[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

                              ----------                              


                     WEDNESDAY, SEPTEMBER 16, 2020

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:12 a.m. in room SD-G50, Dirksen 
Senate Office Building, Hon. Roy Blunt, (chairman) presiding.
    Present: Senators Blunt, Alexander, Graham, Moran, Capito, 
Kennedy, Hyde-Smith, Lankford, Murray, Durbin, Reed, Shaheen, 
Merkley, Schatz, Baldwin, Murphy, and Manchin.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                         Coronavirus Response: 
               A Review of Efforts to Date and Next Steps


           opening statement of senator roy blunt


    Senator Blunt. The Appropriations Subcommittee on Labor, 
Health and Human Services, Education, and Related Agencies will 
come to order.
    I want to thank our witnesses for appearing before the 
subcommittee today to provide an update on where we are on the 
areas that they are so involved in on COVID-19.
    As we continue to be challenged by this pandemic, in the 
country, we know that 195,961 Americans have died as part of 
the pandemic and 6.6 million have tested positive during the 
process of testing in the pandemic. This has rapidly swept 
across the globe, and even countries who thought their cases 
were contained are facing new outbreaks and dealing with those 
new and unanticipated outbreaks.
    This is a new disease in many ways, and even after 9 
months, we still know relatively little about this disease or 
coronaviruses generally. This has hindered our public health 
response. In many ways, this has been like trying to build a 
plane while we were flying the plane, and that is a 
challenging, challenging thing to deal with.
    That is not to fully exonerate certainly the way the 
administration has dealt with it or the way it has been funded, 
and I am sure that justified criticisms can and will be 
leveled.
    But history allows us to look over past events and to put 
current ones into perspective. If we wanted to look back just 6 
years to 2014, for instance, when West Africa faced the largest 
Ebola outbreak the world had ever seen, and unlike COVID-19, we 
knew a lot about Ebola at the time. The disease has been around 
since the mid-1970s. It was a disease that scientifically we 
knew a lot more about in 2014 than we do about COVID-19 even 
today.
    And frankly, we just did not handle it very well. We made 
significant mistakes, and we have seen those mistakes occur in 
other disease areas. Members of Congress used words when they 
talked about the CDC (Centers for Disease Control and 
Prevention) response like ``cryptic'' and ``misleading'' and 
thought that the information provided was not enough. We even 
had an Ebola case that was found in a Dallas hospital, and the 
CDC Director blamed the hospital. At the same time, one of the 
nurses in the hospital was allowed to board a commercial flight 
with CDC's consent.
    So we seem to keep having to learn these lessons over and 
over again that we have to be better prepared. Public health is 
hard, and it seems to be hard for us to keep our eye on what 
might happen in the future once we get beyond that moment. We 
should have learned and, more importantly, implemented more 
than we did from Ebola or from H1N1, both of which created real 
response problems, but real lessons if we had tried to learn 
them. Hopefully, we will do a better job learning the lessons 
we need to learn right now.
    Neither this administration nor the last one, frankly, 
prioritized research like this committee has, and we know that 
in our committee we have worked hard in the last 6 years and in 
the last five budgets in a bipartisan manner to increase the 
funding in the annual appropriations bills for the NIH 
(National Institutes of Health) by nearly 40 percent, for CDC 
by 21 percent, and for preparedness by 44 percent. But those 
numbers all have to be coming together before we begin to use 
them the way that our witnesses today or this committee would 
like to see them used.
    We have proven in our committee that medical research, 
public health, preparedness are all priorities, and because we 
have done so, we are more ready than we were at the last time 
or hopefully more ready in the future for the next pandemic. 
Right now, 238 FDA (Food and Drug Administration) emergency use 
authorizations for diagnostic tests and antigen tests are on 
the market, and every day we get closer to an affordable, 
reliable rapid test where you can get an answer in a way that 
allows us to really fight the pandemic rather than have another 
data point.
    In a few years, when someone gives a history lesson about 
COVID-19 response, there will be criticism. It will go back 
about 20 years, and it will be significant.
    But I know there are things we all agree on. We need to 
have more investment in testing, more resources for our vaccine 
candidates to finish their trials, manufacture the vaccine and 
for CDC to distribute through a vetted, well thought out plan. 
I hope we learn more about--and I am going to insist that we 
learn more about--all of those things today.
    I had hoped we might be able to include child care in our 
hearing today. We were not able to do that because of time, but 
clearly if you are going to get back to school, back to work, 
and back to better health, child care has to be part of that 
and something this committee has to stay focused on.
    So, again, I welcome 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 provide an update on COVID-19.
    This continues to be an incredibly challenging time for our 
country. COVID-19 has killed 195,961 Americans and 6.6 million have 
tested positive. It has rapidly swept across the globe and even 
countries that thought their cases were contained are facing new 
outbreaks.
    COVID-19 is a new disease and even after 9 months, relatively 
little is known about it, or even coronaviruses generally. This has 
hindered our public health response. Trying to find the answers has 
been like building the plane while flying it.
    That comment is not to exonerate this Administration's handling of 
the response. Can justified criticisms be leveled? Yes.
    But history allows us to look at past events to put current ones 
into perspective. For this history lesson, we only need to remember 
back 6 years to 2014 when West Africa faced the largest Ebola outbreak 
the world had ever seen.
    Unlike COVID-19, Ebola is a disease that has been around since the 
mid-1970s. It is a disease that, scientifically, we knew a lot more 
about in 2014 than we do COVID-19 in 2020.
    But even the kindest recollections of our public health response to 
Ebola would call it flawed. As the threat of an Ebola patient flying to 
the U.S. was a growing reality, the Obama Administration refused to 
consider closing borders.
    When CDC began implementing infection control guidelines, critics 
said they were too complicated and too hard to follow. Healthcare 
worker unions stated that their members had inadequate training and 
protective equipment. Public health experts said the CDC Director 
should be more upfront about the unknowns and uncertainties of the 
disease.
    Members of Congress used words like ``cryptic'' and ``misleading'' 
to describe the information that was provided to them by the 
Administration.
    And when a case finally was found in the U.S. at a Dallas hospital, 
the CDC Director blamed the hospital for a ``breach in protocol'' that 
led to the infection of two nurses.
    Yet, when one of those nurses wanted to board a commercial flight 
while running a fever, she was allowed to with the CDC's consent.
    This lesson is to illustrate a simple reality: public health is 
hard. And it is especially difficult for a disease we are still 
learning about as we fight it in pandemic form. Those in charge of the 
response are never going to get everything right and it will always be 
easier for talking heads or other experts to criticize those making the 
tough decisions.
    But we should have learned, and more importantly implemented, more 
than we did from Ebola and H1N1. For example, the top two lessons 
learned from the Ebola outbreak in West Africa according to the World 
Health Organization were: (1) research at the heart of the response; 
and (2) test results turned around quickly.
    Neither this Administration nor the last prioritized medical 
research. Would we have had a better response if there were more money 
during the early 2000s for medical research? We'll never know. But I do 
know that NIH turned its attention from other coronaviruses like MERS 
or SARS when funding became tight.
    And like Ebola, we all know the importance of rapid testing for 
coronavirus. It can make or break a response. We need to ask ourselves 
why CDC wasn't more prepared.
    As someone who has chaired the LHHS Subcommittee for nearly 6 
years, I have tried to refocus our efforts on medical research and 
preparedness. Over the past 5 years, in a bipartisan manner, the 
Subcommittee has been able to increase funding in the annual 
appropriations bills for the National Institutes of Health by nearly 40 
percent. CDC funding has increased 21 percent. And preparedness funding 
is up 44 percent.
    I believe the Appropriations Committee's job is to ensure funding 
is prioritized to the most important activities. If everything is a 
priority, then nothing is a priority. In the past 5 years, I think we 
have proven that medical research, public health, and preparedness are 
the priorities, and have done so in a bipartisan manner.
    And because we had done so, we were more ready for an unknown 
pandemic. This is illustrated by how quickly medical research pushed 
several vaccine candidates into late-stage development only 6 months 
after we discovered the disease in this country.
    There are now 238 FDA emergency use authorizations for diagnostic 
and antigen tests on the market, and every day we get closer to an 
affordable, reliable, rapid test that can be deployed anywhere to be 
taken at any time.
    In a few years, when someone gives a history lesson about the 
COVID-19 response there will be criticism. And it will be significant.
    But I know there are things both sides agree to. This includes a 
further investment in testing--so it can be as widespread as possible--
more resources for our vaccine candidates to finish their trials, 
manufacture the vaccine, and for CDC to distribute it through a vetted, 
well thought through plan.
    We also know that parents are struggling to return to work without 
many schools or child care facilities open. Child care programs 
operated on razor thin margins prior to the pandemic. Now, with 
additional costs and decreased enrollments, and social distancing, many 
child care programs are being stretched beyond their breaking point. 
More investment is needed to help child care providers safely stay open 
or re-open, and to provide safe, high-quality child care so their 
parents can return to work.
    I know if we focus on COVID-19 related funding, we can reach an 
agreement with the other side.
    I want to once again thank the witnesses for appearing today. I 
look forward to your testimonies and appreciate your thoughtful 
dialogue with us. Thank you.

    Senator Blunt. And Senator Murray is joining us from her 
office, I believe. Senator Murray, we are ready for your 
opening comments.

                   STATEMENT OF SENATOR PATTY MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman, 
and thank you to all of our witnesses who are joining us today.
    You know, as our country approaches a tragic milestone in 
this pandemic, 200,000 dead, I want to recognize that our 
rising national death count represents countless personal 
losses. Families have lost parents, grandparents, and children. 
Communities have lost educators, healthcare providers, and 
other frontline workers, and people have not only lost loved 
ones, but many have lost a small solace of being able to visit 
and comfort those they care about in their final moments. My 
heart goes out to everyone who is struggling with the hardship 
caused by this virus whether they are suffering with the loss 
of life or livelihood.
    You all deserve leaders who take this crisis seriously, who 
take action to support and protect you, your family, and your 
community, who arm you with the facts you need to stay safe. 
Unfortunately, we have yet to see that leadership from the 
President. Like many Americans, I was deeply angered last week 
to hear President Trump admitting that even though he 
understood COVID-19 was more deadly than even your strenuous 
flu--that is a quote--he was intentionally playing down this 
crisis. But I was not surprised. These recordings were not a 
revelation. The reality has been painfully obvious for months.
    Early on, President Trump not only claimed this virus was 
contained, controlled, going away, he claimed it was a 
Democratic hoax. His Vice President wrote an op-ed arguing that 
there would be no second wave just before we saw a 
heartbreaking and record-breaking increase in new cases and 
deaths across our country.
    When it came to testing, President Trump did not just say 
he took no responsibility at all, he said he liked the numbers 
where they were. He said he wanted to slow down testing, and he 
blamed testing for the rising case numbers.
    When it came to wearing masks, he not only said that masks 
caused problems too, he also shared a tweet saying masks 
represent a culture of silence, slavery, and social death, and 
a video falsely claiming people do not need to wear masks and 
there is no cure.
    He made false claims on treatments as well, continuing to 
promote hydroxychloroquine and has suggested we look at bleach 
as an option.
    And he is still--still--downplaying this virus. He is still 
saying it will just go away. He is saying we are, quote, 
rounding the final turn. Dr. Fauci has made it clear that is 
not true and pointed out that we have plateaued at around 
40,000 cases a day, that daily deaths are still regularly 
around 1,000, and experts have warned that we still need to 
prepare for a fall wave that will coincide with the flu season. 
But President Trump has not been listening to the public health 
experts. He has been fighting them, suggesting FDA is part of a 
deep state conspiracy, and CDC is overstating the death counts.
    But not only is he spreading inaccuracies and outright lies 
at a time when truth is a matter of life and death and trust--
trust--in our public health agencies is paramount, his 
administration has been recklessly interfering with the work of 
these agencies for political benefit to promote unproven 
treatments, alter CDC guidance on reopening and testing and 
more. Just over the last week, we have learned that President 
Trump put pressure on NIH and FDA to authorize convalescent 
plasma as a treatment and that political appointees at HHS 
(Department of Health and Human Services) have worked 
unsuccessfully to dictate talking points for Dr. Fauci and has 
succeeded in demanding oversight of and changes to CDC's 
flagship scientific publication, the Morbidity and Mortality 
Weekly Report. That publication is a cornerstone of public 
health work across the world. It is dangerous and unprecedented 
that political appointees are editing, censoring, and 
ultimately undermining a report that is intended to give 
families, public health professionals, researchers, and 
healthcare providers what they need: the truth.
    The Trump administration's political meddling shows a 
dangerous disregard for truth, facts, science, and most 
importantly, people's lives. Data and science are key tools in 
our fight against any health crisis, and the damage being done 
to public trust in those tools by this administration threatens 
to undermine our ability to respond to this pandemic, public 
trust in an eventual vaccine, and public health efforts for 
years to come.
    The Trump administration needs to leave the science to the 
scientists immediately.
    The leaders of our public health agencies need to provide a 
full account of what political pressure has been applied and 
what steps they are taking to make sure it does not influence 
their work or the work of the agencies they lead.
    Congress needs to act now to demand the transparency we 
need to hold this administration accountable. Democrats will be 
laying out steps soon for how we can do that, and I hope every 
Republican who has said they believe we need to follow the 
science will prove it by working with us on this because you 
cannot be for science if you are not against political 
interference.
    I also hope Republicans will come to the table to work with 
us in earnest on a larger COVID-19 package that our communities 
so desperately need. Unfortunately, they have not taken this 
seriously so far, and when Democrats put forward the HEROES Act 
back in May, Republicans said there was no rush, they would 
wait to see if more was needed. When Republicans finally did 
put forward a proposal months later, it was woefully inadequate 
to address the crisis at hand. And while Democrats have moved 
to find common ground and even offered to negotiate towards a 
lower top line number, Republicans refused that offer and 
instead put forward a bill last week that moved us even further 
away from common ground. This is not serious negotiating, and 
the ideas that have been put forward are not serious solutions. 
But the crisis we face remains deadly serious.
    We cannot afford to waste any more time. We need to 
stabilize the child care sector and make sure schools can 
educate students safely whether remotely or in person. We need 
to make significant investments in public health, particularly 
regarding testing and contact tracing, and distributing and 
administering a safe, effective, and trusted vaccine.
    And we need to demand the type of comprehensive national 
plan for those efforts that has been long overdue. The 
distribution plan that CDC finally put out just today is a long 
overdue step forward, but there is still more to do. I am still 
reviewing this, and I will have more to say. But it is clear 
this is still not the kind of comprehensive, end-to-end 
national plan I have called for and that we desperately need. 
We are still missing important details on research and review 
like what standards FDA would use to authorize a vaccine for 
emergency use development, like how we make sure disparities 
are addressed in clinical trials, and manufacturing, like how 
we address supply chain issues and avoid bottlenecks. And we 
still need more details on addressing disparities.
    We also need to protect the safety and civil rights of 
those going to work and provide relief to those who have lost 
their jobs.
    We need to support families who are struggling to make rent 
and afford healthcare and get nutritional meals.
    And we need to address the severe disparities we are seeing 
and how much harder this crisis is hitting black and Latino and 
Tribal communities.
    We need to provide relief for our State, local, and Tribal 
governments.
    And last but, as we have seen recently, certainly not 
least, we need to make sure once and for all that political 
interference from President Trump does not further undermine 
our response to this crisis.
    Now, I am going to have several questions for our 
witnesses, but I hope we are all able to get more than just 
answers in the days ahead. I hope we are all able to finally 
come together and take action before we lose any more time to 
save lives and prevent costly mistakes.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Murray.
    Again, let me welcome our guests today, our witnesses 
today. Admiral Brett Giroir is the Assistant Secretary for 
Health. Dr. Robert Kadlec is the Assistant Secretary for 
Preparedness and Response, and Dr. Robert Redfield is the 
Director of the Centers for Disease Control and Prevention. We 
are pleased you are here. I would like to give you time to make 
an opening statement. We have the statements you have 
presented. You can summarize those if you want, but we are 
eager to get to questions, but we are also eager to hear from 
you. So, Admiral Giroir, why do you not go ahead and start with 
your opening statement.
STATEMENT OF HON. ADMIRAL BRETT GIROIR, M.D., ASSISTANT 
            SECRETARY FOR HEALTH, DEPARTMENT OF HEALTH 
            AND HUMAN SERVICES
    Admiral Giroir. Chairman Blunt, Ranking Member Murray, and 
distinguished members of the subcommittee, I am honored to 
update you on our Nation's effort to combat COVID-19 with a 
specific focus on testing.
    Testing is an essential component of America's public 
health response to the pandemic. Recommended practices like 
wearing a mask, avoiding crowds, especially indoors, and 
washing your hands, combined with smart testing, is the formula 
to effectively slow the spread, flatten the curve, and save 
lives.
    By being evidence-based, providing county-specific weekly 
guidance to governors, expanding supplies, and managing their 
distribution, providing the right test to the right person at 
the right time, and developing and allocating safe and 
effective therapeutics, we are seeing promising results.
    Specifically, since the post-Memorial Day peaks in 
community spread, the number of new COVID-19 cases is down 48 
percent. The number of people hospitalized with COVID-19 is 
down 49 percent. The number of people in an intensive care unit 
due to COVID is down 62 percent, and deaths associated with 
COVID are down 33 percent.
    But let me say emphatically that these gains could be 
fleeting or even reversed if we do not continue to follow the 
national plan and exercise personal responsibility, especially 
wearing masks and avoiding crowds.
    Now, specifically regarding testing, the Nation will 
surpass 100 million viral tests completed this week. We have 
purchased and shipped over 95 million swabs and 81 million 
tubes of media to States, Tribes, and Federal partners. 
Starting April 7, we have purchased and delivered to public 
health laboratories and the Indian Health Service 2.3 million 
Abbott ID NOW point-of-care molecular tests to support outbreak 
control and rural testing. We have established Federal surge 
testing in 19 different sites, helping to squelch emerging 
outbreaks typically among asymptomatic young adults. These 
sites are in addition to the over 2,700 federally supported or 
federally enabled community-based testing sites at trusted 
retailers focused in areas of moderate to high social 
vulnerability and the literally thousands of HRSA (Health 
Resources and Services Administration) federally qualified 
health centers that offer testing to predominantly racial or 
ethnic minority patients.
    We are now at an inflection point in testing. This month we 
anticipate the availability of approximately 3 million tests 
per day, and at least half of these will be rapid point-of-
care. We will have available more point-of-care tests in 
September than the total number of tests performed in August. 
We have been building towards this inflection point, and I have 
previously testified to its coming several times over the past 
months.
    As a result of regulatory flexibility, investments in 
coordination with the public and private sectors, we have 
implemented comprehensive, cutting-edge testing initiatives to 
flatten the curve and save lives while supporting reopening of 
America. Let me discuss just two of these.
    Protecting the elderly has been, is, and will continue to 
be a foremost priority for this administration. So on July 14, 
we announced that every single eligible nursing home in America 
would receive a point-of-care instrument and point-of-care 
testing supplies. We have delivered on this promise. All 13,850 
eligible nursing homes have now received a total of 13,985 
instruments and over 4.9 million rapid point-of-care tests 
ahead of schedule.
    On August 27, after months of planning and only 1 day after 
its FDA authorization, the administration announced a $760 
million contract with Abbott for the delivery of 150 million 
rapid BinaxNOW point-of-care tests. This test is easy to 
perform, does not require an instrument, delivers test results 
in 15 minutes or less, and costs 5 bucks. It can easily be 
deployed to many settings across the country, and it comes with 
a companion app that enables instantaneous reporting. We have 
already deployed 50,000 of these tests in support of disaster 
operations in California, Texas, and Louisiana and now another 
15,000 to support wildfire operations in Oregon.
    This week, we will ship our first 2 million tests to 
further prevent spread of COVID in nursing homes, assisted 
living, and in Tribes. In the coming weeks, we will begin 
shipping millions of tests per week in support of our teachers 
and students to open and keep open K through 12 schools and to 
support vulnerable populations at HBCUs (Historically Black 
Colleges and Universities).
    Thank you for the opportunity to provide these remarks, and 
I look forward to your questions.
    Senator Blunt. Thank you, Admiral.
    Dr. Kadlec.
STATEMENT OF DR. BOB KADLEC, M.D., ASSISTANT SECRETARY 
            FOR PREPAREDNESS AND RESPONSE, DEPARTMENT 
            OF HEALTH AND HUMAN SERVICES
    Dr. Kadlec. Thank you, Chairman Blunt, Ranking Member 
Murray, and distinguished members of the committee. I am Dr. 
Bob Kadlec, the Assistant Secretary for Preparedness and 
Response.
    As a medical doctor and former Senate staffer, retired 
military officer, and having served in the White House, I have 
spent my adult career working to serve and protect the American 
people.
    I appreciate the opportunity to testify before you to 
highlight ASPR's (Assistant Secretary for Preparedness and 
Response) response to the COVID-19 pandemic, our progress in 
vaccine development and our efforts to confront and mitigate 
this pandemic.
    I want to thank this committee for providing both 
supplemental resources for COVID response, as well as 
supporting and sustaining the ASPR organization in the past. 
Your investments have been critical to support our operations 
and ensure we have tools available to respond to the COVID-19 
pandemic.
    Throughout 2020, ASPR has used these resources to protect 
American lives. We have assisted in the repatriation of 
Americans from China and Japan at the start of the pandemic. 
ASPR has provided medical surge support in Louisiana, Texas, 
and Mississippi after Hurricane Laura, and today we have teams 
deployed to Louisiana and Mississippi prepared to assist in 
response and recovery operations following Hurricane Sally. We 
have deployed personnel and teams to California and Oregon to 
support wildfire response, and the Secretary has just signed 
the public health emergency for Oregon to assist in the search 
and rescue of personnel--of individuals who have been affected 
there.
    We have deployed personnel to Beirut to assist the 
government in Lebanon with hospital recovery following the 
catastrophic explosion.
    With that, we have supported these calls to action while 
simultaneously responding to State, local, territorial, and 
Tribal requests for assistance in the COVID response.
    It is an honor to lead this organization. I am truly 
humbled by the selflessness and dedication of the men and women 
of ASPR. While we have seen a decline in new cases and deaths 
and hospitalizations, we know it takes constant vigilance and 
personal responsibility by every American to wear masks, wash 
hands, and keep our social distance. But as everyone does their 
part, ASPR continues to work hard to enhance our country's 
preparedness and response capabilities. I am proud that ASPR 
has been part of a driving force in this whole-of-America 
effort.
    Since early 2020, ASPR and BARDA (Biomedical Advanced 
Research and Development Authority) began working to accelerate 
vaccine development. This work was foundational to the 
development of Operation Warp Speed, a whole-of-government 
approach working with our private sector partners to produce 
and deliver a safe and effective vaccine as fast as possible.
    The supplemental appropriations provided by this committee 
have been essential in permitting significant advancements 
under Warp Speed. As a result, America is far better positioned 
than before to keep Americans safe, protect vulnerable 
communities and individuals, and defeat the COVID-19 virus. To 
date, we have awarded $13.6 billion to support over 50 medical 
countermeasure projects. Seven of these awards are vaccine 
contracts. We are making significant progress in advancing 
these vaccines through a clinical trial process. In fact, three 
candidates are in phase 3 clinical trials, meaning that we are 
closer than ever to a safe and effective vaccine available to 
the public. Three others are in phase 1 and 2.
    Safety is our top priority in the development of vaccines 
and therapeutics, which is why science is driving the 
development of all COVID-19 countermeasures to ensure they meet 
FDA's gold standard of approval. In the meantime, we have 
implemented an intensive, efficient process to promote vaccine 
development and, in parallel, manufacturing. Supporting these 
efforts simultaneously ensures we are positioned to distribute 
and administer the vaccine quickly once approved.
    ASPR also continues to support advancements in lifesaving 
therapeutics. For example, ASPR has taken a data-driven 
approach to oversee the fair and equitable distribution of 
remdesivir. To date, we have distributed to States enough 
remdesivir to treat almost 650,000 patients.
    ASPR has also supported the mitigation efforts to slow 
virus transmission. Since March, ASPR has produced and 
distributed more than 500 million cloth facial coverings across 
the country to protect vulnerable populations and essential 
workers. This month, we are supporting the administration's 
school facial coverings initiative by sending an additional 125 
million cloth facial masks to States and territories for 
distribution to low-income students in order to support the 
safe reopening of America's schools.
    As the Federal agency leading the emergency support 
function 8, ASPR is capitalizing on existing relationships with 
DoD (Department of Defense), VA (Department of Veterans 
Affairs), and DHS (Department of Homeland Security) to 
coordinate a more comprehensive medical nationwide response. We 
have responded to requests from 32 States, three territories, 
five Tribes with nearly 100 medical support missions with over 
5,700 staff from ASPR's national disaster medical teams, the 
Public Health Service, the VA, and DoD.
    We have provided personal protective equipment that I know 
will be subject to quite a few questions under the SNS 
(Strategic National Stockpile) 2.0 initiative to expand the 
depth and breadth of our stockpile, grow the U.S. industrial 
base, and reduce our vulnerabilities to foreign suppliers. We 
have used the Defense Production Act as well.
    I thank you again for your support and the opportunity to 
testify before you on ASPR's efforts during this pandemic, and 
I am happy to answer any questions you may have at this time.
    Senator Blunt. Thank you, Dr. Kadlec.
    Dr. Redfield.
STATEMENT OF DR. ROBERT R. REDFIELD, M.D., DIRECTOR, 
            CENTERS FOR DISEASE CONTROL AND PREVENTION
    Dr. Redfield. Good morning, Chairman Blunt and Ranking 
Member Murray and members of the committee. Thank you for the 
opportunity to be here today.
    On behalf of CDC, thank you also for your continued support 
of our public health professionals and the lifesaving work they 
are committed to do 24/7.
    Over 6,700 CDC staff have been engaged in the agency's 
COVID-19 response, 1,200 of whom have been deployed to more 
than 200 locations in the United States and abroad. And I know 
you share with me the gratitude for their resilience, 
dedication, and service to our Nation.
    Throughout this global pandemic, CDC has brought its 
scientific expertise to the front lines, conducting rapid 
investigation of disease outbreaks that identified the highest 
risk populations and settings. Understanding which populations 
are at risk and how the virus is spreading in various settings 
is critical to developing the guidance and protecting the 
health of Americans.
    Today and even after we have a vaccine, CDC encourages all 
Americans to embrace the powerful tools that we have right now: 
to wear a mask, particularly when they are in public; maintain 
social distancing; routine, vigilant hand washing; be smart 
about crowds; and stay home when you are sick.
    And as we move into the fall, we are adding one of the most 
significant scientific contributions to medicine to our 
evidence-based mitigation strategies: flu vaccination. Flu 
vaccine is safe and CDC encourages Americans to embrace flu 
vaccine with confidence for themselves, their families, and 
their communities. These simple actions combined could help 
this Nation avert a very difficult fall, lessening the burden 
on our healthcare system and saving lives.
    CDC has awarded $140 million to 64 jurisdictions through 
our existing immunization cooperative agreements to scale up 
flu vaccination this season. This funding is supporting staff 
and preparedness with the focus of ensuring that flu vaccine 
coverages can reach the populations at most risk. This year, 
CDC purchased an additional 9.3 million doses of adult 
influenza vaccine, up from the usual annual 500,000-dose 
purchase in prior years, as well as 18.5 million doses for 
children.
    And CDC has developed a new multiplex laboratory test that 
can check for three viruses at the same time, influenza A and 
B, plus SARS-CoV-2, in a single test from a single sample. This 
test was granted an EUA (Emergency Use Authorization) by the 
FDA and will save public health laboratories time and resources 
and help better understand and identify co-infections with 
influenza 1 and SARS-CoV-2. To date, CDC has distributed over 
135 multiplex kits to more than 100 laboratories across the 
country, with each kit having enough reagents to do 
approximately 500 tests.
    CDC is also working with 64 immunization grant recipients 
to build readiness for timely and, most importantly, equitable 
administration when a COVID-19 vaccine becomes available. CDC 
is leveraging its expertise and immunization infrastructure to 
support Operation Warp Speed and vaccine promotion, 
distribution, administration, and monitoring. In coordination 
with Operation Warp Speed, CDC is working closely with State 
and local, territorial, Tribal health departments and community 
organizations to prepare a detailed, yet flexible plan for 
vaccine distribution to critical infrastructure workers and 
people at risk, increased risk for serious outcomes.
    At this time, CDC continues to support partners with its 
ongoing community mitigation efforts, including case 
identification, contact tracing, surveillance, and reporting, 
as well as testing capacity.
    To support these activities on behalf of HHS, CDC has 
awarded $12 billion to these jurisdictions in 2020, thanks to 
the support of Congress. Included in that amount was more than 
$200 million to support the American Indian and Alaska Native 
communities, which have had some of the most significant 
effects from COVID-19.
    Timely, accurate and, most importantly, actionable data are 
essential if we are going to learn to impact COVID-19 on all 
Americans, particularly the populations at greater risk such as 
older Americans, those with chronic medical conditions, racial 
and ethnic minority populations. CDC reports monthly to the 
Congress the most recent data analysis on the impact in racial 
and ethnic groups.
    As I have emphasized in my prior hearings, now is the time 
to commit to prioritize a sustained investment in the core 
capabilities of public health, that is, data and data 
analytics, laboratory resilience, workforce expansion, and 
rapid response capabilities. Years of under-investment in 
public health have led to a system that has been sorely tested 
by the current pandemic. COVID-19 is the most significant 
public health challenge to face our Nation in more than a 
century. Now is the time to build not only the public health 
core capability that our Nation needs, but that the people of 
our Nation deserve. As we work together collectively to fight 
COVID-19 to end the pandemic, CDC is committed to the mission 
to protect all Americans from the disease threats to save lives 
now and in the future.
    Thank you for the opportunity, and I look forward to your 
questions.
    [The statement follows:]
Prepared Statement of Admiral Brett P. Giroir, M.D., Bob Kadlec, M.D., 
                       and Robert Redfield, M.D.
    Chairman Blunt, Ranking Member Murray and distinguished members of 
this subcommittee. It is an honor to appear before you today to discuss 
the Department of Health and Human Services' ongoing response to the 
COVID-19 pandemic. 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), 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. Congress 
passed 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. 
Within HHS, the Centers for Disease Control and Prevention (CDC), the 
Assistant Secretary for Health, and the Assistant Secretary for 
Preparedness and Response along with additional components not 
represented today, play critical roles in the response to this public 
health emergency as discussed below.
               centers for disease control and prevention
    CDC is America's health protection agency, and works 24/7 to 
prevent illness, save lives and protect America from health, safety and 
security threats. CDC has a key role in preparedness and response in 
the U.S. and abroad. Addressing infectious diseases like COVID-19 is 
central to our mission and CDC has decades of leadership in infectious 
disease response.
    When there is an emerging pathogen like the SARS-COV2 virus, CDC 
expertise lies in our ability to study the new pathogen to understand 
how it is transmitted, and translate that knowledge into public health 
action. Since first learning of the cluster of cases in Wuhan, CDC has 
rapidly advanced the science around this new human pathogen, SARS-CoV-
2. CDC has both been on the forefront of understanding this new disease 
and led the Nation's efforts to protect Americans from infection. 
Currently, over 6,700 CDC employees have been engaged in the agency's 
COVID-19 response, and over 1,200 of these staff have been deployed to 
nearly 200 different locations in the U.S. and abroad. CDC staff have 
conducted rapid investigations of outbreaks that identified highest-
risk priority populations and settings. Understanding specific 
population-level vulnerabilities and how infections spread in various 
types of settings has been instrumental in the development of guidance 
that will help keep the American people healthy and allow critical 
infrastructure services to be provided safely.
    The Morbidity and Mortality Weekly Report (MMWR), sometimes called 
the ``voice of CDC,'' has published more than 100 COVID-19 reports 
since the beginning of the pandemic, providing cutting-edge scientific 
articles that have been viewed by tens of millions of readers. These 
reports have provided the public, scientists, healthcare workers, and 
policymakers critical information about the virus, how it spreads, and 
the communities it has impacted. MMWR reports yielded the earliest 
descriptions of asymptomatic and pre-symptomatic transmission of the 
virus and elucidated the substantial risk of transmission at large 
gatherings, choir practices, and congregate living situations including 
nursing homes, prisons and jails, homeless shelters, and camps for 
children. They have described the disparate impact of COVID-19 in 
racial and ethnic minorities and identified the elevated risk of severe 
outcomes for older adults and people with underlying conditions. 
Finally, MMWR reports have indicated what successful control of the 
virus looks like, through careful mitigation efforts in everyday high-
risk settings such as hair salons and childcare centers. In short, 
MMWR's rapid publication of the highest quality science has laid the 
foundation of what we know about COVID-19 and illuminated the way 
forward.
    In addition to publishing our own scientific information, CDC 
scientists are monitoring in real time the rapidly expanding scientific 
literature and have reviewed over 100,000 scientific papers thus far. 
This approach ensures that CDC responders are armed with the best 
information available. This comprehensive understanding of the emerging 
science base helps direct CDC's scientific agenda and informs CDC 
guidance, and helps guide CDC's direct support of clinicians and the 
public. CDC's Clinical Response Line has fielded over 32,000 individual 
inquiries from frontline healthcare providers, and the agency's hotline 
for public inquiries has responded to nearly 500,000 calls and e-mails.
    CDC is drawing on its emergency response capacity and its 
relationships with State, Tribal, local, and territorial (STLT), 
global, and private sector partners; and is leveraging our workforce's 
strengths in public health surveillance, prevention, and laboratory 
capacity to carry out research and share new knowledge related to this 
novel pathogen and its consequences. CDC provides guidance for 
healthcare professionals, essential workers, businesses, schools, and 
the public to encourage safer practices, improve health outcomes, and 
save lives. CDC works with partners to develop decision tools to assist 
STLT officials and other stakeholders with mitigation strategies. 
Importantly, CDC is preparing the Nation's public health system and the 
private sector to disseminate a vaccine when one is available. CDC is 
leveraging investments in global health security and pandemic influenza 
preparedness infrastructures in over 60 countries to mitigate the 
effects of COVID-19 and stop the disease from spreading.
    As of September 9, 2020, there have been 6,310,633 COVID-19 cases 
reported and 189,147 deaths attributed to the virus in the U.S. The 
latest data can be found on CDC's website: https://www.cdc.gov/covid-
data-tracker/index.html. The U.S. Government has taken unprecedented 
action to address the public health threat posed by this new 
coronavirus. CDC has substantial supplemental funding to help respond 
to this pandemic at home and abroad. This funding supports a federally 
guided, State managed, and locally implemented response to COVID-19 in 
the United States.
    With funds provided by the Coronavirus Preparedness and Response 
Supplemental Appropriations Act and the Coronavirus Aid, Relief, and 
Economic Security (CARES) Act, CDC is providing States with needed 
resources needed to detect, respond, and prevent the spread of COVID-19 
and to inform community mitigation strategies.
    CDC's highest priority is to ensure that STLT public health 
programs have the resources they need to address the COVID-19 pandemic. 
These jurisdictions are best positioned to understand the unique 
situation of each community, including the status of their public 
health infrastructure and workforce and its needs for enhancement. CDC 
is supporting STLT partners who are working to identify cases; conduct 
contact tracing; implement containment measures and mitigate spread in 
the community. CDC is working alongside these health departments to 
improve surveillance and reporting and enhance testing capacity. 
Together, STLT and CDC teams are responding to COVID-19 outbreaks in 
high-risk settings and implementing best practices to control the 
spread.
    As a public health agency and the Nation's primary resource for 
STLT health departments on managing disease outbreaks, CDC provides 
guidance and support on the development and implementation of effective 
containment and community mitigation strategies. The goal is for all 
jurisdictions to have robust public health systems which include a 
contact tracing infrastructure that meets their unique needs. As of 
September 2020, CDC has posted over 30 contact tracing guidance 
documents, including case investigation guidelines, checklists for 
developing a case investigation and contact tracing plan, digital 
contact tracing tools, and a Contact Tracing Communications Toolkit for 
Health Departments. To support these activities, described in further 
detail below, CDC has awarded $12.1 billion to these entities in fiscal 
year 2020, including $10.25 billion in funds executed on behalf of HHS 
to be used primarily to support each jurisdiction's testing goals (as 
outlined in State testing plans).
Testing Strategy
    Beginning in April, the White House, and Federal partners including 
CDC, convened calls with all 50 States, Puerto Rico, and the District 
of Columbia to identify testing capacities and needs. Through these 
calls and other outreach efforts, CDC has worked with individual 
jurisdictions to identify needs, develop plans, and offer technical 
assistance to enhance testing capacity. CDC, under the leadership of 
the Office of Assistant Secretary for Health and in collaboration with 
the Association of Public Health Laboratories, reviewed individual 
State testing plans with a focus on achieving increased monthly testing 
targets. These discussions and plans for action emphasized the need to 
serve vulnerable populations and include focused efforts for long-term 
care facilities, federally qualified health centers, and Tribal 
Nations, among others.
    CDC is working with STLT health departments to support forward-
looking testing strategies that ensure that vulnerable or high-risk 
populations, such as some racial and ethnic minorities, have adequate 
access to testing. For example, CDC worked with the Health Resources 
and Services Administration and health centers to survey health centers 
and better understand the populations they are serving. Approximately 
60 percent of responding FQHCs are in urban areas, where persons of 
Hispanic or Latinx ethnicity were the largest proportion of individuals 
testing positive. This information allows STLT health departments to 
implement strategies to increase testing in FQHCs and provide them with 
the tools and resources to diagnose, treat, and monitor COVID-19 
illness in the populations they serve.
    CDC has developed a new multiplex laboratory test that checks for 
three viruses at the same time, two types of influenza viruses (A and 
B) and SARS-CoV-2, the virus that causes COVID-19, using a single 
sample collected from an individual. Testing for all three viruses will 
allow public health laboratories to continue surveillance for influenza 
while testing for COVID-19. This will save public health laboratories 
both time and resources, including testing materials that are in short 
supply. Another benefit of the new test is that laboratories will be 
better able to find co-infections of influenza and SARS-COV-2. The FDA 
issued an Emergency Use Authorization (EUA) for this combined 
laboratory test on July 2, 2020 and CDC released these reagents for 
distribution to States' public health laboratories on August 5, 2020. 
As of August 17, 2020, 135 multiplex kits were shipped to more than 100 
laboratories. Each of these kits provides approximately 500 tests. 
Adjusting for the controls, these 135 kits provide approximately 67,000 
tests. CDC has provided these kits to each State's or territory's main 
public health laboratory, as well as any regional or local laboratories 
that is approved to provide SARS-CoV-2 surge testing support. 
Importantly, multiplex assay technical information is publicly 
available on CDC's website so that commercial developers can use this 
information in developing proprietary tests. CDC also granted assay 
manufacturers right of reference to its EUA, allowing developers to use 
the data CDC submitted to FDA to streamline their efforts when applying 
for an EUA. CDC took these steps to catalyze the development and 
validation of these assays by the commercial sector which is better 
equipped to scale up testing capacity.
    In March 2020, CDC and public health partners began seroprevalence 
surveys of community transmission of SARS-CoV-2. Seroprevalence surveys 
help identify infections that might be missed due to lack of symptoms 
or testing not being performed. Serology studies can also help 
determine risk factors associated with SARS-CoV-2 infection, including 
transmission in healthcare settings and communities, and inform 
guidance and mitigation strategies. For example, CDC has published the 
results from one of the seroprevalence studies that used remnants of 
samples collected during routine clinical care. This was done in 
conjunction with two commercial companies and results suggested that 
greater than 10 times more SARS-CoV-2 infections occurred than the 
number of reported COVID-19 cases. Another study on healthcare 
personnel who routinely cared for COVID-19 patients found that 6 
percent had evidence of previous SARS-CoV-2 infection. This study 
identified two factors potentially associated with SARS-CoV-2 infection 
among HCP: personal protective equipment (PPE) shortages and not 
wearing a mask while interacting with patients.
Data Collection, Analysis and Understanding of the Pandemic
    Accurate data are critical as we continue to assess the burden 
placed on the American healthcare system to inform reopening. CDC is 
leveraging all available surveillance systems, including influenza and 
viral respiratory disease systems, to monitor COVID-19 and protect 
vulnerable communities. These data collected by CDC help target 
critical COVID-19 interventions. In collaboration with STLT public 
health partners, CDC is committed to making data available to the 
public, while protecting individual privacy.
    This crisis has highlighted the need to continue efforts to 
modernize the public health data systems that CDC and States rely on 
for accurate data. Public health data surveillance and analytical 
infrastructure modernization efforts started in fiscal year 2020. 
Timely and accurate data are essential as CDC and the Nation work to 
understand the impact of COVID-19 on all Americans, particularly for 
populations at greater risk for severe illness, such as older 
Americans, those with chronic medical conditions, and some racial and 
ethnic minorities. Modernization efforts include support for 
surveillance and data workforce, a key asset of the public health 
system. For example, CDC is working closely with our partners to help 
STLT health departments implement the Sara Alert system. Sara Alert is 
a standards-based, open source tool that increases interoperability 
among laboratory and clinical systems and automates the process of 
public health monitoring and reporting individuals exposed to or 
infected with COVID-19. To date, eleven States and territories, along 
with nine jurisdictions including one Tribal Nation, have adopted the 
Sara Alert system. Twenty additional jurisdictions including two 
territories are in progress of or considering joining. At the current 
level of participation during an average 10-14 day timeframe, 
approximately 80,000 individuals are either entering, being monitored 
by or exiting the system .
    CDC's population-based COVID-NET system monitors COVID-19 
associated hospitalizations that have a confirmed positive test in 
greater than 250 acute care hospitals in 99 counties in 14 States. Data 
gathered provide weekly estimates for age-specific hospitalization 
rates and describe characteristics of persons hospitalized with COVID-
19 illness as well as predictors of those with more severe outcomes. 
CDC's existing National Healthcare Safety Network (NHSN) continues to 
collect COVID-19 data from nursing homes and other long-term care 
facilities. NHSN also continues to collect data from hospitals across 
the U.S. to address healthcare-associated infections and fight against 
antibiotic resistance.
    The COVID-19 Case Report Form includes variables such as race and 
ethnicity to enable identification of populations that may be at higher 
risk for severe illness and risk factors. Though States are not 
required to report demographic information in the Case Report Form, 
they have improved the completeness of their reporting. In particular, 
the percentage of reports that include race data has increased from 21 
percent in April to 61 percent in mid-August, while the percentage of 
reports that include ethnicity data increased from 18 percent to 50 
percent during the same time period. While progress has been made, CDC 
will continue to work with States and other health system partners to 
improve completeness of the data.
Health Disparities
    COVID-19 has disproportionately impacted many racial and ethnic 
groups. CDC continuously looks to enhance our COVID-19 outreach and 
mitigation efforts for communities identified as most at risk. For 
example, CDC is supporting local activities in African American, 
Hispanic/Latino, American Indian and Alaska Native, and Asian American, 
Pacific Islander, and Native Hawaiian communities to deliver COVID-19 
prevention messages and community mitigation strategies. CDC recently 
released a COVID-19 Health Equity Strategy (www.cdc.gov/coronavirus/
2019-ncov/community/health-equity/cdc-strategy.html) that provides an 
evidence-based, comprehensive and coordinated framework for reducing 
COVID-19 disparities. The Strategy includes expanded plans for 
collecting and reporting timely, complete, representative, and relevant 
data on testing, incidence, vaccination, and severe outcomes among 
populations at highest risk. Additionally, CDC is working with existing 
program grantees, such as Racial and Ethnic Approaches to Community 
Health (REACH), to enhance outreach to populations at increased risk of 
complications from COVID-19. These broad-based community engagements 
and strategies are working with the aim of ensuring equitable access to 
testing, healthcare, and future COVID-19 vaccines.
    American Indian and Alaska Native communities are some of the most 
affected by COVID-19. As of August 2020, CDC has provided $206.4 
million to tribal nations, consortia, and organizations for responding 
to COVID-19 across tribal communities. This amount exceeds the minimum 
of $165 million directed by Congress through the Coronavirus 
Preparedness and Response Supplemental Appropriations Act and the CARES 
Act. CDC is using a multifaceted approach, guided by data, to allocate 
COVID-19 funding to tribal communities, enabling broad access to COVID-
19 resources through a variety of direct and indirect supports.
Children
    We are learning more about how COVID-19 impacts children every day. 
Although children are less likely than adults to develop severe illness 
when infected with SARS-CoV-2, household studies and outbreak 
investigations confirm that children can transmit the virus and often 
have the same or higher viral loads in their nasopharynx compared with 
adults. Though the mortality rate is low for children aged 18 years and 
younger, COVID-19--associated hospitalization rates increased among 
this age group during the summer months and are continuing to rise. 
From March 1, 2020 to July 25, 2020, one in three hospitalized children 
was admitted to an intensive care unit.
    CDC is committed to providing schools, teachers, staff, parents, 
and caregivers with information and guidance to help keep our children 
as safe and healthy as possible as schools reopen. CDC has developed 
enhanced guidance based on the most recent science, including 
considerations for operating schools during COVID-19, considerations 
for Institutions of Higher Education regarding the appropriate use of 
testing, and a school decisionmaking tool for parents, guardians, and 
caregivers. These resources provide students, school administrators, 
and parents the information the y need to guide decisionmaking and how 
to adapt to local conditions.
Community Mitigation and Workplace Safety
    The American people, communities, public health professionals, 
medical providers, businesses, and schools look to CDC for trusted 
guidance on responding to COVID-19. CDC is building and using a 
growing, data-driven evidence base to develop and disseminate guidance 
for a range of audiences, including business, schools, and healthcare 
professionals. These recommendations include actions that every 
American should take, such as wearing a mask, following good personal 
hygiene practices, staying at home when sick, and practicing social 
distancing to lower the risk of disease spread. CDC recently released 
Interim Guidance for Businesses and Employers Responding to COVID-19 to 
help prevent the spread of COVID-19 in the workplace and protect 
critical infrastructure workers. CDC guidance specifies that business 
operation decisions should be based on both the level of disease 
transmission in the community and their readiness to protect the safety 
and health of their employees and customers. CDC guidance for 
businesses is available here: http://www.cdc.gov/coronavirus/2019-ncov/
community/guidance-business-response.html.
Vaccine Planning
    While surveillance, testing, contact tracing, and community 
mitigation interventions are the best tools we have right now, looking 
to the future, CDC continues to work to prepare our Nation's public and 
private health systems to deliver a COVID-19 vaccine once it is 
available. CDC is using 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. CDC is working closely with the 
Advisory Committee on Immunization Practices (ACIP), a group of medical 
and public health experts who develop recommendations on the use of 
vaccines to control disease in the United States. ACIP members have 
expertise in areas such as vaccinology, immunology, internal medicine, 
family medicine, virology, public health, infectious diseases, and/or 
preventive medicine, and one member is a consumer representative who 
provides perspectives on the social and community aspects of 
vaccination. An August ACIP meeting focused on post-marketing vaccine 
safety surveillance, epidemiology of individuals at increased risk of 
COVID-19, and modelling allocation strategies of the initial COVID-19 
vaccine supply. Any recommendations ACIP makes for who should get 
COVID-19 vaccine and in what order will be grounded in guidance from 
the country's foremost experts on immunization science.
    CDC is working closely with state and local health departments and 
community organizations to prepare a detailed yet flexible plan for 
vaccine distribution that will be informed by a prioritization 
framework recommended by ACIP.
    These efforts include working with CDC's 64 immunization grant 
recipients to help ensure that the U.S. immunization system can mount 
an effective vaccine delivery program, including vaccine distribution 
and tracking. State and local health departments have conducted 
pandemic vaccination planning with immunization and preparedness 
funding from CDC for over a decade. Updating these vaccination response 
plans for implementation of a COVID-19 vaccine will build readiness for 
timely administration when a vaccine becomes available. During August 
2020, CDC completed in-person and virtual site visits to assess needs 
as vaccine planning intensifies. Lessons learned during these site 
visits will inform CDC's provision of technical assistance to all 
jurisdictions to aid in the development of State-specific COVID-19 
vaccination plans.
    In addition, some State and local health department's utilized 
supplemental resources to build infrastructure that would address 
current COVID-19 response needs and incorporated planning for future 
phases. One example is in Chicago, where the health department has 
developed the Chi COVID Coach app to communicate directly with 
Chicago's residents who may be COVID-19 positive. The forward-thinking 
app, built by private sector companies, can be adapted throughout the 
course of the pandemic. It now allows users to register to receive the 
vaccine once it becomes available.
    While it remains unclear how long the pandemic will last, COVID-19 
activity will likely continue for some time. It is also unclear what 
impact the ongoing COVID-19 pandemic will have on healthcare and public 
health systems during the upcoming influenza season and beyond. 
Circulation of COVID-19 and influenza virus at the same time could 
place a tremendous burden on the healthcare system. Therefore, getting 
a flu vaccine is especially important. 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, promote immunization for adult vaccine-preventable 
diseases, and increase coverage for flu vaccinations, and prepare for a 
potential COVID-19 vaccine.
    CDC works with public health and clinical partners each year to 
increase the number of people who get a flu vaccine and eliminate 
barriers to vaccination. Ongoing COVID-19 activity may affect where and 
how flu vaccines are given. On June 4, CDC awarded $140 million to 64 
jurisdictions through CDC's existing immunization cooperative agreement 
to launch a scale up for influenza season, given the increased risk of 
COVID-19. Funds are supporting staffing and preparedness with a focus 
on ensuring flu vaccine coverage for populations most at risk.
Conclusion
    COVID-19 is the most significant public health challenge to face 
our Nation in more than a century. CDC is providing the American public 
with the information and assistance it needs to defeat COVID-19. As we 
work together to fight COVID-19 and end this pandemic, CDC is committed 
to its mission to protect all Americans from disease threats and to 
save lives, now and in the future.
              office of the assistant secretary for health
Diagnostics and Testing
    Testing is an essential component of the public health response to 
SARS-CoV-2 (the virus that causes COVID-19). It enables clinical 
decisionmaking, informs resource allocation and disease prevalence 
monitoring, and is necessary to minimize community and economic 
disruption through targeted infection prevention and control measures. 
The indications for viral testing depend on the stage of the pandemic 
and the extent of community spread. In general, testing is indicated 
for diagnosis of those who are symptomatic or asymptomatic, tracing of 
those in contact with those who are infected, screening of specific 
employees (for example nursing home staff), and surveillance testing of 
those who are asymptomatic to achieve infection control and/or other 
public health objectives.
    Repeated testing of a majority of the U.S. population is not 
feasible at this time, nor necessary to assure safe return to work, 
school, and other activities. Rather, a targeted testing strategy that 
rapidly diagnoses those who are ill, protects the vulnerable, and 
identifies emerging outbreak areas--when combined with public health 
mitigation measures like mask wearing, is proven to reduce the spread 
and flatten the curve.
    To date, the U.S. has accomplished over 95 million tests, at an 
average current rate of between 700,000--800,000 tests per day, with 
enough tests in the market to perform three to four times that amount. 
Since early March, we have increased our daily testing by over 30,000 
percent. In June, July, and August, States far surpassed their goals 
for testing. Specifically, State goals for June were 12.9 million 
tests, and nearly 16 million were actually performed. The goals for 
July were 13.7 million tests; again, States far exceeded their goals by 
conducting over 25 million tests. In August the Nation completed over 
25.2 million tests, far exceeding the August goal of 21.1 million 
tests. Over the next several months, the Nation's testing capacity will 
continue to increase. We anticipate that supplies and reagents will be 
sufficient to conduct approximately 90 million tests in September. If 
pooling occurs even for a fraction of these tests, there is capacity to 
perform much greater than 100 million tests per month today. Turnaround 
time is improving and continuing to improve. Currently, 97 percent of 
ACLA tests ordered in the previous week received results within 3 days, 
and 99 percent received results within 5 days.
    The role of the Federal Government is to set the overall testing 
strategy and requirements, provide technical guidance, secure the 
supply chain, scale scarce resources, enable innovation, and support 
State plans to achieve the overall national objectives as well as any 
specific State objectives. States, territories, and tribes are 
responsible for formulating and implementing testing plans that meet 
national objectives and additional goals for their State. The academic, 
commercial, and private sectors will continue to develop and produce 
technologies, supplies, and services to meet the needs of the States 
and the Nation at large.
    The national strategy for testing was formally outlined in the 
Testing Blueprint: Opening Up America Again, and the Addendum to the 
Testing Blueprint. The immediate objectives of the strategy are to:
  --Identify newly emergent outbreaks
  --Support public health isolation and contract tracing
  --Diagnose COVID-19 rapidly in hospitalized patients
  --Protect the vulnerable
  --Support safe reopening of schools and businesses
  --Enable state testing plans
    The national strategy for testing was further enumerated in the 
COVID-19 Strategic Testing Plan Report to Congress initially submitted 
to Congress on May 24th. On August 22nd, HHS submitted the first update 
to the Strategic Testing Plan. The report outlines how HHS increased 
domestic testing capacity across the United States and provides 
additional guidance and information about diagnostic technologies, 
platforms and inventory that States, territories and tribes can utilize 
to develop flexible, adaptable, and robust COVID-19 testing plans.
Identifying Newly Emergent Outbreaks
    In addition to public health surveillance systems monitored by the 
CDC, the Nation is currently maintaining sufficient baseline testing 
for SARS-CoV-2 in order to detect early changes in percent positivity. 
At present, a minimum target of testing 2 percent of a State's 
population per month has been sufficient to detect early changes in 
percent positivity, and thus enable State and local officials--with the 
technical assistance of the Federal team--to implement mitigation steps 
rapidly to curb the emerging outbreak.
    In order to assure that states meet this 2 percent threshold to 
detect any threat of emergence in that State, the Federal Government 
will continue to:
  --Assist states with the procurement of collection supplies to 
        achieve minimum of 2 percent population testing per month; and 
        if possible, provide more supplies if needed to meet the 
        approved state plan targets. To date, the Federal Government 
        has procured and delivered 95 million swabs and 77 million 
        tubes of media
  --Assure sufficient supply of reagents to achieve testing goals in 
        the context of point of care utilization and use of commercial 
        referral labs;
  --Prioritize states with outbreaks or potential outbreaks, if needed, 
        and;
  --Continue to expand the availability and use of point of care tests.
Support Public Health Isolation and Contact Tracing
    A key function of testing is to support identification of infected 
individuals, many of whom may be asymptomatic, in communities 
identified with outbreaks or emerging outbreaks. In response to 
``hotspot areas'', the Federal Government has set up surge testing to 
increase baseline testing 2X-5X for short periods of time. Surge 
testing sites have been implemented in Miami, FL; Jacksonville, FL; 
Edinburg, TX; Uma County, AZ; Pima County, AZ; Coconino, AZ; Phoenix, 
AZ; Atlanta, GA; Birmingham, AL; Cochise County, AZ; Mohave County, AZ; 
Yavapai County, AZ; Baton Rouge, LA; New Orleans, LA; Bakersfield, CA; 
Houston, TX; Harris County, TX; Clark County, NV; and Honolulu, HI. 
These 19 sites have conducted approximately 290,000 tests. Surge 
testing is a supportive adjunctive activity; it cannot substitute for 
disciplined adherence to mitigation measures including masking, 
hygiene, avoidance of indoor crowded areas and crowds, and protection 
of the vulnerable. These mitigation techniques, when combined with 
selective surge testing--have proven highly effective to reverse recent 
community outbreaks.
    In order to support public health isolation and contact tracing, 
and to reduce turnaround time, the Federal Government has:
  --Provided massive surge testing to localities prioritized by the 
        White House Coronavirus Taskforce, and agreed to by State and 
        local officials;
  --Augmented testing, both baseline and surge, for federally Qualified 
        Health Centers (FQHCs) and retail sites, both fully federally 
        sponsored and federally enabled;
  --Supported local testing efforts with surge of collection supplies 
        and reagents;
  --Worked collaboratively to validate and promote EUAs for pooling 
        across all laboratory platforms;
  --Worked collaboratively to validate and promote EUAs for new 
        extraction methods to increase productivity;
  --Invested in new testing technologies that improve sensitivity, 
        specificity, and/or turnaround time, including new point-of-
        care tests, and;
  --Providing point-of-care testing to all nursing homes in America.
Diagnose COVID-19 Rapidly in Hospitalized Patients
    Because there are now treatments authorized for hospitalized 
patients with COVID-19, including Remdesivir, convalescent plasma, and 
steroids, it is critical to diagnose patients as soon as possible. 
Currently, large commercial labs are prioritizing inpatient samples to 
ensure diagnosis within 24-36 hours. Our best information also suggests 
that the great majority of individual hospitals are able to meet this 
timeframe for patients within their hospital systems.
Protect the Vulnerable
    Older Americans, particularly those in nursing homes, are much more 
likely to suffer serious consequences including death, from COVID-19. 
In addition to older Americans, racial and ethnic minorities are also 
disproportionately affected.
    To ensure that specimens are collected without overburdening the 
traditional healthcare system, and to ensure testing in the most 
vulnerable communities, in mid-March, the Federal Government 
established Community-Based Testing Sites (CBTS) in CDC-prioritized 
locations across the country. The CBTS model was developed for States, 
local public health agencies, healthcare systems, and commercial 
partners as they work together to stop the spread of COVID- 19 in their 
communities, focusing initially on healthcare facility workers and 
first responders.
    The CBTS federally supported, State managed, locally executed model 
has been a profound success, testing approximately 400,000 individuals. 
For the initial 41 sites, CBTS 1.0, the Federal Government provided a 
Federal physician who ordered all of the COVID-19 tests, the Federal 
contracts for shipping the specimens, laboratory processing, patient 
notification, and logistics (to include supplies, personal protective 
equipment, language translation services). The Federal Government also 
utilized U.S. Public Health Service personnel to provide data 
management, safety and quality control checks at each site.
    Building on the initial success of the CBTS model, the Federal 
Government next leveraged public-private partnerships with pharmacy and 
retail companies (CVS, Health Mart, Kroger, Rite Aid, Walgreens, and 
Walmart), also known as CBTS 2.0, to accelerate testing for more 
Americans in more communities across the country. The public-private 
partnership model operates on the federally supported, State managed 
model.
    As the transition of CBTS federally run sites to State-run sites 
has been completed, the Federal Government has broadened its community 
testing support to a more sustainable model--specifically by continued 
support of retail and pharmacy partnerships in more than 800 locations 
in all 50 States and the District of Columbia, which collectively have 
conducted over 2 million tests to date. The Federal Government focused 
on communities with high social vulnerability using the CDC's Social 
Vulnerability Index (SVI) as one of the main factors to select site 
locations. Approximately 65 percent are located in communities with 
moderate to high social vulnerability. The SVI measures the resilience 
of communities when confronted by external stressors along four main 
themes: socioeconomic status, household composition and disability, 
minority status, and housing type.
    This pharmacy and retail partnership provides convenient access to 
COVID-19 testing, but it is also a bridge for retailers to implement 
new regulatory flexibilities and expanded reimbursement options HHS has 
provided through private insurance, Medicare, and Medicaid. This 
partnership also leverages the newly expanded authority given to 
pharmacists to order and administer COVID-19 testing, this effort is 
also known as CBTS 3.0. Now, CVS and Walmart have over 1900 sites 
utilizing these new regulatory and reimbursement options with over 2 
million tests performed.
    Health Resources & Services Administration (HRSA) supported health 
centers are community-based and patient-directed organizations that 
deliver affordable, accessible, quality, and cost-effective primary 
healthcare to medically underserved communities and vulnerable 
populations across the United States. Nationwide, nearly 1,400 HRSA-
funded health center grantees operate approximately 13,000 sites, 
providing primary and preventive care to more than 28 million patients 
each year. Over 91 percent of health center patients are individuals or 
families living at or below 200 percent of the Federal Poverty 
Guidelines and nearly 63 percent are racial/ethnic minorities. Health 
centers are uniquely situated in communities to serve those that are 
most vulnerable and 97 percent of these centers offer COVID-19 testing. 
As of September 4, 2020, health centers have administered 3,690,098 
COVID-19 tests (including 215,231 antibody detection tests), with over 
49 percent of tests provided to racial and/or ethnic minority patients. 
Of these tests, 444,186 returned positive, with 59 percent of racial 
and/or ethnic minority patients testing positive.
    To prevent further spread and deaths in nursing homes, CDC and CMS 
recommended that nursing homes perform baseline testing of all 
residents and staff, followed by routine testing of staff to reduce 
outbreaks, morbidity, and mortality. CMS requires a regimen of staff 
testing based on the degree of community spread. To protect the 
vulnerable and to assist States in meeting these recommendations and 
requirements, on July 14, 2020, the Trump Administration announced that 
HHS would embark on a one-time procurement of rapid point-of-care 
testing instruments and tests to be distributed to nursing homes using 
the Defense Production Act.
    Through this aggressive action, nursing homes will be able to 
augment their current capacity for coronavirus testing, bolstering 
their response and helping to prevent the spread of SARS-CoV-2. This 
will facilitate baseline testing among nursing home residents and 
staff, and enable a pathway to conduct ongoing testing according to 
public health guidelines.
    I am pleased to announce that all 13,850 initially eligible nursing 
homes have received one or more point of care instruments, and nearly 5 
million tests. Following this initial distribution, we will facilitate 
nursing homes being able to reorder supplies via their normal 
commercial distribution channels.
    Vulnerable populations in many underserved communities are 
suffering disproportionate health impacts resulting from COVID-19, 
including number of infections, hospitalizations, and deaths. As part 
of the HHS response to this crisis, on June 23, the HHS Office of 
Minority Health (OMH) announced the selection of the Morehouse School 
of Medicine as the awardee for a new $40 million initiative to fight 
COVID-19 in racial and ethnic minority, rural and socially vulnerable 
communities.
    Morehouse School of Medicine has entered into a cooperative 
agreement with OMH to lead the initiative to coordinate a strategic 
network of national, State, territorial, tribal and local organizations 
to deliver COVID-19-related information to communities hardest hit by 
the pandemic. The three-year initiative will include the development 
and coordination of a strategic and structured network of national, 
State, territorial, and local public and community based organizations 
that will help mitigate the impact of COVID-19 on racial and ethnic 
minorities as well as rural and socially vulnerable communities across 
the Nation. The initiative also includes a national multi-media 
outreach and education effort. One of the primary goals of these 
information dissemination efforts is to provide additional education 
and community-level information on resources to help fight the pandemic 
to those who need it most.
Support Safe Reopening of Schools and Businesses
    While we must be prudent to protect those most vulnerable, we must 
also be mindful of the prolonged effects that school and business 
closures have on millions of children and parents. The efforts of the 
Federal Government to galvanize the testing infrastructure in the 
United States, and the efforts to reduce turnaround times, have 
provided communities with the resources they need to safely reopen 
schools and businesses.
Enable State Plans
    To enable States to achieve the testing goals developed in 
coordination with the Federal Government, the Federal Government has 
worked with manufacturers to gain insight into diagnostic instrument 
install bases; procured and shipped collection supplies; and determined 
reagent inventory. The Federal Government then provided all information 
to States so they could better determine how to optimize their testing 
strategy. The Federal Government also purchased and allocated POC 
devices and over 2.3 million tests; developed, implemented, and 
facilitated community-based testing sites across the country; and 
provided significant guidance and technical assistance for State plans. 
The increase in the numbers of tests performed since early March is a 
direct reflection of these efforts.
    States and territories have now submitted two iterations of their 
testing plans. These plans were developed in collaboration with Federal 
multidisciplinary experts through teleconferences and other meetings. 
Plans were reviewed by a multidisciplinary Federal team that included 
leadership from CDC, the Immediate Office of the Secretary, and the 
Office of the Assistant Secretary for Health.
    The first iteration of the jurisdictional testing plans for May and 
June were released to the public on July 10, 2020, and are available 
for viewing here. The Federal team provided feedback to each State, and 
each State incorporated this feedback into detailed plans covering July 
through December. The State plans for July-December have been reviewed 
and scored and were released to the public on August 10, and are 
available for viewing here.
    To ensure states meet their testing goals, the Federal Government 
procured FDA authorized swabs and transport media, and is distributing 
these supplies to a single location in each State determined by the 
Governor's office. Starting in May and through September 11, the 
Federal Government has distributed over 95 million swabs and more than 
77 million tubes of transport media.
    Moving forward, jurisdictions should use the $10.25 billion 
provided to States, territories, and localities by the Federal 
Government to support the purchase of tests and related supplies, 
personnel for contact tracing, and reporting infrastructure, etc., for 
their jurisdictions, as needed to fulfill their approved testing plans.
Other Initiatives
    In order to capture feedback and foster communication between 
Federal officials and the private sector, HHS created the National 
Testing Implementation Forum. The Forum brings together representatives 
from key stakeholder groups to share information and provide input to 
Federal leaders about SARS-CoV-2 testing. Members of the Forum provide 
their perspectives on how HHS can best identify and address end-to-end 
testing supply chain issues across commercial, public health, academic, 
and other sectors and define optimal testing in various settings 
(diagnostic, screening, surveillance, others). Members also provide 
input to improve technical assistance across the Nation to target 
testing among the vulnerable and underserved and create a sustainable 
diagnostics ecosystem that is sustainable and fully capable for future 
public health challenges. The first Forum meeting was held on July 30th 
and the principle topic of discussion was testing supply chain. On 
August 13th the second meeting was held and surveillance and reopening 
strategies were discussed. The third forum, with the topic of engaging 
minority and underserved communities, was held on September 3rd.
    On August 27th, the Administration announced that a $760 million 
contract was awarded to Abbott for the delivery of 150 million rapid 
BinaxNOW COVID-19 point of care tests. This initiative will expand 
strategic testing in the United States. The Abbott BinaxNOW COVID-19 Ag 
Card, which recently received an EUA from the FDA, does not require 
instrumentation and will deliver COVID-19 test results in 15 minutes or 
less. This test uses nasal swabs and can be easily deployed in many 
settings across the country.
United States Public Health Service Commissioned Corps
    Since the early stages of the COVID-19 outbreak, the Corps has been 
an indispensable asset leveraged to address the public health needs of 
the Nation in response to this crisis. The Corps is one of the eight 
uniformed services of the United States and the only uniformed service 
committed to protecting, promoting, and advancing the health and safety 
of the Nation. Corps officers serve throughout the Nation in 
communities that are most in need by providing essential healthcare 
services to underserved and vulnerable populations.
    In January, the Corps deployed officers to provide expert outbreak 
response in direct support of CDC. Deployment expanded rapidly from 53 
officers on January 24, 2020 to 4,170 officers deployed as of September 
8th, with many officers being deployed numerous times. Corps officers 
provided critical assistance to community-based testing sites 
throughout the Nation and their contributions to this effort are 
immeasurable. In response to the escalating crisis, the Corps 
established COVID-19 Clinical Strike Teams, which include officers from 
the variety of disciplines needed on the frontlines. This kind of 
ready-made unit allows the Corps to deploy a ``cavalry'' to support 
healthcare systems under stress in States across the country. COVID-19 
Clinical Strike Teams have deployed to a long-term care facility in 
Kirkland, Washington, to the Javits Center in New York City, and to the 
TCF Center in Detroit. At the end of March, the Navajo Nation requested 
CDC assistance to provide care amidst a surge of COVID-19 cases. Since 
that time, the Corps has deployed teams to support the response.
    The United States Public Health Service Commissioned Corps stands 
ready and willing to respond to the public health needs of our country 
and to provide essential healthcare services.
             assistant secretary for preparedness 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 domestic health components of a 
response.
    For the current COVID-19 domestic response, ASPR funding has been 
used to accelerate development of medical countermeasures, 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, 
provide grants to hospital associations and healthcare centers to aid 
in the ongoing response, and provide support via the National Disaster 
Medical System (NDMS) to augment care in communities significantly 
impact by COVID-19.
    It is important to note that while the COVID-19 response remains 
the primary mission and duty at ASPR today, there are other existing 
requirements the organization has supported throughout 2020. Throughout 
2020, ASPR has assisted in the repatriation of Americans from China and 
Japan at the start of the COVID-19 outbreak. We deployed personnel to 
Lebanon in August to assist with response and recovery efforts 
following the explosion in the Port of Beirut. ASPR provided temporary 
medical surge support in Louisiana, Texas and Mississippi after 
Hurricane Laura, and we still have National Disaster Medical System 
(NDMS) teams deployed to Louisiana to assist with recovery efforts 
following Tropical Storm Sally. In addition, ASPR deployed personnel to 
California and Oregon to support search and rescue efforts for the 
wildfires. We supported these calls for action and support while 
simultaneously responding to domestic requests for assistance to aid in 
the COVID-19 response. . ASPR is a unique and nimble organization and 
has been able to respond to emerging needs throughout the COVID-19 
response.
               medical countermeasure development efforts
    Since late January, the Biomedical Advanced Research and 
Development Authority (BARDA) within ASPR 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 in the Democratic Republic of the 
Congo, as well as the Zika outbreak in 2015.
    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.
    To date, utilizing the supplemental funding provided by this 
Committee, ASPR/BARDA is supporting over 50 medical countermeasure 
projects for COVID-19 response. All of these contract awards are listed 
on medicalcountermeasures.gov in detail and include: nine therapeutics, 
29 diagnostics, and seven vaccine candidates. Six vaccine candidates 
are operating under Operation Warp Speed (OWS). In support of securing 
a safe and effective vaccine as quickly as possible to protect the 
American people and return to normal operations, we are making 
significant progress in advancing these vaccines. In fact, three--
AstraZeneca, Moderna, and Pfizer--are in Phase 3 meaning that we are 
closer than ever before in having a safe and effective COVID-19 vaccine 
available to the public. The remaining three--Novavax, Sanofi Pasteur/
GSK, and Janssen are in Phase 1/2.
    It is important to note that we are strictly adhering to and 
following all regulatory and safety requirements to support 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: vaccine development and vaccine manufacturing. Supporting 
these efforts simultaneously ensures 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. Specifically, the recent awards to 
Pfizer, Novavax, AstraZeneca, Moderna, and Sanofi Pasteur/GSK all 
include product development and investments in large-scale 
manufacturing capabilities in the contract award.
    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, in June, BARDA reserved existing 
vaccine manufacturing capacity as well as expanded manufacturing 
capacity at the Texas A&M CIADMThrough OWS, manufacturing capacity at 
the Department of Defense's (DoD) Advanced Development and 
Manufacturing facility, 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.
    Lastly, ASPR/BARDA is supporting efforts to expand capacity for 
fill-finish to ensure that, once we have an approved vaccine, we can 
begin manufacturing without having to wait for ancillary products (e.g. 
(vials, needles, and syringes). Contracts include: capacity expansion 
for needles and syringes (contracts with Smiths Medical, Inc., 
Retractable Technologies, Inc., and Becton, Dickinson, and Company); 
capacity expansion for glass tubing and vials/cartridges (Corning 
Pharmaceutical Technologies); expansion of sterile injectable capacity 
(Thermo Fisher Scientific); establishment of manufacturing systems for 
durable, high-performance glass/plastic vials (Si02); and, general 
capacity expansion and reservations for fill/finish (Grand River 
Aseptic Manufacturing, Inc.).
              resupply of the strategic national stockpile
    ASPR, through the Strategic National Stockpile (SNS) maintains a 
national repository of large quantities of medical countermeasures for 
a variety of threats (chemical, biological, radiological, and nuclear 
(CBRN) threats as well as general public health responses) stored in 
strategic locations around the nation. While SNS assets can be deployed 
for CBRN incidents, the SNS is also poised to provide assets to support 
response operations to large-scale public health emergencies, such as 
those caused by hurricanes, disease outbreaks, or other natural 
disasters..
    Specific to the current COVID-19 response, as of August 18, 2020, 
and in coordination with interagency partners including the Department 
of Defense and the Department of Homeland Security, the SNS has 
provided more than 18.5 thousand tons of personal protective equipment 
(PPE) and other medical material to support States to aid in medical 
response as well as the Federal repatriation effort to bring American 
citizens back from abroad. This deployment of PPE encompassed 
approximately 90 percent of the total SNS PPE inventory available at 
the beginning of the COVID-19 pandemic. In addition to PPE, the SNS 
deployed ventilators and Federal Medical Stations (FMS) to support the 
response.
    To respond and prepare for COVID-19, as well as prepare for any new 
and emerging public health threat, ASPR/SNS is working to implement SNS 
2.0. This initiative has three main objectives:
  --Ensure the SNS has the breadth and depth to meet any future 
        pandemic or public health emergency;
  --Bolster the U.S. industrial base for critical pharmaceuticals and 
        medical supplies; and,
  --Reduce America's vulnerabilities and reliance on foreign suppliers 
        and manufacturers.
    Under the first initiative, current planning is underway to achieve 
a capacity to meet 90 days of need by this fall, which will require a 
combination of actions to increase the supply of PPE and other critical 
items in the SNS, in the commercial supply chain, and at the point of 
use (such as hospitals). Since the start of the pandemic, orders have 
been placed for approximately 800 million N95 respirators and face 
masks for delivery to the SNS. The SNS currently holds approximately 80 
million N95 respirators and face masks within the overall stockpile. 
The SNS is currently on track to have 10 times more masks on hand by 
the fall of 2020 than were available prior to the start of the COVID-19 
pandemic. Additionally, the SNS has received more than 125,000 new 
ventilators from COVID-19-related contracts awarded in the spring. The 
SNS currently has more than 130,000 ventilators on hand for deployment, 
which is more than seven times the quantity held in pre-COVID-19 
pandemic inventory. The SNS has also began procuring necessary testing 
supplies, including test kits, swabs, and viral transport media, to 
ensure that Americans have access to the most advanced and robust 
COVID-19 tests in the world. The SNS inventory is projected to include 
44 million swabs and 65.5 million viral transport media by the end of 
2020.
    To support a number of these contracts, HHS has leveraged and 
utilized actions under the Defense Production Act (DPA). Title I of the 
DPA allows the President, among other authorities, to require 
businesses and corporations to prioritize and accept government 
contracts for materials and services. HHS has exercised Title I DPA 
authorities using the Health Resource Priority and Allocations System 
(HRPAS) in order to prioritize contract action to compel a direct 
response to the place of greatest need. A number of health resource 
materials have been identified that are essential to respond to the 
COVID-19 pandemic; however, these items, like PPE and ventilators, are 
in high demand. A priority rating has at times proved necessary to 
provide the requested quantities and qualities of these health 
resources within a specified time period or delivery date. These rated 
orders are filled first when there are both commercial demands and 
government demands for the same product, or component(s) of a product. 
Utilizing this authority has enhanced national preparedness and is 
helping ensure there is product available if and when it is needed.
    Under the second initiative, ASPR/SNS is working with DoD to expand 
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 the U.S. Government's efforts to expand domestic 
production capacity of medical supplies during the COVID-19 pandemic. 
Using CARES Act funding, the SNS has funded a number of projects 
including:
  --Melt blown fiber (MBF)--to date the SNS has expanded the domestic 
        manufacturing capacity to produce MBF, a critical component in 
        N95 and surgical mask production.
  --Increased domestic production capacity for surgical masks--to date 
        the SNS has supported contracts 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 
        the supported contracts to increase annual domestic production 
        capacity of nitrile gloves by 450 million starting July 2020, 
        to be completed by July 2021.
  --Increased domestic production capacity for testing swabs--to date 
        the SNS has supported an increase domestic production capacity 
        for swabs
  --Increased domestic production capacity for rapid point-of-care test 
        kits--to date the SNS has supported an increase in annual 
        domestic production capacity of COVID-19 test kits by 8 million 
        a month by February 2021.
    Lastly, to support efforts under the third initiative, ASPR is 
working in partnership with the HHS Food and Drug Administration (FDA) 
to understand and identify, as early as possible, supply chain issues. 
Much of our supplies and medical materiel come from international 
partners. We must, and will, continually evaluate and understand these 
dependencies to best inform acquisitions and planned procurements.
                preparing the nation's healthcare system
    ASPR's Hospital Preparedness Program (HPP) strengthens healthcare 
sector readiness to provide coordinated, life-saving care in the face 
of emergencies and disasters. As the only source of Federal funding for 
healthcare system preparedness and response, HPP promotes a consistent 
national focus to improve patient outcomes during emergencies and 
disasters and enables rapid recovery.
    HPP was established after the September 11, 2001, terrorist 
attacks, with the goal of improving the capacity of local hospitals 
across the country to deal with disasters and a large influx of 
patients in an emergency. Prior to COVID-19, HPP's annual appropriation 
supported: the annual cooperative agreement program to 62 State, local, 
and territorial health department recipients to support healthcare 
coalitions; the Regional Disaster Health Response System (RDHRS); the 
National Emerging Special Pathogens Training and Education Center 
(NETEC); and ten Regional Ebola and Other Special Pathogen Treatment 
Centers (RESPTCs).
    In response to COVID-19, HPP has awarded additional funds COVID-19 
supplemental funding to support National Special Pathogen System 
(NSPS), building upon many of HPP's core programs and activities. Funds 
were distributed to support the traditional HPP recipients, the 10 
RESPTC recipients, the NETEC, and a new funding mechanism to directly 
support hospitals and other healthcare facilities through 53 hospital 
associations. The NSPS supports a coordinated national approach to 
preparing for public health and medical emergencies so that the U.S. 
has a tiered, capable system that coordinates national expertise, 
regional capabilities, and State and sub-State healthcare capacity 
across the public and private sectors in order to drive an effective 
and safe pandemic response. The NSPS will continue to deploy and 
enhance capabilities to address continued surge events during the 
current pandemic--as well as prepare to address potential future 
special pathogens.
    Additional supplemental funding was awarded by HPP to support 
efforts to secure the Nation's blood supply through a partnership with 
the American Red Cross. Through this effort, we will be better able to 
maintain blood operations, enabling hospitals and other healthcare 
entities to meet demand for blood and avoid shortages of this 
lifesaving medical resource. Lastly, HPP is also supporting a 
collaborative effort with DoD to establish a National Emergency Tele-
Critical Care Network (NETCCN) to support expanded telehealth 
capabilities nationally. The NETCCN is comprised of a cloud-based, low-
resource, stand-alone health information management system for the 
creation and coordination of flexible and extendable ``virtual critical 
care wards.'' These wards bring high-quality critical care capability 
to nearly every bedside, whether in a healthcare facility, or in an 
alternate care site such as a field hospital, or in a gymnasium--
enabling critical care anywhere.
                  aspr's support for covid-19 response
    While we await a vaccine, ASPR has supported other efforts to help 
mitigate the transmission of the virus when and where possible. 
Beginning in March 2020, ASPR initiated the production and distribution 
of more than 500 million cloth face masks across the country. Many of 
these face masks were provided to long term care and dialysis 
facilities to help protect some of the most vulnerable in our 
communities. And, more recently, we are sending 125 million cloth face 
masks to States and territories for distribution to schools.
    ASPR also works to enhance medical surge capacity by organizing, 
training, equipping, and deploying Federal public health and medical 
personnel, such as National Disaster Medical System (NDMS) teams, and 
providing logistical support for Federal responses to public health 
emergencies. NDMS was originally created during the Cold War to take 
care of military casualties from overseas in U.S. civilian hospitals.
    At the start of the COVID-19 outbreak in January and February, 
2020, NDMS teams were deployed to strategic locations across the 
country to care for U.S. citizens evacuated from Japan who may have 
been exposed to SARS-CoV-2, effectively providing medical care and 
limiting the potential spread of the disease. Overall, HHS deployed 
over 600 Public Health Service Commission Corps Officers and NDMS 
personnel to support this repatriation effort. In addition, HHS 
provided cache equipment, (e.g., medical supplies and resources) to the 
repatriation sites to aid in the medical needs and care of returning 
Americans.
    As the response shifted and cases increased domestically, NDMS 
teams have been deployed, when requested by a State, to provide 
augmented care. Specifically, NDMS has supported hospital augmentation 
(such duties include: emergency room support, hospital decompression, 
setting up medical overflow centers for patients, and mortuary 
support). As of September 10, 2020, ASPR has supported approximately 
3200 NDMS deployments of medical, mortuary, and veterinarian 
specialists to various missions across the country to 18 different 
States. With the aid of NDMS personnel and resources, communities have 
been able to continue to provide care to those in need of medical 
assistance and treatment. NDMS will continue to support such requests, 
and we appreciate the funding this Committee has provided to date to 
support these efforts.
                               conclusion
    On behalf of all the witnesses, we thank you again for your 
support. Whether supporting hurricanes, floods, influenza outbreaks, 
and other infectious disease outbreaks 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.
    Your partnership and support enable our mission accomplishment. We 
would be happy to answer any additional questions you may have.

    Senator Blunt. Well, thank you, Dr. Redfield.
    So we are going to have a series of 5-minute rounds of 
questions. There are a dozen members either here or virtually 
here ready to ask questions. There will be an 11:30 vote that 
we will just kind of work around those votes that come at 
11:30, and certainly, we would hope to have an opportunity for 
a second round of questions if people have them after their 
first round is gone.

                                TESTING

    Let me start, Admiral Giroir, with you. On tests, I think 
tests are essential to get back to school, back to work, and 
for tests to really work, they have to be easily taken. There 
needs to be a quick response, and they need to be affordable. 
It seems to me that with the Shark Tank effort that members of 
this committee, particularly Senator Alexander and I, were 
involved in trying to encourage looking at ideas that are out 
there, I think the Shark Tank has approved at least 16 
different tests now. In your testimony, you mentioned that a 
significant number of these tests were point-of-care response 
tests.
    What should we expect in October or this month? I have been 
told in October, we could reach 100 million tests between the 
Shark Tank and Abbott alone. Is that a number that you think is 
close to right?
    Admiral Giroir. Yes, sir. And thank you for the question, 
and thank you for the support of the Shark Tank and all of the 
NIH efforts. We have seen just a tremendous blending of 
programs at DARPA (Defense Advanced Research Projects Agency), 
at NIH, at CDC, at BARDA and my office with the Defense 
Production Act, all coming together, and we do meet every week 
to put these together in a very cogent, synergistic way.
    Yes. In October--and again, these are conservative 
estimates based on what we know has EUAs and what we know the 
manufacturing will be. In October, we are looking at somewhere 
in the neighborhood of 125 million to 135 million tests 
available. That does not mean that 125 million to 135 million 
tests will be done, but these will be easily and readily 
available. And the majority of them--we really hit that 
inflection point--will be point-of-care.
    Senator Blunt. Good.
    Admiral Giroir. Many of them will be the Binax that we 
talked about. That will be made at approximately 48 million to 
50 million per month, again a $5 test, 15-minute result, no 
instrument. Very, very important. But we are starting to see 
the point of tests coming from the RADx program, the Shark 
Tank, really hitting the street. So the next generation 
sequencing, the microfluidics platforms like Fluidigm and some 
advance point-of-care are all starting to hit from Shark Tank.
    Senator Blunt. And I think you said in your testimony that 
sometime this month we will have passed the first 100 million 
tests that people have taken. Is that right?
    Admiral Giroir. Yes, sir. Today's total as of about 5 
o'clock this morning was 99.3 million tests having been 
performed in the U.S. Those are viral tests, not serological 
tests.
    Senator Blunt. And starting the first of the year, 
sometime--this is from the outbreak of the COVID-19. Right?
    Admiral Giroir. Right. I mean, when I took over on March 
12, I think there were 15,000 or 20,000 tests done. It was a 
very small number. So this has ramped in a historic way not 
just in number. Numbers are important, but it is the ecosystem, 
the point-of-care, the laboratory. These all have to fit 
together in a----
    Senator Blunt. I think I am right in assuming--but the 
three of you would know this better than anybody--if you take a 
test and you do not get a result for 3 days or 5 days or 7 
days, you find out a data point and you find out for that 
individual the problem they have, but you have generally done 
nothing to tell them that they could be spreading this disease. 
Is that correct?
    Admiral Giroir. Clearly we want tests to be turned around 
as rapidly as possible, and that is why point-of-care is so 
important. The issue with most point-of-care tests is they are 
not as, quote, good, sensitive, and specific as the very 
important laboratory tests. Now everybody is making progress.
    But you are right. We want rapid turnarounds. And because 
we have more point-of-care tests and because we are doing more 
in the nursing homes that way, for the major referral labs that 
had such an issue with turnaround times, our average turnaround 
time for Quest, Labcorp, et cetera, this month is 1.49 days. So 
that has been improved dramatically because of expansion of 
their capability but also the insertion of point-of-care tests.
    Senator Blunt. But again, that is the average. That 
averages out the point-of-care plus the tests that averages all 
this down to 1.----
    Admiral Giroir. No, sir. That is just the referral 
laboratories, Quest, Labcorp----
    Senator Blunt. Got it.
    Admiral Giroir. The other half of testing is either point-
of-care at your local hospital, which is generally either 15 
minutes or within 24 hours. So the turnaround time, at least 
right now with all the investments coming together, is under 
control.
    Senator Blunt. I think our sense--many of the members on 
this committee--certainly my sense of testing has been we want 
a test that millions of people can take, maybe dozens of times 
and get the information at the time they take the test. And it 
sounds like to me that we are finally getting to where that is 
a realistic likelihood. All right.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman.

                         POLITICAL INTERFERENCE

    And let me just say again I am deeply troubled by reports 
of rampant political interference in scientific decisionmaking 
at the CDC. It is unprecedented and it is unacceptable. We 
learned last week that despite knowing in January how serious 
COVID-19 was, President Trump has been working to downplay this 
crisis. And on Friday night, we learned that Trump political 
operatives in HHS's Communications Office have been 
manipulating CDC's flagship publication for months to align 
with that messaging.
    Dr. Redfield, did anyone at CDC advise the President to 
downplay this crisis?
    Dr. Redfield. No.
    Senator Murray. Did you agree with the President's decision 
to downplay it?
    Dr. Redfield. I am not going to comment on that, but no one 
advised the President to downplay this crisis.
    Senator Murray. Well, understanding the dangers, why have 
you not done more to push back on President Trump's political 
interference and its efforts to downplay this?
    Dr. Redfield. I want to make it really clear, Senator--and 
I appreciate your question and the opportunity--about the 
respect for the science at CDC and the independent integrity of 
the MMWR (Morbidity and Mortality Weekly Report). At no time 
has the scientific integrity of the MMWR been compromised, and 
I can say that under my watch, it will not be compromised.
    Senator Murray. Well, I understand the efforts to edit the 
CDC publication started in response to a May report that 
reviewed the spread of COVID-19 in the U.S. It was authored by 
CDC highly respected career deputy, Dr. Schuchat. HHS political 
officials perceived this report as reflecting negatively on the 
President.
    Dr. Redfield, yes or no. Did that May report, as drafted by 
Dr. Schuchat, adhere to the agency's strict code of scientific 
integrity?
    Dr. Redfield. Yes.
    Senator Murray. Well, the spokesperson for HHS claimed that 
there is a resistance unit at CDC and voiced concerns about 
ulterior deep state motives, and President Trump has bolstered 
skepticism in the agency's death toll. Do you agree with me 
that there is no truth to all those claims?
    Dr. Redfield. Absolutely, Senator. And I want to make a 
comment that not only is not true, it deeply saddened me when I 
read those comments because, as I said in my statement, CDC is 
made up of thousands of dedicated men and women highly 
competent--it is the premier public health agency in the 
world--dedicated 24/7 to use their skills to protect the 
American public and the world from the health issues. And it 
deeply saddened me that those false accusations were made by a 
group of really unbelievably professional people that serve 
this Nation.
    Senator Murray. Well, I agree.
    Let me ask you then, what can Congress do to make sure we 
are hearing directly from public health officials without 
political interference?
    Dr. Redfield. Well, again, I am willing to commit that we 
are going to continue to give Congress and the Nation the best 
public health advice. We are not going to let political 
influence try to modulate that.
    As I mentioned, the MMWR--and it is another thing that has 
saddened me to hear on our watch the concern that somehow--some 
have that the integrity of this really important publication 
was somehow compromised. And I just want to assure you and the 
other Senators and the American public that the scientific 
integrity of the MMWR has not been compromised. It will not be 
compromised on my watch. And I will stand by the men and women 
that are the scientific experts that are there to do their job, 
to express what they know in a way that can be interpreted to 
the American public.
    Senator Murray. Well, I hear you, but I do think Congress 
needs to make clear that there is no political interference 
there. I will be pursuing that.

                          SCIENTIFIC INTEGRITY

    Admiral Giroir, on the same issue, you are among HHS's top 
health officials. What are you doing to protect scientific 
integrity of the work done by the scientists and public health 
experts at CDC, HRSA, and NIH from political interference?
    Admiral Giroir. Part of my job as the senior scientific 
advisor to the Secretary is to make sure that he gets the best 
science and the best evidence base that is unfiltered. I do 
that every single day. I work with Bob Redfield. I work with 
Bob Kadlec. Francis Collins and I are on speed dials; Tom 
Engels, very, very important with HRSA. So you have my 
commitment, as you always have, Senator, that I will provide 
the best advice to the decision-makers that will be based on 
science and evidence, and that is the way we are going to 
operate going forward.
    Senator Murray. But can you right now reject the unfounded, 
harmful conspiracy theory that career professional leadership 
of CDC or any of our public health agencies have, quote, deep 
state ulterior motives that compromise their ability to act in 
the best interest of public health, as other Trump political 
appointees have claimed? Can you reject that? Yes or no.
    Admiral Giroir. I have not seen anything out of CDC, HRSA, 
any of the agencies I work with that is anything but people 
acting in the best interest of the American people. I have 
certainly not seen anything that you described.
    Senator Blunt. Thank you, Senator Murray.
    Senator Alexander.
    Senator Alexander. Thank you, Mr. Chairman. And thanks to 
the witnesses for coming.

                    PREPARING FOR THE NEXT PANDEMIC

    This committee has shown on many occasions a good capacity 
to work in a bipartisan way. So I would like to say something 
to my Democratic friends, as well as my Republican colleagues, 
on a subject that I think we agree on, but the Congress has had 
a hard time doing over the last 20 years, and that is preparing 
for the next pandemic.
    I have been re-reading Jared Diamond's book, ``Guns, Germs, 
and Steel.'' And he wrote an article in the ``Wall Street 
Journal'' a few months ago about the current infectious 
disease. He said the most different thing about COVID-19 is not 
that it is more infectious, but the jet plane is what is 
different about this disease, that it can spread instantly from 
Wuhan to San Francisco to Nashville to Boston, and that the 
next pandemic could be next year.
    So we had a hearing about preparing for the next pandemic, 
and people like Bill Frist, who was majority leader 20 years 
ago, said we keep trying to do things to prepare for the next 
pandemic, but we go, in Dr. Tom Frieden's words, from panic to 
neglect to panic. In other words, while we are in the middle of 
a pandemic, it has got our attention, but as soon as it is 
over, we do not do all the things that we should do.
    So my hope is that with any action that we take this year, 
we would include the three or four things that we should take 
to make sure that we sustain funding, which is the hardest 
thing to do. How do you fund for more than 1 year for onshore 
manufacturing of vaccines, for example, or stockpiles that were 
depleted between pandemics to making sure that FEMA (Federal 
Emergency Management Agency) and Dr. Kadlec's organization are 
aligned properly and operating together? Dr. Redfield has 
talked about and Mike Leavitt to our committee, the former 
Governor of Utah, that we have been underfunding public health 
for 30 or 40 years. I think it is important we do it this year.
    And so in the Republican bill that we offered last week, we 
did have in there some authorization from our committee to fund 
onshore manufacturing and continuous funding of stockpiles, so 
they would be full. And I would just like for our committee to 
give that the same kind of attention in the subcommittee that 
we gave, for example, to funding for NIH because it will take 
some sort of mandatory funding or advance appropriation as this 
committee did under Senator Gregg a few years ago for 
Bioshield. It is not a lot of money. I think what we suggested 
was a half billion dollars a year for 10 years for onshore 
manufacturing.
    Why is that important? In 2012, we created three 
manufacturing plants just for this purpose, but two of them, in 
Governor Leavitt's words, went cold. They were not available 
instantly to do what we needed done. And the third one had a 
hard time finding anything to do between pandemics. So we need 
some funding for it.
    And then for the stockpile, stockpiles got depleted at the 
Federal level, in hospitals, and States because of budget cuts. 
And so we were not ready for what we needed to be ready for.
    And then public health funding is a separate one. Bioshield 
is another one.
    So I think we are not talking about lots of money. What we 
are talking about is different is sustained funding for a 
period of years.
    Now, Dr. Kadlec, I have taken most of my time, but would 
you comment on that? And precisely in the ideal world, what 
should we do now to prepare for the next pandemic, which Jared 
Diamond says might be next year?
    Dr. Kadlec. Well, thank you very much, Senator Alexander. 
And I agree entirely with your proposition that we do need to 
make investments over the long term, that we need to look at 
this problem as a national security problem as it is a public 
health problem.
    We lose on a day----
    Senator Alexander. Yes, but what are the specific things. 
We have got about 30 seconds.
    Dr. Kadlec. Sir, manufacturing, domestic manufacturing, for 
biologics and vaccines. We also basically need to have a 
capacity to basically manage those stockpiles effectively 
through both commercial and State-level processes. And we need 
to probably require hospitals and other healthcare institutions 
to have some baseline level of preparedness and stockpile.
    Senator Alexander. So we need to keep the stockpiles full. 
Are we talking about a lot of money?
    Dr. Kadlec. No, sir. I think in your bill you have 
identified about $2 billion. I think that is where you start. 
And then again, most of these items are common used anyway 
daily in hospital use and healthcare use, and just maintaining 
that stockpile over time. But it does require a business model 
to support that.
    Senator Alexander. Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Alexander.
    Senator Durbin.
    Senator Durbin. Thanks, Mr. Chairman.

                             VACCINE TIMING

    Dr. Kadlec, last night the President of the United States 
said--and I quote--we are within weeks of getting a vaccine. 
Could be 3 weeks, 4 weeks. True or false?
    Dr. Kadlec. Sir, it is possible. And so with Operation Warp 
Speed, we have basically worked to basically do simultaneously 
the clinical trials as well as doing the manufacturing of 
vaccines. So if and when, whether that is 2 weeks, 3 weeks, 2 
months, or 4 months, once a clinical trial is complete and that 
scientific data is reviewed by the FDA and approved, then we 
have vaccine potentially available immediately to use. And that 
is the strategy that has been adopted in Operation Warp Speed, 
sir.
    Senator Durbin. So I want to make sure this is on the 
record.
    Dr. Kadlec. Yes, sir.
    Senator Durbin. You are saying 3 weeks to 4 weeks for a 
vaccine?
    Dr. Kadlec. Sir, that is manufactured. Yes, sir. Now, is it 
approved by the FDA? That is a decision that they will have to 
do based on the scientific data that they receive from the 
clinical trials.
    Senator Durbin. So what you are saying to me is they could 
manufacture it, but before it is approved as being safe and 
effective for distribution in America is going to be beyond 3 
or 4 weeks.
    Dr. Kadlec. Sir, it depends on the outcomes of those 
clinical trials. And so I cannot predict that. They are ongoing 
right now, some of them complete in October, and the FDA is the 
one who will make the decision to determine safety and 
efficacy, sir.
    Senator Durbin. The President predicted it last night.
    We have about 4.5 percent of the world's population in the 
United States. We have more than 20 percent of the deaths from 
COVID-19. Last night, the President said, we have 20 percent of 
the cases in the world because of the fact that we do much more 
testing. If we would not do testing, you would not have cases. 
You would have very few cases.
    So let me ask Admiral Giroir, would ending testing end the 
spread of the COVID-19 disease?
    Admiral Giroir. No, sir.
    Senator Durbin. Could you explain the President's 
explanation last night? Does it make any sense to you?
    Admiral Giroir. I did not hear----
    Senator Durbin. Oh, we have heard this over and over again. 
Come on. He is repeating what he said over and over again.
    Admiral Giroir. So let me just clarify that the number of 
cases are going to be the number of cases. We do more testing 
so we could detect more and more cases. That is a good thing. 
We want to detect as many cases as we can so that they can be 
appropriately isolated, do contact tracing, et cetera.
    It is true that the more testing you do, the more cases you 
will discover, but the cases are there no matter what.

                           EXPANDING TESTING

    Senator Durbin. Now, you talked in your testimony here 
about expanding testing. And I could not endorse that more 
heartily. The President says just the opposite. If we would not 
do testing, you would not have cases. I mean, do we not want to 
create the mindset in America that regular testing to make sure 
that we are not positive and not spreading this disease should 
be routine until we come to grips with a therapy or vaccine to 
deal with this?
    Admiral Giroir. So I do want to state what I did state 
earlier in multiple testimonies. I have never been asked, told, 
hinted, suggested that we should decrease testing. In fact, 
basically every time at the task force, we work to expand 
testing to the degree possible, investing hundreds, billions of 
dollars in that. So my job is to expand testing as much as 
feasibly, even infeasibly, possible and get the right tests to 
the right people at the right time. And that has been my 
mission. No one has told me to alter that.

                    AFFORDABLE CARE ACT REPLACEMENT

    Senator Durbin. In July of 2017, the United States Senate 
considered the repealing of the Affordable Care Act on the 
floor of the Senate. I will remember that morning, that night 
forever. A few feet away from me the late Senator John McCain 
cast a no vote, and the Affordable Care Act survived.
    The President has said repeatedly that he has a replacement 
plan for the Affordable Care Act. As head of the agencies 
responsible for dealing with such a public health undertaking, 
I would like to ask you, does a replacement plan exist that you 
are aware of? Any of you? Yes or no. Admiral?
    Admiral Giroir. I am not involved in the replacement plan. 
I do not know what that is. I supply public health advice as 
much as I can for whatever that plan would be----
    Senator Durbin. Dr. Kadlec, are you aware of such a 
replacement plan?
    Dr. Kadlec. Sir, it is not in my portfolio, and sir, 
honestly I have been so busy with the other things. I have no 
awareness of that.
    Senator Durbin. Dr. Redfield, are you aware of a 
replacement plan?
    Dr. Redfield. Again, it is really not in my main lane, but 
I am not aware of one.

                             VACCINE SAFETY

    Senator Durbin. Just a few weeks ago, the nine major 
pharmaceutical companies had full-page ads saying they would 
not bow to political pressure to rush vaccine production. Were 
any of you consulted before they made the decision to buy that 
ad across the United States?
    Dr. Kadlec. Sir, not consulted, but aware of it. And it 
conforms with I think the feelings and the commitments that the 
leadership in Warp Speed and in my organization are committed 
to as well.
    Senator Durbin. Do you know why they did it?
    Dr. Kadlec. Sir, I think to the point of being sure that 
everyone is believing in the same way, which is a safe and 
efficacious vaccine, has to be trusted.
    Senator Durbin. Thank you.
    Senator Blunt. Thank you, Senator Durbin.
    Senator Capito.
    While we are trying to figure out how we get Senator Capito 
for her questions, Senator Kennedy why do you not go ahead with 
yours and then we will go to Senator Reed after Senator Kennedy 
and see if Senator Capito is ready. Senator Kennedy.
    Senator Kennedy. Thank you, Mr. Chairman.
    Thank you, gentlemen, for being here today.
    You are all M.D.s, medical doctors. Is that correct?
    Dr. Kadlec. Yes.
    Admiral Giroir. Yes, sir.
    Senator Kennedy. Would any of you do anything to violate 
your Hippocratic oath?
    Admiral Giroir. Never.
    Dr. Kadlec. No, sir.
    Senator Kennedy. Have any of you, as Senator Murray 
alleged, recklessly interfered with the treatment or prevention 
of COVID-19?
    Admiral Giroir. No.
    Dr. Kadlec. No, sir.
    Dr. Redfield. No.
    Senator Kennedy. Do you know of anyone who has in the Trump 
administration?
    Admiral Giroir. No.
    Dr. Kadlec. No, sir.
    Dr. Redfield. No.
    Senator Kennedy. Okay.
    Dr. Redfield, have you ever had polio?
    Dr. Redfield. No, sir.
    Senator Kennedy. Me neither. Thank you, science.
    When the coronavirus was first discovered, we did not have 
much science about it. Did we?
    Dr. Redfield. No, sir.
    Senator Kennedy. You could not go to like WebM.D. and look 
it up. Could you?
    Dr. Redfield. No, sir.
    Senator Kennedy. We have learned a lot about it. Have we 
not?
    Dr. Redfield. Yes, sir.

                            COVID-19 SPREAD

    Senator Kennedy. Would it be fair to say--and disagree with 
me--if you do, I know you will--that the coronavirus is a lot 
more contagious than we originally thought. Is that fair?
    Dr. Redfield. Yes, sir.
    Senator Kennedy. Now, I read on the CDC site--tell me if I 
misinterpret this--that out of every 1,000 people who get 
coronavirus, not out of every 1,000 people but out of every 
1,000 people who get the virus, 6 are going to die. Is that 
accurate?
    Dr. Redfield. It depends on age group and risk factors, 
sir. So if you were to look right now, individuals under the 
age of 18, it is about .01 percent. 19 to, say, 69, it is more 
like .3 percent. And if you are over the age of 70, it is about 
5 percent now.
    Senator Kennedy. But if you look at population as a whole, 
it is about 6 out 1,000. Is that correct?
    Dr. Redfield. I would have to get back to you. Overall, we 
are probably looking at an overall mortality in the range of 
somewhere between .4 and .6 percent----
    Senator Kennedy. Right. That would be 6 out of 1,000. That 
is on the high end. Obviously, the older you get, the more at 
risk you are.

                             VACCINE TIMING

    Tell me when you think we will have a vaccine, as best you 
can, ready to administer to the public, Dr. Redfield.
    Dr. Redfield. Well, I think as Dr. Kadlec said, I think 
there will be vaccine that initially will be available sometime 
between November and December but very limited supply and will 
have to be prioritized. If you are asking me when is it going 
to be generally available to the American public so we can 
begin to take advantage of vaccine to get back to our regular 
life, I think we are probably looking at late second quarter, 
third quarter 2021.
    Senator Kennedy. And so you think by the late second or 
third quarter, we will have started to vaccinate people?
    Dr. Redfield. I think the vaccination will begin in 
November-December, and then we will pick, you know, and it will 
be in a prioritized way, those first responders and those at 
greatest risk for death. And then eventually that will expand. 
You know, there is about--it is hard to believe, but there are 
about 80 million people in our country that have significant 
comorbidities that put themselves at risk.
    Senator Kennedy. Right.
    Dr. Redfield. They have to get vaccinated, and then the 
general public.

                          OPERATION WARP SPEED

    Senator Kennedy. But I am about to run out of time.
    And what do you call this effort, this worldwide effort led 
by the United States of America to develop a vaccine? What is 
the term for it?
    Dr. Redfield. Operation Warp Speed, sir.
    Senator Kennedy. Have you ever seen anything like Operation 
Warp Speed?
    Dr. Redfield. It is unprecedented.
    Senator Kennedy. How long does it usually take--this will 
be my last question, Mr. Chairman--to develop a vaccine?
    Dr. Redfield. I think the fastest prior was 2 years and 
usually 4 to 6 years.
    Senator Kennedy. Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Kennedy.
    Senator Reed.
    Senator Reed. Thank you very much, Mr. Chairman, and thank 
you, gentlemen, for your testimony.

                               FACE MASKS

    I was particularly struck how emphatic you all were 
insisting that the use of face masks is absolutely critical in 
a social setting. You are all wearing face masks. I have mine. 
I took it off so I could question. Yet, last evening, the 
President once again disparaged the importance of wearing face 
masks. He does not wear one usually. He has conducted rallies 
in which many of the participants are not with face masks. He 
does not have on a face mask.
    So let me just ask all of you. Admiral, you are a uniformed 
officer. Is the President providing appropriate leadership when 
it comes to this critical issue, one of the most direct and 
important things anyone can do to protect themselves and the 
community from this disease?
    Admiral Giroir. Well, as a uniformed officer, I am not 
going to comment about the President, but I do want to 
emphasize that wearing a mask is one of the most important 
things that we can do to prevent spread particularly because 
people who are asymptomatic--you could feel totally fine but 
still be spreading the virus, which is why wearing a mask when 
you cannot physically distance is absolutely critical. And I 
think I probably speak for my other two colleagues, but you 
will want them----
    Senator Reed. I want them to. But I think you just directly 
contradicted the President's behavior and the President's 
comments even though you have done it politely.
    Doctor.
    Dr. Kadlec. Sir, we are supportive of the mask. That is why 
we produced a half a billion of them and made them available to 
the American public at large.
    Senator Reed. But the answer is----
    Dr. Kadlec. Yes.
    Senator Reed. Is the President undercutting what you have 
all said and you have repeated one of the most important steps 
that Americans can take to defend themselves and the country 
against this disease?
    Dr. Kadlec. Sir, my view is that he is an individual who 
can exercise his rights to do what he pleases, as we see other 
Americans doing that. And so he is----
    Senator Reed. But it is also the leader of the country 
trying to cope with a disease, a pandemic that has killed over 
100,000 people, and he is rejecting this emphatic advice that 
you give repeatedly and you yourselves demonstrate.
    Dr. Redfield, your comment.
    Dr. Redfield. I am not going to comment directly about the 
President, but I am going to comment as the CDC Director that 
these face masks are the most important powerful public health 
tool we have. And I will continue to appeal for all Americans, 
all individuals in our country, to embrace these face 
coverings. I have said if we did it for 6, 8, 10, 12 weeks, we 
would bring this pandemic under control. We have clear 
scientific evidence they work, and they are our best defense. I 
might even go so far as to say that this face mask is more 
guarantee to protect me against COVID than when I take a COVID 
vaccine because the immunogenicity may be 70 percent, and if I 
do not get an immune response, the vaccine is not going to 
protect me. This face mask will. So I do want to keep asking 
the American public to take the responsibility, particularly 
the 18 to 25-year-olds where we are seeing the outbreak in 
America continue to go like this because we have not got the 
acceptance, the personal responsibility that we need for all 
Americans to embrace this face mask.
    Senator Reed. Once again, I think you have refuted the 
President more eloquently than I have heard. You are the 
expert. Leaders have to depend on expert advice. That is why 
they have people like you there, and when they do not take your 
advice, in fact when they disregard it--and it has been said so 
emphatically here. It is not a question of any doubt at all in 
your views, all of you.

                      STATE DISTRIBUTION PLANNING

    Just a final quick question, and I only have a bit of time. 
Dr. Redfield and Dr. Kadlec, quickly. Your vaccine plan has to 
involve the States. Can you just very, very briefly, Dr. 
Redfield--is there a conscious integration of the States in 
terms of their public health services, and are there resources 
available for the States in this plan because they will need 
them?
    Dr. Redfield. Yes, sir. It is critical. We have done micro-
planning already with five jurisdictions, North Dakota, 
Minnesota, California, Florida, and Philadelphia. And this plan 
will be going out today to all of the States. I will be talking 
to the State public health leaders this week. We will be 
working with them so that they can integrate this plan in their 
own unique way for their own State, and there will be support 
to help them begin to resource this plan.
    Senator Reed. Thank you.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Reed.
    Senator Capito.
    Senator Capito. Thank you, Senator Blunt, and thank all of 
you. I am pleased to be a part of this hearing today.

                         QUARANTINE GUIDELINES

    And I will start off with Dr. Redfield. I am not sure if 
you are aware, Dr. Redfield, but I am abiding now by the CDC 
guidelines. I was made aware on Monday that I had been exposed 
to somebody who tested positive for COVID. According to what 
the physician told me, I had been in and around that individual 
for at least 15 minutes within 48 to 72 hours of when he 
exhibited symptoms. And out of an abundance of caution and I 
think acceding to your guidelines, I went immediately to the 
physician at the Capitol who advised me then that I must 
quarantine for 14 days. I did subsequently take a test and 
tested negative, which I am very obviously pleased about.
    But I want to ask you are your guidelines on quarantining--
for those of who are quarantining following the rules, what 
kind of success does that bring in terms of isolating and 
containing the spread? And do you further recommend further 
testing as people are coming out of their quarantine, and at 
what points of the quarantine would they need to get retested, 
if that is necessary?
    Dr. Redfield. Well, first, I want to thank you for setting 
the example and embracing these guidelines.
    Although misinterpreted, some of the changes that we put in 
our guideline, the whole purpose of those guidelines was to 
engage the public health and medical community back into the 
decisions when people get tested so, as was talked about 
earlier, there was the appropriate public health action. So the 
tests led to an action. It was not just a test.
    And so I want to thank you for setting that example.
    The reality is if you have had close contact, it could take 
7 days, it could take 10 days, it could take 12 days before you 
turn virus-positive. That is why we have our current 
recommendations, based on the data we have, for isolation for 
14 days. And as we get more data, that may change, but the 
reality is that the data that we have today, we still support 
the 14 days of isolation.
    We do have very good data in our household studies where 
households that have introduced COVID, where individuals 
practice masks and hand washing and distancing, we have been 
able to show there is limited transmission in those household 
settings. And in households that did not, we have seen attack 
rates of 20 percent, 30 percent, 40 percent, 50 percent within 
the household.
    So again, that is where the state of knowledge is right 
now. There may come a time when we have better data that can 
shorten it. But right now, even if we shortened it to 10 days--
and a number of people have asked to look at the data--we would 
still send home probably 10 to 12 percent of people who would 
later turn out virus-positive.
    Senator Capito. Well, thank you for that.

                              RAPID TESTS

    Admiral Giroir, Dr. Redfield brought up an issue that I 
know is cascading across the country, and that is, as some of 
our colleges and universities are opening, the incidence in 
testing and the incidence of positives have gone way up because 
of some behavioral issues and just the whole atmosphere at 
times in a college and university setting.
    So there is a great interest on tests to get the rapid 
turnaround test. The Abbott test I know is of interest to the 
universities.
    I know you are beginning to deploy these to nursing homes 
and highly challenged communities, which I applaud. But how do 
you deal with a college and university setting in terms of 
testing, and what do you recommend here? What do you see in the 
future?
    Admiral Giroir. So thank you for that question.
    Universities generally have a very substantial capability 
to do testing in their research laboratories, in their 
veterinary diagnostic laboratories. Senator Durbin, the 
University of Illinois is one of the real leaders in being out 
front. So we have had multiple calls, seminars, technical 
webinars to allow the universities to turn on their research 
equipment. We have done the CLIA waivers. We have done all of 
that to really use that to support testing.
    Eventually we want to get to a point that rapid point-of-
care tests are available for everyone. But 50 million a month 
does not go into 300 million people. So what we are advising 
universities is to use those rich resources that have been 
funded by the NIH that they have to use them. A nursing home 
cannot do that. Many universities, using their veterinary 
laboratories, which are very successful--and again, the 
University of Illinois has done just really tremendous. We had 
them on one of our leadership calls as an example telling the 
rest of the country.
    Senator Capito. Thank you very much.

                  OVERDOSE DEATHS DURING THE PANDEMIC

    And just in closing--I know my time is up--I am concerned, 
Dr. Redfield, as we talked about before. The rise in overdose 
and overdose deaths during this pandemic is extremely alarming. 
And I am very concerned, as we keep moving forward, what kind 
of impacts this is going to have on the addiction community. 
You and I have talked about it. We got to keep our eye on it. 
Thank you so much.
    Senator Blunt. Dr. Redfield.
    Dr. Redfield. Yes. I could not agree with you more. I mean, 
we have seen an increase of almost 18 percent now, in our 
suspected overdose----
    Senator Capito. A lot.
    Dr. Redfield [continuing]. In admissions into hospitals. 
Clearly the isolation that has been associated, also the 
ability to get access to the proper pain control when a lot of 
the medical services cut back. CDC recently did a survey--and 
it actually shocked me--just a survey across our Nation, and 
found that 31 percent of adults reported now significant 
anxiety and depressive disorders. So this is a significant 
comorbidity that has been negatively influenced by the COVID 
response, and it is something that we have to continue to 
double our efforts to try to prevent death from overdose.
    Senator Blunt. Thank you, Dr. Redfield. Thank you, Senator 
Capito.
    Senator Shaheen.
    Senator Shaheen. Thank you, Mr. Chairman, and thank you to 
each of you for being here.

             INFECTION CONTROL IN LONG-TERM CARE FACILITIES

    Admiral Giroir, in your opening statement, you talked about 
the importance of protecting the elderly, which I think all of 
us would agree is critical. And yet, the elderly have been 
impacted the most by this COVID-19. In New Hampshire, over 80 
percent of our deaths from COVID-19 have been in long-term care 
facilities.
    That is why I am so concerned about the slow pace that HHS 
has provided in giving support for infection control in these 
facilities. The CARES Act provided up to $200 million for 
nursing home infection control efforts, and to date, only $17 
million of that has been spent.
    On top of that, HHS has only spent about half of the $16 
billion that Congress has provided for the acquisition of 
personal protective equipment, which continues to be a need. 
Nursing facilities and providers across the CARES system in New 
Hampshire desperately need these supplies.
    So, Admiral, the infection control funds are vital to 
helping our nursing homes reduce the spread of diseases. You 
have alluded to that. So when can we expect the remaining funds 
to be distributed?
    Admiral Giroir. I cannot answer that on that specific. I do 
not know when they will be distributed.
    What I can say is that I know even in the last couple of 
months there have been $5 billion of extra funding to nursing 
homes. $2.5 billion of that is to support testing, which is 
really in our regime. And we do get--Admiral Polacek, the other 
admiral on the team with an unpronounceable name--every day we 
get about 99 percent of nursing homes reporting. So we know 
exactly what their PPE (Personal Protective Equipment) 
situation is.
    But in terms of that specific fund, I am going to have to 
have the team get back to you on that.
    Senator Shaheen. I would appreciate that.
    One of the challenges with that $5 billion that was just 
distributed is that it can only be used for hiring only, not 
retention, and the biggest challenge our nursing homes have in 
New Hampshire is retention of employees. So is there going to 
be any thought given to providing more flexibility for long-
term care facilities in how those funds can be used?
    Admiral Giroir. And I am really sorry. I am going to have 
to get Seema Verma and the Secretary to respond to that. That 
is not within my realm of responsibilities.
    Senator Shaheen. Well, I would urge you to do that because 
if we are providing funds to long-term care facilities that 
cannot be used, then it is not accomplishing the concern that 
all of us share.

                       PUBLIC RELATIONS CAMPAIGN

    I want to go on to another issue because there was a report 
that just came out about HHS seeking bids for a $250 million 
contract for a public relations campaign to defeat fear and 
inspire hope regarding the pandemic. And while I think all of 
us want to make sure that Americans know that there is going to 
be a better time ahead for us, the timing of this contract 
raises real concerns about the potential intersection with the 
President's reelection campaign, and more importantly, Congress 
did not direct HHS to conduct this campaign. So is the $250 
million that is going to that coming from funding that should 
be going out to our long-term care facilities, to our 
hospitals, to our medical providers to actually respond to the 
spread of COVID-19? And what is the purpose of this contract at 
this time to do a public relations campaign? Would it not be 
better to give information to the American public about what 
all of you have said so eloquently this morning about what we 
need to do to respond to this virus and what we need to do to 
ensure that people have the health care they need if they 
contract it? Admiral, can you answer that?
    Admiral Giroir. And, ma'am, I really do apologize, but I do 
not know anything about public affairs campaigns or where that 
money comes from or what it is going to do. That is just not 
something that I deal with. We all try to provide the best 
information we can through whatever vehicles we can, but I just 
do not know about public affairs contracts.
    Senator Shaheen. So you were not aware that the Department 
is going to be spending $250 million on that advertising 
campaign?
    Admiral Giroir. I mean, I am generally aware from what I 
read in the news, but I am not involved in--I am really not 
involved in that. All I know about public affairs is that we do 
want to get all of us in front of the public to make sure, 
number one, they get their flu vaccines this year because that 
is really critically important.
    Senator Shaheen. Thank you. I think that is very helpful.
    Dr. Kadlec, were you aware of this expenditure?
    Dr. Kadlec. No, ma'am.
    Senator Shaheen. Mr. Chairman, I would hope that this 
committee would ask some very tough questions about what is 
going on here because that is a lot of money for a campaign 
that we ought to be spending to address this pandemic.
    And, Senator Alexander, I totally agree with you on doing 
some work now to respond to the next pandemic, and I would 
suggest that we also ought to restore the Global Health 
Security and Biodefense Unit either at the National Security 
Council or somewhere where it can provide an early warning for 
what is ahead.
    Thank you very much.
    Senator Blunt. Thank you, Senator Shaheen.
    Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Mr. Chairman.
    And to the panel, I truly thank you for all you have done 
and your tremendous tireless efforts of guiding this country 
through COVID-19. You are to be commended, applauded, and I am 
certainly one that appreciates you being here today and 
answering the questions that we have and being willing to serve 
in the capacity that you serve in.

                              RURAL HEALTH

    I represent Mississippi. We are less than 3 million people. 
And one of our largest challenges is rural healthcare and 
getting these vaccines to rural areas such as those in 
Mississippi. Of course, I am very concerned about the 
universities and colleges and the protection that we need there 
through that age population.
    But I am just going to ask you, what are your agencies 
working on to help address the challenges in unique rural 
America's response to COVID-19? But mainly, how can this 
subcommittee support you in that? How can we help you address 
those issues there? And I would like to hear from all three of 
you on that and getting the vaccines to rural America where it 
needs to be where we have such a challenge.
    Dr. Redfield. Thank you very much, Senator.
    Very, very important, we have continued to try to develop 
outreach in vaccine distribution particularly in the hard-to-
reach rural areas. This is part of the efforts that we have 
accelerated with our flu program right now with the idea of how 
to vaccinate with confidence by trying to protect communities, 
empower families, and stop myths.
    We have developed rural partnerships with the National 
Rural Health Association, the National Association of Rural 
Health Clinics, and the National Organization of State Rural 
Health Offices with the goal to really work to improve the 
acceptance of vaccination in general, flu being the important 
one with confidence.
    I do think the recent decision that the Secretary made in 
expanding the ability of pharmacies to vaccinate down to age 3 
to down to age 18 is going to be an important expansion of 
being able to engage pharmacies throughout our Nation as 
vaccine centers.
    But we are continuing to work with those rural 
organizations to see if there are other innovative solutions to 
try to expand vaccination. I am hopeful that the pharmacy 
expansion is going to have a significant impact.
    Senator Hyde-Smith. Thank you very much.
    Dr. Kadlec. Ma'am, with regard to rural healthcare, what 
ASPR has been doing in the last years prior to the COVID event 
was trying to expand what would be the regionalization of 
disaster care, emergency care to really focus on areas where 
you have critical access hospitals or underserved populations.
    In the current COVID event, we have been working with the 
Department of Defense to employ a system that they originally 
started, which was called the National Emergency Telecritical 
Care Network, or NETCCN, which is a means by which to do 
telemedicine to again rural and critical access hospitals to 
make them available the best information critical care 
specialty support, as well as arranging for transportation and 
referral of cases to a higher level of care. So we are actively 
doing that right now. We have done it in many parts of the 
country as a result of our work in COVID response. And we are 
also trying to do that for ambulatory care telemedicine as 
well. So by building out our regionalization approach, our hope 
is to not only create the established referral patterns but 
also establish telemedicine consulting support so that we can 
support the rural parts of this country over.
    Senator Hyde-Smith. Thank you.
    Admiral Giroir. And I will add on again with the PREP Act 
guidance that allowed pharmacists to do COVID vaccines--I 
issued that last week to get in the pharmacy communities.
    But I just want to be a little bit of a cheerleader for 
federally qualified health centers. We now have 221 federally 
qualified health center sites in Mississippi performing 
testing. I think FQHCs are a real gem. They take care of 30 
million people and very much of the underserved migrant farm 
workers, homeless, and they do so at a savings, better outcomes 
at less cost. So again, that is a major point for us in 
Mississippi where we are reaching people both urban and rural. 
And anything I could do something for HRSA and health centers, 
that is going to be money well invested.
    Senator Hyde-Smith. Thank you all for those answers, and I 
truly appreciate that because it is one of my top priorities. 
We had a young lady not long ago that died of an asthma attack 
because the emergency room had been closed in her area. So I 
certainly appreciate your work there.
    Senator Alexander [presiding]. Thank you, Senator Hyde-
Smith.
    Senator Merkley.
    Senator Merkley. Thank you very much.

                          ASYMPTOMATIC TESTING

    Director Redfield, I am concerned that the CDC has revised 
guidelines that no longer recommend testing for asymptomatic 
individuals who have been in close contact with a person with 
COVID-19 infection for at least 15 minutes.
    Just a few days ago in a media interview on September 10, 
Admiral Giroir stated that all of us in the room have been 
hearing from public health experts we need to test asymptomatic 
individuals.
    So explain this to me. Is the admiral right or wrong?
    Dr. Redfield. Thank you very much, Senator, for the 
opportunity to address your question.
    I think, first and foremost, I want to say the CDC guidance 
that came out was clearly misinterpreted, and within 24 hours, 
I published a statement to try to make it clear what CDC was 
recommending. We were never recommending not to test 
asymptomatics, and we were never recommending obviously not to 
do the public health contact tracing and trace them.
    What was attempted was to replace the emphasis of testing 
so that, as we talked about earlier, testing led to an action. 
It drove public health objectives. So we placed the emphasis on 
testing symptomatics, but then we placed the emphasis on 
individuals with significant exposure--they are asymptomatic--
or vulnerable populations, nursing homes, long-term care 
facilities, critical infrastructure workers, healthcare 
workers, first responders--they are asymptomatic. And the last 
group that we talked about was individuals who may be 
asymptomatic and rather than just get tested, what we asked 
them to do was consult, like we heard from the Senator from 
West Virginia--consult with your medical and public health 
officials and follow their direction because, as you saw with 
the Senator, when she chose to get tested, even though the test 
was negative, there was a critical public health action. That 
was for her to stay home for 14 days.
    So we are going to continue to try to make sure our 
guidance is not interpreted incorrectly because as the admiral 
said and as I have said, asymptomatic infection and pre-
symptomatic infection is a critical component of the 
transmission cycle of this virus.
    Senator Merkley. I am going to ask you to stop there 
because I have got other questions, and I think you have 
answered it. And even the example you have given shows the 
positive impact of testing asymptomatic individuals because 
they can get appropriate guidance on how to behave thereafter. 
And we know that a tremendous amount of infections are 
happening from people who are asymptomatic. And so I think that 
is such an important point to keep driving home.

                       STATE VACCINE DISTRIBUTION

    I wanted to also ask you. You had told governors to prepare 
for the distribution of COVID-19 vaccine on November 1. It 
escapes no one's perspective that you are deliberately laying 
it out 2 days before the election. Who in the administration 
asked you to choose that particular date?
    Dr. Redfield. No one, sir.
    Senator Merkley. You just thought on your own political 
motivation to try to influence the election in this manner. 
What happened to science driving decisions?
    Dr. Redfield. There was no political interest in it 
whatsoever. It was actually prepared by our subject-matter 
experts because we wanted to get to the point of realizing that 
vaccine may be available--we do not know when--and we wanted 
the governors to be able to not have red tape interfere with 
the distributor McKesson from setting up their distribution 
sites.
    I will argue that the thing that I was most concerned of 
and my subject-matter experts were, who actually generated the 
letter which I signed, was that the worst thing that could 
happen is we had vaccine delivered and we are still not ready 
to distribute.
    But I can tell you there was absolutely no political 
thinking about it. You could say in a retroactive--somebody 
should have thought a little more political. But there was no 
political intention whatsoever.
    Senator Merkley. Okay. Well, I must say that I do not find 
that persuasive. You are saying that there was not a single 
contact from the administration after the President said I 
would like to have a vaccine before November, before the 
election. No one from the administration contacted your team at 
any level to say can you please emphasize that message. There 
were no emails, no meetings, no phone calls, not back room 
chats connected with your choosing that particular date.
    Dr. Redfield. Absolutely not. It was independently 
developed by our subject-matter experts that were laying out 
this document to start to plan for the jurisdictions that we 
needed to get that letter out so McKesson could get the 
licensing agreements that they needed to get their distribution 
sites up. And they drafted the letter--the subject-matter 
experts--that I signed.
    Senator Merkley. Yes.
    Senator Alexander. Thank you, Senator Merkley.
    Senator Merkley [continuing]. So much misrepresentation by 
the administration. I think Americans would find it hard to 
believe that there were no conversations when the 
administration is actively pushing every piece of the Federal 
Government to engage in actions to promote their election. So 
it undermines your credibility. You should have at least 
thought about how it undermines your credibility because it is 
so important to have the CDC be above politics.
    Senator Alexander. Thank you, Senator Merkley.
    Senator Lankford.
    Senator Lankford. Thank you.
    It has been interesting how much the dialogue today has 
been about politics and about the election. I do appreciate the 
work that you are doing regardless of party. I do not find 
people getting COVID only if they are Republican, Democrat, or 
independent voters and non-voters. So I appreciate the ongoing 
work that you have done for a very long time to be able to work 
us through this. Your days are very long, and your work is very 
important. So we appreciate the work that you continue to be 
able to do. And this hearing should not try to be some sort of 
political trap for the President. It should be about the facts 
and details. So I appreciate that.
    Let me ask you a couple of quick questions on this. One I 
want to dig into more.

            FUNDING FOR VACCINE PRODUCTION AND DISTRIBUTION

    The first one is there has been a lot of conversation about 
the amount of resources that is needed for the vaccines 
especially and for vaccine production and distribution. What do 
you still need for vaccine production and distribution as far 
as supplemental appropriations?
    Dr. Kadlec. Senator, thanks for that question.
    At this point, we have funded six vaccine candidates for 
both advanced development and manufacture. I think at this 
stage the $13.6 billion that have been appropriated or--pardon 
me--committed for this purpose is adequate for that, for the 
initial part of this. If you are talking about at the point in 
time when one vaccine candidate may fail and we may have to 
replace it with another candidate or expand production of 
another, that could basically change our accounting and our 
calculus for what we would need. But at this stage, we have 
what we need, and we are poised, at least at this point I think 
by the end of this month and into early October, to at least 
have the funds that we need to basically provide for the first 
several candidates.
    Senator Lankford. Okay. That is good to know. There are 
obviously six different candidates going through the vaccine 
process right now, and because no one knows if any one of them 
is going to be successful, so you got basically six hooks in 
the water at this point.
    I am going to drill down a little bit on the vaccine 
candidates that are out there and also some of the treatments.

                     ETHICAL PRODUCTION OF VACCINES

    Some of the pharmaceutical companies have chosen to do 
ethical production, that is, they are not using tissue from 
aborted children for the production of the treatment or of the 
vaccines. Some of them have chosen to use aborted fetal tissue 
in the production of the vaccines. How are you balancing out to 
be able to make sure that there will be an ethical alternative 
for individuals that do not want to take a vaccine that is also 
produced using the tissue of an aborted child?
    Dr. Kadlec. Sir, thank you for that question. I am going to 
have to take that for the record and bring you back an answer 
to get more details on those particular matters. I do not have 
those immediately available, and I do not want to misspeak on 
this issue.
    Senator Lankford. That is fair enough.
    Dr. Redfield, do you have comments or thoughts on that on 
the production?
    Dr. Redfield. Again, I would have to go back and see 
specifically. I think my recollection is we are going to have a 
number of candidates. It is not going to compromise one's 
ethics related to the use of human tissue. But I will have to 
get back to you too because I do not want to say something that 
is incorrect.
    Senator Lankford. No. I get that. And it is not just human 
tissue in the production. I mean, there are some companies that 
are using adult stem cells. There are some that are using 
placentas from children after birth. Those are not 
objectionable. I do not find anyone challenging that. So it is 
not just the use of human tissue. It is specifically the use of 
tissue that is from aborted children that becomes the 
challenge. Moderna is using embryonic kidney cells from aborted 
children. Johnson & Johnson is using aborted children embryonic 
retinal tissue for its production of the vaccines. There are 
others that are not choosing to use those tissues from 
children. So I think there just needs to be as many options out 
there as we can.
    And again, I just wonder on the science side if we do not 
have to use tissue from aborted children, why would we do that 
when there are others that are choosing to be able to develop 
vaccines that are not being used that way.
    So I want to be able to follow up with you on that just be 
able to see what options are out there and how we are handling 
the funding and what direction that we are going to go. And 
long term for vaccines, most of the vaccines that we have in 
America now do not use embryonic tissue in it. There are still 
some that still do, that that is the line that is still used. 
And again, when we do not have to do that, why would we do that 
and to have it as ethical as we possibly can.
    So again, I appreciate the work. We will follow up in the 
days ahead on this particular topic because I think it is very 
important that as many people get vaccinated as possible. And I 
do not want to have a reason for people to not go get a vaccine 
because they are concerned about the origin of the vaccine. I 
want as many people as possible to actually get a vaccine 
because I think it is important. And it has been an odd 
conversation to hear so much of people saying, well, I am 
challenging whether we are going to get a vaccine because the 
Trump administration may be rushing this, and so I do not want 
to go get one. I think we have to have nothing that distracts 
from the science and the details of this as we walk through it 
as well.
    So I appreciate your work.
    Senator Alexander. Thank you, Senator Lankford.
    Senator Schatz.
    Senator Schatz. Thank you, Mr. Chairman. Thank you to the 
panelists for being here.

                                TESTING

    I will start with Admiral Giroir. You said in July that it 
was not a question that we would be soon running a million 
tests per day. We have gone from about 800,000 tests per day to 
675,000 tests per day. What is happening?
    Admiral Giroir. I want to be clear that we are talking 
about capability to produce tests. And I think we need to 
always draw the distinction between how many tests we have that 
can be deployed and what the States are doing.
    In August, for example, the States' combined goals were in 
the low 20 millions of tests, which they exceeded to 25 
million.
    But what we are seeing at some parts of the country is 
testing is going down. We are trying to change that. I know you 
are from Hawaii. We have a surge site in Honolulu right now 
that we can test up to 5,000 per day and moving----
    Senator Schatz. Right. You are saying this is volitional? I 
guess the question is, is this a supply chain problem, or are 
you saying that States are individually deciding to do less 
testing?
    Admiral Giroir. This is not a supply chain problem. We had 
double the availability of tests that were done in August, and 
we will be over 90 million tests available in September. I 
would presume that a higher proportion will be done because 
they are going to be very easy to do. They are going to be 
point-of-care Binax testing and that we are surging nursing 
homes.
    Senator Schatz. Can we just talk a little bit about the 
Binax testing?
    Admiral Giroir. Yes.
    Senator Schatz. Because I guess where a lot of people are 
coming from is that we hope you are right that this new test is 
a game-changer. And we are pleased, and I think it will be very 
helpful in the context of first responders and in nursing homes 
and perhaps educational contexts as well. But it is a card, and 
as you know, you cannot really process that many tests at once 
this way. And so although it is really useful in certain 
contexts, it is not going to get you to your 90 million tests 
goal. I mean, in your testimony today--today--you say that we 
should have 90 million tests completed by the end of September.
    Admiral Giroir. I did not say that.
    Senator Schatz. We are about halfway through September --
    Admiral Giroir. I did not say that.
    Senator Schatz [continuing]. And we are at 10 million 
tests.
    Admiral Giroir. I did not say that. I said we have----
    Senator Schatz. In today's testimony?
    Admiral Giroir. I said we will have the availability of 90 
million tests in September. I never stated that we would do 90 
million tests in September. We are certainly hoping that the 
testing goes up.
    And let me just say about Binax, it only takes a swab and 
put it in and wait 15 minutes. I could probably go through this 
room and swab everyone and do that within about 5 or 10 
minutes. So it is a low throughput test, but you could do them 
very rapidly and quickly. So I would expect that as many of 
these that get put in the market, particularly used in nursing 
homes, assisted livings, and to support K through 12, that they 
would be used very rapidly.
    Senator Schatz. Just because I have limited time.
    Admiral Giroir. Yes.

                         AVAILABILITY OF TESTS

    Senator Schatz. What is the difference between testing 
availability and tests being completed? Because that seems like 
a sort of a distinction that is lost on the ground. To know 
that there are 90 million tests theoretically available but the 
nursing homes, the schools, the first responders, the 
firehouses--they do not have the tests available. So what does 
it mean that it is theoretically available to do 90 million 
tests and yet people cannot get their hands on a test?
    Admiral Giroir. I do not think that is true. I think people 
can get their hands on the test. Even with Federal sites, we 
have 2,700 in retailers. We have surge sites. There is enormous 
capability in the referral labs. So the testing is available 
even when we do surge sites. Unless there is--you know, there 
is not a public order that demands people to come in and get a 
swab up their nose. This is voluntary, and sometimes the demand 
is not there.
    But let me just turn that around and say with the Binax, 
that is one reason why we purchased them all for the Federal 
Government, the first 150 million, to make sure they got to 
sites that would use them and really could benefit them like 
nursing homes, assisted living, Tribes, HBCUs, disaster 
situations, and in just a couple of weeks, to support K through 
12.
    Senator Schatz. Admiral, I know you are working on this, 
and I know you are trying to do this in good faith. But I just 
want to convey to you that when the surge testing happened in 
the State of Hawaii on the Island of Oahu over the last 2 
weeks, it was only then that we were able to test our fire 
fighters. It was only then that we were able to test our first 
responders. It was only then that we were able to have the 
tests available to do what it is that is theoretically possible 
under other circumstances. And it was only because we saw a 
precipitous spike in COVID cases. And so it is not true--it is 
not true--that tests are available for first responders except 
in certain----
    Admiral Giroir. I respectfully disagree with you that if 
the State of Hawaii--you have a turnaround time of 124 hours 
with the ACLA labs. And I am happy to work with your State. But 
there is no reason before the surge--you could have hired this 
company to come do the surge for you. We did it, sent it down 
there. And the demand was great. Hawaii has been unbelievable 
to work with. We have been doing fully subscribed 5,000 tests a 
day. But I am very happy to work with Hawaii. The Surgeon 
General just went down. We are expanding on the big island. But 
there is no reason that first responders could not have been 
tested before the surge.
    Senator Schatz. Well, I will just end with this, and I am 
sure my time is almost up.
    There continues to be a disconnect with how things are 
represented in this committee, in the United States Congress, 
and how things are felt on the ground. This was evident in 
February when we met with HHS, and it continues to be the case 
here. We hear lots of triumphant statements with lots of data, 
but on the ground people still lack resources.
    Thank you, Mr. Chairman.
    Senator Blunt [presiding]. Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman.

                        AVAILABILITY OF SUPPLIES

    So the administration's failure to confront this deadly 
pandemic has led to lost lives. There is still an urgent need 
to provide more support to our communities. And I am 
increasingly concerned that the funds appropriated thus far 
have not been handled as well as they could. They have been 
misused and mishandled.
    Last month, I wrote to Vice President Pence about a health 
system in my State that temporarily suspended COVID testing for 
patients undergoing surgery because of supply shortages. I have 
heard from assisted living facilities that they cannot get the 
tests they have ordered and academic medical centers that are 
not able to secure a reliable source of reagent. However, 
Wisconsin did receive un-requested hydroxychloroquine before it 
ever received a ventilator.
    Congress provided more than $16 billion for the strategic 
national stockpile for critical supplies of PPE. Less than $9 
billion of that has been obligated for the stockpile.
    Dr. Kadlec, what percentage of the funds appropriated for 
the stockpile this year have helped States get the PPE and 
testing supplies they need? As of this moment, what is that 
percentage?
    Dr. Kadlec. Ma'am, I am going to have to get back to you 
with a percentage. But what we have done in terms of our 
approach to basically managing the PPE part--and I will defer 
to Admiral Giroir to talk about the testing piece--is that we 
have basically made available everything that we had in our 
stockpile by May. Beginning with March with the monies that 
were available in the CARES Act and subsequent to CARES Act, we 
have been basically funding, if you will, the purchase of 
personal protective equipment to be distributed through 
commercial distributors directly to hospitals. And only 
beginning in June and July have we been filling, if you will, 
replenishing our stockpile as part of a strategy to make 
available 3 months of supply for the fall and winter, should 
that be necessary.
    We are, by virtue of teletracking, now getting information 
from hospitals. Last week, about 95 percent of hospitals have 
been reporting to us. And I am just looking at your State, 
ma'am. We have identified that 16 percent of hospitals have one 
shortage of PPE that may be--one type of PPE that may be 3 days 
of supply or less.
    Senator Baldwin. Right. I am aware of the Wisconsin 
statistics, but I am also aware of the $16 billion that we 
appropriated to address stockpile issues. So you may have 
chosen a different strategy, but I think when we are 6 months 
into this pandemic and we still cannot get the supplies we need 
and you have identified the supplies that are in high demand, 
that you should use the money we appropriated to obtain those 
things.
    Congress also provided $1 billion for the Department of 
Defense for similar purposes. And the President delegated 
authorities under the Defense Production Act to HHS to increase 
production of personal protective equipment. The Department of 
Defense has only used $300 million for PPE and said they would 
use the rest to support the defense industrial base.

                    DOMESTIC MANUFACTURING CAPACITY

    Dr. Kadlec, how much funding have you spent on increasing 
domestic manufacturing capacity using all of the DPA (Defense 
Production Act) authorities available to you so that we can 
prepare for the remainder of this pandemic or future pandemics?
    Dr. Kadlec. Yes, ma'am. So far we have awarded $638 million 
for that purpose, which runs the gamut from addressing 
shortages of diagnostics and ancillary supplies, N95 
respirators, injection technology for the use for vaccine 
administration, filter media for masks, as well as ventilators, 
gloves, surgical masks, as well as the ventilator supply chain. 
There are other things that are being considered at this point 
in time to use the rest of those funds, but we are trying to be 
very strategic.
    Senator Baldwin. Dr. Kadlec, what is melt-blown?
    Dr. Kadlec. Ma'am, that is the material, the fiber 
material, that is used in the disposable surgical masks, N95 
respirators, as well as ventilators----
    Senator Baldwin. Okay. And have you used the DPA to either 
increase production of melt-blown in the U.S.? I am not talking 
about contracting. I am talking about using the DPA 
authorities.
    Dr. Kadlec. Yes, ma'am, we have.
    Senator Baldwin. And have you used DPA authorities to shut 
off the export of melt-blown when it is obviously so needed 
here?
    Dr. Kadlec. Ma'am, I am going to have to get back to you on 
a firm answer on that, but my recollection is that we have. We 
did limit the export of that material, but I have to just be 
sure and return you a----
    Senator Baldwin. Please do.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Baldwin.
    Senator Graham.
    Senator Graham. Thank you, Mr. Chairman.
    Dr. Redfield, have you been part of the task force since 
its beginning?
    Dr. Redfield. Yes, sir.

                           COVID-19 TIMELINE

    Senator Graham. Okay. So see if I have got the timeline 
right. I believe President Trump was briefed by Mr. O'Brien on 
January 28 you had a major problem coming out of China when it 
comes to the coronavirus. He sets up the task force on January 
29. Is that correct?
    Dr. Redfield. That is my recollection, sir.
    Senator Graham. On January 31, the President issues an 
order called the China travel ban. Does that sound right?
    Dr. Redfield. Yes, sir. 31 of January was when the request 
was to inhibit travel to China.
    Senator Graham. On February the 29, Dr. Fauci was asked by 
a host of the ``Today Show'' this is Saturday morning. People 
are waking up right now were real concerned about this. They 
want to go to malls and movies, maybe the gym as well. Should 
we be changing our habits, and if so, how? Dr. Fauci says, 
February the 29, no, right now at this moment there is no need 
to change anything that you are doing on a day-by-day basis. 
Right now, the risk is still low, but this could change.
    Is that the general view back on February 29? Did you agree 
with that assessment?
    Dr. Redfield. At that time, there was limited evidence of 
community transmission in the United States.
    Senator Graham. So in March, there was an order basically 
issued declaring this a national emergency. Do you recall that? 
March 11?
    Dr. Redfield. Yes, sir. I think Secretary Azar called it a 
public health emergency. I think it was January 27, and then 
the President, the national emergency----
    Senator Graham. On March the 13. March 11, we do a travel 
ban from Europe. Is that about right?
    Dr. Redfield. Yes, sir.
    Senator Graham. Between January the 29 and March 13, did 
the task force ever recommend shutting the country down?
    Dr. Redfield. No, sir.
    Senator Graham. When the task force recommended to the 
President to declare this a national emergency and to basically 
encourage shelter-in-place orders, did the President respond to 
the recommendation of the task force?
    Dr. Redfield. Yes, sir.
    Senator Graham. Was there any time when the President 
refused to do what the task force recommended about shutting 
the economy down before he made that decision?
    Dr. Redfield. Not in the decisions that I was involved in.
    Senator Graham. Thank you.

                          VACCINE DISTRIBUTION

    So vaccines. If we found a vaccine, let us say, next month 
at the end of October, how long would it take for it to be 
distributed throughout the country and to become effective?
    Dr. Redfield. Well, I think that is the critical question 
because currently we have used the supplemental resources to 
get this distribution capacity up, about $600 million, but the 
funds that we currently have are not sufficient for us to get 
all 64 jurisdictions ready to be able to implement this plan 
that we issued----
    Senator Graham. Right. And I am sure you have made a 
request of the committee for additional money, and I am sure we 
will respond.
    But what I want the American people to know if a vaccine 
was developed tomorrow that was considered to be safe and 
acceptable, how long would it be before it would have a real 
effect in terms of controlling the virus.
    Dr. Redfield. I think we have to assume that if we had a 
vaccine, say, released today that it is going to take us 
probably in the order of 9 months--6 to 9 months to get the 
American public vaccinated.
    Senator Graham. So I just want everybody to understand that 
we are working--Operation Warp Speed--do you feel like that it 
is going well?
    Dr. Redfield. Yes, sir.
    Senator Graham. So if we got a vaccine in the near future, 
before it would really have a massive impact, it would take 6 
to 9 months to get it distributed and for it to begin to take 
effect, for lack of a better word. Is that accurate?
    Dr. Redfield. In order to have enough of us immunized so we 
have immunity, I think it is going to take us 6 to 9 months.
    Senator Graham. So during that 6 to 9 month period, we will 
continue to do sort of basically what we are doing now. Is that 
correct?
    Dr. Redfield. Yes, Senator. That is why it is so important 
to embrace these mitigation steps that we talked about.

                           ECONOMIC SHUTDOWN

    Senator Graham. So is it fair to say that at no time did 
President Trump reject the recommendation by the task force 
when it came to slowing down the economy or putting shelter-in-
place orders, that when it was recommended to him to take those 
actions, he complied? Is that correct?
    Dr. Redfield. Yes, sir.
    Senator Graham. Is it fair to say that as late as February 
the 29, Dr. Fauci, one of the experts of our time, was telling 
people it is okay to go to the gym, it is okay to go out and 
about because at that time, we thought the risk was relatively 
low?
    Dr. Redfield. I have to defer that. I didn't follow Dr. 
Fauci's statements. But I would say in general we all felt----
    Senator Graham. That is what he said on national 
television. That is what he said that day on February the 29. 
So this idea that President Trump did not respond I think is 
ridiculous for the President to be shutting the whole economy 
down when his leading expert is telling people you can go to 
the gym, you can go to a movie, you go out and about. So let us 
do not rewrite history here.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Graham.

                            VACCINE PRIORITY

    Before we go to Senator Murphy, Dr. Redfield, let us be 
sure we are clear here on the vaccine. You are not saying that 
it would take 6 to 9 months before the vaccine would do any 
good for anybody, but you are trying to come up with a priority 
that the country and governors should look at of who is the 
most at risk that would get that vaccine first. Is that right?
    Dr. Redfield. Yes, sir.
    Senator Blunt. And if the vaccine works with the efficacy 
that we would hope for, most of the people that get the vaccine 
are then protected from the virus for at least the near-term 
future. Is that right?
    Dr. Redfield. The FDA has set guidance that if it is 50 
percent efficacious, which is similar to the flu vaccine, that 
that would meet their threshold for approval. And I do want to 
be clear that as soon as this vaccine gets approved by an EUA 
or actually approved, we want to be in the position to 
distribute that within 24 hours because you pointed out very 
clearly this vaccine has the potential to save a lot of lives 
in November and December. But we need to be able to get that 
vaccine, once it is ready to--once it is approved, we need to 
get it distributed as rapidly as we can.
    Senator Blunt. Right. And in July, at the hearing we had in 
July, I asked you specifically to focus on being able to report 
back on a plan that hopefully we will get to later. I just do 
not want to leave this moment with any thought that just 
because everybody that wants to have the vaccine might not have 
it before Memorial Day, that does not mean that many people who 
do have it--and hopefully would be the most in need--would be 
substantially better off than they are right now. Is that 
right?
    Dr. Redfield. Yes, Mr. Chairman. You are going to have an 
enormous impact, we believe, on the mortality and the most 
vulnerable and an enormous impact in protecting those at 
greater risk of infection. And we should see that impact 
relatively immediately.
    Senator Blunt. Thank you, sir.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman.
    Thank you for spending so much time with us today.

                    COVID-19 PUBLIC HEALTH CAMPAIGN

    Just first a note on communication to and through Congress 
and this committee. Senator Shaheen earlier asked about a $250 
million contract that is being awarded by HHS to defeat despair 
and promote hope, which sounds an awful lot like a political 
reelection year-oriented message out of the administration. And 
we have two deputy secretaries of HHS before us today, and 
neither one of them can testify as to whether that contract was 
awarded, why it was awarded, what the reasons for it were. It 
is increasingly impossible for any of us to know who is charge. 
We have got two people who are at the highest echelon of HHS 
and cannot answer a question about a massive contract that has 
been awarded.
    And I think that is the same thing for the American public. 
Dr. Birx was in charge. Then Vice President Pence was in 
charge. It is really hard for there to be any accountability 
around decisions when we cannot get these basic questions 
answered.

                                TESTING

    I want to come back to Senator Merkley's question regarding 
the changed guidance, Dr. Redfield. So the President says he 
wants less testing. He say that out loud. He is asked for 
clarification. He doubles down and says I want less testing. 
And then right around that time, you issue this guidance that 
dramatically scales back recommendations for who gets tested. 
And the ``New York Times'' reports that that is because, in 
part, of instruction from the White House. You say today that 
that report is in fact untrue.
    But to many of us, it just belies reason that we would be 
encouraging fewer people to get tested today given the massive 
expansion of this virus. On the day that we passed the CARES 
Act, there were 10,000 new cases reported in this country. On 
average, we are seeing 34,000 new cases all across this country 
today.
    Your testimony was that you were not necessarily saying 
folks who are asymptomatic should not get tested. You are 
saying they should just see a doctor first. Is that correct? 
That was your clarification today.
    Dr. Redfield. No. What I was saying that when you get a 
test, like any physician who does a test, it needs to be linked 
to an action. And what we were trying to do is reemphasize that 
testing is linked to an action, just like the Senator said. She 
got tested. She was in quarantine. She got tested. She was 
negative, but that still was linked to an action to stay in 
quarantine for 14 days. What was happening was people were 
getting tested, and there was no action. So we were trying to 
bring action back into testing. We were not trying to limit.
    And I will be very clear----
    Senator Murphy. Let me just--before you do that, let me 
just read you this. This is from a medical journal. This is 
from the American Journal of Managed Care. Earlier in this 
week, CDC changed its guidance saying even if you come into 
contact with an infected individual, a test is not necessary if 
there are no symptoms.
    Dr. Redfield. That is not true what the guidance was 
attempting to say. It is true that some people interpreted it 
that way, and that is why I issued a very clear statement in 24 
hours afterwards to say CDC is not trying to emphasize. I do 
believe that more tests, as was said by Senator Durbin--more 
tests actually can lead to less cases if testing is linked to 
public health actions.
    Senator Murphy. But you did recommend--you did say they do 
not need a test.
    Dr. Redfield. No. We said they may not necessarily need a 
test.
    Senator Murphy. What does that mean? Listen, you are 
speaking to the American public when you tell them that they do 
not necessarily need a test.
    Dr. Redfield. You need to consult a doctor, a public health 
person to make that decision----
    Senator Murphy. What is the difference?
    Dr. Redfield [continuing]. So the appropriate public health 
action can be taken in conjunction----
    Senator Murphy. Okay. When you tell them that it is not 
automatic that they need a test, that they should see a doctor 
first, it gets communicated to people that the urgency is much 
lower.
    Dr. Redfield. For all contexts, sir, we are recommending 
all of them be tested. So it was a misinterpretation by some. 
And again, we are going to continue to clarify because we are 
not recommending less tests. I do believe more tests ultimately 
are going to lead to less cases in this country because it is 
going to allow public health action to happen, just like it did 
for the Senator. And we can use those tools to stop this 
pandemic.

                       WORLD HEALTH ORGANIZATION

    Senator Murphy. I will ask this question for the record, 
Mr. Chairman, to Admiral Giroir. There was a report earlier 
this month that the United States is going to scale down its 
engagement further with the WHO, including recalling detailees 
from WHO headquarters, regional offices, and country offices, 
and then reassigning these experts. I acknowledge I do not have 
time to get the answer today, but I think it is incredibly 
concerning that we might not have American personnel on the 
front lines to sort of watch this virus and others through WHO 
(World Health Organization) field offices. And so I would 
appreciate an answer for the record regarding who is going to 
replace those individuals inside countries of concern and how 
we keep eyes on this virus and future viruses.
    Thank you, Mr. Chairman.
    Senator Blunt. Thank you, Senator Murphy.
    Senator Moran.
    Senator Moran. Chairman, thank you.

                              VENTILATORS

    Dr. Kadlec, let me start with you. I want to talk a moment 
about ventilators.
    HHS has entered into a number of ventilator contracts, most 
of which were cancelled a week or so ago before they reached 
their intended, I guess, conclusion. And is there an accounting 
of how many ventilators--which is troublesome to me because the 
signals even a week before that was fulfill your 
responsibilities first to USAID (U.S. Agency for International 
Development) and then come back and finish your contract to us 
at HHS. And then a week later, the message is we do not want 
any more ventilators. And it is interesting to me that the 
contract requires HHS, the taxpayers, to pay for the startup 
costs, the closing down costs, and all the equipment and 
materials that have been purchased. So for a marginal amount of 
money, the contract could be fulfilled.
    Setting that aside, what is the accounting on how many 
ventilators that are high acuity ventilators in the strategic 
national stockpile? And is there a calculation by HHS as how 
many need to be this higher acuity as compared to a more 
standard ventilator with kind of one dial that you adjust?
    Dr. Kadlec. Well, thank you, sir, for the question.
    And, yes, sir, we have been looking at our ventilator 
supply. Just to put this in context, when the COVID-19 event 
occurred in January, we had 17,000 ventilators in our stockpile 
with another 10,000 ordered. As a consequence of the modeling 
and the concern that we may need much more ventilators by pre-
pandemic calculations for pandemic influenza, it was figured or 
calculated that you needed about 170,000 ventilators. As the 
course of this event, there was a concern that we may actually 
need more than that number, and that is when we went into 
agreements with seven companies across the country and a few 
from outside the United States to basically produce over 
200,000 ventilators.
    As things progressed as we learned more about the disease 
and, more importantly, how to clinically manage this disease 
both from a respiratory setting, as well as an intensive care 
setting, we identified we needed to change maybe our strategy 
with the ventilators, maybe needing less but also different 
kinds of machines. And so with your point, the higher acuity 
kind of ventilators, which we have over 120,000 of at this 
point, was to basically diversify that so that we could use 
some that could be used for high flow nasal cannula which seem 
to have better clinical outcomes.
    So adjusting that number with modifications to some of the 
orders that we made, we basically also identified that we could 
meet our pandemic requirements of 170,000, make available to 
other countries an additional 20,000 ventilators, that we 
decided to then, if you will, cut back on the number of 
ventilators that we needed to order and to have shipped.
    Yes, there is a cost to that, but there is a significant 
cost on the back end of this with the maintenance requirements 
that you need to maintain these ventilators.
    And so that is why we did it, sir. I am the responsible 
party. And sir, I will be happy to get with you and your staff 
to provide you any other details you need.
    Senator Moran. Doctor, thank you.

                          PROVIDER RELIEF FUND

    Let me quickly turn to Admiral Giroir. I think the position 
the witnesses have taken this morning is that you are incapable 
of telling us but would take back these issues for the record--
you are in capable of telling us about future spending from the 
provider relief fund.
    Let me just suggest to you that please take back for the 
record that the ability to get information from HHS on any 
spending from the provider relief fund has been minimal at 
best. As a United States Senator who appropriates money, who 
supported the CARES package, my ability to communicate with my 
constituents as to how you are going to spend the money, what 
the plan is has been next to nil. And I have not experienced 
that during coronavirus with other departments, with other 
agencies, but HHS has failed time and time again to respond to 
congressional inquiry and provide us with information about how 
taxpayer money is being spent, about how to help our 
constituents prepare for what you might be doing or what you 
are not going to do.

                       LONG-TERM CARE FACILITIES

    Admiral, somewhat in that regard, the increasing costs 
associated with complying with HHS rules and regulations by our 
nursing homes, our skilled nursing facilities, our senior 
living facilities is significant. And my question for HHS, 
because I would understand that you will defer to somebody else 
than who is here today to answer the question, is what can they 
expect to help them pay for the tremendous increase in costs in 
compliance with COVID regulations in policies that they are 
attempting to comply with to protect the safety and wellbeing 
of their residents but have little financial capability to 
actually pay for?
    Admiral Giroir. Thank you for that question.
    Independent of whatever regulations there are nursing homes 
have the responsibility and the ethical responsibility to do 
the types of testing that we recommended. It is the only way 
that you protect the elderly. Full stop.
    Number 2, the reason why we distributed point-of-care tests 
to the nursing homes is because they are about 20 percent of 
the costs that they would incur as opposed to a laboratory 
test. The Binax test that we are distributing to all of those 
right now, 2 million this week, are at no cost to the nursing 
homes, and they come with automated reporting.
    And finally, again I do defer to Seema about sending money, 
but I know $5 billion was sent to nursing homes, of which $2.5 
billion was to support testing. That is the level of detail I 
know, but I am happy to bring anything back from her or from 
our Assistant Secretary for Finances to you, sir.
    Senator Moran. Admiral, I am using you as a conduit for 
purposes of expressing my concern and expressing my desire for 
a lot more information.
    Admiral Giroir. Yes, sir.
    Senator Moran. I would point out that every time that I 
have raised this issue--these issues with HHS, I talk about 
senior living, nursing home, and skilled nursing facilities, 
and every response, just as I think yours was, comes back to 
what we are doing for nursing homes. And again, I cannot 
determine if there is any plan to be helpful, which I think is 
necessary, for example, to senior living.
    Admiral Giroir. So I will bring that back, and we will take 
it for the record. I do want to let you know that the moment we 
had the Binax test, we are sending it to 5,000 assisted living 
centers this week to support testing in an assisted living 
environment, not a nursing home environment. There are still 
6,000 of those or even more that do not have a CLIA waiver that 
we need to work with, but we are going to work with them. You 
know, as soon as we get the technology, it is out the door to 
support our seniors.
    Senator Moran. Admiral, you caused me just to change my 
commentary slightly. So every time I raise this topic, now you 
mentioned two of the three topics, and I still would raise for 
you and for HHS senior living, which never seems to be a 
component of any conversation that I have had with--what few 
conversations I have been able to have with HHS.
    Admiral Giroir. Yes, sir.
    Senator Blunt. Thank you, Senator Moran.
    Senator Moran. My time has expired.
    Senator Blunt. Thank you.
    I have got a couple of other questions and Senator Murray 
has another question or two.

                          FUNDING FLEXIBILITY

    On the point that Senator Moran raised, what is going to 
happen at the Department is going to be an increasing 
reluctance by this committee to appropriate money and give the 
Department flexibility. You know, when we appropriate money for 
the provider fund, we expect that money to go to the provider 
fund, not to go to whatever other fund the Department think it 
is better spent. So in fact, when we appropriated the second 
$75 billion to the provider fund, we absolutely prohibited 
spending that money any other way or some language close to 
that. And that is all because of the Department's actions. The 
appropriating committee appropriates, based on your request and 
responds to that request, in ways we think it is appropriate, 
and you cannot just decide to ignore that.
    On the vaccine, Dr. Kadlec, we specifically did not 
appropriate to Warp Speed. We appropriated money to the 
partners, NIH and BARDA. My understanding is that at least $16 
billion has come through those agencies for the vaccine up 
until now. HHS has told us that to have 300 million copies of 
vaccine available, they need another $20 billion that they do 
not have in any specifically appropriated line. Do you agree 
with that number?
    Dr. Kadlec. Sir, based on the current situation, yes, sir, 
that seems to be the number.
    Senator Blunt. All right.

                        STATE VACCINATION PLANS

    Dr. Redfield, the plans you expect to get back from the 
States by November 1 on distribution of the vaccine--do you 
think you will be ready shortly after that to announce your 
final distribution plan for vaccine?
    Dr. Redfield. Senator, it is going to be dependent on the 
Advisory Committee of Immunization Practices, which will make 
the final recommendation for prioritization. We will----

                         VACCINE PRIORITIZATION

    Senator Blunt. I think I am asking another question. Maybe 
I did not ask it well. Prioritization--I want to talk about 
that too, but surely prioritization will not impact how you 
send this out to the States. It might impact the number they 
get, but in terms of the protection of the vaccine, the way it 
is distributed, to be sure that you have a plan to get this in 
response to all these State plans as soon as possible, is that 
your intention?
    Dr. Redfield. Yes, sir. Obviously, the issue that I tried 
to mention earlier is that--and I have said this in our earlier 
testimony. Some people--it does not seem like they see this. 
Just as it was important----
    Senator Blunt. It is important. It is a second issue, but 
it is really important. And that was my next question.
    Where are we on the prioritization? And that will be 
recommended to the States or will that be a prioritization we 
expect the States to comply with?
    Dr. Redfield. Yes. It will be in a recommendation of the 
advisory committee for how this vaccine, whichever ones are 
approved, are recommended to be used.
    Senator Blunt. And when will that be available?
    Dr. Redfield. That will be available after the committee 
gets to see the data on the particular vaccine.
    But to answer your first question, because I think it was 
really important and I want to get to it, this plan for 
distribution is what we are now to get. And what I was trying 
to say is I said before this committee it is as important that 
we start that plan back in June as manufacturing. And right 
now, we have leveraged about $600 million, but we do not have 
the resources to support 64 jurisdictions to get this plan 
operational. So to me it is an urgency, you know, that we get 
that. We have done this in the past. We have experience in what 
it is going to take for us to do distribution and monitoring 
safety and get the vaccines. As I mentioned, we distribute 80 
million doses of vaccine a year at CDC. We have an idea. But 
this is going to take substantial resources, and like I 
suggested in June, the time is now for us to be able to get 
those resources out to the States, and we currently do not have 
those resources.

                      VACCINE DISTRIBUTION FUNDING

    Senator Blunt. The best I could tell, there were no 
resources provided in the HEROES Act in the House. In both the 
bill we voted on in the Senate and the bigger bill we proposed 
in the Senate, we had roughly $6 billion for distribution. Is 
that the right number, or is that close to the right number?
    Dr. Redfield. Senator, in my professional opinion, I think 
you have got that really nailed. Somewhere between $5.5 million 
and $6 million is what I think it is going to take to 
distribute this vaccine.
    Senator Blunt. And you do not have that money right now.
    Dr. Redfield. No, sir.
    Senator Blunt. And you need it to distribute the vaccine.
    Dr. Redfield. I think it is as urgent as getting these 
manufacturing facilities up.
    Senator Blunt. I think I said in July--and you agreed--that 
if you have the vaccine and do not have either the plan or the 
resources to distribute it, that is a huge failure on the part 
of the Congress to provide the resources that we know are going 
to be necessary. I hope it is a part of whatever package we put 
together this very month to be sure you have the capacity to do 
that.
    Senator Murray.
    Senator Blunt. She may have gone to vote.
    Senator Murray. Mr. Chairman, can you see me?
    Senator Blunt. There you are. I see you now.
    Senator Murray. Well, thank you so much. I appreciate it, 
and I am just getting back to my desk here so hold on one 
second.
    Thank you very much. I appreciate it.

                         PUBLIC HEALTH CAMPAIGN

    Listen, I wanted to follow up on Senator Shaheen's question 
regarding HHS' $250 million contract for public service 
advertisements to, quote, defeat despair and inspire hope amid 
the coronavirus pandemic.
    Based on comments made by Michael Caputo, it looks like the 
administration intends to use a quarter of a billion dollars on 
a massive media campaign to mislead the public, to actually 
downplay the pandemic, and that is really unacceptable. 
Congress provided these funds to fight COVID-19, not to support 
any kind of campaign or reelection campaign.
    Dr. Redfield, let me just ask you, can you clarify if CDC 
was tapped to provide that funding?
    Dr. Redfield. Thank you, Senator.
    CDC received the direction from HHS and OMB (Office of 
Management and Budget) to transfer $300 million to HHS ASPA.
    Senator Murray. What role has CDC played in the award 
process and developing that media campaign?
    Dr. Redfield. We have not played a role. We were just, as I 
mentioned, instructed by HHS and OMB to transfer the funds to 
HHS ASPA.
    Senator Murray. Well, then what role is CDC going to play 
in making sure the messages put out will include accurate 
public health information based on science?
    Dr. Redfield. Again, Senator, at this moment, we have not 
been involved other than given the directive from HHS and OMB 
to transfer the funds.
    Senator Murray. So funds only. You are not going to help 
them with information to make sure it is accurate?
    Dr. Redfield. Well, again, I would assume that they would 
want our instruction to do all of that, but we have not been 
involved in this other than the extent that the funds were 
transferred to HHS ASPA. I assume that they are going to come 
back to the different subject-matter experts, but again, we 
have not been involved in that.
    Senator Murray. Okay.
    Dr. Giroir, what role are you going to play in making sure 
the media campaign will only be used to disseminate public 
health information based on science?
    Admiral Giroir. Thank you, Senator.
    I have not been involved in any discussions. I have only 
been asked peripherally, which I think is the same campaign, to 
be subject to questions and to have a dialogue about public 
health issues. But I have not been involved in the development 
of the content, the same way that Dr. Redfield mentioned.
    Senator Murray. Do you think it is your role, either of 
you, to weigh in to make sure this is accurate?
    Admiral Giroir. I certainly believe that the CDC Director 
has an important role in messaging, and I am the senior public 
health advisor to the Secretary. So we certainly would welcome 
the opportunity to help support the correct messages to the 
American people. I do not mean to speak for Bob.
    Dr. Redfield. Again, I would echo that, you know, if given 
the opportunity, the CDC would obviously want to put forth the 
accurate messaging for the American public.

                          VACCINE DISTRIBUTION

    Senator Murray. Well, finally, Dr. Redfield, public health 
groups have really raised the alarm that billions of dollars 
are needed for vaccine distribution and administration. CDC 
should be leading that effort, and I wanted to know what 
activities should be included in a distribution campaign and 
how you plan to make sure you are involved.
    Dr. Redfield. Thank you very much, Senator.
    I think it is critical. CDC does have the lead within 
Operation Warp Speed. Again, the playbook that we put out is in 
its version 1. It is going to go through, I am sure, iterations 
as the States get involved and help improve the plan. And so 
CDC is in the lead of working with the State and territorials 
to do this.
    As I mentioned, since the last time--I think it was June--
when you asked me and we really did not have funds, and we have 
been able to leverage about $600 million to start some of the 
most critical activity. But as I mentioned to the chairman just 
a minute--now is the time. It is now. I mean, the rubber is 
hitting the road now to get these 64 jurisdictions up to speed. 
This is going to be a very resource-intensive distribution. We 
have never tried to distribute a vaccine that has a cold chain 
requirement like this one does, minus 80 degrees potentially 
for one of the vaccines. And so we are prepared. We did meet 
with five of the jurisdictions, North Dakota, California, 
Minnesota, Florida, and Philadelphia, to go down to micro-
planning. So we got a pretty good idea. But now we are getting 
the plans for the rest of the 61 jurisdictions. And it really 
is going to require resources. These jurisdictions are not 
going to be able to put these plans in place without resources.
    Admiral Giroir. Senator Murray----
    Senator Murray. Mr. Chairman, let me emphasize that 
response because as we just heard, one of these vaccines is 
going to require very cold storage. I think you said minus 60 
or minus 80 degrees. Distribution across this country is going 
to be extremely challenging, and we need to make sure the 
resources are there and that it is planned at a national--has a 
national plan for distribution and that communities that do not 
actually have often access to healthcare really get access to 
this and the distribution and storage and all the things that 
go along with this is going to be very complex, will require 
resources, and it, again, requires a national plan.
    Senator Blunt. Thank you, Senator Murray. I could not agree 
more. It is all about priorities, and this should be one of our 
top priorities at this moment.
    Senator Moran for the last question.
    Senator Moran. Mr. Chairman, thank you for that courtesy. 
And I know the second vote has been called.

                          LABORATORY SCALE UP

    So this question is for the admiral, and I think it should 
be brief, at least if I would start asking it. Admiral, we were 
alerted just recently about an HHS request for information that 
was posted. I think it was posted last week. It was soliciting 
interests from laboratories that could scale up with additional 
equipment from Thermo Fisher Scientific. Thermo Fisher is 
located in Kansas, and just recently they had an expansion to 
create more test tubes to do the test results.
    Could you tell me what the ultimate plans are, assuming 
that you receive interest from these laboratories, and more 
specifically, what is the budget for this strategy? How many 
labs do you intend to support, and how much more testing will 
be accomplished?
    Admiral Giroir. So let me just say first it was an NIH 
solicitation, and we received information from about 27 
universities that had interest.
    Let me just say a top line piece particularly now is that 
there are certain types of assays like Hologic, like Roche, 
like Cepheid that are relatively flat, but there is a huge 
supply of other outstanding assays, of which Thermo Fisher has. 
They have a huge industrial capability. They have instruments. 
They have everything that goes with it, soup to nuts, a full 
Happy Meal, however you want to say it. So we are trying to 
encourage laboratories around the country, including 
universities, to use these because Thermo Fisher can make tens 
of millions of high quality laboratory-based assays.
    We have supplied some of these to private laboratories like 
Sonic and Aegis, and we are trying to make sure that the 
universities use what they have, but also if they need help, we 
are happy to fund this. This is a relatively small amount of 
money to get them the capability to do assays. And Thermo 
Fisher has been really good to work with about really knocking 
down the prices, particularly for surveillance.
    So it is really another way to try to get the message out. 
We talk of thousands of universities. But Thermo is just one of 
those assets that we have a lot of. It is an excellent test. It 
is a great company. We want people to use it.
    Senator Moran. And too early to tell whether there is a 
response, whether your outreach is having any effect?
    Admiral Giroir. Seriously, probably three times a week we 
match a major laboratory up with Thermo Fisher, getting their 
instruments together with their supplies. So it is absolutely 
having effect. Again, we have a lot of capability. We just want 
to make sure that people understand where the capabilities are, 
and Thermo is one of them.
    Senator Moran. Admiral, thank you for your work.
    Senator Blunt. Thank you, Senator Moran.
    I think I am going to turn to Senator Alexander for a final 
question, but before I do that, we are going to go vote. And I 
want to thank all of you for being here. The country is 
depending on all three of you to lead in these critically 
important issues. As Dr. Redfield and one way or another all of 
you have said this--we are at a critical moment in testing and 
vaccines and therapeutics and distribution and prioritization. 
All these things need to come to as much of a conclusion as 
they can so we can move forward.
    I think you have all been great witnesses today. There were 
questions that were asked that were outside of your area of 
responsibility, and of course, the proper answer to that is 
that is not what I am doing every day and that is totally fine. 
We are grateful for your time. I know this is a critical time 
for all of you, and I am grateful to you for having been here.
    Senator Alexander will mention that the record will stay 
open for a week for additional questions, but we hope you will 
respond as quickly as possible to those questions. We are 
intensely involved in being your partner in this effort, but we 
need to know what we need to do so we can do it and do it in 
the right way.
    Senator Alexander.
    Senator Alexander [presiding]. Thank you, Mr. Chairman. And 
thanks to Senator Blunt for being aggressive on all these 
issues and leading especially in the area of support for the 
maximum number of tests.
    I do have some wrap-up questions.

                          VACCINE DISTRIBUTION

    Dr. Redfield, I heard the questions that Senator Merkley 
asked you about whether there was some invidious scheme in 
asking the States to get ready to receive the vaccine, and you 
said no, that it had been recommended.
    Am I remembering right that when we had a problem with a 
virus called H1N1 that the administration and the companies had 
a vaccine to distribute, but the States were not ready to 
receive it and that was a big problem. Is that right?
    Dr. Redfield. Yes, Senator.
    Senator Alexander. When was that?
    Dr. Redfield. 2009, 2010.
    Senator Alexander. And what happened.
    Dr. Redfield. Well, I was not there, but we are very 
fortunate to have the gentleman that was part of that and had 
the opportunity to learn from all of the experiences now 
leading our distribution for this to ensure that we do not have 
the same hiccups. That is why I was stressing how important it 
is for us now to be able to operationalize this plan.
    Senator Alexander. Yes, more than a hiccup. I mean, it 
would be a tragedy if we had vaccines ready and available and 
we could not distribute them because no one had asked the 
States to be ready.
    Now, I believe you said, Dr. Kadlec said--I believe you 
said that vaccines could be ready as early as November-
December. Is that correct?
    Dr. Kadlec. Yes, sir.
    Senator Alexander. And they would be ready in much larger 
volume most likely after the first of the year and then on into 
the second and third quarter. Correct?
    Dr. Kadlec. Yes, sir.
    Senator Alexander. And how long does it take a State to get 
ready to manage the distribution of these vaccines and make 
sure they go properly to the right people with the right 
equipment at the right time?
    Dr. Kadlec. I will defer to Dr. Redfield.
    Dr. Redfield. Senator, I think this is why I have said it 
is urgent. I mean, when we say that the vaccine could be ready 
in November, you know, that is really 6 weeks away.
    Senator Alexander. Yes.
    Dr. Redfield. So it is really urgent that we operationalize 
as rapidly as possible.
    Senator Alexander. What do you suppose this committee and 
many others would say to you if you had a vaccine ready in 
November and December and you had not asked the States to get 
ready to receive it?
    Dr. Redfield. You would probably be recommending that I get 
replaced.
    Senator Alexander. I think so. I think so. So I think this 
criticism of you and the professionals at the CDC for asking 
States to get ready to receive the vaccine, when we know full 
well that it is likely to begin to be available in November and 
December, is very misplaced. And I appreciated your comments 
and the way you handled them.

                       COVID-19 TRANSMISSIBILITY

    A dentist told me that there is no evidence, Dr. Redfield, 
of transmissibility of COVID-19 in a dentist office. Is that 
true?
    Dr. Redfield. I would not necessarily have stated that. I 
think the dentist is probably going to say there has been no 
proven transmission in a dentist's office.
    Senator Alexander. So I was a little surprised by that. The 
dentist said that dentists have a history of handling 
infections all the time, all the way back to HIV, and so they 
are trained to do that and they know how to wear protective 
equipment and they know how to adopt practices.
    Do you any of you know whether it is true that in other 
parts of the world and the United States, there have been 
problems with going to the dentist because of transmissibility 
of COVID?
    Dr. Redfield. I would just come back to the statement I 
tried to make earlier. These masks work, and one thing you will 
know about when you go to a dentist, everyone is masked up. So 
I can say that we have not had evidence--outbreaks that we have 
linked back to dentists. I am not going to say it will never 
happen. But just like we reported recently, two hair salon 
people that were highly infected--they went and did their work 
to do, I think, over 150 people, but they wore masks. And there 
was no evidence of transmission. So I keep coming back to the 
importance of wearing masks.
    Senator Alexander. And I have one last question, and I 
understand Senator Murray would like to make a closing 
statement or question. So I will go to her when I finish.

                          ASYMPTOMATIC TESTING

    I want to go back to the CDC guidance on asymptomatic 
testing, which you acknowledged has created confusion. And I 
wonder what else you might be able to do to eliminate that 
confusion. And let me tell you why I think it is important.
    My feeling all along has been that it was a good idea to 
produce tens of millions of rapid tests so that anybody who 
wanted a test could get one basically. Now, from a medical 
point of view, there is no reason to do that. But that is not 
the only concern we have in the United States right now. I 
mean, we would like to go back to school. We would like to go 
back to college. We would like to go back to child care. We 
would like to go back to work. We would like to go out to eat. 
And if by frequent testing or surveillance testing or any of a 
whole number of strategies that test a lot of people who do not 
have symptoms, we build confidence that your school is a safe 
place, your college campus is a safe place, that your child 
care center is a safe place, that your workplace is safe, that 
your restaurant is safe. If we build confidence, we will have 
better lives.
    And so it seems to me, particularly since Admiral Giroir 
has said that we are now heading toward a situation where we 
may have 120 million, 150 million tests a month, we are going 
to have plenty of tests. We are going to have capacity for 
plenty of tests. And by frequent tests, I mean what if a school 
wanted to test every student at the beginning of school or at 
the beginning of a week for 2 or 3 weeks just to make sure that 
there was not some spreading and wanted to create a regime 
where you do random testing--surveillance testing is I think a 
word for it--of the kind of testing--when you go through the 
airport, for example, they pull you out of line every now and 
then and check to see if you have got explosives on your hands. 
That makes us feel better when we get on an airplane that we 
are not going to blow up. And so people fly, 2 million a day, 
without worrying too much about getting blown up by passengers 
with explosives on their hands.
    The University of Illinois, as one of you have mentioned, 
is I think testing twice a week. I think the University of 
Illinois must have 40,000-50,000 students and faculty members 
and staff on that campus. I know the President of Brown said 
she wanted to test everybody before they came back. I can 
imagine in a workplace that somebody would worry about working 
next to somebody who is infected and worry they might have--
just be afraid that they might have COVID, and would it not be 
a good idea for the manager to say come in here and take a 15-
minute test and you do not have it today? That is all that 
means. Or you could say to all your employees we give you tests 
if you are symptomatic, but we also give random tests on a 
regular basis throughout the plant so you can have more 
confidence when you come back to work.
    So it seems to me that it is a good thing for our country 
to have more tests than we need, more rapid tests than we need 
so that anyone who wants a test can get one if they feel it is 
necessary.
    Now, I think once they know that they can, they will not 
want one. And I think that is one reason we are seeing a lower 
demand in other parts of the country because people understand 
the limited value of a diagnostic test. It just tells you on 
that one day whether you have it.
    But this is a little bit of a long question, but what I am 
trying to get around to, is there some way that the CDC could 
clear up whatever confusion has been caused and make it clear 
that since we now have such a large supply of tests, that 
different strategies for testing people without symptoms is a 
perfectly good idea and does not take tests away from 
healthcare professionals or people in nursing homes or assisted 
living or people like that? That clearly would help I think, as 
we move into October, November, and December, to encourage 
people to use this growing number especially of rapid tests 
that we have to build confidence that the school, the college, 
the child care center, the workplace, and the restaurant are 
safe places to go regularly check, and that would help us 
restore our economy. What could you do about clearing up the 
confusion?
    Dr. Redfield. Yes. I appreciate the comment, Senator.
    First--there are three areas here, but I will be very 
brief.
    First is we are working on a clarification document related 
to the diagnostic and public health use of testing. And again, 
we have never recommended against asymptomatic testing. You 
will see in the clarification it is very clear that we make it 
very clear that asymptomatic and pre-symptomatic transmission 
is important. We make it very clear that if you have been 
exposed to somebody, you need to be tested and contact traced. 
So that is going to come out hopefully--you know, I have done 
my clarification statement 24 hours after, but it did not solve 
the problem. So we are going to come out with that hopefully 
sometime in the next--I hope before the end of the week.
    Secondly--and the Admiral may want to comment--we are 
working on guidance because in addition diagnosis--public 
health, as you pointed out there is screening. And screening 
can be very powerful for maybe non-public health reasons, maybe 
getting us back to life and screening in schools, K through 12, 
screening in universities, screening in business. So you will 
see that CDC will be coming out, in conjunction with the 
Admiral--we will be coming out with some guidance around 
screening.
    Then there is the other word that you used, which we also 
believe is really important, which is surveillance where you 
can actually systematically begin to look at random individuals 
to get an idea is this outbreak starting to pop into a new 
community.
    So all three of those are important. All three of those you 
are going to see that we are developing follow-up guidance for. 
It really was not possible to really have a lot of that 
guidance when there was no test.
    Senator Alexander. Right.
    Dr. Redfield. But as you point out, Admiral Giroir has 
really done a yeoman's job with the private sector and really 
has gotten to the point now so that we have--we are going to 
try to clarify the clinical public health use. We are going to 
try to give guidance to screening particularly in K through 12s 
and universities, but it is also going to have a role in 
businesses and also in entertainment activity like sports. And 
then there is the other side of how to set up systematic 
surveillance so that we do not get blindsided by all of a 
sudden finding that there was a huge, new outbreak that we just 
did not have eyes on until it got too big.
    But, Admiral, do you want to----
    Senator Alexander. Admiral, do you want to add to that?
    Admiral Giroir. I just agree 100 percent with everything 
that has been said. We are going to continue to invest in a 
number of different types of platforms, but clearly low-cost, 
ultra-available, sensitive and specific tests like the 
BinaxNOW--and there are going to be more like that coming 
through. And again, we are going to increase that supply as 
much as possible. There also are going to be some new point-of-
care tests that are actually very sophisticated and very 
sensitive and specific that could be layered on top of the 
Binax. And our goal is to provide as many tools as possible in 
the right domain so we could implement this type of guidance.
    Again, in March, it does not make sense to talk about 
random screening of children going to school because you did 
not have that available. Now that we have a very robust 
ecosystem of testing, this is the exact right time, which is 
why we purchased 150 million of those card-based tests while we 
have point-of-care and distributing them first to protect the 
vulnerable, but then within a couple weeks, they are going out 
to States to support school reopening and other infrastructure 
according to their priorities. We are at that point.

                         DISTRIBUTION OF TESTS

    Senator Alexander. Now, how many will be going out to 
States in a couple of weeks? Could you give me a rough idea?
    Admiral Giroir. So when Binax--when Abbott gets to their 
full production capability, about 12 million per week, which 
will be within a few weeks, we anticipate, depending on how 
things go with the nursing homes, et cetera, somewhere between 
5 million to 8 million per week going to States that we could 
provide them for those needs. Again, if the cases continue to 
go down in nursing homes, we will need less and less tests to 
protect the nursing homes. If it stays high----
    Senator Alexander. So that is 5 million to 8 million a 
week?
    Admiral Giroir. Yes, sir.
    Senator Alexander. Well, 5 million to 8 million a week--
Tennessee is usually about 2 percent of everything. So that 
would mean a State like Tennessee would be getting a few 
hundred thousand tests a week or several hundred thousand tests 
a month at least that the State could distribute according to 
its priorities. Is that the general idea after you have--with 
that 5 million to 8 million?
    Admiral Giroir. Yes, sir. There is some policy discussion. 
We certainly want to support the States but we think it is a 
priority, as I know you do, to open education, K through 12, 
even pre-school and potentially universities. But I think 
universities are in a different class because they have 
resources. So we do want to emphasize very strongly the 
protection of teachers and the reopening of K through 12 as a 
significant priority.
    Senator Alexander. Well, I certainly do too. But some 
States are doing some things; some States are doing others. I 
think it is a good idea to reserve some of--first, I 
congratulate the administration on buying the full 3 months' 
supply of that which is, as I understand it, about 50 million 
tests a month starting in October, with several million this 
month, and then assigning it to the priorities like nursing 
homes, et cetera, and then giving a lot to States, which would 
be--I mean, if the State of Tennessee got 200,000 tests a week 
that it knew it could distribute during the rest of this school 
semester, my guess is many of them would go to schools because 
the ones who are most worried about that are not the kids, it 
is the teachers and the parents and the grandparents when the 
kids go home. So I think that is a tremendously reassuring 
prospect that a State might receive that many rapid tests just 
from that source.
    And, Dr. Redfield--and we will conclude with this because I 
think Senator Murray does not want to say anything now. But one 
time, you and I had a discussion about a guidance that used 
examples. I think we talked about colleges, and I think you did 
that. And maybe one way to help clarify the use of tests for 
asymptomatic individuals would be to list five, six, eight, ten 
examples of schools, colleges, workplaces that are doing that 
now. That makes sense whether--and I will let you decide what 
those might be, and it would not be only those things. But I 
think if you said these are all the kinds of ways that this 
large number of tests that we have may be used effectively and 
sensibly to build confidence in going back to school, work, 
child care, and out to eat. That might be easier for people to 
read and understand than the words in a guidance. So the use of 
examples is a suggestion I would make.
    Dr. Redfield. I appreciate your advice, sir.
    Senator Alexander. Thanks to the three of you. As Senator 
Blunt said, we are grateful to you for your long hours, for 
your effective work, for your planning. And if the money that 
this appropriations subcommittee has targeted for you is not 
forthcoming in the way the Congress intended for it to be, we 
expect you to let Senator Blunt, Senator Murray, and others of 
us on the subcommittee know that.

                     ADDITIONAL COMMITTEE QUESTIONS

    The record will stay open for 1 week.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
           Questions Submitted to Admiral Brett Giroir, M.D.
                Questions Submitted by Senator Roy Blunt
                          vaccine distribution
    Question. Which agency is lead for managing the vaccine 
distribution plan?
    Answer. Operation Warp Speed (OWS) is a joint effort that utilizes 
a whole-of-America approach that leverages the expertise and experience 
of the Department of Health and Human Services (HHS) and the Department 
of Defense. As the vaccine manufacturing process continues, the focus 
of OWS moves to supporting the Centers for Disease Control and 
Prevention (CDC) in planning and execution of the distribution and 
administration of any Food and Drug Administration (FDA) approved or 
authorized COVID-19 vaccine.
    CDC has successfully utilized both public and private 
infrastructure to deliver vaccines in the past, and the current 
planning efforts within the CDC jurisdictional framework builds upon 
the existing CDC structure in the distribution of COVID-19 vaccines. As 
the distribution of these crucial life-saving vaccines begins, CDC will 
execute the distribution plan.
    Question. What assumptions is HHS making about the quantity of 
vaccine that will be distributed in November and December?
    Answer. Biological science is an unpredictable art, and the process 
of developing an FDA licensed or authorized vaccine can involve 
unanticipated issues. The highest standards of science drive the 
decisions being made regarding these vaccines; this process results in 
an imprecise timeline for vaccine approval. Currently, there are four 
vaccine candidates in Phase III clinical trials and two additional 
candidates approaching this critical milestone. All six of these 
vaccine candidates are in the process of being manufactured at-scale.
    Based on the data from these clinical trials, a vaccine 
manufacturer will submit to FDA either a request for an Emergency Use 
Authorization (EUA) or a Biologics License Application (BLA). After 
authorization or licensure of a candidate vaccine, demand will most 
likely outweigh supply, necessitating allocation of the limited number 
of initially available doses. A prioritization policy will be informed 
by the National Academies of Sciences, Engineering, and Medicine 
(NASEM), and a formal recommendation by the independent Advisory 
Committee on Immunization Practices (ACIP) that has been adopted by the 
CDC Director.
                             reagent supply
    Question. We have seen, firsthand, during the COVID-19 pandemic 
supply shortages affecting the ability to do wide scale testing. In 
particular, I'm concerned with the upcoming flu season we may continue 
to experience strain on the supply chain for raw materials. Can you 
discuss the importance of these raw materials if we need to ramp up 
testing and what we are doing to address another sharp spike in demand?
    Answer. To enable States to achieve the testing goals developed in 
coordination with the Federal Government, the Federal Government has 
worked with manufacturers to gain insight into diagnostic instrument 
install bases; procured and shipped collection supplies; and determined 
reagent inventory. The Federal Government then provided all information 
to States so they could better determine how to optimize their testing 
strategy. States, including the District of Columbia, selected large 
cities and territories have now submitted two iterations of their 
testing plans. These plans were developed in collaboration with Federal 
multidisciplinary experts through teleconferences and other meetings. 
Plans were reviewed by a multidisciplinary Federal team that included 
leadership from CDC, the Immediate Office of the Secretary, and the 
Office of the Assistant Secretary for Health. To ensure that 
jurisdictions meet their testing goals, the Federal Government procured 
swabs and transport media, and is distributing these supplies to a 
single location in each State determined by the Governor or Mayor's 
office. Starting in May and through September 11, the Federal 
Government has distributed over 95 million swabs and more than 77 
million tubes of transport media. These supplies were provided to 
jurisdictions over the course of each month to equip them with 
sufficient materials to meet their specific testing goals.
    To further secure and galvanize the testing supply chain in the 
United Sates, the Federal Government used the Defense Production Act 
(DPA). One example of leveraging the DPA to increase the production of 
supplies was the investment in Puritan Medical Products. After in- 
depth market research on testing availability and producibility, the 
Federal Government applied DPA title III authorities to award a $75.5 
million contract to Puritan Medical Products to increase foam specimen 
collection swab manufacturing capacity by 20 million swabs per month. 
An additional swab requirement was identified for both COVID-19 and 
influenza specimen collection; a second expansion investment of $51.15 
million CARES Act funds in Puritan (the only U.S. based manufacturer of 
flock tip swabs) to produce an additional 45 million flock tip swabs 
per month. HHS is leveraging all authorities, including DPA title III, 
to acquire additional testing capability. HHS has exercised title I DPA 
authorities using the Health Resource Priority and Allocations System 
(HRPAS) in order to prioritize contract action to compel a direct 
response to the place of greatest need. A number of health resource 
materials have been identified that are essential to respond to the 
COVID-19 pandemic; however, these items, like PPE and ventilators, are 
in high demand. Utilizing this authority has enhanced national 
preparedness and is helping ensure there is product available if and 
when it is needed.
    Because the Federal Government has equipped jurisdictions with the 
materials they need to meet or exceed their State testing plans each 
month, the United States has conducted over 125 million COVID-19 tests 
and capacity continues to increase. Since early March, we have 
increased our daily testing by over 30,000 percent. These efforts and 
the increased availability of point of care testing will ensure the 
Unites States will be equipped to conduct the amount of testing needed 
during flu season and if there is a spike in cases.
    The supply chain for raw components and consumables, the 
manufacturing capacity to produce diagnostic tests, and, in many cases, 
the instrument systems needed to perform the tests are to a great 
extent common for both SARS-CoV-2 and Influenza testing. Because 
existing manufacturing capacity is operating at maximum for SARS-CoV-2 
response, influenza testing with a separate test would reduce available 
COVID-19 testing capacity. Foreseeing this issue, ASPR/BARDA, CDC, and 
industry began work in the summer to develop multiplexed tests that 
test for both SARS-CoV-2 and influenza simultaneously in one testing 
action. Though there are a small additional amount of reagents needed 
for these multiplexed tests, the majority of the components that are in 
short supply (e.g. swabs, plastic consumables, pipette tips, etc.) can 
be used for both tests and no additional supply is needed. These 
multiplexed tests can also be performed in the same amount of time as 
one single test so no testing capacity negative impact either. Three 
multiplex tests ASPR/BARDA has funded have received emergency use 
authorization (EUA) so far, CDC has developed and received an EUA for a 
multiplexed test for public health lab use, and industry has developed 
and received EUAs for an additional three multiplexed tests so far in 
preparation for influenza season. More multiplexed tests are in 
development.
    Question. Admiral Giroir and Dr. Redfield, we all hope and expect 
that the U.S. will develop a safe and effective COVID-19 vaccine first. 
When that happens, what is our strategy for deploying this vaccine 
internationally and how is its coordination being implemented? What 
discussions have you had with other countries or international 
organizations about the plan to ensure that a vaccine is distributed to 
more countries than those that can produce them or afford to buy them?
    Answer. CDC is building on its longstanding global immunization 
efforts focused on polio, measles, influenza, and other priorities, and 
is planning to use CARES Act funding to provide technical assistance 
and help ensure select low- and middle-income countries are ready and 
able to deploy and evaluate COVID-19 vaccines when they become 
available. Through CDC country offices around the world, and through 
headquarters-based subject matter experts, CDC is beginning to engage 
international organizations and select low- and middle-income partner 
countries to support these efforts.
    The COVID-19 pandemic has demonstrated once again that infectious 
diseases do not respect borders and threaten local, regional, and 
global economies. Recognizing the critical role that medical 
countermeasures play in controlling and ending a public health 
emergency, especially in a pandemic, the U.S. Government remains 
committed to working closely with partners overseas to mitigate the 
impact of this devastating pandemic.
    Question. Admiral Giroir, even though the Chinese have not yet 
developed a safe and effective coronavirus vaccine, they have already 
started a so-called charm offensive to provide access to a Chinese 
vaccine to pro-Chinese nations as well as using it to repair damaged 
diplomatic ties with other nations. What steps are we taking to counter 
China's aggressive COVID-diplomacy? And how is the Department working 
with USAID and the State Department on the international response?
    Answer. HHS is working with other countries in the Indo-Pacific and 
around the world to communicate U.S. values and to highlight successful 
COVID-19 responses among friendly nations. Most significantly, in 
August, Secretary Azar became the highest ranking Cabinet Secretary to 
travel to Taiwan since the U.S. established diplomatic relations with 
the People's Republic of China in 1979. His trip emphasized U.S. 
support for Taiwan's role as a leader in COVID-19 response, as 
evidenced by their transparent and highly effective evidence based 
COVID-19 response and Taiwan's ability to access a COVID-19 vaccine 
when a safe and effective vaccine becomes available. HHS also has been 
working through regional bodies in Asia to support other like-minded 
country responses and to counter Chinese narratives that falsely assert 
their leadership in the global response to COVID-19. Misinformation and 
disinformation have been serious problems throughout the pandemic, 
especially regarding the development of COVID-19 vaccine candidates. 
The urgent need exists to address and manage COVID-19 misinformation 
and disinformation, and to continuously dispel myths and re-assert 
facts with evidence.
                          provider relief fund
    Question. Admiral Giroir, by my count, HHS has yet to announce how 
$52 billion of the Provider Relief Fund will be allocated. Hospitals 
need funding now. Can you outline how and when you think the remaining 
resources will be distributed to providers?
    I am concerned that HHS is holding back the Provider Relief funding 
because you may be planning to transfer it to another account. Should I 
be concerned?
    Answer. From the very start of this pandemic, HHS has led a whole-
of-government, whole-of-America approach to defeating the virus. A 
critical part of that work includes ensuring that our healthcare system 
remains strong and financially viable during this unprecedented time. 
HHS is distributing $175 billion to hospitals and healthcare providers 
on the front lines of the COVID-19 response via the Provider Relief 
Fund (www.hhs.gov/providerrelief).
    HHS acted quickly to distribute the Phase 1 General Distribution 
payments on a rolling basis beginning on April 10, 2020. These payments 
were made to providers who billed Medicare on a fee-for-service basis 
(Parts A or B) in Calendar Year 2019. For example, as of September 14, 
2020, HHS has made 16,472 payments totaling more than $2.1 billion to 
healthcare providers in Pennsylvania.
    In June, HHS began making General Distribution payments to Medicaid 
and Children's Health Insurance Program providers, dentists, and 
assisted living facilities. HHS further expanded this Phase 2 General 
Distribution to Medicare providers that have not received a full 
payment, including Medicare Part A providers who experienced a change 
of ownership in 2019 or 2020 that was approved by the Centers for 
Medicare & Medicaid Services as of August 10, 2020. Phase 2 payments 
are made on a rolling basis to providers based on approximately 2 
percent of a provider's annual revenue from patient care. As of 
September 14, 2020, HRSA has distributed more than $104 million to 
2,191 providers in Pennsylvania as part of this distribution.
    On October 1, HHS announced $20 billion for another General 
Distribution allocation of the Provider Relief Fund. For this Phase 3 
funding, applicants that have not yet received payments of 2 percent of 
patient revenue will receive a payment that, when combined with prior 
payments (if any), equals 2 percent of patient revenue. Phase 3 
payments will also consider changes in patient care revenues and 
increased expenses incurred related to the coronavirus. Providers will 
have from October 5, 2020 through November 6, 2020 to apply for Phase 3 
General Distribution funding.
    Question. Beyond the General Distributions, HHS made several 
Targeted Distributions to facilities and geographic areas that have 
been particularly susceptible to lost revenue or increased healthcare 
expenses as a result of the pandemic. Admiral Giroir, Congress 
appropriated $175 billion for the Provider Relief Fund to make sure our 
healthcare providers keep their doors open as coronavirus continues to 
change how frequently patients go to their doctors. I want to 
acknowledge the challenges the Department has faced in executing these 
funds and the effort made to get funds to those who need it. At the 
same time, I hear from many different providers, particularly 
behavioral health providers, that they continue to have challenges 
accessing funds. What more can HHS do to make sure all providers are 
being treated equally and that providers that focus on mental health 
services are not overlooked?
    Answer. In the Phase 3 General Distribution, an expanded group of 
behavioral health and other providers will be eligible for relief 
payments. While behavioral health providers who participate in 
Medicare, Medicaid, and Children's Health Insurance Program (CHIP) have 
had the opportunity to apply for prior General Distribution payments, 
others have not. Working with the Substance Abuse and Mental Health 
Services Administration (SAMHSA), HRSA developed a list of the nation's 
behavioral health providers now eligible for funding, which includes, 
for example, addiction counseling centers, mental health counselors, 
and psychiatrists.
    Phase 3 will take into account documentation of the financial 
impact of COVID-19 by assessing a provider's change in operating 
revenues and expenses. The Phase 3 payment methodology also ensures 
providers have received 2 percent of annual revenue from patient care.
    Question. I applaud the Department's release of a comprehensive 
Rural Action Plan earlier this month. It is important to note the 
significant challenges rural communities face with regard to the 
healthcare infrastructure and that nearly 1 in 5 Americans live in a 
rural community. COVID-19 is only exacerbating the challenges facing 
rural healthcare providers. Can you speak to the targeted distribution 
of provider relief funds to rural communities and any ongoing gaps in 
funding to rural healthcare providers? HHS has targeted $11 billion to 
rural healthcare providers that is less than 10 percent of the Provider 
Relief Fund. Can we anticipate another tranche of funding to rural 
communities specifically and when would this occur?
    Answer. HHS identified 4,460 organizations that were eligible for 
the Rural Targeted Distribution. These organizations operate 11,640 
healthcare delivery sites including 2,374 rural hospitals and critical 
access hospitals, 383 hospitals in small metro areas or with Medicare 
special payment designations, 4,655 Rural Health Clinics, and 4,228 
Community Health Center sites in rural areas.
    Rural providers were also eligible for other General and Targeted 
Distributions. As of November 17, 2020, providers located in rural and 
frontier areas received approximately $21 billion across all Provider 
Relief Fund distributions.
    At this point, HHS does not anticipate an additional Targeted 
Distribution for rural communities. Providers in rural areas are 
eligible to apply for Phase 3 General Distribution payments.
                                testing
    Question. The Paycheck Protection Program and Health Care 
Enhancement Act included over $8 billion to give flexibility to the 
Administration to address future testing needs. How much of that 
funding remains unspent? What is the plan and timing for allocation of 
those resources? Why is HHS not spending this funding when we know that 
testing is still in short supply across the country?
    Answer. The testing infrastructure in the United States has been 
galvanized and has reached unprecedented levels. The U.S. has conducted 
over 125 million tests, at an average current rate of about 1 million 
tests per day, with enough tests in the market to perform three to four 
times that amount. Since early March, we have increased our daily 
testing by over 30,000 percent. Turnaround time in providing test 
results continues to improve. Currently, in the cases of 97 percent of 
tests that were performed by American Clinical Laboratory Association 
laboratories and that were ordered in the previous week, the 
individuals received results within 3 days, and 99 percent received 
results within 5 days. In June, July, and August, States far surpassed 
their goals for testing. Specifically, State goals for June were 12.9 
million tests, and nearly 16 million were actually performed. The goals 
for July were 13.7 million tests; again, States far exceeded their 
goals by conducting over 25 million tests. In August the nation 
completed over 25.2 million tests, far exceeding the August goal of 
21.1 million tests. The United States continues to conduct testing at a 
large scale and as more point of care tests are developed and become 
available, the testing capacity will continue to increase HHS continues 
to leverage funds to support, grow, and drive the testing 
infrastructure in the United States.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Admiral Giroir, I want to commend you for your efforts in 
supporting the manufacturing of vaccine candidates to ensure a 
sufficient supply upon approval. I believe a safe and effective vaccine 
is the pathway for America's return to normal daily life. But there are 
still people that are vulnerable to the virus who become infected and 
could greatly benefit from a treatment. I think vaccines and 
therapeutics can both be a priority. I understand that there are some 
therapeutic candidates currently undergoing stage III clinical trials 
that have shown promising results. Why is OWS not funding the 
manufacturing of promising therapeutic candidates to prepare for the 
winter season?
    Answer. BARDA, in conjunction with OWS, has a strong ongoing effort 
to support development of many therapeutic candidates. OWS and BARDA 
are supporting platform clinical trials under the Accelerating COVID-19 
Therapeutic Interventions and Vaccines (ACTIV) public private 
partnership, which was announced in April 2020 by the National 
Institutes of Health (NIH), and is being coordinated by the Foundation 
for NIH. The five platform trials (ACTIV 1 through 5) allow for testing 
multiple therapeutics in the same trial. This is the most efficient use 
of funding and clinical resources, which have been stretched thin 
throughout the pandemic response.
    Individual funding awards to companies for research and development 
have focused on candidate therapeutics with the highest likelihood of 
success, such as the monoclonal antibody therapeutics that are being 
developed using platform technologies that were established for other 
pathogens like influenza and Ebola.
    Additionally, the antibody testing and collection of convalescent 
plasma has been a pillar of the OWS therapeutic response. While we are 
still investing in randomized, controlled clinical trials to study the 
safety and effectiveness of this investigational product, which was 
issued an EUA, we are encouraged by the early results from the expanded 
access protocol. The therapeutic portfolio will continue to evolve in 
the coming weeks as results from clinical trials become available.
    Lastly, OWS provided PPE and COVID-19 test capabilities critical to 
the clinical teams executing therapeutics trials and staffed a 
logistics support element dedicated solely to the advancement of the 
therapeutics effort's clinical trial needs. That team is posturing to 
deliver trial-site expansion capabilities to prospective test locations 
to advance and accelerate their programs' subject enrollment.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
                         unspent testing funds
    Question. Admiral Giroir, 5 months ago Congress appropriated $25 
billion to expand COVID-19 testing capacity through the Paycheck 
Protection Program and Health Care Enhancement Act. To date, the 
Department has yet to spend approximately $12 billion of this funding. 
HHS' spend plans submitted to this committee outline comprehensive 
testing-related activities focused on procurement and distribution, POC 
diagnostics, serological testing, community based testing, and building 
future capacity all from a large $8.3 billion flexible pot of funding 
that was provided to the Department.
    How much of the $8.3 billion in ``other activities'' funding 
provided to HHS under the Public Health and Social Services Emergency 
Fund through the Paycheck Protection Program and Health Care 
Enhancement Act have been obligated?
    Why, as States across the country grapple with trying to get this 
virus under control, has HHS not spent more of these resources to build 
up our testing capacity?
    To date, none of the $1 billion provided for testing for the 
uninsured has been obligated. Please explain why these funds continue 
to languish in Federal coffers.
    Answer. The testing infrastructure in the United States has been 
galvanized and has reached unprecedented levels. The U.S. has conducted 
over 125 million tests, at an average current rate of about 1 million 
tests per day, with enough tests in the market to perform three to four 
times that amount. Since early March, we have increased our daily 
testing by over 30,000 percent. Turnaround time in providing test 
results continues to improve. Currently, in the cases of 97 percent of 
tests that were performed by American Clinical Laboratory Association 
laboratories and that were ordered in the previous week, the 
individuals received results within 3 days, and 99 percent received 
results within 5 days. In June, July, and August, States far surpassed 
their goals for testing. Specifically, State goals for June were 12.9 
million tests, and nearly 16 million were actually performed. The goals 
for July were 13.7 million tests; again, States far exceeded their 
goals by conducting over 25 million tests. In August the nation 
completed over 25.2 million tests, far exceeding the August goal of 
21.1 million tests. The United States continues to conduct testing at a 
large scale and as more point of care tests are developed and become 
available, the testing capacity will continue to increase.
    One example of leveraging funds to increase the amount of tests 
available is the HHS procurement and distribution of point of care 
tests. On August 27th, the Administration announced that a $760million 
contract was awarded to Abbott for the delivery of 150 million rapid 
BinaxNOW COVID-19 Ag Card point-of-care tests. This initiative will 
expand strategic testing in the United States. The Abbott BinaxNOW 
COVID-19 Ag Card, which recently received an EUA from the FDA, does not 
require instrumentation and generally delivers COVID-19 test results in 
15 minutes or less. This test uses nasal swabs and can be easily 
deployed in many settings across the country.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
           expediting allocation of covid-19 testing funding
    Question. Continued expansion of testing capacity and improved 
contact tracing will be critically important to our effort to mitigate 
the spread of COVID-19 this fall. That's why I'm concerned with the 
slow pace at which HHS is distributing the $25 billion that Congress 
provided in COVID-19 testing funding. It's been almost 5 months, and to 
date, HHS has only allocated about half of the money.
    Dr. Giroir, when will HHS distribute the rest of the testing 
dollars?
    Answer. As new technologies and opportunities arise, HHS will 
allocate funds based on the needs of the United States and based on the 
current data on the pandemic and the options available. The testing 
infrastructure in the United States has been galvanized and has reached 
unprecedented levels. The U.S. has conducted over 125 million tests, at 
an average current rate of about 1 million tests per day, with enough 
tests in the market to perform three to four times that amount. Since 
early March, we have increased our daily testing by over 30,000 
percent.
                                 ______
                                 
              Questions Submitted by Senator Brian Schatz
    Question. Why have daily testing numbers declined between the 
summer and September?
    Answer. As of October 13, 2020 the 7 day average for COVID-19 tests 
has exceeded 1 million tests, and continues to grow. Since early March, 
we have increased our daily testing by over 30,000 percent Daily 
testing numbers continue to increase and the turnaround times are 
continuing to improve as well. The United States has conducted over 125 
million COVID-19 and with the investments made by the Federal 
Government, the success in galvanizing the testing infrastructure in 
the United States, and the introduction of new technologies, testing 
numbers will continue to increase.
    Question. At the hearing, Admiral Giroir stated that supply chain 
issues have not played a role in declines in the number of new tests, 
yet this is not consistent with the experience of labs in Hawaii, which 
recently faced significant supply chain shortages of pipette tips and 
test kits that meant they could not maximize their testing capacity. In 
addition, a recent survey found that 67 percent of labs surveyed 
reported issues getting test kits and reagents and that shortages had 
recently become worse.\1\ Why did Admiral Giroir state that there are 
no supply chain issues?
---------------------------------------------------------------------------
    \1\ https://www.wsj.com/articles/covid-19-testing-is-hampered-by-
shortages-of-critical-ingredient-11600772400.
---------------------------------------------------------------------------
    Answer. To enable States to achieve the testing goals developed in 
coordination with the Federal government, the Federal government has 
worked with manufacturers to gain insight into diagnostic instrument 
install bases; procured and shipped collection supplies; and determined 
reagent inventory. The Federal Government then provided all information 
to States so they could better determine how to optimize their testing 
strategy. States and territories have now submitted two iterations of 
their testing plans. These plans were developed in collaboration with 
Federal multidisciplinary experts through teleconferences and other 
meetings. Plans were reviewed by a multidisciplinary Federal team that 
included leadership from CDC, the Immediate Office of the Secretary, 
and the Office of the Assistant Secretary for Health. To ensure States 
meet their testing goals, the Federal Government procured swabs and 
transport media, and is distributing these supplies to a single 
location in each State determined by the Governor's office. Starting in 
May and through September 11, the Federal Government has distributed 
over 95 million swabs and more than 77 million tubes of transport 
media. These supplies are provided to States throughout the month to 
equip them with sufficient materials to meet their specific testing 
goals.
    To further secure and galvanize the testing supply chain in the 
United Sates, the Federal Government has utilized the Defense 
Production Act. One example of leveraging the DPA to increase the 
production of supplies was the investment in Puritan Medical Products. 
After in-depth market research on testing availability and 
producibility, the Federal Government applied DPA title III authorities 
to award a $75.5 million contract to Puritan Medical Products to 
increase foam specimen collection swab manufacturing capacity by 20 
million swabs per month. An additional swab requirement was identified 
for both COVID- 19 and flu specimen collection; a second expansion 
investment of $51.15 million CARES Act funds in Puritan (the only U.S. 
based manufacturer of flock tip swabs) to produce an additional 45 
million flock tip swabs per month. HHS is leveraging all authorities, 
including DPA title III, to acquire additional testing capability. HHS 
has exercised title I DPA authorities using the Health Resource 
Priority and Allocations System (HRPAS) in order to prioritize contract 
action to compel a direct response to the place of greatest need. A 
number of health resource materials have been identified that are 
essential to respond to the COVID-19 pandemic; however, these items, 
like PPE and ventilators, are in high demand. Utilizing this authority 
has enhanced national preparedness and is helping ensure there is 
product available if and when it is needed.
    Because the Federal Government has equipped States with the 
materials they need to meet or exceed their State testing plans each 
month, the United States has conducted over 125 million COVID-19 tests 
and capacity continues to increase. Since early March, we have 
increased our daily testing by over 30,000 percent. Turnaround time in 
providing test results continues to improve. Currently, in the cases of 
97 percent of tests that were performed by American Clinical Laboratory 
Association laboratories and that were ordered in the previous week, 
the individuals received results within 3 days, and 99 percent received 
results within 5 days. These efforts and the increased availability of 
point of care testing will ensure the Unites States will be equipped to 
conduct the amount of testing needed during flu season and if there is 
a spike in cases.
    Question. Has the administration taken every step possible to ramp 
up manufacturing of tests, including utilizing the Defense Production 
Act to the fullest extent? Has the DPA been used to increase 
manufacturing of pipette tips?
    Answer. One example of leveraging the DPA to increase the 
production of supplies was the investment in Puritan Medical Products. 
After in-depth market research on testing availability and 
producibility, the Federal Government applied DPA title III authorities 
to award a $75.5 million contract to Puritan Medical Products to 
increase foam specimen collection swab manufacturing capacity by 20 
million swabs per month. An additional swab requirement was identified 
for both COVID-19 and flu specimen collection; a second expansion 
investment of $51.15 million CARES Act funds in Puritan (the ONLY U.S. 
based manufacturer of flock tip swabs) to produce an additional 45 
million flock tip swabs per month. HHS is leveraging all authorities, 
including DPA title III, to acquire additional testing capability. HHS 
has exercised title I DPA authorities using the Health Resource 
Priority and Allocations System (HRPAS) in order to prioritize contract 
action to compel a direct response to the place of greatest need. A 
number of health resource materials have been identified that are 
essential to respond to the COVID-19 pandemic; however, these items, 
like PPE and ventilators, are in high demand. Utilizing this authority 
has enhanced national preparedness and is helping ensure there is 
product available if and when it is needed.
    Information in regards to the use of the DPA as it relates to 
testing and related materials can be found in the numerous National 
Testing Strategy Reports to Congress that have been submitted.
    Question. Why has HHS failed to obligate almost half of the $25 
billion in funding that Congress appropriated for testing? When does 
HHS plan to spend those funds?
    Answer. The testing infrastructure in the United States has been 
galvanized and has reached unprecedented levels. The U.S. has conducted 
over 125 million tests, at an average current rate of about 1 million 
tests per day, with enough tests in the market to perform three to four 
times that amount. Since early March, we have increased our daily 
testing by over 30,000 percent. Turnaround time in providing test 
results continues to improve. Currently, in the cases of 97 percent of 
tests that were performed by American Clinical Laboratory Association 
laboratories and that were ordered in the previous week, the 
individuals received results within 3 days, and 99 percent received 
results within 5 days. In June, July, and August, States far surpassed 
their goals for testing. Specifically, State goals for June were 12.9 
million tests, and nearly 16 million were actually performed. The goals 
for July were 13.7 million tests; again, States far exceeded their 
goals by conducting over 25 million tests. In August the nation 
completed over 25.2 million tests, far exceeding the August goal of 
21.1 million tests. The United States continues to conduct testing at a 
large scale and as more point of care tests are developed and become 
available, the testing capacity will continue to increase.
    One example of leveraging funds to increase the amount of tests 
available is the HHS procurement and distribution of point of care 
tests. On August 27th, the Administration announced that a $760 million 
contract was awarded to Abbott for the delivery of 150 million rapid 
BinaxNOW COVID-19 Ag Card point-of-care tests. This initiative will 
expand strategic testing in the United States. The Abbott BinaxNOW 
COVID-19 Ag Card, which recently received an EUA from the FDA, does not 
require instrumentation and generally delivers COVID-19 test results in 
15 minutes or less. This test uses nasal swabs and can be easily 
deployed in many settings across the country.
    To further secure and galvanize the testing supply chain in the 
United Sates, the Federal Government has utilized the Defense 
Production Act. One example of leveraging the DPA to increase the 
production of supplies was the investment in Puritan Medical Products. 
After in-depth market research on testing availability and 
producibility, the Federal Government applied DPA Title III authorities 
to award a $75.5 million contract to Puritan Medical Products to 
increase foam specimen collection swab manufacturing capacity by 20 
million swabs per month. An additional swab requirement was identified 
for both COVID- 19 and flu specimen collection; a second expansion 
investment of $51.15 million CARES Act funds in Puritan (the only U.S. 
based manufacturer of flock tip swabs) to produce an additional 45 
million flock tip swabs per month. HHS is leveraging all authorities, 
including DPA title III, to acquire additional testing capability.
    HHS is utilizing funds based on available technologies, data and 
the needs across the country. We will continue to ensure that the 
testing infrastructure throughout the country is supported and grows.
    Question. Why hasn't HHS developed a national testing plan, which 
States and public health experts have pleaded for?
    Answer. HHS and the Federal Government have released numerous 
documents enumerating and laying out the national testing plan. The 
administration released the Opening Up America Again Guidelines: 
Testing Overview on April 27, 2020 and on that same day the Opening 
America Again Guidelines: Testing Blueprint was released. These 
documents outline the test strategy early on in the pandemic and 
several documents have followed that provided further detail. On June 
15, 2020 the Addendum to the Testing Blueprint was released which 
provided more details to the national testing strategy. Furthermore, 
HHS submitted on May 24, 2020 the COVID-19 Strategic Testing Plan 
Report to Congress, this 84 page document clearly lays out and provides 
information about the national testing plan. On August 22, 2020 the 
first update to the COVID-19 Strategic Testing Plan Report to Congress 
was submitted. This first update to the report was 142 pages of 
information about the national testing plan. On November 20, 2020 the 
second update to the COVID-19 Strategic Testing Plan Report to Congress 
was submitted. This second update was 22 pages of additional 
information in regards to the national testing plan. All of these 
documents have been made widely available to Congress, States, and the 
American people.
    The CDC has also released many testing related guidance documents 
and technical assistance that further provide States and public health 
experts with information on how to implement testing in a variety of 
settings.
    Question. How is it effective for States, cities, schools, and 
other institutions to compete against each other and individually 
manage testing resources?
    Answer. To ensure States meet their testing goals, the Federal 
Government procured swabs and transport media, and is distributing 
these supplies to a single location in each State determined by the 
Governor's office. Starting in May and through September 11, the 
Federal Government has distributed over 95 million swabs and more than 
77 million tubes of transport media. These supplies are provided to 
States throughout the month to equip them with sufficient materials to 
meet their specific testing goals and many States have continued to 
exceed their testing goals each month. Equipping States with the 
materials they need to meet or exceed their testing goals has reduced 
competition for supplies and for the governors of each State to 
determine how best to meet the needs of their State. Also, as stated 
before, there are currently more tests in the market place to test 
three to four times the amount typically tested each day.
    On August 27, 2020, the Administration announced that a $760 
million contract was awarded to Abbott for the delivery of 150 million 
rapid BinaxNOW COVID-19 Ag Card point-of-care tests. HHS will 
distribute approximately 100 million tests to States and territories 
through the end of December 2020, distributed by proportion of their 
population. Governors will determine the best use of tests for their 
States; suggested deployment includes use cases for which a low-cost, 
rapid, easily administered test is uniquely able to fill State needs, 
such as opening of K-through-12 schools through testing of teachers, 
staff, and students, protecting first responders, supporting critical 
infrastructure, enhancing higher education programs, and other 
priorities the governors deem fit. Overall, we have distributed over 58 
million BinaxNOW tests to date.
    Question. What is HHS' exact role in the allocation and 
distribution of diagnostic tests and testing supplies from private 
companies to labs across the country?
    Does HHS instruct diagnostic and medical supply companies how to 
allocate test kits and testing instruments? How are these decisions 
made?
    What improvements should HHS make in its testing distribution 
process?
    Answer. HHS has exercised title I DPA authorities using the Health 
Resource Priority and Allocations System (HRPAS) in order to prioritize 
contract action to compel a direct response to the place of greatest 
need. A number of health resource materials have been identified that 
are essential to respond to the COVID-19 pandemic; however, these 
items, like PPE and ventilators, are in high demand. Utilizing this 
authority has enhanced national preparedness and is helping ensure 
there is product available if and when it is needed. Allocation and 
prioritization, when used, are based off of data and where these 
supplies are needed the most and decisions are made by the Coronavirus 
Taskforce. Testing distribution is guided by the national testing 
strategy and implemented by States based off of their testing plans 
that have been reviewed by experts at HHS and CDC.
    Question. At the beginning of the pandemic, did State public health 
departments have adequate staff capacity, resources, and infrastructure 
to respond to a crisis of this magnitude?
    Answer. The COVID-19 pandemic put a spotlight on the needs and 
disparities in public health infrastructure and highlighted the 
importance of public health core capabilities across the country and 
throughout the world. These core capabilities form the backbone of 
CDC's capacity to protect America's health. A strong public health 
system includes robust data and analytics, laboratory capacity, a top-
tier workforce, rapid response capabilities and a broad global 
footprint to stop disease at its source. The Administration worked 
closely with Congress to ensure that State and local public health 
departments had necessary resources to respond to COVID-19.
    Question. To what extent has the lack of investment in public 
health increased spending, delays, and ultimately the loss of life as 
health departments struggled to hire staff and upgrade technology 
during the pandemic?
    Answer. The COVID-19 pandemic put a spotlight on the needs and 
disparities in public health infrastructure across the country and 
throughout the world. The Administration worked closely with Congress 
to ensure that State and local public health departments had necessary 
resources to respond to COVID-19.
    Question. Public health experts have proposed that key health 
defense line items at CDC, BARDA, and NIH should not be subject to 
annual budget caps in order to sufficiently invest in the country's 
health security. Does HHS agree that this proposal would be beneficial, 
and would it help us prepare for the next pandemic?
    Answer. The structure of the President's Budget and current 
Congressional appropriations does not contemplate excluding health line 
items in HHS from annual budget caps.
                                 ______
                                 
            Questions Submitted by Senator Joe Manchin, III
                             drug epidemic
    Question. A majority of adults believe the pandemic is taking a 
toll on their mental health and one in three adults report symptoms of 
anxiety (up from one in twelve last summer). Reports of drug overdoses 
are on the rise as well, triggered by the factors that are contributing 
to mental health issues, with recent reports estimating that 75,000 
Americans are at risk of drug overdose and suicide due to this 
pandemic. Social isolation, increased anxiety, and economic and social 
pressure have created what experts are calling a ``perfect storm'' for 
suicide and substance misuse. West Virginia has been ravaged by the 
drug epidemic and we already have some of the highest suicide rates in 
the country. Now we are facing these two public health crises at the 
same time as we combat the ongoing COVID-19 pandemic. What can we do to 
help ensure patients suffering from substance use disorder get the 
resources they need?
    Answer. During the COVID-19 pandemic, normal resources that 
individuals may use to manage treatment or distraction from harmful 
substance using behaviors may no longer be available or have changed in 
important ways (e.g., no face-to-face contact). Lockdowns, shelter-in-
place orders, and social distancing have forced treatment facilities, 
social services, and support groups to shut down, reduce hours, or move 
online-leaving people who use drugs and those in recovery to face 
greater risks with less support. As CDC continues to work with states, 
territories, and localities to provide technical assistance to identify 
mitigation strategies. For example, one State is now using social media 
and other virtual communications to message the importance of naloxone.
    Harm reduction organizations, including syringe service programs 
(SSPs) and facilities that provide medications for opioid use disorder 
(MOUD), have had to adapt in the wake of this pandemic and change their 
practices in order to continue to serve their clients. In response, CDC 
is working to identify and support innovative and emerging practices. 
Strategies will be summarized in technical assistance tools for 
dissemination to partners.
    CDC is also working to curb and lower substance use patterns and 
attitudes among youth whose use has risen during COVID-19 CDC is 
working with States engaged in Overdose Data to Action (OD2A), a 3-year 
cooperative agreement that began in September 2019 and focuses on the 
drug overdose epidemic, to respond to the realities of how their work 
is changing in this environment. This includes assessing overdose data 
and to understand trends in light of COVID-19, as well as working with 
our 66 funded jurisdictions to provide flexibilities where needed and 
technical assistance to inform public health action during the 
pandemic.
    CDC Foundation has collaborated on a new initiative, called How 
Right Now, that addresses people's feelings of grief, loneliness, 
stress, and worry during the pandemic. This initiative is managed by 
NORC at the University of Chicago, with support from the CDC 
Foundation. CDC is providing technical assistance. The initiative 
offers information and resources (in English and Spanish) to help 
people cope and be resilient during this time, including a 
comprehensive suite of culturally appropriate materials from a variety 
of national partners.
    The current pandemic is unprecedented and it is likely to impact 
the health, safety, and well-being of individuals and communities for 
many years to come. The effects of emotional isolation, insecurity, 
economic hardship, school closures, furlough, unemployment, and reduced 
access to resources will translate into an array of emotional reactions 
(such as distress or psychiatric conditions), unhealthy behaviors (such 
as excessive substance use), and noncompliance with public health 
directives (such as home confinement and vaccination) among people 
directly and indirectly impacted by COVID-19. Extensive research in 
disaster mental health has established that emotional distress is 
ubiquitous in affected populations and that such times are associated 
with increased rates of substance abuse and treatment relapse.\2\
---------------------------------------------------------------------------
    \2\ Brooks SK, Webster RK, Smith LE, et al. The psychological 
impact of quarantine and how to reduce it: rapid review of the 
evidence. Lancet 2020;395:912-920.
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    Some groups may be more vulnerable than others to the psychosocial 
effects of a pandemic. In particular, people who contract the disease, 
those at heightened risk for it (including the elderly, people with 
compromised immune function, and those living or receiving care in 
group settings), and people with preexisting medical, psychiatric, or 
substance use problems are at increased risk for adverse psychosocial 
outcomes. Beyond this, mass home-confinement directives (including 
stay-at-home orders, quarantine, and isolation) raise concern about how 
people will react individually and collectively. A recent review of 
psychological sequelae in samples of quarantined people and of 
healthcare providers revealed numerous emotional outcomes, including 
stress, depression, irritability, insomnia, fear, confusion, anger, 
frustration, boredom, and stigma associated with quarantine, some of 
which persisted after the quarantine was lifted.\2\ Specific stressors 
include greater duration of confinement, having inadequate supplies, 
difficulty securing medical care and medications, and resulting 
financial losses.\2,\\3\ Such conditions are also known to potentiate 
substance abuse or to be a risk factor for relapse.\4\ Moreover, social 
distancing measures can limit access to meetings of peer-support groups 
or other sources of social connection that are important to those in 
recovery from substance use disorders.
---------------------------------------------------------------------------
    \3\ DiGiovanni C, Conley J, Chiu D, Zaborski J. Factors influencing 
compliance with quarantine in Toronto during the 2003 SARS outbreak. 
Biosecur Bioterror 2004;2:265-272.
    \4\ Volkow ND. Collision of the COVID-19 and Addiction Epidemics. 
Ann Intern Med. 2020;173(1):61-62.
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    In recognition of these potential impacts, the Substance Abuse and 
Mental Health Services Administration (SAMHSA) has not only provided 
$425,000,000 in emergency grants and funding to the States and tribes 
since the start of the pandemic, but it has also supported rules that 
allow the provision and monitoring of evidence-based treatments through 
telemedicine and remote platforms. SAMHSA has also issued new 
regulations at 42 C.F.R. part 2 around the management of patients so 
that treatment and services will not be substantially limited by 
illness or quarantine measures.
    In the current environment most psychosocial services, which are 
increasingly delivered in primary care settings, are being offered by 
means of telemedicine. In the context of COVID-19, psychosocial 
assessment and monitoring should include queries about COVID-19-related 
stressors (such as exposures to infected sources, infected family 
members, loss of loved ones, and physical distancing), secondary 
adversities (economic loss, for example), psychosocial effects (such as 
depression, anxiety, psychosomatic preoccupations, insomnia, increased 
substance use, and domestic violence), and indicators of vulnerability 
(such as preexisting physical or psychological conditions). Some 
patients will need referral for formal mental health evaluation and 
care, while others may benefit from supportive interventions designed 
to promote wellness and enhance coping (such as psychoeducation or 
cognitive behavioral techniques). In light of the widening economic 
crisis and numerous uncertainties surrounding this pandemic, suicidal 
ideation may emerge and necessitate immediate consultation with a 
mental health professional or referral for possible emergency 
psychiatric hospitalization. State programs can support these 
activities while also ensuring timely access to substance abuse and 
mental health services.
    Many of the experiences of patients, family members, and the public 
can be compassionately normalized by providing information about usual 
reactions to this kind of stress and by pointing out that people can 
and do manage even in the midst of dire circumstances. Healthcare 
providers can offer suggestions for stress management and coping (such 
as structuring activities and maintaining routines), link patients to 
social and mental health services, and counsel patients to seek 
professional mental health assistance when needed. Such interventions 
should be supported by consistent messaging across the public and 
private sector while also providing reassurance.
    Given that most COVID-19 cases will be identified and treated in 
healthcare settings by workers with little mental health training, it 
is imperative that assessment and intervention for psychosocial and 
substance abuse concerns be administered in those settings. Ideally, 
the integration of mental health considerations into COVID-19 care will 
be addressed at the organizational level through State and local 
planning; mechanisms for identifying, referring, and treating severe 
psychosocial consequences; and ensuring the capacity for consulting 
with specialists.\5\ To this end, education and training regarding 
psychosocial issues should be provided to health system leaders, first 
responders, and healthcare professionals. The mental health and 
emergency management communities should work together to identify, 
develop, and disseminate evidence-based resources related to disaster 
mental health, mental health and substance abuse triage and referral, 
the needs of special populations, and bereavement care. Risk-
communication efforts should anticipate the complexities of emerging 
issues such as prevention directives, vaccine availability and 
acceptability, and they should address a range of psychosocial and 
substance abuse concerns. Mental health professionals can help craft 
messages to be delivered by trusted leaders.\4\
---------------------------------------------------------------------------
    \5\ Pfefferbaum B, Schonfeld D, Flynn BW, et al. The H1N1 crisis: a 
case study of the integration of mental and behavioral health in public 
health crises. Disaster Med Public Health Prep 2012;6:67-71.
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    The COVID-19 pandemic imparts both current and long-term 
implications for individual and collective health, as well as emotional 
and social functioning. Rates of substance abuse should not be looked 
at in isolation, since they are linked to psychologic wellbeing, 
community health and access to resources. In this way, the already 
stretched health system has an important role in monitoring 
psychosocial needs and delivering support to their patients, healthcare 
providers, and the public. Such activities should be integrated into 
general pandemic healthcare and delivered in a variety of settings and 
through different platforms. An integrated approach between government 
officials and health system leaders can facilitate this while also 
creating the foundation for longer-term coordinated care platforms.
    Question. What financial resources is HHS providing to our 
behavioral health and recovery services to continue treating patients 
during this time?
    Answer. In one example, CDC provided $12 million to tribal-health-
serving consortia organizations to build public health capacity in the 
COVID-19 response in preventing injuries and violence, focusing on 
suicide, adverse childhood experiences, and intimate partner violence. 
In addition, CDC is funding two projects to prevent substance use 
during this COVID-19 pandemic, Novel Harm Reduction and Treatment 
Strategies to Support Individual with Opioid Use Disorder and Youth 
Substance Use and Messaging Development during COVID-19.
    The Substance Abuse and Mental Health Services Administration 
(SAMHSA) is a grant-making agency within the U.S. Department of Health 
and Human Services (HHS) that leads public health efforts to advance 
the behavioral health of the nation.
    The Coronavirus Aid, Relief, and Economic Security (CARES) Act 
provided $425 million in funding to SAMHSA to address the mental health 
and substance use disorder effects of COVID-19.
    To date, SAMHSA has awarded $424,244,671 in Emergency Grants to 
Address Mental and Substance Use Disorders during COVID-19 to the 
following:
  --Certified Community Behavioral Health Clinics (CCBHC COVID) 
        Expansion Grants totaling $249,657,910 to provide a 
        comprehensive range of mental health and substance use disorder 
        services to vulnerable individuals;
  --Tribal Behavioral Health (TBH COVID) supplements totaling 
        $14,999,908 to meet the increased mental and substance use 
        disorders of tribes during the COVID-19 pandemic;
  --Suicide Prevention Lifeline Crisis Center Follow-Up (CCF-COVID) 
        Expansion Grants totaling $2,978,828;
  --Suicide Lifeline/Disaster Distress Helpline (SPH COVID) supplement 
        totaling $12,077,216 to support the Lifeline's use of text 
        messaging and expand access to the Lifeline's suicide 
        prevention services;
  --COVID-19 Emergency Response for Suicide Prevention (ERSP) Grants 
        totaling $40 million to support States and communities during 
        the COVID-19 pandemic in advancing efforts to prevent suicide, 
        suicide attempts and domestic violence.
                              rural health
    Question. In West Virginia, we have had 3 hospitals shut down this 
year alone. Many more rural hospitals and health centers are operating 
on shoestring budgets. Congress provided $175 billion to the Provider 
Relief Fund to directly support health providers responding to the 
pandemic. So far, only $11 billion has been allocated directly to rural 
health providers. With 20 percent of Americans living in rural America, 
their access to care is in jeopardy if their hospitals shut down. That 
is why I have asked HHS to allocate at least 20 percent of the Provider 
Relief Fund to rural providers. The Save Our Rural Providers Act is a 
bipartisan, bicameral legislation targeting these funds to rural 
providers who serve high rates or Medicaid and vulnerable patients. Are 
there plans to direct more resources to our struggling rural providers?
    Answer. Rural hospitals, many of whom were operating on thin 
margins prior to COVID-19, have also been particularly devastated by 
this pandemic. As healthy patients delay care and cancel elective 
services, rural hospitals are struggling to keep their doors open. 
Acknowledging these unique barriers, HHS distributed $11 billion 
through two Rural Targeted Distributions.
    Organizations that received these targeted distributions operate 
11,640 healthcare delivery sites including 2,374 rural hospitals and 
critical access hospitals, 383 hospitals in small metro areas or with 
Medicare special payment designations, 4,655 Rural Health Clinics, and 
4,228 Community Health Center sites in rural areas.
    In addition to targeted rural distributions, rural providers are 
also eligible for other General and Targeted Distributions. As of 
November 17, 2020, providers located in rural and frontier areas 
received approximately $21 billion across all Provider Relief Fund 
distributions.
    At this point, HHS does not anticipate an additional Targeted 
Distribution for rural communities. Providers in rural areas may be 
eligible to apply for Phase 3 General Distribution payments.
    Question. What other actions is HHS taking to support rural health 
providers in West Virginia and across America to prevent more hospitals 
from shutting down?
    Answer. As of October 5, 2020, West Virginia providers received and 
attested to 2,615 Provider Relief Fund payments totaling 
$622,122,647.10. Payments to rural providers account for 24 percent of 
all attested payments in West Virginia. This includes 78 payments to 
organizations operating 294 healthcare delivery sites under the Rural 
Targeted Distribution totaling $152,080,433.20, as well as 13 payments 
to hospitals under the Safety Net Hospital Targeted Distribution 
totaling $192,273,920.32.
    In May, HRSA made $225 million available to over 4,500 RHCs across 
the country to support COVID-19 testing efforts and expand access to 
testing in rural communities. In addition, under HRSA's Health Center 
Program, 84 HRSA-funded health centers in West Virginia received COVID-
19 supplemental funding grants totaling $33,712,162.
    In addition to grants and payments, HRSA also has three programs 
that provide support to hospitals in West Virginia or other parts of 
the country.
    The Vulnerable Rural Hospital Assistance Program (VRHAP) provides 
targeted assistance to at-risk rural hospitals struggling to maintain 
healthcare services. VRHAP works with hospitals and their communities 
to understand community health needs and resources, ensure hospitals 
and communities can keep needed healthcare local, and address economic 
challenges. Solutions may include assessing key healthcare services to 
provide, identifying cost efficiencies, exploring other mechanisms to 
meet community healthcare needs. This $800,000 per year award supports 
one awardee to provide consultative support to five hospitals in depth 
and 25 hospitals virtually in groups. A hospital in West Virginia is 
part of the five selected for comprehensive support for the current 
program year (Sept 2020-August 2021).
    The Rural Healthcare Provider Transition Project is new in Fiscal 
Year (FY) 2020. This project provides technical assistance to assist 
eligible small rural hospitals and RHCs in strengthening key elements 
of value-based care: quality, efficiency, patient experience, and 
patient safety. Technical assistance will be designed to give hospitals 
and RHCs a clear understanding of value-based care and the strategies 
they can implement to be effective participants in a healthcare system 
focused on value. This program will target hospitals and RHCs that are 
not yet at the level to participate in value-based programs. HRSA 
awarded $800,000 in 2020, with technical assistance to begin later this 
year.
    The Federal Office of Rural Health Policy in partnership with the 
Delta Regional Authority administers the Delta Region Community Health 
Systems Development Program. The program provides technical assistance 
through comprehensive onsite consultations to eligible healthcare 
facilities located in the 252 counties and parishes across eight States 
served by the Delta Regional Authority. The program supports capacity 
building for healthcare facilities around quality improvement, 
financial and operational improvement, telehealth, community care 
coordination, workforce, emergency medical services, and population 
health.
                             covid testing
    Question. National testing reports have consistently fallen far 
below even the lowest estimated targets, and supply limitations and 
lengthy test turnaround times continue to be an obstacle for frontline 
providers and patients. HHS funding for expanded testing capacity has 
helped to alleviate existing shortages but capacity remains 
insufficient for a long- term, strategic response. Beyond the immediate 
challenges, a successful national testing strategy must consider 
medium- and long-term planning for capacity, including for supply 
stockpiles, public health workforce and infrastructure, health system 
preparedness, and more. How are CDC and ASPR supporting State and local 
health departments to ensure they have adequate capacity for widespread 
COVID-19 testing and what additional resources are required to increase 
testing for all populations?
    Answer. The majority of COVID funds CDC awarded to date--over $12 
billion--has gone directly to States, tribes, territories, and 
localities to support a wide range of COVID-19 response activities 
including testing, reporting data, contact tracing, personnel, and 
health department readiness and coordination. These funds also help 
health departments respond to current COVID-19 outbreaks and prepare 
for future outbreaks, including supporting accelerated laboratory 
testing, data collection, and real- time reporting to CDC for 
identification and tracking of COVID-19 cases in the community, as well 
as supporting implementation of COVID-19 community intervention plans. 
CDC also works with State, tribal, local, and territorial health 
departments to provide guidance, detect and investigate cases, 
implement mitigation measures, identify needs for surge staff, develop 
new resources and tools, support epidemiologic investigations and data 
analysis efforts, and more.
                    local health department funding
    Question. Congress has appropriated billions of dollars for COVID 
response to State and local health departments. So far, funding has 
gone out to States and territories that are either battling outbreaks 
of the virus or at risk for an outbreak. However, since many 
communities are dependent on States to pass through Federal dollars, 
there are vast inconsistencies across the country with Federal funds 
making it to local health departments to support this response. For 
example, in my home State of West Virginia, 50 percent of our local 
health departments only have 90 days of cash on hand, and 13 percent 
have only 30 days of cash hand. What can CDC do to ensure in the future 
that local health departments have the resources they need to protect 
the public from COVID-19?
    Answer. The majority of COVID funds CDC awarded to date--over $12 
billion--went directly to States, tribes, territories, and localities 
to support a wide range of COVID response activities including testing, 
reporting data, contact tracing, personnel, and health department 
readiness and coordination. CDC has, and will continue to, encourage 
States to support their local health departments with these 
supplemental funds.
                                 ______
                                 
                Questions Submitted to Bob Kadlec, M.D.
                Questions Submitted by Senator Roy Blunt
               chinese vaccine and international strategy
    Question. Dr. Kadlec, the U.S. has invested in several strong 
contenders in the race to get a vaccine. However, of the eight vaccines 
in Phase III trials, half are Chinese. That makes it entirely possible 
that a Chinese vaccine could be the first to succeed. What happens if 
China gets the vaccine first?
    Answer. The U.S. Government is focused on developing a safe and 
effective vaccine as quickly as possible. It is not a competition. 
Through Operation Warp Speed (OWS), the U.S. Government has invested in 
multiple COVID-19 candidate vaccines using different platform 
technologies, so that we have the best chance of securing at least one 
safe and effective COVID-19 vaccine for the American people. Of the 
four Chinese-developed vaccine candidates currently in Phase 3 trials, 
three are developed using an inactivated SARS-CoV-2 platform, which 
some researchers feel has a higher potential of significant safety 
concerns, including antibody- dependent enhancement of disease. For 
this reason, OWS has deliberately chosen not to invest in vaccine 
candidates that are developed using this platform, including 
inactivated vaccine candidates from companies outside China. Under OWS, 
we also continue to increase our domestic manufacturing capacities for 
COVID-19 vaccines, to maintain availability of a reliable vaccine 
supply for the American people.
    We are aware that several of the Chinese-developed vaccine 
candidates have been used outside of clinical trials to vaccinate 
individuals in China and the United Arab Emirates under their 
respective emergency use programs. Russia approved a vaccine candidate 
before large-scale phase 3 safety trials of the vaccine had been 
completed, with several countries planning to acquire the vaccine. 
Making such vaccines available to the public prior to completion of 
clinical trials is a risky approach when data on safety and 
effectiveness are still pending that could set back confidence in 
vaccines everywhere and damage the global fight against COVID-19.
                          vaccine development
    Question. Dr. Kadlec, both the HEALS Act and the targeted 
supplemental that received a majority of votes in the Senate last week 
provides an additional $20 billion to BARDA to continue investing in 
vaccine manufacturing and purchasing. HHS has reached agreement to 
purchase roughly 100 million doses of various vaccine candidates. 
Knowing that HHS is nearly out of funding specifically appropriated for 
vaccine manufacturing and purchase, are you concerned that HHS does not 
have the resources from such accounts to purchase vaccine in the event 
that only one or two candidates are successful?
    When do you need additional funding to avoid delays in either 
vaccine, therapeutic, or diagnostic development, manufacturing, or 
purchase?
    Answer. To accelerate the development and subsequent production of 
a vaccine for COVID-19, in mid-May, President Trump announced Operation 
Warp Speed (OWS), which aims to deliver up to 300 million doses of a 
safe and effective vaccine for COVID-19 in early 2021. OWS is a 
partnership among components of the Department of Health and Human 
Services (HHS), including the Centers for Disease Control and 
Prevention (CDC), 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 sector 
partners and other Federal agencies, including the Department of 
Agriculture, the Department of Energy, and the Department of Veterans 
Affairs.
    BARDA supported early research and development for five of these 
candidates prior to OWS and has continued and expanded these 
partnerships to include large-scale prototype manufacturing. Unlike the 
typical sequential vaccine development pathway, which can take up to 10 
years, the U.S. Government is asking its industry partners to develop 
and manufacture their vaccine candidates in parallel to rapidly 
accelerate this process into less than 1 year. Rapid acceleration of 
manufacturing while clinical trials to test the safety and efficacy of 
candidate vaccines are still underway is a financially high risk 
proposition. To mitigate this risk for our partners, multi- billion 
dollar investments were required to secure the necessary manufacturing 
capacity for drug substance and fill-finish capacity for final drug 
products as well as to secure the supply chain needed to produce 
hundreds of millions of vaccine doses. The U.S. Government has 
contracted with its partners for 100 million doses of the Moderna, 
Janssen, Pfizer, Novavax and Sanofi/GSK vaccines and 300 million doses 
of the AstraZeneca vaccine at the Government's financial risk. Once the 
safety, efficacy, and large-scale manufacturability of one or more of 
the candidates are confirmed, the Government may procure additional 
vaccine doses to ensure enough doses are available for every American 
who wishes to be vaccinated.
    Specific to manufacturing efforts, OWS continues to analyze and 
engage domestic pharmaceutical manufacturing and fill/finish capacity 
across the vaccines landscape. OWS is also identifying suppliers of 
secondary items for administration of any authorized or licensed 
vaccines, and providers of pharmaceutical distribution to ensure 
sufficient capacity exists once products have been granted FDA EUA 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) 
as soon as possible.
    HHS has accelerated the availability of diagnostics for the COVID-
19 response. ASPR/BARDA is funding established and newly emerging 
diagnostics test manufacturers to develop COVID-19 diagnostic tests, 
which has resulted in more than 45 million tests being available to 
test Americans. ASPR/BARDA, with the assistance of DoD, is working to 
expand domestic manufacturing capacity with many of these diagnostics 
developers to further increase the rate that tests are available. One 
company that ASPR/BARDA funded to develop a SARS-CoV-2 test was just 
awarded a DoD/OASH contract to increase manufacturing capacity to over 
100,000 tests per day for use in non-traditional testing sites.
                        therapeutic development
    Question. Dr. Kadlec, the Committee has provided $6.5 billion to 
BARDA for the development and manufacturing of vaccines, therapeutics, 
and diagnostics. As I said in our last hearing on COVID-19 and during 
this hearing, our priority should be vaccine development, 
manufacturing, and distribution. However, we should not put all our 
eggs in one basket. Until every American who wants a vaccine receives 
one, we need to have readily available treatments for those who are 
sick. But it appears that the vast majority of the money we provided to 
BARDA has gone to vaccines. What is the plan for therapeutics 
development? Why is there not more focus on this area? Is it because 
you're lacking resources or because it is lacking priority?
    Answer. BARDA, in conjunction with OWS, has a strong ongoing effort 
to support development of many therapeutic candidates. OWS and BARDA 
are supporting platform clinical trials under the Accelerating COVID-19 
Therapeutic Interventions and Vaccines (ACTIV) public private 
partnership, which was announced in April 2020 by the National 
Institutes of Health (NIH), and is being coordinated by the Foundation 
for NIH. The five platform trials (ACTIV 1 through 5) allow for testing 
multiple therapeutics in the same trial. This is the most efficient use 
of funding and clinical resources, which have been stretched thin 
throughout the pandemic response.
    Individual funding awards to companies for research and development 
have focused on candidate therapeutics with the highest likelihood of 
success, such as the monoclonal antibody therapeutics that are being 
developed using platform technologies that were established for other 
pathogens like influenza and Ebola.
    Additionally, the testing and collection of convalescent plasma has 
been a pillar of the OWS therapeutic response. While we are still 
investing in randomized, controlled clinical trials, we are encouraged 
by the early results from the expanded access protocol. The therapeutic 
portfolio will continue to evolve in the coming weeks as results from 
clinical trials become available.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Dr. Kadlec, we are in the middle of the worst pandemic in 
a century. You predicted this, but you thought it was going to be the 
flu just as so many in public health did. Can you speak for a minute or 
two on your thoughts on our current state of pandemic flu preparedness 
and whether you think we have the medical countermeasures, public 
health infrastructure, and perhaps most importantly sustainable 
resources our nation needs to help prevent what is likely an inevitable 
influenza pandemic that could happen 5 years from now, or 5 months from 
now.
    Answer. ASPR's priorities include helping to meet the requirements 
of Executive Order (EO) 13887, Modernizing Influenza Vaccines in the 
United States to Promote National Security and Public Health, signed by 
President Trump on September 19, 2019. Influenza is a very serious 
threat to human health and poses a significant national security risk, 
it leads to hundreds of thousands of hospitalizations, placing a 
significant strain on our healthcare system. Mitigating the impact of 
both seasonal and pandemic influenza is critical to saving lives and 
reducing economic and healthcare burdens. To mitigate such risks, EO 
13887 requires accelerated vaccine development of faster, more scalable 
platforms to expand domestic manufacturing. Consistent with the EO, 
ASPR promotes the modernization of facilities and infrastructure in 
ways that expand the domestic manufacturing capacity for non-egg based 
vaccines and adjuvants. ASPR is dedicated to advancing the development 
of broad-acting antivirals, transition to near-patient or in- home 
diagnostics, and addressing gaps in capabilities.
    The National Influenza Vaccine Task Force-established by the EO 
13887 and co-chaired by Secretaries of Defense and Health and Human 
Services-published the National Influenza Vaccine Modernization 
Strategy 2020-2030. This ten-year strategy prioritizes U.S. Government 
efforts toward (1) strengthening domestic advanced manufacturing of 
influenza medical countermeasures, (2) promoting innovative 
technologies to detect, prevent, and respond to influenza, and (3) 
increasing influenza vaccine access and coverage across all 
populations. The Task Force-with representation from the Departments of 
Health and Human Services, Agriculture, Defense, Homeland Security, 
Justice, State, and Veterans Affairs, and the National Security 
Council-is responsible for implementation of the strategy through an 
iterative process. The Task Force has identified short-, mid-, and 
long-term activities necessary to accomplish the above priorities, and 
will consult with State, local, tribal, and territorial government 
officials as well as industry leaders as appropriate to coordinate 
actions. Progress will be reported to the White House on an annual 
basis.
    ASPR's investments in pandemic influenza preparedness to date have 
made our nation significantly prepared for an outbreak. These include:
  --Built dual-purpose infrastructure and capabilities that were 
        utilized to support the COVID-19 response;
  --Developed a standard process to rapidly develop vaccine banks for 
        different production platforms. As a result, multiple vaccine 
        seed stocks are readily available for rapid vaccine production 
        as the need arises, including against H5N1, H5N6, and H7N9;
  --Developed and purchased H5N1, H5N6, and H7N9 influenza bulk vaccine 
        antigen (the component of vaccine that stimulates the human 
        immune system) for the National Pre-Pandemic Influenza Vaccine 
        Stockpile (NPIVS);
  --With FDA licensure, developed new seasonal and pandemic influenza 
        vaccines using modern cell- and recombinant-based production 
        technologies to expedite and expand domestic production 
        capacity;
  --Supported improved assessment of the relative effectiveness of 
        newly licensed influenza vaccines produced in cell cultures or 
        recombinant platforms as compared to traditional egg- based 
        vaccines; Advanced the development of sensitive diagnostic 
        tests to detect influenza viruses that can be used in near-
        patient settings, and high-throughput diagnostics capable of 
        detecting influenza strains at hospital-based, reference, and 
        public health laboratories;
  --Developed, tested, and stockpiled new antigen-sparing adjuvants 
        that are required for vaccines to stimulate sufficient immunity 
        and decrease the amount of antigen needed in each vaccine dose 
        for the vaccine to be effective;
  --Expanded the surge capacity of domestic vaccine manufacturing, 
        while increasing its flexibility to help manufacture pandemic 
        influenza vaccines as quickly as possible;
  --Supported development of new technologies that will help influenza 
        vaccines become available faster than currently possible in 
        response to a pandemic or other public health emergency;
  --Conducted clinical trials for stockpiled and newly manufactured 
        adjuvanted H5N1 and H7N9 vaccines in response to an emerging 
        pandemic;
  --Supported development of broad-spectrum monoclonal antibodies, 
        host-targeted therapeutic drug candidates, and small molecule 
        antivirals with novel mechanisms of action--when compared to 
        currently licensed influenza antiviral drugs these candidates 
        have shown activity against drug-resistant influenza viruses 
        and are currently under evaluation in phase two and phase three 
        clinical trials;
  --To significantly increase the supply of respirators available 
        during an influenza pandemic, supported the development of 
        technology and processes that promote rapid production of N95 
        respirators;
  --Supported the development through FDA authorization of next-
        generation portable ventilators needed for a surge in 
        hospitalized patients of all ages during a pandemic;
  --Supported development of re-usable elastomeric respirator masks;
  --Responded to the 2017 H7N9 influenza threat, with production, 
        stockpiling and clinical trial testing of vaccine antigen for 
        H7N9 influenza vaccine from the 2016-2017 Yangtze River Delta 
        virus lineage candidate vaccine virus provided by CDC. ASPR 
        worked with partners to improve preparedness at the local, 
        State, and international levels, including:
    --Improved technical knowledge and capacity for manufacturing in 
            developing countries in order to increase global pandemic 
            influenza vaccine capacity;
    --Conducted surveillance, research, and international collaboration 
            on policies, plans, and training;
    --Provided risk communication to improve public understanding of 
            the actions that individuals, businesses, and organizations 
            can take to protect the public from emerging infectious 
            diseases, including those with pandemic potential;
    --Supported development, through FDA authorization, of point-of-
            care clinical diagnostics;
    --Increased stockpiling of vaccines, next-generation ventilators, 
            and medical supplies, including adjuvants and antiviral 
            drugs, and,
    --Through capacity expansion and support of adjuvant production, 
            enabled development of additional seasonal influenza 
            vaccine products.
    All of these investments have led and contributed to innovative 
technologic advancements for pandemic influenza MCMs including, inter 
alia, cell-based and recombinant vaccine technology, vaccine adjuvants, 
advanced development and manufacturing, and vaccine surge capacity.
    The rapid vaccine development response to COVID-19 has, further, 
revealed the value of new manufacturing technologies. We may be nearing 
the dawn of a new era in response capability if the ``genetic 
vaccines'' whose development is being supported by Operation Warp Speed 
prove to be safe and effective, because these production approaches can 
be applied to pandemic influenza.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
                        antivirals for influenza
    Question. Dr. Kadlec, as devastating as the coronavirus pandemic 
has been to date, the situation could get even worse this fall and 
winter, when the nation is expected to face a ``twindemic'' of COVID-19 
and the annual influenza season. If the nation could--to the extent 
possible--mitigate the impact of flu, that would greatly improve our 
ability to address COVID-19's second wave. Flu vaccinations are, of 
course, a critical component of that strategy, and I commend ASPR for 
allocating additional funding to procure vaccines. You have stated many 
times that we also need significantly more antivirals, especially for 
high- risk populations, to treat influenza.
    How much funding does ASPR need to procure a sufficient number of 
antivirals for this flu season?
    Does ASPR currently have the necessary funding on hand--either in 
emergency or regular annual funds--and at the President's fiscal year 
2021 request level?
    Answer. ASPR/BARDA supports efforts to address the threat of a 
pandemic influenza. While these efforts generally augment the annual 
influenza response, ASPR/BARDA does not procure or support the 
development of antivirals for the common flu. Rather, ASPR/BARDA is 
supporting innovative manufacturing capabilities to rapidly manufacture 
and produce vaccine for an influenza event, as well as novel 
technologies to enhance such production (such as cell-based 
technologies).
    The commercial market for influenza antivirals can support the 
needs of a typical influenza season. If we have a pandemic level event, 
there are millions of influenza antiviral treatment courses in the 
Strategic National Stockpile (SNS). SNS resources can be activated if 
the commercial market cannot keep up with demand.
    The SNS lacks diversity in its influenza antiviral stockpile A 
diverse antiviral stockpile will allow the U.S. Government to respond 
if the pandemic virus is resistant to any one mechanism of action.
    ASPR/SNS seeks to maximize the value of the SNS appropriation in 
collaboration with the Food and Drug Administration (FDA) through the 
Shelf Life Extension Program (SLEP). In December 2019, prior to the 
COVID-19 pandemic, the FDA reviewed pertinent data and agreed to extend 
the shelf life for some influenza antivirals for use during emergency 
responses. This action represents a significant cost avoidance in 
fiscal year 2020 and beyond, as large volumes of SNS held antivirals 
approaching final expiration in 2019 and 2020 will remain viable for 
additional years without replacement. In addition, pending availability 
of funding in fiscal year 2021, SNS plans to expand its holdings of 
antivirals to respond to pandemic influenza.
                           rapid diagnostics
    Question. Dr. Kadlec, the availability of point-of-care and over-
the-counter tests would allow people to be screened for COVID-19 easily 
and quickly by yielding results in minutes instead of days. In short, 
if these kinds of tests were reliable and widely available, they would 
be game-changing for our testing capacity. BARDA currently has 29 
diagnostics in its COVID-19 countermeasure portfolio and some of them 
offer rapid point of care options that require no equipment, 
processing, or refrigeration, and can be deployed in homes or the 
workplace to deliver lab quality results in minutes.
    How much of the $16 billion that has been spent by BARDA for 
developing medical countermeasures against COVID-19 has gone toward 
diagnostics?
    Answer. ASPR has obligated approximately $370 million on 
diagnostics to date.
    Question. How much of the $16 billion has gone toward therapeutics 
and vaccines?
    Answer. ASPR has obligated approximately $15.7 billion on vaccines 
and therapeutics to date.
    Question. Could rapid antigen tests obviate some of the supply 
chain issues that have emerged with processing molecular PCR tests?
    Answer. Rapid antigen tests (RATs) would obviate some supply chain 
issues that are being experienced with molecular tests, such as 
shortages of pipette tips, but shortages of other supplies (like swabs 
and viral transport medium) are also applicable to RATs.
    Question. How does HHS plan to address any new or unique supply 
chain issues that emerge with rapid antigen tests?
    Answer. ASPR is working with the Joint Acquisition Task Force to 
reduce supply chain issues for diagnostics tests. This includes 
investments in manufacturing capacity for swabs, viral transport media, 
and pipette tips.
    Question. How does the cost of running the traditional molecular 
PCR test for coronavirus compare to one of these rapid antigen tests? 
What is the estimated cost per test for each of them?
                             ows spend plan
    Please provide a detailed obligations table and spend plan of 
obligated and anticipated uses of any appropriated supplemental funds 
made available for Operation Warp Speed by HHS, including estimated 
personnel and administrative costs and contract obligations that exceed 
$5,000,000. Please include any inter-agency transfers or IAAs of funds, 
and a breakdown of medical countermeasure activities by therapeutics 
and vaccines.
    Answer. Please see attached PDF labeled, ``QFR OWS--Contracts Over 
$5 million.'' Note, the response was drafted as of the date of the 
hearing (i.e. September 16, 2020).
                                 ______
                                 
              Question Submitted by Senator Jeanne Shaheen
    Question. Dr. Kadlec, has anyone from the White House or HHS asked 
the companies or researchers participating in Operation Warp Speed to 
seek FDA review of the company's vaccine candidate by a certain date or 
time on the calendar?
    Answer. No. We are 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.
                                 ______
                                 
              Questions Submitted by Senator Brian Schatz
    Question. What are the key steps in setting up the vaccine 
distribution network, and what is the status of each step?
    Answer. OWS, through the CDC, is establishing a central 
distribution network through the McKesson Corporation, our primary 
distributor under contract. The key steps in establishing the network 
are bringing into operation the McKesson facilities that will 
distribute COVID vaccines and supporting ancillary supply kits. Select 
facilities will be ready to conduct operations in November 2020, and 
all will be operational no later than early in 2021. Additionally, 
States and Territories are in the process of identifying the locations 
to which vaccines will be distributed and from which they will be 
administered. The initial versions of these plans were completed and 
submitted to the CDC from all jurisdictions in mid-October 2020.
    Question. Do we currently have sufficient amounts of all of the 
equipment and materials needed for vaccine administration--such as 
syringes, glass vials, and refrigerators? How will those materials be 
distributed to States?
    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, Biological, Radiological, and 
Nuclear Defense (JPEO-CBRND) CBRND, on behalf of HHS, have awarded 
three agreements to increase needle and syringe capacity in the United 
States 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, on behalf of HHS, 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, May 19, 2020, 
BARDA announced a $354 million four-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.
    Projected administration sites include pharmacies, public and 
private clinics, hospitals, and doctor's offices, the vast majority of 
which have refrigerated storage capacity. Jurisdiction planning that is 
currently ongoing will further refine potential administration sites to 
identify those that are planned for use for both refrigerated and 
frozen vaccines. All jurisdictions have submitted vaccine distribution 
plans or playbooks to CDC. Executive summaries have been published 
here: COVID-19 Vaccination Program Operational Guidance (cdc.gov). OWS 
and CDC continue to provide technical assistance to all jurisdictions 
to ensure initial readiness for vaccine allocations. There is no 
identified need, or current plan, to acquire and distribute 
refrigerators to jurisdictions.
                                 ______
                                 
            Questions Submitted to Robert R. Redfield, M.D.
                Questions Submitted by Senator Roy Blunt
    Question. How much has CDC obligated in supplemental resources for 
this effort? Please provide by specific activity. How much does CDC 
have available to spend for this purpose?
    Answer. As of October 1, 2020, more than $500 million has been 
invested in the COVID-19 vaccination effort to support distribution, 
vaccine safety and effectiveness, and investment in tracking systems. 
On June 4, 2020, CDC awarded $140 million to 64 jurisdictions through 
CDC's existing immunization cooperative agreement to enable State 
including the District of Columbia, tribal, local, and territorial 
health departments to enhance their immunization programs, including 
launching an initial scale-up for influenza season, given the increased 
risk of COVID-19. On September 23, 2020, CDC also awarded $200 million 
to 64 jurisdictions through the existing Immunizations and Vaccines for 
Children cooperative agreements. These funds, along with the previous 
support CDC has provided, will help jurisdictions plan for and 
implement COVID-19 vaccination services. In addition, CDC invested $180 
million in a centralized depot for distribution of 200 million 
refrigerated vaccine doses and $21 million in vaccine safety 
surveillance ramp up.
    Question. What deadline has CDC established for the Federal 
Government to be ready to roll out all of the requirements necessary 
for successful vaccine distribution and administration?
    Answer. Based on early data from OWS that vaccine could be 
available in November, CDC had asked that all jurisdictions be prepared 
to distribute initial doses of vaccine to prioritized populations by 
November 1, 2020.
    Question. Dr. Redfield, on April 28th, President Trump issued an 
Executive order under section 101(b) of the Defense Production Act to 
``take all appropriate action under that section to ensure that meat 
and poultry processors continue operations consistent with the guidance 
for their operations jointly issued by the CDC and OSHA.'' How will CDC 
take into account industries like meat and poultry processors 
specifically, but any industry deemed critical generally, into their 
vaccination distribution plan?
    Answer. CDC is planning for the many logistical considerations 
involved in implementation of COVID-19 vaccination. After FDA 
authorization or approval of a COVID-19 vaccine, ACIP will review and 
provide its recommendations to the CDC Director for adoption. Within 
this recommendation, ACIP may prioritize certain groups of the 
population, such as essential workers (including those working in the 
food industry), while COVID-19 vaccines are limited. The National 
Institute for Occupational Safety and Health at CDC will assist with 
dissemination of information to all Americans, including essential 
industries and workers via well-established partnerships, and with 
development of customized communications materials. CDC also plans to 
help with development of workplace-specific guidance and will conduct 
surveillance to track vaccine uptake in various occupational groups.
    Question. Some poll results show that anywhere between 25-35 
percent of Americans have no interest in getting a vaccine which could 
be a major setback to protect Americans from this virus. Specifically, 
what steps has the CDC taken to engage community groups, physicians, 
and the general public about the importance of being vaccinated?
    Answer. Understanding public confidence in any and all vaccines is 
necessary for promoting high vaccine uptake, and CDC is adapting its 
strategic framework, Vaccinate with Confidence, to strengthen public 
trust in COVID-19 vaccines. The framework emphasizes three key 
priorities: reinforcing communication to the public about the vaccine's 
rollout and its safety and benefits, empowering healthcare providers to 
communicate effectively with patients about the vaccine and engaging 
with individuals and communities. Because COVID-19 affects so many 
aspects of society, CDC is engaging with a wide breadth of community 
groups, local partners and stakeholders, and trusted messengers to 
conduct communications about the vaccine development process and roll 
out, promote vaccine uptake with a focus on priority populations, and 
increase confidence in the vaccine. Building confidence is inherent to 
all our work, and CDC will continue to build upon the investments of 
our immunization program as we prepare both the nation's public health 
system and the private sector to disseminate a safe and effective 
COVID-19 vaccine.
    As COVID-19 vaccine developments continue, CDC is working with OWS 
to ensure community groups, healthcare providers, and the general 
public receive the most up to date guidance and data on available 
prevention measures that can help reduce COVID-19 infection and spread. 
Adapting from approaches used with past coronavirus-related threats, 
CDC will work with its public health partners to deliver resources on 
COVID-19 vaccine that assist physicians with proper vaccine 
administration and enhances public confidence in COVID-19 vaccine 
uptake.
    Question. What are CDC goals for getting Americans vaccinated in 
2021? Given that less than half of Americans took a seasonal flu 
vaccine last year, what percentage of the population is CDC targeting 
to have received the vaccine by this time next year?
    Answer. While influenza vaccination is always important, getting 
vaccinated this season is more important than ever, especially for 
people who are at higher risk of exposure or serious complications from 
influenza and COVID-19. Co-circulation of the viruses that cause COVID-
19 and influenza could place a tremendous burden on the healthcare 
system and result in many illnesses, hospitalizations, and deaths. In 
addition to prolonging the influenza vaccine season into spring 2021, 
CDC is working across various fronts to increase influenza vaccination 
coverage. CDC's goal is that 70 percent of adults ages 18 years and 
older are vaccinated annually against seasonal influenza.
    Vaccine manufacturers are maximizing the available number of doses 
for all age groups to accommodate increased demand. CDC is projecting 
this will increase available doses to 194-198 million this season, 
about 12 percent more than last year. CDC has also purchased an 
additional two million pediatric and 9.3 million adult doses of 
influenza vaccine to enhance coverage in under-served and under-
vaccinated communities. This includes optimizing the use of federally 
procured vaccine through promotion of influenza vaccination within the 
Vaccines for Children program and expanding partnerships to increase 
vaccine utilization by community health centers. A critical component 
of the effort is to ensure that parents who are newly unemployed are 
informed about the Vaccines for Children safety net program that 
provides access for uninsured or underinsured children.
                           seasonal influenza
    Question. Dr. Redfield, what efforts are currently underway at CDC 
to improve seasonal influenza vaccination?
    Answer. While flu vaccination is always important, getting 
vaccinated this season is more important than ever, especially for 
people who are at higher risk of exposure to or serious complications 
from flu and COVID-19. Co-circulation of COVID-19 and flu could place a 
tremendous burden on the healthcare system and result in many 
illnesses, hospitalizations, and deaths. In addition to vaccine 
manufacturers maximizing the available number of doses for all age 
groups and CDC purchasing additional doses of influenza vaccine, CDC is 
working across various fronts to increase influenza vaccination 
coverage.
    Regarding the focus on high-risk patient categories and other 
critical populations (e.g., healthcare workers), CDC collaborated with 
CMS to develop an additional module in CDC's National Healthcare Safety 
Network (NHSN) for long-term care facilities' (LTCF) resident and 
healthcare practitioner influenza vaccination reporting data. The 
module adapts the current NHSN module used by acute care facilities for 
healthcare practitioner influenza vaccination reporting. Currently, all 
CMS-certified nursing homes (15,400) already use the existing NHSN 
LTCF component for other required weekly COVID-19 reporting. CDC also 
updated and augmented the LTCF Flu Vaccination Toolkit for posting on 
the web and dissemination to partners.
    CDC is leveraging a number of new and existing partnerships to 
promote influenza vaccination among communities of color. For example, 
CDC is working with the Million Hearts Campaign to address 
sociodemographic disparities in influenza vaccines among adults with 
Atherosclerotic Cardiovascular Disease. CDC is also collaborating with 
partners to explore strategies to reduce racial and ethnic disparities 
in adult immunization. Additionally, this year's flu communication 
campaign will be enhanced through a partnership with the American 
Medical Association and the Ad Council and include messaging tailored 
to African American and Hispanic audiences as these groups have lower 
rates of flu vaccination, but higher risk for COVID-19 complications. 
While CDC is updating guidance and providing messaging toolkits to 
partners, engaging local communities and leveraging trusted messengers 
at the ground level will be critical to expanding coverage.
    Question. The HEALS bill included $500 million to bolster CDC's 
efforts to increase seasonal influenza vaccination rates. How would CDC 
us those resources for seasonal influenza and why are they needed 
sooner rather than later?
    Answer. If additional funds were appropriated, CDC would allocate 
them consistent with the purpose outlined in relevant appropriations 
language. In this case, additional funds would support CDC's work to 
increase seasonal influenza vaccination coverage.
                                 ______
                                 
            Questions Submitted by Senator Cindy Hyde-Smith
    Question. Dr. Redfield, Do you anticipate additional support for 
State governments to support and implement COVID-19 vaccine mass 
administration once effective and safe vaccines are available in large 
numbers?
    Answer. Yes.
    Question. Dr. Redfield, I have been hearing from a lot of my 
constituents that they have concerned with coronavirus vaccines being 
developed using aborted cell lines. From what I understand, there are 
several candidates moving along the process some using ethical sources 
and others using aborted cell lines. I know the need for getting a 
vaccine to market as quickly as possible but the pro-life community 
does very much care about if the vaccine is ethically sourced. Are 
Federal funds being used to develop coronavirus vaccines that use 
aborted fetal cell lines?
    If so what are those specific trials and what is their status?
    Answer. President Trump announced Operation Warp Speed (OWS) to 
accelerate the development and subsequent production of a vaccine for 
COVID-19. 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). This unprecedented action by the Administration 
means we are closer than ever before to having a vaccine for COVID-19 
in the coming months.
    Because there are no guarantees of successful development of any 
particular vaccine, and vaccines may impact populations differently, it 
is only prudent to pursue a number of vaccine candidates.
    With this in mind, we would like to emphasize that, as an 
Administration, we are proud to have the highest commitment to 
protecting the life of the unborn through our policies across the 
departments. HHS and the Trump Administration have taken multiple steps 
to protect life, and one clear action relevant to this discussion is 
the policy we announced last year with regard to the use of fetal 
tissue in research. NIH-employed scientists may no longer use fetal 
tissue from elective abortions in their research. Research grants made 
by NIH to outside institutions and scientists follow a statutory policy 
requiring an ethics advisory board comprised of individuals who are not 
Federal employees to review new grant applications or current research 
projects in the competitive renewal process that propose to use fetal 
tissue and recommend whether, in light of the ethical considerations, 
NIH should fund the research.
    Among the COVID-19 vaccine candidates being developed by the seven 
companies which are receiving Federal support (both through OWS and 
BARDA), five companies do not use any cell lines developed from human 
fetal tissue from elective abortions. These candidates are vaccines 
being developed by Moderna, Pfizer, Novavax, Sanofi, and Merck.\6\ Two 
of the companies receiving Federal dollars use established fetal cell 
lines in their vaccine candidates. Those vaccine candidates are from 
Jansen/Johnson & Johnson and AstraZeneca.
---------------------------------------------------------------------------
    \6\ The Merck vaccine has received support only through BARDA.
---------------------------------------------------------------------------
    The Department's support for the development of COVID-19 vaccines 
is consistent with the Administration's policy on the use of human 
fetal tissue from elective abortions in research. The policy 
specifically excluded ``already-established (as of June 5, 2019) human 
fetal cell lines (e.g. induced pluripotent cell lines from human fetal 
tissue, immortalized cell lines, differentiated cell lines).'' Both 
AstraZeneca and Jansen/Johnson & Johnson use such ``already-
established'' human fetal cell lines.
    Scientific evidence will determine the FDA's approval of any 
vaccine, but with five of the seven vaccine companies not using fetal 
cell lines in the development of their vaccine candidates, we are 
hopeful we will see an option for individuals who do not wish to take a 
vaccine that has been developed with human fetal tissue from elective 
abortions. Part of the OWS strategy has been to plan for approval of 
more than one vaccine, knowing that different vaccines may work better 
in specific populations.
    Question. Dr. Redfield, as we look at this seasons flu campaign, 
CDC is taking special efforts increase vaccination rates among higher 
risk populations for Covid-19 and/or flu-related complications. As I 
understand it the CDC recently purchased as many as 9 million flu 
vaccine doses to target these at-risk populations. Can you speak for a 
minute or so on how CDC plans to ensure the unprecedented number of 
influenza doses, over 190M manufactured and under distribution will be 
administered? What efforts are planned to drive an extended season 
campaign?
    Answer. 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 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 as 
these groups have lower rates of flu vaccination, but higher risk for 
COVID-19 complications. 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. CDC has expanded outreach to 
populations at high risk of severe COVID-19 by working with new and 
existing partners, including leveraging existing partnerships with the 
National Association of Community Health Centers (NACHC) and State and 
local immunization programs to distribute 9.3 million supplemental 
influenza vaccine doses to those seeking care at community health 
centers.
    Congress's recent investments through the Coronavirus Aid, Relief, 
and Economic Security Act (CARES Act) have allowed CDC to provide its 
immunization awardees $140 million in supplemental funding to support 
and enhance their immunization programs.
    In addition, CDC has been working with influenza vaccine 
manufacturers to maximize influenza vaccine supply; CDC is projecting 
this will increase available doses to 194-198 million this season, 
about 12 percent more than last year. CDC is also increasing the length 
of the vaccination season through the duration of flu season, into 
spring 2021. CDC also purchased an additional 2 million pediatric doses 
and 9.3 million adult doses to enhance influenza vaccine coverage in 
under-vaccinated communities. This includes optimizing the use of 
federally procured vaccine through promotion of influenza vaccination 
within the Vaccines for Children (VFC) program and expanding 
partnerships to increase vaccine utilization by community health 
centers.
    CDC is providing increased support and resources for immunization 
programs and partners, including disseminating guidance for safe 
immunization services, encouraging vaccination where it is most 
convenient to maximize vaccine uptake, and developing and disseminating 
guidance for planning vaccination clinics held at satellite, temporary, 
or off-site locations.
    Question. What is the outreach plan to these communities to reach 
your stated goal of 65 percent total flu vaccination this year which is 
so important?
    Answer. 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 individual 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.
    CDC is also working with Vaccines for Children program providers to 
ensure they are prepared for a potential 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.
    CDC is also enhancing its efforts in promoting influenza 
vaccination in high-risk populations. CDC collaborated with CMS to 
develop an additional module in CDC's National Healthcare Safety 
Network (NHSN) for long-term care facilities' (LTCF) resident and 
healthcare practitioner influenza vaccination reporting data. The 
module adapts the current NHSN module used by acute care facilities for 
healthcare practitioner influenza vaccination reporting. Currently, all 
CMS- certified nursing homes (15,400) already use the existing NHSN 
LTCF Component for other required weekly COVID-19 reporting. CDC also 
updated and augmented the LTCF Flu Vaccination Toolkit for posting on 
the web and dissemination to partners.
    With respect to communities of color, CDC is leveraging a number of 
new and existing partnerships to promote influenza vaccination. For 
example, CDC is working with the Million Hearts Campaign to address 
sociodemographic disparities in influenza vaccines among adults with 
Atherosclerotic Cardiovascular Disease. CDC is collaborating with 
partners to speak with Health Equity Directors to explore strategies to 
reduce racial and ethnic disparities in adult immunization. 
Additionally, this year's flu communication campaign will be enhanced 
through a partnership with the American Medical Association and the Ad 
Council and include messaging tailored to African American and Hispanic 
audiences as these groups have lower rates of flu vaccination, but 
higher risk for COVID-19 complications. While CDC is updating guidance 
and providing messaging toolkits to partners, engaging within local 
communities and leveraging trusted messengers at the ground level will 
be critical to expanding coverage.
    Question. Additionally, how do you plan to monitor influenza 
vaccine doses administered assure we are on track in real time, and do 
you need additional resources for to collect data from each State 
Immunization Information Systems (IIS) program to collect State and 
national aggregate numbers of doses administered?
    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. For example, 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 to ensure proper 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 flu diagnoses from 
Covid-19 diagnoses?
    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 compares COVID-19 and flu, given the best available 
information to date.
    Question. What will CDC's guidance be on things like antivirals for 
instance--will someone with influenza and COVID like symptoms be 
advised to get an antiviral by default?
    Answer. CDC developed guidance for clinicians during times when 
influenza viruses and SARS-CoV-2 are in co-circulation. The guidance 
includes information on testing to help distinguish between influenza 
virus infection and SARS-CoV-2 infection and provides information about 
initiating empiric antiviral treatment for influenza in priority 
groups. People who fall into priority groups include hospitalized 
patients with respiratory illness; outpatients with severe, 
complicated, or progressive respiratory illness; and outpatients at 
higher risk for influenza complications who present with any acute 
respiratory illness symptoms (with or without fever).
    Question. Do we have enough antivirals to achieve that?
    Answer. CDC is in regular contact with influenza antiviral 
manufacturers regarding supply and other issues. There are currently no 
major market shortages of antiviral drugs for treatment of influenza 
being reported. CDC provides information on antiviral drug supply on 
our website and will update as needed with respect to influenza 
antiviral supply this season.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
                     guidance to child care centers
    Question. Child care providers are confused by conflicting public 
health guidance that CDC has provided to date and are waiting for 
concrete actions and practices they can take to keep children and staff 
safe. While a CDC study of reopened childcare centers in Rhode Island 
showed that resuming operation at a time of low community spread can 
successfully limit new coronavirus cases, providers still need clear 
guidance on how to translate health and safety precautions that have 
become widely accepted for adults to young children. Dr. Redfield, I 
sent you a letter with dozens of other lawmakers on this topic last 
month.
    It's now mid-September, 7 months into the pandemic. Why haven't you 
already issued comprehensive guidance for child care centers?
    When is the CDC going to issue this guidance?
    Answer. CDC has developed guidance to assist childcare centers: 
(www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/
guidance-for-childcare.html). In part, this guidance includes 
considerations to help childcare programs promote behaviors that reduce 
the spread of COVID-19 and maintain healthy environments, as well as 
monitor and prepare for absenteeism among staff. CDC will update this 
and other resources as new evidence becomes available.
    In addition, CDC collaborated with the Administration for Children 
and Families (ACF) within HHS on the development and periodic updating 
of the CDC guidance for childcare providers. ACF has also shared the 
CDC Foundation's webinar, Adapting, Evolving, and Thriving: Tools to 
Evolve Your COVID-19 Child Care Strategy (https://
childcareta.acf.hhs.gov/covid-19-resources), to their partners and 
grantees. This webinar provides strategies for childcare providers to 
make evidence-based, actionable decisions, grounded in the CDC 
guidance, to keep staff and children safer in childcare programs 
regardless of provider type.
    CDC recognizes that there is no one-size-fits-all national solution 
for childcare providers during this time. Differences exist among types 
of childcare providers, and local contexts vary in terms of the levels 
of transmission of COVID-19 and community mitigation strategies that 
may already be in place. Many other factors, such as socioeconomic 
status, the availability of personal protective equipment and supplies 
and childcare staffing capacity, including the health status and age of 
individual providers, also shape decisions about how to safely reopen 
and continue the operation of childcare programs.
    As childcare providers think about how and when to open or have 
questions about operating during this time, we encourage them to 
consult State and local health officials and their local childcare 
licensing agency for data on community transmission, as well as support 
for implementing mitigation strategies and other guidance to promote 
the health and safety of children, staff, and their community.
    As more data becomes available and our scientific understanding of 
COVID-19 evolves, CDC is committed to sharing additional evidence-
informed guidance to childcare program administrators, staff, and 
families to help keep them as safe and healthy as possible.
                                 ______
                                 
             Questions Submitted by Senator Jeanne Shaheen
 ensuring vaccine review and distribution is free of political pressure
    Question. Dr. Redfield, last month, you told governors to prepare 
for distribution of a COVID-19 vaccine by November 1st. Yet, Dr. Moncef 
Slaoui, the chief advisor for Operation Warp Speed, said that this 
timeline is ``extremely unlikely'' and public health experts make it 
clear that despite President Trump's predictions, a vaccine may not be 
available on election day.
    Dr. Redfield, what is CDC doing right now to build trust with the 
American people and ensure that science and public health--not 
politics--is dictating decisionmaking for distributing and 
administering a vaccine?
    Answer. CDC continues to fulfill its mission as a data-driven, 
science-based agency. Our scientists are working 24/7 to respond to the 
current COVID-19 pandemic, and we are proud of the long history of 
scientific integrity in our guidance and our publications.
    CDC will receive recommendations regarding any potentially licensed 
or authorized COVID-19 vaccine from both the Advisory Committee on 
Immunization Practices (ACIP) and the National Academies of Science, 
Engineering, and Medicine (NASEM).
    As outlined in our Vaccination Program Interim Playbook, published 
on September 16, 2020, we have prepared a vaccination program 
communication designed to build trust and confidence in the process, 
and to guide jurisdictions including State, local, and tribal partners 
to share useful, actionable information with their constituents:
  --We recognize the importance of messaging through partners and 
        trusted sources,
  --We emphasize key crisis communication principles: be first, be 
        right, be credible, express empathy, and show respect,
  --We describe the different phases of communication that will be 
        required through the vaccine rollout process, and
  --We encourage development of culturally relevant and sensitive 
        messages.
               recent changes in ppe assistance from fema
    Question. Dr. Redfield, I am deeply concerned with the 
administration's decision to stop FEMA reimbursements for purchases of 
PPE and other medical equipment for what it considers to be non-
emergency work. Manchester, NH alone expects approximately $11 million 
in COVID-19 related expenditures over fiscal years 2020 and 2021, some 
of which the City expected FEMA to reimburse. This decision is 
particularly reckless as communities attempt to reopen schools safely.
    Dr. Redfield, do you agree with the administration's decision to 
stop reimbursement for purchases of PPE that go towards protecting our 
schools and other critical institutions?
    Answer. Employers are responsible for providing a safe and healthy 
workforce. Some school staff need PPE to perform their jobs safely, 
such as janitorial and maintenance staff. In light of potential PPE 
shortages, school administrators should consider modifying staff and 
student interaction and use engineering and administrative controls as 
primary prevention and control measures that reduce the need for PPE.
    When engineering and administrative controls cannot be implemented 
or are not fully protective, employers are required by OSHA standards 
(29 CFR part 1910, Subpart I) to:
  --Determine what PPE is needed for their specific job duties
  --Select and provide appropriate PPE to staff at no cost, if required
  --Train their staff on hazard identification and correct use 
        (including putting on and removing) of PPE.
    relationship between substance use disorders and covid-19 risks
    Question. This week, the National Institutes of Health released a 
study showing that people with a history of substance use disorder were 
more susceptible to COVID-19 infection. People with substance use 
disorders made up 10.3 percent of the study's participants, but 
accounted for 15.6 percent of COVID-19 infected individuals in the 
study.
    Dr. Redfield, what is the CDC doing to support State efforts to 
mitigate the spread of COVID-19 among people with behavioral health and 
substance misuse issues?
    Answer. CDC shares your concern about the intersection of drug 
misuse and the COVID-19 pandemic. CDC is monitoring data closely. CDC 
is working with States, territories, and localities to provide 
technical assistance to identify mitigation strategies. For example, 
one State is now using social media and other virtual communications to 
message the importance of naloxone CDC is also supporting work to track 
youth substance use during COVID-19 to intervene and prevent long-term 
issues.
    Harm reduction organizations, including syringe service programs 
(SSPs) and facilities that provide medications for opioid use disorder 
(MOUD), have had to adapt in the wake of this pandemic and change their 
practices to continue serving their clients. In response, CDC is 
working to identify and support innovative and emerging practices; up 
to 15 organizations will be funded. Strategies will be summarized in 
technical assistance tools for dissemination to partners.
    CDC is also working to curb and lower substance use patterns and 
attitudes among youth whose use has risen during COVID-19.
    CDC is working with States engaged in Overdose Data to Action 
(OD2A), a 3-year cooperative agreement that began in September 2019 and 
focuses on the drug overdose epidemic, to respond to the realities of 
how their work is changing in this environment. This includes assessing 
overdose data to understand trends in light of COVID-19, as well as 
working with our 66 funded jurisdictions to provide flexibilities where 
needed and technical assistance to inform public health action during 
the pandemic.
        addressing connection between covid-19 and pfas exposure
    Question. Dr. Redfield, last time you were here before the 
Subcommittee, I asked you about a statement from your agency indicating 
that ``exposure to high levels of PFAS may impact the immune system'' 
and ``more research is needed to understand how PFAS exposure may 
affect illness from COVID-19.'' At that time, you said the CDC and the 
Agency for Toxic Substances and Disease Registry (ATSDR) were examining 
those connections.
    Dr. Redfield, will CDC and ATSDR help facilitate COVID-19 
serological testing for participants in the Pease PFAS Study and the 
nationwide Multi-Site PFAS Study? Getting serological testing would 
help determine whether these individuals with known PFAS exposures are 
more likely to have contracted COVID-19.
    Answer. CDC and ATSDR are not currently planning any serological 
testing for COVID-19 in the Pease Study. The agency is focused on 
getting back in the field to conduct the PFAS study using the 
appropriate safety measures to keep staff and community members safe at 
the Pease Study office by following CDC COVID-19 guidance. At this 
time, there would be significant challenges to including serological 
testing for participants in the study, including amending the Office of 
Management and Budget (OMB) and Institutional Review Board (IRB) 
protocol which would further delay implementing the study in the field. 
We continue to explore the possibility of including cohorts, such as 
those captured in the Pease Study and the multi-site study, in a future 
study on PFAS and SARS-CoV-2 exposure.
                                 ______
                                 
              Questions Submitted by Senator Brian Schatz
    Question. A recent poll found that public confidence in the CDC has 
dropped significantly since April. What actions has Dr. Redfield taken 
to increase public confidence in the CDC?
    Answer. CDC is providing the American public with the information 
and assistance it needs to address COVID-19 head on and continues to 
issue guidance and recommendations based on the best available science 
and data. As we work together to fight COVID-19 and end this pandemic, 
CDC is committed to its mission to protect all Americans from disease 
threats and to save lives.
    Question. Given President Trump's statements contradicting Dr. 
Redfield's statements on masks and vaccines at the hearing, does Dr. 
Redfield maintain his statements?
    Answer. Dr. Redfield fully believes in the importance of vaccines 
and the importance of a COVID-19 vaccine. A COVID-19 vaccine is one 
tool to helping Americans get back to normal everyday life. The best 
defense we currently have against this virus are the important 
mitigation efforts of wearing a mask, washing your hands, practicing 
social distancing and avoiding large gatherings.
    Question. Was the White House, in any way, involved in the CDC's 
removal of guidance from its website on how COVID-19 spreads?
    Answer. The airborne transmission information posted in late 
September to the CDC website was posted in error. The guidance had not 
yet completed appropriate technical review by CDC. Thus, CDC reverted 
to the guidance that had been technically reviewed. We are reviewing 
our protocols to prevent this from happening again. Appropriate 
technical review has now occurred on this topic, and CDC posted updated 
information to the website October 5: https://www.cdc.gov/coronavirus/
2019-ncov/prevent-getting-sick/how-covid-spreads.html.
    Question. Does the CDC believe that the main way that COVID-19 
spreads is through airborne transmission of droplets and aerosols?
    Answer. COVID-19 is thought to spread mainly through close contact 
from person to person, including between people who are physically near 
each other (within about 6 feet). People who are infected but do not 
show symptoms can spread the virus to others. Infections occur mainly 
through exposure to respiratory droplets when a person is in close 
contact with someone who has COVID-19. When people with COVID-19 cough, 
sneeze, sing, talk, or breathe, they produce respiratory droplets. As 
droplets travel further from the person with COVID-19, the 
concentration of these droplets decreases. These droplets can range in 
size from larger droplets, which fall out of the air due to gravity, to 
smaller droplets which spread apart in the air. Small droplets can also 
form particles when they dry very quickly in the airstream.
    Some infections can be spread by exposure to virus in small 
droplets and particles that can linger in the air for minutes to hours. 
This kind of spread is referred to as airborne transmission. These 
viruses may be able to infect people who are further than 6 feet away 
from the person who is infected or after that person has left the 
space. There is evidence that under certain conditions, people with 
COVID-19 seem to have infected others who were more than 6 feet away. 
These transmissions occurred within enclosed spaces that had inadequate 
ventilation. Sometimes the infected person was breathing heavily, for 
example while singing or exercising. Under these circumstances, 
scientists believe that the amount of infectious smaller droplets and 
particles produced by the people with COVID-19 became concentrated 
enough to spread the virus to other people. However, available data 
indicate that it is much more common for the virus to spread through 
close contact with a person who has COVID-19 than through airborne 
transmission.
    Question. There have been major cuts to the public health workforce 
and State and local health departments are overwhelmed in responding to 
the pandemic. How is the CDC supporting 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).

                          SUBCOMMITTEE RECESS

    Senator Alexander. The subcommittee stands adjourned.
    [Whereupon, at 12:56 p.m., Wednesday, September 16, the 
subcommittee was recessed, to reconvene subject to the call of 
the Chair.]

 
              MATERIAL SUBMITTED SUBSEQUENT TO THE HEARING

    [Clerk's Note.--The following outside witness testimony was 
received subsequent to the hearing for inclusion in the 
record.]
         Prepared Statement of the Alzheimer's Association and 
                      Alzheimer's Impact Movement
    The Alzheimer's Association and Alzheimer's Impact Movement (AIM) 
appreciate the opportunity to submit this statement for the record for 
the Senate Committee on Appropriations, Subcommittee on Labor, Health 
and Human Services, Education, and Related Agencies hearing entitled 
``Review of Coronavirus Response Efforts.'' The Association and AIM 
thank the Subcommittee for its continued leadership on issues important 
to the millions of people living with Alzheimer's and other dementia 
and their caregivers. This statement provides an overview of urgent 
policies that are needed now to protect this vulnerable population 
during the COVID-19 pandemic and beyond, including actions for the 
long-term care community, robust fiscal year 2021 funding for 
Alzheimer's activities at the CDC and NIH, and efforts to expand 
capacity for health outcomes through Project ECHO.
    Founded in 1980, the Alzheimer's Association is the world's leading 
voluntary health organization in Alzheimer's care, support, and 
research. Our mission is to eliminate Alzheimer's and other dementia 
through the advancement of research to provide and enhance care and 
support for all affected, and to reduce the risk of dementia through 
the promotion of brain health. AIM is the Association's sister 
organization, working in strategic partnership to make Alzheimer's a 
national priority. Together, the Alzheimer's Association and AIM 
advocate for policies to fight Alzheimer's disease, including increased 
investment in research, improved care and support, and development of 
approaches to reduce the risk of developing dementia.
                   covid-19 impact on long-term care
    Nursing homes and assisted living communities are on the frontlines 
of the COVID-19 crisis, where 48 percent of nursing home residents are 
living with dementia, and 42 percent of residents in residential care 
facilities have Alzheimer's or another dementia. Residents with 
dementia are particularly susceptible to COVID-19 due to their typical 
age, their significantly increased likelihood of coexisting chronic 
conditions, and the community nature of long-term care settings. Across 
the country these facilities, their staff, and their residents are 
experiencing a crisis due to a lack of transparency, an inability to 
access the necessary testing, inaccurate reporting, and more. According 
to some reports, nearly 70,000 residents and employees of nursing homes 
and long-term care facilities have died, representing more than 40 
percent of the total death toll in the United States.
    The Alzheimer's Association released policy recommendations, 
Improving the State and Federal Response to COVID-19 in Long-Term Care 
Settings, to address both the immediate and long-term issues impacting 
these settings during the COVID-19 pandemic. These recommendations 
focus on four main areas: enhancing rapid, point-of-care testing in 
long-term care community settings; implementing timely reporting; 
developing protocols to respond to a rise in cases; and ensuring all 
facilities have necessary support, like personal protective equipment 
(PPE) and televisitation services.
    It is absolutely imperative that each nursing home and residential 
care community have the onsite testing capability to verify that all 
residents, staff, and visitors are free of COVID-19 infection, whether 
or not they are symptomatic. We appreciate the Administration's recent 
purchase of 150 million rapid tests, a portion of which we expect will 
be directed to long-term care settings. We also appreciate the recent 
announcement by the Centers for Medicare and Medicaid Services (CMS) 
that certain nursing home workers should receive testing as frequently 
as twice a week. However these actions still fall woefully short of 
what is urgently needed to protect the vulnerable Americans living in 
long-term care communities. We continue to advocate for the ``White 
House Standard'' of daily rapid-response testing for all new 
individuals who come onsite, and retesting for returning individuals 
who enter the facility, in accordance with local guidance. We also 
support the immediate and accurate reporting of long-term care COVID-19 
cases. These reports should be updated upon remission, death, transfer, 
or other appropriate status update. With all appropriate privacy 
safeguards for individuals, this reported data should be freely and 
immediately accessible to everyone, down to the facility level. Any 
reported cases should trigger careful, ongoing monitoring and, if 
conditions warrant, ``strike teams'' should be deployed to provide 
needed support until the outbreak is appropriately contained and 
eliminated. It is also essential that all nursing homes and residential 
living communities have full, timely access to all needed PPE, testing 
equipment, training, and external support to keep them COVID-19-free. 
Importantly, this includes requiring these settings to address social 
isolation and ensure people with Alzheimer's and other dementia are 
able to communicate with their family and friends.
       fiscal year 2021 alzheimer's appropriations at cdc and nih
    Now more than ever it is apparent how crucial it is to have an 
established infrastructure in place to respond to public health 
threats. Public health plays an important role in promoting cognitive 
function and reducing the risk of cognitive decline. Investing in a 
nationwide Alzheimer's public health response will help create 
population-level improvements, achieve a higher quality of life for 
those living with the disease and their caregivers, and reduce 
associated costs. The Alzheimer's Association and AIM thank the 
Subcommittee for it's leadership in providing the Centers for Disease 
Control and Prevention (CDC) $10 million in fiscal year 2020 to 
implement the first year of the BOLD Infrastructure for Alzheimer's Act 
(Public Law 115-406). This funding enabled CDC to recently award three 
Public Health Centers of Excellence, one focused on Dementia Risk 
Reduction, one on Dementia Caregiving and one on Early Detection of 
Dementia. CDC also awarded BOLD funding to 16 public health departments 
at the State, local and Tribal level. While this funding is an 
important step forward, CDC must receive the full $20 million 
authorized for fiscal year 2021 to ensure the meaningful impact that 
Congress intended.
    Furthermore, as the current pandemic has shown, continued 
investment in medical research is absolutely critical to understanding 
and responding to diseases. We thank the Subcommittee for it's 
leadership in providing a $350 million increase in Alzheimer's research 
funding at the National Institutes of Health (NIH) in fiscal year 2020. 
However, if America is going to succeed in the fight against 
Alzheimer's, Congress must continue to provide the resources scientists 
need to do their work. Therefore we urge the Subcommittee to fund the 
research targets outlined in the Alzheimer's Professional Judgment 
Budget by supporting an additional $354 million for NIH Alzheimer's 
funding in fiscal year 2021.
         expanding capacity for health outcomes (project echo)
    Finally, we ask the Subcommittee to support provisions to expand 
the use of technology-enabled collaborative learning and capacity-
building models. These education models, often referred to as Project 
ECHO, can improve the capacity of providers, especially those in rural 
and underserved areas, on how to best meet the needs of people living 
with Alzheimer's. During the COVID-19 pandemic, Project ECHO is helping 
primary care physicians in real-time understand how to use validated 
assessment tools appropriate for virtual use to make early and accurate 
diagnoses, educate families about the diagnosis and home management 
strategies, and help caregivers understand the behavioral changes 
associated with Alzheimer's, which can be heightened during isolation. 
Project ECHO is also helping long-term care providers understand in 
real-time how to train temporary staff that may not be familiar with 
how to best care for people with Alzheimer's, implement important 
health strategies such as hand-washing and social distancing for people 
with Alzheimer's, and effectively communicate with residents to help 
them understand the COVID-19 pandemic. In fact, the Alzheimer's 
Association developed a special topic Project ECHO dementia series to 
help assisted living communities during COVID-19 based on our 
guidelines, Emergency Preparedness: Caring for persons living with 
dementia in a long-term or community-based care setting.
                               conclusion
    The Alzheimer's Association and AIM appreciate the steadfast 
support of the Subcommittee and its priority setting activities, 
especially during this time. However, our Nation must do more to 
support the millions of Americans living with Alzheimer's and other 
dementia, and their caregivers. We urge the Subcommittee and other 
members of Congress to work in a bipartisan way to advance policies 
that will help protect this vulnerable population during the COVID-19 
pandemic and beyond, including actions for the long-term care 
community, robust fiscal year 2021 funding for Alzheimer's activities 
at the CDC and NIH, and efforts to expand capacity for health outcomes 
through Project ECHO.
                                 ______
                                 
        Prepared Statement of the North American Meat Institute
    Chairman Blunt, Ranking Member Murray, and Members of the 
Committee:
    Thank you for holding the hearing, ``Review of Coronavirus Response 
Efforts.'' The North American Meat Institute (Meat Institute) 
appreciates your leadership as the Nation has responded to the novel 
coronavirus, COVID-19.
    The Meat Institute is the Nation's oldest and largest trade 
association representing packers and processors of beef, pork, lamb, 
veal, turkey, and processed meat products, and Meat Institute member 
companies account for more than 95 percent of United States output of 
these products. The Meat Institute provides regulatory, scientific, 
legislative, public relations, and educational services to the meat and 
poultry packing and processing industry.
    On March 18, 2020, the Department of Homeland Security identified 
food manufacturing as a critical infrastructure sector, which included 
meat and poultry workers.\1\ Those employees have been on the front 
lines, working in plants and ensuring Americans have access to safe, 
nutritious, and affordable food. Despite a range of challenges 
fulfilling unprecedented demand during the pandemic, the industry has 
proven to be resilient and the supply chain remains intact.
---------------------------------------------------------------------------
    \1\ Cybersecurity & Infrastructure Security Agency. https://
www.cisa.gov/identifying-critical-infrastructure-during-covid-19.
---------------------------------------------------------------------------
    Developing an effective vaccine to COVID-19 is priority 1; 
developing an effective plan for its distribution is priority 1A. The 
many workers in the food sector, including those who work in meat and 
poultry processing plants, should be a top priority for receiving a 
vaccine. Specifically, meat and poultry workers and USDA inspectors 
should be given the highest priority for vaccinations in the Tier 2 
population.
    The National Academies of Sciences, Engineering, and Medicine 
(NASEM) got it right when NASEM asserted that workers in the population 
group that includes meat and poultry workers ``need to be provided the 
vaccine, and special efforts must be made to reach these workers in 
ways that encourage them to be vaccinated.'' \2\
---------------------------------------------------------------------------
    \2\ National Academies of Sciences, Engineering, and Medicine, 
Discussion Draft of the Preliminary Framework for Equitable Allocation 
of COVID-19 Vaccine, p. 67.
---------------------------------------------------------------------------
    Thank you again for leadership during the pandemic and holding the 
hearing to review the coronavirus response. The Meat Institute hopes 
this statement is helpful as the Subcommittee considers COVID-19 
vaccine distribution.
                                 ______
                                 
             Prepared Statement of Patient ID Now Coalition
    On behalf of the Patient ID Now coalition, thank you for the 
opportunity to provide written testimony regarding the U.S. Senate's 
Appropriations Subcommittee on Labor, Health and Human Services, 
Education, and Related Agencies (Labor-HHS) hearing, ``Review of 
Coronavirus Response Efforts.''
    Patient ID Now is a coalition of healthcare organizations that 
represents a wide range of healthcare stakeholders committed to 
advancing through legislation and regulations the development and 
implementation of a national strategy to address patient identification 
and matching.
    The response to the COVID-19 pandemic has highlighted the need to 
address patient misidentification throughout the health system. 
Accurate identification of patients is one of the most difficult 
operational issues during a public health emergency, including the 
gathering of patient demographic information (e.g.--address, phone, 
email, etc.) and ensuring such information remains attached to the 
correct patient. Field hospitals and temporary testing sites in parks, 
convention centers, and parking lots have exacerbated these challenges.
    Without the ability to accurately identify and match patients to 
their health information, this critical information becomes lost and 
safe, effective and timely diagnosis and is jeopardized. For example, 
there are reports of instances where patient specimens are collected 
for COVID-19 testing in temporary sites and then sent off-site to a 
public health lab for testing. Once the results were returned, there 
have been difficulties matching the results to the correct patient 
given the inconsistent and scant amount of demographic information 
included with the sample. This has resulted not only in a backlog of 
COVID-19 results unable to be sent to patients, but even results being 
sent to the wrong patient, increasing the privacy and safety risks to 
the entire community. Without test results being returned to the 
correct patients, contact tracing and individuals' own ability to 
quarantine effectively is hindered.
    Correctly matching patients to their information is not just vital 
for the initial COVID-19 diagnosis. Ensuring the correct patient 
medical history is accurately matched to the patient is also critical 
for future patient care, claims billing, patients' long-term access to 
their complete health record, and for tracking the long-term health 
effects of COVID-19, which the medical community does not currently 
know.
    Furthermore, the nationwide response in the coming months to the 
COVID-19 pandemic hinges on accurate information. For example, once a 
vaccine is created, any large-scale immunization programs will depend 
on accurate patient information to identify who has had the disease, 
who has been vaccinated, and what their outcomes are. Multiple dose 
vaccines will rely even more heavily on patient records being complete 
to ensure the correct timing and dosage for patients to be fully 
protected. As public health systems increasingly rely on patient data 
pulled from electronic health records (EHRs), we must make sure that 
the patient information within these EHRs is accurate in order to have 
the best public health response to these emergencies.
    The COVID-19 pandemic has also laid bare healthcare disparities in 
underserved communities and populations. As the coronavirus has 
disproportionately affected these communities, so has patient 
misidentification, increasingly putting these patients' health at 
higher risk. According to OCHIN, a national, non-for-profit, health IT 
service provider for a national network of more than 500 healthcare 
delivery sites across the country--
  --Black patients make up 13 percent of their patient population but 
        21 percent of duplicate records;
  --Hispanic/Latino patients make up 21 percent of the population that 
        OCHIN's members serve, yet they make up 35 percent of 
        duplicates;
  --The homeless population makes up 4.3 percent of OCHIN patients, but 
        12 percent of its duplicates (almost three times the expected 
        rate); and
  --Migrant patients make up 2.1 percent of the OCHIN patient 
        population but 3.6 percent of its duplicates.
    Failure to accurately identify and match patients to their health 
information raises serious quality of care and patient safety concerns, 
which must be a top priority during a pandemic. Difficulties in 
correctly matching patients to their health information across health 
information technology systems limits health information exchange, 
which can result in medical errors, delayed or lost diagnoses, 
duplicative testing, and wrong patient orders. The problem of patient 
misidentification is so dire that one of the Nation's leading patient 
safety organizations, the ECRI Institute, named patient 
misidentification among the top ten threats to patient safety.\1\ 
Patient matching issues can cause everything from delayed or 
unnecessary care, to adverse drug events, to even death.\2\
---------------------------------------------------------------------------
    \1\ Top 10 Patient Safety Concerns for Healthcare Organizations, 
Available at: https://www.ecri.org/EmailResources/PSRQ/Top10/
2017_PSTop10_ExecutiveBrief.pdf.
    \2\ http://www.healthcarebusinesstech.com/patient-identification-
errors/.
---------------------------------------------------------------------------
    The problem of patient misidentification extends to hospitals and 
providers that are already overburdened during this health crisis. 
Approximately 33 percent of all denied hospital claims are associated 
with inaccurate patient identification, costing the average hospital 
$1.5 million each year, and the healthcare system more than $6 
billion.\3\ Patient misidentification costs the average clinician 
almost half an hour in wasted time per shift at a time when many 
providers are already stretched thin.\4\
---------------------------------------------------------------------------
    \3\ https://www.securitymagazine.com/articles/88999-inaccurate-
patient-ids-cost-hospitals-15m-a-year.
    \4\ https://www.imprivata.com/company/press/positive-patient-
identification-can-dramatically-improve-patient-care-and-
hospital%E2%80%99s.
---------------------------------------------------------------------------
    Finally, patient privacy must continue to be a priority during a 
pandemic. Without a national strategy addressing patient identification 
and matching, the healthcare ecosystem faces an ``inverse'' privacy 
problem, whereby individuals must repeatedly disclose individually 
identifiable information to each healthcare provider they see to 
accurately match the patients to their medical record. Furthermore, 
each payer still maintains separate proprietary identifiers for 
patients, increasing the number of identifiers in use. Even more 
worrying for patient privacy is risk of overlays--i.e.--the merging of 
multiple patients' data into one medical record, causing patients to 
have access to other patients' health information, which could result 
in an unauthorized disclosure under HIPAA.
    The issues around patient identification arise due to a narrow 
interpretation of a two-decade old appropriations restriction included 
in Section 510 of the Labor-HHS appropriations bill that prohibits the 
U.S. Department of Health and Human Services from spending Federal 
dollars to promulgate or adopt a unique health identifier for 
individuals. This archaic ban has had a detrimental impact across the 
healthcare system to patients, providers, and public health. Striking 
Section 510 from the Labor-HHS appropriations bill will provide the 
U.S. Department of Health and Human Services the ability to evaluate a 
full range of patient matching solutions and enable it to work with the 
private sector to identify a nationwide strategy that is cost-
effective, scalable, secure and one that protects patient privacy.
    Accurate patient identification and matching must be a top priority 
during public health emergencies to protect patient safety, patient 
privacy, and strengthen the public health response. While Section 510 
remains in the Labor-HHS appropriations bill, the ability to address 
these issues will continue to be stifled.
    We appreciate the opportunity to provide comments on the issue of 
patient identity and matching as it relates to the national coronavirus 
response. We look forward to working with you and acting as a resource 
on patient identification. Should you or your staff have any additional 
questions or comments, please contact Kate McFadyen, Director, 
Government Affairs, AHIMA, at [email protected].
                                 ______
                                 
         Prepared Statement of the Premier Healthcare Alliance
    The Premier healthcare alliance appreciates the opportunity to 
submit a statement for the record on the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, Education and Related 
Agencies hearing titled ``Hearing to review Coronavirus Response 
Efforts'' scheduled for September 16, 2020. We applaud the leadership 
of Chairman Blunt, Ranking Member Murray and members of the 
Subcommittee for holding this hearing to examine the Nation's response 
to the COVID-19 pandemic.
    The Premier healthcare alliance is a leading healthcare improvement 
company, uniting an alliance of more than 4,100 U.S. hospitals and 
health systems and approximately 200,000 other providers and 
organizations to transform healthcare. With integrated data and 
analytics, collaboratives, supply chain solutions, and consulting and 
other services, Premier enables better care and outcomes at a lower 
cost. Premier plays a critical role in the rapidly evolving healthcare 
industry, collaborating with members to co-develop long-term 
innovations that reinvent and improve the way care is delivered to 
patients nationwide.
    COVID-19 has exposed one of healthcare's fundamental weaknesses: 
the fragmented and siloed nature of care delivery and the lack of 
centralized coordination when it comes to managing and preventing 
disease spread. The public health system continues to rely on flawed 
data and obsolete technology that consistently fails to accurately 
identify and track current cases, monitor disease progression, or 
predict future surges. Not only do these blind spots create 
opportunities for the disease to spread, they also undermine the 
ability to safely plan for economic recovery and re-opening of the 
country.
America Needs to Modernize its Disease Surveillance Process Using the 
        Existing HIT Infrastructure
    The COVID-19 public health emergency has heightened the awareness 
of the need to modernize our public health surveillance capabilities. 
America needs an automated, near real-time means to collect this 
symptom and confirmed case information consistently and comprehensively 
so that it can be shared between and among multiple stakeholders, 
including Federal, State, local, and tribal public health agencies and 
authorities. Existing health IT infrastructure and policies governing 
interoperability, standards and electronic health records (EHRs) can be 
leveraged to achieve effective and efficient public health systems 
modernization. The modernized public health infrastructure should 
include the following components.
  --Collection and reporting of standardized and consistent data for 
        use by Federal, State, local and tribal health agencies and 
        authorities.
  --Ensure that nationwide syndromic surveillance is achieved by 
        beginning with the collection of signs and symptoms data and 
        add confirmed cases as testing results become available.
  --Provide clinical decision support (CDS) to help clinicians follow 
        the latest evidence-based guidelines at the point of care.
    Inaccurate patient matching is widespread, disrupts the 
coordination and quality of care during the COVID-19 pandemic, can 
cause serious safety events and is costly to the healthcare system
    One of the most significant challenges impeding the safe, secure 
and efficient electronic exchange of health information is the lack of 
a consistent, national approach to patient data matching. As our 
Nation's healthcare providers innovate care to test, treat and prevent 
the spread of COVID-19, patient identification and data matching errors 
have become exponentially more problematic and dangerous.
    These challenges stem from a narrow interpretation of archaic 
language that has been included in Labor- HHS Appropriations bills 
since fiscal year 1999. We urge the Senate to follow the House of 
Representatives' lead and remove the language from the fiscal year 2021 
Labor-HHS Appropriations bill that prohibits spending Federal dollars 
to promulgate or adopt standards for a national unique patient 
identifier (UPI) to help improve the Nation's pandemic response and 
overall public safety. This effort is widely backed by a broad array of 
healthcare leaders who are united in their commitment to improve safety 
processes for our Nation's healthcare providers and the patients they 
serve.
    While the issue has received little attention, accurately matching 
patients to their records is an ongoing challenge for providers and 
patient mismatching happens at an alarming rate. The Government 
Accountability Office found that inaccurate, incomplete or 
inconsistently formatted demographic information in patients' records 
can pose challenges to accurate matching. When records for different 
patients are mistakenly matched, or records for the same patient are 
not matched, it can adversely affect the patient's care. A Pew 
Charitable Trusts study found that patient matching rates can fall as 
low as 80 percent, leaving as many as one in five patients not matched 
to the correct record when receiving care from different providers.
    The problem is so serious in fact, that the ECRI Institute, a 
widely respected national safety patient organization, ranked patient 
misidentification as one of the top ten patient safety concerns for 
healthcare organizations. Not only is the lack of unique patient 
identifiers putting patients in danger and compromising their privacy , 
misidentification costs the average healthcare facility $17.4 million 
per year in denied claims and potential lost revenue. The adoption of 
electronic health records and the exchange of electronic health 
information to better coordinate care and encourage value-based payment 
arrangements is also suffering due to the lack of a national strategy 
for patient matching and identification.
COVID-19 Elevates the Urgency to Remove the Ban that Threatens the 
        Lives of Americans
    As patients' information is exchanged among various types of 
providers--including hospitals, primary care physicians, specialty 
physicians, pharmacies, and laboratories--it's imperative that the 
healthcare information belonging to the same patient is correctly 
matched. This has never been so critical than during the current public 
health emergency. With patients getting tested for COVID-19 in 
different settings such as drive-through and other makeshift testing 
sites and being treated in field hospitals, ensuring that healthcare 
records follow the right patient has become extremely problematic.
    Providers treating COVID-19 patients in hospitals or other 
facilities urgently need current and accurate information about 
patients' laboratory or other diagnostic test results, their medication 
history and any comorbidities or diagnosed medical conditions to inform 
their treatment decisions. Public health experts must similarly rely on 
accurate and timely information on patients to conduct contact tracing 
and track outbreaks to stem the spread of the disease. Once a vaccine 
is developed, records must be accurately matched to the correct patient 
in order to identify who has been infected, who has been vaccinated, 
and what are the clinical outcomes.
    Implementing unique patient identifiers will also help the Nation 
address the disparate impact of COVID-19 that the Administration has 
identified during the pandemic. According to OCHIN, the Black, 
Hispanic/Latino, homeless and migrant population make up a 
disproportionate share of those who experienced duplication of 
healthcare records.
    Premier urges Congress to remove the ban in the appropriation 
process to finally address the impediment to patient matching and 
identification which is putting patients at risk, increasing costs to 
the healthcare system, perpetuating inefficiencies in care delivery and 
coordination, and undermining efforts to achieve nationwide 
interoperability.
                               conclusion
    In closing, the Premier healthcare alliance appreciates the 
opportunity to submit a statement for the record on the Senate 
Appropriations Subcommittee on Labor, Health and Human Services, 
Education and Related Agencies hearing on the response to the 
coronavirus. Premier is available as a resource and looks forward to 
working with Congress as it considers policy options to continue to 
address this very important issue.
    If you have any questions regarding our comments or need more 
information, please contact Duanne Pearson at 
[email protected].