[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN
SERVICES, EDUCATION, AND RELATED AGENCIES
APPROPRIATIONS FOR 2022
_______________________________________________________________________
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
_________
SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES,
EDUCATION, AND RELATED AGENCIES
ROSA L. DeLAURO, Connecticut, Chair
LUCILLE ROYBAL-ALLARD, California
BARBARA LEE, California
MARK POCAN, Wisconsin
KATHERINE M. CLARK, Massachusetts
LOIS FRANKEL, Florida
CHERI BUSTOS, Illinois
BONNIE WATSON COLEMAN, New Jersey
BRENDA L. LAWRENCE, Michigan
JOSH HARDER, California
TOM COLE, Oklahoma
ANDY HARRIS, Maryland
CHUCK FLEISCHMANN, Tennessee
JAIME HERRERA BEUTLER, Washington
JOHN R. MOOLENAAR, Michigan
BEN CLINE, Virginia
NOTE: Under committee rules, Ms. DeLauro, as chair of the full
committee, and Ms. Granger, as ranking minority member of the full
committee, are authorized to sit as members of all subcommittees.
Stephen Steigleder, Jennifer Cama, Jaclyn Kilroy, Jared Bass,
Philip Tizzani, Laurie Mignone, Rebecca Salay, and Trish Castaneda
Subcommittee Staff
_________
PART 8
Page
National Institutes of Health.........
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Fiscal Year 2022 Budget Request for
the Center for Disease Control and
Prevention..............................
203
U.S. Role in Global Covid-19 Vaccine
Equity..................................
259
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U.S. GOVERNMENT PUBLISHING OFFICE
46-728 PDF WASHINGTON : 2022
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COMMITTEE ON APPROPRIATIONS
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ROSA L. DeLAURO, Connecticut, Chair
MARCY KAPTUR, Ohio
DAVID E. PRICE, North Carolina
LUCILLE ROYBAL-ALLARD, California
SANFORD D. BISHOP, Jr., Georgia
BARBARA LEE, California
BETTY McCOLLUM, Minnesota
TIM RYAN, Ohio
C. A. DUTCH RUPPERSBERGER, Maryland
DEBBIE WASSERMAN SCHULTZ, Florida
HENRY CUELLAR, Texas
CHELLIE PINGREE, Maine
MIKE QUIGLEY, Illinois
DEREK KILMER, Washington
MATT CARTWRIGHT, Pennsylvania
GRACE MENG, New York
MARK POCAN, Wisconsin
KATHERINE M. CLARK, Massachusetts
PETE AGUILAR, California
LOIS FRANKEL, Florida
CHERI BUSTOS, Illinois
BONNIE WATSON COLEMAN, New Jersey
BRENDA L. LAWRENCE, Michigan
NORMA J. TORRES, California
CHARLIE CRIST, Florida
ANN KIRKPATRICK, Arizona
ED CASE, Hawaii
ADRIANO ESPAILLAT, New York
JOSH HARDER, California
JENNIFER WEXTON, Virginia
DAVID J. TRONE, Maryland
LAUREN UNDERWOOD, Illinois
SUSIE LEE, Nevada
KAY GRANGER, Texas
HAROLD ROGERS, Kentucky
ROBERT B. ADERHOLT, Alabama
MICHAEL K. SIMPSON, Idaho
JOHN R. CARTER, Texas
KEN CALVERT, California
TOM COLE, Oklahoma
MARIO DIAZ-BALART, Florida
STEVE WOMACK, Arkansas
JEFF FORTENBERRY, Nebraska
CHUCK FLEISCHMANN, Tennessee
JAIME HERRERA BEUTLER, Washington
DAVID P. JOYCE, Ohio
ANDY HARRIS, Maryland
MARK E. AMODEI, Nevada
CHRIS STEWART, Utah
STEVEN M. PALAZZO, Mississippi
DAVID G. VALADAO, California
DAN NEWHOUSE, Washington
JOHN R. MOOLENAAR, Michigan
JOHN H. RUTHERFORD, Florida
BEN CLINE, Virginia
GUY RESCHENTHALER, Pennsylvania
MIKE GARCIA, California
ASHLEY HINSON, Iowa
TONY GONZALES, Texas
Robin Juliano, Clerk and Staff Director
(ii)
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR 2022
----------
Tuesday, May 25, 2021.
NATIONAL INSTITUTES OF HEALTH
WITNESSES
FRANCIS S. COLLINS, M.D., DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DIANA W. BIANCHI, M.D., DIRECTOR, EUNICE KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES
GARY H. GIBBONS, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE
NORMAN E. SHARPLESS, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
The Chair. This hearing will come to order.
As this hearing is fully virtual, we must address a few
housekeeping matters.
For today's meeting, the Chair or staff designated by the
Chair may mute participants' microphones when they are not
under recognition for the purposes of eliminating inadvertent
background noise.
Members are responsible for muting and unmuting themselves.
If I notice that you have not unmuted yourself, I will ask you
if you would like the staff to unmute you. If you indicate
approval by nodding, staff will unmute your microphone.
I remind all members and witnesses that the 5-minute clock
still applies. If there is a technology issue, we will move to
the next member until the issue is resolved, and you will
retain the balance of your time.
You will notice a clock on your screen that will show how
much time is remaining. At 1 minute remaining, the clock will
turn yellow. At 30 seconds remaining, I will gently tap the
gavel to remind members that their time is almost expired. When
your time has expired, the clock will turn red, and I will
begin to recognize the next member.
In terms of the speaking order, we will begin with the
chair and ranking member. Then members present at the time the
hearing is called to order will be recognized in order of their
seniority, and finally, members not present at the time the
hearing is called to order.
Finally, House rules require me to remind you that we have
set up an email address to which members can send anything they
wish to submit in writing at any of our hearings or markups.
That email address has been provided in advance to your staff.
And with that, I want to acknowledge Ranking Member Cole
and all of our colleagues for joining this morning, and I want
to thank our witnesses for testifying.
Good morning to Dr. Collins. Welcome back to the Labor,
HHS, Education Appropriations Subcommittee.
I would also like to welcome the five institute directors
joining Dr. Collins today: Dr. Diana Bianchi, Director of the
Eunice Kennedy Shriver National Institute of Child Health and
Human Development; Dr. Anthony Fauci, Director of the National
Institute of Allergy and Infectious Diseases; Dr. Gary Gibbons,
Director of the National Heart, Lung, and Blood Institute; Dr.
Ned Sharpless, Director of the National Cancer Institute; and
Dr. Nora Volkow, Director of the National Institute on Drug
Abuse.
I want to note that I intend to invite an additional panel
of institute and center directors to testify in front of the
subcommittee later this year. We were not able to hold a second
panel last year due to the pandemic, but I want to make sure
the subcommittee hears from every institute about its promising
research.
The last time Dr. Collins and the IC directors were here to
testify on the National Institutes of Health budget was March
4, 2020. There were 128 newly reported COVID cases that day in
the United States, which more than doubled the total number of
cases that had been identified to date.
Later that day, the House would pass the first COVID
supplemental bill, which included over $800 million to support
NIH on basic research, diagnostics, treatments, and vaccines
for COVID-19.
Today, over 14 months later, the Congress has provided over
$4.8 billion to support NIH research related to COVID.
Based in part on these investments and the partnerships
with other agencies and the private sector, three COVID-19
vaccines were developed in record time and are now widely
available in the United States, and nearly 300 million vaccine
doses have been administered, including nearly 4 million in my
home State of Connecticut.
In my view, this is a remarkable achievement made possible
not only by targeted investment in COVID research, but also by
the annual sustained investment in biomedical research made by
this committee in recent years.
In the 20 years before the COVID-19 pandemic, the National
Institute of Allergy and Infectious Diseases, NIAID, invested
over $650 million in basic research on coronavirus, and in
particular on the spike protein that is the target of
coronavirus vaccines. This crucial breakthrough allowed
researchers at the NIAID Vaccine Research Center to rapidly
generate a stabilized spike protein for use in developing the
COVID-19 vaccines in use today.
In addition, NIH has also made substantial investments into
mRNA technology and its potential use in vaccines and
therapeutics, which was essential to the rapid development of
COVID vaccines.
I call your attention to an article that was November of
2020, and I will just give you the title: ``Government-Funded
Scientists Laid the Groundwork for Billion-Dollar Vaccines.''
And I mention this because I think it is critical in what this
committee is able to accomplish and also what our scientists at
the NIH, with the funds, Federal funds, are able to accomplish.
Quite frankly, it is such a relief to millions of Americans
to finally have access to the COVID vaccine.
In Connecticut a couple of weeks ago we had a FEMA mobile
vaccination clinic open on the New Haven Green. A family with
two teenagers was there to get their vaccines. Their father,
Roberto, said that he wanted his daughter, Sophia, and his son,
Diego, to get vaccinated as soon as possible to avoid the risk
of their contracting COVID and spreading it to the youngest of
their younger sisters, who is only 4 years old.
After receiving her shot, Sophia, who is 16, said, and I
quote, ``Now I am vaccinated. It means I won't be afraid to get
COVID-19 as much as I was before,'' end quote.
Can you imagine being a 16-year-old and fearing for your
life and the health of your family? Thanks to the vaccine,
Sophia and her brother can finally stop living in fear and get
back to being normal teenagers.
This is just one of the many stories of how the COVID
vaccine has made such an immeasurable difference in our lives.
None of it would have been possible without the increased
funding that Congress has consistently provided for the NIH.
And I am proud that we have increased NIH funding by $12.9
billion, 42 percent, over the past 6 years. And this support
has been bipartisan from this subcommittee. Last year, the
Congress provided an additional $1.25 billion increase over the
fiscal year 2020 level for the NIH.
I am pleased to see President Biden's budget request to
continue the momentum in fiscal year 2022. The request proposes
an increase of about $2.5 billion to expand funding for NIH's
core activities, such as research grants, clinical trials, and
infrastructure support. The request also proposes to establish
a new Advanced Research Projects Agency for Health, or ARPA-H,
to accelerate the development of treatments and cures.
I am especially glad to see that the budget proposes
increased investment in research on maternal health to address
the crisis of maternal mortality. In the U.S., maternal
mortality is such a major problem and an issue that I have been
working on for quite some time, as have so many of my
colleagues.
I also look forward to further details about how the budget
proposal will support research on how to reduce racial and
ethnic disparities in maternal health outcomes and improve
maternal mental health.
In that vein, I am grateful that this budget proposes
increased funding for research into other health and mental
health disparities that are disproportionately affecting
underrepresented communities.
As I have often said, these issues have been further
exposed and exacerbated by the COVID-19 pandemic. And as Dr.
Collins says so eloquently in his written testimony, it is, and
I quote, ``forcing a recognition that our country is still
suffering the consequences of centuries of racism.''
I was also glad to see that the budget doubles funding for
research on gun violence prevention at the NIH, building off
the investments the subcommittee has made over the past 2
years. I am interested in getting a progress report on the
funded projects and any potential evaluation that you may have.
I know it may be too early, but I hope you can let us know a
little more about the status of this program.
I might add that I am intrigued by the proposal to
establish ARPA-H as it appears to be a novel approach to
supporting innovation to address problems in health and medical
research. I look forward to learning more about this proposal.
And I want to emphasize that it is critical that we strike
a balance between this new approach and investments in basic
research and fundamental discovery at NIH.
As I noted earlier, the Congress and this subcommittee have
consistently provided funding for basic research at NIH that
was integral in setting the stage for the rapid development of
COVID-19 vaccines.
As we move forward, I think it will be important to balance
the promise of this new approach with a continued commitment to
basic research.
One of my priorities on a Labor-HHS bill has been to ensure
a strong across-the-board increase for NIH research so that we
continue to invest in all areas of research instead of limiting
new investments to a few of the most high profile diseases.
I am disappointed that research on amyotrophic lateral
sclerosis, ALS, has not been mentioned as a potential area of
focus for ARPA-H and hope to learn more about how NIH proposes
to make decisions about how best to target ARPA-H funding.
I am also curious to hear more about how ARPA-H would
differ from existing NIH centers and programs that support high
risk, high reward research, such as the National Center for
Advancing Translational Sciences, NCATS.
I realize that because the administration's full budget has
not yet been released, Dr. Collins, you cannot provide all of
the details on the NIH request today. But I believe we can have
a good discussion on the priorities that have been announced,
and we look forward to receiving the full NIH request in a few
days.
Now let me turn to my friend from Oklahoma, the ranking
member, Congressman Cole, for any opening remarks that he may
have.
Mr. Cole. Well, thank you very much, Madam Chair. And I
could probably just say ``amen'' and dispense with my remarks
because there is essentially nothing in your opening statement
that I don't agree with wholeheartedly.
I have enjoyed all the hearings held by the subcommittee
this year, and that is a compliment to you, Madam Chair. I
think we have had a succession of really terrific hearings on a
variety of topics.
But, I must admit, welcoming the scientific leaders from
the National Institutes of Health is the hearing I most look
forward to every year.
I am pleased to once again welcome Director Francis
Collins. As I often say, clearly the best politician in
Washington, DC, having been appointed by President Obama,
President Trump, and now President Biden. I challenge anybody
to match that record. But I think it is a clear indication of
how much regard the Director is held in, and, frankly, the NIH
itself.
Each year brings new and exciting innovations in medicine
and treatment and a glimpse into the world and the
possibilities of our future. I am always encouraged when we
learn about these scientific advancements.
And I know I have said this numerous times, but it bears
repeating: Increasing funding for the NIH is one of the best
bipartisan accomplishments of this subcommittee, Madam Chair,
as you noted in your opening statement.
Let me break from my prepared statement to make a point
that I think is important to make here.
I have made the point repeatedly in previous hearings that
I think the administration's budget is pretty heavy on domestic
spending, it goes up 18 percent, pretty light on defense
spending, which is flat and actually has an inflation adjusted
cut. And I have said that that needs to change, that the
defense number needs to come up and the domestic number, in my
opinion, needs to come down, or we run the risk of a CR.
Having said that, I want to make it crystal clear, I
support the President's topline budget number for the NIH, and
I would throw in the CDC and the Strategic Stockpile as well. I
think those are areas of critical national investment that we
can all work together on and see the benefit of.
And I say that just to make it clear to my friends, while I
haven't changed my view on the overall budget in this area, I
doubt there is much daylight between the chairman and me as to
the importance of this investment for our future. I think we
have demonstrated that together over the last 6 years. I am
comfortable and confident we will demonstrate that again going
forward.
The sustained commitment to increasing funding for the NIH
is a vital step in preserving our status as the world's leader
in biomedical research and to finding novel treatments and
cures for the many diseases burdening our strained healthcare
system.
The funding also does far more. Several studies have shown
funding for the NIH has a multiplier effect, contributing to
overall U.S. economic growth.
The investments made at NIH over the past few years, and,
even further back, over the past decades, as our chair pointed
out, laid the groundwork for our response to the COVID
pandemic.
The National Cancer Institute stepped in with advanced lab
capacity.
The National Institute of Allergy and Infectious Diseases
led the way with expertise related to infectious disease.
The Office of the Director supported efforts to make rapid
advancements in therapeutics and diagnostics.
And of course, last but certainly not least, with NIH
support, Operation Warp Speed provided enough doses of vaccine
for every adult in America.
The NIH is a shining example of what can be achieved when
we put our best minds together and work to accomplish bold and
challenging goals.
Much attention in the past year has gone to COVID and the
associated scientific discoveries, and rightly so. But I hope
in the coming years we can also continue our conversations and
scientific advancements in Alzheimer's disease and cancer
treatment.
These two areas have seen strong congressional interest and
represent a foundational shift in how we treat diseases
responsible for the loss of most Americans each year.
I also hope that the promises of precision medicine can be
experienced by more patients and believe that the All Of Us
Program can improve how we use genetic information in routine
medical care.
Dr. Collins, you have once again brought an excellent team
representing some of the largest institutes and most promising
frontiers of new discoveries. I look forward to hearing from
all of you.
I also want to recognize that the NIH is composed of 27
institutes and centers, most of whom are not able to be with us
today. Even though we are not able to have each director come
before us, our offices continuously hear about the
groundbreaking work and collaborative partnerships at all of
the NIH components. We know that work is done across the NIH
and that each institute or center is a contributor.
In closing, I want to stress that each dollar invested in
the NIH is a down payment on our future. This work has in the
past, and will in the future, continue to improve the course of
disease detection, treatment, and even cures in the years and
generations to come. I know congressional commitment to
advancing these shared objectives has been unwavering.
And I want to thank you, Madam Chair, for holding the
hearing. And, frankly, more importantly, thank you for your
long record of support for the NIH and dealing with the issues
of disease. It has been an area where you have led throughout
your career, and you continue to lead today. And you certainly
have all of our support on this committee in that effort.
With that, Madam Chair, I yield back.
The Chair. Thank you for your comments, but again, most
importantly, the friendship, but working together on this
issue, which is so critically important. And it has been really
a team effort, and I am most appreciative of that.
Before I turn to Dr. Collins, I want to ask unanimous
consent to put into the record the article I referenced,
``Government-Funded Scientists Laid the Groundwork for Billion-
Dollar Vaccines.''
[The information follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
The Chair. Dr. Collins, your full testimony will be
included in the record. You are now recognized for 5 minutes
for your opening statement.
Dr. Collins. Well, thank you, Chair DeLauro, Ranking Member
Cole, and distinguished members of this subcommittee. I am
honored to be here today with my colleagues representing the
National Institutes of Health, the NIH.
I could spend hours describing the exciting work that the
President's budget is proposing for NIH, including major
investments to address impacts of the COVID-19 pandemic, reduce
health disparities in maternal mortality and morbidity, improve
mental health, broaden approaches to pain and opioid addiction,
and establish a bold new agency within NIH called ARPA-H.
But in our brief time together it is also important to
emphasize how the steady funding increases that you have
provided to NIH, starting well before the pandemic, made it
possible for the NIH to meet the challenges of the pandemic and
to prepare for what comes next.
You know, often at these hearings I share the story of a
patient whose life has been saved by NIH research. But in this
uniquely challenging year, it is hard to single out any one
person. In fact, all of the more than 160 million Americans who
have received COVID-19 vaccines are success stories made
possible by the sustained investment that this committee made
years ago to basic biomedical research.
The road to these mRNA vaccines that Pfizer and Moderna now
are distributing around this country and around the world
actually started in the 1960s when the function of messenger
RNA was first understood. These messengers carry instructions
from the cell's DNA manual to produce the proteins that do the
work.
For vaccines, we knew that certain proteins, like the spike
proteins on this coronavirus, could spur an immune response.
But might it be safer and just as effective to use RNA to
instruct the patient's own body to produce these proteins?
Though it took surmounting numerous obstacles to get there,
we are blown away by how well it works.
In parallel, other scientists, including some in our
Vaccine Research Center, learned that locking that spike
protein into the right configuration could make an even better
vaccine.
So when COVID hit, we knew exactly what to do. As the
seriousness of the pandemic became clear, research institutions
and drug companies started off in multiple directions,
competing over trial capacity, duplicating efforts, and
flooding the FDA with disparate data.
NIH was prepared to step in with a coordinated playbook.
Working with other agencies and industry partners, we stood up
something called ACTIV, A-C-T-I-V, the Accelerating Covid-19
Therapeutic Interventions and Vaccines Partnership, and we
stood it up in just 2 weeks. ACTIV's teams of public and
private sector visionaries implemented objective prioritization
of therapeutic candidates, knitted together clinical trial
networks, and wrote master protocols to streamline approvals.
Another vital partnership NIH was able to build on was one
we have with underserved communities. As we pushed to enroll
patients in phase 3 vaccine trials, NIH opened a dialogue with
communities disproportionately affected by COVID.
The Community Engagement Alliance, or CEAL, initiative
built on existing long-term partnerships with trusted leaders
in underserved communities to encourage trial participation. We
were able to use the enrollment techniques we learned in large
longitudinal studies, such as All of Us, that you have
championed.
The result is that all Americans can look at the major
vaccine trials and see that people like them were included, and
CEAL has now moved on to help with vaccine hesitancy in these
same communities.
Now the President's budget proposes a major investment to
build on this momentum, the Advanced Research Project Agency
for Health, or ARPA-H. This new agency within NIH will catalyze
novel strategies to speed transformational and innovative
ideas. Ideas like simple blood tests to detect free-floating
DNA or protein markers that signal a cancer is growing
somewhere in the body. Maybe a micro needle patch that delivers
a vaccine to hard-to-reach communities in the mail. Or using an
innovation funnel to recruit, test, and scale up new
technologies for ambulatory blood pressure measurement with the
potential to transform the management of hypertension.
Those are just three of the bold ideas that ARPA-H could
tackle. But they are not science fiction. With standard
approaches, they might happen in a decade or two. With ARPA-H,
it could take half that time.
The President believes that, with your help, we can learn
from the lessons of the pandemic and transfer this scientific
momentum into big improvements in the health of all Americans.
I do, too.
My colleagues and I would be pleased to answer your
questions.
[The information follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
The Chair. Thank you. Thank you very much, Dr. Collins.
I just want to say, I sometimes make reference to this
panel when you come up, and I use the Yankee baseball team,
talking about the power and the hitting power of Murderers Row.
But today I just want to talk about Healers Row and really
extraordinary work that has translated to the benefit of so
many and have already saved so many lives. So thank you for the
work that you do.
I know that you can't share so many details about the
structure of ARPA-H. That will be, I understand, in the
President's budget. You just started to talk about some of the
things. I have kind of three questions in this area.
Again, share some examples of the kind of research that
this might support and how it differs from the types of
research typically supported by the NIH.
How is ARPA-H different than NCATS, which was established a
decade ago, and that was about promising medical research into
treatments and cures that are available, and how is this
approach different?
And then I just wanted to ask about how ALS research could
benefit from the high risk, high reward accelerated approach
proposed by ARPA-H.
Dr. Collins. Well, thank you. That is a wonderful set of
questions. And I want to tell you that my colleagues and I are
really excited about the potential that ARPA-H offers for us to
move biomedical research even more nimbly and aggressively
forward to make the kinds of discoveries that the public is
waiting for.
We learned a lot in the space of our experience with COVID-
19 about how it is possible when there is an urgent sense of
the need for clinical advances to happen at unprecedented
speed. And that happened with vaccines. That happened with
diagnostics. That happened with setting up therapeutic trials.
And from that, we have gathered the general sense that this
momentum ought not to be lost.
In talking with all of the 27 institutes and centers, the
notion of taking the DARPA approach to biomedical research has
gathered a lot of enthusiasm. DARPA, as you know, as part of
DOD, has had that experience of moving things in a very bold
and risk-taking way. And that is why we ended up with the
internet and with GPS and with self-driving cars and a long
list of other things.
And we think there is a subset of biomedical research that
would also be amenable to this kind of approach. This would
involve program managers who are given the flexibility to
identify in an area of opportunity ways that you could bring
together partners who might not normally write an NIH grant--
those might be academics, they might be small businesses--and
figure out how to create the kind of momentum with appropriate
financial support to move things forward at unprecedented
speed.
You could think, for instance, taking what we have learned
about messenger RNA for COVID-19, and speeding up the process
of cancer vaccines, which are showing a lot of promise but
could go faster.
What about something such as a new approach to hearing aid
development, which has been a little stuck in one place and
might greatly be advanced by this kind of innovation funnel or
``Shark Tank''?
Such things as using the technologies we now have to learn
ZIP Codes of all of the human cell types so that you could
deliver drugs or gene therapies an appropriate and rapid
fashion.
Those are all ideas that are coming up. Every one of the 27
institutes and centers is hitting me with lots of great ideas.
The Chair. So tell me how this differs from NCATS.
Dr. Collins. So I am very much proud of NCATS, having had a
lot to do with nurturing that idea, coming up with something
that would provide translational efforts, and they have in
things like tissue chips, in terms of making high-throughput
screening available.
But it is on a modest scale. Most of NCATS is supporting
the CTSAs, a very important part of our clinical research
effort.
This basically takes the NCATS model and puts it on
steroids, takes the kinds of things that have been in the Cure
Acceleration Network and makes it possible to do so at a much
more rapid pace and across all diseases in a way that all the
institutes at NIH can join in on and very much want to.
So, yeah, I think it is building on that experience, but
taking it to the next level.
The Chair. I understand that, but just let me ask you this
then. What happens with NCATS? If we are going to build on
that, do we then fold in this? Do we then have one area that we
are looking at here rather than two, ARPA-H and NCATS, and then
we just create one effort?
Dr. Collins. It is a very good question, Madam Chair. I
don't think we have a completely clear best option at the
present time. It might be possible, for instance, for the CTSAs
to move into ARPA-H or potentially to stay where they are with
NCATS. We might take the Cures Acceleration Network model and
move that into ARPA-H.
Those are all issues that need to be worked out. We need a
lot more input now that we can talk more publicly about this,
or we can in a couple of days, to get input from stakeholders.
The Chair. It would appear to me that when you talked about
Alzheimer's, diabetes, and cancer with regard to ARPA-H, I
don't know where ALS fits in that and was that left out for
some reason. And it is a devastating neurological disease, as
you know.
Dr. Collins. Yes.
The Chair. And there are no current effective treatments to
stop or even slow the progression, as I understand it, and you
know I am not a scientist.
Dr. Collins. So, if I may, I know the clock has run out,
but just very quickly.
Cancer, Alzheimer's, and diabetes were put forward as
examples of common diseases that ARPA-H could work on. But the
intention is for this model to be applied to all of the
diseases that are ready for this scientifically.
And I think ALS is a great example. Already had
conversations with the Neurology Institute about an ARPA-H
project specifically focused on ALS, recognizing that we are
learning some fundamental things about what happens to the
motor neurons in the spinal cord that could, with a crash
program, be advanced much more quickly to understand the
pathogenesis and ultimately new approaches to therapy using
such things as RNA approaches.
So I think it is a great example, Madam Chair, of what we
could do that we currently can't quite do with this new
mechanism.
The Chair. Thank you. And I will have questions for Dr.
Fauci and Dr. Gibbons.
But with that, let me yield to the distinguished ranking
member of the committee, Congressman Cole.
Mr. Cole. Thank you very much, Madam Chair. And I want to
build on your line of questioning because, as I said in my
opening remarks, look, I am very supportive of the President's
topline proposal here.
As a matter of fact, I am pleased to have a President who
set out a marker. With all due respect to the last two, this
committee went well beyond what was proposed here.
And so it is nice to have a partner at the other end of
Pennsylvania Avenue who sees this, the value of this
investment, I think the same way the chairman and I do.
Having said that, I am wondering, I look at the $6 billion-
plus investment in ARPA-H, and as you said, Dr. Collins, we
still have unresolved questions and procedures.
Would it be better to start with a more modest investment--
DARPA itself is about $3.8 billion--and plow the rest of that
money into our normal research? Again, I am not arguing for a
reduction in total spending. I am just arguing for we are going
a little fast here before we actually have this thing worked
through.
So I would love your thoughts on that, with the recognition
that you work for the President of the United States, so your
job is to defend his proposal.
Dr. Collins. Thank you for pointing that out.
Mr. Cole. May be a little bit more aggressive here,
although I like the instinct that he is showing.
Dr. Collins. Well, thank you, Congressman Cole, and I
appreciate your thoughtfulness in this regard in terms of what
is the right balance here.
Let me point out, though, that ARPA-H is not intended to be
a freestanding entity that is sort of over here somewhere, and
then you have the 27 institutes and centers over there doing
something different.
This is an engine for discovery that is going to be tapped
into by every one of those 27 institutes and centers, extending
their reach beyond what they could do with their current budget
line. So we shouldn't think of these as competitive, but rather
as synergistic.
Yeah, it is a big deal to start something up with a $6.5
billion budget. Fortunately, this has been put forward by the
President as 3-year money, which would help a lot as we are
sort of ramping this up.
But I believe, based upon the experience we have had with
COVID-19--and again, thank you, Congress, for providing us
during this crisis with, as Chairman DeLauro said a little bit
ago, over $4 billion of additional funds to help. We had no
difficulty figuring out how to invest those in vaccines, in
therapeutics, and in diagnostics.
And I believe, if funds are available, there are enough
ideas and enough science and enough scientists out there to do
the work that we could very well utilize what has been proposed
by the President.
Mr. Cole. Well, good. Well, I look forward to working with
you on that. I still have some concerns, but we can resolve
those in dialogue because we don't have any differences on the
top line here.
Let me turn to Dr. Sharpless, if I may.
One of the more both impressive and challenging problems we
have had is there have been so many wonderful proposals in the
area of cancer research in recent years. And while we steadily
pushed up the number of money at NIH, it seems to me we have
had a hard time funding all the good proposals in front of us
in terms of cancer. There seems to be a lower percentage of
grants funded than in most of the other areas.
So could you sort of bring us up to date where we are in
funding good science and give us your thoughts as to what else
we ought to be doing to make sure that we are not leaving good
ideas on the table in terms of cancer research?
Dr. Sharpless. Thank you, Representative Cole. It is a
really important topic.
I think the good news to start off with is that, thanks to
the support of this Appropriations subcommittee, we have had
the ability to increase our pay lines and success rates, these
metrics we follow, which had gone down to very low levels
because of the dramatic increase in applications to the
National Cancer Institute. So applications were up 47 percent
since 2013, and that is hard to keep up with.
So I think our pay line, one metric we follow, nadired at 8
percent, but is now up to 11 percent, so that is a 35 percent
increase in the last 2 years, which I think is good progress,
but that is still a pretty low support rate.
I think we would like to get to a number that would be more
like 15th percentile, which would match sort of the rest of the
NIH a little more closely. As you know, there are a lot of
important things we support outside of that pool that we have
to fund as well.
So I think that this is a good problem in some ways. It
says there are a lot of scientists coming to NCI with ideas
that are very, very valuable, and we need to be able to get to
them all. And the support of this subcommittee has been very
important in the past, but I think that is still an area where
our pay lines are still too low.
Mr. Cole. Well, we don't have a lot of time left, so I am
not going to use all mine. But I want to say I am glad you are
back at the NCI after your stint at the FDA. I know you did a
great job there, but we really like you where you are at and
appreciate the job that you have done.
I have got a lot of questions, like you do, Madam Chair,
but I will hold them for the next round, and I yield back.
The Chair. I thank the chair, and I appreciate that
question to Dr. Sharpless. It is a question that I had as well.
So thank you very, very much. I say that to the ranking member.
Now, Congresswoman Roybal-Allard.
Ms. Roybal-Allard. Thank you, Madam Chair.
Let me begin, Dr. Collins, first of all, by joining my
colleagues in thanking you for the incredible work that you do.
However, I would like to address my questions with regards to
the ECHO program.
It has been 6 years since the congressionally directed
National Children's Study was prematurely canceled, despite an
investment of approximately $1.5 billion over its 14 years of
planning and implementation.
At the time of its termination, without informing Congress,
this subcommittee was guaranteed that newly developed
environmental influence on child health outcomes, quote,
``would make use of the existing maternal pediatric cohorts
that were recruited through the National Children's Study.''
We were further reassured that the ECHO program would
attempt to answer many of the original seven critical research
questions about the environment's influence on child
development and health.
We are now 6 years into what was designed to be a 7-year
program, and it is my understanding that over 67,000 children
are being followed in longitudinal core study factors affecting
child health in the areas of [inaudible] Child development and
well-being.
Which of the original NCS study questions are being
addressed through the ECHO program? And can you give us some
examples of the research that is being done utilizing these
cohorts?
Dr. Collins. Thank you very much, Congresswoman, for the
question. I am going to turn to Dr. Diana Bianchi, Director of
the National Institute of Child Health and Human Development,
who has been quite engaged as one of the advisers for the ECHO
program, which is managed by Dr. Matthew Gillman.
Dr. Bianchi.
Dr. Bianchi. Thank you, Dr. Collins and Representative
Roybal-Allard.
As you know, the ECHO program brings together 72 different
cohorts, and they are currently doing observational studies of
over 50,000 children.
One of the most impactful studies that has recently been
completed has looked at women entering pregnancy and looking at
the connection between a healthy weight in the mother or the
pregnant woman and eating a healthy diet during pregnancy, and
that has resulted in a statistically significant decrease in
the rate of pre-term birth.
And, interestingly, it was significant in both Black and
White women, because Black women do have a higher incidence of
pre-term birth. So that is quite impactful.
In addition, NICHD is working with the ECHO program on an
interventional study using the IDeA States Pediatric Clinical
Trials Network, which is part of the ECHO program, and we are
working together to provide comparative effectiveness studies
to determine how best to treat neonatal opioid withdrawal
syndrome.
So these include pharmacology-free intervention, which is
eat, sleep, and console the babies, as well as a weaning trial,
and we have trials planned for the future to look at
buprenorphine in infants.
Mrs. Roybal-Allard. Okay. I have several questions
regarding this program, but I will just go to my last question
because time is running short.
Is the NIH considering extending the ECHO program, given
that the original NCS study was designed to follow children
from birth through age 21, and the cohorts, as I understand it,
have not yet reached the age of 21?
Dr. Bianchi. Dr. Collins, do you want to answer that since
the program sits in the Office of the Director?
Dr. Collins. Sure.
No, I think that is a very important question, and we do
want to fully realize the potential of this very important
cohort of over 50,000 kids. And, obviously, the time is about
right in the course of the next year to figure out exactly what
that future course will be.
We have engaged internally in some deeper discussions about
that, and we would like to get back to you, Congresswoman,
about possible paths that we might take this forward.
But I do want to endorse how critical we see the ECHO
program is for answering all those questions that you and we
are quite concerned about.
Mrs. Roybal-Allard. Okay. Well, I hope it will continue
because, as you know, the purpose was to evaluate the effects
of chronic and intermittent exposures on child health and human
development in the United States. And it would actually be the
first study to collect this broad range of environmental
exposure measures for a national probability sample of 100,000
children followed from birth or before birth at age 21.
And this is extremely important for communities such as the
one that I represent because it looks at the disparities of
children in rural and underserved communities which often have
greater health issues and problems. So I am hoping that you
will find a way to continue this program because, as you said,
it is extremely important.
I yield back the balance of my time.
The Chair. Congressman Harris.
Mr. Harris. Thank you very much.
And thank you all for being here again this year.
One of the things that we have to do is provide some
oversight of the moneys that have been appropriated to NIH. For
instance, this morning's front page story in The Wall Street
Journal is the Wuhan lab leak debate. So this continues to be
discussed. And I just would like, Dr. Collins, maybe just a
couple of clarifications.
I understand we did not directly fund the Wuhan Institute
of Virology, but my understanding is we did send about $3.7
million in grants to EcoHealth Alliance, of which $600,000 went
to the Wuhan Institute of Virology to various studies there. Is
that true?
Dr. Collins. That is correct. I am going to ask Dr. Fauci
also----
Mr. Harris. No, I only have 5 minutes. I just need that is
true, okay, because I read it. That is true.
Do we know whether the Wuhan Institute of Virology does
gain of function research?
Dr. Collins. They were not approved by NIH for doing gain
of function research. We do not--and that is the official
governmental identification of that term, by the way. We are,
of course, not aware of other sources of funds or other
activities they might have undertaken outside of what our
approved grant allowed.
Mr. Harris. Okay. So we could have sent money through
EcoHealth Alliance. Money could have ended up in the Wuhan
Institute of Virology, which might be doing gain of function
research. And, in fact, since they sent a general of the
Communist Party Army to take over the lab in February 2020, it
is not out of the realm of possibility they are doing that.
So because I do know that money is somewhat fungible once
you send money to institutes, it bothers me a little bit that
we would send money to an institute that might be doing gain of
function research, especially China.
Do we send any money to any sub-agencies or sub-grantees
that could be sending money to Russia?
Dr. Collins. I don't know the specific answer to that. I
think we have in the past, and I don't know whether we
currently do or not.
Mr. Harris. Okay. And we will submit it as a QFR, if you
could get back to us about that.
Now, in Nature.Com, a publication occurred in last
September about the development of humanized mouse and rat
models with full thickness human skin and autologous immune
cells.
Dr. Fauci, this was funded out of the NIAID. It involved
scalp skin transplants from 18- to 20-week aborted fetuses.
And what I want to know is, does the NIH ever follow up on
how these specimens are obtained on a mid-second level--mid-
second trimester aborted fetuses for studies like this?
Dr. Fauci. Well, Dr. Harris, that grant and that study you
are referring to was gone through all the appropriate
guidelines and oversight. So I am not sure exactly what you are
asking, but all of the research that comes out of that was done
with the appropriate oversight and guidelines that have to do
with fetal tissue research.
Mr. Harris. Okay. So I will--again, I will submit a QFR.
Perhaps if you could send me what the NIH knows about how these
tissues were obtained.
You know, I don't know, the idea of taking 18- to 20-week
human fetus scalps, obviously, this would have to result from
decapitation because you have to harvest the scalp, implanting
it on the backs of rats. I am just not sure that is something
we should be involved with to any significant level.
Now, one issue that has come up is the question of research
on the immunology of COVID. And the immune response T cells, I
think, are going to be found to be fairly important, and I
think most people recognize they are pretty important in
determining immune response.
Would measuring T cells and T cell immunity, especially in
people who have had the disease, would that be of interest? And
if so, is the NIH urging the FDA to promote the EU, emergency
use authorization, for T cell testing, which is not widely
available but may be very useful in informing us about the
immune response?
Dr. Collins.
Dr. Collins. I think, yes, FDA is intensely interested in
this. I don't know that we have to particularly urge them. They
have approved one T cell test from adaptive technologies, and I
know they are interested in looking at others. And I agree with
you, this is a very important part of understanding immune
response to COVID.
Mr. Harris. Dr. Collins, I will have to inform you that
they are not, and they have, in fact, informed other companies
that this is not a priority for FDA and they are not actively
looking at further EUAs.
But my time is up. I yield back.
The Chair. Congresswoman Lee.
Ms. Lee. Thank you very much. Thank you, Madam Chair and
Ranking Member.
Thank you to Dr. Collins and all of our directors for your
tremendous leadership.
And thank you, Dr. Collins and all of you, for really
fighting so hard to crush this virus, and all of the work that
you have done, you said for the last 30 years, in just getting
us prepared to save lives and to address the coronavirus. So
thank you so much.
Let me ask you, Dr. Collins, we have talked a little bit
about the continued commitment to address disparities of Black
men and women in science and medicine. And I would like for you
to share how NIH has incorporated the findings of the
recommendations of the National Academies of Sciences'
Roundtable on Black Men and Women in Science, Engineering, and
Medicine to address really the--and it is a major, alarming
underrepresentation of Black men in the medical schools and in
the medical profession.
That is the first question. I am going to do a couple of
questions at one time.
Also, just in terms of health disparities, Dr. Collins, let
me ask you, what specifically--and I know NIH is committed to
this--but specifically to address the health disparities
stemming from structural racism and more research and resources
into behavioral health, trauma-related informed mental
healthcare, diversity in clinical trials, diversified
workforce, all of the major issues that address African
Americans, people of color, within the whole--within the health
space, the National Institutes of Health, as it relates to
dismantling structural racism and building systems which
include equity and justice.
Dr. Collins. Well, thank you, Congresswoman Lee. I think
those questions actually I can fold into a synthesized
response, because we at NIH are deeply invested in taking a
very fresh and aggressive look at what we can do about the
problem of structural racism in the United States, which we
have come to recognize is something that affects all
institutions, and that includes the biomedical research
institutions that we support.
And I have to recognize this is the one-year anniversary of
the killing of George Floyd, which I think was a very
significant event for many people who had somehow imagined that
we were past the point where racism existed in this country.
And we at NIH took that and other episodes like that very
seriously and have formed together an effort called UNITE, U-N-
I-T-E.
There are five groups in UNITE, each of which has a
specific focus. One is on the workforce. And you specifically
have highlighted the problem about the diminishing numbers of
Black men going into medicine and medical research, and that is
a concern.
But, frankly, we have a much broader set of concerns. When
you look at the diversity of our workforce, it does not look
like our country.
We have worked hard on that, Congresswoman, and we have
made some progress, if you look at the numbers of those who are
applying for grants and getting funded, but we are still well
short of where we need to be.
We aim with this UNITE initiative to make a much stronger
push in that direction, both in terms of recruiting and
retaining. Because it is one thing to recruit Black men into
medical research. It is another if they find an environment
that is not welcoming, and then they don't stay. We have to
work on that part as well in terms of our whole culture, our
whole environment.
And then, when it comes to health disparities, we are aware
of the facts that health disparities are oftentimes based upon
deep-seated structural racism in our environment, in our
culture. And it is not sufficient for us to categorize the
various factors. We need to invest more in interventions to see
how those can be changed.
We have announced a Common Fund program of $24 million, it
is already out there, to do transformative research on health
disparities. And we have a joint funding announcement that now
involves a whole bunch of institutes, led by the Minority
Health and Health Disparities Institute, that is putting
another $30 million into research in fiscal year 2022 on this
very topic.
We will be publishing in the fairly near future a broad
description of this UNITE initiative that I think all of the
members of the subcommittee will be interested in.
I just want to tell you, personally, of the things that
happened in 2020, COVID-19, well, yeah, we will all remember
that. But I think we also had this wakeup call that we have to
address this issue of structural racism. And my colleagues and
I are determined to do so in a bold, energetic, and determined
way.
Ms. Lee. Thank you so much, Dr. Collins. And we will follow
up on the specifics in terms of the budget.
Very quickly, Dr. Fauci, good to see you. HIV and AIDS. We
know you recently were addressing the COVID-19 virus, but you
played such an important role in HIV and AIDS early on. How far
backwards have we gone now as a result of the COVID virus, and
will we achieve an AIDS-free generation?
Dr. Fauci. I don't think we have gone--thank you for that
question, Congresswoman Lee. I don't think that we have gone
backwards. Obviously, when you shut down a society, the
accessibility for testing and for the chain of drug
availability can be disrupted, the way everything is disrupted
in this very terrible time, including vaccinations for children
and things like that.
However, there have been a number of really important
advances that have been under the radar screen with regard to
HIV and AIDS. For example, the demonstration that cabotegravir,
the long-acting injectable, can be very adequately used for
pre-exposure prophylaxis, which I think is going to increase
dramatically the adherence to that.
And as I have discussed with you in the past, the PrEP,
pre-exposure prophylaxis, is an important ingredient in our
attempt over the 10 years from 2020 to 2030 to end the epidemic
in the United States. And I believe, notwithstanding COVID-19,
that we will achieve that goal as trying to implement many of
the things that we are doing.
So although it appears that things have been under the
radar screen, they have, in fact, been going on I believe at a
good pace. But thank you for that question.
Ms. Lee. Thank you. Thank you, Dr. Fauci.
Thank you, Madam Chair.
The Chair. Thank you.
Congresswoman Herrera Beutler.
Ms. Herrera Beutler. Thank you, Madam Chair. And like
everyone else, this is probably my favorite hearing of the
year, just getting a chance to talk with really the world class
experts on just about everything.
I have a few different questions. The first one, Dr.
Collins, I think would be for you.
Last year I requested that NIH develop a comprehensive
pediatric research agenda to study the impacts of COVID-19 on
children and to report to this committee in 120 days. And I
wanted to ask about the status of that report, and what are the
NIH's maybe preliminary findings and plans for this research
agenda.
Dr. Collins. Well, it was a very appropriate assignment to
give us, because we know that children have been affected
significantly by COVID-19. They can get the illness. They can
have this strange and somewhat unusual outcome of MIS-C, Multi-
System Inflammatory Syndrome of Children. They also can get
long COVID where they don't seem to recover. And we have a big
effort on this.
Actually, if I may, I would like to call on Dr. Bianchi,
our pediatrician, who can tell you a bit more about what we
have been doing.
Ms. Herrera Beutler. Great. And I apologize. I have a
couple of questions I am going to fit in here, so----
Dr. Bianchi. Okay. I will try to be brief.
But, as you know, almost 4 million children have had
positivity for SARS-CoV-2. The critical question is, of those
children, most of them are going to be mildly affected, but who
is the one in a thousand who is going to get very sick with
Multi-System Inflammatory Syndrome in Children, requiring
perhaps an ICU stay and perhaps serious illness and death?
To address this through the RADx-rad program, which is
developing radical approaches to testing, we are leading a
program, a trans-NIH program called PreVAIL kids, which
comprises eight different programs that are all taking a
different piece of the pie and are looking at children who, for
example, come into the emergency room with a fever. Do they
have COVID? Are they going to be at risk for MIS-C?
And all of these different programs are taking biospecimens
and using bioinformatics to predict who is going to get sick
with MIS-C and then possibly the long COVID.
Ms. Herrera Beutler. Do we have that preliminary
information? Do we have some answers on that?
Dr. Bianchi. No. The program has started within the last
few months.
Ms. Herrera Beutler. Okay. Okay. I am interested to be kept
abreast of that. Thank you, Dr. Bianchi.
Dr. Bianchi. Absolutely.
Ms. Herrera Beutler. You know, I read something earlier
this week about how 16-year-olds, I think it was with Moderna's
shot, after 4 days show an enlarged heart. I have seen other
things about different kids and how it impacts them. And I
cannot stress enough how important I think it is that we turn
our attention to the children as it relates to the pandemic.
One of the things I do have some challenges with--my 2-
year-old just hopped on my lap, and she hopped off--the mental
health and developmental issues that these kids have been
through in the last year.
Like, I took my kid, my youngest, to Costco. She hadn't
been in a big box store. It kind of flipped her out, seeing
that many people. That is a small thing, right?
I think about telling a 2-year-old who maybe is in daycare,
you have to wear a mask now all day long, and all the other
kids have masks. There is learning and speech developmental
issues. There is interaction.
So my 2-year-old doesn't speak very much yet. We read a ton
to her. But so much of what we do is nonverbal. In fact, most
communication is nonverbal anyway.
I am really concerned that now that we have reached this
point where you can get a vaccination if you want one, that we
are further putting the burden on children to keep the adult
population safe by telling young children, ``Indoors, outdoors,
you are going to mask.''
While everybody else is now feeling this sense of freedom,
we are putting more of the burden on kids--who have, I believe,
borne the disproportionate share of this, whether it is school
and learning loss, mental health, possibly domestic violence,
all these different things that we are not going to know for
the next--we are going to know in the next 10 years.
I was hoping someone could speak to that. The mask mandate
for children that age at this point, I need to be convinced
that that is appropriate.
Dr. Collins. Thank you for that question and those
observations.
I think we are all really concerned about this. People sort
of shrug and say, ``Well, kids are resilient.'' But, wait a
minute, this is really an incredible, unprecedented challenge
to their life experience.
The National Institute of Mental Health has recently issued
that we are asking for grant applications to look specifically
at the mental health consequences of COVID-19 for children.
What has it meant for them to be out of school, which is
normally the place where a lot of socialization and education
happens for this prolonged period.
And what about this issue of being fearful of an illness
that might actually affect your families, might suddenly be
blamed on you if you were the one who happened to bring the
illness in?
I totally am with you here. There are a lot of unanswered
questions. We are going to be studying that, I think, with some
considerable intensity, and hopefully we can provide some
better answers about how best to help.
Ms. Herrera Beutler. Can we be kept abreast?
Dr. Collins. Absolutely.
Ms. Herrera Beutler. Thank you, Madam Chair.
The Chair. Congressman Pocan.
Mr. Pocan. Thank you very much, Madam Chair. And thanks to
everyone for being here. I completely agree with Representative
Herrera Beutler. This is my favorite hearing of the year as
well. I have tremendous respect for every single one of the
witnesses here.
And thank you for all of the incredible work you do every
single day for all of us. I just wish we could direct more of
the Department of Defense funds to the defense that you are
doing for this country and the defense that we needed to do so
much in the last year, things like COVID-19.
I have lots of questions, but I do want to give you a
chance, Dr. Collins. I think you were trying to pass a question
to Dr. Fauci about the Wuhan lab. I heard lots of things like
``could,'' ``might,'' and ``not out of the realm of
possibility'' is really hard evidence there. I believe there is
some white whale narrative changing trying to occur. But if you
wanted to have Dr. Fauci answer that briefly, because I do have
a lot of questions, I would be glad to give some time out for
that.
Dr. Collins. Dr. Fauci, please.
Dr. Fauci. So, what is the question, Congressman Pocan,
please? What specific question do you want me to answer?
Mr. Pocan. Well, I believe the question Dr. Harris was
asking is did we fund COVID-19, my bad? I am paraphrasing it
because we have 5 minutes. But that seems to be the new
narrative that is out there that somehow, let's not worry about
vaccinating people and getting the economy going. Let's figure
out how to somehow say there is a different way this all
started. And I am just kind of curious because I know you have
had some interviews on this, but you were asked the question
but not given the opportunity to answer.
Dr. Fauci. Well, thank you, Congressman Pocan. Let me first
say that I think one of the things that was perhaps was a
subtext of Dr. Harris' question is, why do any research in
collaboration with our Chinese colleagues? Well, the underlying
reason for that is that we had a big scare with SARS-CoV-1 back
in 2002, 2003, where that particular virus unquestionably went
from a bat to an intermediate host to start an epidemic and a
pandemic that resulted in 8,000 cases and close to 800 deaths.
It would have been almost a dereliction of our duty if we
didn't study this. And the only way you can study these things
is you have got to go where the action is. So I often say
somewhat tongue in cheek, you don't want to study bats in
Fairfax County, Virginia, to find out what the animal/human
interface is that might lead to a jumping of species.
So we had a modest collaboration with very respectable
Chinese scientists who are world experts on coronavirus, and we
did that through a sub grant from a larger grant to EcoHealth.
The sub grant was about $600,000 over a period of 5 years. So
it was a modest amount. And the purpose of it was to study the
animal/human interface to do surveillance and to determine if
these bad viruses were even capable of transmitting infection
to humans.
And the question of, well, did you do gain of function
research? And, as Dr. Collins clearly articulated, there was
nothing in the grant application and/or granting of the purpose
of the grant and the description of the grant that would call
for what is referred to as gain of function, gain of function
meaning taking the virus that could infect humans and making it
either more transmissible and/or pathogenic to humans. That
categorically was not done. So that is the answer to that
question.
Mr. Pocan. Thank you. So I have got minute and a half left,
and I know there is going to be a second round. But in the
minute and a half, I am very concerned about, I think, the more
important issues of making sure we get more people vaccinated.
Is there anything, initiatives or funding, that you might need
from this committee to enhance vaccinations? Are you concerned
of where we are at? Then a very specific question that I have
had, if someone can ask--someone was concerned about spike
proteins and the long-term consequences and their potential
health effects on cold and flu season. So, if you can answer
all of those, I will keep the rest of my subjects for the next
round.
Dr. Collins. This goes to Dr. Fauci again.
Dr. Fauci. I am sorry, Congressman Pocan, specifically,
your question?
Mr. Pocan. Specifically, how are we doing on vaccinations?
Is there anything else we need to get funding or initiatives to
do that? And then, very specifically, a question about spike
proteins, long-term consequences. I think there is a concern
about potential health effects during cold and flu season. Some
of the people who are reluctant right now that I am talking to,
that was an issue on vaccinations.
Dr. Fauci. Well, we are doing extremely well with
vaccinations, as you well know. We have now more than 60
percent of the adult population has been vaccinated. The
toxicities adverse events are remarkably low in this when you
look at the denominator of the literally tens if not hundreds
of millions of vaccine doses that have been given.
However, whenever you get adverse events, even though they
are very, very rare, we obviously are interested in whether or
not there is anything about the spike protein that would
trigger something, such as an autoimmune reaction, that might
give you a deleterious effect. Again, these things are
extremely rare. We don't see anything that we can directly
relate to the spike protein, but we are certainly looking for
that. And there are immunologists who are right now looking to
see if there is any connection there. But, again, to
underscore, Congressman, these are really extraordinarily rare
events.
Mr. Pocan. Thank you very much, Madam Chair. I will be
ready for the second round.
The Chair. Thank you. Congressman Moolenaar.
Mr. Moolenaar. Thank you, Madam Chair. And I want to thank
everybody for their participation today.
Dr. Collins, Dr. Fauci, I first of all want to congratulate
you on Operation Warp Speed and the record timing to get this
out, to get this working in America. I think it has been a
tremendous success.
Because of the nature of, you know, how quickly the
vaccines were developed, I know there is some percentage of the
population that has hesitancy, kind of viewing it as somewhat
experimental, kind of seeing how it all works out. And
especially women of childbearing age who would like to have
children in the future, I know there have been some concerns
about whether or not the vaccine would in any way affect them
in a negative way. I wonder if you could talk to that and just
mention if there is any evidence of any risk or concern to
women who might be considering that in the future.
Dr. Collins. I think the evidence is actually quite
reassuring, but let me ask Dr. Fauci to give a specific answer
to your question.
Dr. Fauci. Yes, thank you very much, Congressman, for that
very important question. So, if you look at--the vaccine trials
did not include pregnant women in the trials. There are now
trials that are looking at vaccines specifically for effects in
pregnant women and in lactating women. Those are ongoing right
now.
However, if one looks at post-EUA, the number of pregnant
women who elected to get vaccinated because of the clear
indication that the effect of COVID-19 disease on the pregnant
woman and the fetus is really something to be concerned about.
So many, many women elected after the EUA to get vaccinated.
There have been about 115,000 to 120,000 of these pregnancies,
and there have been 5,000 to 6,000 of the births that have now
been followed by the CDC and by the FDA. And as alluded to by
Dr. Collins, there is no red flag signal at all that there is
any concern about deleterious effects of the vaccine on
pregnant women. This is really important because the one thing
we do know for sure is that when pregnant women get infected
with COVID-19, they can have a serious deleterious outcome.
Mr. Moolenaar. Thank you for that. And I just, I think that
that message is really important to get that out there, and I
appreciate hearing that directly from you.
I wanted to talk a little bit about the patent protection.
And, you know, Dr. Collins, maybe you can answer this question.
There has been some discussion, and I believe the Biden
administration recently announced it will support waiving
intellectual property protections for COVID-19 vaccines. I
think everyone wants to see these vaccines readily available
and the supply. But I am concerned about waiving the patent
rights for these biopharmaceutical companies and how that might
impact their willingness and their ability to partner with the
Federal Government in the future when addressing pandemics
because we are taking away significant protections for their
investment in research.
Dr. Collins. So it is a very important question, and it is
a complicated issue that no one should just assume can be
superficially understood. I think all of us, companies,
government, and academics, just citizens of the world believe
we need to do everything we can to get vaccinations made
available to all the people who need them, and especially so in
low- and middle-income countries, where the need is great and
the availability in terms of the supply is low.
But it should not be assumed that it would be possible just
by a quick effort over the course of a couple of months to
establish vaccine manufacturing capacity in lots of other parts
of the world that don't have it. These are very complicated
biochemical processes, biotechnology processes that require--if
you start from basically no previous experience, more than just
a few months, more like years.
And so, while this, I think, is in the long term, what we
need to see is this expansion of manufacturing capability, in
the short term, we are going to depend on the companies that
have that capacity to do as much as they can to expand their
capabilities. And, certainly, I think all of us would agree
that is what we need to see happen.
So it is going to have to play out over the course of time
to see whether this opening up of intellectual property can
help with low- and middle-income countries. But we should not
assume that, in the short run, that this is going to be an
immediate solution.
Mr. Moolenaar. Are you concerned about the long-term
impact, though, and the message that sends to, you know,
private sector investment and research?
Dr. Collins. I don't think industry is terribly concerned
about that. Stephane Bancel, the CEO of Moderna, said he didn't
lose a minute of sleep the night after this announcement was
made by the White House. Moderna had already announced they
were going to make their intellectual property available to
manufacturing capabilities in low-income countries.
What is really more necessary than just the IP is the
technology transfer capabilities, the skills that have to be
transferred, the training that has to be done. And that is
where we are going to need industry to participate, and I think
they are ready and willing to do so.
Mr. Moolenaar. Okay. Thank you very much.
And I yield back, Madam Chair.
The Chair. Thank you.
Congresswoman Clark.
Ms. Clark. Thank you so much, Madam Chair. And I share the
enthusiasm over having this incredible group of panelists here
today. And we have all witnessed the incredible benefits of R&D
investments at the NIH, which have produced lifesaving vaccines
during this pandemic. And I am encouraged by the President's
vow to end cancer through proposals like ARPA-H, but I have
heard some concerns that a new agency may diminish your base
funding.
I know that we are eagerly awaiting the President's budget
this week, but, Dr. Collins, can you do anything to assure us
that this new agency can maximize its effectiveness without
supplanting any funding from existing budgets at NIH?
Dr. Collins. I would very much like to reassure you about
that. And, again, there will be more details available in a
couple of days. The proposal, though, is for ARPA-H to provide
an opportunity for all of the institutes to be able to take on
this DARPA-like approach to the projects that could move much
more swiftly with the kind of flexibility and nimbleness and
risk-taking that ARPA-H will provide. So it augments the
capabilities of the rest of what NIH is about. It is not
detracting from the base; it is adding a layer of translation
of clinical application that can now go faster.
I would also say the way the President's budget rolls out,
it proposes a $2,500,000,000 increase for all of the rest of
NIH, which is a pretty reasonable number as well. So when you
put that together, I think for cancer, diabetes, heart disease,
and everything else, including ALS, Chair DeLauro, we are going
to have an opportunity, through all of these mechanisms, to do
more. And the proposal of this total of an increment of
$9,000,000,000 is going to open up all kind of vistas of
opportunity.
Ms. Clark. Thank you. And to Dr. Sharpless, we have also
heard reports that grant funding has gone down [inaudible].
Dr. Sharpless. Uh-oh. I think I lost Representative Clark.
The Chair. Let's try to find out if we can get Congressman
Clark. Can anybody tell me anything? Well, maybe what we will
do is to--we will come back to Congresswoman Clark.
Congressman Cline.
Mr. Cline. Thank you, Madam Chair, and I want to thank our
witnesses for being here and for their diligent work in
developing the vaccine for COVID and for working with its
distribution.
I want to first start by quoting from a 2011 opinion piece
that Dr. Fauci and Dr. Collins wrote for The Washington Post,
``A flu virus risk worth taking,'' where it includes that--you
conclude: Along with support for this research comes a
responsibility to ensure that the information is used for good.
Safeguarding against the potential accidental release or
deliberate misuse of laboratory pathogens is imperative. The
engineered virus developed in the ferret experiments--in your
column--are maintained in high-security laboratories. The
scientists, journal editors, and funding agencies involved are
working together to ensure that access to specific information
that could be used to create dangerous pathogens is limited to
those with an established and legitimate need to know.
So, when I am looking at a letter that Congressman Mike
Gallagher sent to you back in early May, it says that funding
for the--sorry, let me find this here--that funding was about
$17,000,000 was directed to EcoHealth Alliance, and rather than
$600,000, much of that was sent to the Wuhan lab.
Can you account for the $17,000,000 that was allocated to
Eco lab, and speak to the disparity and the amounts that you
are discussing, Dr. Fauci.
Dr. Fauci. Yeah, Congressman Cline, it is absolutely
correct that about $600,000, about $800,000 was allocated, and
about $600,000 was spent over a 5-year period, no more than
that. That comes through between $125,000 and $150,000 per year
that went to collaboration with Wuhan. So the number of
hundreds of thousands, as opposed to millions, is correct. The
millions number is incorrect. EcoHealth had several millions. I
don't know the exact amount that went to EcoHealth, but would
be happy to get you that precise number.
Mr. Cline. I see it now: 13.7 that was allocated to
EcoHealth; 17 projects sponsored by NIAID, providing over
$7,900,000 in Federal rewards for the research of viral
emergence from bats in Southeast Asia. EcoHealth Alliance
passed some of its funding to WIV, the Wuhan lab. And in 2020,
NIH made efforts to obtain information from EcoHealth Alliance
about Wuhan lab related to concerns about the origins of COVID-
19.
It says that in your letter to EcoHealth: It is our
understanding that one of the sub recipients is Wuhan lab. It
is our understanding that WIV studies the interaction of
coronavirus in bats. And there are now allegations that the
current crisis was precipitated by the release of--from WIV of
the coronavirus responsible for COVID-19. Given these concerns,
we are pursuing suspension of WIV from participation in Federal
programs. It is in the public interest that the NIH ensure that
a subrecipient has taken all appropriate precautions to prevent
the release of pathogens that it is studying.
Would you say it has come to your conclusion that the Wuhan
lab was not engaged in a safe--ensuring the safety of its
facility, as you wrote back in 2011? Is that your conclusion?
Dr. Fauci. I didn't--I am sorry, Congressman Cline. I am
not sure what you are reading from. I didn't write anything in,
I don't believe, in 2011. You are reading from something that I
don't have in front of me. Was that something that I signed?
Mr. Cline. This is an April 2020 NIH letter to EcoHealth
Alliance.
Dr. Fauci. I think that was from Building One perhaps, but
that is not from me.
Mr. Cline. Okay. Let me just go ahead and ask real quick,
have you responded to the letter to Congressman Gallagher,
dated May 25, Dr. Collins?
Dr. Collins. There is a draft of that letter that is in the
process of going through appropriate clearance and should be
received by Congressman Gallagher fairly soon.
Mr. Cline. Have you responded to the letter from House
Commerce Ranking Committee Member Cathy McMorris Rodgers? She
has written two, one dated March 18, one dated May 6. Have you
responded to either of those?
Dr. Collins. Again, those responses are in the works. Those
were very detailed with some 29 questions of 11 pages and 40
footnotes. So it is taking us a little while.
Mr. Cline. All right. And you have a May 20th letter from
several Senators that is waiting for an answer as well?
Dr. Collins. We do indeed on similar topics from Senator
Johnson and others, and that is also in the works.
Mr. Cline. All right. Thank you.
The Chair. Let me ask, is Congresswoman Clark back on yet?
Okay.
Congresswoman Frankel.
Ms. Frankel. Good morning. Thank you, Madam Chair.
And thank you to the panel for your great work, for saving
so many lives.
I am going to start with two questions, somewhat personal.
I am the grandmother of a newborn nursing grandson. I would
like to know where we are in terms of implementing any findings
that will include pregnant and lactating women in clinical
trials?
Dr. Collins. Dr. Bianchi.
Dr. Bianchi. Thank you, Congresswoman Frankel, and
congratulations on the birth of your grandson.
As you know, one of the goals of the PRGLAC Task Force was
to create recommendations and then create a plan as to how to
implement them. And we have already shown a big effect in our
institute's priorities because we have established a maternal
and pediatric precision therapeutics hub that is going to take
the recommendations to the next level and create a center for
knowledge around medications that lactating women can take
safely and what are the effects on the newborn. So that is
coming up. But also the PRGLAC recommendations influence our
institute's strategic Plan, where we have a whole team
dedicated to safe therapeutics and devices for pregnant women,
lactating women, children, and people with disabilities.
Ms. Frankel. Thank you very much. If you can keep us posted
on that.
Dr. Bianchi. Absolutely.
Ms. Frankel. Then, of course, I have another personal
question because I had a really lousy night's sleep like a lot
of Americans. And, you know, I read--I have read many times
that a lack of sleep is related to all kinds of health
problems, cognitive impairment. And I am just curious--and that
most Americans are not getting the recommended amount to sleep.
I am just curious, what kind of research is being done in order
to help us sleep better?
Dr. Collins. It is a great question, Congresswoman. As one
of those who is not getting enough sleep, I resonate with your
question very personally. And I bet a lot of the other people I
am looking at on this screen are in the same boat trying to
wrestle with all of our responsibilities, especially with
COVID-19.
Yeah, we have a whole program on sleep research. It is part
of the National Heart, Lung, and Blood Institutes. And Dr.
Gibbons, as the director of that institute, might want to take
a quick shot at your question about sleep research.
Dr. Gibbons. Sure.
Thank you, Congresswoman Frankel. And as you say, it is a
common challenge we all face, but it is clear that sleep and
its restorative power are really important to our
functionality. And, indeed, disturbances of sleep appear to
affect almost every organ in the body. The body has its own
natural rhythm. It affects your blood pressure, and your body's
temperature. In fact, every cell in your body has a clock that
has a rhythm that aligns with the clock. And when it is
perturbed, it can promote diseases; a number of them related to
obesity, diabetes, heart disease. When you have a heart attack,
it is all influenced by sleep and circadian rhythms.
In fact, one of the studies we have been doing in
collaboration with NIH's child health institute relates to,
again, women in pregnancy. And what we have learned is that
many women develop a sleep disturbance during pregnancy. That
is surprising to men, well-known by women. And, indeed, those
sleep disturbances in which you stop breathing can impair and
have an influence on the course of the pregnancy and on the
child. In fact, we are doing an intervention study after making
that observation to see whether interventions that reduce sleep
apnea, which is stopped breathing during sleep, can actually
improve outcomes of both mom and child.
Ms. Frankel. Dr. Gibbons, sorry to interrupt, but now you
are really getting me nervous about this. But what is the cure
for us that are--for people who are not sleeping? What are you
suggesting, or what are you researching?
Dr. Gibbons. There are simple things that you can do. As it
turns out, a lot of them are probably what your grandmother
told you is, when you get good exercise, you tend to have a
better sleep. When you have a healthy diet and when you watch
your screen time, particularly at night, and when you avoid all
those distracting noises or eating late and you actually rest
and start to cool down before you go to sleep, all those sleep
hygiene habits are nonpharmacologic and can help you get a
better sleep.
Ms. Herrera Beutler. So, basically, we are all toast. Like
none of that is going to happen. We are all toast. Excuse my
language.
Ms. Frankel. I just want to know if there is a pill.
Dr. Gibbons. Well, our hope, is that, in fact, lifestyle
and even nonpharmacologic things as well as medication can
help. Certainly, in the disease context, we are looking at
sleep medications that can be nonaddictive. A key part of it is
in the NIH common fund where we are looking at, how can we
figure out biomarkers of sleepiness as well as understand the
restorative, refreshing parts of sleep in ways that might be
manipulated therapeutically?
Ms. Frankel. Thank you. I am going to follow up with you.
And I will share the research, folks.
I yield back.
The Chair. Thank you very much, Lois, for opening up the
Pandora's box here for all of us here.
I understand that Congresswoman Clark is back on. So let me
yield to Congresswoman Clark.
Ms. Clark. Well, thank you, Madam Chair. I hope this is a
more successful outing.
I had a brief question for Dr. Sharpless about NCI. I just
wanted see if he can review for us why the National Cancer
Institute needs more funding while we are seeing a decline in
grants being awarded at the same time?
Dr. Sharpless. Sure. So, Congresswoman Clark, our grant
applications are up 47 percent. So we have got this massive
influx of new ideas to the NCI. What has gone down is our
ability to fund a large percentage of them because with that
many coming in, it is hard to--the pay lines and success rates
are on the decline.
So, you know, they nadired at about 8 percent 2 years ago,
which the success rates are a little higher than that. But that
is an important metric. They have now come up to 11 percent,
which is progress, but it is still too low. You know, this is
one of the things that is keeping me up at night, frankly, is
the idea that there is this great investigator-initiated
science and these pools of grants that we are not able to get
to. So, for example, that pool of money has funded things like
checkpoint inhibitors to cure melanoma, the CAR-T cells to cure
the leukemia and drugs, problems like that, and then, you know,
things like PROTACs, this new invention to do medicinal
chemistry that is all the rage in the pharmaceutical industry
presently. All of this came out of this pool of moneys. So it
really drives progress in cancer research. And if 89 percent of
them are not getting funded, that makes me very anxious.
So I think that that is our problem is that we need further
support to reach these great ideas because there may be a cure
for pancreatic cancer in there. And that is why we really need
to support them.
Ms. Clark. Well, thank you. Thank you for that explanation.
And Doctors Volkow and Fauci, I want to talk a little bit about
COVID survivors who have long-term symptoms. It has come to my
attention that patients that have different symptoms, fatigue,
depression, brain fog, also can have significant muscle and
bone pain. And we are seeing [inaudible].
The Chair. We will get back for a final question.
Congresswoman Bustos.
Mrs. Bustos Thank you, Madam Chair.
And, obviously, if Katherine comes back on, I am happy to
either yield time to her or----
The Chair. Sure.
Mrs. Bustos [continuing]. I can start all over as well.
Dr. Fauci, I would like to talk to you a little bit about
vaccine hesitancy. We have seen the polls out there, the
research out there that talks about the top reasons why people
aren't taking the vaccine. They want more evidence that it is
safe. They don't think COVID will seriously impact them. They
already had COVID and have antibodies. I think those are the
top three reasons that we are hearing about. This is more
prevalent in rural America, much like the congressional
district that I serve, very, very rural.
I saw also a poll that found that it is 21 percent of rural
residents are saying now that they definitely would not get a
vaccine as compared with about 10 percent of those who live in
more of our bigger cities.
So what we are seeing on the ground here in the State of
Illinois, we have 102 counties altogether. So we have got of
the 15 least populated counties, 8 of them are overall the
least vaccinated counties. And then, of the most populated
counties, we have got 11 of those 15 that are doing the best.
So, again, we are seeing this divide on the ground. We are
certainly seeing it in the district that I serve.
I am wondering, Dr. Fauci, as a trusted voice in all of
this, what do you have to say to the folks who are holding off
getting vaccinated for the reasons that I just listed?
Dr. Fauci. Well, thank you for that question, Congresswoman
Bustos. The answer is the first thing we have got to do is make
sure we don't point fingers at them to do that and make them
feel guilty about that. But you try to explain to them each and
every one of the potential reasons why they feel they don't
want to get vaccinated. One of the most common is that ``this
was done so quickly that I am not sure that it is safe. And
that you have got to get trusted messengers out there to
interact with them. And when I say ``trusted messengers,'' what
we put together is a COVID-19 community corps where there have
been thousands of trusted messengers. They could be sports
figures, celebrities in the entertainment business, clergymen,
we find and women, we find are having an important role in
getting out and extending themselves to address each and every
one of the reasons because if you just take the time to examine
those reasons, there is a really logical firm scientifically
sound counter to each of those concerns, including the safety,
including the quickness that it was done, et cetera.
The other thing that we have found interesting that if you
make the capability of getting vaccines to the hesitant people
as easy as you possibly can, that mitigates some of the
concern. For example, right now, in 40,000 pharmacies,
including pharmacies that are located in areas that are the
rural areas that you are talking about, that anyone can get to
a pharmacy within 5 miles of where they are no matter where
they live, that you can go now, walk into a pharmacy, you don't
need a computer, you don't need an appointment, you don't need
anything, you just go in and get vaccinated. The same things
for mobile units to going into the rural areas when people
don't have the transportation capability to get to a place. So
there are a lot of things that we are doing.
Obviously, we are concerned about vaccine hesitancy because
we want to get as many people vaccinated as quickly as we
possibly can. But there are many things going on now to try to
address that, particularly in those areas that you correctly
indicated are more likely to not want to get vaccinated.
Mrs. Bustos. Dr. Fauci, in addition to--I am thinking of,
we have got one county in this congressional district that I
represent, which is pretty much the entire northwestern corner
of the State of Illinois, we have one county where the entire
population of the county is a little more than 6,000 people.
The vaccination as of this morning--I get a daily report on
this--is 19 percent. And so I appreciate--here was part of the
problem too. They have one phone line to sign up to get the
vaccine. That grown now to two. The high-speed internet is a
problem in a very, very rural county; this is along the
Mississippi River. Is there--I don't know. I am just trying
to--I want to do everything that I can to help get those
numbers up. But you have got pharmacies. You have got
validators. Anything else when you think about a very rural
part of the country that we might be able to help as Members of
Congress, or any other ideas you have in a county like I just
spelled out.
Dr. Fauci. Yeah, I think mobile units would likely be one
of the most important things to do because you are describing
people who don't have real ready access to the kinds of things
that would make it really easy.
Let me get back to the medical unit at the White House and
see if there is anything that could be done. Because I believe
mobile units to bring the vaccines to those rural areas are
probably the best way to do that.
Mrs. Bustos. Okay. All right. Well, we would welcome any of
that. I am out of time. I am sorry. But I can't ask my second
question that I was going to ask Dr. Collins about Down
syndrome. Maybe we will revisit that another time.
Thank you very much, Dr. Fauci.
And, again, Dr. Collins, to you and your entire time, thank
you for all you are doing to help people.
With that, Madam Chair, I yield back.
The Chair. We will have a second round, Congresswoman
Bustos. So, if you can stay, you know, I would be happy to get
your question on Down syndrome.
I am going to ask again if Congresswoman Clark is----
Ms. Clark. I am here. Can you hear me?
The Chair. Yes, go for the last bit here with your second--
and then we are going to have another round, Katherine.
Ms. Clark. Okay. Super quick, I am concerned about the rise
in prescriptions for COVID long-haulers to address some of the
bone pain and other medical pain they are experiencing. I
wonder if this concern is shared by Dr. Fauci and Dr. Volkow,
and if we are looking at nonopioid treatments for the
neurological effects.
Dr. Collins. Dr. Volkow.
Dr. Volkow. Opioids are quite addictive, and this
highlights actually why it is so important that we continue
training on the proper use of opioid medications but also on
the proper management of pain many instances not requiring
opioids, which of course triggered that whole opioid crisis.
But this is also why one of the priorities of the HEAL
Initiative for which we got specific funds by Congress
allocated to address the challenges of the opioid crisis. One
of the main initiatives is to accelerate the development of
effective pain medications that are nonaddictive.
Ms. Clark. Thank you. And thank you for your patience,
Madam Chair.
The Chair. Thank you.
Congresswoman Watson Coleman.
Mrs. Watson Coleman. Thank you, Madam Chair.
And thank you Dr. Collins and to all of your colleagues,
this has been so helpful, and it is so good to talk to you
scientists about the value of science.
Dr. Fauci, I have a quick question for you. I am like Lois;
I have got a personal issue here. I have got an 8-year-old
granddaughter that I don't want to go back to school until she
is vaccinated. How close are we to getting children vaccinated
from that age?
Dr. Fauci. Yeah, you know, unfortunately, Congresswoman, I
don't believe that they are going to be able to be vaccinated
by the time the fall term comes. We certainly will get high
school adolescent individuals vaccinated then. But the age de-
escalation studies that we are doing to get to an 8-year-old
would likely not be available towards the end of this calendar
year, but at the latest the first quarter of 2022. I would
imagine late fall, early winter.
Mrs. Watson Coleman. So does that concern you about sending
your granddaughter back to school under those conditions?
Should we be seeking virtual, continue virtual educating?
Dr. Fauci. Well, what the CDC and other organizations, but
certainly the CDC is trying to do is, given the number of and
the percentage of teachers that will be vaccinated that are
already vaccinated, that there should be no reason not to get
children of any age back to in-person school by the time we get
to the fall term. I myself would likely, would not be--I don't
have children that young, but I would not be concerned when we
get to the fall.
The reason I say that, Congresswoman, because if you look
at the rate of vaccinations now, what is an important factor in
the safety of the children is the degree of infection that is
ongoing in the community. And if you look at the last few
weeks, the number of infections per day have gone down in a
very steady encouraging manner, from 60,000 a day to 50 to 40
to now we are well into lower than 30.
If we get to the President's goal of getting 70 percent of
adults vaccinated with at least one dose by July 4, I believe
by the time we get to the fall, that even though young children
might not be vaccinated, it will be really rather safe in
school. I do believe that.
Mrs. Watson Coleman. I pray so. I pray so. And I thank you
for being such a stand-up person throughout all of this.
Dr. Collins, I am very interested in NIH as it relates to
all of the space that it could improve in terms of diversity,
whether it is the researchers, the clinical participants,
whether it is the individuals or the groups of or the work
groups that review these grants. I am interested in all of
that. And in last year's funding bill, I added the language
that I would ask the NIH to develop a strategic plan and
establish the working group to address the lack of diversity
among researchers and staff and among those who are reviewing
the grants. And I realize that you had initiated the UNITE
Program since March. But I really would like to know some of
the specific strategies that you all are employing to get at
and overcome these barriers. And I would like to know what have
you been actually focusing on in these initiatives, and what is
your intention with regard to continued reporting back to us on
the progress which is made? I am really interested in some of
the strategies that you are employing to this extent.
Dr. Collins. Congresswoman, those are great questions, and
we appreciate your asking us for the strategic plan. I
appreciate Congress also giving us a little bit more time
because we are in the midst of this groundbreaking UNITE
initiative, which touches on all the areas you have just
mentioned.
Time is short, but I will give you one example of how we
are seeking to really improve the diversity of our workforce.
Most of our workforce, of course, is out there in our grantee
institutions; 85 percent of our money goes to those academic
institutions where the science gets done. And yet their
workforce is not as diverse as it could be. And when they go to
try to recruit individuals of diverse backgrounds, oftentimes
they are not successful. If they are successful, individuals
are recruited, but they are not retained.
A new model where we would encourage them, and this is now
possible to do with an additional common-fund program to
recruit not just single individuals from underrepresented
groups but a cohort, and to bring them on board collectively
together. Something that we have piloted in our intramural
program with considerable success. And then they are not like
the only person of color in their community of researchers.
They have this kind of opportunity to arrive together to be
mentored, to be encouraged. This is a program called FIRST, F-
I-R-S-T. And I think we are going to watch closely to see what
this does in terms of the expanding the capabilities of our
workforce to be more diverse. And this is not just something we
are doing because it is a nice idea. We know that diversity
equals productivity, and we want to be sure we are not missing
out on that productivity by the lack of our diversity in many
of our institutions. We are going to work really hard on that.
Mrs. Watson Coleman. And I thank you. I am going to want to
hear about the use of HBCUs in this. And I am also going to
want to understand the sort of contractual relationship you
have with the grantees that are expected to bring on this
diversity and whether or not their mechanism success is
connected to the stability of these diverse researchers and
professionals. So those are some of the areas I am very
interested in.
I have run out of time unfortunately, but I yield back, and
I thank you very much.
Dr. Collins. Thank you.
The Chair. Thank you.
Congressman Harder.
Mr. Harder. Thank you so much, Chair DeLauro, for hosting
this.
And thank you so much to all of our witnesses for taking
the time to be here and sharing their testimonies.
I want to take this in a little bit of a different
direction than what we have been doing so far and talk about
asthma and air quality, which are two interconnected issues in
our district. Many of the cities in the California Central
Valley are classified as the most polluted cities in the U.S.
for both particulate matter and ozone pollution that have a lot
of the direct impacts on the health of folks in our
communities, especially for kids. One in six children in the
San Joaquin Valley have asthma, the highest in the State, and I
believe among the highest in the country. And asthma prevalence
across the valley has reached as high as 20 percent in school-
aged kids.
I had childhood asthma as a kid. My brother had it. It is
incredibly and heartbreakingly common in our area. We, of
course, have seen that in the health data even afterwards. We
have among the highest emergency room visits for asthma in
California. And add in the devastating wildfires in California,
as well as the respiratory impacts of COVID-19, and it really
creates a lot of impact for our healthcare system, and some of
the costs are high. And yet it seems like we haven't
necessarily made major breakthroughs in asthma research in
recent decades. And many Americans are resistant to current
asthma therapies.
Dr. Gibbons, I would love to hear from you as the director
of the National Heart, Lung, and Blood Institute, what can you
tell us about the use of Federal funds to research and develop
programming to address childhood asthma? And is there more that
this committee can be doing to assist in this program?
Dr. Gibbons. Thank you for that important question,
Congressman Harder. As you point out, asthma is one of the
leading chronic conditions of children, in general. It
certainly affects certain communities disproportionately. You
recognize the rural health challenges. In addition, we are
seeing similar patterns in communities of color, inner city,
underserved communities where, again, these exposures can be
concentrated. Indeed, that is an area of research in part
related to the ECHO Program. It is a children's study where we
have been assessing that.
We have learned through those studies that exposure to air
pollution, particularly early in life, actually, has influence
on lung development. We have learned that lung development
actually continues all through childhood, even into early
adulthood. It is driving the overall reserve and structure of
the lungs over time. And that is why it is so important, as you
indicate, to mitigate those exposures that are happening both
in these rural communities and some of the inner city
communities that also occur in these hot spots or pockets of
high air pollution.
We also are making progress in further defining the
mechanisms of the disease, to advance therapeutics beyond the
drugs that currently exist and have been used for the last
decade or so. Indeed, we have been engaged in a program called
TOPMed in precision medicine in which we have gathered together
cohorts of children and adults with asthma in a large
sequencing study to identify new mediators of asthma as a part
or means of developing new targets and new therapeutics.
Similarly, we have developed a platform in which we are
starting to engage in precision medicine for asthma. We call it
PrecISE, where we are recognizing asthma as kind of a catch-all
and recognizing that there are certain subsets of patients that
may respond to particular interventions that have a certain
biological impact.
Mr. Harder. That research, I am sure--I want to make sure I
have a chance to ask a second question as well. I appreciate
that.
I think that is great segue to my question for Dr. Collins,
which is: In the President's budget, there is proposed $110
million for the Climate Change and Human Health Program. Can
you describe some of the research projects that you expect to
come from that, especially any projects that focus on health
outcomes related in poor air quality and how it impacts
underserved communities like ours? Do you have a big piece of
where this might then go or not?
Dr. Collins. Absolutely. And it does tie in very nicely to
the question you just posed to Dr. Gibbons. Climate change
affects human health in numerous ways. People tend to think
about it as perhaps it is more in the area of infectious
disease. And there is a lot to be concerned about there as well
as climate makes different opportunities for different
pathogens to find their way into the human population.
But it also affects, as you have just pointed out, air
quality, the issues that are going to relate to such things as
asthma, as well as heart disease, as well as cancer. All of
those are wrapped up in what we think is now an appropriate
moment for an enhanced and expanded effort to understand the
health consequences of climate change.
Our National Institute of Environmental Health Sciences,
NIEHS, will be taking the lead on this. But already they have
reached out to numerous other institutes at NIH so that we can
come forward with a really exciting, very broad holistic
approach to how we could tackle this issue of environmental
science related to health and the effects of the climate. So I
am glad you highlighted it. We are excited about the
opportunity here.
Mr. Harder. Thank you. Thank you, Dr. Collins.
I yield back, Madam Chair.
The Chair. Congresswoman Lawrence.
Mrs. Lawrence. Good morning. Thank you, Chairman DeLauro. I
represent a majority-minority district in Michigan, and the
past year has exposed the alarming disparities for communities
of color. I believe it is absolutely critical that we act on
these disparities to develop a plan for research.
Dr. Collins, it was heartbreaking when I saw the
disproportionate number of African Americans being hospitalized
and dying from this past pandemic. And it is almost as if in
unison the response was, well, it is expected because they have
underlying conditions.
When are we going to start planning? And what is the plan
to address these underlying conditions in the Black community,
which I know are multiple? We have--access to healthcare is an
issue, food deserts, lack of proper nutrition, obesity. We were
the highest in heart disease, in cancer. And so I want us as a
country to move from ``Yes, this is the problem'' to ``This is
what we are going to do.'' So can you please talk to me how the
Minority Health and Health Disparities Institute, when will we
start see a plan and results of that?
Dr. Collins. Well, your question is incredibly well-
articulated. And it certainly resonates with myself and my
colleagues, as we really have to look at what has happened with
COVID-19 as another example of just how devastating health
disparities are in the United States and that those same
populations that have suffered from disparities, like obesity,
diabetes, hypertension, got hit extremely harder by COVID-19.
And nobody can look at that and not say, ``We have got a
serious issue here.''
If your ZIP Code is a stronger predictor of your longevity
than your DNA code--and it certainly is--there is something
serious awry here in terms of the way in which structural
racism, which undergirds so much of what is happening
institutionally and across the country, has played out in terms
of health effects.
We at NIH have been studying minority health and health
disparities intensively over the course of many years. I think
we are energized by these observations and again by this UNITE
initiative that I have mentioned already to go deeper, to
really understand not just what are the causes of health
disparities--some people have cynically called that admiring
the problem--but actually to intervene and to come up with
studies that would involve those kind of interventions to see
if they work.
We can't fix the healthcare system in the United States. As
the NIH, we are a research organization, but we can understand
studies to see what would happen if you changed certain
approaches to health and other aspects that are contributing to
this. And we aim to do that with a new common fund program that
is more progressive than what has been possible before. So we
are right with you.
Mrs. Lawrence. Thank you, and I am on executive board of
Black Caucus, and I am also co-chair of Women's Caucus. And so
my philosophy in life is that you can't tell me what the
problem is more than once because once you can identify it,
then let's get about fixing it.
My next question is about mental health. The other thing
that COVID ripped the scab off during this pandemic is the
critical need for mental healthcare and especially in our
children.
Dr. Collins, realizing the alarming rates of mental
illness, how will the National Institute of Mental Health
leverage the partnerships to ensure that the grant recipients
receive the cutting-edge discoveries in this field, and how do
we move mental health to the top of the--to the front of the
line?
Dr. Collins. Well, you are quite right that this is another
crisis, and COVID-19 has accentuated it. We can see that both
the disease itself, which is capable of inspiring various
mental health issues to depression and sometimes even frank
psychosis, which is frankly the whole experience that our
country has had where mental health services have oftentimes
been injured by a lack of access because of the concerns about
being in the physical space together.
But one bright light in all of this, Congresswoman, is the
way in which, because of COVID, we have seen telemedicine
finding its way into the mental health arena in ways that it
previously hadn't. And we have a number of research studies
underway right now that are looking pretty promising in terms
of showing that that actually works really well. If there is a
silver lining here, it might be that we learn how to use mental
health services remotely by telemedicine in a way that benefits
people who otherwise just don't have access to those services.
That is just one example.
There are many other things that we need to do. We have big
programs now trying to come up with new approaches to treat
depression, for instance, in ways that would not be the
traditional methods with the traditional drugs but other
approaches that might be more successful. It is a huge broad
portfolio in that particular part of NIH that I would love to
tell you more about if we had more time.
Mrs. Lawrence. Thank you, Doctor.
Thank you all.
The Chair. Thank you.
What I would like to do now is I think we can move to a
second round. And we will make it a 3-minute round so that--and
try to please hold to the 3 minutes so we give everyone a
chance to ask additional questions of our panelists.
And, with that, let me let me start off. Dr. Fauci, this
was about universal flu. I am going to ask three--I have got
two questions. And I want to get Dr. Gibbons in as well. With
regard to the universal flu, does the mRNA technology show the
promise for use in vaccines for other diseases, such as flu? Is
there a hope that mRNA technology could be used to develop a
universal flu vaccine? What other progress has been made in the
past unit towards developing a universal flu vaccine?
Dr. Fauci. Thank you for those important questions, Madam
Chair. The answer to your first question is that the mRNA
technology, which as you know is spectacularly successful in
developing a COVID-19, is now being used in a number of other
attempts of vaccines, including a universal influenza vaccine,
including vaccines against HIV, and including in cancer
immunotherapy. So mRNA is now very exciting.
It is very interesting that you asked that question about
where we are with other areas of universal flu vaccine. Just
today, just today, we started a phase 1 trial on the
nanoparticle, using a mosaic where we have multiple different
hemagglutinins--these are the different colors--that are now
very, very promising because we have at least four or five
different hemagglutinins to cover the waterfront of the
troublesome influenza components that we are dealing with. And,
literally, it just started today, a phase 1 trial of simply
what is called a nanoparticle mosaic approach towards universal
flu vaccine. So thank you for asking that question. This is
what it looks like.
The Chair. This is fabulous. It looks like something I
would have in my office as well, Dr. Fauci. So thank you. Thank
you.
Dr. Gibbons, this is about cardiovascular disease in women.
In 2017, 300,000 women died as a result of heart disease. And
heart disease and stroke is the leading cause of death of women
in the United States. Critical, research in heart disease.
Quick update, NHLBI-supported research and yeah--let me go
there, and I don't think that there is--we need to have more
information out about women and heart disease and what we are
doing on that research. Dr. Gibbons.
Dr. Gibbons. Yeah, thank you for that. Yes, we need to
continue to beat the drum of awareness and ensure that all
women recognize that it is the number one killer. We have
actually--polls and surveys suggesting that we may even be
moving backwards in that regard, particularly in communities of
color.
The Chair. How much time and money are we spending on heart
research for women.
Dr. Gibbons. Well, we can give you that exact number. But
is certainly one of our highest priorities. A couple of
examples include leveraging the Women's Health Initiative,
where we found out about physical activity in elderly women.
And we are now doing an intervention study to demonstrate that
it is both safe to engage in that exercise and indeed still
improve cardiovascular health in elderly women.
The Chair. Dr. Gibbons, what I am going do is ask because
my time is out. I would like to follow up with you and get
information, chapter and verse, about what we are doing on
heart disease in women, and how much research, how many
research dollars are being appropriated to do that? And so
thank you.
And, with that, Congressman Cole, let me yield to you.
Mr. Cole. Delighted. Thank you. As the chair, you are never
out of time, number one. Number two, when you held the--when
Dr. Fauci held that thing up, I thought that should be in
Rosa's office. So we think exactly the same way.
Let me first go to Dr. Collins. A couple of my colleagues
have raised, and I think very appropriately, concerns about
China. But, look, we know China is sort of a bad actor. They
will steal anything that is not nailed down. And we have plenty
of evidence of them trying to penetrate our research within the
biomedical sphere in particular.
So I would like you to take a moment and tell us what you
are doing in response to that? What are the things that, you
know, are underway at the NIH to make sure that our
intellectual property is safe and, frankly, that science is
used in an appropriate way, which I think our people at the NIH
do? I am not sure what the Chinese counterparts always do as
well. I don't mean that individually. I mean that in a regime
way.
Dr. Collins. Well, I appreciate the question. This is a
very serious issue and one where we, the NIH, are out in front
of all the science agencies in trying to be sure that our
resources are not being misused and intellectual property being
appropriated inappropriately to another country.
First of all, let me say that we depend for the success of
the American scientific enterprise on a broad diversity of
folks who come to our country from other places and contribute
wonderfully to progress, including winning Nobel Prizes. And I
want to be really clear that the vast majority of those
foreign-born scientists are wonderful additions to our
community that we greatly value.
But there are some bad actors. We have been very aggressive
in seeking those out, finding examples of individuals. And,
yes, most of them are from China, who have been supported
through something called the Thousand Talents program or
similar programs like that from China where they basically have
deceived us in terms of the support they have for their work
from the Chinese Government and, in some instances, have in
fact been diverting intellectual property as a result.
We have acted on that. We have worked with the FBI. There
have been at least 80 instances of individuals who have quickly
resigned or been terminated, and there are criminal actions
that have been undertaken in some instances. So I think we are
taking this with a grain of seriousness in watching for other
examples. I think nobody at this point would imagine that we
are looking the other way. We are looking really carefully to
try to identify if there are people who are misusing the
resources that we provide them and that we will not allow that
to continue.
Mr. Cole. Well, I very much appreciate that and commend you
for your diligence and urge you to double down on that.
Now, Dr. Fauci, if I could turn to you very quickly, I am
very interested in the efforts on tick-borne research. One of
our best supporters who is not on this committee is our good
friend from New Jersey, Chris Smith. That has been an interest
of his, and, honestly, I appreciate his advocacy for this
program. So I want to give you a chance to update us on that.
Dr. Fauci. Yeah. Thank you very much for that question,
Congressman Cole. We actually, as you probably know, the HHS
has a Tick-Borne Disease Working Group, which we are now
coordinating work not only at the NIH but also with the CDC and
other agencies to address tick-borne disease.
Particularly, one that is particularly problematic, as you
well know, is Lyme disease. We still have what I believe is not
yet an adequate vaccine to be able to be used. We had one
vaccine early on that was not used probably because of, I
think, some ill-advised concern that was not really justified
about the toxicity of the vaccine, which it really was not. So
we are going to be starting all over again to try and do that.
There are a number of other things also looking at how you
can block transmission by inhibiting proteins in the ticks that
actually transmit it. So there are four or five other things
that are going on right now. So we are taking that very
seriously because, as we all know, tick-borne disease,
particularly Lyme disease, is of concern as you get into the
post-Lyme syndrome, which is something that is bothersome not
only to individuals but actually to communities as a whole
where you have a lot of Lyme disease in a community.
Mr. Cole. Thank you very much.
Dr. Fauci. So we are on it.
Mr. Cole. I Appreciate that. Madam Chair, thanks for the
indulgence on the time. I yield back.
The Chair. Thank you.
Congresswoman Roybal-Allard.
Ms. Roybal-Allard. Dr. Collins, according to a 2019 Survey
USA nationwide poll, 80 percent of voters said that medical
researchers seeking funding for animal tests should first be
required to show that an alternative is not available.
Unfortunately, this is not always the case. The OIG reports
have repeatedly found that failure to search for alternatives
to pain procedures and to document the availability of
alternatives in research proposals is common, and scientists
who have served on laboratory oversight committees have echoed
this concern.
I am going to ask all three questions in the hope that I
can get to Dr. Volkow. What role has NIH played in educating
the research community about non-animal research methods? What
steps is NIH taking to incentivize researchers to utilize
existing human non-animal approaches? And have you offered any
training grants or any stage investigator or warrants or
supplementary grant funding to give researchers the resources
and confidence needed to switch from an animal-based to animal-
free research method?
Dr. Collins. Well, very quickly, because I know you want to
ask another question, we are very much interested in trying to
be sure that every experiment that involves animals is done
appropriately with rigor and reproducibility and that the
animal model is, in fact, one that is going to give valuable
information for human health. In many instances, there really
are no alternatives to the animal model to be able to get those
answers, and so we need to support that to be sure we are doing
it, though, with great responsibility.
In terms of grants to others, yes, we are supporting
vigorously such things as tissue chips, which allow you to look
at the effect of a drug or some other intervention in a chip.
And it is basically made up of human cells, maybe closer to
humans, but that doesn't work for lots of other applications.
So we still are going to need animals. But we are looking at
this as vigorously as we can, looking forward to a time where
we have more substitutions.
I think, though, to be honest, for the foreseeable future,
if we are going to make advances in things like cancer,
diabetes, heart disease, rare diseases, we are still going to
need to depend for a lot of that effort on animal research.
Ms. Roybal-Allard. Well, I look forward to working with you
on this issue. I will be introducing a bill, which I would like
to talk to you about later.
Dr. Volkow, the last time we met, you were starting to do
some research on marijuana. Can you give us an update on the
research that you are doing and the impact of marijuana on the
brain, especially the developing brain?
Dr. Collins. We are not hearing.
Dr. Volkow. Research on marijuana, and one of the most
prominent ones is [inaudible] targeted towards understanding in
a longitudinal study in a large sample size of children how
exposure to marijuana may influence the development of the
brain, how it may influence cognition and behaviors, and how
ultimately it may affect their performance at school. That
study is ongoing and already has resulted in publications that,
for example, show that the use of marijuana during pregnancy
was associated with delayed development of the newborn brain.
But this is not the only project that we are doing. We are
actually very interested also on establishing better ways of
standardizing the metrics of consumption so that when people
look at whether it is for medical purposes or to understand
negative consequences, what are the doses that people are being
exposed to? So, yes, we have not neglected at all this area of
research. It is extremely important.
Ms. Roybal-Allard. I see my time is up. Thank you so much.
The Chair. Congressman Harris.
Mr. Harris. Thank you very much. And, first, I just want
to--just to correct the record. I think Mr. Pocan paraphrased
what my question was about the Wuhan Institute. It did not have
to do with globally not funding overseas research. It had to do
with through the indirect costs that are associated with grants
actually sending money to the Wuhan Institute of Virology when
we don't know if they are doing gain of function research.
Now, Dr. Collins, although you do mention that Moderna
might not have had a problem with the transfer of IP to other
countries regarding vaccines, I will tell you that the CEO of
Pfizer certainly had a different opinion, and the CEO of BIO,
the Biotechnology Innovation Organization, certainly has a
different opinion about that effect. And I would ask unanimous
consent to enter their statements into the record that oppose
the transfer of intellectual property to other countries.
[The information follows:]
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Mr. Harris. I am also concerned, Dr. Collins, because you
are, you know, the researcher general of the country, that you
would--I hope that you will take the position on the effect of
H.R. 3, if it should become law, on the negative impact it
would have on research. And I would ask unanimous consent to
enter into the record a report from Vital Transformations, a
group that would report on the devastating effect it would have
on biotechnology research going forward since so much of our
biotechnology research is funded by private companies, not by
the NIH.
Madam Chair, I ask unanimous consent that they be entered
into the record.
The Chair. So ordered. Sorry. So ordered.
Mr. Harris. Thank you. Now, two other--just two very quick
things. One is, is that I do worry about therapeutics. And, you
know, we seemed to have solved the vaccine problem, but
therapeutics are an issue because if variants become prevalent
and our vaccines don't work against the new variants,
therapeutics will be important.
And I was a little concerned that BARDA has suddenly
suspended their broad agency announcement. Of course, you know,
the NIH is not BARDA, but there was no public explanation why,
and some unofficial discussions indicated that the funding was
being channeled to NIH. So I would hope that NIH and, Dr.
Collins, that you share my concern for the vital importance of
the private sector in funding our biotechnology research.
And just a final question for Dr. Volkow. Just put plainly,
is recreational use of marijuana in youth with a still
developing brain a good idea?
Dr. Volkow. No.
Mr. Harris. Okay. So there is no new research that shows
somehow because there is an acceleration among States of
legalizing recreational marijuana, but there is no research
that would indicate, new research, that it is actually not a
bad thing. Is that right? There is no new research indicating
that it is good for developing brains, for instance.
Dr. Volkow. There is no research indicating that it is
benign in young people, but there is increasing research
indicating that it has deleterious effects.
Mr. Harris. Okay. Thank you very much, and I yield back the
few remaining seconds I have, Madam Chairman.
The Chair. Okay. Yes.
Congresswoman Lee.
Ms. Lee. Chairman, this has been such an informative
hearing, but, also, it gives me a lot of hope. It is truly life
affirming, all of the work that you do.
And I wanted to follow up with Dr. Gibbons on so many of
the issues that we have been working with over the years
because it relates to diseases that I have personal knowledge
of that NIH has been so helpful in putting on the radar and
conducting research. One is our COPD action plan. You all know
my late mother died from complications of COPD, and I would
like to know where we are with our COPD plan.
Secondly, with the issue of multiple sclerosis, again, the
research, where we are on MS in terms of a cure. And, of
course, many of you know my sister has MS, and I have worked on
this issue for many, many years.
Finally, Dr. Gibbons, the whole issue around sickle cell
disease, where we are in terms of a cure, and have we figured
out how to address the sickle cell trait as it relates to HIV--
excuse me--as it relates to diabetes and how to identify those
most, you know, prone to sickle cell trait and the A1C test.
Dr. Gibbons. Well, thank you, Congresswoman.
Again, I appreciate your leadership in this area. And,
again, in the spirit of your mom, we are making continued
advances in COPD. Our Top Med program of precision medicine
where we have sequenced over 150,000 individuals has been a key
driver, and where we are starting to identify pathways that may
be driving COPD. We hope that will usher in a new generation of
therapeutics.
With regard to sickle cell, we are very excited about the
opportunities. It is on the horizon to cure sickle cell
disease. And we have made substantial progress in a number of
trials now that are testing various curative genetic therapies
that offer a lot of promise and have very encouraging
preliminary results to suggest that we may be very much on the
brink of a transformative kind of therapy to advance the lives
of those living with sickle cell disease.
Critical to your point about sickle cell trait, that if,
indeed, we have a curative therapy, it will be critical that
there be genetic counseling to identify early on who is at most
risk and, eventually could be cured from this disease. Thank
you.
Ms. Lee. Thank you again.
Thank you, Madam Chair, very much.
Thank you all for this hearing.
The Chair. Thank you.
Ms. Lee. I yield back my time.
The Chair. Congresswoman Herrera Beutler.
Ms. Herrera Beutler. Thank you, Madam Chair.
And, Dr. Volkow, just following up on what Dr. Harris was
mentioning where you said you do see deleterious effects on the
developing brain. To what age are brains developing, just so
that I have an end point on that?
Dr. Volkow. Our brain does not stop developing until our
mid-20s.
Ms. Herrera Beutler. Okay. So people who are legally
allowed to purchase recreational marijuana are still possibly
developing, and it can have a deleterious effect on their
brains.
Dr. Volkow. That is correct, and we are doing the studies
to actually document how it negatively affects the brain.
Ms. Herrera Beutler. Thank you. I wanted to ask, switching
gears a little bit, in one of your blogs about the--and I am
speaking fast to get it all in--monitoring our future survey
for 2020, you--basically I wanted to see when we can expect to
see results from the supplemental funds NIDA issued to research
the impact of the pandemic on adolescence risk of substance
use.
Dr. Volkow. We already are getting some of the results
back. For example, one of the questions that we had was the
extent to which the COVID pandemic was going to negatively
influence vaping, which has been taken up so rapidly by
teenagers. And what the data seems to show is in some
instances, when the parents are there at home, this has
resulted in a decrease in vaping among teenagers overall. So
that is one example.
But on the other hand, we are seeing negative effects, for
example, of alcohol drinking or smoking in those families where
the parents actually themselves take these drugs, or they are
not at home to observe the behavior of these teenagers.
Ms. Herrera Beutler. Got it. Thank you.
Dr. Volkow. We will get more data.
Ms. Herrera Beutler. Thank you. I look forward to that.
I am going to switch over, I think over to Dr. Gibbons.
Yes. So acute and chronic kidney disease in children are
often--well, maybe--maybe, which doctor--in children often
differs from that in adults, both in its underlying causes and
its treatments. There are not enough pediatric nephrologists,
not enough pediatric researchers. And we continue to struggle
to obtain funding for research proposals, or at least the ones
that are out there do. Without this funding, children with
kidney disease are not able to benefit from the resources that
Congress allocates to NIH and NIDDK.
So what is NIH doing to ensure that study sections have
access to pediatric subspecialist reviewers who have the unique
expertise required to review pediatric research proposals? And
what other steps are you all taking to ensure research meets
the needs of children with kidney disease?
Dr. Bianchi.
Dr. Collins. Dr. Bianchi is probably better positioned--
Dr. Bianchi. Yes. So we have formed, actually, a trans-NIH
Pediatric Research Consortium or N-PeRC, and that group meets
every other month to discuss areas of shared interest. We
happen to have a pediatric nephrologist on that committee. We
also have a representative from the Center for Scientific
Review. So the CSR knows that we are very interested in getting
more pediatric reviewers onto the study sections. And by having
a representative there, that person can hear what we are
discussing. And we are particularly interested in adolescence,
which is a gap area across NIH, and also the transition of
adolescence to adulthood in terms of transferring their medical
care. We have recently had a workshop on that whole issue. So
it is a very active area of research.
Ms. Herrera Beutler. Thank you. I yield back.
The Chair. Thank you.
Congressman Pocan.
Mr. Pocan. Thank you very much, Madam Chair.
Dr. Volkow, I have a question for you. In the last
appropriations bill that we did, we added some language that
said that the committee encourages NIDA to expand research on
all health aspects of kratom. Specifically, we talked about
people who may be abusing opioids, how it can help. We also
directed some funds to the Agency for Healthcare Research and
Quality, $500,000 to do such, and we have had some promising
results come back on that.
Just in the last month, the FDA did a major raid on a
company in Florida on kratom using some old rhetoric that the
FDA used to use in this area. I know there is no new guidance,
there is no new head of FDA, but have you had any conversations
with them? And there is also a letter that we just recently got
access to from 2018 sent from the Secretary of HHS to DEA about
kratom saying: Back off our early guidance. We were wrong. We
need research on this.
Have you had any conversations with the FDA or anything we
can do because I do think there is some really strong results
for people who are getting addicted to opioids that can be help
by kratom, and now we are seeing the opposite actions happening
again under the FDA?
Dr. Volkow. We have not had discussions with the FDA during
the COVID pandemic, but we did have them beforehand. We are
very interested on the products, the chemicals that are within
kratom, the most notable Mitragynine, which it has many
interesting properties that could be of value potentially as
medication for pain, but, also interestingly, it could also
hold value as treatments for addiction. At the same time, we
are aware that kratom can produce an addiciton in some
instances and that it can have toxicity. Therefore, highlights
why this is important to actually do research on the substance
that people are taking. They are taking it for multiple things.
Mr. Pocan. No. I appreciate that. If it would be possible,
since the FDA doesn't have a technical head right now, to maybe
reach out to them and let them know some of this because we
really appreciate that great research work that you are
advocating for right now. Thank you.
Dr. Collins, isn't it true, I believe you updated the
report in the last year that in the last now, I believe it was,
decade every single drug approved by the FDA had NIH research
support. Is that correct?
Dr. Collins. That is correct. That was 100 percent of those
drugs, and that was a study done by Dr. Fred Ledley and
published in the Proceedings of the National Academy.
Mr. Pocan. Yeah. I have got that document, and, Madam
Chair, without objection, I would like to enter that into the
record as well.
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Mr. Pocan. And then, finally, very quickly, Dr. Collins. If
you had 10, 20, 70 billion dollars more, literally, what would
that mean as far as research, and what new areas would we be
going to, in a very quick amount of time?
Dr. Collins. What a lovely question. You know, a lot of it
would be basically that we could provide for this amazing
research workforce that is out there the opportunity to pursue
all kinds of ideas that we currently can't quite get to. We are
still only funding about one grant application out of five, and
I know we are leaving really good science on the table when
that happens. To be healthy, really, to take advantage of all
that creativity, it ought to be at least one out of three.
So that would be a big part of what I would do, and I would
particularly focus on those early stage investigators. They are
our future. They are the ones that are most vulnerable when
things seem a little tight, and we would want to be sure that
they felt this experience to be something that was going to be
sustainable and, particularly, if they come from diverse
backgrounds where we have this need, as we have been talking
about in this whole hearing, to enhance the ability of all
those different voices to come and join us, to make their
careers out of biomedical research and for us to sustain them.
That is what I would want to do is just make sure the whole
landscape is advantaged by this kind of opportunity.
Mr. Pocan. Thank you very much. And working towards that
with DOD, but we will get back to you on it. And I yield back,
Madam Chair.
The Chair. Thank you.
Congresswoman Cline.
Mr. Cline. Thank you, Madam Chair.
Let me start with a question for Director Collins. There
was an NIH OIG report from January of last year that found that
NIH resolved 262 of the 487 audit recommendations that were
outstanding during fiscal year 2015 and 2016. However, it did
not resolve about 63 percent or 166 out of the 262
recommendations within the 6-month resolution period required.
In addition, as of September 30 of 2016, NIH had not resolved
225 audit recommendations that were past due for resolutions.
Are you familiar with this report, Director Collins?
Dr. Collins. This is a report about our IT systems and
cybersecurity
Mr. Cline. It is several different audit recommendations,
but the OIG report, yes.
Dr. Collins. So, yes, I am very familiar. And we have
worked hard working with IG to respond to those. And I think
actually a lot of work got done that doesn't necessarily get
reflected in that report in that we inspired actions across the
board. And the actual numbers now of responses would be
considerably better than what you have seen there.
So, yes. I think all organizations are struggling a bit
with this. Many of us have had government agencies that have
been around a long time, and the new era of cyber security is
challenging us, and we are going to need more resources for
that as well in order to try to be sure we are doing everything
we can to keep the bad actors out of our systems.
Mr. Cline. Well, I was pleased to find that a March 2020
OIG report found that NIH successfully checks all applications
to identify instances of duplicate grant funding. As funding
levels are increased and new grants are established, the
Federal Government does continue to grow. This dramatic
increase in Federal spending is of great concern, and I am
reminded of a quote by Milton Freedom, who said, nothing so
permanent as a temporary government program. Can you answer
what safeguards you are putting in place that work to eliminate
duplicative funding for NIH?
Dr. Collins. We have worked hard on that, Congressman,
because we are in agreement. Every dollar that the taxpayer is
providing, that you, the Congress, gives to us needs to be
considered as something that we hold a great deal of
responsibility for. We are able, through our now very much far
advanced portfolio analysis system, to see exactly what is in
our portfolio, what we are funding. And we can compare what is
in our grant portfolio with other agencies, like the National
Science Foundation, like ARC, like Department of Defense,
identifying if there are instances where somebody is basically
trying to double dip. And if we find those, obviously, we are
going to take appropriate action. So I think I can reassure you
that we are on top of that using a lot of the latest tools for
doing text mining to discover things like that.
Mr. Cline. All right. Thank you, Madam Chair. I yield back.
The Chair. Thank you.
Congresswoman Frankel.
Ms. Frankel. Hello. Thank you again. I have a couple of
questions.
First, I think this would go to Dr. Sharpless.
Gynecological cancers are impacting millions of women each
year, yet I am told that we are experiencing declining NCI
funding levels and that there is a very huge disproportionate
amount between what is funded for, for example, prostate cancer
versus ovarian, cervical, and uterine cancer. It is almost
like--I will just give one example. Not that I want less for
prostate cancer. That is not the point here. But $1.8 million
per person, a year's life lost for prostate; ovarian, $97,000.
So I guess really the question is, do we need more money for
research for women's gynecological cancers?
Dr. Sharpless. Thank you for raising the issue, and this is
something we have looked at carefully. I share your concerns
about, you know, funding major diseases like endometrial
cancer, ovarian cancer, and cervical cancer. I think, you know,
if you look at our GYN portfolio, there are some really strong
areas of progress but also some areas where we need to see more
attention. I would say endometrial in particular is an area
that we have spoken to the community about and heard a lot
about where I think we can do more.
We have seen some really remarkable progress in these
areas, you know. Our networks enrolled something like 675 women
on GYN oncology trials. We have these specialized programs of
research excellence, these large grants. And I think we have
seven of those now dedicated to gynecological malignancies,
including five in ovarian cancer. So I think that, you know, we
have to take the opportunity to fund where the scientific
availability is, but, you know, it is certainly an area that we
are watching closely.
Ms. Frankel. I hate to interrupt, but do you need more
funding for that kind of research? That is the question.
Dr. Sharpless. Well, you know, I think as I answered
earlier, we have a lot of grants that we can't get to, you
know, and we certainly have a lot of great gynecological
malignancy grants in that pool of moneys that we are unable to
get to. So, yes, I think more funding for gynecological
malignancy research would be very much appreciated.
Ms. Frankel. Okay. So, if you could just follow up with,
like, an amount, that would be helpful.
Dr. Sharpless. Sure.
Ms. Frankel. I did have another question, Madam Chair, but
I guess I don't really have time for it. There are only 32
seconds. Okay. You are going to let me ask it. Well, here is
the thing. No. I guess you are not going to let me ask it.
The Chair. I am not going to let you ask it. I thought you
were waiting for an answer from Dr. Sharpless.
Ms. Frankel. Dr. Sharpless, do you want to answer that
question? How much more do you need?
Dr. Sharpless. Well, we will provide that to you, that
number to you? Let us give it thought.
Ms. Frankel. Okay. Thank you so much.
Now I yield back, Madam Chair.
The Chair. Thank you very much.
Congresswoman Watson Coleman.
Mrs. Watson Coleman. Thank you, Madam Chair.
Tackling onto what Lois just said, I agree. I support
additional resources in this area, particularly concerned about
issues of the disparity in outcomes in health as it relates to
some of these issues like uterine cancer, like cervical cancer,
and its disparate impact on Black women; like sickle cell
anemia, when are we going to be able to really be able to
tackle this disease; and also maternal and infant mortality and
morbidity. I just kind of want to lay them on the table. I know
they are of concern. Some of them have been mentioned. I just
need to know that they are a part of the priorities, even with
all the competing needs and requests, that these issues of
disparity in healthcare and in outcomes to minorities in
particular are your top--are one of your top priorities.
And, Dr. Collins, you can just answer for everybody.
Dr. Collins. I can speak for everybody. Absolutely, yes,
and you will see when the President's budget is fully fleshed
out in a couple of days that health disparity research is going
to be one of the most highly prominently featured areas that we
want to do more.
Let me just quickly ask Dr. Bianchi to say something about
maternal mortality because we haven't talked about it at this
hearing, and we have this program she can tell you about called
INCLUDE, which I think is really important.
Dr. Bianchi. No. IMPROVE, not INCLUDE.
Dr. Collins. Yeah. That is right. I got the wrong acronym.
Dr. Bianchi. Maternal Health and Pregnancy Outcomes Vision
for Everyone, and this was in response to the meeting we had
prepandemic with the Black Maternal Health Caucus, where we
were challenged to do something, and, indeed, we did. And last
time when I came to this committee in early March of 2020, we
introduced it. But since then, we have funded over $7 million
in grants addressing disparities in maternal morbidity and
mortality, and we as an institute are very committed to this.
We are the largest funder in maternal health research.
And just as an example, in California, research that we
funded implemented a quality improvement to address obstetric
hemorrhage, which was an area of major disparity between Black
women and White women. And by implementing 17 recommendations,
the rate of severe morbidity in Black women went down by 9
percent. So it had----
Mrs. Watson Coleman. I know that there is a lot being done.
I want you to know I need to give New Jersey a shoutout. Our
first lady, Tammy Murphy, and our Governor, they have made this
a priority in New Jersey. And I am sure they are looking for
the funding, but they are also looking to be a model. Thank you
so much, and I yield back.
The Chair. With that, let me yield to the ranking member
for any closing remarks as he would like to make.
Mr. Cole. I am sorry, Madam Chair. It took a minute to
unmute. You came to me faster than I anticipated. I am very
happy to have the opportunity.
First, I want to begin by thanking you for this hearing. It
is wonderful to hear how many members on both sides of the
aisle say, ``This is my favorite hearing of the year.'' And
more profoundly, I want to thank you for your partnership over
6 years in the majority and the minority in working to increase
the resources available to the NIH.
And I think your questions and some of the responses we
got, certainly from Dr. Collins and others, showed what a
difference this subcommittee has made by prioritizing this
particular investment for the American people. It has saved a
lot of lives, you know, in a variety of ways, but certainly in
the pandemic that we have been going through.
I am really proud of what this committee did, and I am very
proud of what the NIH, more profoundly, accomplished in this
year, not only for us but for all of humanity. Everybody in the
world benefited from this investment. So I am pleased and proud
about that.
I also want to do something that is probably a little
unusual. I want to associate myself with the remarks of Mr.
Pocan. We don't agree on everything; we agree on this. If we
could do additional resources here, that would be wonderful.
Although, again, I really want to point out, I am very pleased
with what the administration has proposed as a top line. I have
some questions about how we should distribute those funds and
whether ARPA-H should get, you know, exactly the amount we are
talking about or we should put that to more traditional things
and let this initiative grow, but those are matters of
discussion and debate. They are not matters of disagreement.
And so I certainly will be working hard with you to see that we
reach these top lines because I think they are really important
for the American people.
I will disagree with my friend from Wisconsin on one thing.
It shouldn't come at the expense of defense. And I just say
this as an old historian. Look. The cost of great power rivalry
in history is very high, and we should not underestimate the
kind of world we live in today with China and Russia. It is a
dangerous world.
So we can debate, and we will in another forum, what is
appropriate for defense. I don't think that investment there,
whether it is as high as I would like or lower as others might
prefer, should interfere with this investment because I think
this investment is as important for the health and security of
the American people as any other that we make.
So I am going to be working with my friend, the Chairwoman,
to try and get the maximum number here and certainly working
with the administration where I have some disagreements, as I
have expressed in other areas, but we don't disagree here. And
I am very pleased to see the President actually, you know,
frankly stepping up to Congress.
My friend, the Chair, and I have talked about this before.
Congress has been the leader in this area for, not a few years,
but for generations. It has been Congress that has made these
investments. I always tell people I think it is because we are
at townhall meetings, and we interact more with people that
tell us about their challenges in their family with cancer,
their challenges with Alzheimer's or what they have seen a
friend at church or at work or at their civic clubs go through
in terms of chronic illness. And I think we feel that
collectively, Republican and Democrat, very deeply, and I think
that is why this committee has done what it is done over many,
many years.
And, particularly, though, I am proud of my association
with you, Madam Chair, over what we have done in the last 6
years. So I would just say, number one, thank you for the
hearing. It is always a great hearing. Much more importantly,
thank you for your commitment in this area. It is well known
and widely appreciated on both sides of the aisle.
And I want to thank Dr. Collins and his associates at the
NIH. We really appreciate the work that you and your colleagues
do. We really appreciate not just the immediate science but the
thoughtfulness about what it takes to create an infrastructure
of science, if you will, where we are attracting young
researchers, where we are, you know, presenting people with the
opportunities to good science.
I think about what our good friend, Dr. Sharpless, said
about cancer in particular. You know, it is a great thing to go
from 8 to 11 percent, I guess, funding the proposals, but it is
11 percent. None of us should be excited about that. I can
assure you not every one of the proposals we didn't fund is
good science, but a lot of them are, and we lose over 600,000
people a year, 650,000, as I recall, to cancer. That is as much
as COVID, you know. That is on an annual basis, and that is
with a 65-percent recovery, rate which is something this
committee in particular can be proud of when it is done, but we
need to do more.
So let me just end with this: What a great hearing. I want
to thank all the members, you know. Their participation was
great on both sides of the aisle. I want to thank you, Madam
Chairwoman, for holding it. I particularly want to thank Dr.
Collins and his colleagues at the NIH. I think most Americans
probably don't realize what an extraordinary thing we saw in
the last year. The idea that we could create in this country in
less than a year multiple vaccines for a pandemic is an
extraordinary achievement. NIH wasn't the only player in that,
but they were the quarterback in the big game, and they were a
major player all the way through. I particularly appreciate Dr.
Collins pointing out how the previous investments of this
committee over multiple years and multiple iterations of who
was in control have really made a difference for the American
people. This is something, and we have talked about this many
times, Madam Chair, where we need sustained, annual, above-
inflation increases. We have achieved that all 6 years you and
I have worked together. It is very much my hope we will achieve
that again as we go forward. I think it is really in the
interest of the American people, and, frankly, in this case, in
the interest of all humanity because the engine of the NIH does
a lot more than just help us here in this country. I think the
best thing we can do, you know, diplomatically in terms of our
geopolitical situation is just help people around the world. It
is a wise investment, whether it is in foreign assistance,
whether it is the science that is made available here. I do
associate myself with my friends who are worrying about the
decision to, you know, willy-nilly give away intellectual
property. I personally think that is a mistake, but I think the
instinct behind helping people beyond our own borders is
something that we should be proud of and something an asset for
our country.
So, with that, Madam Chair, again, thank you for a great
hearing. I am sorry I won't be with you tomorrow, believe me,
in multiple ways, but I appreciate very much again this
hearing. Not only this hearing, the sequence of hearings you
have put together. They have been spectacular for this
committee. And, with that, I yield back to my friend.
The Chair. Thank you very, very, very much, and I will miss
you tomorrow. I will miss you. And I thank you. I think you
have, you know, laid out both how we sustain what is happening,
how we really, in effect, utilize this opportunity to build
that architecture for the future, you know, that we need
because this is about the noble mission of saving lives. That
is where we--you know, there isn't a greater goal or a mission
of anything that we do at the Federal level as what is really
accomplished through the NIH.
I do believe that Congresswoman Lawrence is still here, and
she didn't get a chance. If you had a quick question or a quick
comment, Congresswoman Lawrence, because we need to wrap up.
Mrs. Lawrence. Yes. I wish that the system hadn't gone
down.
I just want to express this concern, that I was so
impressed at the response and all hands on deck when it came to
fighting this virus. But as you have heard from multiple
members, there is, for me, the impression that it is just
business as usual with some very chronic diseases like cancer,
hypertension, and other diseases that we know is what they call
the underlying conditions. Where is it--is it more money
needed? Is it the direction of leadership that we can keep this
overall--Dr. Fauci, I mean, you led the way of not allowing any
stone unturned, and I feel that our science in some of these
critical diseases, dementia and others, we are not getting the
same amount of a sense of urgency. Can you address that? Is it
money? Is it--what is it that we need to do?
Dr. Collins. So let me take a first stab at that, but Tony
may want to add. I think you put your finger on exactly the
reason why we think at NIH, there are two major things we need
to push harder in this coming year: health disparities research
being one, and mechanisms to be able to do that more
aggressively, more nimbly, more in a different way of actually
trying to achieve results. And that is where this ARPA-H model
actually fits in. And I don't think I have said it until now,
and I should have. ARPA-H also offers opportunities to pursue
problems like the ones you are mentioning, the chronic
illnesses, diabetes, hypertension, that cause health
disparities, and we would aim to use that engine for that
purpose as well. I have had many ideas already brought to me
about what we might be able to do with that mechanism that our
traditional method of grant giving can't quite achieve at the
same timetable.
Tony, I don't know if you want to add something because I
think she really addressed the question to you.
Dr. Fauci. Well, you know, Congresswoman Lawrence, it goes
well beyond the NIH. So not to pass the buck to others, but I
think it is important, what you point out, that the COVID-19
pandemic has shown a bright light on these kinds of disparities
which are really due to literally decades-long social
determinants of health that start from birth. As you mentioned
in a very articulate way in your presentation, from diets that
are not available to people to not getting your hypertension
diagnosed when you are young and to present when you have
already scars of hypertension and renal disease and heart
disease.
There are things that we can do at the NIH, but I hope that
the rest of the world and the rest of the country specifically
realizes that this is a decades-long commitment to remove those
social determinants that are really part, as Dr. Collins said
in his opening remarks, part of the racism that has existed in
this country for such a long period of time.
Mrs. Lawrence. Thank you. I just want to say that we really
need all hands on deck on this, and thank you for everything
you have done with COVID. Thank you.
I yield back.
The Chair. Thank you. And let me just--I am just--I will
wrap up, but I want to just say to my friend, the ranking
member, Congressman Cole, I think about how blessed we are that
we are serving in the United States House of Representatives,
that we are part of an effort, and particularly with this
subcommittee, where we have come together over the last several
years and increased NIH funding by $12.9 billion, 42 percent
over the last 6 years. We did it in a collaborative way. And it
is not just to give lip service to being bipartisan, but it is
genuinely understanding the value of the research that is done
at the NIH.
And, you know, we often think about we are in these
positions, you know, and it is what you do with a position,
that you come to understand why you come to serve. And I know
why Congressman Cole has come to serve, and that is to make the
institution work for the benefit of people that he represents,
but for the entire country, and yes, in this context, for
humanity.
So it is really an honor and a pleasure to be able to work
with him on these issues because there is such a commonality of
purpose and, you know, a sense of a moral responsibility to be
able to get these--to be able to get things done and to provide
the resources that this committee has to be able to get these
efforts underway and to fruition.
I want to say a thank you. I would just say to you, Dr.
Sharpless, I know that your sleepiness, you are staying up at
night, I think it could be resolved and remedied by resources.
So I think that that is what, you know, I picked up during the
course of your exchanges with our colleagues today.
But to all of our witnesses here today, it is exhilarating.
I don't know how best to say it. It is exhilarating. And my
hope and yours is that we are together next year in person. I
believe that we will. And one of the reasons why this is the
most important hearing, in my view, that we have is because
what we do is we learn of the discoveries to cure that you are
engaged in and what you are doing. What is it that we learn?
What your future research will result in, what it can do. And
we know that the resources that we provide for a specific area
can, in fact, lead to the discovery in so many other areas. And
it is all with the goal of saving lives. And as I said a few
moments ago, there isn't any more important mission.
I always say, you know, I represent, you know, a State that
deals with helicopters. We deal with roads. We deal with
bridges. We deal with all kinds of issues. But nothing is more
important than the content of what is the subject matter of
today's hearing. I will again repeat: The tremendous success of
COVID-19, the mRNA technology. Listen. This is the biomedical
research that you have been working on, and you never know. You
can tell us better than we can tell you because we are not
scientists. You never know where the years and the decades of
basic research are going to take you, where the breakthroughs
are going to be made. And in that context, I reiterate the
importance of continuing to support sustained increases in
funding for basic research at NIH. None of the successes that
we have discussed today would be possible without that basic
research.
So, you know, I am excited about the administration's
proposal to create ARPA-H. It is so promising. You know I have
questions about how we avoid duplicating the efforts of
existing NIH activities, how we balance investments with ARPA-
H, investments in basic research, and how the NIH will make the
decisions about what the research is that we pursue. And we
want you to make those decisions. You know that this has been a
subcommittee that has tried very, very hard not to earmark, if
you will, areas of research. That is not our jurisdiction. It
really isn't. That is yours.
So excited about the proposals that we know are going
forward, and those proposals that are going to look at the
health disparities which have been mentioned today, the
maternal issues, and so many other critical areas. So I thank
the witnesses not just being here today but for the commitment
that you have made in your professional careers to focus on how
we, in fact, yes, use your talent, your ability, use the NIH to
save people's lives. Thank you.
And, with that, I bring this hearing to a close. Thank you.
Material submitted for inclusion in the record follows:
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Tuesday, May 26, 2021.
FISCAL YEAR 2022 BUDGET REQUEST FOR THE CENTERS FOR DISEASE CONTROL AND
PREVENTION
WITNESSES
ROCHELLE WALENSKY, M.D., DIRECTOR, CENTERS FOR DISEASE CONTROL AND
PREVENTION
ANNE SCHUCHAT, M.D., PRINCIPAL DEPUTY DIRECTOR, CENTERS FOR DISEASE
CONTROL AND PREVENTION
The Chair. This hearing will come to order.
As this hearing is fully virtual, we must address a few
housekeeping matters.
For today's meeting, the chair or staff designated by the
chair may mute participants' microphone when they are not under
recognition, for the purposes of eliminating inadvertent
background noise.
Members are responsible for muting and unmuting themselves.
If I notice that you have not unmuted yourself, I will ask you
if you would like the staff to unmute you. If you indicate
approval by nodding, staff will unmute your microphone.
I remind all members and witnesses that the 5-minute clock
still applies. If there is a technology issue, we will move to
the next member until the issue is resolved, and you will
retain the balance of your time.
You will notice a clock on your screen that will show how
much time is remaining. At 1 minute remaining, the clock will
turn yellow. At 30 seconds remaining, I will gently tap the
gavel to remind members that their time has almost expired.
When your time has expired, the clock will turn red and I will
begin to recognize the next member.
In terms of the speaking order, we will begin with the
chair and ranking member. Then, members present at the time the
hearing is called to order will be recognized in order of
seniority; and, finally, members not present at the time the
hearing is called to order.
Finally, House rules require me to remind you that we have
set up an email address to which members can send anything they
wish to submit in writing at any of our hearings or markups.
That email address has been provided in advance to your staff.
With that, I would want to acknowledge Congressman Harris,
who is serving as ranking member today for this hearing in
Congressman Cole's absence. And I also want to thank all of our
colleagues for joining.
I am pleased to have the Centers for Disease Control and
Prevention leadership back before the subcommittee to discuss
the current state of the pandemic and our Nation's response and
the President's budget request for fiscal year 2022 for the
CDC.
On February 23, this subcommittee held a roundtable session
with CDC focused on the COVID-19 response, and, a day later, we
held a hearing focused on public health infrastructure.
Since that roundtable and hearing in February, our Nation's
response to COVID-19 has made significant advancements.
Vaccines are now widely available. One vaccine is now approved
for those age 12 and above. Nearly 300 million vaccine doses
have been administered, including nearly 4 million in my home
State of Connecticut.
Last week, we heard from the Yale New Haven Health System
that they are now treating a, and I quote, ``staggeringly
small'' number of COVID patients. This is a tremendous
accomplishment. Our public health workers are finally able to
sleep again. Our families are finally breathing a sigh of
relief. And our workforce and our economy are beginning to
rebound.
But the messages from the public health infrastructure
hearing in February were clear. COVID-19 exposed numerous
realities in our Nation, including that our Nation's public
health infrastructure is extremely fragile.
Many health departments are still using fax machines or
doing data entry by hand. Information about patients' names,
sex, or pregnancy status are not being shared across
departments. Health workers are leaving the field in droves,
while others need workforce development. And our research labs
are struggling to find the equipment, capacity, and trained
workforce they need.
But, now, communities are realizing that our public health
partners are essential, not only for infectious diseases but
for health promotion and protection to keep our communities
healthy and functioning. Our Nation's public health system can
no longer only get attention during a crisis. We must invest in
the public health workforce, laboratories, and data
modernization, not just to respond to the pandemic but every
year.
After this pandemic is over, our public health agencies
cannot go back to where they were. We need to meet this moment
and build a public health architecture to move our public
health partners and workforce forward. Today's hearing is the
next step in turning those recommendations into action.
While we will not receive the details of the President's
budget until later this week, we know from the budget blueprint
that the administration is requesting $8,700,000,000, an
increase of $1,600,000,000 over 2021 enacted, for the CDC. The
administration has described this request as, and I quote,
``the largest increase in budget authority for CDC in nearly
two decades.''
But, while this is a very welcome increase, I think in
general we need to consider increasing investments for the CDC
not just this year but every year. As I have said many times,
one-time investments do not ensure the CDC and our public
health departments are ready to address chronic challenges.
And we need to ensure our public health infrastructure is
ready to address the challenges or pandemics of the future.
This COVID-19 pandemic has only further underscored the need to
view public health infrastructure as a fundamental service, not
just something we fund when the need arises. The tide has
turned. We need to start providing funding to address core
public health activities.
While I look forward to receiving detailed requests for
CDC, the programs highlighted to receive increases in the
summary released in April are very welcome: maternal mortality
prevention, firearm injury and mortality prevention research,
climate and health, social determinants of health, and the
establishment of a new community-based violence intervention
program.
In terms of gun violence research, I am particularly
interested in getting a progress report. I know it may be too
early, but I hope that you can let us know a little more about
the status of gun violence research and what we have learned.
In terms of maternal mortality prevention, I also want to
say that I am pleased to see increased investments in research
on maternal health to address the crisis of maternal mortality
in the U.S. We absolutely need to make this a nationwide
effort. Not one more mother should die just for participating
in the miracle of birth.
I also think the increased funding for research on how to
reduce racial and ethnic disparities in maternal health
outcomes and improving maternal mental health is particularly
crucial.
I might add that, 2 weeks ago, the CDC made a significant
update to its guidance: that fully vaccinated people no longer
need to wear a mask or physically distance in most situations.
Dr. Walensky committed to leading the CDC with science, and
I know that we will have a lot of questions about the current
scientific evidence that led to this updated guidance and the
subsequent guidance that we are all awaiting to be updated by
CDC.
I know that many people I have spoken to are still
uncomfortable with this change and are not confident that being
around people who are unmasked is safe. There is still a lot of
uncertainty about the nuances that may be implied in such
guidance.
Throughout this pandemic, CDC has been in the unenviable
position of making black and white recommendations in a world
of gray areas. So I think it will be helpful to drill down on
what this guidance means and how we can continue to restore
public confidence in such guidelines. That is why I greatly
look forward to today's discussion.
Now, let me turn to my colleague, Congressman Harris, for
any opening remarks that he may have.
Mr. Harris. Thank you very much, Madam Chair.
And good morning, Dr. Walensky. Thank you for coming before
the subcommittee this morning.
Before I begin, I want to recognize the outstanding work
and careers of Drs. Anne Schuchat and Nancy Messonnier, two
longtime CDC physicians who have both recently announced their
departures. I want to thank both of these remarkable scientists
for their public service, dedication, and commitment to public
health, especially during the COVID pandemic. You will both be
missed.
Just over 14 months since the COVID pandemic began, it is
finally winding down in America. I think it is worth
recognizing once again the stunning success that rapidly
bringing a COVID-19 vaccine to market has had on the trajectory
of this disease in America.
The COVID-19 vaccines are the most quickly developed
vaccines in history, thanks not only to the skill of
researchers at Pfizer, Moderna, and other manufacturers but
also due to the work of Operation Warp Speed under the previous
administration. Operation Warp Speed set our country up for the
outstanding results of our current vaccination efforts.
It has been a pleasure for me personally to lend a hand to
help get Marylanders vaccinated, and I continue to encourage to
get everyone vaccinated as soon as they can. The vaccines are
relatively safe and effective and are enabling us to resume our
normal lives quickly.
On that note, I was glad to see that the CDC finally began
to follow the science and recognize that vaccinated individuals
can safely resume activities. Studies have shown for months
that vaccines are effective and that outdoor transmission is
almost nonexistent.
I continue to question why the CDC resisted making these
statements for so long, why many of our schools continue to be
closed, why the mask mandate continues in the House of
Representatives, and why children at outdoor camps this summer
need to wear a mask.
One wonders whether pressure from teachers' unions and the
need to distract from other difficulties facing our Nation,
such as growing inflation, spiking gasoline prices, renewed
conflict in the Middle East, have influenced this public health
guidance on schools. I certainly hope this is not the case, but
the timing and information about the influence that teachers'
unions had on CDC guidance are troubling.
A key part of our transition back to normalcy will rely on
fully reopening our schools. Census data shows that 50,000,000
working Americans have children who are school-age or younger.
For many of these individuals, schools are the primary form of
childcare. As such, it is imperative that all schools fully
reopen immediately, not only so parents are not forced to
choose between working and caring for their children but also
so that the children can continue learning in the best
educational environment.
Children with disabilities and those without as many
resources at home have been robbed of over a year of academic,
social, and emotional growth during this pandemic. But the
science is clear: We need to bring these children back into the
classroom now.
These are important issues to discuss, and I am sure there
will be questions about them this morning, but let me briefly
touch on the fiscal year 2022 budget request before I conclude
my remarks.
The fiscal year 2022 request contains the largest budget
authority increase in CDC in nearly 20 years. You are asking
for funding to enhance State and local public health
infrastructure as well as to build international capacity to
detect and respond to emerging global biological threats.
I support many of these efforts. As an obstetric
anesthesiologist, for instance, I especially support the focus
on reducing maternal mortality and morbidity. But I do question
the magnitude of these increase in a single year, especially
when overlaid on top of the billions of dollars provided in
emergency COVID relief bills last year.
I also question whether some of the funding items
highlighted in your request are outside of CDC's core mission.
For example, the budget will request double the amount of
funding for firearm prevention research.
You are also asking for $110,000,000 for CDC's Climate and
Health Program, a 1,000-percent increase, to, quote, ``identify
potential health effects associated with climate change and
implement health adaptation plans.''
Are these kind of activities in the same priority category
as combating COVID or other chronic diseases that threaten our
most vulnerable populations or reducing antibiotic resistance?
I would argue that they are not and that we should focus our
CDC resources on communicable and chronic diseases rather than
on controversial, politically charged activities.
I look forward to the hearing this morning, and I yield
back the balance of my time.
The Chair. With that, we would like to again welcome and
introduce our witnesses: Dr. Rochelle Walensky, Director,
Centers for Disease Control and Prevention.
Good morning and welcome, Dr. Walensky. And many, many,
many thanks for the outstanding work that you have been doing
and really using science as your guide, particularly with
regard to COVID and the manner in which we should proceed. And
we are grateful for that guidance and, really, returning the
CDC to, really, its former past in being drivers of science and
letting the CDC, and not politics, engage in the direction that
we take a pandemic or any other illness.
Dr. Anne Schuchat, Principal Deputy Director, Centers for
Disease Control and Prevention.
And as my colleague has mentioned, you recently announced
your plans to retire, Dr. Schuchat, after 33 years at the CDC.
I say thank you to you for your dedication, for your public
service. We have been many times--whether it was Ebola or
whether it was the lead poisoning of our children in Michigan
and other areas, you have had a stellar career. And we are
delighted to have you once again before this subcommittee.
And, Dr. Walensky, your full written testimony will be
included in the record. You are now recognized for 5 minutes
for your opening statement.
Dr. Walensky. Good morning. Thank you very much. Good
morning, Chairwoman DeLauro, Dr. Harris, and distinguished
members of the committee. Thank you for your support of CDC.
I am here today, as you note, with Dr. Anne Schuchat, CDC's
Principal Deputy Director. I have enormous gratitude for Dr.
Schuchat's leadership and contributions over three decades as
well as during this very challenging time for our country and
for her rock-solid support of me in my transition into this
role.
Anne embodies selfless public service, the pinnacle of
scientific and intellectual standards, and has given her heart
to our agency and to the public health community. I will be
forever grateful that I had the opportunity to work with Anne,
even if just during this brief period of time.
The COVID-19 pandemic threw the United States and the world
into a health, economic, and humanitarian crisis. As the crisis
unfolded, it put a spotlight on the fragility of our public
health infrastructure. It illuminated great disparities in
health outcomes by race and ethnicity, reminding us that, thus
far, we have failed to address the systemic racism that results
in poorer health for people of color in the United States.
I am committed to working with you, the administration, and
our public health partners to ensure that every lesson from
this horrible crisis is used to build a better, stronger,
healthier America. I also commit to using our public health
expertise and experience, in partnership with the global
community, to move the world into a safer, healthier future.
CDC's fiscal year 2022 discretionary budget request of
$8,700,000,000 is an increase, as noted, of $1,600,000,000 over
fiscal year 2021, the largest increase CDC has received in
nearly 20 years.
The increase is focused on four critical areas: building
public health infrastructure, reducing health disparities,
using public health approaches to reduce violence, and
defeating diseases and epidemics. These increases build on the
investments made in the COVID-19 supplements and are an
important first step in addressing deficits in the public
health infrastructure.
COVID-19 not only exposed the vulnerability within the
United States' public health infrastructure but also how
underlying chronic conditions and lack of access to healthcare
put too many Americans at great risk. Across the globe, we see
billions of people without access to vaccines and medical care,
which means that SARS-COVID-2, its variants, and other
infectious disease threats will continue to threaten us all.
Experts had warned for years that a pandemic of this scale
was coming, and we must expect additional diseases to emerge.
We need to ask ourselves, are we ready? We must have a strong
infrastructure that can identify and detect outbreaks at their
source and take quick action before they take hold.
Over the last 12 years, the United States has faced four
significant emerging infectious diseases threats: the H1N1
influenza pandemic, Ebola, Zika, and now COVID-19. We are also
confronting an overdose epidemic, a drug overdose epidemic,
with nearly 500,000 people dying from an opioid-related
overdose between 1999 and 2019. The increase continued in 2020
and appears to have accelerated during the COVID-19 pandemic.
These experiences show that public health emergencies are
here to stay. Each of these threats demanded a rapid and unique
response, but none resulted in the sustained public health
improvements we need.
Long-term investments in public health infrastructure,
flexible infrastructure, will save lives and avert economic
losses caused by public health emergencies and chronic public
health problems.
The fiscal year 2022 request makes initial investments to
continue public health data modernization, build the public
health workforce, enhance global health security, and
strengthen our immunization infrastructure.
In addition, we are requesting funds to help States and
communities be climate-ready and prepared to confront new
health risks, such as those associated with vector-borne
diseases.
The fiscal year 2022 request also makes specific
investments in programs that work to improve health equity,
such as maternal mortality review committees.
With new resources outlined in this request, CDC will also
significantly expand efforts to address the social determinants
of health. Proposed increases will address public health
problems that have been exacerbated by the pandemic, such as
opioid, injuries and violence, HIV, and sexually transmitted
infections.
We at CDC are grateful for your support and look forward to
working together to build a sustainable, resilient public
health system that can respond effectively to emerging threats
and meet the public health needs of every American. We will
work tirelessly to ensure the health of this Nation and the
world.
Thank you. Dr. Schuchat and I very much look forward to
your questions.
[The information follows:]
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The Chair. Thank you very much, Dr. Walensky.
I also might add, before I get to my question, that when
you spoke about the work done by CDC with the vaccine, et
cetera, I also want to mention--because yesterday we had the
NIH appear before the committee for their budget hearing. And
it was remarkable that the achievements that you have made
were--you know, this was possible not only by targeted
investments in COVID research but, I believe, also--and I think
that the subcommittee agreed yesterday on a bipartisan basis--
also by the annual and the sustained investments in biomedical
research made by this committee over the years, which was over
$650,000,000 in basic research on coronavirus that helped us to
be able to move as rapidly as we were able to. And, again,
thank you for your outstanding work in this area.
I have a question for you, Dr. Walensky, and I will also
ask Dr. Schuchat to respond to it.
It is clear to me that our Nation's public health agencies
cannot go from crisis to complacency to crisis. We can't think
about public health agencies just during the crisis, about
thinking about the infrastructure of our public health system.
In your opinion, what COVID-related lessons and response
efforts need to be sustained post-pandemic that public health
agencies, including CDC, as well as State and local health
agencies, are better positioned every day to support the health
of our communities?
When we did our hearing, our health partners testified
about core needs--public health data, workforce, laboratory--
that are not specific to one disease or activity. Do you agree?
Dr. Walensky. Thank you, Chairwoman DeLauro.
First, let me say congratulations to you and the State of
Connecticut for all of your extraordinary work----
The Chair. Thank you. Thank you.
Dr. Walensky [continuing]. On getting the vaccine rolled
out. You have been a beacon example. Thank you to you and the
State. That has been extraordinary.
Maybe I will just jump off of where you started with this,
which is the NIH, and just comment that what we are looking for
in the CDC budget is something very similar to what has
occurred with NIH, and that is long-term, longitudinal,
sustainable increases.
And maybe I will just highlight that there is evidence
that, once a scientific study has been published, that by the
time it gets to the community, the core community, in the rural
South, in the urban settings, that it can take up to 17 years
before it gets from the scientific data to a guidance, to
training doctors, to reaching people in hospitals, to then
reaching people in the core community. It can take that long.
And that is the work of what public health can do. And that is
why we need the sustainable resources.
I think the buckets that you have just described are
exactly where we need to be on what we have learned where we
were fragile in the COVID-19 pandemic.
Our workforce. We need an upskilled, trained workforce that
is diverse both in discipline and in background coming from the
communities that they are going to serve. We know that, over
the last decade, when we have had all of these infectious
threats, that we have lost over 60,000 public health jobs. We
also know that about a quarter of our public health workforce
is eligible to retire. So we now need a data-savvy, skilled
workforce that works at State health departments, local health
departments, and, in the communities, community health workers
to reach the people that they serve.
We need to bolster our public health labs. When we started
in this administration, we were doing less than 3,000 samples
of genomic sequencing a week. We are now up to 35,000 samples a
week. We didn't have the infrastructure in the lab to be able
to bolster that.
And then, finally, as you note, the data modernization and
the need--you mentioned the faxes, the personal data entry, the
need to bolster our data to make sure it is interoperable
across different health departments, across different States,
and up to the CDC.
The Chair. Okay.
Dr. Schuchat, would you like to please comment? Thank you.
Dr. Schuchat. Thank you so much. And thank you for your
kind remarks.
Just to, of course, agree with Dr. Walensky about the
priorities, I would just add that we live in a global world and
that COVID has taught us that a threat anywhere is a threat
everywhere.
We were not as prepared as we thought we were here. And we
know that every Nation needs that capacity to prevent, detect,
and respond adequately. And we need systems that can surge
rapidly. And we need to work together on that.
I regret that I will be 33 years at CDC, leaving with a
public health infrastructure that is not stronger than when I
got here. When I look at the NIH and the enormous improvements
in biomedical research capacity that we have seen, I wish that
we have seen the same kind of strengthening of our public
health capacity.
Because I think we have all seen that, regardless of the
fantastic scientific breakthroughs, if we don't have that
frontline workforce and we don't have a nimble and resilient
system, if we don't have data systems that surge and are faster
than the threats we are facing, that we are all vulnerable.
So I hope that the incredible investments in COVID will be
extended for the other threats that are out there.
The Chair. Just a quick followup. We included in the
emergency supplemental last year expediting the modernization,
the data modernization initiative. Just very quickly, can you
give us, you know, any kind of a progress update on the
multiyear initiative?
Go ahead. Dr. Walensky.
Dr. Walensky. Sure.
You know, this has been something that we knew we needed to
address early on. And we are now working across--so, for
example, the electronic health records that we were able to do
in COVID, we were able to bridge test results with electronic
health records from Cerner and Epic to be able to gather more
date in a HIPAA-compliant way.
So all of these systems have been bolstered very much. We
have had to move quickly through the COVID-19 pandemic. But we
really do need to work with our health centers, our public
health workforce, bioinformatics and information through the
private sector. And all of that work is actively ongoing.
The Chair. Thank you.
My time has expired. So, Congressman Harris, please. Sorry
I went over time. Go for it, Dr. Harris.
Mr. Harris. Thank you very much.
And, you know, one thing that is important is that the
public have trust that science is behind decisions made by CDC
and public officials.
So the first question I want to get out of the way quickly
is that--Dr. Walensky, are you and Dr. Schuchat in the same
room?
Dr. Walensky. We are.
Mr. Harris. You are. And neither of you have masks on.
So what I am going to ask you is--you know, if we were
conducting this hearing in a House committee room, we would all
have to wear masks, whether we were vaccinated or not, because
that is the ruling of the Speaker. In fact, in the House
Chamber, we have to wear masks.
I have a very simple question. Did the Speaker or the
Attending Physician of the House consult with you or anyone
else at CDC before coming up with that policy--a policy that,
by the way, results in a fine of up to $2,500 for someone who
is not wearing a mask who has been vaccinated.
Did they consult with you?
Dr. Walensky. We put our mask on till about 2 weeks ago
to--that spoke to the science about individual risks, and, in
fact, those decisions have to be made locally. So our guidance
was data-informed, scientific----
Mr. Harris. Did they consult with you before coming up with
the House policy?
Dr. Walensky. We have been in contact with both the Capitol
Physician as well as the Speaker's office.
Mr. Harris. So they consulted with you about this policy?
Dr. Walensky. There has been--we have been in dialogue----
Mr. Harris. That is a simple question. Before they came up
with the policy, which is a new policy now, that 100 percent of
people have to be vaccinated before anybody takes a mask off,
did they consult with you about science behind that policy?
Dr. Walensky. The science that we put in our guidance is
related to the science of individual risk. And then the
decisions have to be made at the local level with data that we
do not have access to.
Mr. Harris. Dr. Walensky, that is not responsive. And, you
know, I am actually puzzled by why you are not--it is a simple
``yes'' or ``no'' answer. Did they consult with you?
This is why America doesn't trust public health officials.
This is why America doesn't trust elected officials. Because I
can't get a straight answer about whether the Speaker of the
House and Attending Physician consulted about the latest change
in policy, which is that 100 percent of Members and staff have
to be vaccinated before anyone takes their mask off.
Let me turn to the problem with schools. Is it true that
the teachers' unions helped drive the CDC policy on reopening
schools?
Dr. Walensky. As a matter of practice within the CDC, we
engage with many partner organizations related to any guidance
that we have put out. So it----
Mr. Harris. Okay. So it is just coincidence that the
wording of the guidance pretty closely mirrors some of the
discovered communications between the teachers' union and CDC?
Dr. Walensky. We engage with many partners. I spoke to
teachers, I spoke to parents, I spoke to many people before
that guidance came out. And what became clear in some of those
discussions is that there was a piece missing.
The teachers were asking for, what happens if we have a
teacher who is immunosuppressed? How do we act if we have a
teacher who is immunosuppressed or a family member of that
teacher who is immunosuppressed?
That piece was missing from our original document. With the
feedback, we were able to include science-based
recommendations.
Mr. Harris. Okay.
Now, the other thing that--and, again, I appreciate we
discussed at some length yesterday on the telephone the need
for people who have had prior infections to be vaccinated with
two vaccines, if they are receiving Pfizer or Moderna, despite
the evidence that there is a--first of all, that there is a
good T-cell response following natural infection, whether
symptomatic or asymptomatic. That information has been out
there for months. And a recent study by the Penn Institute of
Immunology indicated that there is a very robust response after
only one additional vaccine.
So, given that these are still experimental vaccines, these
are under emergency-use authorization, would it be reasonable
to begin looking at saying that people who have had disease
should either have tests for antibodies or T cells or should
only get one vaccine if they are in a two-vaccine regimen?
Dr. Walensky. Dr. Harris, I think you bring up one of the
things that is going to be the Holy Grail of this, and that is,
what are the correlates of protection, both in the T cells as
well as the B cells?
As we had the pleasure of discussing the other day, we
don't have great correlates of protection in either of these.
And, in fact, we can easily measure antibody response. We don't
even have a good measurement of T-cell response right now.
When we get those measurements that we can use in a large-
scale public health sort of way----
Mr. Harris. So the Oxford--and I only have a few seconds
left. The Oxford Immunotec test, which, unfortunately, FDA has
put on the back shelf for evaluating for EUA but is licensed in
England, is not a good test?
Dr. Walensky. I am saying it is not applicable that we can
use now in a public health way to make a decision about whether
somebody who is sitting in front of us should get vaccinated or
not.
Mr. Harris. Sure.
Thank you. I yield back.
The Chair. Thank you.
I would just like to make a comment. I am looking at a
document that is dated May 13, 2021, and this was a major
speech made by the American Federation of Teachers president,
Randi Weingarten, where she says, ``There is no doubt: Schools
must be open, in person, 5 days a week, with the space and
facilities to do so. We know that is how kids learn best and
that prolonged isolation is harmful. Educators have yearned to
be back in school with their students. They only ask for two
things: a safe workplace during this pandemic and the resources
they and their students need to succeed.''
With that, I am going to recognize Congresswoman Lee. But I
am going to step away for a moment to pose a couple of
questions to Secretary Mayorkas in the Homeland Security
hearing, and Congresswoman Lee will take over the gavel while I
am gone. I should be back in short order.
So, Congresswoman Lee, you are recognized.
Ms. Lee. Thank you very much, Madam Chair.
And thank you to Dr. Walensky for your testimony and also
for your leadership in declaring that racism is a public health
threat.
And also to Dr. Schuchat, thank you so much for your 30
years of service and your commitment to public health. We are
going to miss you, but you have really made your mark. So thank
you so much.
Let me ask Dr. Walensky, with regard to the whole issue of
structural racism and public health--it is undeniable, so,
again, thank you for the declaration.
We have to work together to ensure that our healthcare
systems work to confront and dismantle the racist systems and
practices that perpetuate racial disparities. And so
Congresswoman Ayanna Pressley, Senator Warren, and myself, we
introduced the Anti-Racism and Public Health Act, which calls
for the development of a national center for anti-racism at the
Centers for Disease Control and Prevention and also a law
enforcement violence prevention within the National Center for
Injury Prevention and Control at the CDC in coordination with
the Department of Justice.
Now, the President has included $100,000,000 for CDC to
start a new community-based violence prevention--or violence
intervention initiative. And so in what other ways are you
going to ensure the interagency and interdepartmental
collaborations and accountability to really begin to address
and dismantle racism in public health? And is this $100,000,000
appropriate to use to begin to establish some of these programs
that we have laid out in our legislation?
Dr. Walensky. Thank you so much, Congressman Lee, and
really to you for your extraordinary leadership in this area.
As I think you know, I have history in my work in HIV, which is
where this interest for me had started, and I know you share
that interest as well.
As you know, about a month ago, we declared here at CDC
racism as a serious public health threat. Through COVID-19, we
very much saw that: 0.8 years of life lost for people who are
White, 1.7 years of life lost for people who are Hispanic, and
2.9 years of life lost for people who are Black in this country
due to COVID-19. Truly extraordinary years of life lost. And
that has, you know, opened the door for us to be able to do
that for everybody else to see what you and I have been seeing
for years, that health is different for people of color in this
country.
One of the things I charged my agency with, my center
directors with, when we made this declaration is to say, yes,
we have documented the problem in all sorts of different kinds
of screening mechanisms and in all sorts of different care, we
have documented that these are disparities in care; I want to
now do something about it.
So I have asked each of my agency center directors to plan
an intervention for the next year, a measurable intervention,
that will show impact in how we can improve health in people of
color in this country.
And among the areas where we are going to be using these
resources is deep in these communities. It is among the reasons
that we need community workers, to understand the impact of
what is happening in those communities and understand how we
can reach them.
And I really look forward to seeing what our center
directors are planning and what they find.
Ms. Lee. Thank you.
And one thing I am working on, Dr. Walensky, is the issue
of the lack of Black men in medicine and behavioral health
professionals. And so anti-racism strategies have got to be
integrated into all areas where we see shortages of people of
color.
And so I am wondering, as you move forward on this, how are
you looking at putting these strategies together, across the
board, everywhere within your authority?
Dr. Walensky. You know, one of the things I think that is
so important is that our workforce be diverse, both in their
expertise as well as in their background and the communities
they serve. They need to come from the communities they serve.
I had the great pleasure of being in rural Georgia last
week talking to a rural community, and I said, ``How are you
doing at vaccination?'' And they said, ``Well, it didn't work
when they sent in the National Guard.'' They trust the local
firefighter, right? These communities trust the people who have
been in the communities, from the communities.
I have seen that in working with community health workers
in my own HIV work back in Boston. They trust the people from
their community. It has to be at every single level of
expertise.
Ms. Lee. Okay. Thank you.
And, finally--I have a few seconds left--let me just ask
you as it relates to sterile syringes. We know it is the most
effective intervention to prevent the spread of infectious
diseases. And so how are those syringe service programs
working? And how are we encouraging organizations, healthcare
entities, to use this program, syringe service programs?
Dr. Walensky. You know, the opioid crisis is a real
challenge. It had been a challenge before the pandemic. It
continues to be a challenge, both with--and, in fact, was
exacerbated by the pandemic, both in terms of infectious
threats that are transmitted through injection use--and so,
yes, we are working closely to embrace the sterile syringes
under the context of the law and what we are able to do. And we
are really looking forward to moving forward with you.
Ms. Lee. Thank you very much.
I guess our chair--I will yield back to you now, Chairwoman
DeLauro. You made it back.
The Chair. Congresswoman Herrera Beutler.
Ms. Herrera Beutler. Thank you, Madam Chair.
And thank you both for being here and for your service.
I think my question is for you, Dr. Walensky. And I think
part of my challenge is, it is all based around how we are
treating children in this pandemic.
You know, there is a large amount of discussion around
school reopening, but I hear from parents in my parent whose
children are being forced to quarantine for long periods of
time beyond CDC guidance, which ultimately interrupts their
learning.
And, in some cases, a medical provider is not allowed to
clear a child to return to school. And throughout your guidance
for school reopening, the CDC has encouraged students and
parents to talk to their healthcare providers, but it seems
like their opinions are being overlooked, which is hugely
disappointing.
So, on one hand, I want to make sure that you are
communicating, and I wanted to ask what you are doing to
communicate down through the levels to the local level that can
provide some of this guidance.
But then I think the broader observation that I have is, I
do think we are getting so many mixed messages. It is very
difficult to have one source of information. You know, I saw a
story in The New York Times from a week or two ago that said
that CDC's benchmark for outdoor transmission was about 10
percent, which, if you dig down on the science on that, it is
really--leading doctors will say it is actually less than 1
percent. So to say 10 percent is not inaccurate; it is just
really imprecise.
And so, when you have this kind of muddle of information
flowing around, it causes some real challenges on how do we
provide leadership in our communities with regard to what to
do.
That brings me to the next point, which is masking in
children. I brought this up yesterday. I think children have
disproportionately borne the isolation burden throughout this
whole pandemic, whether it is learning loss through school,
interaction with one another, especially children in the
younger grades who are learning to talk, who are learning to
interact, whose social and emotional interaction is really what
is at stake.
You know, I saw some remarks from--I am not going to say
his last name right, so I am not going to try--a doctor from
Stanford, but I can provide you his name--I just don't want to
butcher it--citing studies from Sweden and the WHO, who
recommend in The Wall Street Journal that we avoid masking kids
up until at least age 11 because they are at low risk for
infection and the very real hazard is stunting their
development.
And yet our only recommendation at this point is, kids,
young kids, you are going to have to continue to mask. As we
are lifting this burden on everyone else, we are going to make
you do it. We are even going to make you do it outside, where
there isn't a single documented, you know, infection instance
anywhere in the world from that casual outdoor interaction.
So I wanted you to speak to--because science, science,
science is our base, right? That is what you said; that is what
the chair said. I believe that. But the science doesn't show
that children are at high risk. And a CDC study from last July
shows that they are not at high risk for spreading it either,
when we are talking about, you know, about 2 to 7, 8, 9, right?
So why are we making the kids bear this burden?
Dr. Walensky. Thank you, Congressman.
First, maybe I will acknowledge two important things. One,
I have three kids myself. One has been home all year. I
understand the challenge. I deeply understand the challenge.
And maybe the second is the complexity of managing guidance
and information and providing it to the public when it is
changing and when it is evolving and when we are learning so
much so quickly, and how we are able to evolve our guidance in
the context of that.
And I think you are highlighting something that is really
important. This is complex. And as we change things, things
that we knew a year ago are different now because we have much
more information and they continue to evolve.
I have always said schools should be the last place to
close and the first place to open. And I very much still agree
with that. I very much want those to be safe places. My own
kids were home from camp last summer, and I want camps to be
open this summer.
All of our guidance has highlighted it is better to be
outside than inside. And what I really want in our camp
guidance--and we are working through revising that guidance in
the context of vaccination for 12- to 15-year-olds. My whole
goal is to make sure that camps can remain open and that
outbreaks don't occur.
Ms. Herrera Beutler. But can I jump in on there, just
because my time is running low? And I appreciate that.
Based on the science, children 0 to 4 are less than, I
think it is, 1 percent or 1.3 percent of all infections. And so
I guess part of me is saying--I get it, 12 and up, you can get
a vaccination, but you can't vaccinate the younger kids. Yet
they are at low risk for getting it. They are at even lower
risk for hospitalization. They are at low risk for spreading
it. So why are we making them mask? Because the science doesn't
support that.
Dr. Walensky. There are still transmissions associated with
young children. They have been vectors of transmission for
older people. And----
Ms. Herrera Beutler. What studies--that is the thing I need
to know. Maybe you can provide that, because my time is up.
Dr. Walensky. I would be happy to do that.
Ms. Herrera Beutler. Can you provide the studies for that?
Because that is not readily available.
Dr. Walensky. Absolutely.
Ms. Herrera Beutler. Thank you.
The Chair. Congressman Pocan.
Mr. Pocan. Thank you very much, Madam Chair.
And thank you both for being with us.
First, I just want to say, you know, I am very happy with
the increase that you have. You have outlined many ways you are
going to spend it. I guess my only regret, and this might be
Barbara Lee's as well, is that the Pentagon increased budget
alone is more than 50 percent than your total budget. For
perspective, I think that is important for people to
understand, given the biggest threat to this Nation in the last
year was COVID-19.
Having said that, let me ask a couple questions, first
about contact tracing. Is this a good time to really be very
specific in our contact tracing efforts?
I know it was hard at moments last year to keep up. I think
at one point we were doing one out of every five people is the
best we could do in the State of Wisconsin. But now that you
have far fewer people, is this something worth intensifying the
efforts on to really help further eradicate its spread?
Dr. Walensky. Thank you, Congressman.
Contact tracing has always been a strategy for containment.
We have used it in measles when we have fewer cases. And, in
fact, it is hard to do contact tracing when you are in a
mitigation strategy with hundreds of thousands of cases, as you
exactly note. So, yes, I think now is a good time. With fewer
cases, we are able to do so, we are able to isolate.
But I think one of the bigger things to mention is, who are
those contact tracers? They are the community health workers.
They are the people who are on the ground, the infrastructure
we never had, that we couldn't deploy to do the contact tracing
to begin with.
And that is what a sustainable public health infrastructure
will be able to do. They will be able to be in the community,
working on hypertension, childhood vaccinations, diabetes
control, and then pivot quickly when you have an emerging
threat.
So I believe our contact tracers should not only serve as
contact tracers now but as vaccine navigators--they know their
community--and, really, to promote both quarantine of people
who are potential contacts but then vaccination.
Mr. Pocan. I don't want to put words into your mouth, but I
would like to be able to pass on this information. So this
would be a good time to make sure that we are thoroughly doing
contact tracing with the limited cases that we now have?
Dr. Walensky. And I would emphasize, contact tracing with
vaccination.
Mr. Pocan. Yes.
Dr. Walensky. Because those who have to quarantine are
likely those who are not vaccinated.
Mr. Pocan. Gotcha. Thank you very much.
Second question is--I know that, you know, when you put out
the new guidelines, it was a lot of new guidelines, ones for
everybody.
And, last night, Secretary Walsh was in town, so I was out
doing a few things in the community. And, based on your
guidelines, I haven't been doing many things--I wasn't supposed
to--in my district that previously I have.
But it seems like the change has been very--a lot of people
are doing a behavior without masks and things, which is in many
ways okay.
Are there things that, if you are vaccinated, that we
should still not be doing right now, and if you are in a mixed
crowd, that we should not be doing right now?
Dr. Walensky. Thank you.
You know, the guidelines that we put out for fully
vaccinated people was really intended at the individual level.
And I think what we really need to understand is that the
policies have to be locally driven.
What we know is that there are counties that still have
less than 20 percent of people vaccinated and still greater
than 100 per 100,000 cases of disease every 7 days.
And so this was the start, because, in fact, we needed
people to recognize that this was important information,
science-based information, to make those local policies. But
the heterogeneity of both vaccine rollout and cases, I think,
really needs to be taken into account here.
Mr. Pocan. So, for example, indoor situation but mixed. If
you know at least a quarter of the people aren't vaccinated and
you are within 2 feet of people in the size of the room, should
you be wearing a mask?
Dr. Walensky. I would defer to the local policy. But I
would say, if you need to make that decision yourself and you
are vaccinated and you are not immunocompromised, it is not you
that is at risk; it is the unvaccinated cohort.
Mr. Pocan. Gotcha.
And then a last question in the minutes left about sending
vaccines abroad. You mentioned in your initial comments--I
personally am trying not to do any international travel this
year, just because I think, you know, the rest of the world is
not as far as we are in vaccines.
But what should the U.S. be doing more to make sure--
because we are never really going to be in the place we want to
until we get people vaccinated across the world. What more
should we be doing?
Dr. Walensky. I think, as Dr. Schuchat already noted,
disease anywhere now is a threat to us here. And so we need to
be assisting.
We have already put $4,000,000,000 into COVAX--
$2,000,000,000 that has already been given and another
$2,000,000,000 that is going to be--80,000,000 doses of vaccine
that we are hoping to get out before the end of June.
And we at CDC are going to be providing global support,
technical support, how we do massive immunization campaigns,
how we do vaccine safety. And we will be providing all that
support.
Mr. Pocan. Great.
And just in the remaining 9 seconds, thank you. I know you
have all put a lot of extra time in. It has been a pretty
tremendous time in our history. I just want to say thank you.
And I yield back, Madam Chair.
Dr. Walensky. Thank you so much.
The Chair. Congressman Cline.
Mr. Cline. Thank you, Madam Chair. I appreciate you having
this hearing today.
I want to thank our witnesses and ask Director Walensky, in
encouraging vaccinations--and I encourage people to get
vaccinated--you mentioned that we need to be specific for each
locality, each individual.
But suffice it to say that your recommendations include the
idea that, if you are vaccinated, not only do you run a reduced
risk of contracting COVID but you have a reduced risk of
transmitting COVID. Is that accurate?
Dr. Walensky. That is what emerging science is telling us,
yes.
Mr. Cline. Okay.
So, circling back to the ranking member's questioning, were
you in contact with the Attending Physician, Dr. Monahan, as he
developed this most recent policy announced by the Speaker,
where 100-percent vaccination was encouraged? Were you in
contact with the Attending Physician?
Dr. Walensky. We have been a resource for the Capitol
Physician throughout this pandemic. I know our offices have
been in contact with him. I can't tell you exactly the timing
of that, in terms of when the last discussion was versus when
the guidelines for the House came forward.
Mr. Cline. Okay.
Were you in contact with his office as he developed
recommendations for the Senate? Because the Physician also
provided a recommendation to the Senators as well. Were you
aware of that?
Dr. Walensky. Congressman, my reply to that would be the
same. I know our office has been in contact, but I just
couldn't tell you when our office was directly in contact with
him and when his decisions for either the House or Senate
occurred.
Mr. Cline. And would it surprise you to learn that the
Attending Physician issued a recommendation to the Senate that
was substantially different than the recommendation to the
House, in that the Senate was encouraged to proceed with normal
business without masks being required, social distancing
respected, but that 100-percent vaccination was not required in
recommendations from the Attending Physician's Office to the
Senate, but in the House it is somehow being mandated? Does
that surprise you?
Dr. Walensky. Congressman, one of the things we have just
mentioned is how complex these decisions are. In the case of
evolving science, of course the Capitol Physician has much more
information than I do about both the vaccination rates in each,
the House and the Senate, as well as the medical records of
people, as well as the average age and immunity durability. So
I think he would be best equipped to make those decisions.
Mr. Cline. Well, the Senators, on average, are older. The
average age of the Senators is higher. And the science of the
virus is not different in the Senate Chamber than it is in the
House Chamber, correct?
Dr. Walensky. I just don't know the immunization rates of
each of the House and Senate. And he would be equipped with
that information that I don't have.
Mr. Cline. Is it your opinion that American society should
be 100-percent vaccinated before we open back up?
Dr. Walensky. As I mentioned, I think that these have to be
locally driven, both based on vaccination as well as based on
background rate of disease. So----
Mr. Cline. But that is a pretty good softball for you. Do
you have to be 100-percent vaccinated to open back up and stop
wearing masks?
Dr. Walensky. No, I don't believe so.
Mr. Cline. Okay. Thank you.
Let me ask you about the business community. The
livelihoods of many businesses in my district have been
threatened over the last year as they worked to adjust to the
changing environment during COVID. As more has been discovered
over the last year, guidance has changed as well. A Federal
Reserve study found that the pandemic resulted in the permanent
closure of roughly 200,000 U.S. businesses.
What will you do to empower States to determine how best to
govern so that overly burdensome recommendations and
regulations from the Federal Government do not cause further
harm?
Dr. Walensky. We have been putting forward--first of all,
we are working to get people vaccinated. Because I think, as we
have seen, when people get vaccinated, disease rates in their
local areas come down, and that is the ticket out of this, in
my mind, when people get vaccinated.
We are working really hard with all jurisdictions, with all
communities, at the State, the local level, to get people
vaccinated to ensure confidence, to provide the best
information possible so that people feel empowered to make
these decisions, that they are the right decisions coming from
trusted messengers in those communities.
And so we are working to do that at the public health
level. And then we are providing the guidance that can lead to
informed decisions in communities with local jurisdictions,
with Governors--I spoke to the Governors yesterday--to make
sure that our guidance is applied in a safe manner at the local
level.
Mr. Cline. Thank you.
I yield back.
The Chair. I would like to recognize Congresswoman Clark.
But, for one moment, I am going to again hand the gavel to
Congresswoman Lee so I can just--see, it did not work the last
time, of getting to Homeland Security, and I will get there and
get right back.
So, Congresswoman Clark, you are recognized.
Congresswoman Lee, take the gavel.
Ms. Clark. Thank you so much, Chairwomen.
And thank you both for joining us. And just the deep
gratitude of a Nation for the work of the CDC and the response
to this pandemic.
Dr. Walensky, you and I have talked about the value of
public service, the importance of treating public health jobs
as we would a career at DOJ or Defense. Are there programs or
incentives that the CDC would like this committee to prioritize
that would address the needs of our public health workforce?
And, in particular, how can we work with the CDC and State
and local level to build a more diverse public health
workforce?
Dr. Walensky. Thank you very much, Congressman Clark.
I think one of the things that is really important here is
to make sure that the compensation is competitive with the
private sector in our public health jobs. As I talked to the
State health officials, they would tell me they can't hire an
M.D. In a State public health--the compensation wasn't
competitive. Somebody who came out of medical training and
medical school with, on average, $200,000 worth of debt was not
going to enter the public health workforce, because they didn't
have salaries that are competitive.
As we are working on expanding our ``disease detective''
EIS program, one of the things we are really looking forward to
is hoping to do loan repayment programs.
And across our workforce, of our training, loan repayment
programs would really go a long way so that people could enter
into public health, which obviously pays less than the private
sector. Many of the training programs that we would put forward
to be tuition-free, to be accessible to people who have had
less resources.
Ms. Clark. Great. Thank you for that.
And anything specific around your plans and strategies for
increasing diversity in your workforce?
Dr. Walensky. We are reaching people where they are. We are
working to, you know, go to historically Black universities. We
are working in communities to try and bolster people within the
communities.
We have the potential now, as we are scaling up our
workforce within public health that we have had to do by
necessity through this pandemic, to retain them. These are
people who are interested in public health. They have
demonstrated, they have volunteered to help. And now is the
time to scale them up, to retain them, and to make sure that
they can continue the important work they have been doing, to
continue the outreach that they have already made, to maintain
that network. And that, I think, is really going to be key for
our next step forward.
Ms. Clark. And just really quickly, if an employer made a
decision around masks based on two different groups, one that
had a 96-percent vaccine rate, one that had a 77-percent
vaccination rate, would you think that was a fair way and
aligned with the science to make a decision around masks at the
workplace?
Dr. Walensky. Most definitely. Almost every morning, I look
at a map of vaccination rates across this country by county.
Ms. Clark. Thank you.
Dr. Schuchat, I was wondering if you could tell me a little
bit about the gun violence research that was first funding in
20 years in the fiscal year 2020 budget. And I wondered if you
can tell me what you are learning in our research on firearm
injury and mortality prevention.
And we just so appreciate you treating this as the public
health crisis that it is. And any updates and strategies and
interventions that have emerged from the research that you can
share?
Dr. Schuchat. Thanks so much for that question,
Congresswoman Clark, and for the congressional resources that
we first got in 2020. Our call for proposals for firearm safety
opened a flood of applications, and we were really pleased to
be able fund several that were focused on the gaps that the
National Academy of Medicine had identified.
The scientific research that we are supporting is helping
us understand firearm-related injury across different types of
incidents, different types of populations, and different
settings.
We had 18 funded sites in that research. They are looking
at firearm behaviors and co-occurring mental health and
behavioral risks among youth. They are looking at individual-
and neighborhood-level risks for firearm-related violence so
that communities can design tailored interventions. And they
are setting a clinical screening tool to assess youth risk for
future firearm violence.
These are really important projects that span the Nation.
But I can say, we had so many more applications than we were
able to fund. So the ability to scale it up is going to be
precious.
The other aspect of the resources that we received helped
us strengthen the data gathering on the surveillance, just so
we would know who was getting injured by firearms and where
these events were occurring, when they were occurring, so that
we could understand trends and risk factors.
So I think it is a really important, precious area for us
to continue.
Ms. Clark. Thank you so much.
I see my time has expired. I yield back, Chairwoman Lee.
Ms. Lee [presiding]. Thank you very much.
Now I will yield to Representative Frankel.
Ms. Frankel. Good morning. And thank you both, Doctors, for
all your good work.
And not to monotonize this discussion on Members wearing
masks, but, Madam Chair, I just would respectfully suggest that
our colleagues who do not want to wear masks, whom we have
heard from today, ask their colleagues who have not gotten
vaccinated to get the vaccine.
Because, you know, I think I speak for most Americans who
have been vaccinated. And we don't want to wear masks, but we
do not want to be sitting in small areas with people who are
refusing--who know better, who are refusing to get vaccinated.
So my next question, Doctor--either of you can answer
this--is, what is expected for when we are going to need
boosters for our vaccinations?
Dr. Walensky. Thank you for that question, Congresswoman.
And congratulations on your grandbaby, who I think was pending
as we last spoke.
Ms. Frankel. Yes, he is here, thank goodness. Something
good came out of the pandemic.
Dr. Walensky. That is right.
On the topic of boosters, I think that it is really
important for us to understand several things.
First, if you have received two doses of vaccine or you are
completed vaccinated, right now you don't need a booster. You
are protected. Or, at least, the data that we understand now
for the general population implies that you do not need a
booster right now.
I think all of us recognize that we don't want to be back
to where we were again. And so we would like to study this. We
are studying when we might need a booster.
And, in fact, that gets back to the, what are the true
correlates of protection? We do know that antibody levels, over
time, we have seen they wane. And so the question is, when they
wane, are these people still protected? What do these
quantitative numbers mean with regard to protection?
We also know, importantly, that we vaccinated first our
most vulnerable. We vaccinated people who are in long-term-care
facilities, we vaccinated our elderly, we vaccinated people who
might not have had the most robust immune response to start.
And so we are looking at the timing of when boosters might
be needed. Will it be 6 to 9 months, will it be 9 to 12, or 1
to 2 years? We have seen data from SARS, the SARS-1, that has
demonstrated reinfections after 2 or 3 years. That is after
natural infection.
And so I think the most important thing is, we certainly
want to be ready. And so that is where we are right now.
Ms. Frankel. That is good.
And do you expect, though, that with the next shots, we are
going to be able to get them like with the flu shots, you know,
not having to go to mass sites and things like that?
Dr. Walensky. I think one of the things that is really
important to recognize here is, we don't have an adult
immunization structure in this country. We haven't. We have a
childhood immunization structure in this country, but we do not
have one for adults. We don't have a mechanism to do this right
now.
And among the reasons for the funding is to develop and
bolster an adult immunization structure in this country, for
flu shots, for COVID vaccines if we need them again. That would
be the vision for Shingrix, for all the other--for, you know,
tetanus when we need tetanus updates, for all of the things. We
don't have that mechanism right now.
Ms. Frankel. Well, thank you. That is a good idea. Because
our rollout in Florida of the vaccines was chaotic. I said it
was like ``The Hunger Games'' here. So, I mean, it was really--
it was frightening.
You know, I think one part of our population that really
suffered were the elderly, and I am just interested in whether
you are doing any work to address, you know, how we handle
these kinds of situations with our elderly population. There
was so much isolation and depression.
Dr. Walensky. I think--you are noting the elderly
specifically, and I totally agree, the isolation here had been
so challenging, and in long-term-care facilities, so
devastating to watch. But I think you are raising a larger
issue too, which is, the mental health of this Nation has
suffered.
And so we are doing a lot of work in collaboration with
SAMHSA, to evaluate mental-health-related issues, to look at
issues related to suicide, to do more surveillance, and to do
outreach with interventions that are data-driven, that have
toolkits provided by the CDC for how we can do outreach in
these communities with community workers to really do evidence-
based science in mental health across the age spectrum.
Ms. Frankel. And real quick, talking about toolkits, how
about in terms of ideas for communities on how to increase
vaccination rates? Is there a place that our health departments
can go to get different ideas or strategies?
Dr. Walensky. Yeah. Thank you for that. We have an
extraordinary number of resources.
We have vaccine confidence consults. You can call the CDC
and get a vaccine confidence consult.
We have, through HHS, the We Can Do This campaign. It is
5,000 community corps. So if you have a group that NASCAR
speaks to, you can go get your vaccine and then take a ride
around the Talladega track. So there are lots of different ways
to engage with this community corps through the
wecandothis.gov.
I would really encourage your State departments to engage
these community corps organizations, be it NASCAR, NFL, country
music, or Infectious Disease Society of America. Faith-based
organizations can really help do the outreach so that people
are talking to people they trust.
Ms. Frankel. Thank you very much.
I yield back, Madam Chair.
The Chair [presiding]. Let me thank my colleague,
Congresswoman Lee. Mission accomplished.
And, with that, let me recognize Congresswoman Bustos.
Mrs. Bustos. All right. Thank you, Madam Chair.
And, Dr. Walensky, thank you so much for taking time
earlier in the week to chat. I am going to talk with you a
little bit as an extension to what you just shared with
Congresswoman Frankel about new ways and innovative ways to
reach out to people, specific, in this case, to rural America.
I talked with Dr. Fauci about this yesterday at our
hearing. He was going to take the questions that I was asking
about reaching rural residents and try to come up with some new
ideas.
But I want to talk specifically about the disparity between
those who live in rural counties compared with those who live
in more urban counties. We know by the numbers that CDC has
released that it is less than 40 percent of residents in rural
counties who have received at least one dose, compared with
just about 46 percent in urban counties.
And so I want to hear your thoughts about vaccine
hesitancy, other issues that are specific to rural counties.
If I may throw out an example, in the congressional
district that I serve here in northwestern Illinois, we have
one county, which is a couple counties south of where I am
talking to you right now, it is along the Mississippi River.
The entire county has 6,700 residents. And early in the--for
people to sign up for the vaccine, they just had a couple phone
lines. Broadband is spotty at best. Their volunteer corps, as
far as getting people out to help, were very, very senior
themselves and were concerned about getting COVID themselves,
so that was all brought to a halt. They were registering
people. There was no online portal to register. It was all
handwriting, you know, paper and pencil.
And so, now, with the announcement that just came out
earlier today, where we have half of the adult population that
is vaccinated, in this county only 19 percent overall is
vaccinated. And so, just these great big disparities.
So I am just wondering, Dr. Walensky, on top of what you
just talked about, I am very curious, like, can I get a Chicago
Bears player to come to Henderson County? I mean, I am just
wondering how that might work.
But what steps is the CDC taking to increase these
vaccination rates in rural areas? And, specifically, also, how
we can address vaccine hesitancy. And maybe even really talk
through, like, these celebrities, because maybe that would be a
way to have this work. I am wondering if we could get some
folks in my neck of the woods to help out.
Dr. Walensky. Thank you for that question and for
highlighting data that we have discussed about these
discrepancies in vaccine rates really through the end of April.
Another piece you didn't actually raise is the
discrepancies in telehealth, right? In rural counties, it would
be so helpful to have telehealth. And yet we saw in a previous
MMWR that telehealth wasn't reaching, for exactly the comments
you said--broadband, telephone, you know, decreased access.
I think it speaks to the fact that we don't have community
workers in these communities that have had a long-term public
health infrastructure in these communities to do the work of
public health. We don't have a public health department that is
sustained, that has been viable, that has been well tended to,
that has competitive salaries, respected positions, and
community workers in those communities to do the work that you
are talking about.
And that is exactly what--we have had resources that have
gone out that are specifically line-itemed for rural areas
because we recognized that deficit through the context of
COVID. We have had community-based organizations specifically
outlined for rural areas through the context of COVID. And what
we are asking for, not just to have it for the context of
COVID, but now you are going to find them, you are going to
find these people who are devoted to this community work.
We need to make sure that they are trained. We need to
scale them up. They need to be able to interact with the data
systems. You don't have data systems there for people. You are
doing it by hand, by paper and pencil. That is not a way to do
public health in this country in 2021, never mind for what we
need to reach for in 2030.
In terms of what we are doing now, you and I discussed, you
know, I was in rural Georgia, and it was really incredible to
talk to the people who are doing this work, who are going door
to door, the elderly people, as you note, and who are hearing,
``The National Guard didn't work.'' What did we need to do? We
needed to be at the change of shift at 4:00 a.m. And have
people trip over us and say, ``Can you get your vaccine now?''
That is the kind of grassroots efforts that we are moving
forward with now.
We have these confidence consults, that people can call the
community corps. I am a Patriots fan, I am sorry to say, but I
bet the Bears might be something to facilitate. You know, I do
think when you call these--wecandothis.gov, you will get a
wealth of resources. These people want to help.
Mrs. Bustos. Good to know.
Dr. Walensky, again, thank you to you and your team for all
you are doing to help our country get past this pandemic.
Grateful to you.
With that, Madam Chair, I yield back.
Ms. Clark. I don't think you need to apologize for being a
Patriots fan, though.
The Chair. Now we get to the real core of the issues here.
But my hope is that you are a Yankees fan so there doesn't have
to be a Red Sox fan here.
Right, Katherine? Anyway.
Congressman Harder.
Mr. Harder. I don't know if I want to get myself in the
middle of this. But thank you so much, Chair DeLauro, for
hosting this hearing.
And thank you so much to the witnesses for taking their
time. And a special thanks to Dr. Schuchat for your decades of
service.
One of the things that I really wanted to focus on is how
this pandemic has highlighted some of the gaps in our public
health system. And I think one of things that has become
abundantly clear to me is just how critical a strong, well-
funded public health workforce is to care for folks across the
country, especially in rural districts like mine, where
capacity, especially healthcare capacity, is already thin.
I have seen the beginning of some grant announcements out
of the CDC that are going to help fund some of the programs
outlined in the American Rescue Plan, specifically the
$7,000,000 investment to hire and train public health workers.
Dr. Walensky, could you describe the rollout of the public
health hiring and training programs and especially how the CDC
will support these positions on an ongoing basis after the
rescue funds expire?
Dr. Walensky. Thank you for that, Congressman.
You know, we just put out the first tranche of
$7,400,000,000. Really, $4,400,000,000 is intended to help
scale up where we are now to get us out of this pandemic, to do
the hard work of continuing testing, continuing disease
diagnostics, continuing workforce for lab and genomic
surveillance, and to make sure that we are--and vaccine
distribution and community workers for that vaccine
distribution.
The other piece of it, the $3,000,000,000, is an investment
in the future, to be able to take that infrastructure and to
invest in the workforce that will be moving forward.
But I think the most important thing you highlight is that
these are not one-time investments. One-time investments will
not fix the problem that led to this pandemic of COVID-19 and
our inability to handle it. They need to be sustainable. They
need to be longstanding. They need to be keeping the pace with
inflation. They need to be keeping the pace with technological
advancements. And so this is an investment now, but it needs to
be a sustained investment over time.
Mr. Harder. How will it be a sustained investment over
time? Do you expect that to be--I haven't necessarily seen that
investment in the budget document. How do you expect that to
manifest itself in the discussions we are having today?
Dr. Walensky. I think this is going to be a continued
conversation. I think I am going to probably see you here this
time next year to demonstrate all the hard work that we have
been able to do with the resources that we have had and what we
still need to do in the years ahead.
Mr. Harder. Well, I look forward to working with you on
that and especially, I think, making sure that rural areas that
are especially strained in some of the public health capacity,
like our district in the California Central Valley, have some
of the opportunities to get some of these grants, because I
think it is very much needed.
My second question is, you know, just a little bit more
broad, and to you, Dr. Schuchat. I think we have a tendency to
only invest in public health during times of crisis, and I
think we need to be doing a lot more to improve the capacity of
State and local public health departments, not even for the
pandemic we are dealing with now but to prevent others in the
future.
What else can we be doing to consistently and sustainably
equip public health departments for future public health
emergencies and especially for the special considerations we
may need for rural districts?
Dr. Schuchat. Yeah. Every aspect of an emergency response
is improved by the work that is done beforehand, the
relationships that have been built, the data systems that are
in place, the skill level of the staff, and the familiarity
that they have with the communities and the other organizations
nearby.
We were not ready for this pandemic. Our data systems were
very far behind, and our public health workforce was gone,
basically, you know, the 60,000-some jobs that were no longer
filled. And so, you know, looking back on what has happened
over the past year and over the past few decades, I think we
can see that we just need to do better going forward.
I want to say a few words about the public health data
modernization, because I think that left us lead-footed at the
beginning of this response, with not really knowing what was
going on and not being able to keep up.
And so we know--you know, I have talked to healthcare
executives who have described investments in a single hospital
of $700,000,000 versus, you know, what our initial resources
were, $50,000,000 for the entire public health data
modernization effort.
I think, going forward, we really need to take data and its
complexity and the full ecosystem seriously, both with data
scientists and with interoperable systems, migrating our
systems to the cloud, strengthening what public health local
and State capacity is and also what the CDC's is.
So that is a really big, complex job. And it also relates
to what Dr. Walensky was describing, where it is tough for
public health at any level to be competitive with the private
sector. And so we have to figure out how to attract quality
individuals to work with us and have strong public-private
partnerships to go even further.
So I see data hand-in-hand with workforce in getting us out
of the state of preparedness that we were in.
Mr. Harder. Excellent. Yeah, you can't fight what you can't
find. Well, thank you so much.
And, with that, I yield back, Chair DeLauro.
The Chair. Congresswoman Watson Coleman.
Mrs. Watson Coleman. Thank you, Madam Chair.
Dr. Walensky, thank you for all the work that the CDC has
been doing, not only in this space as it relates to getting us
through COVID and having an after-COVID experience, but all the
other work that you all do at the same time.
And, Dr. Schuchat, thank you so much for your 30-some
years. God bless you. You have been enormously important to all
of us and our well-being, and we wish you the very best.
Dr. Walensky, I am sorry that we didn't get a chance to
talk beforehand, because I have, really, a lot of questions. I
am just going to raise some of them, but hopefully we will talk
about them a little bit further down the road.
I want to talk about the gun violence issue. I appreciate
the fact that we funded research for the first time in, I
guess, a very, very long time, and that is being used valuably
by you all.
I am wondering, with the President's new initiative where
he is talking about more local interventions, what that means.
How do you see that rolling out? What are the kind of
interventions that will have an impact on the kind of violence
and death by guns that we see in our communities now,
particularly our inner-city and low-income communities?
Dr. Walensky. Thank you so much for that question,
Congresswoman.
We are really looking forward to seeing how the investment
of the initial funds from fiscal year 2020 and 2021, and as
those data mature, what we learn, and then really looking
forward, using the template of the information that we need
from the National Academy of Medicine to inform the kinds of
research that is being done.
Of course, that research, as you note, has to be at the
local level. It has to be related to behavioral health and
mental health, but, importantly, it has to be at the
neighborhood level and at the level--and because, you know, not
every neighborhood is going to be the same.
So the science that we are going to do is going to be about
the who, the how, the why of firearm injury prevention. And we
are going to move forward, and I really look forward to seeing
how that science matures.
Mrs. Watson Coleman. So do you think we are at the
beginning of that? And how long will we see the actual
implementation of effort evidenced by the research that was
being done? Because we are in a very urgent, crisis situation
with gun violence in our communities.
Dr. Walensky. I would agree with you. I will say, we will
need to, sort of, see what the science demonstrates, and then
we are going to implement at an actionable level within those
communities. We need to understand what the science says before
we can act. And we are really looking forward to seeing how
that evolves.
And maybe Dr. Schuchat?
Dr. Schuchat. Yeah. Just to expand a little bit, you know,
we had that first investment of the $3,000,000 in this work,
but the proposed expansion--excuse me--the proposed community
violence work is a larger scale.
And the idea there is to take what we have shown to work
through the technical packages that we have issued on violence,
including on youth violence for instance, and to scale those
up, to have communities take on the ability to implement proven
methods.
They may involve, you know, strengthening connectedness
between kids and schools and adult mentors in the community. It
will really vary community to community. But we are hoping to
fund a large number of communities to really take those to
scale.
Mrs. Watson Coleman. And, Dr. Schuchat, I am really
interested in hearing some of the specifics that are going to
be employed under this effort.
The President also said in his skinny budget he wanted to
end the HIV/AIDS crisis. And one of those things I think is
very important in this is the bill that I sponsored with regard
to PrEP.
And so what I am wondering is--two things. Number one is,
what do you say about the trend in HIV/AIDS right now? Is it
still going down? Do we see an upshot because of the pandemic
or whatever?
And what do you think of how the resources should be
applied? How are we going to ensure that they are applied
across the board to all races and communities?
Dr. Walensky. Thank you for that question. As you know,
prior to my coming here, my career was in HIV disease and
prevention. I am an HIV doc by training.
Yes, I think, you know, right now, the Ending the HIV
Epidemic initiative has been invested in 57 jurisdictions with
the highest rates of HIV. I think that, as with many diseases
that were pre-occurring before this pandemic, they have been
exacerbated by social isolation, by inaccess to medical care,
by many things. We are looking at the investments that were
made in those 57 jurisdictions, some of the lessons learned
there.
As I am certain you are aware, with your interest in pre-
exposure prophylaxis, it is not getting to the communities that
need it, necessarily, for cost reasons, for access reasons,
behavioral health reasons, that places that have the highest
rates of HIV actually have the lowest rates of pre-exposure
prophylaxis use. And that mismatch is something we need to fix
in the years ahead.
Mrs. Watson Coleman. Thank you.
I know my time is up, but I think that that is a crisis
that needs to be addressed. That is what we saw with testing
for COVID. That is what we saw with contact tracing. That is
what we are seeing in some respects with vaccinations but not
as much. And so that is a crisis, in and of itself, as it
relates to poor communities or minority communities. And I want
to know specifically at some point how we are going to get at
those communities.
I thank you, Madam Chair. I yield back.
Thank you, Doctor.
The Chair. Thank you.
Congresswoman Lawrence.
Mrs. Lawrence. Thank you. Good morning.
As you know, I represent Michigan and was very involved
with the lead crisis in Flint. And we know that lead exposure
is unfortunately prevalent across Michigan, and that includes
the lasting effects of the Flint water crisis. I am proud to
work with my colleague, Congressman Kildee, to provide funding
for the Flint Lead Exposure Registry at the CDC.
Dr. Walensky, I am incredibly concerned with the high
levels of lead in cities across the country, especially in the
schools. When I talk to my colleagues, there are numerous
schools that put the plastic bag over the drinking fountain,
with no research of how long the children drank from that water
fountain before we put that plastic bag over it, the lasting
effect.
Can you speak to how the CDC will utilize the Childhood
Lead Poisoning Prevention Program with more targeted
initiatives like the Flint Registry to combat lead poisoning in
our communities, especially the impact it has on children and
their developing brains?
Dr. Walensky. Thank you very much, Congresswoman.
And one thing I think we learned from this pandemic--and
this was reported in the MMWR as well--is the decrease in lead
poisoning surveillance that happened because of the pandemic or
lack of access to care.
I think one of the things that we will really understand as
we invest in our public health infrastructure is different
communities need different things. We heard in rural
communities they need broadband, but in other communities we
need investments in our community workers to do surveillance of
lead.
We are doing active surveillance, and maybe I will ask Dr.
Schuchat to chime in as well.
Dr. Schuchat. Just to thank you for your leadership around
the Flint crisis. And, you know, the registry has been
incredibly valuable for the community as a community-owned and
-led response. You know, the children affected potentially
could have long-term consequences, but with mobilizing
wraparound services and engagement, we hope that some of that
will be mitigated.
We don't know how many other communities are in the same
boat that Flint was in, and that is part of the focus of
expanding lead surveillance through the public health systems.
There are other departments that are really engaged in
investments that can help reduce the exposures, the lead pipes
and so forth that you mentioned, but we think that data is the
first thing. We have to know what is going on to be able to
target effective responses.
And, ideally, those are community-owned, the way that they
were in Flint, to not just have, you know, a distant government
trying to figure out what was going on but having those
community workers who could help the families that are
affected.
So I share your sorrow about what happened and enthusiasm
about the registries and the ability for us to strengthen
surveillance around the country.
Mrs. Lawrence. I will tell you, if we had a hearing on lead
poisoning, many members will step up and talk about the concern
they have in our communities, urban and rural.
The last thing I wanted to add is to add my voice to gun
violence. We know for decades there was a refusal to establish
or identify gun violence as a health crisis, because, for
whatever reason, administrations did not have the wherewithal
or the desire to do the data, as you talked about, so that--we
knew that we could use the data from car crashes to implement
safety belts and airbags, but we have never had the courage to
see through the research so that we can begin a federally led
program to address gun violence.
And I just want to tell you why this is so critical. In
2020, there were 327 homicides, 1,017 nonfatal shootings in
Detroit alone, a 19- and 53-percent increase respectively. This
problem is not getting less; it is increasing.
And this obsession we have in America with guns, I can only
see it getting worse. And for mayors--I am not a mayor, but for
people in Congress who are seeing these deaths so frequently,
this has to be a priority.
So, with that, I want to yield back and say thank you so
much for everything that you and the administration are doing.
The Chair. Thank you so much.
And we are now going to move to round two, and I think we
have the time to do a 5-minute round. So thank you very much.
I want to begin by, I know several of my colleagues have
addressed the firearm injury, the mortality research. And I
just wanted to say that I was so proud that this subcommittee
held the first hearing in 20 years on gun violence prevention
research. And we began funding for the NIH and for CDC, the
ability to do this research, which can take a look at suicide,
can take a look at gun storage, and a whole variety of other
areas that could help bring relief to prevent this violence.
And I am pleased that the President's budget proposes to
double the funding to $25,000,000. My hope is that--but I just
have a very quick question here, because I want to get to a
couple of others.
And I guess, Dr. Schuchat, when do you believe that you
will have the opportunity, or CDC will have the opportunity, to
share some results?
Dr. Schuchat. Yeah, the research projects are in progress,
and, you know, I hope that within a year or 2 there will be
preliminary results from the initial investments. You know,
they are doing extraordinary work, but, as you know, research
can take time, and these are complex issues to fully
investigate.
The Chair. Right. Thank you. Thank you very, very much.
Let me ask both Dr. Walensky and Dr. Schuchat, this is
about cardiovascular disease in women. Heart disease, stroke
continues to be a leading cause of death of women in the U.S.
In 2017, nearly 300,000 women died as a result of heart
disease.
And the research shows that women often experience
different symptoms of heart attack than men, leads doctors to
misdiagnose women, results in worse treatment outcomes.
Critical for the CDC to support an education and an awareness
campaign in all 50 States and territories on heart disease so
that women can receive appropriate care.
My question is to both of you. Give us an update on CDC-
supported activities to educate women about heart disease and
cardiovascular health, and the need to create an urgency about
our looking at this issue to impact the research that needs to
get done.
Dr. Walensky. I am going to let Dr. Schuchat start with
that one. Thank you.
The Chair. Okay. Thank you.
Dr. Schuchat. Sure. Thanks so much for raising this issue.
It is so important as a leading cause of death in women and as
an underrecognized, preventable problem.
We know women are less likely to--they have atypical
symptoms. You know, I was telling colleagues the story about my
mom, you know, had neck pain playing tennis, which we thought
was arthritic, and it turned out it was angina, and, you know,
fortunately got surgery in time.
But it is very common for women to have different symptoms,
delay, to be detected later because of clinician as well as
bias and to have bad outcomes because of that. So I think there
can be benefit from education and communication efforts.
You are familiar with our Million Hearts initiative, which
is really trying to get hypertension to be well-treated, to
prevent a million heart disease and stroke events, which takes
public and clinician and institutional effort. And I think that
the communication and education call that you raised can be
done as part of that system.
We are working together with the Center for Medicare and
Medicaid Services in partnership on this, and education and
communication campaigns are part of that.
Obviously, you know the Wear Red event that I have seen
many Congresswomen be part of, that can't just be a 1-day or a
1-month thing. It needs to be year-round and sustained, because
there are a lot of preventable deaths that we could attend to.
The Chair. Uh-huh. Thank you. That is going to be one of
the issues I would like to focus on, you know, as we move
forward.
I just wanted to ask this question, and this is about the
global response to COVID. We have made significant progress
here, but the pandemic will not be over until there is a global
success.
Dr. Walensky, how is CDC working with international
partners to support the global response to COVID? How is the
agency planning to expand surveillance, prevention, and
response to pandemic threats around the globe?
Dr. Walensky. Thank you very much.
A threat anywhere is a threat everywhere, right? And so we
do, we have a responsibility to not just take care of ourselves
but around the world. CDC has collaborations in 60 countries,
150 sites, and the ability to have these collaborations that
have been longstanding have served us well.
So, for example, we have a regional office in India that is
20 years old. We have trusted colleagues there. They trust us.
For the last year, we have been training up infection control
preventionists in India, over 10,000, within these
collaborations within country. So, when it came time and India
was having challenges, we were able to mobilize those
collaborations. We were able to rapidly get oxygen canisters to
India.
Our work at CDC is really in our technical surveillance,
our technical advice, our technical and scaling-up capacity.
And it really is critical to have those trusted people on the
ground so that we are able, in times of crisis, like we also
have done in the Congo and Guinea for Ebola just this past year
as well, to be able to scale up in times of crisis. And so that
is exactly what we are doing and what we are looking for
resources to be able to continue.
The Chair. Okay.
I know my time is up, but I want to make this one comment.
I was pleased that the administration and Ambassador Tai was at
the WHO and talking about lifting the waiver on supplying
India, South Africa, other countries with the opportunity for
the benefit, in a temporary way, of the licensing, the patents,
et cetera, so that they can deal with manufacturing.
Your point earlier, it is not good enough for us to be 80,
90 percent covered and 20 to 30 percent in other countries,
because we are at risk if that is the case. So I look forward
to working with you on that effort.
Congressman Harris.
Mr. Harris. Thank you very much, Madam Chair.
And, again, thank you, Doctors, for coming before the
subcommittee.
And I would be remiss--I forgot to thank Dr. Redfield, a
fellow Marylander, for the work he did at CDC. You know, the
job sometimes--you have to take slings and arrows, no question
about it. Because, if you recall, he was highly criticized for
suggesting that the Wuhan virus came from a lab in the
Institute of Virology, castigated in the public media. And now
it seems we have come 180 degrees around where that is actually
something that we actually should look at if we are to truly
determine how this got started and where it came from.
But let me go ahead and just ask about--and just to clear
something up, by the way, the--because it was suggested that
somehow Florida had kind of a bad response to COVID, I guess. I
don't know. I think that Florida actually has among the lower
rates of infection. And despite the possible description of a
vaccine rollout as hectic, it seems that the public health goal
should be to get to a good result, and I think Governor
DeSantis did. That is just my comment. I mean--and it is
objectively backed up by objective data, which is what we
should be talking about, is objective data.
So let me just ask a brief followup on gun violence,
because, last year, in the 28 largest cities, there was a 36-
percent increase in gun violence between June and October. Very
briefly, any ideas, what could possibly have resulted in such a
huge increase in gun violence in our cities?
Dr. Walensky. Thank you, Congressman. I also--or Dr.
Harris. I also neglected in our first round to applaud you and
thank you for all of your public service in trying to get
people vaccinated. I did want to highlight that and thank you
for that.
We are actively doing research on firearm injury
prevention, as highlighted by the priorities of the National
Academy of Medicine, the who, what, when, and how of gun
violence, of firearm injury. And we will look forward to those
studies.
Mr. Harris. Okay. No, thank you very much, because I think
we have to get to the root of the increasing gun violence and
then question whether or not it is because policing activities
have decreased. Many police forces in my local jurisdiction,
for instance, have up to a third of their positions vacant
because you can't find someone who wants to be a law
enforcement officer anymore.
The other thing that I wanted to ask about is the data. As
you look at robust data collection, I would hope two things.
One is that you do it, obviously, across the various parts of
the CDC and bring it into what you suggest, Doctor, should be
the way we collect data in 2021, not on the backs of envelopes,
and develop a robust system, because it certainly is necessary.
But as part of that, I do hope that you look at what went
on with nursing home deaths in New York during the COVID
epidemic. Because I think we owe it to our seniors to
understand what appears to have been data manipulation in New
York, and I think we need to get to the end of it.
Now, I will just close out the last minute and a half and
ask you to update us on Zika, which we haven't heard about for
a while, thank goodness. Zika and--very briefly, you in passing
mentioned Ebola, but we know that it is still simmering in
Africa. What are the threats of these two diseases right now to
Americans?
Dr. Walensky. I am going to pass that to Dr. Schuchat, but
just sort of comment and say that, among the things that I
think of as critically important is the investment in SET-NET,
which is the review of mother-baby pairs, which I think helps
us evaluate not only Zika but also COVID-19.
But Dr. Schuchat?
Dr. Schuchat. Yeah. I think there are a lot of lessons from
the Zika epidemic, you know, a virus that had been recognized
many years earlier with a mild syndrome, but a lab test that
was developed because of that initial outbreak in Yap, and
then, you know, the introduction into our hemisphere and the
terrible outbreak in Brazil and then in many other countries,
including southern U.S.
That reminded us how important it is to have entomologists
in public health, a discipline that had been lost, and to have
surveillance at the local level for mosquitoes. We know there
are a lot of threats right now in mosquitoes and ticks and
other vectors that can be the carriers of new diseases to
susceptible populations.
So the result of the Zika work was strengthening that
infrastructure that we have with some centers of excellence,
the SET-NET that you just heard about that helps us track not
just Zika but other threats like opioid-related harms,
syphilis, other things that can affect mothers or babies.
And so it really gets back to the public health
infrastructure and the need for sustained focus. We get
investments, and then we lose them, and then we are surprised
when a new threat takes us without preparation.
I can tell you from meetings with the World Health
Organization, they were very concerned about loss of
researchers to be able to continue to understand Zika as it hit
newer communities that hadn't yet been through what we went
through in the Americas.
So I just think the emerging threats are out there and that
we need systems that are agnostic to pathogen or agnostic to
disease that protect all of us.
Mr. Harris. Thank you very much.
I yield back.
The Chair. Congresswoman Lee.
Ms. Lee. Thanks very much.
For Dr. Schuchat: One lesson that we learned during COVID-
19 was the need for consistent, standardized, disaggregated,
culturally appropriate data collection methods to really
determine how to address and where to address targeted
resources for medically underserved communities.
Now, this was a heavy lift. We put this in all of our
legislation. We asked CDC to collect the data, to work with
States, to give us the information as it relates to language,
and to disaggregate the database on race, ethnicity, gender,
socioeconomic status. We never really--I don't think CDC ever
took us seriously.
So I am wondering now, where are we in terms of data
collection? Because we have to know, not only for COVID, but
also for any healthcare initiatives that disproportionately
impact people of color.
And then, Dr. Walensky, let me follow up. I wanted to just
ask you, following up from Congresswoman Bonnie Watson
Coleman's question on HIV and AIDS, you know, we have an HIV/
AIDS national strategy and plan. We went around the country
seeking input from impacted communities to develop this plan.
And I am wondering if we have an update of a national HIV/
AIDS strategy/plan and if we have a point person in the White
House who is really putting all of this together and
coordinating it.
Dr. Schuchat.
Dr. Schuchat. Yeah, thank you. I really appreciate the
attention that Congress gave to race and ethnicity and
socioeconomic variables. And it was a tragedy at the beginning
of the epidemic, how behind we were.
We are not done with improvements, but this has been a very
high priority for the administration and the CDC, and we have
made it a priority for State and local public health.
They are somewhat hamstrung by what data they have access
to, and so we have been trying to take a systematic approach to
address both tracking cases, hospitalizations, deaths, as well
as vaccinations, in a way that gives us complete, actionable
information.
We have been using something called the Social
Vulnerability Index, which has really driven where we try to
get vaccine access to be improved. And that has borne results.
We have seen narrowing of the disparities of who is getting
vaccinated.
We have deployed through partners, with HRSA and FEMA, to
get federally qualified health centers out in the areas of
greatest need, to get the pop-up and the mobile clinics that
FEMA is facilitating into the areas of need.
In our pharmacy partnership, we have been reaching much
greater percentages of individuals who reside in high Social
Vulnerability Index areas. We have been looking at the ZIP Code
level, not just the county level, to get those resources out.
And I just really applaud Congress for saying this is
important, you have to do it, and us being able to have the
resources to try to follow up. But it----
Ms. Lee. Thank you. And I would like--we only have a couple
minutes left--to get a report back from CDC at some point on
the status of what we asked for in all of the legislation, as
it relates to data collection, if that is possible.
Dr. Schuchat. Yes. And we have been providing a monthly
update on the data systems, but I think a more comprehensive
one, I am sure we are happy to follow up on.
Ms. Lee. Thanks a million.
Dr. Walensky, what about--and like you mentioned earlier,
we have known each other for many, many years, as it relates to
getting a handle on how we achieve an AIDS-free generation by
2030.
So have we updated our national AIDS strategy? And are we
coordinated now with the White House in implementing one, if we
have one?
Dr. Walensky. I--well--so what I know is, I used to use
that AIDS strategy as my research bible. These are where we
needed to study, so I am very familiar with it.
I am not familiar--I don't believe we have yet updated it
in this administration. Of course, this administration for the
last 4 months has been really focused on making sure that we
can get out of COVID so that we can focus on other areas of
health.
But I do know that, in the months ahead, when COVID is no
longer what we are doing most of the time, that this is a high
priority for this administration. I will look forward to that.
Ms. Lee. Okay. Thank you.
Madam Chair, I will yield the balance of my time. And thank
you again, Madam Chair. Thank you.
The Chair. Thank you.
Congresswoman Herrera Beutler.
Ms. Herrera Beutler. Thank you, Madam Chair.
I wanted to go back to maternal mortality. I know that was
discussed a little bit earlier.
In my district, two of my counties, Skamania and Pacific
County, are considered maternity care deserts. And Lewis
County, which is near there, is classified as having low access
to maternity care. And lack of access to care stops women from
receiving care that they need, especially those struggling with
mental health and substance use, which I have seen a spike in
in those counties and in that area.
So a 2020 or 2018 report found that the rate of maternal
mortality in the U.S. could be even higher if we consider
suicide and accidental overdose. And, as you know, our rates
are not good.
I wanted to ask how the CDC is going to work to help the
State MMRCs, our maternal mortality review committees, build
their capacity to collect data on mental health and substance
use issues. Obviously, they are investigating the deaths, but I
want to make sure that we are collecting more and complete data
to better understand that piece of substance use in mental
health problems.
Dr. Walensky. Thank you for that question.
The high rates of maternal mortality in this country, to
me, are inexcusable. This is something that we have to address.
I think you commented on the MMRCs. Not only are we
interested in focusing on expanding the depth of what they do,
including mental health, but also the breadth, because they are
not covering every area, as you note. And so we are interested
in resources to do both, expand the breadth and expand the
depth in mental health as well.
I know you are aware of the Hear Her campaign, the campaign
to make sure that people know and understand and can see the
warning signs in the pregnancy period, in the peripartum
period, and the postpartum period. And those are all parts of
the efforts that we intend moving forward.
Ms. Herrera Beutler. Awesome.
I am going to switch gears to kidney transplant patients
and probably others who are in a similar, you know, solid-organ
transplant group who are immunosuppressed.
You know, most of these folks have spent the last year in
deep isolation to protect themselves from COVID, and the
immunosuppressant drugs that maintain their transplant is
making them uniquely vulnerable to severe COVID infection.
And now, as the vaccine becomes widely available, it has
been reported that patients on these immunosuppressants
obviously may not be creating the antibodies anticipated after
receiving the vaccine.
What is the CDC planning to do for these communities who
are following all the guidelines, getting vaccinated, but still
may not be protected?
Dr. Walensky. Thank you. I cared for these patients last
year, so I am deeply aware of, following these patients, their
worse COVID outcomes and now the challenges associated with how
we care for them moving forward, given the vaccine may not be
protective.
We know this is true of a lot of vaccine-preventable
diseases, both in the oncology world before transplant as well
as in the transplant world as well. And there is a whole
discipline of transplant infectious diseases for exactly this
reason.
And, in fact, what you are raising is not unique to kidney
transplant. This was studied out of Hopkins; Dr. Dorry Segev
demonstrated it is many different kinds of transplants. And it
is not just unique to transplant. They also demonstrated that
dialysis patients, even before they were transplanted, didn't
have as robust an immune response.
We continue to learn an extraordinary amount about these
vaccines, who they protect, how long it lasts, and what we can
do about it.
We have very much indicated that we will continue to need--
that those patients, in order to remain protected, will
continue to need to mask until we understand this further for
their own health.
Ms. Herrera Beutler. I think when it comes to the masking
piece--you know, one of my family members is immune-
compromised, and I also have small children. So I understand
that tension between public and the need for my younger kids to
have that access to social/emotional development, but also want
to protect, you know, one of my other kids, who, obviously, a
vaccine isn't going to do it. So I understand this.
I think the data really has to lead us. And that is a
really easy thing to say, considering I recognize there were
challenges with the last administration and politics. There are
challenges with this administration and politics. That is the
name of the game. But making sure that you, as the Director,
the CDC Director, that it is all backed up with policies based
on the data, I think is going to give us the best path forward.
No one knows all the answers on this. I don't think anybody
is expecting you to do that. But the trust, to me, is the most
important thing, is making sure I know I can trust the data and
the recommendations that are coming out and I can back those up
at home with my constituents as well. So thank you for that.
Dr. Walensky. And maybe what I will just add is, for those
who can't get vaccinated or for those who are not going to have
a robust immune response, the best protection we as a society
can give them is to have everybody else around them vaccinated.
Ms. Herrera Beutler. That is true. I had my shot.
Thank you.
The Chair. Thank you.
Congresswoman Clark.
Ms. Clark. Thank you.
And staying on children and the pandemic for a moment, we
know that kids are at a lower risk for severe infection, but my
understanding is that COVID-19 has also become one of their top
10 causes of death in this country, which is, of course, a
cause for alarm.
What do you see as the benefits of vaccinating our children
and youth? And when do you expect to have enough safety data
available to vaccinate a child of any age?
Dr. Walensky. Thank you for that question, because I do
think that some of the data and numbers are hard. You know, it
is the case that a young person may be less likely to die of
COVID-19 than an old person. But a young person is less likely
to die of anything than an old person. And so comparing these
are not always easily compared.
And when you say, like, it is one of the top 10 causes of
death among young people, that, I think, really does highlight
the importance of protecting our children.
And so, you know, of course I want to see what the clinical
trials demonstrate and what the data shows on the safety, as
they do these scaled-down trials, down from age 12 to age 9, to
age 6, to age a year. As we look at those and we see the trial
data that demonstrate they are both safe and effective, I think
there is an extraordinary role for vaccinating our children to
protect their own health, to protect their family's health, and
to protect their community's health.
Ms. Clark. Do you have any sense of a timeline, or is that
just too hard to really know at this point?
Dr. Walensky. My understanding is they are looking for a
timeline of late fall, early 2022, is the last that I have
heard. I don't know whether that will be the entire spectrum or
whether that will be, like, down to age 9 or age 6.
Some of this really--I hate to say it--it depends. You get
outcomes in these trials when people, you know, in the placebo
arm get infected. If there is less disease out there, you have
less infections in the placebo arm. So, really, it does depend
on where we are with the pandemic too.
Ms. Clark. Okay.
I also wanted to talk to you about, recently, the World
Health Organization urged that wealthy countries, like the
U.S., postpone vaccinations for children in order to donate
more doses to COVAX, the vaccine sharing initiative.
Is your agency concerned that vaccinating our children will
detract from participating in being a partner and ending the
global pandemic? And, sort of, how are you approaching this
balancing act?
Dr. Walensky. I think we have to do both.
I think we were the country with the largest number of
deaths across the world due to COVID-19. This was a ``put on
your own face mask so that you are able to help others,'' and
that is what we are working to do right now.
We are actively scaling up in our efforts not only to
provide funds to COVAX but also to provide vaccine, as I
mentioned, the 80,000,000 doses.
We at CDC are now working as those doses get donated and
implemented with countries so that we can help them in
immunization programs, help them with vaccine confidence, help
them with adverse outcome events, surveillance, and to do all
the work that we have been doing here in this country scaled up
around the world.
Ms. Clark. Great. Thank you.
And in my brief minute left, I want to go back to talking
about data collection. And we know extensive evidence showing
communities of color are disproportionately impacted.
Dr. Schuchat, I wonder if you can tell me how CDC's data
collection has changed, and how are you working to make sure
that we are collecting impact data on communities of color and
disaggregating that data?
I am sorry. There is, like, no time left, basically.
Dr. Schuchat. That is all right. This is such an important
issue. If we don't know where the problems are, we can't
address them. And so the public health data modernization
effort needs to reach every community with trust and with
skilled systems--you know, skilled people working on skilled
systems.
We have made progress this past year with increased
completeness of race/ethnicity data. We have much more timely
mortality data now. The laboratory reporting has gotten to be
quite speedy, but it is usually missing all the information we
are interested in. So some of our highest-yield focus areas now
relate to electronic health records and other data systems that
can be linked to the public health information so that we can
have complete, actionable, timely data.
So a lot of progress, but a lot more to do. And we do think
this really needs to go beyond COVID, because the next thing is
not going to be COVID. We are not done with this, but we can't
develop a beautiful, perfect, pristine system for one disease
and then have everything else fall behind.
You will recall with the EVALI lung injury problem, just a
couple thousand cases really exhausted our data capacity. Now
with many millions of cases of COVID, we have learned that we
have to scale, we have to have the systems and the workforce
that can handle them.
Ms. Clark. Thank you.
My time has expired. I just want to thank you again, Dr.
Schuchat, for your remarkable service. We are very grateful.
Thank you, Madam Chairwoman.
The Chair. Thank you.
Congressman Cline.
Mr. Cline. Thank you, Madam Chair.
I understand the need to ensure that we vaccinate as many
as possible. And, in considering that, we also want to make
sure that our children are kept safe. But I am concerned that,
in the effort to keep children safe, by going beyond
vaccinations, to continuing to keep lockdowns in place,
continuing to keep mask requirements in place--my colleague
from Washington spoke to it earlier--we are doing just as much
harm as we are potentially doing good to these children.
One thing we do need to remember is that, when we are
talking about COVID deaths, of the 500,000 deaths in the United
States involving COVID-19 as officially reported by CDC, 238
have been in children 17 and younger. That equals 0.04 percent
of all COVID-19 deaths reported in the United States.
So we do have to make sure that, as we consider protecting
our children, we also consider the effects of locking down too
much, keeping them out of harm's way in excess.
And, to that end, I would ask, do you have statistics on
the suicide rates of children over the past year and how much
that has risen?
Dr. Walensky. Thank you for that question. I don't have
them off the top of my head.
My understanding is that there have been increase in mental
health challenges with children, increase in emergency
department visits. It is not yet clear, and the research will
show in the months and years ahead, whether and how much those
are related to lockdowns or other adverse childhood events that
are associated with this pandemic, such as food insecurity and
parents losing jobs and whatnot.
One thing I do want to highlight--and I want to just make
sure you understand we are aligned--is, I very much believe
that all schools should be open in person, full-time, 5 days a
week, come the fall.
And we have put extraordinary resources and measures and
outreach to make sure that that can be the case, through
teacher vaccination through the month of March, which was able
to vaccinate over 80 percent of teachers, and through testing
initiatives in places that cannot vaccinate younger children.
We have routine screening testing in the schools--extraordinary
resources and efforts that are science-driven, so that we can
make sure that our schools are not only open full-time in the
fall but are safe to do so.
Mr. Cline. Okay.
I want to shift over to the study that you all are going to
be undertaking into gun ownership. The last study you all
undertook was in 2013, I believe.
I am concerned about some bias within your organization
regarding gun ownership. So I want to confirm right from the
start that underpinning this study will be a recognition of the
right to bear arms as a basic human right established in our
Constitution and affirmed in D.C. v. Heller.
Dr. Walensky. Congressman, I don't know the specifics of
that study. That is not one that I am familiar with. I am
certainly happy to have our staff get back in touch with you to
discuss the details.
Mr. Cline. Okay. Well, can you commit to me that that will
be an underpinning in the study that your organization
undertakes as a result?
Dr. Walensky. You know, I would like to understand and know
the study before I speak to it.
Mr. Cline. Well, you all were just appropriated funds to
study gun safety.
Dr. Schuchat. Yeah, maybe I can clarify.
In 2020, we received funds to be able to reinitiate
proposals for research on firearm safety, gun violence, et
cetera, and have the----
Mr. Cline. And when was the last one?
Dr. Schuchat. Yeah, you are right that this was suspended
since the 1990s, I believe.
Mr. Cline. 2013 was the last one that came out, I believe.
The Obama administration issued an executive order to conduct a
study regarding----
Dr. Schuchat. Yeah, that I am not--I am not familiar with
the details.
But what I can say is that we do not do advocacy. We are
funding evidence-based research. And the funds for research
that we have put out have followed the research gaps that were
identified by the National Academy of Medicine. So that is----
Mr. Cline. Okay.
Well, in my closing seconds, let me just urge you to speak
to the benefits, in addition to any risks associated with gun
ownership, that law-abiding gun ownership provides to society
as a whole by the defensive use of guns by crime victims as a
common occurrence.
Although exact numbers do remain disputed, defensive gun
usage by victims are at least as common as offensive uses by
criminals. Estimates range from about 500,000 to more than
3,000,000 per year, in the context of about 300,000 violent
crimes involving firearms back in 2008.
So there is a way to look at this issue from a balanced
perspective, and I would urge you to do so.
Thank you. I yield back.
The Chair. Thank you.
And if I may comment to my colleague, because it has been
on my watch in which we have really held the first hearing--and
please understand this--it is gun violence prevention research.
And it is about the public health crisis. And the amount of
research has been--there has been no research in the same way
that we have dealt with automobile accidents and crashes, et
cetera, and what that did in terms of helping to prevent the
loss of life.
And this is research that is--I guess it was our colleague,
Congresswoman Lawrence, who talked about a public health crisis
in this area. And that is what the research is focused on.
I will give you--and we had an entire hearing, and I am
happy to provide you with the transcript of that hearing, but
we are not looking into--or the dollars appropriated were not
looking at gun ownership. The issue is, how do we--there are
more suicides than homicides. Why do we have suicides? And
those suicides are of the highest number with our veterans. Why
is that happening? If we can store guns, as people across the
board from wherever position are, in a better, safer way, would
that cut down on gun violence?
So that is the basis of the--and we can provide, again, as
I say to you, what is in the legislation, the language of the
legislation which lays out what the scope and the mission of
the resources are for the gun violence prevention research.
And, with that, let me recognize Congresswoman Frankel.
Ms. Frankel. Thank you, Madam Chair.
Yeah, I mean, sadly, as we are speaking here today, there
is a mass shooting happening right now in California, in San
Jose.
Madam Chair, I just want you to know that I actually live
in Florida. I don't know if you knew that, but I do.
The Chair. I know.
Ms. Frankel. There have been so many questions, so, to our
guests--thank you very much--if this has been asked, just say,
okay, you missed it.
This whole issue of the vaccine passports have been a
little controversial, especially in my State where I live,
Florida. And I would just like to get your feedback on that, on
the use of requiring, you know, vaccine passport to go into
certain establishments or cruises or so forth.
Dr. Walensky. So the Federal Government has made the
decision not to use--not to be the leader in vaccine passports
but has said that local communities, the private sector may use
it for their industry if they so choose.
I can envision that there would be certain sectors where
this would be incredibly helpful. And, for example, cruise
ships I think would be one of those, where cruises would like
to be able to know the status of the people who are taking the
voyage.
What I will say is that the most important thing is that
people get vaccinated. And if there are a lot of people who are
getting vaccinated, the utility of this passport--in fact, if
everybody gets vaccinated, the utility of these passports is
nil, right?
So, really, the most important--the reason that we even
have to have a discussion about passports is because people are
not getting vaccinated. But if we can get people vaccinated,
then the importance of these passports really diminishes
entirely, or these verification mechanisms really diminish
entirely. You know--yeah. I will just stop.
Ms. Frankel. Okay. And if you could get us--maybe someone
on the staff can get us that confidence hotline number, that
would be helpful.
Dr. Walensky. I would be happy to do that.
Ms. Frankel. I am going to just switch the subject for a
moment, and I want to talk a little bit about domestic
violence. Because I know that you have a program; I think it is
called DELTA. You also manage the Rape Prevention and Education
Formula Grant. And I would like to ask you a little bit how
that is going, what kind of progress is being made.
Dr. Schuchat. You know, these are such difficult issues for
the individuals involved and those who love them. You know, CDC
has been developing technical packages, the toolkits of what we
know works, the evidence-based, and facilitating that to be
used by communities around the country.
And we have funded additional programs to, sort of, scale
up these efforts. You know, things are different in one place
or another, and sometimes, you know, whether it is rural or an
urban area, the nature of the challenges are complex.
The team working on this is incredibly dedicated and
empathetic in their carrying out the research efforts, but
mainly what we are doing is supporting programs to implement
evidence-based strategies.
Ms. Frankel. Thank you.
I will give one softball question. I know we have been
talking a lot about COVID and AIDS and other diseases and so
forth. What, in your opinion, are the top healthcare issues
that face Americans today?
Dr. Walensky. I am not even a good hitter, but I am going
to take a swing.
You know, we need to bolster our public health
infrastructure--our workforce, data, our labs.
We need to work on health equity in this country.
Everything that we do has to be founded in health equity in
this country.
We obviously need to get through this COVID-19 pandemic and
get everyone vaccinated.
And, you know, we have a lot of work to do in opioids. We
have a lot of work to do in HIV. We have a lot of work to do in
mental health. We have a lot of work to do in health losses
that we saw during this pandemic. Eleven-point-seven million
childhood vaccinations have not been given.
And so I look forward in leading this agency through this
pandemic and to address all of the public health infrastructure
of this country.
Ms. Frankel. Thank you so much, everybody. I am going back
to the beaches.
Dr. Schuchat. Wear sunscreen.
Ms. Frankel. Maybe this weekend.
The Chair. We will get into that issue as well, Lois.
I don't know that there are any other members with
questions, because if there are not, what I would want to do is
yield to Congressman Harris and recognize you for any closing
remarks you would like to make, Dr. Harris.
Mr. Harris. Yeah. Thank you very much, Madam Chair.
And, as usual, you know, some of the hearings we have in
this subcommittee are the most fascinating hearings, I think,
in all of Congress, to be honest with you.
And I want to thank again the doctors for being with us
today. I want to say that the CDC, obviously--you know, look,
the CDC plays an incredibly important role in the interface
between science and the American public to a large extent. The
American public looks to leadership in the CDC, grounded in
science.
You know, for an example, I am glad to hear that the
Federal Government is not going to get involved in vaccine
passports. Because we have to admit, there is no data that
vaccine passports would contribute anything right now. There is
just no data. Now, it might, and it might be tempting to think
it would. But it was very tempting to think the fomite
transmission was also very, very important at the beginning. It
kind of made sense. Look, I used all the hand cleaner in the
world. It turns out that is not really as important as we
thought. But there is a big difference between making someone
carry a vaccine passport and making someone clean their hands
with hand sanitizer.
And I think that this is where the difficulty lies in
public health and, kind of, treading that fine line between
what really will help people and recognizing that there are
civil liberties in this country. And that is the best way I can
explain it.
And, again, Dr. Walensky, she said, I am more than happy to
help staff vaccine clinics, and I have done it. But, in the
end, it is an individual's choice to get this vaccine, because
it is an EUA; it is not an FDA-approved vaccine. I encourage
the vast majority of people I speak to to get it, but, in the
end, it is their decision.
And I think the CDC has taken a tremendous step in their
mask mandate removal or mask guidance removal for people with
vaccines. Because I think that that engenders a lot of
confidence in Americans. Finally, a lot of Americans I meet
would say, ``Wow, yeah, my common sense is, I got in line, I
got the vaccine, now I should be able to take my mask off,''
and now our policies are aligned on that.
And I think that sent a very important signal. I think that
is why we are approaching the 70-percent mark in adults being
vaccinated. And, of course, you know, that combined with the
natural immunity, we should be pretty near herd immunity, and I
think that is what the figures are beginning to show now.
So thank you all for the work you do. It is thankless work.
As has been pointed out in your testimony, public health
officials are underpaid relative to their skill and training.
This leads to some problems, there is no question about it.
There is no easy solution. But hopefully some of the budget
things you discuss for the fiscal year 2022 budget will get us
on a better path into getting the public health workforce that
we need for the 21st century.
And, again, Madam Chair, thank you again for a fascinating
hearing, and I yield back.
The Chair. I want to thank Dr. Harris for his comments.
And, I mean, I think I agree, and I--not in a self-serving
way, but I think that this subcommittee has the best hearings.
And I think, between yesterday and today, there really is--I
used the word yesterday ``exhilarating.'' I mean, what we
learn, you know, and what both the NIH and the CDC can do to
save lives, to keep people healthy in this country is quite
remarkable. And I think it is a hallmark of the United States,
in terms of our healthcare system.
I am going to just--and I am going to ask both Dr. Walensky
and Dr. Schuchat to be absolutely, singularly, like, in a
nanosecond: What keeps you up at night?
Dr. Walensky. Variants and the concern that people won't
get vaccinated and the fact that we are not serving everybody
in the country equally.
The Chair. Yeah. Okay.
Dr. Schuchat.
Dr. Schuchat. I think we have to remember the rest of the
world, and that while it is getting better here, there are many
places at risk. So, until we are all out of this, none of us
are out of this.
The Chair. Uh-huh.
Thank you. Thank you very, very much. Really, I think we
covered some very important topics today.
And I just wanted to say this: You know, historically, the
CDC has been the trusted voice in leading the response to
public health crises. And I will say this--and, look, whether
it was Ebola, Zika, lead poisoning, and so many others. But I
think we saw a recent departure from that standard.
So I want to just say a thank you, a real thank you, to
both of you and CDC for returning the CDC to be that trusted
voice and relying on the science and the data that is necessary
to create the confidence in this country that we do have the
agency that they can take a lead from. People want to know the
truth, they need to be given the truth, and then we could look
to how we can direct them.
I would again add that COVID exposed a number of realities
in this country. We need a robust public health infrastructure.
We can't go back to where we were, and we have to go forward.
So we look forward to receiving the comprehensive
President's budget. That is later this week. And then the
subcommittee has the challenging task of addressing so many
critical issues included in your bill.
And it is remarkable, the range of issues that you look at.
We talked about some of them today--you know, maternal
mortality. But you do food safety, you do so many other things,
you know. And it is immunization and mental health and opioids
and HIV, and doing all of that work at the same time of dealing
with a pandemic.
So we want to provide the resources that you need, and we
will continue to fight for that sustainability that I think has
come through as the thread of this hearing today. And that, for
the CDC to do the job that we want them to do, you need to have
the continued resources, not for just this pandemic, but for
whatever else comes to pass for this country.
So thank you.
And, with that, this hearing is adjourned.
Wednesday, November 17, 2021.
U.S. ROLE IN GLOBAL COVID-19 VACCINE EQUITY
WITNESSES
GARY DISBROW, DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
DAVID A. KESSLER, CHIEF SCIENCE OFFICER, COVID-19 RESPONSE
LOYCE PACE, DIRECTOR, OFFICE OF GLOBAL AFFAIRS, DEPARTMENT OF HEALTH
AND HUMAN SERVICES
The Chair. This hearing will come to order.
As this hearing is fully virtual, we must address a few
housekeeping matters. For today's meeting, the chair or staff
designated by the chair may mute participants' microphones when
they are not under recognition for the purposes of eliminating
inadvertent background noise.
Members are responsible for muting and unmuting themselves.
If I notice that you have not unmuted yourself, I will ask you
if you would like the staff to unmute you. If you indicate
approval by nodding, staff will unmute your microphone.
I remind all members and witnesses that the 5-minute clock
still applies.
If there is a technology issue, we will move to the next
member until the issue is resolved, and you will retain the
balance of your time.
You will notice a clock on your screen. That will show how
much time is remaining. At 1 minute remaining, the clock will
turn to yellow. At 30 seconds remaining, I will gently tap the
gavel to remind members that their time has almost expired.
When your time has expired, the clock will turn red, and I will
begin to recognize the next member.
In terms of the speaking order, we will be going with the
chair and ranking member; then members present at the time the
hearing is called to order will be recognized in order of
seniority; and, finally, members not present at the time the
hearing is called to order.
Finally, House rules require me to remind you that we have
set up an email address to which members can send anything they
wish to submit in writing at any one of our hearings or
markups. That email address has been provided in advance to
your staff.
And, with that, I want to acknowledge Ranking Member Cole
and all of our colleagues for joining this morning.
And a thank you to our witnesses--Dr. Kessler, Dr. Pace,
Dr. Disbrow--for speaking with us on our Nation's role in
global COVID-19 vaccine equity.
Let me just start by saying that I am disturbed. I am
disturbed by the general lack of urgency in ensuring that every
person across the world has access to the COVID-19 vaccine.
This pandemic has already sickened 250 million people and
claimed more than 5 million lives across the globe. People are
dying every day, and, yet, little progress has been made to
deliver more vaccines to the countries that are being left
behind.
Even as many of us in the United States are receiving
booster shots, fewer than 5 percent of people in low-income
countries have received a single dose. By some estimates, many
people in low-income nations will not have access to a
vaccination until 2023 without significant increases in
worldwide vaccine production and distribution.
I do sincerely appreciate the work that the Biden
administration has done. After all, this administration has
been delivering vaccine doses abroad since June. And, so far,
United States has donated more vaccines than all other
countries combined.
It is also encouraging that President Biden has pledged to
donate at least 1.1 billion doses of vaccine by the end of next
year while calling for 70 percent vaccination in all countries
by fall 2022.
I am particularly proud of the work that my friend, Dr.
David Kessler, who joins us here today, has done both during
this pandemic and for many years as former Commissioner of the
Food and Drug Administration and under the leadership of three
American Presidents. I welcome his testimony, and I applaud his
commitment to the health and the safety of the people.
I just might add here that I was pleased, Dr. Kessler, to
hear the administration's announcement today of a new
initiative to invest in domestic vaccine production to increase
vaccine by 1 billion doses per year. That is the kind of effort
we are looking for, but also wanting to hear is how we are
going to accomplish that and how we are going to oversee that
distribution as well.
I also want to note the important role that BARDA has
played during this pandemic, working extensively to scale up
production of everything from PPE and at-home tests to vaccine
and therapeutic treatments. I am also grateful that BARDA has
used funds provided by Congress to work with COVID vaccine
manufacturers, such as Moderna, and that it was BARDA's many
years--BARDA's many years of support for mRNA, the platform
technology, along with decades of basic research at the NIH
that enabled Moderna to produce the COVID-19 vaccine.
And I want to commend the efforts of Dr. Pace, whose Office
of Global Health will be instrumental, along with USAID and
CDC, in addressing vaccine equity efforts on the ground.
But, on the other hand, it is shocking to me that we have
not received full and unfettered cooperation from all of our
partners in this effort, including the private companies, such
as Moderna, making billions of dollars from U.S. taxpayers.
The fact of the matter is every day low-income countries
remain vulnerable to COVID-19 is another day for the virus to
mutate and to adapt. And, if we fail to ensure their access to
vaccines, those countries will become the breeding grounds for
new variants, variants that may be more transmissible or, even
worse, vaccine resistant.
I will be blunt. I do not believe we are moving fast
enough. Unless we take a more active role in significantly
increasing vaccine production and accelerating distribution
worldwide, sharing technology and expertise, and scaling up
health system capacity, and strengthening multilateral
institutions, we are essentially shooting ourselves in the
foot, putting ourselves collectively at the risk of a fifth,
sixth, or seventh wave.
We absolutely need to accelerate the production of COVID
vaccine by any means necessary, including by invoking any legal
authorities at our disposal to compel these vaccine companies
to work with partners in the U.S. and throughout the world.
Quite frankly, it is not just our moral imperative to ensure
the health and safety of our friends across the globe; it is in
our own self-interest.
While the United States, as I noted earlier, has donated
more vaccines than all other countries combined and has become
a powerful leader in the fight to vaccinate the world, why is
it taking so long to manufacture the vaccine? Why are we as a
Nation being held captive by a botched Trump administration
contract, one that allowed Moderna to ignore the involvement of
the NIH and benefit from millions of dollars in taxpayer funds?
Just this week, it was announced that Moderna is close to
making an agreement to pledge doses to low- and middle-income
countries in 2022. This is a positive step forward, but not
enough. For the life of me, I cannot understand why we are
beholden to this company. People are dying. Time is of the
essence. And, in the midst of it all, Moderna is making
billions of dollars, controlling vaccine production and
negotiations of a lifesaving vaccine that HHS helped them to
create.
This is unacceptable. NIH and BARDA must be aggressive in
protecting and asserting legal rights to their work. This
administration must be aggressive in pursuing every option to
work around that botched contract and to use every tool at its
disposal to accelerate vaccine production, including the
Defense Production Act. And President Biden must be aggressive
in compelling other countries to back the TRIPS waiver, which
would allow more countries to manufacture more COVID-19
vaccines.
When the World Trade Organization meets later this month
for its 12th ministerial conference, I will be watching closely
to ensure the proposal on temporarily waiving some intellectual
property rights rules under the TRIPS agreement is accepted.
I know these are serious and they are complex issues that
cannot be easily resolved, but I also know that failure is
simply not an option. This pandemic will not be over until it
is over around the world.
I hope that, through this hearing, we can gain some clarity
as to why we are not moving fast enough, why we are enabling a
system that allows pharmaceutical companies like Moderna to
profit off of global suffering and how exactly we plan to
vaccinate 8 billion people as soon as humanly possible.
With that, let me turn to my good friend from Oklahoma, the
ranking member of the committee, Congressman Tom Cole, for any
opening remarks that he may have.
Mr. Cole. Thank you very much, Madam Chairman.
And, just before my remarks, a quick housekeeping piece of
advice to you as you preside over. I may have to leave at some
point because of my duties in Rules, so I might not be here at
the end, but I certainly am going to stay for as much as
possible.
Madam Chair, the United States' investments in biomedical
research and medical countermeasures have paved the way for the
fastest vaccine ever developed in our Nation's history. These
strategic investments led by--with Federal support have also
enabled the U.S. to lead the world in vaccine availability. As
the President has said, anyone who wants a shot can get one.
That is a remarkable achievement, and we are fortunate to be in
such a position.
I want to thank the thousands of government and private-
sector employees who worked tirelessly to make this reality.
Operation Warp Speed, in my mind, remains one of the most
undervalued achievements of the last administration.
And I want to associate myself, Madam Chair, with your
remarks about the role our country is playing in trying to help
other less fortunately situated countries and to get the
vaccine as rapidly as possible. I think those are important
goals and important questions need to be raised and answered.
And I know we are here today to discuss the United States--
what the United States Government can do to bolster global
supply of coronavirus vaccines. But, before we delve into that
topic, I want to spend a few minutes on a fact that I find
deeply troubling.
The Build Back Better legislation introduced in the House
contains just $3,000,000,000 for pandemic preparedness. That is
less than 0.2 percent of the total. Let's pause and think about
that. Nearly $2,000,000,000,000 in spending, and just 1.7
percent--that is just less than one-fifth of a percent--is
dedicated to preparing for the next pandemic.
Of that amount, less than half is dedicated to funding for
public health and preparedness research, development, and
countermeasures capacity. Such a de minimis amount dedicated to
so critical a function should be unacceptable to everyone.
I have said multiple times that you are far more likely to
die from a pandemic than a terrorist attack, and, sadly, the
results of the last 2 years have shown how devastatingly true
that is. I would hope the majority's flagship effort to build a
better tomorrow after a global pandemic that has shook the
world would recognize the need to invest in a substantial way
in biomedical and biodefense research enterprise.
I find this omission another sign of shortsightedness that
we see throughout the legislation with short-term extensions
and unreasonable policies that most Americans do not support.
I also want to acknowledge, however, that the chair's
markup contains six times as much funding compared to the Build
Back Better bill, and that is with nearly seven times less
money.
Now, while I still believe we need to invest more in
biodefense infrastructure, I am pleased to see the levels
proposed in the chair's fiscal year 2022 appropriations for
this subcommittee. I know our chair strongly supports access to
childcare, improving our Nation's schools, and paving a way to
affordable higher education for all children.
She also recognizes, in addition to human infrastructure
investments, that we cannot neglect the biomedical and
biodefense infrastructure. She supported these programs in her
markup, and I hope she sustains that level of support going
forward.
We have always found these areas of agreement to serve as
the basis for our partnership for 6 years running. I also want
to recognize that, in her annual funding bill, she is proposing
nearly the same amount of funding as what was put forward in
the Build Back Better bill, which covers up to 10 years.
I think this fact shows this subcommittee, possibly more
than any other, understands how important these programs are.
Underinvestment here ensures the Nation will be less prepared
for the next outbreak.
I led with the importance of the continuing investment in
biomedical research and programs like BARDA because it was past
funding that enabled the United States to be in the--be the
current leader by far in global COVID vaccination donations.
U.S. has donated and delivered more than 235 million doses of
COVID vaccines to more than a hundred countries, and I am
pleased at the even more aggressive plans that the
administration has unveiled in recent days.
In addition to efforts by the Federal Government, vaccine
manufacturers have also made commitments to increase production
and availability to ensure vaccination becomes a global
reality. As proud as I am of our Nation leading the way, United
States should not have the sole responsibility for vaccinating
the global population. It is a shared problem and a shared
responsibility.
In addition, in my opinion, the Department of Health and
Human Services should not be responsible for vaccinations
abroad. I understand the agency may have a supporting role to
the Department of State and USAID, but events over the last 18
months have shown that we have enough challenges domestically
for HHS to focus on, and it should not try to achieve
objectives beyond its responsibility and capability.
I would like to end by noting that now is the time for us
to be looking at opportunities for the next generation of
vaccine technology, development of new therapeutics, and more
affordable diagnostics. I know some of those efforts are
underway, but too much focus has been given to the continuing
of the status quo.
If we continue that approach, we will not achieve global
vaccination for years to come. We need to look to new
technologies to achieve our goal and should not be neglecting
those investments now.
I also think we need to expand our focus to future threats.
Now is the best time to leverage what we have learned about
COVID to begin research into new countermeasures and potential
pathogens. We know the devastation that can be caused by a new
virus.
We need to do a better job to identify future threats on
the horizon and work on mitigation now. Waiting for the next
virus to strike and hoping it is far into the future is
foolish. The more we shortchange our preparedness today, the
less prepared we are when what may be--just for what may be
just around the corner.
I want to thank our witnesses for their time today, and I
look forward very much to their testimony.
With that, Madam Chair, I yield back my time.
The Chair. Thank you very, very much.
And now what I would like to do is to turn to our
witnesses: Dr. David Kessler, who is the chief science officer
of COVID-19--the COVID-19 response; Ms. Loyce Pace, director,
Office of Global Affairs, the Department of Health and Human
Services; Dr. Gary Disbrow, director, Biomedical Advanced
Research and Development Authority, BARDA, the Department of
Health and Human Services.
Our first witness is Dr. David Kessler. Your full written
testimony will be included in the record, Dr. Kessler.
You are now recognized for 5 minutes for your opening
statement, and welcome, welcome to the committee.
Dr. Kessler. Thank you so much, Chair DeLauro.
Chair DeLauro, Ranking Member Cole, distinguished members
of the committee, I am David Kessler. I am honored to be
serving as chief science officer for the COVID-19 response.
Thank you for having me here today and for the opportunity to
testify before you.
I have the great privilege of working closely with my
colleagues from the Department of Health and Human Services--
Director Pace, Dr. Disbrow--who are also appearing before you
today.
The United States, by far, is leading the effort to
vaccinate the world. We have proudly donated more doses than
all other countries combined. We will continue and must
continue to donate more and more doses.
Currently, we are donating 1.2 billion doses to the world.
This includes the U.S. Government's groundbreaking deal to
deliver 1 billion donated doses of Pfizer vaccine to countries
in need through COVAX. As of today, 250 million donated doses
have been shipped to 108 countries. For every one shot we have
put in the arm of an American, we are donating about three
shots globally.
Because of what you have allowed--because of what you have
allowed HHS and USAID to do, we are spending over
$11,000,000,000 on global vaccine supply. And we continue to
encourage our international partners to share more doses and
expedite the delivery of those already committed.
Today, we are announcing that, to meet short- and long-term
needs both domestically and globally, the United States
Government is seeking to enter into a historic partnership with
one or more experienced pharmaceutical manufacturers to
increase the mRNA vaccine U.S.-based production capacity for
domestic and global use by at least 1 billion doses annually,
not later than the second half of 2022. This will allow us to
address the current COVID-19 pandemic and prepare for future
pandemic response efforts.
I want to be clear that I personally continue to engage
vaccine manufacturers to increase production and availability
of vaccines for low- and low-middle-income countries. Chair
DeLauro, we share--we share your urgency and the passion to
make sure that we are a leader--the leader in making available
vaccines for low- and low-middle-income countries.
As part of those conversations, we negotiated a deal with
Moderna and the African Union where the United States defers
deliveries of 33 million doses, allowing the AU to buy up to
110 million Moderna vaccines at a reduced rate negotiated by
the United States.
We also broke through a logjam and brokered a deal between
Moderna and COVAX enabling the two parties to reach an
agreement where COVAX will purchase, to date, 56 million doses
of Moderna vaccine.
Moderna is also retroactively discounting doses already
sold to COVAX, all because of the United States Government's
intervention. We have told Moderna that we expect them to help
fill the remaining COVAX shortfall. We expect that the number
of doses that Moderna will make available to COVAX will
increase in the next few weeks.
Let me tell you about another step that we took that I
think is a first. The United States Government brokered a
historic deal with J&J and COVAX to facilitate the first-ever
delivery of COVID-19 vaccines to people in conflict zones and
other humanitarian settings that cannot be reached by
government vaccination campaigns.
The USG and COVAX worked with J&J to waive liability for
doses, pioneering a novel legal approach that will allow COVAX
to give donated doses to NGOs to administer to people in these
conflict zones and other humanitarian settings.
The U.S. also negotiated a path-breaking deal to make
300,000 doses of J&J available to humanitarian workers around
the world.
As the Biden administration continues this critical work,
we also need the world to do more. We need every other country
to step up against this virus like the United States is doing.
Thank you very much, Chair DeLauro. I am happy to answer
your questions.
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The Chair. Thank you for your testimony, Dr. Kessler.
And our next witness is Dr. Loyce Pace.
Your full written testimony will be included in the record,
and you are now recognized for 5 minutes for an opening
statement.
Ms. Pace. Well, good morning, distinguished members of the
subcommittee.
We see the numbers. COVID has caused more than 5 million
deaths worldwide, more than half of these in low- and middle-
income countries. Vaccination rates in some of these countries
are in the single digits. Less than 10 percent of the
population of Africa is vaccinated compared to more than 50
percent in North America and Europe. We know this is
unacceptable.
So I want to thank you, Chairwoman DeLauro, Ranking Member
Cole, and your esteemed colleagues for convening us today to
talk about global vaccine equity and the role our government
should play in driving that.
Now, two things I want to say upfront. One, this isn't only
up to us. It is going to take actors from all over the world--
government officials, industry leaders, community
organizations, philanthropists, and others--to make this
happen. This is why the President convened those very
stakeholders this fall and called on them to fulfill their
promises and help close the global access gap. He issued this
challenge not only for vaccines, but also for treatments,
tests, and critical supplies.
Number two, the U.S. is doing its part, playing a lead role
and practicing what we preach. At this point, we have donated
close to 250 million vaccines to more than 100 countries around
the world, both directly and through partners like COVAX,
CARICOM, and the African Union. That is millions of people
protected from this virus, thanks to our commitments and
action.
We have engaged governments and companies in Asia and
Africa to expand manufacturing in those regions, and also
called for voluntary technology transfer to facilitate those
efforts.
Of course, the world needs more, which is why our work
continues. We are not letting up. Those of us in the center of
this work know what is at stake if we don't follow through. Not
only could we face the constant threat of COVID, but we could
continue to burden our health workforce, supply chains, and
overall society with an ongoing and seemingly neverending
pandemic.
Not only are our efforts practical; they are personal. We
read the same headlines you do, and we hear those accounts
ourselves every day. Many of us have lived and worked in
countries still lacking what they need. Some of us have friends
and family there, managing an unsettling reality and all-too-
common stories of persistent health disparities.
HHS staff take calls from colleagues around the world,
partners with whom we have worked for years, describing what
life is like without access to vaccines. Those are tough
conversations, recognizing how great the demand is worldwide.
But they are easier when we can offer help, and we do.
Our staff meet with ministries of health about their
national vaccination campaigns and how to maximize the supply
they receive. We have engaged foreign regulators and
researchers so that more product comes to market when and where
it is needed. And we have worked with policymakers from Africa
to Asia to Latin America and the Caribbean on real-time
responses throughout this crisis, helping to establish or
reinforce health surveillance systems and essential services
required to succeed.
So, when Kenya or Mexico needed vaccines, they reached out
to us. And, when Brazil or India found themselves in crisis, it
was the same. Whether working through country-based health
attaches, our hundreds of international staff focused on global
health security, or contacting the Secretary directly,
governments around the world look to HHS for solutions to their
public health problem. That has been as true in this pandemic
as any other time.
Our track record speaks for itself, built on decades of
international relationships and programs that have been tested
through multiple health crises, like Ebola, Zika, and HIV. We
know how to get this right, and we can do this together. It is
in the spirit of partnership that is critical to showing up in
the world in a way that matters.
From day one, the President has talked about the importance
of international cooperation as part of our COVID response.
Similarly, his administration is committed to using equity as
the guiding principle for these efforts, but, while ensuring we
address health disparities across borders, we must also do so
within countries.
We know from our own American experience how vital it is
that lifesaving innovations are available to those who need
them. Otherwise, we are all at risk. I want to be able to tell
a different story, one that has countries not in the tenth
percentile but meeting our global goal of 70 percent coverage
for COVID vaccine; a world focused on getting back to life
rather than fearing another variant or worse.
I want us all to feel safe again and to remember this time
as a moment when we did right by one another. We have both a
strategic imperative and a moral one to deliver what we can
where we can, working to end this pandemic once and for all.
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The Chair. Thank you. Thank you very much.
Our next witness is Dr. Gary Disbrow. Your full written
testimony will be included in the record.
You are now recognized for 5 minutes for your opening
statement. Thank you.
Mr. Disbrow. Chairwoman DeLauro, Ranking Member Cole, and
distinguished members of the committee, thank you for your--the
opportunity to testify today on our efforts to develop,
manufacture, and procure safe and effective COVID-19 vaccine.
I am grateful for the opportunity to address this committee
and appreciate your continued support for the ongoing response
efforts. I want to start by thanking this committee for the
funding and support provided to BARDA over the years and during
this pandemic, and the entire BARDA team for their tireless
efforts for the last 21 months to develop critical medical
countermeasures, or MCMs, to develop--address COVID-19.
BARDA continues to play a critical role in the development
of vaccines, therapeutics, diagnostics, and other supportive
efforts to bring forth these lifesaving medical
countermeasures. BARDA has invested over $49,000,000,000 to
develop and procure products to address COVID-19,
$33,000,000,000 in vaccines, $16,000,000,000 in therapeutics,
and over $500,000,000 in diagnostics.
To date, BARDA had supported the delivery of over 556
million doses of vaccine, and over 443 million doses have been
administered; the delivery of over 3.3 million treatment
courses of therapeutics; and over 168 million diagnostic tests.
BARDA has been proactive in engaging with our stakeholder
communities since the very beginning of the pandemic, to
include holding an industry call in January of 2020 with over
1,500 participants. In that same month, BARDA established an
MCM portal to act as a single point of entry for parties
interested in working with the U.S. Government.
To date, BARDA has received over 4,500 submissions to the
portal, and interagency representatives have met with over 670
companies, providing transparent feedback and guidance. BARDA
made initial investment to jump-start the development of MCMs
utilizing annual appropriations under advanced research and
development and pandemic influenza funding.
We received--we have reviewed our portfolio of partnerships
and identified proven technologies that could quickly pivot to
develop COVID-19 products. These initial investments and
additional investments made once supplemental funds were
provided laid the groundwork for the portfolio of products
supported under Operation Warp Speed and now the Countermeasure
Acceleration Group, or the CAG. The CAG has been able to
support development of one licensed vaccine, two vaccines
granted emergency use authorization, two vaccines that have
positive phase 3 efficacy readouts, and one vaccine that is
completing a phase 3 efficacy trial.
Vaccines are now available for primary series, booster
doses, third doses for immunocompromised individuals,
adolescents, pediatrics 5 to less than 12 years of age, and
studies are ongoing for pediatrics ages 6 months to less than 5
years of age.
Development was accomplished in 11 months, providing safe
and effective vaccine, and represents the best of what the U.S.
Government and industry can do when we work together. Moving
forward, these unprecedented collaborations will be critical to
better prepare the U.S. and the globe for future pandemic
threats.
BARDA supported the collaboration between Johnson & Johnson
and Merck to enhance production capacity announced by the
President. BARDA provided funding to Merck to modify one of
their manufacturing facilities, a fill/finish facility, and a
storage facility to expand domestic production of the J&J
vaccine for their international effort.
In addition to the direct support for development of
vaccine candidates, BARDA has worked with the International
Development Finance Corporation, providing technical expertise
for their global investments to expand manufacturing capacity
for vaccines.
BARDA initiated efforts to expand domestic manufacturing
capacity for the critical components that are necessary to
support population-scale manufacturing of vaccines.
BARDA has been provided $2,600,000,000 under the American
Rescue Plan Defense Production Act to expand capacity for raw
materials, consumables, fill/finish capacity, needles and
syringes and vials. Expanding production of these vaccine
components is critical to support expanded domestic and global
vaccine production.
As David mentioned, the administration is committed to
donating over 1.2 million doses of vaccine. Under HHS CAG
efforts, over 133 million doses have been already donated, and
an additional 500 million doses are being donated under the
USAID-JPEO contract. BARDA and JPEO are in discussions for an
additional 500 million doses of Pfizer vaccine to be purchased
in a not-for-profit price for donation.
As David mentioned, we recently modified our contract with
Moderna to support Moderna's commitment to making vaccine
available to the African Union at a not-for-profit price.
Thank you again for inviting me to testify before you on
efforts within ASPR and BARDA to support the COVID-19 response.
I look forward to answering your questions and working with my
team at BARDA and our colleagues across HHS and DOD to end this
COVID-19 pandemic.
Thank you.
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The Chair. Thank you all very, very much for your
testimony.
We now will move to questions, and I will start with the
questions, and I would just--and the questions--these are a
question, Dr. Kessler, and a couple of followups, but all of
which I will mention at what time and--at one time in the
interest of time.
I will be frank, and you know that I am. We have dealt with
each other before. The irresponsible, monopolistic behavior of
Moderna is infuriating. Moderna has made billions in profits
through an arrangement gifted to the company by the prior
administration, by the Trump administration, and the company's
refusal to recognize NIH's role in the development of the
vaccine.
Further, Moderna has refused to cooperate, lend its
expertise to partners that could increase production of its
vaccine by hundreds of millions of doses. That is unacceptable.
So my questions are: Why is Moderna able to limit
production of a vaccine that U.S. taxpayers spent billions of
dollars to develop and manufacture?
What is the administration doing to compel the company to
increase production as well as distribute the vaccine at a
reduced cost to low-income countries?
How is the administration going to guarantee that Moderna
meets all of its commitments?
Should NIH scientists who were involved in developing
Moderna's vaccine be listed on the principal patent application
as coinventors, and should NIH receive coownership interest in
the vaccine?
Dr. Kessler. Chair DeLauro, the government's position is
that mRNA-1273, the Moderna vaccine, was coinvented by
government and Moderna scientists. However, Moderna has so far
refused to name the government scientists to the principal
patent application. Omitting NIH inventors from the principal
patent application deprives NIH of coownership interest in that
application and the patent that will eventually issue from it.
With regard to your questions about what we have asked
Moderna to do and what we expect, we have gone to the extent of
actually calling in and discussed this with the chair of the
board of Moderna, members of the board, as well as the senior
management of Moderna. Very explicitly, we have asked Moderna
to do four things.
One, we have asked them, in the short term, now--not wait
quarters from now--but to provide the African Union with doses.
To their credit, they have stepped up. And, with our colleagues
in the African Union and through the fact that the United
States basically deferred our doses so the doses could go to
the African Union, that is happening.
Number two, we have told Moderna that we expect them to
help fill the supply gap with COVAX at not-for-profit prices
with significant doses. We will hear, I expect, over the next
several weeks the result of those discussions that are
currently underway between Novavax and Moderna.
Number three, we have commitment from Moderna to build a
plant--to build manufacturing capacity on the African
Continent. That is very important to us.
Chair DeLauro, you know I chair the Elizabeth Glaser
Pediatric AIDS Foundation. We have been with you for 30 years.
We have worked on the continent in HIV, and I understand, if
there is a manufacturing capacity on that continent, that
continent will not be last in line. It is just that simple. We
have Moderna's commitment. We will see what their followup is.
Lastly, as we testified this morning, we have asked all
manufacturers with experience in mRNA to help us expand that
capacity for both global and U.S. needs, for both pandemic and
for COVID, and we would like Moderna's assistance in there.
A lot to be done. We are watching closely. The President is
watching closely. These needs are absolutely essential.
The Chair. Thank you.
And I have just a short period of time remaining, but I
need to ask the question: The NIH scientists, as you offered at
the outset, that there was a coinvention. Are we going to have
them labeled and listed as principal patent application as the
coinventors, and thereby getting coownership interest in the
vaccine, which, as you know, opens the door to the U.S. being
able to deal with some of these issues?
So just--I really want to know. If I can very, very
quickly, what is our guarantee that that is going to happen?
Dr. Kessler. That is the United States Government's
position, Madam Chair.
The Chair. Okay. I will get back. Just--and I want to be
able to guarantee. And you said that we have a way in which we
can talk about further of guaranteeing that Moderna meets all
of the commitments that it has made, so thank you.
Thank you, and let me now yield to Ranking Member Cole.
Mr. Cole. Thank you very much, Madam Chair.
Dr. Kessler, I just actually had some questions that are
informational to help me and hopefully the committee get a
better idea of the task in front of us.
How much funding remains for the purchase of additional
doses for the U.S. population, either booster shots for adults
or for children?
Dr. Kessler. Ranking Member Cole, just how much money
remains?
Mr. Cole. Yeah.
Dr. Kessler. Can I just ask you to repeat your question?
Mr. Cole. Yeah. I am just curious what we may need to do
going forward, how quickly we need to do it?
Dr. Kessler. So we have assured adequate supply for
boosters for all Americans, and that is also true for
adolescents and children. Obviously, you know, the question
beyond that, you know, variants, I always try to stay one step
ahead of where we are. But the good news is we really, through
your help, right--I mean, this is--this should not be
understated. Okay? We could not have done what we have done in
providing primary vaccines, boosters, adolescents, now school-
age children, without this committee's help----
Mr. Cole [continuing]. You are kind for saying that.
Dr. Kessler. That was essential, and we have done that.
Mr. Cole. Well, you are kind to say that. I share your
opinion. This committee, I think, has done an exceptional job
under our chairman in this regard.
How about--let me ask--switch now. How much funding remains
for the purchase of international vaccines, which I know you
are really focused on? And, again, what do we need to look at
going forward there to fulfill the commitments that our country
has made?
Dr. Kessler. Let me, if I may, Ranking Member Cole, let
Director Pace answer that question.
Mr. Cole. Of course.
Ms. Pace. Well, thanks for this question.
It is our understanding that we have the funding available
to fulfill the President's commitment of the additional 500
million Pfizer vaccines. Beyond that, additional funds through
the American Rescue Plan are being utilized towards vaccine
readiness and ensuring those shots get into arms once they are
delivered.
Mr. Cole. Terrific. This may be more appropriate to you,
Dr. Pace. I will let you guys decide who is the best person to
answer the question. I trust your judgment.
I am curious, of what we have committed, how much has been
distributed? And I know there is a lot of logistical problems
involved in a distribution effort like this. So, if you would
address that a little bit, too, because I know it is going to
impact the speed with which you can get what you have out the
door literally.
Ms. Pace. Of course. I can try and address some of this,
and then defer to my colleagues. And so, with this initial
tranche of 500 million Pfizer doses that is being--that has
been procured and being distributed by our partners at USAID,
we have 100 million that has gone out. There will be some--an
additional 100 million, we hope, by the end of this year, and
then tracking towards finishing that tranche in the first
quarter of next year, followed by the additional 500 million
that the President committed at the summit back in September.
And I defer to my colleagues for anything I might have
missed in that regard, Congressman.
Mr. Cole. Do either of you have additional information you
would like to provide?
Mr. Disbrow. Yeah. Ranking Member Cole, this is Gary
Disbrow from BARDA.
So, in addition to the USAID doses that Director Pace
mentioned, for vaccine that was purchased by HHS for domestic
use, as vaccine supply exceeded the demand, we have also
donated over 133 million doses to over 95 countries.
Mr. Cole. Well, I will say--I don't have a lot of time, but
I just want to thank all of you for your efforts in this
regard, and I would just ask you to keep the committee abreast.
I really do worry. We are juggling a lot of balls right now on
Capitol Hill. And, looking forward in funding, this is a stream
where I don't think anything should ever be at risk either in
terms of obviously taking care of our people here, but also
fulfilling these very important international commitments. We
want to make sure that you have the resources that you need in
a timely fashion, particularly given some of the logistical
problems I think are involved in, you know, dealing literally
with a global project and conditions that very, very broadly in
many places are very, very difficult.
So, with that, Madam Chair, thank you very much, and I
yield back.
The Chair. Thank you.
And Congresswoman Lee.
Ms. Lee. Thank you very much, Madam Chairman. Thank you,
Chairwoman. Thank you so much for this hearing, and to our
ranking member, and to all of our witnesses.
I think everyone agrees it is imperative that the United
States lead this fight because we won't be able to end this
pandemic and Americans will continue to be under threat unless
we find a way to assist every country in the world to vaccinate
their people.
And I wanted to focus on the equity issues today. And I
guess, Dr. Kessler, you mentioned, if there is capacity on
the--manufacturing capacity on the continent of Africa, that
certainly would be welcome and supported.
But I think--and I guess maybe Dr. Disbrow, you may be able
to answer this, in terms of the United States providing the
support for the manufacturing of pharmaceuticals on the
continent of Africa. I mean, we know that it is going to be--it
is a challenge, and so how do we increase vaccine manufacturing
on the continent of Africa using United States' leveraging and
with the private companies, with the pharmaceuticals? I mean,
what could be a plan, or do we have a plan? That is the first
question.
And then, to Director Pace, let me just ask you: Less with
regard to CARICOM countries and the continent of Africa, last
time I looked, it was pretty dismal in terms of the Caribbean,
in terms of the numbers of vaccine, the percentages that had
been distributed on the continent of Africa and in the
Caribbean. And so I would like to find out--and this was about
a month ago when I looked at those numbers. It was horrible.
And so what is the problem? What is the bottleneck, and are
we getting any better with countries where there are, quite
frankly, the descendants of Africa, because, once again, we see
the inequities in Black and Brown countries throughout the
world?
So I want to know why in the world are we seeing this when,
in fact, we are investing so much into vaccine production and
distribution?
Mr. Disbrow. Congresswoman Lee, thank you for that
question. I will address your first part of your question.
So agreed. And, as David mentioned, ensuring that we have a
vaccine manufacturing facility on the African Continent will
make sure that those individuals are not last now and in the
next pandemic.
As you are aware, BioNTech has made a commitment to
building a facility and supporting a facility on the African
Continent. As Dr. Kessler mentioned, Moderna has also committed
to supporting a facility on the African Continent. And then we
are also working with our colleagues at CEPI and WHO and the
Gates Foundation, as they want to establish a vaccine hub on
the African Continent.
And what we need to do is, even though this is not directed
from--I am sorry--funded directly through USG efforts, the
funds that have been provided to Moderna and Pfizer to support,
either through vaccine manufacturing--procurement, actually has
provided them the funds to, you know, be able to expand and
establish these facilities in Africa.
And I think it is important that Gates, CEPI, WHO, and the
companies collaborate so that there is a concerted effort to
make sure that the vaccine manufacturing facility or facilities
that are established in Africa can be sustained in the long
run. That is my biggest concern. You know, everybody is, you
know, making these, you know, concerted efforts, but we need to
make sure it is coordinated so that we can sustain this beyond
the COVID pandemic.
Thank you.
Ms. Lee. Thank you.
Director Pace.
Ms. Pace. Yes. Congresswoman Lee, thank you for your
question as well.
So, with regards to the Caribbean in particular, sharing
your concerns about where they have been in terms of their
vaccination. We have been proud to be able to contribute the
vaccines that we have, and now we are facing a pivot point,
right, where they have received the vaccines, and now we are
working closely with them and the Caribbean Public Health
Agency and others on readiness and absorption.
One of the challenges honestly is around demand, the same
issue we faced in this country when it came to the distribution
of vaccines. The availability and accessibility was there, but
we still have to work through community engagement and our
longstanding programs to ensure that people really lined up for
their shots.
Similarly, there are some logistical and operational
challenges that we are working across the interagency to
resolve, particularly with some of these mRNA vaccines, as you
are well aware, and some of the cold chain capacity that is
required on the ground.
And then, finally, there are just workforce constraints,
particularly as we continue to pull from existing programs,
other immunization programs for those vaccinators, and so that
presents a challenge as well, not only in CARICOM, but on the
African Continent in terms of readiness.
Ms. Lee. So we have the same challenges in the CARICOM
countries as we have on the African Continent?
Ms. Pace. Similar, yes, ma'am.
Ms. Lee. We have the CDC in Africa, on the continent of
Africa. We don't have a comparable CDC in the Caribbean. You
would think that we would see better results on the continent
of Africa because CDC is sited there.
Ms. Pace. That is a fair point, Congresswoman, and I
appreciate the work that the African CDC has done. And, yet, I
think they require additional support from our CDC, from USAID,
and others. And so we are working hand in glove with them and
the Africa regional office to resolve those issues as soon as
possible, and making progress along the way.
Ms. Lee. Thank you very much.
Thank you, Madam Chair.
The Chair. Thank you. And just a quick note with regard to
that. It really is about not just the vaccine, but it is about
the skills development and the skills training that is required
and the technical assistance that is required in terms of
capacity building. Those are the critical ingredients I think
we need to focus on.
And I want to thank Congresswoman Lee.
Congressman Harris.
Mr. Harris. Thank you very much, and thanks--thank you all
for appearing this morning.
Dr. Kessler, I have a question. The vaccines--and, as a
background, you know, I think what we are talking about is
using last year's technology for this year's problems, or for
next year's problems. So these vaccines that we are talking
about giving to other countries, or enabling other countries to
get, these are the leaky vaccines. Is that right?
I mean, it is pretty clear now that this generation of
vaccine that we are talking about sending to other countries
are leaky vaccines? They--people who get the vaccines can get
coronavirus. They can get--maybe it is a variant. Maybe their
immunity wanes. Is that true? Is that clear now?
Dr. Kessler. These vaccines, Congressman--you and I--I
mean, over our careers, what, we have--you know, we trained
together, I mean, at Hopkins. I think we have seen a lot of
vaccine development. I have never seen vaccines developed in as
short a period of time that are as effective. I mean, these are
remarkably, remarkably effective. No----
Mr. Harris. But they are not----
Dr. Kessler. No new medicine, no therapy is 100 percent
effective. You and I know that.
Mr. Harris. Sure.
Dr. Kessler. These are remarkably effective. To think that
these are----
Mr. Harris. Right, but they are not as effective as we had
hoped they would be. I don't think anybody anticipated that we
were going to have people get boosters at 6 months, and that,
at 6 months--I am just telling you, you know, I talked to
people out in the real world.
They were kind of promised that this vaccine was going to
be like the other vaccines they have taken. That is, you know,
if they have had the disease, they wouldn't have to take the
vaccine. You know, if they got the vaccine, they wouldn't have
to get a booster in 6 months.
I don't think there is any other vaccine we administer, is
that correct, Dr. Kessler, where you get a booster in 6 months?
Is that correct?
Dr. Kessler. Go back to your immunology, your----
Mr. Harris. But there are none.
Dr. Kessler. Our basic immunology passage right. Remember
those, sir?
Mr. Harris. But there are none.
Dr. Kessler. Many of these vaccines, if I may----
Mr. Harris. Dr. Kessler, I have very limited time. It was a
very simple question.
Dr. Kessler. If I can just answer your question.
Mr. Harris. Is there any other vaccine where you need a
booster in 6 months?
Dr. Kessler. There are many vaccines--in fact, majority of
vaccines--a lot of vaccines require three doses as primary
series, so I would ask you to think about----
Mr. Harris. I am talking about a booster--Dr. Kessler, come
on. I am talking about a--and this is important here because we
not only have to get the doses to Africa. We have to get
boosters to Africa.
So let me move on.
Dr. Kessler. No, no, no, but, Congressman, I think this is
very important.
Mr. Harris. Dr. Kessler, I am sorry. It is my--Dr. Kessler,
I am the one who asks the questions here.
Dr. Kessler. I understand, but, please, if I may answer the
question.
Mr. Harris. Well----
Dr. Kessler. There----
Mr. Harris. Madam Chair, could you please direct the
witness to let me ask a question of Dr. Disbrow?
The Chair. Well, yes. And I will allow you to do that.
Mr. Harris. And not have it count toward my time.
The Chair. Congressman, no. And I will provide----
Mr. Harris. Thank you.
The Chair [continuing]. The time. But, Dr. Kessler, answer
your question. You will have time to ask Dr. Disbrow a question
as well. Dr. Kessler.
Mr. Harris. Madam Chair, it is----
Dr. Kessler. If you will excuse me.
Mr. Harris. I have 5 minutes. I have more questions than
Dr. Disbrow. I was going to go back to Dr. Kessler. I need to
keep--the witnesses cannot filibuster in this.
Dr. Kessler. You are raising doubts about the efficacy of
this vaccine, and that is wrong, sir.
Mr. Harris. Oh, I am sorry, sir. Let me tell you, I am a
scientist. You are a scientist. Science raises questions about
everything. There may be more effective----
Dr. Kessler. Very important. You are undermining----
Mr. Harris. Yes, it is important.
Dr. Kessler [continuing]. The confidence of the American
people----
Mr. Harris. There have been more effective vaccines----
Dr. Kessler [continuing]. And the world in the vaccine, and
that is wrong, sir.
Mr. Harris. Oh, good. I am glad you have decided what is
right and wrong.
Dr. Disbrow, is it true that Florida did not fund the phase
3 trials for molnupiravir, which looks like it is going to be
the breakthrough therapeutics? Is that true?
Mr. Disbrow. That is correct, sir.
Mr. Harris. So, despite sending BARDA billions and billions
of dollars, the decision was made not to fund a phase 3 trial
of a drug that now could be made available to millions of
people worldwide who get COVID, even maybe from a leaky vaccine
or unvaccinated.
So I have got to--I am going to come back to Dr. Kessler.
What are you doing as the COVID czar to see to it that
therapeutics are rapidly advanced as rapidly as possible
through the FDA, things like fluvoxamine, very cheap, could be
widely available, as a second-prong approach, we send vaccines
and therapeutics to these other countries?
So if you could answer about therapeutics.
Dr. Kessler. From day one, therapeutics has been very high
on our agenda. We invested $3,200,000,000. We are the ones,
right, that work with Merck and work with Pfizer. NIH
developed--wrote the protocol for the Pfizer antiviral that now
has where we are seeing very, very important results that are
going before the FDA. We are pushing very hard.
I would like to work with you, Congressman, right, to make
sure, once FDA has reviewed these data, that antivirals in
addition to vaccines, right--complementing, not substituting
for vaccines. Vaccines are still one, two, and three on the
list, but I want to get a safe and effective antiviral,
accessible to all, so we can turn this around. That is what I
would like to work with you on, sir.
Mr. Harris. Thank you, and I look forward to that.
I yield back, Madam Chair.
The Chair. Thank you.
Congressman Pocan.
Mr. Pocan. Thank you, Madam Chair, and to the witnesses. My
apologies for the cult-like fervor to discredit vaccines that
some people seem to be obsessed about that could cost American
lives. I don't get it, but I am not a doctor. I am just a small
business owner, so--but I still want to say apologies because
it is rather embarrassing to watch this.
My questions are specifically around the distribution, and
I think these will probably be for either Director Pace or Dr.
Disbrow. Four questions around distribution.
One, cold chain. I had someone who knows quite a bit about
this. I believe the country is Zambia, where they are concerned
that, as the vaccines go to the proper cold storage, they have
talked to some of the folks that are the insurers who put
little thermometers in with the product and that they see
spikes going to 45 degrees in those cold storage overnight.
I am concerned about how closely we are watching the cold
chain aspects and the consistent deliverable nature of power to
these, specifically in some Third World countries like Africa.
Two, do we--are we putting enough resources into the human
distribution of these vaccines because that is one issue I have
heard that could be another factor in some of these especially
Third World countries?
Three, are we investing in--by doing this, in some
infrastructure so that perhaps whatever we do with this vaccine
could turn out to have other positive health ramifications in
these countries?
And, finally, four, can you talk a bit about the
demographic discrepancies? We have seen that, in many of these
countries, far more men rather than women and other populations
aren't getting the vaccine. What are we doing in trying to
address that?
So I just thought I would put the four questions out there,
and whoever wants to answer them, but specifically I think
Director Pace and Dr. Disbrow.
Ms. Pace. I am happy to----
Mr. Disbrow. Would you like to go first?
Ms. Pace. Yes, sir. Thank you, Dr. Disbrow. I appreciate
that. And thank you, Congressman Pocan, for those questions.
I want to leave time for my colleague to come in. Briefly,
I will say one of the things we are trying to do across U.S.
Government is build on existing global health programs and
platforms, and so we talked about even leveraging the PEPFAR
platform. Again, not to put that under a constraint, but to
utilize the health workforce, supply chain, and other capacity
in place in countries to help speed up the rate of COVID
vaccinations.
We are also hopeful, though, to your point, that, by adding
additional resources or support to these national vaccine
campaigns, that they will then sort of survive into the future
and be able to address some of these existing global health
programs, and so it is a nice cycle, if you will.
On the point of reaching women or other special populations
and subgroups in particular, we know this from other
immunization programs that that is key, and so we are focused
on those historically marginalized or vulnerable groups
certainly in our efforts working with WHO, Africa CDC, or other
community-based organizations in particular.
I will say one thing about the cold chain support, which is
just to say we are factoring that into our readiness analysis,
if you will, in ways that we can provide technical assistance,
not only through CDC and HHS, but through USAID, DOD, and
others, and so part of this package of technical assistance.
That is part of our sort of global vaccination strategy. But it
is also why it is critical to think about other vaccines that
can come into the picture that don't require the same level of
logistics.
Dr. Disbrow, please.
Mr. Disbrow. Yeah. Director Pace, I think you answered the
questions very well and completely. I really don't have
anything to add.
Mr. Pocan. Can I just follow up, then, on the cold storage,
though, because this was from a very, very reliable source,
that, you know, in some of this cold storage where the
insurance companies actually are gauging the temperatures,
because they do for obvious reasons, they are seeing spikes go
up to 45 degrees at night.
So how do we know--yes, they might have the right cold
storage, but how do we know that the vaccine is still secure at
that level? Are we doing extra to ensure they either have
adequate power or they are keeping the temperature so that we
are not giving a nonuseful vaccine to people? I would just like
to ask that again.
Mr. Disbrow. Yeah. So I think it is critically important
that, you know, we work with the countries that are receiving
the vaccine to make sure that they have ample not only primary
power but secondary power as well. We had to do this during the
2014-2015 outbreak of Ebola in West Africa. We actually sent
people over there to make sure that they had, you know, primary
power and backup generators because you have to ensure that the
cold chain is maintained to make sure that the vaccine is still
effective.
Mr. Pocan. All right. Thank you.
I yield back, Madam Chair.
The Chair. Congressman Fleischmann.
Mr. Fleischmann. Thank you, Madam Chair.
I would like to thank the chairwoman and all of the
witnesses for their compelling testimony today, for taking this
opportunity to highlight our country's role in the global
vaccine distribution effort.
We have heard testimony today about the great success of
Operation Warp Speed, and I think we ought to really underline
success. The previous administration worked diligently with
vaccine manufacturers to develop a safe and effective vaccine,
and we are still working to administer primary COVID-19 doses
and booster to individuals who voluntarily wish to be
immunized.
While I think forced vaccine mandates are counterproductive
and send the wrong message on immunization, I am happy to note
that the domestic production meets current demand in this
country, and I think that is something that all of us can be
proud of regardless of our branch: the House, the Senate, or
the administration.
In regard to the global vaccine distribution, Dr. Kessler
has stated in his written testimony to the committee that the
United States has pledged to donate more COVID-19 doses than
all of the other countries combined, a whopping 1.2 billion
doses worldwide. That effort will provide much-needed relief
for lower income countries, and I think that is a goal that
both of us share on both sides of the aisle.
That being said, I have heard concern from one of the
vaccine manufacturers, Moderna, about that effort. And I think
this point is very important to be made in defense of Moderna's
position. Twice in 2021, the Biden administration requested
contractual modifications requiring Moderna to accelerate and
prioritize deliveries from its U.S. factories to the United
States Government. These were contractual modifications that
were made with the government and with Moderna. My question, I
guess for Dr. Kessler, is, how could Moderna have supplied more
doses to COVAX under these conditions, sir?
Dr. Kessler. Moderna has the ability to supply the United
States and COVAX, in our judgment, with doses that are needed.
They certainly have today, Moderna has that capacity, and we
hope that they use it.
Mr. Fleischmann. Yes. And it appears that they are trying
to do that. But given the contractual modifications that they
were faced with, you would agree that that did place additional
contractual constraints on them.
Dr. Kessler. Early on, Congressman, you are exactly right.
I mean, I sat there, and the President's position was that it
was very important to get Americans the vaccine and to do that,
and also the world.
So we have done that. We have plenty of vaccine here. We
are donating that. And now it is up to Moderna. And we will see
over the next couple of weeks. We have enough vaccine in the
United States. Moderna has significant capacity. I hope the
deal between COVAX and Moderna gets signed, and let's see.
Mr. Fleischmann. I appreciate your response, Doctor.
And for everyone, I think the United States, all of us, can
be proud of all of the manufacturers, including Moderna and the
others, for stepping up in unprecedented times. We can look
back now and say maybe things should have been done
differently. But I think the United States of America came
together, all of us, yourself included, to work towards
combating this COVID pandemic.
So as we go through this, Madam Chair, and to the
committee, I think sometimes we need to laud some of the people
and praise them as we continue to move forward. Because God
forbid if we are ever faced with this situation again with
another pandemic or epidemic, we want private companies to
partner with the government to get to our end goal.
And with that, I yield back in a great spirit of
cooperation. Thank you.
The Chair. I thank the gentleman.
And I would just say with regard to that, I understand the
cooperative relationship between the pharmaceutical companies
and the Federal Government.
I just think the pharmaceutical companies, and in this case
Moderna, need to acknowledge the very serious role that the
National Institutes of Health and the government played in
getting its product to the market.
In fact, they hadn't gotten a product to the market prior
to the infusion of both capital and technology that resides
with the National Institutes of Health, with the three NIH
scientists who co-invented.
And so that ought to be acknowledged in a very public way,
and they should not--our scientists should not be frozen out of
that process.
And with that, let me recognize Congresswoman Watson
Coleman.
Mrs. Watson Coleman. Thank you, Madam Chair.
And thank you to all of the witnesses for your testimony.
I want a clarification on a couple of things I have heard.
Number one, we keep referring to 2022. So are you telling
me that we are going to be masked and vulnerable even into the
second half of 2022? Can I get that from each of you really
quickly, yes or no?
I will start with you, Doctor.
Am I being heard?
Dr. Kessler. Yes, you are, Congresswoman.
Can I just say, just a point of clarification, will we need
to be masked and vulnerable in the----
Mrs. Watson Coleman. Yeah, yeah, yeah, in the second half
of 2022, because that is a time of the year that has been
mentioned a couple of times in terms of having to do these
various things to get us where we need to be. I just am trying
to understand my future here.
Dr. Kessler. Congresswoman, I go to bed every night, and
before I go to bed, I mean, I look at the numbers for the day.
One of the hardest jobs I have when I had the opportunity to
brief the President was to be able to project out where we are
going to be in 4 weeks, in 8 weeks, and by the end of 2022.
Anyone who tells you they know where we are going to be in
2022, I don't think it is going to be accurate. I think the
most important thing is these vaccines----
Mrs. Watson Coleman. Are vitally important.
Dr. Kessler [continuing]. They will prevent hospitalization
and death.
Mrs. Watson Coleman. Thank you.
Dr. Kessler. You do not have to worry, if you are
vaccinated, and as long as you are not immunosuppressed, these
are protectors. These prevent hospitalization and death from
COVID. That is the key.
And I hope with the antiviral, let's see what the FDA does.
And I think we are going to have significant quantities of
antiviral.
Vaccines plus the antiviral, it is the first time I can sit
here and I am beginning to see a way we can get this under
control--not eliminate, not get rid of the virus entirely, but
I think we can get this under control.
I am sorry for going on, Congresswoman.
Mrs. Watson Coleman. Thank you, Dr. Kessler. I can talk to
you for a long time, I am sure.
So if we can't do better on the continent of Africa and in
the Caribbean, and even if we are doing better in terms of
total vaccinations and boosters, how does that negatively
impact our well-being here?
I guess I am going to give that to Doctor--the
representative from BARDA, Doctor--I am sorry.
Mr. Disbrow. Congresswoman, this is Gary Disbrow. I can
take your question.
Mrs. Watson Coleman. Disbrow. Dr. Disbrow. I am sorry.
Mr. Disbrow. No, that is fine.
So, I mean, obviously, until everybody is vaccinated, I
mean, or the vast majority, the 70 percent set by the
administration, that goal, there are potentials for variants to
arise.
And so we need to maintain our vigilance, and we need to do
everything that we can to make sure that the COVAX commitments
are met, that we are working with countries to make sure that
their capacity is increased, so that they----
Mrs. Watson Coleman. Dr. Disbrow, I am sorry. I want to
interfere because I want to ask two quick questions that can be
answered by you or anybody.
Number one is, how many variants are we monitoring now and
what is happening in countries with regard to those variants
since we are not having access to one of the three of four
vaccines that we are talking about?
And number two is, if we are talking about there being a
vaccine capacity manufacturing presence on the continent of
Africa, are we talking about 2021, 2022, 2023? What are we
talking about?
Those are my two questions.
Mr. Disbrow. Sure. I can answer your second question first.
The commitments by Moderna and BioNTech are in 2022, calendar
year 2022.
For your first question, there is an interagency group
called the SARS-CoV-2 Interagency Working Group, which is made
up of experts, subject matter experts from across the Federal
Government who are working with WHO and GISAID to evaluate,
then monitor different variants, variants of concern, variants
of interest, and determining, testing those variants against
the monoclonal antibodies that we have as well as the vaccines
that we have.
Mrs. Watson Coleman. How many are there, do you know, kind
of a round number, how many variants we are tracking,
monitoring?
Mr. Disbrow. It varies, both as variants of concern, but I
am happy to provide that in a written response.
Mrs. Watson Coleman. Thank you very much.
Thank you, Madam Chair. I yield back.
The Chair. Congressman Cline.
Mr. Cline. Thank you, Madam Chair.
I want to thank our witnesses. And I want to thank the
committee for working in a bipartisan manner with both the
previous administration and this administration to distribute
as many vaccines as possible, as many doses as possible through
Operation Warp Speed. The development of the vaccine was
critical, and its distribution is still ongoing and remains
important.
Dr. Kessler, Moderna is the only company to pledge not to
enforce COVID-19 IP during the pandemic. Do you support this
pledge?
Dr. Kessler. Yes.
Mr. Cline. They have also offered NIH co-ownership,
including the ability to license IP, covering Moderna scientist
inventions made as part of the NIH collaboration. What is the
status of that offer?
Dr. Kessler. I will let the lawyers at NIH and Department
of Justice who are handling this respond. I am not part of
those discussions.
Mr. Cline. But it is safe to say they are ongoing?
Dr. Kessler. Again, let me defer, if I may, to counsel on
negotiations with regard to the patent issues.
Mr. Cline. Okay. Counsel is not testifying today, and so if
you could get me that information, that would be helpful.
It is also disappointing that Moderna was not invited to
testify today to actually defend themselves against some of the
allegations that have been made.
Dr. Kessler, at a recent event by Yale Law School titled
``How to Vaccinate the World'' you stated it would likely take
several years to build vaccine facilities in places like South
Africa. And further, these facilities wouldn't be ready in time
to help with this pandemic. Is that correct?
Dr. Kessler. There is to doubt that building manufacturing
capability will take several years. We have done that. But
saying that, it is still very important because we have to
prepare for future pandemics.
That is why we are working very hard and expect Moderna to
be able to work with COVAX to get doses now to low- and low-
middle-income countries and to the AU, as well as prepare for
the future, sir.
Mr. Cline. Thank you.
Dr. Disbrow, is it true that money that was appropriated in
previous COVID legislation for BARDA to assist with the
development of COVID-specific vaccines was diverted to NIH for
other purposes? I think this was referenced in an earlier
question.
Mr. Disbrow. Yeah. Sir, I would have to check with the
Assistant Secretary for Finance and Resources for HHS and
provide you that in a written response.
BARDA is appreciative of the funds that this committee has
provided to them and the investments that you have made.
Mr. Cline. Okay. If you come to find that it was diverted,
do you believe it should have been diverted if it stymies the
ability of entrepreneurs and others in their efforts to find
other solutions besides an injectable vaccine?
Mr. Disbrow. So I think it is important that across the
U.S. Government we continue to look at other technologies,
vaccine technologies. I know there is a vaccine that is being
developed that is an oral vaccine as well as one that is a
nasally administered vaccine, and I think those are all
important to be evaluated, especially as we move forward for
pandemic preparedness for the future.
Mr. Cline. I would agree it is important, and, in fact,
there are significant complexities involved in manufacturing,
storing, and transporting mRNA vaccines.
So you would agree that rather than forcing companies to
give up their intellectual property, we should be encouraging
them to develop other forms, including oral and therapeutics?
Mr. Disbrow. So, I mean, we work with companies from all
different sectors, and we are happy to have those engagements.
We have what is called the market portal, the MCM portal, that
companies can submit their ideas. And we have a CoronaWatch,
TechWatch meeting. If companies are interested in potentially
partnering with BARDA, they can submit their ideas to us, and
we would be happy to meet with them and have those discussions.
Mr. Cline. And I understand the portal exists, but why is
it that very little advanced developments for next-generation
COVID vaccines and therapeutics have gone through BARDA in the
past year and a half?
Mr. Disbrow. So the funds that we have been provided to
support the priorities under Operation Warp Speed and now the
Countermeasures Acceleration Group for vaccines and
therapeutics, we have made key investments to bring those
vaccines and therapeutics forward.
And as Dr. Kessler mentioned, we have multiple vaccines
that are available as well as therapeutics. But we have not yet
been provided additional resources for advanced research and
development for earlier symptoms.
Mr. Cline. And it seems to me that the bigger problem isn't
that companies aren't sharing their intellectual property or
patent, but there are many other considerations as it relates
to making vaccines available around the world.
And that is a troubling trend by this administration. Big
government solutions, mandates on employers, and a complete
disregard for property rights ultimately does more harm than
good. So I hope that the Biden administration will reverse
course on both of these issues and instead focus on real
solutions for the pandemic.
Madam Chair, I yield back.
The Chair. Thank you.
Is Mr. Moolenaar back? No.
If not, we will move to a second round of questioning, a
second round of 5-minute questioning.
I think while we acknowledge the role of the pharmaceutical
companies, we need to continue to really acknowledge the role
of the National Institutes of Health and American taxpayers'
dollars and the contribution that it makes to developing these
vaccines.
Let me ask about the donation of domestic excess vaccine.
Dr. Kessler, the excess vaccines in the domestic supply,
can they be donated, dealing with that before there are
expiration dates involved?
When I asked this question at an earlier time of USAID,
they told me to deal with HHS on this and looking at the chain
of custody issues once the vaccine has been distributed.
What steps is HHS taking to reduce the number of vaccines
going to waste in the United States? And what are the chain of
custody challenges to sending the valuable vaccine where it
will be administered both domestically and internationally?
Dr. Kessler. Chair DeLauro, thank you very much for that
very important question. It is something we spend a lot--both I
and my colleagues spent a lot of time on.
Number one, what is most important is that the United
States will always and only distribute and donate high-quality
vaccines. There is no difference between a vaccine that we are
donating and a vaccine that I would put in my family's arms. So
it is quality vaccines across the board.
With regard to specifically, we spend a lot of time dealing
with expirations. The good news is, in circling, we have seen
and we have been able to work to extend the expiration date.
And certainly no, for example, no Moderna vaccine--there is no
expiration of any vaccine that occurs in our possession. We
monitor expiration very carefully, and we plan accordingly.
Now, you are right that sometimes--and we have seen this,
and it has been enormous efforts for our State colleagues to do
the efforts and get everyone who has wanted a vaccine as
quickly as possible, vaccines in the arms of American citizens.
It is a heroic effort.
But you are right, when you distribute vaccines out in the
field, and they keep on going to certain fields, we are limited
by our FDA colleagues, correctly, that we can't send vaccines
that we can't assure that chain of quality.
So we work very carefully to make sure that the States
don't order more than they actually need. So we are on top of
this, I promise you, Chair DeLauro.
The Chair. And that has to do with the international side
of that as well as extending of vaccines that are not going to
expire in short order, given that in some places the domestic
capacity--the international domestic capacity--is limited. In
some countries, it is much more limited than it is in the
United States.
So it is that technical assistance that I think we have to
be really focused on as well to be able to get them distributed
at the appropriate time so we are not wasting the vaccine.
So thank you.
Let me just ask one question. It has to do with our
international partners, Dr. Kessler.
The U.S. has donated 250 million doses, more than all other
nations combined. Are other G7, G20 countries fulfilling their
pledges for vaccine donations to the low- and middle-income
countries? What is the U.S. doing to pressure other high-income
countries to meet their pledges and with more urgency?
Dr. Kessler. With your permission, I would ask Director
Pace to answer that.
The Chair. Thank you.
Director.
Ms. Pace. Thank you, Dr. Kessler.
And thank you, Chair DeLauro.
So I am really glad you asked this. We have really been
pressing on this issue ourselves, recognizing it is going to
take all of us.
As you said, the G7 did make a commitment to sharing
vaccine, half of which included U.S. commitments, but the
others coming from those countries, and we have not fully seen
those realized. It is one of the reasons the President convened
those world leaders in September and at that event pushed those
very countries to come through with their commitments.
Following that meeting, and most recently, the Secretary of
State, Secretary Blinken, convened foreign ministers as well
and reiterated that call to action.
Since then we published--or what has been published--is a
dashboard of sorts that shows how countries are tracking toward
their various commitments. And so it is a very transparent look
at how not only the U.S., but these other countries, including
the G7, are doing with their commitment to COVAX.
So now it is online for the world to see, and we are hoping
that that also provides some additional impetus for them to
take action.
The Chair. Okay. Thank you.
Congressman Cole.
Mr. Cole. Thank you, Madam Chair.
And thanks again to our witnesses.
Dr. Kessler, we have talked about lots of ways in which we
have tried to help, and it is certainly appropriate to have
additional vaccines sent overseas. And some of our companies
have offered to build facilities overseas to try and distribute
supply.
Probably one of the more controversial things is the idea
of intellectual property transfer. Do you have any thoughts
about that, whether or not that is effective, whether or not
that is wise?
And, frankly, are other countries--because we are not the
only vaccines in the world, obviously, there are other
countries--are other companies considering transferring
intellectual property?
Dr. Kessler. I think that companies working together, joint
strategic partnerships, the voluntary transfer, the voluntary
tech transfer, I think we applaud and we are seeing. We are
seeing, for example, Pfizer partner on fill/finish in South
Africa. There are a whole host of those examples.
The world needs these vaccines. No one company can do it.
We need that technology shared. We have a lot to do here.
Mr. Cole. Well, again, there is a difference between
companies working together across international lines to meet
what we all agree is an incredible need and us forcing
companies, mandating them to share intellectual property.
And I just, for the record, I would be very much opposed to
that. I don't think that is fair to those companies, and I
think it would discourage investment later. That is my personal
view. Others may have a different point of view.
So I am curious about your thoughts about that, whether or
not that is happening. And, again, we are not the--we don't
think they are nearly as effective.
And, again, you may know more about it. I am sure you know
more about it than I do. There are Chinese vaccines, there are
Russian vaccines, there are other countries that have vaccines
in one sort or another.
Are they considering transferring intellectual property, to
your knowledge? And, again, it may not be something that is in
your purview even.
Dr. Kessler. I can give you probably the best example that
I think we can all applaud and should applaud. We have seen
Merck and yesterday Pfizer agree to transfer, in essence, to
the Medicines Patent Pool with regard to their antiviral.
That is enormously important. If these antivirals are as
effective as I hope they will be, they are going to be
important not only to the United States, they are going to be
essential to the world.
And generic drugs--I will let my colleagues, Director Pace
and Dr. Disbrow, add--but the generic availability of these
drugs, it took us, Ranking Member Cole, I mean, it took us
several decades to get this right with HIV. You will remember,
the Chair will remember the efforts that we went through in the
1990s, finding those drugs and then spending a good decade to
figure out how to make these available.
I think the antivirals that we have now, through really
heroic efforts, that we may be able to get on the market here
in the United States are going to need to be available around
the world, and we are going to need to have generics available.
So I think there are tools to do that. I will let my
colleagues comment.
Mr. Disbrow. So, Ranking Member Cole, to answer your
question, I am not certain if the Chinese companies that are
developing the vaccines, Sinovac and Sinopharm, are tech
transferring their technologies.
I think it is important, as Dr. Kessler mentioned, for the
companies to tech transfer where they can to expand capacity.
But I think it is even more important that we are supporting
all of the critical components that are necessary to
manufacture additional vaccines.
We have to do more than just do tech transfers for drug
substance and drug product. We need to make sure that we are
expanding capacity for the raw materials, the consumables that
are in short supply, the fill/finish capacity that was in short
supply even before the COVID-19 pandemic hit, needles and
syringes which are going to be necessary across the globe, as
well as vials.
So we are making those investments. And, again, I
appreciate the funding that has been provided by this
committee. We are doing that. The primary investments will be
here domestically and to onshore those, but they will not only
support domestic manufacturing but our global partners who also
need those materials as well.
Mr. Cole. Very helpful.
One quick last question, and this is directed at you, Dr.
Kessler, but, again, please feel free to share it around.
I am just trying to get a clearer--and you may not be in a
position to give it--but a clearer view of the level of funding
we need to deal with the problem.
So what do you anticipate HHS needing, and I mean in
dollars, for the global COVID response for the next year? My
friend the Chair and I will be probably dealing with this at
some level when we are negotiating what is the appropriate
level of funding next year. Or, I don't know, maybe it is a
supplemental, maybe it takes time to get around it.
We all have the same objective here. I think owing or
having some sense of what the scope of the efforts should be is
really important in getting it right.
So your best judgment now, with the caveat you can revise
it when you need to, because I am sure it is a pretty complex
question and pretty moving target.
Dr. Kessler. It is a very welcome question, Congressman
Cole.
I will take responsibility. You gave us the resources. And
I will tell you, we have put those resources to very good use.
You see that. That is why we have the vaccines we have today.
That is the reason why we can get our school-age kids, it is
because of those resources.
But I will tell you, Congressman, I have spent those
resources, and we are scratching. Let me let our colleagues,
our staffs work together. But it is really because of this
committee we got to where we got. And it is not done without
real investment by the American people for both the United
States and for the world.
And we have spent a lot of dollars, and we are very
grateful for that. And if we can work together on that
question, I would appreciate it, sir.
Mr. Cole. Yeah, absolutely. And, again, it is absolutely
not a critical question, it is just an informational one to try
and get to where we are going.
I appreciate what has been done. I think it is an
extraordinary effort. I think it is something the country can
be proud of and all of humanity benefited from.
So I think you have used the resources we have given you
wisely and well. I am just trying to get an idea of what we
might need going forward. So we will work on that together.
Madam Chair, thank you very much for your indulgence on the
time. I am very grateful. Yield back.
The Chair. Thank you.
Congressman Pocan.
Mr. Pocan. Thank you, Madam Chair.
And I am going to follow up on Ranking Member Cole's
question, because that was exactly what I was going to ask, and
maybe even a little more specifically, to Director Pace.
I know from last month's SFOPs hearing USAID funding is
soon to be finished. How much more money are you going to need
before the end of year to accomplish our goals? And are we
going to be seeing an additional request from the White House?
I am just trying to get a little better idea, because I
completely agree with our Ranking Member, what we have done
already has been very important, but I know it is not enough,
and you have broader goals than the funding we have given you.
I would like to have a little better understanding of what you
may need.
Ms. Pace. Sorry. I was trying to get myself off mute here.
Well, like Dr. Kessler said, we very much appreciate this
question. And as he also said, we have fully obligated the
funds that we have received and graciously so.
One of the issues that we have focused on in this hearing
has been the issue of readiness and the fact they are at this
pivot point. And so that truly is a focus of our moving
forward. Not to say we won't keep our foot on the pedal when it
comes to sharing, but we still need to be focused on shots in
arms and some of the logistical issues, demand generation, and
other areas that you flagged for us earlier, Congressman.
So that is one way we could use additional resources or
might use additional resources should they be available.
We also have a cadre of Health Attaches around the world
who have been working tirelessly on these efforts for longer
than I think they expected. And so sometimes we, because that
is not what is in front of us, we don't realize how much man or
woman power is sort of powering this engine to allow us to
respond effectively worldwide.
So those are just some examples of what has been working or
where we would like to lean into our work, but obviously we
defer to R&D (ph) to present the case more broadly.
I suppose the last thing I will offer is the idea of
preparedness and not forgetting that alongside our response.
And I know the Vice President made this announcement at the
President's summit committing $250,000,000 to a Financial
Intermediary Fund and furthermore requesting of Congress
another $850,000,000 toward that effort.
And so ensuring we have a balance across response and
preparedness will be important for us too. Thank you.
Mr. Pocan. Thank you.
And then one final question for Dr. Disbrow on vaccine
access in some difficult places. I know last week the U.S.
announced it negotiated a deal to ship additional doses of
vaccines like Johnson & Johnson overseas to conflict zones. And
Secretary Blinken specifically talked about the need to get
that in some of the areas that have humanitarian concerns.
Can you talk a little bit about what technology
infrastructure and human resource investments are needed to
deliver those vaccines to humanitarian settings? And can you
talk a little bit more about that J&J deal, please?
Mr. Disbrow. Yeah. So I apologize. I am going to defer to
Dr. Kessler who brought it up in his earlier comments.
Mr. Pocan. I apologize. I am getting the wrong spot. Thank
you.
Mr. Disbrow. David.
Dr. Kessler. Congressman, you are exactly right. This was
the first. It may not have been the most doses that we have
shipped, but I will tell you, among many of us, my colleagues,
it was some of the most meaningful doses, to be able to get
doses to people for whom no government program has ever gone
before.
And I want to applaud our colleagues at J&J for working
with us. Because we talk about donating doses, it sounds
simple, but I can tell you the regulatory, legal, all those
things are important because of the safety of this.
So to those humanitarian centers, just absolutely critical
and very important.
Mr. Pocan. And is there anything on the actual delivery
side you can share with us, specifically more information on
this J&J deal? I know you said it may be smaller than we would
like, but still extremely significant that this is happening.
Can you just share a little more on the details?
Dr. Kessler. No, the only reason I said smaller than we
would like is we tend to talk in tens of millions and billions
of doses. And here every 10,000, a hundred, is a big deal. I am
not minimizing. I will get you the delivery schedule if I can,
if I could submit that to you. I will get you the delivery
schedule.
Mr. Pocan. I would love to see that.
I would yield back, Madam Chair. Thank you.
The Chair. Thank you.
Mr. Fleischmann. Congressman Fleischmann.
Mr. Fleischmann. Thank you, again, Madam Chair.
And to Dr. Kessler, Director Pace, and Director Disbrow,
thank you for your testimonies today and for your very good and
candid, informative answers to the committee's questions.
We are all appropriators today, and our oversight questions
are so important, not only to the committee, but to the
Congress, but to the American people. So I thank you.
I want to touch on a couple of issues that we have touched
on before, but really just for clarification purposes more than
anything.
Dr. Kessler, do you fear that there is a lack of
infrastructure that would safely support independent vaccine
manufacturing and distribution in some of these other countries
in which we want to help their citizens?
Dr. Kessler. I will let Director Pace comment in a second.
I do recognize, sir, that getting vaccines delivered is
only part of the equation. I think I mentioned I spent a decade
chairing the board of the Elizabeth Glaser Pediatric AIDS
Foundation.
Some of you will remember Elizabeth. That foundation was
started in the U.S. because of her kids becoming infected. And
we moved globally very early on to be able to get doses to low-
and low-middle-income countries.
That technical assistance, that capacity, that absorption,
that uptake, I mean, again, we have more to do on supply. But I
think your question is absolutely key with regard to that kind
of technical assistance with regard to that uptake.
Director Pace, please correct me.
Ms. Pace. Thank you very much, Dr. Kessler.
I want to draw on something Dr. Disbrow said earlier about
the sort of spectrum of needs and technical assistance when it
comes to manufacturing capacity in some of these countries and
clarify our sense that it is not only building some of the
facilities, if you will, or hubs from scratch, but there is
some existing infrastructure there, and it is a capacity on
which we might be able to build the various investments the
U.S. Government is making.
So in addition to some of the other examples that my
colleagues have offered, our Development Finance Corporation,
working with the Department of Health and some of our Health
Attaches in places like India and South Africa, have identified
those locales to sort of again build on existing capacity in a
way that can accelerate us getting to scale.
I am not sure if Dr. Disbrow has more to add or if you,
Congressman, have additional questions. Thank you.
Mr. Disbrow. In addition to that, Director Pace--and your
question is a great question. So it is more than just the
facilities. You also have to make sure that you have trained
people who can work in the facilities.
And so in some of the countries where they may have not had
the experience of manufacturing vaccines and fill injectables,
you really need to make sure that you have that, they become
very--once they are trained, other companies want to take them
away and use them because training and making sure that those
individuals are available is very difficult.
But it is more than just the facility, it is also making
sure that you have the people and the infrastructure to support
it.
Mr. Fleischmann. I sincerely appreciate all three of your
answers to clarify that for the committee.
In closing, I would like to say this to everyone involved.
It is my hope that these conversations progress in a way that
will provide for a solution that continues our humanitarian
work while staying sensitive to the protections and the
liabilities of U.S. companies.
As you know, I am a champion for the free enterprise
system. I think all of the companies involved have done a very
laudatory job stepping up at a time of crisis, coming together,
working with the government to accomplish the goal of defeating
COVID both nationally and internationally.
So with that, I thank you, Madam Chair, and I yield back.
The Chair. I thank the gentleman.
And what I will do is to just--I just want to ask one
question and then we will close. And if the gentleman would
just bear with me because we need the two of us to continue. I
think we are the only two left. But I will make my case here.
I will submit for the record questions that have to do with
vaccine equity to you, Ms. Pace.
I would love to know about the antivirals, Dr. Disbrow, and
I will get this question to you about how BARDA contributed to
that development.
And to you, Dr. Kessler, about our negotiations with Pfizer
or others or using the Defense Production Act for us to up our
production in order until we have 20--while we pledged 1.1
billion doses, only 226 million doses have been shipped, 20
percent or so, and Pfizer is producing the 1 billion. So what
is it that we can do to accelerate the pace? And I note that
people are working very, very hard at this.
But I will submit those questions.
And if I might just close, and I want to just say a thank
you to you, Dr. Kessler, Dr. Pace, Dr. Disbrow. I think we
covered important topics today.
I would make one. It would be my hope that we could move on
our appropriations bills for 2022 because locked within those
bills at the moment are serious, very, very serious resources
for the areas that you cover and for the issues attached to
this discussion. That would be very, very helpful in your being
able to further continue your work.
A couple of points here. The virus exposed a number of our
shortcomings in our preparedness, but also our
interconnectedness with the world. And so COVID is not just a
domestic challenge, it is a global challenge. And the United
States needs to contribute to that solution, and we are working
at that.
But the longer COVID is allowed to spread, it becomes a
breeding ground for new variants that may be more transmissible
and that could evade current vaccine.
So not enough vaccine in the world now. Limited vaccine
needs to be better. That includes providing as much vaccine as
quickly as possible to other countries.
We must also support the efforts to accelerate
manufacturing capacity, and that is a conversation with BARDA,
to maximize vaccine access and equity as soon as possible.
We have had the discussion about facilitating tech
transfers sooner rather than later because in some ways the
lack of capacity that some of these countries have. And we have
this capacity, but they don't. And we need to help them with
that effort.
I would urge you to explore every avenue to continue to
exert pressure on those companies that were supported with U.S.
taxpayer dollars to accelerate production and distribution of
the vaccine. I know some of the companies have been excellent
partners. I commend them for their leadership.
I would find it unconscionable for any company to make
billions in profits without doing everything in its power to
reach the most needy throughout the world. It is not just a
moral imperative to ensure the health and safety of billions of
people, it is in our Nation's national security interest to
bring this pandemic to a close as rapidly as possible to save
lives. And we have the power to do that, I might add.
And a final note. It is my hope--and I know that this is
not your bailiwick, I am sure you will refer me to USTR--but
that we do have a ministerial meeting on the 30th of this month
where the issue of the temporary transfer of intellectual
property--and I emphasize the word temporary transfer of that
intellectual property--will be the point of discussion.
And I want to commend the work that the United States has
done already in this area at the last TRIPS meeting and my
optimism for what we will do at the ministerial on the 30th.
I just say, all in all, it is so much within our power here
in the U.S. to be able to deal with these issues. I thank you
for your work, for your life's work, and for what you are doing
for all of us now, what you are doing for our country, and what
you are doing internationally. Thank you so much for being with
us.
And with that, I call this hearing to a close. Thank you
all very much.
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