[Senate Hearing 116-]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2021
----------
THURSDAY, JULY 2, 2020
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:05 a.m. in room SD-106, Dirksen
Senate Office Building, Hon. Roy Blunt (chairman) presiding.
Present: Senators Blunt, Shelby, Alexander, Moran, Capito,
Kennedy, Murray, Durbin, Shaheen, Merkley, Baldwin, Murphy, and
Manchin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Operation Warp Speed: Researching, Manufacturing and Distributing a
Safe and Effective Coronavirus Vaccine
opening statement of senator roy blunt
Senator Blunt. The Appropriations Subcommittee on Labor,
Health and Human Services, Education, and Related Agencies will
come together.
I'm glad to be here this morning with my colleagues, some
of whom are joining us from their offices or from some other
location.
This is the first Appropriations hearing being held in-
person and virtually and I want to thank Chairman Shelby and
his staff for letting us try this and see how this kind of
information gathering works for appropriators. It's not a
markup. There will be no voting today, but we're going to get
some really important information.
Yesterday, coronavirus cases passed 50,000 for the first
time, making it a single-day record. This morning, 128,000
Americans have died, and nearly 2.7 million have tested
positive for COVID-19, and, of course, the thoughts of myself
and everyone on this committee are with those individuals and
those families who've been affected.
I've called this hearing really to look at an update on the
efforts that the Administration's put together and, frankly,
members of this committee were very involved in to see if we
couldn't establish a new way to look at responding to
pandemics.
I think we have the chance to actually write a new
important chapter in what that response looks like. Developing
the right vaccine, the right therapeutics, the right testing is
important, and I think we're going to talk today about ways to
try to have all of the safeguards in developing all of those
things but with a Federal partner going forward more quickly
than we would have ever gone forward.
Today, I saw that Pfizer just passed an important mark with
the vaccine they're working on. Maybe the most significant
thing I saw in that article was that Pfizer believes they may
have a hundred million doses of that vaccine available by the
end of the year. That would be an extraordinary thing if it
happens and I think what we're going to hear from our witnesses
today is that there are other companies that would be
developing different vaccines that also would add to that
figure that might be available late this year or early next
year.
I think the Administration's willingness to take this new
initiative, the willingness of the Administration and, frankly,
our Appropriations Committee and the Congress in what we did in
the last COVID Act to put some money behind taking a chance,
not a chance with an effective vaccine or test, but a chance
that we may move forward with something that doesn't work more
to also allow us to move forward early with something that does
work.
This committee, the full committee and the Congress has
provided nearly $10 billion for this overall effort and the
vast majority of this investment will support the research and
development of vaccines and treatments.
There are over a hundred vaccines in development worldwide.
Operation Warp Speed, I believe, is beginning to focus in on
about seven that we would encourage the advancement of in
clinical trials and further development.
Importantly, as NIH (National Institutes of Health) and the
Biomedical Advanced Research Development Authority continue to
oversee the development of these vaccines, we're also going to
be talking today about how manufacturing for maybe the first
time ever would begin while the vaccine is still going through
the other process and maybe while tests are still going through
the other process.
As we saw earlier this year with diagnostic testing
research at NIH, the current processes can be streamlined to
make them faster. Just because something is new doesn't mean
it's better, but this is a time to try things and to see what
we can figure out to make work.
Under the NIH's Shark Tank Program, the program that
particularly Senator Alexander and I spent a lot of time
talking to people at this table about, principally Dr. Collins
but people at this table, manufacturers and others, we're
hoping to fast track diagnostic tests, to have tests that are
easier to take with a quicker response that frankly millions of
people can take dozens of times, getting schools started in the
fall at residential campuses and elementary and secondary
schools, and all other campuses. Having a test available will
make a big difference.
Some people have warned that the time table to develop both
tests and vaccines next year is far too fast. Others have said,
well, maybe accelerating the process means the regulatory
corners will be cut. We're going to be working really hard to
be sure that is absolutely not the case and I think our leaders
here today will help reassure us of what they're doing to see
that that doesn't happen.
This is an opportunity for our witnesses to explain to our
committee and the American people how the development process
works, how they'll ensure that the vaccine will be safe, and
even with an accelerated research and development time table
how the vaccine will be distributed across the country as
quickly as possible.
I've said to several people lately on the topic of vaccine
and distribution that obviously developing the vaccine is the
top priority, but right below that top priority is having a
plan that distributes that vaccine in a way that people believe
is fair and equitable and meets the standards that we should be
establishing right now.
There are clearly concerns about the vaccine. About half of
Americans are either reluctant, about one out of five Americans
say they're just not going to take the vaccine. I certainly
intend to, and I think most Americans will, and as we reassure
people about this process, I also think about smallpox and
polio and other things that in many cases vaccines have been
able to move outside the system because vaccines did their job
and, you know, kids in the fourth and fifth grade don't line up
any longer so that every single person takes their smallpox
shot like they did when most of us were kids.
I hope today's hearing really makes an impact on those
concerns, I believe it will, and look forward to our witnesses.
[The statement follows:]
Prepared Statement of Senator Roy Blunt
Good morning. I want to thank our witnesses for appearing before
the Subcommittee today to discuss the development of a coronavirus
vaccine.
This is the first Appropriations Committee hearing that is being
held both in-person and virtually. We are virtual because the United
States is currently experiencing its worse, large-scale public health
outbreak in a generation. Across the country, this has changed our
daily lives, and in the Senate, it is no different. Yesterday, new
coronavirus cases in the U.S. passed 50,000 for the first time to reach
a sing-day record. As of this morning, 128,000 Americans have died and
nearly 2.7 million have tested positive for COVID-19. My thoughts are
with all those affected.
I called today's hearing to receive an update on the
Administration's efforts to develop a COVID-19 vaccine through
Operation Warp Speed.
The mantra underlying this pandemic is that we need a vaccine to
truly get this pandemic under control.
And I think that is right--that life will not return to resembling
pre-outbreak normal until there is an effective and widely available
coronavirus vaccine. But how do we get there?
Developing the right vaccine, putting it through its necessary
clinical trials to see if it is both safe and effective takes time.
Then it must be manufactured, distributed, and administered to
potentially hundreds of millions of Americans. These are daunting steps
that have already received significant investment by the Federal
Government, and will likely need more, to achieve.
It is important to manage our expectations, to understand that as
much as we want a vaccine as soon as possible, the most important thing
is that it is safe.
The Administration should be commended for their new initiative,
Operation Warp Speed. This Committee has provided nearly $10 billion
for this effort and the vast majority of this investment will support
the research and development of vaccines and treatments.
There are over 100 vaccines in development worldwide and Operation
Warp Speed will narrow down those candidates to about 7 to advance into
clinical trials and for further development. Importantly, as NIH and
the Biomedical Advanced Research and Development Authority continue to
oversee the development of these vaccines, we will also provide
resources to begin manufacturing now.
This will allow us to have hundreds of millions of doses ready to
go when a vaccine is determined to be safe and effective.
As we saw earlier this year with diagnostic testing research at
NIH, the current processes can be streamlined to make them faster. Just
because something is new, doesn't make it better. But the opposite is
also true--just because that's the way something has always been, it
doesn't make it right.
Under NIH's Shark Tank program, which is fast-tracking more COVID-
19 diagnostic tests to the market, NIH was able to start a new research
program that would probably take a year to design and implement before
the pandemic and do it in only a month. In the first 24 hours, they had
400 inquiries. As of this week, they had 542 applications.
Unfortunately, for political reasons or not, Operation Warp Speed
immediately had its detractors.
Some warned that the timeline to develop a vaccine by early next
year was too fast. Others said that by accelerating the process,
regulatory corners will be cut. Still others said that there will be
pressure to release a vaccine before the election even if clinical
trials are not complete. I understand these concerns and that is
exactly why I wanted to have today's hearing.
This is an opportunity for our distinguished panel of witnesses to
explain to the American people how the development process works, how
they will ensure that a vaccine will be safe, even with an accelerated
research and development timeline, and how a vaccine will be
distributed across the country as quickly as possible.
The other issue this hearing must tackle is that, just because we
have an effective vaccine, doesn't mean Americans will take it. A poll
by the Associated Press found 31 percent of Americans weren't sure if
they would take a COVID-19 vaccine if one was offered. Another one in
five said they'd outright refuse. This is going to be a huge hurdle for
us as a Nation to overcome.
Despite extraordinary victories fighting devastating diseases like
smallpox and polio through vaccination campaigns--we don't even
vaccinate for smallpox in the U.S. anymore because the vaccine was so
successful--too many have forgotten or are unaware of the havoc that
these diseases played on the world before vaccines became available to
combat them.
It is concerning to think that future generations who did not live
through the coronavirus pandemic may think of the vaccine as more
problematic than the disease.
I hope today's hearing allays some of these concerns by providing
clear answers on the steps ahead. Americans need to be reassured that
the government will not distribute a vaccine that is not safe.
This hearing should allow us all to have a better understanding of
where the vaccine development process stands. How far are we really
from an effective vaccine? What are we doing to ensure we're
manufacturing enough vaccines to stop the pandemic worldwide? What
investments have already been made and what might taxpayers be asked to
support in the coming months? And what is the plan to distribute the
vaccine once we have one?
These are incredibly important issues that this Subcommittee has
invested $9.5 billion toward.
Will it succeed? It is too soon to tell. Will some of the vaccine
candidates fail? Of course. In science, there is never a straight line
to success. But we know we have to invest in this process for success
to occur.
I look forward to our panel's testimonies and appreciate your
dialogue with us. Thank you.
Senator Blunt. Senator Murray is here, and I'm going to
recognize her for her opening statement.
Senator Murray, thanks for being with us today, and thanks
for working together to have this hearing.
STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman. I
really want to thank you and Chairman Shelby for allowing our
committee members to participate in this hearing virtually
today, and I want to thank all of our committee staff for
setting everything up, and I want to thank all of our witnesses
who are joining us today, as well.
Your agencies play a critical role in the development of
some of the most important tools against the COVID-19 pandemic:
safe and effective diagnostics to identify the cases, NRPs
(National Response Plan) to help patients and frontline workers
fight this disease, and ultimately a vaccine to move towards
ending this crisis.
That is why Congress has appropriated more than $6.5
billion to BARDA (Biomedical Advanced Research and Development
Authority) and three billion to NIH for work on medical
countermeasures against COVID-19, and we know we need more
funding, particularly to distribute a safe, effective vaccine
down the line, and we also know we're going to need to hold
this Administration accountable to avoid repeating the mistakes
and delays.
The Trump Administration put politics ahead of COVID-19 by
promoting unproven treatments and steering PPE (personal
protective equipment) contracts to unqualified political
allies. They failed to plan in a comprehensive way for
nationwide challenges, like standing up testing and contact
tracing, and they ignored and exacerbated existing health
disparities that left black, Latino, and tribal communities to
face the worst of this crisis.
If we want to get out of this mess any time soon, the Trump
Administration has to do better, particularly when it comes to
developing a safe, effective vaccine that is widely available.
What I hear from experts is that while we all want a
vaccine fast, a vaccine that is fast but ineffective will fall
short of what is needed to turn the tide on this pandemic.
That is why it is more than concerning that the Trump
Administration sidelined our leading scientists at CDC (Centers
for Disease Control and Prevention), removed the head of BARDA
reportedly for putting science and public health over
allegiance to President Trump, and took BARDA experts off
leadership of contracts related to the search for a COVID-19
vaccine.
I also have concerns about why BARDA has chosen to invest
solely in new vaccine technologies that have only been studied
experimentally and never made it to market while not pursuing
older proven technologies.
Meanwhile, the Administration still has not provided any
explanation of how it is selecting vaccine candidates, what the
risks are of narrowing down that short list, or addressed
concerns about potential conflicts in contracts that predate
this crisis, and it still has not provided a comprehensive
national vaccine plan.
We saw with testing how the Administration stubbornly
refusal to plan led to totally avoidable delays. So Congress
clearly needs to act and hold President Trump accountable when
it comes to vaccines or risk another inadequate plan that
offers too little too late or, worse, no plan at all.
That's why I am working on a proposal to require the Trump
Administration to provide a comprehensive plan for how to make
sure we get a vaccine that is safe and effective produced at
scale and distributed nationwide and free and available to
everyone in a way that addresses the health disparities this
pandemic has made worse.
This plan must ensure that research and development is
rigorous, science-proven, and inclusive, and it must lay out
specific standards, timelines, and milestones, a commitment to
be fully transparent about the clinical trial data experts will
use to evaluate safety and efficacy, and strategies for
combating vaccine hesitancy and misinformation.
When we finally develop a vaccine, we will need to safely
manufacture hundreds of millions of doses for the U.S. alone
and billions globally as fast as possible and that means just
as many specialized glass vials, syringes, stoppers, and a lot
more. Making all that happen requires planning to manage the
supply chain and navigate challenges, like potential
bottlenecks.
We also need a plan for when we begin to distribute
vaccines, to guide critical decisions about who gets the
vaccine first, like frontline healthcare workers, high-risk
groups, and tackles barriers that could otherwise limit access
by making sure the vaccine is free for everyone, and addressing
health disparities which have only made this crisis so much
worse for communities of color.
While we need this plan as soon as possible, we also need
to be clear about what scientists and clinicians have
cautioned, which is that while there is no guarantee a vaccine
will be ready by the end of this year, much less by this fall,
there are people suffering with COVID-19 right now who need
proven therapeutics to help them beat this disease.
While a vaccine is our best hope for stopping this virus,
it is not our only means of fighting it nor is it a panacea on
its own. So I'm alarmed that while this Administration has
invested heavily in vaccine development, it is treating other
priorities as an afterthought by investing far less in the
diagnostics that can identify infections early in the course of
the illness and prevent further spread and tying the plug on
therapeutics that could provide lifesaving relief for
hospitalized patients at the greatest risk of dying or
suffering long-term health effects.
Congress provided funding for HHS (Department of Health and
Human Services) to invest in a spectrum of medical
countermeasures to fight this virus, not just vaccines. We need
to invest in every type of medical countermeasure and to do it
in a way that benefits everyone in our country equitably
because we know right now this virus is disproportionately
impacting communities of color.
For months now, I have been pressing for comprehensive
demographic data on access to testing, positive test results,
hospitalizations, intensive care unit admissions, and
fatalities, and I'm frustrated that we don't have all the data
we need yet, but the picture we do have is alarmingly clear.
People in the black community, Latino community, and tribal
communities are three to five times more likely to be
hospitalized with COVID-19 than white people, and the death
rate for people of color is two to three times that for white
people.
Those devastating health disparities are a symptom of a
larger pattern of systemic racism and underinvestment in
communities of color and a warning that we need to work as fast
as possible on an additional relief package to address those
disparities before they get worse, to protect our workers, our
students, our families, and continue to support our communities
as they fight this historic crisis.
We can't know exactly how long until a safe, effective
vaccine is widely available or how long before we can all
safely go back to work, back to school, greet our friends with
a handshake or a hug, but we do know that the decisions that we
make today, whether we prioritize science or not, whether we
plan ahead or not, whether we care for every community or not,
will make a huge difference in terms of where we are a year
from now. So it's absolutely critical we get this decision
right.
Thank you very much, Mr. Chairman. I look forward to the
testimony and to our questions today.
Senator Blunt. Well, thank you, Senator Murray.
We've got a great panel today. Dr. Francis Collins, the
Director of the National Institutes of Health, Dr. Robert
Redfield, the Director of the Centers for Disease Control and
Prevention, Dr. Gary Disbrow, who's the Acting Director of the
Biomedical Advanced Research and Development Authority, usually
referred to as BARDA.
This is Dr. Disbrow's first time to testify but our other
two witnesses have been before this committee many times and
it's possible that Dr. Collins may have set the record as a
witness before this committee.
But, Dr. Collins, why don't you start? We have your
statements. Try to limit your opening comments to 5 minutes
each and you can do that however you want to, but we're glad
all three of you are here, and, as you can tell, we're eager to
ask questions.
STATEMENT OF FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR,
NATIONAL INSTITUTES OF HEALTH
Dr. Collins. Well, thank you, and good morning, Chairman
Blunt and Ranking Member Murray, and Distinguished Subcommittee
Members.
I want to thank you for your sustained commitment to the
National Institutes of Health. It has enabled NIH to be at the
forefront of research to address the COVID-19 public health
emergency.
I'm grateful for this opportunity to update you on that
work. You should have at your place or if you're on the video
connection maybe an electronic version of a couple of images
that I want to point you to in a moment.
Over the last 6 months, COVID-19 has spread around the
world with frightening speed. To respond to this crisis, we
need to find answers to many urgent questions about how to
diagnose, treat, and prevent this disease. At NIH, it is our
mission to help find those answers, using the best science and
technology in the world.
[The graphic follows:]
Dr. Collins. A critical question is to understand what we
are up against. When it comes to new infectious diseases,
knowledge is power and as you can see on the image on Page 2 of
your handout and also in this 3-D printed model that I brought
along with me, which happily was not confiscated by the
Security people when I entered the building, even though I
guess you could say I brought virus to your hearing room, this
one will not cause you illness, this model shows you the cause
of COVID-19.
It's this coronavirus called SARS-CoV-2. Note the
distinctive array of these spiky proteins on its surface. When
the virus invades the human body, these spike proteins
literally open the door to infection. They act as keys that fit
into specific locks on the surface of cells and once inside the
cell, the virus takes over its machinery, begins replicating,
producing thousands of viruses like itself and goes on to
infect other cells. This can cause severe pneumonia, blood
clots, and other life-threatening complications.
Now based on hard work, we now have better means of
treating COVID-19 than just a few months ago. Remdesivir and
dexamethasone have proven beneficial in rigorous trials and are
now standard of care for hospitalized patients, but we have
much more to do.
Let me say something about testing. Testing in the U.S. has
come a long way. More than 30 million tests for presence of the
virus have been administered in the last few months, more than
any other nation. Yet these tests, most of which rely on
nasalpharyngeal swabs and processing in centralized labs, are
not entirely satisfactory for the needs at hand. Scaling to
rapid routine point-of-care testing would be a major advantage
but that requires new technology.
[The graphic follows:]
Dr. Collins. With that in mind, Congress, on April 25th,
provided additional resources for development of new COVID-19
tests. Just 4 days later, NIH launched the Rapid Acceleration
of Diagnostics or RAD-X Initiative, and if you turn to the next
page, you'll see there an innovation funnel which includes a
Shark Tank component.
This basically is an opportunity for those who've invested
and invented new kinds of technologies to put their ideas
forward and have them evaluated by a distinguished team of
business, engineering, technology, and scale-up experts. In
just 2 months, we have received more than 2,400 expressions of
interest and over 560 completed applications, most of these
from small businesses.
Many of these proposed tests use convenient samples, like
saliva, which would be better than a nasal swab because you
could self-collect. These 23 have already made it through the
Shark Tank and are undergoing intense validation and what you
see here as Phase 1, preparing for possible massive scale-up in
Phase 2, and we expect to have at least one of these
technologies into Phase 2 within the next week.
By fall, we expect that the winning technologies will make
it possible to deploy several million more tests each week. In
fact, I would say maybe more than a million more each day.
[The graphic follows:]
Dr. Collins. But it's not enough to diagnose the disease.
We must treat it as soon as possible to prevent it. To that
end, on your next page, you'll see NIH has launched the
Accelerating COVID-19 Therapeutic Interventions and Vaccines.
That will be an acronym, ACTIV, A-C-T-I-V, Initiative.
This initiative is shown here and the handout provides a
high-level overview of the organization of this remarkable and
unprecedented public/private partnership involving 18
biopharmaceutical companies, academic experts, and multiple
Federal agencies. In 2 short months, ACTIV has developed five
master protocols that will accelerate research trials and
hasten FDA (Food and Drug Administration) review and possible
approval. These will rigorously test the series of antivirals,
anticoagulants, immunomodulators, and monoclonal antibody
treatments in both inpatient and outpatient settings.
Supported by Operation Warp Speed, we expect four treatment
trials to get underway in the next 6 weeks and we're quite
excited about their potential for success.
But still the ultimate tool we need to end the COVID-19
pandemic is a vaccine. Operation Warp Speed and the ACTIV
Initiative are working together intensively on vaccine
development.
[The graphic follows:]
Dr. Collins. A scientific review of more than 50 candidates
has already been conducted. The furthest along in U.S. testing,
shown on Page 5, is an experimental vaccine from NIH's Vaccine
Research Center in partnership with Moderna. This vaccine
features a small non-infectious snippet of messenger RNA.
Injecting this mRNA into muscle spurs a person's own body to
make the viral spike proteins, which in turn will encourage the
production of protective antibodies against SARS-CoV-2.
A Phase 2 clinical trial of this vaccine candidate began on
May 29 and this month, we plan to launch a Phase 3 clinical
trial that will seek to enroll 30,000 volunteers with results
expected in a few months.
So clearly we've already learned much about this
devastating virus and we've made significant strides at
unprecedented speed in developing diagnostics, therapeutics,
and vaccines, yet far more work is needed to end this global
health crisis.
With your support, NIH is on the case. So thank you for
this opportunity, and I look forward to your questions.
Senator Blunt. Thank you, Dr. Collins.
Dr. Redfield.
STATEMENT OF ROBERT R. REDFIELD, M.D., DIRECTOR,
CENTERS FOR DISEASE CONTROL AND PREVENTION
Dr. Redfield. Good morning, Chairman Blunt, Ranking Member
Murray, and Members of the Subcommittee.
I'm pleased to be here today with my HHS colleagues.
Together, we are working on the critical issues related to
COVID-19 vaccine development, manufacturing, and distribution
under the auspices of Operation Warp Speed.
Vaccines are one of public health's greatest scientific
achievements. With the support of Congress, investments in
CDC's domestic and global immunization programs continue to
diminish disease threats and advance the human condition.
Most importantly, vaccines save lives. Preparing for the
implementation of a safe, effective COVID-19 vaccine program is
a critical next step. Through our existing Influenza Vaccine
Program, CDC continues to work with State, Tribal, local
territorial health partners to prepare and maintain public
health distribution pipeline.
This includes training personnel, building strategic
relationships, utilizing data systems, identifying the
resources to sustain an efficient and effective immunization
infrastructure. Leveraging the existing system, CDC stands
ready to support our partners with the distribution once a
COVID vaccine is available.
Each year, CDC safely distributes vaccine from
manufacturers to nearly 40,000 public and private health
providers across the Nation and in a typical year, we provide
vaccine for more than 80 million individuals.
During an emergency, this system has the ability to scale
and the capacity to manage and distribute up to 900 million
vaccine doses. This is possible because CDC has established an
extensive integrated network inclusive of public health
departments, health providers, and community-based groups that
extend far and wide.
Drawing on the lessons from 2009 H1N1 pandemic, we've
identified critical considerations for rapid deployment of a
new COVID vaccine. Distribution strategies will be based on
many factors. One strategy likely will be prioritizing who is
vaccinated. The goal is to ensure that vaccine access for all
Americans who can benefit from vaccination. To do this, we must
consider the logistical aspects of where vaccines are
administered and who's administering.
Monitoring systems will be required to document
vaccination, manage inventory, and gauge vaccine supply
nationwide. CDC currently manages the supply through its
Vaccine Order System and collects vaccine coverage data from
jurisdictions to help them make informed decisions.
CDC's Immunization Safety Office has a longstanding history
of monitoring the safety and efficacy of vaccines and will
continue to provide leadership in this area.
Scientifically-based vaccine policies are the foundation of
the U.S. immunization system. These policies are formulated by
recommendations from the Advisory Committee on Immunization
Practice or ACIP and then provided to me as CDC Director.
Another key component is the efficient distribution
strategy to ensure that people have clear and accurate and
ample information on vaccines so they can make informed
decisions about getting vaccinated.
Experience has shown us that vaccines are powerful tools
and reaching every individual who could benefit from
immunization is an important goal.
A successful vaccine program will require a combination of
traditional and new innovative approaches to how to administer
and deliver vaccines. Pharmacies and other complementary
community locations will be more important during our response
to this pandemic.
And, finally, public health considerations have to look at
the management of the vaccine itself. Every vaccine has
requirements for storage and handling that must be addressed
for the vaccine to be effective when delivered.
Ensuring the cold chain, a system that maintains the
vaccine's integrity from when it's manufactured to when it's
administered. To meet these aggressive goals, it's going to be
important to enhance our Nation's cold chain infrastructure.
In the coming months, we will be confronted with a
confluence of COVID-19 and seasonal flu. CDC is working to
encourage Americans to embrace flu vaccination with confidence.
This is an important public health goal and serves two
important purposes for COVID-19.
First, increasing flu vaccine coverage can reduce the
strain on our health system which we've already seen in some
areas from COVID-19. Second, the flu vaccine uptick is another
opportunity to test our systems and infrastructure that will
need to be leveraged during the COVID-19 vaccine delivery
program.
As we confront to fight the pandemic, it's important that
all Americans have confidence in all vaccines. Through the
CARES Act, CDC was provided a $140 million in funding to
support States and local departments for early planning of the
flu influenza season and to enhance these immunization programs
across our Nation.
COVID-19 is the most significant public health challenge
that our Nation has faced in more than a century. In the
absence of a vaccine and countermeasures today, we are
implementing effective public health measures and encouraging
the adherence to what I've referred to as the powerful weapons
of social distancing, face coverings, and hand hygiene.
In doing so, I'm confident that we will emerge from this
pandemic united together, stronger than ever.
I encourage you to see the possible as both the public and
private sectors pursue a vaccine and that we as a Nation
confront this pandemic globally.
Thank you and I look forward to your questions.
Senator Blunt. Thank you, Dr. Redfield.
Dr. Disbrow.
STATEMENT OF GARY DISBROW, PH.D., ACTING DIRECTOR
BIOMEDICAL ADVANCED RESEARCH AND
DEVELOPMENT AUTHORITY, ACTING DEPUTY
ASSISTANT SECRETARY FOR PREPAREDNESS AND
RESPONSE
Dr. Disbrow. Chairman Blunt, Ranking Member Murray, and
Distinguished Members of this Committee, thank you for the
opportunity to testify today.
I want to highlight how BARDA is supporting efforts to
develop vaccines, treatments, and diagnostics in response to
the COVID-19 pandemic.
BARDA is a unique government organization created to bridge
the valley of death between basic research and late-stage
development of products, vaccines, therapeutics, and
diagnostics, collectively called medical countermeasures, to
address 21st Century health security threats.
In its brief 13-year existence, BARDA has formed over 300
industry partnerships and supported products that have received
55 FDA approvals.
BARDA staff are experts in government contracting and in
pharmaceutical and diagnostic development, many with over 25
years of experience working in the pharmaceutical industry.
BARDA has a track record of success in delivering effective
medical countermeasures in response to public health
emergencies. Past examples include H1N1, Ebola, and Zika.
BARDA has unique authorities, allowing my organization to
leverage and rapidly expand partnerships to push candidates
forward to the review, testing, and approval phase.
BARDA's longstanding expertise in accelerating the advanced
research and development of candidate diagnostics,
therapeutics, and vaccines is a testament to its dedicated and
experienced team.
I want to thank my BARDA colleagues as they work long hours
and weekends to support this response.
In the typical fiscal year, BARDA's highly-experienced
contracting professionals invest approximately $1.6 billion to
support the development of MCMs (medical countermeasures) to
address chemical, biological, radiological, and nuclear
threats, and pandemic influenza.
This year, in addition, in just 3 months, we have obligated
over 3.5 billion as part of the COVID-19 response. BARDA has
leveraged funds provided under the CARES Act and additional
funds from HHS to invest in multiple vaccine candidates,
multiple therapeutic programs, and multiple diagnostics. Twelve
diagnostics have been granted emergency use authorization by
the FDA. The BARDA COVID-19 portfolio now supports over 40
projects.
When HHS Secretary Azar declared a public health emergency
in January, BARDA immediately responded. ASPR/BARDA established
an interagency call with industry highlighting our high-level
strategy for the development of vaccines, therapeutics, and
diagnostics to address COVID-19, attracting over 1,500
participants.
That same day, BARDA opened a medical countermeasure portal
to accept market research submissions from stakeholders,
receiving over 3,300 submissions to date.
Prior to receiving supplemental funds, BARDA modified our
two solicitations to allow for submissions of COVID-19-specific
products. To date, we have received over 267 submissions under
our broad agency announcement or BAA and 426 to our Easy BAA, a
streamlined solicitation with a cap of 750,000 in funding.
This is what we do. We engage innovative stakeholders,
establish partnerships, develop medical countermeasures and
bring them forward to the American people to save lives.
Early in the COVID-19 outbreak, BARDA developed our
strategy for medical countermeasure development. For vaccines,
our strategy was to engage with vaccine manufacturers,
developing different platform technologies, some already
licensed by the FDA or nearing licensure, and who had
established manufacturing processes to quickly manufacture
large quantities of vaccine.
Our therapeutics strategy was similar, invest in multiple
technologies to increase our chances of success. For
diagnostics, our strategy was to invest in multiple
technologies, molecular, antigen, and antibody-based tests.
Prior to the first COVID supplemental, BARDA made initial
investments in the development of vaccines, therapeutics, and
diagnostics, using our existing funding and authorities. This
early strategy has partially served as the basis for Operation
Warp Speed's strategy or OWS.
OWS is an unprecedented collaboration between the
Department of Health and Human Services and the Department of
Defense to expedite development of vaccines, therapeutics, and
diagnostics and bringing them to the American people.
OWS aims to deliver up to 300 million doses of safe and
effective vaccines for COVID-19 in early 2021 as part of a
broader strategy to accelerate the development, manufacturing,
and distribution of COVID-19 vaccines, therapeutics, and
diagnostics for the American people.
BARDA is a key component of OWS, along with various NIH
institutes, the CDC, and DOD. The primary goal of OWS is to
develop safe and effective medical countermeasures.
As a USG effort, we will need to take financial risks to
expedite the development of vaccines and therapeutics. The key
to success is to invest in multiple candidates and support
parallel development activities to meet the expedited
timelines.
The risk is purely financial, a financial risk of
manufacturing large amounts of medical countermeasures while
we're still determining the safety and efficacy. We will not
risk the safety of these products. This financial risk is
necessary to ensure MCMs are available for use as soon as the
FDA has deemed them safe and effective.
Some of our investments will be in products that do not
make it. This is the financial risk that we must take because
the risk in lives lost and the impact to our economy is far
greater.
This committee and Congress at large have been very
supportive of BARDA and our mission and we are very thankful.
Today, more than ever, we need your continued support and
flexibility to ensure our staff can stay focused on the task at
hand.
I look forward to discussing how we can work together on
this important issue.
Thank you.
[The statement follows:]
Prepared Statement of Francis Collins, M.D., P.h.D.,
Robert R. Redfield, M.D., and Gary Disbrow, Ph.D.
Chairman Blunt, Ranking Member Murray and distinguished members of
this committee.
It is an honor to appear before you today to discuss the Department
of Health and Human Services' Operation Warp Speed efforts and the
Department's efforts on vaccines, diagnostics, and therapeutics. We are
grateful for this opportunity to address how each of our agencies and
offices are harnessing innovation to prevent, diagnose, and treat the
novel coronavirus SARS-CoV-2.
COVID-19 is a new disease, caused by a novel (or new) coronavirus
that has not previously been seen in humans. This new disease,
officially named Coronavirus Disease 2019 (COVID-19) by the World
Health Organization (WHO), is caused by the SARS-CoV-2 virus. There are
many types of human coronaviruses including some that commonly cause
mild upper- respiratory tract illnesses. Coronaviruses are a large
family of viruses. Some cause illness in people, and others, such as
canine and feline coronaviruses, only infect animals. Rarely,
coronaviruses that infect animals have emerged to infect people and can
spread between people. This is suspected to have occurred for the virus
that causes COVID-19. Middle East Respiratory Syndrome (MERS) and
Severe Acute Respiratory Syndrome (SARS) are two other examples of
coronaviruses that originated in animals and then spread to people.
The Department of Health and Human Services (HHS) is working
closely with all of our government partners in this response. We thank
Congress for supporting our efforts through the passage of the
Coronavirus Preparedness and Response Supplemental Appropriations Act,
2020; the Families First Coronavirus Response Act; the Coronavirus Aid,
Relief, and Economic Security (CARES) Act; and the Paycheck Protection
Program and Health Care Enhancement Act. These laws have provided
additional resources, authorities, and flexibility. We thank Congress
for your continual partnership that has allowed us to expedite this
critical effort to respond to COVID-19.
To accelerate the development and subsequent production of a
vaccine for COVID-19, in mid-May, President Trump announced Operation
Warp Speed (OWS). OWS aims to deliver up to 300 million doses of a safe
and effective vaccine for COVID-19 in early 2021, as part of a broader
strategy to accelerate the development, manufacturing, and distribution
of COVID-19 vaccines, therapeutics, and diagnostics (collectively known
as countermeasures). OWS is a partnership among components of HHS,
including CDC, FDA, NIH, and BARDA, and the Department of Defense
(DoD), with the aim of a unified government approach to respond to the
pandemic. OWS engages with private firms and other Federal agencies,
including the Department of Agriculture, the Department of Energy, and
the Department of Veterans Affairs. OWS coordinates with existing HHS-
wide efforts, including the NIH's Accelerating COVID-19 Therapeutic
Interventions and Vaccines (ACTIV) partnership, NIH's Rapid
Acceleration of Diagnostics (RADx) initiative, and work by BARDA and
the National Institute of Allergy and Infectious Diseases (NIAID).
To accelerate development while maintaining standards for safety
and efficacy, OWS has been selecting the most promising countermeasure
candidates and providing coordinated government support. Protocols for
the demonstration of safety and efficacy are being aligned, which will
allow the trials to proceed more quickly, and the protocols for the
trials will be overseen by the Federal Government, as opposed to
traditional public-private partnerships, in which pharmaceutical
companies decide on their own protocols. Rather than eliminating steps
from traditional development timelines, steps will proceed
simultaneously, such as starting manufacturing of the vaccine at
industrial scale well before the demonstration of vaccine efficacy and
safety, as happens normally. This increases the financial risk, but not
the product risk.
We will be working constantly with the FDA, sending a constant
stream of data to their scientists. Once the data are complete, FDA
will perform the analysis they need to determine safety and efficacy as
quickly as possible. The FDA will pursue its regulatory work in the
standard manner, and by keeping the lines of communication open, they
can produce ongoing guidance to support the clinical trials for the OWS
candidates, as they often do for agency priorities.
To put it really simply, drug development is a series of boxes you
have to check--very complicated boxes, but boxes nonetheless. You
proceed through the different development phases, you need
certification of your manufacturing processes, then you begin large
scale manufacturing, and then you begin distribution. OWS requires
checking each and every one of those boxes just like we would for any
other project, but we aren't going one by one down the list. We're
aiming to check as many of them simultaneously as we can.
The following testimony will detail how the NIH, BARDA and CDC are
contributing to OWS and overall vaccine, therapeutic, and diagnostic
efforts.
national institutes of health
NIH is the HHS agency leading the research response to COVID-19 and
the novel coronavirus that causes the disease, SARS-CoV-2. Research to
address the COVID-19 public health emergency is an NIH-wide effort.
NIH, in collaboration with the Foundation for the NIH, recently
launched an innovative public-private partnership to speed the
development of COVID-19 therapeutics and vaccines.
The ACTIV public-private partnership brings together stakeholders
from across the U.S. government, industry, and the European Medicines
Agency to develop an international strategy for a coordinated research
response to the COVID-19 pandemic. Other Federal partners include
BARDA, DoD, the Department of Veterans Affairs, CDC, and FDA. The ACTIV
working groups are making rapid progress. For example, the Therapeutics
Clinical Working Group developed and openly shared master protocols
with agreed upon endpoints, sampling, and analysis for evaluating
monoclonal antibody and vaccine candidates, in order to enhance trial
efficiency.
Developing Vaccines to Prevent SARS-CoV-2 Infection
A safe and effective vaccine for SARS-CoV-2 will be essential to
stopping the spread of infection, reducing rates of morbidity and
mortality, and preventing future outbreaks.
HHS NIAID is supporting development of several SARS-CoV-2 vaccine
candidates, including vaccines based on platform technologies that have
shown promise against the coronaviruses that cause SARS and MERS. As
part of a longstanding collaboration, the NIAID Vaccine Research Center
worked with the biotechnology company Moderna, Inc., to develop a
vaccine candidate using a messenger RNA (mRNA) vaccine platform
expressing the SARS-CoV-2 spike protein. On March 16, 2020, NIAID
initiated a Phase 1 clinical trial of this experimental vaccine at the
Kaiser Permanente Washington Health Research Institute, and later added
clinical sites at Emory University and the NIH Clinical Center. This
trial was recently expanded to enroll older adults to better define the
safety of and immune response to the vaccine across various age groups.
On May 18, 2020, Moderna announced encouraging interim findings from
the Phase 1 clinical trial and, on May 29, 2020, a Phase 2 clinical
trial was initiated to further study safety and the immune response to
the experimental mRNA vaccine. NIAID and BARDA are working with Moderna
to launch a Phase 3 clinical trial as early as this month, pending
positive results from this Phase 2 trial. The Coalition for Epidemic
Preparedness Innovations funded the manufacture of the vaccine
candidate for the Phase 1 trial, and BARDA is supporting advanced
development of the candidate.
Scientists at NIAID's Rocky Mountain Laboratories in Hamilton,
Montana have collaborated with University of Oxford researchers to
develop a SARS-CoV-2 chimpanzee adenovirus-vectored vaccine candidate
AZD1222, formerly known as ChAdOx1, now in a Phase 3 clinical trial in
the United Kingdom, supported by the University of Oxford. BARDA
recently announced plans to support advanced development and production
of AZD1222 in the U.S. NIAID is working with additional academic and
industry partners to develop several other vaccine concepts.
The rigorous clinical testing required to establish vaccine safety
and efficacy means that it might take some time for a licensed SARS-
CoV-2 vaccine to be available to the general public, but there is
growing optimism that one or more of these vaccine candidates may prove
safe and effective by late 2020 or early 2021.
Identifying Therapeutics to Treat COVID-19
Effective therapeutics for COVID-19 are critically needed to treat
patients who have been infected with SARS-CoV-2. On February 21, 2020,
NIAID launched a multicenter, randomized placebo-controlled clinical
trial, the Adaptive COVID-19 Treatment Trial (ACTT), to evaluate the
safety and efficacy of therapeutics for COVID-19, initially examining
the antiviral drug remdesivir for treatment of severe COVID-19 in
hospitalized adults (ACTT-1). An analysis of preliminary data from
ACTT-1 indicated that those who received remdesivir had a 32 percent
faster time to recovery, a median of 11 days compared with 15 days for
those who received placebo. Additionally, the analysis found that
remdesivir may benefit survival, although the mortality data did not
reach statistical significance. A mortality rate of 7.1 percent was
observed for the group receiving remdesivir versus 11.9 percent for
placebo. These initial findings were published on May 22, 2020, in the
New England Journal of Medicine. Working as part of the ACTIV
partnership, NIAID is developing and testing other novel and repurposed
therapies. The adaptive design of this trial will enable the evaluation
over time of additional promising therapies, such as the anti-
inflammatory drug baricitinib, which has been added to the next
iteration of the study (ACTT-2), currently underway.
Another promising therapeutic is the use of monoclonal antibodies
or mAbs. There are 21 companies developing mAbs and a number of them
have started early clinical trials. As part of the ACTIV partnership,
and in collaboration with other NIH Institutes, NIAID plans to launch a
study to evaluate mAbs in outpatients with mild-to-moderate COVID-19
early this month. A separate trial will evaluate mAbs in inpatients.
NIAID also is planning separate clinical trials to assess hyperimmune
intravenous immunoglobulin and mAbs for treatment of COVID-19 in
hospitalized adults.
The National Heart, Lung, and Blood Institute (NHLBI) sponsored the
addition of a U.S. site for a Canadian Institutes for Health Research-
funded trial of colchicine--an anti- inflammatory drug commonly used to
treat gout--for treating COVID-19 in the outpatient setting.
Additionally, NHLBI is leveraging the NIH-funded Strategies to Innovate
Emergency Care Clinical Trials Network to study whether convalescent
plasma, or blood plasma from individuals who have recovered from COVID-
19, can help reduce the progression of COVID-19 in patients with mild
symptoms. In the near future, NHLBI will begin a clinical trial on the
use of anticoagulants, hoping to stem the life-threatening blood clots
that COVID-19 causes in many patients.
The National Center for Advancing Translational Sciences (NCATS) is
leveraging the NCATS Pharmaceutical Collection, a compilation of every
drug approved for human use by major regulatory agencies worldwide, and
other collections of small molecules and compounds to identify
potential SARS-CoV-2 therapeutics for further investigation. Other
Institutes and Centers across NIH also are working concurrently with
partners in academia and industry to pursue the development and testing
of mAbs, antiviral, and anti-thrombotic drugs for potential treatment
of COVID-19. NIAID, NCI, NHLBI, NCATS, the National Institute of
Arthritis and Musculoskeletal and Skin Diseases, and the National
Institute of Neurological Disorders and Stroke (NINDS) are all engaged
in this critical effort.
NIH also has convened the COVID-19 Treatment Guidelines Panel,
comprised of representatives of NIH and five other Federal agencies
along with representatives of eight professional organizations,
academic experts, and treating physicians including providers from high
COVID-19 incidence areas. On April 21, 2020, the panel issued the first
release of COVID- 19 treatment guidelines for clinicians. The
guidelines provide recommendations regarding specific treatments
currently available and address considerations for special populations,
including pregnant women and children. On May 12, 2020, in response to
the preliminary analysis of ACTT-1, the Panel updated these treatment
guidelines to recommend remdesivir for the treatment of COVID-19 in
hospitalized patients with severe disease requiring supplemental
oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
The guidelines are updated regularly as new evidence-based information
emerges, including the recent report of benefit of the drug
dexamethasone in hospitalized patients, based on results of a
randomized trial in the United Kingdom.
Enhancing Diagnosis and Understanding the Pathogenesis of COVID-19
NIH is supporting an HHS-wide effort to promote the development and
commercialization of diagnostic tests to detect current SARS-CoV-2
infection. On April 29, 2020, NIH announced the Rapid Acceleration of
Diagnostics (RADx) initiative, which is working to identify, support,
and make innovative strategies for COVID-19 testing widely accessible,
in collaboration with FDA, CDC, and BARDA. The RADx initiative has four
focused programs to scale-up testing and enhance access to those most
in need. The RADx Tech initiative is leveraging the Point-of-Care
Technologies Research Network established by the National Institute of
Biomedical Imaging and Bioengineering (NIBIB) to allow for the
potential roll out of new products by fall 2020. NIH has received over
2,000 expressions of interest and over 500 complete applications for
RADx Tech. Innovators will be matched with technical, clinical,
regulatory, business, and manufacturing experts to increase the odds of
success. So far, nine companies have products in Phase 1 testing and
are close to commercialization. In addition, NIAID is using CARES Act
funds to support diverse SARS-CoV-2 diagnostic platforms including RT-
PCR and enzyme-linked immunosorbent assays, and facilitating
development of sensitive, specific, and rapid diagnostic tests by
providing critical SARS-CoV-2 isolates and reagents to the developers
of tests.
The RADx Underserved Populations (RADx-UP) initiative will augment
the reach and power of technologies developed and enhanced through RADx
by identifying and addressing implementation factors that present
barriers to testing and follow-up in populations that need it the most.
On June 12, 2020, NIH announced four new funding opportunities for
community- engaged projects within RADx-UP. The goal of this is to
understand factors that have led to disproportionate burden of the
pandemic on vulnerable populations so that interventions can be
implemented to decrease these disparities.
The National Cancer Institute is coordinating with FDA and NIAID to
assess the sensitivity and specificity of certain SARS-CoV-2
serological tests, which can detect antibodies indicative of a prior
exposure to SARS-CoV-2. NCI and NIAID also are working to establish a
collaborative national network to increase national capacity for high-
quality serological testing with return-of-results to subjects. In
addition, they will conduct research to increase the understanding and
application of those results and support related clinical efforts,
including clinical trials of convalescent serum and the creation of
registries of tested subjects for sero-protection studies.
NIAID, NCI, NCATS, and NIBIB also are partnering on a new study to
investigate whether adults in the United States without a confirmed
history of infection with SARS-CoV-2 have antibodies to the virus,
indicating prior infection. In addition, NIH is supporting COVID-19
natural history studies to understand the incidence of infection in
specific populations, including children and their household contacts,
and aspects of the clinical course of infection, including incidents of
thrombosis, strokes, heart attacks, and other sequelae of infection.
Some of these studies will examine the quality and durability of the
immune response to SARS-CoV-2 and evaluate whether unique immune
responses may be associated with clinical disease trajectories; this
information may be leveraged to develop SARS-CoV-2 therapeutics or
vaccines. Natural history studies also will inform our understanding of
COVID-19 pathogenesis, including factors that may predict disease
progression and help to identify individuals or groups at high risk.
In order to improve understanding of neurological consequences of
SARS-CoV-2 and inform potential treatment strategies, NINDS is
supporting development of a database that would collect data on the
prevalence and spectrum of neurological symptoms observed in patients
with SARS-CoV-2 infection. NHLBI and the Eunice Kennedy Shriver
National Institute of Child Health and Human Development are leading a
trans-NIH effort, with participation from NIAID, to coordinate research
into the multisystem inflammatory syndrome in children (MIS-C), an
extremely serious inflammatory condition that has been associated with
SARS-CoV-2 infection in children and adolescents.
NIH continues to expand efforts to elucidate the viral biology and
pathogenesis of SARS-CoV-2 and employ this knowledge to develop the
tools needed to diagnose, treat, and prevent disease caused by this
virus. NIH is focused on developing and evaluating safe and effective
COVID-19 vaccines and therapeutics, and sensitive, specific, and rapid
point-of-care molecular diagnostic and serological tests. These efforts
will improve our response to the current pandemic and bolster our
preparedness for the next, inevitable emerging disease outbreak.
centers for disease control and prevention
CDC has worked for decades with its State and local partners to
ensure public health systems are prepared with plans, trained
personnel, strategic relationships and partnerships, data systems, and
other resources needed for sustaining a successful routine immunization
infrastructure, which will help ensure effective distribution can occur
once a safe and effective COVID-19 vaccine is available.
CDC is working closely with our government partners in response to
this pandemic, including with our sister agencies at HHS. Each year
through the Vaccines for Children program and the section 317
immunization program and in partnership with State immunization
programs, CDC safely distributes over 80 million doses of vaccines from
every vaccine manufacturer to approximately 40,000 public and private
health providers across the country. We have strong networks connecting
public health departments, healthcare providers, community groups, and
others that can be used to efficiently reach the population. From these
sites, vaccine may be transported in small quantities to clinical sites
for immediate use, while maintaining cold chain. During an emergency,
this proven system has the capacity leveraged to manage and distribute
many more doses of vaccine than in a typical year.
For decades, CDC's public-private partnerships have safely
distributed tens of millions of doses of routinely recommended vaccines
to thousands of provider sites each year. CDC's experience shows the
importance of strategic engagement across public and private components
of the vaccine enterprise in a collaborative effort to ensure
appropriate planning and coordination from development and
manufacturing, to distribution, administration, and tracking. Early
engagement and planning can help ensure quick and efficient bi-
directional exchange of information, so that everything needed to
administer the vaccine, including personal protective equipment, is
available where and when it is needed. And finally, the public must be
well- informed, and misinformation must be addressed with timely,
accurate, and trusted information.
CDC tracks and manages public vaccine inventory through its vaccine
ordering system, allowing visibility into vaccine supply nationwide.
CDC monitors vaccination coverage across the country providing
national, regional, and local level data that can inform decisionmaking
and outreach priorities. Vaccine coverage is monitored by jurisdictions
through their Immunization Information Systems and CDC's National
Immunization Surveys. Suspected adverse events are captured through the
Vaccine Adverse Event Reporting System and evaluated through the
Vaccine Safety Datalink. Together these systems help streamline the
inventory management of Federal vaccine assets; monitor national,
regional, State, local vaccination coverage to guide targeted outreach
and program priorities; inform vaccine program modifications based on
vaccine safety findings; implement outreach and program activities;
tailor communications and provider education; and coordinate data
sharing across jurisdictions.
Building on lessons learned from the 2009 H1N1 pandemic and CDC's
experience with routine domestic and global vaccine delivery, there are
many critical components to consider in rapid implementation of a new
vaccine during and in response to a pandemic. Many of these factors
will be determined by the vaccine or vaccines that are licensed for
use, and when and how much vaccine is available. Priority populations
for receiving the initial supply of vaccine will need to be identified.
This could be based on high-risk for exposure, high-risk for disease or
other factors. In addition, critical plans will need to be developed
for how the vaccine is allocated, distributed, and administered across
the United States. These decisions have implications for both the
public and private sectors, including who pays for the vaccine and
administration fees, where and by whom vaccine is administered, and how
to ensure equity and avoid disparities in access. Monitoring supply,
tracking who received vaccine, especially if more than one dose is
needed, and assessing vaccination coverage are important. Critical to
success of the Nation's immunization program is ensuring vaccine
safety, effectiveness, and ultimately confidence in the Nation's
immunization programs and policies.
COVID-19 is not the only health threat in our midst. The 2020-2021
influenza (flu) season is fast approaching, posing a risk of serious
complications, hospitalization, or death, even among otherwise healthy
children and adults. Pediatric outpatient visits and routine childhood
vaccination have also declined substantially in recent months, leaving
children and communities at risk for preventable disease outbreaks.
Utilization of core preventive services has been disrupted by COVID-19.
In order to ensure adequate hospital and medical care capacity, we must
work aggressively to increase influenza and other routine childhood
immunizations. Further, as we continue to fight the pandemic, it is
important that Americans have confidence in all vaccines. CDC will
leverage its immunization program to help maintain high coverage in
routine childhood immunizations, to increase coverage for flu
vaccinations, and prepare for a potential COVID-19 vaccine.
CDC's Immunization Program
Vaccines are one of public health's greatest achievements.
Investments in CDC's immunization program have improved the health of
Americans. The immunization of children in the United States has saved
millions of lives, contributed to longer life expectancy, reduced
health disparities, improved quality of life, and saved trillions of
dollars in societal costs.
Immunizations have become a routine part of how we care for our
children. Coverage for many childhood vaccinations are at, near, or
above 90 percent, and reported cases for most vaccine preventable
diseases have decreased by 90 percent or more in the United States with
the introduction of vaccines. Adults need vaccines too. Every year
thousands of adults in the U.S. become seriously ill and are
hospitalized because of diseases that vaccines can help prevent.
CDC's immunization program plays a fundamental role in achieving
national immunization goals and sustaining high vaccination coverage
rates to prevent death and disability. The signature pieces of this
program include the Vaccines for Children (VFC) entitlement program and
CDC's discretionary Section 317 Immunization Program.
VFC is one of the largest and most successful public-private
partnerships, designed to ensure that eligible children do not contract
vaccine-preventable diseases because of inability to pay. Approximately
50 percent of children from birth to 18 are eligible to receive free
vaccine through VFC as part of routine care, supporting the
reintegration of vaccination and primary care. CDC works with its 61
awardees to distribute vaccines directly to more than 40,000 public and
private providers enrolled in the VFC program. VFC has been
instrumental to achieving high childhood and adolescent vaccination
coverage rates and reducing disparities.
The Section 317 Immunization Program is a national resource that
will continue to fill critical public health needs, such as providing a
safety net for adults with no health insurance and responding to
outbreaks of vaccine preventable diseases (VPDs) and other urgent
public health issues. The program supports the Nation's ability to
maintain public health preparedness for a response to a vaccine-
preventable emergency, such as a pandemic or biological attack. To
implement the program, CDC works collaboratively with 64 awardees
comprised of the 50 States, six large cities including the District of
Columbia, five territories, and three Pacific Freely Associated States.
CDC's support of national, State and local programs has
dramatically improved access to vaccination for all children and put
systems in place to detect and respond to outbreaks of VPDs and to
monitor vaccine effectiveness and safety. However, we know from our
surveys and data systems that COVID-19 interrupted access to routine
medical services. CDC observed notable declines in pediatric outpatient
visits and routine childhood vaccination since March, leaving some
children and communities at risk for preventable disease and outbreaks.
Corresponding declines were also observed in the number of measles-
containing vaccine doses administered in eight U.S. healthcare
organizations serving publicly and privately insured patients. On a
positive note, however, we have started to see recovery in vaccine
ordering data.
CDC is working with partners to catch up and restore the high
levels of immunization. Fortunately, these efforts will provide
opportunities to develop innovative systems and partnerships that will
pave the way for COVID-19 vaccine distribution. For example, CDC is
supporting providers in the safe administration of vaccines during the
COVID-19 pandemic through development of guidance and support materials
and helping to support catch-up vaccination for children who missed
visits through the use of reminder/recall systems. CDC is increasing
communication efforts to remind parents, providers and partners of the
importance of routine vaccinations during the COVID-19 pandemic and
expanding outreach to provide information about the VFC program to
families, especially those who may have recently lost insurance
coverage. CDC is also working with partners to encourage back-to-school
vaccination activities during the summer and influenza vaccination in
the fall. Continued coordinated efforts between healthcare providers
and public health officials at the local, State, and Federal levels
will be needed to restore and maintain routine pediatric vaccination
services during the pandemic.
Another activity that is key to effective distribution and uptake
of COVID-19 vaccine is ensuring people have accurate information to
make decisions about getting the vaccine.
Preparing for COVID-19 Vaccines
CDC is working closely with the interagency staff to determine a
path forward on critical issues related to a COVID-19 vaccine program
through OWS. CDC stands ready to use its expertise in public health
preparedness and response along with its immunization infrastructure to
support OWS in vaccine promotion, distribution, administration, and
monitoring. Congress's recent investments through the Coronavirus Aid,
Relief, and Economic Security Act have allowed CDC to provide its
immunization awardees $140 million in supplemental funding to support
and enhance their immunization programs. This supplemental funding will
be used to support awardee and local health department staffing,
communications campaigns, pandemic preparedness, and mass vaccination.
In addition to other COVID-19 vaccine response work, awardee activities
will include a specific focus on enhancing influenza coverage,
especially in historically underserved populations, and enrolling and
working with additional vaccinators (e.g., pharmacists, mass
vaccinators).
Scientifically-based vaccine policies are a foundation of the U.S.
immunization system. In the U.S., the Advisory Committee on
Immunization Practices (ACIP) advises the CDC Director on national
vaccine policy for preventing infectious diseases in the civilian
population. The immunization systems and expertise supported by CDC's
immunization program make substantial contributions to the evidence
base that informs immunization recommendations made by ACIP. The ACIP
makes recommendations based upon data about the burden of disease,
safety and efficacy of vaccines, economic analyses, including cost-
effectiveness data, and information about other factors such as how
recommendations can be implemented by the healthcare system in
conjunction with other recommended vaccines.
To prepare for potentially FDA-licensed COVID-19 vaccines, ACIP has
established a workgroup that is evaluating safety and immunogenicity
data of vaccine candidates, as well as the epidemiology of COVID-19 to
target populations and priorities for vaccination. ACIP workgroups are
responsible for collection, analysis, and preparation of information
for presentation, discussion, deliberation, and vote by the ACIP in an
open public forum. While the ACIP workgroup does not have the authority
to act on behalf of the advisory committee and they cannot vote on ACIP
vaccine recommendations, workgroups review specific topics in detail
and clarify issues in a way that helps ACIP voting members make
informed and efficient decisions, with the best and most current
information available. ACIP meets routinely approximately three times
per year (February, June, October), but may meet more frequently as
needed. An additional meeting to discuss COVID-19 vaccines is already
being planned for August 2020. In addition, under exceptional
circumstances, an emergency ACIP meeting may be called without prior
notice. If COVID-19 vaccines became available, it is expected that an
emergency meeting will be called for the vaccine to receive
consideration.
Experience shows that, while vaccines are powerful tools, reaching
every individual who would benefit from an immunization is not easy.
For example, persistent racial and ethnic disparities exist among adult
influenza vaccination rates with 9 percent and 12 percent lower
coverage among black, non-Hispanics and Hispanics, respectively, as
compared to the vaccination rate of whites.\1\ To ensure that every
American has access to the COVID-19 vaccine will require enhanced
partnerships across sectors. This can build on and expand on existing
partnerships that are in place for routine immunizations, and can also
leverage other public health programs as well as the private sector. It
is also important to recognize that the COVID-19 pandemic has affected
the ways people engage with the healthcare system, and that a
successful vaccine program will need to incorporate various sites and
approaches for vaccine administration. For example, worksites that have
served as locations for adult immunization may be less accessible due
to increased telework, so other complementary sites such as pharmacies
and innovative locations that work for a given community may be more
important during our response to this pandemic. Regardless of
traditional or complementary vaccine provider site, it will be critical
to ensure that all sites are linked to data monitoring systems.
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\1\ CDC. Flu Vaccination Coverage, United States, 2018-19 Influenza
Season. Available from: https://www.cdc.gov/flu/fluvaxview/coverage-
1819estimates.htm.
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A final public health consideration relates to the management of
the vaccine itself--every vaccine has requirements regarding storage
and handling that must be addressed in order for the vaccine to be
effective when administered. Most vaccines require refrigeration, while
others require being held at specific temperatures beyond the capacity
of regular refrigerators. Ensuring that the cold chain is maintained
from the point of manufacture until the time of use is a significant
concern in any vaccination program. Improper storage can lead to
vaccine being wasted, or more importantly, reduce its effectiveness.
Careful consideration of all of these factors will be critical to
ensuring that the investments that have been made in the development of
a vaccine for COVID-19 achieve their intended purpose--protecting
Americans from the threat of this novel coronavirus.
Preparing for the 2020-2021 Influenza Season
Unfortunately, COVID-19 is not the only public health threat we are
facing. CDC is also working to increase vaccination coverage for the
2020-2021 flu season. This is an important public health goal in its
own right, but also serves two important purposes related to COVID-19.
First, increasing vaccine coverage this fall can reduce the strain on
the healthcare system, which will be facing COVID-19 at the same time
as seasonal influenza. Second, it is another opportunity to test the
systems and infrastructure that will be leveraged to deliver a COVID-19
vaccine.
During the 2018-2019 flu season, only 49 percent of the U.S.
population received the flu vaccine. Still, flu vaccination helped to
prevent 4.4. million flu illnesses, 58,000 flu-related
hospitalizations, and 3,500 deaths. Any flu infection can carry a risk
of serious complications, hospitalization or death, even among
otherwise healthy children and adults. Increased flu vaccination
coverage will protect more Americans from this seasonal health threat,
while decreasing stress on the healthcare system.
CDC is committed to the goal of increasing flu vaccine uptake,
especially in people at higher risk of serious flu and COVID-19
outcomes. We will continue to work with our public health and clinical
partners to eliminate barriers to vaccination. The ongoing COVID-19
pandemic may affect where and how vaccines are given, and we are
working with health departments to develop contingency plans. CDC is
also looking at operational considerations such as access to vaccine
with potential need for social distancing, and prolonging vaccine
uptake throughout the flu season. CDC is making additional influenza
vaccine available to State health departments for uninsured adults at
higher risk for morbidity and mortality. To support this effort, we are
enhancing communications to target audiences, including older
Americans, persons with disabilities, people of any age with underlying
health conditions, workers in long- term care facilities, other
essential workers, African Americans, and Hispanics. Understanding that
African American and Hispanic communities have lower rates of flu
vaccination and a higher risk for COVID complications, we will enhance
our education and communication efforts toward these key communities.
We will be assessing the impacts the pandemic may have on vaccination,
evaluating the quality of communications with patients regarding
vaccinations, and focusing on influenza vaccination and African
American and Hispanic patients.
We are taking many considerations into account in our efforts to
expand flu vaccine coverage and focusing on specific efforts to address
racial and ethnic disparities. Specifically, CDC will be working with
the National Association for Community Health Centers to implement
evidence-based strategies to increase adult vaccination coverage among
underserved priority populations. We will be engaging in expert
consultation to develop strategies for addressing racial and ethnic
disparities in adult immunization, soliciting simultaneous individual
expert opinion from 15 national leaders in health disparities, health
equity, and social determinants of health.
On June 4, CDC awarded $140 million from the CARES Act to 64
jurisdictions through CDC's existing immunization cooperative agreement
to enable State health departments to launch an initial scale up for
influenza season, given the increased risk of COVID-19. Funds will
begin to support staffing and preparedness early this summer and focus
on ensuring flu coverage for vulnerable populations.
There are many critical components to consider in implementation of
a pandemic vaccine. Many of these factors will be determined by the
availability and characteristics of licensed vaccines and the priority
populations identified for receiving the vaccines. Critical to success
of the vaccine program is ensuring vaccine safety, effectiveness, and
ultimately vaccine confidence. COVID-19 is the most significant public
health challenge to face our Nation in more than a century. CDC is
building upon our existing programs to provide the American public with
the information and assistance it needs to address COVID-19 head on,
while simultaneously working with our State and local public health
partners to maintain routine childhood immunization coverage and
prepare for the upcoming flu season. As we continue to work together to
fight COVID-19 and end this pandemic, CDC is committed to its mission
to protect all Americans from disease.
assistant secretary for preparedness and response, biomedical advanced
research and development authority
ASPR's Role in Response
The Assistant Secretary for Preparedness and Response's (ASPR)
mission is to save lives and protect Americans from 21st century health
security threats. During previous public health emergencies, ASPR has
led, on behalf of HHS, Emergency Support Function #8: Public Health and
Medical Services, under the National Response Framework. This means
ASPR serves as the primary coordinator for public health information
and deployment of assets to support the health components of a
response.
For the current COVID-19 pandemic response, ASPR. funding has been
used to not only to accelerate development of medical countermeasures
under BARDA but also to deploy trained medical teams to augment care in
communities overwhelmed with COVID-19 cases, enter into contracts to
resupply personal protective equipment and other critical components
deployed from the Strategic National Stockpile (SNS) to aid in the
treatment of persons with or suspected of having COVID-19 and provide
grants to hospital associations and healthcare centers to aid in the
ongoing response. We appreciate this Committee's support of our efforts
and are utilizing the provided funds to ensure communities have the
tools and resources to detect and treat those diagnosed with or
suspected of having COVID-19.
Vaccine Development Efforts
Since late January, BARDA has collaborated with counterparts across
the government to identify potential COVID-19 medical countermeasure
candidates and accelerate their development. BARDA has a track record
of success in delivering effective countermeasures in response to
public health emergencies. Past successes include the 2009 H1N1
influenza pandemic, Ebola outbreaks in 2014-2016 in West Africa and in
2018 the Democratic Republic of the Congo, as well as the Zika outbreak
in 2015. For these past response operations as well as the current
response to COVID-19, Congress has provided emergency supplemental
funding to support the urgent need for medical countermeasure
development.
At the onset of the pandemic, BARDA reviewed investments, modified
contracts, and began working with Regeneron, Janssen, and Sanofi
Pasteur to initiate the development of vaccines and therapeutics for
COVID-19. All three have successfully developed both prophylactic and
therapeutic medical countermeasures for emerging infectious diseases in
the recent past. BARDA's early leveraging of these existing
partnerships and established platforms may help shave months off the
development timelines for medical countermeasures and has been made
possible by flexible authorities authorized and provided by Congress as
well as prior investment into these platforms.
The BARDA portfolio now includes over 40 medical countermeasure
projects including nine therapeutics, 26 diagnostics (12 of which have
been granted Emergency Use Authorization by the FDA) and five vaccine
candidates. Three of these five candidates are operating under OWS. On
March 30, 2020, HHS announced $456 million in funds for Janssen's (part
of Johnson & Johnson) candidate vaccine, with Phase 1 clinical trials
set to begin this summer. On April 16, 2020, HHS awarded $483 million
to support Moderna's candidate vaccine, which began Phase 1 trials on
March 16 and received a fast-track designation from the FDA. Lastly, on
May 21, 2020, HHS announced up to $1.2 billion in support for
AstraZeneca's candidate vaccine, developed in conjunction with the
University of Oxford.
It is important to note that we are strictly adhering to and
following all required regulatory and safety requirements required for
vaccine development. We are not sacrificing the safety of the vaccine
in order to expedite its development. We are instead supporting two
steps at the same time. In addition to vaccine development, we are
supporting manufacturing efforts to ensure we are positioned to produce
and manufacture the vaccine quickly and effectively.
Specifically, we are making investments in the necessary
manufacturing capacity at Federal risk, giving companies confidence
that they can invest aggressively in development and allowing faster
manufacturing and potential distribution of an eventual vaccine.
Manufacturing capacity for selected candidates being advanced while
vaccine candidates are still in development, rather than scaled up
after approval or authorization. The May 21, April 16, and March 30,
2020, HHS agreements with AstraZeneca, Moderna, and Janssen/Johnson &
Johnson respectively include product development and investments in
large-scale manufacturing capabilities. Additionally, the June 1, 2020,
HHS task order with Emergent BioSolutions to advance domestic
manufacturing capabilities and capacity for a potential COVID-19
vaccine, as well as therapeutics, worth approximately $628 million.
Under the terms of the contracts for manufacturing capacity,
reservations can be shifted as needed from one candidate vaccine to
another more promising candidate based on the findings from clinical
trials that are being conducted in parallel with manufacturing scale-
up. OWS has also been working to address fill/finish capacity, to
acquire needles and syringes, and to expand domestic capacity for
manufacturing of needles, syringes, and vials.
BARDA is also working with and reviewing the capabilities and
capacity of our Centers for Innovation in Advanced Development and
Manufacturing (CIADMs). The CIADMs are government-sponsored facilities
that were created as public-private partnerships to establish domestic
manufacturing capacity and response capabilities in order to ensure the
Nation has adequate surge capacity for rapid medical countermeasure
production to address pandemics or other biological threats. The two
HHS CIADMs are Emergent BioSolutions in Baltimore, MD, and Texas A&M
University System in College Station, TX. Currently, AstraZeneca and
Janssen have reserved space at the Emergent facility to manufacture
vaccines at scale. In addition, BARDA is engaged in active discussions
to reserve and expand capacity at the Texas A&M University System
CIADM. Through OWS, manufacturing capacity at the DoD ADM, Ology
Bioservices Inc. could also be utilized if necessary. I would be happy
to keep the Committee updated on the progress of utilizing CIADMs as we
move forward in this space.
Since its establishment in 2006, ASPR has proven its success in
supporting past public health and medical emergencies. Whether the
organization supported hurricanes, floods, influenza outbreaks, and
other infectious diseases such as Pandemic Influenza, Ebola, Zika, or
the current COVID-19 pandemic, we have utilized the authorities and
resources provided by Congress to best support the Nation in responding
to the threat and mitigating the lasting impact. BARDA has successfully
established over 300 industry partnerships and obtained 55 FDA
approvals for medical countermeasures. Further, BARDA has worked with
its partners to develop robust platform technologies that facilitate
rapid development and manufacturing of medical countermeasures in the
face of a newly emerging threat.
Thank you again for your support. Your partnership and support
enable our mission accomplishment. I am confident that we can quickly
develop and distribute a safe and effective vaccine to reduce the
impact of COVID-19 to our Nation.
conclusion
HHS appreciates the support and interest of Congress in our work
related to Operation Warp Speed and the development of vaccines,
therapeutics, and diagnostics. Considering the potential health,
social, and economic benefits of getting a safe and effective vaccine
faster, placing big financial bets on these vaccines is a fiscal
investment for the Nation. One economic analysis put the costs of
nationwide stay-at-home orders at about $20 billion a day--to say
nothing of the lives that are being lost that we can save with faster
progress toward a vaccine. We're putting billions of dollars on the
line to solve a multi-trillion-dollar challenge.
We look forward to partnering with Congress and working together as
the country continues to open safely again. Thank you for the
opportunity to testify today and we look forward to your questions.
Senator Blunt. Well, thank you, Dr. Disbrow.
We're going to do our best to stick with 5 minutes so every
member has time. There will certainly be a second round and
everybody's going to be dissatisfied at the end of their first
5 minutes with what they didn't get to ask, but the person that
follows them will be particularly satisfied that they stayed
close to the 5 minutes.
VACCINE SAFETY
Dr. Collins, Dr. Disbrow just said development has not
risked safety.
Do you have any concerns on the vaccine side that FDA is
not going through every safety step that they would normally go
through?
Dr. Collins. Mr. Chairman, I have no concerns, and I'm
deeply engaged in this whole process, working with Operation
Warp Speed.
I think the ability to do things so quickly is not
compromising safety. It's taking advantage of other areas where
we can speed things up, even though it may involve doing
manufacturing at risk when we don't know yet whether that
vaccine is going to work and ultimately throw out a lot of what
gets manufactured if it doesn't work, but there will be no
compromise at all on the safety and the efficacy standards.
That is absolutely clear.
Senator Blunt. Dr. Disbrow, let's follow up immediately.
You mentioned the risk factor and Dr. Collins just said we will
throw out anything that's produced that doesn't go through the
final certification of safety and efficacy. Tell us a little
more about that process.
I also noticed you said we were engaged in review, testing,
and the approval phase. Are we engaged yet with anybody in the
manufacturing phase?
Dr. Disbrow. We are fully engaged with multiple companies
in the manufacturing phase under Operation Warp Speed. We're
investing in a diverse array of technologies, different
technologies, because we're uncertain of which vaccine
technology may produce a safe and effective vaccine.
We are doing, as Dr. Collins mentioned, manufacturing at
risk. This is a risk that we have to take if we want to
expedite the timeline. So there is a reason that the FDA is not
part of Operation Warp Speed. They are an independent
regulatory body and they will review the safety and efficacy,
but we will manufacture at risk large volumes of vaccine and
there is the potential that if those vaccines do not prove to
be efficacious in Phase 3 studies, that we would not move
forward with that vaccine.
Senator Blunt. All right. Every time I hear ``at risk,''
and I'm pretty comfortable with vaccines, I think, oh,
somebody's hearing at risk. I don't think we can emphasize
enough that what we're risking is losing some money that we
invested to move multiple products forward so that when the
products that did get through the whole process would be
available at maybe roughly the same time they're finally
approved for use.
Nothing will be more frustrating in this moment than for
FDA to certify a product and then hear it's going to be months
before that vaccine would be available, and am I right in
believing that those months are what you're trying to avoid
through BARDA?
Dr. Disbrow. That is correct. Again, under the entirety of
Operation Warp Speed, but, yes, BARDA is investing in multiple
vaccine candidates and you are exactly right. It is a financial
risk, it is not a safety risk, and we are manufacturing and the
government is assuming that financial risk.
Senator Blunt. And I'm sure we're going to talk more about
specific money later, but, remember, we've already invested $3
trillion to try to fight the virus and save the economy.
If somehow we lose $3 billion in an effort to get both of
those fights in the right place quicker, I think we all ought
to be willing to eagerly talk about the fact that, frankly, if
we don't lose some money, we didn't try hard enough.
If you choose six vaccines and they all make it, I think
the question will be, well, why didn't you choose eight
vaccines because again, as Dr. Disbrow pointed out, that all of
these vaccines will be slightly different than the other
vaccine.
When you get a vaccine for COVID, am I right in assuming
that people will not all get the same vaccine in all likelihood
for their COVID vaccine?
Dr. Disbrow. So there's the potential. Again, we're
investing in multiple candidates. We hope to develop one or
more safe and effective vaccines. If there are one or more safe
and effective vaccines, there is the potential that one vaccine
may work better in a certain population than the other vaccine,
but we will continue to evaluate those through the safety and
efficacy trials, the Phase 2 trials.
Senator Blunt. And, Dr. Redfield, I'm going to come back to
you later on this question, but in your view, who is
responsible for the plan for distribution in the current
structure?
Dr. Redfield. Thank you for the question, Mr. Chairman.
This is really the center space for the CDC. As I mentioned
before, we're currently involved in the distribution of a
variety of vaccine programs throughout this Nation. So this is
really the prime responsibility of the CDC to work in
coordination to take advantage of some of the logistical
capabilities of the Department of Defense, but this is really
CDC's prime responsibility.
Senator Blunt. Thank you, Dr. Redfield.
Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman. Thank
you to all of our witnesses today.
Dr. Redfield, this crisis, as we all know, will not end
until we do have a safe and effective vaccine that can be
widely and equitably distributed.
VACCINE DISTRIBUTION
On Tuesday, you agreed that we need a comprehensive
national plan whose implementation will hinge on the ability of
public health agencies to deploy vaccine to every community
once it is available.
CDC's deputies are experienced at managing a national
immunization program and have to central to that planning. I
think I just heard you answer Chairman Blunt, but under
Operation Warp Speed, does CDC lead the planning for the
immunization infrastructure and distribution or is that in any
way the Department of Defense responsibility?
Dr. Redfield. Thank you very much for the question, Senator
Murray. Again, it's leveraging. We're going to leverage the
logistical capability of DOD with obviously the experience and
essential role that we play in distribution with the State,
local, Tribal, territorial community partners around the
Nation.
So again, as I said to the Chairman, this is CDC's lead
with the logistical support of the Department of Defense.
Senator Murray. Has the DOD ever managed vaccine
distribution at this kind of scale before?
Dr. Redfield. I would have to refer that question to the
Department of Defense, but I can just reiterate, which I
mentioned, that CDC has a system in place that we use routinely
and in the----
Senator Murray. Okay. I'm going to move on. That's a
question that's important here.
Let me ask you. CDC hasn't used funding for any of the
supplemental appropriations bills to prepare for a mass vaccine
distribution campaign. Can you tell us why that is?
Dr. Redfield. I'm sorry, Senator. I didn't quite understand
the question.
Senator Murray. CDC has not used any of the funding of the
supplemental appropriations bill that you've been given to
prepare for a mass vaccine distribution campaign, and I wanted
to know that why that was.
Dr. Redfield. Yes. Senator, I'd have to have our group get
back to you, but we've expended a substantial amount of the
money that Congress has provided as I know I've moved out over
$12 billion already to State and local, territory, Tribal
health departments to begin to augment their public health
capacity.
So I would need to get our team to get to the specifics of
it. We moved out the $140 million that you gave us to help us
improve----
Senator Murray. Yes. But you used that for flu vaccine,
important, but the lack of preparation for COVID-19 vaccine
distribution is concerning to me, and it doesn't sound to me
like CDC is in that effort.
So, Mr. Chairman, I will move on, but I do need an answer,
I think we all do, to that question.
Dr. Disbrow, last month HHS announced a $628 million deal
with Emergent BioSolutions to help manufacture the eventual
COVID-19 vaccine. As the second largest award in the
government's COVID-19 response, that deal cemented Emergent's
dominance as the highest-paid contractor for the HHS Office of
the Assistant Secretary for Preparedness and Response.
A Washington Post investigation revealed that before the
pandemic, ASPR (Assistant Secretary for Preparedness and
Response) paid Emergent more than double what it paid any other
contractor. Dr. Kadlec, who oversees ASPR, consulted for
Emergent as a strategic advisor for years and was once part-
owner of a Biodefense company with Emergent's founder and
chairman, a connection, by the way, which he failed to disclose
to the Senate during his confirmation process in 2017.
BARDA CONTRACTS
So, Dr. Disbrow, this is my question to you today. Can you
say with a hundred percent confidence that companies are
awarded BARDA contracts based solely on scientific merit and
not their personal relationships?
Dr. Disbrow. Yes, I can.
Senator Murray. Okay. Well, it was reported yesterday that
three companies making coronavirus drugs and vaccines removed
standard language from their contracts with BARDA that give the
government march-in rights to intervene in cases of
unreasonable drug prices.
I'm very concerned that pharmaceutical companies have
dictated the terms of BARDA contracts and watered down the
government's march-in right protections. At a time when we are
spending billions of dollars in vaccine development, why did we
weaken our ability to ensure fair vaccine pricing?
Dr. Disbrow. So I appreciate the question, Senator. So for
the U.S. Government to use march-in rights requires a very high
threshold.
The U.S. Government can ask the holder of the IP to grant a
non-exclusive, partial exclusive or exclusive license to
responsible applicant and if that does not move forward, then
the U.S. Government may grant that license.
However, the contractor has to show that they are not or
expected to not within reasonable time achieve practical
application of invention that is not occurring. We are all
working very quickly to push forward with the development of
vaccines and therapeutics.
Action is necessary to alleviate health or safety needs not
reasonably satisfied by the contractor. I also do not believe
that threshold has been met.
So again under BARDA contracts, we work under the Federal
Acquisition Regulations. We do have some contracts, which are
called Other Transactional Agreements, which are outside of the
FAR, but we always--everything is based on science and to
protect the Federal Government's investment.
Senator Murray. Mr. Chairman, respecting time, I just want
to say this. We are spending billions of dollars in vaccine
development. We should not be weakening our ability to ensure
fair vaccine pricing for the people of this country.
Thank you.
Senator Blunt. Thank you, Senator Murray.
Chairman Shelby.
Senator Shelby. Thank you.
I'll address this to all three of you. Where are we today?
The American people are watching this hearing. We believe that
we have sent you enough money. If we haven't, tell us why not,
but tell us where we exactly are, if you can be exact, on
coming up with a vaccine. I think the vaccine--I know you're
trying every approach in the world, you know, logical approach,
and you've got a lot of people working on it, but the American
people are dying and getting sick and they're looking for
results, and we know you just can't just wave the magic wand.
VACCINE PROGRESS
Dr. Collins, I'll start with you. What do you say to the
American people today of where we are and when the timeline and
what do you think we will be where?
Dr. Collins. Yes. Mr. Chairman, this is the right question
and something that I think all of us working on COVID-19 are
obsessed about night and day because this is one of those
crises where science is not only important, it's crucial, and
every mistake we make would set us back and every wasted
opportunity would have a consequence for somebody's life. So I
want to tell you we are all in, everybody working on this Warp
Speed Team.
Where we are with the vaccine, remember that generally it
takes 5 to 10 years to develop a vaccine from a new infectious
agent. We don't have that time. So in record time, the very
first vaccine went from knowing what the sequence of this viral
genome was to injecting the first patient in a Phase 1 trial in
63 days. That's a world record by a long shot because of new
technologies that made that possible.
Then going quickly from the Phase 1, which looks very
promising, to Phase 2, which started on May 29th, and Phase 3
which will begin this month, and how long will that take? We
need to enroll 30,000 volunteers and that should take a matter
of some months, we are all optimistic that the goal that we
have set to have a vaccine that works and is safe by the end of
2020 will be met by one of the vaccines. I've just mentioned
one, but, of course, there's several all being conducted side-
by-side, and that we would then have by early 2021 300 million
doses of a vaccine that's safe and effective.
So all of that is where we're putting ourselves on the line
and I think everybody at this table would agree that's really a
stretch goal but it's the right goal for the American people.
Senator Shelby. Dr. Redfield.
Dr. Redfield. Thank you, Chairman. Two comments. First and
foremost, the most important thing is we move forward with
these vaccines. As was said before is that our role at CDC
again, along with others that are here, and FDA is to assure
that they're safe and efficacious.
Where we are right now, the two areas that we have the most
important role is to figure out how to get that vaccine into
the individuals that would benefit from it. So two things
there, building vaccine confidence. We talked about that----
Senator Shelby. That's presupposing you come up with a
vaccine, right?
Dr. Redfield. Yes. I think we have to start working on that
right now.
Senator Shelby. Absolutely.
Dr. Redfield. We are working on that right now, Chairman,
just because the complexity of giving a new vaccine to the
American public, as we learned during the H1N1 in 2009, it's
seriously complicated, and so we are working on that, if you
will, distribution mechanism now, and we are working on
building the confidence of the American public now with the
supposition that our colleagues that are evaluating the actual
vaccine itself between their seven shots on goal or as many
different vaccines as they're developing now, that one of those
vaccines will come and show an adequate safety and efficacy
profile to go forward and be distributed.
Senator Shelby. Dr. Disbrow.
Dr. Disbrow. Thank you, Senator. So building off the
previous comments, I think we look at incremental success as
we're moving along.
You saw some results yesterday. Pfizer published results
from a Phase 1 clinical trial. I think those are important to
get out to the American people. Initiation of Phase 3 clinical
trials has already been reported by one of the companies that
we're working with. They will initiate their Phase 3 trial, as
Francis said, in July. There will be additional Phase 3 trials
that are staggered later in the summer. I think those are
important milestones to let the American people know that we
are making progress.
In addition is the scale-up and manufacturing and
validating those process. That is a critical milestone, as
well.
So where we are right now is we're in the phases of the
different clinical trials, Phase 1, Phase 2, Phase 3, and we're
ramping up manufacturing.
Senator Shelby. Dr. Collins, how much cooperation around
the world since so many nations and so many people are affected
do your researchers collaborate on and what are they getting?
Dr. Collins. Science has always been an international
effort and never more so than when we're faced with a global
pandemic. I think the collaboration and cooperation is really
excellent.
One of the vaccines we're talking about actually was
originally developed in the United Kingdom, has now been
embraced in a way that the U.S. can take advantage of it, also,
with support from BARDA's very excellent way of doing those
negotiations.
So, yes, we are looking in every nook and cranny for the
kinds of collaborations and cooperation that will make this go
faster. That's our scientific tradition.
Senator Shelby. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Shelby.
Senator Durbin.
Senator Durbin. Mr. Chairman, I want to follow up on
Senator Murray's question. We're in the middle of a national
pandemic. We're also in the middle of a national presidential
campaign, and I think her question goes to the fundamental
basic desire for testimony here on where we stand in terms of
the political world before we address the medical world.
POLITICAL INFLUENCE IN VACCINE DEVELOPMENT
I'd like to ask the three witnesses here if any of them
have felt any pressure, political pressure from the White House
or other agencies in terms of the selection of the companies to
develop a vaccine, the timing of the vaccine development, the
announcement of a vaccine, or any other aspect that is part of
your responsibility on the medical side.
Dr. Collins. No, sir, no political pressure, lots of
internal pressure as a physician and as a member of the world,
to find the answers.
Senator Durbin. Dr. Redfield.
Dr. Redfield. Senator, my answer is no.
Senator Durbin. Dr. Disbrow.
Dr. Disbrow. My answer is no, as well. I'm a scientist, not
a politician.
Senator Durbin. Thank you. That's what I was hoping for and
I think that's what the American people are looking for and so
let me go to the next question on the medical side and here's
where I think we have to have some candor.
What I'm told that the Phase 3 clinical trial of the
Moderna vaccine that's being conducted by the University of
Illinois at Chicago will kick off in about a week and they
anticipate that it will last years, 2 years before they've
completed it, collecting information from all of the people who
volunteered for the test, blood samples, and the like, to
determine the safety and effectiveness of that vaccine.
I find it difficult to square that reality that's been
announced in their Phase 3 clinical trial with the promises
that I'm hearing over and over again that within 12 months
we're likely to have a vaccine. It suggests to me that the
Phase 3 clinical trial which ordinarily takes 2 years is going
to be somehow abbreviated.
Now I understand the emergency use authorization at FDA
that may be utilized to choose a vaccine and go into production
and distribution of such a vaccine, but that has had at least
some mixed results recently when it came to the
hydroxychloroquine EUA that was announced.
VACCINE SAFETY IN ABBREVIATED TIMELINE
So how do we maintain the confidence of the American people
of the safety and effectiveness of vaccine if it appears that
we are shortcutting this Phase 3 clinical trial that is usually
required in these vaccine circumstances?
Dr. Collins. Senator, maybe I can help explain why that 2-
year time interval might have been there in terms of the
assessment of the vaccine.
Again, what we would need to know as soon as possible is
does this vaccine, when administered to people who currently
are not infected but are likely to get exposed, does it protect
them from becoming infected?
So each of the vaccine trials will aim to enroll 30,000
participants, half of whom will get the vaccine, half of whom
will get a placebo, and we will watch then as these
individuals, and they're going to be particularly recruited in
areas where the vaccine is currently spreading, either get
infected or don't, and it will only take about a 126 episodes
where somebody with the placebo gets infected and somebody with
the vaccine doesn't to know that this has worked. That will be
the point where you'd be happy to say this now has efficacy
and, of course, you'll also have a lot of people to see if
there was any safety signal.
The reason, though, to prolong the study after that has
already been achieved is a number of other things. Are there
any long-term side effects that weren't anticipated? We don't
think so, but you want to be able to follow. Also, how durable
is this particular immunity? Is this vaccine going to be
something that works for life or will you need a booster in a
year or two? Hence the reason to extend the time table.
Senator Durbin. But, Doctor, if I'm going to make the
decision, good news, 126, whatever it happens to be, in a span
of 3 or 4 months, here's your vaccine, if I'm going to make
that decision, what you're telling me is the Phase 3 clinical
trial still has elements, important elements in my
decisionmaking process to be resolved which are going to take
time in terms of long-term impact to the vaccine, is that
correct?
Dr. Collins. And that is actually the way we do a lot of
trials of drugs, not just vaccines, where you assess whether
the drug is safe or effective in the circumstance where you
really need a treatment, but then you don't stop looking once
FDA has given an approval. You carry out long-term studies to
make sure there's not some unexpected result or the drug stops
working.
So that's basically the plan here with vaccines, as well.
We don't want to miss the chance to collect that downstream
data.
Senator Durbin. Dr. Collins, are you familiar with the
Cutter vaccine issue?
Dr. Collins. I am.
Senator Durbin. Dr. Salk and polio vaccine?
Dr. Collins. Yes.
Senator Durbin. Can you reflect on that for a moment of
what the world of vaccine development looks like today compared
to then?
Dr. Collins. Well, yes, that was a terrible tragedy and a
circumstance where a vaccine actually turned out not to be
fully inactivated and therefore created actually the illness
that it was supposed to prevent.
I think I could reassure you and the American people that
that strategy of trying to administer a killed vaccine is not
currently being pursued for SARS-CoV-2 because of those risks.
Instead, the vaccines choose to produce just a small
component of the virus. I think I showed this before. These
proteins, these spike proteins that sit on the surface, that's
what the vaccine produces. There's no intact virus there at all
but yet you can still generate the immunity.
So the Cutter experience, which was a terrible tragedy, is
really not possible with the way these vaccines are being
designed.
Senator Durbin. Thank you.
Senator Blunt. Thank you, Senator Durbin.
Senator Alexander.
Senator Alexander. Thank you, Mr. Chairman, and thank you
to the witnesses.
We've been talking about vaccines and next year, I'd like
to talk about tests and treatments and this fall, which is only
a few weeks away, let's start with tests.
Dr. Collins, with all the depressing news we hear about
COVID-19 for the last several months, Americans are hungry for
sports. So will there be enough COVID-19 tests that we can
watch some football this fall or some basketball this winter?
I noticed the National Hockey League said it was going to
test every player every day. The president of Brown University
told our committee that she wanted to test every student before
they come back.
TESTING CAPACITY
Admiral Giroir has said that the country will have 40 to
50,000 test capacity a day by September. That will probably be
enough to have widespread testing to go back to school and back
to work, but will it be enough for sports teams to take the
field? Probably the answer lies with your RADx effort to make a
new way of creating quick, reliable diagnostic tests that can
be administered frequently, maybe even every day.
So we'll be able to watch some football and some basketball
this year or do we have to wait until next year?
Dr. Collins. Well, I'm probably the least qualified sports
fan, but I do appreciate that this is important to a lot of
people and we want to see Americans have a chance to have some
normal experiences of enjoying life.
I do believe this should be possible. What RADx is doing,
and appreciate the strong support from this Congress to make
this possible, is to speedily put together these kinds of
point-of-care tests that can be done onsite, can give you a
result within an hour, and can tell you immediately whether
that person is actually infected with the SARS-CoV-2 virus, in
which case they can be immediately quarantined.
I think the general sense is for athletic teams, you really
need to know that. Otherwise, you're going to have an outbreak
that will wipe out the entire team.
Senator Alexander. But your goal is to have these tests
available this fall?
Dr. Collins. Yes.
Senator Alexander. September? That's your goal?
Dr. Collins. That is the goal. The path we are on right
now, and again this is a white knuckle goal because it's never
been done at anything like this kind of time-table before,
would be to have an additional one million tests per day
available for the kind of point-of-care on-the-spot testing
that's very much needed for going back to school and going back
to sports events.
Senator Alexander. And these would mostly not be the tests
that have to be shipped off to a lab and then come back?
Dr. Collins. That is our goal or if they're going to be
shipped to the lab, the lab needs to be very nearby. We're
aware that there are places where there are labs that have
instruments that could be brought to bear on this that are
widely distributed already but haven't been adapted to this
purpose. That would be sort of a next best thing is to have
them at least in your own local arena.
The best, of course, is to have your gadget right there at
the front desk when somebody shows up for practice and find out
is this person somebody who's safe to send to the field.
Senator Alexander. Okay. That's this fall. Now let's go to
treatments in medicine. I think Senator Kennedy may be here. He
said in his inimitable way that he thinks what people are
really afraid of with this virus is not just getting it but
that they might die and they might die or have a very severe
illness because there's no medicine for it, except you
mentioned two that have been approved by the FDA.
So as we go back to school, for example, with 75 million
students going back to elementary and secondary school, we're
happy that COVID-19 doesn't seem to affect children very much
or even college students very much, but there is the danger
that they might infect their teachers or their older
administrators or they go home to their parents or their
grandparents and might infect them.
Dr. Collins. Exactly.
TREATMENTS AVAILABLE IN FALL
Senator Alexander. So what can you say to the teachers and
the administrators and the parents and the grandparents about
medicines that this fall will help them not die and not have a
severe illness? What will be available this fall when the kids
go back to school?
Dr. Collins. Well, there are intense efforts to expand that
repertoire from remdesivir and dexamethasone, which are already
approved, as you mentioned, to other kinds of ways to do
effective treatment.
A big promise here is the use of what you might call
``passive immunization'' where you basically provide to
somebody who's ill antibodies derived from somebody who has
survived already and this is the idea behind convalescent
plasma which is being rigorously studied and right now analyzed
by the FDA to see what the results have been.
But even more than that, one could develop what are call
monoclonal antibodies----
Senator Alexander. Is this the so-called ``antibody
cocktail'' of the kind that was developed and approved by the
FDA with Ebola?
Dr. Collins. Exactly. It worked for Ebola. It worked really
well, and the idea is you have these antibodies taken from
somebody who has survived the disease and you turn that into a
product and those trials are going to get started this month.
Senator Alexander. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Alexander.
Senator Shaheen.
Senator Shaheen. Thank you, Mr. Chairman. Good morning, and
thank you all for being here, for your testimony, and for your
service to try and address what is obviously the worst threat
to Americans in my lifetime.
I am particularly concerned about the impact on older
Americans and those in long-term care facilities. In New
Hampshire, 80 percent of our COVID-19 deaths have been in long-
term care facilities. That's the highest percentage in the
country.
VACCINE PRIORITIZATION EFFORTS
I'm concerned, as you've talked, Dr. Redfield, about how
you prioritize who gets the vaccine when we have one. How do
you prioritize these residents and those with underlying
conditions, like diabetes?
Dr. Redfield. Thank you very much, Senator. A very, very
important question. Obviously this is going to be discussed
through our Advisory Committee on Immunization Practices, but
clearly the most vulnerable and those individuals that are at
greater risk for mortality have to be highly considered as well
as those individuals at great risk for infection because of
what they do.
It turns out among healthcare workers that get infected,
we've recently looked at it, turns out the most common
healthcare workers who get infected were the non-nurse, sort of
the caregiver in the nursing home were the most common there.
So these are going to be critically important.
I will say one thing, though. Depending on which vaccine is
approved, it may have particular characteristics that make it
more or less appropriate to begin with in different populations
and this is why I think it's hard to know exactly until we
know----
Senator Shaheen. Sure.
Dr. Redfield [continued]. Which of the virus, but clearly
the vulnerable are going to be, if not the top priority, one of
the top priorities.
Senator Shaheen. And do you have a time table for when
you're going to make those decisions because obviously things
are moving rapidly?
Dr. Redfield. There's discussions already going on to work
frameworks for, but as I mentioned, at the end of the day it's
going to really be dependent on the characteristic of the
particular vaccine product that we're now planning to do.
PFAS EXPOSURE AND COVID-19 RISK
Senator Shaheen. Staying with you, Dr. Redfield, last month
the Agency for Toxic Substances and Disease Registry issued a
statement expressing concerns about the relationship between
exposure to PFAS (Perfluoroalkyl and Polyfluoroalkyl
Substances) chemicals and the risk for COVID-19 infections and
complications.
In New Hampshire and in communities across this country, we
have a number of people who have been exposed to PFAS who are
very concerned about this statement.
So can you tell us what the agency is doing, what CDC is
doing to assess the impact of PFAS exposure on COVID-19 risks?
Dr. Redfield. Yes. We're currently working--both our Agency
for Toxic Substances and Disease Registry and the National
Center for Immunization and Respiratory Diseases Influenza
Division are working together in a study to try to learn better
about the interrelationship between the PFAS serum
concentrations, for example, and the association between
symptomatic rates or asymptomatic COVID infections, severity,
symptoms, and hospitalizations. So we do have a study ongoing
to try to understand that association, Senator.
Senator Shaheen. And do you have any timeline again for
that study when you expect to have data that could give us some
insights on that?
Dr. Redfield. I think I've really learned that I have to be
careful in trying to predict. You know, as my colleague, Dr.
Collins, said, science has its own timeline.
Senator Shaheen. But do you think we're talking months,
years, decades?
Dr. Redfield. We're not talking decades, okay, but
obviously we're trying to get that information as soon as we
can and I really am not able to commit how fast the science
will be done, Senator.
Senator Shaheen. Well, it seems to me that would speak to
trying to address PFAS exposure wherever we can.
VACCINE SUPPLY CHAIN
I think this is for you, Dr. Disbrow. As we're talking
about the challenge in this pandemic, one of those testing at
least has been trying to provide access to all of the ancillary
supplies that are required. I think that is probably going to
also be true as we think about the vaccination plan and
distribution.
We've heard from one manufacturer in New Hampshire who
makes syringes that they need some certainty so they can order
the equipment they're going to need to make those syringes that
are going to be available for vaccinations.
So can you give us any details on the anticipated timeline
for the award of contracts for production and supplies?
Dr. Disbrow. Sure. Thank you for that question. So as
everybody knows, making a vaccine is more than just making the
bulk vaccine. There are multiple steps involved.
You have to have fill finish capacity. So BARDA is working
very hard with our partners, the Joint Program Executive
Office, CBRND at DOD, as well as under OWS, to reserve excess
capacity for fill finish so that you can not only make the
vaccine but you can fill it.
We're working with JPEO to expand capacity for vials
because you need the vials to put the vaccine in. We have
awarded contracts for needles and syringes acquiring needles
and syringes.
We're also working with JPEO to expand capacity for needles
and syringes, so that there are sufficient needles and syringes
when the vaccine becomes available. So we are working on all
aspects of the vaccine.
There's also kitting. When you send out a vaccine, you have
to have, you know, the needles and syringes, alcohol wipes,
band-aids, all of that, and then there's the distribution, and
as Dr. Redfield mentioned earlier, it is very important that
the people who are developing a vaccine--and under Warp Speed
are tied in with the group that is talking about distribution
and kitting because they have to know what that vaccine is
going to look like.
Is it a single-dose vial, a multi-dose vial? What is the
cold chain requirement? So we are working across Operation Warp
Speed in multiple different work streams that are fully
integrated.
Senator Blunt. Thank you, Senator.
Senator Moran.
Senator Moran. Chairman, thank you. Thanks to you and the
Ranking Member for having this hearing. Gentlemen, thank you
for joining us.
Dr. Collins, let me first thank you for joining me on a
phone call with the University of Kansas Health System in which
your report on a vaccine was the highlight of the day, month,
and year. So I'm pleased to hear that medical researchers and
practitioners in Kansas heard what you said and found it to be
a very pleasing kind of an optimistic note.
FUTURE PANDEMIC PREPARATION
Let me ask something. Is COVID-19 or is a virus so unique
that there are not things that can be done to better prepare us
for the next virus, the next pandemic, so that a vaccine
development is developed, the development occurs in a shorter
period of time, or is it just starting--I don't know that
scratch is the right word, but starting from scratch each time?
Dr. Collins. It's a great question, Senator, and, yes, I
enjoyed talking to the folks in Kansas. It's a wonderful bunch
of scientists and physicians.
Coronaviruses, of which this is one, have been around a
long time. Some of them cause the common cold and we still
haven't cured that one, but it hasn't been such a high
priority, and SARS and MERS were also Coronaviruses. We learned
something from them.
If we had not had already an effort to try to develop
vaccines for SARS and MERS, we wouldn't have been able to jump
on SARS-CoV-2, this guy, quite as quickly.
So every time you do this, you get a little better at it
and, plus, the overall technology for how we develop vaccines
has been advancing. The lead vaccine now in terms of its
earliest out-of-the-gate, which is the Moderna vaccine and also
the Pfizer one that was announced yesterday, same principle,
utilizing RNA as the thing that you actually inject so that you
ask the body to make the protein which then becomes the antigen
that your immune system reacts to, that's pretty new.
We would not have done that 10 years ago. We wouldn't have
known how and we'll keep getting better at new ideas at that.
I do hope, and maybe this is part of your question, that we
learn from this experience, that when we get through this
because we're going to get through this, we don't then go back
in-to some complacency and say, well, that's it, we won't ever
have another one like that again because we all know we will.
What will it be? Will it be another coronavirus? Will it be
that influenza epidemic that we've been worried we're overdue
for coming out of somewhere that's actually going to be very
dangerous?
We should never again step back to the point of complacency
with these kinds of emerging infections and I hope we will
therefore from what has been built to deal with COVID-19
sustain that.
Senator Moran. Dr. Collins, thank you. I want to follow up
on that, but I want to make sure I get a question to Dr.
Redfield, and I'll try to be back to Dr. Collins.
Dr. Redfield, thank you for the telephone conversation we
had several months ago. I would highlight for you and others
who might be listening that the issue of PPE, personal
protection equipment, is back front and center. It seemed to me
in my life it had diminished a bit, but in a conversation with
community leaders, including hospital and public health
officials, the concern is the supply is short once again as the
numbers increase and the potential of a greater circumstance, a
more challenging circumstance comes in this fall.
So any suggestions that anyone who hears this statement of
mine has on how I can get additional PPE to Kansas public
health, hospitals, and employers, I would welcome that.
But let me ask you. One of the things I take away from
what's transpired is the importance of public health
departments and I think generally we have--until I served on
this committee, I didn't realize the significant role that CDC
plays in support of our community and public health
departments.
PUBLIC HEALTH DEPARTMENT'S ROLE IN VACCINE DISTRIBUTION
What is it that needs to take place so that when the
vaccine is developed, our public health departments are
prepared to administer that vaccine in the distribution? How
can CDC, how can this committee help make certain that occurs
well?
Dr. Redfield. Thank you very much, Senator. I think you
heard me say before we've had decades of underinvestment in our
public health departments across this Nation and this is the
time now to correct that and you all have really made great
support.
CDC has already awarded $12 billion with a B to the local,
State, territorial, Tribal health departments in the last 8
weeks or so to begin to give them the resources they need to
begin to build up their capacity.
You know, the human capacity usually takes longer than
weeks to build up and we're obviously,--as you know, I said CDC
has over 650 people now embedded in the local health
departments to help with that human capacity, and we're going
to continue to work with them.
Recently, with the resources you did with the CARES Act, we
were able to get a little over 10 billion out for each of the
jurisdictions to put up plans as to how to expand their
testing, their contact tracing, their isolation, their public
health infrastructure.
So we're doing it on the run. I think you've heard me say
before when it comes to public health, this is something we as
a Nation should plan to be over-prepared, not underprepared,
and I do believe this is the moment in time when this Nation
can actually help put the public health infrastructure across
this Nation not only that we need but this Nation deserves.
As you mentioned, most of CDC's money actually gets
distributed to the local, State, territorial, Tribal health
departments, and some of these health departments, it's 70
percent of their overall funding.
So we are the Nation's funder through you of the public
health infrastructure of this Nation and we need to augment
that to where we're now over-prepared for the next pandemic.
Senator Moran. Mr. Chairman, if you have a second round,
I'll try to follow up with Dr. Collins.
Senator Blunt. Thank you, Senator Moran.
Senator Merkley.
VACCINE MODIFICATIONS AND EXPECTED VARIANTS OF THE VIRUS
Senator Merkley. Thank you very much, Mr. Chairman.
Dr. Collins, I wanted to get some sense from you of our
understanding in a short, simple version of whether this
coronavirus is such that we anticipate that its mutations will
mean that different vaccines may be effective against some
versions of the disease but not others and whether it means we
will likely have to have an annual production of modified
vaccines based on those mutations, like we have with the flu.
Dr. Collins. Senator, thank you. That's a very important
scientific question that many of us are wrestling with, trying
to collect as much data as we can.
I think the somewhat reassuring news is that this
particular virus, which is an RNA virus, does not have a rapid
mutation rate. It's not like influenza or HIV where you know
you're going to have to have a really tough time getting a
vaccine to work or to stay effective, but it does change over
time.
There is at least one significant variant in the virus
that's already happened since it originally appeared about 6
months ago that may have made it somewhat more infectious than
the original strain coming out of Wuhan. We're not absolutely
sure of that but it looks like that might be the case.
The good news is that those variants that we've detected do
not seem to be those that would interfere with the
effectiveness of the current vaccines that are being designed
and tested nor with the monoclonal antibody strategies that are
also being attempted, but we're going to watch that very
carefully.
A big question we will all have is whether this is a
circumstance where, once vaccinated, you are basically
protected for life or whether over the course of time this
virus will change its coat enough that you will need to have a
booster that's slightly better in its design for whatever it is
that this turns into next.
We don't know the answer to that, but I think the good news
is this is not like HIV, this is not like influenza. It's a
fairly well-behaved virus that we think we ought to be able to
tackle effectively with a vaccine strategy.
CONTRACTS AND PRICE SAFEGUARDS
Senator Merkley. Thank you very much, Doctor, and I want to
turn to the question that Senator Murray raised about the
elimination of the Bayh-Dole safeguards. Those safeguards for
reasonable pricing when the government has invested in the
development have never been implemented but many people feel
they serve as an effective instrument of leverage should the
American people be gouged after investing millions or now
perhaps billions of dollars.
Was NIH consulted about removing the Bayh-Dole safeguards
from the contracts?
Dr. Collins. We were not asked about that. We've been asked
about those safeguards in other circumstances.
Senator Merkley. And do you support inclusion of those
safeguards to protect the American people from price gouging
after we invest in the development of drugs?
Dr. Collins. I certainly think the American people ought to
have access to vaccines that they're helping to pay for and I
think the plan has been nicely made to be sure that that is the
case so that nobody would be denied access to this, regardless
of their healthcare coverage.
The march-in rights issue actually is rather complicated.
When you look at the original language of Bayh-Dole, it does
seem, as Dr. Disbrow said earlier, that these were intended to
try to allow the government to step in when there was a company
that basically refused to try to produce a product that would
benefit the public.
It does not look as if those particular parts of the bill
were intended to do something where the price was considered to
be unacceptable.
We've been caught in this many times before and that's what
the lawyers tell me. So in this circumstance, I have to defer
to BARDA in terms of why the decision was made, but my
understanding was there was really no likelihood that the
product wasn't going to be pursued, in which case march-in
rights would be a tough thing to try to apply.
Senator Merkley. In which case it would be okay to leave
them in the contract. The Moderna contract still has those
march-in rights and NIH claims joint ownership of the Moderna
vaccine. So I find it interesting that NIH wasn't consulted
over the difference between that contract and some of these
other contracts.
Dr. Collins. I have to be careful here because it's
possible somebody at NIH was consulted, but I was not made
aware of it. So I'll have to check on that and see if there was
a consultation.
Senator Merkley. Thank you.
And, Dr. Redfield, was there a CDC consultant over the
elimination of this contract language designed to ensure fair
pricing?
Dr. Redfield. Not to my knowledge, sir.
Senator Merkley. Okay. Thank you.
And, Dr. Disbrow, why suddenly eliminate this language in
some of these contracts but not others? Who was it who asked
you to do this, and why did you include language in some
contracts and not others?
Dr. Disbrow. So I think some of the confusion is that in
our FAR-based contracts, it is in there. Some of the documents
that were requested by the group that asked for them under
FOIA, Freedom of Information Act, were other transactional
agreements, which are outside of the FAR, and also remember
that these are research and development contracts. We are not
acquiring product under these contracts.
Senator Merkley. Well, recognize, too, that it's research
and development being funded by the American people with a vast
potential for profit for the companies. So the American people
have a stake in fair pricing.
I think the American people are aware that they are gouged
on drugs routinely, that we pay more than citizens in any other
developed country. 80 percent of Americans routinely respond
they want fair pricing, that they shouldn't be charged more
than the citizens of other countries. We spend more on the
development of the products and I think that plays double here.
The reason I'm emphasizing this is we're going to spend
billions of dollars in this development and we should
absolutely use that investment to make sure that we're not
gouged on the back end and so I just want to say that this
conversation that Murray initiated and I'm following up on here
is an important one and I hope you're going to take full and
thoughtful consideration on how to make sure that Americans do
not pay more for these drugs through the government payments or
through citizens having to pay for them than do the citizens of
any other developed country.
In fact, I hope you'll pledge to make sure that that's the
case.
Senator Blunt. Thank you, Senator Merkley. If you want to
come back for a second round, you can.
Senator Capito.
Senator Capito. Thank you, Mr. Chairman, and thank you all
for not just being here today, I know you've been on Capitol
Hill many times, but thank you for what you've done and what
you're going to do to meet this crisis.
SUPPLY CHAIN CONCERNS
Dr. Disbrow, I had a question. Many of my questions that I
had initially you all have sort of answered on the safety and
efficacy issues around a vaccine, but as I recall back when we
first started, we had an issue with China making the PPE, with
Italy having the swabs, I might have this a little wrong, but
the reagents in Germany, and there was a competition globally
for all of these supplies.
I imagine that there's going to be a competition globally
for the vaccine supplies and the vaccine itself.
Dr. Collins mentioned that they have been working with the
U.K. in a collaborative way, but how much of what you're seeing
of the development is actually manufactured in this country
where we can sort of control our own destiny?
Dr. Disbrow. Thank you for the question, and it's a very
important question.
This global pandemic has highlighted the vulnerability in
our supply chains for medical devices, raw materials, and
active pharmaceutical ingredients for drugs.
I can't give you the specific number of what percent of the
products are manufactured here in the United States, but what
we are doing, as I responded to one of the earlier questions,
is we are working for needles and syringes and vials to expand
domestic capacity so that we don't have to worry about this in
the future, in the immediate future and the near future.
We are also working with all of our manufacturers to make
sure they acquire the raw materials that are needed to
manufacture vaccines and/or therapeutics because, don't forget,
therapeutics are also important.
Senator Capito. Right.
Dr. Disbrow. So that they can manufacture at scale.
Senator Capito. Is this a question that you ask when you're
looking at giving contracts, whether it's produced in the
United States where you can control your own destiny?
Dr. Disbrow. So we look at their raw supply material chain.
We do that for all of our manufacturers to identify risks early
on and try to address those risks very early on.
Senator Capito. I'd like to dig down on that because I
think, you know, that that's concerning I think obviously
because this is a global issue but also I think it sort of
shook the American public when we realized we weren't really
controlling the ability to have testing supplies or the ability
to produce our own PPE.
OPIOID EPIDEMIC DURING THE PANDEMIC
Dr. Collins, a question I have that's a little off topic
but equally as important. You know that NIH has invested
heavily and so have we here on the opioid epidemic, but the
latest stats coming out of our State of West Virginia, Senator
Manchin's here, and across the country is that there has been a
big spike in overdoses during this COVID epidemic and I'm
wondering--I know you're fast at work on this in a lot of
different various ways, but how are you seeing that and how
might having a vaccine or having better therapeutics be able to
help us meet this challenge of folks that are in therapy for
addiction or have this addiction issue to be able to cope
during these very stressful times?
Dr. Collins. Senator, I really appreciate your bringing
this up and it's not off topic at all. It's a really serious
national tragedy that has now gotten even worse because of the
coalescence of the COVID-19 crisis and the opioid use disorder
crisis, and I've seen those same statistics about maybe a 42
percent increase in overdoses in just the last 3 months and
deaths associated with that are going up.
After we had started to make some headway with this crisis,
with all of the things that have been done with various
programs and use of medications that we know can work, and yet
now prescriptions for those medications have plummeted because
people aren't able to get into treatment programs.
We are doing everything we can at NIH with supplements to
some of our research programs to try to understand how best to
intervene, how to provide people with support, even if it has
to be done remotely by telemedicine kinds of interventions.
We've been supporting the idea that methadone, which
traditionally required people to show up every day in a crowded
location, could actually be done in a fashion where people
could receive this at home because otherwise the dangers are
too great and people were simply dropping out.
But I can tell you how desperately we need to get back in a
place where people can congregate together and that will
require, of course, effective treatments and vaccines and
that's on my mind every day as we're trying to accelerate that
progress. This is a very serious situation indeed.
Senator Capito. It is, and, anecdotally, I heard that
really the counseling that was going on by telehealth initially
was actually having greater--they were staying more true to
their appointments and it was going well and then it just has
gone back down.
Dr. Collins. People need interaction more than just through
a Zoom call and that's hard to do right now.
VACCINATION EFFORT OUTREACH
Senator Capito. All right. Dr. Redfield, I have four
seconds. Our vaccination rate in West Virginia is falling. How
are we going to do a PR campaign to say the vaccination for
this is important and other vaccinations?
Dr. Redfield. That's a critical point, Senator, and I
always look at the consequences of COVID. As the Secretary
said, health versus health.
85 percent decline in pediatric vaccinations in those just
under five. We're obviously in the process of making a play
with the American Academy of Pediatrics and throughout to
really respond to that. It's really, really important.
Globally, it's a big issue, too. I've tried to say in Sub-
Saharan Africa, where COVID now is a significant problem, but a
much bigger problem is there's a 120 million children now who
haven't gotten the measles vaccine and they're going to have
significant mortality in Africa.
Senator Capito. Thank you.
Senator Blunt. Thank you, Senator Capito.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman.
VACCINES IN DEVELOPMENT
I have a couple of, I hope, quick questions. Dr. Disbrow,
can you just quickly list for me the vaccine prospects that are
being invested in right now? You know, you've narrowed it from
many, many who have come forward to I think it was first 14 and
now fewer.
Can you just list those for me and what type of vaccine it
is?
Dr. Disbrow. So I appreciate the question, Senator. I
cannot specifically mention some of the companies. We're in
active negotiations with many of them. One that I can mention
is AstraZeneca, where we already have a very large contract
that covers both advanced research and development and
procurement.
We are in the process of moving forward with large
manufacturing contracts and acquisition of the vaccine for
multiple other candidates.
Senator Baldwin. So those company names in terms of the
vaccine prospects are not public?
Dr. Disbrow. So some of the companies that were originally
funded by BARDA for advanced research and development, those
are public, who we've invested in.
I think your specific question may be the composition of
the portfolio under Operation Warp Speed. That I cannot today
talk about, but we are very quickly moving and negotiating
contracts and hopefully in the very near future we will be able
to make an announcement with the entire portfolio under
Operation Warp Speed.
Senator Baldwin. How many have been finalized right now
versus how many are you still in negotiations with?
Dr. Disbrow. So I already told you about the one which is
the AstraZeneca, and we have multiple other candidates that
we're working with.
Senator Baldwin. How many do you think you'll have in
total?
Dr. Disbrow. More than one. Sorry. It really is
procurement-sensitive. These are market-moving negotiations
that we're having with these companies, you know. So I just
need to be very careful about that, but again we are happy to
publicly announce. You will see the press releases when we
award these contracts so that everybody is aware of what's
being supported.
Senator Baldwin. So you have the intellectual property
prospect. You also have the manufacturing. You want to make
sure time-wise that you'll be able to have [technical glitch]
are U.S. based?
Dr. Disbrow. So, I'm sorry, you cut out for a little bit,
but you're asking is manufacturing going to be U.S.-based?
Senator Baldwin. Yes.
Dr. Disbrow. Correct. 100 percent.
Senator Baldwin. Okay. And are you looking at any vaccine
prospects that you [technical glitch].
Senator Blunt. Let's go to Senator Kennedy, and we'll come
back to Senator Baldwin once we think that we've got this
technical problem worked out.
Senator Kennedy.
Senator Kennedy. Thank you, Mr. Chairman, and thank you,
gentlemen, for being here.
MASK GUIDELINES
Gentlemen, I'd like your opinion on something. When the
pandemic first became apparent in the United States, a number
of busy and important people, smart people in the Federal
Government, also in State and local governments, told us, the
American people, that we shouldn't wear a mask, that a mask
would not protect other people, it wouldn't protect us, and, in
fact, in some cases it might actually hurt us.
When I heard that, I thought to myself, you know, this is
odd because I turn on television and I see doctors and nurses
wearing masks when they're treating coronavirus patients. I
remember thinking this is odd. Wonder where they went to med
school or nursing school.
Next, we were told, well, by these busy, important people,
we were told, well, you should wear a mask, but the reason you
should wear a mask is not for yourself but to protect other
people who might get the coronavirus from you.
And then I turned on TV again and I saw these doctors and
nurses wearing masks treating people with coronavirus and I
thought to myself this is odd. Why are they trying to protect
the patient? The patient already has coronavirus, for God's
sakes.
And then it occurred to me that maybe these busy and
important people were wrong and are wrong. So I talked to a lot
of doctors and nurses, not the ones I saw on TV but others
whose judgment I respect, and I've read a little bit, and I
came to the conclusion that a mask is very helpful and it will
protect us. It will protect other people and it will protect
you and that's why I wear a mask because I don't want other
people to die and I don't want to die.
Now how come these busy, important people who are smart
people in the Federal Government told the American people this?
Dr. Collins. Well, may I? As a busy person, I don't know if
I'm important, but let me try as a physician to explain the
history here.
A mask is not a mask is not a mask. The kind of mask that
I'm wearing, that most people in this room are wearing, cloth
masks or something like that are pretty good at capturing any
kind of droplets that might be coming out of your mouth while
you're speaking because I'm producing them right now.
If I happen to have SARS-CoV-2, you don't want those
droplets getting anywhere near you.
Senator Kennedy. I get all that.
Dr. Collins. So but we didn't really know that, Senator,
until March or thereabouts. This is a very unprecedented way
for a virus to spread, to have asymptomatic people spewing out
virus like this----
Senator Kennedy. Excuse me for interrupting, Doctor,
because I don't have a lot of time.
Then why were the doctors and nurses wearing the mask?
Dr. Collins. They were not wearing these kinds of masks.
They were wearing N95s which have the ability to protect them.
Senator Kennedy. They didn't all have N95s. Some of them,
we didn't have enough N95s to go around.
Dr. Collins. Well, they should have had N95s and face masks
and other means to protect them.
Senator Kennedy. Well, would have, could have.
Dr. Collins. This kind of a mask doesn't do a great job of
protecting me against somebody else who's near me. It still
allows enough air flow around the edges----
Senator Kennedy. Well, isn't some mask better than no mask?
Dr. Collins. I'd say this is better than no mask in part
because----
Senator Kennedy. How come we didn't tell the American
people from day one that, look, you may not be able to get an
N95 but some mask is better than no mask? Don't you think it
would have been better if we had gotten it right initially to
convince people now to wear a mask?
Dr. Collins. Again at the beginning----
Senator Kennedy. I'm not just picking on you but you happen
to be here.
Dr. Collins [continuing]. Senator, I don't think we
realized the risk of asymptomatic people spreading this and we
thought that if you were around people who were healthy, you
weren't going to catch this. If you went into a sick bed, you
might need to worry about it and then we learned otherwise.
Senator Kennedy. The doctors and nurses on the front lines
got it.
EXPEDITED VACCINE TRIAL SAFETY
Let me ask you one other quick question. Just give me a yes
or no. I think you're all going to say yes. Is the expedited
process for developing and testing therapeutics and vaccines
safe that we're using right now?
Dr. Redfield. Yes.
Dr. Disbrow. Yes.
Dr. Collins. Yes, I would roll up my sleeve.
Senator Kennedy. Well, how come we don't always use it
then?
Dr. Collins. I think we do. I'm not sure of the question.
I'm sorry.
Senator Kennedy. Well, we're going faster than we normally
do, right?
Dr. Collins. Yes.
Senator Kennedy. How come we didn't always go faster and
will we go back to doing it the old slower way once we're past
the pandemic?
Dr. Collins. I think we talked about we are spending a heck
of a lot of money by going really fast and doing things that
are probably ahead of where they should be and running the risk
therefore of needing to throw out a lot of materials that we
don't use. We can't usually afford to justify billions of
dollars in this circumstance but this time, we can, given the
public health emergency and people are dying.
Senator Blunt. Thank you, Senator Kennedy.
Senator Kennedy. Thank you, sir.
Senator Blunt. Let's go back to Senator Baldwin and about
half of your time is still left, Senator.
Senator Baldwin. I'm not sure what happened. So this is my
question with Dr. Disbrow and perhaps also address it to Dr.
Collins.
Are we considering any vaccine candidates where the
delivery method would be something other than syringe and
needle?
Dr. Disbrow. So not at the current time but there are
products----
Senator Baldwin. Okay. Thank you.
VACCINE DEVELOPMENT AND SMALL BUSINESSES
Let me move to Dr. Collins. I know that a lot of the
companies that are catching the most attention are very large
scale with the capacity to produce in large quantities, but
some innovation comes from very small companies. I know
Wisconsin has a number of small biotech companies that are
working both in the vaccine space and in the treatment space.
What can you tell me about their opportunities to
participate?
Dr. Collins. Senator, there were more than a hundred
vaccine opportunities coming forward and, of course, we had to
because of the public health emergency choose the ones that had
the best chance of being able to scale up really rapidly, but
there are lots of great ideas out there about vaccine
development which might not be the ones that you want to bank
in for SARS-CoV-2 right now because we have such a sense of
urgency but this is not the last time we're going to face an
infectious disease and so I hope all of those ideas will
continue to be developed for whatever comes next or perhaps if
we end up in a circumstance where this vaccine is needed to
have a booster down the road, this virus doesn't seem to be
completely vanquished, some of those ideas could be helpful. We
just had to prioritize in this circumstance.
Finally, I would say in terms of small businesses, Senator
Alexander was asking earlier about diagnostics for the RADx
Program, which aims to try to bring on some great ideas about
new ways to do diagnostics at point-of-care, of the more than
560 applications we've gotten, two-thirds of those have been
from small businesses virtually from every State in the
country. So in that space, there's been a wonderful opportunity
for innovators to come in and have a chance to be scaled up
rapidly.
VACCINE DISTRIBUTION PUBLIC PLAN
Senator Baldwin. And final question for Dr. Redfield. With
regard to a master plan for vaccine development and production
and prioritizing initial delivery, can you let me know how far
along we are on a plan that all of us will be able to review in
writing, particularly with regard to the tail end of when it is
available, who will it first be made available to, because I
think that is something that we really need to see.
I know there's an ongoing set of panels and experts who are
tying themselves to these decisions, but I want to know the
timeline for such a written plan.
Dr. Redfield. Thank you very much, Senator. You are right
that a number of us are working on this plan. Unfortunately at
this moment, I can't tell you exactly when we're going to have
a plan released, but I can commit to you that we will, when
we've completed the plan, have a plan that will be released,
and as I said, part of the nuances of it is going to depend
upon the actual vaccines, but the background plan independent
of that is definitely being developed and working through and
being coordinated through Operation Warp Speed.
But as I mentioned, CDC does have the lead on this
distribution and as we get it completed, we will make it
available.
Senator Baldwin. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Baldwin.
I'm going to ask a question on the ethics and that
discussion later. So you all might be thinking about that as
you try to determine a priority of who gets access as access is
available.
I'm going to go to Senator Murphy, Senator Schatz, and
Senator Manchin, in that order, and then we'll start a second
round.
Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman. Thank
you all for being here and being so attentive to our concerns
and questions.
First, let me just follow up on a series of questions that
Senator Merkley raised. I don't have a question connected to
it. It always puts me in an uncomfortable position to disagree
with Dr. Collins and maybe I'm more disagreeing with your
lawyers, but the United States Government has never exercised
march-in rights under a contract and so it is true that there
is a lot of question and dispute regarding exactly what the
government is allowed to do but the language in the underlying
statute is in fact very broad.
It requires companies who sign contracts with the U.S.
Government to provide these drugs upon reasonable terms and
there are plenty of legal scholars who read into that term
price, that if you are gouging consumers, then you aren't
offering the drug on reasonable terms, and so I would disagree
with any guidance that's being given that says the government
cannot use that underlying statute, the Dole-Bayh statute, as a
mechanism to prevent price gouging, and I frankly think it's
been a real success of the pharmaceutical industry to get
lawyers to make recommendations that provide that kind of
limitation. I think it's really concerning that that language
is not in many of these contracts that are being signed by the
government today.
That's, I think, important to say, but, Mr. Disbrow, I had
one particular question that arises out of concerns that have
been presented to be by smaller and medium-size drug discovery
companies in and around the Northeast.
BARDA CONTRACTS WITH SMALL BUSINESSES
I've had a number of smaller companies, but companies with
track records of success, who have tried to be in contact with
BARDA and have received absolutely no response and given these
concerns about cronyism and the potential track record that I
think deserves investigation regarding companies that are big
and multinational and have connections to people inside BARDA
getting preference, do you think you have the resources to
field inquiries and respond adequately to every company that
may have a promising proposal to make to you because it does
concern me to have heard from many very good companies in my
State and my region who have been, frankly, completely unable
to get any response from BARDA.
Dr. Disbrow. Thank you, Senator. I appreciate the question
and also the comment.
So as the new Acting Director of BARDA, I am committed to
doing a much better job. In a typical year, we are able to
interface with multiple companies. We hold approximately a 150
to 200 Tech Watches each year where companies can actually come
in and speak with us about their technologies.
As I mentioned in my opening statement, to date we have
received 3,394 submissions that we are trying to get through so
that they receive a fair evaluation and we are working as
quickly as possible.
So under normal circumstances, I think the answer is yes,
we are always looking to bring on new and bright and talented
people, but we are a bit overwhelmed right now, but we are
still working through the process. We have had over 391 Tech
Watches, our Corona-Watches, where companies--it's a virtual
Tech-Watch now, not an in-person Tech-Watch, but we continue to
strive to improve our best business practices.
Thank you.
Senator Murphy. Well, I appreciate that answer, and I hope
that you will make recommendations to us on what additional
resources we can give you because it would be absolutely tragic
for a small or medium-size company who might have the key that
unlocks a treatment or a vaccine to be left on the outside
here.
CDC GUIDANCE ON SPORTS EVENTS
In the remaining time, I'm going to take the bait from
Senator Alexander. As he knows, I care a lot about college
sports as a fan but also as someone who wants to make sure that
we start playing games in a way that's safe for especially
college athletes who receive no compensation to go out there
and frankly make billions of dollars for other adults and so my
question is to you, Dr. Redfield.
Has the CDC given recommendations regarding whether it is
appropriate to have fans in attendance at either college sports
games or professional games this fall? I can see having enough
resources to be able to test athletes, but we certainly don't
have the resources to test every fan that walks into a crowded
stadium and even a college stadium that's one quarter full
still has tens of thousands of people in close proximity with
each other.
Has CDC released any guidance with respect to attendance at
sporting events?
Dr. Redfield. Not directly, Senator. We have had
interactions with most of the sports industries, both at the
professional, collegial level.
Senator Murphy. Why not? Why not? That's a really important
question. Should we put 20,000 people in a college football
stadium? Why haven't you released that information?
Dr. Redfield. Well, I guess I misspoke then. I thought if
you thought we directly recommended that we have fans. We have
put out our guidance several weeks ago on mass gatherings,
which would include obviously those events, and we have
obviously commented directly in our guidance over the last 3 or
4 months on gathering size and precluded fans from going to--
being recommended in these sporting events.
I was looking at the other way around. Did you think we
made a positive recommendation to include them? So clearly in
our mask guidance and clearly in all of our previous guidance
to slow the spread and for the 15 and then 30 days, we've not
recommended these gatherings to be such that you would have
fans in the stands.
Senator Blunt. Thank you, Senator Murphy.
Senator Manchin.
Senator Manchin. Thank you all for being here. It's good to
hear from you.
I'm just trying to--Dr. Disbrow, just a simple explanation.
Of the money that we've invested so far, and I know--my tally
shows Johnson & Johnson got 456 million, Moderna's got 483,
AstraZeneca was 1.2 billion, Emergent BioSolutions 628. That
was all for developing vaccines. That comes out to about $2.76
billion, and then for distribution and manufacturing, ApiJect
got a 138, Corning 204, Valor Glass 164, SIO2 Materials Science
143, for a total of about $650 million. So when you put it all
together, you're up at around 3-34, in that neighborhood so
far.
TAXPAYER INVESTMENT INTO VACCINE
What do we get back as taxpayers when this vaccine, when
one of these companies or all these companies have a proven
vaccine? Are we like a private investor from the Federal
Government? Do we get something in return? Do we get this value
back as far as in the vaccine that can be distributed to all of
our health centers or do now we have to buy it back?
Dr. Disbrow. So there will be future procurements of the
vaccine, but to address your specific point, yes, we do
receive--so when we are doing contracting for acquisition, we
seek consideration to the U.S. Government for our previous
investment and it's more than just a dollar-per-dollar
investment. It is also the cost of capital because the U.S.
Government took the risk to make that investment.
Senator Manchin. Right. I mean, we're taking the risk the
same as the private sector. We're taking the risk, right?
Dr. Disbrow. Correct.
Senator Manchin. So private citizen would take this type of
risk, they get a bigger return for the risk----
Dr. Disbrow. Right. So our investments would be taken off
the----
Senator Manchin. Our investments are part to what the
private would make as far as the return back?
Dr. Disbrow. No. So if the company was going to charge $10
for a dose of vaccine, this is just an arbitrary number, I'm
not saying anybody's charging $10 a dose, for, you know, sale
outside the United States, in the United States, the U.S.
Government would buy it at a reduced price because we've
already invested $450 million, you know, to support the
research.
Senator Manchin. Okay. So basically we're going to get our
value back?
Dr. Disbrow. Correct.
Senator Manchin. Okay. And are we able to control any of
the pricing on this, too, or be able to put pressure on them
not to gouge?
Dr. Disbrow. So again whenever we are negotiating, we
always negotiate best value to the U.S. Government. We seek
consideration. I mean, these are hard negotiations we have.
Senator Manchin. Sure.
Dr. Disbrow. But, yes, we seek best value to the U.S.
Government.
Senator Manchin. Well, and I know you already touched on
basically how we're going to get--PPEs didn't get out the way
they were supposed to get out as far as we still have a few
problems there, and we're concerned about getting distribution,
and I know you all spoke about the community health centers,
Dr. Collins and all that, and I appreciate what you all have
done there.
But I can tell you they're still hurting very much so
because a lot of the States have not distributed the money that
they received as help from the CARES package to keep them
viable and there's money there that hasn't been distributed
properly and we all should be putting pressure on our governors
to do their job to make sure our first responders and our
county health departments have the necessary funds and they're
not getting it, I can assure you.
RURAL DISTRIBUTION OF VACCINE
Rural health. Rural providers have been hit particularly
hard by the epidemic across the United States. COVID-19 are
growing faster in rural areas at 13 percent than the national
rate of 9 percent for the second week in a row. Rural counties
have had the highest number of new cases of COVID-19 in a 7-day
period since the pandemic began. West Virginia saw its single-
day high just yesterday.
So we have 12 hospitals and all of our hospitals are rural.
12 hospitals already closed, three in West Virginia, and we're
concerned about the rural healthcare that we have to
distribute.
How's the vaccine going to be distributed in the rural
areas to make sure that we're able to meet the rising
challenges that we have there, rural providers have the
necessary equipment or they have the personnel to administer
the vaccine?
Dr. Redfield. Thank you, Senator. Really, really important
question, as you know, in the broader question of how we
maintain health capacity in Rural America.
As I said, there's going to need to be a variety of
innovative strategies to ensure that we can get broad
distribution, particularly the groups that have been under-
vaccinated. You mentioned the rural. We've also had under-
vaccination historically in African American and Hispanic
populations, and, you know, we need to more aggressively--in
the H1N1, there was reluctance to fully engage the pharmacies
and those opportunities as vaccine outlets. Clearly we need to
expand that in this distribution.
There is going to need to be clear inter-linkages, as you
mentioned, with the community health centers that are there and
augment them to be part of it, along with the local health
departments, but, in addition to that, I think there's going to
need to be mobile units that are going to be able to go and
provide broader vaccination access, particularly in Rural
America.
Senator Manchin. Let me just say--my time is up--Rural
America basically is getting hit hard now. We knew it would be
a delayed reaction of how they're getting hit, but we have the
most vulnerable population in the country in West Virginia
because of our age and the type of hard work that they've done.
So they have underlying health conditions, too, and if it hits,
it's going to be of disastrous proportions.
So we need to stay ahead of that and right now we had a
hard time getting everything else. If we have a hard time
getting a vaccine or an antibody when it comes, we're really up
the creek. So we hope that you put the attention towards rural
and make sure that your associates understand the need for
rural.
Dr. Redfield. We're committed to make sure that all those
in need get access to this vaccine.
Senator Manchin. Okay. Thank you.
Senator Blunt. Thank you, Senator Manchin.
PRIVATE PARTNER OBLIGATIONS
Dr. Disbrow, let's talk a little more about any obligation
these companies we've partnered with have to be sure that the
vaccine is available at a reasonable price. If they fail, we
underwrite their failure for that. I want to get plenty of
opportunities out there on the field advancing forward so that
we have as many vaccines as we can have available as soon--as
many of the individual vaccines available as soon as we can,
but if we're successful, we basically get our money back, plus
interest.
Are there--surely there are other obligations here in that
partnership of the private partner to make the vaccine
available in a reasonable way. Would you expand on that a
little bit?
Dr. Disbrow. Sure. And thanks for the question, Senator.
So also remember that, you know, each of the companies that
we're working with, it's a true partnership. The U.S.
Government has assumed risk. Many of the contracts that we have
are cost share contracts, meaning that the company also assumes
risk.
The companies, while we're working on, you know, awarding
the contracts that I mentioned earlier, are agreeing to proceed
at risk under Operation Warp Speed because, you know, they're
committed to developing a vaccine, but, yes, the goal is to
negotiate the best price for the U.S. Government.
We would probably have to pay a slightly higher price for
industry partners who chose not to receive government funding
because they assumed a hundred percent of the risk.
VACCINE DISTRIBUTION AND HEALTH PRIORITIES
Senator Blunt. All right. Dr. Collins, so what's going on,
and others can enter into this discussion if you want to, but
in terms of determining the health priorities--or we should be
doing this right now. We know we're eventually going to have a
vaccine. We know we'll have therapeutics.
Let's focus on where we're going to be with the vaccine in
terms of distribution and accessibility. Who's talking about
health priorities or ethical issues that relate to the rapid
opportunity for people who want a vaccine to get a chance to
have the vaccination?
Dr. Collins. So a very important question and one that is
occupying the minds of a lot of us, thinking about this future
that we hope to have as soon as possible.
You've heard Bob Redfield talking quite a bit about what
CDC's role is, which is absolutely central in terms of this
distribution effort, but I think there may also be an
opportunity before we get to that moment where we actually have
a vaccine that has been proven safe and effective to have a
broader discussion that brings into this ethics experts in
public health, people who are particularly aware of the
challenges for reaching out to those who've suffered from
health disparities for a long time and are being hit
particularly hard by COVID-19 is another area where we want to
be sure as far as priorities. That is considered in a big way.
Bob Redfield and I have talked a bit about this. This may
be a moment to actually bring together a group of such big
thinkers who could take a high-level view of this and lay out a
foundation of principles that then could be utilized by his CDC
committee, the ACIP, when the moment comes to actually turn
that into an implementation plan.
We think that that might be something best done in a
circumstance by an organization that is not itself governmental
because it's still the case, I think, that people are a little
uneasy about the government calling the shots here and so we
are having a conversation very early on with the National
Academy of Medicine about whether they would be the place to
convene such a discussion.
We can keep you posted on that. It looks pretty promising.
I personally think that would be a really good step right now
and to do that quickly and have those principles laid out, say,
before Labor Day.
Senator Blunt. I'm confident we'll hear from others about
whether the National Academy of Medicine is the best place to
do this or not and that's good. That input will be good and
we'll share it with you as we hear it and you may hear it even
before we do, but it does seem to me that this should be
happening right now.
Just like every other plan about distribution of the
vaccine, of therapeutics, of testing, but particularly the
vaccine, I would think if we're going to have this discussion,
let's not have it after we have a vaccine and we're waiting to
distribute it because we haven't had a discussion of the ethics
or healthcare priorities.
Dr. Redfield, do you want to talk about this?
Dr. Redfield. I just wanted to make one comment, Mr.
Chairman, because I couldn't agree with you more, but I do also
want to say how important it is that we have it now because
it's not just about who's going to get the vaccine. It's also
about we have a requirement to study the safety and efficacy of
the vaccine in these populations.
Historically, if you have underlying medical conditions
significant, you don't get into vaccine trials. If you have
pregnancy, you don't get into vaccine trials. If you're a
child, you don't get in vaccine trials, and I know Dr. Collins
and I have discussed this, and I know they're planning to make
sure these populations are included because the last thing we
want to be is trying to recommend who gets the vaccine and we
don't have any data on how the vaccine works in the population
that we really think this vaccine needs.
So clearly right now, there's really thoughtful thinking
among the vaccine trialists how do we make sure that we have
good representation of African Americans, Hispanics, children,
pregnancy women, individuals that are elderly that have
multiple chronic medical conditions, because that's where this
vaccine needs to go, and so I don't know if Francis wants to
comment any more on it, but I know that they are thinking how
to move those populations into the Phase 3 trial efforts so
that we'll have that data when we need it.
Senator Blunt. Dr. Collins, and then we'll go to Senator
Murray.
Dr. Collins. Well, Dr. Redfield has said it well. This has
got to be a really high priority. This may make it more
challenging to run a Phase 3 vaccine trial when you're trying
to enroll a very diverse set of volunteers.
It would be much easier just to line up a whole bunch of 20
somethings who happen to be from the white population, but that
is not the only answer we need. We need to really have this
diversity and many of us are working hard to make sure that as
those trials get launched in the very near future that they
have that kind of outreach.
Senator Blunt. Yes. Well, let's be sure that the trials
aren't needlessly waiting because we haven't had this
discussion as quickly as we need to have it.
Senator Murray.
Senator Murray. Thank you, Mr. Chairman, and that's exactly
what I've been talking about, why we need to plan and why we
need to see that plan and specifically the public needs to see
this plan because even if everything goes well and we have a
vaccine and it is safe and effective and to the best of
everybody's knowledge, it isn't going to be available for
everybody September 1st, and we need to know how it's going to
be distributed, where it's going to go, what the priorities
are.
The public is good at dealing with facts. They're not good
at dealing with very high expectations that have no chance of
being met and then we run into all kinds of problems. So that's
why I have been pushing for a public plan for us to see it and
for us to be able to know how this is going to happen. So I'm
in that game.
BARDA CLINICAL TRIALS FOR THERAPEUTICS
Dr. Disbrow, let me ask you. Experts are saying that
clinical trials for treatments can move more quickly than
vaccine trials and that an effective drug that renders the
virus less deadly could allow us to begin to return to normal
faster.
So I was concerned last month that BARDA abruptly notified
researchers that it was halting funding for treatments for
severe lung ailments that were associated with the virus as
well as treatments that dampen the overactive immune response
that causes the body to actually turn on itself.
I wanted to ask you why did BARDA decide that the
development of therapeutics for severe forms of COVID-19 is not
a priority and how did it communicate that change?
Dr. Disbrow. Right. So thank you for the question, Senator.
Two-part response and I promise to be very quick.
So BARDA continues to invest heavily in therapeutics. We
are investing in a collection of convalescence plasma
supporting the very large expanded access protocol that you
heard about before. Over 25,000 people have been transfused.
We're further supporting hyper immune globulin which is
where you take pooled plasma and further process that to
concentrate the antibodies, and we're also supporting
neutralizing monoclonal antibodies. All of that is being done
under Operation Warp Speed, similar to what we're doing for
vaccines.
We did close the immunotherapeutics portion of our broad
agency announcement because at the same time, under Operation
Warp Speed and in collaboration with Dr. Collins' active
program, what we were receiving were individual proposals with
no clear identification that the products would work as an
immune modulator but requesting very large Phase 2/3 studies.
So under the active partnership and with OWS, the decision
was made to stand up large clinical trials, a clinical network,
under a master protocol where you can evaluate multiple
candidates for immune modulators and they will also be looking
at anticoagulants, as well, in a smaller cohort to determine if
there's clinical benefit.
If any of these drugs that are run through the active
protocols show clinical benefit, we are happy to engage with
those developers to help them with manufacturing.
Senator Murray. So it was also reported that BARDA's
suspending applications for the development of preventive
treatments for COVID-19. Can you explain that?
Dr. Disbrow. I'm sorry. I didn't hear the question, the
last part.
Senator Murray. It was reported recently that BARDA is
suspending applications for the development of preventive
treatments for COVID-19. Explain that.
Dr. Disbrow. So preventive therapeutic treatments?
Senator Murray. Correct.
Dr. Disbrow. So I will have to look into that and get back
to you. I apologize.
Senator Murray. Okay. Well, vaccines are important. We all
want that, but I think that we can't put all of our eggs in one
basket, especially since we know there's no effective vaccine
yet and we've seen issues in the past where it's hard to
develop. We all want it, but we can't put all of our eggs in
one basket. So I am concerned and I will be following that.
NIH CLINICAL TRIAL DIVERSITY EFFORTS
Dr. Collins, I want to direct a question to you. Given the
devastating impacts of COVID-19 on black, Latino, Tribal
communities, it's so important that we ensure equitable
representation in our clinical trials for vaccines and
therapeutics.
There was an internal analysis on inclusion that showed
that only 29 percent of participants in NIH-funded clinical
research were members of racial minority groups, only 9 percent
were ethnic minorities, and initial reports suggest we're still
not achieving adequate enrollment for these groups in clinical
trials for potential COVID-19 treatments and vaccines.
Can you tell us what NIH is doing to reduce the barriers
for participation and recruit people for these?
Dr. Collins. Senator, I really appreciate this question.
This is an extremely high priority. As has already been pointed
out at this hearing, the burden that has been laid upon the
shoulders of minority groups, particularly African Americans,
Latinos, and Native Americans from COVID-19 has been extreme
with much higher rates of hospitalization and death in those
groups and that means that the health disparities that we have
known, been around for a long time, have a very bright light
now being shown on them, and this is our opportunity and our
responsibility to take this on with the greatest seriousness.
Certainly when it comes to running the clinical trials,
both for vaccines and for therapeutics, this will be the
highest priority. We want to work with the parts of NIH that
have expertise in this space, like the National Institute of
Minority Health and Health Disparities, but we also want to
work with the institutions out there, like the HBCUs
(Historically Black Colleges and Universities), that have that
kind of credibility and capability.
There's an irony here in that we're also at a moment, I
think, where there is perhaps more suspicion about government
involvement in such things and yet this is the very moment
where we need to have the trust of those communities to reach
out to them and that means we need to engage community leaders
in that space. That means the churches. That means the heads of
various organizations that represent these underserved
populations.
We are building all those bridges as fast as we can and I
totally agree with you. If we fail at this at this moment where
health disparities have emerged in such a dramatic way, we will
have really failed to live up to our responsibility as stewards
of the public trust.
PREGNANT AND LACTATING WOMEN IN CLINICAL TRIALS
Senator Murray. Mr. Chairman, let me just ask one quick
follow-up on that because there was a recent report from CDC
that pregnant women are more likely to be hospitalized with
COVID-19 than non-pregnant women and despite a lack of data,
it's clear women of color are disproportionately at risk. So
I'm really concerned about the lack of inclusion of pregnant
and lactating women in COVID-19 clinical trials.
Are you going to follow the FDA guidance by including
pregnant and lactating women in clinical trials in COVID-19?
Dr. Collins. Absolutely, and you may know we've had this
committee, the PRGLAC Committee, that has been looking at ways
that we could have more inclusion of pregnant women and
lactating women and it applies very strongly in this place.
This is another high priority at NIH. Dr. Diana Bianchi,
who's our Institute Director for Child Health and Human
Development, has been a leader in this space. We are trying to
put together some additional research efforts to try to improve
the ability to do successful outreach safely to pregnant women
and lactating women. We have to have that included as part of
this mission.
Senator Murray. Thank you, and thank you for indulging me,
Mr. Chairman. Thank you.
Senator Blunt. Thank you, Senator Murray.
Senator Alexander.
Senator Alexander. Thanks, Mr. Chairman.
Dr. Collins, I believe you said that you're considering
involving the National Academy of Medicine in determining the
fairness of the distribution of vaccines, is that correct?
Dr. Collins. That is correct.
Senator Alexander. The National Academy describes itself
this way. If I remember, it was founded by President Lincoln,
chartered by the United States Congress to attempt
authoritative, objective, and scientifically-based answers to
difficult questions of national importance.
The New York Times called the National Academy of Medicine,
``The United States' most esteemed and authoritative advisor on
issues of health and medicine.''
So put me down as thinking that's a good idea to involve
because as people across the country look up at what's
happening here, they'll see agencies with alphabetical names
and they may be greatly respected agencies or bodies, but I
don't believe they have the prestige of the National Academy of
Medicine.
So in terms of the fairness of the distribution, I think
the only downside I can think of because I've worked with the
Academies many times, you may have to speed them up a little
bit because the Academies are accustomed to not moving at warp
speed and you're trying to move at warp speed, but we're not
talking about safety. We're talking about fairness. I think
that's a good idea and I would endorse it.
Now let me move on to something else, Dr. Collins. I want
to pick up words that either you or Senator Moran said,
something like sustaining what we've built. We had a whole
hearing about this in our committee that Senator Murray and I
chair, the Health Committee.
For 20 years, we've had four presidents and several
Congresses past nine laws and try to be prepared for pandemics
and we thought we were and then we get assaulted with this
sneaky, dangerous COVID-19 virus, and we find gaps that didn't
happen.
Senator Frist, the former Majority Leader, testified before
our committee. He pointed out that he made 20 speeches when he
was the Majority Leader identifying exactly what needed to be
done, tried to do them, but in between pandemics we got our eye
off the ball. We have other things to do and we don't do the
hard things.
So it seems to me that I'm going to work hard with Senator
Blunt, Senator Murray, anyone else, Senator Shelby, others, to
try to make sure that we don't make that mistake this time and
that while we've got our eye on the ball, while we're paying
attention, while we have these lessons in front of us, that we
deal with them.
For example, manufacturing. We're building up capacity.
We're building up onshore capacity, BARDA says. Well, are we
going to sustain that or are we just going to let happen to it
what Governor Leavitt testified happened with the last
manufacturing plant Stockpiles?
We know what happened with the stockpiles. They diminished.
Hospitals and States sold them off. They didn't have the money
to keep them up.
Data. We're not all happy with the way data is being
aggregated by CDC and need to take a look at that. Are we going
to wait until next year when we're worrying about something
else? Are we going to do it now?
Hospital preparedness. We're getting our hospitals prepared
again, but are we going to sustain that for the next pandemic?
This is not the last sneaky, dangerous virus that's going to
assault our people.
State and local support for public health. Governor
Leavitt, the former Secretary of Health, former governor, said
for 30 or 40 years, as Dr. Redfield has said, we've gradually
underfunded public health. So we're not as prepared as we think
we are when we're assaulted by a virus like this.
FUTURE PANDEMIC PREPAREDNESS
So I would like in my remaining moments, Dr. Collins, to
have your comment on the importance of, in the middle of this
pandemic, sustaining what we've built up for the next pandemic
because I'm pretty sure, based on my experience, that if we
wait 6 months and everything is over and we're back to normal,
we'll be worried about something else and we won't make the
difficult funding decisions, which most of them are, on
manufacturing stockpiles, data, hospital preparedness, and
State and local public health.
Dr. Collins. Well, I'd love to capture the words you've
just spoken and try to be sure that we all look at those every
month or so after we get through this current crisis, which we
will, but our track record's not so good here.
We don't really think about this as sort of we need an
insurance policy against the next pandemic. We would never
think about going bare in terms of insurance for our homes or
our cars, but we've gone bare too often in terms of insurance
against pandemics, which requires that sustained investment.
You've enumerated quite nicely the areas that have been
allowed to slip in between these episodes. We might have a
COVID-23. Who knows what the next coronavirus is. Or we might
have an influenza that comes, which is sort of overdue now, and
my sincere hope would be, given that this has been, after all,
the most serious infectious threat in the lifetime of any of
us, that this time we would have a little sustained memory and
I for one would very much like to help with that, too.
Senator Alexander. Thank you. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Alexander.
Senator Moran.
Senator Moran. Mr. Chairman, thank you very much, and I
have been listening in my office to all of the hearing today,
but I'm glad I was here in person to hear what Senator
Alexander just said and, Lamar, while your tenure in the United
States Senate is coming to an end, I hope your voice on this
and many other things does not cease.
Senator Alexander. Thank you.
Senator Moran. What you just said is important for us and
for the American people to hear and I appreciate how you've
conducted yourself always, but what you had to say today was
especially valuable.
ONGOING RESEARCH DURING THE PANDEMIC
Dr. Collins, I promised I'd come back to ask you a
question. It deals with the consequences of the pandemic on
research that was ongoing pre-pandemic and so I'm worried. This
subcommittee, this Appropriations Committee, NIH, our
colleagues in Congress have highlighted the importance of NIH
research and in many instances have put our money where our
mouths are, and I'm worried that we have set the stage for a
step backwards rather than a step forward as a result of the
virus.
And so my question is, that you can discount that if that's
not true, but my impression is that research that should be
ongoing today is not, that laboratories are not at capacity,
many are shut down. People have not been able to come to work.
I don't know prevalent that is in university research
versus in institutions in Maryland, but what is it that we need
to know to make certain that we provide the resources perhaps
in a Phase 4 that would quickly restart the capabilities of NIH
to be on the path toward finding the cures to all the things we
want to cure?
Dr. Collins. Senator, I really appreciate your asking the
question. This is very much on my mind as I see the way in
which, by necessity for safety reasons, so much of our research
enterprise, not just at NIH and our laboratories in Bethesda
but all over the country since that's where most of NIH's
dollars go, has been very much scaled back.
Any research that involved something other than COVID-19
was pretty much put into a very slow pace because people needed
to head home to protect against the further outbreaks and
people were still able to do science and many of them have
worked incredibly hard doing what they can do, but if you need
a lab bench and you need some equipment and some supplies, you
can't do that in your dining room.
So it is fair to say we have lost a lot of time with
research that required that kind of action, whether it's in
cancer research or something to do with gene therapy or a
diabetes project, like in my lab because all of my people had
to go home, too. This has been a major negative consequence
among many others of COVID-19.
We do not want to see that have a lasting impact. I will
tell you the universities who are our major grantees are
hurting bad right now because of the way in which this has hit
them financially. They both had the difficulty of not being
able to conduct research that they thought they were doing but,
of course, many of them have medical centers that have been
hemorrhaging money because of the inability to do elective
surgeries and other procedures that would normally allow them
to balance the books. They're in deep trouble.
We have estimated just on the basis of the research that's
been lost something in the neighborhood of $10 billion of
Federal funds that may be necessary to recoup if we're going to
bring these institutions back up to where they need to be.
On top of that, I think there's a wide variety of areas
that NIH--my watch is talking to me, thinking I'm talking too
long--a wide variety of areas that NIH really would like to
also put more efforts into to compensate for this in terms of
our efforts in COVID-19.
So, yes, we have been very interested in hearing what might
be possible in terms of that compensation and I know the
institutions who are grantees are particularly so, probably
including in Kansas. I would be surprised if you've not heard
from the leaders there about the situation they're in.
Senator Moran. Doctor, thank you. You know, I don't know
how many times I've asked you when are we going to be able to
delay the onset, when is the research going to be sufficient to
delay the onset of Alzheimer's? When are we going to be able to
rid ourselves of diabetes, and you have in your ways tried to
tell us the timeframe on which things seem to be on, and I
worry that if we ask the question today it would have to be a
timeframe that is much shorter and while the pandemic is
certainly severe and serious, a crisis in many ways, the cure
for cancer, the ridding ourselves of diabetes and Alzheimer's
is so significant, as well,----
Dr. Collins. It is.
Senator Moran [continuing]. That we cannot now allow this
circumstance to keep us from being on the path necessary to do
the things that we've set out to do.
Dr. Collins. And, Senator, I want to assure you NIH is
doing everything within our power to allow flexibilities
amongst our grantees in terms of ways that they can keep things
going. Young investigators can have an extension on the time-
table for their career next step and all of that. But it is
still a heartbreaking situation to see the consequences.
Senator Moran. Since I used most of my time to brag on
Senator Alexander, I'm going to try to get another question in
and that is, we see and hear Dr. Fauci regularly, and tell me
about the other institutes at NIH. What else--I didn't mean to
discount him.
THE ROLE OF INSTITUTES AT NIH DURING THE PANDEMIC
My actual question is, what do the other institutes have to
do with the pandemic? It wouldn't just be Infectious Diseases
that are trying to help us solve this problem. I assume NIH
across the board is engaged fully.
Dr. Collins. Absolutely. I convened all of the institute
directors back in March and said what could we do collectively
that just one institute can't do, although certainly Tony
Fauci's institute is in the lead, and every single one of our
27 institutes and centers has a significant role they would
like to play, some of which they don't have resources for but
hope that perhaps it might be possible to obtain them, such
things as the Heart, Lung, and Blood Institute.
Since this is a lung disease and they're actually running a
trial right now of anticoagulants because that is the place,
Heart, Lung, and Blood, where they have their greatest
expertise to be able to see if that can help people who are the
most ill patients on ventilators and ICUs.
The Genomics Institute is trying to figure out what's the
difference between individuals that predicts who's going to get
really sick after an exposure and who kind of shrugs it off.
There's probably some big story to be learned there that could
be useful even in terms of figuring out who ought to be the
highest priority to get a vaccine.
I mentioned already Child Health and the importance of
worrying about kids but also about pregnant women. Certainly
the Health Disparities issues that you've heard about are
absolutely pressing and we have expertise in that space, as
well.
So it is all hands on deck with people designing programs,
trying to figure out if there are ways that they can reallocate
dollars in the very rapid turnaround and hoping there's a way
that they can expand that because of the great needs.
So thanks for the question. It is very important and very
much on everybody's minds at NIH.
Senator Moran. I've utilized more than my good will. So I
can't ask anybody else any other questions, but, Dr. Disbrow
and Dr. Redfield, I have issues and things I'd like to discuss
with you and I look forward to doing that when it becomes
possible.
Senator Blunt. Senator Kennedy.
Senator Kennedy. Thank you, Mr. Chairman.
Gentlemen, I want to thank you for being here today. I want
to thank you for your hard work. I know you've been under a lot
of pressure, and I know this has been a learning process and
we're learning more each and every day.
I don't know whether we're in the middle of a new surge or
the first surge never ended. It doesn't really matter. But the
American people are scared. They're scared not just about their
health and their families' health. They're not just scared
about dying. They're scared about their job. They're scared
about their country. They're scared about their world. They're
scared about their church.
This is overwhelming for all of us, but they are really
overwhelmed, and they're not morons. They're very intelligent.
They don't have time, of course, because they're too busy
earning a living to read every day on the latest information.
I want to echo my colleagues and strongly encourage you at
some point to, if you haven't already, prepare a report but
also with your other colleagues, perhaps Dr. Birx, Dr. Fauci,
set aside some time to talk straight to the American people,
tell them the truth, as I know you will.
Under promise, over deliver, no spin, explain where we are
on vaccines. I'm encouraged by the progress that's been made. I
think the speed is breathtaking. I'm impressed that the whole
world's working together and explain where we are in terms of
delivering that vaccine, if we develop it.
You may have to do this in several different reports or
press conferences. I know this is an easy thing for me to
suggest. There are others that will have input in terms of you
holding a press conference, but I would do the same thing about
therapeutics.
As I've said a number of times, people aren't afraid of
getting sick, they're afraid of dying, and nobody wants to get
sick but people would feel a lot better if they knew if they
got sick they're not likely to die, and I know they're not
likely to die but many people don't understand that and that's
where the therapeutics comes in.
I would also encourage you to talk frankly to the American
people about what they can do to make themselves as safe as
possible. It's been a lot of misinformation about social
distancing and masks. I think the information has been pretty
consistent about good hygiene, but you gentlemen and others
have credibility and I would strongly encourage you to do that.
I want to thank you for your service. I mean that. Give the
American people some hope but tell them the truth, and I think
there is hope out there.
The other issue I wanted to talk about but I'm not, will
save it for another day, we've got to get our kids back to
school. We've got to do it and we need your help figuring out
how to do it safely.
Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Kennedy.
I did notice a major pediatric group came out yesterday
talking about for nutritional reasons, for socialization
reasons, for the sanity of their parents, kids need to get back
to school. It'll be the most likely touchstone that things are
returning to normal if we can get that done.
TESTING FOR SCHOOLS TO RE-OPEN
So, Dr. Collins, on the testing area, I'm concerned the
dates I'm hearing don't seem to quite match up with the
millions of school kids and college kids taking tests multiple
times when school starts that would be easily taken and quickly
responded to. Do you want to talk about that for me just a
little bit more?
Dr. Collins. I'll try. So currently the way that testing
has been progressing, you've seen substantial increases across
the country now to the point where there are more than 30
million tests have been administered and we're at the point now
where between half a million and a million tests are happening
each day.
But as I said earlier, many of those are circumstances that
require a central laboratory and where the results may not come
back for a day or two or three.
What we're trying to do with RADx is to greatly enhance the
ability for those kinds of point-of-care tests to be there. We
are both looking at platforms that go into the Shark Tank and
then have the opportunity for rapid expansion.
We're also looking at a few things that are a little bit
more advanced but not advanced enough. They sort of bypassed
the Shark Tank and go to the next phase in a program called
RADx ATP for Advanced Technology Program.
Some of those are also looking promising and we are doing
everything we can to pull them up into a higher throughput
space. Again, we had said if this went really well, we'd have
millions more of tests per week by the end of the summer,
beginning of the fall.
I'm talking to Bruce Tromberg, who's the Director of RADx
and a very gung-ho engineer, as you know from having met with
him. He believes that we could get to the point of an extra one
million tests per day just from the RADx Program by the first
of September, by Labor Day. That is a heck of a stretch since
we started this program at the end of April but that's the
trajectory we're on.
But that would go fairly steadily upward then over the
course of the next 2 or 3 months. So it might be more in the
neighborhood of five to 10 million additional tests per day by
December. That's our current projection, again taking the
exhortation from Senator Kennedy about sort of under promise
and the over deliver.
I'm not trying to tell you what I think the absolute most
amazing outcome would be. I think I'm trying to tell you what
we could achieve and then hold us accountable and see if we can
do it.
COST OF TESTING
Senator Blunt. From elementary school to big university to
an employer, are you thinking about cost as one of the things
you're looking at? I don't think these can cost $50 a test or a
$120 a test. I think we've got to be very cost conscious here
in what we encourage.
Dr. Collins. That is absolutely part of the way each one of
these platforms is being assessed and if you have something
that's like really cool technologically but it costs a hundred
bucks, it's not clear to me that that's what we should be
investing in right now.
Now, of course, there are oftentimes where somebody says
it's going to cost a hundred bucks and once you actually get
the Shark Tank folks involved, you find you can drive that
price way down.
VACCINE DISTRIBUTION MANAGEMENT
Senator Blunt. Right. Dr. Disbrow and Dr. Redfield, I heard
Dr. Disbrow, in responding to another question, brought up the
reality that when you have a vaccine, you have to have a
package that will house that vaccine to be administered.
I can't imagine the outrage if we had a vaccine and we
need, let's say, a handful of items to be able to give that
vaccine and we only have four of them. I can't imagine how
aggravated people would be starting right here if somehow we're
not totally prepared for that.
Tell me whose job that is to be sure that we have all of
that in line so that not only can the vaccine be developed and
delivered but we have everything we need to be sure it can be
administered.
Dr. Disbrow. Correct. Thank you for the question. It is
important to have an end-to-end plan for vaccine development
and delivery and so right now under Operation Warp Speed, the
Strategic National Stockpile is working on the kitting of the
vaccine--sorry--the----
Senator Blunt. I understand.
Dr. Disbrow [continuing]. Components.
Senator Blunt. Go ahead.
Dr. Disbrow. They are the ones that are doing it, but again
under Operation Warp Speed, it is a continuum. So the people
who are developing the vaccines, those working groups are
letting them know, you know, it's going to be a five-dose vial,
so you would need to send out, you know, seven, you know,
needles, seven syringes, seven band-aids, seven alcohol wipes
because you have to have excess, overage, and we are all
working together on that, but the SNS is putting together those
kits.
Senator Blunt. And who's responsible for that?
Dr. Disbrow. The Strategic Stockpile----
Senator Blunt. The Strategic Stockpile.
Dr. Disbrow. Correct.
Senator Blunt. Is it part of BARDA?
Dr. Disbrow. So it's part of ASPR, the Assistant Secretary
for Preparedness and Response, but again under Operation Warp
Speed, they are at the table as part of Operation Warp Speed.
Senator Blunt. All right. We're going to ask some questions
of them about this topic then.
Dr. Redfield, do you want to add anything to that?
Dr. Redfield. Thank you, Mr. Chairman. The only thing I
would add because it is important, we've done pandemic
exercises, you know, to prepare for pandemics, and we have
identified, as you pointed out, that everything was fine but we
didn't have enough needles or everything was fine, we didn't
have enough vials. So clearly that's been taken into account
here with----
Senator Blunt. I hope so.
Dr. Redfield. But the other area I wanted to just emphasize
once again is don't underestimate the importance of making sure
we have the cold chain capability, depending on what the
restrictions are of the product, that that product needs to be
handled within that cold chain for that distribution.
Senator Blunt. Right. And as I believe I understand what
we're trying to accomplish here, these various vaccines would
have different levels of what they need to have to maintain
their efficacy and----
Dr. Redfield. That's correct.
Senator Blunt [continuing]. Then--okay.
Dr. Redfield. That's correct. Some of them that are there
are going to require minus 80, you know, which is a higher
level cold chain requirement. Some may require less. So I just
think it's important that we are preparing to make sure we have
redundancy in our cold chain capability.
FUTURE SUPPLEMENTAL FUNDING NEEDS
Senator Blunt. Dr. Disbrow, there may be more than one more
COVID bill, but I think we should assume that between now and
some time very late this year, there's probably one more chance
to get this right funding-wise. How much money do you need?
Dr. Disbrow. So I can't go on the record and say how much
we need, but we will work with Congress and through our ASFR
colleagues, our Budget Office at HHS, as additional needs are
identified to bring them quickly to you.
Senator Blunt. Well, so you're going to work that up
through the Secretary?
Dr. Disbrow. Correct.
Senator Blunt. All right. We need to know that number and
we need to know that number pretty quick and then we'll have a
discussion about whether it's appropriate or not, but we need
to be thinking about that.
Dr. Redfield, do you want to talk about this topic? What do
you need to enhance the flu vaccines at a level we haven't been
able to encourage people to take them before? What do you need
to use that network to see what your plan might be 60 days
later for a vaccine network? What resources do you need that
you will not have unless we provide them?
Dr. Redfield. Thank you, Mr. Chairman. I want to echo one
of the sentiments of Chairman Alexander. Just to go back to my
view that now is the time to make the investment in the core
capabilities of public health that this Nation not only needs
but is deserves. That's a broad issue in terms of data
modernization, the ability to have predictive data analysis,
laboratory resilience, and the public health workforce.
In terms of distribution of the vaccine, largely one of our
key responsibilities, I think it's just important for people to
realize that distributing a new vaccine to everyone in this
Nation is a complicated process and it is going to take
resources. It's not measured in the millions, it's measured in
the billions. It's not like we're just going to send the
vaccine off to a bunch of doctors' offices and it's all going
to happen.
So I do think it's important that we make that investment
so that just like we're developing the vaccine at risk right
now, when it's finished, the company's going to have enough to
actually start to give it to the American public. We need the
exact same thing for the distribution strategy that was
commented by Senator Murray and others. That process has to
happen now and it is going to take resources to build it.
Senator Blunt. Well, absolutely. We know we're going to
have to--we have confidence we're going to have a vaccine. We
know it's going to have to be distributed. We need to figure
out what that plan is. There's no reason for that plan to wait
any longer than we have to, you know. We ought to have that
plan put together right now that has the flexibility that
allows you to deal with different vaccines from different
locations in different ways, but right now is the time that
ought to happen and whoever you need to work through to get the
information we need about what that's going to cost, we need to
know that in the next couple of weeks.
Dr. Redfield. Yes, sir.
Senator Blunt. Dr. Collins, I think we put a billion
dollars in Shark Tank and put substantial money at NIH for all
of these various institutions to be looking at what they need
to be doing. What do you need next?
Dr. Collins. Well, I appreciate the question and I'll
consider this that you're asking for my professional judgment.
Senator Blunt. I am. I am.
Dr. Collins. So I already mentioned in response to Senator
Moran's question the desperate need that our grantee
institutions have for what's happened as a result of COVID-19
and that the loss in research capabilities adds up to about $10
billion. That's part of it.
We do have these Trans-NIH initiatives that have been
developed over the course of the last few weeks that I do think
would make major contributions to our advances here. There's
about $1.6 billion in those projects that involve multiple
institutes and another $2.2 billion for specific institute
initiatives that I think have very high value.
Then on top of that, we also are thinking about whether
there are ways that we could help with the economic
difficulties in the country because NIH, every dollar we give
out we know has a big stimulus for the economy, and we have an
additional set of ideas there about things that would be shovel
ready that would add up to another $5 billion. Those are the
things we've been thinking about.
Senator Blunt. Okay. And I think on the grantee front, I
know we've been talking about the grants that are going to run
out this year. Basically, they lost this year. An extension of
those grants, some money to start laboratories back up, and
some absolute authority that the grants you didn't get to
determine this year don't get lost in this process and you have
more time to do that. Would those three things all be correct?
Dr. Collins. That is very much correct and appreciate your
being so on top of those things. They're going to matter a lot.
Senator Blunt. Senator Alexander.
Senator Alexander. Thanks, Mr. Chairman. It's been a very
helpful hearing for me. I've learned a lot.
Dr. Collins, Nashville Metropolitan Schools start August 4
and so do a lot of other schools in the South. I know in the
North they think that's uncivilized but that's what we do and
so the relevance of that is to tests and treatments.
As I said earlier, we've had a lot of talk about vaccines.
They're down the road. Tests and treatments are upon us and I
get a sense, I can't prove it, but that we're going to really
need those point-of-care tests you're working on and we're
going to need them quickly.
I hear lots of anecdotal stories about lab technicians that
are overworked, machines that are overworked, about people even
in our State where the governor has said if you want a test, go
down to your public health department and get it. I get
conflicting rumors that some public health departments say only
if the doctor, you know, says so.
I hear stories of delays of 3, 4, 5 days before the
diagnostic test comes back and, of course, it's not very useful
when it comes back several days late.
So what I'm getting around to is I want to underscore the
importance of your point-of-care tests and I hope you will let
Senator Blunt and the rest of us know if there's anything that
we can do to accelerate your RADx effort because creating
millions of new tests a day that are point-of-care rapid,
quick, reliable.
Senator Blunt said our surest path toward normalcy is when
75 million students go back to school and college and it will
build a lot of confidence in those schools and colleges if the
schools and colleges can test as frequently as they want to,
randomly or every class or every floor in a dorm or as the
Brown University president said, she wants to test every
student before they come back. Okay. Most campuses aren't going
to do that, but she wants to.
So if that's what builds the confidence to come back, your
project is the answer to that, it seems to me, and I have the
same confidence in it that I did earlier when Senator Blunt and
others worked on it.
My other question is treatments. We're talking about going
back to school. Having the point-of-care tests so you can test
any student, any class, any teacher, whenever you want is one
thing.
A second thing would be able to say, as I mentioned
earlier, and to say in the preliminary meetings that come back
to school. We're going to try to be open 5 days a week and we
want to assure the teachers and the administrators and the
parents and the grandparents at home that when you come back,
there are some specific medicines that are going to be
available that will help make sure that your illness is not as
severe and that you're less likely to die.
CURRENT TREATMENT OPTIONS AVAILABLE
Could you take a minute and just quickly list those, two or
three of them are already approved, two or three like the
``antibody cocktails'' are very promising, and what would those
things do? I mean, like the remdesivir, if I've said that
right, that I hear someone say that decreases by 32 percent the
amount of time to recovery. That's important specific
information to someone.
Dr. Collins. Right. Well, I totally agree with you. This is
critical and it's a major part of Operation Warp Speed and I'm
glad to say Janet Woodcock is now the leader of the Therapeutic
Workstream for Operation Warp Speed, a very experienced
scientist who knows how to get things done. It's a privilege to
work with her.
Yes, remdesivir has been approved and it does reduce
hospitalization and it had----
Senator Alexander. So if I get sick, if I'm a parent, my
kid comes home sick, is that available to me to help make my
hospital stay shorter?
Dr. Collins. Remdesivir is produced by Gilead. The U.S.
Government has recently acquired large numbers of doses to make
sure it's available. It is intravenous. So this is something
that you save for people who are in the hospital and who are
pretty sick but that's where we know it works.
Senator Alexander. Okay. What else would reassure me?
Dr. Collins. Dexamethasone, which is a steroid, was shown
in a study done in the U.K. but we've worked closely with the
U.K. all the way along and knew they were doing this, basically
showed a significant improvement in survival of people on
ventilators and also people who were not on ventilators but who
were on oxygen. So that's now become standard of care. So we
have those two.
But that's not nearly enough. We need to be able to push
forward all these other things quickly that look like they
could have promise.
The ACTIV Partnership that I described, public/private
partnership, looked hard to see what would be the most
important therapeutics to get prioritized because there were
hundreds of ideas out there and then try to get those into
clinical trials.
There is a trial coming soon of other immunomodulators,
basically things to try to damp down the overreaction of the
immune system that seems to happen in people who are very sick,
particularly those in ICUs.
There is a trial getting started very soon on anti-
coagulants because it's clear that this virus does something to
make the blood overly clottable and so it clots in the lungs
and other places and that can end up being a fatal outcome. We
need to figure out how that works.
And then there are all these immune systems, like the
antibody cocktails, the convalescent plasma, the hyper-immune
globulin, all of those now being subjected to rigorous testing
this summer, as well, in the United States.
Senator Alexander. And there's a possibility or a
likelihood that some more of those will be available for
parents, grandparents, teachers, administrators who might be
infected?
Dr. Collins. We are going to push hard to get those trials
to the point where you can draw a conclusion about their
effectiveness by the end of the summer, early fall. That's
really pushing the agenda, but it is the goal, and if I had to
pick one, I think the monoclonal antibody cocktails have a lot
going for them because we know they worked for Ebola and
there's all kinds of reasons to think this is the kind of virus
it should work for, too.
Senator Alexander. And you have several companies making
those, right?
Dr. Collins. We do.
Senator Alexander. And if they work and are safe, you
should be able to produce a lot of those, is that correct?
Dr. Collins. That will be part of the challenge is the
manufacturing and here again, having Warp Speed involved,
thinking ahead of time about the manufacturing so we don't get
to the point of having a successful trial and then have to wait
a long time to scale it up. These all have to be done in big
fermenters and BARDA is very engaged in that as is NIH as is
the whole Warp Speed Team. So we want to be sure if we have
something that works there's a lot of it out there.
Senator Alexander. Thank you, Mr. Chairman.
Senator Blunt. Thank you, Senator Alexander.
Thanks to our witnesses. We've taken a lot of your time
today, but it's been very helpful to us. I think for those
people at HHS who are here or who are following this hearing, I
think we need more clarity in the next 2 weeks on specifically
who's in charge of what, what are the deadlines, and what do
you need to meet those deadlines and do the job that the
country is counting on you to do, and we're going to help you
do that, but we need answers to those three questions.
The record on this----
Senator Alexander. Mr. Chairman, may I comment on what you
just said?
Senator Blunt. You can.
Senator Alexander. It reminds me of Admiral Rickover who
personally hired all of the commanders of the Navy nuclear subs
from the 1950s and he said to them you've got two jobs. One is
your ship and one is your reactor and if anything happens to
your reactor, your career is over, and he never had a problem
with a reactor----
[Laughter.]
Senator Alexander [continuing]. Because he put somebody on
the flag pole. So I think that's what you just said.
Senator Blunt. Well, we need to know and we need to know in
a hurry and we can't be helpful if you don't tell us how to
help and we need these questions answered.
So thank all of you. Thank you for sticking with me here.
Senator Murray was with us right up until the end of this, as
well.
ADDITIONAL COMMITTEE QUESTIONS
The record will stay open for 1 week for additional
questions.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to Francis S. Collins, M.D., Ph.D.
Questions Submitted by Senator Roy Blunt
vaccine research
Question. Dr. Collins, do you have animal models that are designed
for high-throughput analysis of vaccine efficacy and safety?
Answer. The National Institutes of Health (NIH), through the
National Institute of Allergy and Infectious Diseases (NIAID), develops
and maintains a comprehensive suite of preclinical services for the
scientific community. These services include in vitro and in vivo
screening, assay development, product optimization, safety and
toxicology testing, manufacturing process development, and good
manufacturing practice (GMP) production of candidate medical
countermeasures. As part of these services, NIH supports the
development of animal models to enable safety and efficacy testing of
candidate medical countermeasures (MCMs), including vaccines. Building
on ongoing and longstanding research on related coronaviruses and a
fundamental understanding of how SARS-CoV-2, the virus that causes
COVID-19, infects cells, NIH was able to support the rapid development
of small and large animal models and quickly evaluate their suitability
for evaluation of COVID-19 candidate MCMs. In the case of candidate
vaccines, these models can help identify and address any early concerns
related to vaccine-induced immune enhancement. Small animal models are
especially valuable for early rapid screening of MCMs. NIAID has
supported development of a number of small animal models, including
mouse and hamster models that facilitate infection by the virus by
expressing human ACE-2, a protein on the surface of human cells that
SARS-CoV-2 uses as a receptor to gain entry to the cells.
Evaluation of candidate MCMs in large animal models such as non-
human primates is also crucial for advancing promising MCMs into early
stage clinical trials. For example, results from non-human primate
studies were crucial for the advancement of a SARS-CoV-2 chimpanzee
adenovirus-vectored vaccine candidate, AZD1222, developed by
researchers at NIAID's Rocky Mountain Laboratories and collaborators at
the University of Oxford, to Phase 1 clinical trials. AZD1222 is being
further developed through a partnership between the University of
Oxford and AstraZeneca. A longstanding collaboration between the NIAID
Vaccine Research Center and the biotechnology company Moderna, Inc.,
led to the development of mRNA-1273, a SARS-CoV-2 vaccine candidate
that showed early promise in animal models. Moreover, interim results
from a Phase 1 study showed this candidate vaccine was generally well
tolerated and able to prompt neutralizing antibody activity in healthy
human adults. Phase 2 trials of mRNA-1273 are ongoing and Phase 3
trials are expected to begin in late July 2020. Animal models developed
with NIAID support also have been used to evaluate a wide range of
additional COVID-19 candidate vaccines based on various platforms,
including vaccine candidates developed utilizing DNA-, RNA-, protein/
adjuvant-, and viral vector-based vaccine technologies.
NIAID is committed to supporting the development of improved animal
models to help advance promising COVID-19 candidate MCMs through the
development pipeline. NIAID will continue to make these valuable
resources available to support the rapid development of vaccines and
other MCMs for COVID-19.
Question. Are you supporting vaccines that are not totally
dependent on the spike protein?
Answer. The NIH is taking a strategic approach to COVID-19
candidate vaccine development. Through the Accelerating COVID-19
Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH has
moved quickly to accelerate progress by conducting a scientific review
of more than 50 vaccine candidates already identified. The vast
majority of COVID-19 vaccine development efforts across the globe are
focused on the SARS-CoV-2 spike protein. This is because the SARS-CoV-2
spike protein is how the virus binds with and gains entry to human
cells. In addition, studies of related coronaviruses that cause Middle
East respiratory syndrome (MERS) and severe acute respiratory syndrome
(SARS) have demonstrated that neutralizing antibodies against
coronavirus spike proteins have protected animal models from
coronavirus challenge. However, not all NIH COVID-19 vaccine
development efforts are focused solely on the SARS-CoV-2 spike protein.
For example, NIAID is supporting Codagenix to develop a live-attenuated
vaccine candidate based on the same technology used to develop their
influenza vaccine candidate currently in Phase 1 clinical trials.
NIAID-supported researchers also are exploring vaccines that target
other proteins encoded by the virus, as well as identifying and
targeting specific regions of viral proteins to stimulate both an
antibody and a T-cell response. NIAID intramural scientists are
conducting early stage research to explore ``universal'' coronavirus
vaccine approaches using an assortment of chemically inactivated
coronaviruses or virus-like particles. These approaches also are being
used by NIAID scientists to develop universal influenza vaccine
candidates. NIH and Operation Warp Speed will continue to pursue
development and manufacture of the most promising COVID-19 vaccine
candidates.
Question. Are you supporting vaccine candidates in vectors that
have already been used safely in humans?
Answer. Developing safe and effective vaccines against COVID-19
continues to be a top priority of the Administration. Operation Warp
Speed (OWS) is the Administration's national program to accelerate the
development, manufacturing, and distribution of COVID-19 vaccines,
therapeutics, and diagnostics. There are a number of NIH and OWS-
supported investigational COVID-19 vaccines at various stages of
development that use protein/adjuvant platforms that have been used
against other viral respiratory pathogens such as influenza and RSV or
viral vector platforms whose safety has been demonstrated through past
clinical trials evaluating vaccine candidates for Middle East
respiratory syndrome and Ebola virus disease. These include chimpanzee
adenovirus-vectored, adenovirus 26-vectored (Ad26), and vesicular
stomatitis virus- vectored (VSV) vaccine candidates. Both the Ad26 and
VSV platform technologies have been used to develop approved vaccines
for other infectious diseases in either the U.S. or Europe. In
addition, there have been a number of Phase 1 studies assessing the
safety and immunogenicity of RNA vaccines against various viral
pathogens. NIH will conduct clinical trials to assess safety and
efficacy of OWS-supported vaccine candidates using the COVID-19
Prevention Network (CoVPN), in partnership with the Department of
Defense. NIH and OWS will continue to pursue development and
manufacture of the most promising COVID-19 vaccine candidates,
including those that use existing viral vector platforms.
Question. Are you supporting vaccine candidates in vectors that can
be easily scaled in production?
Answer. Developing safe and effective vaccines against COVID-19
continues to be a top priority of the Administration. Operation Warp
Speed (OWS) is the Administration's national program to accelerate the
development, manufacturing, and distribution of COVID-19 vaccines,
therapeutics, and diagnostics. Among its objectives, OWS aims to have
substantial quantities of a safe and effective vaccine available for
Americans by mid 2021.
OWS aims to speed the typical vaccine development and distribution
process by initiating large-scale manufacturing alongside highly
coordinated clinical research. This will ensure we will have sufficient
quantity of vaccine to distribute as soon as we identify safe and
effective candidates, including investigational vaccines using viral
vectors. For example, OWS is supporting advanced clinical trials,
regulatory support, and large-scale manufacturing to produce up to 300
million doses of Johnson & Johnson's Ad26-vectored COVID-19 vaccine
candidate. OWS also is supporting development of a protein/adjuvant
vaccine from Sanofi and GSK, companies which have extensive experience
with large scale manufacturing.
OWS aims to build the necessary plans and infrastructure for
distributing vaccines to hundreds of millions of Americans in a timely
and equitable manner. This includes expanding the supplies of
specialized materials and resources for distributing vaccines, such as
cold-chain storage, glass vials, and other materials. The involvement
of the Department of Defense in OWS, and its coordination with the
Centers for Disease Control and Prevention, will enable faster
distribution and administration than would have otherwise been possible
using traditional vaccine distribution pathways. Ultimately, OWS aims
for the rapid distribution of large quantities of a safe and effective
vaccine to the majority of all Americans.
phase 3 clinical trials
Question. It is critical for the rapid approval of funding for the
vaccine phase 3 trials for COVID-19. It is my understanding that some
sites participating in this work are being told to begin in mid-July,
but as of the first week of July, have not received any specific
funding for the trial beyond an agreement for $250,000 starter fund.
Without additional funding it makes it difficult to scale-up work. Dr.
Collins, when do you expect institutions participating in Phase 3 will
receive funding for the trial?
Answer. The NIH, as a component of Operation Warp Speed, is
committed to advancing the development and testing of COVID-19 vaccine
candidates as rapidly as possible. In early July 2020, NIH plans to
provide grant funds to sites in the U.S. participating in the first
Phase 3 SARS-CoV-2 vaccine trial through the COVID-19 Prevention
Network (CoVPN), a network of NIAID-funded sites throughout the U.S.
and the world. This trial will investigate Moderna's mRNA-1273, a
vaccine candidate that was developed in collaboration with scientists
at the NIAID Vaccine Research Center. Funding for additional NIH-
supported Phase 3 candidate vaccine trials through the CoVPN will be
made available to institutes participating in such studies as
expeditiously as possible.
NIH would defer to BARDA to provide information on Phase 3 clinical
trials not supported through NIH.
Question. What are the specific recruitment strategies institutions
participating in Phase 3 trials need to implement? Specifically, what
are the targeted populations? Are you incorporating those from
underrepresented groups, including from minority populations and those
with co-morbid conditions?
Answer. NIH has established the COVID-19 Prevention Trials Network
(CoVPN) by leveraging four existing NIAID-funded clinical trials
networks: the HIV Vaccine Trials Network (HVTN), the HIV Prevention
Trials Network (HPTN), the Infectious Diseases Clinical Research
Consortium (IDCRC), and the AIDS Clinical Trials Group (ACTG), in
partnership with the Department of Defense. The CoVPN aims to enroll
thousands of volunteers in large-scale clinical trials testing a
variety of investigational vaccines, monoclonal antibodies, and drugs
intended to either protect people from COVID-19 or to effectively treat
those with the disease. The CoVPN is a functional unit of the Operation
Warp Speed (OWS) partnership led by HHS to invest in and coordinate the
development, manufacture, and distribution of COVID-19 vaccines,
therapeutics, and diagnostics. The CoVPN will participate in harmonized
protocols, developed in collaboration with the Accelerating COVID-19
Therapeutic Interventions and Vaccines (ACTIV) public-private
partnership, that will enable analyses across multiple trials of
candidate vaccines. The network is expected to participate in numerous
trials at more than 100 clinical trial sites across the United States
and internationally. Phase 3 clinical trials overseen by the CoVPN will
target populations at greatest risk from COVID-19, including
individuals of older age, individuals with comorbid health conditions,
and racial and ethnic populations disproportionately impacted by COVID-
19. The CoVPN has developed an extensive community engagement framework
to reach out to diverse groups of potential research volunteers and
explain the specific details involved in participating in an
investigational vaccine or monoclonal antibody clinical study.
______
Questions Submitted by Senator John Kennedy
Question. While we have the best minds in the world working on this
vaccine, some may be concerned that every step in the research process
is happening concurrently rather than sequentially. Can you assure us
the vaccine will be safe and effective once it's finished?
Answer. Developing safe and effective vaccines against COVID-19
continues to be a top priority of the Administration. Operation Warp
Speed (OWS) is the Administration's national program to accelerate the
development, manufacturing, and distribution of COVID-19 vaccines,
therapeutics, and diagnostics. Among its objectives, OWS aims to have
substantial quantities of a safe and effective vaccine available for
Americans by mid 2021. OWS aims to speed the typical vaccine
development and distribution process by initiating large-scale
manufacturing alongside highly coordinated clinical research. Clinical
research trials will occur as expeditiously as possible without
jeopardizing participant safety. The concurrent manufacturing will be
conducted at financial risk as we will not know in advance whether
these investigational vaccines will prove safe and effective and
suitable for distribution, but we will be making investments in large-
scale production of the vaccine candidates. This will ensure we will
have sufficient quantity of vaccine to distribute as soon as we
identify safe and effective candidates.
Safety and efficacy of the vaccine candidates will be evaluated by
OWS through clinical trials conducted by NIH using the COVID-19
Prevention Network in partnership with the Department of Defense. The
network will develop and execute a series of harmonized protocols to
allow for the rapid, thorough evaluation of COVID-19 vaccine
candidates. The use of established clinical trials networks and
harmonized protocols will enhance efficiency and help ensure the
consistency of data across OWS-supported candidate vaccine clinical
trials. Moreover, all OWS trials are overseen by a common, independent
Data and Safety Monitoring Board, whose specific purview is to protect
the safety of volunteers enrolled in the trials. It is important to
note that while the strategy described above increases the financial
risk of developing these countermeasures, it does not affect the safety
of any final product. Vaccines supported by OWS will not be distributed
until they are shown to be safe and effective and are authorized for
use by the U.S. Food and Drug Administration.
Question. There have been concerns regarding the transparency of
Operation Warp Speed and a lack of up to date information about its
progress and findings. Can you ensure that Congress and the American
people will receive clear and transparent information from this panel
and other respected public health experts moving forward?
Answer. NIH will continue to provide the Congress with clear and
transparent information on the activities of the NIH, including NIH
activities coordinated by Operation Warp Speed.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Collins, Dr. Redfield, and Dr. Disbrow, preliminary
data suggests that secondary bacterial infections are prevalent amongst
those infected with COVID, which raises concerns about increases in
antibiotic resistance. Are you concerned by the ongoing decline in
industry investment for novel antimicrobials?
What actions can be taken to support a sustainable pipeline moving
forward?
Answer. Antibacterial resistance remains an important public health
crisis. BARDA has provided over 241 million to support early stage
product developers, via our CARB-X project. These resources have
ensured product developers have access to the tools and support to
bring innovative life-saving antibiotics from the bench to the market
that overcome the evolving threat of antibiotic resistance.
Importantly, with this funding, BARDA has established a robust
portfolio composed of CARB-X, with over 30 candidates in development,
and 16 advanced development public-private partnerships focused on the
development of 16 novel, small molecule candidates.
Antibacterial resistance remains an important public health crisis.
NIH is advancing the discovery, development, and clinical testing of
novel antibiotics, monoclonal antibodies, and new antibacterial
formulations, including therapeutics for difficult-to-treat infections.
NIAID, the lead NIH Institute for research on antibacterial resistance,
supports research to understand the fundamental biology of disease-
causing microbes and to develop and test novel diagnostics,
therapeutics, and vaccines to address drug-resistant infections. As
part of broader NIH COVID-19 efforts, NIAID is supporting research at
the intersection of SARS-CoV-2, the virus that causes COVID-19, and
bacterial infections, including a study by NIAID intramural researchers
of secondary staphylococcal infections in individuals with COVID-19.
Additionally, several NIAID-funded cohort studies are evaluating the
incidence and potential impact of secondary bacterial infections in
hospitalized individuals with COVID-19.
NIAID also continues to provide research resources and reagents at
no cost to scientists in academia and industry to help de-risk
investment in antibiotic discovery and early-stage development. These
resources are meant to lower the development costs of novel
antimicrobial therapies, making it easier for both industry and
academia to invest in this important area of research. NIAID also
supports a clinical trials network overseen by the NIAID Antibacterial
Resistance Leadership Group (ARLG) that is focused on evaluating
potential solutions to the problem of antibacterial resistance. This
network has initiated more than 40 wide-ranging clinical studies of
diagnostics, therapeutics, and treatment strategies for antimicrobial
resistance.
As part of broader HHS efforts to address antimicrobial resistance,
NIH is partnering with the Biomedical Advanced Research and Development
Authority (BARDA) to support the ``AMR Rapid, Point-of-Need Diagnostic
Test Challenge'' a $20 million prize competition seeking innovative,
rapid point-of-care laboratory diagnostic tests to combat the
development and spread of drug resistant bacteria. The Challenge calls
for new, innovative, and novel laboratory diagnostic tests that
identify and characterize antibiotic resistant bacteria and/or
distinguish between viral and bacterial infections to reduce the
unnecessary use of antibiotics, a major cause of antibiotic resistance.
On August 5, 2020, NIH announced that a rapid diagnostic for gonorrhea
won the $19 million Federal prize.\1\ NIH also supports the Combating
Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a
public-private partnership led by BARDA that has funded 65 research
projects, including 16 focused on new antibiotic classes. CARB-X seeks
to accelerate the development of tools to combat antibiotic resistance
by supporting a robust pre-clinical and early developmental pipeline of
antibiotics and other therapeutics, diagnostics, and vaccines. NIAID
remains committed to supporting this important area of research and
will continue to work with our partners across HHS to support a robust
pipeline of discovery and development of antibiotic therapies.
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\1\ https://www.nih.gov/news-events/news-releases/rapid-diagnostic-
gonorrhea-wins-19-million-Federal-prize-competition-combat-antibiotic-
resistance.
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Question. Dr. Collins, Dr. Fauci said that the National Institutes
of Health is currently making challenge doses. Could you describe the
NIH's current plans for producing the virus under good manufacturing
practices as well as a rough timeline for its completion?
Answer. Safe and effective vaccines will be a critical tool to
prevent infection with SARS-CoV-2 and help to end the COVID-19
pandemic. NIH is participating in a whole-of-government effort to
pursue the development of safe and effective SARS-CoV-2 vaccines as
rapidly as possible. NIH currently is prioritizing randomized
controlled clinical trials to evaluate the safety and efficacy of SARS-
CoV-2 vaccine candidates. A number of candidates have entered clinical
trials, with several of these poised to enter Phase 3 randomized
controlled clinical trials. These trials are designed to provide
information that may support licensure of the vaccines and availability
to the public, should they provide evidence that the candidate is safe,
immunogenic, and protective. Controlled human infection (CHI) studies
are one research approach that might help determine the effectiveness
of a vaccine.
NIH has not yet made a determination about whether to support CHI
studies. By the end of 2020, preliminary (and potentially final) data
from Phase 3 SARS-CoV-2 candidate vaccine clinical trials should be
available and will be used to inform the assessment of future SARS-CoV-
2 human challenge studies. NIH has begun early stage investigations of
the technical, ethical, and community considerations of conducting such
studies. Although NIH is prioritizing assessment of SARS-CoV-2 vaccine
candidates through clinical trials, these early stage investigations of
CHI studies would allow us to be prepared should they be deemed
necessary and safe and ethical to employ.
NIH also has begun to identify the research reagents and resources
that would be required for potential CHI studies and to develop SARS-
CoV-2 strains that could be used. The development of strains for use in
human challenge studies is a multi-stage process. First, strains with a
documented history must be identified, including their clinical source,
their growth in different cell lines, and other characteristics. They
must be purified in conditions consistent with clinical good
manufacturing practice (cGMP) and determined to be free from
microorganisms that may have unintentionally been introduced during the
manufacturing process; for SARS-CoV-2, this manufacturing must be done
in specialized biocontainment facilities. Clinical lots of challenge
strains must then be characterized in animal model studies. NIAID is
pursuing this process for 2-3 strains that may be available for further
consideration by December 2020.
Question. Dr. Collins, according to reporting, NIH staff
recommended the preparation of a challenge model back in early March.
How have you since considered the role of challenge trials in the
vaccine development process?
Answer. As discussed in the response above, CHI studies are one
research approach that might help determine the effectiveness of a
vaccine. NIH's position is that the best way to determine both safety
and efficacy is through the conduct of adequately powered, randomized,
controlled trials. NIH currently is prioritizing such trials to
evaluate the safety and efficacy of SARS-CoV-2 vaccine candidates.
Although NIH is moving forward rapidly with assessment of SARS-CoV-
2 vaccine candidates through clinical trials, CHI studies could be an
important and scientifically sound complementary strategy to more
traditional vaccine development approaches. As described in detail
above, NIH has begun early stage investigations of the technical,
ethical, and community considerations of conducting CHI studies to be
prepared should they be deemed necessary and safe and ethical to
employ.
Question. Dr. Collins, we understand that there are a limited
number of suitable quarantine units in which to run challenge studies--
how many beds in these units exist that could easily be made available
for challenge studies in the U.S. in the near future?
Answer. Clinical centers with isolation units (to prevent
transmission of SARS-CoV-2 from human challenge study participants to
others) and intensive care unit capability would be needed to conduct
CHI studies with SARS-CoV-2. In addition, as live SARS-CoV-2 virus must
be handled in biosafety level 3 (BSL-3) containment facilities,
locations under consideration for challenge studies must have the
requisite facilities and personnel trained to handle BSL-3 pathogens.
The NIH Clinical Center in Bethesda, Maryland, is one location that
would be able to provide the required capabilities and could be used to
conduct SARS-CoV-2 human challenge studies. The NIH Clinical Center
could dedicate up to 27 beds for CHI studies.
It is possible that additional isolation units operated by academic
centers would be able to provide the capabilities needed for CHI
studies with SARS-CoV-2. To date, NIH is aware of at least one academic
center with an isolation unit that has expressed interest in conducting
such studies.
Question. Dr. Collins, what are the benefits and weaknesses of
using a challenge study model for vaccine development and testing?
Separately, could a challenge study model be used to uncover
information about how long immunity lasts in patients with COVID-19
antibodies in their blood?
Answer. When it is possible to conduct them safely and ethically,
CHI studies can provide detailed information about the natural course
of an infectious disease. They also can be used to assess the effect of
interventions to prevent or treat an infectious disease. When there is
low disease transmission in the community, a CHI study can in theory
help to evaluate effectiveness of a vaccine candidate more quickly, as
it is certain that the study participants will be exposed to the
infection during the experiment. In these situations, a traditional
clinical trial may require more participants over a longer period of
time to generate a statistically valid signal of efficacy of the
vaccine because the likelihood of any one participant being exposed to
the infection in the community may be low.
CHI studies also present challenges. There are ethical concerns due
to potential health risks to the participants who are experimentally
infected. This is particularly true for infectious diseases such as
COVID-19, where we do not fully understand the scope of disease or have
effective treatments for all manifestations of disease. In addition,
CHI studies typically target young, healthy participants to help reduce
or mitigate potential health risks from experimental infections. This
practice can raise concerns about whether the findings of CHI studies
can be generalized to other populations, such as older adults or
individuals with comorbid health conditions. For COVID-19, this is
especially concerning because these other populations are at high risk
for complications and therefore will be prioritized in testing and
eventual distribution of vaccines. In addition, it is unknown how well
intranasal administration of a SARS-CoV-2 challenge strain will
reproduce aspects of natural infection, including viral replication,
symptomology, and the quality and magnitude of immune responses. As any
SARS-CoV-2 human challenge model is being developed, it will be
important to understand the strengths and limitations of the model for
informing candidate vaccine development and evaluation.
Separately, it may be possible to evaluate how long immunity lasts
in patients with SARS-CoV-2 antibodies in their blood by recruiting
such patients for CHI studies. However, it is important to note that
the same challenges and limitations as described for CHI vaccine
studies would apply to these types of studies. In addition, such a
proposed study would introduce additional ethical considerations, as
the health effects of repeated SARS-CoV-2 infections are currently
unclear.
Question. To all witnesses, an antibody therapeutic to fight COVID-
19 holds the distinct advantage over a vaccine in that the former can
be used to treat currently sick patients, while the latter can only be
used as a preventative measure on healthy people with immune systems
strong enough to learn how to recognize and fight the novel pandemic
coronavirus. The number of patient cases and deaths are of primary
concern for the country at this time because it is this load that
pushes our healthcare system to the brink and slows our economy to a
halt. While a vaccine is important in the long-term, how is Operation
Warp Speed ensuring additional focus on antibody therapeutics since
they hold the key to managing our current crisis?
Answer. The NIH, in collaboration with the Foundation for the NIH,
recently launched an innovative public-private partnership, ACTIV, to
speed the development of COVID-19 therapeutics and vaccines. As part of
the ACTIV partnership, and in collaboration with other NIH Institutes
and Centers, NIAID plans to launch a series of clinical trials
supported by Operation Warp Speed (OWS), a Federal partnership led by
HHS to invest in and coordinate the development, manufacture, and
distribution of COVID-19 countermeasures, to evaluate the efficacy of
monoclonal antibodies (mAbs) as therapeutics for COVID-19 in both
outpatient and hospitalized settings. NIAID also is planning separate
clinical trials to assess hyperimmune intravenous immunoglobulin.
As part of OWS, NIAID recently established the COVID-19 Prevention
Trials Network (CoVPN), in partnership with the DoD, by leveraging four
existing NIAID-funded clinical trials networks. The CoVPN aims to
enroll thousands of volunteers in large-scale clinical trials to test a
variety of investigational therapeutics and vaccines intended to treat
or protect people from COVID-19. Through the CoVPN, NIAID is supporting
additional trials to evaluate mAbs directed against SARS-CoV-2 as
potential tools to prevent transmission and spread of SARS-CoV-2. One
clinical study is evaluating the use of mAbs for prevention of SARS-
CoV-2 infection in households where there is a confirmed case of COVID-
19. A second clinical study is investigating the use of mAbs for
prevention of COVID-19 disease in senior living facilities. The NIH
ACTIV Therapeutics Clinical Working Group also has developed and openly
shared master protocols for OWS-sponsored clinical trials to enhance
trial efficiency of mAbs.\2\ In addition to the evaluation of mAbs for
prevention of COVID-19, ACTIV and CoVPN also are supporting OWS efforts
to develop safe and effective COVID-19 candidate vaccines.
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\2\ https://www.nih.gov/research-training/medical-research-
initiatives/activ
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Developing safe and effective medical countermeasures against
COVID-19 continues to be a top priority of the Administration. NIH will
continue to support the development and evaluation of mAbs and other
antibody-based therapies for treatment and prevention of COVID-19 as a
component of OWS.
Monoclonal antibodies are one kind of therapeutic that show early
promise in the treatment of COVID-19. So far, BARDA has invested in
both Regeneron and AstraZeneca to develop monoclonal antibodies for
COVID-19. Additional monoclonal antibodies are being evaluated for
potential funding. Under the ACTIV Public Private Partnership, clinical
trials will be established to assess safety and efficacy of multiple
monoclonal antibody products under a master protocol. The trials are
being supported under OWS and the companies can submit information
about their product for evaluation and prioritization. If selected they
simply need to provide their product and it will be evaluated in
collaboration with the company under the clinical trial. A key criteria
for moving each candidate forward is the timing of candidate
therapeutic availability. Regeneron's monoclonal antibody cocktail
entered clinical trials in June, and AstraZeneca's monoclonal antibody
cocktail will be entering the clinic very soon. In addition, if the
clinical trials demonstrate that the antibodies are safe and
efficacious, it is important that the company can manufacture
significant amounts of therapeutic.
Question. To all witnesses, can you detail the plans each of you
has for pursuing medical treatments, antibody therapies, and potential
cures of COVID-19?
Answer. NIH is the HHS agency leading the research response to
COVID-19 and the novel coronavirus that causes the disease, SARS-CoV-2.
NIH is building on previous NIAID-supported research on the closely
related SARS and MERS coronaviruses to accelerate the development of
COVID-19 candidate therapeutics. To further speed the development of
COVID-19 therapeutics and vaccines, NIH has launched an innovative
public-private partnership in collaboration with the Foundation for the
NIH. The ACTIV public-private partnership brings together stakeholders
from across the U.S. Government, industry, and the European Medicines
Agency to develop an international strategy for a coordinated research
response to the COVID-19 pandemic. Other Federal partners include
BARDA, DoD, the Department of Veterans Affairs, CDC, and FDA. NIAID,
the NIH Institute responsible for conducting and supporting research on
emerging and re-emerging infectious diseases, including COVID-19, also
has developed the NIAID Strategic Plan for COVID-19 Research. This
Strategic Plan details NIAID's plan for accelerating research to
diagnose, prevent, and treat COVID-19.\3\ NIH also is an active member
of Operation Warp Speed (OWS), a Federal partnership led by HHS to
invest in and coordinate the development, manufacture, and distribution
of COVID-19 vaccines, therapeutics, and diagnostics.
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\3\ NIAID Strategic Plan for COVID-19 Research: https://
www.nih.gov/news-events/news-releases/niaid-strategic-plan-details-
covid-19-research-priorities.
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Effective therapeutics for COVID-19 are critically needed to treat
patients who have been infected with SARS-CoV-2. Guided by the ACTIV
and OWS partnerships, as well as the NIAID Strategic Plan for COVID-19
Research, NIH Institutes and Centers are taking a multi- pronged,
coordinated approach to develop and test candidate therapeutics for
COVID-19. On February 21, 2020, NIAID launched a multicenter,
randomized placebo-controlled clinical trial, the Adaptive COVID-19
Treatment Trial (ACTT),\4\ to evaluate the safety and efficacy of
therapeutics for COVID-19. The adaptive design of this trial will
enable the evaluation over time of additional promising therapeutics,
in coordination with the ACTIV partnership. The initial iteration of
this study showed that the antiviral drug remdesivir increased rate of
recovery from severe COVID-19 in adults and may benefit survival (ACTT-
1). The anti-inflammatory drug baricitinib has been added to the second
iteration of the study (ACTT-2), currently underway. Additional
promising therapeutics may be added to further iterations of the trial
as appropriate. NIAID also is developing and testing other novel and
repurposed therapies including direct-acting antivirals and monoclonal
antibodies that target either SARS-CoV-2 or are meant to modulate over-
exuberant immune responses to severe COVID-19. NIAID also is planning
separate clinical trials to assess hyperimmune intravenous
immunoglobulin for treatment of COVID-19 in both outpatients and
hospitalized adults. As part of the ACTIV partnership, and in
collaboration with other NIH Institutes and Centers, NIAID plans to
launch a series of OWS-supported studies to evaluate monoclonal
antibodies in both outpatient and hospitalized settings.
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\4\ https://www.niaid.nih.gov/clinical-trials/adaptive-covid-19-
treatment-trial-actt.
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Institutes and Centers across NIH are working with partners in
academia and industry to pursue the development and testing of mAbs,
antiviral, and anti-thrombotic drugs for potential treatment of COVID-
19. For example, the National Heart, Lung, and Blood Institute (NHLBI)
is supporting research to evaluate the efficacy of the repurposed anti-
inflammatory drug colchicine for treating COVID-19 in the outpatient
setting and the use of anticoagulants to prevent life-threatening blood
clots experienced by some COVID-19 patients. NHLBI also is leveraging
the NIH-funded Strategies to Innovate Emergency Care Clinical Trials
Network \5\ to study whether blood plasma from individuals who have
recovered from COVID-19 can help reduce the progression of COVID-19 in
patients with mild symptoms. The National Center for Advancing
Translational Sciences (NCATS) is leveraging the NCATS Pharmaceutical
Collection,\6\ a compilation of every drug approved for human use by
major regulatory agencies worldwide, and other collections of small
molecules and compounds to identify potential SARS-CoV-2 therapeutics
for further investigation.
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\5\ https://siren.network/.
\6\ https://ncats.nih.gov/expertise/preclinical/npc.
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In addition to supporting the discovery and development of
therapeutics for COVID-19, NIH also has convened the COVID-19 Treatment
Guidelines Panel to provide up-to-date treatment guidelines for
clinicians. The panel is comprised of representatives of NIH and five
other Federal agencies along with representatives of eight professional
organizations, academic experts, and treating physicians including
providers from high COVID-19 incidence areas. The guidelines are
updated regularly as new evidence-based information emerges.\7\
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\7\ Coronavirus disease 2019 (COVID-19) Treatment Guidelines:
https://www.covid19
treatmentguidelines.nih.gov/.
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The goal of OWS is to develop safe and effective vaccines and
therapeutics against COVID-19. In support of OWS project goals, HHS
intends to carefully evaluate the safety and efficacy of both vaccines
and therapeutics. OWS will ensure the American people are poised to
receive safe and effective vaccine(s) and therapeutics as soon as
possible
______
Questions Submitted by Senator Marco Rubio
Question. If a vaccine isn't available by 2021, or is not 100
percent effective, what would herd immunity look like?
What factors would states and cities have to evaluate before we
achieved herd immunity and how long would that take?
Answer. Herd immunity occurs when a large portion of the population
becomes immune to a disease, which helps limit the spread of the
disease from person to person. In order to achieve herd immunity to
SARS-CoV-2, greater than 70 percent of the population likely would need
to gain immunity either through recovery from infection or through
vaccination. The length of time necessary to attain herd immunity is
difficult to predict and will be dependent not only on the availability
and public acceptance of a vaccine, but also the durability of the
immune reaction induced by vaccination or natural infection. It is
important to note that no vaccine is 100 percent effective, and even a
vaccine with a moderate efficacy could significantly decrease the
spread of COVID-19, in combination with other public health measures
outlined by CDC such as social distancing, appropriate use of masks and
face coverings, and increased handwashing. Prophylactic treatments such
as monoclonal antibodies also could be used to protect individuals who
may need immediate protection or may not be able to receive a vaccine.
NIH is supporting a broad portfolio of cohort studies to better
understand the incidence and prevalence of SARS-CoV-2 infection and the
immune response to SARS-CoV-2. This includes a longitudinal cohort
study at the NIH Clinical Center of individuals who have recovered from
COVID-19, a NIAID and NCI co-funded longitudinal cohort study of
healthcare personnel and other high-risk populations, and an additional
NIAID-supported observational study of adults and children diagnosed
with COVID-19. These studies, scheduled to evaluate immune responses
over periods of one to 3 years, will help us to better understand the
types and quantity of antibodies elicited by SARS-CoV-2 infection, the
potential for re-infection, and the durability of immunity following
infection. This information may help inform vaccination strategies as
well as improve our understanding of what herd immunity for COVID-19
may look like.
Question. Research indicates that vaccines tend to be less
effective amongst elderly populations--the very population that's most
vulnerable to the coronavirus.
If a coronavirus vaccine is less effective in seniors and only has
a 60 percent effectiveness overall, will the elderly population still
be highly vulnerable to COVID?
What long-term steps should we be taking to ensure to prepare for a
scenario in which older Americans are still highly vulnerable to this
virus?
Answer. The development of a safe, highly effective COVID-19
vaccine would be an invaluable tool in our efforts to control the
COVID-19 pandemic. As older adults have been shown to be particularly
vulnerable to this disease, it will be important to evaluate promising
vaccine candidates in this group in order to understand their efficacy
in this population. NIAID expanded an ongoing Phase 1 clinical trial of
an mRNA-based vaccine candidate to include adults age 56 and older in
April 2020 and plans to enroll older adults in additional studies of
this and other vaccine candidates. NIH also has established the COVID-
19 Prevention Trials Network (CoVPN), in partnership with the
Department of Defense, to support large-scale clinical trials of COVID-
19 candidate vaccines and therapeutics. Phase 3 clinical trials
overseen by the CoVPN will target populations at greatest risk from
COVID-19, including older adults, individuals with comorbid health
conditions, and racial and ethnic populations disproportionately
impacted by COVID-19.
The results of these studies will provide valuable information on
the efficacy of vaccination in high-risk populations and may suggest
the use of adjuvants or other strategies that could be used to boost
the immune response. Adjuvants, which are added to some vaccines to
improve vaccine efficacy, have been shown to be particularly effective
in boosting immunity in older adults. NIAID is working with
collaborators to provide synthetic and other adjuvants to the research
community for use in COVID-19 vaccine candidates. NIAID also is
conducting and supporting research into multiple adjuvanted vaccine
candidates that may be good candidates for vaccination in older adults.
Many of these adjuvanted vaccine candidates are currently being
evaluated in animal models with plans for clinical trials in the near
future. NIH also is supporting the development of prophylactic
treatments such as monoclonal antibodies that could be used to protect
individuals who are at increased risk of disease, need immediate
protection, or do not mount an effective immune response to a vaccine.
Until a safe and effective COVID-19 vaccine is available, it is
important that all individuals, especially those who are senior
citizens or have underlying health conditions, take precautions to
prevent infection by SARS-CoV-2. Precautions include maintaining social
distance and limiting interactions with other people as much as
possible, wearing a face covering when in public places or in
situations where it is not possible to maintain social distance,
washing hands often, and cleaning and disinfecting frequently touched
surfaces daily. Individuals should also monitor their health on a daily
basis and follow CDC guidance should they develop symptoms of COVID-19.
Additional guidance specific to older adults is available on the CDC
website.\8\
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\8\ CDC Coronavirus Disease 2019 (COVID-19)--Older Adults: https://
www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-
adults.html.
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Question. Last week, the Chinese Military approved the use of
CanSino Biologics' COVID-19 vaccine.
What can you tell us about the safety and efficacy of this vaccine
candidate?
Should we be concerned that the Chinese government has already
approved a vaccine candidate for limited use?
What does this mean for the United States' status as a leader in
medical innovation?
Answer. Currently there is no efficacy data for the CanSino
Biologics vaccine candidate, a recombinant adenovirus type-5 (Ad5)
vectored COVID-19 vaccine expressing the spike glycoprotein of SARS-
CoV-2. A Phase 1 trial of a low, medium, and high dose of this vaccine
candidate was initiated on March 16, 2020, in China. The trial enrolled
108 participants, and 50 percent of subjects who received the low or
medium dose developed neutralizing antibodies, with an increase to 75
percent of subjects who received the high dose. Significant side
effects were noted however, and side effects with the high dose were
severe enough to eliminate that dose from future studies. Although more
information is needed, it is possible that the low immunogenicity seen
in the trial may be due to inhibition by pre-existing immunity to the
adenovirus vector itself. A Phase 2 trial of this vaccine candidate was
initiated April 12, 2020. Safety and immunogenicity data from this
Phase 2 trial were published online in the journal Lancet on July 20,
2020.
The COVID-19 global pandemic has elicited an unprecedented global
response from the world's biomedical research community. For its part,
NIH is working with international partners to improve fundamental
knowledge of SARS-CoV-2 (the virus) and COVID-19 (the disease) as well
as to optimize the development and delivery of diagnostic tests,
treatments, and vaccines to populations most in need. We are encouraged
whenever progress is made domestically or globally on any of these
fronts.
Numerous international efforts are currently underway to develop
vaccines against SARS-CoV-2. Comparing the performance of independently
derived vaccine candidates will enhance our ability to identify the
most safe and effective vaccines to prevent COVID-19. One such effort
involves an experimental vaccine co-developed by the Chinese military
and CanSino Biologics. According to press reports, on June 30, 2020,
the Chinese military issued a limited approval of the experimental
vaccine for its military personnel. This limited approval was issued
prior to the July 20, 2020, publication of the experimental vaccine's
Phase 2 clinical trial results.\9\
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\9\ https://www.thelancet.com/journals/lancet/article/PIIS0140-
6736(20)31605-/fulltext.
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The United States remains in the vanguard of the global effort to
diagnose, treat, and prevent COVID-19. For example, NIH plans to launch
in July 2020 a Phase 3 clinical trial of an experimental COVID-19
vaccine co-developed by Moderna, Inc., and NIH. The trial, which will
be conducted at U.S. clinical research sites, is expected to enroll
approximately 30,000 adult volunteers who do not have COVID-19.
______
Questions Submitted by Senator Patty Murray
vaccine development
Question. OWS seeks to condense the traditional vaccine development
timeline by testing multiple candidates at once and evaluating safety
and efficacy simultaneously, rather than in turn. Experts caution that
truncated trials may put patients at increased safety risk. At present,
five candidate vaccines have entered phase two trials. At least five
other candidate vaccines have commenced phase one safety studies in
healthy human volunteers. The time required to adequately scale-up
vaccine production will depend on the technology chosen. It is critical
this process be transparent and data driven-meaning that as clinical
trials progress, the data should be made public and available to those
in industry, academia, and government to analyze.
What are the selection criteria for determining which vaccine
technologies are chosen and who within OWS makes these decisions?
Does the Administration plan to substantially invest resources
toward investigating recombinant protein, VLP or inactivated virus
vaccines for COVID-19. If so, how?
Answer. Operation Warp Speed (OWS) aims to deliver 300 million
doses of a safe, effective vaccine for COVID-19 by mid 2021, as part of
a broader strategy to accelerate the development, manufacturing, and
distribution of COVID-19 vaccines, therapeutics, and diagnostics
(collectively known as countermeasures). To accelerate development
while maintaining standards for safety and efficacy, OWS has been
selecting the most promising countermeasure candidates and providing
coordinated government support. 14 promising vaccine candidates have
been chosen from the over 100 vaccine candidates currently in
development-some of them already in clinical trials with U.S.
government support. The 14 vaccine candidates are being narrowed down
to the most promising candidates from a range of technology options,
which will go through further testing in early-stage clinical trials.
Large- scale randomized trials for the demonstration of safety and
efficacy will proceed for the most promising candidates. Rather than
eliminating steps from traditional development timelines, steps will
proceed simultaneously, such as starting manufacturing of the vaccine
at industrial scale well before the demonstration of vaccine efficacy
and safety as happens normally. This increases the financial risk, but
not the risk of the product to the recipient, as vaccines supported by
OWS will not be distributed until they are shown to be safe and
effective and are authorized for use by the U.S. Food and Drug
Administration.
OWS will support the most promising COVID-19 vaccine candidates
with no preference for one specific vaccine technology over any other.
OWS has supported several distinct vaccine platforms. These include
nucleic acid RNA vaccines, such as the Moderna SARS-CoV-2 vaccine
candidate, mRNA-1273 and viral vector vaccines such as the Johnson and
Johnson Ad26 SARS-CoV-2 vaccine candidate and the AstraZeneca/
University of Oxford AZD1222 vaccine candidate, with additional
platforms under consideration. NIAID also is providing support for a
candidate prime/boost vaccination strategy developed by the
biopharmaceutical company Vaxine whereby a SARS-CoV-2 DNA or RNA
vaccine candidate will act as a `prime', followed by a `boost'
containing recombinant SARS-CoV-2 protein plus the Advax-CpG adjuvant
vaccine candidate. In addition, NIAID intramural researchers are
investigating the use of virus like particles (VLPs) for the
development of a universal coronavirus vaccine. NIH and OWS will
continue to pursue development and manufacture of the most promising
COVID-19 vaccine candidates regardless of the underlying vaccine
technology.
The criteria to select candidates for funding are driven by the
science of the pre-clinical and initial clinical trials and the ability
of the vaccine companies to do the following: (1) Provide a vaccine
that has the potential to be determined by the FDA to be safe and
effective vaccine, (2) Execute clinical trials and deliver the vaccine,
ideally by end of the year 2020, (3) rapidly scale manufacturing from
clinical trials to meet quantity and distribution required to deliver
millions of doses to United States and territories ideally by mid 2021.
The Advisory Committee on Immunization Practices (ACIP) COVID-19
Vaccine Work Group has been established to help inform evidence-based
approaches to COVID-19 vaccination policy, including an initial vaccine
prioritization strategy. While the end goal is to offer vaccines to the
entire U.S. population, identifying priority groups for COVID-19
vaccination is critical for implementation planning. ACIP has embarked
on early planning in hopes of preventing distribution delays post
vaccine approval. The framework developed during, and the lessons
learned from, the H1N1 influenza vaccine implementation are being used
to guide COVID-19 vaccine prioritization. Given that many decisions
regarding the vaccine will depend on the vaccine itself, specifics are
unknown at this time.
adjuvant use in vaccine and therapeutic development
Question. HHS officials have stated that the Department has made
substantial investments in monoclonal antibodies for a COVID-19
therapy. According to the Infectious Disease Research Institute in
Seattle, WA, the use of adjuvants as stand-alone countermeasures have a
number of advantages over monoclonal antibodies including that they are
(1) easier to mass produce, (2) less expensive to manufacture, (3)
given as a prophylactic versus intravenously, (4) not specific to
COVID-19 and can adjust as mutations occur, and (5) proven to be
protective against future pandemics as well.
Has HHS looked into a similar investment in alternative therapies,
such as the use of adjuvants as a stand-alone countermeasure?
Do modern, synthetic adjuvants currently, or will they in the near
future, play a role in the Administration's pursuit of a COVID-19
vaccine, especially given their ability to maximize the manufacturing
and distribution of a compatible vaccine(s)? If so, please describe the
strategic resources and planning. What type of funding could be
provided to ensure manufacturing capabilities match population needs?
Has the Administration considered including synthetic adjuvants,
which have a long shelf life and can be produced at scale when needed
quickly, as part of the National Stockpile to ensure we are
sufficiently prepared to pivot should COVID-19 mutate or we inevitably
encounter a new infectious pandemic in the future?
Answer. Adjuvants are an important tool that can be used to enhance
and optimize the immune response to current and future vaccines. NIH
conducts and supports research on the development of novel adjuvants as
well as research to learn more about how adjuvants work to stimulate
specific immune responses. Adjuvants alone are unable to create a
targeted immune response to a specific pathogen. In combination with
targeted vaccine constructs however, adjuvants can greatly increase the
efficacy of the vaccine leading to a more robust and protective immune
response. Within the NIH, NIAID supports immunology research to better
understand underlying immune mechanisms and inform the development of a
robust adjuvant pipeline. In 2018, NIAID released a Strategic Plan for
Research on Vaccine Adjuvants which provides insights and
recommendations that guide the NIAID adjuvant research program.\10\ The
NIAID adjuvant research program aims to develop a ``toolbox'' of
adjuvants that can be matched with candidate vaccine antigens to
optimize vaccine efficacy.
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\10\ 2018 Strategic Plan for Research on Vaccine Adjuvants: https:/
/www.niaid.nih.gov/sites/default/files/
NIAIDStrategicPlanVaccineAdjuvants2018.pdf.
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NIAID already is working with a number of collaborators to provide
adjuvants of different types to the research community for potential
use to enhance the immune response to SARS-CoV-2 vaccine candidates.
These adjuvants are in various stages of development and include
compounds that specifically improve vaccine efficacy in older adults or
modulate host immunity to increase protection while limiting or
preventing harmful inflammatory responses. NIAID scientists are
currently evaluating well established adjuvants, such as AS03 from GSK,
or CpG and CpG/alum, in collaboration with Dynavax, combined with the
SARS-CoV2 Spike protein in non-human primate animal models. NIAID also
is supporting scientists at the biotechnology company Vaxine who are
exploring the use of adjuvants to generate an enhanced immune response
by 'priming' with a SARS-CoV-2 DNA or RNA vaccine candidate followed by
'boosting' with a recombinant SARS-CoV-2 protein plus the Advax-CpG
adjuvant vaccine candidate. The efficacy of Vaxine's SARS-CoV-2 vaccine
is being evaluated in non-human primates with NIAID support and
recently entered a Phase 1 clinical trial for safety in humans. NIAID
also is supporting projects to identify optimal adjuvants for a
particular SARS-CoV-2 vaccine candidate, as well as a project to test
the usefulness of a novel category of anti- inflammatory co-adjuvants
for a COVID-19 vaccine candidate.
In addition, NIAID scientists are developing vaccines using
platforms that have inherent adjuvant, or immune boosting, properties.
An example of this type of technology is the lipid nanoparticle
platform used in the mRNA-1273 vaccine candidate developed by
scientists at the NIAID Vaccine Research Center and the biotechnology
company Moderna, Inc. Interim results from a Phase 1 study showed this
candidate vaccine was generally well tolerated and able to prompt
neutralizing antibody activity in healthy human adults. Phase 2 trials
of mRNA-1273 are ongoing and Phase 3 trials are expected to begin in
late July 2020.
NIH will continue to support development of these vital resources.
NIH defers to BARDA to provide information related to manufacturing
capabilities for adjuvants as well as questions related to the
Strategic National Stockpile.
Adjuvants alone are not under current development at BARDA for
prophylaxis. To date none of the proposed immunostimulatory approaches
have been shown to prevent infection.
______
Questions Submitted by Senator Richard J. Durbin
health workforce capacity
Question. Two Fridays ago, the AAMC projected that our nation faces
a shortage of 139,000 doctors by 2033. Of course, we also face gaps in
nurses, mental health and addiction treatment, and dental care. Whether
it is in urban or rural areas, these health workforce shortages harm
patient access to care-and they have only been magnified by this
pandemic.
In Illinois, Gov. Pritzker called in health reinforcements from
other states and out of retirement, and the University of Illinois at
Chicago graduated 4th year medical students early to go serve. As we
deal with the crisis at hand, we must look to the future and ensure we
have a pipeline of health professionals ready and the pandemic
preparedness in place.
Today, we take our brightest students, put them through years of
medical school and residency, rigorous training, and license them on
one condition: an average student debt of more than $200,000. The sheer
economics of this equation steers newly minted health providers into
higher-paying specialties or communities, while leaving many rural and
urban areas with shortages. Unfortunately, the alarming racial and
ethnic disparities we are seeing in COVID-19 cases and mortality are in
part a reflection of these existing gaps in healthcare access, provider
capacity, emergency response, and the ability to reach minority
populations. The same will be true for targeting these populations for
vaccine uptake.
Two weeks ago, Senator Rubio and I introduced legislation (S. 4055,
Strengthening America's Health Care Readiness Act) to restore the
pipeline of health workers and boost our nation's emergency surge
capacity by expanding scholarship and loan repayment through the
National Health Service Corps, Nurse Corps, and National Disaster
Medical System. It would provide billions in a supplemental, multi-year
investment to address care gaps in underserved communities, bolster
preparedness and deployment capacity for health emergencies, and make a
commitment to recruiting health workers from communities of color and
underrepresented urban and rural areas.
Dr. Redfield, Dr. Collins: can you please comment on the health
workforce strains and shortages we have seen both prior to and during
the COVID-19 pandemic, and the challenges that debt from graduate
health education can have on our healthcare delivery and emergency
preparedness systems?
Answer. Prior to the COVID-19 Pandemic, our colleagues at the
Health Resources and Services Administration (HRSA) in the National
Center for Health Workforce Analysis (NCHWA) (https://bhw.hrsa.gov/
data-research/review-health-workforce-research) noted that, under
current workforce utilization and care delivery patterns, the 2025
demand for primary care physicians is projected to exceed supply at the
national level.\11\ Aging and population growth account for most of the
anticipated shortage of primary care physicians, but its impact varies
by discipline. There is substantial regional variation in the estimates
of both supply and demand for primary care physicians in 2025.\12\ Even
in states with estimated surpluses, localized shortages in primary care
providers may exist, especially for rural and underserved communities.
As of June 30, 2020, there are over 18,700 primary care, mental health,
and dental health professional shortage areas (HPSAs) in the United
States, the majority of which are in rural areas.\13,14\
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\11\ U.S. Department of Health and Human Services, Health Resources
and Services Administration, National Center for Health Workforce
Analysis. 2016. National and Regional Projections of Supply and Demand
for Primary Care Practitioners: 2013-2025. Rockville, Maryland. https:/
/bhw.hrsa.gov/sites/default/files/bhw/health-workforce- analysis/
research/projections/primary-care-national-projections2013-2025.pdf.
\12\ Id at page 4.
\13\ Health Professional Shortage Area designations are used to
identify areas, population groups, and facilities in the United States
that are experiencing a shortage of primary medical care, dental, or
mental health providers.
\14\ U.S. Department of Health and Human Services, Health Resources
and Services Administration, Bureau of Health Workforce. Third Quarter
of fiscal year 2020 Designated HPSA Quarterly Summary. Available at:
https://data.hrsa.gov/topics/health-workforce/shortage-areas. As of
June 30, 2020.
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While it is too soon for NCHWA to measure the impact of COVID-19 on
the primary care workforce due to a number of factors, the Health
Workforce Research Centers have developed many resources that may be
found on their website at this address, https://
www.healthworkforceta.org/covid-19-the-health-workforce.
The Council on Graduate Medical Education (COGME) has made several
recommendations in light of COVID-19. With regards to the healthcare
workforce, some portions of their recommendations include:
--Strengthen and modernize the public health workforce by continuing
to invest in preventive medicine residency training,
--Address stress, fatigue, and burnout among healthcare providers,
and
--Continue to support and accelerate Federal program flexibilities to
sustain, prepare, and strengthen the existing, entering, and
returning health workforce.\15\
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\15\ Accessed August 24, 2020 from: Council on Graduate Medical
Education. Letter to DHHS Secretary and Congress Concerning Section
3402 of the Cares Act Amendment 2020. June 30, 2020. https://
www.hrsa.gov/sites/default/files/hrsa/advisory-committees/graduate-
medical-edu/letters/congress-letter-covid19-recommendations.pdf.
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In addition, COGME also addressed the issue of educational debt as
it affects the health workforce in their Advisory Committee report
published in 2017. In summary, although there will probably always be a
dedicated group of students interested in the field of medicine, high
debt burdens may suppress recruitment, especially from low-income or
minority populations, and high debt may also skew interest toward
higher-paying specialties.\16\ It is to be noted that, although the
debt burden of medical students is high, 39 percent of dental school
graduates have debt exceeding $300,000--significantly more than medical
school debt.\17\
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\16\ Accessed August 24, 2020 from: ``Towards the Development of a
National Strategic Plan for Graduate Medical Education''. Council on
Graduate Medical Education. 23rd Report. April 2017. https://
www.hrsa.gov/sites/default/files/hrsa/advisory-committees/graduate-
medical-edu/reports/April2017.pdf.
\17\ Accessed August 24, 2020 from: https://www.adea.org/GoDental/
Money_Matters/Educational_Debt.aspx.
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Finally, Section 3402 of the CARES Act calls on the Secretary of
Health and Human Services, in collaboration with the Advisory Committee
on Training in Primary Care Medicine and Dentistry (ACTPCMD) and COGME,
to ``develop a comprehensive and coordinated plan with respect to the
healthcare workforce development programs of the Department of Health
and Human Services, including education and training programs.'' The
Department has begun working on this plan and is taking into account
the recommendations from COGME noted above and the challenges of the
COVID-19 pandemic.
______
Questions Submitted by Senator Brian Schatz
Question. The United States' lack of participation in global
vaccine collaborations.
What is the reason for not participating in the Access to COVID-19
Tools Accelerator? Why would the United States not participate in every
possible effort to identify promising approaches and find effective
therapeutics and vaccines?
Answer. While the United States Government has not joined the ACT-
Accelerator officially, USG subject matter experts are integrated into
the vaccine, therapeutic, and diagnostic pillars coordinated by CEPI,
Wellcome Trust, and FIND, respectively, to advance the pre-licensure
development, clinical trials, and manufacturing work streams to
identify safe and effective medical countermeasures. In addition, HHS
coordinates an interagency working group that engages the ACT-A access
and allocation work streams working with CEPI and Gavi, to provide
leadership, participate in the work, and influence outcomes on the
Allocation Framework to be used on approved therapeutics and vaccines.
The NIH, along with the Foundation for the NIH, has launched the
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
public-private partnership to speed the development of COVID-19 vaccine
and therapeutic candidates. This effort is complementary to the Access
to COVID-19 Tools Accelerator (ACT Accelerator), which is being
coordinated by multiple organizations.
The ACTIV partnership has brought together stakeholders from across
the U.S. government, industry, and the European Medicines Agency (EMA)
to develop an international strategy for a coordinated research
response to the COVID-19 pandemic. This effort is part of the
Administration's whole-of-government, whole-of-America response to
COVID-19. Other Federal partners include the Department of Defense
(DoD), the Department of Veterans Affairs (VA), and sibling agencies in
HHS, including the Biomedical Advanced Research and Development
Authority (BARDA), the Centers for Disease Control and Prevention
(CDC), and the Food and Drug Administration (FDA).
Through the ACTIV partnership, NIH has moved quickly to advance the
development of diagnostics, therapeutics, and vaccines by conducting a
scientific review of the available diagnostic tools, approximately 170
therapeutic compounds, and more than 50 vaccine candidates already
identified. The ACTIV Clinical Trial Capacity Working Group is focused
on maximizing clinical trials capacity in order to test the highest
priority candidates and standardize evaluation methods to assist FDA
review. The Working Group aims to establish a coordination mechanism
across clinical research networks to expedite trials, track incidence
across sites, and project future capacity. The ACTIV Therapeutics
Clinical Working Group and Vaccines Working Group aim to develop
harmonized master protocols for adaptive trials of multiple SARS-CoV-2
candidate therapeutics and vaccines. Information gained in ACTIV
partnership trials, such as the identification of biomarkers, could
both speed up the authorization process and provide evidence to address
cross-cutting safety concerns. Multiple candidate therapeutics and
vaccines will be evaluated. All these activities will help inform ACT
Accelerator efforts and other COVID-19 research activities worldwide.
The NIH also has taken steps to ensure the ACTIV partnership is
closely interconnected and complementary with other COVID-19 efforts,
including those led by the FDA and BARDA's Medical Countermeasures Task
Force, as well as international initiatives led by the Bill & Melinda
Gates Foundation, the Wellcome Trust, the European Commission, the
government of the United Kingdom, and WHO. Specifically, in relation to
the ACT Accelerator, NIH and other U.S. experts provide advice and
guidance on numerous planning, coordination, and oversight entities
associated with the ACT Accelerator program. NIH also participates in
regular coordination calls with WHO-affiliated scientific leadership to
facilitate scientific cooperation and help avoid duplication of effort.
Under the leadership of the White House Office of Science and
Technology Policy, NIH also participates in regular SARS-CoV-2 research
coordination calls with senior science advisors from approximately 20
countries. The NIH will continue to engage with international partners
through bilateral, multilateral, and regional efforts, to coordinate
SARS-CoV-2 research and to expeditiously advance the development and
testing of medical countermeasures that will urgently address the
clinical and public health response to COVID-19.
______
Questions Submitted by Senator Tammy Baldwin
Question. Nanovaccines represent a new type of vaccine delivery
technology that can enhance our future preparedness because they offer
faster global impact, higher effectiveness, lower cost, and higher
safety for medical staff. This approach has already been used to design
effective vaccines against respiratory infections such as influenza,
pneumonia, and respiratory syncytial virus and tested in multiple pre-
clinical and clinical models, and is particularly suited for pandemic
scenarios.
What efforts are underway through Operation Warp Speed to ensure
new delivery technologies such as nanovaccines are in the pipeline to
be readily adapted to develop a new COVID-19 vaccine?
Answer. Developing safe and effective vaccines against COVID-19
continues to be a top priority of the Administration. Operation Warp
Speed (OWS) is the Administration's national program to accelerate the
development, manufacturing, and distribution of COVID-19 vaccines,
therapeutics, and diagnostics.
OWS is coordinating existing HHS-wide efforts, including the NIH
ACTIV public-private partnership goals of streamlining clinical
evaluation of these vaccine candidates. NIH's role in OWS-led vaccine
development will be to conduct clinical trials to assess safety and
efficacy of COVID-19 vaccine candidates via the COVID-19 Prevention
Network (CoVPN). In July 2020, the CoVPN is expected to begin a Phase 3
clinical trial of the investigational mRNA-1273 vaccine, which was
developed by scientists at the National Institute of Allergy and
Infectious Diseases (NIAID) and their collaborators at the
biotechnology company Moderna, Inc. The mRNA-1273 vaccine candidate
uses a lipid nanoparticle delivery system. OWS also plans to support
mRNA-based vaccine candidates developed by Pfizer, Inc./BioNTech that
use similar nanotechnology delivery systems. In addition, NIAID is in
the early stages of exploring additional nanovaccine approaches,
including the development of nanoparticles capable of displaying key
SARS-CoV-2 surface proteins. NIH and OWS will continue to pursue the
development and manufacture of the most promising COVID-19 vaccine
candidates, including those that use nanotechnology delivery platforms.
______
Questions Submitted by Senator Joe Manchin, III
immunization programs
Question. In your testimony you highlighted several vaccine
candidates and your plan to test the vaccine across age groups. One of
the key lessons we've learned from COVID so far is how it has affected
different vulnerable populations. According to the Kaiser Family
Foundation, West Virginia has the most vulnerable population in the
U.S. with 51 percent of our population falling into that category. So
far West Virginia has had 2,979 cases with 93 deaths. Do you have any
initial plans for prioritizing essential groups or vulnerable
populations initially?
What input have you sought to date from immunization program
leaders in state and local public health agencies?
Answer. NIH has established the COVID-19 Prevention Trials Network
(CoVPN) by leveraging four existing NIAID-funded clinical trials
networks: the HIV Vaccine Trials Network (HVTN), the HIV Prevention
Trials Network (HPTN), the Infectious Diseases Clinical Research
Consortium (IDCRC), and the AIDS Clinical Trials Group (ACTG), in
partnership with the Department of Defense. The CoVPN aims to enroll
thousands of volunteers in large-scale clinical trials testing a
variety of investigational vaccines, monoclonal antibodies, and drugs
intended to either protect people from COVID-19 or to effectively treat
those with the disease. The CoVPN is a functional unit of the Operation
Warp Speed (OWS) partnership led by HHS to invest in and coordinate the
development, manufacture, and distribution of COVID-19 vaccines,
therapeutics, and diagnostics. The network is expected to participate
in numerous trials at more than 100 clinical trial sites across the
United States and internationally. Phase 3 clinical trials overseen by
the CoVPN will target populations at greatest risk from COVID-19,
including individuals of older age, individuals with comorbid health
conditions, and racial and ethnic populations disproportionately
impacted by COVID-19. The CoVPN has developed an extensive community
engagement framework to reach out to diverse groups of potential
research volunteers and explain the specific details involved in
participating in an investigational vaccine or monoclonal antibody
clinical study.
medical research
Question. Investment into medical research is key to finding COVID-
19 treatments and vaccines. However, research universities across the
country have had to suspend a majority of the work at their labs. In
West Virginia, researchers at West Virginia University have stepped up
in developing COVID-19 tests and work with public officials to
distribute the tests. This work is critical to helping fight this
pandemic. How are you working with medical research universities to
develop a COVID vaccine?
Answer. NIH supports research at academic and research institutions
through funding opportunities including grants, contracts, and
cooperative agreements. This funding is provided through both
supplemental awards that allow researchers to expand existing research
projects to include research on COVID-19, as well as opportunities to
apply for funding for new research projects on COVID-19. NIAID, the
lead NIH Institute for infectious diseases research, conducts and
supports basic and applied research to better understand, treat, and
ultimately prevent infectious, immunologic, and allergic diseases.
NIAID is actively developing new funding opportunities to provide the
extramural research community with vital funding to support the
development of COVID-19 candidate vaccines, therapeutics, and
diagnostics.
NIAID currently is supporting vaccine development efforts at a
number of research universities. This includes basic research to
characterize antibodies that target the SARS-CoV-2 spike protein to
better inform the design of candidate vaccines. NIAID-supported
research at universities also includes the development of novel SARS-
CoV-2 vaccine candidates based on a number of different vaccine
technologies. The Ad26 viral vector platform, now being developed by
Janssen, was originally a university-developed HIV vaccine candidate
developed with NIAID support. In addition, NIAID intramural scientists
are collaborating with university research groups to advance candidate
vaccines for SARS-CoV-2. For example, researchers at the NIAID Rocky
Mountain Laboratories collaborated with scientists at University of
Oxford on the development of a chimpanzee adenovirus-vectored SARS-CoV-
2 vaccine candidate, AZD1222. This collaboration built on longstanding
work with the University on the chimpanzee adenovirus vaccine platform.
University of Oxford has partnered with the pharmaceutical company
AstraZeneca on this candidate, which currently is undergoing clinical
trials supported by the University. Investigators at NIAID's Rocky
Mountain Laboratories also are conducting animal studies for additional
RNA-based and vesicular stomatitis virus-vectored SARS-CoV-2 vaccine
candidates in collaboration with researchers at the University of
Washington and Washington University, respectively.
In addition to monetary funding, NIAID and NIAID-funded groups make
research support services available to scientists at medical research
universities and other research institutions. These resources include
preclinical support such as in vitro and in vivo screening, assay
development, product optimization, safety and toxicology testing,
manufacturing process development, and good manufacturing practice
(GMP) production for the advancement of promising candidate medical
countermeasures. NIAID also supports the development of small and large
animal models to evaluate the safety and efficacy of COVID-19 vaccine
candidates. These resources are available to researchers regardless of
whether they currently have NIH funding. NIAID also is working to
develop a toolbox of potent adjuvants that are being made available to
researchers developing novel COVID-19 vaccines to help optimize vaccine
efficacy. A comprehensive list of resources available to medical
research universities and the rest of the research community is
available on the NIAID website.\18\
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\18\ Coronaviruses--Information for Researchers: https://
www.niaid.nih.gov/diseases-conditions/coronaviruses?researchers=true.
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NIH will continue to support university research to develop
candidate vaccines for SARS-CoV-2 through the funding of meritorious
research proposals, collaborations between NIH intramural scientists
and university researchers, and the provision of preclinical support
services to advance promising vaccine candidates along the development
pipeline.
______
Questions Submitted to Robert R. Redfield, M.D.
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Redfield, as we look at vaccine development with
special efforts taken to increase vaccination rates among higher risk
populations of Covid-19 and/or flu-related complications, what are CDCs
plans to target higher risk populations for Covid and flu vaccinations?
Answer. CDC is enhancing communications efforts to target special
audiences, including older Americans, people of any age with underlying
health conditions, workers in long-term care facilities and other
essential workers. Targeted communication and education efforts will be
implemented for African American and Hispanic/Latino communities
realizing that these groups have lower rates of flu vaccination, yet
higher risk for COVID complications.
CDC will also be working with the National Association for
Community Health Centers to implement evidence-based strategies to
increase adult vaccination coverage among underserved priority
populations. In addition, CDC will be engaging in simultaneous
individual expert consultation with 15 national leaders in the field of
health disparities, health equity, and social determinants of health to
develop strategies to address racial and ethnic disparities in adult
immunization.
CDC is testing flu vaccine messages to learn what impacts the
pandemic may have on the intent to vaccinate, including fears about
getting vaccinated in a safe environment, and CDC will continue to work
with our public health and clinical partners to eliminate barriers to
vaccination.
Question. We have seen some troubling statistics about the low
number of anticipated flu vaccinations in the fall. What is HHS doing
to combat this anticipated trend and provide flu vaccinations to
Americans if we are under stay at home orders?
Answer. As we expect SARS-CoV-2 to continue to circulate in fall,
CDC is working to significantly increase flu vaccination coverage,
particularly for populations most at risk. Increasing flu vaccine
coverage is an important public health goal on its own , but this year,
it will also serve to reduce the strain on the healthcare system that
will need to address the COVID-19 pandemic at the same time as seasonal
influenza.
We will be conducting flu message testing to learn what impacts the
pandemic may have on the intent to vaccinate, including fears about
getting vaccinated in a safe environment. Additionally, this year we
are implementing a project designed to assess the quality of
communications with patients about vaccinations; areas of focus will
include communications about influenza vaccination in African American
patients. We will continue to work with our public health and clinical
partners to eliminate barriers to vaccination.
The ongoing COVID-19 pandemic may affect where and how flu vaccines
are given, but CDC is working with health departments to develop
logistical contingency plans for vaccine distribution, with the
understanding that social distancing and extended vaccine distribution
may be necessary. Additionally, CDC has purchased 7.1 million
additional doses of influenza vaccine directly from vaccine
manufacturers to help uninsured and under-insured Americans get their
flu vaccines. These vaccines will be provided to State health
departments to focus on adults at higher risk of COVID-19 infection.
CDC is taking many considerations into account in its efforts to expand
flu vaccine coverage and is focusing on specific efforts to address
racial and ethnic disparities.
Question. Dr. Redfield, one of the key questions this fall will be
how a potential Covid-19 and/or current flu vaccines will be
distributed to the American people. What are the current plans in place
to achieve the goal of a seamless and efficient distribution process?
Answer. Recognizing that demand may exceed supply at the onset, HHS
plans for a tiered approach to vaccine distribution. The approach
builds on allocation methodology developed as part of pandemic flu
planning and will be adjusted based on experience during the first wave
of the COVID-19 response, data on the virus and its impact on
populations, the performance of each vaccine, and the needs of the
essential workforce.
CDC has a strong vaccine delivery infrastructure connecting public
health departments, healthcare providers, community groups,
pharmacists/chain drug stores, and others that can be used to
efficiently reach the population. During an emergency, this proven
system can be scaled up and expedited to manage and distribute many
more doses of vaccine than in a typical year.
CDC has worked for decades with its State and local partners to
ensure public health systems are prepared with plans, trained
personnel, strategic relationships and partnerships, data systems, and
other resources needed for sustaining a successful routine immunization
infrastructure, which will help ensure effective distribution can occur
once a safe and effective COVID-19 vaccine is available. CDC is working
closely with our government partners in response to this pandemic,
including with our sister agencies at HHS.
CDC will work with communities, government, and private partners to
rapidly distribute vaccine. The ongoing COVID-19 pandemic may affect
where and how vaccines are given, and we are working with health
departments to develop contingency plans. Additionally, State, tribal,
local and territorial health departments have hiring resources through
supplemental funding for contact tracing. Jurisdictions can build on
these recruitment pathways to support vaccine distribution.
Question. Supporting data exchange between States and community
immunization providers is key for many reasons, in particular to ensure
tracking of vaccination status for both flu and Covid-19. How much of a
priority is this data sharing process and what needs to be done better
moving forward?
Answer. Data sharing through vaccine tracking is a critical
component of CDC's COVID-19 vaccination initiative. CDC is actively
working to improve the data infrastructure needed to better track
vaccines, vaccination, and related information. The Immunization
Gateway is a data exchange hub that routes messages between State
immunization registries and multi-State providers and allows consumers
to access their immunization record. The support of the COVID-19
vaccine response requires significant enhancement of the Gateway's
infrastructure and rapid onboarding of State immunization registries
and multi-State providers. Enhancements and data exchange are critical
for a multi-dose candidate, should one or more be approved, to ensure
proper vaccine administration of the second dose.
Question. Dr. Redfield, the flu and Covid-19 look very similar and
most public health experts believe that Covid-19 and influenza will
circulate widely this upcoming fall and winter. What are your views on
how medical professionals can further distinguish the flu from Covid-
19?
Answer. Because some of the symptoms of flu and COVID-19 are
similar, it may be hard to tell the difference between them based on
symptoms alone, and testing may be needed to help confirm a diagnosis.
CDC has developed a new diagnostic laboratory test (multiplex PCR
assay) to assist with efforts to determine if an individual is infected
with SARS-CoV-2, the virus that causes COVID-19. The diagnostic test
can identify three viruses: Influenza A, Influenza B, and SARS-CoV-2.
Although flu and COVID-19 share many characteristics, there are some
key differences between the two. While more is learned every day, there
is still a lot that is unknown about COVID-19 and the virus that causes
it. This table (https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm)
compares COVID-19 and flu, given the best available information to
date.
Question. What is the government doing to expand sites of care?
Answer. Healthcare systems have adjusted the way they triage,
evaluate, and care for patients during the COVID-19 pandemic, using
methods that reduce exposure when appropriate. Telehealth services help
provide necessary care to patients while minimizing the transmission
risk of SARS-CoV-2 as well as other infectious diseases, such as
influenza. These new methods help reduce staff exposure to ill persons,
and preserve critical resources, such as personal protective equipment
(PPE). They also minimize exposure in patients who may be at high risk
for severe outcomes. Telehealth is not new, but new policies reducing
barriers to access and endorsement by medical societies, has increased
uptake and utilization during COVID-19. It has allowed access to acute,
chronic, primary and specialty care without risking exposure.
Telehealthcare can also improve compliance and patient outcomes.
Question. What is the administration doing to provide adequate
reimbursement for telemedicine services related to diagnosis and
treatment of flu and Covid-19?
Answer. Insurance payers and HCP professional associations have
supported the transition to telehealth services during the pandemic.
The Centers for Medicare & Medicaid Services (CMS) issued multiple
waivers, providing flexibility (e.g., geographic location, type of
health site) during the pandemic and granting payment parity between
telehealth and in-person clinical care for Medicare. Medicaid programs
are administered at the State level and States can choose whether or
not to cover telehealth services as an alternative to traditional in-
person methods of care. The HHS Office of Inspector General (OIG) is
also providing flexibility for healthcare providers to reduce or waive
cost-sharing for telehealth visits and other virtual care paid for by
Federal healthcare programs, such as Medicare, Medicaid, and the
Children's Health Insurance Program (CHIP), during the public health
emergency.
Question. Dr. Redfield, as reported by the CDC, routine vaccination
rates have plummeted since the beginning of the pandemic. Are you
concerned that this gap in immunization could lead to additional
infectious disease outbreaks, particularly among pediatric populations,
further exacerbating the existing public health crisis we're facing as
a result of the pandemic?
Answer. During the COVID-19 pandemic, pediatric outpatient visits
and routine childhood vaccination declined substantially. CDC observed
notable reductions in the number of vaccine doses ordered through the
Vaccines for Children (VFC) program. Corresponding declines were also
observed in the number of measles-containing vaccine doses administered
in eight U.S. healthcare organizations serving publicly and privately
insured patients.\19\
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\19\ https://www.cdc.gov/mmwr/volumes/69/wr/mm6919e2.htm.
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To combat these trends and prevent outbreaks of vaccine-preventable
diseases, CDC has been working with our immunization awardees and
public health partners, including the American Academy of Pediatrics,
to implement targeted intervention and communication strategies. We are
supporting providers in the safe delivery of vaccines during the COVID-
19 pandemic both through the development of guidance and support
materials and by helping to support catch-up vaccination using
reminder/recall systems for children who missed visits. We have
increased communication efforts to remind parents, providers, and
partners of the importance of routine vaccinations during the COVID-19
pandemic and expanding outreach to provide information about the VFC
program to families, especially those who may have recently lost
insurance coverage.
We are collaborating with our partners to encourage back-to-school
vaccination activities during the summer and influenza vaccination in
the fall. In addition, CDC's Vaccinate with Confidence strategic
framework aims to strengthen public trust in vaccines and prevent
vaccine-preventable disease outbreaks. Because of these efforts, we are
starting to see signs of recovery with greater numbers of children
presenting for preventive health services. For example, CDC's recent
Morbidity and Mortality Weekly Report,\20\ documents efforts taken by
the NYC health department in response to reduced immunization visits;
these efforts appear to have rapidly improved vaccinations, especially
for children under 24 months of age, highlighting the key role that
public health can play in conjunction with providers and the public.
The majority of VFC providers are now offering vaccination services,
and the number of vaccine doses ordered and delivered are increasing
and trending towards pre-pandemic levels.
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\20\ https://www.cdc.gov/mmwr/volumes/69/wr/
mm6930a3.htm?s_cid=mm6930a3_w.
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CDC also recognizes that the 2020-2021 flu season is fast
approaching, posing a risk of serious complications, hospitalization,
or death, even among otherwise healthy children and adults. As we
expect SARS-CoV-2 to continue to circulate in fall, CDC is working to
significantly increase flu vaccination coverage, particularly for
populations most at risk.
Question. What actions should be taken now to address this and
avoid adding additional stress to our already fragile healthcare
system?
Answer. Dr. Robert Redfield, CDC Director and Dr. Nancy Messonnier,
Director, National Center for Immunization and Respiratory Diseases,
communicated a Call to Action to State Health Officers and key partners
via a Dear Colleague Letter on June 22, 2020; the letter asked for help
in protecting our communities through vaccination. CDC's Call to Action
highlights several CDC resources, including Interim Guidance for
Immunization Services During the COVID-19 Pandemic (https://
www.cdc.gov/vaccines/pandemic-guidance/index.html). This interim
guidance is intended to assist immunization providers in a variety of
clinical and alternative settings for the safe administration of
vaccines during the COVID-19 pandemic. The guidance will be continually
reassessed and updated based on the evolving epidemiology of COVID-19
in the United States. Healthcare providers who administer vaccines
should also consult guidance about immunization services options in
their communities from State, local, tribal, and territorial health
officials. Ultimately, we hope the guidance helps immunization partners
reduce the burden on the healthcare system.
Question. Dr. Redfield, what actions is HHS currently taking to
address misleading and inaccurate information about vaccine safety?
Answer. CDC's Vaccinate with Confidence framework aims to
strengthen public trust in vaccines and prevent vaccine-preventable
disease outbreaks. The framework emphasizes three key priorities:
protect communities, empower families, and stop myths. CDC is working
with local partners and using trusted messengers to establish new
partnerships and contain the spread of misinformation. To advance this,
we've recently collaborated with social media companies like Pinterest
and Facebook to promote trustworthy information. To help protect them
from misinformation, CDC seeks to reach new groups and stakeholders and
provide clear information about vaccination and the critical role it
plays in protecting the American public. CDC will continue to build
upon the investments of our immunization program as it prepares both
the Nation's public health system and the private sector to disseminate
a COVID-19 vaccine once available.
Question. Does HHS have sufficient funding to support these efforts
now, so that we are well prepared when an effective COVID-19 vaccine is
available?
Answer. Vaccination will be a complex effort, because once
available it will be an entirely new vaccine that will require broad
distribution . Some variables that will impact cost and planning are
unknown until the vaccine is licensed or granted Emergency Use
Authorization. CDC will work with the department and administration to
further examine needed resources.
Question. Dr. Redfield, once we have a proven vaccine or vaccines,
efficient and seamless procurement and distribution will be critical to
realizing the potential of a vaccine in a ``return to normal.''
Following the H1N1 influenza pandemic, the CDC developed a series of
pandemic planning guidances, which include information on the planned
distribution of a vaccine during a pandemic.
How do you plan to distribute the vaccines to ensure high standards
of equality, efficiency, and safety? What agency will have the lead?
Will CDC's existing plans be utilized or are new plans under
development?
Answer. CDC is working closely with the interagency staff to
determine a path forward on critical issues related to a COVID-19
vaccine program through Operation Warp Speed. CDC stands ready to use
its expertise in public health preparedness and response, along with
its immunization infrastructure, to support Operation Warp Speed in
vaccine promotion, distribution, administration, and monitoring.
The Advisory Committee on Immunization Practices (ACIP) Workgroup
is evaluating safety and immunogenicity data of vaccine candidates as
well as the epidemiology of COVID-19 to present to the parent ACIP for
its deliberation, development of recommendations and presentation to
the CDC for the CDC's consideration in order to target populations and
priorities for vaccination.
Question. Will CDC's Advisory Committee on Immunization Practices
be the recommending body for prioritization of populations to get the
vaccine?
Answer. For COVID-19 vaccines, ACIP will review evidence on COVID-
19 epidemiology and burden, vaccine safety, vaccine efficacy, evidence
quality, and implementation issues to inform recommendations for COVID-
19 vaccine policy, including priority groups for vaccination. To
prepare for potentially FDA-licensed COVID-19 vaccines, ACIP has
established a workgroup that is evaluating safety and immunogenicity
data of vaccine candidates, as well as the epidemiology of COVID-19, to
identify target populations and priority groups for vaccination and
will present its findings to the parent ACIP for its deliberation,
development of recommendations and presentation to the CDC for the
CDC's consideration in determining population prioritization. Lessons
learned from the H1N1 influenza vaccine implementation are being used
to guide COVID-19 vaccine prioritization.
While the end goal is to offer vaccines to the entire U.S.
population, identifying priority groups for COVID-19 vaccination is
critical for implementation planning. Among adults, the risk for severe
illness from COVID-19 increases with age, with older adults at highest
risk. However, people at any age with certain underlying medical
conditions are at increased risk for severe illness from COVID-19.
Question. Dr. Redfield, the annual flu season is around the corner.
Do you foresee and difficulties with distributing a flu vaccine along
with a COVID-19 vaccine?
What is the potential impact of a low flu vaccination rate on the
healthcare system?
Answer. CDC has worked for decades with its State and local
partners to ensure public health systems are prepared with plans,
trained personnel, strategic relationships, data systems, and other
resources needed for sustaining a successful routine immunization
infrastructure. Each year, CDC safely distributes over 80 million doses
of vaccines from every vaccine manufacturer to 40,000 public and
private health providers across the country. CDC has a strong
infrastructure that connects public health departments, healthcare
providers, community groups, and others and can be used to efficiently
reach every population. During an emergency, this proven system can be
scaled up and expedited to manage and distribute many more doses of
vaccine than in a typical year.
CDC has provided its immunization awardees $140 million in
supplemental funding to support and enhance their immunization
programs. This supplemental funding will be used to support awardee and
local health department staffing, communications campaigns, pandemic
preparedness, and mass vaccination. In addition to other COVID-19
vaccine response work, awardee activities will include a specific focus
on significantly enhancing influenza coverage, especially in
historically underserved populations, and enrolling and working with
additional vaccinators like pharmacists.
Question. To Dr. Redfield and Dr. Disbrow, managing production
capacity for therapeutics and vaccines is paramount to Operation Warp
Speed's success. What challenges have you identified with respect to
rapid manufacturing and distribution of multiple products that span a
broad variety of technologies?
How do you plan to balance manufacturing capacity between antibody
products, therapeutics, and vaccines?
How do you intend to engage companies with the necessary
manufacturing capabilities, many of which would need to pause their
work on other products to meet these accelerated timelines?
Answer. Antibodies, small molecule therapeutics, and vaccines all
deploy different manufacturing technologies, and require different type
of manufacturing capacity, not interchangeable between categories. For
the vaccines, HHS has strived to maximize the amount of capacity
available. In many cases, the limiting factor to the number of doses
projected to be available by year-end is the timeline of the
manufacturing process. OWS is expediting the overall development
timeline by supporting development activities in parallel. For
antibodies, HHS is maximizing the internal capacity of the
manufacturers, while at the same time encouraging the transfer to
contract manufacturers to further boost the production rate. For small
molecules, the limiting factor determining the number of doses
available by the end of the year is the availability of raw and
starting materials, rather than the manufacturing capacity.
An effective influenza pandemic response includes developing,
manufacturing, distributing, dispensing, and administering medical
countermeasures, such as vaccines, in the shortest time possible, and
monitoring their impact when used during a public health emergency. A
safe and efficient vaccine distribution system (including storage and
handling), tracking and monitoring systems, communication strategies,
and technical assistance and analysis are integral components of a
prospective pandemic vaccine program. CDC will work with HHS and the
administration to coordinate COVID-19 vaccine allocation, distribution,
and administration.
HHS has developed and refined tools and guidance over the past
decade to help guide different aspects of pandemic planning and
response, including processes for vaccines. Given that vaccine supply
would likely increase incrementally as it is produced during the
pandemic, targeting decisions may have to be made.
Additional efforts are underway to request that manufacturers
produce additional needles and supplies to support the pandemic
vaccination program. As part of this effort, HHS is taking care to
avoid negatively impacting supplies used for routine and flu
vaccination. Additionally, OWS is ramping up production of reagents and
consumables to make sure that we have enough supplies to administer any
vaccine as soon as it is ready.
______
Questions Submitted by Senator Marco Rubio
Question. The CDC recommends daily screening for COVID-19 symptoms
before student athlete participation in practices and games.
Who is qualified to administer and record these screenings?
Should it be left to medical professionals, or should coaches and
trainers have the ability?
Answer. Any sports program administrator may conduct screenings for
symptoms. Steps should be taken to help ensure staff that are
responsible for these screenings are able to employ mitigation
strategies, such as maintaining social distancing or using physical
barriers to minimize close contact with children who may have symptoms,
so that they can stay healthy and avoid transmission. Additionally,
encouraging parents to be on the alert for signs of illness in their
children can be helpful in assuring that children who are sick don't
come to practice or games.
Question. What action should be taken if one player tests positive
for COVID-19? Should the entire team quarantine for 14 days?
Answer. Programs should ensure coaches, staff, officials, players,
and families know that sick individuals should not attend the youth
sports activity, and to alert the team if they have been exposed to
someone suspected or confirmed to have COVID-19. If someone tests
positive for COVID-19, programs should close off areas used by a sick
person within the last 24 hours and avoid using these areas until after
they are cleaned and disinfected. The organization should comply with
any State or local law or regulation that requires notifying local
health officials, youth sports program staff, umpires/officials, and
families immediately of anyone with COVID-19 while maintaining that
person's confidentiality in accordance with any applicable law or
regulation. Last, if any coaches, staff members, umpires/officials, or
players get sick, they should not return until they have met CDC's
criteria to discontinue home isolation (https://www.cdc.gov/
coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html#discontinue-
isolation). In addition, individuals who recently had close contact
with a person with COVID-19 should quarantine for 14 days since their
last exposure to the individual.
Question. How can schools and sports programs utilize test result
data while still complying with health privacy laws, like HIPAA?
Answer. Youth sports organizations should comply with any State or
local law or regulation that requires notifying local health officials,
youth sports program staff, umpires/officials, and families immediately
of any case of COVID-19 while maintaining confidentiality in accordance
with any applicable laws and regulations. Schools and sports programs
can work with local health officials to develop a reporting system that
youth sports organizations can use to notify health officials and close
contacts of cases of COVID-19. They can also advise students and staff
who have had close contact with a person diagnosed with COVID-19 to
stay home and self-monitor for symptoms and to follow CDC guidance if
symptoms develop.
______
Questions Submitted by Senator Patty Murray
planning a mass covid-19 vaccination campaign
Question. Having an authorized vaccine is only the first step in a
long process of actually distributing and administering that vaccine to
the entire U.S. population--a task that will require significant
coordination and planning. As Operation Warp Speed (OWS) races to
develop a safe and effective vaccine for COVID-19, the Federal
Government must fund the infrastructure to deliver vaccines and prepare
for various vaccination needs and scenarios associated with a mass
vaccination campaign. This effort must be led by the CDC, which has the
expertise and experience in protecting communities from vaccine
preventable diseases, responding to outbreaks, and ensuring a
scientifically sound and robust immunization infrastructure.
Please provide a comprehensive list of the various activities that
need to be fully accounted for and budgeted in planning for all aspects
of a mass COVID-19 vaccination program across the country. What
preliminary budget estimates are associated with each of these
activities?
Answer. A pandemic places extraordinary and sustained demands on
both public health and healthcare systems and on providers of essential
community services. Vaccination for COVID-19 will be a complex effort,
because it will utilize an entirely new vaccine that will require broad
distribution. A safe and efficient vaccine distribution system
(including storage and handling), tracking and monitoring systems,
communication strategies, vaccination of individuals in settings that
permit optimal social distancing, and technical assistance and analysis
are integral components of a prospective pandemic vaccine program.
However, some variables that will impact cost and planning are unknown
until the vaccine is licensed or granted Emergency Use Authorization.
CDC will work with the department and administration to further examine
needed resources.
Question. Please include estimated costs for State and local
vaccination infrastructure, cold chain supply, standing up additional
vaccination sites, workforce recruitment and training, immunization
information systems, reporting on coverage, effectiveness, safety and
evaluation, targeting hard to reach populations, and any other relevant
activities.
Answer. A pandemic places extraordinary and sustained demands on
public health and healthcare systems and on providers of essential
community services. Vaccination will be a complex effort because it is
an entirely new vaccine, or multiple different new vaccines, that will
require broad distribution A safe and efficient vaccine distribution
system (including storage and handling), tracking and monitoring
systems, communication strategies, and technical assistance and
analysis are integral components of a prospective pandemic vaccine
program. However, some variables that will impact cost and planning are
unknown until the vaccine(s) is/are licensed or granted EUA. CDC will
work with the department and administration to further examine needed
resources.
There are many critical components to consider in implementation of
a pandemic vaccine. Critical to success of the vaccine program is
ensuring vaccine safety, effectiveness, and ultimately vaccine
confidence. CDC is working closely with our government partners in
response to this pandemic, including with our sister agencies at HHS.
CDC stands ready to assist Operation Warp Speed to be successful in
achieving its coverage goals by building on our long- standing
immunization infrastructure and leveraging our broader public health
partnerships to address this health emergency (www.hhs.gov/about/news/
2020/06/16/fact-sheet-explaining-operation-warp-speed.html). Below are
the major program considerations in developing and implementing a
vaccine campaign:
--Prioritization and Allocation of Vaccine: The overarching aim of a
national pandemic vaccination program is to vaccinate all
persons in the U.S. who choose to be vaccinated. The vaccine
supply needed to meet this goal will increase incrementally
over time as vaccines are produced; however, initial supply is
likely to not meet demand. Since most vaccines in development
are expected to require two doses, and individuals will need to
receive a second dose of the same type of vaccine given for
their first dose, prioritization of limited supplies needs to
incorporate this element (e.g., will available doses of a given
product preferentially go to complete individuals' series or
for first doses for additional individuals). Once priority
populations are determined, guidance on vaccine prioritization
will be disseminated to State, tribal, local, and territorial
partners to inform planning and decisionmaking.
--Support State Immunizations Programs: State and local public health
programs will be largely responsible for directing vaccine to
target these federally identified priority populations. State
and local public health programs will enlist providers to
vaccinate the public who are eligible for USG VFC and section
317-purchased vaccine. State and local public health
authorities will need to train providers in storage, handling,
and administration of COVID-19 vaccine.
--Distribution of Vaccine: Each year, CDC safely distributes more
than 80 million doses of vaccines to approximately 40,000
public and private health providers across the country. During
the 2009 H1N1 pandemic, more than 70,000 provider sites
participated in the expanded vaccination program. Distribution
includes moving vaccines from manufacturer, to distribution
center, to States, and/or to vaccination administration entity
(e.g. doctor's offices, pharmacies, occupational clinics).
Strong networks connect public health departments, healthcare
providers, community groups, pharmacists/chain drug stores, and
others that can be used to efficiently reach diverse
populations. From these sites, vaccine may be transported in
small quantities to clinical sites for immediate use while
maintaining cold chain. During an emergency, this proven system
can be scaled up and expedited to manage and distribute many
more doses of vaccine than in a typical year.
--COVID-19 vaccine distribution will require scale-up of the existing
centralized vaccine and ancillary supply allocation and
distribution. Additional distributors are also under
consideration for larger scale up. COVID-19 distribution will
also require additional IT infrastructure and support of
existing ordering systems.
--Monitoring, Tracking and Data Infrastructure: CDC is actively
working to improve the data infrastructure needed to track
vaccines, vaccination, and related information. The
Immunization Gateway is a data exchange hub that routes
messages between State immunization registries, multi-State
providers, and allows consumers to access their immunization
record. The support of COVID-19 vaccine response requires
significant enhancement of the Gateway's infrastructure and
rapid onboarding of State immunization registries and multi-
State providers. Enhancements and data exchange are critical
for a multi-dose candidate to ensure proper vaccine
administration of the second dose.
--Vaccine Safety Systems and Vaccine Effectiveness Studies: Post-
licensure (post- approval) vaccine safety monitoring is the
continued assessment of a vaccine's safety after it has
received U.S. Food and Drug Administration (FDA) approval and
is being administered in the population; it is a Federal
responsibility. Due to the compressed regulatory approval
timeline, the anticipated vaccine administration of large
numbers of doses during a short time window, and heightened
public concern about vaccine safety, enhanced monitoring will
be an important component of a large-scale national SARS-CoV-2
immunization program.
--Post-approval monitoring can generate the large volumes of data
necessary to detect and characterize rare adverse events
following immunization. CDC uses multiple, complementary
systems and processes to monitor and assess vaccine safety.
In addition, CDC will work with partners to establish or
develop systems to fill gaps in post-approval safety
monitoring (i.e., in older age groups, the indigent,
special populations, etc.). CDC systems will be especially
important for monitoring new SARS-CoV-2 vaccines that are
made using novel manufacturing techniques not previously
used for other U.S. vaccines.
--Communications and Outreach: A strong and comprehensive
communication strategy is critical to any vaccine initiative.
Identifying the right messages, countering misinformation, and
targeted outreach to vulnerable and at-risk populations will be
necessary to achieve high coverage and herd immunity. CDC will
build on its existing relationships with public health partners
and health departments to effectively implement communication
efforts.
Question. What are the plans to centralize the pricing, purchase,
initial allocation, reallocation, and distribution of vaccines under
one Federal agency?
Answer. CDC is working closely with the interagency staff to
determine a path forward on critical issues related to a COVID-19
vaccine program through Operation Warp Speed. CDC stands ready to use
its expertise in public health preparedness and response along with its
immunization infrastructure to support Operation Warp Speed in vaccine
promotion, distribution, administration, and monitoring.
Question. How is the Administration working to make sure States are
not competing with each other to get access to a vaccine or vaccine
supplies to deliver the COVID-19 vaccine broadly? Will the
Administration make public a clear set of criteria and guidance to make
initial allocation and distribution prioritization decisions for a
vaccine or vaccines?
Answer. CDC has worked for decades with its State and local
partners to ensure public health systems are prepared with plans,
trained personnel, strategic relationships, data systems, and other
resources needed for sustaining a successful routine immunization
infrastructure. Each year, CDC safely distributes over 80 million doses
of vaccines from every vaccine manufacturer to 40,000 public and
private health providers across the country. CDC has a strong
infrastructure that connects public health departments, healthcare
providers, community groups, and others and can be used to efficiently
reach every population. During an emergency, this proven system can be
scaled up and expedited to manage and distribute many more doses of
vaccine than in a typical year.
The Advisory Committee on Immunization Practices (ACIP) COVID-19
Vaccine Work Group has been established to help inform evidence-based
approaches to COVID-19 vaccination policy, including an initial vaccine
prioritization strategy. While the end goal is to offer vaccines to the
entire U.S. population, identifying priority groups for COVID-19
vaccination is critical for implementation planning. ACIP has embarked
on early planning in hopes of preventing distribution delays post
vaccine approval. ACIP meetings are open to the public, and committee
records are required to be made available to the public, thereby
increasing transparency and visibility of the recommendation-making
process.
Question. What is OWS doing to work with CDC and State and local
public health officials to ensure an adequate public health workforce
to execute a nationwide vaccination campaign?
Answer. CDC stands ready to assist Operation Warp Speed to be
successful in achieving its coverage goals by building on our long-
standing immunization infrastructure. Each year, CDC distributes over
80 million doses of vaccines from every vaccine manufacturer to health
departments and private health providers across the country. We have a
strong vaccine delivery infrastructure connecting public health
departments, healthcare providers, community groups, and others that
can be used to efficiently reach the population. During an emergency,
this proven system can be scaled up and expedited to manage and
distribute many more doses of vaccine than in a typical year.
CDC has provided its immunization awardees $140 million in
supplemental funding to support and enhance their immunization
programs. This supplemental funding will be used to support awardee and
local health department staffing, communications campaigns, pandemic
preparedness, and mass vaccination. In addition to other COVID-19
vaccine response work, awardee activities will include a specific focus
on significantly enhancing influenza coverage and enrolling and working
with additional vaccinators such as pharmacists.
Question. What steps is OWS taking now to educate the American
public about a possible vaccination campaign? How is it ensuring that
the American people have access to early, clear, and consistent
information to make the best decisions about the health of their
families?
Answer. CDC recognizes that effective communication is a critical
component of any vaccine program, and CDC is working collaboratively
within Operation Warp Speed to ensure that consistent and accurate
information is at the foundation of the communication plan currently
being developed. Understanding that public confidence in vaccines is
necessary for vaccine uptake, CDC's strategic framework, Vaccinate with
Confidence (https://www.cdc.gov/vaccines/partners/vaccinate-with-
confidence.html), aims to strengthen public trust in vaccines and
prevent vaccine-preventable disease outbreaks. This framework
emphasizes three key priorities: protect communities, empower families,
and stop myths. Within this framework, CDC is working with local
partners and using trusted messengers to establish new partnerships and
contain the spread of misinformation. In addition to accurate
communication of what we do and do not know, building confidence
requires setting realistic expectations. CDC will continue to build
upon the investments of our immunization program as the agency works
with both the Nation's public health system and the private sector to
plan and prepare for dissemination of a COVID-19 vaccine, once
available.
Question. What steps is OWS taking to ensure access to vaccines for
communities of color, high-risk populations, low-income populations,
uninsured populations, and rural and frontier areas?
Answer. CDC is enhancing vaccination messaging to target special
audiences, including older Americans, people of any age with underlying
health conditions, workers in long-term care facilities, and other
essential workers. Targeted communication and education efforts will be
implemented for African American and Hispanic communities with the
understanding that these groups have lower rates of flu vaccination,
yet higher risk for COVID complications.
CDC will also be working with the National Association for
Community Health Centers to implement evidence-based strategies to
increase adult vaccination coverage among underserved priority
populations. In addition, we will be engaging in simultaneous
individual expert consultation with 15 national leaders in the field of
health disparities, health equity, and social determinants of health to
develop strategies to address racial and ethnic disparities in adult
immunization.
CDC is testing flu vaccine messages to learn what impacts the
pandemic may have on the intent to vaccinate, including fears about
getting vaccinated in a safe environment, and CDC will continue to work
with our public health and clinical partners to eliminate barriers to
vaccination.
Question. What is the role of CDC's Advisory Committee on
Immunization Practices (ACIP) in developing recommendations for a
COVID-19 vaccine? How does the planned study by the National Academy of
Medicine that is being coordinated by NIH relate to, and not duplicate,
ACIP's role?
Answer. The Advisory Committee on Immunization Practices (ACIP) was
established in 1964 and is chartered as a Federal advisory committee
that provides guidance to the CDC Director on the use of vaccines in
the U.S. civilian population. For COVID-19 vaccines, ACIP will review
evidence on COVID-19 epidemiology and burden, vaccine safety, vaccine
efficacy, evidence quality, and implementation issues to inform
recommendations for COVID-19 vaccine policy, including priority groups
for vaccination. ACIP meetings are open to the public, and committee
records are required to be made available to the public, thereby
increasing transparency and visibility of the recommendation- making
process.
The committee convened by the National Academy of Medicine (NAM)
will focus on developing a framework for equitable allocation of COVID-
19 vaccines both in the United States and abroad. The findings from the
NAM committee will be shared with ACIP and may help inform the
committee's deliberations related to vaccine priority groups and
ensuring equity in vaccination in the United States.
Question. Given that CDC recently disbursed $140 million to States
and localities to assist with preparation for the coming flu season,
what more is needed to scale up our vaccination efforts for the
seasonal flu this fall and winter?
Answer. Funds from the recent CDC award of $140 million to
jurisdictions will begin to support staffing and preparedness early
this summer and focus on ensuring flu coverage for vulnerable
populations. CDC has also increased communication efforts and has
purchased 7.1 million additional doses of seasonal influenza vaccine
directly from vaccine manufacturers to help uninsured and under-insured
Americans get their flu vaccines. These vaccines will be provided to
State health departments, and adults at higher risk will be prioritized
to receive vaccine. CDC is taking many considerations into account in
its efforts to significantly expand flu vaccine coverage and is
focusing on specific efforts to address racial and ethnic disparities.
Specifically, CDC will be working with the National Association for
Community Health Centers to implement evidence-based strategies to
increase adult vaccination coverage among underserved priority
populations. CDC will engage in expert consultation to develop
strategies for addressing racial and ethnic disparities in adult
immunization by, soliciting simultaneous individual expert opinions
from 15 national leaders in health disparities, health equity, and
social determinants of health. The focus will be on African Americans,
with similar activity focused on Hispanic populations under
consideration.
CDC is also working with Vaccines for Children program providers to
ensure they are prepared for a potentially increased number of eligible
children, due to the economic impact of the pandemic. Children and
adults with private insurance should be able to access the flu vaccine
at no cost, if they are seen at in-network providers. The Affordable
Care Act requires that all vaccines recommended by the Advisory
Committee on Immunization Practices and adopted by the CDC Director are
covered by insurance providers. CDC is also supporting efforts for
school-located vaccination clinics to expand access to flu vaccines for
children. Additionally, Section 317 Immunization program provides some
vaccine to be used as a safety net for outbreaks and uninsured adults.
______
Questions Submitted by Senator Jack Reed
vaccine infrastructure funding
Question. Once a safe and effective COVID-19 vaccine is approved,
it will require a serious undertaking to launch a nationwide vaccine
campaign, which would include vaccine distribution, safety monitoring,
education and awareness campaigns, and tracking vaccine coverage rates.
Do you think that more funding will be necessary for State and local
health departments to do this critical work? Do you think that this
funding is needed now so that when a vaccine is approved, systems will
be in place to deploy the vaccine as soon as possible?
Answer. The cost and planning for vaccine distribution are
contingent on multiple variables, many of which are unknown. CDC will
work with the department and administration to further examine needed
resources, as necessary.
lessons learned from h1n1
Question. Is CDC leveraging its existing vaccine infrastructure to
prepare a national COVID-19 vaccine distribution plan? What lessons
were learned from the H1N1 vaccine strategy to help inform us now?
Answer. CDC has worked for decades with its State and local
partners to ensure public health systems are prepared with plans,
trained personnel, strategic relationships and partnerships, data
systems, and other resources needed for sustaining a successful routine
immunization infrastructure. This will help ensure that effective
distribution can occur once a safe and effective COVID-19 vaccine is
available. CDC is using both its expertise in public health
preparedness and response and its immunization infrastructure to
support Operation Warp Speed in planning for vaccine promotion,
distribution, administration, and monitoring. As part of our influenza
pandemic preparedness and planning we have developed guidance that is
available online. The COVID-19 pandemic has likely accelerated a trend
towards different ways of engaging with the healthcare system, and
successful delivery of this vaccine will need to incorporate new types
of sites and approaches for vaccine delivery. For example, during H1N1,
once vaccines became widely available pharmacies played an important
role in the vaccine distribution, and their role is even more critical
today.
CDC learned several lessons from the H1N1 response and vaccine
distribution. One relevant example is that there can be uncertainties
in the pharmaceutical manufacturing process; we should anticipate
delays and build flexibility into our planning process to respond to
adapting circumstances. Another is that demand is likely to vary in
different parts of the country and in diverse populations within a
given geographic area. Equitable distribution, trusted communication,
and nimble delivery strategies will be important.
national vaccine campaign
Question. What work is underway on a national vaccine campaign?
Once a vaccine is approved, how can we ensure that the public feels
confident in the safety of the vaccine? What strategies will CDC employ
to ensure that vulnerable communities, such as minority communities--
who have been hit hardest by COVID-19 and historically have lower
immunization rates--get the vaccine? How will CDC work to combat
misinformation about a COVID-19 vaccine and vaccines more broadly to
increase confidence in a vaccine and therefore increase vaccination
rates?
Answer. CDC recognizes that effective communication is a critical
component of any vaccine program, and CDC is working collaboratively
within OWS to ensure that consistent and accurate information is at the
foundation of the communication plan currently being developed.
Understanding that public confidence in vaccines is necessary for
vaccine uptake, CDC's Vaccinate with Confidence (https://www.cdc.gov/
vaccines/partners/vaccinate-with-confidence.html) strategic framework
emphasizes protecting communities, empowering families, and stopping
myths.
--Protecting Communities: Immunization information system data will
be important to help find and respond to pockets of low vaccine
coverage and CDC will continue to help build immunization
program capacity and leadership to effectively respond to
outbreaks in vulnerable communities.
--Empowering Families: CDC will assist with strengthening parent-
provider conversations about vaccination by developing a
provider toolkit to address parents' vaccine questions during
outbreaks; encourage early conversations about vaccination; and
ensure vaccination resources are available to families
throughout the Nation's community health centers
--Stopping Myths: CDC will work with social media companies to
promote trustworthy vaccine information, provide accurate and
accessible information to policy makers, and engage State and
local health officials to advance effective local responses to
misinformation
CDC is also working on developing its campaign strategy and
messages for this fall. CDC will conduct outreach to those at higher
risk for both COVID-19 and flu, such as those living and working in
long-term care facilities, adults with underlying conditions, other
essential workers, and certain racial/ethnic groups. CDC will enhance
education and communication efforts related to flu by aligning with
COVID messaging and targeting African American and Hispanic
communities, given that these groups have lower rates of flu
vaccination and higher risks for COVID complications.
In addition, CDC continues to update its Vaccine Guidance During a
Pandemic, available on the CDC website. This resource provides the most
up to date information for healthcare providers to properly prepare for
vaccine planning and distribution in their area. In addition the CDC
website (https://www.cdc.gov/vaccines/index.html) provides regularly
updated information on vaccination guidance and immunization, including
specific links for special populations and race/ethnic groups. As
developments are made in COVID-19 vaccines, additional information will
be available on the public website for healthcare providers and the
general public.
flu vaccine
Question. Vaccination rates for the flu have always been low across
the country, and still we experience shortages of the flu vaccine some
years. It will be absolutely critical that more people get the flu
vaccine this year and that we have sufficient supplies of the vaccine
so that we keep people healthy and out of the hospital during a
potential second wave of COVID-19 this fall and winter. How is the
Administration working to improve flu vaccination rates this year? What
are the plans for flu vaccine purchase and for ensuring sufficient
supplies of the flu vaccine this year? How much funding will be needed
to achieve these goals?
Answer. We will use a multipronged approach to increase the uptake
of flu vaccinations this year:
--Implement evidence-based strategies to increase adult vaccination
coverage among underserved priority populations.
--Make additional influenza vaccine available to State health
departments for uninsured adults at increased risk.
--Execute targeted communication and education efforts for under
vaccinated and priority populations.
Through CDC's existing immunization cooperative agreement, CDC
awarded $140 million from the Coronavirus Aid, Relief, and Economic
Security Act to 64 jurisdictions to enable State health departments to
scale up for influenza season given the increased risk of COVID-19.
Funds will support staffing and preparedness this summer and focus on
ensuring flu coverage for vulnerable populations.
The ongoing COVID-19 pandemic may affect where and how flu vaccines
are given, but we are working with health departments to develop
contingency plans. CDC is also looking at operational considerations
such as potential need for social distancing measures in vaccination
settings and prolonging seasonal influenza vaccine uptake from
September through December. In addition to these efforts, CDC has
purchased 7.1 million additional seasonal influenza vaccine doses
directly from vaccine manufacturers to help uninsured and under-insured
Americans get their flu vaccines. These vaccines will be provided to
State health departments to focus on adults at higher risk. We are
taking many considerations into account in our efforts to significantly
expand flu vaccine coverage and focusing on specific efforts to address
racial and ethnic disparities.
______
Questions Submitted by Senator Brian Schatz
Question. Anti-vaccination attitudes and public confidence in a
vaccine.
Even before the pandemic, public trust and belief in the importance
of vaccines had been falling. When there is a safe and effective
vaccine available, there are significant concerns that the public will
not be confident enough in the vaccine to become vaccinated at a level
to achieve herd immunity. What are the most important factors in
increasing public confidence in a vaccine and improving vaccination
rates?
Answer. To both increase the public's confidence in vaccination and
enhance provider and policy makers' role in supporting improving
vaccination rates, CDC's Vaccinate with Confidence strategic framework
emphasizes the following important actions:
--Leveraging diverse data sources to find and protect communities at
risk;
--Expanding resources for working with local communities;
--Building and fostering a culture of immunization in healthcare
practices;
--Continually improving communication strategies; and
--Further investing in and collaborating with vital partners
Within this framework, CDC is working with local partners and using
trusted messengers to establish new partnerships and increasing public
confidence in vaccination. Building confidence is inherent to all our
work, and CDC will continue to build upon the investments of our
immunization program as it prepares both the Nation's public health
system and the private sector to disseminate a COVID-19 vaccine, once
available.
CDC is committed to ensuring the most up to date and accurate
information is available to healthcare providers and the general
public. The CDC website is updated regularly with the latest guidance
and recommendations on vaccines and immunizations. CDC will continue to
offer the latest information on vaccine preventable disease, including
COVID-19, on the public website, which features resources and
information to educate the general public on the safety and purpose of
vaccination.
Question. For this pandemic, how will Operation Warp Speed both
counter the reasons why people may be anti-vaccination and increase the
general public's confidence in a vaccine?
Answer. CDC recognizes that effective communication is a critical
component of any vaccine program. We are working collaboratively within
Operation Warp Speed to ensure consistent and accurate information is
at the foundation of our work, and a communication plan is currently
being developed. Understanding public confidence in any and all
vaccines is necessary for vaccine uptake, and CDC is implementing a new
strategic framework, Vaccinate with Confidence, to strengthen public
trust in vaccines and prevent vaccine-preventable disease outbreaks.
The framework emphasizes three key priorities: protect communities,
empower families, and stop myths. Within this framework, CDC is working
with local partners and using trusted messengers to establish new
partnerships and increase public confidence in vaccination. Building
confidence is inherent to all our work, and CDC will continue to build
upon the investments of our immunization program as it prepares both
the Nation's public health system and the private sector to disseminate
a COVID-19 vaccine once available.
Question. How will vaccine distribution be designed to improve
public confidence in a vaccine?
Answer. CDC is using its expertise in public health preparedness
and response and its immunization infrastructure to support Operation
Warp Speed in planning for vaccine promotion, distribution,
administration, and monitoring. We recognize that the pandemic has
likely accelerated a trend towards different ways of engaging with the
health system; thus, we will work closely with trusted State and local
partners to deliver vaccines from new sites, using approaches that meet
communities' unique needs.
One critical point that we will reiterate for public confidence is
that safety and efficacy are of paramount importance. Operation Warp
Speed will not allow for any risk with respect to the safety profile
required of a vaccine intended for wide distribution.
The overall distribution plan will be designed working with HHS and
other agencies
Question. It is critical that the public hears consistent, factual
messaging about a vaccine. What are the plans and steps the CDC is
taking now to establish a vaccination promotion campaign to ensure
sufficient coverage of a vaccine, when available?
Answer. As part of CDC's Vaccinate with Confidence strategic
framework, CDC will work to ensure availability of accurate and
effective messaging and aim to dispel myths about vaccination by:
--Working with social media companies to promote trustworthy vaccine
information
--Ensuring State policy makers have access to accurate vaccine
information and support vaccine uptake in their communities
--Engaging State and local health officials to advance effective
local response to misinformation and bring attention to
credible resources
In addition, CDC will maintain accurate and up to date information
on the CDC website which is accessible to the general public,
healthcare providers, and policy makers, and contains additional
resources that can be used for vaccine messaging, education, and
promotion.
Question. What lessons from the H1N1 vaccination campaign is the
CDC applying to the COVID-19 pandemic?
Answer. CDC learned several lessons from the H1N1 response,
including that there can be uncertainties in the pharmaceutical
manufacturing process of vaccines; we should anticipate delays and
build flexibility into our planning process to respond to adapting
circumstances.
During H1N1, CDC as a public health agency and providers who offer
vaccination services already had a lot of experience and knowledge of
flu vaccines, which provided a good base understanding when the H1N1
vaccine was rolled out. With COVID 19 being a novel virus, we do not
have the same baseline. CDC recognizes the need to be out front talking
to healthcare providers and State and local health departments about
the vaccine(s) to help ensure that providers are comfortable with the
administration of the vaccine, once available. CDC also learned with
H1N1 that we need to be nimble about access to vaccine, keeping an eye
on the disease and on differing levels of demand for vaccine in order
to determine who we need to reach most quickly.
vaccine distribution
Question. Does the Federal Government intend to coordinate vaccine
allocation, distribution, and administration, including determining
priority populations to receive the vaccine first?
Answer. CDC is using its expertise in public health preparedness
and response and its immunization infrastructure to support Operation
Warp Speed in planning for vaccine promotion, distribution,
administration, and monitoring. This is a tremendous undertaking, and
in anticipation of a vaccine, there is much to prepare for by the fall.
Our goal is to effectively and efficiently implement a COVID-19
vaccination program immediately after FDA licenses and the Advisory
Committee on Immunization Practice recommends, and the CDC Director
adopts that recommendation for, a vaccine. While the end goal is to
offer vaccines to the entire U.S. population, identifying priority
groups for COVID-19 vaccination is critical for implementation
planning. Specifically, CDC will be working with the National
Association for Community Health Centers to implement evidence-based
strategies to increase adult vaccination coverage among underserved
priority populations. We will be engaging in expert consultation to
develop strategies for addressing racial and ethnic disparities in
adult immunization by soliciting simultaneous individual expert opinion
from 15 national leaders in health disparities, health equity, and
social determinants of health. The focus will be on African Americans,
with similar activity focused on Hispanic/Latino populations under
consideration.
Question. Will the CDC or Operation Warp Speed have the lead on
vaccine allocation, distribution, and administration? If the CDC is not
the lead, what is the rationale for taking this key responsibility out
of the CDC?
Answer. CDC is working closely with the interagency staff to
determine a path forward on critical issues related to a COVID-19
vaccine program through Operation Warp Speed. CDC stands ready to use
its expertise in public health preparedness and response along with its
immunization infrastructure to support Operation Warp Speed in vaccine
promotion, distribution, administration, and monitoring.
Question. Given cuts to the public health workforce and how
overwhelmed State and local health departments are in responding to the
pandemic, how will Operation Warp Speed support State and local health
departments in carrying out a vast vaccination program?
Answer. CDC has worked for decades with its State and local
partners to ensure public health systems are prepared with plans,
trained personnel, strategic relationships and partnerships, data
systems, and other resources needed for sustaining a successful routine
immunization infrastructure. This will help ensure that effective
distribution can occur once a safe and effective COVID-19 vaccine is
available. CDC is working closely with our government partners in
response to this pandemic, including with our sister agencies at HHS.
CDC has provided its immunization awardees $140 million in supplemental
funding to support and enhance their immunization programs. This
supplemental funding will be used to support awardee and local health
department staffing, communications campaigns, pandemic preparedness,
and mass vaccination. In addition to other COVID-19 vaccine response
work, awardee activities will include a specific focus on significantly
enhancing influenza coverage and enrolling and working with additional
vaccinators (e.g. pharmacists).
______
Questions Submitted by Senator Tammy Baldwin
Question. CDC currently distributes 80 million doses of vaccines
every year. We will need at least 300 million doses of a COVID-19
vaccine to achieve herd immunity, in addition to tens of millions of
doses of the flu vaccine and other needed vaccines to protect public
health. We are months into this pandemic and the Administration has
failed to secure the supply chain for COVID-19 tests, and I am not
confident that we can count on the Administration to secure the supply
chain for hundreds of millions of vaccines. Furthermore, we will face
significant challenges and international competition in obtaining all
of the needed supplies.
Does the CDC currently have a plan in place for the allocation,
distribution, and prioritization of all vaccine supplies that accounts
for severe supply shortages? Once the CDC has developed such a plan,
will you commit to making it public?
Answer. An effective pandemic response includes developing,
manufacturing, distributing, dispensing, and administering medical
countermeasures, such as vaccines, in the shortest time possible, and
monitoring their impact when used during a public health emergency. A
safe and efficient vaccine distribution system (including storage and
handling), tracking and monitoring systems, communication strategies,
and technical assistance and analysis are integral components of a
prospective pandemic vaccine program. CDC will work with HHS and the
administration to coordinate COVID-19 vaccine allocation, distribution,
and administration.
HHS has developed and refined tools and guidance over the past
decade to help guide different aspects of pandemic planning and
response, including processes for vaccines. Given that vaccine supply
would likely increase incrementally as it is produced during the
pandemic, targeting decisions may have to be made.
CDC has worked for decades with its State and local partners to
ensure public health systems are prepared with plans, trained
personnel, strategic relationships and partnerships, data systems, and
other resources needed for sustaining a successful routine immunization
infrastructure. This will help ensure effective distribution can occur
once a safe and effective COVID-19 vaccine is available. The cost and
planning for vaccine distribution are contingent on multiple variables,
many of which are unknown. CDC will work with the department and
administration to further examine needed resources, as necessary.
______
Questions Submitted by Senator Joe Manchin, III
vaccine supply chain
Question. Back in March of this year, we saw shortages of common
necessary medical equipment for COVID-19 testing, such as swabs for
sample collection and PPE. These shortages led to people rationing
their tests and it slowed our ability to know where hot spots were
happening. Once we have an approved vaccine, this vaccine will need to
be widely distributed. That means: having personnel to administer the
vaccine, supplies such as syringes and PPEs, and reliable refrigeration
for the vaccine. Can you elaborate on how you plan to ensure health
providers have the needed equipment to administer a COVID vaccine?
Answer. HHS is leading efforts to purchase needles and syringes for
the pandemic vaccination program, and CDC is working collaboratively to
provide technical assistance. Additional efforts are underway to
request that manufacturers produce additional needles and supplies to
support the pandemic vaccination program. As part of this effort, HHS
is taking care to avoid negatively impacting supplies used for routine
and flu vaccination. Additionally, HHS is ramping up production of
reagents and consumables to make sure that we have enough supplies to
administer any vaccine as soon as it is ready.
Question. What is your vision of how COVID vaccine should be
delivered to the American public?
Answer. CDC will continue to work with its State and local partners
to ensure public health systems are prepared with plans, trained
personnel, strategic relationships and partnerships, data systems, and
other resources needed for sustaining a successful routine immunization
infrastructure. This will help ensure effective distribution can occur
once a safe and effective COVID-19 vaccine is available.
CDC will continue to use its expertise in public health
preparedness and response and its immunization infrastructure to
support Operation Warp Speed in planning for vaccine promotion,
distribution, administration, and monitoring.
CDC plays an important role in ensuring success of Operation Warp
Speed because of our expertise in the delivery of vaccines through a
robust immunization delivery infrastructure. This infrastructure can
and will be leveraged to deliver a COVID-19 vaccine and protect
Americans from this novel health threat.
vaccine distribution
Question. In your testimony, you highlighted the fact that in the
2018-2019 flu season, only 49 percent of the U.S. population was
vaccinated. The Food and Drug Administration (FDA) has stated that we
would need upwards of 70 percent of the population vaccinated to create
immunity to COVID. Not only is this an incredibly high threshold to
meet, but now we have the 2020-2021 flu season on the horizon, and will
need to ensure supplies are available to vaccinate and treat the flu.
What is your plan to ensure we have adequate supply to vaccinate the
public against both the flu and COVID?
What is your plan for vaccinating the U.S. population for both of
these viruses?
Have you developed a budget estimate on how much it will cost to
vaccinate every American?
Answer. As we expect SARS-CoV-2 to continue to circulate in fall,
CDC is working to significantly increase flu vaccination coverage,
particularly for populations most at risk. Increasing flu vaccine
coverage is an important public health goal on its own, but this year,
it will also serve to reduce the strain on the healthcare system that
will need to address the COVID-19 pandemic at the same time as seasonal
influenza.
Through CDC's existing immunization cooperative agreement, CDC
awarded $140 million from the Coronavirus Aid, Relief, and Economic
Security Act to 64 jurisdictions to enable State health departments to
launch an initial scale up for influenza season given the increased
risk of COVID-19. Funds will support staffing and preparedness this
summer and focus on ensuring flu coverage for vulnerable populations.
In addition to other COVID-19 vaccine response work, awardee activities
will include a specific focus on significantly enhancing influenza
coverage and enrolling and working with additional vaccinators such as
pharmacists, mass vaccinators.
The ongoing COVID-19 pandemic may affect where and how flu vaccines
are given, but we are working with health departments to develop
contingency plans. CDC is also looking at operational considerations
such as potential need for social distancing measures in vaccination
settings and prolonging seasonal influenza vaccine uptake from
September through December. In addition to these efforts, CDC has
purchased 7.1 million additional seasonal influenza vaccine doses
directly from vaccine manufacturers to help uninsured and under-insured
Americans get their flu vaccines. These vaccines will be provided to
State health departments to focus on adults at higher risk. CDC is
taking many considerations into account in our efforts to significantly
expand flu vaccine coverage and focusing on specific efforts to address
racial and ethnic disparities.
We will be conducting flu message testing to learn what impacts the
pandemic may have on the intent to vaccinate, including fears about
getting vaccinated in a safe environment. Additionally, this year we
are implementing a project designed to assess the quality of
communications with patients about vaccinations; areas of focus will
include communications about influenza vaccination in African American
patients. We will continue to work with our public health and clinical
partners to eliminate barriers to vaccination.
local media
Question. Once we have a vaccine, the government will need to get
critical information to the American public. Unfortunately, local
newspapers and broadcasters--which were already struggling--have been
hard hit financially by the epidemic, losing much of the local
advertising revenue they rely on to stay open. We will need to provide
essential information to the American public, such as where they can
get and where they can receive the vaccine. However, some of the most
vulnerable newsrooms, which were already struggling prior to the
pandemic, are located in the areas that rely on them the most. In rural
areas like West Virginia, broadcast stations and local papers are the
predominant or only form of localized information. Federal funding
could ensure that this information reaches the American public while
also providing a financial lifeline to our local media. Throughout this
process, how will you work to keep the American public informed through
local media?
Answer. A strong and comprehensive communication strategy is
critical to any vaccine initiative. Identifying the right messages,
countering misinformation, and targeting outreach to vulnerable and at-
risk populations will be necessary to achieve high coverage and herd
immunity. CDC will build on its existing relationships with local
public health partners and health departments to effectively implement
communication efforts. CDC is also convening a critical populations
workgroup to work on innovative approaches to vaccinate hard to reach
populations.
Question. Some of your agencies have extensive ad budgets. Would
you commit--where possible--to increasing advertising in local
newspapers and broadcast stations to ensure they are able to
disseminate important information and continue to operate throughout
the pandemic?
Answer. A strong and comprehensive communication strategy is
critical to the COVID-19 public health response. Identifying the right
messages, countering misinformation, and targeting outreach to
vulnerable and at-risk populations are important elements of CDC's
approach. CDC has made available a variety of communication resources
including public service announcements, social media and communications
materials, posted online (https://www.cdc.gov/coronavirus/2019-ncov/
communication/index.html). CDC has collaborated with an advertising
campaign that has been organized by the Ad Council (www.adcouncil.org).
The Ad Council has developed public service ads, social media assets
and more that has been seen in media around the nation since February.
The entire campaign has aired utilizing donated media and digital
platform time and space. The Ad Council has a number of ads and other
assets that are available free to media to take and use http://
coronavirus.adcouncilkit.org/.
CDC will partner with the necessary groups and individuals, such as
local public health partners and health departments, to disseminate
information through appropriate channels and effectively implement
communication strategies.
______
Questions Submitted by Senator Patrick J. Leahy
vaccine availability and rural distribution
Question. The rapid increases in cases of COVID-19 over the past
weeks should be alarming to everyone. Congress has provided
unprecedented resources to help the country address this public health
crisis, including more than $5 billion in congressional appropriations
to support research, development, construction, manufacturing and
purchasing of vaccines. We must develop a vaccine that is safe and
accessible to all.
Vermont has worked effectively to manage and control COVID-19
outbreaks. As a result, Vermont currently has the third lowest rate of
cases per 100,000 people in the contiguous United States. Nonetheless,
Vermonters shoulder the same risk as someone from Missouri, Washington
State, New York, Texas or anywhere else around the country.
How is the Centers for Disease Control and Prevention (CDC)
preparing to ensure that rural regions have adequate, equitable and
timely access to a coronavirus vaccine?
Answer. CDC is committed to ensuring rural populations can access
the vaccine. We have decades of experience working with public health
partners addressing the needs of hard to reach populations. We will
work with communities, government, and other local partners to identify
the best places and times to reach this population and utilize
strategic distribution points via community health centers, schools,
workplaces, mobile clinics, and pharmacies. Our immunization programs
have built a strong public health immunization infrastructure,
including through the provision of a safety net for those with no
health insurance and through response to outbreaks of vaccine
preventable diseases and other urgent public health issues. This
infrastructure can be leveraged to reach these populations.
Question. Will the CDC provide vaccines based on total populations,
COVID-positive populations, or a combination of both?
Answer. The Advisory Committee on Immunization Practices (ACIP)
COVID-19 Vaccine Work Group has been established to help inform
evidence-based approaches to COVID-19 vaccination policy, including an
initial vaccine prioritization strategy. While the end goal is to offer
vaccines to the entire U.S. population, identifying priority groups for
COVID-19 vaccination is critical for implementation planning. ACIP has
embarked on early planning in hopes of preventing distribution delays
post vaccine approval. The framework developed during, and the lessons
learned from, the H1N1 influenza vaccine implementation are being used
to guide COVID-19 vaccine prioritization. Given that many decisions
regarding the vaccine will depend on the vaccine itself, specifics are
unknown at this time.
Question. If based on total populations, can you assure this
Committee that there will be an all-State minimum for the distribution
of vaccines?
Answer. The Advisory Committee on Immunization Practices (ACIP)
COVID-19 Vaccine Work Group has been established to help inform
evidence-based approaches to COVID- 19 vaccination policy, including an
initial vaccine prioritization strategy. While the end goal is to offer
vaccines to the entire U.S. population, identifying priority groups for
COVID-19 vaccination is critical for implementation planning. ACIP has
embarked on early planning in hopes of preventing distribution delays
post vaccine approval. The framework developed during, and lessons
learned from, the H1N1 influenza vaccine implementation are being used
to guide COVID-19 vaccine prioritization. Given that many decisions
regarding the vaccine will depend on the vaccine itself, specifics are
unknown at this time.
Question. Is the CDC preparing to provide the necessary resources,
equipment and support to States to administer the vaccine?
Answer. CDC is working with State and local health department on
preparing a detailed but flexible plan for vaccine distribution and
administration which includes consideration of critical infrastructure
workers, high risk individuals, health equity issues, and lessons
learned from H1N1. CDC awarded $140 million using resources from the
CARES Act to help immunization programs begin preparation for vaccine
distribution and administration. The funding will be used to enhance
capacity to support staffing, communications campaigns, pandemic
preparedness, and mass vaccination.
Question. Are you working to manufacture and procure vaccination
equipment, such as syringes and needles, in advance of approving a
vaccine?
Answer. HHS is leading efforts to purchase needles and syringes for
the pandemic vaccination program, and CDC is working collaboratively to
provide technical assistance. Additional efforts are underway to
request that manufacturers produce additional needles and supplies to
support the pandemic vaccination program. As part of this effort, HHS
is taking care to avoid negatively impacting supplies used for routine
and flu vaccination.
______
Questions Submitted to Gary Disbrow, Ph.D.
Questions Submitted by Senator Roy Blunt
manufacturing
Question. What is the current vaccine manufacturing capacity to
manufacture vaccine by January 2021? What about by August 2021? What
additional capacity is necessary to prepare for sufficient supply of
multiple vaccine candidates?
Answer. To accelerate the development and subsequent production of
a vaccine for COVID-19, in mid-May, President Trump announced Operation
Warp Speed (OWS). OWS aims to deliver up to 300 million doses of a safe
and effective vaccine for COVID-19 in early 2021, as part of a broader
strategy to accelerate the development, manufacturing, and distribution
of COVID-19 vaccines, therapeutics, and diagnostics (collectively known
as countermeasures). OWS is a partnership among components of the U.S.
Department of Health and Human Services (HHS), including the Centers
for Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA), the National Institutes of Health (NIH), and the
Biomedical Advanced Research and Development Authority (BARDA), and the
Department of Defense (DoD), with the aim of a unified government
approach to respond to the pandemic. OWS engages with private firms and
other Federal agencies, including the Department of Agriculture, the
Department of Energy, and the Department of Veterans Affairs. OWS
coordinates with existing HHS-wide efforts, including the NIH's
Accelerating COVID19 Therapeutic Interventions and Vaccines (ACTIV)
partnership, NIH's Rapid Acceleration of Diagnostics (RADx) initiative,
and work by BARDA and the National Institute of Allergy and Infectious
Diseases (NIAID).
Specific to manufacturing efforts, OWS continues to analyze and
engage domestic pharmaceutical manufacturing and fill/finish capacity
across the vaccines and therapeutics landscape. OWS is also identifying
suppliers of secondary items for administration of any successful
vaccines, and providers of pharmaceutical distribution to ensure
sufficient capacity exists once products have been granted FDA
emergency use authorization or licensure/approval. HHS is procuring
secondary items (syringes, needles and other ancillary supplies) and
investing in the expansion of domestic manufacturing capacity while
countermeasures are still in clinical development to maximize domestic
supply chains and ensure that the American people are poised to receive
safe and effective vaccine(s) and therapeutics as soon as possible.
Question. What is the current therapeutic manufacturing capacity to
manufacture therapeutics by January 2021? What about by August 2021?
What additional capacity is necessary to prepare for sufficient supply
of multiple therapeutic candidates?
Answer. In support of OWS project goals, DoD and HHS personnel are
working with industry partners to ensure all of their available in-
house capacity is immediately deployed to manufacture COVID-19
therapeutics. This effort will make available hundreds of thousands of
treatment courses by the end of the 2020, should the candidate
therapeutics demonstrate efficacy in clinical trials. Additionally, OWS
is working to implement manufacturing partnerships among domestic
antibody manufacturers, to make significantly more capacity available
to developers of COVID-19 therapeutics. These combined efforts are
expected to make hundreds of thousands of treatment courses available
each month during the second quarter of 2021.
Question. What are the assumptions for price of vaccine in the
research and manufacturing contracts?
Answer. There will be variations in the cost of each vaccine or
therapeutic based on factors unique to each company and product.. Major
factors impacting determination of a fair price are the cost of Active
Pharmaceutical Ingredients (API)/raw materials, type of expression
system, Contract Manufacturing Organization (CMO) costs, cost of fill--
finish (to include vials and stoppers), and associated fees.
strategic national stockpile
Question. A critical part of the distribution plan will be an
adequate supply of all the ancillary products such as syringes,
bandages, alcohol wipes, etc. What efforts are being made to ensure
adequate supply of these products is available? Who is responsible for
this effort?
Answer. Supporting and securing an adequate supply of ancillary
products is a collaborative, interagency effort.
Specific to securing needles and syringes, to date, BARDA has
awarded four large task orders for such products. Going forward, BARDA
will support additional solicitations, in coordination with the
Strategic National Stockpile (SNS), to maximize the availability of
needles and syringes toward the end of 2020. BARDA and the Joint
Program Executive Office for Chemical, Biological, Radiological, and
Nuclear Defense (JPEO-CBRND) CBRND have awarded three agreements to
increase needle and syringe capacity in the U.S. for the future, some
of which will be available in time to support the COVID-19 vaccination
in early 2021. Lastly, BARDA and JPEO-CBRND have awarded agreements
with two domestic manufacturers of vials to increase production
capacity of vials to support multiple vaccine candidates.
To specifically support domestic manufacturing efforts for active
pharmaceutical ingredients and other essential medicines, on Tuesday,
May 19, 2020, BARDA announced a $354 million 4-year contract with Phlow
Corporation and its partners-including CivicaRx, Virginia Commonwealth
University's Medicines for All Institute, and AMPAC Fine Chemicals. The
partnership with PHLOW allows flexibility in selecting and prioritizing
active pharmaceutical ingredients and finished drugs for manufacturing
to allow for rapid response to situations such as the current COVID-19
public health emergency. Phlow's criteria for prioritizing APIs and
finished drugs for early manufacturing are based on data on essential
medicines shortages that have been exacerbated by COVID-19-associated
increases in hospitalized patients.
______
Questions Submitted by Senator John Kennedy
Question. In May and June, HHS and DoD announced around $400
million in contracts for pre-filled syringes and glass vials for
vaccine distribution, do you anticipate any potential domestic
production shortages with this aggressive vaccine timeline?
Answer. HHS funded contracts with negotiated delivery dates and
quantities sufficient to meet the Nation's needs for administering any
FDA approved vaccine(s) as it becomes available. While HHS has
endeavored to contract with domestic sources, in some cases the
Department has been required to work with off-shore companies. In cases
where HHS has awarded such contracts to non-domestic companies, HHS is
funding additional contracts to ensure supplies are readily available
to administer vaccine. HHS is working with DoD's Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense office to expand domestic capacity for needles and syringes and
vials that will be required for sterile injectable products.
Question. There have been concerns regarding the transparency of
Operation Warp Speed and a lack of up to date information about its
progress and findings. Can you ensure that Congress and the American
people will receive clear and transparent information from this panel
and other respected public health experts moving forward?
Answer. In recognizing this important relationship, the leadership
of Operation Warp Speed is committed to remaining transparent with
Members of Congress, their staffs and the American people. Accordingly,
Operation Warp Speed will continue to provide written updates and
announcements as OWS reaches new milestones. The offices responsible
for interacting with Congress at both HHS and DoD are in close
coordination to ensure Members are provided frequent updates on
development milestones and other activities. Most recently, OWS
provided briefings to Member of Congress on June 16, July 2, and July,
13, 2020. In addition, as products are brought under the OWS portfolio,
public announcements will be made in a transparent manner.
Question. CARES provides BARDA with no less than $3.5 billion for
the development and purchases of countermeasures, ``including the
development, translation and demonstration at scale of innovations in
manufacturing platforms.'' In CARES, Congress prioritized funding of
domestic platform-based technologies. How important is it to BARDA to
invest in domestic platform technology companies which use continuous
manufacturing?
Answer. The global pandemic has highlighted the vulnerabilities of
the global supply chain for many products. It is critical that steps be
taken to invest in expansion of domestic manufacturing capacity. BARDA
has made an investment in PHLOW, a consortium of organizations that
will expand domestic manufacturing of raw materials and active
pharmaceutical ingredients for drugs. This effort includes support for
continuous manufacturing. The efforts will target drugs on the FDA drug
shortage list that have become even more critical during the COVID-19
response. BARDA is working with the FDA to identify which products to
manufacture. Vaccine manufacturers are relying on proven technology
platforms and other methods to provide for the large volume of vaccine
doses being required in a short period of time.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Disbrow, Dr. Fauci has indicated that highly
effective COVID-19 vaccines may take years to develop and may never
result in total herd immunity. What is BARDA's position on continued
development of monoclonal antibody therapeutics, a permanent way to
make society work as a treatment? Are there funds currently available
to support novel monoclonal therapeutics developed by small businesses?
I understand that BARDA has funded large companies and their monoclonal
antibody approaches. Are there funds currently available for smaller
businesses?
Answer. Monoclonal antibodies are one kind of therapeutic that show
early promise in the treatment of COVID-19. So far, BARDA has invested
in both Regeneron and AstraZeneca to develop monoclonal antibodies for
COVID-19, both large businesses. A key criterion for moving a candidate
forward is the timing for availability of the candidate therapeutic.
Regeneron's monoclonal antibody cocktail entered clinical trials in
June, 2020, and AstraZeneca's monoclonal antibody cocktail will be
entering the clinic very soon. In addition, if the clinical trials
demonstrate that the antibodies are safe and efficacious, it is
important that the company can manufacture significant amounts of
therapeutic. BARDA's review criteria are independent of company size.
The review criteria are based on the science and the company's ability
to have an immediate impact on the pandemic. Any business that can meet
the technical criteria are eligible for funding. If a small or large
business has a monoclonal antibody that can enter the clinic before
September and manufacture significant amounts of drug in the United
States by the end of December, funding is available.
Question. Dr. Disbrow, How are you making sure that both large and
small businesses have the opportunity to participate in Operation
Warpspeed?
Answer. BARDA's review criteria are independent of company size.
The review criteria are based on the science and the company's ability
to have an immediate impact on the pandemic. Any business that can meet
the technical criteria are eligible for funding. Proposals that can
meet the immediate needs of the nation are prioritized over those that
require more time to achieve key milestones such as Emergency Use
Authorization or FDA approval/licensure/clearance.
Question. Dr. Disbrow, where is BARDA putting its emphasis on COVID
diagnostics? Has BARDA considered the need for specific antibodies for
diagnostic use?
Answer. BARDA's initial focus has been on the development of
molecular tests that could be used on existing FDA-cleared platforms
commonly used in commercial and clinical laboratories. BARDA is
currently supporting the development of multiple types of diagnostics,
including molecular assays that detect the virus in respiratory
samples, antigen tests that detect viral proteins in respiratory
samples, and tests that detect antibodies to SARS-CoV-2 in blood.
Current investments include tests that can be used in small and large
laboratories, and in point-of-care settings. Twelve diagnostic assays
developed with BARDA support have received Emergency Use Authorization
and, as of July 20, 2020, contributed over 22 million tests to the
response.
Tests that detect antigens (viral proteins) require specific
antibodies that will detect SARS-CoV-2 antigens and not cross-react
other coronaviruses. BARDA supports diagnostic companies in developing,
manufacturing, or acquiring the antibodies needed for their proprietary
assay. BARDA is coordinating with FDA, NIH (NIAID and RADx) and DoD to
ensure efficient and effective development of COVID-19 diagnostics.
Question. Dr. Disbrow, I understand that there is currently a
backlog in manufacturing capacity for vaccines and antibodies. What is
BARDA doing to fund alternative manufacturing routes?
Answer. BARDA is working with each of the vaccine developers and
multiple vaccine manufacturing companies (contract manufacturing
organizations (CMO)) to ensure sufficient capacity exists to support
all vaccine production. DoD and HHS are collaborating to monitor each
asset in the production process to minimize or eliminate conflicting
production needs and maximize throughput. Where required, HHS is
funding capacity expansion and/or reserving capacity for vaccine and
antibody production. Additionally, OWS is working to implement
manufacturing partnerships among domestic antibody manufacturers, to
make significantly more capacity available to developers of COVID-19
therapeutics.
Question. Dr. Disbrow, it is my understanding that there are
multiple groups pursuing manufacturing and clinical trials for antibody
therapeutics against COVID-19. This requires significant manufacturing
capacity through relatively standard, established methods in
bioreactors; however, there is not nearly enough capacity for any one
of these companies to produce enough of their medicine to meet national
demand, yet this is necessary for the best-in-class therapeutic to
emerge and treat patients. What plans are there to handle the problem
of scale in manufacturing for antibody therapeutics, looking at short-
term crisis management? In the long term, the same concern applies for
vaccines. What plans exist on that front? Are there novel or unusual
manufacturing techniques that can be used to address these concerns?
How does BARDA consider the manufacturing techniques required when
choosing which products to invest in?
Answer. In support of OWS project goals, DoD and HHS personnel are
working with industry partners to ensure all of their available in-
house capacity is immediately deployed to manufacture COVID-19
therapeutics. This effort will make available hundreds of thousands of
treatment courses by the end of the year should the candidate
therapeutics demonstrate efficacy in clinical trials. Additionally, OWS
is helping to implement manufacturing partnerships amongst domestic
antibodies manufacturers, to make significantly more capacity available
to developers of COVID-19 therapeutics. These combined efforts are
expected to make available hundreds of thousands of treatment courses
per month during the second quarter of 2021. OWS continues to analyze
and engage domestic pharmaceutical manufacturing and fill/finish
capacity across the vaccines and therapeutics landscape. OWS is also
identifying suppliers of secondary items for administration of any
successful vaccines, and providers of pharmaceutical distribution to
ensure sufficient capacity exists once FDA approved products are
available. HHS is investing in procuring secondary items (syringes,
needles and other ancillary supplies) and domestic manufacturing
capacity while product approval is pending in order to maximize
domestic supply chains and ensure Americans are poised to receive safe
and effective vaccine(s) and therapeutics as soon as possible.
Question. Dr. Disbrow, what are you doing to bolster those smaller
companies such as CentiVax, CytoDyn, Serronto, and S-Cell Biosciences
to advance treatments, antibody therapies and potential cures of COVID-
19?
Answer. BARDA's review criteria are independent of company size.
The review criteria are based on the science and the company's ability
to have an immediate impact on the pandemic. Any business that can meet
the technical criteria are eligible for funding. Proposals that can
meet the immediate needs of the nation are prioritized over those that
require more time to achieve key milestones such as Emergency Use
Authorization or FDA approval/licensure/clearance.
______
Questions Submitted by Senator Marco Rubio
Question. In the CARES Act, money was provided for the development
of COVID countermeasures, prioritizing platform based technologies,
such as continuous manufacturing, using domestic manufacturing. What is
BARDA doing to partner with platform companies with domestic
manufacturing capability to respond to COVID?
Answer. The global pandemic has highlighted the vulnerabilities of
the global supply chain for many products. It is critical that steps be
taken to invest in expansion of domestic manufacturing capacity. BARDA
has made an investment in PHLOW, a consortium of organizations that
will expand domestic manufacturing of raw materials and active
pharmaceutical ingredients for drugs. This effort includes support for
continuous manufacturing. The efforts will target drugs on the FDA drug
shortage list that have become even more critical during the COVID-19
response. BARDA is working with the FDA to identify which products to
manufacture. Vaccine manufacturers are relying on proven technology
platforms and other methods to provide for the large volume of vaccine
doses being required in a short period of time.
Question. What steps are being taken to ensure the United States
has the manufacturing capacity--from the drug to the glass vials and
syringes--needed to produce hundreds of millions of vaccines by early
2021?
Answer. HHS funded contracts with negotiated delivery dates and
quantities sufficient to meet the Nation's needs for administering any
FDA approved vaccine(s) as it becomes available. While HHS has
endeavored to contract with domestic sources, in some case we have been
required to work with off shore companies. In cases where we have
awarded such contracts to non-domestic companies, HHS is funding
additional contracts to ensure supplies are readily available to
administer vaccine. HHS is working with DoD's JPEO-CBRND office to
expand domestic capacity for needles and syringes and vials that will
be required for sterile injectable products.
Question. This pandemic has exposed multiple problems in our
medical supply chains. What have been some of the more alarming issues
you've seen and what can Congress do to help correct those problems?
Answer. In the early days of the COVID-19 pandemic, personal
protective equipment (PPE) shortages caused by a rapid increase in
demand were exacerbated when manufacturing was shut down in China.
China manufactures not only much of the world's PPE but also a large
percentage of the active ingredients that manufacturers use to make
drugs. While HHS broadly understands that a large percentage of the
world's API is made in China and India, the FDA has had limited insight
into the extent to which the U.S. drug supply chain is reliant on API
from specific countries, regions, or manufacturers. Although the CARES
Act expanded the scope of information FDA is able to collect about API
manufacturing, it did not expressly provide FDA the authority to
collect information about API at the level of detail that would help us
understand the extent to which the U.S. drug supply chain is reliant on
API from specific countries, regions, or manufacturers. Congress could
consider granting FDA authority to collect additional data about the
drug supply chain, including the sources of API that finished dosage
form manufacturers are actually relying upon and how reliant they are
on each such supplier (e.g., how many dosage units were manufactured
from each supplier of API during a given period).
______
Questions Submitted by Senator Patty Murray
manufacturing of ancillary supplies
Question. Manufacturing over 300 million doses of vaccine will
require significant planning and national-level coordination by the
Federal Government to effectively execute. In addition to producing the
necessary volume of vaccines to inoculate more than 300 million people,
manufacturing must also scale up for necessary ancillary supplies like
vials, rubber stoppers, and syringes, that will likely be necessary for
a COVID-19 vaccine, the seasonal flu, and other routine vaccines or
drugs over the next year or two.
In addition to the $110 million ASPR has spent on two orders for
needles and syringes, what other funding has been allocated for
ancillary supplies for COVID-19 vaccines and therapeutics?
Answer. Supporting and securing an adequate supply of ancillary
products is a collaborative, interagency effort.
Specific to securing needles and syringes, to date, BARDA has
awarded four large task orders for such products. Going forward, BARDA
will support additional solicitations, in coordination with the
Strategic National Stockpile (SNS) to maximize the availability of
needles and syringes toward the end of 2020. BARDA and the DoD Joint
Program Executive Office for Chemical, and Biological, Radiological,
and Nuclear Defense (JPEO-CBRND) have awarded three agreements to
increase needle and syringe capacity in the U.S. for the future, some
of which will be available in time to support the COVID-19 vaccination
in early 2021. Lastly, BARDA and the JPEO-CBRND have awarded agreements
with two domestic manufacturers of vials to increase capacity of vials
to support multiple vaccine candidates.
______
Questions Submitted by Senator Jack Reed
defense production act
Question. This Administration failed in ensuring sufficient
supplies of personal protective equipment (PPE) and testing supplies
are available, in part because of a reluctance to invoke the Defense
Production Act (DPA) to speed manufacturing and distribution of these
supplies. This question is for all the witnesses, will you commit to
fully use available HHS DPA or other authorities to fund industrial
expansion authorities if needed for a vaccine or other equipment and
supplies? Do you have sufficient funding to meet industrial expansion
needs and to maintain a domestic supply of needed equipment and
supplies? We cannot afford to repeat the same mistakes.
Answer. NIH defers to BARDA regarding manufacturing and
distribution of supplies.
Under the SNS 2.0 initiative, SNS is working with DoD to expand
domestic manufacturing capacity. Using CARES Act funding SNS has funded
a number of projects including:
--Melt blown fiber (MBF)--to date SNS has obligated $16.25M to expand
the domestic manufacturing capacity to produce MBF, critical
component in N95 and surgical mask production.
--Increased domestic production capacity for surgical masks--to date
SNS has obligated $17.85M to allow manufacturers to stand up
additional production lines and production centers to produce
surgical masks.
--Increased domestic production capacity for nitrile gloves--to date
SNS has obligated $22.5M to increase annual domestic production
capacity of nitrile gloves by 450M.
--Increased domestic production capacity for testing swabs--to date
SNS has obligated $51.15M to increase domestic production
capacity for swabs. Under a cost-sharing agreement with the
manufacturer, the USG has agreed to fund the cost of machinery,
equipment, and facility retrofit costs to increase capacity in
this area.
Prior to the COVID-19, response SNS did not have experience with
expanding domestic manufacturing capacity. The partnership between DoD
and HHS, which allowed SNS to tap into DoD's contracting resources and
experience with industrial based expansion projects, was critical for
the success of USG's efforts to expand domestic production capacity of
medical supplies during the COVID-19 pandemic.
Importantly, it will continue to be difficult for FDA to prevent
and mitigate shortages of medical devices including PPE, ventilators,
and testing supplies that are critical for U.S. patients and our
healthcare workers on the front lines because Agency does not have
sufficient authorities for medical device shortages. The linchpin for
tracking potential supply chain issues to avoid medical product
shortages, is to be able to obtain information on potential shortages
and other supply chain disruptions well in advance of an actual
shortage occurring. In the absence of the broader authorities FDA has
asked for so that the device program has comparable authorities to the
drug program, there will not be sufficient intel to deal with supply
chain issues during outbreak, as a result. By the time the PHE is
declared, there is already a problem. COVID exemplifies this. For
instance--consider some of the supply-chain issues we saw during this
pandemic. Even if the outbreak had not reached the U.S., there would
have been supply chain issues for PPE and other supplies within the
U.S. because other nations had outbreaks and were going to need
supplies, rapidly and in greater quantities than anticipated. Absent
the broad authority FDA has asked for, the Agency would not be able to
get the intelligence necessary to anticipate impacts on the U.S. supply
chain or the global supply chain generally, including which essential
devices could be in short supply and the production volume of impacted
manufacturers to better understand the extent of the impact.
By the time the U.S. formally declared the public health emergency
for COVID-19, there were problems and shortages for weeks. With such
additional authorities, the U.S. could have been planning well before.
Lack of broad shortage authorities and the requirement for
manufacturers of essential/critical medical devices to routinely
monitor their supply chains and take mitigating actions when
appropriate undermines the U.S. ability to act and this was evident for
the ongoing COVID pandemic.
______
Questions Submitted by Senator Brian Schatz
Question. Factors for selecting vaccine candidates for BARDA
investment and to move to Phase 3 trials.
Is the primary reason for BARDA's focus on a gene-based vaccine
that it can be developed faster?
Answer. Under OWS, all vaccine approaches have been considered to
support the quick, efficient, and safe development of a vaccine to
protect again COVID-19. OWS selected vaccine candidates on the basis of
four criteria. We required candidates to have robust preclinical data
or early stage clinical trial data supporting their potential for
clinical safety and efficacy. Candidates had to have the potential,
with our acceleration support, to enter large phase 3 field efficacy
trials this summer or fall (July to November 2020) and, assuming
continued active transmission of the virus, to deliver efficacy
outcomes by the end of 2020 or the first half of 2021. Candidates had
to be based on vaccine-platform technologies permitting fast and
effective manufacturing, and their developers had to demonstrate the
industrial process scalability, yields, and consistency necessary to
reliably produce more than 100 million doses by mid-2021. Finally,
candidates had to use one of four vaccine-platform technologies that we
believe are the most likely to yield a safe and effective vaccine
against Covid-19.
Question. Are traditional vaccine approaches also being
prioritized?
Answer. Under OWS, all vaccine approaches are being considered to
support the quick, efficient, and safe development of a vaccine to
protect against COVID-19. Selection of the approaches was based on the
overall assessment of delivering a safe and effective vaccine.
Question. Does the evidence indicate that a gene-based vaccine will
produce a durable immune response?
Answer. The durability of gene based vaccines is supported by
observations in animal models and tumor suppression in individuals with
recurrent or refractory melanoma. However, the duration of protection
afforded by gene-based COVID-19 vaccines remains to be established.
This is true for any vaccine technology used to develop a vaccine.
Duration of immunity can only be determine through clinical trials for
each vaccine candidate.
Question. How is Operation Warp Speed ensuring adequate
representation of racial and ethnic groups, as well as of age groups,
in vaccine trials, and would a trial without adequate representation be
disqualified from moving into a Phase 3 trial?
Answer. The goal of OWS is to develop a safe and effective vaccine.
In support of OWS project goals, HHS intends to carefully evaluate the
safety of any identified vaccine and will deliver a vaccine that is
safe and effective for the American people. Vaccine development
companies are responsible for planning and executing clinical trials
for their candidate vaccine. The companies do this in coordination with
NIH, and under the regulatory oversight of FDA.
The FDA remains an independent body to protect and promote the
public health. The FDA accomplishes their mission by rigorously
reviewing new medical products against the agency's time-honored
standards of safety and effectiveness. Like for all other medical
products, the FDA will independently review both the safety and
effectiveness of vaccines developed through HHS funding in support of
OWS project goals. HHS will follow standard practices and procedures to
ensure that the development conforms to the requirements and best
practices of medical product development for the intended populations
for these vaccines. Additionally, HHS is ensuring that the development
conforms to the Federal Food, Drug, and Cosmetic Act and the Public
Health Service Act, codified in titles 21 and 42, respectively, of the
U.S. Code, and to FDA's implementing regulations in title 21 of the
Code of Federal Regulations.
Criteria for representation of racial and ethnic groups, as well as
of age groups, in clinical trials are outlined in FDA guidance document
titled Development and Licensure of Vaccines to Prevent COVID-19--
Guidance for Industry, published in June 30, 2020 and can be found at
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/development-and-licensure-vaccines-prevent-covid-19.
Question. Supply chain and manufacturing issues in mass producing a
COVID-19 vaccine.
What are the most pressing issues with the supply chain and mass
manufacturing of a coronavirus vaccine? What are each of the key
components necessary to administer a vaccine, and what is the current
availability of each component?
Answer. Successful development and manufacturing of a vaccine for
COVID-19 requires a holistic view of the vaccine supply chain (vaccine,
vials, syringes, etc.) to ensure there are ample quantities to meet
demand. HHS is funding needle and syringe manufacturers to ensure
sufficient supply remains available throughout the duration of the
vaccine administration campaign. BARDA and JPEO-CBRND have collaborated
to support domestic expansion of manufacturing lines for needles,
syringes and vials. Finally, within OWS, working groups supporting
vaccine development and supply chain issues are working closely with
CDC in the distribution and administration of vaccines without
disrupting existing vaccine programs.
Question. How will Operation Warp Speed avoid the supply chain
issues that have led to States and countries competing against each
other for test kits and PPE?
Answer. HHS funded contracts include negotiated delivery dates and
quantities sufficient to meet the nation's needs for administering any
FDA approved vaccine(s) as it becomes available. While HHS has
endeavored to contract with domestic sources, in some case we have been
required to work with off shore companies. In cases where contracts
were awarded to non-domestic companies, HHS is funding additional
contracts to ensure supplies are readily available to administer
vaccine. In addition, HHS is working with DoD's JPEO-CBRND office to
expand domestic capacity for needles and syringes and vials that will
be required for sterile injectable products.
______
Questions Submitted by Senator Tammy Baldwin
Question. Nanovaccines represent a new type of vaccine delivery
technology that can enhance our future preparedness because they offer
faster global impact, higher effectiveness, lower cost, and higher
safety for medical staff. This approach has already been used to design
effective vaccines against respiratory infections such as influenza,
pneumonia, and respiratory syncytial virus and tested in multiple pre-
clinical and clinical models, and is particularly suited for pandemic
scenarios.
What efforts are underway through Operation Warp Speed to ensure
new delivery technologies such as nanovaccines are in the pipeline to
be readily adapted to develop a new COVID-19 vaccine?
Answer. Nanovaccines encompass a broad range of vaccine types.
Generally, nanovaccines use particles made of lipid and detergents as
carriers or as adjuvant for a protein or nucleic acid. Recombinant
vaccines combined with adjuvants and mRNA vaccines associated with
lipid nanoparticles are nanovaccines. The OWS portfolio currently
includes such vaccines, recombinant proteins combined with nanoparticle
adjuvants and mRNA vaccines carried by lipid nanoparticles.
Reports indicate that BARDA has stopped funding potential
treatments for severe lung disease caused by COVID-19, and has
suspended requests for proposal for prophylactic countermeasures for
COVID-19.
Question. Why was the decision made to suspend funding or requests
for proposal for these countermeasures? What funding efforts are
underway by BARDA and OWS to invest in treatment and prevention
countermeasures in addition to a future vaccine?
Answer. BARDA and OWS have focused on antivirals as products with
potential to safely and effectively treat SARS-CoV-2 infections. While
immune modulators and therapeutics targeting lung repair are
interesting candidates for the treatment of COVID-19, clinical trials
evaluating each potential therapy individually is not efficient. Under
the ACTIV Public Private partnership, clinical trial networks and
clinical trials are being established to evaluate multiple antivirals,
immunomodulators, anticoagulants and other products to address
secondary pathologies associated with SARS-CoV-2 infection. Companies
can submit their data to the ACTIV portal and the information will be
reviewed and prioritized for inclusion in the clinical trials. This is
a more efficient way to evaluate multiple candidates.
The pathology of severe COVID-19 is still unknown, and there are
many plausible hypotheses on how to use immune modulators or
therapeutics targeting tissue repair. Instead of using a one-drug-one-
clinical-study paradigm, BARDA and OWS are using platform clinical
trials to investigate many candidate therapeutics at once. The ACTIV
clinical trials will be investigating coagulopathy and immune
modulators in addition to antivirals with possibilities to expand to
new candidate therapeutics as each candidate completes its enrollment.
Platform clinical trials allow for increased efficiency because there
can be shared placebo arms, potential patients that are ineligible to
receive one of the therapeutics being tested can possibly be enrolled
into other arms of the study that they are eligible for and allows for
the removal of candidates that are toxic or not performing as expected.
Vaccines are the main focus for prevention because vaccines are the
only technology that can manufacture enough doses in the timeframe
needed. Therapeutics can be used to prevent disease, such as using
oseltamivir to prevent an influenza infection when someone in your
household gets infected. However, by using the drug to prevent disease
in someone who may never have been infected, it is taking away a
treatment from someone with COVID-19. The balance between treatment and
prevention must be weighed carefully.
One area under investigation by OWS and BARDA is prevention of
disease in the nursing home population. Outbreaks of SARS-CoV-2 in
nursing homes has devastating consequences, and the U.S. Government is
investigating candidate prophylaxis drugs that could be used in this
population as well as investigating how to test efficacy.
Released documents indicate that HHS and BARDA have waived certain
Federal march-in rights in its contracts with treatment and vaccine
manufacturers. These rights were conceived as an important tool to
ensure the provision of drugs on reasonable terms, including with
respect to price, and the removal of these contract provisions erases
an important oversight tool at the government's disposal.
Question. Please detail why a decision was made to waive Bayh-Dole
``reasonable terms'' provisions from manufacturer contracts.
Particularly considering the Federal investment in these drugs, how
will the Administration ensure that these countermeasures are priced in
a fair and equitable manner and accessible to all patients?
Answer. The Bayh-Dole Act pertains to intellectual property arising
from Federal Government-funded research. Specifically, Bayh-Dole
includes ``march-in rights'' under 35 U.S.C. Sec. 203, which give the
Government the ability to obtain a license, in four limited
circumstances, to ``subject inventions'' that are first conceived or
reduced to practice in the performance of a Government contract, grant,
or cooperative agreement. Importantly, march-in rights do not apply to
IP that is created or reduced to practice before the Federal funding
agreement is awarded. Neither do they apply to activities undertaken
outside the scope of the Federal funding agreement.
BARDA is funding several agreements under Operation Warp Speed
(OWS)319L(c)(4)(B)(iv) of the PHS Act (42 U.S.C. 247d-7e(c)(4)(B)(iv)),
which gives BARDA other transaction authority (OTA). By design, OTA
allows for flexible intellectual property (IP) and data rights. The
Bayh- Dole Act and associated patent and data rights regulations do not
apply to Other Transactions. OWS generally leverages OTA flexibility to
negotiate more favorable IP and data rights terms than the Government
would have under Bayh-Dole.
In the case of OWS, the Government has used OTA flexibility to
negotiate corresponding rights that put the Government in a better
position than would be the case under the Bayh-Dole regime.
Some OTA agreements may incorporate provisions that permit the
Government to obtain a non-exclusive license to background IP (i.e., IP
generated before or outside the scope of the Government agreement). For
example, some OWS OTA agreements give the Government the ability to
license background IP if the original party to the OTA is unwilling to
continue pursuit of the vaccine, which could permit the Government to
find alternative ways to manufacture the vaccine. These licensing
provisions, permitted under OTA authority, place the Government in a
significantly better position than would be the case if Bayh-Dole
rights were in place.
Finally, BARDA's goal in contracting with treatment and vaccine
manufactures is to negotiate for a specific price per dose and not rely
on undefinitized ``reasonable terms.''
SUBCOMMITTEE RECESS
Senator Blunt. The subcommittee will stand in recess.
[Whereupon, at 2:45 p.m., Thursday, July 2, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]