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Live Coverage as U.S. Health Officials Testify on COVID-19 Response; Opening Statements by Anthony Fauci, Robert Redfield, Admiral Brett Giroir, and Stephen Hahn; Sen. Lamar Alexander (R-TN) Questions the Witnesses. Aired 10:30-11a ET

Aired September 23, 2020 - 10:30   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

[10:30:00]

MATT RIVERS, CNN INTERNATIONAL CORRESPONDENT: Of course, now there might be that second wave, as we just heard, but in Mexico it has just been a consistent rise. Yes, cases are a little bit lower than they used to be, but that could change in the next couple weeks.

It was last week that we had the Mexican Independence Day celebrations, basically two days at least that people took off ,and we're going to be waiting to see if here in Mexico we see something similar to what we saw in the United States after Memorial Day, after July Fourth, surges in cases.

Could that happen here in Mexico? It's certainly a possibility. And when you look at hospitalizations, here in Mexico City, which has been the epicenter of this country's pandemic, hospitalizations due to this virus have not gone down, they have remained consistent. And so here in Mexico, it really just seems like this is going to be the reality until a vaccine comes out.

JIM SCIUTTO, CNN ANCHOR, NEWSROOM: Right. Meanwhile, folks, the advice is consistent: wear a mask, keep distant. Matt Rivers, good to have you there in Mexico City.

Back here in the U.S., an important hearing under way now on Capitol Hill. We're waiting to hear from the head of the CDC regarding the nation's pandemic response. Actually, Dr. Anthony Fauci is going to speak first, let's have a listen.

ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: -- on the role of the National Institutes of Health research in addressing COVID-19. As I mentioned to this committee in a prior hearing, the NIH and NIAID has a four-part strategic plan for research to address COVID-19.

The first is to improve the fundamental knowledge of the virus itself, viral biology and the clinical manifestations resulting from infection. We have continued to push the frontier of understanding this virus, particularly with regard to the confirmational structure of the spike protein, which serves as the basis for all of the vaccines that are being pursued now, which I'll get to in a moment.

In addition, there have been a number of important clinical observations that we will be pursuing in the future. I bring to your attention the fact that a number of individuals who virologically have recovered from infection, in fact have persistence measures in weeks to months of symptomatology that does not appear to be due to persistence of the virus.

They're referred to as long-haulers. They have fatigue, myalgia, fever, an involvement of the neurological system as well as cognitive abnormalities such as the inability to concentrate.

In addition, we found to our dismay that a number of individuals who have completely recovered and apparently are asymptomatic, when they have sensitive imaging technologies such as magnetic resonance imaging or MRI, have found to have a disturbing number of individuals who have inflammation of the heart.

These are the kind of things that tell us we must be humble, and that we do not completely understand the nature of this illness.

Next, with regard to diagnostics, you know we have the RADx program that is going to, in the next several months, allow us to have a considerable number of point-of-care testing.

Moving on to therapeutics, I mentioned to this committee some time ago that the NIH put together an expert panel for treatment guidelines, which is a living document that reviews the literature as well as the areas of expertise that are pre-publication, to help clinicians throughout the world to address the clinical components of this outbreak.

I must tell you that as of last night, there have been 4.5 million views of this treatment guideline, so it clearly is helping people throughout the world.

I want to mention two of the drugs that have actually now be part of the -- these guidelines. Remdesivir, which you've heard about, has been shown in a randomized placebo-controlled trial to diminish the time to recovery in individuals who are hospitalized who have lung disease.

In addition, dexamethasone, a commonly used steroid, has been shown in a randomized placebo-controlled trial involving more than 6,000 individuals, has been shown to clearly and significantly reduce the 28-day mortality.

In addition, there are a number of other treatments including antiviral convalescent plasma, which is still being tested in randomized controlled trials. And you mentioned -- appropriately and correctly -- that we feel optimistic about monoclonal antibodies, which are currently being tested in an outpatient setting, in an inpatient setting.

Family prophylaxis -- which means when an individual in a given family gets infected, if you give monoclonal antibodies to the rest of the family, can you prevent the spread within the family unit? And finally, nursing home prophylaxis. As you mentioned, there are three companies involved in this. And finally and importantly, the issue of vaccine. We have put

together what's called the strategic approach to COVID vaccine development.

[10:35:01]

As you mentioned, Mr. Chairman, there are six companies that the federal government is playing a role in either helping to develop, subsidizing or supporting the clinical trials. We're harmonizing the trials so that information from one can be applicable to another. Currently, there are three platform candidate vaccines that have entered into phase three trial. Very soon, there will be a fourth.

As I mentioned to this committee, we feel cautiously optimistic that we will be able to have a safe and effective vaccine -- although there is never a guarantee of that. Early studies in animals and in human -- phase one and phase two -- indicate that individuals induce a response that is comparable to, if not better, than natural infection.

And so as these trials go on, we predict that sometime by the end of this year, let's say November or December, we will know whether or not these are safe and effective. And as you mentioned, Mr. Chairman, right now, doses of this vaccine are being produced so that they'll be ready to be distributed.

I'll close with the comment that we feel strongly that if we have a combination of adherence to the public health measures, together with a vaccine that will be distributed to people in this country and worldwide, we may be able to turn around this terrible pandemic, that which we have been experiencing.

Thank you, Mr. Chairman. Happy to answer questions later.

SEN. LAMAR ALEXANDER (R-TN): Thank you, Dr. Fauci.

Let's go to Dr. Redfield and then Admiral Giroir and then Dr. Hahn.

Dr. Redfield, welcome.

ROBERT REDFIELD, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION: Thank you, Chairman Alexander, Ranking Member Murray, and members of the committee. And I want to thank you for the opportunity to be here today. On behalf of CDC, I also want to thank you for your continued support of our public health professionals and their life-saving work that they're committed to 24/7.

Over 6,700 CDC staff have been engaged in our agency's COVID-19 response so far, and more than 1,200 have been deployed to more than 200 locations, tribal nations in the United States and abroad. I know that you join me in expressing our collective deep gratitude to the women and men of CDC for their resilience, their dedication, and their service to our nation.

Throughout this global pandemic, CDC has brought its science expertise to the frontlines, grounded in science and data, conducting rapid investigations of disease outbreaks that identify the highest risk populations and settings, and putting in place measure to prevent further spread of COVID-19.

Understanding which populations are most at risk and how this virus spreads in various settings is critical in developing guidance and protecting the health of Americans.

As you are aware, in the United States, we are approaching nearly 7 million cases and sadly, over 200,000 deaths. Every death means that a loved one was lost. But there is some progress to report. Since the pandemic peaked on July 24th of this year, we've experienced nearly a 50 percent reduction in daily cases and a 32 percent reduction in deaths.

There's also been significant improvement in the mortality, particularly in the elderly. For example, during the peak of the epidemic, April 17th, a 75-year-old American had a mortality of about 46.8 per 100,000. And by the end of August, the numbers had significantly declined into about 10 per 100,000.

These improvements, however, do not mean that we can let our guard down. Over the last week, we had an average of over 40,000 cases and nearly 800 daily deaths.

I do want to emphasize the shift in age in these case counts. The 18- to-25-year-olds currently make up over 26 percent of new infections, and more than any other group. It's imperative that these young adults recognize that even though they are unlikely to get seriously ill from this virus, they are major contributors to the spread of COVID-19 in our country at this time.

In order to understand what proportion of the population's been infected with COVID-19 and what proportion remains at risk, CDC is currently performing large-scale serology testing across the United States. Preliminary results appear to show that most Americans have not been infected with the virus, and are still vulnerable to the infection serious illness and death. We hope to be able to post the analysis of the first round of this study in the next several weeks.

As I have stated before, the CDC encourages all Americans to embrace the powerful public health tools that we have right now: wear a mask, maintain social distance, practice routine hand-washings with vigilance, be smart about crowds and stay home when you're feeling sick.

[10:40:14]

And as we move into the fall, I want to add one more critically important step: flu vaccination. Flu vaccination is safe. CDC encourages all Americans to embrace the flu vaccine with confidence for themselves, their families, their loved ones and their communities.

This year, CDC has purchased an additional 9.3 million doses of adult flu vaccine as well as 18.5 million doses for children. This is a significant increase than previous years. When combined with the tools that I mentioned above, this could help our nation avert a very difficult fall, and lessen the burden on our health care system and save lives.

To further strengthen our public health resilience, CDC awarded $140 million to 64 jurisdictions through the CDC existing immunization cooperative agreements, to begin to scale up staffing and preparedness for flu season.

We also developed a new multiplex laboratory diagnostic test that's capable of measuring both influenza A and influenza B, as well as COVID too using a single specimen in a single assay. This test will help our public health professionals better identify infections with influenza and COVID.

I also am announcing today an additional $200 million from the CARES Act funding that will be used a first step to help the jurisdictions complete their individual plans and implement for their COVID vaccination, in follow-up to the playbook that we released last week.

CDC is an integral part of Operation Warp Speed. We're leveraging our expertise in immunization infrastructure to support and promote distribution, administration and monitoring of the future COVID-19 vaccines. In coordination with Operation Warp Speed, CDC is working closely with state and local community organizations on their detailed, flexible plans for vaccine distribution.

As I've emphasized in prior hearings, now is the time to commit to sustained investment in core capabilities of public health: data analytics, laboratory resilience, workforce expansion and rapid response capabilities. Years of underinvestment in public health infrastructure have led to a system that has been sorely tested in this current pandemic.

COVID-19 is the most significant public health challenge that our nation's faced in more than a century. Now is the time to build not only the public health core capability that our nation needs, but the capability that the people of our nation deserves.

As we work together collectively to fight COVID-19, to end the pandemic, CDC and all of the outstanding women and men of CDC remain strongly committed to our mission to protect all Americans from disease, threats, and to save lives.

I want to thank you for your time and I look forward to your questions.

ALEXANDER: Thank you, Dr. Redfield.

Admiral Giroir, welcome.

ADMIRAL BRETT GIROIR, ASSISTANT SECRETARY FOR HEALTH, HEALTH AND HUMAN SERVICES: Chairman Alexander, Ranking Member Murray, and distinguished members of the committee, I am honored to update you on our nation's efforts to combat COVID-19 with a specific focus on testing.

Recommended public health practices like wearing a mask, avoiding crowds especially indoors, and washing your hands, combined with smart testing, is the formula to effectively slow the spread, flatten the curve and save lives.

By providing county-specific guidance to governors on a weekly basis, expanding and managing supplies, providing the right test to the right person at the right time, and developing an equitably distributing safe and effective therapeutics, we are seeing promising results.

Specifically, since the post-Memorial Day peaks in community spread, the number of new COVID cases is down, as Dr. Redfield just testified. The number of people hospitalized with COVID-19 is down 54 percent. The number of people in an intensive care unit due to COVID is down 65 percent, and deaths associated are down 32 percent.

But let me emphasize that to sustain these gains, we must continue our disciplined mitigation efforts, especially wearing masks when we can't physically distance, avoiding crowds, particularly indoors, and increasing our screening and surveillance testing.

Now specifically regarding testing, the nation has performed over 106 million tests for the virus causing COVID-19. On 10 separate days, we performed over 1 million tests per day. The federal government has purchased and delivered over 106 million swabs and 88 million tubes of media to states, tribes, and federal partners.

[10:45:11]

Starting on April 7th, we have purchased and delivered to public health laboratories in every state and the Indian Health Service over 2.5 million Abbott ID NOW point of care molecular tests to support outbreak control and rural testing. We have implemented federal surge testing sites in 20 different cities, helping to squelch emerging outbreaks typically among asymptomatic young adults.

We are now at an inflection point in testing. This month, we will have available on average 3 million tests per day, nearly half of which will be rapid point of care. We have been building toward this inflection point and I have previously testified to its coming several times over the past months.

Now, let me discuss two specific testing initiatives.

Protecting the elderly has been, is and will continue to be a foremost priority for this administration. So on July 14th, we announced that every single eligible nursing home in America would receive a point- of-care instrument and testing supplies.

We have delivered on this promise. All 13,850 eligible nursing homes have now received a total of 13,985 instruments and over 4.9 million rapid point of care tests, ahead of schedule.

On August 27th, after months of planning and only one day after its FDA authorization, the administration announced a $760 million contract with Abbott for the delivery of 150 million rapid BinaxNOW COVID-19 point of care tests. This test is easy to perform, does not require an instrument, delivers test results in 15 minutes or less and costs $5.

We have already deployed 65,000 of these tests in support of disaster operations in California, Oregon, Texas and Louisiana. Last week, we also shipped 974,000 tests to 7,600 nursing homes in areas of significant community transmission, 541,000 tests to over 5,500 assisted living facilities with a CLIA certificate of waiver, and 300,000 tests to the Indian Health Service.

This week, we will be shipping 249,000 tests to historically black colleges and universities and 2.6 million tests to assisted living, nursing homes, home health and hospices. In the coming weeks, we will begin shipping millions of tests per week in support of our teachers and our students to open and keep open our K through 12 schools.

Now, I would like to close by recognizing my fellow officers in the public health service, the uniformed service, which I have the honor of leading. Four thousand, one hundred and seventy-two women and men have deployed 8,918 times in direct support of this pandemic on the Diamond Princess cruise ship in Japan, to our community-based testing sites, to FEMA and our task forces, and to nursing homes and field hospitals in hardest-hit communities.

I thank each and every one of these officers and their families. And on their behalf, thank all of you in Congress for supporting our training needs and the establishment of a ready reserve to supplement our ranks during inevitable future national emergencies.

Thank you for the opportunity to provide these remarks.

ALEXANDER: Thank you, Admiral Giroir.

Dr. Hahn, welcome.

STEPHEN HAHN, COMMISSIONER, FOOD AND DRUG ADMINISTRATION: Good morning, Chairman Alexander, Ranking Member Murray, and members of the committee.

Over the past several months, I have had the honor to work shoulder- to-shoulder with FDA's career staff as we fought a historic pandemic that has altered the lives of every American. I am proud of all FDA employees and how they have measured up to this extraordinary challenge.

The efforts of the FDA's expert workforce are critical to ensuring the safety and health of the American public at any time, but it is magnified during a public health emergency.

Of course, our work on COVID-19 and non-COVID issues comes with unprecedented public scrutiny and sometimes criticism. Any agency that has the broad responsibilities and far-reaching impact of FDA, particularly involving issues of public health, can't expect to do its job without inviting controversy and disagreement.

But it's also essential that the criticism we get never shakes the underlying faith the public has and should have in FDA and our commitment to protecting the public health. I am confident in the decisions that are being made related to COVID-19, and that will be made in the coming months as we continue to address this challenges of this pandemic.

[10:50:00]

Now, I know there's been particular attention paid to a few of the decisions reached by FDA over the past several months. I want to assure you and emphasize that every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics.

FDA represents science in action. Often we must make real-time decisions based on ever-evolving data concerning a previously unknown highly contagious virus that we are still learning about. And sometimes, it is necessary to reverse decisions as new data emerge.

This is inherent in the emergency use authorization process, otherwise known as EUA, and it is akin to how a doctor might approach a patient in an emergency situation, constantly updating a treatment plan as new data emerge.

So in the interest of transparency, I'd like to use this opportunity today to lay out the process we will use to review vaccines for COVID- 19.

When a vaccine sponsor reaches the conclusion that the data from its phase three clinical trials are adequate to submit to FDA, they will decide whether to apply for approval or emergency use authorization. This will be based upon the trial meeting pre-specified success criteria that were established by that sponsor. Now, this is really important. They should also be consistent with FDA recommendations regarding those criteria.

FDA will receive that application or submission, and our career scientists will review it, safety and efficacy data as well as manufacturing quality and consistency data.

FDA made clear recommendations in our June 30 guidance regarding the safety and effectiveness of vaccines so that we can see that prior to the approval process. We will also work to provide additional information so that it is clear what we expect to see should a sponsor choose to submit an emergency use application -- emergency use authorization application.

As we have indicated previously, we plan on seeking advice from the Vaccines and Related Biological Products Advisory Committee, comprised of independent members who have been screened for ethics conflicts. The safety and effectiveness data and the committee's decision will be public, although we will need to adhere to confidentiality requirements.

The public will have an opportunity to comment. The process will be transparent and independent. FDA career staff will then take the committee input into account as they make their decisions regarding the application or EUA request. Now, before we were to issue an EUA, if that were to happen, FDA would

have to determine, among other things, that the statutory standard is met. We expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine's quality and consistency. And data from at least one well designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner.

Let me emphasize that again. Data from at least one well designed phase three clinical trial that demonstrates its safety and efficacy in a clear and compelling manner.

FDA also expects that an EUA request would include a plan for active follow-up to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families.

On behalf of the 17,000-plus employees of the FDA, I want to make the following commitments today to the American public and this committee.

FDA will not authorize or approve any COVID-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes. And science will guide our decisions. FDA will not permit any pressure from anyone to change that.

I will fight for science, Mr. Chairman; I will fight for the integrity of the agency and I will put the interests of the American people before anything else. Thank you and I look forward to answering your questions.

ALEXANDER: Thank you, Dr. Hahn.

We'll now turn to questions from senators. We have full participation today, so I'd like to ask the senators and witnesses to keep your exchanges within five minutes so all senators will have a chance to participate.

And for my five minutes, I'd like to ask for the courtesy of short answers so I can ask all my questions.

[10:55:05]

Dr. Hahn, let me go back to two things you said. Who makes decisions about safety and efficacy at the FDA? Do you do it? Does career scientists do it? Or does the White House do it?

HAHN: Career scientists at the FDA do it. We -- that's very clear. I am briefed on all major medical product decisions. Overruling a center's decision is a very rare event. I have expressed on multiple occasions my intention -- and have done during this COVID-19 -- to make sure that those decisions are made by career scientists in the centers.

ALEXANDER: You referred to this, but once FDA approves a vaccine -- as we've said today, we're going to have tens of millions of doses ready, none can be distributed until FDA approves it. Will you be willing to take that vaccine for you and for your family?

HAHN: Absolutely, yes, Senator, Mr. Chairman. I have the complete and absolute faith in the expertise of the scientists who are terrific at FDA. If they were to make a determination that a vaccine would be safe and effective, I would do that and I would encourage my family to take the vaccine.

ALEXANDER: Dr. Fauci, you've been around since the Reagan years. You've seen lots of diseases, pandemics, and lots of responses to it. Is the administration cutting corners in safety and efficacy in its effort to produce vaccines and treatments rapidly?

FAUCI: Not at all, Mr. Chairman. In fact, the rapidity of where we are right now is a reflection of the technological advances in vaccine platform technology as well as the risks that were taken financially so that the -- we'll have doses available when the decision is made by the FDA as to the safety and efficacy, as you've heard from Dr. Hahn. So there's no cutting corners.

ALEXANDER: We're risking -- we're risking the taxpayers' money, but we're not risking safety and efficacy? Is that your testimony?

FAUCI: Yes, it is. That's absolutely correct.

ALEXANDER: Now, millions of students are going back to thousands of colleges and there are inevitably outbreaks of COVID-19, Dr. Fauci. Is the smart thing for college administrators to do, is to send those college students home when the outbreaks occur on campus?

FAUCI: Absolutely not, Mr. Chairman. They should be able to accommodate the students in a facility, maybe a separate dorm or a separate floor so they don't spread among the student body. But do not sent them home to their community because of the likelihood of then re-seeding infection in a community.

ALEXANDER: Dr. Fauci, I've listened to your testimony for the last several months. Some people say that your message is that you want to lock down the country in order to stop the spread of the vaccine. Is that accurate?

FAUCI: That's completely inaccurate, Mr. Chairman. I've said multiple times, we do not need to shut down. If we follow carefully and prudently the recommendations and the guidelines for opening America again, I believe we can do that safely and still accomplish the goal of opening the economy again.

ALEXANDER: Dr. Fauci, some people said it was political to ask the states to get ready to distribute the vaccine in October. Is that true or false?

FAUCI: That's false. The reason that that was done is because we want to make sure that when a decision is made, that we will be ready to distribute the vaccine. ALEXANDER: Dr. Redfield, the British ambassador told me yesterday the

government studies in the United Kingdom said that based on serology testing, that five to 25 percent of their country's population, depending on the location, has been exposed to COVID-19. What does -- what about the American population? How many of us have been infected by COVID-19?

REDFIELD: Thank you, Mr. Chairman.

CDC is in the process of a very large sequential study across the entire United States, measuring serology. As I mentioned, the preliminary results from the first round show that a majority of our nation -- more than 90 percent of the population -- remains susceptible. It varies in different geographic parts from states that have less than one percent with evidence of previous infection, to some that have more than 15, 20, and one as high as 24 percent.

We'll have that finalized and probably published in the next week or so, but it does show that a majority of Americans are still susceptible to this virus.

ALEXANDER: So just so I understand, you're saying that based on the preliminary indications from your serological testing and studies, that as many as 90 percent of Americans are still -- still haven't had the virus yet?

[11:00:08]

REDFIELD: Yes, sir.