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Live Coverage of Senate Hearing on COVID-19 Reopening Progress. Aired 10:30-11a ET

Aired June 30, 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]

BARBARA STARR, CNN PENTAGON CORRESPONDENT: Tell me everything you know.

JIM SCIUTTO, CNN ANCHOR: Yes.

STARR: If there is a threat to U.S. troops, I want to know everything you know about and make some decisions on how to proceed.

Right now, all we've heard from the president is he wasn't briefed --

SCIUTTO: Yes.

STARR: -- because it wasn't verified information.

SCIUTTO: OK, stand by Barbara.

Kylie, thanks very much.

Let's go live to the Hill, this is Dr. Anthony Fauci testifying on the outbreak.

ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: -- COVID-19. And as you indicted, Mr. Chairman, I will during the question period, and alluding to in the presentation, address some of the issues regarding schools.

The NIAID, NIH strategic plan for COVID research involves four major components. The first is to improve the fundamental knowledge, understanding of the biology of the virus, and the immune response to the virus in order to better inform us in the development of diagnostics, therapeutics and vaccines.

Some of the work that has come out of that program right now informs very greatly how we will address vaccine development, particularly understanding the confirmation of the components of the virus that induce and appropriate immune response.

In addition, we will develop -- and are developing -- animal models. Apropos of what you mentioned about children in school, we have a program called HEROES, which is Human Epidemiology and Response to SARS Coronavirus, which is determining the incidence and transmissibility among children, a very important issue when you talk about opening schools and the impact that might have.

In addition, the development of diagnostics, point-of-care and specific diagnostics under the RADx program, including the RADx-UP for underserved populations.

Third, to characterize and test therapeutics. You mentioned the importance of this as we open up schools. There are a number of programs, very active, that have already shown efficacy or not in some drugs, as well as a number of clinical trials that are ongoing.

One in particular was the first randomized placebo-controlled trial, showing that the drug remdesivir diminishes by about 32 percent the time it takes to get to recovery in people with advanced disease pulmonary involvement. In addition, we have another study combining this with an anti-inflammatory agent.

Next, we have vaccines. As several have mentioned, it's extremely important to have safe and effective vaccines available for everyone in this country, as well as globally. In that regard, we put together -- myself and some of my colleagues -- and published in "Science Magazine," a few weeks ago, what we call "A Strategic Approach to Coronavirus-19 Vaccine Research and Development."

It's not a comprehensive plan about every aspect of vaccine, but it is a strong plan regarding the research and development pathway. And what we have done in this, is that we have what's called a harmonized effect, because we know there are many vaccines that are in trial now at various stages.

And what we did, and the federal government -- thanks to the generosity of the Congress -- has put a considerable amount of money in order to harmonize the trials of multiple candidates from different companies so that we have common end points, common data and safety monitoring board, and common immunological parameters that are being funded and are being pursued.

In addition, there are a number of different platforms that are being pursued so that we don't have all our eggs in one basket. As you know, one of those is right now getting ready, as we approach next month, of going into phase three trials, and others will be staggered along the way in the middle of the summer, end of the summer, early on (ph).

There is no guarantee -- and anyone who's been involved in vaccinology will tell you -- that we will have a safe and effective vaccine. But we are cautiously optimistic, looking at animal data and the early preliminary data, that we will at least know the extent of efficacy sometime in the winter and early part of next year.

Again, working with the companies and the investment made by this Congress, hopefully there will be doses available by the beginning of next year. These are the things that we feel aspirationally hopeful about, and we will continue to pursue this.

I'll stop there, Mr. Chairman, and be happy to answer questions later. Thank you. SEN. LAMAR ALEXANDER (R-TN): Thank you, Dr. Fauci.

Dr. Redfield, welcome.

ROBERT REDFIELD, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION: Good morning, Chairman Alexander, Ranking Member Murray and distinguished members of the committee. I want to thank you for the opportunity to testify before you today with my HHS colleagues.

The COVID-19 pandemic is the most significant global public health challenge that we have faced as a nation in more than a century. In the United States, daily cases are increasing after an extended decline. We're seeing significant increases in the southeast and southwest regions of this nation. The number of jurisdictions in upward trajectory has continued to increase, now 29 of 55 jurisdictions fall into this category.

[10:35:22]

The evidence tells us that these cases are driven by many factors, to include increased testing, community transmission and outbreaks in the settings such as nursing homes and occupational settings. Hospitalizations now are going up in 12 states. And as of this weekend, daily death now has increased in the state of Arizona.

CDC is closely monitoring these increases and have 48 teams with more than 140 staff currently deployed in 20 states and two territories. CDC is providing technical expertise to the health departments and epidemiology contact tracing, infection prevention and control and communication.

Beyond providing this critical boots on the ground, CDC is working with your states and community in other ways. CDC is speaking with the states, tribal, local and territorial health departments on a daily basis to develop strategies to stop COVID while reopening businesses and schools.

The initial guidance for institutes of higher learning was shared in March and the K through 12 setting was shared in February. Both these guidances have been updated since, and over the past several months. As more information becomes available, we'll continue to disseminate that more broadly.

CDC released consolidated recommendations for COVID testing including interim testing guidelines for nursing homes, as well as testing options for high-density critical infrastructure workplaces after a COVID case is identified. Testing guidance for higher education in K through 12, the higher education should be posted today and K through 12 later this week.

These recommendations are consistent with previously published testing guidelines, and are meant to supplement, not replace the guidance of local jurisdictions. CDC continues to advance science around the COVID-19 impact in certain populations and those who are at heightened risk for severe outcomes. Our most recent analysis of the United States case data from the

pandemic hospitalizations were six times higher, and deaths 12 times higher among those with reportedly underlying conditions compared to those who did not have these conditions.

We have expanded the list of underlying conditions where the evidence is clear that they put people at higher risk of severe illness. These conditions include chronic kidney disease, COPD, having a weakened immune system from a solid organ transplant, obesity, serious heart disease, sickle cell disease and type II diabetes.

Our analysis also provides further evidence that racial and ethnic populations are disproportionately affected by this epidemic.

While data is the backbone of this response, containing the outbreak depends on four core interventions: readily available testing, comprehensive contact tracing, timely isolation of known cases and quarantine to break the transmission.

We are not defenseless against this disease. We have powerful tools at our disposal: social distancing, wear a face cover in public, and be disciplined about the frequent hand-washing.

it is critical that we all take the personal responsibility to slow the transmission of COVID-19 and embrace the universal use of face coverings. Specifically, I am addressing the younger members of our society, the Millennials the the Generation Zs. I ask those that are listening to spread the word.

Before I close, I'd like to speak briefly about how CDC is assisting the frontlines of our health departments to fight COVID. With your support, CDC has awarded $12 billion to 64 jurisdictions, data modernization is under way, public health laboratories are building resilience, number of contact tracers have grown 345 percent.

The disease impacts us all, and it's going to take all of us working together to stop it. Together, I believe we can achieve the possible. Thank you, and I look forward to your questions.

ALEXANDER: Thank you, Dr. Redfield.

Admiral Giroir, welcome.

SCIUTTO: You just heard the director of the CDC there, Robert Redfield. Before him, Dr. Anthony Fauci, testifying before the Senate regarding the coronavirus outbreak.

One notable comment there form Dr. Fauci, saying that it remains -- as he described it -- their aspirational hope to have a working vaccine by late 2020, early '21.

Actually, let's go back to continue to hear the testimony on the Hill.

BRETT GIROIR, ASSISTANT SECRETARY FOR HEALTH: -- coordinating testing, including now the NIH RADx diagnostics program, along with Dr. Collins, to assure that innovations are immediately translated into practice.

[10:40:10]

In order to get back safely to work and school, the overarching most critical and essential action we must first accomplish is to control the virus, meaning rapidly extinguishing any outbreaks and minimizing community transmission.

All of us are concerned about recent data from several states, indicating rising infections and now an uptick in hospitalizations and deaths, even as other states and the majority of counties are maintaining a low infection burden.

Knowing what we know now about asymptomatic transmission and the fact that we are in a much better position today in terms of our mitigation strategies, PPE and testing, we can reverse these concerning trends if we work together.

First, we must take personal responsibility and be disciplined about our own behavior. Maintain physical distancing, wear a face covering whenever you can't physically distance, wash your hands, stay at home if you feel sick. If you have been in close contact with someone infected, or in a gathering without appropriate precautions, get tested. Shield the elderly and the vulnerable of any age, and follow the guidelines for opening up America again.

The criteria are very specific, and are as relevant today as when we released them. In addition, this week, we are initiating surge testing in multiple communities of highest concern, in coordination with state and local officials.

Now, back to schools and businesses. As Dr. Redfield states, the CDC will release recommendations on K through 12 institutions of higher education and general business reopening. These will include considerations for integrating testing, especially surveillance testing, into a comprehensive strategy.

As you asked me, Mr. Chairman, if you are a superintendent of a school system or a president of a university, number one, apply the CDC guidelines in consultation with your state and local public health officials so that testing is a part of your comprehensive plan, which should also include prevention and clear mechanisms to isolate positive students.

Number two, assure your testing needs are incorporated into your state testing plans. As we outlined in the national testing strategy, each state has developed and will continue to build upon a customized state testing plan, developed in full coordination with the federal government. The next iteration, covering July to December, is due on July 10th.

These state plans drive the allocation of certain scarce resources. For example, in May and June, the federal government has distributed nearly 26 million collection swabs and over 19 million tubes of transport media. HHS also prioritizes allocation of certain key laboratory tests, like point-of-care tests, according to state- specific needs.

There are also strategies particularly relevant to surveillance testing, especially in universities and businesses. For example, pooling of samples, meaning combining two or more samples and possibly up to 10 into a single test, makes sense where the prevalence of infection is low. And such pooled surveillance testing can be conducted in a university research lab, outside of a CLIA environment. But if a pooled sample is positive for COVID, every individual in that pool would need to be tested through a health system.

I would like to close by recognizing my fellow officers in the United States Public Health Service Commissioned Corps, the uniformed service that I lead: 4,536 officers have deployed to support the pandemic response, exemplifying the care and compassion that all of us feel for those who have suffered during this pandemic.

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

Thank you for the opportunity to provide these remarks.

ALEXANDER: Thank you -- thank you, Admiral Giroir.

Welcome, Dr. Hahn.

STEPHEN HAHN, FDA COMMISSIONER: Thank you, Chairman Alexander, Ranking Member Murray and members of the Health Committee. I appreciate very much the support that you all have provided for our efforts during this time of COVID-19.

FDA has a vital role in the government's response to the pandemic. One of our core missions is to advance the public health by helping to speed medical products that are safe and effective. We have provided appropriate regulatory flexibilities to assure that the American public has access to critical medical products and safe food, and confidence that our decisions are based on medicine and science.

[10:45:17]

Since the public health emergency was declared, FDA has issued more than 100 emergency use authorizations for diagnostic tests, personal protective equipment, ventilators, other devices and drug products. And we have issued more than 50 guidance documents to ensure the continuity of health care in the food supply.

I am pleased to announce that today, FDA is taking action to aid the timely development of a safe and effective vaccine to prevent COVID-19 by providing guidance for developers with recommendations on the data needed to facilitate manufacturing, clinical development and approval.

We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19, and we want to work collaboratively with industry, researchers and other partners to accelerate these efforts. While the FDA has committed to help expedite this work, we will not

cut corners in our decision-making and we are making clear in our guidance, what are the data that we need that should be submitted to meet our regulatory standards of approval? This is particularly as important as we know that some people are skeptical of vaccine development efforts.

The FDA strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19 and specifically racial and ethnic minorities, as well as adequate representation in late-phase trials of elderly individuals and those with medical comorbidities. We also have information in this guidance about including women who are pregnant, as well as for pediatric assessments of safety and effectiveness.

The American people should know that we have not lost sight of our responsibility to maintain our regulatory independence and ensure that our decisions related to all medical products, including COVID-19 vaccines, are based on sound science and the available data. This is a commitment the American public can have confidence in, and that I will continue to uphold personally.

While vaccine research is ongoing, rapid testing and therapeutic development can aid in the safe return to school, college and the workplace. FDA is constantly evaluating new data we receive on testing so that we can promote the development of new and better tests, and remove tests that are not reliable from the market.

And we have put into place an initiative to accelerate the development of treatments, called the Coronavirus Treatment Acceleration Program, or CTAP. We have seen some of the consequences of that program, such as the authorization of remdesivir and the recent information regarding other therapeutics that might be of benefit to patients with COVID-19.

We are working day and night to provide guidance to and review proposals from companies, scientists and researchers who are developing therapies for COVID-19.

We are now preparing for the next phase of addressing this evolving crisis. It is mission-critical that the agency constantly evaluate whether our processes are maximal to promote and protect the public health. And therefore, we are beginning a comprehensive real-time review and assessment of our actions to date to address the COVID-19 pandemic. And I am glad to answer questions about that review.

I want to thank the more than 17,000 FDA employees who have been working night and day to help expedite medical products, but also to provide the necessary oversight with the appropriate science and data.

We know that the virus remains with us. FDA is committed to doing the critical work that will get the country to the point at which Americans judge it safe to return to work and school as quickly as possible.

I am incredibly proud of the dedicated women and men of the FDA, whose commitment to defeating this pandemic has been unwavering. I can assure you the FDA will continue to provide leadership, expertise, guidance and information as we continue to address this unprecedented challenge and fulfill our mission to protect and promote public health.

Thank you, and appreciate and look forward to your questions.

ALEXANDER: Thank you, Dr. Hahn.

And thanks to each of our witnesses. We'll now begin a round of five- minute questions. All the senators are participating today, almost all, and so I would ask the senators and the witnesses to try to keep each segment within five minutes.

Dr. Fauci, assume I'm superintendent of one of 14,000 school districts. In our community, we've -- we understand that there are health risks for children going back to school, but we've concluded that the risks of -- to their education, mental health and social development is a greater risk if they don't go back to school.

[10:50:05]

So what would your advice be to a school superintendent about what he or she should be thinking about as children go back to school in a few weeks, to keep them safe?

FAUCI: Thank you for that question, Mr. Chairman. It is an important question, but I think we need to point out that it really will depend on the dynamics of the outbreak and the particular location where the school is.

And one of the things we want to emphasize -- and have been emphasizing -- is to take a look at where you are in the particular area of the so-called Opening America Again. Are you at the gateway, phase, one, phase two, phase three?

The CDC has guidelines about the opening of schools at various stages of those checkpoints. The basic fundamental goal there would be, as you possibly can, to get the children back to school. And to use the public health efforts as a tool to help get children back to school.

Let me explain what I mean. In other words, if we adhere to guidelines of what we've heard in many of these presentations you just heard about the physical distancing in the community, the use of masks, things like that, that will help to keep the level of infection in the community down, which will then make it easy to get the children back to school.

If you are in an area where you have a certain amount of infection dynamics, there are things that can creatively be done about modifying things like the school schedule, alternate days, morning versus evening; allowing, under certain circumstances, online virtual lessons. Those are the kind of things that we need to consider, but also importantly always make the goal that it is very important to get the children back to school, for the unintended negative consequences that occur when we keep them out of school. ALEXANDER: Thank you, Dr. Fauci.

Dr. Redfield, one of the concerns would be that children, who, generally speaking, haven't been damaged nearly as much as adults -- particularly elderly adults -- by this virus, might carry the virus to their teachers, administrators or parents or grandparents at home.

Seems to me that the availability of treatments this fall -- medicine for the environments that reduce the risk of sickness and death could be very important in increasing confidence in going back to school.

You mentioned some of those in your testimony. Are there others? What would the availability of treatments be this fall? And specifically, what about so-called antibody cocktails of the kind that were developed for Ebola and approved by the FDA?

REDFIELD: Well I think that'd be a great question also for Dr. Fauci. I'm going to make a small statement. He may want to add to it.

Clearly, we do have remdesivir, as you mentioned. We have now evidence that steroids can improve therapy. And as you mentioned, we have convalescent plasma that Steve Hahn could comment on, that's using the -- the antibodies from individuals that have gotten better from COVID that are currently under evaluation, and potentially be available --

ALEXANDER: I'm sorry, I have just a minute, Dr. Redfield. Let me go to Dr. Hahn, and let him answer that question too. Thank you.

HAHN: As -- as I mentioned, remdesivir has been authorized based on its reduction in hospitalization days. The steroids were mentioned. Convalescent plasma, we have evaluated the safety through a large expanded access program at the Mayo Clinic, and it's been found to be safe in over 20,000 patients who administered it.

We are waiting for the safety data, and we will be passing those data along to BARDA, who's the sponsor of that program. I think that antibody data will help us in terms of the development of monoclonal antibodies.

We have a number of sponsors who have come in for monoclonal antibody studies. We are already well into that treatment. Monoclonal antibodies are synthetic antibodies that will provide -- the theory is, will provide protection against the infection of the virus.

And we're hopeful that those studies, by the late summer, early fall, will provide us information about their effectiveness and safety. And as you --

(CROSSTALK)

ALEXANDER: So you're optimistic that there will be more than one treatment available this fall for teachers, administrators, older adults?

HAHN: Yes, sir. I'm optimistic.

ALEXANDER: Thank you very much.

Senator Murray?

SEN. PATTY MURRAY (D-WA): Thank you very much to all of our witnesses. We all very much appreciate your service and your work.

[10:55:01]

Dr. Fauci, last time you testified before this committee, you warned us of needless suffering and death if states begin reopening too early. And just over a month later now, we are seeing a record number of cases. We do not have enough tests, and we do not have enough contact tracers. And just yesterday, CDC's Dr. Schuchat said we have too much virus to control in the U.S., arguing -- and I quote -- "This is really the beginning."

Our strategy hasn't worked. I want to ask you, what do the federal government and the more than 30 states with rising case numbers need to do to reverse this trend?

FAUCI: Thank you very much for that question, Senator Murray. I am also quite concerned about what we are seeing evolve right now in several of the states. As you know, in four of the states -- in Florida, Texas, California and Arizona -- more than 50 percent of the new infections are in those areas where we're seeing surges.

The things we need to do, I think you alluded to in your question to me. We've got to make sure that when states start to try and open again, they need to follow the guidelines that have been very carefully laid out with regard to checkpoints. What we've seen in several states are different iterations of that. Perhaps maybe in some, going too quickly and skipping over some of the checkpoints.

But even in states in which the leadership, in the form of the governors and the mayors, did it right with the right recommendations, what we saw visually in clips and in photographs, of individuals in the community doing an all-or-none phenomenon, which is dangerous. And by all or none, I mean either be locked down or open up in a way where you see people in bars, not wearing masks, not avoiding crowds, not paying attention to physical distancing.

I think we need to emphasize the responsibility that we have, both as individuals and as part of a societal effort to end the epidemic, that we all have to play a part in that.

And I think if you look at the visuals, what we saw were a lot of people who maybe felt that because they think they are invulnerable -- and we know many young people are not, because they're getting serious disease -- that therefore their getting infected has nothing at all to do with anyone else, when in fact it does.

Because if a person gets infected, they may not be symptomatic, but they could pass it to someone else who passes it to someone else, who then makes someone's grandmother or grandfather, sick uncle or a leukemic child on chemotherapy, get sick and die. We've got to get that message out, that we are all in this together. And if we are going to contain this, we've got to contain it together.

MURRAY: Well, I assume that would mean that elected and community leaders need to model good public health behavior and wear a mask.

FAUCI: We recommend masks for everyone on the outside. Anyone who comes into contact in a crowded area, you should avoid crowds where possible. And when you're outside and not had the capability of maintaining distance, you should wear a mask at all times.

MURRAY: Thank you.

Dr. Redfield, last week, Dr. Julie Gerberding, who served as the CDC director under President George W. Bush, testified to our committee that if she were in charge, one of her top priorities would be the creation of a national vaccine plan that addresses the science, development, allocation, uptake and monitoring of a vaccine, saying, quote, "We know this is in our future and we are not ready for it."

I couldn't agree more. And that plan has to detail how the federal government will scale up manufacturing, coordinate the supply chain so we avoid the missteps we saw with testing, needs to combat misinformation and vaccine hesitancy, and make sure that vaccine distribution addresses health disparities, and a lot more.

Dr. Redfield, do you agree a plan like that is needed?

REDFIELD: Senator, I think it's very important that we have an integrated plan for this vaccine.

MURRAY: When can we expect (INAUDIBLE)?

REDFIELD: Well, I'm going to ask Dr. Hahn if he'd like to comment. I know recently, they had a vaccine planned for -- at least for the FDA's perspective. CDC is working on the issues that you said that I think are so important, in building vaccine confidence in this country --

(CROSSTALK)

MURRAY: Well, can you tell me (ph) (inaudible) CDC will be giving us their plan, since CDC would be providing the comprehensive plan?

REDFIELD: We're developing a plan, as we speak. And again, to keep building on the efforts that we have to rebuild what I call vaccine confidence in this country.

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