with the votes coming up. Dr. Collins, let's take 
the announcement to which you referred about AstraZeneca 
slowing it's trials this morning or stopping it.
    What does that do to the effort, to the goal of producing 
hundreds of millions of vaccines by the end of the year? We 
have always said that if vaccine is not safe and does it work, 
we will throw away the vaccines that are manufactured. But 
let's say AstraZeneca or one of the others doesn't work or 
isn't safe, will we still have enough vaccines?
    Dr. Collins. Thank you, Senator. The reason that we are 
investing not in one but six different vaccines is because of 
the expectation that they won't all work. Although it would be 
lovely if they did. To have a clinical hold as has been placed 
on AstraZeneca as of yesterday because of a single serious 
adverse event is not at all unprecedented. This certainly 
happens in any large scale trial where you have tens of 
thousands of people invested in taking part and some of them 
may get ill and you have to try to figure out, is that because 
of the vaccine or were they going to get that illness anyway.
    With an abundance of caution at a time like this, you put a 
clinical hold, you invest to gate carefully to see if anybody 
else who received that vaccine or any other vaccines might have 
had a similar finding of a spinal cord problem. So this ought 
to be reassuring to everybody listening when we say we are 
going to focus first on safety and make no compromises, here is 
Exhibit A about how that is happening in practice. If it turns 
out that is a real consequence of this vaccine and can be shown 
to be cause and effect then all the doses that are currently 
being manufactured for that will be thrown away because we do 
not want to issue something that is not safe.
    The Chairman. As I understand your description, when I take 
a COVID-19 vaccine shot, it doesn't give me COVID. It sits--at 
one time in the history, I guess that was the way with 
smallpox. For example, you gave somebody a mild case of 
smallpox and hope they recovered and were inoculated. But when 
you take a vaccine shot for COVID-19, you are not giving me 
COVID, correct?
    Dr. Collins. Absolutely. The old way of making vaccines, 
and it is still done in some instances, is to take the actual 
virus, inactivate it in a certain way or kill it, and then use 
that as the way of inducing an immune response. Hoping that you 
were completely successful in that inactivation. None of the 
vaccines I am talking about today are done that way. They are 
taking a small bit of the virus, namely that spike protein, and 
are putting it into a fashion that the body can raise an 
antibodies to it. But that is all you are getting is that part, 
that little bit of the virus. You are not going to get infected 
by COVID-19 by any of these, I promise you.
    The Chairman. The Center for Disease Control said that last 
year the flu vaccine was 39 percent effective and that last 
year between 24,000 and 52,000 Americans--24,000 and 62,000 
Americans died of the flu. On the other hand, the polio vaccine 
seems to be 100 percent effective. If you get the polio 
vaccine, you don't get polio. Same with some others. Will the 
COVID-19 vaccine be more like the flu vaccine or more like the 
polio vaccine in terms of effectiveness?
    Dr. Collins. Senator, what a great question and I wish I 
knew a really crisp answer to that. That is why we are doing 
these large-scale trials to look at safety and efficacy to see 
how protective this will be and how long the protection lasts. 
If I had to guess I would say this is probably a better virus 
for a vaccine to really work well than the influenza virus 
which is a tough one because it is changing every year and that 
is why we have to be getting a new shot every year. It will be 
as good as polio or as good as measles, which is 95, 98 percent 
effective. I would love it if that turned out to be the case, 
but we will not know until we get through these trials and see 
what really happens.
    Dr. Adams. Mr. Chairman, can I jump in really quickly? You 
mentioned----
    The Chairman. Let me finish my question, if I may. Between 
24,000 and 52,000 or 62,000 Americans died of flu last year. Is 
it possible that the hand-washing, masking and six feet staying 
apart practices will mean that we will have fewer deaths from 
flu this year?
    Dr. Collins. It is entirely possible and that would be, I 
guess, a silver lining of this very difficult year we are all 
living through. It has already been observed in the southern 
hemisphere that is going through their flu season already that 
they had a lower number of cases of influenza by far than 
usual. And again, they have been practicing most of them the 
same kind of measures that we are talking about. So we might in 
fact benefit that way but that is no reason for anybody to say, 
oh, we will be fine. Get your flu shot everybody. This is a 
really important year to do that as the Surgeon General has 
already emphasized. Thank you very much.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman. And Dr. 
Collins as I said, I have been very concerned about political 
interference in decisionmaking we have seen in this 
Administration's response and the impact it might have on the 
acceptance of a vaccine. I wanted to ask you, what steps you 
think Federal agencies should be taking right now to build 
trust with the American people and develop our type processes 
to make sure science and public health, not political interest, 
dictate decisionmaking for COVID-19 vaccines?
    Dr. Collins. Well, thank you, Senator. I am a scientist and 
I believe that the best way we can engender that kind of trust 
is by being as transparent as possible, and you use the same 
word in your opening statement, so that people can see the 
facts. There is so many conspiracy theories out there right 
now, even before we have a vaccine that has come anywhere near 
to being judged safe and effective. About what is going on 
here, some of those are breath taking in terms of their stretch 
of the imagination and yet sometimes some people seem to attach 
themselves to those. So our best antidote is to say exactly 
what we are doing. I am reassured and I hope it will be 
reassuring to you that there are a number of steps in terms of 
how vaccines are going to be evaluated that are going to give 
that kind of sense of scientific objectivity.
    First of all, none of these trials will go even to an FDA 
review until the DSMB, the Data and Safety Monitoring Board, 
which is the only group that gets to see what happens as 
protection as far as safety events looks at the data. And these 
are not Federal employees. These are very experienced, 
qualified scientists. Only when they say something is happening 
here, that looks like it might be actually worth reviewing, 
does this get brought forward. I hope you also saw the nine 
CEOs of the companies involved in vaccine development all 
signed a statement that they won't put forward something to FDA 
until they are convinced that it meets the highest standards of 
safety and efficacy.
    Then FDA has its own advisory process and Commissioner Hahn 
who will speak to you all in 2 weeks has already said that he 
will use this Vaccine and Related Biological Products Advisory 
Committee, the VRBPAC, to advise about any idea of using an 
emergency use authorization for this purpose.
    You can be confident in that as well. If we can put all 
that information forward in a way that is digestible, I am 
hoping it will help turn the tide in what is right now a 
troubling situation where a lot of people are quite skeptical 
about this vaccine. And what a heartbreak that would be if we 
go through all of this, we come up with a vaccine that is safe 
and effective, we have already lost 190,000 people, we could 
prevent many more deaths, and yet people are afraid to use it. 
We can't let that happen.
    Senator Murray. Yes. Well, Dr. Adams, let me ask you 
because polls show that about 35 percent of Americans wouldn't 
get a COVID vaccine even if it were FDA approved and available 
to them at no cost. If confidence in COVID-19 vaccines is 
eroded by political interference or misinformation, what impact 
would that have on a successful COVID-19 vaccination campaign 
as well as vaccine confidence for years to come?
    Dr. Adams. Well, thank you so much for that question. And I 
think it is important that we start understanding that we have 
unprecedented level of vaccine hesitancy in our country. And 
globally the World Health Organization has called this one of 
their top 10 public health threats. I think it is also 
important to understand that we have a once in a century global 
pandemic superimposed on top of a Presidential election and 
that has made messaging even more difficult and concerning. 
Here is what I can tell you. As a member of the coronavirus 
task force, there have been no politicization of the vaccine 
process whatsoever. We have a process in place that I trust as 
a doctor, as a dad. I get vaccinated every year. I get my 
family vaccinated every year and we will be----
    Senator Murray. Okay. I appreciate that and I am running 
out of time so I just wanted to say, we need vaccine confidence 
and that is really important and political interference can be 
a huge detriment to that, so can misinformation. Are you making 
sure the President understands that risk?
    Dr. Adams. I am using my bully pulpit as Surgeon General to 
make sure the entire country understands that vaccines are safe 
and effective. In this COVID vaccine, I am telling people to 
focus on the process over the politics and the process is what 
will assure us that these are safe.
    Senator Murray. Okay. Dr. Collins, you mentioned in your 
answer to me the data safety monitoring board. I am concerned 
about the lack of transparency around the role of these boards 
in evaluating the safety and efficacy of COVID-19. Who sets the 
standards for the DSMBs to determine the data and whether the 
data from a Phase 3 trial showed a vaccine is safe and 
effective enough to end that trial early, as some have said?
    Dr. Collins. When the trial is first proposed, the FDA has 
to review whether in fact the demonstration of safety and 
efficacy is going to meet a certain standard, and that means 
you have to prove, and FDA has already said this, that the 
vaccine is at least 50 percent effective. If it is less than 
that, it doesn't meet that standard. The DSMB has those 
particular parameters in front of them and they are very 
careful statistical expertise----
    Senator Murray. Okay, who sets the standards?
    Dr. Collins. Sorry?
    Senator Murray. Who sets the standards DSMB uses?
    Dr. Collins. The FDA.
    Senator Murray. Does NIH have access to those?
    Dr. Collins. We are certainly consulted but it is FDA's 
authority and responsibility to set those standards.
    Senator Murray. Okay. I hope that NIH has that critical 
information. It is alarming if they don't.
    Dr. Collins. I would say yes, we do. I do want to make it 
clear though that we are not the deciders when it comes to 
exactly what is going to be considered acceptable. That is 
FDA's Congressional authority.
    Senator Murray. Okay.
    The Chairman. Thank you, Senator Murray.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman and Ranking Member. 
Thanks to the two who testified. Some great information. I 
really enjoyed watching Dr. Collins and Rene Fleming last night 
use all of their talents in a marvelous performance at the 
Whitehead Awards. It is good to see you this morning in your 
normal role. I appreciate the questions that Senator Murray 
asked about the people worrying about a fast track and 
accelerated approval and the FDA perhaps short changing the 
safety.
    One of the things that worries me is what we can do to make 
sure that the health professionals that may be helping patients 
to make their decisions about a COVID-19 vaccine understand the 
regulatory terminology and then feel comfortable communicating 
that the patients about what it means. Dr. Collins, I am very 
appreciative of your explanation of how vaccines work in the 
charts that you had. That was very helpful. I hope that--will 
you be involved in some of these communication things for when 
the vaccine is available to help people understand how it works 
and why it works?
    Dr. Collins. Thank you, Senator. And yes, NIH has a role 
there in terms of communication and education about the science 
behind all of this, working closely with our colleagues in the 
Department of Health and Human Services and especially with 
CDC. Just in terms of clinical guidelines, we do have a role 
there that has already been helpful, I think, in providing 
physicians with information about how best to treat patients 
who have fallen ill with COVID-19.
    When it comes to the vaccines, in terms of information for 
physicians, we will try to help in that space as well, along 
with their professional societies, who will also be very 
important in terms of educating their own members about what 
are the pros and cons of a particular approach. So, yes, we 
will be right in the middle of that.
    Senator Enzi. I am appreciative of that and have more 
confidence in it because of that. Vice Admiral Dr. Adams, you 
mentioned childhood vaccination. I know that plays an important 
role in predicting other age groups and limiting the spread of 
the disease, and helps kids get back to school, which is back 
to normal, which helps to reassure adults and also allows 
adults to go back to work. There are unique challenges in that 
pediatric vaccine research because of the safety and ethics 
concern about enrolling kids in trials. There can be 
differences in how their manufacturing immune systems work 
compared to adults. What do we know about a natural immune 
response that kids have with COVID-19? And when should the 
company start the process of developing these pediatric 
products?
    Dr. Adams. Great question. Thank you for that, Senator. 
Important to understand that the initial vaccine trials will be 
on people aged 18 and up. And we will make sure--and this is 
the way we have done it for other vaccines that have been 
developed in the past. We will make sure it is safe and 
effective in adults and then we will slowly start to move down 
in age.
    The next round, I anticipate, will be aged 12 to 18. And 
then after that, if it continues to be safe and effective, we 
will test in people younger than that. And that is the way we 
have done it for every vaccine because we can't just assume 
that something is safe and effective in an adult will be safe 
and effective in a child. But here is the important point. That 
is why it is even more critical that we work to ensure vaccine 
confidence and that all adults who can't get a vaccine do get a 
vaccine because it will be even more important that we have a 
higher percentage of adults getting vaccinated to get closer to 
that level of herd immunity that we need to break transmission 
of disease, knowing that the initial round of vaccinations 
won't be available for children. And Dr. Collins, anything that 
you want to add about testing in kids?
    Dr. Collins. I think there is maybe an effort in one of the 
trials to begin to enroll children in the next month or so. But 
again, as the Surgeon General very accurately said, we 
generally want to wait until you are sure that it looks safe 
and effective in adults before you take that next step. But it 
shouldn't be a whole lot longer.
    Senator Enzi. You are actually working on--working with the 
process for getting that envelopment started as soon as 
possible too Dr. Collins?
    Dr. Collins. Yes, again, with a clear sense of wanting to 
have the safety and efficacy reviews through the DSMBs and 
through the FDA before deciding it is time to move downward in 
age. We don't want to make any risks here happen to children in 
particular that we could avoid. So first, we want the data from 
the adults.
    Dr. Adams. You mentioned the COVID vaccine. It is 
important, again, that folks go to vaccine.org. We have a catch 
up to get a head campaign. Over four million children are 
behind on childhood vaccinations. So we want to prevent the 
disease that we can prevent right now and every child should 
get their flu vaccine this year.
    Senator Enzi. Thank you both.
    The Chairman. Thank you, Senator Enzi.
    Senator Sanders.
    Senator Sanders. Let me thank Dr. Collins and Dr. Adams not 
only for being here today, but for the years of public service. 
Gentlemen, thank you very much. Senator Murray covered a lot of 
the territory that I was interested in. But I want to ask two 
questions. No. 1, the taxpayers of our country have already 
spent billions of dollars, many billions of dollars on research 
and development for this new vaccine.
    It seems to me with that type of development and with the 
fact that we have some 90 million Americans today who are 
uninsured or underinsured, it seems clear to me and I think a 
number of other Senators that we must make that vaccine free of 
charge to all people if we want to maximize the number of 
people who will, in fact, get it and given the fact that we 
have already paid for it. This is something I am going to be 
working very hard on. Other Senators will as well. Will you 
join us in the effort to make sure that this vaccine will be 
distributed free of charge to all Americans?
    Dr. Adams. Senator Sanders, this is the Surgeon General, 
Vice Admiral Adams here. Thank you for bringing that up and I 
will give you a very direct answer. Yes, as surgeon general of 
the United States, I promise you we will use every Federal tool 
that we have to make sure that cost is not an obstacle for 
people receiving what will perhaps be the most important and 
highly anticipated vaccine of our lives.
    Dr. Collins. I share that 100 percent.
    Senator Sanders. Okay. Thank you both for that very 
definitive statement. Is that the posture of the Administration 
right now? Is the Administration saying that vaccine will be 
distributed free of charge to all Americans?
    Dr. Adams. I asked that question right before I came in to 
make sure because I feel strongly about this, the most honest 
answer I can give you is to the extent that we can ensure that 
from a Federal perspective, yes. As you know, there are things 
we can do in the executive branch. There are things that you 
all can do through the legislative branch. But every tool that 
we have, we will bring to bear to make sure that cost is not an 
obstacle.
    Senator Sanders. Well, thank you very much for that answer. 
Gentlemen, let me just raise another issue, and it is an issue 
that Senator Murray touched on. You know recently we had a 
President, the President of the United States, telling us that 
this vaccine will be ready to go or develop before Election 
Day, not a week after the Election Day, not 2 weeks after not a 
month, but before Election Day because of his great leadership 
and that it would have taken President Obama years more to 
develop that process. What we need is assurance from scientists 
and doctors like yourself and from others in the Administration 
to make it clear that this President is not speaking for the 
scientists of this country. That you believe, as I believe and 
I think every Member of Congress believes, we need to get that 
vaccine out to the American people as quickly as possible, 
whether it is a week after Election Day or 6 months after the 
election or before Election Day.
    But what is most important is that vaccine is safe, is safe 
and ready to go. Will you join me? I know this is difficult 
given the political moment and the nature of that 
Administration, but will you join me and many others in telling 
the President of the United States to get out of science and 
let the scientists do their job in moving as rapidly as 
possible, in getting a safe vaccine out to the American people?
    Dr. Collins. Senator, I am a scientist. I have had the 
privilege of serving as the NIH director for 11 years. I can't 
say strongly enough that the decisions about how this vaccine 
is going to be evaluated and assessed is going to be based on 
science. And I know I speak for my colleagues in the Government 
and certainly for the scientific community broadly, that can be 
the only basis upon which this decision is made, otherwise the 
public would not be expected to trust us. So that will be the 
only measure. Will it be done by a certain date? I could not 
possibly tell you right now because I don't know what is going 
to happen in the coming months.
    I do have cautious optimism that by the end of 2020 at 
least one of these vaccines will have emerged and turned out to 
be safe and effective. But even that is a guess and certainly 
to try to predict whether it happens on a particular week 
before or after a particular date in early November is well 
beyond anything that any scientist right now could tell you and 
be confident that they know what they are saying. So, yes, 
science and science alone will be the way in which this 
decision is made. Otherwise, I will have no part of it.
    Dr. Adams. Senator, I know that some people still do care 
about what the Surgeon General has to say so I think it is 
important that I weigh in on this--.
    [Laughter.].
    Dr. Collins. Jerome, I care what you have to say. Please 
go.
    Dr. Adams. I want the American people to hear me say this. 
There will be no shortcuts. This vaccine will be safe. It will 
be effective or it won't get moved along. And when a vaccine is 
either approved or authorized by the FDA, I and my family will 
be in line to get it.
    Senator Sanders. Well, thank you, gentlemen. I think that 
is the kind of answer that the American people are looking to 
hearing. Thank you very much.
    The Chairman. Thank you, Senator Sanders.
    Senator Burr.
    Senator Burr. Thank you, Mr. Chairman. To both our 
witnesses today, thank you for the long hours that you have 
devoted in this infection to try to come up with solutions for 
the American people and for the health care of the world 
really. Admiral, I may have a question for you if I have got 
time, but I think this is a good inflection point to talk about 
how we got to where we are.
    I think Dr. Collins, you know really well that we have 
spent two decades changing statute to allow some of the 
processes that we have seen enacted for COVID that aren't the 
first time. We created BARDA so that we had an agency that 
looked at novel threats. They were the first ones to look at 
how we stack some of the processes, the trowels, how we process 
the data. That we don't wait until the end of the session dump. 
That we process it in real time. And what we have seen is we 
have seen Congress, this legislative body, every so many years 
change that legislative statute to allow emergency youth 
authorizations, not just from a President, from a secretary of 
HHS down to the FDA itself.
    Dr. Hahn has been unbelievable at how you use the emergency 
use authorizations in consultation with NIH, HHS, CDC to 
provide new testing out there in real time, which is what the 
American people wanted and needed. We haven't harmed anybody. 
In some cases, we found that the data didn't support the tests 
that was out there and they have been yanked from the 
marketplace. Vaccine production historically has taken, as you 
said, tens of years to actually happen, and now we are trying 
to do it in one. And what is important for the American people 
to understand is we haven't rewritten the protocols.
    We haven't said the FDA operate outside of the powers that 
we have given in statute, nor NIH nor HHS or CDC. But we have 
said we are giving you these new authorities, use them. And for 
the first time, I think in development of drugs, vaccines, 
biologics, we have actually seen clinical trials that are 
stacked. If at any point the data doesn't support, at the end 
of the day, they are stopped as we saw with the AstraZeneca, 
Oxford trial.
    Now, in your testimony, Dr. Collins, you talked about NIH's 
efforts to partner with private sector to develop so-called 
adaptive master protocols for clinical trials. Are we doing 
something novel here or are we doing it exactly the same way we 
have always done it?
    Dr. Collins. We are doing something very novel, and I 
appreciate your raising all of the background here about how we 
got here. And Senator, your role in getting BARDA to where it 
is right now has just been critical for where we are with 
Operation Warp-Speed and having that capability of moving 
quickly and doing things in a very business friendly way to try 
to get the tools that we need in place.
    But another thing that I had the privilege of helping make 
happen back in late March and April was to go to all the 
pharmaceutical companies that we knew had things they could 
offer here, both in therapeutics and in vaccines, and saying 
instead of all going off in our own directions, let's see if we 
could do something together. And out of that came this 
partnership called ACTIV, which stands for Accelerating COVID-
19 Therapeutic Interventions and Vaccines. That group rolled up 
their sleeves 24/7.
    100 people, mostly high ranking scientists in both public 
and private sector, designed these master protocols to be able 
to launch clinical trials without the long process that it 
often takes to decide about the nitty gritty of protocol 
details and out of that have come a whole series of trials on 
monoclonal antibodies, on anticoagulants, on immunomodulators. 
And all of that, I think has gotten us much further than we 
would have been if we hadn't decided, let's do it differently 
this time. Let's really get everybody around the same table--.
    Senator Burr. All driven by the scientific community?
    Dr. Collins. Absolutely. From both sectors----
    Senator Burr. Because you had the latitude in the statute 
to do that?
    Dr. Collins. We did. And it helped a lot that nobody was 
feeling like, oh, my gosh, we have got to do 6 months of legal 
consultation because we already had the framework to see how we 
could do it.
    Senator Burr. I think the takeaway for today is we actually 
see the U.S. Government functioning. We see the process of 
development, partnership with the private sector in 
coordination with the Government actually working. We haven't 
changed the rules. We haven't changed the protocols. We have 
exercised the latitude that was there in statute for an 
instance just like this. Admiral, I will ask you one question 
as we end.
    As I end, with the quarantine of especially our younger 
population over the past 7 months, we have got a lot of infants 
to 1 year old that have not been exposed to the normal things 
that they will be exposed to had they not been quarantined. As 
our public health entity, doctor, what concerns do you have 
about the normal exposure that they haven't had and how that is 
going to affect us, especially as we determine, do they need to 
go to get a COVID test or is this a normal thing that they are 
just running into?
    Dr. Adams. Well, I am incredibly concerned about, again, 
the fact that over 4 million, almost 5 million children are 
behind on their vaccinations because of the COVID-19 pandemic. 
Their regular childhood vaccinations. I am concerned about the 
levels of herd immunity among the populace because adults and 
children now haven't gotten their vaccinations that they 
normally would have and that lowers the levels of herd 
immunity.
    For measles, for instance, we know you need 90 to 93 
percent of people in a community to be vaccinated in order to 
have herd immunity and prevent an outbreak like we saw in New 
York. And so it is critically important to protect our youngest 
and our most vulnerable that everyone who can catch up on their 
vaccinations gets caught up on their vaccinations--.
    The Chairman. Admiral, we need to move on to the next--.
    Dr. Adams. Yes.
    Senator Burr. Thank you.
    Dr. Adams. Thank you.
    The Chairman. Thank you, Senator Burr.
    Senator Casey.
    Senator Casey. Mr. Chairman, thank you very much for the 
hearing. I want to thank you and Senator Murray for having this 
hearing as we start this new work period. And I want to thank 
Dr. Collins and Dr. Adams for their appearance as well as their 
testimony and their public service. While it is encouraging, as 
I think all Americans are encouraged by the pace of the work 
that is being done to develop vaccine candidates, we still have 
a lot of questions. So many Americans have questions about how 
the vaccine will be both manufactured and distributed.
    Many Americans also have real concerns, grave concerns, 
about how the Trump administration appears to be interfering 
with the FDA's review process for political gain. And some see 
it. Also, Americans trust in public health and in public health 
that expertise has been undermined by a history of 
institutional racism and injustice in our health care system, 
as well as by misinformed anti-vaccination campaigns. It is 
imperative, and I think this bears repeating, imperative that 
any COVID-19 vaccine authorized or approved by the FDA and 
recommended for widespread dissemination be both safe and 
effective, of course, as evidenced by reliable data from 
randomized control clinical trials.
    It is also imperative the President, the Vice President, 
the White House COVID-19 Task Force must A, tell the truth all 
the time, not play political games, and lead by example. And 
though I understand, as many of us do, that there will be 
recommendations from public health experts on who should 
receive the vaccine first and what we should do, and all of us 
should follow those recommendations, I also believe that the 
American people should see that any COVID-19 vaccine is safe 
and effective and essential for ending the pandemic.
    Americans have to see it. They have to see others taking 
the vaccine. So I ask both of you, starting with Dr. Adams, 
will you commit to receiving the COVID-19 vaccine in public 
view once a vaccine becomes available and as authorized or 
approved by the FDA? Yes or no?
    Dr. Adams. Absolutely.
    Senator Casey. Thank you, and Dr. Collins?
    Dr. Collins. I am ready to roll up my sleeve as soon as 
they say it is safe and effective.
    Senator Casey. Thank you. I think it is important we 
practice what we preach. That means all of us in public office 
and in appointed office as well, because it is important for 
the American people to see this. I wanted to move to a 
question, a more focused question on immunization information 
systems for Dr. Adams. And this is a question I hope to ask Dr. 
Redfield. And I know, and as Senator Alexander mentioned, 
Chairman Alexander, that he is going to be testifying in 2 
weeks but I had hoped he would be here today.
    But given that most of the vaccine candidates being tested 
will require not just one but two doses, it is absolutely 
essential to track which vaccines people are getting. We have 
to understand who received the dose and ensure that each person 
receives the correct number of doses, especially initially 
where over vaccination or cross vaccination of different 
vaccine types could further stress the already short supply. We 
know that the immunization information systems already exist at 
the state level and they do exactly this type of tracking.
    I am concerned the Administration may be planning to use--
maybe plan to not use these existing systems. An article in USA 
Today on September the 6th cited the CDC documents saying, 
``people getting vaccinated will get a COVID-19 vaccination 
record card that will tell them which vaccine they got, when 
they got it, and when they should get their next shot.''
    My first question for you, Dr. Adams is has HHS, Health and 
Human Services, provided any support to these state 
immunization information systems, and how are you integrating 
their capabilities into your planning or vaccine distribution?
    Dr. Adams. Well, very quickly, we are working with states, 
with advisory committees and with professional organizations to 
figure out the distribution of what will likely be the most 
logistically difficult vaccine that we have ever deployed. We 
recognize that there are infrastructures in place at the state 
level through the Vaccines for Children's Program, and we are 
going to lean on that existing infrastructure. And so what I 
can promise you is we are going to work with all the 
appropriate partners and we are not going to try to reinvent 
the wheel when we don't have to.
    Senator Casey. I will have some follow-up questions, but I 
am out of time. Thank you very much.
    The Chairman. Thank you very much, Senator Casey, for 
sticking to the time. I appreciate that and so do your 
colleagues.
    Senator Paul.
    Senator Paul. No one disputes the medical miracle of 
vaccines. In fact, we have discussed some of Edward Jenners 
contributions, but even 70 years prior to that, we were doing 
inoculation and maybe even a couple hundred years prior to that 
in the Middle East. There were inoculating with live, from live 
pustules, basically live virus with maybe some antibodies in 
the mix. They did this, though, because the disease was 
incredibly deadly. You know, 10 percent, maybe 20 percent of 
the public, 30 percent of those who got it.
    But not every disease is the same. And I think that's what 
annoys me some about the discussion is that we think everything 
is smallpox and we say submit or else and you can't go to 
school unless you get this. And this is the debate we are going 
to have is how mandatory and what we are going to do to people. 
But there is a difference between smallpox. So you had 10 to 20 
percent, maybe even 30 percent mortality. For children with 
COVID from the CDC website, it is 0.68 per million. So we are 
talking about a different disease here. And while the 
recommendation on vaccines may be appropriate, I think each 
individual needs to make their decision. If we are prioritizing 
it, the death rate for those in their 80's are those in nursing 
home is incredibly high, 10 fold, 20 fold, maybe a 100 fold 
higher. It is significantly higher.
    That is where the priority should go. But really, I think 
in each individual in a free society should assess the risks of 
the disease versus the risks of the vaccine. But it is 
important that we not get so carried away with, oh, we have a 
vaccine. Everybody has got to have it and you can't go to 
school and we are going to ostracize you if you don't take it.
    Now, why don't we try to through persuasion? I mean, this 
worked for the most part for most of our history. Let's try to 
persuade people about it. Look, we have vaccines that we have 
recommended for a certain age groups, pneumavax is mostly 
recommended for those over 65 or those who have a significant 
comorbidity. I have had it. I am 57. I have had all my 
vaccines. I have been to Central America--I have had all my 
vaccines. But I am still for choice. Doesn't mean we just turn 
our brains off and say blindly, everyone must submit or else. I 
had pneumavax, had part of my lung removed and I thought, well, 
maybe I am at some risk for it so I took the pneumavax. But 
even that, it wasn't absolutely recommended. Flu vaccines used 
to be more recommended for those who were in risk categories 
and those who were older.
    I think a one-time flu vaccine was recommended over 50. Now 
it sounds like it is more extensive and that is fine. You know, 
the vaccines are incredibly safe, but at the same time, I think 
we really, really, really need to think through sort of our 
fervor here before we start mandating and making people take 
these tests. And so my question to Dr. Collins is, considering 
that the death rate for COVID among children is 0.68 per 
million, are you in favor of adding a school mandate that you 
can't go to school unless you get a COVID vaccine?
    Dr. Collins. Well, I think it would be premature for me to 
make a statement about what would be appropriate or not, since 
we don't even know to what extent the vaccines that are 
currently being studied are going to be safe and effective in 
adults. And as we have talked about, we won't know until later 
how they work for children.
    Senator Paul. Let's say they are safe and effective for 
children. Would you--are you in favor of mandating that you 
can't go to school unless you take one?
    Dr. Collins. I would have to really understand what the 
consequences would be. I am not ready to give an answer to that 
right now. I do think there is this issue about children 
getting infected and then infecting others around them that may 
have an immune system that can't handle it. And that is one of 
the reasons I think we are so concerned about having children 
vaccinated to avoid the kind of terrible circumstance where a 
child who is getting chemotherapy for cancer and ends up 
getting sick and gets much more sick. The 0.68 is not zero.
    Senator Paul. But that was never--that was always true. We 
have hundreds of thousands of people every year on chemotherapy 
and yet we have never sort of decide to mandate to everyone 
that they get vaccinated to protect us on chemotherapy. What we 
did traditionally is those on chemotherapy try to protect 
themselves from others, acknowledging that the common cold 
was--can be devastating to someone who is on chemotherapy and 
with very low immune response. So it is important that we think 
about that and we not say that we are going to mandate everyone 
because of a certain population. We have a vaccine that works, 
by all means let's try to vaccinate everybody that is willing 
to, voluntarily take it, particularly the nursing homes. Those 
and the elderly. And we should prioritize that. But we should 
acknowledge that there is an extraordinary difference in 
mortality. From the CDC website, less than one per million 
children die from this.
    That has to be weighed into the fact of whether or not you 
are going to mandate. If you are going to tell every kid in 
America they can't go to school, you are not willing to tell me 
you are not, that is a big deal. The death rate is less than 
one per million, and if we are going to mandate you can't go to 
school without that, when you look at contact tracing studies 
in China, the Netherlands, Bermuda and England we find very 
little transmission.
    I just talked to a gentleman who runs a school called--
can't remember the name of the school in North Carolina, they 
have 6,000 students and teachers and have been open for 8 
weeks, they have zero cases. You know, lots of schools have 
been open. And it is a question we need to answer and we need 
to discuss and not have it all be about fear, fear, fear. The 
truth of the matter is, kids don't get it as often, don't 
transmit and rarely die from it.
    We need to tell the truth about the statistics and not 
overblow the statistics into telling people something is not 
true. But that is also why the decisionmaking ought to be 
decentralized, where people in Washington don't get to tell 
everybody what to do. Every individual, every thinking 
individual in a free society gets to make those choices. Thank 
you.
    The Chairman. Thank you, Senator Paul.
    Senator Baldwin.
    Senator Baldwin. Alright. Thank you, Mr. Chairman. This is 
for--this first question is for Dr. Collins, and I am going to 
ask a bit about the importance of having diversity in the 
clinical trials that are taking place for a vaccine. And I am 
going to note this context. Last month, the University of 
Wisconsin announced that it had been selected as one of the 
first sites in the country to participate in Phase 3 clinical 
trials for AstraZeneca's COVID-19 vaccine candidate.
    Before I get into the importance of recruiting a diverse 
population, I want to just note the news that you have 
commented on already that AstraZeneca is pausing their Phase 3 
because, to investigate whether an unexpected medical event in 
one of their eligible candidates was related to the vaccine. So 
before I ask you about the importance of diversity, I just want 
to note that we have already enrolled in Wisconsin many 
participants in this Phase 3 trial. What should you and others 
in, look at overlooking project warp speed, be telling these 
folks who are already about to or already participating in this 
Phase 3 trial? I imagine some of them are very concerned.
    Dr. Collins. Yes, I agree, they probably are, and again, 
this is very fresh information. But again, the company who has 
connections now and knows exactly who the individuals are who 
have already been enrolled are in the best position to 
basically let them know why there is currently a clinical hold.
    Again, this is based upon a single severe adverse event 
which may or may not have anything to do with the vaccine, but 
it is the best sort of cautious approach to quickly stop and 
look and see if there is any other evidence to be concerned 
about. I assume and I can certainly check and see if this is 
the case. Not much time should go by until all the people 
involved in the trial get a direct communication from the 
company and the sites where they were enrolled about the fact 
that it is on hold and this is why and that more information 
will be forthcoming.
    Senator Baldwin. Great. I appreciate that and I am sure I 
will get some constituent feedback on that very issue. The 
University of Wisconsin has announced that it will focus on 
ensuring that a diverse population takes part in the trial and 
they have developed resources in both Spanish and Mang to help 
address language barriers. And they are going to have qualified 
medical interpreters available to speak with potential 
participants in 240 different languages.
    Researchers are also working to enroll a diverse patient 
population across gender, age, race and ethnicity. I would like 
for you, Dr. Collins, to describe how a lack of diversity in 
clinical trials undermines our efforts to develop safe, 
effective and accessible vaccines. And given the 
disproportionate impact that COVID-19 has had on communities of 
color, what should clinical trial sites take into consideration 
as they work to recruit participants?
    Dr. Collins. Well, thanks for the question, because this is 
something that I am passionate about and where I think we have 
to work especially hard to try to achieve that kind of 
diversity in the participants in these trials. As you said, 
particular groups have been hit hard by COVID-19, African-
Americans, Latinos, Native Americans. And we particularly 
therefore want to know, does the vaccine provide benefits to 
those groups because they may be the ones who will benefit the 
most if we can develop one that is safe and effective.
    But it is without a doubt that there is also concerns in 
many of those communities about whether this is something they 
should trust to be in their best interest. There is skepticism. 
There is distrust. We are at a time of considerable social 
upheaval, which means that the recruiting efforts have to be 
done with particular intention to try to do the community 
outreach and engagement that might just not happen. And I 
appreciate what you have said is going on in Wisconsin. And my 
hat is off the way in which you describe the kinds of outreach 
you are doing in the communities, including those who speak 
other languages. We are trying to do that same sort of thing 
across other vaccine trials.
    The NIH has a long history in doing this kind of community 
engagement for other things like HIV, for instance. We are 
tapping into that. Just a couple of days ago, you might now see 
public service announcements in the areas where vaccine trials 
are happening that are particularly reaching out to African-
Americans to explain why this might be something to look at and 
think about seriously getting engaged in. And we know that is a 
steep hill to climb, but we are trying to climb it. If we don't 
succeed in having diversity in the participants in these 
trials, I think that takes scientifically away from the value 
of what we are trying to learn and it certainly makes people 
wonder, was this really something that I could say is about me 
and my community if we weren't involved in the trial? Why 
should we then think about getting engaged when you say you 
have succeeded? This has to be one of those things that we do 
all together.
    Senator Baldwin. Thank you.
    The Chairman. Thank you, Senator Baldwin.
    Senator Collins.
    Senator Collins. Thank you, Mr. Chairman. Dr. Adams in my 
state the three groups of people who have been 
disproportionately affected by COVID-19 have been frontline 
healthcare workers, Black residents of my state and nursing 
home residents. Who is going to make the decision on the 
allocation of the vaccine once it becomes available? Who will 
decide who gets the vaccine first?
    Dr. Adams. Thank you for that question, Senator. And you 
hit on some of the key points, healthcare workers and nursing 
home workers and people of color are disproportionately hit by 
this virus. It is important for people to know that we aren't 
just making this decision in a room. We are working with the 
National Academies of Science Engineering and Medicine, with 
again, professional organizations and other advisory groups to 
come up with an answer to this incredibly difficult question 
about who gets the vaccine first. I can tell you some 
principles that we agree on. There are no final recommendations 
yet, but principles are that healthcare workers and front line 
workers should be first in line because we know they are most 
likely to be exposed and most likely to spread.
    Behind them, it is looking at who is most vulnerable and 
using a scientifically driven and data-driven process to 
determine who is most vulnerable and where that vaccine will 
have the biggest impact. So what the American people need to 
know is we are thinking about this now, we are working with an 
array of partners to make sure it makes sense and it is 
ethically appropriate to distribute vaccines in a way that we 
ultimately will have the largest impact.
    Senator Collins. Thank you. Dr. Collins, a major healthcare 
system in the State of Maine has contacted me to express 
concern about the equipment that they may need to store the 
vaccine safely. They have already bought additional 
refrigeration units in order to store the flu vaccine and they 
are stocking up on that. But at least some of the vaccine 
presentations that are under study would require a subzero 
refrigeration. That is expensive, particularly for rural 
hospitals in a State like Maine that are already struggling 
financially.
    If we are going to ensure that there is access to the 
groups that I mentioned with Dr. Adams, how can we do so--how 
can we ensure that we are not creating inequities and uneven 
access unless were helping with the purchase of those very 
expensive refrigeration units?
    Dr. Collins. That is a great question, Senator. And I think 
there is an intense effort underway right now to figure out how 
best to address this and certainly the Surgeon General and I 
have been engaged in some of those discussions. This is an 
Operation Warp-Speed component that is being done in a way that 
has never really been done before. To try to imagine how to do 
the distribution when we aren't even quite sure yet which 
vaccines are going to end up being the ones to distribute.
    You are right that one of the vaccines, the one that is 
being produced by Pfizer, requires storage at -70 degrees 
Celsius, which is I think--94 Fahrenheit or some really low 
number and that is a challenge for a lot of refrigeration 
situations. But I think warp speed is totally in the space here 
trying to figure out with CDC how to make sure that doesn't 
become a deterrent to distribution. If that turns out to be the 
vaccine that they need, then we want to be sure that is the 
vaccine that they can get, and that includes in rural areas not 
just in the big cities. So intense attention.
    I have to say I have been very impressed General Perna who 
is leading this part of the effort for Operation Warp-Speed. He 
is a guy who knows how to do supply chain and that is what we 
are going to be all about here and that is being intensively 
pursued.
    Senator Collins. Thank you both.
    The Chairman. Thank you, Senator Collins. The voting has 
begun. And I will go vote in a few minutes. Senator Burr will 
preside while I am gone.
    Senator Warren. Senator Warren.
    Senator Warren. Thank you. Can you hear me, Mr. Chairman?
    The Chairman. I can now. Welcome.
    Senator Warren. Okay. I was--I couldn't hear you either. 
Thanks very much. So the coronavirus pandemic has claimed the 
lives of roughly 190,000 people. Our best hope to stop these 
deaths is a safe, effective COVID-19 vaccine. So, Dr. Adams, 
let me start with you. Estimates vary, but some epidemiologists 
believe that at least 70 percent of the population will need to 
be immune to COVID-19 ideally through taking the vaccine in 
order to provide herd immunity necessary to end this pandemic. 
Is that correct?
    Dr. Adams. Yes, ma'am. The estimates that I have seen from 
experts range from 60 percent to 90 percent. But we certainly 
need to get over half of the population vaccinated so that we 
can achieve herd immunity and stop the transmission of this 
virus.
    Senator Warren. Okay. So as I hear it, kind of our minimum 
target would be about 70 percent, give or take. So the question 
is, can we do that? Now, the last flu season for which we have 
complete data, less than half of U.S. adults, only about 45 
percent, got the flu vaccine. Currently, a CBS News poll shows 
that only 21 percent of people surveyed would take a 
coronavirus vaccine as soon as it became available.
    Convincing enough Americans to take a COVID-19 vaccine is a 
big job. So let's talk about what makes it harder and what 
makes it easier. People are more likely to be vaccinated if 
they trust that Federal officials are basing a vaccine decision 
on science and on data and not on politics or self-interest or 
conspiracy theories. Unfortunately, President Trump has 
undermined this trust. He has overruled scientists and 
pressured the FDA into approving products based on weak 
evidence.
    He has spread dangerous misinformation about COVID-19, a 
practice that other Republicans have parroted. And he has 
appointed a former drug industry executive with financial ties 
to vaccine makers to run the Government's vaccine efforts. And 
now in recent days, he has hinted that he will deliver a 
vaccine, ``before the end of October,'' a claim that public 
health experts fear is driven not by scientific evidence, but 
to boost his chances of winning the election in November. It 
has gotten so out of hand that companies making COVID-19 
vaccines put out a public statement promising to adhere to, 
``high ethical standards and sound scientific principles when 
seeking vaccine approval.'' So, Dr. Collins, I know that you 
and the scientists at NIH and the researchers across the 
Federal Government are working night and day to produce a safe, 
effective vaccine for the American people and we are deeply 
grateful for that.
    But, Dr. Collins, let me ask, do the President's actions 
encourage public trust in vaccines and increase the number of 
people likely to get the vaccine? Or do they discourage 
Americans from getting vaccinated for COVID-19?
    Dr. Collins. I am not sure I know the answer to that 
question. I am more focused on what we can do in the scientific 
community to try to explain how it is that these decisions get 
made and certainly working with the Surgeon General, trying to 
be sure that message is out there.
    You know, Senator, I am hopeful that those scary numbers 
and you just quoted one 21 percent people now saying they would 
accept this vaccine, that is based upon not really knowing what 
the facts are going to be. We are going to have to work really 
hard, though, in the coming weeks and months to get the facts 
out there about how the decisions are going to get made and how 
once we have, and I hope we will by the end of 2020, at least 
one safe and effective vaccine, what is the evidence that 
anybody would want to look at in making their own decision, 
discounting whatever political words they heard, whatever 
conspiracy theories popped up in their Facebook feed and 
actually saying, okay, let's see what the doctors say.
    I hope if we can enlist trusted voices out there in the 
community, not just people in the Government like me, but 
people who are out there, the physicians in the community, 
other community leaders who also get informed about this and 
share that information, that America, which always after a 
while figures out how to do the right thing, will do it again. 
And we will take advantage of something to save lives.
    Senator Warren. Dr. Collins, with all due respect, I really 
appreciate that you are doing everything you can and the 
scientists will continue to do that. And lots of people will. 
But the question I asked you is about what the President is 
doing here and whether what he is doing is helpful or not. You 
know, just in the past few weeks alone, the President has 
accused FDA officials of being deep state operatives.
    He has tweeted conspiracy theories about COVID-19 deaths. 
And he has implicitly tied vaccine development to his 
reelection campaign. If Americans who are watching all of this 
hesitate to take the vaccine because of what he has done, does 
that help us get to the levels we need to be able to create 
herd immunity?
    Dr. Collins. I just hope Americans will take choose to take 
the information they need from scientists and physicians and 
not from politicians.
    Senator Warren. Well, I hope you are right. You know, the 
American people deserve a safe, effective coronavirus vaccine. 
But Congress is lying to itself and to the public if it 
pretends that the President cares about anything other than his 
own political survival when it comes to vaccine development. It 
is time to kick profits and politics out of the vaccine effort 
and let the scientists do their work. Thank you, Mr. Chairman.
    The Chairman. Senator, we are out of time. Your time has 
expired.
    Is Senator Cassidy on? I believe he is.
    Senator Cassidy. Yes, Senator Cassidy is on. Can you hear 
me?
    The Chairman. I can. Proceed.
    Senator Cassidy. Thank you, gentlemen. And if I 
occasionally ask you to make your answer shorter, it is not 
about the rudeness, it is just I have so much to ask. To Dr. 
Adams. Dr. Adams, there is at least one survey granted a little 
bit selected out of New York City suggesting that 20 percent of 
Americans have already, at least New Yorkers, had already been 
exposed. Now we can argue whether or not they have antibodies 
that are protective. But since the whole point of immunization 
is to mimic natural infection, I think it is best to assume 
that the most likely are, and in the case of people being 
reinfected after initial infection occur, but they occur about 
as rare as hen's teeth. So it does seem as if we are going to 
presume vaccines works, we presume the natural infection works.
    Has there been any thoughts as to how to figure out who has 
already been exposed thereby protected naturally and don't need 
the vaccine or at least lower priority as opposed to, let's 
just vaccinate everybody? I say this because as a high ranking 
official, one of the companies producing a vaccine called to 
say that would be very helpful.
    You know, he knew I was concerned about that and he said we 
do have a shortage of vaccine and problems in delivering, 
knowing that 10, 20 to 30 percent have already been exposed in 
certain areas would winnow down those who need to be 
vaccinated. What is your reply to all that?
    Dr. Adams. Well, that is a great question. And I will be 
brief. We have antigen testing. We have PCR testing. And then 
we have antibody testing. An antibody testing is how we figure 
out who has been exposed to the virus. And that is one of the 
questions that has come up in conversations about who gets 
vaccinated first. If you are someone who have been proven to 
have had the coronavirus in the past by antibody testing or by 
a diagnosis, then that is someone who we would not put 
necessarily at the front of the line to get vaccinated until we 
get to the point where we have enough vaccines for everyone. 
But also important to remember, this virus have fooled us many 
times and we still don't know what we don't know in terms of 
how long immunity will last for someone----
    Senator Cassidy. I get that but if I may. But of course, it 
is rare that a vaccine is more effective than actual infection 
in terms of inducing long-term immunity. And so even if it is 
for the next three to four months, that will relieve the 
pressure. Let me return to what Senator Casey asked because it 
is related.
    Senator Casey asked regarding are we going to continue to 
use our immunization registries to document who has been 
vaccinated? The reply was not to reinvent the wheel, but on the 
other hand, if you are going to know whether this person has 
been previously diagnosed, previously infected and or has been 
documented to have antibodies, how are we going to store that 
information and integrate it with the delivery of immunization 
to those who are frontline?
    Dr. Adams. Very quickly, we work with ASTHO, the 
Association of State and Territory Health Officers, and NACCHO, 
the National Association of City and County Health Officers, 
these institutions that already have the systems in place. And 
these discussions are occurring right now in anticipation of 
the vaccine----
    Senator Cassidy. Let me ask you this because I spoke to--
yes, I'm sorry, had some indirect conversations with CDC. It is 
my understanding that for state immunization registries to be 
able to address this, they would have to get an appropriation 
from the Federal Government. They would have to get the vendor 
who does their software to fix it for them. And that vendor, 
there is only four of them and there is obviously 60 something 
states and territories. And so therefore, there would be a 
backlog. Has any effort been made already to adapt these 
registries to take the information as regards to the COVID 
vaccination and or preexisting COVID immunity?
    Dr. Adams. To be brief, I will say that we will have CDC 
follow-up with you, but the answer is, yes, these conversations 
that are occurring right now and the other answer that I have 
to say as Surgeon General is that public health has been long 
underfunded, including surveillance and registries and so we 
would be happy to work with you to figure out how to make----
    Senator Cassidy. To move beyond that, as you move beyond 
the conversations to the actual implementation. For example, 
have RFPs been let in order for these immunization registries 
to be upgraded or is it still on the conversation stage?
    Dr. Adams. I am sorry, I didn't hear the question. Can you 
repeat that?
    Senator Cassidy. Is still on the conversation stage or have 
contracts actually been let to upgrade the immunization 
registries or whatever system we use to document who is immune?
    Dr. Adams. Dr. Redfield will be here in 2 weeks, but I will 
make sure we follow-up with you and get you an answer to that 
question, sir.
    Senator Cassidy. Sounds great. Dr. Collins. One use--there 
has been some question as to whether or not monoclonal 
antibodies will work to prevent infection. Obviously, there are 
several ways that you could get a monoclonal antibody, but one 
would be to give it to those who are vulnerable. Now, a 
monoclonal antibody is merely, again, a mimicry of a vaccine. 
Has any thought been there to give monoclonal antibody to, say, 
an obese diabetic in order to prevent her from being infected 
initially?
    Dr. Collins. Yes, there has. Monoclonals might be useful 
therapeutically for people already sick, but they might also be 
useful as prevention. And you say, yes, this is like a passive 
vaccine. And we do have trials already ongoing for monoclonal 
antibodies for people in nursing homes and also for people in 
families where there have been lots of other infections to try 
to prevent them from getting sick. We don't know yet exactly 
how that is going to work in a preventative mode but that is 
something we really want to know. It is great questions.
    The Chairman. Senator Cassidy, your time has expired.
    Senator Cassidy. Last question to ask, does AstraZeneca 
have Guillain Barre? Because you suggest in your testimony that 
it may have had Guillain Barre.
    Dr. Collins. I am sorry, I didn't hear your question again.
    Senator Cassidy. You suggested that the fellow who had an 
adverse event in the AstraZeneca may have had Guillain Barre. 
Is that the case?
    Dr. Collins. The word that we have had and this is--put in 
The New York Times is it is transverse myelitis, which is 
different. Guillain Barre, although sometimes confused for that 
first presentation, I don't have any other details than that.
    Senator Burr.[presiding]. Senator Cassidy, your time has 
expired.
    Senator Cassidy. Thank you, Mr. Chairman. I yield back.
    Senator Burr. I am going to recognize Senator Kaine first 
but just for the purposes, since there is a vote going on, on 
the majority side, it will be Senator Murkowski, Scott, Romney 
in that order. Senator Kaine, Senator Hassan on the other side 
of people that I know that are here.
    Senator Kaine, you are recognized.
    Senator Kaine. Thank you. Thank you to the witnesses. This 
is a great hearing and observation in three topics for 
questions. Just an observation. We had a hearing in this 
Committee on May 12th. The title was safely getting back to 
work and back to school. I have been critical of the 
Administration for not setting a national testing goal, a 
numerical goal that we should be achieving as tests.
    I was asking questions during the hearing to Admiral 
Giroir. And what he said in the hearing was this, by September, 
taking every aspect of development, authorization, 
manufacturing and supply chain into consideration, we project 
that our Nation will be capable of performing at least 40 to 50 
million tests per month if needed at that time and if new 
technologies are authorized by whole genome sequencing 
approaches or any novel solutions uncovered by NIH's new 
diagnostics initiative, that number will be much higher.
    40 to 50 million tests a month is 1.3 to 1.7 Million tests 
a day. That number is not accepted by all at Harvard. They 
indicate that they think we need 1.2 million tests today to 
mitigate to kind of bump along or 4.3 million tests a day to 
suppress coronavirus. On September 4, we did 900,000--902,000 
tests. That is about 52 percent of the high range of what 
Giroir said we should do by September or 69 percent of the low 
range. So we are still dramatically behind what the 
Administration suggested we should be doing in terms of testing 
to safely open for schools and our workplace.
    I will have a chance to talk to him about that at the next 
hearing. Here is what I want to ask about first. Is there any 
benefit to the United States for not participating in the 
KOVACK Project of the World Health Organization, GAVI and SEPI?
    Dr. Collins. I will say that the United States is engaged 
on the global stage in trying to see what can be done about 
COVID-19, and that is for me personally, a very important 
priority. We have invested and continue to in GAVI, which is a 
critical part of how vaccines can get manufactured and 
distributed. All of our global health experts are deeply 
engaged in communicating and working with their colleagues in 
other countries.
    I do think you have heard from the Administration a clear 
sense that if we are able by the end of the next 6 or 9 months 
to have hundreds of millions of doses of vaccine, we would want 
to be sure that those become available to those countries that 
need the most and may not have their own resources.
    Senator Kaine. Dr. Collins, I recognize that we are engaged 
at the international level, and there is good reasons for it, 
as you state. I understand that you appreciate it. I can see no 
tangible benefit to the United States not participating in 
KOVACK, just as we are looking at multiple vaccines and the 
theory that competition is good. And then there may emerge the 
contenders that we want to. It seems like the diversification 
of portfolio would suggest we have nothing to gain from 
withdrawing from KOVACK. That is my own opinion. I want to ask 
about a particular element of the leading contenders in the 
vaccine which required two doses. I think there is at least one 
candidate that has a one dose vaccine.
    Building upon this and maybe get your guys advice on this 
one. We know that a significant percentage of people have said 
they will not get a vaccine and that is for any vaccine but in 
particular in this and so we have to educate people about it. 
We also know that in other vaccines that require two doses and 
in this case, the leading contenders would require at least 21 
or 28 days between the doses, is my understanding.
    In other vaccines that require two doses, a significant 
percentage of people, somewhere between 40 and 65 percent in 
some studies who get the first dose will not get the second 
dose. And then a significant percentage of the people who get 
the second dose don't get it in time. They will get it months 
or many months later after they are able to get it. What is the 
effect on a two dose vaccine if you just get the first dose and 
don't get the second dose?
    Dr. Collins. We know a little bit about that, Senator, from 
the fact that we have run these Phase 1 trials. And again, you 
can look and see what happens after the first dose as far as 
the production of antibodies, which is our best way of 
assessing whether it worked. I think with all of the two dose 
trials, it looks as if the first dose does give some response, 
but if not at the level that you would really like to see, and 
then you give that second dose and you are up in the range of 
antibodies that people have developed who got actually natural 
infection from COVID-19.
    Hence, if you want to be as effective as possible, you go 
to that second dose. It is not the ideal. I think ideally we 
would love to have a single dose that didn't require 
refrigeration and was easily transported and was totally safe 
and effective. We may not be lucky enough in this very big push 
to get something quickly, to have something with the perfect 
parameters. But it is most important, I think, we get something 
that works and saves lives.
    Senator Kaine. For the record and to our next panel, I will 
ask questions about what we will do to try to educate people on 
the need to get that second dose and get it in a timely 
fashion. I also have a question about vaccine testing on 
pregnant women that I will save for a question for the record. 
I appreciate your testimony today.
    Thanks, Mr. Chairman.
    Senator Burr. Thank you, Senator Kaine.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman. And thank you, 
gentlemen, not only for your comments this morning, but just 
your leadership in this. I take particular interest in this 
discussion about vaccines because Alaska has lagged 
historically in terms of our vaccination rate. We have 
chronically been last, last among the 50 states. It is my 
understanding that we are in there at about 74.2 percent 
compared to all the other 50 states.
    Other states, you get some--Massachusetts is the highest at 
92. So Alaska has a long way to go. And unfortunately, we have 
been this way for a while. So when we talk about vaccine 
hesitancy in Alaska, we know we get it. And so I am very 
concerned about where we are moving forward with this vaccine. 
I also recognize that we have some of the most vulnerable 
populations in Alaska with our Alaska native people. We have 
limited health care facilities. You have had opportunity in 
this hearing date to hear all about it. So we are exactly the 
type of state that needs to have that assurance that, yes, this 
vaccine is going to be safe, that this vaccine has not been 
subject to political initiatives that would speed it up in any 
such way that would cause it to be less effective.
    We have every interest to make sure that there is an 
education campaign that people can believe in. I have been 
working with several of my colleagues on this Committee, 
Senator Braun, Senator Hassan here on the SAVE Act. This is the 
Safe Authorizations for Vaccines during emergencies, basically 
making sure that we are ensuring a level of public independent 
expert review of the vaccine candidates. I know you may not 
wish to comment on specific legislation. Dr. Collins, you have 
already spoken in your initial remarks to the Chairman, into 
the Ranking Member about the assurance that we must, in fact, 
make sure that this process that we have is true, is honest, 
and is going to result in a level of trust and credibility.
    I would just ask you to help me in encouraging Alaskans on 
and other Americans on how we build this trust for a vaccine. 
What can you give me? Do we need more than just the SAVE Act 
here to build that credibility and trust? Because otherwise I 
am fearful that the rates that we have seen with our 
vaccinations, generally what we have seen just this year 
compared to April of last year, we saw a 48 percent decrease in 
total vaccines administered in this state. This past May and 
June we have seen a slight improvement, but we are in a tough 
spot right now. Give me some level of assurance, please.
    Dr. Collins.
    Dr. Collins. I think we have a tough situation for the 
whole nation. But I am sympathetic with your particular 
circumstances, with the history in Alaska of hesitancy being 
even greater. This is going to be a need for all hands on deck. 
Leaders in the Congress, people in the local communities have 
to get all together to figure out how to convey this message. 
The Surgeon General is right in the middle of trying to 
organize a lot of this effort so maybe I should ask him to 
speak as well.
    Senator Murkowski. I mean, do we need a public relations 
campaign that is really amped up? Messengers are important. Who 
is the right messenger? Is that the Surgeon General? Is it 
the--who is it? Because right now it is not working.
    Dr. Adams. Well, we know that when it comes to vaccines and 
most health advice, that people will trust their local provider 
more than they will trust anyone else out there. So what we are 
trying to do with arm local providers, with the facts. CDC's 
campaign really has scripts and sheets to help people talk 
about some of the frequently asked questions. We are engaging 
with social media influencers. So I was in Kotzebue and they 
knew about rappers.
    In the San Francisco 49ers, I remember there was a guy 
wearing a San Francisco 49ers hat. We need to get Lady Gaga, 
for instance, is someone who I never thought I would invoke in 
Congressional testimony. But I gave her a shout out because she 
had mask that she worked the Video Music Awards last week and 
people will listen to Lady Gaga before they listen to the 
Surgeon General. So we need to very much engage. The other 
thing that I would implore you to think about is we need to 
encourage people to stop attacking the process. And there is a 
lot of politics going on here.
    People don't like one party or the other, one person or the 
other. The process is strong. And Dr. Collins and I have been 
adamant that we want people to understand there are protections 
built in. The process is strong. If we follow the process and 
people understand the process, they will have confidence. But 
everyone out there who says, I won't take this vaccine if I 
don't trust this vaccine unless is instilling further hesitancy 
and hurting us.
    Senator Murkowski. I think that is important. And that is 
exactly why the SAVE Act is there to focus on the integrity of 
that process. Thank you, Mr. Chairman.
    The Chairman [presiding]. Thank you, Senator Murkowski.
    Senator Hassan.
    Senator Hassan. Well, thank you, Mr. Chairman and thanks to 
the Ranking Member as well and to both of our witnesses today, 
thank you for your service. And I will echo what other people 
have said. We know everybody in your shops are working round 
the clock here, and we are very, very grateful to you and all 
of them. We have been talking a lot today about public trust in 
the vaccine approval process, which we all agree is critical to 
achieving the widespread use of a vaccine. But right now, 
people are concerned, as you have heard Senator Murkowski say, 
as you heard Senator Warren reference, a CBS poll released this 
past weekend found that two thirds of Americans would think the 
process had been rushed if we got a vaccine this year and only 
one in five plan to get vaccinated as soon as possible.
    Let's drill down a little bit on what the process is so we 
can provide some of this confidence to the American people. Dr. 
Adams, last week you told ABC News that you have confidence in 
the COVID-19 vaccine review process because data safety 
monitoring boards would not allow a product to move forward 
unless there is, ``good evidence that these vaccines are 
efficacious.'' But in addition to ensuring that a vaccine is 
effective, we also have to ensure that it is safe. So could you 
please tell us, Dr. Adams, what protocols are in place to 
ensure that these boards do not stop clinical trials until they 
also collect sufficient safety data, including for high risk 
populations? And what specific steps have been taken to ensure 
that these decisions will not be subject to political influence 
from the White House?
    Dr. Adams. I will be very quick in my answer, because this 
is more on Dr. Collins' lane. But as an example, the FDA 
generally advises a minimum population size for pre licensure 
safety data base for preventive vaccines to exceed 3,000 
patients. These trials have 30,000 patients in them. This isn't 
so much about time as it is about events. And we have so many 
more people, tenfold involved in these trials that we have the 
potential to be able to recognize a safety and efficacy signal 
a lot sooner. We also have a higher incidence of background 
disease prevalence, and that is a bad thing, but it means that 
in terms of getting a signal, there are valid scientific 
reasons to expect that we will both get a safety and an 
efficacy signal in a very short order.
    Senator Hassan. Hold on, just a second please, Dr. Collins. 
Look, I appreciate that. But what people are looking for is 
administratively what are we doing? What systems do we have? 
Because, look, if this Administration's vaccine review process 
is as evidence based and free from political influence, as you 
both are suggesting, why do you believe the leading COVID-19 
vaccine manufacturers took the unprecedented step of jointly 
releasing a public pledge yesterday, committing to an evidence 
based vaccine review process focused solely on safety and 
efficacy?
    Dr. Adams. I can give you at least part of that answer, and 
that is because Dr. Collins and I have been on the phone with 
them and really putting forward a full court press to help 
instill confidence in the vaccine process that we know is, as 
Senator Murkowski just mentioned, has been wavering long before 
COVID.
    Senator Hassan. Okay. And because my time is short, I am 
going to move on to another topic. I understand you have 
something to say too Dr. Collins, but I want to touch again on 
the SAVE Act that Senator Murkowski was talking about. If we 
expect the American public, Dr. Adams, to have confidence in 
these products, we need to ensure that they have full 
confidence in the review process. In addition to the general 
meeting they are holding in October, do you believe FDA's 
vaccines and related biological products advisory committee 
should hold public meetings, review clinical trial data and 
release their findings to the public before FDA approves or 
authorizes any vaccine product as they normally would?
    Dr. Adams. I think we need to follow the process because 
the process works. I think we need to be careful about 
inserting new barriers in the process because it is just as 
unethical to prolong----
    Senator Hassan. But excuse me, just because the time is 
limited, this isn't a new barrier or a new process. This is the 
existing process, right?
    Dr. Adams. I believe we need to follow the existing 
process.
    Senator Hassan. You support that. Do you believe that the 
CDC's Advisory Committee on Immunization Practices should meet 
publicly, review data and issue public recommendations for each 
COVID-19 vaccine that enters the market so health care 
providers across the country are confident giving these 
vaccines to their patients?
    Dr. Adams. Again, I believe we need to follow the process 
and engage health care providers so that everyone has 
confidence.
    Senator Hassan. Okay, because a vaccine is really only 
effective if people are willing to use it. So I just want to 
touch on what the SAVE Act does a little bit. Working with 
Senator Murkowski and Senator Braun, for instance, we have 
introduced, this is bipartisan legislation, that would improve 
public confidence in the vaccine review process by helping to 
ensure that these independent FDA and CDC reviews take place in 
a transparent way, free from political influence without 
slowing down the development of safe and effective vaccines. So 
I just want you both to know that is what the SAVE Act is 
about. We believe these processes are in place.
    These experts are used to doing this work. They are 
independent. I am going to continue to push for this 
legislation to be included in the next COVID relief package. 
And I look forward to working with you with ideas about other 
ways we can strengthen the transparency of this process and 
really, again, help the American people understand what the 
processes are and why you both are so confident that the 
scientists will be able to do their work.
    The Chairman. Thank you, Senator Hassan. Your time has 
expired. I am going to let Dr. Collins, if you had something to 
add, I will give you the time to do it.
    Senator Hassan. Thank you.
    Dr. Collins. Well, just very quickly, you asked about the 
statement by the nine CEOs and I think they were responding out 
of their concern, which we keep very much share, Surgeon 
General, and I think all of you do that there is this strong 
public distrust and skepticism and they wanted to come out and 
say very clearly, hey, we are not trying to pull something 
here. We don't believe in putting forward anything that is not 
absolutely safe and effective. We are pledging this in writing. 
I hope that added a little bit more confidence to the people 
who are still looking at this and wondering. I was glad to see 
it----
    The Chairman. Thank you, Dr. Collins.
    Senator Romney.
    Senator Romney. Thank you, Mr. Chairman. And I want to 
thank members of the panel for your testimony today. I have to 
thank in particular Dr. Collins for the slide, said this 
description of the process that is leading toward a vaccine was 
most informative and colorful. I want to pick up on the line of 
questioning Senator Murkowski described, and that is with 
regards to the growing sentiment, I think, across our country 
of people who are, if you will, anti-vaxxers, people who are 
avoiding vaccines.
    I have been approached during business to my state by 
people who have the whole books that are written describing why 
vaccines are bad and why they are made from adulterated 
sources. And I won't go into all the details, but it is not 
like just a social media phenomenon. It is literally there are 
literally books out there that are written to describe why 
vaccines are bad. And I wonder if it does not makes sense for 
our Government to put out a very comprehensive effort to dispel 
this growing sense of vaccines being bad.
    I don't know how you do that, but it would kind of mind 
that you are doing that with regards to tobacco and massive 
advertising on TV. You can have debates. You could call in 
these people who write these books and have discussions with 
them, which are publicized. You could have a much more 
aggressive campaign on social media.
    I guess the question I am asking is, should we be doing 
more than we are doing and what could we be doing to resolve 
the debate, the uncertainty that so many Americans have about 
the wisdom of receiving vaccine? Now, I will ask Dr. Collins 
and the Surgeon General, both of you respond to that.
    Dr. Collins. Well, I will start. But the Surgeon General 
will have a lot to say about this. This has been, of course, an 
issue for our country, not just in this season of COVID-19, but 
before that. And particularly one has seen the consequences of 
that with measles, for instance, which in the year 2000, we 
declared that the U.S. had succeeded effectively in getting rid 
of measles. And now last year, we had more than a thousand 
cases. And people have forgotten that kids die of that disease 
and continue to die in other parts of the world.
    I think we have benefited from the success of vaccines so 
that a generation has sort of lost track of the fact that these 
are preventing diseases that take lives. I just saw an estimate 
that if you looked at all the children born in 2009 and you ask 
what would have happened if none of these vaccines had been 
available? 42,000 of them would have died. Imagine that, 42,000 
kids dying for preventable conditions because vaccines were not 
available.
    Well, they are available now but if they are not getting 
used, we are facing that same kind of terrible consequence. And 
it is heartbreaking and I must say frustrating and sometimes 
even causes you a little bit of anger and frustration that this 
kind of misinformation is so readily spread by people who have 
another agenda. And we have a hard road to go to try to counter 
that when so many people don't see in their own experience the 
reason why this is such a lifesaving activity. But I am going 
on a bit. Surgeon General, please say what we should do about 
it.
    Dr. Adams. No, thank you, Senator. And I will very quickly 
walk through the Department of Health and Human Services is 
using a three tiered approach to improve vaccine confidence 
through research and evaluation, collaboration and partnership, 
communication strategy, the knowledge dissemination. I put out 
an Op-ed earlier this year with the secretary and with CDC 
Director Redfield. We are working with platforms like Twitter 
and Pinterest and Facebook to make sure appropriate and 
accurate information is displayed prominently when people do a 
search.
    CDC developed vaccinate with confidence, the strategic 
framework to strengthen vaccine confidence. We are working with 
minority medical schools like Morehouse and beyond. But you 
mentioned vaccine, vaccine resistance and the anti-vaccine 
community. It is important to understand that 90 plus percent 
of parents out there are actually doing the right thing. And 
that when you look at the 10 percent who weren't, most of those 
10 percent aren't in that anti vaxx or I say vaccine resistant 
category. They are in the vaccine hesitant category. And that 
is what we need to really work on.
    We need to work on educating them and engaging them and 
being compassionate with them and patient with them to answer 
their questions. And I went out to Washington when they had the 
measles outbreak last year. And I found that when they had 
after hours of conversations with parents, they would come back 
to three, sometimes four times. But most of those parents, when 
they got their questions answered, actually got vaccinated.
    Senator Romney. Thank you, gentlemen. My time is virtually 
out. I will just make one more comment. And that is for Dr. 
Collins. And that is what it regards to the Russian 
announcement of a vaccine. Clearly, very little data. But are 
we evaluating the promise of vaccine efforts in other 
countries? And do they have much prospects for being of value 
to us?
    Dr. Collins. We certainly are to the extent that the 
information is being made available and obviously what you 
would like to see is a publication that has been peer reviewed 
and some of that is starting to come now from the vaccines that 
are being developed in China and Russia. I must say, the way in 
which the Russians roll this out, declaring victory before they 
had gone much beyond a Phase 1 trial, did not win them a lot of 
confidence in the scientific community. And so we really have 
to be insistent that if somebody is going to say this vaccine 
is safe and effective, that they have lived up to that very 
high standard.
    I think our country establishes those standards and others 
generally follow them as well. So, yes, we are watching but 
some might have said that the effort that Russia had put 
forward was putting a lot of people at risk, asking them to 
take a vaccine that hadn't gone through that. Some even called 
that Russian roulette.
    The Chairman. Senator Romney, your time has expired. Thank 
you.
    Senator Romney. Thank you.
    The Chairman. Senator Smith.
    Senator Smith. Great. Thank you so much, everyone. I want 
to first thank Dr. Collins and Dr. Adams for your service to 
our country and for everything that you were doing. I know that 
everybody on this Committee is dedicated and optimistic even 
about the goal of having a safe and effective vaccine that 
distributed at scale and also can be free for everyone. And so 
I want to just touch on that for a minute. You--last month I 
introduced my COVID-19 Treatment Act, which would ensure that 
folks get their health insurance through Medicaid or CHIP or 
people who don't have health insurance at all would be able to 
get a free COVID-19 vaccine.
    This builds on the actions that we have already taken in 
Congress to make sure that folks that have private insurance or 
receive their insurance through Medicare have a free vaccine. 
So, Dr. Collins, I want to drill in on this a little bit with 
you and just understand a little bit about how we can make sure 
that this happens and that folks aren't stuck with out-of-
pocket costs that they are not expecting if they get their 
insurance through Medicaid or CHIP or if they are not insured 
at all. So first, can you just to confirm that the Federal 
Government will buy this vaccine and also will--and also the 
supplies that are needed to administer the vaccine and make 
that available to providers at no cost?
    Dr. Collins. Yes, I can confirm that. It is part of 
Operation Warp-Speed. As these various vaccines are chosen to 
be put forward and new deals are negotiated, that allows the 
Government to buy and own tens or in some cases hundreds of 
millions of doses that then can be provided for free to 
providers. And along with that, of course, all of the other 
materials you need, like syringes and vials and PPE is part of 
the package. The only thing that then needs to be dealt with is 
any kind of charge that the provider might give for 
administering the dose. And I know the Administration is 
committed to making sure that does not become a barrier to 
anybody and you can get this completely for free if that is 
what you need to do.
    Senator Smith. Right. That was my--that is perfect. That 
was my second question, that there aren't hidden charges, 
administrative costs, but that would also be reimbursed by the 
Federal Government so that folks don't get stuck with something 
they are not anticipating, which is, of course, particularly a 
barrier if you don't have any insurance at all or if you have 
Medicaid.
    Dr. Collins. I think the Administration has made it clear 
that no one should be denied this vaccine. It needs to be 
completely free.
    Senator Smith. If let's say that we found out that we 
needed a booster, some sort of a booster shot or shot like a 
two round vaccine that you need to get a booster like we do for 
other infectious diseases over time, would or should the 
Federal Government also cover the cost of those boosters at no 
cost to source?
    Dr. Collins. I don't know that I have heard that 
conversation going on yet because we really don't have the data 
to know whether such boosters will be needed and if so, how 
frequently with the booster have to be provided. We are all 
hopeful, of course, that this vaccine will produce long lasting 
immunity, but that is not always going to be the case. I think 
that is a downstream discussion, at least it is for me.
    Dr. Adams. We are talking about COVID but I think it is 
important that we just operate under the underlying belief that 
all vaccines should be provided at minimal cost to people 
because they save lives and they are cost effective----
    Senator Smith. Well, and Dr. Adams, I think the point here, 
of course, too, is that this is really a matter of public 
health but it is also a matter of equity because we know that 
black and brown and indigenous people, people of color, are 
more likely to be uninsured and more likely to be facing a 
struggle. So I think it is just extremely important. So I am 
going to ask all my colleagues on this Committee, I would be so 
grateful if you would join me on this bill. I think it makes a 
very important statement. It also makes a very important step 
toward ensuring that this vaccine, when it is available and we 
all are optimistic about that and eager to make sure that it is 
safe and effective, that vaccine is available to everyone, and 
not just free of charge. I think I just have a couple more 
questions.
    Dr. Collins, I want to just ask you one question. I think 
people are so concerned about this, how does a process which we 
have to trust and can be trusted? So can you just explain to us 
a little bit about how an event they have--what would be the 
endpoint or when we know that this vaccine trials should be 
completed and be done? What is the end point?
    Dr. Collins. Let me quickly explain how that works. Let's 
say we have 30,000 people involved in a trial, which is the 
number we are aiming for all of these trials. Half of them 
received the vaccine. Half of them received an injection of a 
placebo. Nobody knows whether they got the vaccine or the 
placebo. But then you track those individuals and you look to 
see who, in fact, gets infected with SARS COVID 2.
    What you are looking for, of course, is a circumstance 
where those who got the vaccine have significantly fewer cases 
than the well-matched folks who got the placebo. That tells you 
the vaccine is working. As it turns out, by the time you have 
seen 150 cases of SARS COVID 2 in this group of 30,000 people, 
if your vaccine is at least 50 percent effective, you are going 
to know it because you are going to see a big skewing in terms 
of who got the disease and who did not. And that is basically 
why we say this is an event based decision process for deciding 
about efficacy. You count those events and whether it worked or 
not.
    If the DSMB, which is the part of this enterprise that is 
looking at this, sees that, then they raise their hand, 
assuming they have also looked at safety and found it 
acceptable and said, Okay, FDA, it is time to have a look. That 
is how it works.
    Senator Smith. Thank you. I know I am out of time,
    Mr. Chairman. Thank you very much.
    The Chairman. Thank you, Senator Smith.
    Senator Loeffler.
    Senator Jones.
    Senator Jones. Thank you, Mr. Chairman. And thank you, both 
to our witnesses today for your service and for being here. You 
know, I want to go at this a little bit--I want to get some 
specifics on some of these crazy theories out there, guys. We 
talk about them and we see this. And I appreciate Dr. Adams 
saying that 10 percent of parents out there are only 10 percent 
are not doing the right thing by getting vaccinations. But all 
of this, has been with small pox and measles and other things 
which we have grown up in a different era.
    Now we are in an age of social media and we see Facebook, 
we see Twitter, we see the Internet full of all of these 
conspiracy theories. I would like to get both of you an 
opportunity right now, because one of the things I am not 
seeing from NIH or from the Federal Government is efforts to 
really debunk these theories as opposed to just getting 
positive information out there.
    Dr. Collins, Dr. Adams, each take one or two of these 
theories. Tell us what you have heard. What is the most 
outrageous thing and debunk it for us as quickly as you can so 
that the American people right here on the record know that 
they should not follow these absolutely crazy theories that are 
out there about vaccines. Can I go for comment?
    Dr. Adams. I will take the first one. Vaccines do not cause 
autism and people need to understand that. We have looked at 
the trials. We have looked at studies. Vaccines do not cause 
autism.
    Dr. Collins. I am agreeing with that one. But I will tell 
you the craziest one I have heard, which is this is all 
designed by Bill Gates. And when you get the vaccine, it has a 
chip in it that is going to get stuck into your system and it 
is going to watch everything you are doing. And people believe 
that stuff.
    Senator Jones. None of the vaccines are designed to kind of 
be Big Brother over people and to follow them. They are 
designed, I take it, to save lives. Correct?
    Dr. Collins. That is exactly right.
    Dr. Adams. Exactly. To save life and to save money, sir. 
Vaccinations are over $402 billion in direct cost and $1.5 
trillion in societal cost. And that is just the flu vaccine 
every single year.
    Dr. Collins. I have a T-shirt that I like to wear 
sometimes, although it isn't always well received. And it has 
three words on it. It says vaccines cause adults. Think about 
it.
    Senator Jones. Very good. I would though encourage both of 
you with your respective positions to do a little more in terms 
of actually debunking theories. I appreciate all that you are 
doing to get accurate information out there. I have been doing 
a lot of Facebook live every week with a health care 
professional to try to get accurate information out there. But 
still debunking the theories is also important.
    I would encourage you to kind of do that on your websites 
and do that in information, not just trying to get the 
accurate, but to debunk some of this garbage that we are 
hearing out there. So, Dr. Adams, I want to follow-up with you 
a moment, because I really do think you are in a unique 
position about encouraging minority participation in some of 
these clinical trials. We know that minority participation in 
these clinical trials is down. We know and on the flip side, 
that minority populations are being disproportionately affected 
by this, by COVID-19. And unfortunately, the United States has 
somewhat of a sordid history when it comes to minorities and 
clinical trials. So what would you can you do? What would be 
your voice to encourage more minority participation? And how 
can we in Congress help get that voice out there because I 
believe it is so important to get a saving a vaccine, effective 
vaccine for everyone.
    Dr. Adams. Senator, one of the things you can do is to 
support an institution right in your own community, University 
of Alabama at Birmingham. I was there just two weeks ago and 
they have done a tremendous amount of work in terms of engaging 
the local African-American community in cardiovascular and 
hypertension research. But I think, No. 1, we need to 
acknowledge past wrongs that have occurred.
    You all might be surprised to hear me giving a shout out to 
Bill Clinton. But Bill Clinton apologized for the Tuskegee 
experiment several years ago. We need to acknowledge Tuskegee. 
We need to acknowledge Henrietta Lacks. We need to acknowledge 
the wrongs occurred. And then we need to address the situation 
that caused them to happen. And again, we talk about the 
process, Phase 1, Phase 2, Phase 3 trials, data safety 
monitoring boards, committees, and whole agencies, that HHS 
that have been stood up to make sure these types of things 
never, ever happen again.
    Then we need to engage. And that is what you're talking 
about, sir. We need to get out there where the people are and 
use trusted advocates. I have been working with faith 
communities. I spoke to rabbis last week. I have spoken to a 
pastor of the largest megachurches in the country. We are 
talking to social media influencers like Kylie Jenner and T.I. 
and again, Lady Gaga, because my kids will do something 
because, I believe, because they say it before they believe it 
because Dr. Collins or I say it. But that is kind of our 
approach that we are taking to engage with people, address--
acknowledge, address and engage.
    Senator Jones. Well, thank you, Dr. Adams, and thank you 
for coming down to Birmingham for the opening of some of those 
free clinics. We very much appreciated your visit. And those 
are being very successful. Thank you. Thank you, Mr. Chairman, 
for this opportunity.
    The Chairman. Thank you, Senator Jones.
    Senator Rosen.
    Senator Rosen. Can you hear me?
    The Chairman. I can. Welcome, Senator Rosen.
    Senator Rosen. Sorry, I had a little trouble unmuting. 
Thank you, Mr. Chairman. Thank you for holding this hearing. 
Thank you both doctors for being here today. I really 
appreciate your work and your testimony. But to begin with, I 
really want to raise again the importance of ensuring that we 
got a robust, longitudinal studies on how the virus impacts a 
wide range of patients in the short and the long term, 
including what treatments are most effective. So I have 
introduced a bipartisan Ensuring Understanding of COVID-19 to 
Protect the Public Health Act to make sure that this critical 
research happens. And this includes a very diverse set of 
patients.
    This bill was included in the House's passed CARES Act and 
I ask support from my colleagues and especially on this 
Committee, to ensure it is included in the next COVID package 
passed by the Senate. That is going to help us determine 
future--But I would like to move on now to rural access to 
vaccines and information. And so the CDC has asked the states 
to draft and be ready to follow vaccine distribution plans in 
less than 2 months.
    Our health departments are doing the work of the heroes but 
they are stretched thin and they still lack the robust Federal 
support they need. Last month I was on a statewide virtual 
tour. I heard how the need for basic health care services 
remains a huge issue, particularly in rural towns. In Beatty, 
Nevada, they still lack access to regular primary health care. 
Rural access--across the country, rural areas are continuing to 
struggle as the pandemic exacerbates existing problems with 
access to adequate medical care. So with this in mind Dr. 
Collins, what recommendations do you have for making sure that 
rural areas are not left out of the critical vaccine 
distribution? Both the actual delivery of the vaccines, 
information about who should receive the vaccines.
    I have communities that have no hospital, no physicians' 
offices and no pharmacies with the closest medical services 
potentially 100 miles away. So what is a national plan to 
deploy these vaccines across our states? Mobile clinics, 
perhaps? Can you tell us what is to happen or do will we have 
to figure it out on our own?
    Dr. Collins. Well, I will start. But I am sure the Surgeon 
General might want to add something because even more in his 
domain. But certainly the distribution issues are critically 
important and are under intense planning processes right now, 
recognizing that warp speed has not just the role of trying to 
encourage their clinical trials, but also the manufacturing and 
then the distribution. Everything like the cold chain and how 
do you actually get these doses to the places where they need 
to be, recognizing that we are going to need to do this in a 
priority way so that the most vulnerable people get the doses 
first.
    That means thinking about rural communities and all the 
ways that can happen, but it is going to be working with the 
states and CDC is already deeply engaged in that. I think they 
got a little misunderstood when they said to the states, we 
need to be ready by November 1st just in case. I think they 
were trying to say, let's be prepared here and not wait to the 
last minute. And that is very much the conversation that is 
going on. But the Surgeon General may want to say a little bit 
more about rural areas in particular.
    Dr. Adams. Well, I will be very brief--.
    Senator Rosen. Yes. I want to make sure that Congress is 
your partner and being sure that we leave no rural communities 
behind.
    Dr. Adams. I will be very brief. I grew up in a rural 
community in Southern Maryland where the nearest hospital was 
quite far away. And I ran the State Department of Health in 
Indiana, which is a mostly rural state for three years. We have 
utilized the Vaccines for Children's Program, VFP. We have 
utilized the Section 317 immunization program. We have 
infrastructure in place to get vaccines out to those 
territories. But you are right, we have to acknowledge that we 
still have done a poor job of making sure we have equitable 
distribution of vaccines before there is COVID vaccine in those 
communities and we need to double up on those efforts.
    We are working with state and local health departments to 
make sure that occurs. And I stand ready to work with you to 
make sure people know vaccines are safe and effective and that 
we are addressing the practical issue with availability, 
convenience, cost, service, quality and satisfaction, making 
sure that not just there, but that people can get it easily and 
are happy with the way they received it. And either all issues 
that are on my radar and that we are working with local 
partners to try to figure out before we get a vaccine.
    Senator Rosen. Thank you and I only have a moment left but 
I am going to submit this for the record. But we have seen a 
troubling decline in vaccination rates overall during the 
pandemic. It was reported in May this year, vaccinations 
generally were down by approximately 64 percent. This is 
extremely concerning not just to me, but to everyone across our 
state. And I am sure other states have similar statistics.
    Dr. Collins, how do you think that current drop in 
vaccinations could impact getting a COVID-19 vaccination out? 
Should we pair up getting existing vaccinations to people along 
with the COVID-19 vaccination? Would you recommend that or how 
do you think that we can bring our general vaccination rates 
back to where they should be as well?
    Dr. Collins. Well, the general vaccination rate is a crisis 
right now that ought to be attended to right now. There is no 
reason to have to wait until we see what happens with the 
current COVID-19 vaccines that are in clinical trials. So all 
of those folks who might be listening to this, who fell behind 
on childhood immunizations because of concerns about going to 
the doctor's office, those doctors' offices have figured out 
how to make themselves about the safest place you can be. It is 
time to catch up.
    I know your physicians will be very willing and interested 
to help you do so. And then that ought to be happening this 
fall, as well as everybody getting their flu shot, which is 
another vaccine whose appropriateness and urgency is going to 
be even more the case than ever.
    Senator Rosen. Thank you. My time has expired and I really 
appreciate your service. Thank you, Mr. Chairman.
    The Chairman. A couple--thank you, Senator Rosen. We will 
wrap the hearing up now. We have votes going on the Senate 
floor. I have got a couple of questions in conclusion. Dr. 
Collins, there was some talk earlier during the hearing about 
multiple shots for a vaccine. If I remember right we already do 
that, don't we? I mean, some vaccines require more than one 
shot.
    Dr. Collins. For instance, the HPV vaccine, which is saving 
lives from cervical cancer in prodigious numbers, started out 
as a three dose. I think it is looking pretty good. That two 
will do. But we are not down to one yet. And yet that is 
clearly something that motivated parents very much want their 
children to have, as I think they should. So, yes, this is not 
the first time.
    The Chairman. I believe I have taken tetanus booster shots.
    Dr. Collins. Yes. Every 10 years. That is right.
    The Chairman. That shouldn't be--second, Senator Burr made 
an interesting point, which was that a lot of the statutory 
authority to do all the extraordinary things that the 
Administration is doing right now is already on the books. In 
other words, Congress, after the last several pandemics, took a 
number of steps giving the Food and Drug Administration more 
authority, giving the National Institutes of Health additional 
funding and some more flexibility, creating--moving the 
stockpile management, creating manufacturing plants that would 
be ready in case we needed them.
    How valid is that point that in fact, as we think about 
preparing for the next pandemic, which Jared Diamond reminds us 
could be next year in this age of jet planes, that a lot of 
good work has already been done by the last three or four 
Presidential Administrations of both parties and Members of 
Congress, of both parties, and that this Administration is 
simply using to a full extent the authority Congress has given 
you.
    Dr. Collins. I think that is very true. I think it is 
traditional right now to bemoan that we weren't ready for 
COVID-19, that we somehow let things lapse. We weren't 
perfectly ready, that is for sure. And there were some things 
that probably could have been in better position to be ready 
for this. But there were things that Congress had done over the 
past couple of decades, the creation of BARDA, other things 
that you have mentioned that made it possible to move more 
swiftly now. Now we need to learn from this one.
    Of course, this is the worst pandemic we have had in more 
than a century so maybe we will learn even better this time to 
be prepared so that as we get through this and we are going to 
get through this COVID-19 will slip into the rearview mirror, 
that we don't imagine that we are done with pandemics because 
COVID 23 or whatever the next thing might be is out there 
lurking. And we should learn from these lessons and not do 
anything other than prepare.
    The Chairman. Well, one of the lessons, and Senator Frist, 
Governor Leavitt, a number of others who preceded both of you 
in your positions have said we go from panic to neglect, to 
panic. And even though we have taken some significant steps to 
be better prepared and you are taking advantage of those, I 
mean, there is no way you could have had--you could be 
developing a vaccine this rapidly, this safely, this 
effectively without these steps. Still, we are not as prepared 
as we should be because in between epidemics, we lose our 
focus, which is why I am urging that on onshore manufacturing 
that we make sure we keep those plants warm, as Governor 
Leavitt said.
    On stockpiles, that we make sure the stockpiles stay full 
and aren't depleted because of budget problems at the state or 
in the hospitals or in the Federal Government. And Governor 
Leavitt said we had underfunded public health in this country 
for the last 30 or 40 years. So we need to--and the time to be 
prepared for that is now.
    I have reiterated my strong feeling, and I hope you agree 
with it, that the time to sustain our preparedness is now while 
our ire is on the ball and that while we are dealing with this 
pandemic, we should make sure we are prepared for the next one. 
Dr. Adams, you agree with that?
    Dr. Adams. I have been in public health my entire life. And 
as you mentioned, and we have chronically underfunded public 
health. I have been coming to DC every year for the last 20 
years asking for funding for basic public health. The problem 
with public health is that it is like the oil change in your 
car. You wait until the engine blows up before you decide you 
need to check the oil. We need to fund public health.
    We need to fund vaccination. And I want to thank you for 
being a strong advocate, knowing that this may be the last time 
I testify before you, for your strong advocacy, not just for 
the State of Tennessee, but for the United States in terms of 
making sure we have the resources we need at the Federal level 
and are using our tools to protect the American people.
    The Chairman. Well, thank you, Dr. Adams. One other thing. 
The phrase herd immunity has come up. There is another phrase 
that has been thrown around let's just say inelegantly in the 
news media, and I think it is misunderstood by a lot of people. 
The way I am hearing you talk is that developing herd immunity 
is a good thing, right? I mean, you want to get to a point 
where a large number and I believe you used the numbers, 60 to 
90 percent of the population has some form of immunity from a 
disease. So herd immunity by itself. Nothing wrong with herd 
immunity, right?
    Dr. Collins. No. It is how you get there.
    The Chairman. It is how you get there that is the question. 
And there is the old way to get there, which is just later, as 
Dr. Collins once said, let her rip this, let it roar through 
the whole population, killing people until everybody's either 
killed or recovered with some form of immunity or we have 
vaccines, which is the way we get there. And that is--I think 
it is very important that the American people understand we 
want herd immunity, but we don't want to do it, we can't do it 
by locking everybody in their room the way they used to do with 
leprosy and put everybody with leprosy in a leper colony. Well, 
that is a form of quarantine. But they didn't get rid of the 
disease necessarily.
    What we can do today, we believe and the testimony has been 
consistently, that every one of the public health experts in 
this Administration and most outside are cautiously optimistic 
that we can have a safe vaccine that is also effective by the 
end of the year, cautiously, at least for the most vulnerable. 
And that during 2021 there should be hundreds of millions of 
doses of this. Now, there is no guarantee of that.
    You have told us we have six tracks of vaccines already 
moving, that we don't necessarily expect everyone to work. That 
if they don't work, even though we are manufacturing them ahead 
of time, even while we are testing them, we'll throw them away 
and they will not never be distributed. You have said you will 
be the first of the line to take a safe and effective vaccine 
as Senator Casey, I believe, asked. So to me, it seems 
important to say to the American people that their herd 
immunity is what we want. We want most Americans to be immune 
to COVID-19. And if that happens, then the infection rate will 
go down. Disease will gradually become a minor event in 
American society. But there are only two ways to get there.
    One is just to let it roar through the population killing 
people until we have killed enough and infected or enough of 
recovered to have herd immunity or the much preferable way is 
the vaccine that has a good prospect of being available by the 
end of the year. So I thank you and your colleagues for what 
you have and are doing. I know how hard you are working, Dr. 
Collins, I can't let you get away without asking you one last 
question. You have headed up the so-called Shark Tank, the RADx 
operation, which we funded.
    I want to make sure that I know one. What is the output 
right now? How many how many fast tests have the shark tank 
produced that people can take to determine whether they have 
COVID-19? And do you have the funding you need to get done what 
we ask you to do?
    Dr. Collins. Well, Senator, I really appreciate your 
leadership in making it possible just beginning on April 25th 
for us to ramp up something that has never been done before and 
invite a lot of small businesses and academics who had really 
creative ideas about how to do testing for SARS COVID 2 to come 
forward and jump into the shark tank and show what they could 
do and get a lot of advice and sometimes some difficult 
criticism and see whether they were ready for the big time. 
Could they actually expand their capacity, develop a sufficient 
validation and get exported and deployed?
    Just as of last week, we are now up to 16 of these 
technologies that have made it through this process. Very 
interesting technologies too. 16 different ones. And 
collectively now those add up to roughly 2 million tests a day 
that would not have been there before all of this came along. 
Some of them are lab based tests. Some of them are based on 
genome sequencing. Some of them are point of care. But 
collectively, they are moving along. And together with what 
Admiral Giroir has been doing, which is also dramatic in terms 
of its expansion with things like the Abbott test, I think we 
are on that pathway toward getting to enough tests that almost 
anybody would say.
    Fortunately, I think now increasingly many of them are 
point of care tests. I am also glad to say the lab based tests, 
which were afflicted by slow turnaround time, have now gotten 
down to the point where 97 percent of all the tests are 
returning a result in 3 days or less, which is where we needed 
to be and weren't, frankly, a few months ago. So we are in a 
much better place and we have----
    The Chairman. You are saying 2 million a day simply from 
those that have come out of the shark tank?
    Dr. Collins. That is right.
    The Chairman. That is 2 million times 30. That is 60 
million.
    Dr. Collins. That is a lot.
    The Chairman. A month. And then you add to that what was 
already happening.
    Dr. Collins. What was already--.
    The Chairman. Then you add to that the Abbott test, which 
Abbott says will produce 40 million tests a month in October. 
So I think, Dr. Adams, you said that Admiral Giroir gave a 
number for September and October that was in the neighborhood 
of 100 million tests a month, which is twice as many as he 
testified here a few weeks ago when he estimated that we would 
have 40 to 50 million tests in September, October.
    My own view is when we have an oversupply of fast tests, 
they will cease, testing will cease to be an issue. That as 
soon as everybody knows they can get it fast, test quickly if 
they want one, they will probably not want as many. But 
scarcity causes people to want more. And then on the other 
hand, as you were talking about the University of Illinois 
testing students twice a week. They are able to do that.
    Dr. Collins. Yes, and faculty too.
    The Chairman. Students--and that is a great big--how many 
students and faculty in that universe?
    Dr. Collins. Tens of thousands. It is a lot.
    The Chairman. Yes. So we are moving to the point where 
there are many different strategies and no one is saying you 
have to test everybody every day or twice a week or whatever, 
but different colleges, different schools, different workplaces 
will develop different strategies and if they know that if an 
employee comes up and says, I feel worried working here, I am 
afraid I might have COVID, you could say, come right in here in 
50 minutes we will tell you whether you do or not.
    I think that will help give people the confidence to go 
back to work, back to school, back to child care, out to eat. 
And until we have vaccines broadly available, distributed and 
administered, which surely will be sometime next year, if we 
are successful, then that will--between now and then, that sort 
of testing, plus the treatments that we could discuss at our 
next hearing are a very impressive story.
    Dr. Collins. Senator, just what are you close down, I want 
to add my voice to the Surgeon General to thank you for your 
leadership. And you have just been pointing out a dramatic 
example, which is this area of testing, but you have been a 
clear, compelling, authoritative, evidence based source of 
information for all of us and remarkable voice of leadership in 
the Congress. It has been a great pleasure and a privilege to 
have the chance to work with you in settings like this, but in 
other settings as well, even including the Bluebird Cafe. And I 
just want to say, you are going be sorely missed by all of us 
who have had the chance to work with you.
    The Chairman. That is very generous. And it is a privilege 
to work with both of you. And I am not gone yet. So on that 
note, the hearing record will remain open for 10 days. Members 
may submit additional information for the record within that 
time if they wish.
    The Chairman. I want to thank Senator Murray and her staff 
for working with us on this hearing. One of the Senators said 
to me on the floor, this is the most civil hearing that he had 
attended in the Senate in several weeks and most of our 
hearings are pretty civil. We each get our points in, including 
our political points, but we do that with respect for those of 
you work for the American people like Dr. Adams and Dr. Collins 
do.
    I thank Senator Murray and my Democratic colleagues for 
allowing us to conduct hearings in that way. Our Committee will 
meet twice next week. We will meet again at 10 a.m. on Tuesday 
for a hearing entitled Compensating College Athletes Examining 
the Potential Impact of Athletes and Institutions. So, the 
Commerce Committee is the lead committee in the Senate on that.
    But we are we are looking into that in cooperation with 
them because this makes a difference to students, to student 
athletes and to the American people who like to watch sports. 
And then on Thursday, we will have a hearing on something that 
this Committee has been working on in a bipartisan way for six 
years, which is simplifying the FAFSA, the Federal aid 
application form that 20 million families fill out every year. 
We have made progress on that in the Obama administration, we 
made progress in the Trump administration.
    Senator Murray and I introduced and Congress passed a bill 
making important steps earlier, I guess, earlier this year when 
we fully or recently when we permanently funded historically 
black colleges. But we would like to finish the job and we will 
have a hearing on that next Thursday with the same four 
witnesses, plus one who got us involved in it in the first 
place six years ago. Thank you for being here today. The 
Committee will stand adjourned.
    [Whereupon, at 12:40 p.m., the hearing was adjourned.]

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