Debate live from cleveland tuesday night on cspan. Stream at cspan. Org or listen live on the cspan radio app. And live now to the Senate Health committee who today will hear from dr. Anthony fauci, dr. Robered redfield and other members of the White House Coronavirus task force. Theyre expected to update lawmakers on the federal response to the pandemic. Live coverage here on cspan 3. Senator ted kennedy used to say our committee had the broadest jurisdiction in the senate. You only have to look around the room at a hearing and see that we also have the broadest range of views in the senate and some of the ablest advocates of those views. But thanks to our Committee Members and to senator murray most of our hearings have been bipartisan which means weve agreed on a broad range of witnesses to present points of view. And while the questioning and statements of senators has been probing, theres always been a high level of courtesy both to the witnesses and to the other senators which im grateful for. I believe this ability to Work Together during such a rancorous time is a big contributor to why weve been able to accomplish so much. The work of this committee represents my view that as far as the United States senate goes, its hard to get here. Its hard to stay here. And while youre here you might as well try to accomplish something good for the country, which this committee has done on numerous occasions. The Trump Administrations program to develop and deploy a vaccine against covid19 is on track to be an unprecedented sprint to success. The program called operation warp speed will save lives without cutting corners on safety and efficiency. The covid19 Vaccine Development process is likely, likely to produce its first tens of millions of doses within one year. The United States has never produced a vaccine that rapidly. When i was a child i saw classmates in iron lungs. We waited 10 years for a polio vaccine so we wouldnt be afraid of polio. Many existing vaccines for other diseases that children take routinely before they go to school like chickenpox and the measles have taken 10 years to develop. The secret to the success of this effort is that the government in partnership with private industry is for the first time developing and manufacturing vaccines in parallel. Now, what that means is that operation warp speed is manufacturing tens of millions of doses of the six vaccine candidates at the same time the Clinical Trials are ongoing and the food and Drug Administration works to determine whether those vaccines are safe and effective. If the fda does not approve the vaccine it will not be distributed. So the risk is taxpayer money not the safety and efficacy of the vaccine. The administration had set a stretch goal that once seemed impossible but now seems likely. The administration hopes to have as many as 300 doses of Vaccines Available to be deployed by mid2021 according to an august 26th article by operation warp speed programs principal advisor and vaccine expert that with was published in the new england journ of medicine. The authors also wrote no Scientific Evidence could guarantee success but the Strategic Decisions and choices weve made, the support the government has provided, the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor. With the department of health and Human Services said recently in a meeting if all goes well its possible up to 700 million doses will have been manufactured by april of next year, 2021. The department of health and Human Services, department of defense, private sector, Public Health and medical professionals also are working together to lay the groundwork for deciding who gets the first doses. Such as Health Care Workers and certain high risk populations and how to get those doses to those individuals. The centers for Disease Control has asked states to submit plans by the middle of october of this year next month to begin distribution. Now, theres been a lot of back and forth over exactly which date the first vaccine doses, which remember are already being manufactured and made ready for distribution, when will they be available for distribution to the public . The answer, of course, is that the only people who know when a vaccine will be ready are the scientists at fda who will review the science and the Clinical Trial data and determine whether the vaccine is safe and it works even dr. Steven han, the commissioner of the fda whos testifying today does not know when that date will be because the fda will not approve a vaccine until three things happen. One, independent experts overseeing Clinical Trials determine theres enough Data Available to the fda to make a decision. Two, after demonstrating safety and efficacy based on Clinical Trials the vaccine manufacturer submits an application to the fda, and three fda experts conduct their review and make the final determination the vaccine is safe and that it works. Now as to treatments, the second unprecedented story of the United States response to covid19 is the development of treatments. There are five products authorized for emergency use today to help treat and manage covid19 symptoms including remdesivir, certain steroids, blood thinner, convalescent plasma. Operation warp speed officials are optimistic, they say, that more treatments will be identified and developed and in Clinical Trials this fall. With potential for approval or authorization by the end of the year. The most promising are antibody cocktails. Knowing there is some medicine that will help treat covid19 should greatly relieve the anxiety of americans who want to go back to college, back to school, back to child care, back to work and out to eat. And third, a third Success Story is the explosion of fast, cheap, reliable diagnostic tests. After initial missteps our country lost several crucial weeks in distributing the diagnostic tests that would help to identify and isolate those who contracted the virus but since then an unprecedented effort has provided capacity for administering tests. Abbott laboratory says its on track to produce 50 million of its tests a month by october which can produce a result in 15 minutes and cost 5 a test. The government has purchased 150 million of abbotts test to help expand testing in places like schools and Nursing Homes, and im sure well hear something about how that will be distributed today. Congress funded the socalled shark tank or rapid acceleration of Diagnostics Initiative at nih with the objective of developing and deploying tens of millions of new rampant diagnostic tests. Dr. Francis collins dr. Of nih that reported combined these new technologies have the potential to add at least 60 million new tests a month by december. Dr. Collins has told me, quote, this is not the end of the story. There are lots of additional technologi technologies coming through the pipeline many which are point of care and home based tests, unquote. Until vaccines and treatments are widely distributed, this explosion of many cheap reliable rapid diagnostic testicize our best weapon to build confidence among the American People that its safe to go back to school, back to work and out to eat. There should be plenty of tests. In fact, there are now to do surveillance testing of those without symptoms in certain settings like colleges and child care centers. Its important to give credit to this congress and this president for funding this unprecedented knowing full well one or all might fail with a considerable loss of money. Since march congress has appropriated 47 billion for test treatments and vaccines, a large amount of pales in size, though, to the 3 trillion spent to try to ease the pain by shutting down the economy. Its important to give cred lt to the previous president and congress for the important work theyve done the past 20 years to make possible the successes i just described earlier. The doctor, for example, told me that the government today could not be manufacturing four of the vaccines currently being developed if congress had not provided the department of health and Human Services with funding to make awards in 2012, 8 years ago to build three manufacturing plants that would be on standby for the next epidemic. The decision to look ahead then to the next pandemic and on this committee, senator burr specifically had a role in that, the doctor said that was visionary. On march 1 the New York Times reported that the United States is among the countrys best prepared to prevent or manage such an epidemic focused on covid. Why would they say that on march 1st . Well, lets look at nih. For five consecutive years this congress has significantly increased investment in the National Institute of health for biomedical research. And nih is infectious Clinical Consortium was able to rapidly shift ongoing Clinical Trials and enroll volunteers in treatments or vaccines. Or look at the fda. Congress provided fda with specific authorities beginning in 2004, 16 years ago to issue emergency use authorizations for test, treatments and vaccines to respond to Public Health emergencies. Dr. Han has used that authority. Fda has used that authority to authorize 250 tests and five treatments as quickly as possible and also to remove tests and treatments when additional evidence showed they didnt work as well as they should, or look at barta. Congress established the Biomedical Advanced Research authority in 2006, 14 years ago to help Companies Work to get fda safe and effective vaccines out. Barta was able to announce awards for potential covid19 treatment of vaccine candidates just over one month after the vaccine was first reported in china. As i said earlier four of the first six vaccines are being manufactured in facilities built in 2012 for this purpose, for a future pandemic. And then theres been federal support over the years for state, local and hospital preparedness. 21 billion between 2002 and 2017. Cdc has used existing programs to help states retrain work forces, expand lab capacity, planning for a future pandemic from pandemics during the last several years. And even with super computing, these congresses, the last few have increased funding in the department of energy so that the United States is first in the world in super computing. Theyre in our National Laboratories and theyre being used to help develop treatments and vaccines. So i go through all of that to show that several congresses and several president s have done things to help us get ready towards this unprecedented sprint towards vaccines, treatments and tests. And finally id like for this congress to be visionary as well. And while were in the midst of this pandemic to help get ready for the next one. The author of guns, germs of steel says the main thing about this germ is the jet plane, that people can travel around the country and around the world and spread it. And so he concludes that the next pandemic could be next Year Congress should take stock now while our attention is on the current croesus of covid19 many of the witnesses that have appeared before this committee have agreed we have three things to do. One, sustain onshore manufacturing of test, treatments and vaccines. Two, create a sustained stockpile of supplies so theyll available in a public heth emergency and strengthen the Strategic National stockpile. Weve seen time and time again Attention Spans are short. We must act now to stop the cycle of panic, neglect, panic. I look forward to hearing from all our Witnesses Today about how the federal government is continuing to respond and to help state respond, how soon we can expect more treatments and a vaccine for covid19 and what steps we can take now to prepare for the next pandemic. I will now recognize senator murray for her opening statement. Well, thank you very much, mr. Chairman. And thank you so much to our witnesses for joining us once again today. Before we begin i do want to take a personal moment to acknowledge the passing of justice ginsburg, a friend, a role model and a woman who opened doors for all of us with her genius and her relentless pursuit of justice, freedom and equality. This appointment to our nations highest court could not be more pivotal especially as we face down a Historic Health crisis. We are in the middle of a pandemic that has cost more than 200,000 american lives on this administrations watch, has left nearly 7 Million People across our country with new preexisting conditions, and 5. 4 Million People without coverage. Yet none of that has stopped republicans from using every tool at their disposal including the Supreme Court to attack health care and protections for families across our country. Im not going to let anyone forget many of the same republicans who are considering filling this vacancy with a nominee virtually guaranteed to tip the balance of the court against Peoples Health care and the Critical Care coming up this year critically said in march of 2016 said the American People should have a voice in the selection of the next justice and said many times over the past few years they support protections for preexisting conditions. The entire country is going to be hearing what another Supreme Court nominee hand picked by President Trump will mean for their health care and their rights. Now to todays hearing. Back in january i worked to help organize the first bipartisan briefings with the Administration Officials about the covid19 threat. And i wrote to secretary azar shortly after asking what steps we were taking and specifically asking about our diagnostic testing capacity. At a hearing in february i pressed him directly about issues with those tests. And i asked him pointblank if our country was ready. Tragically the clearest answer i got to that question did not come from the Trump Administration. It came back from families in my home state of washington, and it came as a resounding no. By march im hearing from people in my state who believed theyd been exposed but could not get tested. And who had been tested but were left waiting for results. I was hearing from schools in my state including myground daughters they were canceling classes and closing schools. And i was seeing nothing from the Trump Administration to inspire confidence or to act with urgency. Lets be clear, we had a window to prepare for this and the administration missed it. We had a pandemic play book that warned against some of the very problems we were facing. They ignored it. We had a clear understanding of how dangerous this disease could be, and they downplayed it. So much has changed since those early days of this crisis. Now the number of people infected in our country has passed 6. 5 million. The number of People Killed passed 200,000. The number of people without a job and without Health Insurance has skyrocketed. And businesses have been shuttered. Gatherings from weddings to birthdays to graduation to funerals have been delayed or canceled. But one thing has not changed. President trump is still putting politics ahead of Public Health. He is still downplaying this crisis and falsely claiming it will just go away or were turning the final corner. When the reality is cases and deaths are still alarmingly high. Testing and Contact Tracing are frustratingly inadequate. The health disparities, black, latino and tribal communities and other communities of color face are still severe. And we need to repair for the upcoming flu season when experts warn us we could see another wave of cases and yet President Trump is still trying to sabotage the work of our scientists and Public Health experts for his own political ends. As the leaders of Health Agencies on the front line of our response to this pandemic, our witnesses have an important firsthand perspective on this interference. Dr. Han, the food and Drug Administration has a Critical Role to play in evaluating the safety and efficacy of treatments, diagnostics and vaccines. The American People are counting on you to uphold sound, sign terrific principles and the work of agency specialists, scientists. So it is incredibly alarming that this administration has undermined public trust in the work of your agency by spreading conspiracies and pressuring the agency to ignore the science. Earlier this year the administration dangerously promoted hydroxclor kn, and the administration pressured fda to rush through an emergency use authorization for convalescent plasma therapy. And last month secretary azar reportedly overruled you directly and undermined fdas authority when he loosened oversight of Lab Developed tests, a move that allows unreliable tests to flood the market. Then last week secretary azar further undercut your agency by completely barring fda from signing any new rules without his approval, an alarming power grab for a political appointee to make in the middle of a pandemic. Dr. Redfield, the centers for Disease Control and prevention plays a Critical Role providing data and science based Public Health guidance that our families, Public Health professionals, researchers and Health Care Providers rely on for life and death decisions. Yet the trump sfrgz has repeatedly and recklessly interfered with those efforts. We have seen the white house block and contradict critical guidance on reopening for communities and returning to school. We have seen the president spread conspiracies about the death count and misinformation about masks. And the trump Administration Officials have reportedly taken unprecedented steps to hijack the cdcs voice and undermine its credibility. The administration ignored the objection of cdc scientists and posted guidance under cdcs name advising restricted access to testing, a move that was immediately criticized by Public Health experts and has since thankfully been reversed. Political appointees have demanded to oversee and manipulate the agencys morbidity and mortality weekly reports. And last week you confirmed the administration took hundreds of millions of dollars out of your budget for a feel good pandemic ad campaign spearheaded by a trump official that believed cdc was part of a, quote, deep state conspiracy. In which cdc inexplicably has no role in which they have not even indicated will be reviewed by your agency to make sure it is based on facts and science. And if this werent all bad enough after your testimony before Congress Last week the president said you were, quote, confused. That you made a mistake and had given incorrect information. All of this raises serious concerns about the agencys decision monday to put out guidance with new information on how this virus is transmitted only to immediately reverse course and pull it down. And dr. Fauci, youve been a trusted voice on Public Health issues in this country for decades. Yet the trump Administration Officials have tried unsuccessfully to dictate talking points to you and undermine your credibility through Opposition Research and in an oped. The president himself even retweeted a message calling for you to be fired. Any of these examples of political pressure would be alarming on their own. But together they paint a clear pattern of interference that is down right terrifying. The Trump Administration didnt just start its political interference yesterday, and we are not going to expect them to cut it out tomorrow. So congress has to make it stop. The president has made it clear where he stands between picking between politics and science, politics and Public Health, politics and the safety of our country. Now each of us has to do the same. Yesterday senator schumer and i along with 30 of our democratic colleagues introduced the science and transparency over politics act. It will create a task force to create a thorough investigation into political interference in our Public Health agencies. And i do hope every republican who has spoken out about how important it is we stick to the science will support that bill. Because you cannot stand for science if you will not stand against political interference. Im also going to be asking our witnesses more about this as well because its so critical we know what political pressure theyve been under and what is being done to resist it. Finally, mr. Chairman as this may be the last hearing of this congress i want to recognize again the work weve done in this committee in your time as chair. The list of major bipartisan bills weve gotten signed into law the past years, you know them. Opioid, and more. The kind of bipartisan approach we used to get those bills passed is going to be critical if we are finally going to take the steps we need to take to address the pain of this pandemic, which is why the current state of discussions to pass much more needed relief is so frustrating. Republicans didnt offer anything for months. And after they finally put forward a proposal, they didnt even sit down with us to move towards common ground. Instead they moved further away from us with their next proposal. I think weve shown by example that is just not how bipartisan negotiating works. So im not done pushing for republicans to come back to the table on a new covid19 package, put partisanship aside, put our Families First and Work Together to respond to this pandemic with the kind of sweeping response that is so clearly needed. Thank you, mr. Chairman. Chong, senator murray. Well now introduce our witnesses. We ask them to summarize their comments in 5 minutes each. Our first witness is dr. Anthony fauci, director of the National Institute of allergy and Infectious Diseases at the National Institute of health. Hes held this position since 1984, led the agencys Research Related to hiv aids, influenza, malaria, ebola and other Infectious Diseases. Hes advised six president s on domestic and global Health Issues. He was one of the principal architects of the president s emergency plan for aid relief. Next is dr. Robert redfield. Aez the director at the u. S. Centers for Disease Control and prevention for more than 30 years. Hes been involved in clinical Research Related to chronic human viral infections and Infectious Diseases especially hiv. He served as the founding director at the department of ret row Viral Research in the militarys hiv research program, retired after 20 years of service in the u. S. Army medical corp. Third witness, admiral brett giroir. Hes the assistant secretary for health in the u. S. Department of health and Human Services. He oversees the Commission Core of key Public Health programs. Specific to covid19 hes taken on testing and focused on increasing the number of tests that we can do with existing technology. His federal Service Includes directing the Services Office of the Defense Advanced Research projects agency and several other important responsibilities. Finally we will hear from dr. Steven han, commissioner of the u. S. Food and Drug Administration, the fda. Before joining fda he held leadership roles as chief medical executive at the university of texas mdm Cancer Center and as chair of the department of radiation oncology at the university of pennsylvania. Early in his career he was a senior investigator at the National Cancer institute. At nih additionally he held the rank of commander in the u. S. Public Health Service commission corp. Welcome again to our witnesses. Dr. Fauci, lets gen with you. Mr. Chairman, Ranking Member murray, members of the committee, thank you for giving me the opportunity to speak with you today briefly on the role of the National Institute of Health Research on addressing covid19. As i mentioned to this committee in the prior hearing the nih and niad has research to address covid19. The first is to improve the fundamental knowledge of the virus itself, viral biology and clinical manifestations resulting from infection. We have continued to push the frontier of understanding this virus particularly with regard to the confirmational structure of the spike protein which serves as the basis for all of the vaccines that are being pursued now which ill get to in a moment. In addition, there have been a number of important clinical observations that we will be pursuing in the future. I bring to your the fact that a number of individuals who vire logically have recovered from infection in fact have persistence measured in weeks to months of symptomology. They have fatigue, fever and involvement of the neurological system as well as cognitive abnormalities such as the inability to concentrate. In addition we found to our dismay that a number of individuals who have completely recovered and apparently are asymptomatic when they have sensitive Imaging Technology such as Magnetic Resonance imaging or mri are found to have a disturbing number of individuals who have inflammation of the heart. Tease are the kinds of things that tell us we must be humble and we do not completely understand the nature of this illness. Next with regard to diagnostics you know we have the radx Program Going to ain the next several months allow us to have considerable point of care testing am. Moving onto therapeutics i mentioned to this committee some time ago the nih put together an expert panel for treatment guidelines which is a living dume that reviews the literature as well as the areas of expertise that are prepublication to Health Clinicians throughout the world to address the clinical components of this outbreak. I must tell you that as of last night there have been 4. 5 million views of this treatment guideline, so it clearly is helping people throughout the world. I want to mention two of the drugs that have actually now been part of these guidelines. Remdesivir has been shown in a randomized placebo control trial to diminish the time to recovery in individuals who are hospitalized who have lung disease. In addition a common used steroid has been shown in a randomized placebo controlled trial involving more than 6,000 individuals has been shown to clearly and significantly reduce the 28day mortality. In addition theres a number of other treatments including antiviral convalescent plasma still being tested in randomized control trials and you mentioned appropriately and connectly we feel optimistic about money clonal antibodies. And when an individual in a given family gets infected if you give monyclonal antibodies can you prevent the spread of the virus. And finally and importantly the issue of vaccine. There are Six Companies the federal government is playing a rule in either helping to develop subsidizing or supporting the Clinical Trials. Were harmonizing the trials so that information from one can be applicable to another. Currently there are three platform candidate vaccines that have entered into phase three trial. Very soon there will be a fourth. As i mentioned to this committee, we feel cautiously optimistic that we will be able to have a safe and effective vaccine although there is never a guarantee of that. Early studies in animals and in human phase one and in phase two indicate that individuals induce a response that is comparable to if not better than natural infection. And so as these trials go on we predict that some time by the end of this year lets say november or december we will know whether or not these are safe and effective. And as you mentioned, mr. Chairman, right now doses of this vaccine are being produced so theyll be ready to distributed. We feel strongly if we have a combination of the adherence of the Public Health measures together with a vaccine that will bestributed to people in this country and worldwide we may be able to turn around this terrible pandemic that which we have been experiencing. Thank you, mr. Chairman. Happy to answer questions later. Thank you, dr. Fauci. Lets go to dr. Redfield and then admiral giroir and then dr. Han. Dr. Redfield, welcome. Thank you, chairman alexander, Ranking Member murray and members of the committee. And i want to thank you for the opportunity to be here today. On behalf of cdc i also want to thank you for your continued support of our Public Health professionals and their lifesaving work that theyre committed to 24 7. Over 6,700 cdc staff have been engaged in our agencys covid19 response so far. And more than 1,200 have been deployed to more than 200 locations, tribal nations in the United States and abroad. I know that you joined me in expressing our collective deep gratitude to the women and men of cdc for their resilience, their dedication and their service to our nation. Throughout this Global Pandemic cdc has brought its science expertise to the front lines, grounded in science and data conducting rapid investigations of disease outbreaks that identify the highest risk populations and settings, and putting in place measures to prevent further spread of covid19. Understanding which populations are most at risk and how this virus spreads in various settings is critical in developing guidance and protecting the health of americans. As you are aware in the United States we are approaching nearly 7 million cases and decidedly over 200,000 deaths. Every death means that a loved one was lost. But there is some progress to report. Since the pandemic peaked weve experienced nearly a 50 reduction in pandemic cases, and theres also been significant improvement in mortality particularly in the elderly. For example, during the peak of the epidemic april 17th a 75yearold american had a mortality of about 46. 8 per 100,000. And by the end of august the numbers had significantly declined to about 10 per 100,000. These improvements, however, do not mean we can let our guard down. Over last week we had an average of over 40,000 cases and nearly 800 daily deaths. I do want to emphasize the shift in age in these case counts. The 18 to 25yearolds currently make up over 26 of new infections and more than any other group. Its imperative that these young adults recognize that even though theyre unlikely to get seriously ill from this virus, they are major contributors to spread of covid19 in our country at this time. In order to understand what proportion remains at risk cdc is currently performing large scale serology testing across the United States. Preliminary results appear to show most americans have not been infected with the virus. We hope to be able to post the analysis of the first round of this study in the next several weeks. As i stated before the cdc encourages all americans to embrace the powerful Public Health tools we have right now, wear a mask, maintain social distance, practice routine hand washings with vigilance, be smart about crowds and stay home when youre feeling sick. And as we move into the fall i want to add one more critically important step, flu vaccination. Flu vaccination is safe. Cdc encourages all americans to embrace the flu vaccine with confidence for themselves, their families, loved ones and communities. This year the cdc has purchased an additional 9. 3 million doses of adult flu vaccine as well as 18. 5 million doughs f 18. 5 million doses for children. This is a significant increase than previous years. When combined with the tools i mentioned above this could help our nation avert a very difficult fall and lessen the burden on our Health Care System is save lives. To further strengthen our Public Health cdc awarded 65 million through the existing cooperation agreements to begin to scaleup staffing preparedness for the flu season. And also developed a new diagnostic test capable of measuring both influenza a and b as well as covid 2 using a single specimen and a single assay. This will better help our Public Health professionals. And im also announcing today an additional 200 million funding from the cares act as the first step to help individuals complete their individual plans and implement for their Covid Vaccination and followup to the play book that we released last week. Cdc is an integral part of operation warp speed and leveraging our expertise to support distribution and administration and monitoring of the future covid19 vaccines. In yard nation with operation warp speed cdc is working closely with state and local Community Organizations to on their detailed flexible plans for Vaccine Distribution as ive emphasized in prior hearings now is the time to commit to sustained investment and core capabilities of Public Health. Day to day analytic, work force expansion and Rapid Response capabilities. Years of underinvestment in public has led to a system thats been sorely tested in this pandemic. Covid19 is the most significant Public Health challenge that our nation has faced in more than a century. Nows the time to build not only the Public Health our nation needs but the capability the people of our nation deserves. As we work collectively to fight covid19 and the pandemic, cdc and all the outstanding men and women of the cdc remain strongly committed to our mission to protect all americans from disease, threats and to save lives. I want to thank you for your time, and i look forward to your questions. Thank you, dr. Redfield. Admiral giroir, welcome. Chairman alexander, Ranking Member murray and distinguished members of the committee, i am honored to update you on our nations efforts to combat covid19 with the specific focus on testing. Recommended Public Health practices like wearing a mask, avoiding crowds, especially indoors and washing your hands combined with smart testing is the formula to effectively slow the spread, flatten the curve and save lives. By providing county specific guidance to governors on a weekly basis, expanding and mchgimch managing the right supplies, providing it right test tuesday the right person at the right time and distributing safe and Effective Therapeutics we are seeing promising results. Specifically since the postmemorial day peaks in Community Spread the number of new cases is down as dr. Redfield just testified. The number of people hospitalized of covid19 is down 54 . The number of people in intensive care unit due to covid is down 65 . And deaths associated are down 32 . But let me emphasize that to sustain these gains we must continue our disciplined mitigation efforts especially Wearing Masks when we cant physically distance, avoiding crowds particularly indoors and increasing our screening and surveillance testing. Now specifically regarding testing, the nation has performed over 106 million tests for the veers causing covid19. On ten separate days we performed over 1 million tests per day. The federal government has purchased and delivered over 106 million swabs and 88 million tubes of media to states, tribes and federal partners. Starting on april 7th we have purchased and delivered to Public Health laboratories in every state and the Health Service over 2. 5 million abbott i. D. Now point of care molecular tests. We have implemented federal surge testing sites in 20 different cities helping to squelch emerging outbreaks typically among asymptomatic young adults. We are now at an Inflection Point in testing. This month we will have available on average 3 million tests per day, nearly of of which will be rapid point of care. We have been building towards this Inflection Point, and i previously testified to its coming several times over the past months. Now, let me discuss two specific testing initiatives. Protecting the elderly has been, is, and will continue to be a foremost priority for this administration. So on july 14th we announced that every single eligible nursing home in america would receive a point of care instrument and testing supplies. We have delivered on this promise. All 13,850 eligible Nursing Homes have now received a total of 13,985 instruments and over 4. 9 million rapid point of care tests ahead of schedule. On august 27th after months of planning and only one day after its fda authorization the administration announced a 760 Million Contract with abbott for the delivery of 150 million rapid buy next now point of care tests. It does not require an instrument, delivers test results in 15 minutes or less and costs 5. We have already deployed 65,000 of these tests in support of disaster operations in california, oregon, texas and louisiana. Last week we also shipped 974,000 tests to nurses homes in areas of Significant Community transmission. 541,000 tests to over 5,500 assisted living facilities and 300,000 tests to the indian Health Service. This week well be shipping 349,000 tests to historically black colleges and universities. In the coming weeks we will begin shipping millions of tests per week in support of our teachers and our students to open and keep open our k12 schools. Now i would like to close by recognizing my fellow officers in the Public Health service, the Uniformed Service which i have the honor of leading. 4,172 women and men have deployed 8,918 times in direct support of this pandemic. On the diamond princess cruise ship in japan to our Community Based testing sites to fema and our task forces and to our Nursing Homes and field hospitals in our hardest hit communities. I thank each and every one of these officer and their families, and on their behalf thank all of you in congress for supporting our Training Needs the establishment of a Ready Reserve to supplement our ranks during inevitable future national emergencies. Thank you for the opportunity to provide these remarks. Thank you, admiral giroir. Dr. Han, welcome. Good morning chairman alexander, Ranking Member murray, and members of the committee. Over the past several months ive had the honor to work shoulder to shoulder with fdas career staff as we fought a historic pandemic that has altered the lives of every american. I am proud of all fda employees and how they have measured up to this extraordinary challenge. The efforts of the fdas expert work force are critical to ensuring the safety and health of the American Public at any time, but it is magnified during a Public Health emergency. Of course our work on covid19 and noncovid issues comes with unprecedented public scrutiny and sometimes criticism. Any agency that has the broad responsibilities and far reaching impact of fda particularly involving issues of Public Health cant expect to do its job without inviting controversy and disagreement but its also essential the criticism we get never shakes the underlying faith the public has and should have in fda and our commitment to protecting the Public Health. I am confident in the decisions that are being made related to covid19 and that will be made in the coming months as we continue to address the challenges of this pandemic. Now, i know theres been particular attention paid to a few of the decisions the past s months. I want to assure you and emphasize that every one of the decisions we have reached has been made by career fda scientists based on science and data, not politics. Fda represents science in action. Often, we must make realtime decisions based on ever evolving data concerning a previously unknown, highly contagious virus that we are still learning about. And sometimes it is necessary to reverse decisions as new data emerges. This is inherent in the emergency use authorization process, otherwise known as eua, and it is akin to how a doctor might approach a patient in an emergency situation. Constantly updating a treatment plan as new data emerged. So in the interest of transparency, i would like to use this opportunity today to lay out the process we will use to review vaccines for covid19. When a vaccine sponsor reaches the conclusion that the data from its phase 3 Clinical Trials are adequate to submit to fda, they will decide whether to apply for approval or emergency use authorization. This will be based upon the trial meeting prespecified success criteria that were established by that sponsor. This is really important. They should also be consistent with fda recommendations regarding those criteria. Fda will receive that application or submission and our career scientists will review its safety and efficacy data as well as manufacturing quality and consistency data. Fda made clear recommendations in our june 30 guidance regarding the safety and effectiveness of vaccines so we can see that prior to the approval process. We will also work to provide Additional Information so that it is clear what we expect to see should a sponsor choose to submit an emergency use application, emergency use authorization application. As we have indicated previously, we plan on seeking advise from the vaccines and related Biologics Products Advisory Committee comprised of independent members who have been screened for ethics conflicts. The safety and effectiveness data and the committees decision will be public, although we will need to adhere to confidentiality requirements. The public will have an opportunity to comment. The process will be transparent and independent. Fda career staff will then take the Committee Input into account as they make their decisions regarding the application or eua request. Now, before we were to issue an eua, if that were to happen, fda would have to determine among other things that the statutory standard is met. We expect that this would be demonstrated based on adequate manufacturing data to insure a vaccines quality and consistency and data from at least one well designed phase 3 Clinical Trial that demonstrates its safety and efficacy in a clear and compelling manner. Let me emphasize that again. Data from at least one well designed phase 3 Clinical Trial that demonstrates its safety and efficacy in a clear and compelling manner. Fda also expects that an eua quest would include a plan for active followup to monitor safety among individuals who receive the vaccine. In the end, fda will not authorize or approve a vaccine that we would not feel comfortable giving to our families. On behalf of the 17,000 plus employees of the fda, i want to make the following commitments today to the American Public and this committee. Fda will not authorize or approve any covid19 vaccine before it has met the agencys rigorous expectations for safety and effectiveness. Decisions to authorize and approve any such vaccine or therapeutic will be made by the dedicated career staff at fda through our thorough review processes and science will guide our decisions. Fda will not permit any pressure from anyone to change that. I will fight for science, mr. Chairman. I will fight for the integrity of the agency, and i will put the interests of the American People before anything else. Thank you, and i look forward to answering your questions. Thank you, dr. Hahn. Well turn to questions from senators. We have full participation today. So i would like to ask the senators and witnesses to keep your exchanges within five minutes so all senators will have a chance to participate. And for my five minutes, i would like to ask for the courtesy of short answers so i can ask all my questions. Dr. Hahn, let me go back to two things you said. Who makes decisions about safety and efficacy at the fda . Do you do it . Does career scientists do it . Or does the white house do it . Career scientists at the fda do it. Thats very clear. Im briefed on all Major Medical product decisions. Overruling a centers decision is a very rare event. I have expressed on multiple occasions my intention and have done during this covid19 to make sure that those decisions are made by career scientists in the centers. You refer to this, but once fda approves a vaccine, as we have said today, were going to have tens of millions of doses ready, none can be distributed until fda approves it. Will you be willing to take that vaccine for you and for your family . Absolutely, yes, senator. Mr. Chairman, i have the complete and absolute faith in the expertise of the scientists who are terrific at fda. If they were to make a determination that a vaccine would be safe and effective, i would do that and i would encourage my family to take the vaccine. Dr. Fauci, you have been around since the reagan years. You have seen lots of diseases, pandemics. And lots of responses to it. Is the administration cutting corners in safety and efficacy in its effort to produce vaccines and treatments rapidly . Not at all, mr. Chairman. In fact, the rapidity of where we are right now is a reflection of the technological advances in Vaccine Platform Technology as well as the risks that were taken financially so that well have doses available when the decision is made by the fda as to the safety and efficacy, as you have heard, from dr. Hahn. So theres no cutting corners. Were risking the taxpayers money, but were not risking safety and efficacy, is that your testimony . Yes, it is. Thats absolutely correct. Now, millions of students are going back to thousands of colleges, and theyre inevitably are outbreaks of covid19, dr. Fauci. Is the smart thing for College Administrators to do is to send those College Students home when the outbreaks occur on campus . Absolutely not, mr. Chairman. They should be able to accommodate the students in a facility, maybe a separate dorm or a separate floor so they dont spread among the student body, but do not send them home to their community because of the likelihood of then receding infection in the community. Dr. Fauci, i have listened to your testimony for the last several months. Some people say your message is that you want to lock down the country in order to stop the spread of the vaccine. Is that accurate . Thats completely inaccurate, mr. Chairman. I have said multiple times we do not need to shut down if we follow carefully and prudently the recommendations and the guidelines for opening america again. I believe we can do that safely and still accomplish the goal of opening the economy again. Dr. Fauci, some people said it was political to ask the states to get ready to distribute the vaccine in october. Is that true or false . Thats false. The reason that was done is because we want to make sure that when a decision is made that we will be ready to distribute the vaccine. Dr. Redfield, the British Ambassador told me yesterday the government studies in the United Kingdom said based on serology testing that 5 to 25 of their countrys population depending on the location has been exposed to covid19. What about the American Population . How many of us have been infected by covid19 . Thank you, mr. Chairman. Cdc is in the process of a very large sequential study across the entire United States measuring serology. As i mentioned, the preliminary results on the first round show that a majority of our nation, more than 90 of the population, remains susceptible. It varies in different geographic parts, from states that have less than 1 with evidence of previous infections to some that have more than 15 , 20 , and one as high as 24 . Well have that finalized and probably published in the next week or so, but it does show that a majority of americans are still susceptible to this virus. Just so i understand, youre saying based on the preliminary indications from your sear logical testing and studies that as many as 90 of americans are still havent had the virus yet . Yes, sir. Thank you, dr. Redfield. Senator murray. Thank you, mr. Chairman. Dr. Redfield, we know that a lot of patients avoid getting a necessary test or a treatment because of cost. And i have been pushing to make sure insurers have to cover Covid Treatment at no cost to patients as we fight this deadly disease. Meanwhile, President Trump, as we all know, is fighting at the Supreme Court to overturn the Affordable Care act, which would leave 23 million more people without Health Insurance and allow insurers to once again discriminate against people with preexisting conditions leading to higher costs. Covid19 actually itself could become a preexisting condition. So dr. Redfield, let me just ask you straight out, will increasing the number of uninsured by tens of millions and increasing costs for the 133 Million People with a preexisting condition make it easier or harder to contain this pandemic . Thank you, senator, for the question. Clearly, access to Timely Health care is critically important in terms of Public Health and in terms of this pandemic, its also true, access to timely Effective Health care remains an important Public Health measure. I would take that as if the case is overturned this will make it a lot harder to control this pandemic. Dr. Redfield, we have got to understand what happened with cdcs testing guidance for asymptomatic people exposed to covid19. Im relieved that cdc reversed course on friday, but i am concerned about why cdc put out guidance that contradicted the widespread views of the medical and Public Health community, was not drafted by cdc scientists, and did not undergo cdcs strict scientific review process. Dr. Redfield, how is it a document published on cdcs website was not drafted by cdc scientists nor underwent the agencys strict scientific review process . Senator, the original testing guidance of august 26th had full engagement of individuals at cdc. But it was a cooperative document that included the assistant secretary as well as the Coronavirus Task force. I will say the intent of that document, as i mentioned before, and i tried to clarify in my statement on august 27th, was never to limit testing, never to limit testing of asymptomatic individuals. The attempt was to reengage the medical and Public Health community as part of testing so that there was a Public Health action that happened as a consequence of every test. It became progressively apparent that the guidelines were not interpreted in the manner in which we had intended them to be interpreted, and thats what led me to realize we had to put out a clarification to make it explicitly clear that we believe very much that asymptomatic transmission is an important part of the transmission cycle of this virus. Those individuals when they have been exposed should in fact be tested. I appreciate that answer. I dont hear you answering the question, but let me ask dr. Giroir. You said in at interview that you coordinated editing of the guidance. The american medical association, the Infectious Disease society of america and state Health Departments recommend testing for asymptomatic people. I want to ask you on what scientific basis did members of the task force take a different position . Scientific evidence. So thank you, senator murray. I want to reiterate what dr. Redfield said is that the original guidance that was published by the cdc with the i appreciate that. With the approval of dr. Redfield and the senior scientists did not, unequivocally, it did not recommend against testing asymptomatic individuals. In fact, there are multiple sentences that said it is important to test asymptomatic individuals but in certain circumstances its important to do that within the context of Public Health or medical supervision. Thats all it said. It was widely misinterpreted. It was widely misrepresented. And dr. Redfield told the reason. We have done fda guidance, clea guidance, and i issued a prep act declaration to assure that providers could test asymptomatic individuals. You quietly updated another guidance identifying aerosols as a common root of the virus that cause s covid19. On monday, cdc reversed course. You told me it was poersed in error, but given the Trump Administrations track record, the reversal raises significant red flags. So here is my question to you. If i want the best guidance on the latest science so i can protect myself and my family, can i trust cdcs website to give me that information . Yes. Im going to say again that my agency and myself, were committed to data and science. And to give the American Public the best Public Health recommendations we can based on that data and science, and be open, if necessary, if the data and science changes, to modify that guidance based on that new data. But were committed to data and science, and that will be the grounding of how we make those recommendations. Mr. Chairman, im out of time, but i am concerned the American Public needs to be able to trust the decisions that are made and whats posted on that website needs to be trusted. Thank you, senator murray. Senator enzi. Thank you, mr. Chairman, for continuing to hold these regular hearings so that we and the American Public can check on the federal efforts to fight the coronavirus. I know it can be hard for our witnesses to find the time to testify since theyre all working very hard to respond to the pandemic. But i appreciate them being here and their information. Im glad to see that were making progress in planning how we distribute a safe and effective vaccine when its ready. Im optimistic and pleased that there are all these efforts going forward. I hope were thinking through how to insure access, though, to rural areas. One of the things that im asked about, people have heard that some of the vaccines this is a question for dr. Redfield and dr. Hahn. Some of the vaccines in phase 3 testing evidently need to be stored at extremely cold temperatures. Thats even by wyoming standards, and that would be potentially as low as negative 94 degrees fahrenheit. Hospitals and Nursing Homes, pharmacies, doctors offices, might all be places where americans could go to get their shots. However, they dont have the specialized freezers that would be necessary to store the vaccine. Especially in rural areas. So very few of those help. Is there another solution or how can we insure sufficient freezer and Storage Capacity so theres access to the vaccine and it isnt just limited to major cities . Thank you very much, senator. Again, theres a total commitment to work that this vaccine is distributed in an equitable and fair way across our nation. The funding i announced today that will get out to the individual states to be able to really begin to operationalize their plans on the playbook is critical. And each jurisdiction is going to have to address those issues. Particularly as you looked at the importance of cold change and how theyre going to maintain that. Clearly, we have this is not something that we dont routinely do. I mentioned before, cdc routinely administers and distributes over 80 million vaccine doses a year. Through our routine work, were going to build on that. Obviously, the ability to bring all the pharmacies in is a really important step, but these microplans that your state, the state of wyoming, will do, will identify what other gaps are there, and over the next four, six, eight weeks were going to need to figure out strategies that are going to fill those gaps to insure theres a proper cold storage for the Vaccine Distribution throughout this nation in an equitable way. Were committed to making sure that happens. Dr. Hahn, do you have any comment on that . Well, fdas role, senator enzi, in this, is to insure that the controls around manufacturing and storage are followed. If in fact a vaccine is authorized or approved that requires such cold storage as you mentioned, we will provide Technical Assistance and well work with cdc to insure that that happens. Thank you. Director redfield, do you anticipate that once the food and Drug Administration approves a vaccine that the center you kind of touched on this the centers for Disease Control and prevention will have to work with the states to develop new, more detailed Vaccine Distribution plans . Or will the work the states are doing in advance suffice . Senator, its very important, and i want to stress, this is why its so important. The playbook we put out last week and the funding we announced today, that we get these plans executed. We wanted to see the plans completed by october 16th so we can interact, share best practices of other states, to try to get these plans as rock solid as possible. Im confident there will be some things that werent thought of that will have to be dealt with as they come upon us. But its my expectation that each of the plans we have done the microplanning now in minnesota and north dakota, california, florida, and philadelphia over the summer, just to get a sense on the complexity of it. Now, were looking for each of the 64 jurisdictions to complete that by october 16th, and its our hope that thats going to really lay out the individual plan to get this vaccine equitab equitably distributed in that jurisdiction recognizing there will be things that will come up as we have to Work Together to deal with as we see them, but hopefully well be 95 of the way there based on the planning between now and october 16th. My thanks to you, mr. Chairman, and Ranking Member. Thank you, senator enzi. Senator casey. Mr. Chairman, thank you very much. I want to thank our witnesses for appearing and for their work. This week, we have announced to the world that we have reached the 200,000 grim milestone of deaths in america from covid19. That number translates in pennsylvania into 8,000 deaths. So as were thinking about those, all those we have lost, we now have to consider the possibility that covid19 could be and likely will be considered a preexisting condition just as the Affordable Care act could be struck down by the Supreme Court in early november, at least the argument is starting then. At the same time, weve got to consider the ravages of this disease, the covid19 disease, in the context of Nursing Homes. I released yesterday with senator wyden a report, ill just hold up the cover of it, but the headline on the report is the cost of inaction, 11 deaths an hour. 11 deaths an hour. That means in the months of july and august of this year, 11 nursing home residents died from covid19 every hour. In total, when you look at the total number from the beginning of the pandemic, more than 78,000 residents and workers in longterm care facilities have died from covid19. And unfortunately, the Trump Administration has no effective strategy. No effective plan in place to reduce this number. Either to reduce the death number or the case number in longterm care settings. This is an american tragedy. Theres no excuse for these numbers to keep going up. We should not allow the next couple of months to transpire and have the number of nursing home deaths or the nursing home case number go up again. That is not the america we should be. Now, the majority in the senate could be doing something about this. The majority in the senate has been obsessed with confirmation votes, all kinds of confirmation votes. All summer long. And we did a defense bill as well. But mostly, almost all of our votes were on confirmations. Now the Senate Majority is obsessed with getting a confirmation vote on a Supreme Court justice. I just have one question for the majority. When will Senate Republicans and the Trump Administration become obsessed, yes, obsessed with reducing nursing home deaths . Now, let me get to our winces. I want to ask a question that dr. Hahn was already kind enough to answer, which is about the vaccine. And his response to that in terms of his own family, his own person. One of the most important challenges we face in developing and then distributing and administering a safe and effective vaccine is public confidence. As a way to demonstrate faith in the integrity of both the approval process and to assure the American Public that vaccines are safe, i would ask the other three members of our panel if they will commit to receiving the covid19 vaccine in public view once one becomes available and is authorized and approved by fda. Starting with dr. Fauci. Thank you for the question, senator casey. Yes, i have said that in the past, that if a vaccine is shown to be and proven to be and authorized by the fda to be safe and effective, i certainly would take that vaccine. I would recommend to my family that they take that vaccine. Yes. Thank you. I have every confidence in the fda process to provide us a safe and effective vaccine. I would have no hesitancy to take that vaccine. I would have no hesitancy to recommend to my family. I think the question is a little bit inappropriate. People need to read that vaccine. They need to understand, have a discussion with their physicians or providers before you ask anyone to commit to that. But i just want to tell you, i have complete confidence in the fda process. Dr. Redfield . Yes, senator casey, yes, absolutely. As i would with my wife, children, and 11 grandchildren, i would recommend it to all of them and of course, myself, i would take it. I have total confidence in the fda and the process of getting us a safe one. If they give an eua, i am confident it will be a safe vaccine, and im ready to take it. Dr. Redfield, i have a question for you on state immunization Information Systems in light of the Vaccine Program interim playbook. Just have one question before high time expires. How many jurisdictions immunization Information Systems meet all of the standards set forth in the playbook today . I would have to get back to you to be able to answer that specifically. I will say we are building on, as i mentioned, the system we regularly use in these 64 jurisdictions to distribute 80 million vaccine doses a year. In addition, there will be Additional Information capacity that will be put into where there are new points of service where that technology currently doesnt exist. But ill have my team put together a comprehensive answer for you. Thank you, senator casey. Senator burr. Thank you very much. Welcome to all of our witnesses and our thanks to your agency and the many workers who work on this, and let me say to senator casey, answering his question, the majority has been focused on pandemic since 2002. When we first started passing legislation to create in many ways the architecture that we fall under today and the protocols that allow dr. Hahn, dr. Fauci, dr. Redfield, admiral giroir, to do in fact what theyre doing, and we thank you for that. Dr. Hahn, have we made up new protocols for the review of a Covid Vaccine or are we simply following the protocols that we have used for every vaccine that every member of this committee, every member of congress, and the American People have always seen as a Gold Standard . Well, with respect to our approval or authorization of medical products, fda does represent the Gold Standard. The statutory definition for eua is different of course than for an approval, but were following those criteria, with respect to our performan ancance during co, i want to give you a few examples because in fact youre correct. Fda does represent the Gold Standard. Our scientists are incredible. They have done really remarkable work here. And one of the major things that distinguishes us from other regulatory agencies around the world is that we actually look at the primary data. We dont just look at a paper. We dont just look at a press release. We look at the primary data. Our scientists analyze that data, and then we draw conclusions from that data. We did that with remdesivir, with convalescent plasma. Were doing that with tests. And so those are the sort of things that fda does that i believe represent the Gold Standard and allow us to have great confidence in the decisions that our career scientists are making. Dr. Hahn, would it be appropriate to say that the Clinical Trials, phase 3 Clinical Trials that are now going on for now four manufacturers, the fourth announced this morning, are the most expansive and diverse trials we have seen in recent memory, just simply because theyre global trials and typically we havent picked up that International Data until post approval in many cases and reviewed it. Senator burr, its correct to say they are among the most diverse and expansive trials i think thats a reasonable way to put this. We were very clear in our june 30 guidance about what we needed to see with respect to efficacy. A floor, not a ceiling, a floor of 50 , which led to the power calculations in these trials and therefore 30,000 plus volunteers in each of these trials. And if you think about the number of trials that are ongoing, plus the studies that were done before in phase 1 and phase 2, a great, if you will, number of people who would have received these vaccines which will give us the data we need to see in order to make the determination, so these have been very robust. The private sector has responded, the government has been responded, and its been a great effort to get these trials together. Dr. Hahn, you talked about the steps an applicant would go through and it would be their decision to approve for emergency authorization or approval. The one thing you didnt mention is the data safety monitoring board, dsmb, which looks at the data prior to the application coming to the fda. Is that in fact correct and is that another safety step . Senator burr, exactly, another check and balance, if you will, in addition to the others. Let me just explain that, if you will, sir. When a sponsor, someone thats developing a vaccine, a company performs a phase 3 Clinical Trial, theres something called a data safety monitoring board. That is an independent board, and they have set checkins to look at the data. Now, when they meet, they can make a couple determinations. One, if theres significant safety issues, they could stop the trial because of safety issues. Number two, they could do whats called a futility analysis, meaning that continuing that trial wont do any good because theres not a statistical probability that it will reach the primary end point, that it will be successful. And then of course, they could have met the prespecified criteria around effectiveness in the case of the vaccines, prevention of infection. And that would be another criteria that would be used to say okay, the data are mature. Give it to the company and the company can put that into an application to us. Thank you. Dr. Fauci, i want to turn to you real quick because the Moderna Vaccine works off a Technology Platform that you actually created at niad. Are you confident of the process thats going on at the fda that will in fact review the application of Clinical Data from that platform and as an addon to that, would you also answer for members of congress, for the husband and wife that come to us and say, my husband got covid, and i, the wife, didnt get it. How with a highly transmittible infection like this, can two people live together and one be positive and one never get positive, if theres an answer, i would love to be able to hear it . That happens all the time with infections, senator. That although a virus can be highly transmissible, theres a great degree of variability of a persons natural resistance to a particular type of an infection. So although a highly transmissible virus usually has an attack rate that is high, we see all the time individuals who are exposed to someone with an infection who do not get the infection. If you look at the population as a whole, you see the kinds of things that were seeing as this pandemic evolves that it is highly contagious. We had the same situation where you had hiv, where individuals were living with a person who had sex on a regular basis with someone with hiv, and they never got infected. Whereas another person could have sex one time with a person with hiv and get infected. Thats the nature of variability to susceptibility. So its entirely conceivable. Your confidence in the fda review and the Technology Platform . Were well over time. Absolutely, the answer is yes, im quite confident in the fdas ability to review that technology and determine safety and efficacy based on the data of the trial. Thank you, senator burr. Senator baldwin. Thank you, mr. Chairman. Dr. Redfield, in april, the cdc staff conducted an investigation into a covid19 outbreak at a meat packing plant in south dakota. Following the investigation, your staff sent a report to the state that is south dakotas department of health, that included strong safety recommendations that cdc determined were necessary to stem the transmission of covid19 at the plant. That report was dated april 21st of this year. Last night, it was reported that your office intervened and ordered that the safety recommendations be watered down. The next version of that memo, dated the following day or april 22nd, essentially adds the words if feasible to those strong safety protocols over and over again throughout the document. Telling the plant essentially that these recommendations were voluntary or optional. Workers continued to work shouldertoshoulder at that plant, and the plant ignored the safety guidelines. To date, at least 1200 workers from that very plant have been infected with covid19 virus. 34 have been hospitalized. And four have died. I will also note that in that same time period in april, on tuesday april 28th, thats when President Trump issued his executive order basically naming meat packing as an essential industry and meat packing workers as essential workers. I would like to enter the two documents i referred to, the april 21st and april 22nd safety recommendations concerning this meat packing plant, if thats okay, mr. Chair, i would like unanimous consent to do so. I think i heard somebody indicate that i got unanimous consent. Dr. Redfield, why did your Office Demand that these recommendations be watered down . Thank you very much, senator. I wouldnt characterize it the way that you did. What i would say is that the field teams that we had that were in on the smithfield plant investigation that youre referring to had a report that they did in the field, and they shared it with the local south Dakota Health department. One of the critical things that needed to be stressed in that report was that cdc is not a regulatory authority. These were, in fact, recommendations. The department of labor and osha have regulatory oversight, and their report can direct that regulatory oversight. Our report was recommendations from an epi aid, and as that document was reviewed, we wanted to make clarification to make sure people understood ours was a recommendation and not a regulatory requirement. Thank you. And i will note that osha and the department of labor have failed to issue anything but voluntary guidance as has cdc. There are no pandemic emergency standards in place for workplaces in the u. S. , even though they have had eight months to work on this. But thats not your responsibility. Did your office have any contact with Smithfield Foods or the u. S. Department of agriculture or the white house concerning specifically this memo before it was edited . No, not at that time. There is a multiinteragency discussion between labor, agriculture, and ourselves on a variety of the issues that intersect. But in that regard, again, it was the purpose was to stress clarity that we were not a regulatory agency. These were recommendations. Well, given that i would ask you to consider changing the meat packing guidance, you could simply say we are not a regulatory agency, but these are the safety protocols that we would recommend and not have, if feasible, if feasible, if feasible. It pmakes it sound like these ae not particularly important, if you can do it, great. If you cant you can say these are our safety recommendations without it being construed as an osha standard. And i would ask, will you change that meat packing guidance in light of the death toll and harm . I appreciate your comment, senator. Thank you, senator baldwin. Senator paul. Initially, government officials were honest enough to admit that the goal of mitigation efforts, aka, lockdown, was to flatten the curve. But the area under the curve, the total deaths from the virus, would likely be the same. In other words, the lockdown was to mitigate the spike in viral deaths so our hospitals would thought be overwhelmed, but the same amount of people would likely die with or without the lockdown. The media, and frankly government officials, seem to have forgotten this important caveat. Flattening the curve morphed into a belief we could change the course of the pandemic with an economic lockdown. This is unfortunate and has led to the protracted lockdown recession were currently mired in. Its important that we examine the data, learn from the data, and try to avoid the manmade aspect of this calamity in the future. To those who argue that the lockdown flattened the curve in new york and new jersey, the evidence argues otherwise. New york and new jersey wound up with the sharpest spike or highest death rate in the world. At over 1700 deaths per million. In contrast, sweden had a relatively softer touch. Few mandates, and mostly voluntary guidelines. Swedens death rate ended up about a third that of new york and new jersey. Some might argue that sweden and new york and new jersey are different populations. Perhaps. But even the average death rate for the u. S. Is now greater than sweden. In fact, the u. S. Death rate is quite comparable to less developed parts of the world where social distancing is virtually impossible, such as brazil, bolivia, and ecuador. Which brings us to an important question. Is man really capable of altering the course of an Infectious Disease through crowd control . The statistics argue a resounding no. The evidence argues that mitigation efforts have fwaled to flatten the curve, that most countries, regardless of Public Health policy, suffered a significant spike in deaths and then a gradual decline. Now, some will argue, what about hong kong, taiwan, south korea, japan . Each which have had extraordinarily low death rates . Hong kong, taiwan, and south korea enforced stricter quarantine and Contact Tracing rules than the United States. One explanation for the low death rate in much of asia is that the population may have a higher degree of exposure to coronavirus colds and therefore have more preexisting cross reactive immunity. If scientists were interested, there is a fascinating field of inquiry looking at susceptibility to covid19 and assessment of whether people or not have preexisting immunity to similar coronaviruses. In fact, preexisting cross reactive immunity to coronavirus may explain why we have so many people that have very little symptoms or asymptomatic. While there are still many things we need to learn about this pandemic, its important that we the people not simply acquiesce to authoritarian mandates on our behavior without first making the nanny state prove their hypothesis. As for now, what we do no is new york and new jersey and connecticut and rhode island still allowed the highest death rates in the world. We also know that sweden, who enforced few mandates, ended up with a death rate one third of new york and new jersey. We also know that the overall death rate for the u. S. Now is essentially equivalent to that of south america where social distancing and mitigation efforts are virtually impossible. Dr. Fauci, today you said you are not for economic lockdown. Yet your mitigation recommendations from dating to baseball to restaurants to movie theaters have led to this economic lockdown. Do you have any second thoughts about your mitigation recommendations considering the evidence that despite all of the things we have done in the u. S. , our death rate is essentially worse than sweden, equivalent to the less developed world that is unable to do any of the things you have been promoting . Do you have any second thoughts . Are you willing to look at the data that countries that did very little actually have a lower death rate than the United States . You know, senator, i would be happy at a different time to sit down and go over detail. You have said a lot of different things. You have compared us to sweden, and there are a lot of differences. You said, well, you know, there are a lot of differences between sweden, but compare swedens death rate to other comparable scandinavian countries. Its worse. So i dont think its appropriate to compare sweden with us. Yes, we have i think in the beginning, we have done things based on the knowledge we had at the time. And hopefully, and i am, and my colleagues are humble enough and modest enough to realize that as new data comes, you make different recommendations. But i dont regret saying that the only way we could have really stopped the explosion of infection was by essentially i want to say shutting down. I mean essentially having the physical separation and the kinds of recommendations that we have made. But you have been a been fan of cuomo and the shutdown in new york. You lauded new york for their policy. New york had the highest death rate in the world. How could we possibly be jumping up and down and saying Governor Cuomo did a great job. He had the worst death rate in the world. No, you have misconstrued that, they got hit very badly, they made some mistakes. Right now, if you look at whats going on right now, the things that are going on in new york to get their test positivity 1 or less is because they are looking at the guidelines that we have put together from the task force of the four or five things, of masks, social distancing, outdoors more than indoors, avoiding crowds, and washing hands. Or they have developed enough Community Immunity that they are no longer having the pandemic because they have enough immunity in new york city to actually stop it. I challenge that, senator. Im afraid please, sir. I would like to be able do this because this happens with senator rand all the time. You are not listening to what the director of the cdc said, that in new york, its about 22 . If you believe 22 is herd immunity, i believe youre alone in that. Theres also the preexisting immunity of those who have cross reactivity, which is about a third of the public. You will have to reserve that discussion. I would like to talk to you about that also, because there was a study that recently came out that preexisting immunity to coronavirus is at a common cold do not cross reaction with the covid19. Thank you, senator paul. Senator murphy. Thank you very much, mr. Chairman. Ill stay with you, dr. Fauci. Apologize for not giving you a break. There was a study that got some attention regarding big ten and pac 10athy loots that found that 15 of them who got covid19 had evidence of miocarditis. What are the long term effects for someone with myocarditis. Whats the current understanding of the possible more general longterm effects of somebody who has covid and recovered and are these effects observable and asymptomatic covid19 patients. Thank you for that question. I actually had mentioned that in my opening comments, but thank you for given me the opportunity to expand on that. Thats really quite puzzling. There were two studies. One study not in athletes and then a study you mentioned in athletes. The study in the nonathletes were individuals who had recovered from covid19 and had various degrees of involvement, to moderate disease to disease that would require intervention medically. By doing mris, they found about 60 to 70 of them had indication of inflammatory disease in the heart. Interestingly, they were relatively asymptomatic. So i think we need to be careful and just watch what happens because one of the possibilities that could develop is that, a, it could clear up and they have no problem for the resh of their lives. The other things they could wind up, when you have inflammation, you could have scarring. That could lead to arrythmias later on or that could lead to cardiomyopathy. I do not know what it would be, but its something we really need to keep our eye on. So Insurance Companies tend to err on the side of caution, and so what we believe is that because of this uncertainty, because of this potential for Long Term Health effects, that any diagnosis of covid, whether youre symptomic or not, will become a preexisting condition and its likely, probable, that Insurance Companies, if they are allowed to discriminate against people with preexisting conditions, as will happen if the Supreme Court justices put on the court and the aca is invalidated, well see rates skyrocket for anybody who has had covid. I think something we all need to talk about over the course of the next few weeks. Dr. Redfield, admiral, i want to come back to this question of the guidance on testing. I think this is really important. Because, you know, we have to take the president at his word. He announced that he had instrubli instructed his advisers, to, quote, slow had testing down please. When folks suggested he was kidding, he was asked by reporters, are you kidding . He said, i dont kid. Let me just tell you, let me make it clear. So the president made it clear he wants less testing. So it didnt seem coincidental to us that this strange guidance came out in august that recommended significantly less testing. And yet, thats not what youre testifying to today. Youre both saying that in fact, that august guidance didnt recommend less testing. And all you were doing with this third set of guidance in 30 days was to clarify. But where in the august guidance does it tell people that they should get a test if they are asymptomatic but in close contact . Where in that guidance does it actually tell them that they should proactively see a Health Care Provider if they have been in contact . Because i have read it 20 times. And i dont see anywhere in this guidance that it tells people they should get a test. I dont see anywhere in this guidance where it tells them that they should go see a doctor. It reads, you do not necessarily need a test unless you are a vulnerable individual or your Health Care Provider or your local Health Officials recommend you take one. That doesnt say you should go to the doctor. That just says if you have been recommended to get a test, you should. So it stands to reason that when folks read this, they will be under the impression that they shouldnt get a test, which seems to comport with the directions of the president , slow the testing down, please. Where in this guidance that you issued in august does it tell people that they should get a test or they should proactively see a doctor . Thank you very much, senator. And as i have said before, i take the position that more tests will actually lead to less cases. Particularly if it fully engages Public Health action. And when i issued the clarification on august 27th, again, i said that were placing emphasis on symptomic illness and as you said individuals with significant exposure, vulnerable populations, Critical Infrastructure workers, Health Care Workers, and those individuals who may be asymptomatic when prioritized by a medical or Public Health official. The reason this came from a Public Health perspective, we were seeing individuals drive up, get a test, and then go on to work. There wasnt a Public Health action associated with testing. So we calculated that this would help bring a Public Health action to testing. Notably, you dont tell people in this guidance they should go see a doctor. When i said when we clarified the day after, i put very clearly what the clarification was about the emphasis and the final category with those individuals who are asymptomatic, when prioritized by a medical or Public Health individual. And again, the intent was for testing to drive an action that was for a Public Health objective. It was clear through a variety of Different Reasons when we found that some individuals were not even doing testing for contacts, the individuals with significant exposure, we then put the further clarification. I had thought that the august 27th clarification statement that i put out would carry the football over the goal line. It didnt. But i can tell you, there was no intent in this guidance to decrease testing. On the contrary, the intent was to link testing and to drive a Public Health action. And again, the manner in which it was interpreted by a number of individuals was such that it didnt accomplish that goal. I think im over my time. This has been dizzying, dizzying for Public Health professionals. Theyre just awaiting the next correction. Thank you, senator murphy. In my effort to be fair to everybody, were running over the five minutes pretty well. So we have about 14 senators remaining who would like to ask questions. So i would ask your colleagues to keep that in mind, please, with the fiveminute rule. Senator collins. Let me begin my questions today by thanking each of you for your hard work, your professionalism, and your integrity. I dont think you get the appreciation that each of you deserves. Admiral, the American People clearly need to have confidence that all our federal Health Agencies will abide by their Gold Standard rigorous protocols and preserve scientific integrity. And we have heard this morning just such strong assurances. Nevertheless, just last week, secretary azar barred the nations Health Agencies from signing new rules themselves regarding medicines or medical devices as they normally would do. Such a major change at this critical time could delay progress and cause the American People to doubt whether the proper protocols are being followed. Could you explain why these changes are taking place and whether they could affect new medical countermeasures for covid19 . So thank you for that, senator. I have spoken to several people in the immediate offices of secretary, and as i understand it, and i do absolutely believe it, that this was an administrative decision by the secretary because Rule Making Authority in an agency that has 90,000 people gets disseminated broadly and widely, and he wanted to make sure that whatever rules were proposed by fda or other rule making organizations had review and scientific integrity. I do not believe this will interrupt the process. You have my commitment to make sure that i will provide the best Public Health advise to the secretary on all of these matters. I dont believe it will make a difference, and these can be redistributed back out. This was an administrative process, as i understand it, to bring them back in, to gain control so there arent hundreds of ways to make rules during this very important time. And perhaps dr. Hahn, as a rulemaking agency, might have a comment on that as well. I have a different question for dr. Hahn, but i want to make sure i get to. Let me just say that while i appreciate your assurances, if everything is going to have to flow up to the secretary, it seems inevitable that it is going to create delays and doubts. And neither of those are helpful as we deal with this pandemic. Dr. Hahn, i want to bring up with you an issue that we have discussed many times. And that is the fact that so many of our active pharmaceutical ingredients for medicines for the American Market are manufactured overseas. In fact, 72 of the facilities are located overseas in countries like china and india. India put an export ban on some 26 apis. We know that china hoarded ppe that our country needed. So my question to you is, are we making any progress in insuring that the apis that may be critical in therapeutics for treating people with the coronavirus or in the ultimate vaccine are manufactured right here in the United States . And not in china or india or somewhere else . Thank you, senator collins. You bring up an incredibly important topic, and one that i think has been very much highlighted during the pandemic. We have seen situations where the lack of redundancy in our supply chain, the lack of domestic manufacturing has led to shortages here at home. So we have been very active and believe we are making progress with respect to what were calling advanced manufacturing. Senator collins, we have spoken about this many times, and the issue of making sure that we have this redundancy through advanced manufacturing is important. Its something fda has been involved with for years. With respect to the issue of medications, for example, and ppe, i know that the White House Task force has been particularly focused through fema and now hhs on making sure that we build up our domestic capacity, particularly around ppe. And so yes, those are in progress. It remains a top priority for the food and Drug Administration. Our role in this will be to help to create whatever regulatory pathway we can so that we can facilitate advanced manufacturing thats domestic. Thank you very much. Thank you, senator collins. Senator warren. Thank you, mr. Who are promoting it. If federal officials stand to gain financially from certain Covid Vaccines and not from others, then americans might reasonably worry that the vaccine was pushed for personal profit and not because it was best for our health. So i have a question for all of our witnesses and i think you can answer with just a simple yes or no. Dr. Fauci, do you hold direct Financial Investments like stocks and any of the companies that are developing covid19 vaccines . No. Thank you. What about you, dr. Redfield . No, senator. Dr. Hahn . No, senator warren. And doctor . No, senator warren. None of you stands to get richer if any particular drug company gets money from the government. And im not surprised by your answers because federal ethics law prevents you from owning stocks like that. Public health, not money, guides your work for the American People and that is exactly how it should be. Dr. Hahn, the fda is responsible for deciding whether a covid19 vaccine is safe. In your opinion, if the fda officials making these decisions had financial conflicts, would that increase or decrease peoples confidence in a covid19 vaccine. Senator, im not aware of anyone at fda having a conflict involved in the Decision Making process, so it would be difficult for me to speculate on this since we have very rigorous standards in place. We have monthly review, particularly of senior officials, regular training and a culture. If anyone is aware, i would personally like to know because we will address that right away. The drug and development vaccine process. But heres the problem weve got. Hired him to keep his conflicts from the public. He reportedly owns about 10 million of stock and released by the house. He may own stock in working w h with, the invested billions of dollars in the company that dr. Slolly holds stock in. The the covid19 vaccine must comply with conflict of interest laws. Youve just told me how seriously you take that, so can you explain why dr. Sloly should play by a different set of rules . I cant have, but i can tell you weve established a very bright line between operation warp speed. We do not participate in the decisions, technical decisions just as we would for any sponsor. So with all due respect, dr. Hahn, we told you financial conflicts of interest basically undermined Publics Trust in a vaccine. And dr. Slowy has conflicts of interest. To boost the publics confidence, shouldnt he e eliminate these conflicts . Senator warren, i am not aware of the conflicts youre describing. And so i cant comment. If these conflicts exist and well only know if they exist if he makes a full disclosure. Should he resign . In that hypothetical situation, we take seriously the issue how public perception. Congress should strengthen the federal ethics laws to root out this kind of corruption. It will pass the ethics act, which is a bill that i introduced in order to prohibit conflicts of interest in the federal covid19 response. And the first person to be fired should be dr. Slouy. The American People deserve to know that covid19 decisions with based on science and not on personal greed and congress should pass my bill today. Thank you, chairman. Thank you, senator warren. Senator cassidy. Thank you, mr. Chairman. I was distracted when senator bor rows gave his answer but if did not hear the testimony, what is the administration doing so in case they werent able to erase that. Secondly, commenting on previous testimony i thought you answered senator baldwins, osha said theyre deferring to, because i thought thats a good point. To immunize between ages 3 and 18. Weve had a kind of slowdown and those are missing vaccines they should get. The vaccine records in the state stat states, federal facilities such as d. A. , will they likewise be able to handle their data into the states immunization registry. Prep the guidance on that. Just a suggestion that d. O. D. Should be required. Separated from the military, condition of employment by a health care facility. Dr. Redfield, maybe dr. Jirar, given without cost to the patient. Is there still going to be compensation the immunization . Let me speak generally that of course, we would assume there were costs for the providers, the vaccines itself for the administration of the vaccine. Dr. Hahn, the vaccine may only have 50 efficacy. I think thats the fdas minimum as to considering whether a vaccine is effective is its efficacious 50 of the time. Presumably, the level of antibody response would be a marker as to whether or not somebody has had a response. So my question is, for those folks who are at higher risk think the emergency room nurse, the tech or the clerk, many people to the e. R. , antibody serologies be required, in order to conduct this . We will not yet have data that bridges between a clinical outcome, which is, the primary end point we required for showing effectiveness, that is the prevention of covid19 illness and the development of antibodies. It is unlikely in that situation, although again, i cant prejudge the data that we would have a requirement there. Again, the data will point us in that direction, for subsequent trials if they are, one could imagine a situation that would occur but we havent seen the data yet sir. Thank you all for your brief answers. I yield back. How much im going to miss you as the senator of this committee. Im going to miss a friendship and a leadership. Four friends who died of coronavirus. Weve each had coronavirus. I guess we have preexisting conditions now. Hopefully do something. The New York Times and others did too. The u. S. Was the best prepared of any nation to deal with this. And i believe that. And yet i think the management beginning with our preparation and the resources we have as a country, the management of the crisis is one of the worst failures of domestic governance in the history of the country and dont believe me. Im just a u. S. Senator, but when people who are staffers and saying the same thing, i think weve got to Pay Attention to that. How much worse this would be in virginia, 400,000 people didnt have Medicaid Expansion but many hoping what its like. The dedication of wonderful professionals, very dedicated but i think it goes back to virginia tech, hone thing i learn learned, its absolutely critical and thats where we have fallen down on the job with the president whos preached hydroxychloroquine, or bleach or disinfectant. The day the administration laid out guidelines for states on reopening. This tyrannical, thats really confused the public. Dr. Fauci and dr. Redfield, i was concerned when the cdc changed the web site about how this virus is transmitted and id like to ask this slide be put up. This is hard to read, so ill bring it to your attention but the cdc, i believe on the 18th of september, put up new guidance based on just the ongoing analysis of this crisis about what we could do to protect ourselves and how the virus is transmitted but then almost immediately, reversed it. What about the september 18th version thats on the screen was incorrect . Thank you, senator. I think when i tried to comment before, this was a first draft. The balance of the component that transmission plays to droplet transmission. And change it back to symptoms and is that phrase, people who are infected but do not spread toaster, is that inaccurate . Let me just set the stage here. The document that was reverted to was the original cleared document. It wasnt the changed document. I understand that, but is it accurate to say people infected but do not show symptoms can spread the virus. Absolutely, they can. Thats accurate, isnt it . Absolutely. It can be breathed in by others and travel distances beyond 6 feet, during practice and fitness classes. Is that statement accurate . Any evidence of that . That was removed in the change document and went back to the decisions about the aerosoliz aerosolized, this director, nonscientifically cleared document go up. The point we need to make is to communicate clearly. More minimal, the massive confusion thats so troubling to scientists and so troubling to people and then that leads to well, gosh, is the vaccine going to be safe . That was a draft, not technically reviewed by cdc, a technically reviewed document on the web site. And the point in here. Senator murkowski. I want to echo senator. I think we do owe that to the American Public. I also know that the work that you and those part of your team is hard, hard arduous work and you have definitely been put to the test. They assist us there with the outbreak of the Homeless Population and you are quick when asked and greatly appreciate that assistance. I want to speak about, the guidelines that states considering the drafting to be submitted and alaska native that could be and determined to be critical population. Additional guidance on what qualifies as a health care worker. In our state and Community Health aides are some of those front line workers. The states plan on guidance with allocation. I will say at this moment in time, definitive answers and senator kane in comments to heart and we are currently going to see the plans as you know from each of the states how they would propose to allocate but that decision, the recommendation would be the Advisory Committee of immunization practices, that would give the and reiterate, operation warp speed as the allocation decision is made that is communicated effectively. The cdc that is responsible for determining that allocation. The allocation will be the decision will be made by the operation warp speed that will happen though, the acip the Advisory Group to me, the director of cdc will recommend the prioritization of who should be vaccinated. Should it first be all the individuals vulnerable in Nursing Homes, what kind of health care. The definitions there in critical workers. The Public Health infrastructure and tough when faxing faxing the resul results, ensure the states have the support they need for the requirements on reporting. Health i. T. Thats going to be important point look. The i. T. Capacity, well see the states to develop those plans and really identify the gaps that they have so hopefully there will be further resources to be able to fill the gaps. As well as to make sure we can distribute this vaccine in an effective to the American Public. See if i can get that on. Im going to thank chairman for holding this hearing. I want to step out to vote but thank the chair for this service and an example as a Committee Chair and i want to thank our witnesses for being here today and i want to especially thank you all for wearing your masks even though youre 6 feet apart. Im concerned americans are losing confidence in the federal confidence covid19 review process. 69 will not have confidence in the president vouching for a vaccine and weve seen other data reflecting their lack of confidence in vaccine approval process. Take place in a transparent way free from political influence. The independence of fdas covid19 vaccine review process. In large part due to your own accent over the last several months. The fda driving new guidance for process with emergency use organization. Clarified questions based on what you outlined earlier in your testimony. Will the guidance require that fdas vaccines and related biological and review trial data and release findings to the public for each vaccine candida candidate. Well be flexible, and the, as i mentioned in my remarks, they will be transparent that we provide that will be transparent and public. They will authorize the product . It will be a public process. The vote, the discussion and the recommendations will be public and well incorporate those and then make our decision. To dr. Redfield, my office heard about the importance they place on cdc whether theyre comfortable giving a vaccine to their patients. I talked with a long serving practicing pediatrician yesterday and one of her concerns is how will they know about what dosages to use for children, for instance . Will cdcs Advisory Committee on immunization practices meet publicly, review data and issue public recommendations for each covid19 vaccine before it enters the market, so Health Care Providers are confident giving these vaccines to their patients . Very important that the Advisory Committee immunization practice will conduct their deliberations in public. The only caveat is when theres National Security interest which should not be the case here, or if theres proprietary information and should anticipate a public discussion. Im going to ask you for the same commitments i asked dr. Hahn. Each product. Each product. And before the approval, it will be made public, the recommendations made public before the approval. The acip will make those recommendations after the fda recommends an eua or bla, then they will deliberate how the vaccine will be used in the United States and that will happen in public. Before they are before its recommended to be used for the American Public. Thank you. Do you believe they should conduct an independent transparent evidencebased review efficacy data for each vaccine product seeking approval or emergency use, and help improve public confidence, we heard about i just love your comments about it. I agree with dr. Hahn they have an independent look at that and advisory to the fda, makes the ultimate decision. What they do will be public. Not only a qualified Advisory Committee but alts have the entire Scientific Community that is going to be scrutinying i have confidence in the process. Thank you, senator haassen. From this terrible infection. When do you believe youll receive the first application, something come in the weeks. What are you anticipating before the first application . Senator romney, thanks for the question. I honestly do not know when we will receive our first application, as i mentioned earlier of course not. The dsmb. Is it getting close or is it going to be a month or two from now . Senator, i cannot speak to confidential commercial information that we have for the publicly available data. T its going as expected in the Clinical Trials and in the case of one, exceeded with respect to the 30,000. When they submit an application, including involving prevention of infection. Any applications received by the application . You mean the sponsors . The dsmb. How long is the fda from the time you receive the application, whatever lets go ahead. Typically the complexity of the data and the data set were looking at. The timeline and very much, very seriously our responsibility to protect american lives. We will not delay, but we will not cut corners in our process. Manufacturing vaccines even though we dont know whether theyre going to work or not. Vaccines to the American People as soon as possible. If the fda were to approve an application, lets say on november 1st, how long would it take for the American People to get vaccinated . Maybe change that to say, what proportion of the population, if it were improved on november 1st, what portion would be able to be vaccinated by tepid of the year. Or the great majority. Good question, the production rolling out and when you hear the numbers of all the companies so that in november, youll probably be maybe 50 million doses available. When you get into january or february, by the time you get to april, there will be a total of about 700 million. So if youre talking about whos going to get vaccinated, not a large proportion of the population. It will be according to what we were discussing before and likely been Health Care Providers and likely will be those who are vulnerable with underlying conditions, and if anything, the past is prolonged, likely will be the case. Were not going to have all of the doses available for example by the end of december. Rolling rolling . Chair alexander back for the final hearings, really incredible. I wanted to follow up on something you said, youve said you thought that the vaccine, we have a vaccine that it would be distributed broadly by the Second Quarter or the Third Quarter of next year and you also said that you thought that masks were the most effective tool that we have to stem the spread of the virus. So you think, you still think that and stand by that . Thank you, senator, for the opportunity. When it comes to the question about masks, i have total confidence in the important of vaccines. Vaccines will get us. Senator kane alluded to. If the vaccine only induces the immune response and the people, reemphasized how important this mask is. We have this right now and it will protect the American Public. The second question you ask was dr. Fauci was very clear projected about 700 million doses by april, late march. They require two doses. Late quarter and Third Quarter. How long to get completely vaccinated. Based on protection by late march, early april. I appreciated that and i appreciate that you were pointing out and important context, dr. Redfield, any pushback for saying what you said . The data and the science as i see it. And will continue to do that. Did you get any political pushback and ill stay with the comment, i will continue to present science and data as i see it and its not going to be modulated by whether individuals really appreciate what i say or dont appreciate what i say. I think, didnt the president say he called you to complain to you about what you said . Im not going to comment my conversation with the president. Called the suppress covid19 act which would invest, testing and Contact Tracing, what we need to sprez this virus i wrote with dr. Daniel allen in the Washington Post in the record if i could. Dr. Fauci, will will we still need Contact Tracing even after we have a vaccine. Absolutely. Because the vaccine, depending on the degree of efficacy and dr. Redfield just mentioned, decided they wanted to get the vaccine, youre still going to have Vulnerable People in the United States that would require not only testing Contact Tracing but an implementation of the Public Health measures that weve been talking about but youre not going to completely eradicate or eliminate if you have a vaccine that is even moderately effective. 75 , if you dont have a vaccine, thats 95 effective and everybody takes it. Public Health Practices including testing, identification, isolation and Contact Tracing. Continuing to wear masks and practice good social distancing and other Public Health strategies that we know work to keep the same. Thank you, mr. Chairman. Yesterday, we reached a sad milestone. Recorded over 200,000. I want to go back to the beginning to look at where we started and where we are now. Important to remember and understand what the context was when this outbreak began, where we are now, where that the president called on the American People to come together by shutting down, the catastrophic for millions of deaths march 29th, it was clear the president again followed and d by dr. Bire Task Force Briefing on march 31st. Without mitigation efforts and the foothill that shows a range of 100 to 200,000 deaths explain at a march 31st briefing from the Health Experts show if we did not act that the death tolls by august 1st could exceed a couple million. Yes, thats what we presented. Based on a model, sir. Its a model. Sure. And was the goal of the mitigation effort to bring the projected death tolls down from over 2 million to the range of 140,000 . Yes, with an exception. As i mentioned, the press conference associated with that, i said the model would say it would go down but i dont think we should be accepting that, that we could likely do better. What would have happened, we would have had less than that. We know some states did a good job, some did not so good a job. Some states try to do a good job but people didnt listen. If we did the Public Health measures we were talking about masks, physical separation, et cetera. So outside of that qualification which i think its o admirable, what might be the case. Do you think the actions of the American People hit where you were hoping, notwithstanding the qualification you made . It helps us to look ahead that the kinds of things that were affect the mitigation, saves a lot of lives. Do you agree the president took the outbreak seriously from the beginning, taking unprecedented actions, saving millions of american lives as a result . Yes. I mean, obviously, one of the first things we had said and discussed before was the shutting off the example from china and then second after t t that, particularly, the met toll t metropolitan area. As we can see from this, the president and the task force told the American People on march 31st, millions could die if we did not follow the white house guidelines. If we did everything optimally, then we would be where we are today. If we want to ask the American People to continue to take the virus seriously and keep making sacrifices in their day lives until we have a vaccine, then do you think the media, politicians, and scientists like you need to do a better job reminding the American People about the Blue Mountain warning, a millions dead and how the collective actions will continue to save lives . Yes, senator. And in fact, virtually every time i am in the public and given the opportunity to talk about this, if we all did consistently, not only prevent the surges weve seen but get it down. Some of the areas of the country that are doing it well. Others are not. I think we need uniformity throughout the country of a consistent adherence to the Public Health practices that we talk about. Thank you, senator braun. Senator jones . Well fix it. Thank you, mr. Chairman. For this hearing and service on the committee. I want to thank all the wnt witnesses for being here. I want to comment on something senator kane said. And 400,000 virginians would have done had they not had the benef benefit, in alabama, 400,000 do not have the benefit at all because alabama refused to expand medicaid and cant get folks up here to, giving states like alabama the opportunity. Thats for another day. I would like, its pretty clear, gentlem gentlemen, mixed messages going back and forth and its really difficult. Since the very beginning of this, ive tried to tell people in alabama, listen to the health care folks. Dont listen to politicians. Listen to the health care folks, every week, beginning and april, i had a Facebook Live with media we broadcast. But its gotten more difficult. At one point in the news conference, the fda wanted to limit the use of the convalescent plasma until after the election. A deep state in the fda making difficult, to get people in and the chief of staff said that the president wanted to make the fda feel the heat which im not sure exactly what that meant but dr. Hahn, you said that you have every confidence in the scientists and staff at fda and i appreciate that and i do too, by the way. Is there a deep state youve seen in the fda in any way trying to do anything other than quickly get a vaccine, get therapeutics to the American Public . Your question this way, i have 100 confidence in the outstanding scientists, doctors, nurses, pharmacists at fda who have remarkably stood up during this pandemic to help expedite getting miracle products to the American People. I have complete confidence in their decisions and i have complete confidence in the actions that have been taken to date. That confidence is based on following the science, not any political pressure and thats what were expecting with a vaccine approval. Our career scientists for any medical products and particularly vaccines will follow the science and data in a rigorous standards and wont be politics that make any part of that decision, sir. You said in your testimony that, all of you one way or anoth another, you continue to tell people wear a mask. Added a fourth, be smart about crowds. We see time and time again in political gatherings and to not be partisan here and peaceful protests, folks arent doing that. Some encouraged not to wear a mask. And everybody pretty consistent. To ignore the guidelines. We dont know whether the people are washing their hands or not but most are not wearing a mask or social distancing and certainly not being smart about crowds. What are we doing, how do we get the information to our people . We stress what i said before, we want all americans to embrace wearing a face mask, be smart about social distancing. Obviously, have confidence in the flu vaccine. If we all wore a mask and we were smart about social distancing, dr. Fauci alluded to, this outbreak would really start to come to under control. This simple, simple decision, but unfortunately, its not something that 75 of us can do. And hhs made comments they felt there was a deep state down at a cdc. Confronting the greatest Public Health crisis of our time. 1200 deploying and its offensive to me. You never knew peoples political perspective. I would say, that is the same about the men and women at cdc, dedicated to protect the Public Health of this nation. People dont understand the ability to suck emergency, unfairly criticized, thats the real harm in all of this. Thank you, i completely agree. Thank you, senator jones. Senator rosen. Thank you, mr. Chairman. And again, i want to thank everyone on the panel, everything to save us from this pandemic. Move us forward with therapeutics and vaccines back to our regular lives. Combatting covid alongside the season flu. We can avoid catastrophe by adequately supporting our medical officials the District Court of health in northern nevada recently explained that critical needs to address covid prevention. Extremely close pattern. The flu season fast upon us, extremely important, could you explain if you will, the importance of the current planning for flu shots and Covid Response and should be providing things to get the vaccine or Something Like that individuals with the same location, how are we going to do that. Thank you for the question, senator. First of all, i want to just emphasize with your Health Officials, already mentioned to you, the importance of getting an influenza vaccine. Because what we dont want is two conflated respiratory infections at the same time as we enter into the fall and the winter. We want to get as many people vaccinated as possible, the logistics of how you can get them done, perhaps dr. Redfield can, but one thing i want to mention because weve seen that in australia as well as south, if we continue to do what each of us have been saying regarding the kinds of preventative measures of mask wearing social distancing avoiding crowds, washing hands, et cetera, if we do that as we get into the fall and the winter for the purpose of covid19, it is likely to have a positive impact on the infection rate of influenza because our colleagues in the southern hemisphere, particularly in australia have found because of that, theyve had a very, very low mild influenza season. If we could combine the vaccination as much as we possibly can with influenza, together with the Public Health measures, hopefully we can have a very low level of flu that would not then complicate what would clearly be a challenge in the winter with covid19. Thank you. Senator, im sorry. I just have a minute left. I want to ask about Interesting Research and any of you can take about it if you know about it. Ive seen information come out recently, and how when its overactive, it causes inflammation that could be part of the reason that covid19 causes this buildup in the lungs. Anybody could take this and even talking about that research and is that really going to be helpful . I know there are drugs out there to help reduce this kind of, not sure if its inflammation but attack this kind of response. Maybe someone wants to take that question, is that a possibility for treatment . Real quickly there, a number of interventions to block and blunt the overactive inflammatory response, advance disease, the opening comments a commonly used steroid that blocks inflammation. There are a variety of other tria trials, look at blocking a variety of other inflammatory indicators such as il6 and a variety of others. These are things actively pursued. Theres no evidence thus far, except for the dexamethazone, you can help people with advanced disease and decrease mortality. Hopefully continue to get positive news. Well go to senator murray. Senator lev ler returns from voting in time, well go to her next, and well, mr. Chairman, thank you. I will submit my additional questions for the record. I would like to thank all of our witnesses for joining us today and senator alexander a, you awe announced earlier that this will be the last hearing of the help committee that you chair and i want to start by saying been a pleasure to work with you to lead this committee over the past several years and through many critical challenges for our country. From working to address the opioid crisis, supporting medical innovation, replacing no child left behind. Theres a lot weve gone through and weve been able to do that by listening to each other and most importantly, to the people in our states about what they need. So i just want to say i think that i speak for everyone on my side of the aisle when i say im very proud of the work weve been able to do together with you on the other side and this may be our last hearing, but just know i preeappreciate all have done and will continue to do. I want you to know im going to continue to follow our response to this pandemic very closely. I will continue pressing for answers including on whether our meat packing plants have accurate information, as senator baldwin raised earlier. We need answers on that. Im also going to continue demanding a full, comprehensive plan to finally get testing where it needs to be and fully prepare to make sure we develop, manufacture, distribute and administer a safe, effective and trusted vaccine. Im going to continue to push back against every effort from this president to interfere in our response and put politics over science and Public Health. I will continue to call out misinformation or lies or conspiracies and work to make sure we are communicating clear, science based facts to people in this country. And i am going to urge our republicans to come back to the table and negotiate in earnest so we can finally pass the kind of sweeping relief our communities really need. Despite President Trumps careless claims that we are rounding the final turn or that this disease affects virtually nobody, we know the painful reality. Is that this crisis has tragically killed over 200,000 americans already and that it is far from over. So our work to respond to it cannot be over either. Thank you, mr. Chairman. Thank you for the time. Thank you, senator murray and for your kind remarks and i expressed, i express again today how much i appreciate your, our friendship, your diligence and your leadership, which has been absolutely crucial to the considerable results that have come out of this committee, especially over the last six years. So thank you very much for that. Senator leffler. Thank you, mr. Chairman. And i want to start by thanking each of you here today. I want to thank you and your workforces for the tremendous work, the effort thats been done to combat this virus. Dr. Redfield, this question is for you. Imted to touch on this subject that i feel has been overlooked. That issue is Mental Health. Particularly in younger populations and the front line. Yesterday, i had the opportunity to be briefed by dr. Deborah howry. The director for the b National Center for injury prevention and control and also one of your colleagues at the cdc, and e we spoke on the rising mental Health Issues due to the pandemic and particularly, suicidal ideation. We spoke about the importance of comp hrehensive Community Level outreach policemans to prevent this issue from growing worse. The cdc is funding several different programs aimed at this goal and the comprehensive Suicide Prevention program is currently funding nine grant recipients in different states to a covid Suicide Prevention funded project in georgia, my sta state, thats being run by the department of health ch the question for you is what more can we do on a federal level to shine a light on this issue and make sure these communities have the resources they need to have comprehensive outreach and to ensure were not turning a blind eye to the critical issue of Mental Health that so many are facing due to this pandemic. Thank you. Thank you very much, senator. Its very, very important issue and im glad dr. Howry had the opportunity to debrief you. On one of our recent surveys, it was surprising that over 30 of americans are feeling anxiety and depression as part of the covid experience and we have seen sadly, an uptick, particularly in adults, in suicide. One of the reasons i was so aggressive in reminding the American Public that the Public Health interest of k12s is best served by getting kids back to facetoface learning. Many people may not realize that over 7 million children get their mental Health Services in the context of schools. We also unfortunately have seen an increase in Substance Abuse and drug use disorderer, thats been associated with this covid situation. Some of which had been driven by the lack of availability of medical appointments when the Health Industry basically pulled back to help manage people that would chronic pain syndrome or were recovering from drug use disorderer. So its a very important issue. I think we have to keep it, youve probably seen it on tv, how right now initiative to let people know that its not sigmatizing to say that youre not doing well. Or that youre depressed or youre suicidal. These are medical conditions like ive argued about drug use disorder. These are not behavioral issues. Theyre medical conditions and need to be treated as medical kngs. I think it is one of the collateral damages that we saw as part of the covid pandemic. Thank you. Ill yield my time. Thank you, senator. Well wrap up the hearing now. I have just three or four questions about the vaccine, which ill start with dr. Fauci, but in of the others want to answer it. Pretty simple questions, but it may be important for the American People. One is, and ive had people say this to me. Dr. Fauci, if i take a shot to get the vaccine, does that give me covid . Absolutely not. That would be impossible. That would be impossible . Yes. So, a one of the risks of a vaccine shot is not getting covid. That is correct. That risk does not exist. Will the, will the vaccine for covid, will it likely be more like the polio vaccine or the flu vaccine . By that, i mean you take the polio vaccine, you assume youll never get polio. If you take the flu vaccine each year, its sort of a guess about whether the vaccination really will be effective. And i think it also helps speed the cure if you do get sick, but it may not be more than 50 effective. So, is it more like the polio vaccine or the flu vaccine or do we know that yet . We do not know that yet, mr. Chairman. And thats one of the things that we will learn. Polio is a highly, highly effective vaccine that gives long lasting protection. What we do not know yet is how effective the covid19 vaccine will be. Nor do we know the durabilile ir the protection. How long it will last. We will find out the answer to those questions through the Clinical Trials and the follow up of the Clinical Trials. Will the vaccine be free when its distributed and administered to americans . We have been assured that in fact, the American Public will not have to pay for the vaccine. We have been told that at the level of the task force. When were talking about vaccines, are we in the most, most of the six vaccines were anticipating that youd have to take two shots about four weeks apart then the effectiveness of the vaccine might be two weeks after that or is that wrong . It varies from candidate to candidate. For example, the moderna and pfizer, which are out there now, are two shots. A prime and a boost. One is the boost at 28 days. One is a boost at 21 days, where as the jnj or johnson is a single shot. Well, i want to thank all four of you for what many of the senators said today, which is extraordinarily able and dedicated service to our country. And what ive heard today is that we are in an unprecedented sprint towards success in terms of first, vaccines. The polio vaccine took more than ten years. Other vaccines were familiar with took a long time. But what the administration is telling us is that we likely will have a vaccine approved within a year. From the time it was first developed and we know that we will have tens of millions of doses of a total of six vaccines ready for distribution once its approved. Weve also heard that we have five treatments that if you get covid1919, there are five medicines for it and that there are more coming likely and the most promising may be the socalled antibody cocktails that were used so effectively with ebola. And weve also heard that despite a bumpy start with the diagnostic test with cdc at the beginning of the year, weve had explosion of quick diagnostic tess and the administration for example, has bought up 150 million of the abbott tests, which is 5, 15 minutes, more specific results and well begin to distribute those or is beginning to distribute those to schools, clenl colleges and to states and that dr. Collins shark tank at nih is producing even more. Dr. Hahn, when i asked him who makes the decision, dr. Hahn, the scientist at fda or the white house, he said the scientists at frkda in terms of safety and efficiency and all of you said you would take the test, or the vaccine when its produced and recommend it to your families. Although said what is wise, you should talk to your doctor before you take any kind of shot i assume, but they said they had great confidence in the f. Weve also heard and i think this is most important. Dr. Fauci, as did all of you say, but faucis been involved with these things since 1984, the reagan years or even before, are we cutting corners on safety and efficiency and he said no. And the risk were taking is to the taxpayers because of the new way were doing things. Wegd lose a lot of money if these vaccines arent approved, but i think the congress and the president decided it was well worth it if it saved lives by having a vaccine ready in a year rather than two, three, four years. And finally, i asked whether it was a good idea having been a College President , to send home the students who get sick with covid if an outbreak comes out, as it is, on many College Campuses and dr. Fauci said no, thats not the right way to do it. The right way is to manage your campus in such a way that you can isolate the sick students. Send them home and they just infect grandma, grandpa and everybody else in the community. It was widely carried on televisihe American People had e to see the administrations top Health Experts answer tough questions from democrats and republicans and give straightforward answers. I thank you for your service and i thank you for todays hearing. The hearing record will remain open for ten days. Members may submit Additional Information for the record within that time if they would like. Thank you for being here. The committee will stand adjourned
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