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Dr. Fauci Testifies Before Senate Panel on Coronavirus Response; Dr. Fauci Gives Opening Statement Before Senate Panel. Aired 10:30-11a ET

Aired May 12, 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]

DR. ANTHONY FAUCI, DIRECTOR, NIAID: -- Remdesivir success antiviral in a moment. But, let me emphasize that there are a number of broad spectrum antivirals that are in various stages of testing.

In addition, we will be looking at convalescent plasma, which is plasma from individuals who've recovered from COVID-19, to be used in passive transfer, either in prevention or treatment. In addition, high premium (ph) globulin, which can be used as a gamma globulin shot. We'll be looking at repurposed drugs as well as immune based therapies and host modifiers.

And finally, monoclonal antibodies. Let me take a moment to describe the Remdesivir placebo control randomized trial which was done internationally with the power of more than 1,000 individuals in sites throughout the world. It was in hospitalized patients with lung disease. The end point was primarily time to recovery it.

The result was statistically significant but really modest and we must remember it was only a modest result showing that the drug made a 31 percent faster time to recovery. We hope to build on this modest success with combinations of drugs and better drugs.

Moving on to vaccines, there are at least candidate COVID-19 vaccines in clinical development. The NIH has been collaborating with a number of pharmaceutical companies at various stages of development. I will describe on very briefly, which is not the only one.

But one that we have been involved in heavily developing with Moderna, it's a messenger RNA platform. You might recall in this committee that in January of this year I said that it would take about one year to 18 months, if we were successful in developing vaccine. The NIH trial moved very quickly, on January 10th the sequence was none, on January 11th the vaccine research sent a net to develop a plan.

On the 14th of January we officially started the vaccine development. Sixty-two days later we are now in phase one clinical trial with the two doses already fully enrolled. There will be animal safety, the phase one will directly go into phase two three in late spring and early summer. And if we are successful we hope to know that in the fall and early winter. There are some important issues, however, in COVID-19 vaccine development. We have many candidates and hope to have multiple winners. In other words it's multiple shots on goal. This will be important because this will be good for global availability if we have more than one successful candidate.

We also, as the chairman mentioned, will be producing vaccine at risk; which means we will be investigating considerable resources in developing doses even before we know any given candidate or candidates work. I much warn that there's also the possibility of negative consequences. Where certain vaccines can actually enhance the negative effect of the infection.

The big unknown is efficacy, will it be present or absence and how durable will it be? And finally I want to mention the NIH has launched a public private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines. The purpose of that is to prioritize and accelerate clinical evaluation of therapeutic candidates with near term potential.

Hopefully our research efforts together with the other public heath efforts will get us quickly to an end to this terrible ordeal that we are all going through.

Thank you, very much. Happy to answer questions later.

ALEXANDER: Thank you, Dr. Fauci.

Dr. Redfield?

REDFIELD: Good morning, Chairman Alexander and Ranking Member Murray and members of the committee.

Our nation is confronting the most serious public health crisis in more than a century. Yet we're not defenseless. We have powerful tools to fight this enemy.

We have tried and true effect public health interventions, such as early case identification, isolation and contact tracing combined with important mitigation strategy includes social distancing, frequent hand washing and face covering. These public health tools have and will continue to slow the spread of COVID-19.

I appreciate the opportunity this morning to provide a brief overview of some of CDC's ongoing work and response to COVID-19. The CDC has been working 24/7 to combat the pandemic. CDC Emergency Operations Center is supporting state, tribal, local and territorial public health partners in building core capabilities, particularly workforce, laboratory and data and predictive analytics.

Epidemiologist are conducting surveillance for COVID-19 as well as conducting health system surveillance. Community Mitigation Teams are providing guidance on infection control and contact tracing. And our laboratory experts are performing serological testing to better define the extent of asymptomatic population.

[10:35:00]

As local leadership makes decisions to reopen, they'll require varying degrees of federal support. Each location will be different and will face unique circumstances. CDC has conducted a state by state assessment of public health testing, capacity and contact tracing capacity as well as surge plan.

CDC is providing technical assistance and funding to the states, provided through the supplemental CARES Act and the Paycheck Protection Program and Health Care Enhancement Act (ph).

We're working directly with the state public health leaders to define their needs for testing and testing devices, supplies and manpower, surveillance, data collection and reporting, contact tracing, infection control and outbreak investigation.

I want to spend a moment to focus on several key elements.

First, testing. Rapid, extensive and widely available, timely testing is essential for reopening America. CDC's role in testing continues to support diagnosis and contact tracing, surveillance and outbreak (inaudible). We work with the public health partners to define their particular testing strategy for their jurisdiction.

Admiral Giroir will address the testing components of the response in greater detail.

Contact tracing. Increasing state, tribal, local and territorial contact tracing capacity is critical. It's a critical part to stop the chains of transmission and prevent the occurrence of sustained community transmission. CDC's role is to provide technical training, assistance and support to the states as they hire and build a workforce necessary to be fully prepared to effectively respond to the public health challenges posed by the ongoing COVID pandemic. This will be an expansive effort.

Surveillance. Our nation's surveillance program is built on a combination of systems, including existing syndromic influenza and respiratorial viral disease surveillance systems, and being (ph) combined with commercial and research lab platforms and our care reporting (inaudible) system. CDC's adapting these and optimizing it to have a surveillance system in response to COVID-19.

Importantly, in light of the significant occurrence of asymptomatic infection, the surveillance for asymptomatic infection becomes an important public health tool for (ph) early case identification. CDC is working with each public health jurisdiction to develop a prospective surveillance program, to include active surveillance among those that are most vulnerable, such an individuals in long-term care facilities, inner city clinics and homeless shelters.

We need to rebuild our nation's public health infrastructure: data and (ph) data analytics, public health laboratory resilience and our nation's public health workforce. Now is the time to put it in place for the generations to come, not only for the public health system that our nation needs, but for the public health system our nation deserves.

Before I close, I want to recognize the tireless commitment, the dedicated CDC staff who have deployed to every corner of this nation to fight COVID-19, more than 4,000 employees have deployed here and globally. Science and data continue, with technical expertise and public service, to be the backbone of CDC's contributions to the U.S. response.

I extend my serious gratitude to the health care workers on the front lines as well as their families (ph), and the essential emergency personnel, as well as the American people, to say thank you for adhering to the stay-at-home guidelines and protecting the most vulnerable.

It's important to emphasize that we're not out of the woods yet. (inaudible), but we are more prepared. We need to stay vigilant with social distancing -- it remains an imperative. We are a resilient nation, and I am confident that we will emerge from this pandemic stronger together.

Thank you.

ALEXANDER: Thank you, Dr. Redfield.

Admiral Giroir, welcome.

GIROIR: (OFF-MIKE) here to provide you with an update on the nation's progress in testing for COVID-19. On March 12th, Secretary Azar requested that I lead the COVID-19 testing efforts within HHS, including oversight and coordination of the FDA and CDC with regard to testing.

Since then, the nation has performed more than 9 million COVID-19 tests, a number far greater than any other country and double the per capita tests performed to date in South Korea. To reach this point, we implemented a phased approach to meet testing needs during mitigation, and now, during phase one reopening of America.

[10:40:00]

Beginning March 20th, we pioneered 41 community-based drive-through testing sites in locations prioritized by the CDC. These sites have been a profound success, testing over 167,000 high-risk individuals and demonstrating a prototype that is being duplicated multifold in nearly every state.

Next, the administration leveraged trusted retailers including CVS, Rite Aid, Walgreens, Walmart, Kroger and Health Mart, who are now providing testing at 240 locations in 33 states, 69 percent of which are in communities with moderate to high social vulnerability.

To meet the need for collection supplies like swabs and media tubes, we first secured the global supply chain through a military air bridge (ph). We worked directly with manufacturers to increase domestic production. We collaborated with the private sector and the FDA to validate multiple swab and media types that vastly expanded supplies while minimizing the need for PPE. Finally, we used Title III of the Defense Production Act to further invest in domestic manufacturing to prepare us for reopening.

To support the need for surveillance testing during reopening, on April 27th, we issued a new testing framework that also prioritized testing for persons without symptoms, who were prioritized by health departments or clinicians for any reason, including screening of asymptomatic individuals according to state and local plans.

Next, our federal multidisciplinary team conducted multiple calls with leadership from each state to set state-specific testing objectives. Collectively, states and territories established an overall goal to perform 12.9 million tests over the next four weeks. The federal government is able to -- and will -- support the achievement of this goal.

Specifically, the federal government is shipping to states, 12.9 million swabs and over 9.7 million tubes of media in May alone. Last month, we also detailed the location and capacity of every lab machine in every state that could potentially run COVID-19 assays, and our team has worked with test suppliers to match reagents to these machines.

Looking forward, between now and the end of 2020, the federal government will procure over 135 million swabs and 132 million tubes of media, and distribute these to states as requested, to supplement the now-robust commercial supply.

We anticipate marked increases in current tests as well as a dramatic expansion of new point-of-care tests, like the first-in-class Quidel antigen test, authorized by the FDA just last Friday. Quidel anticipates being able to distribute 300,000 tests per day within just a few weeks.

So by September, taking every aspect of development, authorization, manufacturing and supply chain into consideration, we project that our nation will be capable of performing at least 40 to 50 million tests per month if needed at that time. And, if new technologies are authorized, like whole-genome sequencing approaches or any novel solutions uncovered by NIH's new diagnostics initiative, that number will be much higher.

Finally, I want to acknowledge and express my heartfelt gratitude to the officers of the U.S. Public Health Service Commission Corps, the uniformed service I am honored to lead.

3,471 men and women have deployed in support of this pandemic on the cruise ship in Japan, to our military bases repatriating Americans, to our community-based testing sites and international airports, to FEMA and our task forces, to nursing facilities including King County, Washington, and to field hospitals in hard-hit communities across our nation.

I thank each and every one of these officers and their families, and on their behalf, I thank the members of this committee for supporting our training needs and the establishment of a ready reserve to supplement our ranks in future national emergencies.

Thank you for the opportunity to provide these remarks.

ALEXANDER: Thank you, Admiral Giroir.

And now, Dr. Stephen Hahn, our fourth and final witness?

HAHN: Chairman Alexander, Ranking Member Murray and members of the committee, thank you for inviting me to participate in this hearing today. I first want to start by thanking the American people for their incredible efforts at mitigation, and extend my condolences to those who have lost loved ones.

From day one of this pandemic, the 18,000 FDA employees, who are just incredible scientists, doctors and nurses, have taken an active role in the all-of-government response to this pandemic. FDA has worked to facilitate the development of medical countermeasures to diagnose, treat and prevent COVID-19.

[10:45:30]

We've worked closely with laboratories, manufacturers, academia, product developers, our federal partners and companies -- companies that don't even make medical products, but want to pitch in, for example by making hand sanitizer, personal protective equipment and ventilators.

Every decision we have made have been driven by data, with the goal of (inaudible) protecting the health of the American people. In a public health emergency, however, our response has balanced the urgent need to make medical products available with the provision of a level of oversight that helps ensure the safety and effectiveness of those medical products.

I'd like to take a few minutes to tell you what FDA is doing to help the country at this point, and (inaudible) safe to return to work and to school. It starts with testing, as others have mentioned.

FDA has worked with more than 500 developers, who (ph) have or said they will be submitting Emergency Use Authorization requests for COVID-19 tests. This includes some newer technologies that not -- that heretofore have not been used as part of diagnostic tests in response to a pandemic.

We have issued 92 individual Emergency Use Authorizations for test kit manufacturers and laboratories, and we've been informed by more than 250 laboratories, they have begun testing under the regulatory flexibilities we outlines in March. We are conducting rolling reviews of EUA submissions so that we can quickly authorize tests which the data support.

In a public health emergency, the accuracy of diagnostic tests is important, not only for the individual patient but for the patient at large -- for the public at large. FDA is helping to ensure the availability of tests that are providing accurate answers. We are also monitoring the marketplace for fraudulent tests, and are taking appropriate action to protect the public health. And we are working to provide more clarity about which tests have been reviewed and authorized by FDA, and which have not.

Serologic tests will play a role in our recovery. Unlike diagnostic tests, which detect the presence of the virus, serologic tests measure the amount of antibodies or protein present in the blood when the body is responding to an infection like COVID-19.

These tests can help identify individuals who can (ph) overcome an infection, (inaudible) developed an immune response. We will continue working with labs, manufacturers and across the government to find a balance between the assurance that an antibody test is accurate, and timely access to such tests.

Of course, the way we will eventually beat this virus is with a vaccine, and FDA is working closely with our Fed partners including the NIH, test -- I mean, vaccine developers, manufacturers and experts across the globe. We intend to use our regulatory flexibility to help ensure the most efficient development of a safe and effective vaccine to prevent COVID-19.

Until a preventative vaccine is approved, however, we need medical products to bridge the gap. FDA has been working for several months to facilitate the development and availability of therapeutics as expeditiously as possible. And we have created an emergency program for this acceleration, called the Coronavirus Treatment Acceleration Program, or CTAP.

We had to (ph) reassign staff to work with urgency to review requests from companies, scientists, doctors who are developing therapies. And we're using every available authority and regulatory flexibility that's appropriate, to facilitate the development of safe and effective products to treat COVID-19.

A variety of therapeutic areas are being evaluated, as mentioned by Dr. Fauci and others, including antiviral drugs and immunotherapies, as well as convalescent plasma, hyperimmune globulin and monoclonal antibodies.

As Dr. Fauci also mentioned, we recently announced the positive results of the NIAID trial of remdesivir, and issued an EUA for the treatment of hospitalized patients with COVID-19.

Two other promising treatments that I mentioned are the antibody enrich (ph) products, convalescent plasma and hyperimmune globulin. And I am certainly willing to go into more detail if members of this community had questions about this.

But we are working very aggressively and closely with stakeholders to facilitate the development of monoclonal antibodies, which, if shown to be safe and effective, could act as a bridge therapy to the development of a vaccine.

We recognize that developing vaccines and therapies need to go hand- in-hand with ensuring that there will be sufficient supplies for our companies -- for our country, so we're also working with manufacturers to make sure that this supply chain is robust.

Mr. Chairman, Ranking Member, and members of the committee, please know that in FDA, you have a dedicated team of some of the nation's finest scientists, health care providers and public health professionals. We are guided by science and data, and we won't let up until we facilitate the development of products that our nation needs to get back to work.

[10:50:12]

I look forward to your questions.

ALEXANDER: Thank you, Dr. Hahn.

And thanks to all four of you for you expertise, for your dedication to our country and our hard work.

We'll now begin a round of five-minute questions from each senator on the committee, alternating between Republicans, Democrats. Each senator has, if you're a videoconference, you have a little time clock at the bottom, and I would ask you to try to stay within five minutes for your questions and answers.

I will start. I've got a question for Dr. Fauci, and then Admiral Giroir.

Doctor, let's look down the road three months. There will be about 5,000 campuses across the country, trying to welcome 20 million college students; 100,000 public schools, welcoming 50 million students. What would you say to the chancellor of the University of Tennessee Knoxville? or the president -- or the principal of a public school, about how to persuade parents and students to return to school in August?

Let's start with treatments and vaccines first, Dr. Fauci, and if you could save about half of my five minutes for Admiral Giroir for testing, I would appreciate it.

FAUCI: Thank you very much, Mr. Chairman.

Well, I would be very realistic with the chancellor and tell him that when we're thinking in terms...

ALEXANDER: It's a her in this case.

FAUCI: Oh, I would tell her -- I'm sorry, sir. That in this case, that the idea of having treatments available, or a vaccine to facilitate the reentry of students in to the fall term would be something that would be a bit of a bridge too far. As I mentioned, the drug that has shown some degree of efficacy was modest, and it was in hospitalized patients. Not yet, or maybe ever to be used either yet as prophylaxis or treatment.

So if the issue is that the young individuals who will be going back to school would like to have some comfort in that there's a treatment, probably the thing that would be closest to utilization then would likely be passive transfer of convalescent serum. But we're really not talking about necessarily treating a student who gets ill, but how the student will feel safe in going back to school.

If this were a situation where we had a vaccine that would really be the end of that issue in a positive way. But as I mentioned in my opening remarks even at the top speed we're going, we don't see a vaccine playing in the ability of individuals to get back to school this term.

What they really want is to know if they are safe, and that's the question that'll have to be due (ph) with what we discussed earlier about testing. So I'm about halfway through the remarks.

I'd like to just pass the baton to Admiral Giroir, who would address the question of the availability of testing and what role that might play in returning to school.

Thank you, sir.

ALEXANDER: Well, thank you, Dr. Fauci. And Admiral Giroir, you said that while we're doing about 10 million tests this month, that we might be as high as 40 or 50 million by September in a month, which is a significant increase.

So if I'm chancellor of the University of Tennessee, could I develop a strategy where I'd say to all my students we have for example antigen test which is quick and easy, we want everybody on campus to come by and take it once before you begin school, that will at least let everybody know that on that day we've isolated anybody whose positive and then we can continue to monitor, is that strategy possible in August and September?

GIROIR: So thank you, Mr. Chairman. And I may reserve 20 seconds for Dr. Redfield as well. The strategy that's going to be employed really depends heavily on what is the community spread at that time? If there's almost no community spread, your strategy will be different. If there's high community spread it will also be different. But yes, technically we will have the ability, and your chancellor will have the ability.

We expect there to be 25 million to 30 million point of care tests per month available. It is certainly possible to test all of the students, or it is much more likely that there would be a surveillance strategy done where you may test some of the students at different times to give an assurance that there's no circulation, and that would be done in conjunction with the CDC and the local health department.

There's also strategies that are still needing to be validated, but of pulling samples. We know in experimental labs as many as 10 or 20 samples can be pulled, so essentially one test could test 20 students.

[10:55:00]

And finally, there are some experimental approaches that look interesting, if not promising. That, for example, waste water from an entire dorm, or an entire segment of a campus could be tested to determine whether there's coronavirus in that sewage, the waste water.

So there are other strategies being developed, and I'd like to at least give 20 seconds to Dr. Redfield who really will be working on the strategy of how to employ the test given different community spread.

ALEXANDER: Dr. Redfield?

REDFIELD: Yes, just some quick comments, sir.

First, I think it's really important to evaluate critically the role of changes and social distancing on college campuses, and schools, and the situation -- not to forget the importance of what we've learned. Clearly, also developing aggressive program for wellness education, making sure people understand when they're symptomatic they need to seek evaluation.

I think you are going to have to look at the role of testing, I think there is going to be an important role of testing in these circumstances, and I think it will be individualized based on where these different schools are, how much infection is...

ALEXANDER: I'm going to wrap it up there so I can set a good example for the other senators with their five minutes. Senator Murray?

MURRAY: Thank you very much, Mr. Chairman. And thank you to all of our witnesses. Dr. Fauci, you have warned of needless suffering and death if we push to reopen too soon. But the president has actually been sending the opposite message, I want to ask you today what is the most important message you have for communities and states that are reopening? Even as our public health experts make it clear it's too soon -- tell us what the consequences are?

FAUCI: Thank you very much for that question, Senator Murray. As I've said many times publicly, what we have worked out is a guideline framework of how to safely open America again, and there are several checkpoints in that with a gateway, first, of showing -- depending on the dynamics of an outbreak in a particular region, state, city, or area that would really determine the speed, and the pace with which one does reenter, or reopen.

So my word has been -- and I've been very consistent in this -- that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14 day decrease that would allow you to go to phase one, and then if you pass the checkpoints of phase one go to phase two and phase three.

What I've expressed then, and again, is my concern that if areas, cities, states, or what have you jump over those various checkpoints and prematurely open up without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn in to outbreaks.

So therefore I have been being very clear in my message to try to the best extent possible to go by the guidelines which have been very well thought out and very well delineated. MURRAY: So if a community, or a state, or a region doesn't go by those guidelines and reopens, the consequences could be pretty dire, correct?

FAUCI: The consequences could be really serious, particularly -- and this is something that I think we also should pay attention to that states even if they're doing it at an appropriate pace which many of them are and will -- namely a pace that's commensurate with the dynamics of the outbreak, that they have in place already the capability that when there will be cases there is no doubt.

Even under the best of circumstances when you pull back on mitigation you will see some cases appear, it's the ability and the capability of responding those cases with good identification, isolation and contact tracing will determine whether you can continue to go forward as you try to reopen America. So it's not only doing it at the appropriate time, with the appropriate constraints, but having in place the capability of responding when the inevitable return of infections occur.

MURRAY: Well, thank you for that.

And it's very clear, in order to do that, we need knowledge, which is about testing. And for months, this administration's approach to testing has really been plagued by unrealized goals and disregard for systemic problems within that supply chain.

And last week, an average of just 250,000 tests per day were performed in the United States. That is a small fraction of what we need. And yesterday, President Trump had the gall to declare the U.S. had, quote, "prevailed on testing," in a press conference that was filled with misinformation and distortions.

[11:00:00]