Document text
know. We don’t know if it did—but all
the evidence is pointing that it came from the lab, and there will be responsibility for those who funded the lab, including yourself.
Dr. F
AUCI . I totally resent—.
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The C HAIR . This Committee will allow the witness to respond.
Dr. F AUCI . I totally resent the lie that you are now propagating,
Senator, because if you look at the viruses that were used in the experiments, that were given in the annual reports that were pub-lished in the literature, it is molecularly impossible—.
Senator P
AUL. No one is saying those viruses caused it.
Dr. F AUCI . It is molecularly—.
Senator P AUL. No one is alleging that those viruses caused the
pandemic. What we are alleging is the gain of function research was going on in that lab and NIH funded it.
Dr. F
AUCI . That is not——
Senator P AUL. You can’t get away from it. It meets your defini-
tion, and you are obfuscating the truth.
Dr. F AUCI . I am not obfuscating the truth, you are the one.
The C HAIR . Senator Paul, your time has expired, but I will allow
the witness to——
Dr. F AUCI . Let me just finish. I want everyone to understand
that if you look at those viruses, and that is judged by qualified virologists and evolutionary biologists, those viruses are molecu-larly impossible to result in SARS-CoV–2.
Senator P
AUL. No one is saying they are. No one is saying those
viruses caused the pandemic. We are saying they are going to func-tion viruses—.
Dr. F
AUCI . They are not—.
Senator P AUL. Because they are animal viruses that became
more transmissible in human, and you funded it. Why won’t you admit the truth?
Dr. F
AUCI . You are implying——
The C HAIR . Senator Paul, your time has expired, and I will allow
witnesses who come before this Committee to respond.
Dr. F AUCI . You are implying that what we did was responsible
for the deaths of individual—I totally resent that—.
Senator P AUL. It could have.
Dr. F AUCI . If anybody is lying here, Senator, it is you.
The C HAIR . Senator Smith.
Senator S MITH . Thank you, Dr. Fauci. And thanks to all of our
panelists for being here today. And thank you, Chair Murray and Ranking Member Burr. I just want to say, Dr. Fauci, is there any-thing more that you would like to say to counteract these attacks on your integrity that we have all just witnessed?
Dr. F
AUCI . Well, Senator, thank you. I don’t think I have any-
thing further to say. This is a pattern that Senator Paul has been doing now at multiple hearings based on no reality. He is talking about gain of function. This has been evaluated multiple times by qualified people to not fall under the gain of function definition. I have not lied before Congress. I have never lied, certainly not be-fore Congress. Case closed.
Senator S
MITH . Thank you. So we are 6 months into this pan-
demic, and I think we are at a critical moment. Two-thirds of adults have received at least one dose of the vaccine. And at the same time, we are seeing cases rising to about 41,000 a day. As Dr. Walensky has said, we have an epidemic here of the unvaccinated. And—but, of course, this continues to affect every single one of us. So it seems to me that our actions and messages in this moment
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are going to make a huge difference in whether we move forward
or backward, not only here in the United States, but everywhere in the world.
Today, as I was walking into this Committee hearing, for the
first time in months, I saw a line of people waiting outside of a pharmacy for testing and vaccines. And it made me wonder wheth-er the recent surge of the delta variant is getting people’s attention and moving them from indecision to action. What a terrible way for this to happen. But—so I have a few questions just I hope clear up some of the misinformation and misunderstandings. Dr. Fauci, the COVID–19 vaccine protects against the delta variant, is that cor-rect?
Dr. F
AUCI . It protects against the clinically apparent disease, and
it protects extremely well against hospitalization and death.
Senator S MITH . Right. So if you are not vaccinated, given how
contagious the delta variant is, I mean, it is—would it be fair to say you are almost—you are very likely to get this variant. To get the COVID–19 variant, would you say?
Dr. F
AUCI . Well, certainly when you look at the capability of this
virus to transmit from people to people. I mean, obviously you have to be in an environment in which the virus is present. So if you are in it, for example—and I believe Dr. Walensky mentioned that in her remarks. If you are in an area, be it a state, a city, a county or what have you, well, you have a high level of infection in the community and a very low level of vaccinated people, the chances in that environment of getting infected are reasonably high.
Senator S
MITH . Right. And how do you compare, how do you
think about the risks—the side effect risks of the COVID–19 vac-cine compared to the risks of not being vaccinated? Because this is, I think, what people are struggling with.
Dr. F
AUCI . Right. It refers to the risk benefit ratio of getting a
vaccination. And every time this has been evaluated, not only with this vaccine, but with so many other vaccines, there is no interven-tion that is without some time getting an adverse event. I mean, I don’t think I can think of one that hasn’t.
When you have that situation, you balance the rarity or the un-
commonness of a particular adverse event with the advantage that you would get from protecting yourself against the actual disease against which you are vaccinated. And thus far, whenever this has come up about an adverse event, it has been evaluated, perhaps even a warning has been given, but it is always weighed on the part of saying that the benefit of the protection of the vaccine out-weighs the risk of the adverse event.
Senator S
MITH . Thank you. Dr. Walensky I talk with public—I
have spoken with a lot of public health experts in Minnesota who tell me that they are still challenged getting especially younger adults who are eligible to be vaccinated, getting them vaccinated. And part of it is the challenge, this perception that COVID is just not that big a deal for younger people, people who consider them-selves healthy and have got a strong immune system and so forth. So let me ask you this. Are there a larger number of younger peo-ple getting hospitalized today versus a year ago or 6 months ago?
Dr. W
ALENSKY . We have seen hospitalizations go up for every
age bracket recently as cases go up. Proportionally because there
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are more cases now among younger people, we are seeing more of
those people in the hospital. They still get hospitalized at a less fre-quent rate given unvaccinated than elderly patients. But in fact, because there are more of them now that we are seeing more of them in the hospital.
Senator S
MITH . Okay. So another good piece of advice there to
have, being aware of the risk, even if you are—even if you see yourself as young and healthy.
Dr. W
ALENSKY . Absolutely.
Senator S MITH . Thank you, Madam Chair.
The C HAIR . Thank you.
Senator Moran. Senator M
ORAN . Madam Chair, thank you. Thank you and Sen-
ator Burr for today’s hearing. Thank you for the witnesses for being here. Let me start with Dr. Walensky, please. Doctor, in May, the CDC announced new guidance for fully vaccinated indi-viduals, that they could resume activities without wearing a mask or staying socially six feet apart.
At that time, the CDC further said that they would continue to
update guidance for travel as the science was developing and they would need to collaborate with other agencies regarding a face mask requirement. A month later, a number—me and a number of my colleagues sent a letter to the CDC and the TSA asking for an update regarding the mask requirement during travel.
While we had a response from TSA, we have not had it yet, a
response from CDC. And I wondered if you would tell me where the CDC is in the process of updating the mask requirement for fully vaccinated individuals while traveling.
Dr. W
ALENSKY . Thank you for that question, Senator. Obviously,
as you know, the discussion about masking on Federal aviation and ships is an interagency process, not simply with CDC. I will say a lot has changed since May 13th. As you heard from Dr. Fauci, we now have a variant circulating in this country that is at the time was less than 3 percent and is now 83 percent and much more transmissible.
We are continuing those conversations, working toward a letter
back to you. Thank you for your patience. And we will continue to revisit that as we learn more about vaccine efficacy, as we learn more about transmission in the context of vaccination, and as we understand more about the delta variant.
Senator M
ORAN . Are you expecting a change in the expiration
date of that continued requirement?
Dr. W ALENSKY . I think we still have more looking to do with
that.
Senator M ORAN . Let me turn to Ms. O’Connell. Ms. O’Connell,
you are not the perfect witness from HHS for my statements or questions, but you are my only witness from HHS for my state-ments. It is a bit about the future, which you are fully engaged in. We need a better response to public health emergencies. And I want to talk about—in that regard, I want to talk about the param-eters of the provider relief fund. HHS, in my view, is terribly slow in their release of guidance and on how the funds could be utilized.
There has been a lot of confusion by health care providers. They
have been reluctant to spend the money. It is—we are incapable of
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solving problems if the resources that we provide to those who are
in the health care field, they are not utilized because they are fear-ful that they don’t know what the guidance is and therefore, if they make a mistake, they have penalties at a later date.
I guess the question that could be for you, what is the plan to
get HHS to perform better or more quickly so that providers have the necessary information and comfort level to take the steps nec-essary to prevent the spread of the virus and to care for the health care of Americans and others?
The part that doesn’t necessarily involve you, but in hopes that
HHS is otherwise listening, there is about $24 billion left unspent in the Provider Relief Fund and we have been anxiously awaiting always with the answer that it is in the works about assistance and care for facilities that care for our senior populations. And there is still no answer in that regard.
I don’t know that you have a comment necessarily on that part
of my commentary, but again, I would utilize this as an oppor-tunity to try to get more certainty at HHS on the spending of those dollars.
Ms. O’C
ONNELL . Senator Moran, thank you for your question, for
both parts of it, and I certainly appreciate how frustrating it has probably been not to have the clarity that you and your constitu-ents have been seeking.
We will take the comments that you have made today and bring
them back to the secretary and other parts of HHS senior leader-ship to make sure that we understand how important it is that this money is moving quickly, and that the guidance comes out expedi-tiously and that we can do all we can to support. I mean, we really want to do all we can to support your constituents.
It is helpful to know that this has been a problem, and I look
forward to working with you and your staff on it.
Senator M
ORAN . If you can accomplish that, the purpose of my
comment will be satisfied. I would particularly ask that someone from HHS respond to us about the provider relief fund as it relates to senior care living circumstances.
Dr. Fauci, in the 24 seconds I have left, I will just ask a quick
question. What are the necessary steps—you have talked about mental health. What are the necessary steps to mitigate a mental health and drug overdose crisis? What should Congress and Amer-ican institutions be doing today for a future pandemic?
Dr. F
AUCI . Well, first of all, I think the lesson that we have
learned from this, and we would hope in good preparation for what will inevitably be another challenge in the future, can’t predict when, is to realize the important mental health impact that this outbreak has had, not only in the suffering from the disease itself, but from the extraordinary disruption of our society, which I think we are going to have to realize, that even when we get this under control, the mental health effects of this are going to be following this for months if not years afterwards.
We can’t forget that. When the outbreak is over, the mental
health effects are not going to be over. They are going to linger. And that is what we really need to address.
The C
HAIR . Thank you.
Senator Rosen.
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Senator R OSEN . Thank you, Chair Murray, Ranking Member
Burr, for holding this vitally important hearing today. And I really want to thank all of the witnesses for helping to get our Country vaccinated. It is so important to every person that we know and love in our community and our personal lives that we do every-thing we can to save them and protect them, and I appreciate your hard work in this regard.
I just want to speak a little bit about vaccine outreach, because
our Country—we have made tremendous progress over the past several months in making the vaccine available to most individ-uals, to getting shots and arms. I have had the honor of going to some of the vaccine sites, of course, clinics in my home State of Ne-vada. Our health care heroes, they are pillars of strength in our communities, showing up day after day to be sure that everybody that wants a vaccine can get one.
We just can’t lose ground. But unfortunately, Nevada is—our
cases are growing, and we seem to be getting to the top of the list nobody wants to be in, in the cases of the delta variant. I am ex-tremely concerned about the lag in vaccination rates. In fact, last week, especially a nursing home, Senator Cortez Masto and I sent a letter to Secretary Basara to raise concerns about the low re-ported vaccination rates in Nevada’s nursing homes. And we have to find a solution to protect those most vulnerable who can’t go out to a site and even their loved ones couldn’t take them.
Dr. Walensky, are there any plans for the CDC or in coordination
with other agencies to restart the pharmacy partner program that sent teams directly to every nursing home, perhaps, or every facil-ity with less than a 90 percent vaccination rate for residents and staff and I might even say families of staff who they go home to?
Dr. W
ALENSKY . Thank you for that question, Senator Rosen. And
we recognize this challenge, and we are with you. And that, in fact, we have 10 CDC people deployed to Nevada right now working to assist. You know, part of the long term plan in terms of working to vaccinate our long term care facilities, not necessarily these stac-cato partnerships with the pharmacies, but to have a longitudinal plan, because, in fact, especially in our long term care facilities, there is quite a bit of turnover of the patients.
We want to make sure that there is always vaccine available.
Many of these long term care facilities have access to pharmacies, and we want to make sure that there is a vaccine actually active in the pharmacies so that they can do vaccination when patients come in. I agree with you and in fact we need to work to get our staff vaccinated as well. In fact, staff in some of these long term care facilities are 20 percent less coverage than the facility mem-bers themselves—the residents themselves.
We are working on confidence in those areas, but specifically
strike teams in with a long term care facilities to assist in getting vaccine to those places that is not reliant on a one time mass vac-cination, but really has a longitudinal plan to make sure vaccine can be available in the long term.
Senator R
OSEN . Yes, and I would hope that you would include
the families of the staff, because oftentimes they have a high turn-over, too. They go home to their community and are just going to keep putting out that fire over and over. But I would like to switch
50
now and talk a little bit about the research in vaccines, because ob-
viously we are discovering more about COVID every single day.
I think for years to come, we are going to continue to learn. And
so now is the time to take those additional steps to say—to see we don’t look back and find gaps in data that could have been pre-vented, those gaps could have been prevented if we had acted soon-er, speaking of longitudinal. And so data like this could save lives. That is why I introduced the Ensuring Understanding of COVID– 19 to Protect Public Health Act. And it is bipartisan legislation that requires long term those longitudinal studies on a variety of COVID patient population with regular public reporting.
For example, some of the recent research is showing that
COVID–19 vaccine may actually improve symptoms for some pa-tients with long haul COVID. So, Dr. Fauci, how do we—what do we know about this so far and how common is the vaccine to be a strong prevention tool, but also to work therapeutically in this case? And what else should we be studying?
Dr. F
AUCI . Very good point, Senator. And there has been anec-
dotal reports of people who have been infected, have developed long COVID, and their symptoms have been improved upon getting the SARS-CoV–2 vaccine. That has not been proven under the scrutiny of a clinical trial.
Right now, we are looking at individuals who actually have re-
covered and seeing if, in fact, vaccination does improve. Right now, although the anecdotal cases suggest that I don’t think we can say anything definitively from a scientific standpoint, but that is some-thing that is being looked at.
Senator R
OSEN . Thank you. I see my time is up. Thank you.
The C HAIR . Thank you.
Senator Romney. Senator R
OMNEY . Thank you, Madam Chair. And thank you to
the members of our panel today for being here responding to our questions. Thank you also to the teams of people that you work with. Their tireless work over the last year and a half is something which many of us feel a great deal of gratitude for, for that effort. As we try and understand vaccine hesitancy, I am sure some of that is due to spurious conspiracy theories.
Perhaps and I don’t know this, but social media may be popu-
lated in part by enemies of our Country that are putting out theo-ries to try and get people not to take vaccines. But there is also, I believe, another reason why some people who are not prone to be-lieve those conspiracies don’t get vaccinated, and that is because they don’t know what the data really suggests. And they wonder, Okay, is this really a good thing for my 16 year old?
What are, the serious side effects of this vaccine for a 16 year
old versus the probability of them getting very ill? And I wonder, do we provide or is there a place where people can go to find out what the data show for the side effects of vaccines by age group and how many serious complications there are for people of dif-ferent ages and then compare that perhaps with the serious impli-cations of getting COVID? And I will ask first, Dr. Walensky.
Dr. W
ALENSKY . Yes. Thank you very much, Senator Romney. In
fact, that is exactly what we are doing. So, one of the things I think that is so important to understand is that when people don’t want
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to be vaccinated it’s for a whole host of reasons. And until you start
talking to them about what is their reason, is it, I can’t take off work tomorrow and I may feel unwell, is it because I don’t under-stand these potential side effects for my 6 year old?
We and CDC have what we call vaccine confidence consults. So
we have state departments, local health departments who can call into us and say, these are the things that we are hearing on the ground. What is the real data so that we can have trusted mes-sengers for providing that real data in real time to people and mak-ing sure that their answers are—their questions are answered and that we can empower the people who are the trusted messengers on the ground with exactly those data.
Senator R
OMNEY . Is that information being collected? Are doctors
and hospitals actually collecting the data that shows how many people are getting side effects by age group? Are you getting accu-rate information that people can rely upon? Because, again, I see on social media and some broadcasters a sense that somehow this is being hidden, that the side effects are being underplayed, that you have an incentive not to let people know what the kind of side effects might be and the seriousness of those side effects.
Dr. W
ALENSKY . The answer is absolutely. We have numerous
large scale mechanisms by which to collect these data. We have the first ever V-safe monitoring program where people are—given their vaccine, how did they do today? How are they doing in a week? We have the Vaccine Adverse Event Reporting System. That is a pas-sive reporting system.
Everything gets reported, is supposed to get reported but we rec-
ognize it is passive. Things may get missed. And then we actually also have the vaccine safety data link, which is a link of nine aca-demic centers that were able to get real vaccine data as well as their denominators, which is hard to get in passive reporting so we can check numerators and denominators there and give us real es-timates. We are doing—we are covering the gamut.
Senator R
OMNEY . The talk that Senator Burr described with re-
gards to getting a booster, the suggestion from Israel is it makes sense. There are a number of us that would get in line to get a booster. How long is it going to take before we are able to get suffi-cient information to allow Americans who want to get an additional vaccination to be able to do so? Are we talking weeks, are we talk-ing months? I mean, I guess given the fact that this is being done overseas, can we not use the data that has come from those places to allow people in this country to get a third shot if they want to?
Dr. W
OODCOCK . The agencies represented here are all monitoring
this extremely carefully. As you have heard, 95–99.5 percent of all people are being hospitalized now are unvaccinated. So at the mo-ment, the people that are getting sick are the people who haven’t been vaccinated.
Senator R
OMNEY . I understand but I am looking at the data that
is coming from Israel, and people who have double vaccinations are
still susceptible to the delta variant for serious disease and death. And they are showing that if they get a booster, that dramatically is reduced. Why should we not allow people who are elderly or have other compromised conditions to be able to get that booster?
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Dr. W OODCOCK . Certainly. We are looking at all that. Remember
this vaccine right now, the vaccines that are under emergency use authorization require an additional authorization for a booster.
Senator R
OMNEY . How long is that going to take? That is a ques-
tion. We have people who want to get that booster, and I am hear-ing that from people who are at risk and concerned. They want to take that booster. They are willing to take the additional risk of something that has not been—they have already had two shots of it. They are saying, give me the third, because I got this over a year ago. I got the vaccination over a year ago. I want to get that protection. Why can’t they? And if—I understand, you won’t let them yet. But when will you let them?
Dr. W
OODCOCK . Well, Pfizer, at least has announced that it is
going to submit to their EUA data, both Pfizer data and Senator Burr’s early point, other Israelis—other data that they have avail-able to potentially make the case for a booster. So the FDA will be looking at that.
Senator R
OMNEY . I am sure you will. I don’t like the timeframe,
frankly, given the fact that this is being done elsewhere. My time is up so I will turn back to you, Chair.
The C
HAIR . Dr. Woodcock, for clarification, Pfizer has not re-
quested FDA to approve a booster?
Dr. W OODCOCK . Well, of course, I can’t talk about that, but Pfizer
has publicly announced that they are going to submit an amend-ment to their EUA to request—for a booster dose.
The C
HAIR . Thank you.
Senator Hassan. Senator H
ASSAN . Well, thank you, Chair Murray and Ranking
Member Burr. And thank you to all of our witnesses today for the work you do. I want to just start to talk about a recent news item. It is a deeply disturbing report detailing dangerous inequities that USA Paralympians are facing at this year’s Tokyo Paralympics. Becca Myers is a six time Paralympic medalist who won three golds in Rio 5 years ago. She is deaf, blind, but in the past, that hasn’t stopped her from competing and winning at the highest lev-els.
This year, though, she and other athletes from Team USA who
experienced disabilities are being denied adequate access to per-sonal care assistants, reportedly due to COVID–19 restrictions. In-dividuals who experience disabilities should not be forced to navi-gate the Tokyo Olympics without the support that they need in the midst of a global pandemic. Becca announced on Sunday that she is quitting the team because she is being denied a, and this is her quote, ‘‘reasonable and essential accommodation’’ that would enable her to compete.
This is an outrage and a preventable situation that should never
have gotten to this point. So I want the U.S. Olympic and Paralympic Committee to work immediately to address this issue, and I want them to ensure that all of our athletes are able to com-
pete safely at this summer’s game, including by providing them the basic supports that they need just to navigate the world. So I do have a question though, Director Walensky, because over the last year and a half, the CDC has provided guidance on how to mitigate
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the risk of COVID–19 in various activities, as well as special
events, including sports.
I have a question that you all could answer in writing. You can
comment on it now if you would like. But what I am interested in is your best guidance regarding COVID–19 mitigation, taking into account the needs of people with disabilities. So if you would like to comment now you can or we can just do it in writing.
Dr. W
ALENSKY . Maybe I will just comment and say I share your
concern. We have dedicated resources specifically to disabled com-munities, especially those who are unable to come out and get vac-cinated. I think probably the details of individual sports, which we can do by writing, but I just want to echo your concerns.
Senator H
ASSAN . I just want to be clear that for some people
with disabilities, the accommodation, the aid they need is another human being. And it really needs to be seen as the same kind of accommodations we would make in other situations. So I appre-ciate having an ongoing discussion with you about it.
Now, I would like to turn to you, Ms. O’Connell. Last year, many
states, hospitals, and First Responders struggled to acquire per-sonal protective equipment, and the Federal stockpile did not con-tain the supplies needed to fulfill their requests for help. The stock-pile also contained many expired and unusable products, which fur-ther limited its effectiveness.
I recently introduced bipartisan legislation with Senator Cassidy
that would improve transparency into the stockpile, authorized transfers of expiring products, and assist states in establishing and maintaining their own stockpiles in order to help avoid the kinds of challenges that we faced last year.
What steps are you taking to improve the stockpile, and will you
continue to work with us on this bipartisan legislation to make fur-ther improvements?
Ms. O’C
ONNELL . Senator Hassan, thank you so much for your
question. This is a place where I intend to spend a lot of time in my new role. I am pleased to report that ASPER has spent and in-vested over $10 billion in supplemental funds to restock the stock-pile.
We currently have 35 times the number of N95 respirators we
had at the beginning of the pandemic. We have 17 times the num-ber of gloves, 8 times the number of masks, and of the N95 masks, all 12 contracts are with domestic manufacturers. So we are begin-ning to see some progress.
Senator H
ASSAN . Will you work with us on the bipartisan legisla-
tion that Senator Cassidy and I have introduced?
Ms. O’C ONNELL . I would look forward to. Thank you, Senator.
Senator H ASSAN . Thank you. Dr. Fauci, I have a question for you
about pediatric vaccines. Many parents and family members are understandably eager for updates on the potential availability of COVID–19 vaccine authorized for use for children under 12. I am encouraged that clinical trials for young children are underway, and I am hopeful that we will see the same safety and efficacy that we have seen from previously authorized COVID–19 vaccines. Doc-tor, when do you believe parents and families can expect trials to yield the type of data needed to pursue authorization for use in children under 12?
54
Dr. F AUCI . Thank you for that question, Senator. From the
standpoint of the data that would be required to make a decision, that very likely when you do the age de-escalation studies, so we have gone from 12 to 9, 9 to 6, 6 to 2, and then 6 months to 2 years, likely by late fall, early winter, we will have enough data. But that doesn’t mean that then it is all of a sudden going to be allowed to happen. That will be a regulatory decision that the FDA will have to make.
Senator H
ASSAN . Well, thank you. And I see that I am out of
time. I will follow-up with you in writing because I am also inter-ested in what you think we could do now to help boost confidence and uptake for the pediatric population once the approval is au-thorized.
The C
HAIR . Thank you.
Senator Marshall. Senator M
ARSHALL . Thank you, Madam Chair. My first question
for Dr. Walensky. As a physician, we always want to be able to know and discuss the benefits and risk of anything that we are prescribing, including a vaccine. It is estimated that 40, maybe 50 percent of children have already had the COVID virus. What are the additional benefits to the vaccine to a child who has already had the virus?
Dr. W
ALENSKY . I think it very much depends on what that vari-
ant that child might have had, whether they could potentially be infected or reinfected. And one thing I just want to note with the children is I think we fall into this flawed thinking of saying that only 400 of these 600,000 deaths from COVID–19 have been in children. Children are not supposed to die. And so 400 is a huge amount for a respiratory season.
Senator M
ARSHALL . Thank you. Dr. Woodcock, how many chil-
dren under the age of 18 without a preexisting condition, a signifi-cant health condition, have died from COVID in this country?
Dr. W
OODCOCK . I don’t—I don’t have that at my fingertips. I am
sorry.
Senator M ARSHALL . Dr. Walensky.
Dr. W ALENSKY . Over 400
Senator M ARSHALL . Without a pre-existing——
Dr. W ALENSKY . That, I don’t know.
Senator M ARSHALL . The answer is probably zero. So I think if
you take a deep dive, most of the children that have died had some type of underlying health condition. Dr. Fauci, in my hand is a three dimensional printing of the COVID spike, something that is certainly a scientific—just baffles me in so many ways.
It is composed of two units, as you know. There is an S2 subunit
and an S1. And I would like for you to talk about the S2 subunit for a second. Can you explain the significance of the furin cleavage side, the double arginine CGG codon, if you would, and how that works clinically for us?
Dr. F
AUCI . Yes. Thank you for that question, Senator. The furin
cleavage site is a site of a set of amino acids, which is at the point where the enzyme furin can cleave it so that the virus can then bind to the receptor cell and then enter the cell. So what is seen on a number of viruses, it has been seen on the SARD-CoV–2 and it is also seen on other beta coronaviruses. You asked also about
55
the double CGG codon that is a codon again, that is unusual, but
it is also seen on a number of beta coronaviruses. It is not a very common codon for the amino acid in question, but it is seen in coronaviruses.
Senator M
ARSHALL . Dr. David Baltimore, a Nobel Laureate, I
will quote him here, ‘‘when I first saw the furin cleavage side in the viral sequence with this arginine codon I said to my wife, it was the smoking gun for the origin of the virus. These features make a powerful challenge to the idea of a natural origin for SARS–2.’’ And again, this is Nobel Laureate, Dr. David Baltimore saying this. Would you agree or disagree with Dr. Baltimore?
Dr. F
AUCI . Well, Dr. Baltimore, who is an extraordinarily accom-
plished scientist, has backtracked on that statement, and says, I wish I had not used the word smoking gun when it was pointed out to him that actually this is seen in a number of coronaviruses, including one of the common cold coronaviruses. So I believe, if you would ask—.
Senator M
ARSHALL . You disagree with him?
Dr. F AUCI . Well, I agree with his second statement where he
backtracked and said he wished he had not—.
Senator M ARSHALL . You disagree with his first statement
though?
Dr. F AUCI . He disagrees with his first statement.
Senator M ARSHALL . Okay, not going to answer the question. We
also have the S1 subunit, and I refer to the timeline behind me here that there was a moratorium placed for viral gain of function in 2014. And I think you will agree with me that the NIH funded research that led to this, an S1 spike that looks very similar, if not exactly to what is on the COVID–19 spike.
Dr. F
AUCI . What are you referring to, Senator? Can you please
be more specific?
Senator M ARSHALL . Yes. So I am talking about the S1 subunit
of the current COVID–19 spike.
Dr. F AUCI . What about it? I mean, are you talking about an ex-
periment or are you talking about a paper that was published?
Senator M ARSHALL . I am talking about viral research that was
done using NIH funding with the North Carolina lab and Dr. Xi developed this S1 subunit spike that looks exactly like what we have on the current COVID–19 spike. Is that not true?
Dr. F
AUCI . No, I am not sure exactly what you are referring to.
Are you referring to the paper of Baric and Xi in Nature Immu-nology? Is that what you are referring—I need to know specifically.
Senator M
ARSHALL . Yes, Dr. Baric and Xi printed studies on this
S1 unit that was basically the development of the key to the door that was—specifically took the original SARS virus and made it so it would bind to the human lung cells.
Dr. F
AUCI . No, there was gain—if you are referring, Senator, to
gain of function by the definition.
Senator M ARSHALL . That is not my question. Would you agree
that the spike that was developed there is was also on the cur-rent—
Dr. F
AUCI . Yes, but that is irrelevant to anything until you have
a context in which you are putting it. You are talking about an S1
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and a spike in what context? If you are talking about a paper that
was written by them.
Senator M ARSHALL . But would you agree or disagree that it is
the same spike?
Dr. F AUCI . I am not sure what you are talking about, Senator.
I am really not sure what you are talking about.
Senator M ARSHALL . Okay, thank you.
Dr. F AUCI . Alright.
The C HAIR . Thank you.
Senator Casey. Senator C
ASEY . Thank you, Chair Murray. And I want to thank
the panel for being here today and for your public service. A chal-lenging time for the country. I just wanted to make a couple of statements at the top. Assistant Secretary O’Connell, I was—I want to ask you a question, but just wanted to note on page four and five of your testimony about the information about the inven-tory that you have built up. We are happy to read that. I won’t go through it all.
Also the statement you made about ensuring, ‘‘ensuring a safe
and consistent supply chain for medical materials, ingredients and supplies is critical for any national response to public health emer-gencies.’’ I couldn’t—we couldn’t be, I should say, more pleased with that kind of a focus, because we are going to need that in the future. Dr. Walensky, there was an earlier question, I think, by Senator Hassan talking about nursing homes and nursing home workers in particular.
I want to ask you a question, because I have got a separate ques-
tion. But the lower vaccination rate for nursing home workers is of concern. We are told by Federal data that there are still 13 states with less than half, less than half of nursing home workers have been vaccinated. So the message about vaccinations couldn’t be more important.
Last thing I would say, Dr. Fauci, in reference to the questions
by Senator Paul today and the accusation, I think it is a widely shared view in both houses, in both parties that the integrity that you bring to your work and the knowledge you bring to your work on behalf of the Nation, that I think that sentiment is a broad and deep reservoir, and it is very, very much bipartisan. I want to ask you to comment on that.
But I wanted to—I have a question for Dr. Fauci and Dr.
Walensky about breakthrough infections. We know that even with any—even with the great success of the vaccines, there is no 100 percent effectiveness. So I wanted to ask you about breakthrough infections. I haven’t seen, maybe it is available, but I haven’t seen information about either breakthrough infections or enough infor-mation about cases of long COVID, because—I assume because of a lack of data.
Dr. Walensky, I would ask you, what types of data is CDC col-
lecting to track breakthrough infections? And how are both CDC and the National Institute of Allergy and Infectious Diseases, Dr. Fauci, using data to monitor outcomes in patients with break-through infections?
Dr. W
ALENSKY . Thank you, Senator. So there are different ways
that we are capturing these data. And I think all of them fit to-
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gether in a puzzle. One is passive surveillance where folks give us
data when they break through, the hospital systems provide us data. They know that somebody is hospitalized and has a history of vaccination. We want to know about those cases to the extent possible. We would like to have a sample of the virus so that we can understand the viral load, so that we can sequence it, we can understand their symptoms and their risks that potentially put them in that situation.
However, that is actually limited because it actually doesn’t give
us the denominator. We don’t know who else would have been re-porting or who we missed in that process. And in order to do real effectiveness studies, we need to have both the numerator of the cases as well as the denominator. So we are doing many of those studies across the Nation. We do have them geographically sam-pled. We have a long term care facility study where we are getting data from over 14,000 long term care facilities. We have a health worker study.
We have an essential worker study. That is 5,000 essential work-
ers that are being tested by PCR every single week. And we have numerous other cohorts in 19 academic medical centers, 187 hos-pitals to monitor both the numerator, how many people are break-ing through, how serious is their infection, as well as the denomi-nator, how many people overall were vaccinated, so we can get a really good window as to the breakthrough—the percentage of peo-ple who are breaking through.
Senator C
ASEY . Thank you.
Dr. Fauci. Dr. F
AUCI . Well, thank you very much for your prior comment,
Senator. That is much appreciated. With regard to your question, I think people need to appreciate when you talk about break-through infections, that the original data from the clinical trial, the efficacy data, was based on preventing clinically apparent disease, not preventing infection such as asymptomatic infection.
When you hear about a breakthrough infection, that doesn’t nec-
essarily mean the vaccine is failing because it is still holding true, particularly with regard to protection against severe disease, lead-ing to hospitalization and deaths.
As per your question, what are we doing? We will be following
for two-years the people who are in the clinical trials, the 30,000 and 44,000 people, to be able to determine just what percent now in the context of the delta variant are actually breaking through, to determine if it is more than that original that we saw or in the context of delta, if it is actually much more.
Senator C
ASEY . Thank you, Doctor. Thank you, Chair Murray.
The C HAIR . Thank you.
Senator Cassidy. Senator C
ASSIDY . Thank you all. I will ask—if I cut you off, it
is not—I am not being rude, I just got 5 minutes. Got to hustle. Ms. O’Connell to follow-up on what Senator Hassan said, thank you for replenishing the strategic national stockpile. The one thing that troubled us is that there was no first in, first out. There was no rotation of material before it expired which was just dumped. What—just yes or no, have inventory management systems been implemented to minimize the wastage?
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Ms. O’C ONNELL . Thank you, Senator. Yes, we are looking at that.
Senator C ASSIDY . Looking is a very vague term. If you are one
of my medical students on rounds, I would say, what does that mean?
Ms. O’C
ONNELL . Well, one of the things we are pursuing is the
model of the vendor manage.
Senator C ASSIDY . Wonderful. Thank you. Second, related to that,
I am told there is a lot of vaccine that is about to expire. So it is 6 months from being expired in a state which is not completely using it. Unfortunately, my state, is among those.
Ideally, from my perspective, we rotate that vaccine out to the
border for those who are coming across as undocumented or down to Central America and Mexico, which is having these COVID out-breaks. I am told there is contractual issues with that. But is there any effort to rotate out soon to expire vaccine that doesn’t appear as if it is going to be used into a set in which it could be used quite rapidly?
Dr. W
OODCOCK . We have been working on this, and what we
have been advising the states is where they have repositories to hold on to that vaccine because unlike most medical products you are used to, we are making these stability determinations on the fly.
Senator C
ASSIDY . Dr. Woodcock, that is the news. You are telling
me that even if it goes beyond the expiration date, that the vaccine can still be used?
Dr. W
OODCOCK . No, I am saying we are telling people to hold on
to it, because when the additional stability—because we are doing stability—the companies are doing stability on the fly because we—
Senator C
ASSIDY . I understand.
Dr. W OODCOCK . Yes, so we have extended the date once already
for one of the vaccines. We may be able to keep extending as more stability—as there is longer stability observed.
Senator C
ASSIDY . But it still seems to me inevitably, sooner or
later, you are going to decide you have got to toss it. Now, just an inventory management system. It seems wise to be rotating that to a place where it would be taken up quickly as opposed to a place where it is being taken up quite slowly. Agree, disagree, and if you agree, any thoughts regarding that?
Dr. W
OODCOCK . Well, that is really for probably ASPER to talk
about——
Senator C ASSIDY . Maybe for State Department.
Dr. W OODCOCK . Yes.
Senator C ASSIDY . Are there other contractual obstacles to doing
that? Because someone told me that the contracts with the drug companies would not allow the transfer of the product to another setting. We couldn’t give it to Mexico, for example, because it just has to be tossed. Do you know about that?
Dr. W
OODCOCK . Well, they aren’t FDA’s contract so my under-
standing is that it is possible under EUA to do exports and that could be possible. So that—but we can get back to you on that, be-cause it really isn’t an FDA issue.
Senator C
ASSIDY . Sounds great. Next, as regards Dr. Fauci,
Walensky, it does seem to me this issue of Dr. Woodcock, of wheth-er or not we need a booster would be ascertainable by whether or
59
not we can see a response of antibody to re-challenge within the
window period is what, 4 days for the virus between exposure and an onset of infection if the antibodies after exposure to vaccine, if you will, mimicking an infection, shoot up rapidly, we have got pro-tection. Are any studies taking place along these lines?
Dr. W
OODCOCK . Yes, absolutely, both within the Government and
within the companies. And we certainly are—the Government as a whole, the agencies involved are monitoring this very carefully and we are sharing all the data. And we have heard from——
Senator C
ASSIDY . Now these are very simply done in very short—
and don’t have a lot of timeframe. Obviously, the window period is only 4 days. So, and I have asked about this before, but it doesn’t seem as if there are any answers. What is the delay in knowing this? Because that would answer Senator Romney’s question as re-gards whether or not a booster is required.
Dr. W
OODCOCK . Well as Dr. Fauci said, there are two things
going on here. One is, when does immunity wane to the point that you need to give a booster? Our populace is not just going to—we can’t just boost them all the time, right. We need to boost them when it is appropriate.
Senator C
ASSIDY . But isn’t there a subset of people whom you are
following longitudinally that have negative antibodies? Their anti-bodies are initially positive and now they have gone on either very low or zero.
Dr. W
OODCOCK . They are waning. I wouldn’t say they are nega-
tive. Obviously, Senator, Dr. Cassidy, there are going to be people who don’t respond to vaccination primarily because of some immunocompromise. However, what is being followed is the waning of humoral immunity, as Dr. Fauci described, over time. But it is waning. It isn’t vanished. And that is clear because everybody who is getting hospitalized is unvaccinated and they are being exposed to the delta variant. So the vaccination is holding right now in the U.S.
Senator C
ASSIDY . Good. I thank you all.
The C HAIR . Thank you.
Senator Lujan. Senator L
UJAN . Thank you so much, Chair Murray, for this im-
portant hearing, and to all of our witnesses for being here today. While I am encouraged that data shows vaccine rates are increas-ing across America, still less than half of Hispanics have been vac-cinated despite data showing that it is the least vaccine hesitant group. Dr. Walensky, Federal investment in community health cen-ters increased Hispanic vaccination rates. Yes or no, did this in-vestment in this community save lives?
Dr. W
ALENSKY . I am grateful for your collaboration with HRSA
and the Federal qualified health centers, and I absolutely think that being able to reach out to these communities has saved their lives, some of their lives.
Senator L
UJAN . Dr. Walensky, additionally, when Hispanic com-
munities has received outreach in Spanish, it increased vaccination rates. What is the plan to build on the success of using culturally appropriate outreach and messaging to boost Hispanic vaccination rates?
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Dr. W ALENSKY . I think we need to use culturally appropriate
messaging in all of our vaccination efforts. And not just in our vac-cination efforts, in all of our health care efforts. We have—our vac-cination toolkits are available in more than 20 languages. So it has to work within the vaccination of the Hispanic community, but also many of our other harder to reach communities.
Yes, we are continuing to do outreach by trusted messengers in
their own language and culturally sensitive ways. And in fact, we are seeing that is working. We had a recent NWR in North Caro-lina that demonstrated when we did this outreach, we were able to reach Hispanic communities, increasing vaccination rates from 8 to 19 percent.
Senator L
UJAN . Dr. Walensky, the next question I have is along
those lines. The Administration has enlisted Black owned barber-shops and beauty salons, as well as faith based community out-reach to promote the shots and even serve as vaccination sites to increase Black vaccine rates. Which is important and I applaud. Does the Administration have plans to employ similar targeted out-reach to the Hispanic community?
Dr. W
ALENSKY . The Administration is working to reach people
where they are and to understand the community by community, what is it that community needs, to understand—to have trusted messengers, whether it is in barbershops, whether it is in faith based organizations, whether it is in grocery stores, that is what we are working to do.
Senator L
UJAN . I would be interested if you could submit to me
or get to me what those plans are for outreach into the Hispanic community, similar to the plans I just described. I wish I could ask the panel similar questions about Native American vaccination rates. IHS is not sharing the data, with the exception of the good work that is happening in Alaska, where Alaska is not depending on IHS to get vaccination rates.
We do not have state specific IHS data. Many officials have told
me they are going to fix this. It has not been fixed. Please fix it. Let’s get IHS on board. Let me ask each of you a yes or no ques-tion, has disinformation on tech platforms negatively impacted the response to the pandemic, Dr. Walensky?
Dr. W
ALENSKY . Yes. And in fact, it has propagated 70 percent
more often.
Senator L UJAN . Dr. Fauci.
Dr. F AUCI . Yes, it has.
Senator L UJAN . Dr. Woodcock.
Dr. W OODCOCK . Yes, absolutely.
Senator L UJAN . Ms. O’Connell.
Ms. O’C ONNELL . Yes, it has.
Senator L UJAN . Assistant Secretary O’Connell, viruses don’t re-
spect international borders, and for interconnected border states like New Mexico, our physical and economic health depends on international cooperation. I very much appreciate the line of ques-tioning from Dr. Cassidy. We need to do better in this space and look for every available tool that exists to make sure we are help-ing get vaccine out, especially into neighboring countries across the Americas. What can the Federal Government do to decrease COVID infections in border communities?
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Ms. O’C ONNELL . Thank you, Senator, for that question. And, I
did want to follow-up on what Senator Cassidy asked and Dr. Woodcock was responding to. It is a question of liability, which is one of the things that we work through in these contracts that need to be worked through when vaccines are shared with other countries.
That is the contracting issue that can be an impediment. But it
is important, I think, that we offer tests and vaccines where we can to prevent the spread of COVID in the border communities.
Senator L
UJAN . I recently joined a CODEL to Latin America, and
one of the countries we visited in Ecuador, where I found out that some of the vaccine formularies and samples have not been made available to local regulators to approve the vaccine anticipating if the United States can donate more vaccine or there is more vaccine purchased.
Dr. Walensky and Dr. Woodcock—and I know my time is about
to expire. Maybe submit this into the record. How can the Federal Government better coordinate internationally to ensure that for-eign regulatory bodies have the data and vaccine supply so they can be approved locally? If you want to give me a quick response so then I can follow-up into the record.
Dr. W
OODCOCK . We have—we have collaborations with regu-
lators around the world through EKRA, which is the International Medicines Group, Medicine Regulator Group, as well as other ways. So we are actively reaching out to other foreign regulatory authori-ties to give them information about what we have done to review vaccines and what we know about them.
Senator L
UJAN . Thank you. And I want to thank this trusted
panel. I certainly hope that we can stop the spread of misinforma-tion, that we can listen to the experts, and save more people across America. Thank you for your commitment to saving lives. I yield back.
The C
HAIR . Thank you.
Senator Braun. Senator B
RAUN . Thank you, Madam Chair. Questions for Dr.
Fauci. I am a strong believer in First Amendment protections, and we have obviously seen coming from the business world as well, the tech industry carries so much clout. They are monopolies as ones are defined. And when you have markets that you control over 70, 80 percent, that is so much not only economic power, but it is a lot of other power that goes along with it. When you have any case where the Federal Government gets in cahoots in any way with big companies like that, that is almost unheard of.
Generally the Government would try to do something about that.
In February, Facebook included new criteria for removing misin-formation, and part of it was about the origination of the COVID virus, which now has gone from what they were declaring is misin-formation to maybe the way we think it actually occurred.
Facebook has said that they have made consultations with lead-
ing health organizations. Was your organization, NIAID, one of the leading health organizations Facebook consulted with when decid-ing what speech to filter through?
Dr. F
AUCI . To my knowledge, Senator, that is not the case. When
you say consulting with my agency regarding what speech to filter
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through, I don’t ever recall or have ever heard of any discussion
about filtering speech.
Senator B RAUN . Did they consult with you on any topics, not nec-
essarily whether you would filter through it or not? Have you been in contact with them to give them your personal opinion on this or that?
Dr. F
AUCI . I don’t know what you mean by this or that. There
was one communication or two perhaps with Mark Zuckerberg in which he emailed me and wanted to know if there is anything that he could do that I believe it was promoting vaccination or making sure people do the right thing, wear a mask. But it was mostly propagating a public health message. It had nothing to do with the origins of the virus at all.
Senator B
RAUN . Then do you, on a very frequent basis, consult
with him, either via email or do you have his cell phone number, for instance?
Dr. F
AUCI . I have exchanged a few emails. You probably know
that because you are asking the question. About 10,000 pages of my email have been FOIA’d. And in fact, there is an email ex-change or two between myself and Mr. Zuckerberg. I don’t recall— I can look it up right now and see if I have a cell phone number. I am not sure I do.
Senator B
RAUN . Well, you can get back to me on that. I am
guessing you might. My point is an entity like that, and we have got 190 million users here in the U.S. and they are getting into the fray on so many things. And they are the classic example where there is too much concentration within one entity. And in years past, we have done something about that, not just let it kind of run its course. And we have never had any of the big monopolies get involved with filtering or censoring speech to boot.
Another question related to the White House, has recently said
that they are wanting to flag problematic posts. And working for the President, would you be one that would try to come up with whatever posts that are out there that need to be flagged as misin-formation?
Dr. F
AUCI . No, I have not at all been involved, even indirectly,
in that.
Senator B RAUN . Do you think there is a risk, even though you
haven’t been involved, to the White House wanting to flag stuff that they think is problematic, and then have that same type of communication with entities like Facebook? Just your opinion on that?
Dr. F
AUCI . No, actually, this is beyond my area of expertise. I de-
veloped vaccines to save people’s lives. I don’t get involved in flag-ging things, Senator. So, I am sorry.
Senator B
RAUN . Let’s then pivot to speaking of vaccines.
Dr. F AUCI . Yes.
Senator B RAUN . When you entered grade school, there are many
vaccines that are mandated, and I think accepted over time. Would you, and I would like Dr. Walensky to ask or answer this as well, would you be for mandating ever a vaccine for COVID–19 or any other variants as mandatory for getting into grade school?
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Dr. W ALENSKY . I think first we need to see the data. I hope they
are efficacious. But first we need to see the data. Understand the risk benefit. So I think that is premature at this point.
Senator B
RAUN . What data would you need beyond what we have
got to go to that next step of making that a mandate, along with some of the others that have been so for a long time?
Senator B
RAUN . We don’t have—we don’t have clinical trial data
in the grade school age population yet.
Senator B RAUN . I think that means for you that you might con-
sidering further down.
Dr. W ALENSKY . I think we need to see what the clinical trial data
to see the risk benefit and see the long term data.
Senator B RAUN . Dr. Fauci?
Dr. F AUCI . I think the same thing. You have to make decisions
based on data. We don’t have that data right now. When we do, then we could address that decision.
Senator B
RAUN . Thank you.
The C HAIR . Thank you.
Senator Baldwin. Senator B
ALDWIN . Thank you, Madam Chair. So I have been en-
couraged by this Administration’s use of the Defense Production Act to produce more pandemic supplies in the U.S. And I was proud to be a part of the effort to secure $10 billion in the Amer-ican Rescue Plan to increase the domestic supply of PPP and other medical supplies. In 2020, the U.S. was overly dependent on China, and we did not have sufficient domestic sources of very critical PPE, which was exacerbated by a shortage of raw materials.
When the pandemic hit, there was a bottleneck in the global pro-
duction of medical grade meltblown material that is essential for N95 masks. Today, Wisconsin manufacturers have the ability to provide the meltblowns to provide surge capacity required to produce billions of N95 respirator masks. This type of American manufacturing is exactly what we need to be supporting.
Ms. O’Connell, I know that ASPER has used significant funding
to increase its inventory of supplies, but I am concerned that if we don’t focus some of our expenditures on raw materials, we may re-main dependent on China and other countries. How is ASPER working to secure supplies of raw materials like meltblown to make us better prepared for the future?
Ms. O’C
ONNELL . Senator Baldwin, thank you so much for that
question and thank you for the work that you did to get that $10 billion in the American Rescue Plan. We just recently had released by OMB $2 billion of that $10, which is going to go to, among other things, expanding manufacturing for raw materials for vaccines. So that is one of the first efforts that is going to—that money will be used for. It will also go to make sure that we have enough fill-fin-ish capacity, needles and syringes, and it is just the start.
We are, of course, very anxious to get these contracts awarded
and moving. But it is the beginning of that $10 billion going to ex-actly what you had hoped it would go to. Of course, that is not enough. We have got more to go. But I just wanted to share with you, that is where we are right now. We have also spent, as I men-tioned earlier, other supplemental funds on producing, and in the U.S., gowns and other PPE.
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We are continuing to do that domestic manufacturing. But we do
have this industrial base expansion for vaccine manufacturing ca-pacity right now.
Senator B
ALDWIN . Okay, thank you. During this Committee’s last
COVID–19 hearing, I asked about the Administration’s approach to reducing waste and better targeting vaccines, including by reducing the number of doses in each vial and the number of vials in each package. Experts believe that both of these steps would signifi-cantly aid vaccination efforts as doctors’ offices and community or-ganizations could more easily give interested patient shots without worrying about spoiling additional doses.
In that hearing, Dr. Kessler expressed the Administration’s
strong desire and efforts to move forward on both of those goals. But recent reporting suggests that this might no longer be the case. Dr. Fauci, can you assure me that the Administration is doing all it can to encourage the production of smaller vials and smaller batches as soon as possible? And what steps are being taken and what is your anticipated timeline for changes like this?
Dr. F
AUCI . Well, thank you for that question, Senator. That is
not really in my area of activity. I believe that is more of an FDA question.
Senator B
ALDWIN . Well, Dr. Woodcock, please.
Dr. W OODCOCK . Certainly. And between ASPER and FDA, right.
Basically, to do that, we need to get the manufacturers to change how they are manufacturing the drug and what the storage condi-tions might be and things like that. And I think heroic efforts are being made to try and get a vaccine—get vaccines that don’t re-quire deep freezing storage conditions and that could be then bro-ken up into smaller groups and stored in, say, a pediatrician’s of-fice refrigerator.
I mean, that is the idea here, that—so that pediatricians and
others could—primary care, at the pharmacy, at the nursing home pharmacy, whatever, as new people come in, they could vaccinate them without wasting large amounts of vaccine or having to break into something in the deep freeze.
Those efforts are arduously going on. They are highly technical,
though, and they aren’t simple. And I think the Government and the manufacturers are both united in realizing this is necessary.
Senator B
ALDWIN . Thank you.
The C HAIR . Thank you.
Senator Tuberville. Senator T
UBERVILLE . Thank you very much. Thank you for being
here today, testifying. Dr. Walensky, you have been in your current post since January. You are in the top position, and you surely have heard critiques of the job the CDC has done so far in each— this Administration, even the last, you usually learn from some things that happened in the past. What would you say to those who look to the CDC and say that change is needed, that perhaps the agency needs a bit of restructuring?
Dr. W
ALENSKY . Thank you for that question. Certainly during—
Senator T UBERVILLE . What would you do different?
Dr. W ALENSKY . What would I do differently? You know, certainly
during the times of pandemic, I came in on January 20th. We had our pedal to the metal, shall we say, moving forward to try and do
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everything that we could to get us out of the pandemic. We have
made a lot of progress. We have had to be humble about what this virus can do. And a lot has changed just in the last 6 months. We need a public health infrastructure in this country that allows CDC and our state and local health departments to be prepared for a pandemic.
In that process of restructuring, we need long term disease diag-
nostic funding that isn’t like a roller coaster that comes with one pandemic and, or one infectious disease threat and disappears when that threat is gone. We are going to be dealing with this— when, God willing, everybody is vaccinated and people are well and the pandemic is largely behind us, we have long COVID, we will have boosters to be thinking about, we will be dealing with mental health issues for a very long time to come and we need the public health infrastructure to do so. That would be my biggest—my big-gest task and change.
Senator T
UBERVILLE . Thank you. Dr. Woodcock, FDA currently
has emergency use authorization for three COVID vaccines, but they have not yet received the full FDA seal of approval. What would you say to the vaccine hesitant people who don’t feel com-fortable taking a vaccine that hasn’t been fully FDA approved?
Dr. W
ALENSKY . Well, first of all, I would say we did not cut any
corners in these 30,000 patient trials and these 44,000 patient trials and all the surveillance you have been hearing about of po-tential rare side effects. So compared to other vaccines they would be looking at, these have really gotten the full court press as far as evaluation and study.
They have gone through the FDA process, and they have gone to
the ACIP, the CDC’s advisory committee, and strongly rec-ommended that people take them. That said, it is public that one of the companies put a marketing application before us and we are going to do everything we can to review that in a timely manner. But, of course, I can’t say anything more about that.
Senator T
UBERVILLE . What kind of timeline, do you think, that
we will have full approval?
Dr. W ALENSKY . That is the kind of thing I can’t talk about.
Thank you.
Senator T UBERVILLE . Thank you. Dr. Fauci, we have made this
way too political—this has been tough on the American people. We all know that. Everybody has worked hard to try to get through this. Politics has played a huge role in this. We have all watched it from close and afar.
But I think people need a unifying message from all of us. Be-
cause in my State of Alabama, we don’t have everybody taking a vaccine and we are having outbreaks as we speak. We have had Operation Warp Speed General Perna here in a committee hear-ing—not in this Committee, but in other committee. He took a beating saying how poorly a job he did. And the American people saw that.
A lot of people voted for Donald Trump and a lot of people in the
South, a lot of people in my state, and we have to have a unified message. We can’t be blaming this or that. We have got to go North with this. We can’t go South. We can’t go the other direction.
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Dr. Fauci, can you understand unless this Administration ac-
knowledges the efforts of the last one, a large part of Americans, they are going to continue to feel like nothing is positive. They are not going to take the vaccine. You understand what I am saying?
Dr. F
AUCI . I understand exactly what you are saying, Senator.
And thank you. That is a very appropriate question that I would be pleased to answer. Having been present through the last year, which was the year when COVID began, the last year of the former Administration, I can tell you that no doubt that the former Ad-ministration deserves a considerable amount of credit for the effort that was put into Operation Warp Speed that was able to allow not only the rapid development and testing, but also the implementa-tion of the vaccine.
There is no doubt in my mind, as someone who has been on both
sides of the fence, to say that is the case. But with regard to a uni-fying message, if I might, sir, I think what we need to appreciate is that we are dealing with a common enemy and the common enemy is the virus. The virus doesn’t know if you are a Republican, Democrat or Independent. The virus just knows that it makes peo-ple ill and it kills people.
We have an extraordinarily efficient tool against that common
enemy. And what I would hope the message would be, the unifying message is let’s all pull together and utilize that tool, which is vac-cination, to really crush that common enemy. I think we have it within our capability to do it. And I would hope that would be the message.
Senator T
UBERVILLE . Positive attitude plus effort equals perform-
ance. And if we keep that positive attitude, we can get through this thing. We just need to quit fighting in the media and get everybody believing in the same thing. We are all on the same team. Thank you very much.
The C
HAIR . Thank you.
Senator Hickenlooper. Senator H
ICKENLOOPER . Thank you, Madam Chair and Ranking
Member. Thank you, Coach. I appreciate that. The belief in the positive attitude. As someone who was a part of many scientific de-bates back in my salad days, it just—it makes—it increases my re-spect beyond what I can say in words of how well you have gone through the intense debate, because these are life and death deci-sions you have to make oftentimes where there was conflict among the science, and we were trying to get the facts assembled and sort-ed and prioritized as quickly as we could.
Before I even ask any questions, just let me say that my ques-
tions are always toward a unified future. But I want to make sure I recognized how well you have each served your Country under very difficult circumstances. So, and I don’t know, Dr. Fauci, how many of these types of hearings have you been in so far?
Dr. F
AUCI .
[Technical problems.]
Senator H ICKENLOOPER . Yes. So just to look at the intensity by
which you focus on the answers is remarkably impressive and I want to express my gratitude and our gratitude. I guess first with Dr. Walensky and Dr. Fauci together, we saw yesterday the Pediat-
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rics Academy talk about kids older than two wearing masks. We
know that kids 12 and older should be getting vaccinated.
Well, just quickly, just to give you a platform to talk about that
unified message, what should schools be thinking about and who should they be talking to get ready? Obviously, the more kids we can get that are over 12 and older, the more we get them vac-cinated, there can be—they will be fully protected by the time they get to school in the fall, if we start now.
What does that message look like—would be a couple of—Dr.
Walensky why don’t you start then Dr. Fauci can fill in.
Dr. W
ALENSKY . Thank you for that question, Senator. First of all,
I want to lean in and say I think it is critically important that our schools be open for full in-person learning in the fall. We have learned enough over the last year to understand what we need to do to keep our children safe. And we believe based on the science, that we can keep them safe in those settings. How are we going to keep them safe?
The first and foremost is the best thing would be to have every-
body vaccinated who can be vaccinated. Surround unvaccinated children who are no longer—who are not yet eligible, with people who are vaccinated to protect them. So that is the highest and most important thing. For those children who are not able to be vaccinated, they can and should wear a mask in those school set-tings. And we have said that in our guidance.
I want to also comment on one other thing, and that is that I
think is critically important in the school year coming ahead and that is the role of testing. Senator Burr has talked about the im-portance of other viral syndromes, flu, influenza. We are going to see upper respiratory infections in these schools in the fall. These kids have not been in school.
They have not been with each other. And I am worried about the
upper respiratory infections. And we are going to have to under-stand what is COVID and what is a simple cold among children. So those are among the things that I am thinking about. Thank you.
Senator H
ICKENLOOPER . Great. Thank you. Nothing to add?
Dr. F AUCI . Nothing to add. That was a very good explanation.
Senator H ICKENLOOPER . You have become a good—an admirable
team. Dr. Woodcock, some of the FDA reports on—is it pronounced Adulhelm? Biogen’s new Alzheimer’s drug I think are very con-cerning. Last week, there was an expert panel convened by the In-stitute for Clinical and Economic Review unanimously concluded that it wasn’t—it wasn’t efficacious, it didn’t provide a benefit for patients with Alzheimer’s and certainly wasn’t worth the price tag. And I know that I saw a couple—I was researching or reading my briefs from my remarkable staff last night that it could have been handled differently. How specifically differently should the FDA have looked at this?
Dr. W
OODCOCK . Well, a lot of the confusion is in some of the con-
troversy is simply what you said, this is an accelerated approval. That means it was approved on a surrogate endpoint that we be-lieve is reasonably likely to predict clinical benefit. So the conclu-sion that you just referred to is not surprising, Okay, because they haven’t definitively shown benefit.
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Now, Congress has urged us to use the accelerated approval
pathway for life threatening diseases that don’t have any effective therapy. Alzheimer’s is one. I think part of the issue was that it was brought to an advisory committee and proposed for traditional approval, not on a surrogate endpoint. The advisory committee more or less conclusively shut that down. And so the agency went back and looked at all the data on the surrogate endpoint, which is clearing out the Alzheimer’s plaque, the amyloid plaque from the brain.
They found that correlated with benefit, benefit meaning slowing
a decline of deterioration of thinking, right. And so with Malta looking at other programs with other antibodies to do the same thing, they concluded that this clearing out of a plaque was reason-ably likely to predict clinical benefit, right. But not—doesn’t defini-tively mean that there is a clinical benefit. So I think with such a prevalence—it is very common in cancer. It is well accepted.
That is how we approved HIV drugs from the very beginning, al-
right. And that was a very big success story. That is how we ap-prove many drugs for rare diseases. But this is a common disease and almost everyone probably in this room has had a relative—.
The C
HAIR . Dr. Woodcock, thank you. We do have votes called
and we have got to finish our hearing. So I appreciate the response.
Dr. W OODCOCK . I am sorry.
The C HAIR . Thank you.
Senator Burr. Senator B
URR. Thank you, Madam Chair. Let me say, Dr.
Woodcock, I think the decision that FDA made relative to surrogate endpoints is exactly that forward leaning approach that we envi-sion when we created that expedited pathway. And I applaud the decision. I look back at HIV, who Tony Fauci was very involved in, and had we not done similar things then, we wouldn’t have found the keys that unlock doors that we needed.
I want to turn to Dr. Walensky for just a second. I just want to
ask a quick follow-up on breakthrough. And Dr. Fauci, I under-stood what you said about the NIH following the clinical trials over a two-year period as it relates to breakthrough. That is important. It is not important from a standpoint of today and the decisions that we make. It is my understanding that CDC is only tracking breakthroughs that result in hospitalization. Is that accurate?
Dr. W
ALENSKY . No, it is not. So that is in passive surveillance,
which is, as I mentioned earlier, not the best way to track these breakthroughs and one of the limitations of our passive surveil-lance system, which is why we are collecting longitudinal data in tens of thousands of people, some of whom are getting PCRs so that we can check each test for asymptomatic breakthroughs as well.
Senator B
URR. Okay. I think it is extremely important that we
be as specific on breakthrough exposures. One of the last tools that we have is, yes, you may get vaccinated, but you may become in-
fected, and you are going to have to prove the data that says you probably won’t go to the hospital, and you certainly won’t die. So without that data, you are in a very weak situation. So I would en-courage you to build that data base. I am going to take a couple
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of minutes to make an editorial, and it really gets to the heart of
supply chain.
Ms. O’Connell, this is going to fall in your lap. And this is some-
thing that the Chair and I and the Committee are going to deal with. You talked about a warm base. I know the target for what we want in the strategic national stockpile. Here is the reality. Federal purchases are 4 percent of PPE. And for us to set up a sus-tainable supply chain, it means that you have to compete with dumping practices of China on N95 masks. You have to compete with competition from around the world.
I think, I know Janet and Tony understand that the memory
span of a Member of Congress is about 18 to 36 months. After that, we sort of forget about the last incident that we went through and where we look at it and say, well, why are we funding to keep the lights on in this N95 mask facility. We don’t need any more N95 masks. And the problem is that the 96 percent of the purchasers providers across the country have now turned to the lowest cost competitor, which is probably not the warm base facilities that we have got. We have got to come up with a solution to this, and I want to work with you.
I want to work with the White House. Because I have gotten to
a point through a process of elimination as to what won’t work, faced with the realities of Congress’s inability to continue to fund indefinitely things that don’t produce something tangible. We have had to put BARDA on life support three different times because members didn’t see a need for it. Thank God we were able to keep it resuscitated.
I am not sure that there is a way to do this without creating an
America’s trading bloc, where we incorporate North and South America together, where we incorporate the low cost, low labor areas of Central America, where textile companies already have a presence, where companies could move automatic N95 masks, and not just warm base them, but actually let them compete with China in the open marketplace and sell to the rest of the world, and invite the EU and invite Australia and invite Africa and India to be part of the America’s trading bloc where we can expand.
As Janet knows, we have had problems with Brazilians on
knocking off pharmaceutical manufacturing down there for years. Let’s turn them into a part of our inventory of assets where we can turn to vaccine production down there, pharmaceutical production down there, raw materials of South America.
If not, then show me something that is sustainable without the
condition of Congress coming in and funding at the tune of hun-dreds of billions of dollars on an annual basis to keep that supply chain for us as a purchaser of only 4 percent. Somehow we have got to—we have got to present to the other 96 percent a domestic manufacturing capability that makes them competitive against China even with China’s dumping practices.
I sort of lay that on the table. It won’t be the first time Tony has
looked at me and said, you come up with something crazy, but I am in the business of trying to find solutions that are sustainable. And it will only happen if we think outside the box on this. We thought outside the box with surrogate endpoints and Janet, well down the road people don’t die of HIV. They extend their lives.
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Maybe the keys we find are actually cures in the future, mRNA
technology platform, Tony. We may be curing cancer off of that platform two, three, four years down the road. I wonder what the person who didn’t like mRNA for the vaccine for COVID think when they have got prostate cancer and they have got a cure on an mRNA platform? I think they are going to take it.
Everything is going in our favor, but this is absolutely crucial to
our assurance to the American people and to the American econ-omy and manufacturers that we are going to put them somewhere, in a system that is sustainable for the future. I thank you for lis-tening to me and I thank the Chair. I yield back.
The C
HAIR . Thank you, Senator Burr. Appreciate that. That will
end our hearing for today. And I want to thank all of our col-leagues, our witnesses, Dr. Walensky, Dr. Fauci, Dr. Woodcock, Ms. O’Connell, Assistant Secretary O’Connell, for such a thoughtful dis-cussion about our ongoing response to this pandemic and the path forward.
With that, for any Senators who wish to ask additional ques-
tions, questions for the record will be due in 10 business days, Au-gust 3rd at 5 p.m. The hearing record will also remain open until then for Members who wish to submit additional material for the record.
The Committee will next meet tomorrow, July 21st, for an execu-
tive session to consider the Family Violence Prevention and Serv-ices Improvement Act of 2021 and the nominations of Catherine Lhamon to be Assistant Secretary for Civil Rights at the Depart-ment of Education, Lisa Brown to be General Counsel of the De-partment of Education, Roberto Rodriguez be Assistant Secretary for Planning, Evaluation and Policy Development at the Depart-ment of Education, David Weil to serve as Administrator of the Wage and Hour Division at the Department of Labor, and Gwynne Wilcox and David Prouty to serve as members of the National Labor Relations Board.
Again, thank you to all of our witnesses today. With that, this
Committee does stand adjourned.
QUESTIONS AND ANSWERS
RESPONSE BY DR. ROCHELLE WALENSKY TO QUESTIONS OF SENATOR CASEY , SENATOR
BALDWIN , SENATOR HASSAN , SENATOR BURR, SENATOR BRAUN , AND SENATOR
TUBERVILLE
Responses to the QFRs are accurate as of the date of the hearing .
SENATOR CASEY
Question 1 . Even as the vaccination campaign continues—whether it is reaching
people who thus far have been reluctant to get vaccinated, or hopefully expanding the campaign soon to include younger children—testing remains an important tool in our fight against COVID–19. Especially given that younger children are not yet eligible for vaccination, and with the rise of the Delta variant, testing continues to be a pressing need to ensure that cases are caught early to break the chain of trans-mission—or to rule out COVID–19 when someone is showing symptoms that are common to different illnesses. How is CDC working with local public health officials,
health care providers, employers and schools to support robust testing regimes, and what do those recommendations look like currently?
Answer 1. CDC is actively engaging with our state, tribal, local and territorial
public health partners and with K–12 schools to support implementation of robust
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testing programs. CDC guidance on testing can be found here: https://
www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html .
CDC has provided specific technical assistance (TA) on testing and/or deployed
teams to jurisdictions and school districts who have requested assistance. Support is provided through technical assistance calls, sharing of resources, and creating connections with their state or local school testing teams at the health department or referrals to other opportunities for Federal testing support, such as the HHS Testing and Diagnostics Work Group.
CDC is also partnering with jurisdictions interested in exploring various ways to
expand access to testing and incentives to test in populations they have identified as likely to benefit from additional testing. This includes factors such as current proximity to testing sites, area percent test positivity or case burden, and other fac-tors such as social vulnerability index scores. Pilot activities have explored expand-ing testing in high density workplaces, using pop-up testing in retail sites in the communities, and event-based testing where testing is offered in conjunction with previously scheduled or well-known events or gatherings. As an example, the Race to End COVID project at the Talladega Superspeedway, sponsored by Talladega Superspeedway, the Alabama National Guard, the U.S. Department of Health and Human Services, the CDC Foundation, and the Alabama Department of Public Health, offered an incentive to drive two laps around the track behind a pace car to all participants who were tested or vaccinated at the pop-up site hosted by the
track. The lessons learned from these pilots will be disseminated to inform other jurisdictions who are seeking ways to expand testing availability and desirability within their populations.
Starting in mid-May, one-on-one TA calls were held with 46 health departments
to discuss their testing plans for summer schools and summer camps as well as their plans to offer screening testing to K–12 schools in their jurisdiction using CDC Epidemiology and Laboratory Capacity (ELC) Reopening Schools cooperative agree-ment funds.
Question 2 . Earlier this year, I sent a letter with Senator Wyden, Senator Tim
Scott, and Senator Crapo, calling on CDC to publicly release data that have been provided to the Federal Government by CVS and Walgreens in relation to the Long- Term Care Partnership (LTC Partnership). The LTC Partnership data is the only real time accounting of the COVID–19 vaccine rollout from the beginning, and ex-perts have testified to Congress that it is critical to understanding how the distribu-tion of vaccines proceeded, as well as the racial, economic and geographic equity of the COVID–19 vaccine distribution. As the bipartisan letter noted, releasing such information retrospectively will help researchers and policymakers analyze issues such as the speed and equity of vaccine distribution, and the vaccine’s role in reduc-ing disease and death in nursing homes. One need look no further than your agency for proof of the data’s usefulness—CDC shared the LTC Partnership data with states, and used the data for its own public-facing research. Please provide me with all facility-level vaccination data that has been transmitted to CDC by the LTC Partnership since December 2020. Please provide these data no later than August 20, 2021.
Answer 2. CDC has been in communication with your staff regarding this data
request.
Question 3 . There is concern that cases of influenza this coming winter season will
be significantly higher than last year. Is there an opportunity to encourage in-creased uptake of both flu and COVID–19 vaccines in the coming months, and what would need to occur to make that happen, in terms of patient and provider edu-cation, vaccine distribution plans, etc.?
Answer 3. This influenza (flu) season, CDC will expand education efforts to pro-
mote flu vaccination, including among groups of people for whom vaccination is es-pecially important, such as people with underlying health conditions, pregnant women, children under 3, and people within racial and ethnic minority groups, which typically have lower vaccine uptake. CDC is investing an additional $150 mil-lion to continue to build community engagement around COVID–19 and flu vaccina-tion among racial and ethnic minority groups.
In addition, CDC has planned outreach through social media, press conferences,
web page spotlights, radio media tours, op-eds, and other publications. A digital campaign will launch to educate the public and people who are at increased risk from influenza and COVID–19 complications about the importance of vaccination. Finally, CDC will support a special campaign to inform the general population, with a focus on Black/African American and Hispanic/Latino audiences, about the impor-tance of flu vaccination.
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SENATOR BALDWIN
Question 1 . The CDC is updating its variant tracker once every 2 weeks. Please
provide additional information regarding CDC’s plan to increase the frequency of this reporting, improve the granularity of data provided, and work with state and local health departments to enhance sequencing efforts on the ground.
Answer 1. CDC reports variant proportion data on two-week time intervals with
plans to increase frequency in the coming weeks. CDC developed guidance for state and local public health laboratories to ‘‘tag’’ sequences submitted to public data bases that were generated through state-level baseline genomic surveillance efforts. By tagging these sequences, CDC can incorporate these sequence data into the na-tional analysis of variants. Integration of surveillance across the U.S. maximizes the sequencing capacity, expertise, and available data across the U.S. that is available to inform public health decision-making.
To improve the detection, monitoring, and mitigation of COVID–19 variants, the
American Rescue Plan invested $1.7 billion to help the CDC, states, and other juris-dictions more effectively detect and track variants by scaling genomic sequencing ef-forts. This one-time funding is supporting CDC and state and local public health to increase the use of sequencing in the U.S. public health system. The information from sequencing allows CDC and state and local public health leaders to respond to emerging infectious threats more effectively. Sequencing technology is used not only to help in the detection and prevention of COVID–19, but also with most other infectious disease threats. The CDC Advanced Molecular Detection (AMD) program was established in 2014 and has been funded by Congress at $30 million per year, to incorporate sequencing and relevant technologies into public health and has been applied to food safety, emerging infections, biosecurity, antimicrobial resistance, and many other pathogens. CDC has also funded 29 universities to conduct genomic sur-veillance research in collaboration with public health agencies. The studies are meant to provide deeper insights into viral genomics and molecular epidemiology within the various regions across the country.
SENATOR HASSAN
Recently, deeply disturbing reports have been published detailing dangerous in-
equities that USA Paralympians are facing at this year’s Tokyo Paralympics.
Becca Meyers is a six-time Paralympic medalist who won three golds in Rio 5
years ago. She is deaf and blind, but in the past that hasn’t stopped her from com-peting—and winning—at the highest levels.
This year, though, she and other athletes from Team USA who experience disabil-
ities are being denied adequate access to personal care assistants, reportedly due to COVID–19 restrictions.
Individuals who experience disabilities should not be forced to navigate the Tokyo
Olympics without the support they need in the midst of a global pandemic.
Becca announced on Sunday that she is quitting the team because she is being
denied a, ‘‘reasonable and essential accommodation’’ that would enable her to com-pete.
This is an outrage—and an entirely preventable situation. The US Olympic & Paralympic Committee must work immediately to address this
issue, and ensure that all of our athletes are able to compete safely at this summer’s games—including by providing them the basic supports they need to navigate the world.
Question 1 . Director Walensky, over the last year and a half, the CDC has pro-
vided guidance on how to mitigate the risk of COVID–19 in various activities, as well as special events—including sports. Understanding that the CDC does not have jurisdiction over specific safety measures taken by the US Olympic & Paralympic Committee, can you please explain how COVID–19 mitigation efforts take into ac-count the needs of people who experience disabilities?
Answer 1. We know that most people with disabilities are not more likely to be-
come infected with or have severe illness from COVID–19. However, some people with disabilities might be more likely to get infected or have severe illness because of underlying medical conditions, residing in congregate living settings, or systemic health and social inequities.
CDC is currently providing $93 million to the Administration for Community Liv-
ing (ACL) within HHS to administer grants to aging and disability networks in every state and territory. These funds are providing assistance to older adults and people with disabilities for scheduling vaccine appointments, transportation to vac-
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cine sites, direct support services needed to attend vaccine appointments, connection
to in-home vaccination options, and education about the importance of receiving the vaccine to older adults and people with disabilities. This partnership is also pro-viding an additional $5 million in funding to stand-up and maintain a new Dis-ability Information and Access Line (DIAL) to help people with disabilities find vac-cination locations in their communities, assist callers with making vaccination ap-pointments, and connect callers to local services.
CDC partners with state, territorial, local, tribal partners, and community-serving
organizations to support communities at higher risk for COVID–19. For example,
CDC is partnering with FEMA, CDC Foundation, Georgia Tech Center for Inclusive Design and Innovation, University of North Carolina Center for Literacy and Dis-ability Studies, DeafLink, and National Association of State Directors of Develop-mental Disabilities Services, to provide COVID–19 guidance and resources for peo-ple with disabilities and care providers. There is a need for guidance and resources that are tailored for people with disabilities and their care providers. This project aims to compile and develop guidance and tools to help people with disabilities and those who provide services or care for them make decisions, protect their health, and communicate with their communities. The tools and guidance developed in this project reflect what CDC has learned about the needs of people with disabilities and care providers from partners and listening sessions, projects, and research efforts. Following the launch of the CDC Toolkit for People with Disabilities web page (https://www.cdc.gov/coronavirus/2019-ncov/communication/toolkits/people-with-
disabilities.html ), we gathered feedback from partners indicating a need for more in-
formation geared toward people with disabilities related to vaccine access, accessible vaccination sites, and accessible communications products/web resources to develop web content, fact sheets and one-pagers, scheduling language, and a promising prac-tices document on vaccination access for people who have challenges leaving their home. As a result, we began the integration of information related to people with disabilities as well as social media and web-based graphics that reflect varying dis-abilities throughout the CDC sites instead of just on disability-related webpages.
Another collaborative project involving CDC Foundation and Georgia Tech Center
for Inclusive Design and Innovation is developing accessible materials and culturally relevant messages for people with disabilities. The project focuses on people with disabilities, as well as caregivers of people with disabilities, and organizations serv-ing people with disabilities to deliver essential COVID–19 information. The project helps to ensure that COVID–19 guidance is not only accessible to people with dis-abilities, but also that it is culturally appropriate and relevant to the challenges people with disabilities face during emergency response situations such as COVID– 19.
SENATOR BURR
Question 1 . Is CDC tracking the number of individuals who got vaccinated that
were previously infected with COVID–19?
Answer 1. CDC uses seroprevalence surveys to estimate the proportion of the pop-
ulation that has antibodies as a result of vaccination, infection, or both. Both vac-cination and infection result in production of antibodies. By using a combination of antibody tests and vaccine history, we can distinguish if someone has been infected, vaccinated, or both.
CDC is working with national blood collection organizations to estimate the num-
ber of vaccinated persons that were previously infected based on vaccine history and antibody testing. We are analyzing these data and working to publish soon.
CDC is modifying its national commercial laboratory survey to capture similar in-
formation and hopes to implement this during the upcoming months.
Question 2 . If not, how is CDC estimating the actual level of immunity—both nat-
ural immunity from having COVID–19 and the immunity provided by vaccination— to get a full picture of the road ahead to protect our communities?
Answer 2. CDC is currently estimating the level of immunity through the
seroprevalence studies described above. The type of antibodies detected can deter-mine if the person has antibodies because of past infection or due to vaccination alone. In addition, CDC currently has a manuscript in production that assessed SARS-CoV–2 seroprevalence related to infection and vaccination in the US popu-lation.
Question 3 . Is CDC tracking reinfection rates for those that have been previously
infected with COVID–19?
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Answer 3. CDC is using several data sources to understand reinfections including
cohort studies, review of big data from electronic health record systems, and by working with local jurisdictions as they link cases over time. In terms of surveil-lance, CDC is working closely with public health jurisdictions and the Council of State and Territorial Epidemiologists (CSTE) to update the national surveillance case definition of COVID–19 and enable states to count repeat infections in the same individuals over time. This information will be included in the approved posi-tion statement 21-ID–01 titled ‘‘Update to the standardized surveillance case defini-tion and national notification for 2019 novel coronavirus disease (COVID–19).’’ The rate of reinfections depends on both the level of protection by previous infection, for which there is increasing evidence, and the general rate of infections in the popu-lation, which is highly variable. Unlike ascertaining vaccine status, ascertaining prior infection status relies on data systems linking multiple episodes in local juris-dictions or on widespread sequencing.
Question 4 . Can T-cell testing be used to gain better insight in to how COVID–
19 variants interact with immunity from previous infection or vaccine?
Answer 4. SARS-CoV–2 T cell assays are very complex, and therefore are not
widely available. Individuals cannot obtain these tests from health care providers. T cell studies can be performed in a research setting. However, we do know that T cells contribute to immunity. Preliminary studies indicate that vaccines generate T-cell immunity, and it is maintained against variants. Ongoing studies are being performed to understand T-cell immunity better.
Question 5 . According to CDC, 74 percent of hospitalized or fatal breakthrough
infections occurred in individuals 65 and older. Is CDC tracking how many of these individuals have other conditions that may make them more susceptible to severe illness from COVID–19?
Answer 5. The best data for this come from the Coronavirus Disease 2019
(COVID–19)-Associated Hospitalization Surveillance Network (COVID-NET), be-cause it has more comprehensive and complete information on underlying medical conditions among hospitalized patients.
COVID-NET is a population-based surveillance system that collects data on lab-
oratory-confirmed COVID–19-associated hospitalizations among children and adults through a network of over 250 acute-care hospitals in 14 states covering approxi-mately 10 percent of the U.S. population. Preliminary data from COVID-NET show, among all COVID–19-associated hospitalizations, approximately 29 percent of all vaccinated cases are immunocompromised compared to 11 percent of all unvaccinated cases. Additionally, approximately 68 percent of vaccinated hospital-ized cases have 3 or more underlying medical conditions compared to 52 percent of unvaccinated cases. For adults ages 65 years, 32 percent of all vaccinated hospital-ized cases are immunocompromised compared to 13 percent of unvaccinated hos-pitalized cases. For adults ages 65 years, the proportion of vaccinated hospitalized cases (74 percent) is not significantly different from the proportion seen in unvaccinated cases (69 percent).
For national surveillance, 7,525 vaccine breakthrough infections among people
who were hospitalized or died were reported as of August 2, 2021. Of those, 2,895 (38 percent) had one or more of the following conditions noted: pregnant, diabetes, renal disease, liver disease, autoimmune disease, immunocompromised, or immuno-suppressive medication. However, another 3,352 (45 percent) were missing data re-garding one or more of these underlying conditions. In addition, national vaccine breakthrough surveillance does not collect information on other underlying medical conditions (e.g., obesity, cardiovascular disease, or pulmonary disease) that have been associated with more severe COVID–19 disease but are not presumed risk fac-tors for a vaccine breakthrough infection.
Of note, of the 7,525 reported vaccine breakthrough infections among people who
were hospitalized or died, 5,557 (74 percent) were aged 65 years, including 3,704 (49 percent) who were aged 75 years. Therefore, a large majority likely have one or more underlying medical conditions that might reduce their response to vaccina-tion and/or increase their risk for severe COVID–19 disease.
The number of COVID–19 vaccine breakthrough infections reported to CDC
through national surveillance likely are an undercount of all SARS-CoV–2 infections among fully vaccinated persons. National surveillance relies on passive and vol-
untary reporting, and data might not be complete or representative. These surveil-lance data are a snapshot and help identify patterns and look for signals among vac-cine breakthrough cases.
Question 6 . CDC stated that children who are eligible for the COVID–19 vaccine
can get their routine vaccinations at the same time as their COVID–19 vaccine.
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Looking to the fall and a potential need for boosters, can a person receive the flu
shot and the COVID–19 shot at the same time?
Answer 6. COVID–19 vaccine and other vaccines may be administered on the
same day, as well as any interval without respect to timing ( https://www.cdc.gov/
vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf ). How-
ever, some additional guidance related to co-administration of COVID–19 vaccines and influenza vaccines specifically is under consideration for the upcoming Preven-tion and Control of Seasonal Influenza With Vaccines: Recommendations of the Ad-visory Committee on Immunization Practices (ACIP)—United States, 2021–2022 In-fluenza Season. CDC will provide a further update when available.
SENATOR BRAUN
Question 1 . Can you please provide specific updates on your plans to ensure that
nursing home staff and residents have sufficient point of care molecular diagnostics and access to the most appropriate prophylactics and treatments?
Answer 1. Long-term care facilities (LTCF), such as nursing homes, are high-risk
settings for residents, staff, volunteers, and visitors. Case and death rates for LTCF staff and residents have declined sharply since mid-December 2020 when vaccine rollout began. Recent outbreaks, including those linked to variants and/or break-through cases, further stress the need to vaccinate residents and staff, including vaccinating new residents and staff given relatively high turnover in both cat-egories, and continue to implement appropriate infection prevention and control (IPC) practices effectively and consistently.
More than 80 CDC teams have deployed to LTCFs to investigate outbreaks, as-
sess staff and supply shortages, and recommend IPC measures. Additionally, CDC maintains guidance specifically for nursing homes and long-term care facilities around IPC practices and the appropriate use of testing which are both essential to quickly detect, identify, and prevent the spread of SARS-CoV–2 infections in LTCFs.
CDC continues to provide resources and information on our website and for pa-
tients and healthcare providers regarding the availability of monoclonal antibody treatments and other COVID–19 therapeutics for certain patients at high risk of disease progression.
CDC is working to rapidly characterize emerging variants to understand the po-
tential impacts on critical SARS-CoV–2 medical countermeasures (e.g., vaccines, therapeutics, and diagnostics). CDC provides updated information on variant classi-fications and definitions as well as the national prevalence of variants of interest and concern. These data and other clinical considerations are being used by the Of-fice of the Assistant Secretary for Preparedness and Response (ASPR) within HHS and other Federal and state partners to inform decisions regarding distribution and allocation of testing supplies, therapeutics (i.e., monoclonal antibodies), and personal protective equipment (PPE) supplies to help jurisdictions and their nursing homes. CDC continues to update its information and resources as new science becomes available. CDC also continues to work closely with the Centers for Medicare & Med-icaid Services (CMS) within HHS and jurisdictions to provide technical assistance and support to nursing home facilities across the U.S. through current CDC pro-grams and those stood up as part of the ongoing COVID–19 response. This also in-cludes hosting webinars, Clinician Outreach and Communication Activity (COCA) calls, and engaging LTCF partners to provide the latest information.
Question 2 . Due to mandatory lockdowns, limited doctor office, clinics and emer-
gency room visits, there has been a rapid decline in routine health screenings such as HIV/AIDS. Your agency found that at just one commercial laboratory system, comparing a six-month period in 2019 to 2020, they reported nearly 700,000 fewer HIV screening tests completed and about 5,000 fewer confirmed HIV diagnoses. This is reflective of what has happened across the country: HIV testing is greatly reduced due to patients not accessing healthcare and health departments moving resources to COVID.
Question 2(a) . This is especially troublesome because as we know, early detection
and getting patients on a treatment plan is critical to limiting the spread of HIV/ AIDS. Will you commit to keeping this Committee updated on HIV screening levels? Will you commit to developing a plan to encourage Americans to visit their local healthcare provider for routine screenings?
Answer 2. Yes, and thank you for asking this important question. After an initial
interruption of key HIV prevention activities due to the pandemic, jurisdictions rap-idly prioritized surveillance activities and many scaled up self-testing and mobile
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HIV testing activities. These innovations could help overcome longstanding barriers
to prevention by providing testing in locations beyond traditional testing venues. Al-though overall HIV testing declined in 2020, 2021 HIV testing year-to-date is back on track.
Answer 2(a). CDC will keep the Committee updated on progress related to HIV
screening and testing in the U.S. Through CDC’s core HIV programs and our role in the Department of Health and Human Services-wide initiative, Ending the HIV Epidemic in the U.S., CDC is committed to making testing accessible, convenient, and routine by scaling-up self-testing, making HIV screening a regular part of health care, and increasing testing in non-traditional settings, such as correctional facilities and syringe services programs.
Question 3 . Congress has provided a substantial amount of funding for COVID
testing—nearly $50 billion in the American Rescue Plan alone, plus tens of billions of dollars more last year. A significant amount of testing money appears to be unspent. This is concerning, given that we are hitting a vaccine wall and cases are on the rise due to the delta variant. We need to ensure that our capacity for testing remains high going into the fall and winter.
Question 3(a) . How much money remains for COVID testing from the American
Rescue Plan?
Question 3(b) . How much money remains for COVID testing appropriated in 2020?
Question 3(c) . What is the Administration’s plan for the remainder of the COVID
testing funds? How and when will this money be spent?
Answer 3(a), 3(b), 3(c). As of the end of July 2021, of the approximately $95 billion
identified by Congress across all COVID supplemental appropriations for testing-re-lated activities, all but $17.5 billion had been allocated to support testing, contact tracing and mitigation activities across HHS. HHS is in the process of allocating the remaining balance for priority activities such as increasing community access to testing and supporting domestic manufacturing capacity of tests and enhancing test-ing capacity in congregate settings.
In particular, as of the end of July 2021, the Centers for Disease Control and Pre-
vention awarded approximately $40 billion of the COVID supplemental funding ap-
propriated to HHS for broad testing, mitigation and related activities, support for school testing and to address testing-related health disparities in high-risk and un-derserved communities to state, local, and territorial health departments. In addi-tion, CDC had plans in place for additional awards to targeted settings. These funds support a range of activities, including: enhancing testing and mitigation in targeted settings such as correctional facilities, and among homeless populations; expanding the Nation’s disease intervention specialists; supporting infection prevention and control; expanding the Nation’s wastewater surveillance system; and improving lab-oratory data and capacity.
SENATOR TUBERVILLE
Question 1 . What would you say to those who look at the CDC and say that
change is needed, that perhaps the agency needs restructuring?
Question 2 . What areas or offices specifically do you think could be restructured?
Answer 1 & 2. Thank you for the questions. The ability to respond to a public
health emergency requires a strong day-to-day public health system, supported by infrastructure that is not highly segmented by disease, condition, or activity. In ad-dition to the COVID–19 pandemic, over the past 24 months, CDC has also re-sponded to diverse public health threats from E-cigarette or Vaping Product Use- Associated Lung Injuries (EVALI), Ebola, complex multi-state food-borne disease outbreaks, wildfires, and hurricanes. Responding to the unique characteristics of each of these public health emergencies has required deep scientific expertise to de-ploy a specialized approach and called for a robust public health system with world- class infrastructure nationwide to stop disease at its source. Unfortunately, this re-cent history has revealed the effects of an inadequate public health infrastructure. Ongoing health disparities made us as a nation more vulnerable to outbreaks, large- scale public health emergencies, and pandemics as well as burdening large segments of our population with chronic public health concerns. Additional investments in both domestic and global public health and health security infrastructure are need-ed.
With investments requested in the fiscal year 2022 Budget, CDC will begin to ad-
dress mission-critical gaps in public health infrastructure and capacity nationwide. Transitioning from sporadic influxes of supplemental funding tied to a specific emer-gency to flexible funding that can prevent another crisis will strengthen the current
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public health system. Flexible, sustainable investments in infrastructure and capac-
ity are critical for saving lives and averting economic losses caused by public health emergencies and chronic public health problems. In fiscal year 2022, CDC will prioritize funding to rebuild the most critical public health infrastructure needed to safeguard the Nation’s health and economic security.
Question 3 . Isn’t it important for CDC to track cases in order to determine the
effectiveness of the vaccine against COVID?
Answer 3. CDC has multiple surveillance systems and ongoing research studies
to monitor the performance of vaccines in preventing infection, disease, hospitaliza-tion, and death. CDC also collects data on breakthrough infections through outbreak investigations. Examples of CDC’s systems for monitoring performance of vaccines include: The National Healthcare Safety Network (NHSN), HEROES/RECOVER, In-fluenza and Other Viruses in the Acutely Ill (IVY), and the Coronavirus Disease 2019-Associated Hospitalization Surveillance Network (COVID-NET).
Question 4 . Do you consider it misinformation for individuals to share their stories
of adverse events following vaccination?
Answer 4. Millions of people in the United States have received COVID–19 vac-
cines under the most intense safety monitoring in U.S. history. Communicating timely and transparent information to public health officials, healthcare providers, and the public about the safety of vaccines, including possible adverse events fol-lowing vaccination, continues to be a top priority for CDC. CDC’s communication ef-
fort will always be based on the scientific evidence and data that we have gathered to-date through different sources, including analyzing our vaccine safety monitoring data and vaccine safety clinical research.
CDC recommends that individuals who may have experienced an adverse event
following vaccination speak to their healthcare providers. CDC also encourages any-one experiencing any possible adverse events following vaccination to share this in-formation through CDC and FDA’s vaccine safety monitoring system, Vaccine Ad-verse Event Reporting System (VAERS). When individuals are administered COVID–19 vaccines, they are also given information about the opportunity to reg-ister with CDC’s after-vaccination health checker service, called v-safe. Through v- safe, vaccine recipients can quickly tell CDC if they have any side effects after get-ting a COVID–19 vaccine.
Question 5 . Can you provide the estimated number of reinfections in COVID-re-
covered individuals, to the best of the CDC’s understanding?
Answer 5. CDC is using several data sources to understand reinfections including
cohort studies, review of big data from electronic health record systems, and by working with local jurisdictions as they link cases over time. In terms of surveil-lance, CDC is working closely with public health jurisdictions and the Council of State and Territorial Epidemiologists (CSTE) to update the national surveillance case definition of COVID–19 and enable states to count repeat infections in the same individuals over time. This information will be included in the approved posi-tion statement 21-ID–01 titled ‘‘Update to the standardized surveillance case defini-tion and national notification for 2019 novel coronavirus disease (COVID–19).’’ The rate of reinfections depends on both the level of protection by previous infection, for which there is increasing evidence, and the general rate of infections in the popu-lation, which is highly variable. Unlike ascertaining vaccine status, ascertaining prior infection status relies on data systems linking multiple episodes in local juris-dictions or on widespread sequencing.
Question 6 . Can you explain the scientific differences between CDC and WHO rec-
ommendations for masking children under 5 years old?
Answer 6. Out of an abundance of caution, CDC recommends masks for children
older than age two, carefully weighing the risks and benefits of masking this age demographic. Conversely, most children older than 2 years old do not have any ana-tomic, physiologic, or developmental limitations that should preclude them from wearing a mask safely and effectively. Masks have been shown to be safe in children older than age two. A cohort study among infants and young children in Italy found that the use of facial masks was not associated with respiratory distress or signifi-cant changes in oxygen saturation, including among children age 24 months and younger. In addition, studies suggest that masks are not likely to impact social de-velopment in children.
Additional research emerged during the ongoing COVID–19 pandemic with strong
and consistent evidence demonstrating the effectiveness of mask use among children age 2 years and older in preventing SARS-CoV–2 transmission, especially when it is combined with multiple prevention strategies.
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Question 7 . Can you provide the most recent estimate of the number of COVID
infections in children under 18 years old?
Answer 7. There were 3,757,699 cases aged 0–17 years during the period, January
21, 2020—August 17, 2021, based on the aggregate case surveillance system counts, accessed August 18, 2021.
Question 8 . Are you aware of any ongoing studies into the effectiveness of mask-
ing in children under 12 years old?
Answer 8. CDC regularly scans the published and pre-print literature as well as
other sources for research on this topic. CDC uses this information to assess current guidance and whether any amendments are warranted based on that new science. There are data from studies of children, including children under 12 years old, that demonstrate masking provides an additional layer of protection against spread of in-fection in schools. These data are reviewed in this document: https://www.cdc.gov/
coronavirus/2019-ncov/science/science-briefs/transmission-k-12-schools.html .
Question 9 . Funds in part from NIH/NIAID helped build the 12 Regional Bio-
containment Laboratories (RBLs) and 2 National Biocontainment Laboratories (NBL) to support high consequence infectious disease research after 9/11 and the
anthrax scares in 2001. However, unlike the NBL facilities, the RBL facilities re-ceived no further direct support until last year when Congress provided enhanced investment through NIH/NIAID, targeted specifically to RBL facilities, one of which is at the University of Alabama at Birmingham (UAB) in my state. Nevertheless, it seems as though the RBL infrastructure, most importantly the highly trained staff these facilities maintain and produce is something that falls within the pur-view of the HHS ASPR, considering among other things the UAB RBL has had col-laborations with Altimmune and ImmunityBio for COVID19 vaccine development, and supported BARDA contractors. This type of work strongly aligns with numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and Sustaining Robust and Reliable Public Health Security Capabilities. The RBL infrastructure and per-sonnel is expensive to maintain and operate, and perhaps should not solely rest on either the shoulders of the host University or the NIH/NIAID.
Question 9(a) . Therefore, is support from Assistant Secretary for Preparedness
and Response (ASPR) something under consideration?
Question 9(b) . If not, why not, and if so what is needed to facilitate that conversa-
tion?
Answer 9(a) & 9(b). CDC defers to our HHS colleagues from NIH and ASPR.
RESPONSE BY DR. ANTHONY FAUCI TO QUESTIONS OF SENATOR BURR, SENATOR
BRAUN , AND SENATOR TUBERVILLE
Responses to the QFRs are accurate as of the date of the hearing .
SENATOR BURR
Question 1 . Recent reports from the Administration have indicated that, while we
don’t need a booster for the COVID–19 vaccine just yet, we will likely need one in the near future.
Question 1(a) . What does the data show us so far about the durability of all three
authorized vaccines, particularly against circulating variants, such as Delta?
Answer 1(a). At this time, data indicate that all currently authorized COVID–19
vaccines remain effective at preventing severe disease and death from COVID–19, including from the Delta variant of SARS-CoV–2 (also known as B.1.617.2). The Na-tional Institute of Allergy and Infectious Diseases (NIAID) is supporting research to assess the duration of protection provided by current COVID–19 vaccination regi-mens and further quantify the protective effect of these vaccines against variants of SARS-CoV–2. Moderna and Pfizer/BioNTech recently reported that immune re-sponses to their respective COVID–19 vaccines remained robust 6 months following vaccination. Johnson & Johnson/Janssen also reported that the durability of im-mune response from vaccination with their COVID–19 vaccine lasts at least 8 months and that the average neutralizing antibody levels were greater at 8 months than at 29 days post-vaccination. In addition, data from both lab studies and clinical effectiveness studies show the effectiveness of all three authorized COVID–19 vac-cines against the Delta variant, particularly against hospitalization.
Question 1(b) . What factors should be considered in determining if or when a
booster is needed? Should certain populations be considered for a booster before oth-ers?
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Answer 1(b). The National Institutes of Health (NIH), Centers for Disease Control
and Prevention (CDC), and U.S. Food and Drug Administration (FDA) continue to engage in a science-based, rigorous process to help evaluate whether the durability of immune protection from currently authorized COVID–19 vaccines is waning and whether a booster may become necessary. Current data indicate that all currently authorized COVID–19 vaccines remain highly effective at preventing severe disease and death from COVID–19, including against the Delta variant, and as of the date of the hearing, the CDC and FDA have stated that fully vaccinated people do not need a booster shot at this time.
Whether a booster is needed in the future will depend on multiple factors, includ-
ing the durability of immune protection, the emergence of a SARS-CoV–2 variant that evades protection from currently authorized vaccines, and the strength of im-mune responses elicited by the initial vaccine regimen in certain populations. For example, data indicate that some immunocompromised individuals, including solid organ transplant recipients and individuals with cancer, have a weak response to the standard vaccine regimen. Emerging data suggest that some of these individuals are able to generate immune responses to an additional dose of COVID–19 mRNA vaccines. Given these data, immunocompromised individuals are likely to be consid-ered for additional doses of the COVID–19 vaccine before other populations.
NIH is conducting and planning studies to measure and enhance the immune re-
sponse to COVID–19 vaccines in immunocompromised individuals. In April 2021,
NIH scientists began two clinical trials to assess how adults and adolescents with certain cancers or immune system deficiencies respond to COVID–19 vaccination. These studies will provide valuable information about the immune responses to COVID–19 vaccines in these individuals. NIAID also plans to launch two additional trials in August 2021 that will assess immune responses to an additional dose of a COVID–19 vaccine in patients taking immunosuppressive medications. One of these trials will enroll participants with one of five autoimmune diseases, and the other will enroll kidney transplant recipients. Each study will enroll participants who have absent or weak antibody responses after an initial course of COVID–19 vaccination. NIAID also plans to launch an additional study that will enroll other solid organ transplant recipients who are receiving immunosuppressive medications. Results from these studies will help us to better understand the immune response to vaccination in immunocompromised individuals and identify approaches to safely enhance their responses to vaccination. These studies may also lead to evidence- based guidelines for safely enhancing responses to COVID–19 vaccination in immunocompromised individuals.
Question 1(c) . What is the status of studies looking at using different types of vac-
cines together, such as administering doses of both Moderna and Pfizer to someone or using an mRNA vaccine as a potential booster for Johnson & Johnson?
Answer 1(c). It is possible that the use of mixed vaccine regimens—in which an
individual receives doses of more than one vaccine type—may induce a broader im-mune response, resulting in improved protection against COVID–19. NIAID cur-rently is supporting research to determine the effect of mixed vaccine regimens and on June 1, 2021, launched a study to determine the safety and efficacy of boosting with a COVID–19 vaccine different than the one used for the initial vaccination, such as the Johnson & Johnson/Janssen vaccine followed by one dose of the Moderna COVID–19 vaccine. The study also will evaluate immune responses against SARS-CoV–2 variants. Initial results from this trial are expected in late summer 2021 and may inform public health policy decisions on the potential use of mixed vaccine schedules, should booster doses be needed.
NIH is committed to supporting further research into the use of mixed vaccine
regimens. NIAID also is studying the currently available COVID–19 vaccines— which were designed to target the original strain of SARS-CoV–2—to assess the du-rability of protection they provide against SARS-CoV–2 variants.
Question 2 . Given all of the work that we have put into identifying and tracking
these new variants as they emerge, once a new variant is detected, how quickly can we determine—in days or weeks—whether our vaccines will continue to protect us from severe illness due to COVID–19?
Answer 2. As mentioned in the response to question 1, data indicate that all cur-
rently authorized COVID–19 vaccines remain effective at preventing severe disease and death from COVID–19, including against known variants of SARS-CoV–2. Once a new SARS-CoV–2 variant of interest or of concern is detected and scientists obtain a sample of the variant or the genetic sequence of the variant, they can assess whether antibodies from individuals who have recovered from COVID–19, or who received a COVID–19 vaccine, can neutralize the variant virus. These experiments,
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which provide an early indication of vaccine efficacy against a new variant, can be
performed in a matter of days. However, the process of definitively determining the impact of a variant can take months and can vary based on several factors, includ-ing how widespread, transmissible, and/or pathogenic the variant is. NIAID is fully engaged in efforts to rapidly mitigate the potential impact of emerging variants of SARS-CoV–2.
NIAID, the National Human Genome Research Institute, and the National Li-
brary of Medicine are participating in the SARS-CoV–2 Sequencing for Public Health Emergency Response, Epidemiology, and Surveillance (SPHERES) initiative. SPHERES is a national genomics consortium led by CDC that helps to coordinate SARS-CoV–2 sequencing across the United States. NIAID is working with partners to identify, monitor, and calculate the frequency of current variations in the SARS- CoV–2 genome to help predict emerging variants. NIAID also facilitates the use of cutting-edge modeling and structural biology tools to understand how variants might affect interactions between the virus and the immune system. NIAID sci-entists are helping to inform our understanding of transmissibility of the variants by studying their stability in the environment and their ability to grow in human lung cells. These efforts add to a growing body of knowledge about SARS-CoV–2 variants and our ability to combat them.
As part of the ongoing COVID–19 response, NIAID is collaborating with vaccine
manufacturers on key areas of research to investigate whether vaccines designed for the original strain of SARS-CoV–2 maintain efficacy against emerging variants. NIAID is conducting and supporting comprehensive studies to understand the abil-ity of vaccine-induced antibodies to neutralize the variant viruses. In addition, NIAID is supporting the development of additional COVID–19 candidate vaccines that seek to induce a broader immune response. On March 25, 2021, NIAID launched a Phase 1 clinical trial in healthy adults to assess the safety and immunogenicity of second-generation COVID–19 vaccine candidates developed by Gritstone Oncology, Inc. Gritstone’s COVID–19 vaccine candidates utilize a strategy aimed at inducing both neutralizing antibodies and T cell responses to elicit a broad immune response. This approach could provide protection against emerging SARS- CoV–2 variants by targeting several viral antigens, all of which are highly con-served among known viral strains.
Question 3 . The Regional and National Biocontainment Laboratories were de-
signed to facilitate NIAID-funded research to address biothreats, including emerging infectious diseases. As you know, Duke University is home to one of these regional biocontainment laboratories, and you have previously highlighted some of their promising research, including a pan-coronavirus vaccine candidate that could poten-tially provide increased protection against SARS-CoV–2 and a variety of other coronavirus infections.
Question 3(a) . Could you expand on the role of the Regional and National Bio-
containment Laboratories in the development of medical countermeasures for COVID–19 and other threats?
Answer 3(a). NIAID established the U.S. National Biocontainment Laboratories
(NBLs) and Regional Biocontainment Laboratories (RBLs) to conduct research on biodefense and emerging infectious disease agents and to be available and prepared to assist national, state, and local public health efforts in the event of a bioterrorism or infectious disease emergency. Biocontainment laboratories, including the NBLs and RBLs, are essential for the development of medical countermeasures for emerg-ing and re-emerging infectious diseases.
The NBLs and RBLs offer unique resources for the research community, including
animal models, imaging services, and specialized equipment. In the case of COVID– 19, research that involves the use of live SARS-CoV–2 is required to take place in high biocontainment laboratories, such as the BSL–3 laboratories within the NBLs and RBLs. The NBLs and RBLs were able to utilize their unique BSL–3 capacity to assist with basic, translational, and clinical research on SARS-CoV–2 and COVID–19.
Over the past year, the NBLs and RBLs played a critical role in helping to ad-
dress the COVID–19 pandemic and have been utilized to conduct research with clin-ical samples containing live SARS-CoV–2 to advance the development of COVID– 19 medical countermeasures. The NBLs and RBLs also have been involved in a vari-
ety of pre-clinical research activities to test novel vaccines and therapeutics for COVID–19 and to explore the pathogenesis of, and immune responses to, SARS- CoV–2. This research includes the development of new animal models for COVID– 19 research and the analysis of SARS-CoV–2 variants of concern.
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Question 3(b) . How can these biocontainment laboratories be used in future pre-
paredness and response efforts?
Answer 3(b). As noted in the response to question 3(a), the NBLs and RBLs facili-
tate the conduct of research that aims to prevent, prepare for, and respond to emerging and re-emerging infectious diseases. NIAID recently published a funding opportunity for facility and building system upgrades for the RBLs, which will facili-tate future research efforts in these laboratories. NIAID will continue to support highly meritorious biomedical research in biocontainment laboratories, including at the NBLs and RBLs, to prepare for and respond to future infectious disease threats.
SENATOR BRAUN
Question 1 . Dr. Fauci, what steps are your agency taking to prepare for the in-
creased exposure to flu, COVID variants, and other communicable diseases in nurs-ing homes?
Answer 1. Older adults, and specifically those in nursing homes and long-term
care facilities, are often at higher risk for severe outcomes from infectious diseases, and the Administration is committed to the development and testing of medical countermeasures for this vulnerable population. The Centers for Disease Control and Prevention (CDC), the lead agency for public health, has released guidance on the prevention and management of transmissible diseases in long-term care facili-ties, including nursing homes. This includes specific detailed guidance for COVID- 19, influenza, and other communicable diseases. The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic, translational, and clinical research into infectious diseases, including research into the prevention of infectious diseases. This research encompasses studies in vulnerable populations, such as older adults and individuals living in nursing homes.
Vaccines are the most effective public health tools for preventing infectious dis-
eases, and COVID–19 vaccines currently authorized by the U.S. Food and Drug Ad-ministration (FDA) are well tolerated and effective at preventing severe disease and death, including in older adults. NIAID has played an integral role in the evaluation of COVID–19 vaccines. Early in the pandemic, NIAID supported a Phase 1 clinical trial of Moderna, Inc.’s COVID–19 vaccine, mRNA–1273, which was developed through a collaboration between scientists at the NIAID Vaccine Research Center and Moderna. NIAID included individuals aged 55 and over in this trial to assess the safety and efficacy of mRNA–1273 in older adults. The data from this trial facili-tated progression of mRNA–1273 into more advanced clinical trials that ultimately led to the emergency use authorization (EUA) of this vaccine by the FDA.
New viral threats will continue to emerge, and the development of universal influ-
enza vaccines and pan-coronavirus vaccines, which would protect vaccinated individ-uals against multiple viruses in one shot, can help us be better prepared for future infectious disease threats. NIAID is leading efforts to develop universal influenza vaccines to protect against multiple strains of seasonal and pandemic influenza vi-ruses. NIAID also is conducting early stage research on the development of pan- coronavirus vaccines designed to provide broad protective immunity against mul-tiple coronaviruses, especially SARS-CoV–2 and other viruses with pandemic poten-tial. These vaccines ultimately would be evaluated for use across the age spectrum, including in older adults. NIAID also is investigating the use of therapeutics for pre-vention of COVID–19 in older adults. In collaboration with Eli Lilly and Company, NIAID initiated a Phase 3 clinical trial that demonstrated that the investigational monoclonal antibody, bamlanivimab, could prevent symptomatic and asymptomatic infection in residents and staff of skilled nursing and assisted living facilities. In addition, NIAID is supporting the development of broad-spectrum therapeutics, in-cluding antivirals and antimicrobials, that can be used to treat infections, including in older adults.
NIAID also conducts and supports research into understanding how the immune
system changes as we age. On October 21, 2020, NIAID announced a new funding opportunity announcement (FOA), ‘‘Cohort Studies To Improve Our Understanding of Influenza Immunity, Vaccine Response and Effectiveness in Older Adults.’’ This FOA will support research to increase understanding of (1) factors that correlate with protection against influenza in older individuals, (2) the impact of influenza ex-posure and vaccination history on protective immune responses, and (3) immunological mechanisms associated with vaccine failure, including potential intra-seasonal waning of protection. Moreover, this research may lead to the identi-fication of risk factors for severe outcomes associated with influenza infection. Ulti-mately, this work will inform efforts to develop durable, broadly protective influenza vaccines across the age spectrum of adults.
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Question 2 . COVID vaccines do not appear to be working as well in
immunocompromised individuals or individuals taking immunosuppressants. Could antibody tests be used to greater effect in this population to identify individuals who may need an additional vaccine dose?
Answer 2. Immunocompromised individuals are at an increased risk for poor clin-
ical outcomes from COVID–19. While data indicate that some immunocompromised individuals have a weak response to the COVID–19 vaccines available under FDA EUAs, vaccines remain the most effective tool that we have for preventing COVID– 19. As of the date of the hearing, the FDA does not recommend using currently au-thorized SARS-CoV–2 antibody tests to evaluate a person’s level of immunity or pro-tection from COVID–19, including whether an individual may need an additional dose of the COVID–19 vaccine. Antibody tests have not been evaluated to assess the level of protection provided by immune responses to COVID–19 vaccination, includ-ing in immunocompromised individuals.
NIH is conducting and planning studies to assess and enhance the immune re-
sponses to COVID–19 vaccines in immunocompromised individuals. In April 2021, NIH scientists began two clinical trials to assess how adults and adolescents with certain cancers or immune system deficiencies respond to COVID–19 vaccination. These studies will provide valuable information about the immune responses to COVID–19 vaccines in these individuals. NIAID also plans to launch two additional trials in August 2021 that will assess immune responses to an additional dose of
a COVID–19 vaccine in patients taking immunosuppressive medications. One of the trials will enroll participants with one of five autoimmune diseases, and the other will enroll kidney transplant recipients. Each study will enroll participants who have absent or weak antibody responses after an initial course of COVID–19 vac-cination. NIAID also plans to launch an additional study that will enroll other solid organ transplant recipients who are receiving immunosuppressive medications. Re-sults from these studies will help us to better understand the immune responses to vaccination in immunocompromised individuals and identify approaches to safely enhance their immune responses to vaccination. These studies may lead to evidence- based guidelines for safely enhancing responses to COVID–19 vaccination in immunocompromised individuals.
Results from these studies will help us to better understand the immune re-
sponses to vaccination in immunocompromised individuals and may better inform the development of meaningful antibody tests or other assessments of immune re-sponse to vaccination for this population.
SENATOR TUBERVILLE
Vaccination of Children/Parental Consent
Question 1 . Last November, the District of Columbia passed a bill allowing chil-
dren 11 years and older to get vaccinated without their parents’ consent. It’s been proven that this virus has an insignificant impact on children under the age of 15 or 16.
Question 1(a) . Do you think minor children should be vaccinated without the con-
sent of their parents?
Answer 1 & 1(a). I cannot comment on legislation passed at the local level. While
it is true that young children and adolescents are less likely to experience severe symptoms from COVID–19, a portion of these individuals will still experience severe disease and hospitalization. Additionally, children and adolescents who are infected with SARS-CoV–2 can experience a rare, but extremely serious, multisystem inflam-matory syndrome in children (MIS-C). As the Delta variant (also known as B.1.617.2), which appears to be more transmissible, has become the dominant strain of SARS-CoV–2 in the United States, it is critical that as many people as possible are vaccinated against COVID–19. The U.S. Food and Drug Administration (FDA) has authorized the Pfizer/BioNTech COVID–19 vaccine for use in individuals 12 years old and older, and I would encourage everyone who is eligible to receive the vaccine to do so as soon as they can.
COVID–19 Origins
Question 2 . Did you have knowledge of safety concerns at the Wuhan lab?
Question 2(a) . If so, when did you become aware of those concerns?
Question 2(b) . Was it before or after you said in May 2020 that the virus was
more likely to have emerged naturally?
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Answer 2(a) & (b). NIAID was aware of interest on the part of the Wuhan Insti-
tute of Virology (WIV) to obtain additional information and trained staff as they pre-pared to begin research in a new biocontainment level 4 (BSL–4) facility.
My own view, based on the studies I have reviewed and my prior experience, is
that it is most likely that SARS-CoV–2 infections in people resulted from zoonotic transmission from animals to humans, based on what occurred with two other coronaviruses—Severe Acute Respiratory Syndrome (SARS) and Middle East Res-piratory Syndrome (MERS)—and many other emerging diseases, as well as what is known about the molecular makeup of SARS-CoV–2. The available scientific evi-dence, including information about the sequence of the virus, does not support the assertion that SARS-CoV–2 was engineered. This view is consistent with an emerg-ing consensus from world-renowned experts in virology, genetics, and evolutionary biology based on currently available data. However, as I have publicly stated, the possibility of a laboratory accident exists. A laboratory accident could include sce-narios where a naturally occurring virus was unintentionally released during re-search activities such as collection of animal samples or examination of virus in a laboratory. I am in favor of a full investigation into the origins of SARS-CoV–2, and I look forward to the findings of the experts in the various disciplines relevant to this discussion.
Question 3 . What is your awareness of Dr. Baric’s collaboration with researchers
at the Wuhan lab?
Answer 3. I am aware of collaborations between Dr. Ralph Baric from the Univer-
sity of North Carolina and the WIV. Dr. Baric was listed as a collaborator on a 2014 grant ‘‘Understanding Risk of Bat Coronavirus Emergence’’ submitted by EcoHealth Alliance and also was listed as a co-investigator on the corresponding 2019 grant renewal application. Prior to the renewal, this grant had included subawards to the WIV. Based on results published in peer-reviewed papers that include authors from Dr. Baric’s lab and the WIV, I also am aware that Dr. Baric has collaborated with investigators from the WIV on basic coronavirus research.
Question 4 . At what point did you realize that more investigation is necessary to
determine the origins of the virus?
Answer 4. Since the beginning of the pandemic, I have been supportive of a full
investigation into the origins of SARS-CoV–2 by qualified experts in the relevant fields.
Question 5 . In May, President Biden asked the Intelligence Community to review
the origins of Covid–19. Biden also asked that this effort include work by our Na-tional Labs and other agencies of our government to augment the Intelligence Com-munity’s efforts. Have you participated in this review?
Answer 5. The National Institutes of Health (NIH) is supporting and cooperating
with the President’s call for a U.S. Intelligence Community (IC) investigation and would refer you to the IC for additional information about their review.
NIH Grants
Question 6 . The HHS Office of Inspector General (OIG) is conducting a review of
NIH grants.
Question 6(a) . Have you provided documentation to the OIG?
Question 6(b) . Have you been interviewed as part of this review?
Answer 6(a) & (b). I am unable to specifically comment on any ongoing oversight
engagements; however, I will note that the NIH is fully cooperating with the De-partment of Health and Human Services (HHS) Office of Inspector General.
COVID–19 Vaccine Clinical Trials
Question 7 . Members of your staff served as co-investigators on the COVID–19
Vaccine clinical trials.
Question 7(a) . Have they investigated every report of an adverse event by a trial
participant?
Question 7(b) . If so, what does that investigation entail?
Question 7(c) . Do they evaluate each participant reporting an adverse event?
Answer 7(a), (b) & (c). Vaccine clinical trials are designed, in part, to assess the
safety of candidate vaccines, and all reported adverse events are investigated by the trial sponsor. The National Institute of Allergy and Infectious Diseases (NIAID) was the trial sponsor for the Phase 1 clinical trial for the Moderna vaccine candidate, and the study recorded all adverse events among the 120 enrollees, including cap-
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turing any symptoms, new medical conditions, and laboratory abnormalities. While
NIAID is supporting the underlying critical infrastructure for other clinical trials for COVID–19 vaccines through the COVID–19 Prevention Network (CoVPN), NIAID is not the trial sponsor.
Clinical trial protocols include information surrounding the definition and han-
dling of adverse events. NIAID would note that most of the trial sponsors for the Phase 3 clinical trials of the COVID–19 vaccines tested through the CoVPN have made the protocols for these trials available online, including for Moderna’s COVE trial, Johnson & Johnson/Janssen’s ENSEMLE trial, and Novavax’s PREVENT–19 trial. The protocol for Pfizer/BioNTech’s Phase 3 clinical trial also is available on-line. NIAID recommends contacting the trial sponsors for further information on COVID–19 vaccine clinical trials.
Misinformation
Question 8 . Are you involved in the administrations recently revealed efforts to
flag ‘‘misinformation’’ about COVID–19 for removal by social media companies?
Answer 8. No, I am not involved in the described efforts. Question 9 . Do you consider it misinformation for individuals to share their stories
of adverse events following vaccination?
Answer 9. No. I encourage anyone who has experienced an adverse event fol-
lowing vaccination to report it to the Centers for Disease Control and Prevention and FDA Vaccine Adverse Event Reporting System (VAERS), a national early warn-ing system to detect possible safety issues in vaccines.
Question 10 . Funds in part from NIH/NIAID helped build the 12 Regional Bio-
containment Laboratories (RBLs) and 2 National Biocontainment Laboratories (NBL) to support high consequence infectious disease research after 9/11 and the anthrax scares in 2001. However, unlike the NBL facilities, the RBL facilities re-ceived no further direct support until last year when Congress provided enhanced investment through NIH/NIAID, targeted specifically to RBL facilities, one of which is at the University of Alabama at Birmingham (UAB) in my state. Nevertheless, it seems as though the RBL infrastructure, most importantly the highly trained staff these facilities maintain and produce is something that falls within the pur-view of the HHS ASPR, considering among other things the UAB RBL has had col-laborations with Altimmune and ImmunityBio for COVID19 vaccine development, and supported BARDA contractors. This type of work strongly aligns with numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and Sustaining Robust and Reliable Public Health Security Capabilities. The RBL infrastructure and per-sonnel is expensive to maintain and operate, and perhaps should not solely rest on either the shoulders of the host University or the NIH/NIAID.
Question 10(a) . Therefore, is support from Assistant Secretary for Preparedness
and Response (ASPR) something under consideration?
Question 10(b) . If not, why not, and if so what is needed to facilitate that con-
versation?
Answer 10(a) & (b). NIAID defers to the HHS Office of the Assistant Secretary
for Preparedness and Response to respond to this question.
RESPONSE BY DR. JANET WOODCOCK TO QUESTIONS OF SENATOR BURR, SENATOR
BRAUN , SENATOR SCOTT AND SENATOR TUBERVILLE
Responses to the QFRs are accurate as of the date of the hearing .
SENATOR BURR
Question 1 . Pfizer and Moderna have both submitted or begun to submit applica-
tions for full, standard approval of their vaccines. Given FDA’s extensive knowledge and understanding of the vaccine data, are the agency’s review timelines going to be faster than a traditional application? If not, why not?
Answer 1. FDA’s review of a Biologics License Application (BLA) is among the
most comprehensive in the world. When a BLA is submitted, the Agency evaluates the information supporting safety and effectiveness as well as manufacturing data. FDA also inspects the facilities that are involved in the manufacturing of the prod-uct to ensure that the vaccines that are distributed meet rigorous quality standards.
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FDA scientists are working around the clock and reviewing the applications,
which include hundreds of thousands of pages of data and other information, as ex-peditiously as possible, in a thorough and science-based manner.
Having safe and effective approved COVID–19 vaccines is a top priority for HHS
and FDA. We firmly believe that those eligible to receive a vaccine under the exist-ing EUAs should get their COVID–19 vaccine now.
As you know, FDA first issued an EUA for the use of the Pfizer-BioNTech
COVID–19 Vaccine in individuals 16 years of age and older on December 11, 2020. Additionally, two other vaccines are currently available under EUA for the preven-tion of COVID–19. On December 18, 2020, FDA issued an EUA for the use of the Moderna COVID–19 Vaccine, and on February 27, 2021, FDA issued an EUA for the use of the Janssen COVID–19 Vaccine. The Moderna and Janssen COVID–19 vaccines are authorized for use in individuals 18 and older. For additional informa-tion on COVID vaccines, please visit: https://www.fda.gov/emergency-preparedness-
and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines .
Question 2 . FDA has made great strides in supporting innovative clinical trial de-
signs. How do you plan to continue to advance innovative clinical trial designs to expedite the development of novel products, using the creativity and flexibilities ex-ercised during the pandemic response as a roadmap?
Answer 2. FDA has a long-standing commitment to supporting innovation in clin-
ical development programs to help bring safe and effective drugs to patients more efficiently. Although the COVID–19 pandemic accelerated the use of innovative trial designs, FDA’s policy development in this area long preceded the current public health emergency. FDA recognizes that there are emerging shifts in how diseases are diagnosed, prevented, and treated, and in the development of therapeutics. FDA is working on multiple fronts to provide guidance on innovative approaches to drug development, such as complex, innovative trial designs, master protocols, decentral-ized trials, trials utilizing real world data and evidence (RWD/RWE), modelling, and simulation. Our engagements with stakeholders have supported innovative trial de-signs as part of the COVID–19 pandemic response. These designs improve clinical trial efficiency and may optimize product development.
FDA continues to promote innovation in clinical trial design and conduct, and to
encourage the utilization of advanced technologies. The agency is already working in many ways to facilitate pharmaceutical development and improve the overall clin-ical trial enterprise. We are also leveraging strong national and global partnerships in collectively advancing scientific knowledge to ultimately benefit patients. We are invested in advancing innovations, such as decentralized clinical trials and the use of digital health tools that have the potential of making clinical trials more efficient and may allow for wider inclusivity of diverse populations. Further, recognizing the value of innovative designs, FDA is committed to continuing the Complex Innovative Designs Meeting Program, which provides applicants accepted into the program with additional meetings with FDA to discuss proposed innovative designs.
Question 3 . What has FDA learned from its review of products made using plat-
form technologies, such as the mRNA and viral vector-based platforms, during the response? How will FDA support the development of products for other disease areas that leverage platform technologies?
Answer 3. FDA recognizes that, when scientifically appropriate, certain products
have begun sharing manufacturing platform technologies, allowing certain informa-tion from one product to be applicable to future products with similar production strategies. The Agency is interested in finding ways to streamline the development and review of such innovative technologies. Toward this end, FDA hopes to find ways to best leverage knowledge gained from approved products that rely on certain platform technologies and associated manufacturing methods to be applied to subse-quent products that a sponsor may develop. As this is a novel area, FDA continues to work to determine how to best leverage such platform technologies and looks for-ward to working with Congress in this area.
Question 4 . On July 8th, the FDA and CDC said that Americans who have been
fully vaccinated do not need boosters at this time. Pfizer announced it would file for authorization of a booster with the FDA, and the ACIP has stated that they can-not recommend booster shots for specific groups of individuals without FDA action. What is the timeline for determining whether to authorize a proposed booster, ei-
ther for certain populations or the general public?
Answer 4. At the time of the hearing, FDA was closely monitoring data as it be-
came available from studies administering a booster dose of the authorized COVID– 19 vaccines to immunocompromised individuals. The Agency is collaborating with the Centers for Disease Control and Prevention and continues to evaluate all poten-
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1https://www.fda.gov/regulatory-information/laws-enforced-fda/Federal-food-drug-and-cos-
metic-act-fdc-act .
2https://www.fda.gov/media/97321/download . tial solutions to this growing question in the medical community. For more informa-
tion and updates, please see: https://www.fda.gov/emergency-preparedness-and-re-
sponse/coronavirus-disease-2019-covid-19/covid-19-vaccines .
FDA understands the potential importance of booster vaccine doses for control of
this pandemic and will promptly review any data submitted to the Agency regarding their use in a thorough and science-based manner. Due to legal and regulatory re-strictions, FDA generally cannot discuss product submissions that may be under re-view, including the timing of any potential FDA action to authorize or approve the use of additional doses of COVID–19 vaccines. Please contact the vaccine manufac-turers directly regarding their plans to submit data for their individual vaccines and the timing of such submissions.
SENATOR BRAUN
Question 1 . FDA has authorized large numbers of COVID tests and other products
using emergency use authorizations. Without further action from FDA, when the public health emergency comes to an end these products will no longer be available for use.
Question 1(a) . How does the FDA plan to transition products to full approval or
clearance? What will happen if the public health emergency ends, and critical prod-ucts have not received approval or clearance from FDA?
Answer 1 & 1(a). On February 4, 2020, the Secretary of the Department of Health
and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act,
1that there is a public health emergency that
has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID–19. Pursuant to Section 564 of the FD&C Act, and on the basis of such de-termination, the Secretary of HHS then declared that circumstances exist justifying
the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID–19 (February 4, 2020), personal respiratory protective devices (March 2, 2020), other medical devices (March 24, 2020) for use during the COVID– 19 outbreak, and drugs and biological products during the COVID–19 pandemic (March 27, 2020). (Please note that a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, and subsequently renewed, is insufficient to enable FDA to issue EUAs.)
The declarations under section 564 have enabled FDA to authorize unapproved
products and unapproved uses of approved or cleared products when, based on the totality of the scientific evidence available, it is reasonable to believe that the prod-uct may be effective in diagnosing, treating, or preventing the disease or condition and the known and potential benefits of the product’s use outweigh the known and potential risks, taking into consideration the material threat posed by an emergency situation. Irrespective of the status of the public health emergency declaration under section 319 of the Public Health Service Act, FDA is empowered to authorize such uses until the Secretary terminates the declaration of emergency or threat jus-tifying emergency use under section 564(b), the criteria for EUA issuance are no longer met, or revocation is otherwise appropriate to protect the public health. It may be the case that once the public health emergency declaration under section 319 of the Public Health Service Act expires, the benefit-risk justification for issuance of any particular EUA are no longer met or revoking such use is otherwise appropriate. In some instances, manufacturers of certain devices, especially non-conventional manufacturers, may no longer wish to market or distribute these prod-ucts. In other instances, manufacturers may desire to transition to full approval or clearance and the statute directs FDA to communicate with manufacturers regard-ing such transition.
The Agency is required to periodically review the authorizations made under sec-
tion 564 of the FD&C Act. As part of that review, FDA reviews the progress made toward approval, licensure, or clearance of the products authorized. See section 564(g) of the FD&C Act and FDA’s guidance on Emergency Use of Medical Products and Related Authorities.
2As outlined in FDA’s guidance, Emergency Use Author-
ization for Vaccines to Prevent COVID–19, it is FDA’s expectation that, following submission of an EUA request and issuance of an EUA, a sponsor would continue to collect placebo-controlled data in any ongoing trials for as long as feasible and
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3 https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/
coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices .
4 https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-
covid19-and-medical-devices#guidance .
5 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-
emitting-products/cdrh-proposed-guidances-fiscal-year-2021-fy-2021 . would also work toward submission of a Biologics License Application (BLA) as soon
as possible. FDA’s recommendations regarding the safety and effectiveness data and information are essential to ensure that clinical development of a COVID–19 vaccine has progressed far enough that issuance of an EUA for the vaccine would not inter-fere with the ability of an ongoing Phase 3 trial to demonstrate effectiveness of the vaccine to support licensure and to continue safety assessments, including inves-tigating the potential for vaccine-associated enhanced respiratory disease (ERD). The ability of a sponsor to accrue this information about a COVID–19 vaccine is critical to ongoing assessment of its benefits and risks.
FDA is working on a transition plan for devices that have been authorized under
EUAs
3or that fall within enforcement policies4issued during the COVID–19 public
health emergency. FDA’s intention is to issue guidance in draft form and request public comment before finalization and implementation. Transition plan draft guid-ance is on CDRH’s Fiscal Year 2021 ‘‘A List,’’
5meaning that this is a prioritized
policy that FDA seeks to publish in a timely fashion. FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, pa-tients, consumers, and FDA to adapt and adjust from policies adopted and oper-ations implemented during the public health emergency to normal operations. One of the goals of developing guidance on this topic is to have an orderly transition process and to provide transparency around FDA’s approach to that transition. In addition, FDA is engaging in discussions with individual companies that are inter-ested in obtaining marketing clearance or approval for their devices, and we encour-age companies to initiate those discussions. Note that this proactive engagement is an integral part of FDA’s transition plan. As we shift more resources toward work-ing with sponsors pursuing full marketing status and as more devices achieve this status, there will be a smoother transition away from reliance on products author-ized for emergency use or that fall within enforcement policies issued during the COVID–19 public health emergency.
SENATOR SCOTT
Question 1 . Dr. Woodcock, the COVID–19 pandemic has had a disproportionate
and devastating impact on communities of color. Drivers of this disparate impact correlate directly to social determinants of health, such as health and financial lit-eracy, transportation, housing conditions, employment, safety, and education. I have expressed concerns at a number of hearings on the prevalence of vaccine hesitancy among Black Americans, with a 2020 survey suggesting that only 25 percent of Black adults planned to get vaccinated in the event of a COVID–19 vaccine ap-proval. The pandemic has exposed several disparities that exist within the U.S. healthcare system. One such area is the under-representation of communities of color in clinical trials. Improving the diversity of participants in clinical trials con-tinues to be a challenge due to a number of obstacles, including a lack of racial di-versity in clinical trial investigators, community mistrust and skepticism due to his-toric abuses of racial minorities used as test subjects, as well as a lack of convenient and affordable transportation to clinical trial sites. To improve health outcomes for those most at risk, we must diversify our pool of participants. Our goal should be to include participants from diverse ethnic backgrounds and income levels. It is also imperative investigators make devices and software available to participants in ad-dition to allowing enrollees to participate from diverse settings such as their home, local clinics, and, potentially, skilled nursing facilities.
Question 1(a) . Dr. Woodcock—You have praised the success of the innovations
made within clinical trial designs. What is your vision to expand access to clinical trials and how do we get there?
Answer 1 & 1(a). Modernizing clinical trials is a priority for FDA and the subject
of significant policy work in which we are currently engaged. We view modernizing clinical trial designs and conduct and utilizing innovative technologies as an essen-tial area to improve efficiencies and to facilitate the development of drugs, biological products, and devices.
Prior to the pandemic, the Agency was working on these areas, and the current
public health emergency further catalyzed these efforts. There is a wide range of designs, tools, and methods that can be utilized in this area. For example, decentral-
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6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-
diversityclinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial .
7https://www.fda.gov/media/127712/download . ized clinical trials, hybrid trials, trials embedded in healthcare settings, trials that
allow for seamless transition between phases, the use of digital health technologies, and supporting efficient, risk-based, approaches to trial conduct are all areas that FDA is currently working on or is planning on addressing. We have recently an-nounced that the Agency will be issuing a draft guidance on the use of digital health technologies in clinical investigations and another draft guidance on decentralized clinical trial designs.
Question 1(i) . What was done during the pandemic to ensure COVID–19 treat-
ment and vaccine trials were clinically diverse?
Answer 1(i). FDA published guidance
6to encourage diversity in clinical trials and
make recommendations on how to help increase diversity in trials.
Sponsors who have requested an Emergency Use Authorization have provided
numbers, including enrollment numbers about the diverse populations, in the pack-age submitted to FDA for consideration for potential Emergency Use Authorization (EUA). We continue to strongly encourage the companies to improve their enroll-ment diversity and we provide recommendations on how to do so by leveraging mes-
saging in local communities, site selection, and other strategies to raise the propor-tion of minorities being enrolled.
With regard to COVID–19 vaccines, in the June 2020 guidance, Development and
Licensure of Vaccines to Prevent COVID–19 , the Agency encourages the inclusion of
diverse populations, including those most affected by COVID–19, in all phases of vaccine clinical development.
For the three vaccines that FDA has authorized for emergency use, all clinical
trials included members of racial or ethnic groups at greater risk from COVID–19.
FDA, vaccine manufacturers, and other scientists are currently working to try to
understand how long the authorized vaccines will provide protection for the preven-tion of COVID–19. Many studies are well underway to evaluate how long protection from a COVID–19 vaccine lasts and whether there is any variability based on age, race or ethnicity, or comorbidities that disproportionately impact underserved com-munities. These studies are currently being conducted by government agencies, aca-demia, and industry partners. Specifically, these studies are longitudinal patient fol-low-up studies, which usually entail measuring antibody titers in a cohort of individ-uals before and at multiple times after vaccination, and identifying an association between antibody responses below a certain antibody level threshold and vaccine failure/infection. These studies may be designed to demonstrate differences in var-ious groups based on age, race and ethnicity, or comorbidities.
Question 1 . If successful, how can we implement these changes post-pandemic?
Answer 1. Advancing innovative and inclusive clinical trials is a key part of FDA’s
ongoing efforts that started prior to the pandemic and will continue post-pandemic. FDA will continue to encourage the inclusion of diverse populations in clinical trials and is committed to continue to work on ensuring that best practices for enhancing diversity in COVID–19 treatment and vaccine trials are sustained beyond the pan-demic. Because clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective, enrollment in clinical trials should reflect the diversity of the population that will ultimately use the product. The op-portunity to participate in clinical research should be available to all eligible pa-tients who are impacted by the disease.
In November 2020, FDA issued a final guidance for industry titled, Enhancing the
Diversity of Clinical Trial Populations; Eligibility Criteria, Enrollment Practices, and Trial Designs .
7This guidance recommends approaches that sponsors of clinical
trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and to increase enrollment of underrepresented populations in their clinical trials. FDA has also published several additional guidances supporting clinical trial diversity, in-cluding, Collection of Race and Ethnicities in Clinical Trials (2016); Pregnant
Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (2018); Clinical Lactation Studies: Considerations for Study Design (2019); Postapproval Pregnancy Safety Studies (2019); and Older Participants-ICH E7 .
FDA remains committed to increasing the participation of racial and ethnic mi-
norities and other underrepresented populations in clinical trials that test new med-ical products for all diseases and conditions through issuing guidance, developing
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8http://wcms-internet.fda.gov/media/136238/download .
9https://www.fda.gov/media/127712/download . tools, and encouraging the use of innovative trial designs. In addition, FDA is work-
ing on policies pertaining to the use of decentralized trial designs and digital health technologies. Decentralized clinical trials have the potential to increase diversity of research participants by incorporating, telemedicine and mobile/digital technologies to increase access to under-represented populations and/or communities—rural or remote—that may not have access to major medical and research centers.
Moving forward, FDA will apply lessons learned from COVID–19 to help support
the participation of people in racial, ethnic, and other minority groups in the clinical trials that test new medical products through hosting public meetings, developing tools, and issuing guidance documents.
Question 1(ii) . What are some of the benefits to providing technology to clinical
trial participants? For example, mobile glucose monitors or tablets and phones equipped with software to transmit information back to clinical trial investigators.
Answer 1(ii). Digital health technologies are among the most promising tools we
have for advancing clinical trial innovation and promoting diversity and inclusion. Including digital health technologies in clinical trials may make trial participation less burdensome for participants and expand access to trials by enabling remote data collection and monitoring from the participant’s home instead of traveling to a clinical site. Additionally, providing digital health technologies to participants may enhance a participant’s experience in a clinical trial by promoting engagement and more seamless information sharing between trial participants and clinical investiga-tors. Some of these digital health technologies allow continuous collection of data from trial participants, which could allow round-the-clock monitoring of drug effects. This may improve our ability to understand the safety and efficacy of new drugs in ways that were not previously possible.
When digital health technologies are included in clinical trials, however, FDA rec-
ognizes the crucial importance of maintaining both the safety of trial participants and clinical trial integrity. To promote both, the Agency promptly provided guidance during the COVID–19 pandemic titled Conduct of Clinical Trials of Medical Prod-
ucts during COVID–19 Pandemic
8that included recommendations regarding the re-
mote collection of data in clinical trials.
In this guidance, FDA explains that sponsors planning to use remote electronic
assessments as part of a clinical investigation should use appropriate technology and develop procedures for provision of technology and technical support to trial participants, investigators, and/or other trial personnel to facilitate those assess-ments. For example, sponsors could develop a plan to accommodate trial partici-pants who are either already enrolled in a trial or may be enrolled in a trial in the future, but who do not have access to appropriate communication technology (e.g., cell phones or Internet), by providing trial participants with these services.
FDA encourages the use of digital health technologies in clinical trials that are
beneficial to study participants. The Agency issued final guidance in November 2020, entitled Enhancing the Diversity of Clinical Trial Populations—Eligibility Cri-
teria, Enrollment Practices, and Trial Designs Guidance for Industry .
9This guid-
ance encourages sponsors to think about reducing visit frequency, when appropriate, in addition to considering whether flexibility in visit windows is possible and wheth-er electronic communications, such as phone, email, social media platforms, or other digital health technology tools, can replace site visits and provide investigators with real-time data.
In the above-referenced guidances, FDA provides a few examples of potential ap-
proaches, and encourages the development of other approaches that can make trial participation less burdensome for participants and foster retention and inclusive-ness.
Question 1 . What statutes need to be changed to allow for this exchange?
Answer 1. At this time, FDA has not identified statutory changes that are nec-
essary to facilitate the use of digital health technologies in clinical trials. The Fed-eral Food, Drug, and Cosmetic Act and the Public Health Service Act provide suffi-cient flexibility to enable use of a broad spectrum of technologies when appropriate to a particular development program. Sponsors are already utilizing digital health technologies in clinical development programs, and FDA is working with sponsors to help facilitate such use consistent with applicable regulatory requirements.
Question 2 . The role of the Food and Drug Administration (FDA) in combatting
the COVID–19 pandemic has been critical, and I’d like to thank you for the agency’s
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10https://www.fda.gov/media/142749/download .
11 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-
covid-19/covid-19-frequently-asked-questions#biologics . vital work to support the successful delivery of three vaccines to the American peo-
ple. You have testified in the past before this Committee that no corners were cut in FDA’s evaluation of COVID–19 vaccines in authorizing them under Emergency Use Authorization (EUA), meaning that the FDA’s gold standard review for evalu-ating the safety and efficacy of COVID–19 vaccines was met or surpassed for the vaccines authorized in the United States. Looking to future pandemic preparedness efforts and other biological threats, whether naturally occurring, deliberate, or acci-dental, I would like to better understand the EUA process—not just for vaccines, but also for vaccine manufacturing. Vaccine manufacturers moved at unprecedented speed to develop a product and its manufacturing process while simultaneously scal-ing-up manufacturing capacity—all at a record-breaking pace. These efforts took place in the middle of a pandemic in an environment with serious supply chain con-straints. While not unexpected given the circumstances, our understanding is that there have been a number of challenges with COVID vaccine and therapeutic manu-facturers—with media reports focused on a range of companies, including some of the largest pharmaceutical companies in the world (Merck, Lilly) and some smaller contract manufacturers (Emergent, Texas A&M/Fujifilm DioSynth, Catalent). So, I think explaining the EUA standard for the authorization of the product and the manufacturing process will serve to assure the American public and the world that any product authorized during a public health emergency by the FDA is appro-priate—both for the current pandemic and in preparation for the next.
Question 2(a) . Dr. Woodcock—Can you please briefly explain the standards for
granting an EUA for a vaccine candidate?
Answer 2 & 2(a). FDA may issue an EUA after FDA has determined that the
product that is the subject of an EUA request meets the statutory requirements under section 564 of the FD&C Act. In determining whether to issue an EUA for a vaccine, FDA evaluates the available evidence to determine, among other things, whether it is reasonable to believe that the vaccine may be effective in preventing COVID–19 and whether the known and potential benefits of the vaccine, when used to prevent COVID–19, outweigh any known and potential risks of the vaccine. Once a manufacturer submits an EUA request for a COVID–19 vaccine, FDA evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the Agency. The FDA guidance, Emergency Use Authorization for Vaccines to Pre-
vent COVID–19
10provides more information about FDA’s current recommendations
regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act for an investigational vaccine to prevent COVID–19, including chemistry, manufacturing, and controls information; nonclinical data and information; and clinical data and information, as well as administrative and regu-latory information.
11
Question 2(i) . Can you please explain the standards for authorizing a bulk drug
substance manufacturing facility as part of a product EUA in a public health emer-gency?
Answer 2(i). As stated in FDA’s Guidance for Industry, Emergency Use Authoriza-
tion for Vaccines to Prevent COVID–19 , FDA assesses current good manufacturing
practice (CGMP) compliance for each manufacturing site using all available tools and information. FDA expects manufacturers to submit sufficient data to ensure the quality and consistency of their product, and FDA evaluates the chemistry, manu-facturing, and controls and facility information for the product. FDA uses all avail-able tools and information, including reviews, site visits, inspections, EUA investiga-tions, and previous compliance history, and has utilized the authority under section 704(a)(4) of the FD&C Act to request records and other information from foreign and domestic establishments to assess compliance with CGMP requirements of fa-cilities that are intended to manufacture vaccines to prevent COVID–19 under an EUA. FDA has also used establishment inspection information from capable foreign regulatory authorities under the Pharmaceutical Annex to the U.S. and European Union Mutual Recognition Agreement (MRA), and the Pharmaceutical Annex to the U.S. and United Kingdom MRA, as well as other confidentiality agreements and commitments.
FDA takes its responsibility for helping to ensure the quality of manufacturing
of vaccines and other medical products for use during this pandemic very seriously. As outlined above, the Agency is using a variety of tools to help ensure that prod-
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ucts being produced in different facilities meet the high-quality standards that
Americans have come to expect. It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the EUA to ensure that the required quality standards are met. No product can be distributed by manufacturers until FDA authorizes its distribu-tion from the facility that is manufacturing it. FDA will continue to work with com-panies to ensure that the quality standards it expects for products distributed under an EUA are met, and will continue to work diligently to help bring needed medical products in a timely manner to Americans during this public health emergency.
Question 2(ii) . Can you please explain the standards for authorizing a fill/finish
manufacturing facility as part of a product EUA in a public health emergency?
Answer 2(ii). Please see the response to ‘‘i’’ above. Question 3 . Current data suggests high efficacy rates among the vaccines for
which Emergency Use Authorization was approved, good news for the 85.7 percent of South Carolinian seniors who have received at least one dose and the 77 percent of whom are fully vaccinated. However, as the Delta variant remains extremely con-tagious and the World Health Organization labeling the Lambda version a ‘‘variant of interest,’’ the U.S. cannot remain idle as we work to return students back into the classroom and more adults come back to work. Recently, Pfizer announced it planned to submit COVID–19 booster shot data to the FDA by mid-August 2021. American seniors, their families and caregivers, and stakeholders remain interested in knowing what the Federal Government plans to do regarding the possible author-ization and distribution of booster vaccines. This information is especially timely since the first Americans, including South Carolinian long-term facilities residents, received their initial vaccines in December 2020.
Question 3(a) . Dr. Woodcock—What collaborations are occurring between the Fed-
eral Government, vaccine developers, the states, long-term care facilities, the senior community, and other interested stakeholders regarding information about booster vaccines? When will this information be made public?
Answer 3 & 3(a). The COVID–19 vaccines authorized in the United States con-
tinue to be remarkably effective in reducing risk of severe disease, hospitalization,
and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maxi-mize it.
FDA understands the potential importance of booster vaccine doses for control of
this pandemic and will promptly review any data submitted to the Agency regarding their use in a thorough and science-based manner. Due to legal and regulatory re-strictions, FDA cannot discuss product submissions that may be under review, in-cluding the timing of any potential FDA action to authorize the use of booster doses of COVID–19 vaccines. Please contact the vaccine manufacturers directly regarding their plans to submit data for their individual vaccines and the timing of such sub-missions.
SENATOR TUBERVILLE
Question 1 . Funds in part from NIH/NIAID helped build the 12 Regional Bio-
containment Laboratories (RBLs) and 2 National Biocontainment Laboratories (NBL) to support high consequence infectious disease research after 9/11 and the anthrax scares in 2001. However, unlike the NBL facilities, the RBL facilities re-ceived no further direct support until last year when Congress provided enhanced investment through NIH/NIAID, targeted specifically to RBL facilities, one of which is at the University of Alabama at Birmingham (UAB) in my state. Nevertheless, it seems as though the RBL infrastructure, most importantly the highly trained staff these facilities maintain and produce is something that falls within the pur-view of the HHS ASPR, considering among other things the UAB RBL has had col-laborations with Altimmune and ImmunityBio for COVID19 vaccine development, and supported BARDA contractors. This type of work strongly aligns with numerous ASPR Strategic Goals, such as Fostering Strong Leadership, and Sustaining Robust and Reliable Public Health Security Capabilities. The RBL infrastructure and per-sonnel is expensive to maintain and operate, and perhaps should not solely rest on either the shoulders of the host University or the NIH/NIAID.
Question 1(a) . Therefore, is support from Assistant Secretary for Preparedness
and Response (ASPR) something under consideration?
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Question 1(b) . If not, why not, and if so what is needed to facilitate that conversa-
tion?
Answer 1(a) & (b). FDA defers to ASPR to respond to these questions.
RESPONSE BY DAWN O’C ONNELL TO QUESTIONS OF SENATOR BALDWIN , SENATOR
BURR, SENATOR BRAUN , AND SENATOR TUBERVILLE
Responses to the QFRs are accurate as of the date of the hearing .
SENATOR BALDWIN
Question 1 . I was encouraged to hear Assistant Secretary O’Connell’s announce-
ment that $2 billion of the $10 billion that I secured in the American Rescue Plan for domestic manufacturing and utilization of the DPA would be used to support vaccine industrial base expansion for raw materials, consumables, fill/finish capac-ity, needles, vials, and syringes. Please provide additional details on the recipients of this funding, as well as any information that can be shared regarding future obli-gations.
Answer 1. With $10 billion received for industrial base expansion, ASPR has been
establishing and maintaining domestic capacity for vaccine production and adminis-tration, in addition to a number of other efforts for PPE and pharmaceutical manu-facturing. Specifically, ASPR is executing an acquisition strategy to expand the ca-pacities and surge capabilities for high-speed, reliable sterile filling/packaging oper-ations, domestic conversion of bulk biological drug substance into drug product for distribution, and investments in manufacturing capacities to better avail raw mate-rials and consumables that are commonly used across the commercial sterile biologic products industry for production, delivery and administration (e.g., nucleoside triphosphates (NTPs), enzymes, resins, lipids, and needle and syringe sets).
Question 2 . How is the Administration utilizing this funding to ensure that Amer-
ican companies that shifted and significantly expanded production of raw materials to aid in our pandemic response receive support? How is the Administration work-ing to build on our pandemic response to develop a public health industrial base with the capacity to respond to crises and make us less reliant on