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CDC Chief Says, 90 Percent of U.S. Population Still Susceptible to COVID-19; FDA Chief Says, We Won't Approve Vaccine We Wouldn't Give to Our Families; Fauci Says, I Don't Think it's Appropriate to Compare U.S. and Sweden. Aired 11:30-12p ET
Aired September 23, 2020 - 11:30 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SEN. TAMMY BALDWIN (D-WI): Will you change that meatpacking guidance in light of the death toll and harm?
[11:30:04]
DR. ROBERT REDFIELD, CDC DIRECTOR: I appreciate your comment, Senator.
SEN. LAMAR ALEXANDER (R-TN): Thank you, Senator Baldwin.
Senator Rand Paul?
SEN. RAND PAUL (R-KY): Initially, government officials were honest enough to admit that the goal of mitigation efforts, AKA, lockdown, was to flatten the curve, but the area under the curve, the total deaths from the virus would likely be the same. In other words, the lockdown was to mitigate the spike in viral deaths or our hospitals would not be overwhelmed, but the same amount of people would likely die with or without the lockdown.
The media and, frankly, government officials seem to have forgotten this important caveat. Flattening the curve morphed into a belief that we could change the course of the pandemic with an economic lockdown. This is unfortunate and has led to the protracted lockdown recession we are currently mired.
It's important that we examine the data, learn from the data and try to avoid the manmade aspect of this calamity in the future. To those who argue that the lockdown flattened the curve in New York and New Jersey, the evidence argues otherwise. New York and New Jersey wound up with the sharpest spike or highest death rate in the world at over 1,700 deaths per million.
In contrast, Sweden had a relatively softer touch, few mandates and mostly voluntary guidelines, Sweden's death rate ended up about a third that of New York and New Jersey. Some might argue that Sweden and New York and New Jersey are different population, perhaps. But even the average death rate for the U.S. is now greater than Sweden.
In fact, the U.S. death rate is quite comparable to less developed parts of the world, where social distancing is virtually impossible, such as Brazil, Bolivia and Ecuador, which brings us to an important question. Is man really capable of altering the course of an infectious disease through crowd control? The statistics argue a resounding no.
The evidence argues that mitigation efforts have failed to flatten the curve that most countries, regardless of public health policy, suffered a significant spike in deaths and then a gradual decline.
Now, some will argue, what about Hong Kong, Taiwan, South Korea, Japan, each which have had extraordinarily low death rates? Hong Kong, Taiwan and South Korea certainly enforced stricter quarantine and contact tracing than the U.S., and Japan's rules were largely voluntary since their prime minister lacks the legal powers to enforce a lockdown.
One explanation for the low death rate in much of Asia is that the population may have a higher degree of exposure to coronavirus colds, coronavirus colds and therefore have more pre-existing cross-reactive immunity.
If scientists were interested, there is a fascinating field of inquiry looking at susceptibility to COVID-19, an assessment of people would have pre-existing immunity to similar coronaviruses. In fact, pre- existing, cross-reactive immunity to coronavirus may explain why we have so many people that have very little symptoms or asymptomatic.
While there are still many things we need to learn about this pandemic, it is important that we, the people, not simply acquiesce authoritarian mandates on our behavior without first making the nanny state prove their hypothesis. As for now, what we do know is that New York and New Jersey and Connecticut and Rhode Island still allowed the highest death rates in the world.
And we also know that Sweden, who enforced few mandates, ended up with a death rate one-third of New York and New Jersey. We also know that the overall death rate for the U.S. now is essentially equivalent to that of South America, where social distancing and mitigation efforts are virtually impossible.
Dr. Fauci, today, you said you are not for economic lockdown, yet your mitigation recommendations from dating to baseball to restaurants to movie theaters have led to this economic lockdown.
Do you have any second thoughts about your mitigation recommendations considering the evidence that despite all of the things we've done in the U.S., our death rate is essentially worse than Sweden, equivalent to the less-developed world that is unable to do any of the things that you've been promoting? Do you have any second thoughts? Are you willing to look at the data that countries that did very little actually have a lower death rate than the United States?
DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: Senator, I'd be happy at a different time to sit down and go over detail. You've said a lot of different things. You've compared us to Sweden and there are a lot of differences, and you said, well, you know, there are a lot of differences between Sweden, but compare Sweden's death rate to other comparable Scandinavian countries. It's worse. So I don't think it's appropriate to compare Sweden with us.
[11:35:00]
Yes, we have -- I think in the beginning, we've done things based on the knowledge we had at the time and hopefully, and I am, and my colleagues are humble enough and modest enough to realize that as new data comes, you make different recommendations. But I don't regret saying that the only way we could have really stopped the explosion of infection was by essentially -- I want to say shutting down. I mean, essentially, having the physical separation and the kinds of recommendations that we've made.
PAUL: But you've been a big fan of Cuomo and the shutdown in New York. You've lauded New York for their policy. New York had the highest death rate in the world. How can possibly be jumping up and down saying, Governor Cuomo did a great job? He had the worst death rate in the world.
FAUCI: No, you've misconstrued that, Senator, and you've done that repetitively in the past. They got hit very badly, they made some mistakes. Right now, if you look at what's going on right now, the things that are going on in New York to get their test positivity 1 percent or less is because they are looking at the guidelines that we have put together from the task force of the four or five things of masks, social distancing, outdoors more than indoors, avoiding crowds and washing hands.
PAUL: Or they have developed enough community immunity that they're no longer having the pandemic because they have enough immunity in New York City to actually stop --
FAUCI: I challenge that, Senator, because -- please, sir, I would like to be able to do this because this happens with Senator Rand all the time. You were not listening to what the director of the CDC said that in New York, it's about 22 percent. If you believe 22 percent is herd immunity, I believe you're alone in that.
PAUL: There is also the pre-existing immunity of those who have cross-reactivity, which is about a third of the public which would actually get you to --
FAUCI: I'd like to talk to you about that also because there was a study that recently came out that pre-existing immunity to coronaviruses that a common cold do not cross-react with the COVID-19.
ALEXANDER: Thank you, Senator Paul.
Senator Murphy?
SEN. CHRIS MURPHY (D-CT): Thank you very much, Mr. Chairman.
I'll stay with you, Dr. Fauci, I apologize for not giving you a break. There was a study that got some attention regarding Big Ten and PAC Ten athletes that found that 15 percent of them who had COVID-19, whether or not they showed symptoms, had evidence of myocarditis, an inflammation and damage to the heart muscle.
What are the long-term effects for someone with myocarditis? What is the current understanding of the possibly, more general long-term effects of somebody who has had COVID and recovered and are these effects observable in asymptomatic COVID-19 patients?
FAUCI: Yes. Senator, thank you for that question. I actually had mentioned that in my opening comments, but thank you for giving me the opportunity to expand on that. That's really quite puzzling because the individuals that were -- there were two studies. There was one study not in athletes and then there was a study that you mentioned in athletes.
The study in the non-athletes were individuals who had recovered from COVID-19 and had various degrees of involvement, to moderate disease to disease that would require intervention medically. And by doing MRIs, they found that about 60 percent to 70 percent of them had indication of inflammatory disease in the heart.
Interestingly, they were relatively asymptomatic. So I think we need to be careful and just watch what happens because one of the possibilities that could develop is that, A, it could clear up and they have no problem for the rest of their lives. The other thing is that they could wind up when you have inflammation, you could have scarring. That could lead to arrhythmias later on or that could lead cardiomyopathies.
I have to tell you, I do not know what it would be, but it's something we really need to keep our out eye on.
MURPHY: So, insurance companies tend to err on the side of caution. And so what we believe is that because of this uncertainty, because of this potential for long-term health effects that any diagnosis of COVID, whether you're symptomatic or not, will become a pre-existing condition.
And that it is likely probable that insurance companies, if they are allowed to discriminate against people with pre-existing conditions, as will happen if the Supreme Court justices put on the court and the ACA has invalidated, we will see rates skyrocket for anybody who has had COVID, I think something we all need to talk about over the course of the next few weeks.
Dr. Redfield, Admiral, I want to come back to this question of the guidance on testing. I think this is really important, because, you know, we have to take the president at his word. He announced that he had instructed his advisers that, quote, slow the testing down, please.
[11:40:04]
When folks suggested he was kidding he was asked by reporters, are you kidding, and he said, I don't kid.
Let me just tell you, let me make it clear. So the president made it clear he wants less testing and so it didn't seem coincidental to us that this strange guidance came out in August that recommended significantly less testing, and yet that's not what you're testifying to today. You're both saying that, in fact, that August guidance didn't recommend less testing and all you were doing with this third set of guidance in 30 days was to clarify.
But where in the August guidance does it tell people that they should get a test if they are asymptomatic, but in close contact, where in that guidance does it actually tell them that they should proactively see a health care provider if they have been in contact? Because I've read it 20 times and I don't see anywhere in this guidance that it tells people they should get a test. I don't see anywhere in this guidance where it tells them that they should go see a doctor.
It reads, you do not necessarily need a test unless you are a vulnerable individual or your health care provider or your local health officials recommend you take one. That doesn't say you should go to the doctor. That just says, if you have been recommended to get a test, you should.
So it stands to reason that when folks read this, they will be under the impression that they shouldn't get a test, which seems to comport with the directions of the president, slow the testing down, please. Where in this guidance that you issued in August does it tell people that they should get a test or they should proactively see a doctor?
REDFIELD: The -- thank you very much, Senator. And as I've said before, I take the position that more tests will actually lead to less cases, particularly if it fully engages public health action. And when I issued the clarification on August 27th, again, I said that we are placing emphasis on symptomatic illness and also, as you said, individuals with significant exposure, vulnerable populations, critical infrastructure workers, health care workers and those individuals who may be asymptomatic when prioritized by a medical or public health official.
The reason that this came from the public health perspective, we were seeing individuals drive up, get a test and then go on to work. There wasn't a public health action associated with testing. So we calculated that this would help bring a public health action to testing.
MURPHY: But, notably, you don't tell people in this guidance that they should go see a doctor.
REDFIELD: When I said -- when we clarified the day after, I put very clearly what the clarification was about the emphasis and the final category with those individuals who were asymptomatic when prioritized by a medical or public health individual. And, again, the intent was for testing to drive inaction that was for a public health objective.
It was clear through a variety of different reasons when we found that some individuals were not even doing testing for contacts, the individuals with significant exposure. We then put to further clarification.
I had thought that the August 27th clarification statement that I put out would carry the football over the goal line. It didn't. But I can tell you there was no intent to this guidance to decrease testing. On the contrary, the intent was to link testing and to drive a public health action.
And, again, the manner in which it was interpreted by a number of individuals was such that it didn't accomplish that goal.
MURPHY: I think I'm over my time. This has just been dizzying, dizzying for public health professionals. They're just awaiting the next correction.
Thank you, Mr. Chairman.
ALEXANDER: Thanks, Senator Murphy.
In my effort to be fair to everybody, we are running over the five minutes pretty well. So we have about 14 senators remaining who would like to ask questions, so I would ask colleagues to keep that in mind, please, with the five-minute rule.
Senator Collins?
SEN. SUSAN COLLINS (R-ME): Let me begin my questions today by thanking each of you for your hard work, your professionalism and your integrity. I don't think you get the appreciation that each of you deserves.
Admiral, the American people clearly need to have confidence that all our federal health agencies will abide by their gold standard, rigorous protocols and preserve scientific integrity.
[11:45:09]
And we have heard this morning just such strong assurances.
Nevertheless, just last week, Secretary Azar barred the nation's health agencies from signing new rules themselves regarding medicines or medical devices, as they normally would do. Such a major change at this critical time could delay progress and cause the American people to doubt whether the proper protocols are being followed.
Could you explain why these changes are taking place and whether they could affect new medical countermeasures for COVID-19?
ADM. BRETT GIROIR, ASSISTANT SECRETARY FOR HEALTH, HHS: So, thank you for that, Senator. I've spoken to several people in the immediate offices of the secretary. And as I understand it, and I do absolutely believe it, that this was an administrative decision by the secretary because rule-making authority in an agency that has 90,000 people gets disseminated broadly and widely and he wanted to make sure that whatever rules were proposed by FDA or other rule-making organizations had review and scientific integrity.
I do not believe that this will interrupt the process. You have my commitment to make sure that I will provide the best public health advice to the secretary on all these matters. I don't believe it will make a difference, and these can be redistributed back out. This was an administrative process, as I understand it, to bring them back in, to gain control so that there aren't hundreds of different ways to make rules during this very important time and perhaps Dr. Hahn, as a rule-making agency, might have a comment on that, as well.
COLLINS: I have a different question for Dr. Hahn, but I want to make sure I get to. Let me say that while I appreciate your assurances, if everything is going to have to flow up to the secretary, it seems inevitable that it is going to create delays and doubts, and neither of those are helpful as we deal with this pandemic.
Dr. Hahn, I want to bring up with you an issue that we discussed many times, and that is the fact that so many of our active pharmaceutical ingredients for medicines for the American market are manufactured overseas. In fact, 72 percent of the facilities are located overseas in countries like China and India. India put an export ban on some 26 APIs. We know that China hoarded PPE that our country needed.
So my question to you is are we making any progress in ensuring that the APIs that may be critical in therapeutics for treating people with the coronavirus or the ultimate vaccine are manufactured right here in the United States and not in China or India or somewhere else?
DR. STEPHEN HAHN, COMMISSIONER, FOOD AND DRUG ADMINISTRATION: Thank you, Senator Collins. You bring up an incredibly important topic and one that I think has been very much highlighted during the pandemic. We have seen situations where the lack of redundancy in our supply chain, the lack of domestic manufacturing has led to shortages here at home. So we have been very active and believe we are making progress with respect to what we're calling advanced manufacturing.
Senator Collins, we have spoken about this many times, and the issue of making sure that we have this redundancy through advanced manufacturing is important and something that FDA has been involved with for years.
With respect to the medications, for example, and PPE, I know that the White House task force has been particularly focused through FEMA, and now HHS on making sure that we build up our domestic capacity particularly around PPE.
And so, yes, those are in progress. It remains a top priority for the Food and Drug Administration. Our role in this would be to help to create whatever regulatory pathway we can so that we can facilitate advanced manufacturing that's domestic.
COLLINS: Thank you very much.
[11:50:00]
ALEXANDER: Thank you, Senator Collins.
Senator Warren.
SEN. ELIZABETH WARREN (D-MA): Thanks, Mr. Chairman. Vaccines our best chance to end this pandemic but Americans are not going to take a vaccine if they don't trust the federal officials who are promoting it. If federal officials stand to gain financially from certain COVID vaccines and not from others, then Americans might reasonably worry that the vaccine was pushed for personal profit and not because it was best for our health.
So I have a question for all of our witnesses, and I think you can answer with just a simple yes or no. Dr. Fauci, do you hold direct financial investments, like stocks, in any of the companies that are developing COVID-19 vaccines?
FAUCI: No.
WARREN: Thank you. What about you, Dr. Redfield?
REDFIELD: No, Senator.
WARREN: All right. Dr. Hahn?
HAHN: No, Senator Warren.
WARREN: And Admiral Giroir?
GIROIR: No, Senator Warren.
WARREN: Okay, thank you. So none of you stands it get richer if any particular drug company gets money from the government. I'm not surprised by federal ethics law prevents you from owning stocks like that. Public health, not money, guides your work for the American people and that is exactly how it should be.
Dr. Hahn, the FDA is responsibility for deciding whether a COVID-19 vaccine is safe. In your opinion, if the FDA officials making these decisions have financial conflicts, would that that increase or decrease people's confidence in a COVID-19 vaccine?
HAHN: Senator, I am not aware of anyone at FDA that has a conflict related to vaccines who is involved in that decision-making process. So it would be difficult for me to speculate on that since we have very rigorous standards in place. We have monthly review, particularly of senior officials. We have regular training, and we have a culture at FDA which looks at the issue of self-declared as well as office government ethics review of all conflicts.
So, one thing, I would like to say to you, Senator, if anyone is aware of anyone at FDA who has a conflict related to these, I would personally want to know because we will address that right away.
WARREN: Well, I very much appreciate this, because what you're saying is that financial conflicts are a real problem in the drug and vaccine development process.
But here is the problem we've got. Dr. Moncef Slaoui, the man that President Trump selected as the government's, quote, Vaccine Czar, is a former drug executive. The Trump administration used a loop hole in federal ethics law to hire him to keep his conflicts from the public.
Now, reportedly owns about $10 million of stocks in GlaxoSmithKline, a drug company that's working on a coronavirus vaccine. And according to documents released yesterday by the House, he may own stocks in Lanza Group, which is a company working with Moderna, another pharmaceutical company that is trying to make this vaccine.
Why does this matter? Well, Operation Warp Speed, the federal vaccine project that Dr. Slaoui heads up, has invested billions, that's billions, of dollars in the companies that Dr. Slaoui holds stock in.
So, Dr. Hahn, you and other FDA officials involved in the COVID-19 vaccine must comply with conflict of interest laws. You've just told me how seriously you take that. So can you explain to me why Dr. Slaoui should get to play by a different set of rules?
HAHN: Senator Warren, I can't explain the situation. I don't have any knowledge of what you describe. What I can tell you is that we have established a very bright line between Operation Warp Speed and FDA. We do not participate in their decisions. We provide technical assistance, just as we would for any sponsor.
WARREN: So, with all due respect, Dr. Hahn, you just told me financial conflicts of interest basically undermine the public's trust in a vaccine and Dr. Slaoui has conflicts of interest. So, to boost the public's confidence, shouldn't he eliminate these conflicts?
HAHN: Senator Warren, I am not aware of the conflicts you are describing, and so I can't comment. I can't --
WARREN: Let me put it this way. Hypothetically, if these conflicts exist, and we will only know if they exist if he makes a full disclosure, but there's much evidence that they exist. If these conflicts exist, should he resign?
HAHN: So, in a hypothetical situation that you're describing, again, I can't prejudge because I don't know the facts, but I do take very seriously the issue of conflicts of interest and how that might affect public perception.
[11:55:07]
WARREN: Well, let me put it this way. Congress should strengthen the federal ethics laws to root out this kind of corruption. It should pass the Coronavirus Oversight and Recovery Ethics Act, which is a bill I introduced, in order to prohibit conflicts of interest in the federal COVID-19 response. And the first person to be fired should be Dr. Slaoui.
The American people deserve to know that COVID-19 vaccine decisions are based on science and not on personal greed, and Congress should pass my bill today.
Thank you, Mr. Chairman.
ALEXANDER: Thank you, Senator Warren. Senator Cassidy?
SEN. BILL CASSIDY (R-LA): Thank you, Mr. Chairman.
I was distracted when Senator Burr was giving his answer but may have replied to Senator Casey, and says, if Senator Casey did not hear Admiral Giroir's testimony when he said, what is the administration be doing to prevent deaths in nursing homes and we just heard how many were being deployed to nursing home. And so I just want to -- in case he wasn't able to raise that, I just want to emphasize that.
Secondly, commenting on previous testimony, Dr. Redfield, I thought you answered Senator Baldwin's question very well, but I will say my office called OSHA as regards guidelines for people who are, you know, from businesses in terms of how to conduct themselves, and OSHA has said that they are deferring to CDC. That's not CDC's fault, Mr. Chairman. I would just recommend we have a hearing with OSHA to kind of straighten that out because I thought that is a good point.
Dr. Giroir, the -- the -- it's my understanding that the administration's granting authority to pharmacists to immunize those between ages 3 and 18, because of the crisis, we've had a kind of slowdown, and those children, they're missing their vaccines that they should get. Is there going to about requirement that they put these vaccine records in the states immunization registry?
GIROIR: Yes, sir.
CASSIDY: And what about federal facilities, such as DOD, V.A., Indian Health Service, et cetera? Will they likewise be required to enter their data into the states immunization registry?
GIROIR: Sir, I actually don't know about DOD. I just don't know that specific. I know that for the pharmacists, of course, and anyone in the civilian population, they are required. That was a part of the prep act declaration and my guidance about that.
CASSIDY: And just a suggestion that DOD should be required, because, obviously, many will be separating from the military and it may be a condition of employment by a health care facility that someone be vaccinated. It would be nice have that documented as opposed to someone just stating they have been, just to point that out.
GIROIR: Yes, sir. I wasn't commenting on whether it's good or bad. I just didn't know the regulation for DOD. We would be very happy to look that up and bring it back, sir.
CASSIDY: Oh, yes. And I'm not fussing about it. I'm just kind of pointing that out.
Now, Dr. Redfield -- maybe Dr. Giroir. I understand that the vaccine can be given without cost to the patient, but there is a concern by the provider that they would be compensated for all their costs associated with administering the vaccine. So, in the guidance coming out that the American will not have to pay, but is there still going to be compensation for the provider who is administering the immunization?
GIROIR: So, thank you, Senator, and let me speak generally that, of course, we would assume there are costs for the provider. These are going to be tens or hundreds of millions of vaccines. There are details to be worked, but the administration committed to assuring that no patient has out of pocket expenses, whether it's for the vaccine itself or for the administration of that vaccine.
CASSIDY: Got you.
Dr. Hahn, the vaccine may only have 50 percent efficacy. I think that's the FDA's minimum. As to considering whether a vaccine is effective is that it is efficacious at least 50 percent of the time. Presumably, the level of antibody response would be a marker as to whether or not somebody has had a response.
So my question is, for those folks who are at higher risk, take the emergency room nurse, the tech or the clerk admitting people to the E.R., will antibody serologies be required after the vaccine is given, and do we have enough antibody serologies -- serologic tests, which are sufficiently accurate and are available in order to contact this?
HAHN: Senator, thanks for the question.
[12:00:00]
