[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.
---------------------------------------------------------------------------
    \1\ CDC. Flu Vaccination Coverage, United States, 2018-19 Influenza 
Season. Available from: https://www.cdc.gov/flu/fluvaxview/coverage-
1819estimates.htm.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \5\ https://siren.network/.
    \6\ https://ncats.nih.gov/expertise/preclinical/npc.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \10\ 2018 Strategic Plan for Research on Vaccine Adjuvants: https:/
/www.niaid.nih.gov/sites/default/files/
NIAIDStrategicPlanVaccineAdjuvants2018.pdf.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \18\ Coronaviruses--Information for Researchers: https://
www.niaid.nih.gov/diseases-conditions/coronaviruses?researchers=true.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \20\ https://www.cdc.gov/mmwr/volumes/69/wr/
mm6930a3.htm?s_cid=mm6930a3_w.
---------------------------------------------------------------------------
    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.]