Transcripts For CSPAN White House Coronavirus Task Force Members Testify On Latest Pandemic... 20240712

Of the White House Coronavirus task force gave an update on the response to the pandemic, including the development of vaccines. From the Senate Health committee , this is three hours. I would like to welcome everyone and go through some administrative things. Weve taken the advice of the attending physician that center for Disease Control health and Human Services so we are please come to order, first i would like to welcome everyone and go through some administrative things. Weve taken the advice of the attending physician that center for Disease Control health and Human Services so we are seated six feet apart. There is no room for the public. The press is operating by poll , although this can be watched by streaming or later in an era of fashion. The witnesses were here in person and we welcome them. Some senators are in person in the summer participating by video conference. When we are here although you are free to if you want to. I wear my mask when i am outside of this room according to the recommendation of all four of the witnesses who are here today. Im grateful to the rules committee, sergeant at arms press gallery, the Capitol Police and for all the hard work to keep us online and safe. Senator murray and i will each have an Opening Statement and then we will turn to our witnesses. Wed like to ask you to summarize your remarks in five minutes. Then we will recognize each senator for five minutes of questioning. We have participation today, so i expect a very good hearing. This will be the final. Last week at the hearing i thank senator murray and staff for diligence and Cooperation Without which the committee would not have accomplished all the things we have been able to accomplish. This week i would also like to thinthank the most senior repubn senator and all other 20, both democrat and republican. Senator ted kennedy is to say that our committee had the broadest jurisdiction in the senate. You would only have to look around the room at a hearing in the sea we also had the broadest range of views and some of the ablest advocates but thanks to the Committee Members and to senator murray most of the hearings have been bipartisan which means they have agreed on a broad range of witnesses to present points of view and while the questioning and statements have been probing, theres always been a high level of courtesy both to the witnesses and other senators for which im grateful for. To Work Together during such a rancorous time as a contributor to why we have been able to publish so much. The work of the committee represents my view as far as the senate goes it is hard to get here. Its hard to stay here and while you are here you might as well try to accomplish something good for the country which this committee has done on numerous occasions. To deploy a vaccine against covid19 is on track to become an unprecedented sprint to success. A program called operation warp speed will save lives without cutting corners on safety and efficiency. The Vaccine Development process is 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 High School classmatehigh schoolclassmate i. We waited ten years for a polio vaccine so we wouldnt be afraid of polio. Many existing takes routinely before they go to school like chickenpox and measles have taken ten years to develop. The secret to the success of this effort is the government in partnership with private industries for the first time are developing a manufacturing vaccine in parallel. Now, what that means is operation more 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 worked 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 goal that once seemed impossible but now seems likely. The administration hopes to have as many as 300 million doses of Vaccines Available to be deployed by it made according to an august 26 article operation warp speed principal advisor and vaccine expert doctor matthew f. Byrne published in the journal of medicine the authors also wrotwrote the scientific enterpe could guarantee success they would succeed in this unprecedented endeavor. With the department of health and Human Services said recently in a meeting that if all goes well its possible that up to 700 million doses will have been manufactured by april by next year, 2021. The department of health and Human Services, department of defense and the private sector, medical professionals are also working together to lay the groundwork for deciding who gets the first doses such as as healthcaras healthcare workers n highrisk populations and how to get them to those individuals. The state is to submit plans by the middle of october of this year, next month, to begin distribution. The doses that are being manufactured and ready when will they be available for distribution to the public they answered of course, the only people who know when the vaccine will be ready or the scientists that the fda who will review the science end of the Clinical Trial data and determine whether the vaccine is safe and works. Even doctor stephen hahn, the commissioner who is testifying today does not know when that day will be because the fda will not approve until three things happened. One from independent experts overseeing the trials to determine theres enough Data Available to the fda to make a decision. Number two, after demonstrating safety and efficacy based on Clinical Trials of the vaccine manufacturer submits an application to the fda and three, fda experts conduct the review and make sure that its safe and it works. Authorized for emergency use today and they help treat and manage. Blood thinner and plasma and operation warp speed officials are optimistic they say that more treatments will be identified or developed in Clinical Trials this fall. The most promising has been used to treat other diseases like ebola. Knowing there is some medicine that will help treat the covid19 should relieve the anxiety that want to go back to college back to college, back to worworking out and eat and a thd Success Story is the explosion of fast, cheap reliable diagnostic tests our country lost several crucial weeks and distributing the diagnostic tests that would help identify. But since then an Unprecedented Research has created capacity this month for more than 90 million tests about half of them i did a test according to the admiral who is here today. Its on track to produce 50 million of the tests, 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 the tests to help expand testing in places like schools and Nursing Homes and itoensure that we will hear something about how that will be distributed today. Congress funded the socalled shark tank or rapid acceleration of Diagnostics Initiative and i h. With the objective of developing and deploying tens of millions of rapid diagnostic tests. They told me this is not the end of the story. There are lots of additional technologies coming through the pipeline many of which are rapid and homebased tests. Untold vaccines and treatments are widely distributed come this explosion of many cheap reliable diagnostic tests is 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 what 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 effort to develop and manufacture vaccines before they are all approved knowing full well that one or all of them might fail with a considerable loss of money. Since march congress appropriated for than 47 billion for tests, treatment and vaccines. A large amount of tables in size to the 3 trillion spent to try to ease the pain by shutting down the economy. Its important to give credit to previous president s in the Previous Congress for the bipartisan work theyve done over the last 20 years to make possible the remarkable success i just described earlier. Doctor sally for example told me the government today could not be manufacturing the vaccines currently being developed if congress hadnt provided the department of health and Human Services was funding to make awards in 2012, eight years ago to build three manufacturing plants that would be on standby for the next academi epidemic. The decision to look ahead, senator burr specifically, had a role in that. Doctor sally said that was visionary. The New York Times reported that the United States is among the countries best prepared to manage such an epidemic. Focused on covid. Why would they say that on mar march 1 . Lets look at the nih for five consecutive years the congress significantly increased investment in the National Institutes of health for Biomedical Research and nih infectious Clinical Research consortium that was established last year was able to rapidly shift ongoing Clinical Trials and quickly enrolled volunteers for covid19 trials and treatments and vaccines. Or look at the fda. Congress provided that they specific authorities beginning in 2004, 16 years ago, to review and issue emergency authorization for tests, treatment and vaccinations to respond. Doctor hahn has used that authority and the fda has used that authority to authorize 250 tests and find treatments as quickly as possible and remove tests and treatments when evidence shows they didnt work as well as they should. The congress established the Biomedical Advanced Research development of a ready in mid mid2006, 14 years ago, to help Companies Work with fda for treatment and vaccines. They were able to award candidates just over one month after the vaccine was first reported in china. As i said earlier, four of the first are being manufactured and facilities built in 2012 for this purpose, for a future pandemic. Vendors can support over the years the state, local and hospital preparedness, 21 billion between 2002 and 2017. The cbc has used existing programs to help states retrain workforces expand capacity, planning for the future pandemic, a future pandemic during the last several years and even with supercomputing. Several have done things to help us get ready for this unprecedented spread toward success and vaccine treatments and tests. The next pandemic is in the isna question of if but when. The next pandemic could be next Year Congress should take stock now. While our attention is on the Current Crisis of what they learned during covid19 and address some of the problems we know we can solve like the Previous Congress as in the previous president s did. Many of the witnesses that have appeared before this committee have agreed we have three things to do. One, sustained onshore manufacturing of test treatments and vaccines, number two, create and sustain the stockpile supplies so they will be available to the Public Health emergency and strengthen the Strategic National stockpile. We have 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 the Witnesses Today about how the federal government is continuing to respond if both states respond and how soon we can expect for treatment. Thank you very much mr. Chairman, thank you for the witnesses for joining us once again today. Before i begin i want to take a personal moment to acknowledge the passing of Justice Ginsburg in a wall model that opened doors for all of us. A position to the highest court would be more pivotal especially as we faced down a historic publichealth crisis. They are in the middle of a pandemic that has cost more than 200,000 american lives on this administrations watch and nearly 7 Million People across the country with new preexisting conditions and 5. 4 Million People without coverage. Peoples health care in the critical case coming up this year previously said in march of 2016, the American People should have a voice in this election and said many times over the past few years they support protections for preexisting conditions. The entire country is going to be hearing about with another Supreme Court nominee would mean for their healthcare and their rights. Back in january i helped organize the first bipartisan briefings with the Administration Officials about the covid19 threats coming in favor of two secretary shortly after asking what steps we were taking and specifically asking about our diagnostic testing capacities. At the hearing in february, i addressed him directly about issues and i asked point blank if the country was ready. Tragically the clearest answer that i got the didnt come from the Trump Administration. It came back from families in my home state of washington. And it came at the resounding no. By march i was getting from people in my state that believed they had been exposed but they couldnt get tested and who had been tested but were left waiting for results. I was hearing from schools including my granddaughters that they were canceling classes including school and i was seeing nothing from the Trump Administration to inspire confidence or act with urgency. Lets be clear we had a window to prepare for this and the administration missed it. We had a pandemic playbook that warned against some of the problems they were facing. They ignored it. We had an understanding of how dangerous this could be and they downplayed it. So much has changed since the early days of the crisis. Now the number of people infected in the country have passed 6. 5 million. The number of People Killed in the past 200,000. The number of people without a job and without Health Insurance has skyrocketed and businesses have been shuttered. Gathering some birthdays to funerals and weddings have been canceled about one thing has not changed. President trump is still putting politics ahead of the crisis. The cases of death are still high. Testing and contract for tracing are inadequate. Tracing are inadequate. The Health Disparities in the communities if we need to prepare for the upcoming flu season when experts warn us we could see another wave of cases. And yet President Trump is still trying to sabotage the work of our scientists and publichealth experts for his own political ends. As the leaders of Health Agencies on the front line of the response to the pandemic our witnesses have an important firsthand perspective on this thread doctor hahn good food and Drug Administration had a Critical Role to play in evaluating the treatments, diagnostics and vaccines. The American People are counting on you for this on the scientific principles and work of agency specialists so it is incredibly alarming that this administration has undermined Public Trust Network of the agency by spreading conspiracy and pressuring the agency to ignore the science. Earlier this year the administration promoted hydroxychloroquine. But even more recently the administration pressured the fda to rush through an emergency use authorization for therapy and last month the secretary repeatedly overruled you directly and undermined the authority when he was an oversight of the tests that allowed unreliable tests in the market. Then last week he further undercut your agency by completely barring the fda from signing any new rules without his approval and left a power grab for to make a pandemic. The center for Disease Control and prevention plays a Critical Role providing data and sciencebased public guidance for families, researchers and Healthcare Providers to rely on for life and death decisions. Guess the Trump Administration has repeatedly interfered in those efforts. We have seen the white house contradict critical guidance on reopening the communities and returning to school. We have seen the president conspiracies about the death count and misinformation about masks. The trump Administration Officials have reportedly taken unprecedented steps to hijack the cdc and undermined its credibility. The administration ignores the objections that the cdc scientists into posted guidance under the cpcs name with unrest or that access to testing, a move that was immediately criticized by publichealth experts and has been since thankfully reversed. Political appointees have demanded to oversee and manipulate the agencies morbidity and mortality and last week you confirmed the administration took hundreds of millions of dollars out of your budget for a feelgood pandemic ad campaign spearheaded by a Trump Officials believed the cdc was part of a conspiracy to in which the cdc inexplicably has no role and have not even indicated will be reviewed by your agency to make sure. If this were not bad enough, after your testimony before Congress Last week, the president said you were, quote, confused, that you made a mistake and was given the correct day become misinformation. This is a concern about the decision monday to pick up items with new information on how this virus is transmitted fully and immediately reverse the course. You have been a trusted voice of Public Health issuepublichealts country for decades yet the trump Administration Officials have tried unsuccessfully to dictate wha talking points to yu and undermined your credibility through research and in an oped the president himself even put a message out calling for you to be fired. Any of these examples political pressure would be alarming on their own. Together, they paint a clear pattern of interference that is downright terrifying. The Trump Administration didnt just start its political interference yesterday coming and we do not expect them to cut it out tomorrow. So congress has to make it stop. The president has made it painfully clear where he stands when it comes to picking between politics and science, politics and Public Health, politics and the safety of our country. Now each of us has to do the same. Yesterday senator schumer and i along with over 3 three of our colleagues introduced the transparency of sex acts that will create a task force to conduct the investigation into political interference in our publicHealth Agencies, and i do hope every republican that has spoken out about how important it is that the stick to science will support the bill because you cannot stand for science if you will not stand against political interference. Im also going to be asking the witness is more about this as well because it is so critical that we know what political pressures they have been under in what is being done to resist it. Finally, mr. Chairman this may be the last hearing this congress and i want to recognize the work weve done on this committee and your time as chair. The list of bipartisan bills weve gotten signed into law over the past few years you know them from a 21st century cures act, Opioid Crisis response act of the reauthorization and four. The kind of bipartisan approach we used to get the bill was passed is going to be critical if we are going to take the steps we need to take to address the pain of this pandemic which is why it is important to stay on the discussions. It is so frustrating republicans didnt offer anything for months and after they finally put forth a proposal to move to Common Ground instead they moved further away from us with their next proposal. After all the success we have had in the committee i think that we have 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 package. Put partisanship aside and put Families First and Work Together to respond to the pandemic with a kind of response that is so clearly needed. Thank you mr. Chairman. Thank you, senator murray. We will now introduce the witness. We ask them to summarize their comments at five minutes each. Our first witnesses doctor Anthony Fauci director of the National Institute of allergy and Infectious Diseases at the National Institute of health. Hes held his position since 1984 and led the agencys Research Related to hiv aids, influenza, malaria, a bola and other Infectious Diseases. Hes advised six president s and was one of the principal architects of the president s emergency plan for aids relief. Next, doctor robert redfield, the director of the u. S. Centers for Disease Control and prevention for more than 30 years hes been involved with Clinical Research related to chronic infections and Infectious Diseases especially hiv. He served as the founding director of the part of a department within the u. S. Military is hiv Research Program retired after 20 years of service in the u. S. Army medical corps. Third witness, the assistant secretary for health and oversees the commissioned corps of the United States Public Health service and keep up with programs. Hes taken on testing and focus on increasing the number of tests that we can do with existing technology. Federal Service Includes directing the office of the Defense Advanced Research projects agency and several other important response abilities. Finally we will hear from doctor stephen hahn, commissioner of the u. S. Food and Drug Administration fda. Before joining, he held leadership roles as chief medical executive at the university of Texas Cancer Center and chair of the department of radiation oncology at the university of pennsylvania. Early in his caparisoned as a senior investigator national cancecancer institute and nih additionally he hel holds the rf commander in the u. S. Public Health Service commissioned corps. Welcome again to the witnesses. Doctor fauci, lets begin 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 in addressing this before. As i mentioned in a prior hearing the nih has a fourpart Strategic Plan for research to address. First is the fundamental knowledge of the virus itself. There are clinical observations we will be pursuing in the future. I bring to your attention the fact that a number of individuals who biologically have recovered from infection in fact have persistence measured in weeks to months of symptomatology that does not appear to be due to the persistence of the virus and referred to as longhaul. They have fatigue, myalgi myalga timekeeper and involvement of the neurological system as well as cognitive abnormalities and the inability to concentrate. In addition, we found to our dismay that a number of individuals that have completely recovered and apparently are asymptomatic, when the sensitive Imaging Technology such as magnetic residence imaging or mri have found to have a disturbing number of individuals who have inflammation of the heart. These are the kind of things that tell us we must be humble and we do not completely understand the nature of this illness. Next with regards to diagnostics, you know we have the program that is going to in the next several months allow us to have a considerable number of point of care testing. Moving onto therapeutics, i mentioned to the committee sometime ago that the nih put together an expert panel for treatment guidelines which is a living document that reviews the literature as well as the areas of expertise that our prepublication to help clinicians throughout the world to address the clinical component of this outbreak. I must tell you that as of last night, there have been 4. 5 million views of the treatment guidelines, 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. From the deaths that youve heard about it and show them in randomized controlled trials to diminish the time to recovery and individuals that are hospitalized but have one disease. In addition, a commonly used steroids has been shown in the randomized placebo trial involving more than 6,000 individuals has been shown to clearly and significantly reduce 28 day mortality. In addition, there is a number of treatments including antiviral still being tested and randomized controlled trialscoming at you mentioned appropriately and correctly that we feel optimistic about the antibodies which are currently being tested in an outpatient setting and inpatient setting, family prophylaxis which means when an individual in a given family gets infected if you give this antibody to the rest of the family, can you prevent the spread within the family unit and finally nursing home prophylaxis. Into the issue of vaccine. Weve put together a strategic approach to the Vaccine Development. As you mentioned mr. Chairman, there are Six Companies the federal government is playing a role in either helping to develop, subsidizing or supporting the Clinical Trials. We are harmonizing the trials of that informatiotrial sothat infe applicable to another. Eventually, there are three platform candidate vaccines that have entered into phase three trials. Very soon there will be a fourth. As i mentioned in the committee, we feel cautiously optimistic that we will be able to have a safe and effective vaccine although there is never a guarantee. Early studies in animals and humans phase one and phase two indicate individuals have a response comparable to if not better than natural infection and so as the trials go on, we predict som sometime by the endf this year, lets say november or december, we will know whether or not they are safe and effective and as you mentioned, mr. Chairman, right now doses of vaccine are being produced so they will be ready to be distributed. I will close with a comment that they feel strongly if we have a combination of adherents to the publichealth measures together with a vaccine that will be distributed to people in this country and worldwide, we will be able to turn around this terrible pandemic through which we have been experiencing. Thank you mr. Tribune and i would be happy to answer questions later. Thank you, doctor fauci. Lets go to doctor redfield and then doctor giroir and doctor hahn. Doctor redfield, welcome. Thank you members of the committee. I want to thank you for the opportunity to be here today. On behalf of the cpc, i also want to thank you for your continued support of our publichealth professionals and their lifesaving work that they are committed to 24 7. Over 6700 cpc staff have been engaged in the agencys covid19 response so far and more than 1200 have been deployed to more than 200 locations, tribal nations in the United States and abroad. I know you join me in expressing our collective deep gratitude to them women and men of the cdc further gazillions, dedication and service to the nation. Throughout this global pandemic, the cpc has about its finance expertise to the front lines grounded in science and data and conducting rapid investigations of outbreaks that identify the highest risk populations into settings and putting in place measures to prevent further spread of covid19. Understanding which populations are most at risk and how the virus spreads in various settings is critical to developing guidance and protecting the health of americans. As you are aware in the United States, we are approaching nearly 7 million cases, and sadly over 200,000 deaths. Every death means of a loved one was lost. But there is some progress to report. Since the peak in july 24 of this year, we have experienced nearly a 50 reduction in daily cases and a 32 reduction in deaths. Thereve also been significant improvement in the markup of a particularly in the elderly. For example, giving the peak of the epidemic april 17, 75yearold american had a mortality of about 46. 8 per hundred thousand, and by the end of august, the numbers have significantly declined to about ten per hundred thousand. These improvements however did not mean that we can let our guard down. Over the 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 and accounts. The 18 to 25yearolds currently make up over 26 of new infections in more than any other group. It is imperative that these young adults recognize even though they are likely to get seriously off on the virus they are major contributors to the spread of covid in the country at this time. In order to understand what proportion of the population has been infected with covid and what proportion remained at risk the cpc is currently performing largescale testing across the United States. Preliminary results appear to show most americans have not been infected and are still vulnerable to the infection, serious illness and death. We hope to be able to post the analysis of the first round of the study in the next several weeks. As i stated before, the cdc encourages all americans to embrace the powerful Public Health tools that we have right now. Wear a mask, maintain social distancing, practice routine handwashing with vigilance and be smart about crowds in to stay home when you are feeling sick. And as we move into the fall, i want to add one more critically important step. Flu vaccinations. Flu vaccinations are safe. The cdc encourages all americans to embrace the vaccine with confidence for themselves, their families, their loved ones into their communities. This year the cpc purchase an additional 9. 3 million addresses as well as 18. 5 million doses for children. This is a significant increase than in previous years. When combined with the tools mentioned, this could help the nation avert a very difficult full and lessen the burden on healtthe Healthcare System and e lives. To further strengthen the publichealth resiliency, we ordered 141 million to 64 jurisdictions through the cdc existing immunization cooperative program to scale out the preparedness for the flu season. We also developed a multiplex Laboratory Diagnostic test that is capable of measuring both influenza a and b. As well as covid using a single specimen. This test will help professionals better identify infections with influenza and covid. I also am announcing today an additional 200 million from the cares act funding that will be used as a first step to help the jurisdictions complete their individual plans and implement their further Covid Vaccination a followup to the playbook that we released last week. The cdc is an integral part of operation warp speed and they are leveraging ouwe areleveragid immunization infrastructure to support and promote the distribution of the administration and monitoring of the future vaccines. In coordination with observation warp speed, we are working closely with state and local Community Organizations that under detailed flexible plans for the Vaccine Distribution. As ive emphasized in prayer hearings, now is the time to comment to the data analytics, laboratory resilience, workforce expansion and Rapid Response capabilities. Years of under investment and od Public Health infrastructure has led to a system that has been sorely tested and covid19 is the most significant Public Health challenge the nation has faced in more than a century. Now is the time to build not only of the publichealth capability of the nation needs, but the capability to the people of the nation deserve. As we Work Together to collect the pandemic the cdc and all of the outstanding women and men of the cdc remain strongly committed to the mission to protect all americans from disease, threats and to save lives. I want to thank you for your time. With a specific testing recommended Public Health practice is with the safe and Effective Therapeutics we are seeing promising results. Specifically since the postmemorial day peaks and Community Spread o or the number of people hospitalized with covid19 is down 50 . The number of people in the intensive care unit is down 65 and deaths associated are down 32 . Let me emphasize that to sustain the use, we must continue our disciplined mitigation efforts especially Wearing Masks when we cant physically distance. On ten separate days they performed over 1 million tests per day at the federal government has purchased and delivered over 106 million swabs and 88 million tubes to the states, tribes and federal partners. Starting on april 7 from purchased and delivered to publichealth laboratories in every state over 2. 5 million points of care molecular tests to support control and rural testing. We have implemented federal search testing sites in 20 different cities helping to squelch emergency 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 half of which will be rapid point of care. We have been building towards this Inflection Point and ive previously testified to its coming several times over the past month. Now that they discussed two testing initiatives. Protecting the elderly has been, is and will continue to be a foremost priority for this administration. On july 14, we announced every single eligible nursing home in america would receive a plate of care instruments and testing supplies. Weve delivered on its 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 27 after months of planning in only one day after the fda authorization o, the administration announced a 760 milliondollar contracts to make a contract for 150,000,000point of care tests. This test is easy to perform, doesnt require an instrument, delivers test results in 15 minutes or less it costs only 5. Weve 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 7,600 Nursing Homes and areas of Significant Community transmission. 541,000 tests to over 5500 assisted living facilities with a certificate of waiver and 300,000 to the indian Health Service. This week we will be shipping 249,000 tests to historically black colleges and universities and 2. 6 million tests to assisted living Nursing Homes, home health and hospice is. It but coming weeks we will begin shipping millions per week in support of our teachers and students to open and keep open our k12 schools. Now i would like to close by recognizing my fellow officers and 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 into Nursing Homes and field hospitals in the hardest hit communities i think every one of the officers and families on their behalf i think all of you in congress for supporting the Training Needs and establishment of the Ready Reserve to supplement the ranks during the inevitable future emergencies. Thank you for the opportunity to provide these remarks. Thank you. Doctor stephen hahn, welcome. Over the past several months ive had the honor to work shoulder to shoulder with kirby or staff as they 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 workforce are critical to ensure the safety and health of the American People at anytime but its magnified during a Public Health emergency. Of course our work on covid and long covid issues comes with unprecedented public scrutiny and sometimes criticism. Any agency that has the broad responsibilities and farreaching impact of fda particularly involving issues of Public Health cant expect to do its job without inviting controversy and disagreement, but its also essential that the criticism we get other shakes the underlying faith that the public has and should have been the fda and the commitment to protect Public Health. I am confident in the decisions being made related to covid19 and what will be made in the coming months as we continue to address the challenges of this pandemic. I know that theres been particular attention paid to a few of the decisions reached over the past several months and i want to assure you and emphasize every one of the decisions we have reached has been made by severe fda scientists based on science and data, not politics. Fda represents science in action. Also we must make realtime decisions based on ever evolving data concerning the previously unknown highly contagious virus that we are still learning about. And sometimes it is necessary to reverse the decisions as new data emerges. This is inherent in the emergency use authorization process and it is akin to how a doctor might approach a patient in an emergency situation constantly updating a treatment plan as new data emerges. So come 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. Covid19. When a vaccine sponsor reaches a convolution that the data from its phase three Clinical Trials are adequate to his neck to fda, they will decide whether to apply for approval or emergency use authorization. This will be based upon the trial meeting with the specified success criteria that were established by the sponsor. Now this is important. They should also be consistent with fda recommendations regarding those criteria. Fda will receive the application or submission and our career scientists will review it, safety and efficacy data as well as manufacturing quality and consistency data. Fda made clear recommendations in our june 30 guidance regarding safety and effectiveness of vaccines so that 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 who choose to submit an emergency use application comin, emergency use authorization for sure. As we have indicated previously, we plan on seeking advice from the vaccines and related biological Products Advisory Committee comprised of independent members have been screened for ethics conflicts. The safety and effectiveness of 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 input into account as they make their decisions regarding the application or the requests. Before we are to issue is that were to happen, fda would have to determine among other things that the statutory standard is met. We expect that this would be demonstrated based on adequate manufacturing data to ensure the vaccines quality and consistency data from at least one welldesigned phase three Clinical Trial that demonstrates safety and efficacy in a clear and compelling manner. Let me emphasize that again. Data from at least one welldesigned phase three Clinical Trial that demonstrates its safety and efficacy in a clear and compelling manner. Fda also expects that it would include a plan for active followup to monitor safety among individuals to receive the vaccine. In the end, the fda will not authorize or approve a vaccine that we wouldnt feel comfortable giving to our own families. On behalf of this team thousand plus i want to make the following commitments to the American Public into this committee the fda will not authorize or approve any covid19 vaccine efforts that the agencies expectations for safety and effectiveness. The decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at the fda and the thorough review processes an in science will gue our decisions. The fda will not permit any pressure from anyone to change that. I will fight for science, mr. Chairman, i will fight for the integrity of the agency, and i will put the interest of the American People before anything else. Thank you, and i look forward to answering questions. Thank you, or hahn. We will turn to senators for questions. We have full participation today so id like to ask senators and witnesses to keep exchanges within five minutes so all senators will have a chance to participate. For my five minutes, i would like to ask for the courtesy of short answers so i can ask all of my questions, let me go back to two things you said. Who makes the decisions about safety and efficacy at the fda . Do you to curvier scientists or does the white house . Career scientists at the fda. That is very clear. I am briefed on all Major Medical product decisions. Overruling a decision is a very rare event and i have expressed on multiple occasions my intention and have done so during this to make sure the decisions are made by career scientists. Youve referred to this but once the fda approves a vaccine, as weve said today, we will have tens of millions of doses ready. None can be distributed until the fda approves it. Will you be willing to take the vaccine for you and your family . Absolutely, yes, senator. Mr. Chairman. I have a complete and absolute faith in the expertise of scientists who are terrific at the fda. If they are 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. Doctor fauci, youve been around since the reagan years and you have seen a lot of diseases and epidemics and responses to it. Is the administration cutting corners in safety and efficacy and its efforts 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 we will have doses available when a decision is made by the fda asked the safety and efficacy as you heard from doctor hahn. We are risking the taxpayers money that w but they are not rg safety and efficacy. Is that your testimony . Yes that is absolutely correct. Millions of students were going back to colleges and inevitably there are outtakes of covid19, doctor fauci. Is this working 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 the facility, maybe a separate dorm or floor so they dont spread among the student body, but do not send them home to their communities because of the likelihood of them receiving infection in the community. Ive listened to your testimony for the last several months. Some people say that your message is that you want to walk down the country in order to stop the spread of the vaccines, is that accurate . Database stored in strategy testing between five and 25 percent of the countrys nation depending on the location has been exposed to covid19. What about the American Population that has been infected by covid19 . Cdcs in the process a very large study across the United States measuring serology. The primary result of the firstround show a majority of the nation, more than 80 percent remains susceptible and it varies in different geographic parts have less than 1 percent of evidence of recent action some have more than ten or 20 as high as 24 percent question the next week americans are still susceptible to as well as. Based on the preliminary indications from the logical testing that as many as 90 percent of americans are still one still havent had the virus yet . Yes or. Thank you. We know a lot of should patients avoid getting treatment because of cost ive been pushing to make sure a cover Covid Treatment at no cost meanwhile the president is fighting to turn the Affordable Care act which will only 23 Million People without Health Insurance to discriminate against those with existing conditions it could become the existing condition. So i increasing the number of uninsured by tens of millions and increasing cost 133 Million People with existing conditions make it easier or harder to contain this pandemic . The question. Access to Timely Healthcare is critically important in terms of health. And in terms of this pandemic access to timely protective measure. You make are harder to control bad pandemic afterward. We have to understand what happens with the cdc testing guidance for asymptomatic people i am really the first course but i am concerned why cdc hello guidance to contradict to the widespread views of the Public Health community and was not drafted by scientists and did not undergo the strict scientific review proces process, published on the cdc website was not drafted by scientists nor are under with the agency strict scientific review process . Original testing guidance of august 26 had full engagement of individuals that cdc was cooperative that included the assistant secretary as well as the Coronavirus Task force. The intent of that document as i mentioned before tried to clarify my statement was never to limit testing of the asymptomatic individuals. And the temples to reengage the community so as a Public Health action as a consequence i it became progressively apparent the guidelines were not interpreted we intended them to be interpreted what led me to realize we had better clarification to make it clear that we believe very much asymptomatic transmission is an important part of the transmission cycle of this virus. They should be tested. You said in an interview that the coordinator and it editing of the American Medical Association and recommend testing for asymptomatic people. I went to the doctor so that the original guidance that was published by the cdc. It did not unequivocally recommend against testing asymptomatic individuals in fact it but in the context of Public Health and medical supervision that is all it said it is widely misinterpreted and misrepresented we have done guidance. Also identifying ourselves as transmission of the virus we had on monday cdc reverse course you said it was posted in a. And significant red flags. Is my a question with the latest science to protect myself and my family can a project website to give me that information . Yes. Again, my agency and my health on to give the best cap recommendations we can based on the data and science and if necessary that changes then we modify that guidance based on the new data of your commitment and thats the grounding of we make the recommendations. I am concerned American Public need to rest of the decisions and was posted on the website needs to be trusted. Banking senator for continuing to his regular hearings so we American Public can check on the efforts inside the coronavirus and i can be hard witnesses to testify since are working very hard to respond to the pandemic will appreciate them being here glad to see me are making progress to plan how we distribute safe and effective vaccines and i am optimistic and pleased all these efforts Going Forward for your thinking through how to ensure access to rural areas. One of the things i am asked about in the phase three testing need to be stored at extremely cold temperatures even by wyoming standards may be as low as negative 94 degrees fahrenheit . Pharmacies, doctors officers on offices and thats where places they go to get the shot but they dont have the specialized freezers to store the vaccine especially in the rural areas so very few of those is an option is another solution or how we ensure sufficient freezers in Storage Capacity and it isnt just limited to major cities with an equitable and nation and then the biggest operational plans particularly as she looked at the importance that the administrator and distribute 89 million vaccine doses per year and then we will build on that but the micro plans will identify why gaps are there to ensure that is a popular cold storage for the Vaccine Distribution we are committed to make sure that happens and the controller of the manufacturing standards are followed will require such cold storage as you mentioned to provide Technical Assistance and work with cdc to ensure that happens. Director would feel do you anticipate that once the fda approves the the cdc will have to work with the states to develop more distribution plans . Or where the work the states are doing suffice . With that playbook the last week in defending today that we get the plans and then to interact and share best practices to get the plans as rocksolid as possible and im confident there are things we havent thought of and have to be dealt with as they come upon us. It is my expectation, we have done the micro planning and minnesota and north dakota, philadelphia and florida over the summer and with those 64 jurisdictions to complete by october 16 and it is our hope that will of the individual plans to get that equity distributed to recognize things will come up we have to Work Together. Hopefully we will be 95 percent of their between now and october 16. Senator casey . Thank you for appearing this week we have announced to the world we reach the 200,000 grim milestone of deaths and that number translates into a thousand deaths so as we think about those we have lost we now have to consider the possibility that covid19 could be considered a existing condition just as the Affordable Care act was struck down from the november and at the same time we have to consider the ravages of this disease in the context of Nursing Homes. Released yesterday and the cost of inaction 11 deaths per hour that means in the month of july and august of this year 11 nursing home residents died from covid19 every hour. In total from the beginning of the pandemic more than 70000 residents and workers in longterm care facilities have died. Fortunately the Trump Administration has no effective strategy, no plan in place to reduce this number to reduce the debt number case number it is an american tragedy. There is no excuse for these numbers to keep going up. We should not allow the next couple of months to transpire and have a number of nursing home deaths were the case number go up again that is not america we should be now the majority in the senate could be doing something about this may have been obsessed with confirmation votes all kinds of confirmation will tell several. And the defense bill as well but almost all of them are on confirmations now the Senate Majority is obsessed getting a confirmation vote on this leftdoublequote justice. I have one question for the majority i will cancel the Trump Administration become obsessed with reducing nursing home deaths . Now lets get to witnesses. And to ask the question which will an answer about the vaccine and his response to that in terms of his own family and his own person one of the most important challenges we face in developing and distributing and administering a safe and effective vaccine is a way to demonstrate the says that vaccines are safe we asked the other three members of the will commit to receiving the covid19 vaccine and public view once one becomes available and is authorized to buy fda. Thank you for the question i have said that in the past if the vaccine has shown what is shown to be authorized to be safe and effective for will take the vaccine and rack command that they take the vaccine, yes. I have every confidence in the fda process to provide a safe and effective vaccine have no hesitancy to recommend to my family but the question is whatever is appropriate need to accede and understand and have a discussion with positions or letters asking anyone to commit i have complete confidence in a fda process. Absolutely has a with my wife and children and 11 grandchildren and of course myself i total confidence in the fda that i am confident it will be a safe vaccine and im ready to take it. I have a question on state information and immunization so just have one question before my time expires and all those standards set forth in the playbook . I have to go back to to answer that specifically where building on the system we regularly use in the 64 jurisdictions to distribute 80 million vaccine doses per year and in addition there will be Additional Information capacity to be put in two there are new points of service that technology doesnt currently exist but i will have my team put together a comprehensive answer for you. And those of us want to say to senator casey the majority has been focused on the pandemic since 2200 are starting to pass legislation and of the architecture to do what they are doing and we thank you for that. Did we make up a new protocol for a Covid Vaccine we simply following the protocols for every vaccine every member of this committee are congress have a is used as a Gold Standard pack. With respect to approval or authorization fda does represent the Gold Standard. The statutory definition in is different than it is for the but we were following the criteria with respect to our performance with covid19 want to give a few examples because fda does represent the Gold Standard, scientists are incredible with remarkable work in one of the major things that distinguishes us from regulatory agencies as we look at the primary data and we also do with asthma and the test those Clinical Trials with those diverse sutras in recent memory simply because and typically not to pick up the International Data and then to review that. It is correct to say the most diverse trials that is a reasonable way to put this and in the june through the guidance with respect to efficacy with the floor 50 percent that led to those power calculations and 30000 plus volunteers and the studies at a number of that word with the data to see to make a determination very robust the private sector has responded and its a great effort if that is a decision with the emergency use authorization and with that data safety monitoring board will set the data prior to the application is at another safety step quick. And with the data safety monitoring board if they are significant safety issues i can stop the trial because of safety issues and they can do a futility analysis meaning continuing that trial will not do any good because there is not a statistic properly the prespecified aid criteria from a case of the vaccine prevention of infection and that would be another criteria used to say that the data are mature give it to the company and the company can put that into an applicatio application. That works off the Technology Platform that you created you confident with that and would also answer for members of congress for the husband and wife that come to us that my husband and got covid and my wife didnt get it how does a highly transmittable infection like this one be positive and one never get positive . That happens all the time with infections. Although a wireless is highly transmissible but the resistance to a particular type of infections are the highly transmissible virus has an attack way that is high that we see all the time individuals who are exposed to someone with an infection who do i get the interaction. As a whole you can see the kinds of things we see as this pandemic involves. We have the same situation with hiv individuals living with sex on a regular basis and they never got infected another person could have sex one time and the infected. That is the nature of the variability of susceptibility of infection to individuals it is entirely conceivable. Over time. Absolutely the answer is yes the fda ability to determine safety and efficacy based on the data the trial. Thank you senator baldwin. Thank you mr. Chairman. Doctor redfield time in april, the cdc staff conducted an investigation into a covid19 outbreak at a meatpacking plant in south dakota following the investigation, your staff sent a report to the state south Dakota Department of Health Including strong safety recommendations the cdc determined where necessary to stem the transmission of covid19 at the plant. That was dated april 21st. It was reported last night your office intervened and ordered the safety recommendations be water down. The next version of the memo dated the following day apri apd essentially adds the words it is feasible to the strong safety recalls over and over throughout the document saying that they were voluntary or optional. Workers continue to show their to show that that plant and it ignored the safety guidelines. To date at least 1200 workers from that plant have been infected with covid19 and 34 hospitalized and for have died. We also note in the same time. And april tuesday april 28, that is when President Trump issued his executive order basically naming meatpacking is an essential industry and meatpackers as essential workers the right to enter the two documents with people 21st and 22nd safety recommendations is that okay i take unanimous consent to do so. I think it is a vindicate i do. Doctor right at your office to me and these be water down . Thank you very much senator would not characterize it the way you did. I would say the field teams that were in on the plant and that investigation you are referring to had a report in the field they shared with the local south Dakota Health department. One of the critical things that needed to be stressed that the cdc is not a Regulatory Authority these were recommendations department of labor and osha have Regulatory Oversight and they can direct that. Our report were recommendations so as that document woes reviewed we wanted to be clarification people understood it is a recommendation not a statutory requirement. Thank you will note osha and department of labor has failed to issue anything with voluntary guidance as has cdc there is no endemic emergency standards in place for workplace in the us even though the patty months to work on this but that is my responsibility. Did your office have any contact with Smithfield Foods with usda or the white house concerning specifically this memo before it was edited . Now. Not at that time. Is a multi agency discussion which labor, agriculture, and ourselves on a variety of the issues that intersect by with that regard it was the stress and the clarity the nonRegulatory Agency these were recommendations. Given that i would ask you to consider changing the meatpacking guidance you can say we are not a Regulatory Agency but these are the safety calls will recommend and not put feasible. It makes it sound like these are not particularly important if you can do a great, if you cant. You can say these are the safety recommendations without it being construed as an osha standard and i would ask that you change that guidance in might of the death toll and the harm. I appreciate your comments senator. Thank you senator. Senator paul. The lockdown was to mitigate the spike of i guess the hospitals would not be overwhelmed the same amount of people will die with that the lockdown the media and government officials have forgotten this caveat planning the curve morphed into a relief we can change the course of the pandemic with the economic lockdown it is unfortunate has led to a protracted lockdown recession we admired and its important we examine the data and learn and try to avoid the manmade aspect of this calamity in the future and those who if i am the curve in new york and new jersey the evidence argues otherwise they wound up with the sharpest spike the highest death rate in the world at 1700 deaths per million and in contrast sweden had a softer touch, feel mandates and voluntary guidelines the death rate was one third of new york and new jersey. Submit argue sweden and new york and new jersey are different populations. Perhaps. Even the average rate is now greater than sweden. In fact your stuff rate is comparable to less developed parts of the world is social distancing is virtually impossible like ecuador and bolivia brazil. So he is mentally capable to alter the course of the Infectious Disease through crowd control . Statistics say no. Mitigation efforts have failed to file the curve in those countries regardless of Public Health policies suffered a significant spike in a gradual decline. Some argue for hong kong the title in order to begin . Each had the death rates but those rules were largely voluntary since they lack the freedom powers and the population may have a higher degree of exposure the coronavirus codes were preexisting costs reactive immunity. There is a fascinating field of inquiry looking at susceptibility of covid19 in the assessment people preexisting community to similar coronavirus is in fact that may explain why we have some people who are very will sometimes order are its important we dont acquiesce the first two hypothesis. New york and new jersey and connecticut and and still feel one at the highest death rates in the world in sweden who enforced mandates has a death rate one third new york and new jersey also the to pay for the us is essentially equivalent to that of south america where social distancing and mitigation efforts are virtually impossible. Doctor fauci today you said you are not for economic lockdown but yet your mitigations from dating to baseball to movie theaters have led to this economic lockdown so do you have any second thoughts considering the evidence that despite all of these we had done the death rate is essentially worse than sweden equivalent to a less developed world who cannot do any of the things you have been promoting . To have any second thoughts . Are willing to look at the data countries did very little have a lower death rate to the United States . I would be happy at a different time to go over details you said a lot of different things. He computers to sweden and there are a lot of differences and you said there are to compare swedens death rate to other comparable scandinavian countries. It is worse. So i think is appropriate to compare sweden with us yes. I think in the beginning we had done things based on the knowledge we had at the time and hopefully we are humble and modest enough to realize as new data comes you make different recommendations but i dont regret saying the only way we could have stopped the explosion of infection rose by essentially iowa to say shutting down but having the physical separation and the kind of recommendation. New york has the highest death rate in the world how can we be jumping up and down to say he did a good job . No. You misconstrue miss construed as a new done in the past they were hit probably made some mistakes. Right now if you look at whats going on right now, nothing is going on in new york to get their test positivity a 1 percent or less is because they are looking at the guidelines we have put together from the task force of the for five things of masks and social distancing and avoiding cards but also the immunity they no longer have because they have enough immunity in new york city. I challenge that this happens all senators and all the time. You are listening to what the director said its about 22 percent if you believe 22 percent theres also the existing immunity of those who have crossreactivity. I would like to talk to about that also there is a study that recently came out the existing immunity they do not crossreact with covid19. Thank you mr. Chairman. There is a study that got some attention regarding pac10 and big ten athletes 15 percent that had covid19 whether or not they showed symptoms had evidence of inflammation or damage to the heart muscle what are the longterm effects for myocarditis what is the current understanding the general longterm effects of somebody who had covert one covid and recovered are in on asymptomatic . Actually i mentioned that in my opening comments thank you for giving me the opportunity to expand. It is quite puzzling because the individuals, there were two studies that you mentioned but the one in the nonathletes were individuals had recovered from covid19 with various degrees of involvement and that which would require and 60 to 70 percent and had a vision of the heart and the relatively asymptomatic and just be careful and watch what happens. One of the possibilities that could develop is that it could clear up and i have no problem for the rest of their lives and the other thing they can wind up with information to have scarring that can lead to arrhythmia or cardiomyopathy. I do not know what would be but we need to keep our ion. Insurance Companies Air on the side of caution. What we believe is because of this uncertainty a longterm that affects that any diagnosis of covid symptomatic or not will be the existing condition and it likely probable Insurance Companies if allowed to discriminate think that is something we all need to talk about over the course of the next few weeks. Had to come back to the question we have to take the had instructed advisers to slow the testing down when he was kidding and he said i dont care did. Let me tell you. Let me make it clear. You made it clear he wants less testing so that did not seem coincidental the strange guidance came out in august to recommend significantly less testing. That is not what you are testifying to today. You say that guidance did not recommend less testing and all you are doing with the third set and 30 days was to clarify. But where in the august guidance does it tell people that they should get a test of they were asymptomatic in close contact with us to tell them they should proactively see a Healthcare Provider if they had been in contact . I read it 20 times and i see anywhere in this guidance that it tells people michigan a test. House anywhere in the guidance it tells them to go see a docto doctor. It means you do not necessarily need a test unless you are formidable individual with your Healthcare Provider or local Health Officials recommend you take what it doesnt say you should go to the doctor but if you have been recommended you should. It stands to reason that when folks read this will be under the impression they should not get a test which seems to comport with directions of the president to slow down the testing so where is the guidance they should get a test to see doctor and as i said before. The decision have more test will lead to less cases particularly if it engages Public Health action. And i issue that clarification august 27, again i said we are placing emphasis on symptomatic illness were individuals with significant exposure are vulnerable populations and healthcare workers and those individuals who may be in the reason this campaign will came from a Public Health perspective individuals travel up and get a test and go to wor work. To listen to it is associated so this will help bring a health. When we clarified the after very clearly what the category of those so is dramatic and wet weather objective it was clear that for Different Reasons some individuals were not a fan doing testing for context the individual is a significant exposure to put the further education. That the august 27 clarification statement that i put out word can move from all over the goal line and it didnt but theres no intense guidance to decrease testing and then to drive a Public Health action and the manner in which it was interpreted by number of individuals it doesnt accomplish that goal. This has been dizzying cap officials just waiting for the next correction. In my effort to be fair, we were running over five minutes pretty well we have about 14 senators remaining so i would ask my colleagues to keep that in mind with a fiveminute will. Senator collins. Let me begin my questions today by thinking go clearly the American People need to have confidence peoples confidence and a covid19 vaccine . Im not aware of anyone that has a conflict involved in the decisionmaking process its difficult to speculate since we have very rigorous standards and place with a Monthly Review for senior officials and the culture at fda looking at the issue that is selfdeclared as well as the government ethics review of all conflicts. If anyone is aware of anyone at fda with the conflict i would want to know because we will address that right away. I appreciate this. You say they are we all of them and the drug and vaccine process. Here is a problem. Demand that is a farmers are as a former Drug Company Executive and to hire him and reportedly has 10 million of stock of . And smithkline and then according to documents they may own stock so why does this matter . Operation warp speed the vaccine project that is headed up has invested billions of dollars and the companys they hold stock in. You and other fda officials involved in the vaccine must comply with conflict of interest law telling me how seriously you take that. Can you explain to me why they should get to play by a different set of rules . I cannot explain the situation i have no knowledge i can tell you we established a very bright line between operation warp speed and fda. Who do not participate in the decisions. We provide technical decisions just like every sponsor. You said financial conflicts of interest basically undermine the Publics Trust and that there are conflicts of interest. Shouldnt they eliminate these complex . Senator warren im not aware of the conflicts you are describing. If they exist to make a full disclosure but if they exist sure they resign . And a hypothetical situation you are describing i cannot the judge because i know the facts but i do take very seriously the conflicts of interest and how that affects public perception. Congress showed strength in the federal ethics laws it should pass the coronavirus oversight in order to permit of a conflict of interest in the federal covid19 response. The first person to be fired the American People deserve to know that these decisions are based on science and then to pass my bill today. I was distracted but he may way to senator casey when he said what they are doing to before the death so Nursing Homes we heard how many resources were deployed. And then to the testimony but my office as the guidelines for people for have a recommend we hearing with osha to straighten that out because i thought that is a good point. Roir, it is my immunize thoseo between three and 18, because of the crisis, we have had a slowdown and those children are missing the vaccines that they should get. Is there going to be a requirement to put these vaccine records in the state immunization registry . Yes. Facilitiesut federal , will they likewise be required to put their data into the state immunization registry . Adm. Giroir i dont know about dod i dont know about dod, i just know that anyone and the civilian registration, that was part of the prep act declaration and my guidance about that. Just a suggestion, dod should be required because many of them may be from the military and it may be a condition of employment that some be vaccinated, it will be nice to have that documented rather than someone stating that they have been. I was not commenting on whether it was good or bad, i just did not know the regulation. We would be happy to look that up. And im not i am just pointing that out. Redfield, maybe dr. Giroir, i understand that the vaccine can be given without cost to the patient but there is a concern that the provider would be compensated for their costs associated with an administrative vaccine. There still going to be compensation for the provider who is administering the immunization . Thank you, senator. That we speak generally. Peak to that. We would assume there are costs for the providers. There are details to be worked out so no patient has outofpocket expenses whether its for the vaccine itself or for the administration of that vaccine. Doctor hahn, the vaccine may only have 50 considering whether a vaccine is effective is that its efficacious at least 50 of the time. Presumably the level of antibody response would be a marker as to whether or not somebody is having a response, so my question is for those folks at higher risk like the emergency room nurse, but tech, but clerk, many people to the er, with these antibodies be required after the vaccine is given and do we have enough tests that are now sufficiently accurate and available to conduct this . Senator, thank you for the question. The first of several trials we will not yet have data that bridges between a clinical outcome which is the primary endpoint we provide which is the prevention of the covid19 illness and the development of antibodies so it is unlikely although i canno cannot prejudge data that we would have a requirement. If they are purging data or from the initial trial one could imagine a situation where that could occur but we dont know that because we do not have the data. Thank you for the answers and i will yield back. Thank you, senator cassidy. I want to say a word to q. , senator how much im going to miss you as a benefit of the committee. I learned a lot both working with you and from observing you. I will miss her friendship and leadership. I also want to acknowledge what it means to have 200,000 people in the country no longer with us. My wife and i have four friends who died of coronavirus, wed wh had coronavirus. We had preexisting conditions and some antibodies that might do something. I agree with th the chairman and his opening comments said, the New York Times and others, butt the u. S. Was the best of any nation to deal with this. And i believe that. And yet i think the management beginning with our preparation, the management of the crisis has been one of the worst in history. Dont believe me, im just a u. S. Senator. But when people who are staffers on the task force are resigning and saying the same thing, i think weve got to Pay Attention to that. I am also mindful during the crisis not for a second as the Administration Stopped its effort to take Health Insurance away from millions of people. I can only imagine how much worse this would be in virginia at 400,000 didnt have Medicaid Expansion but many are hoping to see what it would be like if we take our veterans away from millions of people so we may have an opportunity to see that. One of the reasons this has been handled so badly isnt because of the dedication of professionals. We have wonderful professionals that are very dedicated but it goes back to communication. I dont see a lot of crazies, hurricanes, Mass Shootings at Virginia Tech one thing i learned is communication. People who are worried. Its critical. Thats where weve fallen down on the job. A president that preached hydroxychloroquine or bleach, Data Administration laid out guidelines on the states for reopening, my doctor said those are good guidelines im going to trouble them. The next president david obey the president said against this tyrannical governor following the advice. And we have seen so many other examples of poor communication or mixed messages that has confused the public. Just this week the Key Communication center at the nih out of somebody in a website trashing you and other Public Health professionals and your advice about masquerading as suggesting that this was a hoax or and i would say that i was very concerned when the cdc changed its website this week about how the virus is transmitted and i would like to ask that a slide to be put up. This will be hard to read so i will bring it to your attention i believe on the 18th of you can watch this entire hearing on cspan. Org. We are leaving it now to bring you live remarks from joe biden on the Supreme Court nomination. Family, first woman in history of our nation to lie in state in the u. S. Capitol. It should not have taken nearly this long to pesto that honor on a