[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
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-225 PDF WASHINGTON : 2022
-----------------------------------------------------------------------------------
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
---------------------------------------------------------------------------
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.]
[all]