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Top Health Officials Testify on Pandemic, U.S. Response. Aired 11-11:30a ET

Aired September 23, 2020 - 11:00   ET

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

[11:00:00]

DR. ROBERT REDFIELD, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION: Yes, sir.

SEN. LAMAR ALEXANDER (R-TN): Thank you, Dr. Redfield. Senator Murray?

SEN. PATTY MURRAY (D-WA): Thank you, Mr. Chairman.

Dr. Redfield, we know that a lot of patients avoid getting unnecessary tests or treatment because of cost and I've been pushing to make sure that insurers have to cover COVID treatment at no cost to patient as we fight this deadly disease.

Meanwhile, President Trump as we all know is fighting at the Supreme Court to overturn the Affordable Care Act which would leave 23 million more people without health insurance and allow insurers to once again discriminate against people with preexisting conditions leading to higher costs. COVID-19 actually itself could become a preexisting condition.

So, Dr. Redfield, let me just ask you straight out, will increasing the number of uninsured by tens of millions and increasing costs for the 133 million people with the preexisting condition make it easier or harder to contain this pandemic?

REDFIELD: Thank you, Senator, for the question. Clearly, access to timely healthcare is critically important in terms of public health, and in terms of this pandemic it's also true. Access to timely, effective healthcare remains an important public health measure.

MURRAY: I would take that case as overturned that this is going to make it a lot harder to control this pandemic.

Dr. Redfield, we have got to understand what happened with CDC's testing guidance for asymptomatic people exposed to COVID-19. I am relieved that CDC reversed course on Friday, but I am concerned about why CDC put out guidance that contradicted the widespread views of the medical and public health community was not drafted by CDC scientists and did not undergo CDC's strict, scientific review process. Dr. Redfield, how is it a document published on CDC's website was not drafted by CDC scientists nor underwent the agency's strict, scientific review process? REDFIELD: Senator, the original testing guidance of August 26th had a full engagement of individuals at CDC, but it was a cooperative document that included the assistant secretary as well as the Coronavirus Task Force. I will say the intent of that document, as I mentioned before, and I tried to clarify in my statement on August 27th was never to limit testing, never to limit testing of asymptomatic individuals.

The attempt was to re-engage the medical and public health community as part of testing so that there was a public health action that happened as a consequence of every test. It became progressively apparent that the guidelines were not interpreted in the manner in which we had intended them to be interpreted and that's what led me to realize that we had to put out a clarification to make it explicitly clear that we believe very much that asymptomatic transmission is an important part of the transmission cycle of this virus. Those individuals when they've been exposed should, in fact, be tested.

MURRAY: I appreciate that answer. I don't hear you answering the question. But let me ask Dr. Giroir. You said in an interview that coordinated editing of the guidance that you coordinated editing of the guidance, the American Medical Association and the Infectious Diseases Society of America and state health departments recommended testing for asymptomatic people. I want to ask you on what scientific basis did members of the task force take a different position. Scientific evidence.

ADM. BRETT GIROIR, M.D., ASSISTANT SECRETARY FOR HEALTH, HEALTH AND HUMAN SERVICES: So -- thank you, Senator Murray. I want to reiterate what Dr. Redfield said is that the original guidance that was published by the CDC with the --

MURRAY: I appreciate --

GIROIR: -- approval of Dr. Redfield and the senior scientists did not, unequivocally, it did not recommend against testing asymptomatic individuals. In fact, there were multiple sentences that said it is important to test asymptomatic individuals, but in certain circumstances it's important to do that within the context of public health or medical supervision. That's all it said. It was widely misinterpreted. It was widely misrepresented. And Dr. Redfield told the reason, we have done FDA guidance, clear guidance and I issued a PREP Act declaration to assure -

(CROSSTALK)

[11:05:02]

MURRAY: Please --

GIROIR: -- that providers could test asymptomatic individuals.

MURRAY: On Friday, CDC quietly updated another guidance identifying aerosols as common root of transmission of the virus that causes COVID-19. Yet on Monday, CDC reversed course. Dr. Redfield, you told me the earlier guidance had been posted in error, but especially given the Trump administration's track record the reversal raises significant red flags.

So here is my question to you, if I want the best guidance on the latest science so I can protect myself and my family, can I trust CDC's website to give me that information?

REDFIELD: Yes. I'm going to say again that my agency and myself, we're committed to data and science. And to give the American public the best public health recommendations we can based on that data and science, and be open, if necessary, if the data and science changes to modify that guidance based on that new data. But we are committed to data and science and that will be the grounding of how we make these recommendations.

MURRAY: Mr. Chairman, I am out of time, but I am concerned that the American public needs to be able to trust the decisions that are made and what's posted on that website needs to be trusted.

ALEXANDER: Thank you, Senator Murray. Senator Enzi.

SEN. MICHAEL ENZI (R-WY): Thank you, Mr. Chairman, for continuing to hold these regular hearings so that we and the American public can check on the federal efforts to fight the coronavirus. I know it can be hard for our witnesses to find the time to testify since they are all working very hard to respond to the pandemic, but I appreciate them being here and their information.

I'm glad to see that we're making progress in planning how we distribute a safe and effective vaccine when it's ready. I'm optimistic and pleased that there are all these efforts going forward. I hope we're thinking through how to ensure access, though, to rural areas.

One of the things that I'm asked about the people have heard that some of the vaccines -- this is a question for Dr. Redfield and Dr. Hahn. Some of the vaccines in phase three testing, evidently need to be stored at extremely cold temperatures. That's even by Wyoming standards and that would be potentially as low as negative 94 degrees Fahrenheit. Hospitals and nursing homes, pharmacies, doctors' offices, all of the places where Americans can go to get their shots.

However, they don't have the specialized freezers that would be necessary to store the vaccine especially in rural areas. So very few of those -- is there another solution or how can we ensure sufficient freezer and storage capacity so there's access to the vaccine and it isn't just limited to major cities?

REDFIELD: Thank you very much, Senator. Again, there's a total commitment to work that this vaccine has distributed in an equitable and fair way across our nation. The funding I announced today that will get out to the individual states to be able to really begin to operationalize their plans on the playbook is critical and each jurisdiction is going to have to address those issues, particularly as you looked at the importance of cold change and how they're going to maintain that.

Clearly, we have -- this is not something that we don't routinely do. I mentioned before, CDC routinely administers and distributes over 80 million vaccine doses a year through our routine work. We're going to build on that.

Obviously, the ability to bring all of the pharmacies in is a really important step, but these micro plans that your states say to Wyoming will do will identify what other gaps are there and over the next four, six, eight weeks we're going to need to figure out strategies that are going to fill those gaps to ensure that there's a proper cold storage for the vaccine distribution throughout this nation in an equitable way. We are committed to making sure that happens.

ENZI: Dr. Hahn, do you have any comment on that?

DR. STEPHEN HAHN, COMMISSIONER, FOOD AND DRUG ADMINISTRATION: FDA's role, Senator Enzi, in this is to ensure that the controls around manufacturing and storage are followed. If, in fact, a vaccine is authorized or approved that requires such cold storage as you mentioned, we will provide technical assistance and we'll work with CDC to ensure that that happens.

[11:10:00]

ENZI: Thank you. Director Redfield, do you anticipate that once the Food and Drug Administration approves a vaccine, and you kind of touched on this the Centers for Disease Control and Prevention would have to work with the states to develop, new, more detailed vaccine distribution plans or will the work the states are doing in advance suffice?

REDFIELD: Senator, it's very important, and I want to stress, this is why it's so important in the playbook we put out last week and the funding we announced today that we get these plans executed, we wanted to see the plans completed by October 16th so we can interact, share best practices of other states to try to get these plans as rock solid as possible. I'm confident there will be -- there will be some things that weren't thought of that will have to be dealt with as they come upon us.

But it's my expectation that each of the plans -- we've done the microplanning now in Minnesota, in North Dakota, California, Florida and Philadelphia over the summer just to get a sense on the complexity of it.

Now, we're looking for each of the 64 jurisdictions to complete that by October 16th and it is our hope that that's going to really lay out the individual plan to get this vaccine equidistributed in that jurisdiction recognizing that there will be things that come up that we're going to have to work together to deal with as we see them, but hopefully will be 95 percent of the way there based on the planning between now and October 16th.

ENZI: My thanks to you, Mr. chairman and the ranking member.

ALEXANDER: Thank you, Senator Enzi. Senator Casey?

SEN. ROBERT CASEY, JR. (D-PA): Mr. Chairman, thank you very much. I want to thank our witnesses for appearing and for their work.

This week we've announced to the world that we've reached the 200,000 grim milestones of deaths in America from COVID-19. That number translates in Pennsylvania into 8,000 deaths.

So if we're thinking about those, all those we've lost, we now have to consider the possibility that COVID-19 could be and likely will be considered a preexisting condition just as the Affordable Care Act would be struck down by the Supreme Court in early November, at least the arguments starting then. At the same time, we've got to consider the ravages of this disease, the COVID-19 disease, in the context of nursing homes.

I released yesterday with Senator Wyden a report. I'll just hold up the cover of it, but the headline of the report is the cost of inaction, 11 deaths an hour. 11 deaths an hour. That means that in the months of July and August of this year, 11 nursing home residents died from COVID-19 every hour in total when you look at the total number from the beginning of the pandemic more than 78,000 residents and workers in long-term care facilities have died of COVID-19.

And unfortunately, the Trump administration has no effective strategy, no effective plan in place to reduce this number. Either to reduce the death number or the case number in long term care settings. This is an American tragedy. There's no excuse for these numbers to keep going up. We should not allow the next couple of months to transpire and have the number of nursing home deaths or the nursing home case number go up again. That is not the America we should be.

Now the majority in the Senate could be doing something about this. The majority in the Senate has been obsessed with confirmation votes, all kinds of confirmation votes all summer long and we did the defense bill, as well, but mostly almost all of our votes run confirmations. Now the Senate majority is obsessed with getting a confirmation vote on the Supreme Court justice.

I just have one question for the majority, when will Senate Republicans and the Trump administration become obsessed, yes, obsessed, with reducing nursing home deaths? Let me get to our witnesses.

I want to ask a question that Dr. Hahn was already kind enough to answer which was about the vaccine and his response to that in terms of his own family and his own -- his own person. One of the most important challenges we face in developing and then distributing and administering a safe and effective vaccine is public confidence. As a way to demonstrate faith and the integrity of both the approval process and to assure the American public that vaccines are safe.

[11:15:02]

I would ask the other three members of our panel if they would commit to receiving the COVID-19 vaccine in public view once -- when becomes available and is authorized and approved by FDA starting with Dr. Fauci.

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: Thank you for the question, Senator Casey. Yes, I've said that in the past that if a vaccine has shown to be, proven to be and authorized by the FDA to be safe and effective, I certainly would take that vaccine and I would recommend to my family that they take that vaccine. Yes.

CASEY: Thank you.

GIROIR: I have every confidence in the FDA process to provide us a safe and effective vaccine. I would have no hesitancy to take that vaccine. I would have no hesitancy to recommend that to my family, but I think the question is a little bit inappropriate. People need to read that vaccine. They need to understand and have a discussion with their physicians or providers before you ask anyone to commit to that, but I just want to tell you, I have complete confidence in the FDA process.

CASEY: Dr. Redfield?

REDFIELD: Senator Casey, yes. Absolutely as I would with my wife, children and 11 grandchildren, I would recommend it to all of them and of course, myself, I would take it. I have total confidence in the FDA and in the process of getting us a safe - if they - if they give EUA then I am confident it would be a safe vaccine and I'm ready to take it.

CASEY: Dr. Redfield, I have a question for you on state immunization information systems in light of the vaccine program interim playbook. I just have one question before my time expires. How many jurisdictions immunization information systems meet all the standards set forth in the playbook today?

REDFIELD: Senator, I would have to get back to you to be able to answer that specifically. I will say that we are building on, as I mentioned, the system that we regularly use in these 64 jurisdictions to distribute 80 million vaccine doses a year. In addition, there will be additional information capacity that will be put in to where there are new points of service where that technology currently doesn't exist, but I will have my team put together a comprehensive answer for that question for you.

CASEY: Thank you. Thank you, Mr. Chairman.

ALEXANDER: Thank you, Senator Casey. Senator Burr.

SEN. RICHARD BURR (R-NC): Thank you very much. Welcome to all of our witnesses and our thanks to your agency and the many workers who work on this.

And let me say to Senator Casey answering his question. The majority has been focused on the pandemic since 2002. When we first started passing legislation that create in many ways the architecture that we fall under today and the protocols that allow Dr. Hahn, Dr. Fauci and Dr. Redfield, Admiral Giroir to do in fact what they're doing and we thank you for that.

Dr. Hahn, have we made up new protocols for the review of a COVID vaccine or are we simply following the protocols that we've used for every vaccine that every member of this committee, every committee of Congress and the American people have always seen as a gold standard?

HAHN: Well, with respect to our approval or authorization of medical products, FDA does represent the gold standard. Now the statutory definition for an EUA or authorization is different of course than it is for an approval, but we're following those criteria with respect to our performance during COVID-19.

I want to give you a few examples because in fact, you're correct. FDA does represent the gold standard. Our scientists are incredible. They've done really remarkable work here and one of the major things that distinguishes us from other regulatory agencies around the world is that we actually look at the primary data. We don't just look at a paper. We don't just look at a press release. We look at the primary data and our scientists analyze that data and then we draw conclusions from that data.

We did that with remdesivir. We did that with convalescent plasma. We're doing with tests. And so, those are the sort of things that FDA does that I believe represent the gold standard and allow us to have great confidence in the decisions that our career scientists are making.

BURR: Dr. Hahn, would it be appropriate to say that the clinical trials, phase three clinical trials that are currently going on now for manufacturing, I think the fourth one announced this morning are the most expansive and diverse trials that we've seen in recent memory just simply because they are global trials and typically we haven't picked up that international data until post-approval in many cases and reviewed it?

[11:20:06]

HAHN: Senator Burr, it's correct to say that they are among the most diverse and expansive trials, I think, that's a reasonable way to put this. We were very clear on our June 30 guidance about what we needed to see with respect to efficacy, a floor, not a ceiling, a floor of 50 percent which led to the power calculations in these trials and therefore 30,000 plus volunteers in each of these trials.

And if you think about the number of trials that are ongoing and plus the studies that were done before in phase one and phase two are great, if you will, a number of people who would have received these vaccines which will give us the data we need to see in order to make the determination. So, these have been very robust. The private sector has responded. The government has responded. And I think it's been a great effort to get these trials together.

BURR: Dr. Hahn, you talked about the steps that an applicant would go through and how it would be their decision as to how it would apply for emergency use authorization or for approval. The one thing I didn't hear you mention and I think you just left it out is the Data Safety Monitoring Board, DSMB, which actually looks at the data prior to the application coming to the FDA, is that, in fact, correct and is that another safety step?

HAHN: Senator Burr, exactly. It's another check and balance, if you will, in addition to the other. So, let me just explain that, if you will, sir.

When a sponsor, someone that's developing a vaccine, a company performs a phase three clinical trial, there is something called a Data Safety Monitoring Board. That is an independent board and they have set check-ins to look at the data.

Now, when they meet, they can make a couple of determinations. One, if there's significant safety issues, they could stop the trial because of safety issues.

Number two, they could do what's called a futility analysis, meaning that continuing that trial won't do any good because there's not a statistical probability that it would reach the primary end point that it will be successful.

And then of course, they could have met the pre-specified criteria around effectiveness in the case of the vaccines, prevention of infection and that would be another criteria that would be used to say, OK, the data are mature, give it to the company and then the company can put that into an application to us.

BURR: Thank you. Dr. Fauci, I want to turn to you just really quick because the Moderna vaccine works off of a technology platform that you actually created at NIAID.

Are you confident of the process that's going on at the FDA that will, in fact review the application of clinical data from that platform and as an add-on to that, would you also answer for members of Congress for the husband and wife that come to us and say my husband got COVID and the wife didn't get it. How would a highly transmittable infection like this can two people live together, and one be positive, and one never get positive? If there is an answer --

FAUCI: Yes. That happens all of the time with infections, Senator, that although a virus can be highly transmissible, there is a great degree of variability of a person's natural resistance to a particular type of an infection.

So, although a highly transmissible virus usually has an attack rate that's high, we see all the time individuals who are exposed to someone with an infection who do not get the infection. If you look at the population as a whole, you see the kinds of things that we're seeing as this pandemic evolves that it is highly contagious.

We had the same situation where you had HIV where individuals were living with a person who had you know sex on a regular basis with someone with HIV and they never got infected. Whereas another person could have sex one time with a person with HIV and get infected. That's the nature of the variability of susceptibility to infection among individuals. So, it's entirely conceivable. BURR: And your confidence - your confidence in FDA review on the technology platform.

ALEXANDER: We are running well over time.

FAUCI: Absolutely. The answer is yes. I'm quite confident in the FDA's ability to review that technology and to determine safety and efficacy based on the data of the trial.

BURR: Thank you, Mr. Chairman.

ALEXANDER: Thank you, Senator Burr. Senator Baldwin?

Thank you, Mr. Chairman.

SEN. TAMMY BALDWIN (D-WI): Dr. Redfield, in April the CDC staff conducted an investigation into a COVID-19 outbreak at a meat packing plant in South Dakota. Following the investigation, your staff sent a report to the state that is South Dakota's Department of Health that included strong safety recommendations that CDC determined were necessary to stem the transmission of COVID-19 at the plant. That -- that report was dated April 21st of this year.

[11:25:23]

Last night it was reported that your office intervened and ordered that the safety recommendations be watered down. The next version of that memo dated the following day or April 22nd essentially adds the words if feasible to the strong safety protocols over and over again throughout the document, telling the plant essentially that these recommendations were voluntary or optional.

Workers continued to work shoulder to shoulder at that plant and the plant ignored the safety guidelines. To date, at least 1,200 workers from that very plant have been infected with COVID-19 virus, 34 have been hospitalized and four have died.

And we'll also note that in that same time period in April, on Tuesday, April 24th or 28th, excuse me, that's when President Trump issued his executive order basically naming meat packing as an essential industry in meat parking workers as essential workers.

I'd like to enter the two documents I referred to the April 21st and April 22nd safety recommendations concerning this meat packing plant, if that's OK, Mr. Chair, I'd like unanimous consent to do so?

I think I heard someone indicate that I got unanimous consent.

Dr. Redfield, why did your office demand that these recommendations be watered down?

REDFIELD: Thank you very much, Senator. I wouldn't characterize it the way that you did. What I would say is that the field teams that we had that were in on the Smithfield Plant investigation that you're referring to had a report that they did in the field and they shared it with the local South Dakota Health Department. One of the critical things that needed to be stressed in that report was that CDC is not a regulatory authority. These were, in fact, recommendations. The Department of Labor and OSHA have regulatory oversight and their report can direct that regulatory oversight. Our report was recommendations from an Epi-Aid.

And so, as that document was reviewed, we wanted to make clarification that made sure -

BALDWIN: OK.

REDFIELD: -- people understood ours was a recommendation and not a regulatory requirement.

BALDWIN: Thank you. And I will note that OSHA and the Department of Labor have failed to issue anything, but voluntary guidance as has CDC. There are no pandemic emergency standards in place for workplaces in the U.S. even though they've had eight months to work on this, but that's not your responsibility. Did your office have any contact with Smithfield Foods or the U.S. Department of Agriculture or the White House concerning specifically this memo before it was edited?

REDFIELD: No. Not at that time. There is a multi-interagency discussions between labor, agriculture and ourselves on a variety of the issues that intersect, but in that regard, again, it was -- the purpose was to stress clarity that we were not a regulatory agency. These were recommendations.

BALDWIN: Well, given that I would ask you to consider changing the meat packing guidance. You could simply say we are not a regulatory agency, but these are the safety protocols that we would recommend and not have, if feasible, if feasible.

If feasible, it makes it sound like these are not particularly important if you can do it, great. If you can't -- you can say these are our safety recommendations without it being construed as an OSHA standard, and I would ask, will you change that meat packing guidance in light of the death toll and harm?

REDFIELD: I appreciate your comment, Senator.