TAPE: EF02/0975 IN_TIME: 04:26:26 DURATION: 2:34 SOURCES: ABC RESTRICTIONS: DATELINE: USA, November 17, 2002 File SHOTLIST: 1. Black and white file of US President John F. Kennedy and Jackie Kennedy 2. Black and white file of John F. Kennedy 3. SOUNDBITE: (English) Robert Dallek, Presidential Historian: "He had a series of problems that I think would send most of us under the covers to hide." 4. Black and white file of Kennedy at podium 5. Black and white file of Kennedy sitting in car 6. Various shots of Historian Robert Dallek 7. SOUNDBITE: (English) Robert Dallek, Presidential Historian: "Colitis, Addison's disease, prosititus, sinusitis, and terrible back difficulties, he couldn't reach across the desk to pull papers to himself, he couldn't pull the shoe and sock on his left foot." 8. Black and white picture of Kennedy in chair 9. Black and white file of Kennedy signing papers 10. Black and white picture of Kennedy 11. SOUNDBITE: (English) Jeffrey Kelman, Internal Medicine Specialist: "He was on Paregoric, Antispasmodics for his gut, uh, different kinds of steroids, oral cortisone, injected steroids, Testosterone to build his muscles up, he was on Antispasmodics, Phenobarbital, he was on Nembutal to sleep." 12. Black and white file of Kennedy walking 13. UPSOUND (Underlayed with Kennedy speaking in front of crowd): (English) Jeffrey Kelman, Internal Medicine Specialist: "Even in the Cuban missile crisis, when he needed extra medications he did very well." 14. Black and white picture of Kennedy 15. Black and white picture of Kennedy at podium 16. Black and white file of Kennedy 17. SOUNDBITE: (English) Theodore Sorenson, Former Presidential Assistant: "He was a man in very good health there is no doubt about the fact that he had a bad back, as millions of men do, sometimes it hurt worse than others." 18. Black and white file of Kennedy getting off plane 19. Black and white file of Kennedy and wife 20. SOUNDBITE: (English) Robert Dallek, Presidential Historian: "This suggested that he was a man of great resolve and strength of character that we really hadn't quite understood before." 21. Colour file of Kennedy shaking hands with crowds STORYLINE: President John F. Kennedy suffered more pain and illness than previously known, and took as many as eight medications a day, according to a recent report. Newly disclosed medical files from the last eight years of Kennedy's life, including X-rays and prescription records, show he took painkillers, anti-anxiety drugs, stimulants and sleeping pills, as well as hormones to keep him alive, according to a story for the Sunday edition of The New York Times. The records were revealed by historian Robert Dallek, who is writing a biography, "An Unfinished Life: John F. Kennedy, 1917-1963," which is due to be published next year. Dallek was allowed to examine the documents last spring by a committee of three longtime Kennedy family associates, who for decades refused all requests to look at the records. He reviewed the documents with the assistance of physician Jeffrey A. Kelman, but was not allowed to make photocopies, the newspaper said. As president, Kennedy was known for having a bad back, and since his death, biographers have pieced together details of other illnesses, including persistent digestive problems and Addison's disease, a life-threatening lack of adrenal function, the newspaper said. The records reveal that Kennedy variously took codeine, Demerol and methadone for pain; Ritalin, a stimulant; meprobamate and Librium for anxiety; barbiturates for sleep; thyroid hormone; and injections of a blood derivative, gamma globulin, presumably to combat infections. The new information also shows Kennedy went to great lengths to conceal his ailments, even denying to reporters that he had Addison's disease.

00:00:00:00 hepatitis -( vo/sot,537) people lined up to get gamma globulin shots/sot by mervyn silverman/shot of ice cream parlor where employee spread the disease. (0:00) /

Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story. This story aired at 6 P.M.

DR. HART VAN RIPER, MEDICAL DIRECTOR OF THE NATIONAL FOUNDATION FOR INFANTILE PARALYSIS, WAS IN MINNEAPOLIS TO OUTLINE A STRATEG FOR THE 1953 MARCH OF DIMES CAMPAIGN.

Molecular model of an immunoglobulin antibody molecule. This Y-shaped molecule has two arms that can bind to specific antigens, for instance viral or bacterial proteins. In doing this it marks the antigen for destruction by phagocytes, white blood cells that ingest and destroy foreign bodies. Antibodies can also kill some pathogens directly and can neutralise toxins.

Animation showing the structure of an antibody, or immunoglobulin, molecule. These Y-shaped molecules have two arms that can bind to specific antigens, for instance viral or bacterial proteins. In doing so, they mark the antigen for destruction.

THE WORLD HEALTH ORGANIZATION SAYS DEATHS FROM TROPICAL DISEASES COULD DOUBLE IN THE NEXT 20 YEARS. EILEEN WIXTED REPORTS, TRAVELERS TO CERTAIN AREAS NEED TO PROTECT THEMSELVES.

Video footage from the KXAS-TV/NBC station in Fort Worth, Texas, to accompany a news story. This story aired at 5 P.M.

0940 SPEV HEAD ON FS2 79 Senate HELP Committee Hearing on Covid-19 testimony from NIH and Anthony Fauci -Head ON COVID-19: Safely Getting Back to Work and Back to School Full Committee Hearing WITNESSES Anthony Fauci, MD Director National Institute of Allergy and Infectious Diseases, National Institutes of Health Bethesda, MD Robert Redfield, MD Director United States Centers for Disease Control and Prevention Atlanta, GA ADM Brett Giroir, MD Assistant Secretary For Health United States Department of Health and Human Services Washington, DC Stephen Hahn, MD Commissioner Of Food And Drugs United States Food and Drug Administration Silver Spring, MD WASH 10 SENATE HELP COMMITTEE HEARING COVID 19 VIRTUAL WITNESS CAM POOL 100333 ALEXANDER/CHAIRMAN>>> Well, good morning. The committee on Health, Education, Labor and Pensions will please come to order. First of administrative matters, based on the advice of the attending physician and the Sergeant of Arms, after we consulted the Department of Health and Human Services and the Centers for Disease Control and Prevention, individuals in the hearing room are six feet apart. As a result, there's no room for the public to attend in person. Representatives of the Press are working as a pool to relay their observations to colleagues. 100403 The hearing may be watched online. An unedited recording will be available on the committee's website at www.senate.gov. Witnesses are participating via video conference in a one-time exception. Some senators, including the Chairman, are participating by video conference. Senators, we've been advised, may remove their masks, and talk into the microphone when they're in the hearing room, as they are six feet apart. I'm grateful to the rules committee, sergeant at arms, the press gallery, the architect at the Capitol, the Capitol police, the committee staff, [inaud] and Evan Griffith all for their hard work to keep us safe. 100441 At our hearing last Thursday, I said that "all roads back to work about back to school run through testing," and what our country has done so far on testing is impressive, but not nearly enough. Over the weekend, Senator Schumer, the democratic leader, was nice enough to put out a tweet, quoting half of what I said. He left out the other half, the "impressive" part. So let me say again what I meant by that. When I said "impassive," I meant that according to Johns Hopkins university study, the United States has tested over 9 million Americans for covid-19. 100518 That's twice as many as any other country. We don't know what China has done. And it's more per capita than most countries, including South Korea, which many members of our committee had cited as an example of a country that had tested well. According to Dr. Deborah Birx, the United States will double testing in the month of May -- month of May which should get us up to about 10 million tests conducted. Now, here is what I mean by "impressive": here in Tennessee, where I am today, first, anyone who is sick, a first responder or health care worker, can get tested. 100552 Our governor, Bill Lee, is also testing every prisoner, every resident staff and member in a nursing home, he's offered weekend drive-through testing, he's done specific outreach for testing to low-income communities -- any tennessean can get a free test at the local public health department. The governor's slogan is "if in doubt, get a test." Governor Lee sent his testing goals, in May, to the Federal government, as every state has done. 100622 The federal government is helping him ensure that he has enough supplies, in case he has trouble getting them through the labs and the other commercial sources. As a result, our state has tested about 4% the population. The governor hopes to increase that by 7% by May. That's one of the best in the country. This impressive level of testing is sufficient, we believe, to begin phase one of going back to work, which as I said last week is not nearly enough to provide confidence to 31,000 students and faculty members that we hope will show up at the university of Tennessee campus in August when school starts. 100702 Last week, I talked with UT Knoxville Chancellor Donde Plowman about that. We said, "What would persuade those 3100 students as well as the 50 million K through 12 students in the country and the other 5,000 university students, what will persuade them to go back to campus in August?" That's where the new shark tank comes in. Dr. Collins, at the National Institute of Health" calls it "red X." We had our hearing about that on Thursday. It's a really remarkable scientific exercise. 100734 Take a few early stage concepts that are swimming around what we call that competitive shark tank, and see if Dr. Collins and his associates can find a few new technologies to create millions of new tests that will scale up rapidly and make it more likely that students will go back to school in August. For example, the FDA authorized last week its first diagnostic test using saliva that a person provides at home, instead of a nose swab or blood. 100807 It authorized its first antigen test. We're hearing a lot about those, like the ones used for flu or strep throat, which involves the swabbing of a nose, and you can get the result in just a few minutes. Another proposal, not yet approved, is to put in your mouth a sort of lollipop sponge, take a photo of that with your cell phone and send that to your doctor. If it lights up, you're positive. Or the university might send that saliva lollipop to a nearby laboratory, which could be a gene sequencing laboratory, which can deal with thousands of those samples overnight. 100845 That same process could occur at a middle school. It could occur at a factory. Of course, anyone testing negative one day can test positive the next, but such widespread screening of entire campuses, schools, or places of work will help identify those who are sick, trace down those who were exposed. That, in turn, should help persuade the rest of us to go back to school and back to work. In addition to more testing, I expect Dr. Fauci will talk to us about additional treatments that will be available to reduce the risk of death and the administration's plan to do something that our country's never done before, 100924 which is to start manufacturing a vaccine before it actually has been proven to work, in order to speed up the result, in case it does work. Those vaccines, those treatments are the ultimate solution. But until we have them, all roads back to work and school go through testing. The more tests we conduct, the better we can identify those who are sick and exposed, and we can quarantine the sick and exposed, instead of trying to quarantine the whole country. 100954 Now, in my opinion, this will require millions of new tests, many from new technologies. Some of these will fail, but we only need a few successes to get where we want to go. That's why I said on Thursday, what our country has done so far in testing is impressive, but not nearly enough. First, squeeze all the tests we can out of current technologies. Next, try to find new technologies to help us contain the disease and persuade us to go back to work. 101026 Now, one other thing. This is a bipartisan hearing to examine how well we're preparing to go safely back to work and to school, and to determine what else we need to do in the united States Senate. Such an exercise sometimes encourages finger-pointing. Before we spend too much time finger-pointing, I'd like to suggest that almost all of us, the United States and almost every country so far as I can tell, underestimated this virus, underestimated how contagious it would be, underestimated how it can travel silently in people without symptoms to infect other people, how it can be especially deadly for certain segments of our population -- the elderly, those with pre-existing conditions, minority population. 101116 Let me go back to the March 3rd hearing that we had in our committee on coronavirus, six weeks after the first case was discovered in the United States, a day when only two deaths were recorded in this country. I read, at that hearing, this paragraph from "The New York Times" two days earlier on March the 1st. They reported this -- "Much about the coronavirus remains unclear, the Times reported, and it's far from certain" -- this is March 3rd that -- March 1 -- "That the outbreak will reach severe proportions in the United States or affect many regions at once. 101153 With its top-notch scientists, modern hospitals, and sprawling public health infrastructure, most experts agree, the United States is among the countries best prepared to prevent or manage such an epidemic." That was "The New York Times" on March 1. A lot of effort has gone into trying to make our country well prepared. Over the last 20 years, four presidents, several congresses, in response to 9/11, Bird Flu, Katrina, Ebola, H1N1, MERS, passed nine major laws to try to help get this country ready for what we're going through today. 101234 These laws stood (?) up the strategic national stockpile, created an assistant Secretary for Preparedness, it -- it created incentives for the developments of vaccines and medicines that we're using today, strengthened the Centers for Disease Control, and created Barda. Thanks to the leadership of Senator Blunt and senator Murray, for five straight years, we've significantly increased funding for the national institutes of health. 101304 All this was part of a shared goal -- Democrats, Republicans, four presidents, several congresses -- to try to get ready for what we're going through today, whether it was known, like anthrax, or unknown like Bovid-19. But despite all that effort, even the experts underestimated Covid-19. This hearing is about how we improve our response to this virus, as well as the next one. During the oversight hearing, I also intend to focus on, as I just said, the next pandemic, which we know is coming. 101341 What can we learn from this one to be ready for the next one? Can we -- what can we learn from the fast-tracking of vaccines and treatments that we're about to hear about that will make it even faster the next time? How can we keep hospitals and states from selling off protective equipment when their budget gets tight? How can we make sure Congress does our share of the funding responsibility? How do we provide enough extra hospital beds without -- without canceling elective surgery hurting other patients and bankrupting hospitals? 101415 Whose job should it be to coordinate supply lines so that protective equipment and supplies get where they're supposed to go, when they're supposed to go? What's the best way to manage the stockpile? My preacher once said, "I'm not worried about what you do on Sunday. It's the rest of the week that concerns me." I'm afraid that during the rest of the week, between pandemics, we relax our focus on preparedness, we become preoccupied with other important things. 101444 Our collective memory is short. Just three months ago, this country was preoccupied with impeaching a president. Now that seems like ancient Roman history. Now, while this crisis has our full attention, I believe we should put into law this year whatever improvements need to be made to be well prepared for the next pandemic. If there is to be finger-pointing, I hope they're pointed in that direction. We're fortunate today to have four distinguished witnesses who are at the heart of the response of the coronavirus. 101519 We're grateful for their service to our country. I've asked them each to summarize their remarks in five minutes. Then we'll have a five-minute round of questions from each Senator. I've agreed, we'll end our hearing about 12:30, after we have a full round of questions. Every senator will have a chance to have his or her five minutes. Senator Murray will then have an opportunity to ask the last question or close the hearing, and I will then close the hearing. There will be other hearings to follow this hearing, like last Thursday's hearing, and senators may submit their questions in writing within the next ten days. 101557 Staying at home indefinitely is not the solution to this pandemic. There is not enough money available to help all those hurt by a closed economy. All roads back to work, back to school, lead through testing, tracking, isolation, treatment, and vaccines. This requires widespread testing, millions more tests, created mostly by new technologies, to identify those who are sick and who have been exposed so they can be quarantined, and by containing the disease in this way, give the rest of America enough confidence to go back to work and school. 101636 For the near term, to help make sure those 31,000 UT students and faculty members show up in August, we need widespread testing, millions more tests, created mostly by new technologies to identify those who are sick and who have been exposed so they can be quarantined. And by containing the disease in this way, give the rest of America enough confidence to go back to work and back to school. Senator Murray. 101704 MURRAY>> Well, thank you very much, Mr. Chairman. My thoughts are with you and your team right now as you try to navigate the same challenge so many in our country are worried about. We all wish your staff member a speedy recovery. And as everyone works to take appropriate safety precautions today, I'd like to thank not only our witnesses for joining us today, but also our committee staff for working to set up a safe format for members and witnesses and the public to participate in this hearing remotely. 101740 Families across the country are counting on us for the truth about the Covid-19 pandemic, especially since it is clear they will not get it from President Trump. Truth is essential, so people have the facts, so they can make decisions for themselves and their families and their community. Lives are at stake. If the president isn't telling the truth, we must, and our witnesses must, and we're counting on you today. 101811 And families need us to take this opportunity to dig into the facts about where things did go wrong so we can finally get them on track. Because the Trump administration's response to this public health emergency so far has been a disaster on its own. Delays, missteps have put us way behind where we need to be on diagnostic tests and allowed inaccurate antibody tests to flood the market. Corruption and political interference have impeded efforts to secure desperately needed personal protective equipment and promoted dangerous, unproven treatments. 101850 And we recently learned that after experts at the Centers for Disease Control and Prevention spent weeks developing a detailed guide to help our community understand how to safely reopen, when the time comes, the Trump administration tossed it in the trash bin for being too prescriptive. But this is far from the first time this administration has silenced experts who were doing their job and putting public health first. The fact of the matter is, president trump has been more focused on fighting against the truth than fighting this virus. 101926 And Americans have, sadly, paid the price. Since this committee last heard from these witnesses on March 3rd, we have seen over 900 deaths in my home state of Washington, over 80,000 deaths nationally, and the numbers continue to climb. Still, President Trump is trying to ignore the facts and ignore the experts who have been very clear, we are nowhere close to where we need to be to reopen safely. 101956 My hope today is that we can cut through this, and have a serious discussion about what is needed to safely open, how close we are as a country to meeting those needs, and how we actually get there. One thing that's abundantly clear, we need dramatically more testing. It is unacceptable we still don't have a national strategic plan to make sure testing is free, fast, and everywhere. 102026 That is why I fought to make sure our last Covid-19 package included an initial $25 billion testing fund and a requirement that the administration submit a plan by May 24th. And when I say a "plan," I don't mean a PR plan. I mean a plan with specific time lines and numeric goals for supply and funding needs, one that actually addresses the issues we're seeing on testing capacity and distribution and disparity and building out our public health system. 102059 And makes clear to states and tribes and employers and the American people what they can expect and what the administration will do to keep Americans safe. But testing alone won't be enough to reopen our country. We still need far more personal protective equipment than has been available for our health care workers on the front lines, and we will need far more for other workers after we reopen. So we desperately need this administration to step up and get that equipment to states who are doing everything in their powers to purchase supplies but simply cannot get nearly enough. 102135 Because the reality is, unlike states, the federal government has the tools to actually fix the problem, if only the administration would use them. And we also need that equipment to actually work and for the FDA to act promptly if it does not, not weeks later when people may have already been exposed. And just as importantly, we can't expect people to go back to work or to restaurants or to confidently send their kids to school if there isn't clear, detailed guidance about how to do that safely. 102209 Schools, from early childhood through college, need to know how to keep their students, their staff, and their educators safe. When should they wear masks? How do you run a school cafeteria or a school bus? And if they can't reopen classrooms, schools and families need to know we are working to ensure every student gets an education. Tools like online learning can only get us so far if we don't address the digital divide that -- so that every student can access them. And even then, there will be learning loss that could deepen existing educational disparities among low-income students, students with disabilities, English language learners and other vulnerable populations, if we don't make sure they get equal access to resources and support. 102256 And of course, schools aren't the only workplaces we've got to be thinking about. We need to make sure that industries across the country know how to safely reopen and that people know their workplace is safe. Secretary Scalia needs to stop dragging his feet and do his job and have the department of labor set forward a rule that makes it clear, worker safety is not optional. Mr. Chairman, I hope this committee can hear about those critical issues from Secretary Scalia and Secretary DeVos as well as other experts in the space in the days ahead. 102330 And this is especially important to protect workers and residents at our nursing homes and other congregate care facilities, where we've seen some of the most deadly outbreaks. And as the rash of outbreaks at meatpacking plants shows, this isn't just an issue for the healthcare industry, it is an issue for everyone. And just as we need a plan before we can start to reopen, we also need a plan well before we have a safe and effective vaccine to guarantee that we can quickly produce and distribute it on a global scale and make it free and available for everyone. 102407 So, I'll be asking about our progress on those issues today. Today, safely reopening our country may be a ways off, and the administration's planning may be way behind, but there's still a lot that Congress needs to do. There isn't time to spare. Some, including the White House, say they've already provided enough economic relief. Well, my question to them is, what good is a bridge that only gets you to the middle of the river? We don't need to wait around to see if people need more help. We know they do. 102438 We need to work quickly on another aggressive relief package, and we need to make sure our priorities in that bill are protecting our workers, our students, and our families, and addressing this public health crisis, not bailing out corporations and protecting big business from accountability. People across the country are doing their part. They are washing their hands and wearing masks and social distancing and staying home. They need their government to do its part, too. They need leadership. They need a plan. 102510 They need honesty and they need it now, before we reopen, so they can rest assured that we are doing things safely and competently with their health and well-being as a top priority. Thank you, Mr. Chairman. 102529 ALEXANDER>> -- it's an important hearing, and I know lots of people may be watching it for the first time. If they are, I hope they notice that we have 23 members of this committee, I believe, one more Republican than Democrat. We have some very strong views, but we're able to work together and to express those views and respect each other and our witnesses. And I -- and a big part of that goes to Senator Murray and her staff. So, thank you for that. Each witness will have up to five minutes to give his testimony. Thank you for making an exception and agreeing to testify by video because of these unusual circumstances. 102605 And thank you for what you're doing for our country. Our first witness is Dr. Anthony Fauci. He's Director of the National Institutes of Allergy and Infectious Diseases at the National Institutes of Health. He's held that position since 1984, which meant he's advised six presidents and worked on HIV-AIDs, influenza, malaria, ebola, and other infectious diseases. He was involved in treating Ebola patients at NIH and also worked on vaccine trials for ebola. Next we'll hear from Dr. Robert Redfield. He's director of the U.S. Centers for Disease Control and Prevention, which has its headquarters in Atlanta. 102647 For more than 30 years, he's been involved with clinical research related to chronic human viral infections, infectious diseases, especially HIV. He was the founding director of the Department of retroviral research within the U.S. Military's HIV research program. He spent 20 years with the U.S. Army Medical Corps. Third, Admiral Brett Giroir -- Giroir. Admiral Giroir is Assistant secretary for Health at the U.S. Department of Health and Human services. 102720 That puts him in charge of development of public health policy recommendations. He's taken on the responsibility for coordinating testing and focused on the increasing number of tests that we can do with existing technology. His federal service includes a variety of activities with our defense department in advanced research, threat reduction. He was part of the blue ribbon panel to reform the U.S. Veterans health system. 102749 And, finally, we'll hear from Dr. Stephen Hahn. He is commissioner of the Food and Drug administration. Before joining FDA, he was the chief medical executive at the University of Texas MD Anderson Cancer center, and he was chair of the department of radiation oncology at the university of Pennsylvania. He was a senior investigator at the national institutes of health. He was commander of U.S. Public health service commission corps in 2025 (?). 102721 Now we'll ask each witness to summarize their remarks in five minutes. Following that, each senator will have five minutes for question and answers in order of seniority. Dr. Fauci, let's begin with you. Welcome. FAUCI 102836 FAUCI>> Thank you very much, Mr. Chairman, ranking member Murray, and members of the committee. Thank you for giving me the opportunity to discuss with you, today, the role the National Institutes of Health in research addressing covid-19. The strategic plan that we have is four-fold. One, to improve our fundamental knowledge of the virus and the disease it causes. Next, to develop new point-of-care diagnostics. Next, to characterize and test therapeutics. And finally, to develop safe and effective vaccines. 102910 First, with regard to diagnostics. As you probably heard from Dr. Francis Collins last Thursday, the NIH has developed a rapid acceleration of diagnostics program called RadX. With an award to that specific program up to half a billion dollars to support the development of covid-19 diagnostics. It is a national call for innovative technologies that would be evaluated in the shark tank-like selection process to get to either success or failure rapidly. 102944 Moving on to therapeutics, I'll talk a bit about the Remdesivir success antiviral in a moment, but let me emphasize that there are a number of broad-spectrum antivirals that are in various stages of testing. In addition, we will be looking at convalescent plasma, which is plasma from individuals who have recovered from covid-19 to be used in passive transfer, either in prevention or treatment. In addition, high-premium globulin which can be used as a gamma globulin shot. 103018 We'll be looking at repurposed drugs, as well as immune-based therapies and host modifiers. And finally, monoclonal antibodies. Let me take a moment to describe the remdesivir placebo-controlled randomized trial, which was done internationally through the power of more than 1,000 individuals, in sites throughout the world. It was in hospitalized patients with lung disease. The end point was primarily time to recover it. The result was statistically significant but really modest, and we must remember, it was only a modest result, showing that the drug made a 31% faster time to recovery. 103100 We hope to build on this modest success with combinations of drugs and better drugs. Moving on to vaccines, there are at least eight candidate covid-19 vaccines in clinical development. The NIH has been collaborating with a number of pharmaceutical companies at various stages of development. I will describe one very briefly, which is not the only one, but one that we have been involved in heavily developing with Moderna, it's a messenger RNA platform. 103131 You might recall in this committee that, in January of this year, I said it would take about one year to 18 months, if we were successful, in developing a vaccine. The NIH trial moved very quickly. On January 10th, the sequence was known. On January 11th, the vaccine research center met to develop a plan. And on the 14th of January, we officially started the vaccine development. 62 days later, we are now in phase one clinical trial with the two doses already fully enrolled. 103204 There will be animal safety. The phase one will directly go into phase two-three in late spring and early summer. And if we are successful, we hope to know that in the late fall and early winter. There are some important issues, however, in covid-19 vaccine development. We have many candidates and hope to have multiple winners. In other words, it's multiple shots on goal. This will be important because this will be good for global availability if we have more than one successful candidate. 103235 We also, as the chairman mentioned, will be producing vaccines at risk, which means we'll be investing considerable resources in developing doses even before we know any given candidate or candidates work. I must warn that there's also the possibility of negative consequences, where certain vaccines can actually enhance the negative effect of the infection. The big unknown is efficacy. 103303 Will it be present or absent, and how durable will it be? And finally, I want to mention, the NIH has launched a public-private partnership called Accelerating Covid-19 Therapeutic Interventions and Vaccines. The purpose of that is to prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential. Hopefully, our research efforts, together with the other public health efforts, will get us quickly to the end of this terrible ordeal that we are all going through. 103336 Thank you very much. Happy to answer questions later. ALEXANDER>> Thank you, Dr. Fauci. Dr. Redfield, welcome. REDFIELD 103344 REDFIELD>> Good morning, Chairman Alexander and ranking member Murray and members of the committee. Our nation is confronting the most serious public health crisis in more than a century. Yet, we're not defenseless. We have powerful tools to fight this enemy. We have tried and true effective public health interventions, such as early ace (?) identification, isolation and contact tracing, combined with an important mitigation strategy, which includes social distancing, frequent hand washing, face covering. 103413 These public health tools have and will continue to slow the spread of covid-19. I appreciate the opportunity this morning to provide a brief overview of some of CDC's ongoing work in response to covid-19. CDC's been working 24/7 to combat this pandemic. CDC's emergency operations center is supporting state, tribal, local and territorial public health partners in building core capabilities, particularly workforce, laboratory, and data and predictive analytics. 103443 Epidemiologists are conducting surveillance for Covid-19, as well as conducting health systems surveillance. Community mitigation teams are providing guidance on infection control and contact tracing, and our laboratory experts are performing serological testing to better define the extent of the asymptomatic populations. As local leadership makes decisions to reopen, they'll require varying degrees of federal support. Each location will be different and will face unique circumstances. CDC has conducted a state-by-state assessment of public health testing capacity and contact tracing capacity, as well as surge plans. 103523 CDC is providing technical assistance and funding to the states, provided through the supplemental CARES act and the Paycheck Protection Program and Health Care Enhancement Act. We're working directly with state public health leaders to define their needs for testing and testing devices, supplies, and manpower, surveillance, data collection and reporting, contact tracing, infection control, and outbreak investigation. I want to spend a moment to focus on several key elements. 103551 First, testing. Rapid, extensive, and widely available, timely testing is essential for reopening America. CDC's role in testing continues to support diagnosis and contact tracing, surveillance, and outbreak. When we work with the public health partners to define their particular testing strategy, their jurisdiction, Admiral Giroir will address the testing components of the response in greater detail. Contact tracing: Increasing state, tribal, local and territorial contact tracing capacity is critical. 103628 It's a critical part to stop the chains of transmission and prevent the occurrence of sustained community transmission. CDC's role is to provide technical training, assistance, and support to the states as they hire and build a workforce necessary to be fully prepared to effectively respond to the public health challenges posed by the ongoing Covid pandemic. This will be an expansive effort. Surveillance: Our nation's surveillance program is built on a combination of systems, including existing -- existing syndromic and respiratory viral disease surveillance systems, that have been combined with commercial and research lab platforms in our case reporting form system. 103711 CDC's adapting these and optimizing it to have a surveillance system in response to covid-19. Importantly, in light of the significant occurrence of asymptomatic infection, the surveillance for asymptomatic infection becomes an important public health tool for early case identification. CDC's working with each public health jurisdiction to develop a prospective surveillance program to include active surveillance among those that are most vulnerable, such as individuals in long-term care facilities, inner city clinics and homeless shelters. 103745 We need to rebuild our nation's public health infrastructure. Data and data analytics, public health laboratory resilience, and our nation's public health workforce. Now's the time to put it in place for the generations to come, not only for the public health system that our nation needs but for the public health system our nation deserves. Before I close, I want to recognize the tireless commitment of the dedicated CDC staff who have deployed to every corner of this nation to fight covid-19. 102815 More than 4,000 employees have deployed here, and globally. Science and data continue, with technical expertise and public service, to be the backbone of CDC's contributions to the U.S. Response. I extend my serious gratitude to the health care workers on the front lines as well as their family, and the essential emergency personnel as well as the American people, to say thank you for adhering to the stay-at-home guidelines and protecting the most vulnerable. 103842 It's important to emphasize that we're not out of the woods yet. The battle contends [inaud] months but we are more prepared. We need to stay vigilant with social distancing. It remains an imperative. We are a resilient nation, and I am confident that we will emerge from this pandemic stronger together. Thank you. ALEXANDER>> Thank you, Dr. Redfield. Admiral Giroir, welcome. GIROIR 103910 GIROIR>> -- Here to provide you with an update on the nation's progress in testing for Covid-19. On March 12th, Secretary Azar requested that I lead the Covid-19 testing effort within HHS, including oversight and coordination of the FDA and CDC with regard to testing. Since then, the nation has performed more than 9 million covid-19 tests, a number far greater than any other country and double the per capita tests performed to date in South Korea. 103940 To reach this point, we implemented a phased approach to meet testing needs during mitigation. And now, during phase one reopening of America. Beginning March 20th, we pioneered 41 community-based drive-through testing sites in locations prioritized by the CDC. These sites have been a profound success, testing over 167,000 high-risk individuals and demonstrating a prototype that is being duplicated multifold in nearly every state. 104010 Next, the administration leveraged trusted retailers, including CVS, Rite Aid, Walgreens, Walmart, Kroger and Healthmart, who are now providing testing at 240 locations in 33 states, 69% of which are in communities with moderate to high social vulnerability. To meet the need for collection supplies like swabs and media tubes, we first secured the global supply chain through a military air bridge. We worked directly with manufacturers to increase domestic production. 104041 We collaborated with the private sector and the FDA to validate multiple swab and media types. That vastly expanded supplies while minimizing the need for PPE. Finally, we used title three of the defense production act to further invest in domestic manufacturing to prepare us for reopening. To support the need for surveillance testing during reopening, on April 27th, we issued a new testing framework that also prioritized testing for persons without symptoms who are prioritized by health departments or clinicians for any reason, including screening of asymptomatic individuals according to states' and local plan. 104123 Next, our federal multidisciplinary team conducted multiple calls with leadership from each state to set state-specific testing objectives. Collectively, states and territories established an overall goal to perform 12.9 million tests over the next four weeks. The federal government is able to, and will, support the achievement of this goal. Specifically, the federal government is shipping to states 12.9 million swabs and over 9.7 million tubes of media in May alone. 104159 Last month, we also detailed the location and capacity of every lab machine in every state that could potentially run covid-19 assays and our team has worked with manufacturers to match reagent to these machines. Looking forward, between now and the end of 2020, the federal government will procure over 135 million swabs and 132 million tubes of media and distribute these to states, as requested, to supplement the now-robust commercial supply. 104231 We anticipate marked increases in current tests as well as a dramatic expansion of new point-of-care tests, like the first in-class Quidel antigen test, authorized by the FDA just last Friday. Quidel anticipates being able to distribute 300,000 tests per day within just a few weeks. So, by September, taking every aspect of development, authorization, manufacturing, and supply chain into consideration, we project that our nation will be capable of performing at least 40 to 50 million tests per month, if needed, at that time. 104308 And if new technologies are authorized like whole genome sequencing approaches or anything uncovered by NIH's new diagnostics initiative, that number will be much higher. Finally, I want to acknowledge and express my heartfelt gratitude to the officers of the U.S. Public health service commissioned corps, the uniformed service I am honored to lead. 3,471 men and women have deployed in support of this pandemic. 104338 On the cruise ship in Japan, to our military bases repatriating Americans, to our community-based testing sites and international airports, to FEMA and our task forces, to nursing facilities including King county, Washington, and to field hospitals in hard-hit communities across our nation. I thank each and every one of these officers and their families, and on their behalf, I thank the members of this committee for supporting our training needs and the establishment of a ready reserve to supplement our ranks in future national emergencies. 104411 Thank you for the opportunity to provide these remarks. ALEXANDER>> Thank you, admiral Giroir. And now Dr. Stephen Hahn, our fourth and final witness. HAHN 104422 HAHN>> Chairman Alexander, ranking member Murray, and members of the committee, thank you for inviting me to participate in this hearing today. I first want to start by thanking the American people for their incredible efforts at mitigation and extend my condolences to those who have lost loved ones. From day one of this pandemic, the 18,000 FDA employees who are just incredible scientists, doctors, and nurses, have taken an active role in the all-of-government response to this pandemic. 104454 The FDA has worked to facilitate the development of medical countermeasures to diagnose, treat, and prevent covid-19. We've worked closely with laboratories, manufacturers, academia, product developers, our federal partners and companies, companies that don't even make medical products but want to pitch in, for example, by making hand sanitizer, personal protective equipment and ventilators. Every decision we have made has been driven by data with a goal [inaud] of protecting the health of the American people. 104525 In a public health emergency, however, our response has balanced the urgent need to make medical products available with the provision of a level of oversight that helps ensure the safety and effectiveness of those medical products. I'd like to take a few minutes to tell you what FDA is doing to help the country at this point, in order to show Americans it's safe to return to work and to school. It starts with testing, as others have mentioned. FDA has worked with more than 500 developers who have or said they will be submitting emergency use authorization requests for covid-19 tests. 104600 This includes some newer technologies that not -- that heretofore have not been used as part of diagnostic tests in response to a pandemic. We have issued 92 individual emergency use authorizations for test kit manufacturers and laboratories, and we've been informed by more than 250 laboratories, they have begun testing under the regulatory flexibilities we outlined in March. We are conducting rolling reviews of UA (?) submissions so that we can quickly authorize tests which the data support. 104632 In a public health emergency, the accuracy of diagnostic tests is important, not only for the individual patient, but for the patient at large -- for the public at large. FDA is helping to ensure the availability of tests that are providing accurate answers. We are also monitoring the marketplace for fraudulent tests and are taking appropriate action to protect the public health, and we are working to provide more clarity about which tests have been reviewed and authorized by FDA and which have not. Serologic tests will play a part in our recovery. Unlike diagnostic tests, which detect the presence of the virus, serologic tests measure the amount of antibodies or protein present in the blood when the body is responding to an infection like covid-19. 104715 Tests can help identify individuals who can overcome an infection and who have developed an immune response. We will continue working with labs, manufacturers and across the government to find a balance between the assurance that an antibody test is accurate and timely access to such tests. Of course, the way we will eventually beat this virus is with a vaccine. And FDA is working closely with our Fed partners, including the NIH, testing -- Vaccine developers, manufacturers, and experts across the globe. We intend to use our regulatory flexibility to help ensure the most efficient development of a safe and effective vaccine to prevent covid-19. 104756 Until a preventive vaccine is approved, however, we need medical products to bridge the gap. FDA has been working for several months to facilitate the development and availability of therapeutics as expeditiously as possible, and we have created an emergency program for this acceleration called the Coronavirus Treatment Acceleration Program or CTAP. We have reassigned staff to work with urgency to review requests from companies, scientists, doctors who are developing therapy, and we're using every available authority and regulatory flexibility that's appropriate to facilitate the development of safe and effective products to treat covid-19. 104835 A variety of therapeutic areas are being evaluated, as mentioned by Dr. Fauci and others, including antiviral drugs and immuno-therapies as well as convalescent plasma, hyper immunoglobulin and monoclonal antibodies. As Dr. Fauci mentioned, we recently announced the positive results of the NIH-MD (?) trial of remdesivir and issued an EUA for the treatment of hospitalization of patients with covid-19. Two other promising treatments that I mention are the antibody [inaud] products, convalescent plasma and hyper immunoglobulin and I am certainly willing to go into more detail if members of the committee have questions about this. 104913 But we are working very aggressively and closely with stakeholders to facilitate the development of monoclonal antibodies, which, if shown to be safe and effective, could act as a bridge therapy to the development of a vaccine. We recognize developing vaccines and therapies need to go hand in hand with ensuring there will be sufficient supplies for our company -- for our country, so we're also working with manufacturers to make sure that this supply chain is robust. 104940 Mr. Chairman, ranking member, members of the committee, please know that in FDA you have a dedicated team of some of the nation's finest scientists, health care providers and public health professionals. We are guided by science and data, and we won't let up until we facilitate the development of products that our nation needs to get back to work. I look forward to your questions. QUESTIONING 105002 ALEXANDER>> Thank you, Dr. Hahn. And thanks to all four of you for your expertise, for your dedication to our country, and your hard work. We'll now begin a round of five-minute questions from each senator on the committee, alternating between Republicans and Democrats. Each senator has, if you're in a video conference, you have a little time clock at the bottom, and I would ask you to try to stay within five minutes for your questions and answers. I will start. 105031 I've got a question for Dr. Fauci and then admiral Giroir. Doctor, let's look down the road three months. There will be about 5,000 campuses across the country trying to welcome 20 million college students, 100,000 public schools welcoming 50 million students. What would you say to the chancellor of the university of Tennessee Knoxville or the president -- principal of a public school about how to persuade parents and students to return to school in August? 105108 Let's start with treatments and vaccines first. Dr. Fauci, and if you could save about half of my five minutes for Admiral Giroir for testing, I would appreciate it. FAUCI>> Thank you very much, Mr. Chairman. Well, I would be very realistic with the chancellor and tell him that we're thinking in terms -- ALEXANDER>> It's her in this case. FAUCI>> Okay. I would tell her -- I'm sorry, sir -- That in this case, that the idea of having treatments available, or a vaccine, to facilitate the re-entry of students into the fall term would be something that would be a bit of a bridge too far. 105144 As I mentioned, the drug that has shown some degree of efficacy was modest, and it was in hospitalized patients -- not yet, or maybe ever, to be used either yet as prophylaxis or a treatment. So, if the issue is that the young individuals who'd be going back to school would like to have some comfort in that there's a treatment, probably the thing that would be closest to utilization then would likely be passive transfer of convalescent serum. But we're really not talking about necessarily treating a student who gets ill, but how the student will feel safe in going back to school. 105227 If this were a situation where we had a vaccine, that would really be the end of that issue in a positive way. But as I mentioned in my opening remarks, even at the top speed we're going, we don't see a vaccine playing in the ability of individuals to get back to school this term. What they really want is to know if they are safe, and that's the question that has to do with what we discussed earlier about testing. 105256 So, I'm about halfway through the remarks. I'd like to just pass the baton to Admiral Giroir, who would address the question of the availability of testing and what role that might play in returning to school. Thank you, sir. ALEXANDER>> Well, thank you -- thank you, Dr. Fauci. And admiral Giroir, you said that while we're doing about 10 million tests this month, that we might be as high as 40 or 50 million by September and -- a month, which is a significant increase. 105327 So, if I'm chancellor of the university of Tennessee, could I develop a strategy where I'd say to all of my students, we have, for example, an antigen test, which is quick and easy, we want everyone on campus to come by and take it once before you begin school? That will at least let everybody know that on that day, we've isolated anybody who's positive, and then we can continue to monitor? Is that strategy possible in August and September? 105351 GIROIR>> So, thank you, Mr. Chairman. And I may reserve 20 seconds for Dr. Redfield as well. The strategy that's going to be employed really depends heavily on what's the community spread at that time. If there's almost no community spread, your strategy will be different. If there's high community spread, it will also be different. But yes, technically, we will have the ability, and your chancellor will have the ability. We expect there to be 25 to 30 million point-of-care tests per month available. It is certainly possible to test all of the students, or it is much more likely that there would be a surveillance strategy done where you may test some of the students at different times to give an assurance that there's no circulation. 105433 And that would be done in conjunction with the CDC and the local health department. There's also strategies that are still needing to be validated, but a pooling sample. We know in some experimental labs, as many as 10 or 20 samples can be pooled. So, essentially, one test could test 20 students. And finally, there are some experimental approaches that look interesting, if not promising, that for example, wastewater from an entire dorm or an entire segment of a campus could be tested to determine whether there's coronavirus in that sewage, the wastewater. 105507 So, there are other strategies being developed. And I'd like to give at least 20 seconds to Dr. Redfield, who really will be working on the strategy of how to employ the tests given different community spread. ALEXANDER>> Dr. Redfield? REDFIELD>> Yeah, just some quick comments, sir. I mean, first, I think it's really important to evaluate critically the role of changes in social distancing on college campuses and schools and the situation, not to forget the importance of what we've learned. 105535 Clearly, also developing aggressive programs for wellness education, making sure people understand when they're symptomatic, they need to seek evaluation. I think we are going to have to look at the role of testing. And I think there's going to be an important role of testing in these circumstances, and I think it will be individualized based on where these different schools are, and where they -- how much infection is -- ALEXANDER>> I'm going to wrap it up there so I can set a good example for the other senators with their five minutes. Senator Murray. 105605 MURRAY >> Thank you very much, Mr. Chairman. And thank you to all of our witnesses. Dr. Fauci, you have warned of needless suffering and death if we push to reopen too soon, but the president has actually been sending the opposite message. I want to ask you today: what is the most important message you have for communities in states that are reopening, even as our public health experts make it clear it's too soon? Tell us what the consequences are. 105638 FAUCI>> Thank you very much for that question, senator Murray. As I've said many times publicly, what we have worked out is a guideline framework of how to safely open America again, and there are several checkpoints in that with a gateway first of showing, depending on the dynamics of an outbreak in a particular region, state, city, or area, that would really determine the speed and the pace with which one does re-enter or reopen. 105711 So, my word has been -- and I've been very consistent in this -- that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14-day decrease that would allow you to go to phase one. And that, if you pass the checkpoints of phase one, go to phase two and phase three. But I've expressed then and again, my concern that if some areas, cities, states, or what have you, jump over those various checkpoints and prematurely open up, without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn into outbreaks. 105757 So, therefore, I have been being very clear in my message to try to the best extent possible to go by the guidelines which have been very well thought out and very well delineated. MURRAY>> So, if a community or a state or a region doesn't go by those guidelines and reopens, the consequences could be pretty dire, correct? FAUCI>> The consequences could be really serious, particularly -- and this is something that I think we also should pay attention to -- that states, even if they're doing it at an appropriate pace, which many of them are and will, 105836 namely, a pace that's commensurate with the dynamics of the outbreak, that they have in place already the capability that when there will be cases, there is no doubt, even under the best of circumstances, when you pull back on mitigation, you will see some cases appear. It's the ability and the capability of responding to those cases with good identification, isolation, and contact tracing, will determine whether you can continue to go forward as you try to reopen America. 105911 So, it's not only doing it at the appropriate time, with the appropriate constraints, but having in place the capability of responding when the inevitable return of infections occur. MURRAY>> Well, thank you for that. And it's very clear, in order to do that, we need knowledge, which is about testing. And for months, this administration's approach to testing has really been plagued by unrealized goals and disregard for systemic problems within that supply chain. 105940 And last week, an average of just 250,000 tests per day were performed in the United States. That is a small fraction of what we need. And yesterday, president trump had the gall to declare the U.S. had, quote, prevailed in testing in a press conference that was filled with misinformation and distortion. Dr. Giroir, public health experts do not think the U.S. Has prevailed. I'm glad you've finally committed that states, including my home state of Washington, will receive enough tests to meet their goals for may and June. 110011 But this administration has had a record of giving us broken promises that more testing supplies are coming, and they don't. And we know, by the way, that testing needs will persist long past June -- long past June. So I wanted to ask you today, will the administration's forthcoming strategic plan that is now required under the Covid package that was just passed and signed into law, will that strategic plan on testing include specific numeric targets for testing capacity, supply-chain capacity, and projection of shortages? 110053 GIROIR>> Thank you for that question and statement, Senator Murray. Yes, we are, as I've stated. We continue to have a work in progress as we build the testing capacity. We have established the targets with the states of over 12 million tests over the next 4 weeks. We think those targets are gonna be good in May and June, but as Dr. Fauci said, we really have to be evidence-based. We expect those targets to go up as we progressively open, as those communities go into Phase 1 and then into Phase 2. 110128 And certainly those numbers will need to go up significantly again in the fall when we potentially have influenza circulating with Covid. So, yes, there will be targets. The targets will need change based on the evidence that we see but we are highly committed to securing the supply chain. We work daily with every manufacturer. And I'm just pleased we're, in May and June, able to get ahead of the states so that we can supply them what they need so they have those assurances. So there's not gonna be any doubts about that. 110158 MURRAY>> My question to you is when you put out that specific plan that you're required to do, we will see numbers that you are going to tell us you will reach, targeted for testing and supply-chain capacity and protection of [inaud], instead of just saying we hope to have a million this week, next week -- you will give us specific targets, correct? GIROIR>> We know specific -- I'll say yes, ma'am, we know the specific amounts of tests we have over the summer -- 110227 MURRAY>> Not have, how many we need. GIROIR>> Yes, so -- yes, ma'am. We develop the need statements by working with the states individually, with epidemiologists, with the CDC, so that overall in May we'll be testing about 3.9% of the overall USpopulation. MURRAY>> Well, that's fine but what I'm tell you -- ALEXANDER>> You're well over time, Senator Murray. MURRAY>> How many we have -- but how we will need not just for May but in the coming months so we can be prepared to have them? 110300 GIROIR>> Yes, ma'am, not to be repetitive, but, um, we need to be evidence and data driven. Because what we may see in May or June will drive differences in the amount of test goals that we have. So we really just need to be very humble about this. We need to look at the data. We know that the testing needs will go up over May and June, as we progressively open. And we will do our best to predict that. But you have to understand we have to have the data and the evidence show at that time. MURRAY>> Okay, I appreciate that. And again, what our strategic plan requires is what is the goal -- not how many we have, but how many we need. And that's what we'll be looking for, thank you. 110336 ALEXANDER>> Thank you, senator Murray. Senator ENZI? ENZI >> Thank you, Mr. Chairman. And I particularly appreciated your opening statement where you had a very succinct list of preparations we need to learn from this pandemic for the next one. Not only should we be working on this and preparing, but we need to look at the future, too. And I think we have learned a lot. We're fighting a virus at the same time that scientists are learning about it, so we need to be nimble. 110407 We also need to be sure that we are prepared for a second wave of outbreak. It could coincide with the start of the flu season, potentially stressing our healthcare system even more than it already has been. Admiral Giroir, I thank you for your comments. I think they've been comforting about what has been done and what can be done. I agree with senator Murray that we need to have some specific goals. 110437 As an accountant, that's always one of the things I'm looking for. My question is for Dr. Hahn -- our understanding of the clinical picture of Covid-19 continues to evolve. What first looked like a respiratory illness now seems much more comprehensive, potentially affecting the heart, the brain, the kidney and other organs. How does this evolving picture impact the ability to evaluate the appropriate clinical or surrogate endpoints for review of viruses and treatments? 110510 HAHN>> Thank you, senator, for that question. The -- the evolving clinical picture, and obviously the way this is manifesting around the country clinically does, in fact. inform the end points that we will work with developers of therapies on, so that we can get the absolute most efficient, but also the most accurate information and appropriate endpoints to make the necessary authorizations and approvals. We have set up the program called the Coronavirus Treatment Acceleration Program. 110544 Where our top scientists and clinicians have been at the table, consulting with our colleagues at NIH and CDC to actually address those questions. What are the appropriate endpoints? I'll give you an example. We do know that, in some circumstances, patients who had severe Covid disease have developed [inaud] or clotting type of episodes, and so we prioritize review of agents that we think might be beneficial. 110613 And obviously the clinical endpoints for those trials will be different from an agent that's an antiviral like remdesivir where, as Dr. Fauci mentioned, we're looking at time to recovery. So we want to adapt it to clinical circumstance, as well as to the type of therapy that's put before us. ENZI>> Thank you. Another question to Dr. Hahn, we have made a lot of progress in vaccine development, but Barta has identified that domestic manufacturing of the needles and syringes is a significant gap in pandemic preparedness. 110645 What has HHS done in advance of a potential national vaccination campaign to ensure we have sufficient capacity to administer a vaccine? HAHN>> Senator Enzi, thank you for that question. This is a really important point because, as you mentioned, it's not just about the vaccine or hopefully vaccines that are developed, it's all about -- it's also about the supplies that are needed, as well as an operation plan for administering the vaccine. 110715 So this is an all of government approach. There's a program that's been set up, called operation Warp Speed that included Dr. Collins, Dr. Fauci, his colleagues at NIH, the department of defense, as well as other members of HHS and FDA. Dr. Peter marks for our center for Biological Evaluation Research has been helping to coordinate that, and is working very closely with Dr. Fauci and his team. 110739 And we have created what's called a Gantt chart to look forward, what are the necessary supply chain issues, syringes, needles, etc. depending on the various vaccines that are being developed, how many times they have to administer and the route to administration. So we've been leaning in on this supply chain to ensure that when a vaccine is ready to go, we will have the necessary supplies to actually administer it and operationalize the vaccination. ENZI>> I have a couple more questions, but again the clocks visible there so I suspect I've used up my time. I'll submit those in writing. ALEXANDER>> Thank you senator Enzi. Senator Sanders? 110826 SANDERS>> Thank you very much, Mr. Chairman. And let me thank all of the panelists for the hard work they're doing and for being with us today. It is sad to say that we have a president of the United States, the leader of our country who from day one downplayed the dangers facing this country from the pandemic, who told us that the crisis would be over in a few months, that we did not have to worry. 110855 Who fired those members of the government who wanted to act aggressively and among other things at a time when we need international cooperation cut funding for the world health organization. Let me also say that I think we understand that fact are terribly important. Not everybody that we don't fully understand all of the ramifications of the covid-19 epidemic. 110926 Let me ask Dr. Fauci and few questions if I might. For a start, the official statistics, Dr. Fauci, is that 80,000 Americans have died from the pandemic. There are some epidemiologists who suggest the number may be 50% higher than that. What do you think? FAUCI>>I'm not sure not sure, Senator Sanders, if it's gonna be 50 percent higher but most of us feel that the number of deaths are likely higher than that number because giiven the situation particularly in New York City, when they were really strapped with a very serious challenge to their health care system, 111008 there may have been people who died at home who did have covid who were not counted as covid, because they never really got to the hospital. So in direct answer to your question, I think you are correct that the number is likely higher. I don't know exactly what percent higher, but almost certainly its higher. SANDERS>> Dr. Fauci, let me ask you this. In the terrible pandemic of 1918, the virus exploded in the fall, it came back with a vengeance. 111047 Are we fearful that if we don't get our act together, as bad as the situation is now, it could become worse in the fall or winter? FAUCI>> Well, senator, thank you for that question. It's a frequently asked question. I think the possibility does exist. However -- and the reason I say that is that when you talk about will the virus just disappear? And as I've said publicly many times, that is just not going to happen because it's such a highly transmissible virus. 111119 Even if we get better control over the months, it is likely that there will be a virus somewhere on this planet that will eventually get back to us. So my approach towards the possibility of a rebound and a second wave in the fall is that, a, it's entirely conceivable and possible that would happen, but B, I would hope that between now and then, given the capability of doing the testing that you heard from admiral Giroir, and the ability for us to stock up on personal protective equipment and the workforce that the CDC under Dr. Redfield will be putting forth. 111201 to be able to identify, isolate and contact trace -- I hope that if we do have the threat of a second wave, we'll be able to deal with it very effectively to prevent it from becoming an outbreak, not only worse than now, but much, much less. SANDERS>> Okay, and let me ask, we've heard a lot of discussion about vaccines. Obviously everybody in congress and in this country wants a vaccine, we want it as quickly as possible, as effectIve as possible. Let me ask the honorable fda commissioner. 111234 sir, if, god willing, a vaccine is developed and if we're able to produce it as quickly as we all hope we can I would imagine that that vaccine would be distributed to all people free of charge to make sure at least everybody in America who needs that vaccine would get it regardless of their income. Is that a fair assumption? HAHN>> Senator, I certainly hope so. The fda is very committed to making sure that all populations in the United States, including those most vulnerable are included in the clinical trials. 111312 SANDERS>> Sir, that's not what I'm asking. WhatI'm asking is, if and when the vaccine comes, it won't do somebody any good if they don't get it and if they have to pay a sum of money for it in order to profit the drug companies, that will not be helpful. Are you guaranteeing the American people today that that vaccine will be available to all people, regardless of their income? 111340 HAHN>> Sir, the payment of vaccines is not a responsibility of the fda, but I'm glad to take this back to the task force. I share your concern that this needs to be made available to every American. SANDERS>> Does anybody else want to comment on that? Mr. Giroir, Do you think we should make that vaccine when hopefully it's created, available to all, regardless of income? Or do you think that poor people and working people should be last in line for the vaccine? GIROIR>> I'm sorry, senator, were you asking me? SANDERS>> Yes, I was sir. Yes, I was. 111413 GIROIR>> No, I -- um, my office is one of the offices committed to serving the underserved. We need to be absolutely certain that if a vaccine or an effective therapeutic or preventative is available, that it reaches all segments of society, regardless of their ability to pay or any other social determinants of health that there may be. SANDERS>> Good. So you're telling the American people today that regardless of income, every American will be able to gain access to that vaccine when it comes? 111449 GIROIR>> They should gain access to it. I don't control, you know -- SANDERS>> Well, you represent -- you represent an administration that makes that decision. GIROIR>> I will certainly advocate that everyone is able to receive the vaccine, regardless of income or any other circumstance. SANDERS>> Let me just switch gears-- ALEXANDER>> Your time is up, senator Sanders. SANDERS>> I'm sorry. Alright. Thank you, Mr. Chairman. ALEXANDER>>> Those are important questions. I don't want to cut senators off, and it's hard to see the time clock, but if we can stay as close as possible to five minutes, all senators can get their questions in. Thank you, Senator Sanders. Senator burr? BURR 111525 BURR>> Thank you, Mr. Chairman, and thank you to our witnesses for what you have done for the people of this country and their safety and people around the globe. Let me ask you, Dr. Fauci, because you have been in the task force and a majority of the press conferences. Has anybody in this administration ever asked you or any member to take the foot off the gas of trying to find a cure or any type of countermeasure? 111550 FAUCI>> No, senator. Not at all as a matter of fact. We at mih as you know have been right from the very beginning put our foot on that accelerator in every aspect, including the development of vaccines and therapeutics. And as I described in my opening statement we actually started that in January, literally days after the virus was known and its sequence was published. So no I have never been told by anyone to pull back on the development of any countermeasure or any basic clinical that research project we've been involved in. 111627 BURR>> Thank you, Dr. Fauci. This question is for Dr. Redfield. Dr. Redfield, we have authorized in this committee and appropriated out of congress multiple times over the last few decades money for bio surveillance and you talked about it. In the past four years. From fy 16 to fy 20. It's been 23 million dollars a year and with the C.A.R.E.S. Act, it's over a billion dollars in bio surveillance. 111652 We have seen the private sector go out and use data available to track the progress and spread of coronavirus around the world. Why has CDC not contracted with private sector technologies companies to try to use their tools for bio-surveillance? REDFIELD>> Thank you for the question. This is a critical issue, as you know, and also comes into one of the core capabilities I talked about data analytics and data monetization which we're appreciative of the additional funding that congress has given. 111731 I can tell you this is under critical review. We do have contracts with some of the private sector groups now to try to make the type of availability of data we've seen in Florida available in all of our jurisdictions across the country and in the process of making that happen. BURR>> Dr. Redfield, in april of last year -- June of last year, we reauthorized the pandemic and all hazards legislation, which authorized at that time 30 new billets, 30 new employees at CDC specifically in surveillance. 111806 I asked Dr. Schuchat in March how many of those 30 had been filled. She said zero. As of mid April, zero of those 30 billets had been filled. How many of those 30 employees that this committee authorized CDC to bring on and for biosurveillance, have been filled today? REDFIELD>> Sir, again, thank you for the question. I know our staffs have been in discussion since Dr. Schucat's testimony, and I know we're in the process of continuing to try to figure out how to move that forward, sir. 111841 I can get back to you on it as I discuss what progress has been made.since we had that discussion [INAUD] hearing with you when you brought that to light. BURR>> Well, I brought it to light the first of March, and now we're in mid may. So I'm hopeful that we won't just talk about surveillance, we'll actually execute it, and we'll focus on the unbelievable amounts of money that we have provided for you that they will show some benefit to the American people. 111912 Dr. Fauci, let me come back to you. This is one of the fastest development timelines we have ever seen for vaccines, and the American people and hopefully people around the world will be the beneficiary of what you find and the eventual licensure of that product. What are the biggest unknowns with this particular virus that can affect the development process and Dr. Hahn, if you have got anything to add after that to this, please do. Dr. Fauci? 111944 FAUCI>> Thank you very much, senator burr. Well there are a couple things that I think are inherent in all vaccine development. First of all there's no guarantee that the vaccine is actually going to be effective. As you well know, because we have discussed this many times in the past, you can have everything you think that's in place, and you don't induce the kind of immune response that turns out to be protective and durably protective. So one of the big unknown as is, will it be effective? Given the way body respond to viruses of this type, I'm cautiously optimistic that we will, with one of the candidates, get an efficacy signal. 112018 The other thing thats an unknown that's of concern, but we'll be able to get around it by doing the tests properly is that do you get an enhancement effect? Namely, there have been a number of vaccines, two in particular (?) and respiratory censitual virus, when the vaccine induces a suboptimal response and when a person gets exposed, they actually have an enhanced pathogenesis of the disease, which is always worrisome. 112045 So we want to make sure that that doesn't happen. Those are the two major unknowns.Putting all those things together, Senator Burr, I still feel cautiously optimistic that we will have a candidate that will give some degree of efficacy, hopefully a percentage enough that will induce the kind of herd immunity that would give a protection to the population at home BURR>> Dr. Hahn, anything to add to that? HAHN HAHN>> Yes, sir. Thank you for the question. The obstacles from a regulatory point of view I think are being met by the approaches being taken out of the HHS and lead by Peter Marks 112120 and that is a common preclinical development pathway so that we can appropriately assess one vaccine against the other and then a master protocol that allows for a common control group and an assessment of very common end points. That will let us be as efficient as possible for the development of a vaccine. We will evaluate approximately ten candidates clinically, and then in the phase one and two studies, and then take four to five into phase three study in this HHS effort. I think those are the obstacles that can be broken down to speed the development, but also allow us to ensure safety and effectiveness. 112159 HAHN>> Mr. Chairman, yesterday the state of North Carolina started to publicize the recovered numbers, those individuals who had coronavirus, but have recovered. It's my hope that nationally we will start reporting the recovered numbers. I think that's important for the American people to hear. I yield back. ALEXANDER>> Thank you, senator burr. Senator Casey? 112223 CASEY>> Mr. Chairman, thank you for the hearing, as well as ranking member Murray. Mr. Chairman, I wanted to start today with a question regarding nursing homes, in particular across a state like ours, we've had as you might know a high number of cases in Pennsylvania,, at last count over 57,000 cases. The number of deaths have gone above 3,700, and of course a lot of those deaths are in nursing homes. We're told that nationally more than a third, as high as 35% of all deaths have been in nursing homes, either the death of a resident of nursing home or a worker. 112304 I want to start today with a question for Dr. Redfield. Doctor, when we consider this challenge in our long-term care facilities, when we look at the number of deaths in nursing homes, I think a lot of families want basic transparency, and that's one of the reasons why Senator Wyden and I sent you a letter dated April the 2nd that was directed to you, as well as the administrator of the centers on medicare/medicaid services, Seema Verma, 112341 and in that letter we asked for basic information about what the administration was doing to track the outbreaks in nursing homes, to provide information -- basic information to families and residents, the families of residents in nursing homes, certainly to the workers as well as to the community and public health professionals. Now, it took you about a month to respond to that, but in your response, you didn't give us any information about the timeline. 112415 These families need this information. Now we're told by the CMS administrator after pressing her, as senator wyden and I did, that this information may not be available until the end of may. I need to hear from you today. Why has there been a delay -- a three-month delay in basic information that families and people within a community need about the outbreaks in nursing homes, the number of cases, what is happening in nursing homes. Tell us when we're going to see that information. 112452 REDFIELD>> Well, thank you very much, senator, and you've highlighted one of the great tragedies that we have all experienced together. Clearly the long-term care facilities have been particularly hard hit by the pandemic. Several things, I know that the again the CMS who has oversight, several things have been done, and I can get back to you in terms of where they're at in terms of activation, but clearly all nursing homes now are required to report all cases in either individuals that are patients there or staff, to the CDC. 112535 Secondly -- [INAUD] had put a policy in place that all nursing homes are required to notify members of that nursing home of the existence of covid in that nursing home, include family members [INAUD] verify in terms of when thats -- if that's operational today or next week and I will get back to you with that . One of the most important things, we have decided, as we talked about [inaud] and reopening as Tony mentioned [inaud] symptomatic cases. 112619 We need to do contact tracing, but the other thing that we need to do is to do surveillance because this virus does appear to have a high propensity for asymptomatic infection, which means the traditional ways of identifying cases is gonna be blunted. So we developing a national surveillance system, and first and most importantly is to do comprehensive surveillance in all [inaud] united states. CDC will be doing that in partnership with the state and local territorial health departments. I think [inaud] is going to have the responsibility to do it within the inner city clinics that are collected and for the health service clinics. 112700 But this is critical we get in front of this and do comprehensive surveillance of everybody in the nursing homes. We have also done aggressive outreach in all of them enhancing infection control procedures, etc. CDC has been out to help these nursing homes with that and to the guidance along with the [inaud], but i'll get back to you in terms of the -- i'm pretty confident they're already [inaud] operational. But I need to double check to make sure because I know Seema has announced they're all reporting to CDD now any infection with workers or patients and that they are required now to notify other member in the nursing home as well as family members as well When COVID [inaud[ 112748 CASEY>> Mr. Chairman, I just have one question for Dr. Fauci. Doctor, I wanted to ask you, in your testimony earlier in response to a question by senator murray, you outlined a basic concern you have with regard to states reopening. Can you restate that for us? FAUCI>> Yes, thank you, senator casey. Yes, my concern is that states or cities or regions. Their attempt, understandable, to get back to some form of normality disregards a greater loss [inaud] the checkpoints we put in our guidelines about when it is safe to proceed on pulling back on mitigation. 112827 Because I feel if that occurs there is a real risk that you will trigger an outbreak you may not be able to control. Which in fact paradoxically will set you back, not only leading to some suffering and death that could be avoided but could even set you back on the road to trying to get economic recovery because you would almost turn the clock back rather than going forward. That is my major concern, Senator. CASEY>> Thank you, doctor. 112900 CHAIRMAN ALEXANDER>> Thank you senator Casey. Senator Paul. PAUL>>Dr Fauci, scientists have shown that rhesus monkeys that are infected with covid-19 cannot be reinfected. Several studies have also shown that plasma from recently infected coronavirus patients neutralizes the virus in lab experiments. In addition, infusion of convalescent plasma is based on the idea that recovering coronavirus patients are developing immunity, and that it can be beneficial as donated. 112930 Studies show that the recovering covid 19 patients, from the asymptomatic to the very sick are showing significant antibody response. Studies show that SARS and MERs, also coronaviruses, showed immunity for at least two to three years. And yet the media continues to report that we have no evidence that patients who survive coronavirus have immunity. 112952 I think actually the truth is the opposite. We have no evidence that survivors of the coronavirus don't have immunity and a great deal of evidence to suggest that they do. The question of immunity is linked to health policy and that workers who have gained immunity can be a strong part of our economic recovery. The silver lining to so many infections in the meat processing industry is that a large portion of these workers now have immunity. 113018 Those workers should be reassured that they likely won't get it again instead of being alarmed by media reports that there is no evidence of immunity. You've stated publicly that you'd bet it all that the survivors of coronavirus have some form of immunity. Can you help set the record straight, for the scientific record as this is being accumulated that this is supportive that the infection with coronavirus likely leads to some form of immunity, Dr Fauci? WASH 10 SENATE HELP COMMITTEE HEARING COVID 19 VIRTUAL WITNESS CAM POOL P2 113043 FAUCI>> Yup, thank you for the question, Senator Paul. Yes, you are correct that I have said, given what we know about the recovery from viruses such as coronaviruses in general or even any infectious disease with very few exceptions, that when you have antibodies present, it very likely indicates a degree of protection. 113102 I think it's in the semantics of how this is expressed, when you say has it been formally proven by long-term natural history studies which is the only way that you can prove: one, is it protective, which I said and would repeat is likely that it is, and also what is the degree or titer of antibody that gives you that critical level of protection, and what is the durability. 113129 As I've often said, you know, I again repeat, you could make a reasonable assumption that it would be protective. But national history studies over a period of months to years would then tell you definitively if that's the case. PAUL>> And I think that's important because in all likelihood, is a good way of putting it, the vast majority of these people will have immunity instead of saying, there is no evidence. You know, the WHO kind of fed into this by saying no evidence of immunity. And in reality, there is every evidence stacking up -- in fact a lot of the different studies have shown that it's very unlikely that you get it again in the short term. 113205 With regard to going back to school, one thing that was left out of the discussion is mortality. I mena, shouldn't we at least be discussing what the mortality of children is? This is for Dr Fauci, as well. You know, the mortality between zero and 18 in New York data approaches 0. It's not going to be absolutely 0, but it almost approaches 0. Between 18 and 45, the mortality in New York was 10 out of 100000. 113232 So really we do need to be thinking about that. We need to observe with an open mind what went on in Sweden, when the kids kept going to school. The mortality per capita in Sweden is actually less than France, less than Italy, less than Spain, less than Belgium, less than the Netherlands, about the same as Switzerland. But basically, I don't think there's anybody arguing that what happened in Sweden is an unacceptable result. 113254 I think people are intrigued by it. And we should be. I don't think any of us are certain when we do all these modelings. There've been more people wrong with modeling than right. We're opening a lot of economies around, around the US and I hope that people who are predicting doom and gloom and saying "Oh, we can't do this, there's going to be a surge" will admit that they were wrong if there isn't a surge. Because I think that that's what's going to happen. And in rural states, we never really reached any sort of pandemic levels in Kentucky and other states. We have less deaths in Kentucky than we have in an average flu season. 113326 Not to say this isn't deadly, but really outside of New England we have had a relatively benign course for this virus nationwide. I think the one-size-fits-all, that we're gonna have a national strategy and nobody is going to go to school is kind of ridiculous. We really ought to be doing it school district by school district and the power needs to be dispersed because people make wrong predictions and really the history of this when we look back will be of wrong prediction after wrong prediction after wrong prediction starting with Ferguson in England. So I think we ought to have a little bit of humility in our belief that we know what's best for the economy and as much as I respect you, Dr. Fauci, I don't think you are the end-all. 113406 I don't think you're the one person who gets to make a decision. We can listen to your advice, but there are people on the other side saying there's not going to be a surge and we can safely open the economy and the facts will bear this out. But if we keep kids out of school for another year, what's gonna happen is the poor and underprivileged kids who don't have a parent that's able to teach that at home are not gonna learn for a full year. And I think we ought to look at the Swedish model and we ought to look at letting kids back to school. I think it's a huge mistake if we don't open the schools in the fall. Thank you. 113434 FAUCI>> Mr. Chairman, Can I respond to that even though there are only 32 seconds left? CHAIRMAN>> Yes. And you might make it clear whether or not you suggest that we shouldn't go back to school in the fall. FAUCI>> First of all Senator Paul, thank you for your comments. I've never made myself out to be the end all and the only voice on this. I'm a scientist, a physician and a public health official. I give advice according to the best scientific evidence. 113501 There are a number of other people who come into that and give advice that are more related to the things that you spoke about, about the need to get the country back open again and economically. I don't give advice about economic things. I don't give advice about anything other than public health so I want to respond to that. The second thing is that you used the word we should be humble about what we don't know and I think that falls under the fact that we don't know everything about this virus and we really better be very careful particularly when it comes to children. 113533 Because the more and more we learn we're seeing things about what this virus can do that we didn't see from the studies in China or in Europe. For example, right now children presenting with covid-19 who actually have a very strange inflammatory syndrome , very similar to Kawasaki syndrome, I think we better be careful if we are not cavalier in thinking that children are completely immune to the deleterious effects. 113601 So again, you're right. In the numbers, that children in general do much, much better than adults and the elderly, and particularly those with underlying conditions. But I'm very careful and hopefully humble in knowing that I don't know everything about this disease, and that's why I'm very reserved in making broad predictions. Thank you. 113623 CHAIRMAN>> Thank you, Senator Paul, and Senator Bladwin. BALDWIN>>Thank you Mr. Chairman and ranking number Murray and our witnesses.I want to try and cover a lot of territory in my five minutes, so I would certainly be appreciative of concise answers. But I want to start with Dr. Redfield. Dr Redfield, do you think that the current testing protocols at the white house present some models for other essential workplaces? 113653 REDFIELD>> I'm sorry Senator, you broke up at the beginning of your question. If you could just say it again, I'm sorry. BALDWIN>> Yes. Dr. Redfield, do you think that the testing protocols currently in place in the white house present a model for other essential workplaces? REDFIELD>> Well, I think -- Thank you for the question. I think one of the important things that you bring up is the essential worker guidance that CDC put out. And I think it was originally modeled obviously on health care workers where there was significant health care shortages and individuals that were -- 113733 BALDWIN>> Are there any workplaces -- I'm asking you if you think the white house protocol testings are a model for other essential workplaces? REDFIELD>> I would just say that I think each workplace has to define their own approach as how to operationalize our -- BALDWIN>> (inaud.) --- there some considerable comments on the fact that osha has not stood up an enforceable mandatory emergency temporary standard for workers in all sorts of work settings, but that aside, would you say that the ppe rules and protocols in effect right now in the White House are a model for other essential workplaces? 113813 REDFIELD>> We would -- my own view, we would go back to the guidelines that CDC has put out about essential workplaces for people, if they are an essential workforce, if they go in public, they maintain 6 feet distancing and they wear face coverings. 113830 BALDWIN>> Okay. Admiral Giroir, you have testified about how far you have come with regard to testing assessment. I want to ask you if you believe that we already have a national testing strategy today that spans from the nationwide testing needs assessment to the nationwide testing supply assessment and a strategy to fill that gap to procure domestically what we need in terms of bridging that gap with testing platforms, swabs, specimen collection media, and reagents, and the PPE needed to conduct those tests. 113920 GIROIR>> Thank you for that. We do have a strategy that spans us at least to the fall and beyond. As I mentioned we're working individually with every state, and I think senator Paul is correct that Kentucky, Wyoming, New Jersey, Rhode Island are different, and there are vastly different testing needs. The East Coat will have multiples of testing versus other states and we're working those individually. BALDWIN>> So -- GIROIR>> Yes? 113953 BALDWIN>> So, I know you testified earlier that not only are you working with the states, but you're working with every lab in every state, and -- GIROIR>> Correct. BALDWIN>> -- increase capacity. What about working with those who would be -- those who would need testing to sya, reopen their school, their university,their business? Each of them have identified what they think are their testing needs based on you know, guidance and not mandatory enforceable rules. 114028 But, are you in contact at that level? Does your dashboard have visibility at that lowest level, or are you in contact with the states and the labs? GIROIR>> So, over the last few months, we've done a lot of the individual work at nursing homes, at meat packing plants, at other, I mean, really down to the dirt granular level. BALDWIN>> Okay. GIROIR>> Where we are right now, however, is we are really working with the state leadership, with the public health lab, the state epidemiologists, the (?), the state health officials, because they really need to understand what their sum is going to be in their state -- BALDWIN>> Okay. 114106 GIROIR>> And then in the funding, we are asking very specifically in the CDC funding for specific plans for schools, nursing homes, underserved et cetera. BALDWIN>> Thank you. So, I have 2 more points that I'm going to make. I don't have time for questions. One is about the transparency of that needs assessment. Can the public see it? Can the state see it? Can the HUP(?) committee members see it? Is it publically available? 114134 And, secondly, the delivery of this supply is a critical issue. And it seems to me that the logistics of getting this out whether it's ppe, testing or medical equipment is still extremely fragmented leading to price gouging and many other inefficiencies. We need to stand up the full power of the defense production act. GIROIR>> Would you like me to comment on that, ma'am? I'm sorry. 114205 BALDWIN>> I'm happy to have you comment with the indulgence of the chairman, we have gone over time. And why don't you get back to -- CHAIRMAN ALEXANDER>> Why don't we try to get a succinct answer for the senator, please, Admiral Giroir. 114218 GIROIR>> Yes, ma'am, and yes, sir. Particularly for things like swabs and media, there is still a very, I would say, non mature industry within the country. And that's why we've made the decision to procure that all centrally through December and then distribute that to the state. Because there are just too many small companies, too many variables to control without a really heavy federal hand. That;s just an example of where we really moved into that and used the DPA for swabs to help support American industry. In more mature aspects of the industry, like some of the large test producers, we feel by helping direct them to help the states get what they need and the right distribution, that we're not procuring them directly, by us. 114308 But again, we're going to be very evidence and data driven as we move on. Thank you, sir. CHAIRMAN ALEXANDER>> Thank you very much, Senator Baldwin. Senator Collins. COLLINS>> Thank you, Mr Chairman. Let me begin by first by thanking each of our witnesses today for their expertise, their dedication and their hard work. Dr. Redfield, I want to start with you. I am hearing from dentists all over the state of Maine the fact that they cannot practice in our state, despite following very strict infection control protocol, is causing growing health problems. 114354 Dentists tell me that teeth with cavities that could have been filled are now going to need root canals. Teeth that could have been treated with root canals are now going to require extraction. People with oral cancers cannot get the treatment, the cleanings that they need before beginning their treatment. Dental health is clearly so important. And Maine state officials as well as our dentists are seeking assistance in reaching the right decisions. 114433 47 other states either have reopened dental practices or have a day set to reopen. So my question to you is this. If dentists are following the American dental association guidelines, if they they are instituting strict protective measures for their patients, their staff, their hygienists, themselves, and if they are closely examining and seeing a decline in the number of covid-19 infections in their county,are these reasonable actors for states to consider in the reopening the practice of dentistry. 114524 REDFIELD>> Yes, Senator, thank you with the question. You know, we have been interacting and talking with dentists. We are working with the state and local public health officials to update our guidelines on reopening a variety of medical services as you know. And I think you raise a very important point and I would not disagree with what you said about looking at the American dental association's as well as the reality of the outbreak in the area. 114600 But we are in the process of updating those guidelines and they will include direct guidelines for dental practices. COLLINS>> Thank you very much Doctor. Dr. Giroir and Dr Hahn, recently there has been a significant demand for remdesivir, I may be mispronouncing that, which transitions to receiving an emergency use authorization. 114630 Last week, Maine's two largest hospital systems contacted me with questions about how this therapeutic will be allocated going forward. HHS finally released a statement on Saturday about allocations going to states, interestingly, not directly to hospitals, but once again the decision-making behind these allocations is very unclear. 114702 HHS and the assistant secretary for preparedness and response say that each state is expected to receive an allocation but no timetable has been provided. Beyond those who are being treated with this drug at Maine medical center through a clinical trial, I'm concerned that hospitalized patients in Maine will have little or no ability to be treated with this promising therapeutic for the foreseeable future. 114736 As this and more therapeutics and ultimately a vaccine come on to the marketplace, how can these allocation and distribution issues be resolved so that patient care is not delayed and so that it doesn't depend on which state you live in, whether or not you are going to get access to these treatments and ultimately a vaccine. 114809 HAHN>> Senator Collins, this -- oh, go ahead, Admiral Giroir. GIROIR>>Go ahead. Go ahead, commissioner. HAHN>> Senator Collins, I think we completely agree with you that this has to be an evidence-based approach getting the medical therapeutics, vaccines, remdesivir or whichever it happens to be to the people in need. 114834 I think we can all agree upon the fact that we've learned a lot of lessons from the remdesivir situation and, first, as you mentioned, that's being led by HHS and Anasper. What you see in the most recent announcement is, that what the task force did was provide guidance to HHS regarding where the most significant outbreak of hospitalization -- outbreak occurred and where the hospitalizations -- hospitalized patients were. 114903 This represented about a quarter of the supply of drugs that we had and more will be allocated according to methodology that gets drugs where those hospitalized patients are. Other therapies and to vaccines in particular and we must incorporate those into our operational plans moving forward. COLLINS>> Thank you, Doctor. Admiral, do you have anything to add -- I'm over time, sorry. Thank you.If you have anything to add, do so for the record. 114939 GIROIR>> No, Ma'am. I agree with commissioner. It's absolutely critical that it's evidence based, based on the people who could benefit from it, and also fair and just throughout our country. COLLINS>> Thank you. CHAIRMAN ALEXANDER>> Thank you senator Collins. Senator Murphy? MURPHY>> Thank you very much, Chairman. Thank you and Senator Murphy for convening this. Thank you to all of our witnesses for your service.

Thousands of kids in the Los Angeles School District received Gamma-Globulin injections. The inoculations are being given at three Los Angles schools today, as school officials try to head off an outbreak of Hepatitis A. They'll help protect students who were exposed to tainted strawberries that showed up on school lunch menus. Federal health officials say more than 160-cases of hepatitis in Michigan have been linked to the bad berries.

0940 SPEV SIDE CAM FS4 81 Senate HELP Committee Hearing on Covid-19 testimony from NIH and Anthony Fauci COVID-19: Safely Getting Back to Work and Back to School Full Committee Hearing Anthony Fauci, MD Director National Institute of Allergy and Infectious Diseases, National Institutes of Health Bethesda, MD Robert Redfield, MD Director United States Centers for Disease Control and Prevention Atlanta, GA ADM Brett Giroir, MD Assistant Secretary For Health United States Department of Health and Human Services Washington, DC Stephen Hahn, MD Commissioner Of Food And Drugs United States Food and Drug Administration Silver Spring, MD WASH 10 SENATE HELP COMMITTEE HEARING COVID 19 VIRTUAL WITNESS CAM POOL 100333 ALEXANDER/CHAIRMAN>>> Well, good morning. The committee on Health, Education, Labor and Pensions will please come to order. First of administrative matters, based on the advice of the attending physician and the Sergeant of Arms, after we consulted the Department of Health and Human Services and the Centers for Disease Control and Prevention, individuals in the hearing room are six feet apart. As a result, there's no room for the public to attend in person. Representatives of the Press are working as a pool to relay their observations to colleagues. 100403 The hearing may be watched online. An unedited recording will be available on the committee's website at www.senate.gov. Witnesses are participating via video conference in a one-time exception. Some senators, including the Chairman, are participating by video conference. Senators, we've been advised, may remove their masks, and talk into the microphone when they're in the hearing room, as they are six feet apart. I'm grateful to the rules committee, sergeant at arms, the press gallery, the architect at the Capitol, the Capitol police, the committee staff, [inaud] and Evan Griffith all for their hard work to keep us safe. 100441 At our hearing last Thursday, I said that "all roads back to work about back to school run through testing," and what our country has done so far on testing is impressive, but not nearly enough. Over the weekend, Senator Schumer, the democratic leader, was nice enough to put out a tweet, quoting half of what I said. He left out the other half, the "impressive" part. So let me say again what I meant by that. When I said "impassive," I meant that according to Johns Hopkins university study, the United States has tested over 9 million Americans for covid-19. 100518 That's twice as many as any other country. We don't know what China has done. And it's more per capita than most countries, including South Korea, which many members of our committee had cited as an example of a country that had tested well. According to Dr. Deborah Birx, the United States will double testing in the month of May -- month of May which should get us up to about 10 million tests conducted. Now, here is what I mean by "impressive": here in Tennessee, where I am today, first, anyone who is sick, a first responder or health care worker, can get tested. 100552 Our governor, Bill Lee, is also testing every prisoner, every resident staff and member in a nursing home, he's offered weekend drive-through testing, he's done specific outreach for testing to low-income communities -- any tennessean can get a free test at the local public health department. The governor's slogan is "if in doubt, get a test." Governor Lee sent his testing goals, in May, to the Federal government, as every state has done. 100622 The federal government is helping him ensure that he has enough supplies, in case he has trouble getting them through the labs and the other commercial sources. As a result, our state has tested about 4% the population. The governor hopes to increase that by 7% by May. That's one of the best in the country. This impressive level of testing is sufficient, we believe, to begin phase one of going back to work, which as I said last week is not nearly enough to provide confidence to 31,000 students and faculty members that we hope will show up at the university of Tennessee campus in August when school starts. 100702 Last week, I talked with UT Knoxville Chancellor Donde Plowman about that. We said, "What would persuade those 3100 students as well as the 50 million K through 12 students in the country and the other 5,000 university students, what will persuade them to go back to campus in August?" That's where the new shark tank comes in. Dr. Collins, at the National Institute of Health" calls it "red X." We had our hearing about that on Thursday. It's a really remarkable scientific exercise. 100734 Take a few early stage concepts that are swimming around what we call that competitive shark tank, and see if Dr. Collins and his associates can find a few new technologies to create millions of new tests that will scale up rapidly and make it more likely that students will go back to school in August. For example, the FDA authorized last week its first diagnostic test using saliva that a person provides at home, instead of a nose swab or blood. 100807 It authorized its first antigen test. We're hearing a lot about those, like the ones used for flu or strep throat, which involves the swabbing of a nose, and you can get the result in just a few minutes. Another proposal, not yet approved, is to put in your mouth a sort of lollipop sponge, take a photo of that with your cell phone and send that to your doctor. If it lights up, you're positive. Or the university might send that saliva lollipop to a nearby laboratory, which could be a gene sequencing laboratory, which can deal with thousands of those samples overnight. 100845 That same process could occur at a middle school. It could occur at a factory. Of course, anyone testing negative one day can test positive the next, but such widespread screening of entire campuses, schools, or places of work will help identify those who are sick, trace down those who were exposed. That, in turn, should help persuade the rest of us to go back to school and back to work. In addition to more testing, I expect Dr. Fauci will talk to us about additional treatments that will be available to reduce the risk of death and the administration's plan to do something that our country's never done before, 100924 which is to start manufacturing a vaccine before it actually has been proven to work, in order to speed up the result, in case it does work. Those vaccines, those treatments are the ultimate solution. But until we have them, all roads back to work and school go through testing. The more tests we conduct, the better we can identify those who are sick and exposed, and we can quarantine the sick and exposed, instead of trying to quarantine the whole country. 100954 Now, in my opinion, this will require millions of new tests, many from new technologies. Some of these will fail, but we only need a few successes to get where we want to go. That's why I said on Thursday, what our country has done so far in testing is impressive, but not nearly enough. First, squeeze all the tests we can out of current technologies. Next, try to find new technologies to help us contain the disease and persuade us to go back to work. 101026 Now, one other thing. This is a bipartisan hearing to examine how well we're preparing to go safely back to work and to school, and to determine what else we need to do in the united States Senate. Such an exercise sometimes encourages finger-pointing. Before we spend too much time finger-pointing, I'd like to suggest that almost all of us, the United States and almost every country so far as I can tell, underestimated this virus, underestimated how contagious it would be, underestimated how it can travel silently in people without symptoms to infect other people, how it can be especially deadly for certain segments of our population -- the elderly, those with pre-existing conditions, minority population. 101116 Let me go back to the March 3rd hearing that we had in our committee on coronavirus, six weeks after the first case was discovered in the United States, a day when only two deaths were recorded in this country. I read, at that hearing, this paragraph from "The New York Times" two days earlier on March the 1st. They reported this -- "Much about the coronavirus remains unclear, the Times reported, and it's far from certain" -- this is March 3rd that -- March 1 -- "That the outbreak will reach severe proportions in the United States or affect many regions at once. 101153 With its top-notch scientists, modern hospitals, and sprawling public health infrastructure, most experts agree, the United States is among the countries best prepared to prevent or manage such an epidemic." That was "The New York Times" on March 1. A lot of effort has gone into trying to make our country well prepared. Over the last 20 years, four presidents, several congresses, in response to 9/11, Bird Flu, Katrina, Ebola, H1N1, MERS, passed nine major laws to try to help get this country ready for what we're going through today. 101234 These laws stood (?) up the strategic national stockpile, created an assistant Secretary for Preparedness, it -- it created incentives for the developments of vaccines and medicines that we're using today, strengthened the Centers for Disease Control, and created Barda. Thanks to the leadership of Senator Blunt and senator Murray, for five straight years, we've significantly increased funding for the national institutes of health. 101304 All this was part of a shared goal -- Democrats, Republicans, four presidents, several congresses -- to try to get ready for what we're going through today, whether it was known, like anthrax, or unknown like Bovid-19. But despite all that effort, even the experts underestimated Covid-19. This hearing is about how we improve our response to this virus, as well as the next one. During the oversight hearing, I also intend to focus on, as I just said, the next pandemic, which we know is coming. 101341 What can we learn from this one to be ready for the next one? Can we -- what can we learn from the fast-tracking of vaccines and treatments that we're about to hear about that will make it even faster the next time? How can we keep hospitals and states from selling off protective equipment when their budget gets tight? How can we make sure Congress does our share of the funding responsibility? How do we provide enough extra hospital beds without -- without canceling elective surgery hurting other patients and bankrupting hospitals? 101415 Whose job should it be to coordinate supply lines so that protective equipment and supplies get where they're supposed to go, when they're supposed to go? What's the best way to manage the stockpile? My preacher once said, "I'm not worried about what you do on Sunday. It's the rest of the week that concerns me." I'm afraid that during the rest of the week, between pandemics, we relax our focus on preparedness, we become preoccupied with other important things. 101444 Our collective memory is short. Just three months ago, this country was preoccupied with impeaching a president. Now that seems like ancient Roman history. Now, while this crisis has our full attention, I believe we should put into law this year whatever improvements need to be made to be well prepared for the next pandemic. If there is to be finger-pointing, I hope they're pointed in that direction. We're fortunate today to have four distinguished witnesses who are at the heart of the response of the coronavirus. 101519 We're grateful for their service to our country. I've asked them each to summarize their remarks in five minutes. Then we'll have a five-minute round of questions from each Senator. I've agreed, we'll end our hearing about 12:30, after we have a full round of questions. Every senator will have a chance to have his or her five minutes. Senator Murray will then have an opportunity to ask the last question or close the hearing, and I will then close the hearing. There will be other hearings to follow this hearing, like last Thursday's hearing, and senators may submit their questions in writing within the next ten days. 101557 Staying at home indefinitely is not the solution to this pandemic. There is not enough money available to help all those hurt by a closed economy. All roads back to work, back to school, lead through testing, tracking, isolation, treatment, and vaccines. This requires widespread testing, millions more tests, created mostly by new technologies, to identify those who are sick and who have been exposed so they can be quarantined, and by containing the disease in this way, give the rest of America enough confidence to go back to work and school. 101636 For the near term, to help make sure those 31,000 UT students and faculty members show up in August, we need widespread testing, millions more tests, created mostly by new technologies to identify those who are sick and who have been exposed so they can be quarantined. And by containing the disease in this way, give the rest of America enough confidence to go back to work and back to school. Senator Murray. 101704 MURRAY>> Well, thank you very much, Mr. Chairman. My thoughts are with you and your team right now as you try to navigate the same challenge so many in our country are worried about. We all wish your staff member a speedy recovery. And as everyone works to take appropriate safety precautions today, I'd like to thank not only our witnesses for joining us today, but also our committee staff for working to set up a safe format for members and witnesses and the public to participate in this hearing remotely. 101740 Families across the country are counting on us for the truth about the Covid-19 pandemic, especially since it is clear they will not get it from President Trump. Truth is essential, so people have the facts, so they can make decisions for themselves and their families and their community. Lives are at stake. If the president isn't telling the truth, we must, and our witnesses must, and we're counting on you today. 101811 And families need us to take this opportunity to dig into the facts about where things did go wrong so we can finally get them on track. Because the Trump administration's response to this public health emergency so far has been a disaster on its own. Delays, missteps have put us way behind where we need to be on diagnostic tests and allowed inaccurate antibody tests to flood the market. Corruption and political interference have impeded efforts to secure desperately needed personal protective equipment and promoted dangerous, unproven treatments. 101850 And we recently learned that after experts at the Centers for Disease Control and Prevention spent weeks developing a detailed guide to help our community understand how to safely reopen, when the time comes, the Trump administration tossed it in the trash bin for being too prescriptive. But this is far from the first time this administration has silenced experts who were doing their job and putting public health first. The fact of the matter is, president trump has been more focused on fighting against the truth than fighting this virus. 101926 And Americans have, sadly, paid the price. Since this committee last heard from these witnesses on March 3rd, we have seen over 900 deaths in my home state of Washington, over 80,000 deaths nationally, and the numbers continue to climb. Still, President Trump is trying to ignore the facts and ignore the experts who have been very clear, we are nowhere close to where we need to be to reopen safely. 101956 My hope today is that we can cut through this, and have a serious discussion about what is needed to safely open, how close we are as a country to meeting those needs, and how we actually get there. One thing that's abundantly clear, we need dramatically more testing. It is unacceptable we still don't have a national strategic plan to make sure testing is free, fast, and everywhere. 102026 That is why I fought to make sure our last Covid-19 package included an initial $25 billion testing fund and a requirement that the administration submit a plan by May 24th. And when I say a "plan," I don't mean a PR plan. I mean a plan with specific time lines and numeric goals for supply and funding needs, one that actually addresses the issues we're seeing on testing capacity and distribution and disparity and building out our public health system. 102059 And makes clear to states and tribes and employers and the American people what they can expect and what the administration will do to keep Americans safe. But testing alone won't be enough to reopen our country. We still need far more personal protective equipment than has been available for our health care workers on the front lines, and we will need far more for other workers after we reopen. So we desperately need this administration to step up and get that equipment to states who are doing everything in their powers to purchase supplies but simply cannot get nearly enough. 102135 Because the reality is, unlike states, the federal government has the tools to actually fix the problem, if only the administration would use them. And we also need that equipment to actually work and for the FDA to act promptly if it does not, not weeks later when people may have already been exposed. And just as importantly, we can't expect people to go back to work or to restaurants or to confidently send their kids to school if there isn't clear, detailed guidance about how to do that safely. 102209 Schools, from early childhood through college, need to know how to keep their students, their staff, and their educators safe. When should they wear masks? How do you run a school cafeteria or a school bus? And if they can't reopen classrooms, schools and families need to know we are working to ensure every student gets an education. Tools like online learning can only get us so far if we don't address the digital divide that -- so that every student can access them. And even then, there will be learning loss that could deepen existing educational disparities among low-income students, students with disabilities, English language learners and other vulnerable populations, if we don't make sure they get equal access to resources and support. 102256 And of course, schools aren't the only workplaces we've got to be thinking about. We need to make sure that industries across the country know how to safely reopen and that people know their workplace is safe. Secretary Scalia needs to stop dragging his feet and do his job and have the department of labor set forward a rule that makes it clear, worker safety is not optional. Mr. Chairman, I hope this committee can hear about those critical issues from Secretary Scalia and Secretary DeVos as well as other experts in the space in the days ahead. 102330 And this is especially important to protect workers and residents at our nursing homes and other congregate care facilities, where we've seen some of the most deadly outbreaks. And as the rash of outbreaks at meatpacking plants shows, this isn't just an issue for the healthcare industry, it is an issue for everyone. And just as we need a plan before we can start to reopen, we also need a plan well before we have a safe and effective vaccine to guarantee that we can quickly produce and distribute it on a global scale and make it free and available for everyone. 102407 So, I'll be asking about our progress on those issues today. Today, safely reopening our country may be a ways off, and the administration's planning may be way behind, but there's still a lot that Congress needs to do. There isn't time to spare. Some, including the White House, say they've already provided enough economic relief. Well, my question to them is, what good is a bridge that only gets you to the middle of the river? We don't need to wait around to see if people need more help. We know they do. 102438 We need to work quickly on another aggressive relief package, and we need to make sure our priorities in that bill are protecting our workers, our students, and our families, and addressing this public health crisis, not bailing out corporations and protecting big business from accountability. People across the country are doing their part. They are washing their hands and wearing masks and social distancing and staying home. They need their government to do its part, too. They need leadership. They need a plan. 102510 They need honesty and they need it now, before we reopen, so they can rest assured that we are doing things safely and competently with their health and well-being as a top priority. Thank you, Mr. Chairman. 102529 ALEXANDER>> -- it's an important hearing, and I know lots of people may be watching it for the first time. If they are, I hope they notice that we have 23 members of this committee, I believe, one more Republican than Democrat. We have some very strong views, but we're able to work together and to express those views and respect each other and our witnesses. And I -- and a big part of that goes to Senator Murray and her staff. So, thank you for that. Each witness will have up to five minutes to give his testimony. Thank you for making an exception and agreeing to testify by video because of these unusual circumstances. 102605 And thank you for what you're doing for our country. Our first witness is Dr. Anthony Fauci. He's Director of the National Institutes of Allergy and Infectious Diseases at the National Institutes of Health. He's held that position since 1984, which meant he's advised six presidents and worked on HIV-AIDs, influenza, malaria, ebola, and other infectious diseases. He was involved in treating Ebola patients at NIH and also worked on vaccine trials for ebola. Next we'll hear from Dr. Robert Redfield. He's director of the U.S. Centers for Disease Control and Prevention, which has its headquarters in Atlanta. 102647 For more than 30 years, he's been involved with clinical research related to chronic human viral infections, infectious diseases, especially HIV. He was the founding director of the Department of retroviral research within the U.S. Military's HIV research program. He spent 20 years with the U.S. Army Medical Corps. Third, Admiral Brett Giroir -- Giroir. Admiral Giroir is Assistant secretary for Health at the U.S. Department of Health and Human services. 102720 That puts him in charge of development of public health policy recommendations. He's taken on the responsibility for coordinating testing and focused on the increasing number of tests that we can do with existing technology. His federal service includes a variety of activities with our defense department in advanced research, threat reduction. He was part of the blue ribbon panel to reform the U.S. Veterans health system. 102749 And, finally, we'll hear from Dr. Stephen Hahn. He is commissioner of the Food and Drug administration. Before joining FDA, he was the chief medical executive at the University of Texas MD Anderson Cancer center, and he was chair of the department of radiation oncology at the university of Pennsylvania. He was a senior investigator at the national institutes of health. He was commander of U.S. Public health service commission corps in 2025 (?). 102721 Now we'll ask each witness to summarize their remarks in five minutes. Following that, each senator will have five minutes for question and answers in order of seniority. Dr. Fauci, let's begin with you. Welcome. FAUCI 102836 FAUCI>> Thank you very much, Mr. Chairman, ranking member Murray, and members of the committee. Thank you for giving me the opportunity to discuss with you, today, the role the National Institutes of Health in research addressing covid-19. The strategic plan that we have is four-fold. One, to improve our fundamental knowledge of the virus and the disease it causes. Next, to develop new point-of-care diagnostics. Next, to characterize and test therapeutics. And finally, to develop safe and effective vaccines. 102910 First, with regard to diagnostics. As you probably heard from Dr. Francis Collins last Thursday, the NIH has developed a rapid acceleration of diagnostics program called RadX. With an award to that specific program up to half a billion dollars to support the development of covid-19 diagnostics. It is a national call for innovative technologies that would be evaluated in the shark tank-like selection process to get to either success or failure rapidly. 102944 Moving on to therapeutics, I'll talk a bit about the Remdesivir success antiviral in a moment, but let me emphasize that there are a number of broad-spectrum antivirals that are in various stages of testing. In addition, we will be looking at convalescent plasma, which is plasma from individuals who have recovered from covid-19 to be used in passive transfer, either in prevention or treatment. In addition, high-premium globulin which can be used as a gamma globulin shot. 103018 We'll be looking at repurposed drugs, as well as immune-based therapies and host modifiers. And finally, monoclonal antibodies. Let me take a moment to describe the remdesivir placebo-controlled randomized trial, which was done internationally through the power of more than 1,000 individuals, in sites throughout the world. It was in hospitalized patients with lung disease. The end point was primarily time to recover it. The result was statistically significant but really modest, and we must remember, it was only a modest result, showing that the drug made a 31% faster time to recovery. 103100 We hope to build on this modest success with combinations of drugs and better drugs. Moving on to vaccines, there are at least eight candidate covid-19 vaccines in clinical development. The NIH has been collaborating with a number of pharmaceutical companies at various stages of development. I will describe one very briefly, which is not the only one, but one that we have been involved in heavily developing with Moderna, it's a messenger RNA platform. 103131 You might recall in this committee that, in January of this year, I said it would take about one year to 18 months, if we were successful, in developing a vaccine. The NIH trial moved very quickly. On January 10th, the sequence was known. On January 11th, the vaccine research center met to develop a plan. And on the 14th of January, we officially started the vaccine development. 62 days later, we are now in phase one clinical trial with the two doses already fully enrolled. 103204 There will be animal safety. The phase one will directly go into phase two-three in late spring and early summer. And if we are successful, we hope to know that in the late fall and early winter. There are some important issues, however, in covid-19 vaccine development. We have many candidates and hope to have multiple winners. In other words, it's multiple shots on goal. This will be important because this will be good for global availability if we have more than one successful candidate. 103235 We also, as the chairman mentioned, will be producing vaccines at risk, which means we'll be investing considerable resources in developing doses even before we know any given candidate or candidates work. I must warn that there's also the possibility of negative consequences, where certain vaccines can actually enhance the negative effect of the infection. The big unknown is efficacy. 103303 Will it be present or absent, and how durable will it be? And finally, I want to mention, the NIH has launched a public-private partnership called Accelerating Covid-19 Therapeutic Interventions and Vaccines. The purpose of that is to prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential. Hopefully, our research efforts, together with the other public health efforts, will get us quickly to the end of this terrible ordeal that we are all going through. 103336 Thank you very much. Happy to answer questions later. ALEXANDER>> Thank you, Dr. Fauci. Dr. Redfield, welcome. REDFIELD 103344 REDFIELD>> Good morning, Chairman Alexander and ranking member Murray and members of the committee. Our nation is confronting the most serious public health crisis in more than a century. Yet, we're not defenseless. We have powerful tools to fight this enemy. We have tried and true effective public health interventions, such as early ace (?) identification, isolation and contact tracing, combined with an important mitigation strategy, which includes social distancing, frequent hand washing, face covering. 103413 These public health tools have and will continue to slow the spread of covid-19. I appreciate the opportunity this morning to provide a brief overview of some of CDC's ongoing work in response to covid-19. CDC's been working 24/7 to combat this pandemic. CDC's emergency operations center is supporting state, tribal, local and territorial public health partners in building core capabilities, particularly workforce, laboratory, and data and predictive analytics. 103443 Epidemiologists are conducting surveillance for Covid-19, as well as conducting health systems surveillance. Community mitigation teams are providing guidance on infection control and contact tracing, and our laboratory experts are performing serological testing to better define the extent of the asymptomatic populations. As local leadership makes decisions to reopen, they'll require varying degrees of federal support. Each location will be different and will face unique circumstances. CDC has conducted a state-by-state assessment of public health testing capacity and contact tracing capacity, as well as surge plans. 103523 CDC is providing technical assistance and funding to the states, provided through the supplemental CARES act and the Paycheck Protection Program and Health Care Enhancement Act. We're working directly with state public health leaders to define their needs for testing and testing devices, supplies, and manpower, surveillance, data collection and reporting, contact tracing, infection control, and outbreak investigation. I want to spend a moment to focus on several key elements. 103551 First, testing. Rapid, extensive, and widely available, timely testing is essential for reopening America. CDC's role in testing continues to support diagnosis and contact tracing, surveillance, and outbreak. When we work with the public health partners to define their particular testing strategy, their jurisdiction, Admiral Giroir will address the testing components of the response in greater detail. Contact tracing: Increasing state, tribal, local and territorial contact tracing capacity is critical. 103628 It's a critical part to stop the chains of transmission and prevent the occurrence of sustained community transmission. CDC's role is to provide technical training, assistance, and support to the states as they hire and build a workforce necessary to be fully prepared to effectively respond to the public health challenges posed by the ongoing Covid pandemic. This will be an expansive effort. Surveillance: Our nation's surveillance program is built on a combination of systems, including existing -- existing syndromic and respiratory viral disease surveillance systems, that have been combined with commercial and research lab platforms in our case reporting form system. 103711 CDC's adapting these and optimizing it to have a surveillance system in response to covid-19. Importantly, in light of the significant occurrence of asymptomatic infection, the surveillance for asymptomatic infection becomes an important public health tool for early case identification. CDC's working with each public health jurisdiction to develop a prospective surveillance program to include active surveillance among those that are most vulnerable, such as individuals in long-term care facilities, inner city clinics and homeless shelters. 103745 We need to rebuild our nation's public health infrastructure. Data and data analytics, public health laboratory resilience, and our nation's public health workforce. Now's the time to put it in place for the generations to come, not only for the public health system that our nation needs but for the public health system our nation deserves. Before I close, I want to recognize the tireless commitment of the dedicated CDC staff who have deployed to every corner of this nation to fight covid-19. 102815 More than 4,000 employees have deployed here, and globally. Science and data continue, with technical expertise and public service, to be the backbone of CDC's contributions to the U.S. Response. I extend my serious gratitude to the health care workers on the front lines as well as their family, and the essential emergency personnel as well as the American people, to say thank you for adhering to the stay-at-home guidelines and protecting the most vulnerable. 103842 It's important to emphasize that we're not out of the woods yet. The battle contends [inaud] months but we are more prepared. We need to stay vigilant with social distancing. It remains an imperative. We are a resilient nation, and I am confident that we will emerge from this pandemic stronger together. Thank you. ALEXANDER>> Thank you, Dr. Redfield. Admiral Giroir, welcome. GIROIR 103910 GIROIR>> -- Here to provide you with an update on the nation's progress in testing for Covid-19. On March 12th, Secretary Azar requested that I lead the Covid-19 testing effort within HHS, including oversight and coordination of the FDA and CDC with regard to testing. Since then, the nation has performed more than 9 million covid-19 tests, a number far greater than any other country and double the per capita tests performed to date in South Korea. 103940 To reach this point, we implemented a phased approach to meet testing needs during mitigation. And now, during phase one reopening of America. Beginning March 20th, we pioneered 41 community-based drive-through testing sites in locations prioritized by the CDC. These sites have been a profound success, testing over 167,000 high-risk individuals and demonstrating a prototype that is being duplicated multifold in nearly every state. 104010 Next, the administration leveraged trusted retailers, including CVS, Rite Aid, Walgreens, Walmart, Kroger and Healthmart, who are now providing testing at 240 locations in 33 states, 69% of which are in communities with moderate to high social vulnerability. To meet the need for collection supplies like swabs and media tubes, we first secured the global supply chain through a military air bridge. We worked directly with manufacturers to increase domestic production. 104041 We collaborated with the private sector and the FDA to validate multiple swab and media types. That vastly expanded supplies while minimizing the need for PPE. Finally, we used title three of the defense production act to further invest in domestic manufacturing to prepare us for reopening. To support the need for surveillance testing during reopening, on April 27th, we issued a new testing framework that also prioritized testing for persons without symptoms who are prioritized by health departments or clinicians for any reason, including screening of asymptomatic individuals according to states' and local plan. 104123 Next, our federal multidisciplinary team conducted multiple calls with leadership from each state to set state-specific testing objectives. Collectively, states and territories established an overall goal to perform 12.9 million tests over the next four weeks. The federal government is able to, and will, support the achievement of this goal. Specifically, the federal government is shipping to states 12.9 million swabs and over 9.7 million tubes of media in May alone. 104159 Last month, we also detailed the location and capacity of every lab machine in every state that could potentially run covid-19 assays and our team has worked with manufacturers to match reagent to these machines. Looking forward, between now and the end of 2020, the federal government will procure over 135 million swabs and 132 million tubes of media and distribute these to states, as requested, to supplement the now-robust commercial supply. 104231 We anticipate marked increases in current tests as well as a dramatic expansion of new point-of-care tests, like the first in-class Quidel antigen test, authorized by the FDA just last Friday. Quidel anticipates being able to distribute 300,000 tests per day within just a few weeks. So, by September, taking every aspect of development, authorization, manufacturing, and supply chain into consideration, we project that our nation will be capable of performing at least 40 to 50 million tests per month, if needed, at that time. 104308 And if new technologies are authorized like whole genome sequencing approaches or anything uncovered by NIH's new diagnostics initiative, that number will be much higher. Finally, I want to acknowledge and express my heartfelt gratitude to the officers of the U.S. Public health service commissioned corps, the uniformed service I am honored to lead. 3,471 men and women have deployed in support of this pandemic. 104338 On the cruise ship in Japan, to our military bases repatriating Americans, to our community-based testing sites and international airports, to FEMA and our task forces, to nursing facilities including King county, Washington, and to field hospitals in hard-hit communities across our nation. I thank each and every one of these officers and their families, and on their behalf, I thank the members of this committee for supporting our training needs and the establishment of a ready reserve to supplement our ranks in future national emergencies. 104411 Thank you for the opportunity to provide these remarks. ALEXANDER>> Thank you, admiral Giroir. And now Dr. Stephen Hahn, our fourth and final witness. HAHN 104422 HAHN>> Chairman Alexander, ranking member Murray, and members of the committee, thank you for inviting me to participate in this hearing today. I first want to start by thanking the American people for their incredible efforts at mitigation and extend my condolences to those who have lost loved ones. From day one of this pandemic, the 18,000 FDA employees who are just incredible scientists, doctors, and nurses, have taken an active role in the all-of-government response to this pandemic. 104454 The FDA has worked to facilitate the development of medical countermeasures to diagnose, treat, and prevent covid-19. We've worked closely with laboratories, manufacturers, academia, product developers, our federal partners and companies, companies that don't even make medical products but want to pitch in, for example, by making hand sanitizer, personal protective equipment and ventilators. Every decision we have made has been driven by data with a goal [inaud] of protecting the health of the American people. 104525 In a public health emergency, however, our response has balanced the urgent need to make medical products available with the provision of a level of oversight that helps ensure the safety and effectiveness of those medical products. I'd like to take a few minutes to tell you what FDA is doing to help the country at this point, in order to show Americans it's safe to return to work and to school. It starts with testing, as others have mentioned. FDA has worked with more than 500 developers who have or said they will be submitting emergency use authorization requests for covid-19 tests. 104600 This includes some newer technologies that not -- that heretofore have not been used as part of diagnostic tests in response to a pandemic. We have issued 92 individual emergency use authorizations for test kit manufacturers and laboratories, and we've been informed by more than 250 laboratories, they have begun testing under the regulatory flexibilities we outlined in March. We are conducting rolling reviews of UA (?) submissions so that we can quickly authorize tests which the data support. 104632 In a public health emergency, the accuracy of diagnostic tests is important, not only for the individual patient, but for the patient at large -- for the public at large. FDA is helping to ensure the availability of tests that are providing accurate answers. We are also monitoring the marketplace for fraudulent tests and are taking appropriate action to protect the public health, and we are working to provide more clarity about which tests have been reviewed and authorized by FDA and which have not. Serologic tests will play a part in our recovery. Unlike diagnostic tests, which detect the presence of the virus, serologic tests measure the amount of antibodies or protein present in the blood when the body is responding to an infection like covid-19. 104715 Tests can help identify individuals who can overcome an infection and who have developed an immune response. We will continue working with labs, manufacturers and across the government to find a balance between the assurance that an antibody test is accurate and timely access to such tests. Of course, the way we will eventually beat this virus is with a vaccine. And FDA is working closely with our Fed partners, including the NIH, testing -- Vaccine developers, manufacturers, and experts across the globe. We intend to use our regulatory flexibility to help ensure the most efficient development of a safe and effective vaccine to prevent covid-19. 104756 Until a preventive vaccine is approved, however, we need medical products to bridge the gap. FDA has been working for several months to facilitate the development and availability of therapeutics as expeditiously as possible, and we have created an emergency program for this acceleration called the Coronavirus Treatment Acceleration Program or CTAP. We have reassigned staff to work with urgency to review requests from companies, scientists, doctors who are developing therapy, and we're using every available authority and regulatory flexibility that's appropriate to facilitate the development of safe and effective products to treat covid-19. 104835 A variety of therapeutic areas are being evaluated, as mentioned by Dr. Fauci and others, including antiviral drugs and immuno-therapies as well as convalescent plasma, hyper immunoglobulin and monoclonal antibodies. As Dr. Fauci mentioned, we recently announced the positive results of the NIH-MD (?) trial of remdesivir and issued an EUA for the treatment of hospitalization of patients with covid-19. Two other promising treatments that I mention are the antibody [inaud] products, convalescent plasma and hyper immunoglobulin and I am certainly willing to go into more detail if members of the committee have questions about this. 104913 But we are working very aggressively and closely with stakeholders to facilitate the development of monoclonal antibodies, which, if shown to be safe and effective, could act as a bridge therapy to the development of a vaccine. We recognize developing vaccines and therapies need to go hand in hand with ensuring there will be sufficient supplies for our company -- for our country, so we're also working with manufacturers to make sure that this supply chain is robust. 104940 Mr. Chairman, ranking member, members of the committee, please know that in FDA you have a dedicated team of some of the nation's finest scientists, health care providers and public health professionals. We are guided by science and data, and we won't let up until we facilitate the development of products that our nation needs to get back to work. I look forward to your questions. QUESTIONING 105002 ALEXANDER>> Thank you, Dr. Hahn. And thanks to all four of you for your expertise, for your dedication to our country, and your hard work. We'll now begin a round of five-minute questions from each senator on the committee, alternating between Republicans and Democrats. Each senator has, if you're in a video conference, you have a little time clock at the bottom, and I would ask you to try to stay within five minutes for your questions and answers. I will start. 105031 I've got a question for Dr. Fauci and then admiral Giroir. Doctor, let's look down the road three months. There will be about 5,000 campuses across the country trying to welcome 20 million college students, 100,000 public schools welcoming 50 million students. What would you say to the chancellor of the university of Tennessee Knoxville or the president -- principal of a public school about how to persuade parents and students to return to school in August? 105108 Let's start with treatments and vaccines first. Dr. Fauci, and if you could save about half of my five minutes for Admiral Giroir for testing, I would appreciate it. FAUCI>> Thank you very much, Mr. Chairman. Well, I would be very realistic with the chancellor and tell him that we're thinking in terms -- ALEXANDER>> It's her in this case. FAUCI>> Okay. I would tell her -- I'm sorry, sir -- That in this case, that the idea of having treatments available, or a vaccine, to facilitate the re-entry of students into the fall term would be something that would be a bit of a bridge too far. 105144 As I mentioned, the drug that has shown some degree of efficacy was modest, and it was in hospitalized patients -- not yet, or maybe ever, to be used either yet as prophylaxis or a treatment. So, if the issue is that the young individuals who'd be going back to school would like to have some comfort in that there's a treatment, probably the thing that would be closest to utilization then would likely be passive transfer of convalescent serum. But we're really not talking about necessarily treating a student who gets ill, but how the student will feel safe in going back to school. 105227 If this were a situation where we had a vaccine, that would really be the end of that issue in a positive way. But as I mentioned in my opening remarks, even at the top speed we're going, we don't see a vaccine playing in the ability of individuals to get back to school this term. What they really want is to know if they are safe, and that's the question that has to do with what we discussed earlier about testing. 105256 So, I'm about halfway through the remarks. I'd like to just pass the baton to Admiral Giroir, who would address the question of the availability of testing and what role that might play in returning to school. Thank you, sir. ALEXANDER>> Well, thank you -- thank you, Dr. Fauci. And admiral Giroir, you said that while we're doing about 10 million tests this month, that we might be as high as 40 or 50 million by September and -- a month, which is a significant increase. 105327 So, if I'm chancellor of the university of Tennessee, could I develop a strategy where I'd say to all of my students, we have, for example, an antigen test, which is quick and easy, we want everyone on campus to come by and take it once before you begin school? That will at least let everybody know that on that day, we've isolated anybody who's positive, and then we can continue to monitor? Is that strategy possible in August and September? 105351 GIROIR>> So, thank you, Mr. Chairman. And I may reserve 20 seconds for Dr. Redfield as well. The strategy that's going to be employed really depends heavily on what's the community spread at that time. If there's almost no community spread, your strategy will be different. If there's high community spread, it will also be different. But yes, technically, we will have the ability, and your chancellor will have the ability. We expect there to be 25 to 30 million point-of-care tests per month available. It is certainly possible to test all of the students, or it is much more likely that there would be a surveillance strategy done where you may test some of the students at different times to give an assurance that there's no circulation. 105433 And that would be done in conjunction with the CDC and the local health department. There's also strategies that are still needing to be validated, but a pooling sample. We know in some experimental labs, as many as 10 or 20 samples can be pooled. So, essentially, one test could test 20 students. And finally, there are some experimental approaches that look interesting, if not promising, that for example, wastewater from an entire dorm or an entire segment of a campus could be tested to determine whether there's coronavirus in that sewage, the wastewater. 105507 So, there are other strategies being developed. And I'd like to give at least 20 seconds to Dr. Redfield, who really will be working on the strategy of how to employ the tests given different community spread. ALEXANDER>> Dr. Redfield? REDFIELD>> Yeah, just some quick comments, sir. I mean, first, I think it's really important to evaluate critically the role of changes in social distancing on college campuses and schools and the situation, not to forget the importance of what we've learned. 105535 Clearly, also developing aggressive programs for wellness education, making sure people understand when they're symptomatic, they need to seek evaluation. I think we are going to have to look at the role of testing. And I think there's going to be an important role of testing in these circumstances, and I think it will be individualized based on where these different schools are, and where they -- how much infection is -- ALEXANDER>> I'm going to wrap it up there so I can set a good example for the other senators with their five minutes. Senator Murray. 105605 MURRAY >> Thank you very much, Mr. Chairman. And thank you to all of our witnesses. Dr. Fauci, you have warned of needless suffering and death if we push to reopen too soon, but the president has actually been sending the opposite message. I want to ask you today: what is the most important message you have for communities in states that are reopening, even as our public health experts make it clear it's too soon? Tell us what the consequences are. 105638 FAUCI>> Thank you very much for that question, senator Murray. As I've said many times publicly, what we have worked out is a guideline framework of how to safely open America again, and there are several checkpoints in that with a gateway first of showing, depending on the dynamics of an outbreak in a particular region, state, city, or area, that would really determine the speed and the pace with which one does re-enter or reopen. 105711 So, my word has been -- and I've been very consistent in this -- that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14-day decrease that would allow you to go to phase one. And that, if you pass the checkpoints of phase one, go to phase two and phase three. But I've expressed then and again, my concern that if some areas, cities, states, or what have you, jump over those various checkpoints and prematurely open up, without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn into outbreaks. 105757 So, therefore, I have been being very clear in my message to try to the best extent possible to go by the guidelines which have been very well thought out and very well delineated. MURRAY>> So, if a community or a state or a region doesn't go by those guidelines and reopens, the consequences could be pretty dire, correct? FAUCI>> The consequences could be really serious, particularly -- and this is something that I think we also should pay attention to -- that states, even if they're doing it at an appropriate pace, which many of them are and will, 105836 namely, a pace that's commensurate with the dynamics of the outbreak, that they have in place already the capability that when there will be cases, there is no doubt, even under the best of circumstances, when you pull back on mitigation, you will see some cases appear. It's the ability and the capability of responding to those cases with good identification, isolation, and contact tracing, will determine whether you can continue to go forward as you try to reopen America. 105911 So, it's not only doing it at the appropriate time, with the appropriate constraints, but having in place the capability of responding when the inevitable return of infections occur. MURRAY>> Well, thank you for that. And it's very clear, in order to do that, we need knowledge, which is about testing. And for months, this administration's approach to testing has really been plagued by unrealized goals and disregard for systemic problems within that supply chain. 105940 And last week, an average of just 250,000 tests per day were performed in the United States. That is a small fraction of what we need. And yesterday, president trump had the gall to declare the U.S. had, quote, prevailed in testing in a press conference that was filled with misinformation and distortion. Dr. Giroir, public health experts do not think the U.S. Has prevailed. I'm glad you've finally committed that states, including my home state of Washington, will receive enough tests to meet their goals for may and June. 110011 But this administration has had a record of giving us broken promises that more testing supplies are coming, and they don't. And we know, by the way, that testing needs will persist long past June -- long past June. So I wanted to ask you today, will the administration's forthcoming strategic plan that is now required under the Covid package that was just passed and signed into law, will that strategic plan on testing include specific numeric targets for testing capacity, supply-chain capacity, and projection of shortages? 110053 GIROIR>> Thank you for that question and statement, Senator Murray. Yes, we are, as I've stated. We continue to have a work in progress as we build the testing capacity. We have established the targets with the states of over 12 million tests over the next 4 weeks. We think those targets are gonna be good in May and June, but as Dr. Fauci said, we really have to be evidence-based. We expect those targets to go up as we progressively open, as those communities go into Phase 1 and then into Phase 2. 110128 And certainly those numbers will need to go up significantly again in the fall when we potentially have influenza circulating with Covid. So, yes, there will be targets. The targets will need change based on the evidence that we see but we are highly committed to securing the supply chain. We work daily with every manufacturer. And I'm just pleased we're, in May and June, able to get ahead of the states so that we can supply them what they need so they have those assurances. So there's not gonna be any doubts about that. 110158 MURRAY>> My question to you is when you put out that specific plan that you're required to do, we will see numbers that you are going to tell us you will reach, targeted for testing and supply-chain capacity and protection of [inaud], instead of just saying we hope to have a million this week, next week -- you will give us specific targets, correct? GIROIR>> We know specific -- I'll say yes, ma'am, we know the specific amounts of tests we have over the summer -- 110227 MURRAY>> Not have, how many we need. GIROIR>> Yes, so -- yes, ma'am. We develop the need statements by working with the states individually, with epidemiologists, with the CDC, so that overall in May we'll be testing about 3.9% of the overall USpopulation. MURRAY>> Well, that's fine but what I'm tell you -- ALEXANDER>> You're well over time, Senator Murray. MURRAY>> How many we have -- but how we will need not just for May but in the coming months so we can be prepared to have them? 110300 GIROIR>> Yes, ma'am, not to be repetitive, but, um, we need to be evidence and data driven. Because what we may see in May or June will drive differences in the amount of test goals that we have. So we really just need to be very humble about this. We need to look at the data. We know that the testing needs will go up over May and June, as we progressively open. And we will do our best to predict that. But you have to understand we have to have the data and the evidence show at that time. MURRAY>> Okay, I appreciate that. And again, what our strategic plan requires is what is the goal -- not how many we have, but how many we need. And that's what we'll be looking for, thank you. 110336 ALEXANDER>> Thank you, senator Murray. Senator ENZI? ENZI >> Thank you, Mr. Chairman. And I particularly appreciated your opening statement where you had a very succinct list of preparations we need to learn from this pandemic for the next one. Not only should we be working on this and preparing, but we need to look at the future, too. And I think we have learned a lot. We're fighting a virus at the same time that scientists are learning about it, so we need to be nimble. 110407 We also need to be sure that we are prepared for a second wave of outbreak. It could coincide with the start of the flu season, potentially stressing our healthcare system even more than it already has been. Admiral Giroir, I thank you for your comments. I think they've been comforting about what has been done and what can be done. I agree with senator Murray that we need to have some specific goals. 110437 As an accountant, that's always one of the things I'm looking for. My question is for Dr. Hahn -- our understanding of the clinical picture of Covid-19 continues to evolve. What first looked like a respiratory illness now seems much more comprehensive, potentially affecting the heart, the brain, the kidney and other organs. How does this evolving picture impact the ability to evaluate the appropriate clinical or surrogate endpoints for review of viruses and treatments? 110510 HAHN>> Thank you, senator, for that question. The -- the evolving clinical picture, and obviously the way this is manifesting around the country clinically does, in fact. inform the end points that we will work with developers of therapies on, so that we can get the absolute most efficient, but also the most accurate information and appropriate endpoints to make the necessary authorizations and approvals. We have set up the program called the Coronavirus Treatment Acceleration Program. 110544 Where our top scientists and clinicians have been at the table, consulting with our colleagues at NIH and CDC to actually address those questions. What are the appropriate endpoints? I'll give you an example. We do know that, in some circumstances, patients who had severe Covid disease have developed [inaud] or clotting type of episodes, and so we prioritize review of agents that we think might be beneficial. 110613 And obviously the clinical endpoints for those trials will be different from an agent that's an antiviral like remdesivir where, as Dr. Fauci mentioned, we're looking at time to recovery. So we want to adapt it to clinical circumstance, as well as to the type of therapy that's put before us. ENZI>> Thank you. Another question to Dr. Hahn, we have made a lot of progress in vaccine development, but Barta has identified that domestic manufacturing of the needles and syringes is a significant gap in pandemic preparedness. 110645 What has HHS done in advance of a potential national vaccination campaign to ensure we have sufficient capacity to administer a vaccine? HAHN>> Senator Enzi, thank you for that question. This is a really important point because, as you mentioned, it's not just about the vaccine or hopefully vaccines that are developed, it's all about -- it's also about the supplies that are needed, as well as an operation plan for administering the vaccine. 110715 So this is an all of government approach. There's a program that's been set up, called operation Warp Speed that included Dr. Collins, Dr. Fauci, his colleagues at NIH, the department of defense, as well as other members of HHS and FDA. Dr. Peter marks for our center for Biological Evaluation Research has been helping to coordinate that, and is working very closely with Dr. Fauci and his team. 110739 And we have created what's called a Gantt chart to look forward, what are the necessary supply chain issues, syringes, needles, etc. depending on the various vaccines that are being developed, how many times they have to administer and the route to administration. So we've been leaning in on this supply chain to ensure that when a vaccine is ready to go, we will have the necessary supplies to actually administer it and operationalize the vaccination. ENZI>> I have a couple more questions, but again the clocks visible there so I suspect I've used up my time. I'll submit those in writing. ALEXANDER>> Thank you senator Enzi. Senator Sanders? 110826 SANDERS>> Thank you very much, Mr. Chairman. And let me thank all of the panelists for the hard work they're doing and for being with us today. It is sad to say that we have a president of the United States, the leader of our country who from day one downplayed the dangers facing this country from the pandemic, who told us that the crisis would be over in a few months, that we did not have to worry. 110855 Who fired those members of the government who wanted to act aggressively and among other things at a time when we need international cooperation cut funding for the world health organization. Let me also say that I think we understand that fact are terribly important. Not everybody that we don't fully understand all of the ramifications of the covid-19 epidemic. 110926 Let me ask Dr. Fauci and few questions if I might. For a start, the official statistics, Dr. Fauci, is that 80,000 Americans have died from the pandemic. There are some epidemiologists who suggest the number may be 50% higher than that. What do you think? FAUCI>>I'm not sure not sure, Senator Sanders, if it's gonna be 50 percent higher but most of us feel that the number of deaths are likely higher than that number because giiven the situation particularly in New York City, when they were really strapped with a very serious challenge to their health care system, 111008 there may have been people who died at home who did have covid who were not counted as covid, because they never really got to the hospital. So in direct answer to your question, I think you are correct that the number is likely higher. I don't know exactly what percent higher, but almost certainly its higher. SANDERS>> Dr. Fauci, let me ask you this. In the terrible pandemic of 1918, the virus exploded in the fall, it came back with a vengeance. 111047 Are we fearful that if we don't get our act together, as bad as the situation is now, it could become worse in the fall or winter? FAUCI>> Well, senator, thank you for that question. It's a frequently asked question. I think the possibility does exist. However -- and the reason I say that is that when you talk about will the virus just disappear? And as I've said publicly many times, that is just not going to happen because it's such a highly transmissible virus. 111119 Even if we get better control over the months, it is likely that there will be a virus somewhere on this planet that will eventually get back to us. So my approach towards the possibility of a rebound and a second wave in the fall is that, a, it's entirely conceivable and possible that would happen, but B, I would hope that between now and then, given the capability of doing the testing that you heard from admiral Giroir, and the ability for us to stock up on personal protective equipment and the workforce that the CDC under Dr. Redfield will be putting forth. 111201 to be able to identify, isolate and contact trace -- I hope that if we do have the threat of a second wave, we'll be able to deal with it very effectively to prevent it from becoming an outbreak, not only worse than now, but much, much less. SANDERS>> Okay, and let me ask, we've heard a lot of discussion about vaccines. Obviously everybody in congress and in this country wants a vaccine, we want it as quickly as possible, as effectIve as possible. Let me ask the honorable fda commissioner. 111234 sir, if, god willing, a vaccine is developed and if we're able to produce it as quickly as we all hope we can I would imagine that that vaccine would be distributed to all people free of charge to make sure at least everybody in America who needs that vaccine would get it regardless of their income. Is that a fair assumption? HAHN>> Senator, I certainly hope so. The fda is very committed to making sure that all populations in the United States, including those most vulnerable are included in the clinical trials. 111312 SANDERS>> Sir, that's not what I'm asking. WhatI'm asking is, if and when the vaccine comes, it won't do somebody any good if they don't get it and if they have to pay a sum of money for it in order to profit the drug companies, that will not be helpful. Are you guaranteeing the American people today that that vaccine will be available to all people, regardless of their income? 111340 HAHN>> Sir, the payment of vaccines is not a responsibility of the fda, but I'm glad to take this back to the task force. I share your concern that this needs to be made available to every American. SANDERS>> Does anybody else want to comment on that? Mr. Giroir, Do you think we should make that vaccine when hopefully it's created, available to all, regardless of income? Or do you think that poor people and working people should be last in line for the vaccine? GIROIR>> I'm sorry, senator, were you asking me? SANDERS>> Yes, I was sir. Yes, I was. 111413 GIROIR>> No, I -- um, my office is one of the offices committed to serving the underserved. We need to be absolutely certain that if a vaccine or an effective therapeutic or preventative is available, that it reaches all segments of society, regardless of their ability to pay or any other social determinants of health that there may be. SANDERS>> Good. So you're telling the American people today that regardless of income, every American will be able to gain access to that vaccine when it comes? 111449 GIROIR>> They should gain access to it. I don't control, you know -- SANDERS>> Well, you represent -- you represent an administration that makes that decision. GIROIR>> I will certainly advocate that everyone is able to receive the vaccine, regardless of income or any other circumstance. SANDERS>> Let me just switch gears-- ALEXANDER>> Your time is up, senator Sanders. SANDERS>> I'm sorry. Alright. Thank you, Mr. Chairman. ALEXANDER>>> Those are important questions. I don't want to cut senators off, and it's hard to see the time clock, but if we can stay as close as possible to five minutes, all senators can get their questions in. Thank you, Senator Sanders. Senator burr? BURR 111525 BURR>> Thank you, Mr. Chairman, and thank you to our witnesses for what you have done for the people of this country and their safety and people around the globe. Let me ask you, Dr. Fauci, because you have been in the task force and a majority of the press conferences. Has anybody in this administration ever asked you or any member to take the foot off the gas of trying to find a cure or any type of countermeasure? 111550 FAUCI>> No, senator. Not at all as a matter of fact. We at mih as you know have been right from the very beginning put our foot on that accelerator in every aspect, including the development of vaccines and therapeutics. And as I described in my opening statement we actually started that in January, literally days after the virus was known and its sequence was published. So no I have never been told by anyone to pull back on the development of any countermeasure or any basic clinical that research project we've been involved in. 111627 BURR>> Thank you, Dr. Fauci. This question is for Dr. Redfield. Dr. Redfield, we have authorized in this committee and appropriated out of congress multiple times over the last few decades money for bio surveillance and you talked about it. In the past four years. From fy 16 to fy 20. It's been 23 million dollars a year and with the C.A.R.E.S. Act, it's over a billion dollars in bio surveillance. 111652 We have seen the private sector go out and use data available to track the progress and spread of coronavirus around the world. Why has CDC not contracted with private sector technologies companies to try to use their tools for bio-surveillance? REDFIELD>> Thank you for the question. This is a critical issue, as you know, and also comes into one of the core capabilities I talked about data analytics and data monetization which we're appreciative of the additional funding that congress has given. 111731 I can tell you this is under critical review. We do have contracts with some of the private sector groups now to try to make the type of availability of data we've seen in Florida available in all of our jurisdictions across the country and in the process of making that happen. BURR>> Dr. Redfield, in april of last year -- June of last year, we reauthorized the pandemic and all hazards legislation, which authorized at that time 30 new billets, 30 new employees at CDC specifically in surveillance. 111806 I asked Dr. Schuchat in March how many of those 30 had been filled. She said zero. As of mid April, zero of those 30 billets had been filled. How many of those 30 employees that this committee authorized CDC to bring on and for biosurveillance, have been filled today? REDFIELD>> Sir, again, thank you for the question. I know our staffs have been in discussion since Dr. Schucat's testimony, and I know we're in the process of continuing to try to figure out how to move that forward, sir. 111841 I can get back to you on it as I discuss what progress has been made.since we had that discussion [INAUD] hearing with you when you brought that to light. BURR>> Well, I brought it to light the first of March, and now we're in mid may. So I'm hopeful that we won't just talk about surveillance, we'll actually execute it, and we'll focus on the unbelievable amounts of money that we have provided for you that they will show some benefit to the American people. 111912 Dr. Fauci, let me come back to you. This is one of the fastest development timelines we have ever seen for vaccines, and the American people and hopefully people around the world will be the beneficiary of what you find and the eventual licensure of that product. What are the biggest unknowns with this particular virus that can affect the development process and Dr. Hahn, if you have got anything to add after that to this, please do. Dr. Fauci? 111944 FAUCI>> Thank you very much, senator burr. Well there are a couple things that I think are inherent in all vaccine development. First of all there's no guarantee that the vaccine is actually going to be effective. As you well know, because we have discussed this many times in the past, you can have everything you think that's in place, and you don't induce the kind of immune response that turns out to be protective and durably protective. So one of the big unknown as is, will it be effective? Given the way body respond to viruses of this type, I'm cautiously optimistic that we will, with one of the candidates, get an efficacy signal. 112018 The other thing thats an unknown that's of concern, but we'll be able to get around it by doing the tests properly is that do you get an enhancement effect? Namely, there have been a number of vaccines, two in particular (?) and respiratory censitual virus, when the vaccine induces a suboptimal response and when a person gets exposed, they actually have an enhanced pathogenesis of the disease, which is always worrisome. 112045 So we want to make sure that that doesn't happen. Those are the two major unknowns.Putting all those things together, Senator Burr, I still feel cautiously optimistic that we will have a candidate that will give some degree of efficacy, hopefully a percentage enough that will induce the kind of herd immunity that would give a protection to the population at home BURR>> Dr. Hahn, anything to add to that? HAHN HAHN>> Yes, sir. Thank you for the question. The obstacles from a regulatory point of view I think are being met by the approaches being taken out of the HHS and lead by Peter Marks 112120 and that is a common preclinical development pathway so that we can appropriately assess one vaccine against the other and then a master protocol that allows for a common control group and an assessment of very common end points. That will let us be as efficient as possible for the development of a vaccine. We will evaluate approximately ten candidates clinically, and then in the phase one and two studies, and then take four to five into phase three study in this HHS effort. I think those are the obstacles that can be broken down to speed the development, but also allow us to ensure safety and effectiveness. 112159 HAHN>> Mr. Chairman, yesterday the state of North Carolina started to publicize the recovered numbers, those individuals who had coronavirus, but have recovered. It's my hope that nationally we will start reporting the recovered numbers. I think that's important for the American people to hear. I yield back. ALEXANDER>> Thank you, senator burr. Senator Casey? 112223 CASEY>> Mr. Chairman, thank you for the hearing, as well as ranking member Murray. Mr. Chairman, I wanted to start today with a question regarding nursing homes, in particular across a state like ours, we've had as you might know a high number of cases in Pennsylvania,, at last count over 57,000 cases. The number of deaths have gone above 3,700, and of course a lot of those deaths are in nursing homes. We're told that nationally more than a third, as high as 35% of all deaths have been in nursing homes, either the death of a resident of nursing home or a worker. 112304 I want to start today with a question for Dr. Redfield. Doctor, when we consider this challenge in our long-term care facilities, when we look at the number of deaths in nursing homes, I think a lot of families want basic transparency, and that's one of the reasons why Senator Wyden and I sent you a letter dated April the 2nd that was directed to you, as well as the administrator of the centers on medicare/medicaid services, Seema Verma, 112341 and in that letter we asked for basic information about what the administration was doing to track the outbreaks in nursing homes, to provide information -- basic information to families and residents, the families of residents in nursing homes, certainly to the workers as well as to the community and public health professionals. Now, it took you about a month to respond to that, but in your response, you didn't give us any information about the timeline. 112415 These families need this information. Now we're told by the CMS administrator after pressing her, as senator wyden and I did, that this information may not be available until the end of may. I need to hear from you today. Why has there been a delay -- a three-month delay in basic information that families and people within a community need about the outbreaks in nursing homes, the number of cases, what is happening in nursing homes. Tell us when we're going to see that information. 112452 REDFIELD>> Well, thank you very much, senator, and you've highlighted one of the great tragedies that we have all experienced together. Clearly the long-term care facilities have been particularly hard hit by the pandemic. Several things, I know that the again the CMS who has oversight, several things have been done, and I can get back to you in terms of where they're at in terms of activation, but clearly all nursing homes now are required to report all cases in either individuals that are patients there or staff, to the CDC. 112535 Secondly -- [INAUD] had put a policy in place that all nursing homes are required to notify members of that nursing home of the existence of covid in that nursing home, include family members [INAUD] verify in terms of when thats -- if that's operational today or next week and I will get back to you with that . One of the most important things, we have decided, as we talked about [inaud] and reopening as Tony mentioned [inaud] symptomatic cases. 112619 We need to do contact tracing, but the other thing that we need to do is to do surveillance because this virus does appear to have a high propensity for asymptomatic infection, which means the traditional ways of identifying cases is gonna be blunted. So we developing a national surveillance system, and first and most importantly is to do comprehensive surveillance in all [inaud] united states. CDC will be doing that in partnership with the state and local territorial health departments. I think [inaud] is going to have the responsibility to do it within the inner city clinics that are collected and for the health service clinics. 112700 But this is critical we get in front of this and do comprehensive surveillance of everybody in the nursing homes. We have also done aggressive outreach in all of them enhancing infection control procedures, etc. CDC has been out to help these nursing homes with that and to the guidance along with the [inaud], but i'll get back to you in terms of the -- i'm pretty confident they're already [inaud] operational. But I need to double check to make sure because I know Seema has announced they're all reporting to CDD now any infection with workers or patients and that they are required now to notify other member in the nursing home as well as family members as well When COVID [inaud[ 112748 CASEY>> Mr. Chairman, I just have one question for Dr. Fauci. Doctor, I wanted to ask you, in your testimony earlier in response to a question by senator murray, you outlined a basic concern you have with regard to states reopening. Can you restate that for us? FAUCI>> Yes, thank you, senator casey. Yes, my concern is that states or cities or regions. Their attempt, understandable, to get back to some form of normality disregards a greater loss [inaud] the checkpoints we put in our guidelines about when it is safe to proceed on pulling back on mitigation. 112827 Because I feel if that occurs there is a real risk that you will trigger an outbreak you may not be able to control. Which in fact paradoxically will set you back, not only leading to some suffering and death that could be avoided but could even set you back on the road to trying to get economic recovery because you would almost turn the clock back rather than going forward. That is my major concern, Senator. CASEY>> Thank you, doctor. 112900 CHAIRMAN ALEXANDER>> Thank you senator Casey. Senator Paul. PAUL>>Dr Fauci, scientists have shown that rhesus monkeys that are infected with covid-19 cannot be reinfected. Several studies have also shown that plasma from recently infected coronavirus patients neutralizes the virus in lab experiments. In addition, infusion of convalescent plasma is based on the idea that recovering coronavirus patients are developing immunity, and that it can be beneficial as donated. 112930 Studies show that the recovering covid 19 patients, from the asymptomatic to the very sick are showing significant antibody response. Studies show that SARS and MERs, also coronaviruses, showed immunity for at least two to three years. And yet the media continues to report that we have no evidence that patients who survive coronavirus have immunity. 112952 I think actually the truth is the opposite. We have no evidence that survivors of the coronavirus don't have immunity and a great deal of evidence to suggest that they do. The question of immunity is linked to health policy and that workers who have gained immunity can be a strong part of our economic recovery. The silver lining to so many infections in the meat processing industry is that a large portion of these workers now have immunity. 113018 Those workers should be reassured that they likely won't get it again instead of being alarmed by media reports that there is no evidence of immunity. You've stated publicly that you'd bet it all that the survivors of coronavirus have some form of immunity. Can you help set the record straight, for the scientific record as this is being accumulated that this is supportive that the infection with coronavirus likely leads to some form of immunity, Dr Fauci? WASH 10 SENATE HELP COMMITTEE HEARING COVID 19 VIRTUAL WITNESS CAM POOL P2 113043 FAUCI>> Yup, thank you for the question, Senator Paul. Yes, you are correct that I have said, given what we know about the recovery from viruses such as coronaviruses in general or even any infectious disease with very few exceptions, that when you have antibodies present, it very likely indicates a degree of protection. 113102 I think it's in the semantics of how this is expressed, when you say has it been formally proven by long-term natural history studies which is the only way that you can prove: one, is it protective, which I said and would repeat is likely that it is, and also what is the degree or titer of antibody that gives you that critical level of protection, and what is the durability. 113129 As I've often said, you know, I again repeat, you could make a reasonable assumption that it would be protective. But national history studies over a period of months to years would then tell you definitively if that's the case. PAUL>> And I think that's important because in all likelihood, is a good way of putting it, the vast majority of these people will have immunity instead of saying, there is no evidence. You know, the WHO kind of fed into this by saying no evidence of immunity. And in reality, there is every evidence stacking up -- in fact a lot of the different studies have shown that it's very unlikely that you get it again in the short term. 113205 With regard to going back to school, one thing that was left out of the discussion is mortality. I mena, shouldn't we at least be discussing what the mortality of children is? This is for Dr Fauci, as well. You know, the mortality between zero and 18 in New York data approaches 0. It's not going to be absolutely 0, but it almost approaches 0. Between 18 and 45, the mortality in New York was 10 out of 100000. 113232 So really we do need to be thinking about that. We need to observe with an open mind what went on in Sweden, when the kids kept going to school. The mortality per capita in Sweden is actually less than France, less than Italy, less than Spain, less than Belgium, less than the Netherlands, about the same as Switzerland. But basically, I don't think there's anybody arguing that what happened in Sweden is an unacceptable result. 113254 I think people are intrigued by it. And we should be. I don't think any of us are certain when we do all these modelings. There've been more people wrong with modeling than right. We're opening a lot of economies around, around the US and I hope that people who are predicting doom and gloom and saying "Oh, we can't do this, there's going to be a surge" will admit that they were wrong if there isn't a surge. Because I think that that's what's going to happen. And in rural states, we never really reached any sort of pandemic levels in Kentucky and other states. We have less deaths in Kentucky than we have in an average flu season. 113326 Not to say this isn't deadly, but really outside of New England we have had a relatively benign course for this virus nationwide. I think the one-size-fits-all, that we're gonna have a national strategy and nobody is going to go to school is kind of ridiculous. We really ought to be doing it school district by school district and the power needs to be dispersed because people make wrong predictions and really the history of this when we look back will be of wrong prediction after wrong prediction after wrong prediction starting with Ferguson in England. So I think we ought to have a little bit of humility in our belief that we know what's best for the economy and as much as I respect you, Dr. Fauci, I don't think you are the end-all. 113406 I don't think you're the one person who gets to make a decision. We can listen to your advice, but there are people on the other side saying there's not going to be a surge and we can safely open the economy and the facts will bear this out. But if we keep kids out of school for another year, what's gonna happen is the poor and underprivileged kids who don't have a parent that's able to teach that at home are not gonna learn for a full year. And I think we ought to look at the Swedish model and we ought to look at letting kids back to school. I think it's a huge mistake if we don't open the schools in the fall. Thank you. 113434 FAUCI>> Mr. Chairman, Can I respond to that even though there are only 32 seconds left? CHAIRMAN>> Yes. And you might make it clear whether or not you suggest that we shouldn't go back to school in the fall. FAUCI>> First of all Senator Paul, thank you for your comments. I've never made myself out to be the end all and the only voice on this. I'm a scientist, a physician and a public health official. I give advice according to the best scientific evidence. 113501 There are a number of other people who come into that and give advice that are more related to the things that you spoke about, about the need to get the country back open again and economically. I don't give advice about economic things. I don't give advice about anything other than public health so I want to respond to that. The second thing is that you used the word we should be humble about what we don't know and I think that falls under the fact that we don't know everything about this virus and we really better be very careful particularly when it comes to children. 113533 Because the more and more we learn we're seeing things about what this virus can do that we didn't see from the studies in China or in Europe. For example, right now children presenting with covid-19 who actually have a very strange inflammatory syndrome , very similar to Kawasaki syndrome, I think we better be careful if we are not cavalier in thinking that children are completely immune to the deleterious effects. 113601 So again, you're right. In the numbers, that children in general do much, much better than adults and the elderly, and particularly those with underlying conditions. But I'm very careful and hopefully humble in knowing that I don't know everything about this disease, and that's why I'm very reserved in making broad predictions. Thank you. 113623 CHAIRMAN>> Thank you, Senator Paul, and Senator Bladwin. BALDWIN>>Thank you Mr. Chairman and ranking number Murray and our witnesses.I want to try and cover a lot of territory in my five minutes, so I would certainly be appreciative of concise answers. But I want to start with Dr. Redfield. Dr Redfield, do you think that the current testing protocols at the white house present some models for other essential workplaces? 113653 REDFIELD>> I'm sorry Senator, you broke up at the beginning of your question. If you could just say it again, I'm sorry. BALDWIN>> Yes. Dr. Redfield, do you think that the testing protocols currently in place in the white house present a model for other essential workplaces? REDFIELD>> Well, I think -- Thank you for the question. I think one of the important things that you bring up is the essential worker guidance that CDC put out. And I think it was originally modeled obviously on health care workers where there was significant health care shortages and individuals that were -- 113733 BALDWIN>> Are there any workplaces -- I'm asking you if you think the white house protocol testings are a model for other essential workplaces? REDFIELD>> I would just say that I think each workplace has to define their own approach as how to operationalize our -- BALDWIN>> (inaud.) --- there some considerable comments on the fact that osha has not stood up an enforceable mandatory emergency temporary standard for workers in all sorts of work settings, but that aside, would you say that the ppe rules and protocols in effect right now in the White House are a model for other essential workplaces? 113813 REDFIELD>> We would -- my own view, we would go back to the guidelines that CDC has put out about essential workplaces for people, if they are an essential workforce, if they go in public, they maintain 6 feet distancing and they wear face coverings. 113830 BALDWIN>> Okay. Admiral Giroir, you have testified about how far you have come with regard to testing assessment. I want to ask you if you believe that we already have a national testing strategy today that spans from the nationwide testing needs assessment to the nationwide testing supply assessment and a strategy to fill that gap to procure domestically what we need in terms of bridging that gap with testing platforms, swabs, specimen collection media, and reagents, and the PPE needed to conduct those tests. 113920 GIROIR>> Thank you for that. We do have a strategy that spans us at least to the fall and beyond. As I mentioned we're working individually with every state, and I think senator Paul is correct that Kentucky, Wyoming, New Jersey, Rhode Island are different, and there are vastly different testing needs. The East Coat will have multiples of testing versus other states and we're working those individually. BALDWIN>> So -- GIROIR>> Yes? 113953 BALDWIN>> So, I know you testified earlier that not only are you working with the states, but you're working with every lab in every state, and -- GIROIR>> Correct. BALDWIN>> -- increase capacity. What about working with those who would be -- those who would need testing to sya, reopen their school, their university,their business? Each of them have identified what they think are their testing needs based on you know, guidance and not mandatory enforceable rules. 114028 But, are you in contact at that level? Does your dashboard have visibility at that lowest level, or are you in contact with the states and the labs? GIROIR>> So, over the last few months, we've done a lot of the individual work at nursing homes, at meat packing plants, at other, I mean, really down to the dirt granular level. BALDWIN>> Okay. GIROIR>> Where we are right now, however, is we are really working with the state leadership, with the public health lab, the state epidemiologists, the (?), the state health officials, because they really need to understand what their sum is going to be in their state -- BALDWIN>> Okay. 114106 GIROIR>> And then in the funding, we are asking very specifically in the CDC funding for specific plans for schools, nursing homes, underserved et cetera. BALDWIN>> Thank you. So, I have 2 more points that I'm going to make. I don't have time for questions. One is about the transparency of that needs assessment. Can the public see it? Can the state see it? Can the HUP(?) committee members see it? Is it publically available? 114134 And, secondly, the delivery of this supply is a critical issue. And it seems to me that the logistics of getting this out whether it's ppe, testing or medical equipment is still extremely fragmented leading to price gouging and many other inefficiencies. We need to stand up the full power of the defense production act. GIROIR>> Would you like me to comment on that, ma'am? I'm sorry. 114205 BALDWIN>> I'm happy to have you comment with the indulgence of the chairman, we have gone over time. And why don't you get back to -- CHAIRMAN ALEXANDER>> Why don't we try to get a succinct answer for the senator, please, Admiral Giroir. 114218 GIROIR>> Yes, ma'am, and yes, sir. Particularly for things like swabs and media, there is still a very, I would say, non mature industry within the country. And that's why we've made the decision to procure that all centrally through December and then distribute that to the state. Because there are just too many small companies, too many variables to control without a really heavy federal hand. That;s just an example of where we really moved into that and used the DPA for swabs to help support American industry. In more mature aspects of the industry, like some of the large test producers, we feel by helping direct them to help the states get what they need and the right distribution, that we're not procuring them directly, by us. 114308 But again, we're going to be very evidence and data driven as we move on. Thank you, sir. CHAIRMAN ALEXANDER>> Thank you very much, Senator Baldwin. Senator Collins. COLLINS>> Thank you, Mr Chairman. Let me begin by first by thanking each of our witnesses today for their expertise, their dedication and their hard work. Dr. Redfield, I want to start with you. I am hearing from dentists all over the state of Maine the fact that they cannot practice in our state, despite following very strict infection control protocol, is causing growing health problems. 114354 Dentists tell me that teeth with cavities that could have been filled are now going to need root canals. Teeth that could have been treated with root canals are now going to require extraction. People with oral cancers cannot get the treatment, the cleanings that they need before beginning their treatment. Dental health is clearly so important. And Maine state officials as well as our dentists are seeking assistance in reaching the right decisions. 114433 47 other states either have reopened dental practices or have a day set to reopen. So my question to you is this. If dentists are following the American dental association guidelines, if they they are instituting strict protective measures for their patients, their staff, their hygienists, themselves, and if they are closely examining and seeing a decline in the number of covid-19 infections in their county,are these reasonable actors for states to consider in the reopening the practice of dentistry. 114524 REDFIELD>> Yes, Senator, thank you with the question. You know, we have been interacting and talking with dentists. We are working with the state and local public health officials to update our guidelines on reopening a variety of medical services as you know. And I think you raise a very important point and I would not disagree with what you said about looking at the American dental association's as well as the reality of the outbreak in the area. 114600 But we are in the process of updating those guidelines and they will include direct guidelines for dental practices. COLLINS>> Thank you very much Doctor. Dr. Giroir and Dr Hahn, recently there has been a significant demand for remdesivir, I may be mispronouncing that, which transitions to receiving an emergency use authorization. 114630 Last week, Maine's two largest hospital systems contacted me with questions about how this therapeutic will be allocated going forward. HHS finally released a statement on Saturday about allocations going to states, interestingly, not directly to hospitals, but once again the decision-making behind these allocations is very unclear. 114702 HHS and the assistant secretary for preparedness and response say that each state is expected to receive an allocation but no timetable has been provided. Beyond those who are being treated with this drug at Maine medical center through a clinical trial, I'm concerned that hospitalized patients in Maine will have little or no ability to be treated with this promising therapeutic for the foreseeable future. 114736 As this and more therapeutics and ultimately a vaccine come on to the marketplace, how can these allocation and distribution issues be resolved so that patient care is not delayed and so that it doesn't depend on which state you live in, whether or not you are going to get access to these treatments and ultimately a vaccine. 114809 HAHN>> Senator Collins, this -- oh, go ahead, Admiral Giroir. GIROIR>>Go ahead. Go ahead, commissioner. HAHN>> Senator Collins, I think we completely agree with you that this has to be an evidence-based approach getting the medical therapeutics, vaccines, remdesivir or whichever it happens to be to the people in need. 114834 I think we can all agree upon the fact that we've learned a lot of lessons from the remdesivir situation and, first, as you mentioned, that's being led by HHS and Anasper. What you see in the most recent announcement is, that what the task force did was provide guidance to HHS regarding where the most significant outbreak of hospitalization -- outbreak occurred and where the hospitalizations -- hospitalized patients were. 114903 This represented about a quarter of the supply of drugs that we had and more will be allocated according to methodology that gets drugs where those hospitalized patients are. Other therapies and to vaccines in particular and we must incorporate those into our operational plans moving forward. COLLINS>> Thank you, Doctor. Admiral, do you have anything to add -- I'm over time, sorry. Thank you.If you have anything to add, do so for the record. 114939 GIROIR>> No, Ma'am. I agree with commissioner. It's absolutely critical that it's evidence based, based on the people who could benefit from it, and also fair and just throughout our country. COLLINS>> Thank you. CHAIRMAN ALEXANDER>> Thank you senator Collins. Senator Murphy? MURPHY>> Thank you very much, Chairman. Thank you and Senator Murphy for convening this. Thank you to all of our witnesses for your service.

0940 SPEV SWITCHED FEED FS5 82 SWITCHED FEED PROVIDED BY THE SENATE TV GALLERY Senate HELP Committee Hearing on Covid-19 testimony from NIH and Anthony Fauci COVID-19: Safely Getting Back to Work and Back to School Full Committee Hearing Anthony Fauci, MD Director National Institute of Allergy and Infectious Diseases, National Institutes of Health Bethesda, MD Robert Redfield, MD Director United States Centers for Disease Control and Prevention Atlanta, GA ADM Brett Giroir, MD Assistant Secretary For Health United States Department of Health and Human Services Washington, DC Stephen Hahn, MD Commissioner Of Food And Drugs United States Food and Drug Administration Silver Spring, MD WASH 10 SENATE HELP COMMITTEE HEARING COVID 19 VIRTUAL WITNESS CAM POOL 100333 ALEXANDER/CHAIRMAN>>> Well, good morning. The committee on Health, Education, Labor and Pensions will please come to order. First of administrative matters, based on the advice of the attending physician and the Sergeant of Arms, after we consulted the Department of Health and Human Services and the Centers for Disease Control and Prevention, individuals in the hearing room are six feet apart. As a result, there's no room for the public to attend in person. Representatives of the Press are working as a pool to relay their observations to colleagues. 100403 The hearing may be watched online. An unedited recording will be available on the committee's website at www.senate.gov. Witnesses are participating via video conference in a one-time exception. Some senators, including the Chairman, are participating by video conference. Senators, we've been advised, may remove their masks, and talk into the microphone when they're in the hearing room, as they are six feet apart. I'm grateful to the rules committee, sergeant at arms, the press gallery, the architect at the Capitol, the Capitol police, the committee staff, [inaud] and Evan Griffith all for their hard work to keep us safe. 100441 At our hearing last Thursday, I said that "all roads back to work about back to school run through testing," and what our country has done so far on testing is impressive, but not nearly enough. Over the weekend, Senator Schumer, the democratic leader, was nice enough to put out a tweet, quoting half of what I said. He left out the other half, the "impressive" part. So let me say again what I meant by that. When I said "impassive," I meant that according to Johns Hopkins university study, the United States has tested over 9 million Americans for covid-19. 100518 That's twice as many as any other country. We don't know what China has done. And it's more per capita than most countries, including South Korea, which many members of our committee had cited as an example of a country that had tested well. According to Dr. Deborah Birx, the United States will double testing in the month of May -- month of May which should get us up to about 10 million tests conducted. Now, here is what I mean by "impressive": here in Tennessee, where I am today, first, anyone who is sick, a first responder or health care worker, can get tested. 100552 Our governor, Bill Lee, is also testing every prisoner, every resident staff and member in a nursing home, he's offered weekend drive-through testing, he's done specific outreach for testing to low-income communities -- any tennessean can get a free test at the local public health department. The governor's slogan is "if in doubt, get a test." Governor Lee sent his testing goals, in May, to the Federal government, as every state has done. 100622 The federal government is helping him ensure that he has enough supplies, in case he has trouble getting them through the labs and the other commercial sources. As a result, our state has tested about 4% the population. The governor hopes to increase that by 7% by May. That's one of the best in the country. This impressive level of testing is sufficient, we believe, to begin phase one of going back to work, which as I said last week is not nearly enough to provide confidence to 31,000 students and faculty members that we hope will show up at the university of Tennessee campus in August when school starts. 100702 Last week, I talked with UT Knoxville Chancellor Donde Plowman about that. We said, "What would persuade those 3100 students as well as the 50 million K through 12 students in the country and the other 5,000 university students, what will persuade them to go back to campus in August?" That's where the new shark tank comes in. Dr. Collins, at the National Institute of Health" calls it "red X." We had our hearing about that on Thursday. It's a really remarkable scientific exercise. 100734 Take a few early stage concepts that are swimming around what we call that competitive shark tank, and see if Dr. Collins and his associates can find a few new technologies to create millions of new tests that will scale up rapidly and make it more likely that students will go back to school in August. For example, the FDA authorized last week its first diagnostic test using saliva that a person provides at home, instead of a nose swab or blood. 100807 It authorized its first antigen test. We're hearing a lot about those, like the ones used for flu or strep throat, which involves the swabbing of a nose, and you can get the result in just a few minutes. Another proposal, not yet approved, is to put in your mouth a sort of lollipop sponge, take a photo of that with your cell phone and send that to your doctor. If it lights up, you're positive. Or the university might send that saliva lollipop to a nearby laboratory, which could be a gene sequencing laboratory, which can deal with thousands of those samples overnight. 100845 That same process could occur at a middle school. It could occur at a factory. Of course, anyone testing negative one day can test positive the next, but such widespread screening of entire campuses, schools, or places of work will help identify those who are sick, trace down those who were exposed. That, in turn, should help persuade the rest of us to go back to school and back to work. In addition to more testing, I expect Dr. Fauci will talk to us about additional treatments that will be available to reduce the risk of death and the administration's plan to do something that our country's never done before, 100924 which is to start manufacturing a vaccine before it actually has been proven to work, in order to speed up the result, in case it does work. Those vaccines, those treatments are the ultimate solution. But until we have them, all roads back to work and school go through testing. The more tests we conduct, the better we can identify those who are sick and exposed, and we can quarantine the sick and exposed, instead of trying to quarantine the whole country. 100954 Now, in my opinion, this will require millions of new tests, many from new technologies. Some of these will fail, but we only need a few successes to get where we want to go. That's why I said on Thursday, what our country has done so far in testing is impressive, but not nearly enough. First, squeeze all the tests we can out of current technologies. Next, try to find new technologies to help us contain the disease and persuade us to go back to work. 101026 Now, one other thing. This is a bipartisan hearing to examine how well we're preparing to go safely back to work and to school, and to determine what else we need to do in the united States Senate. Such an exercise sometimes encourages finger-pointing. Before we spend too much time finger-pointing, I'd like to suggest that almost all of us, the United States and almost every country so far as I can tell, underestimated this virus, underestimated how contagious it would be, underestimated how it can travel silently in people without symptoms to infect other people, how it can be especially deadly for certain segments of our population -- the elderly, those with pre-existing conditions, minority population. 101116 Let me go back to the March 3rd hearing that we had in our committee on coronavirus, six weeks after the first case was discovered in the United States, a day when only two deaths were recorded in this country. I read, at that hearing, this paragraph from "The New York Times" two days earlier on March the 1st. They reported this -- "Much about the coronavirus remains unclear, the Times reported, and it's far from certain" -- this is March 3rd that -- March 1 -- "That the outbreak will reach severe proportions in the United States or affect many regions at once. 101153 With its top-notch scientists, modern hospitals, and sprawling public health infrastructure, most experts agree, the United States is among the countries best prepared to prevent or manage such an epidemic." That was "The New York Times" on March 1. A lot of effort has gone into trying to make our country well prepared. Over the last 20 years, four presidents, several congresses, in response to 9/11, Bird Flu, Katrina, Ebola, H1N1, MERS, passed nine major laws to try to help get this country ready for what we're going through today. 101234 These laws stood (?) up the strategic national stockpile, created an assistant Secretary for Preparedness, it -- it created incentives for the developments of vaccines and medicines that we're using today, strengthened the Centers for Disease Control, and created Barda. Thanks to the leadership of Senator Blunt and senator Murray, for five straight years, we've significantly increased funding for the national institutes of health. 101304 All this was part of a shared goal -- Democrats, Republicans, four presidents, several congresses -- to try to get ready for what we're going through today, whether it was known, like anthrax, or unknown like Bovid-19. But despite all that effort, even the experts underestimated Covid-19. This hearing is about how we improve our response to this virus, as well as the next one. During the oversight hearing, I also intend to focus on, as I just said, the next pandemic, which we know is coming. 101341 What can we learn from this one to be ready for the next one? Can we -- what can we learn from the fast-tracking of vaccines and treatments that we're about to hear about that will make it even faster the next time? How can we keep hospitals and states from selling off protective equipment when their budget gets tight? How can we make sure Congress does our share of the funding responsibility? How do we provide enough extra hospital beds without -- without canceling elective surgery hurting other patients and bankrupting hospitals? 101415 Whose job should it be to coordinate supply lines so that protective equipment and supplies get where they're supposed to go, when they're supposed to go? What's the best way to manage the stockpile? My preacher once said, "I'm not worried about what you do on Sunday. It's the rest of the week that concerns me." I'm afraid that during the rest of the week, between pandemics, we relax our focus on preparedness, we become preoccupied with other important things. 101444 Our collective memory is short. Just three months ago, this country was preoccupied with impeaching a president. Now that seems like ancient Roman history. Now, while this crisis has our full attention, I believe we should put into law this year whatever improvements need to be made to be well prepared for the next pandemic. If there is to be finger-pointing, I hope they're pointed in that direction. We're fortunate today to have four distinguished witnesses who are at the heart of the response of the coronavirus. 101519 We're grateful for their service to our country. I've asked them each to summarize their remarks in five minutes. Then we'll have a five-minute round of questions from each Senator. I've agreed, we'll end our hearing about 12:30, after we have a full round of questions. Every senator will have a chance to have his or her five minutes. Senator Murray will then have an opportunity to ask the last question or close the hearing, and I will then close the hearing. There will be other hearings to follow this hearing, like last Thursday's hearing, and senators may submit their questions in writing within the next ten days. 101557 Staying at home indefinitely is not the solution to this pandemic. There is not enough money available to help all those hurt by a closed economy. All roads back to work, back to school, lead through testing, tracking, isolation, treatment, and vaccines. This requires widespread testing, millions more tests, created mostly by new technologies, to identify those who are sick and who have been exposed so they can be quarantined, and by containing the disease in this way, give the rest of America enough confidence to go back to work and school. 101636 For the near term, to help make sure those 31,000 UT students and faculty members show up in August, we need widespread testing, millions more tests, created mostly by new technologies to identify those who are sick and who have been exposed so they can be quarantined. And by containing the disease in this way, give the rest of America enough confidence to go back to work and back to school. Senator Murray. 101704 MURRAY>> Well, thank you very much, Mr. Chairman. My thoughts are with you and your team right now as you try to navigate the same challenge so many in our country are worried about. We all wish your staff member a speedy recovery. And as everyone works to take appropriate safety precautions today, I'd like to thank not only our witnesses for joining us today, but also our committee staff for working to set up a safe format for members and witnesses and the public to participate in this hearing remotely. 101740 Families across the country are counting on us for the truth about the Covid-19 pandemic, especially since it is clear they will not get it from President Trump. Truth is essential, so people have the facts, so they can make decisions for themselves and their families and their community. Lives are at stake. If the president isn't telling the truth, we must, and our witnesses must, and we're counting on you today. 101811 And families need us to take this opportunity to dig into the facts about where things did go wrong so we can finally get them on track. Because the Trump administration's response to this public health emergency so far has been a disaster on its own. Delays, missteps have put us way behind where we need to be on diagnostic tests and allowed inaccurate antibody tests to flood the market. Corruption and political interference have impeded efforts to secure desperately needed personal protective equipment and promoted dangerous, unproven treatments. 101850 And we recently learned that after experts at the Centers for Disease Control and Prevention spent weeks developing a detailed guide to help our community understand how to safely reopen, when the time comes, the Trump administration tossed it in the trash bin for being too prescriptive. But this is far from the first time this administration has silenced experts who were doing their job and putting public health first. The fact of the matter is, president trump has been more focused on fighting against the truth than fighting this virus. 101926 And Americans have, sadly, paid the price. Since this committee last heard from these witnesses on March 3rd, we have seen over 900 deaths in my home state of Washington, over 80,000 deaths nationally, and the numbers continue to climb. Still, President Trump is trying to ignore the facts and ignore the experts who have been very clear, we are nowhere close to where we need to be to reopen safely. 101956 My hope today is that we can cut through this, and have a serious discussion about what is needed to safely open, how close we are as a country to meeting those needs, and how we actually get there. One thing that's abundantly clear, we need dramatically more testing. It is unacceptable we still don't have a national strategic plan to make sure testing is free, fast, and everywhere. 102026 That is why I fought to make sure our last Covid-19 package included an initial $25 billion testing fund and a requirement that the administration submit a plan by May 24th. And when I say a "plan," I don't mean a PR plan. I mean a plan with specific time lines and numeric goals for supply and funding needs, one that actually addresses the issues we're seeing on testing capacity and distribution and disparity and building out our public health system. 102059 And makes clear to states and tribes and employers and the American people what they can expect and what the administration will do to keep Americans safe. But testing alone won't be enough to reopen our country. We still need far more personal protective equipment than has been available for our health care workers on the front lines, and we will need far more for other workers after we reopen. So we desperately need this administration to step up and get that equipment to states who are doing everything in their powers to purchase supplies but simply cannot get nearly enough. 102135 Because the reality is, unlike states, the federal government has the tools to actually fix the problem, if only the administration would use them. And we also need that equipment to actually work and for the FDA to act promptly if it does not, not weeks later when people may have already been exposed. And just as importantly, we can't expect people to go back to work or to restaurants or to confidently send their kids to school if there isn't clear, detailed guidance about how to do that safely. 102209 Schools, from early childhood through college, need to know how to keep their students, their staff, and their educators safe. When should they wear masks? How do you run a school cafeteria or a school bus? And if they can't reopen classrooms, schools and families need to know we are working to ensure every student gets an education. Tools like online learning can only get us so far if we don't address the digital divide that -- so that every student can access them. And even then, there will be learning loss that could deepen existing educational disparities among low-income students, students with disabilities, English language learners and other vulnerable populations, if we don't make sure they get equal access to resources and support. 102256 And of course, schools aren't the only workplaces we've got to be thinking about. We need to make sure that industries across the country know how to safely reopen and that people know their workplace is safe. Secretary Scalia needs to stop dragging his feet and do his job and have the department of labor set forward a rule that makes it clear, worker safety is not optional. Mr. Chairman, I hope this committee can hear about those critical issues from Secretary Scalia and Secretary DeVos as well as other experts in the space in the days ahead. 102330 And this is especially important to protect workers and residents at our nursing homes and other congregate care facilities, where we've seen some of the most deadly outbreaks. And as the rash of outbreaks at meatpacking plants shows, this isn't just an issue for the healthcare industry, it is an issue for everyone. And just as we need a plan before we can start to reopen, we also need a plan well before we have a safe and effective vaccine to guarantee that we can quickly produce and distribute it on a global scale and make it free and available for everyone. 102407 So, I'll be asking about our progress on those issues today. Today, safely reopening our country may be a ways off, and the administration's planning may be way behind, but there's still a lot that Congress needs to do. There isn't time to spare. Some, including the White House, say they've already provided enough economic relief. Well, my question to them is, what good is a bridge that only gets you to the middle of the river? We don't need to wait around to see if people need more help. We know they do. 102438 We need to work quickly on another aggressive relief package, and we need to make sure our priorities in that bill are protecting our workers, our students, and our families, and addressing this public health crisis, not bailing out corporations and protecting big business from accountability. People across the country are doing their part. They are washing their hands and wearing masks and social distancing and staying home. They need their government to do its part, too. They need leadership. They need a plan. 102510 They need honesty and they need it now, before we reopen, so they can rest assured that we are doing things safely and competently with their health and well-being as a top priority. Thank you, Mr. Chairman. 102529 ALEXANDER>> -- it's an important hearing, and I know lots of people may be watching it for the first time. If they are, I hope they notice that we have 23 members of this committee, I believe, one more Republican than Democrat. We have some very strong views, but we're able to work together and to express those views and respect each other and our witnesses. And I -- and a big part of that goes to Senator Murray and her staff. So, thank you for that. Each witness will have up to five minutes to give his testimony. Thank you for making an exception and agreeing to testify by video because of these unusual circumstances. 102605 And thank you for what you're doing for our country. Our first witness is Dr. Anthony Fauci. He's Director of the National Institutes of Allergy and Infectious Diseases at the National Institutes of Health. He's held that position since 1984, which meant he's advised six presidents and worked on HIV-AIDs, influenza, malaria, ebola, and other infectious diseases. He was involved in treating Ebola patients at NIH and also worked on vaccine trials for ebola. Next we'll hear from Dr. Robert Redfield. He's director of the U.S. Centers for Disease Control and Prevention, which has its headquarters in Atlanta. 102647 For more than 30 years, he's been involved with clinical research related to chronic human viral infections, infectious diseases, especially HIV. He was the founding director of the Department of retroviral research within the U.S. Military's HIV research program. He spent 20 years with the U.S. Army Medical Corps. Third, Admiral Brett Giroir -- Giroir. Admiral Giroir is Assistant secretary for Health at the U.S. Department of Health and Human services. 102720 That puts him in charge of development of public health policy recommendations. He's taken on the responsibility for coordinating testing and focused on the increasing number of tests that we can do with existing technology. His federal service includes a variety of activities with our defense department in advanced research, threat reduction. He was part of the blue ribbon panel to reform the U.S. Veterans health system. 102749 And, finally, we'll hear from Dr. Stephen Hahn. He is commissioner of the Food and Drug administration. Before joining FDA, he was the chief medical executive at the University of Texas MD Anderson Cancer center, and he was chair of the department of radiation oncology at the university of Pennsylvania. He was a senior investigator at the national institutes of health. He was commander of U.S. Public health service commission corps in 2025 (?). 102721 Now we'll ask each witness to summarize their remarks in five minutes. Following that, each senator will have five minutes for question and answers in order of seniority. Dr. Fauci, let's begin with you. Welcome. FAUCI 102836 FAUCI>> Thank you very much, Mr. Chairman, ranking member Murray, and members of the committee. Thank you for giving me the opportunity to discuss with you, today, the role the National Institutes of Health in research addressing covid-19. The strategic plan that we have is four-fold. One, to improve our fundamental knowledge of the virus and the disease it causes. Next, to develop new point-of-care diagnostics. Next, to characterize and test therapeutics. And finally, to develop safe and effective vaccines. 102910 First, with regard to diagnostics. As you probably heard from Dr. Francis Collins last Thursday, the NIH has developed a rapid acceleration of diagnostics program called RadX. With an award to that specific program up to half a billion dollars to support the development of covid-19 diagnostics. It is a national call for innovative technologies that would be evaluated in the shark tank-like selection process to get to either success or failure rapidly. 102944 Moving on to therapeutics, I'll talk a bit about the Remdesivir success antiviral in a moment, but let me emphasize that there are a number of broad-spectrum antivirals that are in various stages of testing. In addition, we will be looking at convalescent plasma, which is plasma from individuals who have recovered from covid-19 to be used in passive transfer, either in prevention or treatment. In addition, high-premium globulin which can be used as a gamma globulin shot. 103018 We'll be looking at repurposed drugs, as well as immune-based therapies and host modifiers. And finally, monoclonal antibodies. Let me take a moment to describe the remdesivir placebo-controlled randomized trial, which was done internationally through the power of more than 1,000 individuals, in sites throughout the world. It was in hospitalized patients with lung disease. The end point was primarily time to recover it. The result was statistically significant but really modest, and we must remember, it was only a modest result, showing that the drug made a 31% faster time to recovery. 103100 We hope to build on this modest success with combinations of drugs and better drugs. Moving on to vaccines, there are at least eight candidate covid-19 vaccines in clinical development. The NIH has been collaborating with a number of pharmaceutical companies at various stages of development. I will describe one very briefly, which is not the only one, but one that we have been involved in heavily developing with Moderna, it's a messenger RNA platform. 103131 You might recall in this committee that, in January of this year, I said it would take about one year to 18 months, if we were successful, in developing a vaccine. The NIH trial moved very quickly. On January 10th, the sequence was known. On January 11th, the vaccine research center met to develop a plan. And on the 14th of January, we officially started the vaccine development. 62 days later, we are now in phase one clinical trial with the two doses already fully enrolled. 103204 There will be animal safety. The phase one will directly go into phase two-three in late spring and early summer. And if we are successful, we hope to know that in the late fall and early winter. There are some important issues, however, in covid-19 vaccine development. We have many candidates and hope to have multiple winners. In other words, it's multiple shots on goal. This will be important because this will be good for global availability if we have more than one successful candidate. 103235 We also, as the chairman mentioned, will be producing vaccines at risk, which means we'll be investing considerable resources in developing doses even before we know any given candidate or candidates work. I must warn that there's also the possibility of negative consequences, where certain vaccines can actually enhance the negative effect of the infection. The big unknown is efficacy. 103303 Will it be present or absent, and how durable will it be? And finally, I want to mention, the NIH has launched a public-private partnership called Accelerating Covid-19 Therapeutic Interventions and Vaccines. The purpose of that is to prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential. Hopefully, our research efforts, together with the other public health efforts, will get us quickly to the end of this terrible ordeal that we are all going through. 103336 Thank you very much. Happy to answer questions later. ALEXANDER>> Thank you, Dr. Fauci. Dr. Redfield, welcome. REDFIELD 103344 REDFIELD>> Good morning, Chairman Alexander and ranking member Murray and members of the committee. Our nation is confronting the most serious public health crisis in more than a century. Yet, we're not defenseless. We have powerful tools to fight this enemy. We have tried and true effective public health interventions, such as early ace (?) identification, isolation and contact tracing, combined with an important mitigation strategy, which includes social distancing, frequent hand washing, face covering. 103413 These public health tools have and will continue to slow the spread of covid-19. I appreciate the opportunity this morning to provide a brief overview of some of CDC's ongoing work in response to covid-19. CDC's been working 24/7 to combat this pandemic. CDC's emergency operations center is supporting state, tribal, local and territorial public health partners in building core capabilities, particularly workforce, laboratory, and data and predictive analytics. 103443 Epidemiologists are conducting surveillance for Covid-19, as well as conducting health systems surveillance. Community mitigation teams are providing guidance on infection control and contact tracing, and our laboratory experts are performing serological testing to better define the extent of the asymptomatic populations. As local leadership makes decisions to reopen, they'll require varying degrees of federal support. Each location will be different and will face unique circumstances. CDC has conducted a state-by-state assessment of public health testing capacity and contact tracing capacity, as well as surge plans. 103523 CDC is providing technical assistance and funding to the states, provided through the supplemental CARES act and the Paycheck Protection Program and Health Care Enhancement Act. We're working directly with state public health leaders to define their needs for testing and testing devices, supplies, and manpower, surveillance, data collection and reporting, contact tracing, infection control, and outbreak investigation. I want to spend a moment to focus on several key elements. 103551 First, testing. Rapid, extensive, and widely available, timely testing is essential for reopening America. CDC's role in testing continues to support diagnosis and contact tracing, surveillance, and outbreak. When we work with the public health partners to define their particular testing strategy, their jurisdiction, Admiral Giroir will address the testing components of the response in greater detail. Contact tracing: Increasing state, tribal, local and territorial contact tracing capacity is critical. 103628 It's a critical part to stop the chains of transmission and prevent the occurrence of sustained community transmission. CDC's role is to provide technical training, assistance, and support to the states as they hire and build a workforce necessary to be fully prepared to effectively respond to the public health challenges posed by the ongoing Covid pandemic. This will be an expansive effort. Surveillance: Our nation's surveillance program is built on a combination of systems, including existing -- existing syndromic and respiratory viral disease surveillance systems, that have been combined with commercial and research lab platforms in our case reporting form system. 103711 CDC's adapting these and optimizing it to have a surveillance system in response to covid-19. Importantly, in light of the significant occurrence of asymptomatic infection, the surveillance for asymptomatic infection becomes an important public health tool for early case identification. CDC's working with each public health jurisdiction to develop a prospective surveillance program to include active surveillance among those that are most vulnerable, such as individuals in long-term care facilities, inner city clinics and homeless shelters. 103745 We need to rebuild our nation's public health infrastructure. Data and data analytics, public health laboratory resilience, and our nation's public health workforce. Now's the time to put it in place for the generations to come, not only for the public health system that our nation needs but for the public health system our nation deserves. Before I close, I want to recognize the tireless commitment of the dedicated CDC staff who have deployed to every corner of this nation to fight covid-19. 102815 More than 4,000 employees have deployed here, and globally. Science and data continue, with technical expertise and public service, to be the backbone of CDC's contributions to the U.S. Response. I extend my serious gratitude to the health care workers on the front lines as well as their family, and the essential emergency personnel as well as the American people, to say thank you for adhering to the stay-at-home guidelines and protecting the most vulnerable. 103842 It's important to emphasize that we're not out of the woods yet. The battle contends [inaud] months but we are more prepared. We need to stay vigilant with social distancing. It remains an imperative. We are a resilient nation, and I am confident that we will emerge from this pandemic stronger together. Thank you. ALEXANDER>> Thank you, Dr. Redfield. Admiral Giroir, welcome. GIROIR 103910 GIROIR>> -- Here to provide you with an update on the nation's progress in testing for Covid-19. On March 12th, Secretary Azar requested that I lead the Covid-19 testing effort within HHS, including oversight and coordination of the FDA and CDC with regard to testing. Since then, the nation has performed more than 9 million covid-19 tests, a number far greater than any other country and double the per capita tests performed to date in South Korea. 103940 To reach this point, we implemented a phased approach to meet testing needs during mitigation. And now, during phase one reopening of America. Beginning March 20th, we pioneered 41 community-based drive-through testing sites in locations prioritized by the CDC. These sites have been a profound success, testing over 167,000 high-risk individuals and demonstrating a prototype that is being duplicated multifold in nearly every state. 104010 Next, the administration leveraged trusted retailers, including CVS, Rite Aid, Walgreens, Walmart, Kroger and Healthmart, who are now providing testing at 240 locations in 33 states, 69% of which are in communities with moderate to high social vulnerability. To meet the need for collection supplies like swabs and media tubes, we first secured the global supply chain through a military air bridge. We worked directly with manufacturers to increase domestic production. 104041 We collaborated with the private sector and the FDA to validate multiple swab and media types. That vastly expanded supplies while minimizing the need for PPE. Finally, we used title three of the defense production act to further invest in domestic manufacturing to prepare us for reopening. To support the need for surveillance testing during reopening, on April 27th, we issued a new testing framework that also prioritized testing for persons without symptoms who are prioritized by health departments or clinicians for any reason, including screening of asymptomatic individuals according to states' and local plan. 104123 Next, our federal multidisciplinary team conducted multiple calls with leadership from each state to set state-specific testing objectives. Collectively, states and territories established an overall goal to perform 12.9 million tests over the next four weeks. The federal government is able to, and will, support the achievement of this goal. Specifically, the federal government is shipping to states 12.9 million swabs and over 9.7 million tubes of media in May alone. 104159 Last month, we also detailed the location and capacity of every lab machine in every state that could potentially run covid-19 assays and our team has worked with manufacturers to match reagent to these machines. Looking forward, between now and the end of 2020, the federal government will procure over 135 million swabs and 132 million tubes of media and distribute these to states, as requested, to supplement the now-robust commercial supply. 104231 We anticipate marked increases in current tests as well as a dramatic expansion of new point-of-care tests, like the first in-class Quidel antigen test, authorized by the FDA just last Friday. Quidel anticipates being able to distribute 300,000 tests per day within just a few weeks. So, by September, taking every aspect of development, authorization, manufacturing, and supply chain into consideration, we project that our nation will be capable of performing at least 40 to 50 million tests per month, if needed, at that time. 104308 And if new technologies are authorized like whole genome sequencing approaches or anything uncovered by NIH's new diagnostics initiative, that number will be much higher. Finally, I want to acknowledge and express my heartfelt gratitude to the officers of the U.S. Public health service commissioned corps, the uniformed service I am honored to lead. 3,471 men and women have deployed in support of this pandemic. 104338 On the cruise ship in Japan, to our military bases repatriating Americans, to our community-based testing sites and international airports, to FEMA and our task forces, to nursing facilities including King county, Washington, and to field hospitals in hard-hit communities across our nation. I thank each and every one of these officers and their families, and on their behalf, I thank the members of this committee for supporting our training needs and the establishment of a ready reserve to supplement our ranks in future national emergencies. 104411 Thank you for the opportunity to provide these remarks. ALEXANDER>> Thank you, admiral Giroir. And now Dr. Stephen Hahn, our fourth and final witness. HAHN 104422 HAHN>> Chairman Alexander, ranking member Murray, and members of the committee, thank you for inviting me to participate in this hearing today. I first want to start by thanking the American people for their incredible efforts at mitigation and extend my condolences to those who have lost loved ones. From day one of this pandemic, the 18,000 FDA employees who are just incredible scientists, doctors, and nurses, have taken an active role in the all-of-government response to this pandemic. 104454 The FDA has worked to facilitate the development of medical countermeasures to diagnose, treat, and prevent covid-19. We've worked closely with laboratories, manufacturers, academia, product developers, our federal partners and companies, companies that don't even make medical products but want to pitch in, for example, by making hand sanitizer, personal protective equipment and ventilators. Every decision we have made has been driven by data with a goal [inaud] of protecting the health of the American people. 104525 In a public health emergency, however, our response has balanced the urgent need to make medical products available with the provision of a level of oversight that helps ensure the safety and effectiveness of those medical products. I'd like to take a few minutes to tell you what FDA is doing to help the country at this point, in order to show Americans it's safe to return to work and to school. It starts with testing, as others have mentioned. FDA has worked with more than 500 developers who have or said they will be submitting emergency use authorization requests for covid-19 tests. 104600 This includes some newer technologies that not -- that heretofore have not been used as part of diagnostic tests in response to a pandemic. We have issued 92 individual emergency use authorizations for test kit manufacturers and laboratories, and we've been informed by more than 250 laboratories, they have begun testing under the regulatory flexibilities we outlined in March. We are conducting rolling reviews of UA (?) submissions so that we can quickly authorize tests which the data support. 104632 In a public health emergency, the accuracy of diagnostic tests is important, not only for the individual patient, but for the patient at large -- for the public at large. FDA is helping to ensure the availability of tests that are providing accurate answers. We are also monitoring the marketplace for fraudulent tests and are taking appropriate action to protect the public health, and we are working to provide more clarity about which tests have been reviewed and authorized by FDA and which have not. Serologic tests will play a part in our recovery. Unlike diagnostic tests, which detect the presence of the virus, serologic tests measure the amount of antibodies or protein present in the blood when the body is responding to an infection like covid-19. 104715 Tests can help identify individuals who can overcome an infection and who have developed an immune response. We will continue working with labs, manufacturers and across the government to find a balance between the assurance that an antibody test is accurate and timely access to such tests. Of course, the way we will eventually beat this virus is with a vaccine. And FDA is working closely with our Fed partners, including the NIH, testing -- Vaccine developers, manufacturers, and experts across the globe. We intend to use our regulatory flexibility to help ensure the most efficient development of a safe and effective vaccine to prevent covid-19. 104756 Until a preventive vaccine is approved, however, we need medical products to bridge the gap. FDA has been working for several months to facilitate the development and availability of therapeutics as expeditiously as possible, and we have created an emergency program for this acceleration called the Coronavirus Treatment Acceleration Program or CTAP. We have reassigned staff to work with urgency to review requests from companies, scientists, doctors who are developing therapy, and we're using every available authority and regulatory flexibility that's appropriate to facilitate the development of safe and effective products to treat covid-19. 104835 A variety of therapeutic areas are being evaluated, as mentioned by Dr. Fauci and others, including antiviral drugs and immuno-therapies as well as convalescent plasma, hyper immunoglobulin and monoclonal antibodies. As Dr. Fauci mentioned, we recently announced the positive results of the NIH-MD (?) trial of remdesivir and issued an EUA for the treatment of hospitalization of patients with covid-19. Two other promising treatments that I mention are the antibody [inaud] products, convalescent plasma and hyper immunoglobulin and I am certainly willing to go into more detail if members of the committee have questions about this. 104913 But we are working very aggressively and closely with stakeholders to facilitate the development of monoclonal antibodies, which, if shown to be safe and effective, could act as a bridge therapy to the development of a vaccine. We recognize developing vaccines and therapies need to go hand in hand with ensuring there will be sufficient supplies for our company -- for our country, so we're also working with manufacturers to make sure that this supply chain is robust. 104940 Mr. Chairman, ranking member, members of the committee, please know that in FDA you have a dedicated team of some of the nation's finest scientists, health care providers and public health professionals. We are guided by science and data, and we won't let up until we facilitate the development of products that our nation needs to get back to work. I look forward to your questions. QUESTIONING 105002 ALEXANDER>> Thank you, Dr. Hahn. And thanks to all four of you for your expertise, for your dedication to our country, and your hard work. We'll now begin a round of five-minute questions from each senator on the committee, alternating between Republicans and Democrats. Each senator has, if you're in a video conference, you have a little time clock at the bottom, and I would ask you to try to stay within five minutes for your questions and answers. I will start. 105031 I've got a question for Dr. Fauci and then admiral Giroir. Doctor, let's look down the road three months. There will be about 5,000 campuses across the country trying to welcome 20 million college students, 100,000 public schools welcoming 50 million students. What would you say to the chancellor of the university of Tennessee Knoxville or the president -- principal of a public school about how to persuade parents and students to return to school in August? 105108 Let's start with treatments and vaccines first. Dr. Fauci, and if you could save about half of my five minutes for Admiral Giroir for testing, I would appreciate it. FAUCI>> Thank you very much, Mr. Chairman. Well, I would be very realistic with the chancellor and tell him that we're thinking in terms -- ALEXANDER>> It's her in this case. FAUCI>> Okay. I would tell her -- I'm sorry, sir -- That in this case, that the idea of having treatments available, or a vaccine, to facilitate the re-entry of students into the fall term would be something that would be a bit of a bridge too far. 105144 As I mentioned, the drug that has shown some degree of efficacy was modest, and it was in hospitalized patients -- not yet, or maybe ever, to be used either yet as prophylaxis or a treatment. So, if the issue is that the young individuals who'd be going back to school would like to have some comfort in that there's a treatment, probably the thing that would be closest to utilization then would likely be passive transfer of convalescent serum. But we're really not talking about necessarily treating a student who gets ill, but how the student will feel safe in going back to school. 105227 If this were a situation where we had a vaccine, that would really be the end of that issue in a positive way. But as I mentioned in my opening remarks, even at the top speed we're going, we don't see a vaccine playing in the ability of individuals to get back to school this term. What they really want is to know if they are safe, and that's the question that has to do with what we discussed earlier about testing. 105256 So, I'm about halfway through the remarks. I'd like to just pass the baton to Admiral Giroir, who would address the question of the availability of testing and what role that might play in returning to school. Thank you, sir. ALEXANDER>> Well, thank you -- thank you, Dr. Fauci. And admiral Giroir, you said that while we're doing about 10 million tests this month, that we might be as high as 40 or 50 million by September and -- a month, which is a significant increase. 105327 So, if I'm chancellor of the university of Tennessee, could I develop a strategy where I'd say to all of my students, we have, for example, an antigen test, which is quick and easy, we want everyone on campus to come by and take it once before you begin school? That will at least let everybody know that on that day, we've isolated anybody who's positive, and then we can continue to monitor? Is that strategy possible in August and September? 105351 GIROIR>> So, thank you, Mr. Chairman. And I may reserve 20 seconds for Dr. Redfield as well. The strategy that's going to be employed really depends heavily on what's the community spread at that time. If there's almost no community spread, your strategy will be different. If there's high community spread, it will also be different. But yes, technically, we will have the ability, and your chancellor will have the ability. We expect there to be 25 to 30 million point-of-care tests per month available. It is certainly possible to test all of the students, or it is much more likely that there would be a surveillance strategy done where you may test some of the students at different times to give an assurance that there's no circulation. 105433 And that would be done in conjunction with the CDC and the local health department. There's also strategies that are still needing to be validated, but a pooling sample. We know in some experimental labs, as many as 10 or 20 samples can be pooled. So, essentially, one test could test 20 students. And finally, there are some experimental approaches that look interesting, if not promising, that for example, wastewater from an entire dorm or an entire segment of a campus could be tested to determine whether there's coronavirus in that sewage, the wastewater. 105507 So, there are other strategies being developed. And I'd like to give at least 20 seconds to Dr. Redfield, who really will be working on the strategy of how to employ the tests given different community spread. ALEXANDER>> Dr. Redfield? REDFIELD>> Yeah, just some quick comments, sir. I mean, first, I think it's really important to evaluate critically the role of changes in social distancing on college campuses and schools and the situation, not to forget the importance of what we've learned. 105535 Clearly, also developing aggressive programs for wellness education, making sure people understand when they're symptomatic, they need to seek evaluation. I think we are going to have to look at the role of testing. And I think there's going to be an important role of testing in these circumstances, and I think it will be individualized based on where these different schools are, and where they -- how much infection is -- ALEXANDER>> I'm going to wrap it up there so I can set a good example for the other senators with their five minutes. Senator Murray. 105605 MURRAY >> Thank you very much, Mr. Chairman. And thank you to all of our witnesses. Dr. Fauci, you have warned of needless suffering and death if we push to reopen too soon, but the president has actually been sending the opposite message. I want to ask you today: what is the most important message you have for communities in states that are reopening, even as our public health experts make it clear it's too soon? Tell us what the consequences are. 105638 FAUCI>> Thank you very much for that question, senator Murray. As I've said many times publicly, what we have worked out is a guideline framework of how to safely open America again, and there are several checkpoints in that with a gateway first of showing, depending on the dynamics of an outbreak in a particular region, state, city, or area, that would really determine the speed and the pace with which one does re-enter or reopen. 105711 So, my word has been -- and I've been very consistent in this -- that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14-day decrease that would allow you to go to phase one. And that, if you pass the checkpoints of phase one, go to phase two and phase three. But I've expressed then and again, my concern that if some areas, cities, states, or what have you, jump over those various checkpoints and prematurely open up, without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn into outbreaks. 105757 So, therefore, I have been being very clear in my message to try to the best extent possible to go by the guidelines which have been very well thought out and very well delineated. MURRAY>> So, if a community or a state or a region doesn't go by those guidelines and reopens, the consequences could be pretty dire, correct? FAUCI>> The consequences could be really serious, particularly -- and this is something that I think we also should pay attention to -- that states, even if they're doing it at an appropriate pace, which many of them are and will, 105836 namely, a pace that's commensurate with the dynamics of the outbreak, that they have in place already the capability that when there will be cases, there is no doubt, even under the best of circumstances, when you pull back on mitigation, you will see some cases appear. It's the ability and the capability of responding to those cases with good identification, isolation, and contact tracing, will determine whether you can continue to go forward as you try to reopen America. 105911 So, it's not only doing it at the appropriate time, with the appropriate constraints, but having in place the capability of responding when the inevitable return of infections occur. MURRAY>> Well, thank you for that. And it's very clear, in order to do that, we need knowledge, which is about testing. And for months, this administration's approach to testing has really been plagued by unrealized goals and disregard for systemic problems within that supply chain. 105940 And last week, an average of just 250,000 tests per day were performed in the United States. That is a small fraction of what we need. And yesterday, president trump had the gall to declare the U.S. had, quote, prevailed in testing in a press conference that was filled with misinformation and distortion. Dr. Giroir, public health experts do not think the U.S. Has prevailed. I'm glad you've finally committed that states, including my home state of Washington, will receive enough tests to meet their goals for may and June. 110011 But this administration has had a record of giving us broken promises that more testing supplies are coming, and they don't. And we know, by the way, that testing needs will persist long past June -- long past June. So I wanted to ask you today, will the administration's forthcoming strategic plan that is now required under the Covid package that was just passed and signed into law, will that strategic plan on testing include specific numeric targets for testing capacity, supply-chain capacity, and projection of shortages? 110053 GIROIR>> Thank you for that question and statement, Senator Murray. Yes, we are, as I've stated. We continue to have a work in progress as we build the testing capacity. We have established the targets with the states of over 12 million tests over the next 4 weeks. We think those targets are gonna be good in May and June, but as Dr. Fauci said, we really have to be evidence-based. We expect those targets to go up as we progressively open, as those communities go into Phase 1 and then into Phase 2. 110128 And certainly those numbers will need to go up significantly again in the fall when we potentially have influenza circulating with Covid. So, yes, there will be targets. The targets will need change based on the evidence that we see but we are highly committed to securing the supply chain. We work daily with every manufacturer. And I'm just pleased we're, in May and June, able to get ahead of the states so that we can supply them what they need so they have those assurances. So there's not gonna be any doubts about that. 110158 MURRAY>> My question to you is when you put out that specific plan that you're required to do, we will see numbers that you are going to tell us you will reach, targeted for testing and supply-chain capacity and protection of [inaud], instead of just saying we hope to have a million this week, next week -- you will give us specific targets, correct? GIROIR>> We know specific -- I'll say yes, ma'am, we know the specific amounts of tests we have over the summer -- 110227 MURRAY>> Not have, how many we need. GIROIR>> Yes, so -- yes, ma'am. We develop the need statements by working with the states individually, with epidemiologists, with the CDC, so that overall in May we'll be testing about 3.9% of the overall USpopulation. MURRAY>> Well, that's fine but what I'm tell you -- ALEXANDER>> You're well over time, Senator Murray. MURRAY>> How many we have -- but how we will need not just for May but in the coming months so we can be prepared to have them? 110300 GIROIR>> Yes, ma'am, not to be repetitive, but, um, we need to be evidence and data driven. Because what we may see in May or June will drive differences in the amount of test goals that we have. So we really just need to be very humble about this. We need to look at the data. We know that the testing needs will go up over May and June, as we progressively open. And we will do our best to predict that. But you have to understand we have to have the data and the evidence show at that time. MURRAY>> Okay, I appreciate that. And again, what our strategic plan requires is what is the goal -- not how many we have, but how many we need. And that's what we'll be looking for, thank you. 110336 ALEXANDER>> Thank you, senator Murray. Senator ENZI? ENZI >> Thank you, Mr. Chairman. And I particularly appreciated your opening statement where you had a very succinct list of preparations we need to learn from this pandemic for the next one. Not only should we be working on this and preparing, but we need to look at the future, too. And I think we have learned a lot. We're fighting a virus at the same time that scientists are learning about it, so we need to be nimble. 110407 We also need to be sure that we are prepared for a second wave of outbreak. It could coincide with the start of the flu season, potentially stressing our healthcare system even more than it already has been. Admiral Giroir, I thank you for your comments. I think they've been comforting about what has been done and what can be done. I agree with senator Murray that we need to have some specific goals. 110437 As an accountant, that's always one of the things I'm looking for. My question is for Dr. Hahn -- our understanding of the clinical picture of Covid-19 continues to evolve. What first looked like a respiratory illness now seems much more comprehensive, potentially affecting the heart, the brain, the kidney and other organs. How does this evolving picture impact the ability to evaluate the appropriate clinical or surrogate endpoints for review of viruses and treatments? 110510 HAHN>> Thank you, senator, for that question. The -- the evolving clinical picture, and obviously the way this is manifesting around the country clinically does, in fact. inform the end points that we will work with developers of therapies on, so that we can get the absolute most efficient, but also the most accurate information and appropriate endpoints to make the necessary authorizations and approvals. We have set up the program called the Coronavirus Treatment Acceleration Program. 110544 Where our top scientists and clinicians have been at the table, consulting with our colleagues at NIH and CDC to actually address those questions. What are the appropriate endpoints? I'll give you an example. We do know that, in some circumstances, patients who had severe Covid disease have developed [inaud] or clotting type of episodes, and so we prioritize review of agents that we think might be beneficial. 110613 And obviously the clinical endpoints for those trials will be different from an agent that's an antiviral like remdesivir where, as Dr. Fauci mentioned, we're looking at time to recovery. So we want to adapt it to clinical circumstance, as well as to the type of therapy that's put before us. ENZI>> Thank you. Another question to Dr. Hahn, we have made a lot of progress in vaccine development, but Barta has identified that domestic manufacturing of the needles and syringes is a significant gap in pandemic preparedness. 110645 What has HHS done in advance of a potential national vaccination campaign to ensure we have sufficient capacity to administer a vaccine? HAHN>> Senator Enzi, thank you for that question. This is a really important point because, as you mentioned, it's not just about the vaccine or hopefully vaccines that are developed, it's all about -- it's also about the supplies that are needed, as well as an operation plan for administering the vaccine. 110715 So this is an all of government approach. There's a program that's been set up, called operation Warp Speed that included Dr. Collins, Dr. Fauci, his colleagues at NIH, the department of defense, as well as other members of HHS and FDA. Dr. Peter marks for our center for Biological Evaluation Research has been helping to coordinate that, and is working very closely with Dr. Fauci and his team. 110739 And we have created what's called a Gantt chart to look forward, what are the necessary supply chain issues, syringes, needles, etc. depending on the various vaccines that are being developed, how many times they have to administer and the route to administration. So we've been leaning in on this supply chain to ensure that when a vaccine is ready to go, we will have the necessary supplies to actually administer it and operationalize the vaccination. ENZI>> I have a couple more questions, but again the clocks visible there so I suspect I've used up my time. I'll submit those in writing. ALEXANDER>> Thank you senator Enzi. Senator Sanders? 110826 SANDERS>> Thank you very much, Mr. Chairman. And let me thank all of the panelists for the hard work they're doing and for being with us today. It is sad to say that we have a president of the United States, the leader of our country who from day one downplayed the dangers facing this country from the pandemic, who told us that the crisis would be over in a few months, that we did not have to worry. 110855 Who fired those members of the government who wanted to act aggressively and among other things at a time when we need international cooperation cut funding for the world health organization. Let me also say that I think we understand that fact are terribly important. Not everybody that we don't fully understand all of the ramifications of the covid-19 epidemic. 110926 Let me ask Dr. Fauci and few questions if I might. For a start, the official statistics, Dr. Fauci, is that 80,000 Americans have died from the pandemic. There are some epidemiologists who suggest the number may be 50% higher than that. What do you think? FAUCI>>I'm not sure not sure, Senator Sanders, if it's gonna be 50 percent higher but most of us feel that the number of deaths are likely higher than that number because giiven the situation particularly in New York City, when they were really strapped with a very serious challenge to their health care system, 111008 there may have been people who died at home who did have covid who were not counted as covid, because they never really got to the hospital. So in direct answer to your question, I think you are correct that the number is likely higher. I don't know exactly what percent higher, but almost certainly its higher. SANDERS>> Dr. Fauci, let me ask you this. In the terrible pandemic of 1918, the virus exploded in the fall, it came back with a vengeance. 111047 Are we fearful that if we don't get our act together, as bad as the situation is now, it could become worse in the fall or winter? FAUCI>> Well, senator, thank you for that question. It's a frequently asked question. I think the possibility does exist. However -- and the reason I say that is that when you talk about will the virus just disappear? And as I've said publicly many times, that is just not going to happen because it's such a highly transmissible virus. 111119 Even if we get better control over the months, it is likely that there will be a virus somewhere on this planet that will eventually get back to us. So my approach towards the possibility of a rebound and a second wave in the fall is that, a, it's entirely conceivable and possible that would happen, but B, I would hope that between now and then, given the capability of doing the testing that you heard from admiral Giroir, and the ability for us to stock up on personal protective equipment and the workforce that the CDC under Dr. Redfield will be putting forth. 111201 to be able to identify, isolate and contact trace -- I hope that if we do have the threat of a second wave, we'll be able to deal with it very effectively to prevent it from becoming an outbreak, not only worse than now, but much, much less. SANDERS>> Okay, and let me ask, we've heard a lot of discussion about vaccines. Obviously everybody in congress and in this country wants a vaccine, we want it as quickly as possible, as effectIve as possible. Let me ask the honorable fda commissioner. 111234 sir, if, god willing, a vaccine is developed and if we're able to produce it as quickly as we all hope we can I would imagine that that vaccine would be distributed to all people free of charge to make sure at least everybody in America who needs that vaccine would get it regardless of their income. Is that a fair assumption? HAHN>> Senator, I certainly hope so. The fda is very committed to making sure that all populations in the United States, including those most vulnerable are included in the clinical trials. 111312 SANDERS>> Sir, that's not what I'm asking. WhatI'm asking is, if and when the vaccine comes, it won't do somebody any good if they don't get it and if they have to pay a sum of money for it in order to profit the drug companies, that will not be helpful. Are you guaranteeing the American people today that that vaccine will be available to all people, regardless of their income? 111340 HAHN>> Sir, the payment of vaccines is not a responsibility of the fda, but I'm glad to take this back to the task force. I share your concern that this needs to be made available to every American. SANDERS>> Does anybody else want to comment on that? Mr. Giroir, Do you think we should make that vaccine when hopefully it's created, available to all, regardless of income? Or do you think that poor people and working people should be last in line for the vaccine? GIROIR>> I'm sorry, senator, were you asking me? SANDERS>> Yes, I was sir. Yes, I was. 111413 GIROIR>> No, I -- um, my office is one of the offices committed to serving the underserved. We need to be absolutely certain that if a vaccine or an effective therapeutic or preventative is available, that it reaches all segments of society, regardless of their ability to pay or any other social determinants of health that there may be. SANDERS>> Good. So you're telling the American people today that regardless of income, every American will be able to gain access to that vaccine when it comes? 111449 GIROIR>> They should gain access to it. I don't control, you know -- SANDERS>> Well, you represent -- you represent an administration that makes that decision. GIROIR>> I will certainly advocate that everyone is able to receive the vaccine, regardless of income or any other circumstance. SANDERS>> Let me just switch gears-- ALEXANDER>> Your time is up, senator Sanders. SANDERS>> I'm sorry. Alright. Thank you, Mr. Chairman. ALEXANDER>>> Those are important questions. I don't want to cut senators off, and it's hard to see the time clock, but if we can stay as close as possible to five minutes, all senators can get their questions in. Thank you, Senator Sanders. Senator burr? BURR 111525 BURR>> Thank you, Mr. Chairman, and thank you to our witnesses for what you have done for the people of this country and their safety and people around the globe. Let me ask you, Dr. Fauci, because you have been in the task force and a majority of the press conferences. Has anybody in this administration ever asked you or any member to take the foot off the gas of trying to find a cure or any type of countermeasure? 111550 FAUCI>> No, senator. Not at all as a matter of fact. We at mih as you know have been right from the very beginning put our foot on that accelerator in every aspect, including the development of vaccines and therapeutics. And as I described in my opening statement we actually started that in January, literally days after the virus was known and its sequence was published. So no I have never been told by anyone to pull back on the development of any countermeasure or any basic clinical that research project we've been involved in. 111627 BURR>> Thank you, Dr. Fauci. This question is for Dr. Redfield. Dr. Redfield, we have authorized in this committee and appropriated out of congress multiple times over the last few decades money for bio surveillance and you talked about it. In the past four years. From fy 16 to fy 20. It's been 23 million dollars a year and with the C.A.R.E.S. Act, it's over a billion dollars in bio surveillance. 111652 We have seen the private sector go out and use data available to track the progress and spread of coronavirus around the world. Why has CDC not contracted with private sector technologies companies to try to use their tools for bio-surveillance? REDFIELD>> Thank you for the question. This is a critical issue, as you know, and also comes into one of the core capabilities I talked about data analytics and data monetization which we're appreciative of the additional funding that congress has given. 111731 I can tell you this is under critical review. We do have contracts with some of the private sector groups now to try to make the type of availability of data we've seen in Florida available in all of our jurisdictions across the country and in the process of making that happen. BURR>> Dr. Redfield, in april of last year -- June of last year, we reauthorized the pandemic and all hazards legislation, which authorized at that time 30 new billets, 30 new employees at CDC specifically in surveillance. 111806 I asked Dr. Schuchat in March how many of those 30 had been filled. She said zero. As of mid April, zero of those 30 billets had been filled. How many of those 30 employees that this committee authorized CDC to bring on and for biosurveillance, have been filled today? REDFIELD>> Sir, again, thank you for the question. I know our staffs have been in discussion since Dr. Schucat's testimony, and I know we're in the process of continuing to try to figure out how to move that forward, sir. 111841 I can get back to you on it as I discuss what progress has been made.since we had that discussion [INAUD] hearing with you when you brought that to light. BURR>> Well, I brought it to light the first of March, and now we're in mid may. So I'm hopeful that we won't just talk about surveillance, we'll actually execute it, and we'll focus on the unbelievable amounts of money that we have provided for you that they will show some benefit to the American people. 111912 Dr. Fauci, let me come back to you. This is one of the fastest development timelines we have ever seen for vaccines, and the American people and hopefully people around the world will be the beneficiary of what you find and the eventual licensure of that product. What are the biggest unknowns with this particular virus that can affect the development process and Dr. Hahn, if you have got anything to add after that to this, please do. Dr. Fauci? 111944 FAUCI>> Thank you very much, senator burr. Well there are a couple things that I think are inherent in all vaccine development. First of all there's no guarantee that the vaccine is actually going to be effective. As you well know, because we have discussed this many times in the past, you can have everything you think that's in place, and you don't induce the kind of immune response that turns out to be protective and durably protective. So one of the big unknown as is, will it be effective? Given the way body respond to viruses of this type, I'm cautiously optimistic that we will, with one of the candidates, get an efficacy signal. 112018 The other thing thats an unknown that's of concern, but we'll be able to get around it by doing the tests properly is that do you get an enhancement effect? Namely, there have been a number of vaccines, two in particular (?) and respiratory censitual virus, when the vaccine induces a suboptimal response and when a person gets exposed, they actually have an enhanced pathogenesis of the disease, which is always worrisome. 112045 So we want to make sure that that doesn't happen. Those are the two major unknowns.Putting all those things together, Senator Burr, I still feel cautiously optimistic that we will have a candidate that will give some degree of efficacy, hopefully a percentage enough that will induce the kind of herd immunity that would give a protection to the population at home BURR>> Dr. Hahn, anything to add to that? HAHN HAHN>> Yes, sir. Thank you for the question. The obstacles from a regulatory point of view I think are being met by the approaches being taken out of the HHS and lead by Peter Marks 112120 and that is a common preclinical development pathway so that we can appropriately assess one vaccine against the other and then a master protocol that allows for a common control group and an assessment of very common end points. That will let us be as efficient as possible for the development of a vaccine. We will evaluate approximately ten candidates clinically, and then in the phase one and two studies, and then take four to five into phase three study in this HHS effort. I think those are the obstacles that can be broken down to speed the development, but also allow us to ensure safety and effectiveness. 112159 HAHN>> Mr. Chairman, yesterday the state of North Carolina started to publicize the recovered numbers, those individuals who had coronavirus, but have recovered. It's my hope that nationally we will start reporting the recovered numbers. I think that's important for the American people to hear. I yield back. ALEXANDER>> Thank you, senator burr. Senator Casey? 112223 CASEY>> Mr. Chairman, thank you for the hearing, as well as ranking member Murray. Mr. Chairman, I wanted to start today with a question regarding nursing homes, in particular across a state like ours, we've had as you might know a high number of cases in Pennsylvania,, at last count over 57,000 cases. The number of deaths have gone above 3,700, and of course a lot of those deaths are in nursing homes. We're told that nationally more than a third, as high as 35% of all deaths have been in nursing homes, either the death of a resident of nursing home or a worker. 112304 I want to start today with a question for Dr. Redfield. Doctor, when we consider this challenge in our long-term care facilities, when we look at the number of deaths in nursing homes, I think a lot of families want basic transparency, and that's one of the reasons why Senator Wyden and I sent you a letter dated April the 2nd that was directed to you, as well as the administrator of the centers on medicare/medicaid services, Seema Verma, 112341 and in that letter we asked for basic information about what the administration was doing to track the outbreaks in nursing homes, to provide information -- basic information to families and residents, the families of residents in nursing homes, certainly to the workers as well as to the community and public health professionals. Now, it took you about a month to respond to that, but in your response, you didn't give us any information about the timeline. 112415 These families need this information. Now we're told by the CMS administrator after pressing her, as senator wyden and I did, that this information may not be available until the end of may. I need to hear from you today. Why has there been a delay -- a three-month delay in basic information that families and people within a community need about the outbreaks in nursing homes, the number of cases, what is happening in nursing homes. Tell us when we're going to see that information. 112452 REDFIELD>> Well, thank you very much, senator, and you've highlighted one of the great tragedies that we have all experienced together. Clearly the long-term care facilities have been particularly hard hit by the pandemic. Several things, I know that the again the CMS who has oversight, several things have been done, and I can get back to you in terms of where they're at in terms of activation, but clearly all nursing homes now are required to report all cases in either individuals that are patients there or staff, to the CDC. 112535 Secondly -- [INAUD] had put a policy in place that all nursing homes are required to notify members of that nursing home of the existence of covid in that nursing home, include family members [INAUD] verify in terms of when thats -- if that's operational today or next week and I will get back to you with that . One of the most important things, we have decided, as we talked about [inaud] and reopening as Tony mentioned [inaud] symptomatic cases. 112619 We need to do contact tracing, but the other thing that we need to do is to do surveillance because this virus does appear to have a high propensity for asymptomatic infection, which means the traditional ways of identifying cases is gonna be blunted. So we developing a national surveillance system, and first and most importantly is to do comprehensive surveillance in all [inaud] united states. CDC will be doing that in partnership with the state and local territorial health departments. I think [inaud] is going to have the responsibility to do it within the inner city clinics that are collected and for the health service clinics. 112700 But this is critical we get in front of this and do comprehensive surveillance of everybody in the nursing homes. We have also done aggressive outreach in all of them enhancing infection control procedures, etc. CDC has been out to help these nursing homes with that and to the guidance along with the [inaud], but i'll get back to you in terms of the -- i'm pretty confident they're already [inaud] operational. But I need to double check to make sure because I know Seema has announced they're all reporting to CDD now any infection with workers or patients and that they are required now to notify other member in the nursing home as well as family members as well When COVID [inaud[ 112748 CASEY>> Mr. Chairman, I just have one question for Dr. Fauci. Doctor, I wanted to ask you, in your testimony earlier in response to a question by senator murray, you outlined a basic concern you have with regard to states reopening. Can you restate that for us? FAUCI>> Yes, thank you, senator casey. Yes, my concern is that states or cities or regions. Their attempt, understandable, to get back to some form of normality disregards a greater loss [inaud] the checkpoints we put in our guidelines about when it is safe to proceed on pulling back on mitigation. 112827 Because I feel if that occurs there is a real risk that you will trigger an outbreak you may not be able to control. Which in fact paradoxically will set you back, not only leading to some suffering and death that could be avoided but could even set you back on the road to trying to get economic recovery because you would almost turn the clock back rather than going forward. That is my major concern, Senator. CASEY>> Thank you, doctor. 112900 CHAIRMAN ALEXANDER>> Thank you senator Casey. Senator Paul. PAUL>>Dr Fauci, scientists have shown that rhesus monkeys that are infected with covid-19 cannot be reinfected. Several studies have also shown that plasma from recently infected coronavirus patients neutralizes the virus in lab experiments. In addition, infusion of convalescent plasma is based on the idea that recovering coronavirus patients are developing immunity, and that it can be beneficial as donated. 112930 Studies show that the recovering covid 19 patients, from the asymptomatic to the very sick are showing significant antibody response. Studies show that SARS and MERs, also coronaviruses, showed immunity for at least two to three years. And yet the media continues to report that we have no evidence that patients who survive coronavirus have immunity. 112952 I think actually the truth is the opposite. We have no evidence that survivors of the coronavirus don't have immunity and a great deal of evidence to suggest that they do. The question of immunity is linked to health policy and that workers who have gained immunity can be a strong part of our economic recovery. The silver lining to so many infections in the meat processing industry is that a large portion of these workers now have immunity. 113018 Those workers should be reassured that they likely won't get it again instead of being alarmed by media reports that there is no evidence of immunity. You've stated publicly that you'd bet it all that the survivors of coronavirus have some form of immunity. Can you help set the record straight, for the scientific record as this is being accumulated that this is supportive that the infection with coronavirus likely leads to some form of immunity, Dr Fauci? WASH 10 SENATE HELP COMMITTEE HEARING COVID 19 VIRTUAL WITNESS CAM POOL P2 113043 FAUCI>> Yup, thank you for the question, Senator Paul. Yes, you are correct that I have said, given what we know about the recovery from viruses such as coronaviruses in general or even any infectious disease with very few exceptions, that when you have antibodies present, it very likely indicates a degree of protection. 113102 I think it's in the semantics of how this is expressed, when you say has it been formally proven by long-term natural history studies which is the only way that you can prove: one, is it protective, which I said and would repeat is likely that it is, and also what is the degree or titer of antibody that gives you that critical level of protection, and what is the durability. 113129 As I've often said, you know, I again repeat, you could make a reasonable assumption that it would be protective. But national history studies over a period of months to years would then tell you definitively if that's the case. PAUL>> And I think that's important because in all likelihood, is a good way of putting it, the vast majority of these people will have immunity instead of saying, there is no evidence. You know, the WHO kind of fed into this by saying no evidence of immunity. And in reality, there is every evidence stacking up -- in fact a lot of the different studies have shown that it's very unlikely that you get it again in the short term. 113205 With regard to going back to school, one thing that was left out of the discussion is mortality. I mena, shouldn't we at least be discussing what the mortality of children is? This is for Dr Fauci, as well. You know, the mortality between zero and 18 in New York data approaches 0. It's not going to be absolutely 0, but it almost approaches 0. Between 18 and 45, the mortality in New York was 10 out of 100000. 113232 So really we do need to be thinking about that. We need to observe with an open mind what went on in Sweden, when the kids kept going to school. The mortality per capita in Sweden is actually less than France, less than Italy, less than Spain, less than Belgium, less than the Netherlands, about the same as Switzerland. But basically, I don't think there's anybody arguing that what happened in Sweden is an unacceptable result. 113254 I think people are intrigued by it. And we should be. I don't think any of us are certain when we do all these modelings. There've been more people wrong with modeling than right. We're opening a lot of economies around, around the US and I hope that people who are predicting doom and gloom and saying "Oh, we can't do this, there's going to be a surge" will admit that they were wrong if there isn't a surge. Because I think that that's what's going to happen. And in rural states, we never really reached any sort of pandemic levels in Kentucky and other states. We have less deaths in Kentucky than we have in an average flu season. 113326 Not to say this isn't deadly, but really outside of New England we have had a relatively benign course for this virus nationwide. I think the one-size-fits-all, that we're gonna have a national strategy and nobody is going to go to school is kind of ridiculous. We really ought to be doing it school district by school district and the power needs to be dispersed because people make wrong predictions and really the history of this when we look back will be of wrong prediction after wrong prediction after wrong prediction starting with Ferguson in England. So I think we ought to have a little bit of humility in our belief that we know what's best for the economy and as much as I respect you, Dr. Fauci, I don't think you are the end-all. 113406 I don't think you're the one person who gets to make a decision. We can listen to your advice, but there are people on the other side saying there's not going to be a surge and we can safely open the economy and the facts will bear this out. But if we keep kids out of school for another year, what's gonna happen is the poor and underprivileged kids who don't have a parent that's able to teach that at home are not gonna learn for a full year. And I think we ought to look at the Swedish model and we ought to look at letting kids back to school. I think it's a huge mistake if we don't open the schools in the fall. Thank you. 113434 FAUCI>> Mr. Chairman, Can I respond to that even though there are only 32 seconds left? CHAIRMAN>> Yes. And you might make it clear whether or not you suggest that we shouldn't go back to school in the fall. FAUCI>> First of all Senator Paul, thank you for your comments. I've never made myself out to be the end all and the only voice on this. I'm a scientist, a physician and a public health official. I give advice according to the best scientific evidence. 113501 There are a number of other people who come into that and give advice that are more related to the things that you spoke about, about the need to get the country back open again and economically. I don't give advice about economic things. I don't give advice about anything other than public health so I want to respond to that. The second thing is that you used the word we should be humble about what we don't know and I think that falls under the fact that we don't know everything about this virus and we really better be very careful particularly when it comes to children. 113533 Because the more and more we learn we're seeing things about what this virus can do that we didn't see from the studies in China or in Europe. For example, right now children presenting with covid-19 who actually have a very strange inflammatory syndrome , very similar to Kawasaki syndrome, I think we better be careful if we are not cavalier in thinking that children are completely immune to the deleterious effects. 113601 So again, you're right. In the numbers, that children in general do much, much better than adults and the elderly, and particularly those with underlying conditions. But I'm very careful and hopefully humble in knowing that I don't know everything about this disease, and that's why I'm very reserved in making broad predictions. Thank you. 113623 CHAIRMAN>> Thank you, Senator Paul, and Senator Bladwin. BALDWIN>>Thank you Mr. Chairman and ranking number Murray and our witnesses.I want to try and cover a lot of territory in my five minutes, so I would certainly be appreciative of concise answers. But I want to start with Dr. Redfield. Dr Redfield, do you think that the current testing protocols at the white house present some models for other essential workplaces? 113653 REDFIELD>> I'm sorry Senator, you broke up at the beginning of your question. If you could just say it again, I'm sorry. BALDWIN>> Yes. Dr. Redfield, do you think that the testing protocols currently in place in the white house present a model for other essential workplaces? REDFIELD>> Well, I think -- Thank you for the question. I think one of the important things that you bring up is the essential worker guidance that CDC put out. And I think it was originally modeled obviously on health care workers where there was significant health care shortages and individuals that were -- 113733 BALDWIN>> Are there any workplaces -- I'm asking you if you think the white house protocol testings are a model for other essential workplaces? REDFIELD>> I would just say that I think each workplace has to define their own approach as how to operationalize our -- BALDWIN>> (inaud.) --- there some considerable comments on the fact that osha has not stood up an enforceable mandatory emergency temporary standard for workers in all sorts of work settings, but that aside, would you say that the ppe rules and protocols in effect right now in the White House are a model for other essential workplaces? 113813 REDFIELD>> We would -- my own view, we would go back to the guidelines that CDC has put out about essential workplaces for people, if they are an essential workforce, if they go in public, they maintain 6 feet distancing and they wear face coverings. 113830 BALDWIN>> Okay. Admiral Giroir, you have testified about how far you have come with regard to testing assessment. I want to ask you if you believe that we already have a national testing strategy today that spans from the nationwide testing needs assessment to the nationwide testing supply assessment and a strategy to fill that gap to procure domestically what we need in terms of bridging that gap with testing platforms, swabs, specimen collection media, and reagents, and the PPE needed to conduct those tests. 113920 GIROIR>> Thank you for that. We do have a strategy that spans us at least to the fall and beyond. As I mentioned we're working individually with every state, and I think senator Paul is correct that Kentucky, Wyoming, New Jersey, Rhode Island are different, and there are vastly different testing needs. The East Coat will have multiples of testing versus other states and we're working those individually. BALDWIN>> So -- GIROIR>> Yes? 113953 BALDWIN>> So, I know you testified earlier that not only are you working with the states, but you're working with every lab in every state, and -- GIROIR>> Correct. BALDWIN>> -- increase capacity. What about working with those who would be -- those who would need testing to sya, reopen their school, their university,their business? Each of them have identified what they think are their testing needs based on you know, guidance and not mandatory enforceable rules. 114028 But, are you in contact at that level? Does your dashboard have visibility at that lowest level, or are you in contact with the states and the labs? GIROIR>> So, over the last few months, we've done a lot of the individual work at nursing homes, at meat packing plants, at other, I mean, really down to the dirt granular level. BALDWIN>> Okay. GIROIR>> Where we are right now, however, is we are really working with the state leadership, with the public health lab, the state epidemiologists, the (?), the state health officials, because they really need to understand what their sum is going to be in their state -- BALDWIN>> Okay. 114106 GIROIR>> And then in the funding, we are asking very specifically in the CDC funding for specific plans for schools, nursing homes, underserved et cetera. BALDWIN>> Thank you. So, I have 2 more points that I'm going to make. I don't have time for questions. One is about the transparency of that needs assessment. Can the public see it? Can the state see it? Can the HUP(?) committee members see it? Is it publically available? 114134 And, secondly, the delivery of this supply is a critical issue. And it seems to me that the logistics of getting this out whether it's ppe, testing or medical equipment is still extremely fragmented leading to price gouging and many other inefficiencies. We need to stand up the full power of the defense production act. GIROIR>> Would you like me to comment on that, ma'am? I'm sorry. 114205 BALDWIN>> I'm happy to have you comment with the indulgence of the chairman, we have gone over time. And why don't you get back to -- CHAIRMAN ALEXANDER>> Why don't we try to get a succinct answer for the senator, please, Admiral Giroir. 114218 GIROIR>> Yes, ma'am, and yes, sir. Particularly for things like swabs and media, there is still a very, I would say, non mature industry within the country. And that's why we've made the decision to procure that all centrally through December and then distribute that to the state. Because there are just too many small companies, too many variables to control without a really heavy federal hand. That;s just an example of where we really moved into that and used the DPA for swabs to help support American industry. In more mature aspects of the industry, like some of the large test producers, we feel by helping direct them to help the states get what they need and the right distribution, that we're not procuring them directly, by us. 114308 But again, we're going to be very evidence and data driven as we move on. Thank you, sir. CHAIRMAN ALEXANDER>> Thank you very much, Senator Baldwin. Senator Collins. COLLINS>> Thank you, Mr Chairman. Let me begin by first by thanking each of our witnesses today for their expertise, their dedication and their hard work. Dr. Redfield, I want to start with you. I am hearing from dentists all over the state of Maine the fact that they cannot practice in our state, despite following very strict infection control protocol, is causing growing health problems. 114354 Dentists tell me that teeth with cavities that could have been filled are now going to need root canals. Teeth that could have been treated with root canals are now going to require extraction. People with oral cancers cannot get the treatment, the cleanings that they need before beginning their treatment. Dental health is clearly so important. And Maine state officials as well as our dentists are seeking assistance in reaching the right decisions. 114433 47 other states either have reopened dental practices or have a day set to reopen. So my question to you is this. If dentists are following the American dental association guidelines, if they they are instituting strict protective measures for their patients, their staff, their hygienists, themselves, and if they are closely examining and seeing a decline in the number of covid-19 infections in their county,are these reasonable actors for states to consider in the reopening the practice of dentistry. 114524 REDFIELD>> Yes, Senator, thank you with the question. You know, we have been interacting and talking with dentists. We are working with the state and local public health officials to update our guidelines on reopening a variety of medical services as you know. And I think you raise a very important point and I would not disagree with what you said about looking at the American dental association's as well as the reality of the outbreak in the area. 114600 But we are in the process of updating those guidelines and they will include direct guidelines for dental practices. COLLINS>> Thank you very much Doctor. Dr. Giroir and Dr Hahn, recently there has been a significant demand for remdesivir, I may be mispronouncing that, which transitions to receiving an emergency use authorization. 114630 Last week, Maine's two largest hospital systems contacted me with questions about how this therapeutic will be allocated going forward. HHS finally released a statement on Saturday about allocations going to states, interestingly, not directly to hospitals, but once again the decision-making behind these allocations is very unclear. 114702 HHS and the assistant secretary for preparedness and response say that each state is expected to receive an allocation but no timetable has been provided. Beyond those who are being treated with this drug at Maine medical center through a clinical trial, I'm concerned that hospitalized patients in Maine will have little or no ability to be treated with this promising therapeutic for the foreseeable future. 114736 As this and more therapeutics and ultimately a vaccine come on to the marketplace, how can these allocation and distribution issues be resolved so that patient care is not delayed and so that it doesn't depend on which state you live in, whether or not you are going to get access to these treatments and ultimately a vaccine. 114809 HAHN>> Senator Collins, this -- oh, go ahead, Admiral Giroir. GIROIR>>Go ahead. Go ahead, commissioner. HAHN>> Senator Collins, I think we completely agree with you that this has to be an evidence-based approach getting the medical therapeutics, vaccines, remdesivir or whichever it happens to be to the people in need. 114834 I think we can all agree upon the fact that we've learned a lot of lessons from the remdesivir situation and, first, as you mentioned, that's being led by HHS and Anasper. What you see in the most recent announcement is, that what the task force did was provide guidance to HHS regarding where the most significant outbreak of hospitalization -- outbreak occurred and where the hospitalizations -- hospitalized patients were. 114903 This represented about a quarter of the supply of drugs that we had and more will be allocated according to methodology that gets drugs where those hospitalized patients are. Other therapies and to vaccines in particular and we must incorporate those into our operational plans moving forward. COLLINS>> Thank you, Doctor. Admiral, do you have anything to add -- I'm over time, sorry. Thank you.If you have anything to add, do so for the record. 114939 GIROIR>> No, Ma'am. I agree with commissioner. It's absolutely critical that it's evidence based, based on the people who could benefit from it, and also fair and just throughout our country. COLLINS>> Thank you. CHAIRMAN ALEXANDER>> Thank you senator Collins. Senator Murphy? MURPHY>> Thank you very much, Chairman. Thank you and Senator Murphy for convening this. Thank you to all of our witnesses for your service.

A RARE DISEASE THAT AFFECTS CHILDREN HAS BEEN SEEN IN HIGHER THAN USUAL NUMBERS IN ST LOUIS

YOU MAY HAVE ALREADY GOTTEN THE WORD FROM HEALTH OFFICIALS ADVISING PEOPLE IN FLOODED AREAS WHO HAVE NOT HAD A TETANUS BOOSTER IN THE PAST TEN YEARS TO GET ONE..BUT EILEEN WIXTED REPORTS THE FLOOD WATERS ALSO HOLD OTHER HEALTH HAZARDS.

THE NUMBER OF CHILDREN KNOWN TO HAVE THE AIDS VIRUS IS SMALL, BUT GROWING STEADILY. EILEEN WIXTED REPORTS YOUNG CHILDREN WITH HIV INFECTION NEED SPECIALIZED CARE.

Promising medication to deal with a dangerous child respiratory infection.

The Center for Science in the Public Interest and S.T.O.P. (Safe Tables Our Priority) hold a press conference to ask President Clinton to form an independent federal food agency to assure that food hazards are fully addressed.