Chairman: (00:00)
… in parallel. What that means is that operation Warp Speed is manufacturing tens of millions of doses of the six vaccine candidates at the same time the clinical trials are ongoing and the Food and Drug Administration works to determine whether those vaccines are safe and effective. If the FDA does not approve the vaccine, it will not be distributed. The risk is taxpayer money, not the safety and efficacy of the vaccine.
Chairman: (00:36)
The administration had set a stretch goal that once seemed impossible, but now seems likely. The administration hopes to have as many as 300 million doses of vaccines available to be deployed by mid 2021, according to an August 26 article by Operation Warp Speed program’s principal adviser, Dr. Moncef Slaoui, and vaccine expert, Dr. Matthew Hepburn, that was published in the New England Journal of Medicine.
Chairman: (01:08)
The authors also wrote, “No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, the accomplishments to date, make us optimistic that we will succeed in this unprecedented endeavor.
Chairman: (01:28)
Mr. Paul Mango with the Department of Health and Human Services said recently in a meeting that, “If all goes well, it’s possible that up to 700 million doses will have been manufactured by April of next year.” 2021.
Chairman: (01:45)
The Department of Health and Human Services, Department of Defense, private sector, public health and medical professionals also are working together to lay the groundwork for deciding who gets the first doses, such as healthcare workers and certain high-risk populations, and how to get those doses to those individuals.
Chairman: (02:04)
The Centers for Disease Control has asked states to submit plans by the middle of October of this year, next month, to begin distribution.
Chairman: (02:15)
There’s been a lot of back and forth over exactly which date the first vaccine doses, which, remember, are already being manufactured and made ready for distribution, when will they be available for distribution to the public? The answer of course, is that the only people who know when a vaccine will be ready, are the scientists at FDA, who will review the science and the clinical trial data and determine whether the vaccine is safe and it works.
Chairman: (02:46)
Even Dr. Stephen Hahn, the Commissioner of the FDA, who is testifying today, does not know when that date will be because the FDA will not approve a vaccine until three things happen. One, independent experts overseeing clinical trials determine there’s enough data available to the FDA to make a decision. Two, after demonstrating safety and efficacy, based on clinical trials, the vaccine manufacturer submits an application to the FDA and then three FDA experts conduct their review and make the final determination the vaccine is safe and that it works.
Chairman: (03:27)
As to treatments, the second unprecedented story of the United States response to COVID-19 is the development of treatments. There are five products authorized for emergency use today to help treat and manage COVID-19 symptoms, including Remdesivir, certain steroids, blood thinner, convalescent plasma. Operation Warp Speed officials are optimistic, they say, that more treatments will be identified or developed and in clinical trials this fall, with potential for approval or authorization by the end of the year.
Chairman: (04:05)
The most promising appear to be monoclonal antibody cocktails, which have been used to prevent and treat other diseases, like Ebola. Three companies are in clinical trials of antibody cocktails.
Chairman: (04:19)
Knowing there is some medicine that will help treat COVID-19 should greatly relieve the anxiety of Americans who want to go back to college, back to school, back to childcare, back to work, and out to eat.
Chairman: (04:33)
A third success story is the explosion of fast, cheap, reliable diagnostic tests. After initial missteps, our country lost several crucial weeks in distributing the diagnostic tests that would help to identify and isolate those who contracted the virus. But since then, an unprecedented effort of public and private research has created capacity this month for administering more than 90 million tests, about half of them rapid tests, according to Admiral Giroir, who’s here today.
Chairman: (05:08)
Abbott Laboratory says that it’s on track to produce 50 million of its test a month by October, which can produce a result in 15 minutes and costs $5 a test. The government has purchased 150 million of Abbot’s tests to help expand testing in places like schools and nursing homes. I’m sure we’ll hear something about how that will be distributed today.
Chairman: (05:36)
Congress funded the so-called shark tank, or rapid acceleration of diagnostics initiative at NIH, with the objective of developing and deploying tens of millions of new rapid diagnostic tests. Dr. Francis Collins, Director of NIH, has reported that, combined, these new technologies have the potential to add least 60 million new tests a month by December.
Chairman: (06:01)
Dr. Collins has told me, “This is not the end of the story. There are lots of additional technologies coming through the pipeline, many of which are rapid, inexpensive, point of care, and home-based tests.”
Chairman: (06:15)
Until vaccines and treatments are widely distributed, this explosion of many cheap, reliable, rapid diagnostic tests is our best weapon to build confidence among the American people that it’s safe to go back to school, back to work, and out to eat. There should be plenty of tests. In fact, there are now to do surveillance testing of those without symptoms in certain settings like colleges and childcare centers.
Chairman: (06:44)
It’s important to give credit to this Congress and this president for funding this unprecedented effort to develop and manufacture vaccines before they’re all approved, knowing full well that one or all of them might fail with a considerable loss of money.
Chairman: (07:01)
Since March Congress has appropriated more than $47 billion for tests, treatments, and vaccines, a large amount that pales in size though to the 3 trillion spent to try to ease the pain by shutting down the economy.
Chairman: (07:16)
It’s important to give credit to the previous presidents and previous congresses for the bipartisan work they’ve done over the last 20 years to make possible the remarkable successes I just described earlier. Dr. Slaoui, for example, told me that the government today could not be manufacturing for the vaccines that are currently being developed if Congress had not provided the Department of Health and Human Services with funding to make awards in 2012, eight years ago, to build three manufacturing plants that would be on standby for the next epidemic.
Chairman: (07:51)
The decision to look ahead then to the next pandemic and some on this committee, Senator Burr specifically, had a role in that, Dr. Slaoui said that was visionary.
Chairman: (08:02)
On March 1st, the New York Times reported that the United States is among the countries best prepared to prevent or manage such an epidemic, focused on COVID.
Chairman: (08:13)
Why would they say that on March the 1st? Well, let’s look at the NIH. For five consecutive years, this Congress has significantly increased investment in the National Institutes of Health for biomedical research. NIH’s Infectious Clinical Research Consortium, which was established last year, was able rapidly to shift ongoing clinical trials and quickly enroll volunteers for COVID-19 trials and treatments and vaccines. Or look at the FDA. Congress provided FDA with specific authorities beginning 2004, 16 years ago, to review and issue emergency use authorizations for tests, treatments, and vaccines to respond to public health emergencies.
Chairman: (09:00)
Dr. Hahn has used that authority. FDA has used that authority to authorize 250 tests and five treatments as quickly as possible. Also to remove tests and treatments when additional evidence showed they didn’t work as well as they should.
Chairman: (09:17)
Look at BARDA. Congress established the Biomedical Advanced Research and Development Authority in 2006, 14 years ago, to help companies work with FDA to get safe and effective test, treatments, and vaccines out. BARDA was able to announce the award for potential COVID-19 treatment and vaccine candidates just over one month after the vaccine was first reported in China.
Chairman: (09:40)
As I said earlier, four of the first six vaccines are being manufactured in facilities built in 2012 for this purpose, for a future pandemic. Then there’s been federal support over the years for state, local, and hospital preparedness, $21 billion between 2002 and 2017. CDC has used existing programs to help states retrain workforces, expand lab capacity, planning for a future pandemic from pandemics during the last several years. Even with super computing, these congresses, the last few, have increased funding in the Department of Energy so that the United States is first in the world in super computing. They’re at our national laboratories and they’re being used to help develop treatments and vaccines.
Chairman: (10:33)
I go through all of that to show that several congresses and several presidents have done things to help us get ready for this unprecedented sprint towards success in vaccines, treatments, and tests.
Chairman: (10:47)
Finally, I’d like for this Congress to be visionary as well and while we’re in the midst of this pandemic to help get ready for the next one. Former Senator Frist, the majority leader, testified before this committee that the next pandemic is not a question of if, but when. Jared Diamond, the author of Guns, Germs, and Steel, says the main thing that’s different about this germ is the jet plane. That people can travel around the country and around the world and spread it. He concludes that the next pandemic could be next year.
Chairman: (11:26)
Congress should take stock now, while our attention is on the current crisis of what we’ve learned during COVID-19, and address some of the problems we know we can solve just like previous Congresses and previous presidents did. Many of the witnesses that have appeared before this committee have agreed we have three things to do.
Chairman: (11:45)
One, sustain onshore manufacturing of test, treatments, and vaccines. Two, create and sustain state stockpiles of supplies, so they’ll be available in a public health emergency, and strengthen the strategic national stockpile. We’ve seen time and time again, attention spans are short. We must act now to stop the cycle of panic, neglect, panic.
Chairman: (12:10)
I look forward to hearing from all of our witnesses today about how the federal government is continuing to respond and to help state respond, how soon we can expect more treatments and a vaccine for COVID-19, and what steps we can take now to prepare for the next pandemic.
Chairman: (12:28)
I will now recognize Senator Murray for her opening statement.
Patty Murray: (12:33)
Well, thank you very much, Mr. Chairman. Thank you so much to our witnesses for joining us once again today. Before we begin, I do want to take a personal moment to acknowledge the passing of Justice Ginsburg, a friend, a role model, and a woman who opened doors for all of us with her genius and her relentless pursuit of justice, freedom, and equality.
Patty Murray: (12:57)
This appointment to our nation’s highest court could not be more pivotal, especially as we face down an historic public health crisis. We are in the middle of a pandemic that has cost more than 200,000 American lives on this administration’s watch, has left nearly 7 million people across our country with new pre-existing conditions, and 5.4 million people without coverage. Yet none of that has stopped Republicans from using every tool at their disposal, including the Supreme Court, to attack healthcare and protection for families across our country.
Patty Murray: (13:38)
I’m not going to let anyone forget many of the same Republicans who are considering filling this vacancy with a nominee virtually guaranteed to tip the balance of the court against people’s healthcare in the critical case coming up this year, previously said in March of 2016, the American people should have a voice in the selection of the next justice and said, many times over the past few years, they support protections for pre-existing conditions.
Patty Murray: (14:07)
The entire country is going to be hearing about what another Supreme Court nominee handpicked by President Trump would mean for their healthcare and their rights.
Patty Murray: (14:17)
To today’s hearing. Back in January, I worked to help organize the first bipartisan briefings with the administration officials about the COVID-19 threat. I wrote to secretary Azar shortly after, asking what steps we were taking and specifically asking about our diagnostic testing capacity.
Patty Murray: (14:40)
At a hearing in February, I pressed him directly about issues with those tests. I asked him point blank if our country was ready. Tragically, the clearest answer I got to that question did not come from the Trump administration, it came back from families in my home state of Washington, and it came as a resounding no.
Patty Murray: (15:03)
By March, I was hearing from people in my state who believed they’d been exposed, but could not get tested and who had been tested, but were left waiting for results. I was hearing from schools in my state, including my granddaughter’s, that they were canceling classes and closing schools. I was seeing nothing from the Trump administration to inspire confidence or to act with urgency. Let’s be clear, we had a window to prepare for this and the administration missed it. We had a pandemic playbook that warned against some of the very problems we were facing. They ignored it. We had a clear understanding of how dangerous this disease could be and they downplayed it.
Patty Murray: (15:48)
Much has changed since those early days of this crisis. Now, the number of people infected in our country has passed six and a half million. The number of people killed passed 200,000. The number of people without a job and without health insurance has skyrocketed and businesses have been shuttered. Gatherings, from weddings, to birthdays, to graduations, to funerals have been delayed or canceled. But one thing has not changed. President Trump is still putting politics ahead of public health. He is still downplaying this crisis and falsely claiming it will just go away or we’re turning the final corner. When the reality is cases and deaths are still alarmingly high. Testing and contact tracing are frustratingly inadequate. The health disparities, black, Latino, and tribal communities and other communities of color face are still severe.
Patty Murray: (16:51)
We need to prepare for the upcoming flu season, when experts warn us we could see another wave of cases. And yet President Trump is still trying to sabotage the work of our scientists and public health experts for his own political ends.
Patty Murray: (17:08)
As the leaders of health agencies on the frontline of our response to this pandemic, our witnesses have an important firsthand perspective on this interference. Dr. Hahn, the Food and Drug Administration Has a critical role to play in evaluating the safety and efficacy of treatments, diagnostics, and vaccines. The American people are counting on you to uphold sound scientific principles and the work of agency scientists.
Patty Murray: (17:40)
It is incredibly alarming that This administration has undermined public trust work of your agency by spreading conspiracies and pressuring the agency to ignore the science. Earlier this year, the administration dangerously promoted hydroxychloroquine, an unproven treatment for COVID-19, but even more recently, the administration pressured FDA to rush through an emergency use authorization for convalescent plasma therapy.
Patty Murray: (18:11)
Last month, Secretary Azar reportedly overruled you directly and undermined FDA’s authority when he loosened oversight of lab developed tests, a move that allows unreliable tests to flood the market.
Patty Murray: (18:28)
Then last week, Secretary Azar further undercut your agency by completely barring FDA from signing any new rules without his approval, an alarming power grab for a political appointee to make in the middle of a pandemic.
Patty Murray: (18:46)
Dr. Redfield, the Centers for Disease Control and Prevention plays a critical role providing data and science-based public health guidance that our families, public health professionals, researchers, and healthcare providers rely on for life and death decisions. Yet the Trump administration has repeatedly and recklessly interfered with those efforts.
Patty Murray: (19:11)
We have seen the White House block and contradict critical guidance on reopening for communities and returning to school. We have seen the president spread conspiracies about the death count and misinformation about masks. The Trump administration officials have reportedly taken unprecedented steps to hijack the CDC, suppress its voice, and undermine its credibility. Key administration ignored the objection of CDC scientists and posted guidance under CDC’s name advising restricted access to testing, a move that was immediately criticized by public health experts and has since thankfully been reversed.
Patty Murray: (19:55)
Political appointees have demanded to oversee and manipulate the agency’s morbidity and mortality weekly reports. Last week, you confirmed the administration took hundreds of millions of dollars out of your budget for a feel good pandemic ad campaign spearheaded by a Trump official that believed CDC was part of a “deep state conspiracy”, in which CDC, inexplicably, has no role and which they have not even indicated will be reviewed by your agency to make sure it is based on facts and science.
Patty Murray: (20:35)
If this weren’t all bad enough, after your testimony before Congress last week, the president said you were “confused”, that you made a mistake and had given incorrect information. All of this raises serious concerns about the agency’s decision Monday to put out guidance with new information on how this virus is transmitted only to immediately reverse course and pull it down.
Patty Murray: (21:03)
Dr. Fauci, you’ve been a trusted voice on public health issues in this country for decades. Yet the Trump administration officials have tried unsuccessfully to dictate talking points to you and undermine your credibility through opposition research and in an op-ed. The president himself even retweeted a message calling for you to be fired.
Patty Murray: (21:25)
Any of these examples of political pressure would be alarming on their own, but together they paint a clear pattern of interference that is downright terrifying. The Trump administration didn’t just start its political interference yesterday, and we’re not going to expect them to cut it out tomorrow. Congress has to make it stop. The president has made it painfully clear where he stands when it comes to picking between politics and science, politics and public health, politics and the safety of our country. Now each of us has to do the same.
Patty Murray: (22:03)
Yesterday, Senator Schumer and I, along with over 30 of our democratic colleagues, introduced the Science and Transparency Over Politics Act. It will create a task force to conduct a thorough investigation into political interference in our public health agencies. I do hope every Republican who has spoken out about how important it is we stick to the science will support that bill. Because you cannot stand for science if you will not stand against political interference.
Patty Murray: (22:35)
I’m also going to be asking our witnesses more about this as well, because it’s so critical that we know what political pressure they’ve been under and what is being done to resist it.
Patty Murray: (22:45)
Finally, Mr. Chairman, yes, this may be our last hearing this Congress. I want to recognize again the work we’ve done together on this committee and your time as Chair. The list of major bi-partisan bills we have gotten signed into law over the past few years, you know them. Every Student Succeeds Act, 21st Century Cures Act, Opioid Crisis Response Act, [Perkin CG 00:23:05] reorganization, and more.
Patty Murray: (23:07)
The kind of bipartisan approach we used to get those bills passed is going to be critical if we are finally going to take the steps we need to take to address the pain of this pandemic, which is why the current state of discussions to pass more much needed relief is so frustrating. Republicans didn’t offer anything for months and after they finally put forward a proposal, they didn’t even sit down with us to move towards common ground. Instead they moved further away from us with their next proposal.
Patty Murray: (23:39)
After all the success we’ve had on this committee, I think we’ve shown by example that is not how bi-partisan negotiating works. I’m not done pushing for Republicans to come back to the table on a new COVID-19 package, put partisanship aside, put our families first, and work together to respond to this pandemic with the kind of sweeping response that is so clearly needed. Thank you, Mr. Chairman.
Chairman: (24:09)
Thank you, Senator Murray. We’ll now introduce our witnesses. We ask them to summarize their comments in five minutes each. Our first witness is Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institute of Health. He’s held this position since 1984, led the agency’s research related to HIV/AIDS, influenza, malaria, Ebola, and other infectious diseases. Dr. Fauci has advised six presidents on domestic and global health issues. He was one of the principle architects of the president’s emergency plan for AIDS relief.
Chairman: (24:50)
Next, Dr. Robert Redfield. He’s Director of the US Centers for Disease Control and Prevention for more than 30 years. He’s been involved with clinical research related to chronic human viral infections and infectious diseases, especially HIV. He served as the founding director of the Department of Retroviral Research within the US military’s HIV research program. Retired after 20 years of service in the US Army Medical Corps.
Chairman: (25:18)
Third witness, Admiral Brett Giroir. Admiral Giroir is the Assistant Secretary for Health in the US Department of Health and Human Services. He oversees the Commission Corps of the United States Public Health Service and key public health programs. Specific to COVID-19, he’s taken on testing and focused on increasing the number of tests that we can do with existing technology. His federal service includes directing the Defense Service’s Office of the Defense Advanced Research Projects Agency, and several other important responsibilities.
Chairman: (25:57)
Finally, we will hear from Dr. Steven Hahn, Commissioner of the US Food and Drug Administration, the FDA. Before joining FDA, he held leadership roles as Chief Medical Executive at the University of Texas MD Anderson Cancer Center, and is Chair of the Department of Radiation Oncology at the University of Pennsylvania. Early in his career, he was a senior investigator at The National Cancer Institute. At NIH, additionally, he held the rank of Commander in the US Public Health Service Commissioned Corps.
Chairman: (26:29)
Welcome again to our witnesses. Dr. Fauci, let’s begin with you.
Anthony Fauci: (26:36)
Mr. Chairman, ranking member Murray, members of the committee. Thank you for giving me the opportunity to speak with you today, briefly on the role of the National Institutes of Health research in addressing COVID-19.
Anthony Fauci: (26:52)
As I mentioned to this committee in a prior hearing, the NIH and NIAID has a four-part strategic plan for research to address COVID-19.
Anthony Fauci: (27:03)
The first is to improve the fundamental knowledge of the virus itself, viral biology, and the clinical manifestations resulting from infection. We have continued to push the frontier of understanding this virus, particularly with regard to the conformational structure of the spike protein, which serves as the basis for all of the vaccines that are being pursued now, which I’ll get to in a moment. In addition, there have been a number of important clinical observations that we will be pursuing in the future.
Anthony Fauci: (27:35)
I bring to your attention the fact that a number of individuals who virologically have recovered from infection, in fact have persistence measured in weeks to months of symptomatology that does not appear to be due to persistent of the virus. They’re referred to as long haulers. They have fatigue, myalgia, fever, and involvement of the neurological system, as well as cognitive abnormalities, such as the inability to concentrate.
Anthony Fauci: (28:04)
In addition, we found, to our dismay, that a number of individuals who have completely recovered and apparently are asymptomatic, when they have sensitive imaging technologies, such as magnetic resonance imaging, or MRI, have found to have a disturbing number of individuals who have inflammation of the heart.
Anthony Fauci: (28:24)
These are the kinds of things that tell us we must be humble and that we do not completely understand the nature of this illness.
Anthony Fauci: (28:31)
Next, with regard to diagnostics, we have the Radix program that is going to, in the next several months, allow us to have a considerable number of point of care testing.
Anthony Fauci: (28:43)
Moving on to therapeutics. I mentioned to this committee some time ago that the NIH put together an expert panel for treatment guidelines, which is a living document that reviews the literature as well as the areas of expertise that are pre-publication to help clinicians throughout the world to address the clinical components of this outbreak.
Anthony Fauci: (29:06)
I must tell you that as of last night, there have been 4.5 million views of this treatment guideline, so it clearly is helping people throughout the world.
Anthony Fauci: (29:17)
I want to mention two of the drugs that have actually now be part these guidelines, Remdesivir, which you’ve heard about, has been shown in a randomized placebo controlled trial to diminish the time to recovery in individuals who are hospitalized, who have lung disease. In addition, Dexamethasone, a commonly used steroid, has been shown in a randomized placebo controlled trial involving more than 6,000 individuals has been shown to clearly and significantly reduce the 28 day mortality.
Anthony Fauci: (29:49)
In addition, there are a number of other treatments, including antiviral convalescent plasma, which is still being tested in randomized control trials. You mentioned, appropriately and correctly, that we feel optimistic about monoclonal antibody.
Anthony Fauci: (30:03)
… incorrectly that we feel optimistic about monoclonal antibodies, which are currently being tested in an outpatient setting, in an inpatient setting. Family prophylaxis, which means when an individual in a given family gets infected, if you give monoclonal antibodies to the rest of the family, can you prevent the spread within the family unit, and finally nursing home prophylaxis. As you mentioned there are three companies involved in this.
Anthony Fauci: (30:27)
And finally and importantly the issue of vaccine. We have put together what’s called a strategic approach to what’s called vaccine development. As you mentioned Mr. Chairman, there are six companies that the federal government is playing a role in either helping to develop, subsidizing, or supporting the clinical trials. We’re harmonizing the trials so that information from one can be applicable to another. Currently there are three platform candidate vaccines that have entered into phase three trial. Very soon there will be a fourth.
Anthony Fauci: (31:05)
As I mentioned to this committee, we feel cautiously optimistic that we will be able to have a safe and effective vaccine, although there is never a guarantee of that. Early studies in animals and in human phase one and phase two, indicate that individuals induce a response that is comparable to, if not better, than natural infection. And so as these trials go on, we predict that sometime by the end of this year, let’s say November or December, we will know whether or not these are safe and effective, and as you mentioned Mr. Chairman, right now doses of this vaccine are being produced so that they’ll be ready to be distributed.
Anthony Fauci: (31:45)
I’ll close with a comment that we feel strongly that if we have a combination of adherence to the public health measures, together with a vaccine that will be distributed to people in this country and worldwide, we may be able to turn around this terrible pandemic that which we have been experiencing. Thank you Mr. Chairman. Happy to answer questions later.
Chairman: (32:08)
Thank you Dr. Fauci. Let’s go to Dr. Redfield and then Admiral Giroir and then Dr. Hahn. Dr. Redfield, welcome.
Dr. Redfield: (32:18)
Thank you Chairman Alexander, Ranking Member Murray, and members of the committee. And I want to thank you for the opportunity to be here today. On behalf of the CDC, I also want to thank you for your continued support of our public health professionals and their lifesaving work that they’re committed to 24/7. Over 6,700 CDC staff have been engaged in our agencies COVID-19 response so far and more than 1,200 have been deployed to more than 200 locations, travel nations in the United States and abroad. I know that you joined me in expressing our collective deep gratitude to the women and men of CDC for their resilience, their dedication, and their service to our nation. Throughout this global pandemic, CDC has brought its science expertise to the front lines, grounded in science and data, conducting rapid investigations of disease outbreaks that identify the highest risk populations and settings, and putting in place measures to prevent further spread of COVID-19.
Dr. Redfield: (33:23)
Understanding which populations are most at risk, and how this virus spreads, and various settings is critical in developing guidance and protecting the health of Americans. As you are aware, in the United States we are approaching nearly seven million cases and sadly over 200,000 deaths. Every death means that a loved one was lost. But there is some progress to report. Since the pandemic peaked on July 25th of this year, we’ve experienced nearly a 50 percent reduction in daily cases, and a 32 percent reduction in deaths. There’s also been significant improvement in the mortality, particularly in the elderly. For example during the peak of the epidemic, April 17th a 75 year old American had a mortality of about 46.8 per 100,000, by the end of August the numbers had significantly declined into about 10 per 100,000.
Dr. Redfield: (34:24)
These improvements however do not mean that we can let our guard down. Over last week, we had an average of over 40,000 cases and nearly 800 daily deaths. I do want to emphasize the shift in age in these case counts. The 18 to 25 year olds currently make up over 26 percent of new infections, and more than any other group. It’s imperative that these young adults recognize that even though they are unlikely to get seriously ill from this virus, they are major contributors to the spread of COVID-19 in our country at this time.
Dr. Redfield: (35:01)
In order to understand what proportion of the population’s been affected with COVID-19 and what proportion remains at risk, CDC is currently performing large scale serology testing across the United States. Preliminary results appear to show that most Americans have not been infected with the virus and are still vulnerable to the infection, serious illness, and death. We hope to be able to post the analysis of the first round of this study in the next several weeks. As I’ve stated before, CDC encourages all Americans to embrace the powerful public health tools that we have right now; wear a mask, maintain social distance, practice routine hand washings with vigilance, be smart about crowds, and stay home when you’re feeling sick. And as we move into the fall, I want to add one more critically important step, flu vaccination. Flu vaccination is safe. CDC encourages all American to embrace the flu vaccine with confidence for themselves, their families, their loved ones, and their community’s. This year CDC’s purchased an additional 9.3 million doses of adult flu vaccine, as well as 18.5 millions doses for children. This is a significant increase in previous years.
Dr. Redfield: (36:22)
When combined with the tools that I mentioned above, this could help our nation avert a very difficult fall and lessen the burden on our healthcare system, and save lives. To further strengthen our public health resilience, CDC awarded $140 million to 64 jurisdictions through the CDC existing immunization cooperate agreements to begin to scale up staffing in preparedness for flu season.
Dr. Redfield: (36:47)
We also developed a new multi-plex laboratory diagnostic test that’s capable of measuring both influenza A and influenza B as well as COVID 2, using a single specimen in a single assay. This test will help our public health professionals better identify infections with influenza and COVID.
Dr. Redfield: (37:08)
I also am announcing today an additional $200 million from the CARES Act funding that will be used as a first step to help the jurisdictions complete their individual plans and implement for their COVID vaccination and follow up to the playbook that we released last week.
Dr. Redfield: (37:28)
CDC is an integral part of Operation Warp Speed, we’re leveraging our expertise in immunization infrastructure to support and promote distribution, administration, and monitoring of the future COVID-19 vaccines. In coordination with Operation Warp Speed, CDC is working closely with state and local community organizations on their detailed flexible plans for vaccine distribution.
Dr. Redfield: (37:53)
As I’ve emphasized in prior hearings, now is the time to commit to sustained investment and core capabilities of public health. Data, data analytics, laboratory resilience, workforce expansion and rapid response capabilities. Years of underinvestment in public health infrastructure have led to a system that has been sorely tested in this current pandemic. COVID-19 is the most significant public health challenge that our nation’s faced in more than a century. Now’s the time to build not only the public health core capability that our nation needs, but the capability that the people of our nation deserves.
Dr. Redfield: (38:33)
As we work together collectively to fight COVID-19 and the pandemic, CDC and all of the outstanding women and men of CDC, remain strongly committed to our mission to protect all Americans from disease, threats, and to save lives. We want to thank you for your time and I look forward to your questions.
Chairman: (38:52)
Thank you Dr. Redfield. Admiral Giroir, welcome.
Admiral Giroir: (38:58)
Chairman Alexander, Ranking Member Murray and distinguished members of the committee, I am honored to update you on our nations efforts to combat COVID-19 with the specific focus on testing. Recommended public health practices, like wearing a mask, avoiding crowds especially indoors, and washing your hands, combined with smart testing, is the formula to effectively slow the spread, flatten the curve and save lives. By providing county specific guidance to governors on a weekly basis, expanding and managing supplies, providing the right test to the right person at the right time, and developing and equitably distributing safe and effective therapeutics we are seeing promising results. Specifically since the post Memorial Day peaks in community spread the number of new COVID cases is down, as Dr. Redfield just testified. The number of people hospitalized with COVID-19 is down 54 percent. The number of people in an intensive care unit due to COVID is down 65 percent. And deaths associated are down 32 percent.
Admiral Giroir: (40:08)
But let me emphasize that to sustain these gains, we must continue our disciplined mitigation efforts, especially wearing masks when we can’t physically distance, avoiding crowds particularly indoors, and increasing our screening and surveillance testing.
Admiral Giroir: (40:25)
Now specifically regarding testing, the nation has performed over 106 million tests for the virus causing COVID-19. On 10 separate days, we performed over one million tests per day. The federal government had purchased and delivered over 106 millions swabs, and 88 million tubes of media to states, tribes, and federal partners. Starting on April 7th, we have purchased and delivered to public health laboratories in every state, and the Indian Health Service, over 2.5 million Abbott ID NOW point of care molecular tests to support outbreak control and rural testing.
Admiral Giroir: (41:02)
We have implemented federal surge testing sites in 20 different cities, helping to squelch emerging outbreaks typically among asymptomatic young adults. We are not at an inflection point in testing. This month we will have available on average three million tests per day, nearly half of which will be rapid point of care. We have been building toward this inflection point and I have previously testified to it’s coming several times over the past months. Now let me discuss two specific testing initiatives; protecting the elderly has been, is, and will continue to be a foremost priority for this administration. So on July 14th we announced that every single eligible nursing home in American would receive a point of care instrument and testing supplies. We have delivered on this promise. All 13,850 eligible nursing homes have now received a total of 13,985 instruments and over 4.9 million rapid point of care tests ahead of schedule.
Admiral Giroir: (42:06)
On August 27th, after months of planning and only one day after it’s FDA authorization, the administration announced a $760 million contract with Abbott for the delivery of 150 million rapid by next now COVID-19 point of care tests. This test is easy to perform, does not require an instrument, delivers test results in 15 minutes or less, and costs five dollars. We have already deployed 65,000 of these tests in support of disaster operation in California, Oregon, Texas, and Louisiana.
Admiral Giroir: (42:41)
Last week we also shipped 974,000 tests to 7,600 nursing homes in areas of significant community transmission. 541,000 tests to over 5,500 assisted living facilities with a CLIA certificate of waiver, and 300,000 to the Indian Health Service. This week we will be shipping 249000 tests to historically Black colleges and universities, and 2.6 million tests to assisted living, nursing homes, home health, and hospices.
Admiral Giroir: (43:14)
In the coming weeks, we will begin shipping millions of tests per week in support of our teachers and our students to open and keep open our K through 12 schools.
Admiral Giroir: (43:24)
Now I would like to close by recognizing my fellow officers in the public health service. The uniformed service, which I have the honor of leading. 4,172 women and men have deployed 8,918 times in direct support of this pandemic. On the Diamond Princess Cruise Ship in Japan, to our community based testing sites, to FEMA and our task forces, and to nursing homes and field hospitals in hardest hit communities. I thank each and every one of these officers and their families and on their behalf thank all of you in Congress for supporting our training needs, and the establishment of a ready reserve to supplement our ranks during inevitable future national emergencies. Thank you for the opportunity to provide these remarks.
Chairman: (44:11)
Thank you Admiral Giroir. Dr. Hahn, welcome.
Dr. Hahn: (44:16)
Good morning Chairman Alexander, Ranking Member Murray, and members of the committee. Over the past several months I’ve had the honor to work shoulder to shoulder with FDA’s career staff as we fought a historic pandemic that has altered the lives of every American. I am proud of all FDA employees and how they have measured up to this extraordinary challenge. The efforts of the FDA’s expert workforce are critical to ensuring the safety and health of the American public at any time, but it is magnified during a public health emergency. Of course, our work on COVID-19 and non-COVID issues, comes with unprecedented public scrutiny and sometimes criticism. Any agency that has the broad responsibilities and far reaching impact of FDA particularly involving issues of public health, can’t expect to do its job without inviting controversy and disagreement.
Dr. Hahn: (45:13)
But it’s also essential that the criticism we get never shakes the underlying faith the public has and should have in FDA and our commitment to protecting the public health. I am confident in the decisions that are being made related to COVID-19, and that will be made in the coming months as we continue to address the challenges of this pandemic.
Dr. Hahn: (45:36)
Now I know there’s been particular attention paid to a few of the decisions reached by FDA over the past several months. I want to assure you and emphasize that every one of the decisions we have reached has been made by career FDA scientists, based on science and data, not politics.
Dr. Hahn: (45:55)
FDA represents science in action. Often we must make real time decisions based on ever evolving data concerning a previously unknown highly contagious virus that we are still learning about. And sometimes it is necessary to reverse decisions as new data emerged. This is inherent in the Emergency Use Authorization process, otherwise known as EUA, and it is akin to how a doctor might approach a patient in an emergency situation. Constantly updating a treatment plan as new data emerge.
Dr. Hahn: (46:32)
So in the interest of transparency, I’d like to use this opportunity today to lay out the process we will use to review vaccines for COVID-19. When a vaccine sponsor reaches the conclusion that the data from its phase three clinical trials are adequate to submit to FDA, they will decide whether to apply for approval or Emergency Use Authorization. This will be based upon the trial meeting pre specified success criteria that were established by that sponsor.
Dr. Hahn: (47:06)
Now this is really important, they should also be consistent with FDA recommendations regarding those criteria. FDA will receive that application, or submission, and our career scientists will review it, safety and efficacy data, as well as manufacturing quality and consistency data. FDA made clear recommendations in our June 30 guidance regarding the safety and effectiveness of vaccines so that we can see that prior to the approval process.
Dr. Hahn: (47:37)
We will also work to provide additional information so that it is clear what we expect to see, should a sponsor choose to submit an Emergency Use Authorization application. As we’ve indicated previously, we plan on seeking advice from the vaccines and related biologics Products Advisory Committee comprised of independent members who have been screened for ethics conflicts. The safety and effectiveness data and the committees decision will be public, although we will need to adhere to confidentiality requirements. The public will have an opportunity to comment. The process will be transparent and independent. FDA career staff will then take the committee input into account as they make their decisions regarding the application, or EUA request. Now before we were to issue and EUA, if that were to happen, FDA would have to determine among other things that the statutory standard is met. We expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccines quality, and consistency, and data from at least one well designed phase three clinical trial that demonstrates its safety and efficacy in a clear, and compelling manner. Let me emphasize that again; data from at least one well designed phase three clinical trial, that demonstrates its safety and efficacy in a clear and compelling manner.
Dr. Hahn: (49:15)
FDA also expects that an EUA request would include a plan for active follow up to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorize, or approve, a vaccine that we would not feel comfortable giving to our families.
Dr. Hahn: (49:32)
On behalf of the 17,000 plus employees of the FDA, I want to make the following commitments today to the American public and this committee: FDA will not authorize or approve any COVID-19 vaccine before it has met the agencies rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes and science will guide our decisions. FDA will not permit any pressure from anyone to change that. I will fight for science Mr. Chairman. I will fight for the integrity of the agency, and I will put the interest of the American people before anything else. Thank you and I look forward to answering your questions.
Chairman: (50:19)
Thank you Dr. Hahn. We’ll now turn to questions from Senators. We have full participation today so I’d like to ask the Senators and witnesses to keep your exchanges within five minutes so all Senators will have a chance to participate.
Chairman: (50:35)
And for my five minutes I’d like to ask for the courtesy of short answers so I can ask all my questions. Dr. Hahn, let me go back to two things you said. Who makes decisions about safety and efficacy at the FDA? Do you do it? Does career scientists do it? Or does the White House do it?
Dr. Hahn: (50:57)
Career scientists at the FDA do it. That’s very clear. I am briefed on all major medical product decisions. Overruling a center’s decision is a very rare event. I have expressed on multiple occasions, my intention and have done during this COVID-19 to make sure that those decisions are made by career scientists in the centers.
Chairman: (51:20)
You referred to this, but once FDA approves a vaccine, and as we’ve said today we’re going to have tens of millions of doses ready, none can be distributed until FDA approves it. Will you be willing to take that vaccine for you and for your family?
Dr. Hahn: (51:38)
Absolutely, yes, Mr. Chairman. I have the complete and absolute faith in the expertise of the scientists who are terrific at FDA. If they were to make a determination a vaccine would be safe and effective, I would do that, and I would encourage my family to take the vaccine.
Chairman: (51:56)
Dr. Fauci, you’ve been around since the Reagan years. You’ve seen likes of diseases, pandemics, and lots of responses to it. Is the administration cutting corners in safety and efficacy and it’s effort to produce vaccines and treatments rapidly?
Anthony Fauci: (52:14)
Not at all, Mr. Chairman. In fact the rapidity of where we are right now is a reflection of the technological advances in vaccine platform technology as well as the risks that were taken financially so that we’ll have doses available when the decision is made by the FDA as to the safety and efficacy, as you’ve heard from Dr. Hahn. So there’s no cutting corners.
Chairman: (52:43)
We’re risking the taxpayer’s money, but we’re not risking safety and efficacy, is that your testimony?
Anthony Fauci: (52:50)
Yes it is. That’s absolutely correct.
Chairman: (52:52)
Now millions of students are going back to thousands of colleges and they’re inevitably outbreaks of COVID- 19, Dr. Fauci, is the smart thing for college administrators to do is to send those college students home when the outbreaks occur on campus?
Anthony Fauci: (53:10)
Absolutely not, Mr. Chairman. They should be able to accommodate the students in a facility, maybe a separate dorm or a separate floor, so they don’t spread among the student body, but do not send them home to their community, because of the likelihood of then reseeding infection in the community.
Chairman: (53:29)
Dr. Fauci I’ve listened to your testimony for the last several months, some people say that your message is that you want to lockdown the country in order to stop the spread of the vaccine. Is that accurate?
Anthony Fauci: (53:42)
That’s completely inaccurate Mr. Chairman. I’ve said multiple time, we do not need to shut down. If we follow careful and prudently the recommendations and the guidelines for opening America again, I believe we can do that safely and still accomplish the goal of opening the economy again.
Chairman: (54:00)
Dr. Fauci, some people said it was political to ask the states to get ready to distribute the vaccine in October. Is that true or false?
Anthony Fauci: (54:08)
That’s false. The reason that that was done is because we want to make sure that when a decision is made that we will be ready to distribute the vaccine.
Chairman: (54:19)
Dr. Redfield, the British Ambassador told me yesterday the government studies in the United Kingdom said that based on serology testing that five to 25 percent of their country’s population depending on the location, has been exposed to COVID-19. What about the American population? How many of us have been infected by COVID-19?
Dr. Redfield: (54:45)
Thank you Mr. Chairman, CDC is in the process of a very large sequential study across the entire United States, measuring serology. As I mentioned, the preliminary results in the first round show that a majority of our nation more than 90 percent of the population remains susceptible. It varies in different geographic parts from states that have less than one percent with evidence of previous infection, to some that have more than 15, 20, and one as high as 24 percent. We’ll have that finalized and probably published in the next week or so, but it does show that a majority of Americans are still susceptible to this virus.
Chairman: (55:31)
So just so I understand, you’re saying that based on the preliminary indications from your serological testing and studies, that as many as 90 percent of Americans are still… still haven’t had the virus yet.
Dr. Redfield: (55:43)
Yes sir.
Chairman: (55:45)
Thank you, Dr. Redfield. Senator Murray.
Patty Murray: (55:49)
Thank you Mr. Chairman. Dr. Redfield, we know that a lot of patients avoid getting unnecessary tests or a treatment because of cost, and I’ve been pushing to make sure insurers have to cover COVID treatment at no cost to patients 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 a preexisting condition make it easier or harder to contain this pandemic?
Dr. Redfield: (56:47)
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.
Patty Murray: (57:10)
So I take that that case is 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 testing guidance for asymptomatic people exposed to COVID-19. I’m 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’s scientists, nor underwent the agencies strict scientific review process?
Dr. Redfield: (58:04)
Senator, the original testing guidance of August 26th had 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 reengage 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 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-
Patty Murray: (59:17)
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, the Infectious Disease Society of America, and state health departments recommend 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?
Admiral Giroir: (59:45)
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-
Patty Murray: (59:59)
I appreciate that other piece-
Admiral Giroir: (59:59)
… the approval of Dr. Redfield and the Senior scientist did not-
Admiral Giroir: (01:00:03)
… verbal 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 the FDA guidance, CLIA guidance, and I issued a prep-act declaration to assure-
Patty Murray: (01:00:36)
I just have a few seconds.
Admiral Giroir: (01:00:37)
… that providers could test the asymptomatic individuals.
Patty Murray: (01:00:38)
On Friday, CDC quietly updated another guidance, identifying aerosols as common route 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. 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 CDCs website to give me that information?
Dr. Redfield: (01:01:17)
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.
Patty Murray: (01:01:48)
Mr. Chairman, I’m 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.
Mr. Chairman: (01:01:58)
Thank you, Senator Murray. Senator Enzi.
Senator Enzi: (01:02:02)
Thank you, Mr. Chairman, for continuing to hold these regular hearings so that we end 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’re 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 all these efforts going forward. I hope we’re thinking through how to ensure access though, to rural areas.
Senator Enzi: (01:02:48)
One of the things that I’m asked about, that people have heard, that some of the vaccines … This is a question for Dr. Redfield and Dr. Hahn, some of the vaccines in Phase-3 testing, evidently needed to be stored at extremely cold temperatures, that’s even by Wyoming standards. That would be potentially as low as negative 94 degrees, Fahrenheit. Hospitals and nursing homes, pharmacies, doctor’s offices might all be places where Americans could 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. Very few of those … Is there another solution or how can we ensure sufficient freezer and storage capacitor, so there’s access to the vaccine and it isn’t just limited to major cities.
Dr. Redfield: (01:03:46)
Thank you very much, Senator. Again, there’s a total commitment to work that this vaccine is distributed in an equitable and a fair way across our nation. The funding I announced today, that we’ll get out to the individual states, to be able to really begin to operationalize their plans on the playbook is critical. Each jurisdiction is going to have to address those issues, particularly as you looked at the importance of cold chain 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.
Dr. Redfield: (01:04:32)
We’re going to build on that. Obviously, the ability to bring all the pharmacies in is a really important step, but these micro plans that your state, State of Wyoming will do, will identify what other gaps are there. 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’re committed to making sure that happens.
Senator Enzi: (01:05:04)
Dr. Hahn, Do you have any comment on that?
Dr. Hahn: (01:05:06)
Well, 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 culture storage, as you mentioned. We will provide technical assistance and we’ll work with CDC to ensure that that happens.
Senator Enzi: (01:05:31)
Thank you. Director Redfield, do you anticipate that once the Food and Drug Administration approves a vaccine, that the Center, you touched on this, the Centers for Disease Control and Prevention will have to work with the states to develop new, more detailed vaccine district distribution plans, or will the work the states are doing in advance suffice?
Dr. Redfield: (01:05:59)
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’ll 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 micro planning now in Minnesota and North Dakota, California, Florida, and Philadelphia, over the summer, just to get a sense on the complexity of it.
Dr. Redfield: (01:06:44)
Now, we’re looking for each of the 64 jurisdictions to complete that by October 16th. It’s our hope that that’s going to really lay out the individual plan to get this vaccine equity distributed 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, it will be 95% of the way there based on the planning between now and October 16th.
Senator Enzi: (01:07:10)
Thanks to the [inaudible 01:07:11] to you Mr. Chairman and ranking member.
Mr. Chairman: (01:07:16)
Thank you, Senator Enzi. Senator Casey.
Senator Casey: (01:07:20)
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 milestone of deaths in America from COVID-19. That number translates in Pennsylvania into 8,000 deaths. As 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 could be struck down by the Supreme Court in early November, or at least the arguments starting then.
Senator Casey: (01:08:02)
At the same time, we’ve got to consider the ravages of it, 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 on 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 70,000 residents and workers in long-term care facilities have died of COVID-19.
Senator Casey: (01:08:49)
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 longterm 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 a defense bill as well.
Senator Casey: (01:09:38)
But mostly, almost all of our votes were on confirmations. Now the Senate majority is obsessed with getting a confirmation vote on a 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? Now let me get to our witnesses. I want to ask you a question that Dr. Hahn was already kind enough to answer, which is about the vaccine and his response to that in terms of his own family, his own person.
Senator Casey: (01:10:19)
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 in the integrity of both the approval process, and to assure the American public that vaccines are safe, I would ask the other three members of our panel if they will commit to receiving the COVID-19 vaccine in public view, once one becomes available and is authorized or approved by FDA. Starting with Dr. Fauci.
Anthony Fauci: (01:10:57)
Thank you for the question, Senator Casey. Yes. I’ve said that in the past, that if a vaccine that has shown to be and proven to be and authorized by the FDA to be safe and effective, I certainly would take that vaccine. I would recommend to my family that they take that vaccine. Yes?
Senator Casey: (01:11:16)
Thank you.
Admiral Giroir: (01:11:24)
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 to my family, but I think the question is a little bit inappropriate. People need to read that vaccine. They need to understand, 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.
Mr. Chairman: (01:11:53)
Dr. Redfield?
Dr. Redfield: (01:11:53)
Yes. Senator Casey. Yes, absolutely, as I would with my wife, children, and 11 grandchildren, I would recommend it to all of them. Of course, myself, I would take it. I have total confidence in the FDA, in the process of getting us a safe … If they give any way, then I’m confident it will be a safe vaccine, and I’m ready to take it.
Senator Casey: (01:12:18)
Dr. Redfield, I have a question for you on state immunization information systems, in light of the vaccine program interim playbook. Just have one question before my time expires. How many jurisdiction’s immunization information systems meet all the standards set forth in the playbook today?
Dr. Redfield: (01:12:35)
Senator I’d 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 into where there are new points of service, where that technology currently doesn’t exist. But I’ll have my team put together a comprehensive answer for that question for you.
Senator Casey: (01:13:11)
Thank you. Thank you, Mr. Chairman.
Mr. Chairman: (01:13:12)
Thank you, Senator Casey. Senator Burr.
Senator Burr: (01:13:15)
Mr. Chairman, thank you very much. Welcome to all of our witnesses and our thanks to your agency and the many workers who work on this. Let me say to Senator Casey, answering his question, the majority has been focused on pandemic since 2002, when we first started passing legislation to create, in many ways, the architecture that we fall under today and the protocols that allow Dr. Hahn, Dr. Fauci, 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 member of Congress and the American people have always seen as the gold standard?
Dr. Hahn: (01:14:06)
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. 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 just don’t look at a press release. We look at the primary data.
Dr. Hahn: (01:14:49)
Our scientists analyze data, and then we draw conclusions from that data. We did that with Remdesivir. We did that with convalescent plasma. We’re doing that with tests. 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.
Senator Burr: (01:15:11)
Dr. Hahn, would it be appropriate to say that the clinical trials, Phase-3 clinical trials, that are currently going on for, now four manufacturers? 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?
Dr. Hahn: (01:15:42)
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 in our June 30 guidance about what we needed to see with respect to efficacy, a floor, not a ceiling, a floor of 50%, which led to the power calculations in these trials and therefore 30,000 plus volunteers in each of these trials. If you think about the number of trials that are ongoing and plus the studies that were done before in Phase-1 and Phase-2 four, a 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. 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.
Senator Burr: (01:16:29)
Dr. Hahn, you talked about the steps that an applicant would go through and how it would be their decision as to whether they applied for an 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?
Dr. Hahn: (01:16:53)
Senator Burr, exactly. It’s another check and balance, if you will, in addition to the others. Let me just explain that if you will, Sir. When a sponsor, someone that’s developing a vaccine, a company, performs a Phase-3 clinical trial, there’s 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 will reach the primary endpoint, that it will be successful.
Dr. Hahn: (01:17:38)
Then of course, they could have met the pre-specified criteria around effectiveness, in the case of the vaccines, prevention of infection. That would be another criteria that would be used to say, “Okay, the data are mature, give it to the company,” and then the company can put that into an application to us.
Senator Burr: (01:17:57)
Thank you. Thank you. Dr. Fauci, I want to turn to you just real 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? 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 I, the wife didn’t get it. How, with a highly-transmittable infection like this can two people live together and one be positive and one never get positive? If there’s an answer, I’d love to be able to-
Anthony Fauci: (01:18:49)
Yeah. I mean, that happens all the time with infections, Senator, that although a virus can be highly transmissible, there’s a great degree of variability of a person’s natural resistance to a particular type of an infection. 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 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.
Senator Burr: (01:19:54)
Your confidence, in FDA review, and the technology platform-
Mr. Chairman: (01:19:57)
We’re running over.
Anthony Fauci: (01:19:58)
Yeah.
Mr. Chairman: (01:19:58)
We’re well over time.
Anthony Fauci: (01:19:59)
Yeah, 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.
Senator Burr: (01:20:08)
Thank you, Mr. Chairman.
Mr. Chairman: (01:20:09)
Thank you. Senator Burr. Senator Baldwin.
Senator Baldwin: (01:20:12)
Thank you, Mr. Chairman. 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 the CDC determined were necessary to stem the transmission of COVID-19 at the plant. That report was dated April 21st of this year. Last night, it was reported that your office intervened and ordered that the safety recommendations be watered down.
Senator Baldwin: (01:21:10)
The next version of that memo dated the following day, or April 22nd, essentially adds the words “if feasible” to those strong safety protocols over and over again, throughout the document. Telling the plant, essentially, that these recommendations were voluntary or optional. Workers continue to work shoulder to shoulder at that plant, and the plant ignored the safety guidelines. To date, at least 1200 workers from that very plant have been infected with COVID-19 virus. 34 have been hospitalized and four have died. I will also note that in that same time period, in April, on Tuesday, April 24 or 28th, excuse me, that’s when President Trump issued his executive order, basically naming meatpacking as an essential industry and meatpacking 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 meatpacking plant. If that’s okay, Mr. Chair, I’d like unanimous consent to do so.
Mr. Chairman: (01:22:42)
She’s asking if [inaudible 01:22:45].
Senator Baldwin: (01:22:45)
I think I heard somebody indicate that I got unanimous consent. Dr. Redfield, why did your office demand that these recommendations be a watered down?
Dr. Redfield: (01:22:59)
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 were 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 the 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. As that document was reviewed, we wanted to make clarification that sure people-
Senator Baldwin: (01:23:51)
Okay.
Dr. Redfield: (01:23:51)
… understood ours was a recommendation and not a regulatory requirement.
Senator Baldwin: (01:23:56)
Thank you. 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 US, 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 US Department of Agriculture or the White House concerning specifically, this memo before it was edited?
Dr. Redfield: (01:24:33)
No, not at that time. There is a multi-inter-agency discussions between labor, agriculture and ourselves on a variety of the issues and intersect. But in that regard, again, it was, the purpose was to stress clarity that we were not a regulatory agency. These were the recommendations.
Senator Baldwin: (01:24:54)
Well, given that, I would ask you to consider changing the meatpacking 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. I would ask, will you change that meatpacking guidance in light of the death toll and harm?
Dr. Redfield: (01:25:43)
I appreciate your comments, Senator.
Mr. Chairman: (01:25:46)
Thank you, Senator Baldwin. Senator Paul.
Senator Paul: (01:25:51)
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 so 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 in.
Senator Paul: (01:26:32)
It’s important that we examine the data, learn from the data and try to avoid the man-made 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 a sharpest spike or highest death rate in the world, at over 1700 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 populations. Perhaps, but even the average death rate for the US is now greater than Sweden.
Senator Paul: (01:27:18)
In fact, the US 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.
Senator Paul: (01:27:58)
Hong Kong, Taiwan, and South Korea certainly enforced stricter quarantine and contact tracing rules than the US. But 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, and therefore have more preexisting cross-reactive immunity. If scientists were interested, there is a fascinating field of inquiry looking at susceptibility to COVID-19 and assessment of whether people or not have pre-existing immunity to similar coronaviruses. In fact, the pre-existing cross-reactive immunity to coronavirus may explain why we have so many people that have very little symptoms or asymptomatic.
Senator Paul: (01:28:48)
While there are still many things we need to learn about this pandemic, it’s important that we, the people not simply acquiesced 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 allow the highest death rates in the world. 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 US now, is essentially equivalent to that of South America, where social distancing and mitigation efforts are virtually impossible.
Senator Paul: (01:29:29)
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 US, 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_
Senator Paul: (01:30:03)
Any second thoughts, are you willing to look at the data that countries that did very little actually have a lower death rate in the United States?
Anthony Fauci: (01:30:07)
You know, 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, 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. Yes, 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-
Anthony Fauci: (01:31:45)
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.
Senator Paul: (01:31:58)
Or they’ve developed enough community immunity that they’re no longer having the pandemic because they have enough immunity in New York City to actually stop it.
Anthony Fauci: (01:32:06)
I challenge that Senator. [crosstalk 01:32:08] 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 C.D.C. said, that in New York, it’s about 22%. If you believe 22% is herd immunity, I believe you’re alone in that.
Senator Paul: (01:32:28)
There’s also the preexisting immunity of those who have cross-reactivity, which is about a third of the public in many estimates studies [crosstalk 01:32:35] which would actually get [crosstalk 01:32:37].
Anthony Fauci: (01:32:37)
I’d like to talk to you about that also because there was a study that recently came out that preexisting immunity to coronaviruses that are common cold do not cross react with the COVID-19.
Chairman: (01:32:50)
Thank you, Senator Paul, Senator Murphy.
Senator Murphy: (01:32:52)
Thank you very much, Mr. Chairman, I’ll stay with you, Dr. Fauci, apologize for not giving you a break. There was a study that got some attention regarding Big 10 and Pac-10 athletes that found that 15% 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 possible more general long-term effects of somebody who has had COVID and recovered, and are these effects observable in asymptomatic COVID-19 patients?
Anthony Fauci: (01:33:33)
Yeah, Senator, thank you for that question. I actually had mentioned that in my opening comments, but I thank you for giving me the opportunity to expand on that. That’s really quite puzzling because the individuals that was … there were two studies, there was one study not in athletes and then there was the 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 to 70% 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 to cardiomyopathies. I have to tell you, I do not know what it would be, but it’s something we really need to keep our eye out on.
Senator Murphy: (01:34:44)
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 preexisting condition. And that it is likely probable that insurance companies, if they are allowed to discriminate against people with preexisting conditions as will happen if the Supreme Court justice is put on the court and the ACA is 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 we have to take the President at his word. He announced that he had instructed his advisors to “slow the testing down, please.”
Senator Murphy: (01:35:42)
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 coincidentally 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 healthcare provider if they have been in contact?
Senator Murphy: (01:36:38)
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 healthcare 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?
Dr. Redfield: (01:37:31)
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 were placing emphasis on symptomatic illness and also, as you said, individuals with significant exposure, vulnerable populations, critical infrastructure workers, healthcare workers, and those individuals who may be asymptomatic when prioritized by a medical or public health official. The reason that this came from a 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-
Senator Murphy: (01:38:27)
But notably, you don’t tell people in this guidance that they should go see a doctor.
Dr. Redfield: (01:38:31)
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 are asymptomatic when prioritized by a medical or public health individual. And again, the intent was for testing to drive an action 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 the 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 of 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.
Senator Murphy: (01:39:39)
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.
Chairman: (01:39:46)
Thanks, Senator Murphy. And in my effort to be fair to everybody we’re running over the five minutes pretty well. So we have about 14 senators remaining who’d like to ask questions. So I’d ask their colleagues to keep that in mind, please, with the five minute rule. Senator Collins.
Senator Collins: (01:40:07)
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 preserved scientific integrity. 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?
Admiral Giroir: (01:41:42)
So thank you for that, Senator, I’ve spoken to several people in the immediate office of the Secretary and as I understand it, and I do absolutely believe it, that this was an administrative decision by the Secretary. Because rulemaking authority and 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 rulemaking 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 rulemaking agency might have a comment on that as well.
Senator Collins: (01:42:42)
I have a different question for Dr. Hahn that I want to make sure I get to. Let me just 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’ve 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% of the facilities are located overseas in countries like China and India. India put an export ban on some 26 APIs. So we know that China hoarded PPE that our country needed. Some my question to you is, are we making any progress and 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. Hahn: (01:44:15)
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. It’s something that FDA has been involved with for years. With respect to the issue of 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 will be to help to create a whatever regulatory pathway we can so that we can facilitate advanced manufacturing that’s domestic.
Senator Collins: (01:45:29)
Thank you very much.
Chairman: (01:45:36)
Thank you, Senator Collins, Senator Warren.
Senator Warren: (01:45:40)
Thank you, Mr. Chairman. Vaccines are 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?
Anthony Fauci: (01:46:23)
No.
Senator Warren: (01:46:25)
Thank you. What about you, Dr. Redfield?
Dr. Redfield: (01:46:29)
No, Senator.
Senator Warren: (01:46:30)
All right. Dr. Hahn.
Dr. Hahn: (01:46:33)
No, Senator Warren.
Senator Warren: (01:46:34)
And Admiral Giroir.
Admiral Giroir: (01:46:36)
No, Senator Warren.
Senator Warren: (01:46:38)
Okay, thank you. So none of you stands to get richer if any particular drug company gets money from the government. And I’m not surprised by your answers because 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 responsible for deciding whether a COVID-19 vaccine is safe. In your opinion, if the FDA officials making these decisions had financial conflicts, would that increase or decrease people’s confidence in a COVID-19 vaccine?
Dr. Hahn: (01:47:17)
Senator, I’m 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 of Government Ethics review of all conflicts. So, one thing I’d 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.
Senator Warren: (01:47:57)
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’s the problem we’ve got, Dr. Moncef Slaoui, the man that President Trump selected as the government’s “vaccines czar,” is a former drug company executive. The Trump administration used a loophole in federal ethics law to hire him, to keep his conflicts from the public. Now he reportedly owns about $10 million of stock in GlaxoSmithKline drug company that’s working on a coronavirus vaccine. And according to documents released yesterday by the House, he may own stock in Lonza 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?
Dr. Hahn: (01:49:31)
Senator Warren, I can’t explain the situation. I don’t have any knowledge of what you described. What I can tell you is that we have established a very bright line between Operation Ward Speed and FDA. We do not participate in their decisions. We provide technical assistance just as we would for any sponsor.
Senator Warren: (01:49:51)
So with all due respect, Dr. Hahn, you just told me that 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?
Dr. Hahn: (01:50:12)
Senator Warren, I am not aware of the conflicts you’re describing. And so I can’t comment-
Senator Warren: (01:50:18)
Look at 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?
Dr. Hahn: (01:50:31)
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.
Senator Warren: (01:50:45)
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 bill that 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.
Chairman: (01:51:23)
Thank you, Senator Warren, Senator Cassidy.
Senator Cassidy: (01:51:30)
Thank you, Mr. Chairman. I was distracted when Senator Burr was given his answer, but he may have replied to Senator Casey, that says if Senator Casey did not hear Admiral Giroir’s testimony, when he said, “What is the administration doing to prevent deaths in nursing homes?” And we just heard how many resources were being deployed to nursing homes. And so in case Burr wasn’t able to raise that, I just want to emphasize that. Secondly, commenting on previous testimony, Baldwin and Redfield, Dr. Redfield, I thought you answered Senator Baldwin’s question very well, but I will say my office has called OSHA as regards to guidelines for people who are … for businesses in terms of how they’re to conduct themselves. And OSHA said that they are deferring to C.D.C. That’s not C.D.C.’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.
Senator Cassidy: (01:52:23)
Dr. Giroir, it’s my understanding that the administration’s granting authority to pharmacists to immunize those between ages three and 18, because of the crisis, we’ve had a kind of a slowdown and those children, they’re missing their vaccines that they should get. Is there going to be a requirement that they put these vaccine records in the state’s immunization registry?
Admiral Giroir: (01:52:51)
Yes, sir.
Senator Cassidy: (01:52:53)
And what about federal facilities such as D.O.D., V.A., [inaudible 01:52:57] health service, et cetera, will they likewise be required to enter their data into the state’s immunization registry?
Admiral Giroir: (01:53:04)
Sir, I actually don’t know about D.O.D., I just don’t know that specific. I know that for the pharmacist, 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.
Senator Cassidy: (01:53:20)
And just the suggestion that D.O.D. should be required because obviously many of them will be separating from the military and it may be a condition of employment by a health care facility that someone be vaccinated. It’d be nice to have that documented as opposed to someone just stating that they had been, just to point that out.
Admiral Giroir: (01:53:37)
Yes, sir, I wasn’t commenting on whether it’s good or bad. I just didn’t know the regulation for D.O.D. We’d be very happy to look that up and bring it back, sir.
Senator Cassidy: (01:53:45)
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 costs 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?
Admiral Giroir: (01:54:22)
So thank you, Senator. And let me speak generally that of course we would assume that there are costs for the provider. These are going to be tens or hundreds of millions of vaccines. There are details to be worked out, but the administration is 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.
Senator Cassidy: (01:54:45)
Got you. Dr. Hahn, the vaccine may only have 50% 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% 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, think the emergency room nurse, the tech, or the clerk admitting people to the ER, will antibody serologies be required after the vaccine is given? And do we have enough antibodies serologic tests, which we [inaudible 01:55:32] know are sufficiently accurate and are sufficiently available in order to conduct this?
Dr. Hahn: (01:55:36)
Senator, thanks for the question. For the first several trials, when they mature, we will not yet have data that bridges between a clinical outcome, which is the, of course, primary endpoint we’ve required for showing effectiveness. That is the prevention of COVID-19 illness and the development of antibodies. So it is unlikely in that situation, although again, I can’t prejudge the data that we would have a requirement there. Again, the data will point us in that direction for subsequent trials, if in fact there are bridging data or from the initial trials, there’s bridging data. One could imagine a situation where that could occur, but again, don’t know that because we haven’t seen the data yet, sir.
Senator Cassidy: (01:56:23)
Thank you all for your brief answers. I yield back.
Chairman: (01:56:27)
Thank you, Senator Cassidy, Senator Kaine.
Senator Kaine: (01:56:30)
Thank you, Mr. Chair, and I want to just say a word to you, Senator Alexander, how much I’m going to miss you as the chairman of this committee. I have learned a lot from you about how to be a good senator, both from working with you, but also from observing you and I’m going to miss your friendship, and I’m going to miss your leadership. I also just want to acknowledge what it means to have 200,000 people in this country who are no longer with us. My wife and I have four friends who’ve died of coronavirus. We’ve each had coronavirus, so I guess we have preexisting conditions now and hopefully some antibodies that might do something. I agree with the chairman, his opening comment said that as of March 1, the New York Times said and others did too, Johns Hopkins, that the U.S. was the best prepared of any nation to deal with this, and I believe that.
Senator Kaine: (01:57:15)
And yet I think the management, beginning with our preparation and the resources we have as a country, the management of this crisis has been one of the worst failures of domestic governance in the history of this country. And don’t believe me, I mean, I’m just a U.S. Senator, but when people who are staffers on the task force are resigning and saying the same thing, I think we’ve got to pay attention to that. And I’m also mindful of the fact that during this crisis, not for a second has this administration stopped it’s concerted for your effort to take health insurance away from millions and millions of people. I can only imagine how much worse this would be in Virginia, 400,000 people didn’t have Medicaid expansion. But many are hoping to see what it will be like if we take health insurance away from millions of people, so we may have the opportunity to see that. One of the reasons I think this has been handled so badly, it’s not because of the dedication of wonderful professionals. I think we have some wonderful professionals who are very dedicated, but I think it goes back to communication.
Senator Kaine: (01:58:16)
I was a mayor and governor, I dealt with a lot of crises, weather crises, hurricanes, mass shootings at Virginia Tech when I was governor, H1N1, when I was governor. None were at the scale of this. But one thing I learned from dealing with crisis is communication. Clear communication to people who are worried is absolutely critical. And that’s where we’ve fallen down on the job with a president who’s preached hydroxychloroquine, or bleach or disinfectant. The day that the administration laid out guidelines for states on reopening, my governor, who is a doctor said, “Those are good guidelines, I’m going to follow them.” The next morning, the president tweeted out a tweet against him, liberate Virginia against this tyrannical governor who was following my advice.
Senator Kaine: (01:59:03)
And we’ve seen so many other examples of poor communication or mixed messages. And that’s really confused the public. Dr. Fauci, just this week, a key communication staffer at the N.I.H. had to resign when he was outed as somebody who was in a conspiracy laden website, trashing you, trashing other public health professionals, trashing your advice about mask wearing, suggesting that this was just a hoax or an invented crisis. My four dead friends would say it wasn’t an invented crisis. And Dr. Redfield, I was very, very concerned when the C.D.C. changed its website this week about how the virus is transmitted. I’d like to ask that a slide be put up. This is going to be very hard to read and so I’ll sort of bring it to your attention. But the C.D.C., I believe on the 18th of September, put up new guidance based on just the ongoing analysis of this crisis, about what we could do to protect ourselves and how the virus is transmitted, but then almost immediately reversed it.
Senator Kaine: (02:00:02)
But then almost immediately reversed it. What about the September 18th version, that’s on that screen, was incorrect?
Dr. Redfield: (02:00:10)
Thank you, Senator. I think what I tried to comment before that this was a first draft document.
Senator Kaine: (02:00:17)
No, and I heard that, so I don’t want to ask that question. What about it was incorrect?
Dr. Redfield: (02:00:22)
It’s looking at the balance of the component that aerosolized transmission plays compared to droplet transmission.
Senator Kaine: (02:00:31)
Let me read you two examples, the version that posted on the 18th, people who are infected, but do not show symptoms can spread the virus to others, clear unequivocal, but you changed it back to, some people without symptoms may be able to spread the virus. Now is that phrase, people who are infected, but do not show symptoms can spread the virus to others, is that inaccurate?
Dr. Redfield: (02:00:54)
Let me just set the stage here. The document that it was reverted to was the original clear document, it wasn’t the changed document.
Senator Kaine: (02:01:04)
I understand that, but back to my question, is it inaccurate to say people who are infected, but do not show symptoms can spread the virus?
Dr. Redfield: (02:01:11)
Absolutely they can.
Senator Kaine: (02:01:13)
That’s accurate, isn’t it?
Dr. Redfield: (02:01:14)
Absolutely.
Senator Kaine: (02:01:15)
The document further said there is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others and travel distances beyond six feet, for example, during choir practice, in restaurants or in fitness classes, is that statement accurate?
Dr. Redfield: (02:01:32)
There’s definitely evidence of that, sir.
Senator Kaine: (02:01:33)
There’s no inaccuracy in the statement?
Dr. Redfield: (02:01:35)
There’s definitely evidence of that.
Senator Kaine: (02:01:37)
But that was removed in the changed document, and it went back to its original form which didn’t mention it.
Dr. Redfield: (02:01:43)
I just want to highlight that it’s not that anything was removed the-
Senator Kaine: (02:01:47)
Well, it’s not on the website right now, correct?
Dr. Redfield: (02:01:48)
The technical cleared document that went through the proper channels is what was put up. I can say that all these decisions about the aerosolized document was made by career staff individuals far below my level as the director, when they saw this non scientifically cleared document go up, the [crosstalk 02:02:10],
Senator Kaine: (02:02:11)
I’m over my time. I understand, but the point I’m trying to make is we need to communicate clearly. When you put up a document at the CDC that you have just testified is accurate, and then it’s changed to suggest that the risk is more minimal by someone, for some reason, it contributes to the massive confusion that is so troubling to scientists and so troubling to people. And then that leads to, “Well, gosh, is the vaccine going to be safe?”
Dr. Redfield: (02:02:39)
Again, I just want to stress for the American public and for everyone here, that document that went up was a draft, had not been technically reviewed by CDC. It reverted to the document that was tackling the reviewed. There is going to be a technically reviewed document on this issue coming on the website, but the one that was posted on Friday was not technically reviewed, and as a consequence, the career scientist at CDC took it down, put up the technically reviewed document until the new technically reviewed document can be posted.
Mr. Chairman: (02:03:14)
I’m afraid the time [crosstalk 02:03:14].
Senator Kaine: (02:03:14)
But you’ve testified that the one was taken down was accurate, and that was the point that I wanted to make. Thank you, Mr. Chairman.
Mr. Chairman: (02:03:18)
Thank you, Senator Kaine. Senator Murkowski.
Senetor Murkowski: (02:03:24)
Thank you Mr. Chairman and gentlemen. I want to echo Senator Collin’s comment and her thanks and appreciation. I share that. I know that there is plenty to argue and quibble about and whether or not communication has been clear or not clear. I think we do owe that to the American public, but I also know that the work that you and those that are part of your team is hard, hard, arduous work, and you have definitely been put to the task. So I appreciate the work that you do. I’m going to direct my questions to you, Dr. Redfield, and first thank you for CDCs effort to help our State and local public health departments.
Senetor Murkowski: (02:04:12)
Recently, we had a CDC team deploy to Anchorage to assist us there with an outbreak of COVID that we had seen within our homeless population. And you were quick when asked, and we greatly appreciate that assistance. I want to ask you about the interim guidelines that States are considering as they’re drafting these plans to be submitted for mid October. And it goes to Senator Kaine’s comments about the communication and the need for additional clarity that I’m hearing from my State, specifically in the allocation, the first allocation of the vaccine in terms of the jurisdictions and who is to receive that. It States, but for instance, will the tribal health system is that its own jurisdiction for purposes of allocation.
Senetor Murkowski: (02:05:12)
When we talk about critical populations, it’s my understanding that the first phase is going to be allocated based on targeting these critical populations. Well, in Alaska, we’ve got about one quarter of our population, Alaskan native that could be determined to be 18%, determined to be critical population. And then further to additional guidance on what qualifies as a healthcare worker. In our State, our community health aides are some of those frontline workers. Can you help me with a further clarification for purposes of the State’s on guidance with allocation and defining critical population?
Dr. Redfield: (02:06:03)
Thank you, Senator. Obviously critical questions. I will say at this moment in time, the definitive answers in terms of the allocation process have not been completed. I do take Senator Kaine’s and your comments to heart, how important it is that when that is completed, that it’s communicated in an effective way. That we are currently going to see the plans, as you know, from each of the States, how they would propose to allocate. The prioritization of how this vaccine will be distributed, will depend on which vaccine, and what the data says. But that decision, ultimately, the recommendation, will be the advisory committee of immunization practices that will give that recommendation once they know what vaccine they’re recommending it for. But I will reiterate the comments from this hearing back to Operation Warp Speed is as that allocation decision is made, that it’s communicated effectively.
Senetor Murkowski: (02:07:12)
And that allocation decision, can you confirm that it is the CDC that is responsible for determining that allocation?
Dr. Redfield: (02:07:18)
The allocation will be, the decision will be made by the Operation Warp Speed, is what I would believe. What will happen though, is that the ACIP which is an advisory group to me as the director of CDC, will recommend the prioritization of who should be vaccinated. As you said, should it first be all the individuals that are vulnerable in nursing home? Should it be healthcare workers? If so, what kind of healthcare workers? Should it be Native Americans, African-Americans, Hispanics at greater risk? I can’t get ahead of the ACIP.
Senetor Murkowski: (02:07:55)
Dr. Redfield, let me interrupt it to ask just one more question of you here. I’ve got the direction that you’re going with the definitions there in terms of critical workers. We’ve talked before about the public health it infrastructure. I think we recognize that certainly in a State like mine, it’s been pretty tough when you’re faxing, literally faxing the results of your COVID tests, and it’s not just Alaska, State of California, it’s a mess out there. What is the administration’s plan to ensure that States have the support that they need for the requirements on reporting for this new vaccine? Because we’re concerned in our State that we’re not prepared for the level of reporting that will be required. We don’t mind the reporting, but we do not have the infrastructure, if you will, right now on the health IT sector.
Dr. Redfield: (02:08:52)
That’s going to be a very important part of the plan that each of the States jurisdictions, the 64, make. In addition, there is plans within the Operation Warp Speed to augment IT capacity where there are gaps. But again, in order to see that, we’re going to see the state’s plans. I did release $200 million today for the States to begin to develop those plans and really identify those gaps that they have. So then hopefully there’ll be further resources to begin to fill those gaps, because it is going to be very important that we do have the reporting for the monitoring and safety of these vaccines, as well as to make sure that we can distribute this vaccine in an effective way, equitably to the American public.
Mr. Chairman: (02:09:40)
Thank you, Senator Murkowski.
Senetor Murkowski: (02:09:42)
Thank you Mr. Chairman.
Mr. Chairman: (02:09:42)
Senator Hassan.
Senator Hassan: (02:09:47)
[inaudible 02:09:47] see if I can get that on. Thank you. Thank you, Mr. Chair. I want to thank Chairman Alexander and Ranking Member Murray for holding this hearing. I know he stepped out to vote, but I want to thank the Chair for his service and his example as a committee chair. And I didn’t want to thank our witnesses for being here today. And I want to especially thank you all for wearing your masks, even though you’re six feet apart, because there has even been some confusion in this body about what the best practices when we’re inside with others. So thank you for the example you’re setting.
Senator Hassan: (02:10:20)
I am concerned that Americans are losing confidence in the Federal Government’s COVID-19 vaccine review process. An ABC poll from this past weekend found that 69% of Americans will not have confidence in the President vouching for a vaccine. And we’ve seen other data reflecting that lack of confidence in vaccine approval process. FDA and CDC have existing vaccine review processes that are considered the gold standard by public health experts all around the globe. We have to make sure that these proven review processes take place in a transparent way free from political influence. So let me start with a question to you, Dr. Hahn, there is widespread concern about the independence of FDA’s COVID-19 vaccine review process, in large part due to your own actions and inaccurate statements over the past several months. Last week, you received a letter from more than 90 physician groups, doctors, and public health experts asking you to ensure that any vaccine approvals or authorizations are based on facts and science, and free from political influence. And Mr. Chair, I’d like to enter this letter into the record without objection?
Mr. Chairman: (02:11:34)
Without objection.
Senator Hassan: (02:11:35)
Thank you. Dr. Hahn, I appreciate the work that the FDA has done to draft new guidance for vaccine products, seeking emergency use authorization. I look forward to reading that document. I’d like to ask a couple of clarifying questions based on what you’ve outlined earlier in your testimony. In addition to the general meeting scheduled for October, will the guidance require that FDA’s Vaccines and Related Biological Products Advisory Committee hold meetings, review clinical trial data and release their findings to the public for each vaccine candidate?
Dr. Hahn: (02:12:13)
Senator Hassan, we are committed, absolutely, to having meetings that will be scheduled. We’ll be flexible about those, of the vaccine advisory committee, and, as I mentioned in my remarks, they will be transparent. The clinical data and summary that we provide the committee will be transparent and it will be public.
Senator Hassan: (02:12:32)
What I’m asking for is will you do it for each of the vaccine products?
Dr. Hahn: (02:12:36)
Yes, senator.
Senator Hassan: (02:12:37)
And will the findings be made public before the FDA approves or authorizes any vaccine?
Dr. Hahn: (02:12:43)
It will be a public process. The vote, the discussion, and the recommendations will be public, and we will incorporate those, and then make our decision.
Senator Hassan: (02:12:53)
So it will happen before?
Dr. Hahn: (02:12:54)
Yes, ma’am
Senator Hassan: (02:12:55)
Now to Dr. Redfield. My office has heard from clinicians across the country about the importance that they place on CDC recommendations when determining whether they are comfortable giving a vaccine to their patients. I talked with a long serving and practicing pediatrician in New Hampshire yesterday, and one of her concerns is how will they know about what dosages to use for children, for instance? Will CDCs advisory committee on immunization practices meet publicly reviewed data and issue public recommendations, again, for each COVID-19 vaccine before it enters the market, so healthcare providers are confident giving these vaccines to their patients?
Dr. Redfield: (02:13:36)
Very important that the Advisory Committee Immunization Practice will conduct their deliberations in public. The only caveat is when there’s national security interests, which should not be the case here, or if there’s proprietary information on the commercial side, but you should anticipate this will be a public discussion.
Senator Hassan: (02:13:55)
So I’m going to ask you for the same commitments I asked Dr. Hahn, each product?
Dr. Redfield: (02:14:01)
Each product.
Senator Hassan: (02:14:01)
And before the approval, it will be made public, the recommendations will be made public before the approval?
Dr. Redfield: (02:14:07)
Yeah, the ACIP will make those recommendations. After the FDA recommends an EUA or a BLA, then they will deliberate how the vaccine should be used in the United States, and that will happen in public.
Senator Hassan: (02:14:24)
Before they are distributed?
Dr. Redfield: (02:14:26)
Before it’s recommended to be used for the American public.
Senator Hassan: (02:14:30)
Thank you. Dr. Fauci, do you believe that the existing FDA and CDC advisory committees should conduct an independent, transparent, evidence-based review of safety and efficacy data for each vaccine product seeking approval or emergency use authorization, and could those independent meetings help improve public confidence? We’ve heard commitments about them, I just would love your comments about it.
Anthony Fauci: (02:14:53)
Yes, I agree, Senator, with the Dr. Hahn, that that is a process that occurs, and they do have an independent look at that, and they are advisory to the FDA. The FDA makes the ultimate decision, but what they do will be public. And as I have said myself, not only do you have a very qualified advisory committee in [inaudible 02:15:17], but you’ll also have the entire scientific community that is going to be scrutinizing this, because it will be made public, and for that reason, I have confidence in the process.
Senator Hassan: (02:15:29)
Well, I thank you. And I thank you, Mr. Chair. Senator Murkowski and I have legislation that would ensure that the processes that you’ve committed to will be followed. And I look forward to working with you on that. Thank you, Mr. Chair.
Mr. Chairman: (02:15:40)
Thank you, Senator Hassan. Senator Romney.
Senator Romney: (02:15:45)
Thank you, Mr. Chairman, and thanks to the members of this panel for the work that you’ve done to help safeguard as many Americans as possible from this terrible infection. Dr. Hahn, you surely speak with the pharmaceutical companies and get a sense of what progress they’re making on their clinical trials. When do you believe that you’ll receive the first application? Is this something that’s going to come in the next couple of weeks? Are you getting an indication it might be a couple of months? What kind of timeline are you anticipating before you’ll receive your first application?
Dr. Hahn: (02:16:21)
Senator Romney, thanks for the question. I honestly do not know when we will receive our first application. As I mentioned earlier-
Senator Romney: (02:16:30)
Of course not. You wouldn’t know, but you’re speaking with them. Are they getting close to the results from the 30,000, or are they just getting going? Have there been any applications that have been sent to the DSMB? So is it getting close or is it going to be a month or two from now?
Dr. Hahn: (02:16:51)
So Senator, I cannot speak to confidential commercial information that we have. For the publicly available data, the enrollment is going as expected in these clinical trials. And in the case of one has exceeded where they expected to be with respect to the 30,000, when they submit an application will be dependent upon when events occur in this trial, including or involving prevention of infection. When those events occur, and at pre-specified time by the DSMB, that’s when the first judgment will be made about the maturity of the data. And I can’t prejudge that. I don’t know.
Senator Romney: (02:17:29)
I know you can’t predict, but you’re getting an indication as to whether they’re receiving those things or not. And have any applications been received by the DSMB at this point?
Dr. Hahn: (02:17:38)
I do not know the answer to that, sir.
Senator Romney: (02:17:42)
They wouldn’t let you know that, whether they received an application?
Dr. Hahn: (02:17:46)
You mean the sponsor, sir?
Senator Romney: (02:17:48)
No, DSMB.
Dr. Hahn: (02:17:50)
No, I do not know the answer to that question, sir.
Senator Romney: (02:17:52)
Let’s say that tomorrow morning, an application is received. How long, typically, is the process inside the FDA to go from the time you receive an application until you make a determination that, “Yeah, let’s go ahead.”?
Dr. Hahn: (02:18:10)
So typically that process can take weeks, sometimes months. It really depends upon the complexity of the data and the data set that we’re looking at. We have not made a commitment to the timeline per se, because we haven’t seen the data, and we don’t know the complexity of the data or the amount of data that will come our way. What I can tell you, sir, is we do feel the urgency of the moment. We do take very seriously our responsibility to protect American lives. We will not delay, but we will not cut corners in our process.
Senator Romney: (02:18:44)
Dr. Fauci, I think everybody’s very, very pleased with the fact that our government has proceeded with manufacturing vaccines, even though we don’t know whether they’re going to work or not, and that’s so that we’ll be able to have vaccines to the American people as soon as possible. If the FDA were to approve an application, let’s say on November 1st, how long would it take for the American people to get vaccinated? Maybe I’ll change that to say, what proportion of our population, if it were approved on November 1st, what proportion of our population would be able to be vaccinated, let’s say, by the end of the year? That’s a two month period. I don’t know whether these manufacturing facilities are producing a hundred million vaccines right now, or 5 million or 10 million. So is this something that would really just go to a small subset of the population, or could we possibly inoculate the great majority?
Anthony Fauci: (02:19:40)
Well, good question, Senator. The fact is that the production, as it is rolling out, and when you hear the numbers, that’s the totality of all of the companies. So that in November, you’ll probably be maybe 50 million doses available. By December, maybe another a hundred plus million. And then when you get into January, February. By the time you get to April, there’ll be a total of about 700 million. So if you’re talking about who’s going to get vaccinated in December or November, it is not going to be a large proportion of the population, it will be according to what we were discussing before, namely those who are, according to the advisory committee on immunization practices, getting the priority. Likely will be healthcare providers and likely will be those who are vulnerable with underlying conditions.
Anthony Fauci: (02:20:37)
I can’t say that for certain, but if anything is the past is prologue, that likely will be the case, but we’re not going to have all of the doses available, for example, by the end of December, they will be rolling in as the months go by. And by the time you get to maybe the third or fourth month of the 2021, then you’ll have doses for everyone.
Senator Romney: (02:21:01)
Thank you.
Mr. Chairman: (02:21:02)
Senator Romney, thank you. Senator Smith.
Senator Smith: (02:21:07)
I want to thank Ranking Member Murray and Chair Alexander, if you were back, for your final hearing, I understand, it’s really incredible. Dr. Redfield, I wanted to follow up on something you’ve said. You’ve said that you thought that the vaccine, when we have a vaccine, that it would be distributed broadly by the second quarter or the third quarter of next year. And you also said that you thought that masks were the most effective tool that we have to stem the spread of the virus. You still think that’s true, right? You stand by that?
Dr. Redfield: (02:21:52)
Thank you Senator for the opportunity. When it comes to the question about masks, first I want to say I’ve total confidence in the importance of vaccines. And ultimately it’s going to be the vaccines that are going to get us back to the way of life as we get an effective vaccine. What I was trying to comment, as Senator Kaine alluded to, if the vaccine only induces an immune response in half the people, then it’s exceptional that half the people may not get protection from the vaccine. And what really I was trying to say, maybe was just to re-emphasize how important this mask is. We have this right now and it will protect the American public.
Dr. Redfield: (02:22:35)
The second question you asked was that Dr. Fauci was very clear in using the term doses, and we should have, if projected, about 700 million doses by April, late March, and that should be enough to vaccinate 350 million people cause you required two doses. When I was alluding to late second quarter, early third quarter, I was alluding to how long I felt it would take to get those 700 million doses into the American public, and complete the vaccine process. And I can defer to Dr. Fauci for his opinion, but I think that’s going to take us April, May, June, possibly July to get the entire American public completely vaccinated. But we will have the 700 million doses based on projection by late March, early April.
Senator Smith: (02:23:31)
So I appreciated that and I appreciated that you were pointing out as we have this, in some way, this sort of this political campaign against masks, that masks are going to continue to be important, contact tracing and testing will continue to be important as we go forward. I appreciate that, what you were saying, actually. My question is, Dr. Redfield, so did you get any political pushback for saying what you said?
Dr. Redfield: (02:23:55)
I stand by trying to present the data in the science as I see it, and I will continue to do that.
Senator Smith: (02:24:02)
But did you get any political pushback from political folks within the administration for what you said?
Dr. Redfield: (02:24:07)
Again, I’m going to just stay with my comment that I will continue to present science and data as I see it. And it’s not going to be modulated by whether individuals really appreciate what I say or don’t appreciate what I say.
Senator Smith: (02:24:25)
Didn’t the President say that he called you to complain to you about what you said?
Dr. Redfield: (02:24:30)
Again, I’m not going to comment on my conversations with the President.
Senator Smith: (02:24:33)
All right. Well, this has been the worries, I think, so many Americans, but let me ask about something else to the panelists. Senator Cassidy and I are working on a bipartisan bill, which would… This is called the Suppress COVID-19 Act, which would invest in testing and contact tracing, what we need to do to suppress this virus. And it would do this by empowering States to work together through interstate compacts, and to accomplish this. And Mr. Chair, I’d like to enter into the record, the bipartisan op-ed that Senator Cassidy and I wrote with Dr. Daniel Allen that appeared in the Washington post for the record, if I could.
Mr. Chairman: (02:25:16)
Without objection.
Senator Smith: (02:25:17)
Dr. Fauci, will we still need COVID-19 diagnostic testing and contact tracing even after we had a vaccine, and even after that vaccine is available to the public?
Anthony Fauci: (02:25:29)
Thank you Senator for that question. The answer is absolutely, because a vaccine depending upon the degree of efficacy, and depending, as Dr. Redfield just mentioned, depending on the people who ultimately decide they want to get the vaccine, you are still going to have vulnerable people in the United States, which would require not only testing, contact tracing, but implementation of the public health measures that we’ve been talking about all along. The vaccine availability will go a giant step to controlling the infection. But you’re not going to completely eradicate or eliminate it, particularly if you have a vaccine that is even moderately effective, 75%. if you don’t have a vaccine that’s 98% effective and everybody takes it, you’re still going to have vulnerable people in the population. And the presence of those vulnerable people will require the implementation of public health practices, including testing, identification, isolation, and contact tracing,
Senator Smith: (02:26:37)
And continuing to wear masks and practice good social distancing, and the other public health strategies that we know work to keep people safe.
Anthony Fauci: (02:26:44)
Absolutely.
Senator Smith: (02:26:47)
Thank you, Mr. Chair. I’m out of time.
Mr. Chairman: (02:26:49)
Thank you. Senator Smith. Senator Braun.
Senator Braun: (02:26:52)
Thank you, Mr. Chairman. Yesterday, we reached a sad milestone, we recorded over 200, 000 COVID related deaths in the U.S. I want to go back to the beginning to look at where we started and where we are now. I think it is important for the American people to understand and remember what the context was when this outbreak began, where we are now, and that the President called on the American people to come together by shutting down the country for 45 days to avoid the catastrophic models calling for millions of deaths by August 1st.
Senator Braun: (02:27:34)
On March 16th, President Trump issued guidelines for governors calling for a partial shutdown of 15 days to slow the spread. By March 29th, it was clear the President, again, followed the advice of the task force and called for an additional 30 days of shutdown to slow the spread of COVID-19. And Dr. Fauci, I have several questions for you, and a yes or no is fine, unless you want to elaborate further. And then one final question for Dr. Hahn. During those critical days in March, was it your recommendation and that of the task force for President Trump to issue the guidelines to shut the country down for 45 days?
Anthony Fauci: (02:28:21)
Yes. I wouldn’t use the word to shut the country down. It was to implement separation, avoiding contact, all the kinds of things we did in the recommendations. So the short answer to your question is yes.
Senator Braun: (02:28:36)
Thank you. Let’s look at the chart over here. This was used by Dr. Birx at the task force briefing on March 31st. We can all see what Dr. Birx called the giant blue mountain that predicted over 2 million deaths without mitigation efforts, and the stippled foothill that shows a range of a hundred to 240,000 deaths. If we took the drastic actions to put the mitigation into effect, which did require some shutting down in the country, did you and Dr. Birx explain at a March 31st briefing that initial projections from the health experts showed that if we did not act the death tolls by August 1st could exceed a couple million.
Anthony Fauci: (02:29:29)
Yes. That’s what we presented based on a model, sir. It’s a model.
Senator Braun: (02:29:34)
And was the goal of the National Mitigation effort to bring the projected death tolls from over 2 million to the range of a 100 to 140,000?
Anthony Fauci: (02:29:46)
Yes, with an exception, because as I mentioned that a press conference associated with that, I said the model would say it would go down, but I don’t think we should be accepting that, that we could likely do much better. If I could just have 20 seconds.
Anthony Fauci: (02:30:03)
… likely do much better. If I could just have 20 seconds more, I’ll explain it. Because if we had done the kinds of things uniformly and consistently throughout the country of the recommendations of the gateway phase one, phase two, phase three, what would have happened is that we would have had less than that. And we know that some states did a good job, some states did not so good a job. Some states try to do a good job, but people didn’t listen. We saw pictures of people congregating at bars with no masks. So even though the model said that that likely would be the number of deaths, I and my colleagues always said we should strive very hard to not reach that number if we did the public health measures that we were talking about. Masks, physical separation, et cetera.
Senator Braun: (02:30:53)
So outside of that qualification, which I think it’s admirable to try to always best what you think might be the case, do you think the actions of the American people and the actions of President Trump and the task force at least hit where you were hoping, not withstanding the qualification that you made?
Anthony Fauci: (02:31:18)
Yeah. What we did show, and we know the data, and that’s very important because it helps us to look ahead, that the kinds of things that were put into effect, the mitigation going from control as well as mitigation, we believe have saved a lot of lives.
Senator Braun: (02:31:34)
Would you agree that the task force and the president took the outbreak very seriously from the beginning, taking unprecedented action, saving millions of American lives as a result?
Anthony Fauci: (02:31:48)
Yes. I mean, obviously, I think one of the first things that we had said and discussed before was the shutting off of travel, for example, from China. And then second after that, we did it at a time, for example, when we were getting cases from Europe, which actually [seeded 02:32:05] the Northeastern part of our country, particularly the New York metropolitan area.
Senator Braun: (02:32:09)
I think the importance of that is understated in terms of those early decisions, what impact they did have. As we can see from this chart, poster, a quick Google search will reveal that the president and the task force told the American people on March 31st millions could die if we did not follow the White House guidelines. If we did everything optimally, then we would be where we are today. If we want to ask the American people to continue to take the virus seriously and keep making sacrifices in their daily lives until we have a vaccine, then do you think the media, politicians, and scientists like you need to do a better job reminding the American people about the blue mountain warning of millions dead and how their collective actions will continue to save lives?
Anthony Fauci: (02:33:03)
Yes, Senator. In fact, virtually every time I am in the public and given the opportunity to talk about this, I continue to stress the four or five things that if we all did it and we did it consistently, we would not only prevent the surges that we’ve seen, but we would also get those surges down as we’re seeing in different parts of the country now where cases are starting to come down. So some of the areas of the country that are doing it well are seeing a good control, and others are not. I think we need uniformity throughout the country of a consistent adherence to the public health practices that we talk about.
Chairman: (02:33:42)
Thank you, Senator Braun. Senator Jones.
Senator Jones: (02:33:49)
All right.
Chairman: (02:33:57)
We’ll fix it.
Senator Jones: (02:33:58)
[inaudible 00:04:03]. Okay. Thank you, Mr. Chairman, and thank you for having this hearing, but also thank you for service on this committee. I want to thank all the witnesses for being here today. Again, we always appreciate you being here. I want to first comment something that Kaine said. I think he was referring to Dr. Redfield’s testimony about the importance of timely and effective healthcare, the ability to get healthcare. And Senator Kaine noted he wouldn’t know what 400,000 Virginians would have done had they not had the benefit of Medicaid expansion. I can tell you Senator, and unfortunately I’ve got to almost the same number in Alabama, 400,000, who did not have that benefit at all because Alabama refused to expand Medicaid. And I still can’t get folks up here to seem to understand the importance of giving states like Alabama that opportunity with federal incentives again, but that’s for another day. I think it’s pretty clear, gentlemen, that one of the concerns a lot of people have on both sides of the aisle is just mixed messages going back and forth, and it’s really difficult.
Senator Jones: (02:35:15)
Since the very beginning of this, I’ve tried to tell people in Alabama, “Listen to the health care folks. Don’t listen to politicians. Listen to the healthcare folks.” Every week, beginning in April, I had a Facebook Live with media that we broadcast. Dr. Fauci was gracious enough to join me for one of those, which I really appreciated. But it’s gotten more difficult, I’m sure you can see, and it’s gotten more difficult as we approach the election. Dr. Hahn, the president at one point said in a news conference that the FDA wanted to limit the use of the convalescent plasma until after the election. He tweeted that there was a deep state within the FDA that’s making it difficult for drug companies to get people in in order to test vaccines, and his chief of staff said that the president wanted to make the FDA feel the heat, which I’m not sure exactly what that meant.
Senator Jones: (02:36:07)
But Dr. Hahn, you said that you have every confidence in the scientists and staff at FDA. And I appreciate that, and I do too, by the way. Is there some kind of deep state that you have seen in the FDA that is any way trying to do anything other than quickly get a vaccine, get therapeutics to the American public?
Dr. Hahn: (02:36:28)
Senator, I will answer your question this way. I have 100% confidence in the outstanding scientists, doctors, nurses, pharmacists at FDA who have remarkably stood up during this pandemic to help expedite getting medical products to the American people. I have complete confidence in their decisions, and I have complete confidence in the actions that have been taken to date.
Senator Jones: (02:36:51)
And that confidence is based on following the science, not any political pressure. And that’s what we’re expecting with a vaccine approval.
Dr. Hahn: (02:36:59)
Yes, sir. And I’ve said that several times today, and I appreciate the opportunity to say it again. Our career scientists for any medical products, and particularly vaccines, will follow the science and data and our rigorous standards, and it won’t be politics that make any part of that decision, sir.
Senator Jones: (02:37:15)
Great. Dr. Redfield, a similar question with you. You said in your testimony that you, and all of you have in one way or another continued… Every time we’ve talked, every time you’ve been here, you’ve continued to tell the people, ” Wear a mask, social distance, wash your hands.” And Dr. Redfield, you said today you’ve added a fourth, “Be smart about crowds.” But yet, we see time and time again in political gatherings, and to not be partisan here, in public protest, peaceful protest, folks aren’t doing that. They’re not doing that, and in fact, some are being encouraged not to wear a mask, not to do anything. What’s the public to do when you’ve got public officials and others that are giving a different message from what you guys are doing? And everybody has been pretty consistent, but we’ve got clear messages coming from the president and folks on both sides of the aisle, in my opinion, that it’s okay under the circumstances that you want to ignore those guidelines.
Senator Jones: (02:38:16)
We don’t know whether those people are washing their hands or not, but we know that most of them are not wearing a mask. They’re not social distancing, and they’re certainly not being smart about crowds. What do we do? How do we get the information to our people?
Dr. Redfield: (02:38:27)
Thank you very much, Senator. Again, we have to just keep stressing what I’ve said before, that we want all Americans to embrace wearing a face mask, be smart about social distancing and crowds, wash their hands, and obviously have confidence in the flu vaccine. If we all wore a mask and we were smart about social distancing as Dr. Fauci alluded to, this outbreak would really start to come under control. This simple, simple decision. But unfortunately, it’s not something that 75% of us can do and we’re going to get the results we want. This is something that we all have to do to get the results we want, and we will continue to stress that. I want to add how disappointed I have been personally when people at HHS made comments that they felt that there was a deep state down at CDC. I will tell you, these are dedicated men and women that are confronting the greatest public health crisis of our time, working 24/7, over 6,700 of them involved in the outbreak itself, 1200 deploying, and it’s offensive to me when I hear this type of comment.
Dr. Redfield: (02:39:42)
I think in my 21 years, 22 years in the military, you never knew people’s political perspective. I will say that is the same about the men and women at CDC. They’re dedicated to protect the public health of this nation, and I know that you all appreciate that. Obviously, people don’t understand the ability to suck energy out of people that are working 24/7 when they get unfairly criticized or unfairly characterized, and really, that’s the real harm in all of this.
Senator Jones: (02:40:14)
Thank you. Thank you very, very much for that. I completely agree. Thank you, Mr. Chairman.
Chairman: (02:40:19)
Thank you, Senator Jones, Senator Rosen.
Senator Rosen: (02:40:26)
Thank you, Mr. Chairman. And again, I want to thank everyone on the panel for just everything you and your teams are doing to save us from this pandemic, move us forward with therapeutics and vaccines and back to our regular lives. But my office has heard from a number of our local health departments in recent weeks about the challenges that they continue to face, not only in addressing COVID-19, but preparing to combat COVID alongside the seasonal flu, which is just about to begin. So as we enter flu season, we’re again faced with a preventable public health crisis. But this time, we can avoid catastrophe by adequately supporting our medical officials on the ground with the resources they need.
Senator Rosen: (02:41:14)
Dr. John Novak, who leads the Washoe County District Board of Health in Northern Nevada, recently explained the critical need to address both flu and COVID prevention, saying the flu vaccine this year is very COVID related since they’re both respiratory component diseases, the initial symptoms extremely close in pattern. With flu season fast upon us, it’s extremely important to reduce the number of flu patients that need the same overtaxed medical care. So Dr. Fauci, could you just please explain, if you will, the importance of concurrent planning for flu shots and our COVID response, and how maybe we should be providing things at the same… When we get a vaccine, or something like that. Individuals of the same location drive up… How are we going to do that?
Anthony Fauci: (02:42:03)
Yeah. Well, thank you for the question, Senator. First of all, I want to just emphasize what your health officials already have mentioned to you, the importance of getting an influenza vaccine. Because what we don’t want is two conflated respiratory infections at the same time as we enter into the fall and the winter. We want to get as many people vaccinated with the flu vaccine as possible. The logistics of how you can get them done together, I don’t think I can comment on that right now. Perhaps Dr. Redfield can. But one of the things I do want to mention, because we’ve seen that in Australia as well as South Africa and Argentina, is that if we continue to do what each of us have been saying regarding the kinds of preventive measures of mask wearing, social distancing, avoiding crowds, washing hands, et cetera…
Anthony Fauci: (02:42:59)
If we do that as we get into the fall and the winter for the purpose of COVID-19, it is likely to have a positive impact on the infection rate of influenza. Because our colleagues in the Southern hemisphere, particularly in Australia, have found because of that, they’ve had a very, very low, mild influenza season. So if we could combine the vaccination as much as we possibly can with influenza together with the public health measures, hopefully we can have a very, very low level of flu that would not then complicate what will clearly be a challenge in the winter with COVID-19. Thank you.
Speaker 2: (02:43:44)
And Senator, I’m sorry-
Senator Rosen: (02:43:45)
Thank you, I appreciate that. I just have a minute left. I want to ask about some interesting research, and any of you can take this if you know about it. I’ve been seeing some information come out recently about the bradykinin peptide and how, when it’s overactive, it causes inflammation that could be part of the reason that COVID-19 causes this fluid build-up in the lungs. Anybody could take this. Have you been talking about that research, and is that really going to be helpful? I know that there are drugs out there that to help reduce this kind of… Well, I’m not sure if it’s inflammation, but attack this kind of response. So maybe someone wants to take that question. And, is that a possibility for treatment?
Anthony Fauci: (02:44:27)
Yeah, real quickly. There are a number of interventions to block and blunt the overactive inflammatory response, which is relevant as you get into advanced disease. Dexamethasone, which I mentioned in my opening comments, is a commonly used steroid which blocks inflammation. There are a variety of other trials that are either ongoing or being prepared to look at blocking a variety of other inflammatory indicators such as cytokines, IL-6, and a variety of others. These are things that are being actively pursued. There’s no evidence thus far, except for the dexamethasone evidence, that by blocking inflammation, you can actually help people with advanced disease and actually decrease mortality. So it’s one of those things that are involved in blocking inflammation.
Senator Rosen: (02:45:20)
Thank you. I appreciate that, and I appreciate everything that you’re doing. I look forward to speaking with you again, and hopefully going to continue to get positive news. Thank you.
Chairman: (02:45:31)
Thank you, Senator Rosen. We’ll go to Senator Murray now for her closing questions or remarks, and if Senator Loeffler returns from voting in time, we’ll go to her next and then we’ll close the hearing. Senator Murray.
Patty Murray: (02:45:43)
Well, Mr. Chairman, thank you. I will submit my additional questions for the record. I would like to thank all of our witnesses for joining us today. Senator Alexander, you announced earlier that this will be the last hearing of the Health Committee that you chair, and I just want to start by saying it’s been a pleasure to work with you to lead this committee over the past several years and through many critical challenges for our country, from working to address the opioid crisis, supporting medical innovation, replacing No Child Left Behind. There’s a lot we’ve gone through. And we’ve been able to do a lot of that by listening to each other, and most importantly, listening to the people in our states about what they need. So I just want to say I think that I speak for everyone on my side of the aisle when I say I’m very proud of the work we’ve been able to do together with you on the other side of the dais. And this may be our last hearing, but just know I appreciate all you have done and will continue to do.
Patty Murray: (02:46:43)
I want you to know I’m going to continue to follow our response to this pandemic very closely. I will continue pressing for answers, including on issues like whether our meat packing plants have accurate information, as Senator Baldwin raised earlier. Given what’s happened in my state and others, we need answers on that. I’m also going to continue demanding a full comprehensive plan to finally get testing where it needs to be, and fully prepare to make sure we develop, manufacture, distribute, and administer a safe, effective, and trusted vaccine. I’m going to continue to push back against every effort from this president to interfere in our response and put politics over science and public health.
Patty Murray: (02:47:27)
I will continue to call out misinformation or lies or conspiracies, and work to make sure we are communicating clear science-based facts to people in this country. And I am going to urge our Republicans to come back to the table and negotiate in earnest so we can finally pass the kind of sweeping relief our communities really need. Despite President Trump’s careless claims that we are rounding the final turn, or that this disease affects virtually nobody, we know the painful reality is that this crisis has tragically killed over 200,000 Americans already and that it is far from over. So our work to respond to it cannot be over either. Thank you, Mr. Chairman. Thank you for the time.
Chairman: (02:48:17)
Thank you, Senator Murray, and thanks for your kind remarks. And I express again today how much I appreciate our friendship, your diligence, and your leadership, which has been absolutely crucial to the considerable results that have come out of this committee, especially over the last six years. So thank you very much for that. Senator Loeffler.
Senator Loeffler: (02:48:46)
Thank you, Mr. Chairman, and I want to start by thanking each of you here today. I want to thank you and your workforces for the tremendous work, the effort that’s been done to combat this virus. Dr. Redfield, this question’s for you. I wanted to touch on the subject that I feel has been overlooked as we continue to confront the pandemic. That issue is mental health, particularly in younger populations and the frontline. Yesterday, I had the opportunity to be briefed by Dr. Debra Houry. She’s the Director of the National Center for Injury Prevention and Control, and also one of your colleagues at the CDC. And we spoke on the rising mental health issues due to the pandemic, and particularly suicidal ideation. We spoke about the importance of comprehensive community-level outreach programs to prevent this issue from growing worse.
Senator Loeffler: (02:49:38)
The CDC is funding several different programs that are aimed at this goal, and the CDC’s comprehensive suicide prevention program is currently funding nine grant recipients in different states to a COVID suicide prevention funded project in Georgia, in my state, that’s being run through your Department of Public Health. The question for you is, what more can we do on the federal level to shine a light on this issue and make sure that these communities have the resources they need to have comprehensive outreach, and to ensure that we’re not turning a blind eye to the critical issue of mental health that so many are facing due to this pandemic? Thank you.
Dr. Redfield: (02:50:20)
Thank you very much, Senator. It’s a very, very important issue, and I’m glad Dr. Houry had the opportunity to brief you. On one of our recent surveys, it was surprising that over 30% of Americans are feeling anxiety and depression as part of the COVID experience. And we have seen, sadly, an uptick particularly in adults in suicide. One of the reasons I was so aggressive in reminding the American public that the public health interest of K through 12s is best served by getting kids back to face to face learning. Many people may not realize that over 7 million children get their mental health services in the context of schools. We also, unfortunately, have seen an increase in substance abuse and drug use disorder that’s been associated with this COVID situation, some of which has been driven by the lack of availability of medical appointments when the health industry basically pulled back to help manage people that had chronic pain syndrome or were recovering from drug use disorder.
Dr. Redfield: (02:51:29)
So it’s a very important issue. I think we do have to keep it. We did start this, you’ve probably seen it on TV, How Right Now initiative to let people know that it’s not stigmatizing to say that you’re not doing well, that you’re you’re depressed or you’re suicidal. These are medical conditions like I’ve argued about drug use disorder. These are not behavioral issues. These are medical conditions. They need to be treated as medical conditions. And I think it is one of the collateral damages that we saw as part of the COVID pandemic.
Senator Loeffler: (02:52:10)
Thank you. I’ll yield my time.
Chairman: (02:52:15)
Thank you, Senator Loeffler. We’ll wrap up the hearing now. I have just three or four questions about the vaccine, which I’ll start with Dr. Fauci, but any of the others want to answer it… Pretty simple questions, but it may be important for the American people. One is, and I’ve had people say this to me, Dr. Fauci, if I take a shot to get the vaccine, does that give me COVID?
Anthony Fauci: (02:52:40)
Absolutely not. That would be impossible.
Chairman: (02:52:43)
That would be impossible.
Anthony Fauci: (02:52:45)
Yes, sir.
Chairman: (02:52:46)
So one of the risks of a vaccine shot is not getting COVID.
Anthony Fauci: (02:52:50)
That is correct. That risk does not exist.
Chairman: (02:52:56)
Will the vaccine for COVID… Will it likely be more like the polio vaccine or the flu vaccine? By that I mean, if you take the polio vaccine, you assume you’ll never get polio. If you take the flu vaccine each year, it’s sort of a guess about whether the vaccination really will be effective. And I think it also helps speed the cure if you do get sick, but it may not be more than 50% effective. So is it more like the polio vaccine or the flu vaccine, or do we know that yet?
Anthony Fauci: (02:53:39)
We do not know that yet, Mr. Chairman, and that’s one of the things that we will learn. Polio is a highly, highly effective vaccine that gives long lasting protection. What we do not know yet is how effective the COVID-19 vaccine will be, nor do we know the durability of the protection, how long it will last. We will find out the answer to those questions through the clinical trials and the follow-up of the clinical trials.
Chairman: (02:54:12)
Will the vaccine be free when it’s distributed and administered to Americans?
Anthony Fauci: (02:54:18)
We have been assured that in fact, the American public will not have to pay for the vaccine. We have been told that at the level of the task force.
Chairman: (02:54:31)
When we’re talking about vaccines, are we in the… Most of the six vaccines were anticipating that you’d have to take two shots about four weeks apart, and then the effectiveness of the vaccine might be two weeks after that. Or, is that wrong?
Anthony Fauci: (02:54:50)
It varies from candidate to candidate. For example, the Moderna and the Pfizer, which are out there now, are two shots, a prime and a boost. One is the boost at 28 days, one is a boost at 21 days, whereas the J&J or [inaudible 02:55:08] is a single shot.
Chairman: (02:55:13)
Well, I want to thank all four of you for what many of the senators said today, which is extraordinarily able and dedicated service to our country. And what I’ve heard today is that we are in an unprecedented sprint towards success in terms of first, vaccines. The polio vaccine took more than 10 years. Other vaccines we’re familiar with took a long time, but what the administration is telling us is that we likely will have a vaccine approved within a year from the time it was first developed. And we know that we will have tens of millions of doses of a total of six vaccines ready for distribution once it’s approved. We’ve also heard that we have five treatments, that if you get COVID-19, there are five medicines for it and that there are more coming likely. And the most promising may be the so-called antibody cocktails that were used so effectively with Ebola.
Chairman: (02:56:21)
We’ve also heard that despite a bumpy start with a diagnostic test at CDC at the beginning of the year, that we’ve had explosion of quick diagnostic tests. And the administration, for example, has bought up 150 million of the Abbott test, which is $5, 15 minutes, more specific results. And we’ll begin to distribute those to schools, or is beginning to distribute those to schools, colleges, and to states. And the Dr. Collins Shark Tank at NIH is producing even more. Dr. Hahn, when I asked him who makes the decisions, Dr. Hahn, the scientists at FDA or the White House, he said the scientists at FDA in terms of safety and efficiency. And all of you have said that you would take the test or the vaccine when it’s produced, and recommend it to your families, although Admiral Giroir said what is wise, you should talk to your doctor before you take any type of shot, I assume. But they said they had great confidence in the FDA. We’ve also heard, and I think this is most important, Dr. Fauci… As did all of you say, but Fauci has been involved with these things since 1984 or the Reagan years, or even before. Are we cutting corners on safety and efficiency? And he said no. And the risk we’re taking is to the taxpayers, because of the new way we’re doing things. We could lose a lot of money if these vaccines aren’t approved, but I think the Congress and the president decided that that was well worth it if it saved lives by having a vaccine ready in a year, rather than two, three, four years. And finally, I asked whether it was a good idea, having been a college president, to send home the students who get sick with COVID if an outbreak comes out, as it is on many college campuses.
Chairman: (02:58:24)
And Dr. Fauci said, “No, that’s not the right way to do it. The right way to do it is to manage your campus in such a way that you can isolate the six students. Send them home and they just infect grandma, grandpa, everybody else in the community.” So it’s been a very useful and effective hearing. It was widely carried live on television for a couple of hours so the American people had a chance to see the administration’s top health experts answer tough questions from Democrats and Republicans and give straightforward answers. I thank you for your service, and I thank you for today’s hearing. The hearing record will remain open for 10 days. Members may submit additional information for the record within that time if they would like. Thank you for being here. The committee will stand adjourned.