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Dr. Fauci Updates Senate Committee on Efforts to Fight COVID; White House COVID Response Officer Says, Vaccine Supply is Greater Than Demand. Aired 10:30-11a ET

Aired May 11, 2021 - 10:30   ET




Thank you very much.

SEN. PATTY MURRAY (D-WA): Thank you. Dr. Marks?

DR. PETER MARKS, DIRECTOR FDA CENTER FOR BIOLOGICS EVALUATION AND RESEARCH: Chair Murray, Ranking Member Burr, distinguished members of the committee, thank you for the opportunity to testify before you again to describe FDA's continued COVID-19 response efforts and particularly our efforts on vaccines.

First, yesterday evening, the FDA announced the expansion of the emergency use authorization for the Pfzier/BioNTech's COVID-19 vaccine to include adolescents down to age 12 years. We know this is a big step for our country as vaccinating our younger population can bring us closer to a sense of normalcy and to ending this pandemic.

To look at the safety of the vaccine, the FDA evaluated a clinical trial of more than 2,000 adolescents age 12 through 15. Half of the participants received the Pfizer/BioNTech and half received the saline placebo. The side effects experienced by those age 12 through 15 were similar to those experienced by individuals age 16 and older.

To look at effectiveness, the FDA evaluated data about how participant's immune systems responded to the vaccine comparing 1,900 individuals age 12 through 15 to 170 age 16 through 25. The FDA also evaluated data on cases of COVID-19 in among adolescents age 12 through 15 seven days after the second dose of vaccine was given and no cases of COVID-19 occurred among 1,005 adolescents who received the vaccine compared to 16 cases in 978 placebo recipients, thus indicating that the vaccine was completely effective in preventing COVID-19 in the trial that was symptomatic.

Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available scientific data, as we have with all of our COVID-19 vaccine authorizations. And the CDC's advisory committee on immunization practices will next review the data tomorrow. Also, as we announced yesterday, we intend to convene a virtual meeting of the vaccines and related biological advisory committee on June 10th, 2021 during which will provide a status update on our approach to emergency use authorization in individuals age 12 through 17 years of age and will also discuss the data needed to support an emergency use authorization and a biologics license application in children less than age 12.

Second, as COVID-19 vaccination expands into adolescence, we continue to work diligently with CDC and other partners on safety surveillance of the authorized vaccines. We're grateful to Congress for the American rescue plan funds which are supporting expanded vaccine safety surveillance among other critical priorities. We have seen that our safety surveillance systems are doing what they're supposed to do in detecting important adverse events.

Recently, our surveillance detected a safety signal for rare blood clots and low platelets known as thrombosis thrombocytopinea syndrome with the Janssen or Johnson & Johnson COVID-19 vaccine, following a brief pause taken to evaluate the situation and educate providers based on the rare but increased event of this adverse event namely in women age 18 through 50 years of age.

FDA modified the fact sheet for health care providers to include a warning pertaining to the risk of thrombosis with thrombocytopinea and the fact sheets for recipients and caregivers was also updated. We'll continue to diligently monitor the safety of all of these vaccines.

Third, the CDC and FDA are working closely together to track the emergence and the spread of COVID-19 variants. Currently available evidence suggests that the three available FDA authorized vaccine adequately address COVID-19 variants circulating in the United States. However, we're working with manufacturers and government partners to plan the composition of the vaccine so that we can administer booster vaccinations if necessary of an appropriate composition.

Fourth, the FDA recently completed an inspection of emergent biosolutions, a proposed manufacturing facility for the Janssen COVID- 19 vaccine. At the close of the inspection of the emergent biosolutions, FDA investigators cited several observations concerning whether the facility's practices met our regulatory requirements and standards.

We're now working with emergent biosolutions to address the conditions identified. It's been made public that no product has been released from this facility for use in the United States and will not agree to the release of any product from this facility until we're truly confident that it meets our expectations for quality.

Additionally, moving forward, the agency is refining how to optimally evaluate the manufacturing quality during this and any future public health emergency.


We're committed to maintaining the trust of the public and the vaccines and hope that every eligible individual consider getting vaccinated to help end this pandemic. Thank you.

MURRAY: Thank you. Dr. Kessler?

DR. DAVID KESSLER, CHIEF SCIENCE OFFICER, WHITE HOUSE COVID RESPONSE TEAM: Chair Murray, Ranking Member Burr, distinguished members of the committee, thank you for the invitation to provide an update on our COVID-19 response. Allow me to succinctly set out what we are focused on today.

First, we have delivered to date 330 million doses of vaccine in the United States and have administered over 260 million of them. The most important thing we all need to do is to get a vaccine to everyone who wants to be vaccinated in the United States.

The current vaccine supply exceeds demand. Nothing is more important than achieving the president's goal of having 70 percent of adults with at least one shot before -- by July 4th. The long-term fate of many of our communities depends on getting people vaccinated.

There are many reasons why people have not yet been vaccinated. We need to recognize at the core for many is simply a fear of the unknown. All the data support the basic proposition that these vaccines are safe and effective. Getting vaccinated will prevent hospitalization and death.

Second, the FDA took a significant step yesterday in the fight against COVID-19 by expanding the Pfizer EUA to adolescents ages 12 to 15. Pending the recommendation of the ACIP tomorrow, we plan to offer the Pfizer vaccine to all young people ages 12 to 15.

Right now, the Pfizer vaccine is available at many local pharmacies and larger health clinics. We are working to make smaller trades available so that the Pfizer vaccine can be administered by more pediatricians, family doctors and rural health care providers. By late fall, we expect to have data on the safety and effectiveness of vaccines for children under 12.

Third, we're planning, and I underscore the word, planning, to have booster doses available if necessary for the American people. Increased age, the natural waning of antibodies over time and new variants all increase the probability that booster doses may be needed.

Fourth, it is absolutely essential that we begin sharing doses made in the United States with the rest of the world. Supplying other nations with vaccines is not just the right thing to do for life-saving humanitarian purposes, it is also in the best interest of the United States to mitigate the risk of viral evolution.

Fifth, we need to hasten our search for an anti-viral. I am concerned that even after we finish vaccinating most of the people who want to be vaccinated by this summer. There will be a significant number of cases and an unacceptable number of deaths.

People who are immunosuppressed,who do not mount an immunoresponse for a number of reasons or choose not to be vaccinated will continue to be vulnerable and we need options for them. The antibody treatments are one approach but a simple oral anti-viral can add to our armamentarium to bring this epidemic under control.

Lastly, we need to build a program for vaccine preparedness for future pandemics. This will need to be done in partnership with the private sector and build on all the lessons we have learned to date.

Thank you for the opportunity to testify today and I look forward to your questions.

MURRAY: Thank you to all our witnesses for being here today and your testimony.

We will now begin a round of five minute questions of our witnesses, and I ask our colleagues to keep track of your clock and stay within those five minutes. We do have votes starting at 11:30 today.

Dr. Fauci, let me start with you. The surge of COVID-19 that is devastating India is a painful reminder really that we can't end the pandemic here until we end it everywhere. And I'm glad the Biden administration is leading that global fight by rejoining the World Health Organization and funding global vaccine efforts and committing to donate 60 million AstraZeneca vaccines to other countries by July 4th.


India's outbreak really underscores the need for a robust public health infrastructure in the U.S. to respond appropriately to this pandemic and future outbreaks as well. I want to ask you today, Dr. Fauci, what can we learn from India's outbreak that we should apply to our response here in the U.S.?

FAUCI: Well, I think one of the important things is don't ever underestimate the situation. You know, the reason that India is in such dire straits now is that they had an original surge and made the incorrect assumption that they will finished with it. And what happened, they opened up prematurely and wind up having a surge right now that we're all very well aware of is extremely devastating. That's the first thing.

The second thing is preparedness with regard to public health preparedness, which we, as a lesson learned for future pandemics, have to realize that we need to continue to build up our local public health infrastructure, which, over the last decades, we have led to actually many respects to go into disarray likely because of our successes in controlling so many diseases.

The other lesson that is learned, Madam Chair, is that this is a global pandemic that requires a global response and we need to pay attention to the responsibility that we have, not only for our own country but to join with other countries to make sure that we have the access to interventions, particularly vaccines, throughout the world, because if it continues to have dynamics of virus anywhere in the world, we have a threat here in the United States, particularly with variants. And you know there is one variant in India that is also a new variant, number 617, B617.

So those are just a few of the lessons that I believe we can take from what's going on in India. Thank you.

MURRAY: Thank you.

Dr. Marks, I'm really encouraged by how the FDA has worked both quickly and carefully to get multiple COVID-19 vaccines authorized. But having said that, I am very concerned about the reports involving emergent biosolutions. You mentioned it in your remarks. It is a contractor that receives $628 million to manufacture COVID vaccines and wanting to ask you to explain FDA's recent findings. Because after receiving reports of cross-contamination with another vaccine, FDA inspected the emergent facility, as you said, and asked the contractor to pause manufacturing and the cross-contaminated wasn't distributed for any use.

But, Dr. Marks, what steps is FDA taking to make sure the quality, safety and effectiveness of all COVID-19 vaccines?

MARKS: Chair Murray, thank you for that question. So, currently, for the emergent facility, we're actively working with all of the parties involved to ensure that the facility's deficiencies are all remediated so that before they actually are able to release vaccine, it meets all of our quality standards that Americans deserve from vaccines.

Also, as we move on to other facilities that may be producing vaccines, we will take the approach of using all of our inspectional tools to ensure that the quality of those is the highest nature. And as with all of our biologics license applications, we further, generally, will be performing on-site inspections of those facilities to ensure the quality of those products.

MURRAY: Thank you. And I'm really deeply concerned about what happened. And my expectation is, in the future, nothing like that happens again.

Dr. Walensky, in my last minute here, let me just ask you. The CDC says while fewer children have been sick with COVID-19 compared to adults, children can be infected, get sick and spread the virus. With the authorization of Pfizer yesterday for children 12 to 15, what would you say to parents who are considering getting their kids vaccinated now?

DR. ROCHELLE WALENSKY, CDC DIRECTOR: I would encourage all parents to get their children vaccinated. I know many parents are enthusiastic and have been texting me, can't wait to get their children vaccinated. I recognize that some parents want to sort of see how it goes first. But I am encouraging all parents to get their children vaccinated. Some parents don't want to be first. But I'm also encouraging children to ask for the vaccine.

I have a 16-year-old myself and I can tell you he wanted to get the vaccine. He wants his life back. These kids want to go back to school, they want to go back to the things they love.

MURRAY: Thank you.

SEN. RICHARD BURR (R-NC): Thank you, Chairwoman.

Dr. Kessler, we ship 2.7 million doses of AstraZeneca, I think, to Mexico. That's the only country we have shipped to. We've got additional doses of AstraZeneca in inventory in this country.


We talked about July 4th exporting more. Why have we not taken the AstraZeneca, which is not approved for vaccination in the United States, why have we not mobilized that to other countries of the world today?

KESSLER: Senator, it's a very important question. We have shipped a total of 4 million doses to date including to Mexico and I believe 1.5 to Canada. We are ready to ship up to 60 million doses of AstraZeneca. But as the Chair pointed out, and as my colleague, Dr. Marks, responded, there are issues with emergent that are under review by the Food and Drug Administration.

If and when those issues are resolved and we can say that these are quality doses, we will do just as you say.

BURR: Correct me if I'm wrong, I didn't think the emergent Baltimore facility had anything to do with AstraZeneca production. Am I wrong, Dr. Marks?

MARKS: Senator, no. The AstraZeneca was being produced in that facility. And the FDA feels it's imperative that before vaccine can be shipped to any other partner, it has to meet the quality standards it would meet for any American as well.

BURR: So how long do you anticipate the testing the AstraZeneca vaccine that's currently manufactured would take to verify?

MARKS: We are working on that as quickly as we can. We understand the imperative here. There is a working group across our Office of Regulatory Affairs and our center and others at FDA that are working together to try to clear that -- those doses as quickly as we can. I can't give you an exact time but we understand the imperative to be able have them available so that Dr. Kessler can arrange through them to be shipped to those in need.

BURR: Okay. Dr. Kessler, one of the reasons we are as successful today is that partnerships have been leveraging vaccinations around the world and over 275 partnerships had been created to scale up vaccine production and manufacturing.

And I guess I'm asking you this. If we waive intellectual property in the United States, do we not stand the risk of affecting innovation in the future when if we did it to scale up manufacturing capacity, the private sector has done that through partnerships already, and that's the reason that we have been so successful? Shouldn't we let the private sector continue to do something that I think Dr. Fauci and I said in the past, we never anticipated this. This is novel that they would have the relationship to do it. Why mess with a good thing?

KESSLER: I applaud the actions of the pharmaceutical industry. Senator, this is a once-in-a-century pandemic. I think we all recognize that extraordinary circumstances call for extraordinary measures. We know and I agree with you, Senator, that a waiver alone won't result in this scale and speed. We need to make enough vaccines to end the pandemic. That's why we will continue to ramp up our efforts working with the private sector on all possible partners to expand vaccine manufacturing and distribution around that, around the world.

I mean, our job as to do, as you say, to increase the supply. That's what we're focused on. And we want to make vaccines available to the world.

BURR: David, here is the reality. When Pfizer went to open up its Kansas plant to produce vaccine, it took them, I believe, seven months to retool and to get everything done. This belief you can export intellectual property and you're going to have a standup around the world instantaneously of vaccine production is a joke. Dr. Marks has already expressed concern over the backlogs for inspections and how long would it take for us to inspect foreign sites if, in fact, there was a vaccine pool that found its way in and out of the United States.

Let me get this before my time runs out. Can anybody give me the number? There have been 33 million Americans infected with COVID that have actually tested positive.


How many of that 33 million have then been vaccinated? You might know what that number is.

Here is why I make the point, and here is why I think it's relevant. If we're looking at a certain number that we don't know exactly what it is, Dr. Fauci, that we want to get to and we vaccinated 115 million, it's important for us to know of the counted vaccine number how many of those already had protection because they were COVID-19 positive? So if trying to reach a number when the president says 70 percent vaccination, if we get to 65 vaccinated and 5 percent got COVID and they protection, isn't that like being at 70?

I think one of the problems is that the goal post continues to be too far. And we have now got the harder part of how do we take the 40 percent that aren't real comfortable with getting vaccinated and at least have a shot at vaccinating 50 percent of that 40 percent. And it may be that our number is higher today on the protected. I know it is. I don't think 33 million have all been vaccinated that were positive. But I think it's absolutely crucial that we figure out what that number is, not sure whose responsibility it is, that we figure out what that number is and put that into our formula of how many Americans have protections.

I thank the chair.

MURRAY: Thank you, Senator Burr. Senator Casey? SEN. BOB CASEY (D-PA): Chair Murray, thank you very much. And I want to thank our guests, Dr. Fauci, Dr. Kessler and Dr. Marks and Dr. Walensky. I think I'll have at least one question for Dr. Walensky and one for Dr. Marks.

I'm going to start with you, Dr. Walensky. I want to thank you for your leadership and the leadership of the CDC and your efforts to ensure that children and adolescents are up to date on vaccinations, particularly as students return to in-person learning. And you noted, you and others have noted there are over 11 million doses through the vaccines for children program that have been missed. These missed doses could seriously and negatively impact efforts to protect children and their families and communities from vaccine preventable diseases and conditions. Of course, we're talking here about diseases other than COVID-19.

At the same time, with 12 to 15-year-olds now able to get vaccinated against COVID-19, there is an even greater need to ensure parents are aware of all the vaccines, all the vaccines that children should receive in order to remain healthy. The rescue plan contains funding to build vaccine confidence and specifically includes provisions to ensure funding is allocated towards increasing vaccination rates throughout the U.S.

So here's the question, Doctor. In addition to the public awareness efforts that you and CDC have already undertaken, will the CDC be releasing the funding to both states and communities to ensure that children and adolescents are caught up on both routine and recommended vaccinations particularly as children return to in-person learning?

WALENSKY: Thank you, Senator, for that. You raise an issue that is near and dear to my heart and I'm very worried about. More than 20 percent of our measles vaccines were not used this year. We have the same with meningococcal vaccines and especially among our adolescents.

Unfortunately, we actually don't have data on whether we can co- administer the COVID-19 vaccine and other routine immunizations and whether we get the same protection from the COVID-19 vaccines and the routine administration of other immunizations. That is one issue that the experts at ACIP are going to address tomorrow, as to whether that can safely be done and that we could potentially get adequate protection.

You are right. We need to -- as we're putting forward the efforts in vaccine confidence for the COVID-19 vaccine, we need to take this outreach and make sure that we are reaching these communities and not only conveying the importance of getting the COVID-19 vaccine. But if we are not able to co-administer them to make sure we get back to these children and be able to administer the routine vaccines that they have lost before the school year.

CASEY: In terms of the funding though, that will be released, do you have any sense of the timing of that?

WALENSKY: I do not but we can get back to you.

CASEY: Okay, thank you.

Dr. Marks, I wanted to start with you regarding Pfizer. And we'ee heard a lot this year about emergency use authorization. And we know that Pfizer has recently filed their application for full licensure of their COVID-19 vaccine. I think we get a lot of questions at home on a range of these issues, in particular what does it mean?


What does it mean? What does full licensure mean?

One of the concerns that we fear we've heard a lot about is the -- the vaccines are provided this emergency use authorization. But what is -- what's the next step for a vaccine? Can you explain what it means to get full licensure? That's question number one. And, secondly, what additional information would a company need to submit beyond what was required just for so-called EUA?

MARKS: Senator, thanks very much for that question. The full licensure is something that a manufacturer submits with a full data package, which I'll go into in a moment. But I just want to go back to pick up on something that Dr. Fauci said. These COVID-19 vaccines, they were expedited not by cutting corners but by going through a development plan in which kind of empty space, space that would have been normally just not stuff happening was taken away. So manufacturing was done while the clinical trials were done. The large clinical trial programs were of the size of normally licensed vaccines in United States.

The one place where we're a little bit short was the duration of safety follow-up. But we are very confident from the amount of safety follow-up, at least a meeting of two months safety follow-up on this safety dataset for the emergency use authorization, that the large majority of adverse events became apparent. So we're very confident in recommending these vaccines for everyone, our families, all Americans.

The difference that will happen with the biologics license application is that manufacturers will be able to submit additional safety data, perhaps six months of safety data rather than just the median two months safety data. And, additionally, there are some technical things that will be there that many people may not care a lot about but we do that is manufacturing conformance lots, the formal facility's inspections will occur and additional ancillary studies will be put in the that package.

So I think the main message to the American public is that, for all intents and purposes, the vaccine that is being used is very close to what we would normally have in a biologics license application. There are some little things around the margins that will go into the biologics license application when we have a formal approval.

CASEY: Thank you. Thank you, Chair Murray.

MURRAY: Senator Paul?

SEN. RAND PAUL (R-KY): Dr. Fauci, we don't know whether the pandemic started in a lab at Wuhan or evolved naturally, but we should want to know 3 million people have died from this pandemic, and that should cause us to explore all possibilities. Instead, government authorities self interested in continuing gang of function research say there is nothing to see here.

Gain of function research, as you know, is juicing up naturally occurring animal viruses to infect humans. To arrive at the truth, the U.S. government should admit that the Wuhan Virology Institute was experimenting to enhance the coronavirus' ability to infect humans.

Juicing up super viruses is not new. Scientists in the U.S. have long known how to mutate animal viruses to infect humans. For years, Dr. Ralph Baric, a virologist in the U.S., has collaborating with Dr. Shi Zhengli of the Wuhan Virology Institute sharing his discoveries about how to create super viruses. This gain of function research has been funded by the NIH. The collaboration between the U.S. and the Wuhan Virology Institute continues.

Doctors Baric and Shi worked together to insert bat virus spike protein into the backbone of the deadly SARS virus and then used this manmade super virus to infect human airway cells. Think about that for a moment. The SARS virus had a 15 percent mortality. We're fighting a pandemic that has about 1 percent mortality. Can you imagine if SARS virus that has been juiced up and have viral proteins added to it to the spike protein, if that were released accidentally?

Dr. Fauci, do you still support funding of the NIH funding of the lab in Wuhan?

FAUCI: Senator Paul, with all due respect, you are entirely and completely incorrect, that the NIH has not ever and does not now fund gain of function research in the Wuhan Institute.

PAUL: Do they fund Dr. Baric?

FAUCI: We do not fund --

PAUL: Do you fund Dr. Baric's gain of function research?


FAUCI: Dr. Baric does not do gain of function research, and if there is, it's according to the guidelines and it is being conducted in North Carolina.