Transcripts For CSPAN NIH Director Dr. Collins Surgeon General Dr. Adams Testify On Vaccines 20240712

The current drop in Vaccination Committee on health, education, labor and pensions will please come to order. I would like to welcome everyone and go through some administrative matters that we do at the beginning after consulting with the attending physician, the sergeant at arms, cdc, health and Human Services, individuals are seated six feet apart. There is no room for the public to attend and the press is working as a pool and the hearing may be watched gaveltogavel online. Both of our witnesses, dr. Collins and Surgeon General adams are participating in person. Some are in person, some are participating by videoconference. The office of attending physician has advised that senators and witnesses may remove their masks to talk in the microphone since our chairs are six feet apart or more. That is why my mask is off and i am more than six feet apart and when i am in a hall or walking on the senate floor, i wear my mask. We are grateful to the rules committee the sergeant at arms, the press gallery, the architect at the capital, all who have helped us maintain a safe environment for this hearing. I would like to say that votes begin at 11 15 but we will continue the hearing so that all senators will have a chance to participate and if necessary i will leave and ask someone else to reside during the time of voting and i will come back. Senator murray and i will each have an opening statement. We will then turn to our witnesses who we thank for being with us. We would like to ask the witnesses to summarize their remarks in five minutes to leave more time for back and forth questions. I will ask each senator the questions of up to five minutes. I have been reading, i was saying to senator tim kaine and Maggie Hassan that i have been reading guns, germs, and steel, the book that won a pulitzer prize. She wrote that there he wrote that there is nothing new about epidemics that cause massive unrest and social upheaval. He says humans have acquired most of our Infectious Diseases from animals. Throughout most of history there , were basically three ways to deal with these epidemics. One was to isolate the infected. Two was that over thousands of years there have been genetic changes in human populations in response to Infectious Diseases that cause major outbreaks like smallpox. But that did not help the native americans who had no resistance when european settlers arrived here wiping out 90 of a native tribe by handing them a blanket with smallpox on it because the tribe had not previously been exposed to the virus. There is a third way that was most common throughout most of history and that was to let it rip. Let the virus run its course through the population until everyone had either been killed or recovered and developed some immunity. Diamond says the black death killed about one third of europes population between 1347 and 1351. What is new about epidemics is modern medicine including the ability to diagnose the disease and create treatments that make it easier to recover but the true miracle of modern medicine is vaccines which can prevent humans from acquiring the disease at all. That is why today all in 50 states and in the district of columbia, schoolchildren are required to take vaccinations for the following diseases, diphtheria, tetanus, polio, and chickenpox before entering school. The vaccination will protect the child from getting the disease which in turn prevents the child from infecting someone else, a pattern that causes these diseases to disappear. Americans of my generation remember how polio terrified our parents in the early 1940s and 1950s. Many saw their children die or be left dependent on iron lung to breed for the rest of their to breathe for the rest of their lives and those who contracted polio, were like senator mitch mcconnell, the majority leader who is left only with a lamp. This terrified americans until a doctor developed the polio vaccine in the 1950s. After the vaccine was developed, the United States undertook a largescale vaccination programs and polio was declared eradicated from the united 1979. In the purpose of this hearing is to explore the remarkable progression that science is making toward a covid19 vaccine to remind parents to get their childhood vaccines and to encourage as Many Americans as possible to get the flu vaccine this fall. First the progress for a Covid Vaccine. Dr. Collins, the director of the National Institutes of health is here today to talk about that. Research and development, operation warp speed which is working around the clock to develop, manufacture and distribute a safe vaccine to hundreds of millions of americans. Some people believe that warp speed means cutting corners but it refers to the extraordinary investment and research, development and manufacturing a manufacturing scale up for the covid19 vaccine, perhaps most significantly, the Biomedical Advanced Research and Development Authority has taken of the unprecedented step to help speed up manufacturing for hundreds of millions of doses of the vaccine early in the process so they could be ready as soon as the new vaccines are approved by the food and drug administration. In other words, they are being manufactured before they are approved, and if they are approved they will be ready to , distribute and if they are not, they will be thrown in the dumpster. Despite the speed with with scientists are developing a vaccine, dr. Hahn says the administration, or his agency says is quote, not skimping on efficacy. This is not going to be a political decision, he said. That means that if the fda determines that a vaccine is not safe or effective, the vaccine will not be distributed. At the same time, the cdc is working on a plan to distribute the vaccine as soon as it is authorized or approved prioritizing vaccines for , healthcare workers and vulnerable populations. The cdc plan will be a system informed by nonpartisan experts from the National Academies of science, engineering and medicine and the Advisory Commission of immunization practice. As inevitably happened, some have suggested you are speeding up the vaccine because an election is coming and you have asked states to get ready to distribution it because an election is coming. I was thinking this morning, what if dr. Collins showed up and dr. Adams say that it would be five years before we get a vaccine. I think we would throw them out of the room and ask the president to try to find some more effective people. What if we did not ask states to get ready to distribute a vaccine and showed that we have not learned our lesson from what happened with the h1n1 virus when the vaccine was ready, but the states were not ready to distribute it. We should move as rapidly as we can both to develop the vaccine and to be prepared to distribute it. Why are some americans saying they are not persuaded to take the vaccine . Three reasons. One is are they safe. Vaccines are approved by the fda. They can either license a vaccine or authorize it for use doing a Public Health emergency and the fdas stringent approval process is the worlds gold standard. The vaccines are routinely that are given to children are recommended by the Advisory Committee on immunization practices, an outside group of Health Experts that look at all available scientific information about each vaccine. And then medical associations like the American Academy of pediatrics, the American Academy of physicians work with that agency to develop these recommendations. In a 2015 article in the scientific america, it is written that by age two most children will receive almost 30 shots designed to boost a childs natural defenses against disease yet at the same time, parents who take their child for those recommended vaccinations might be inundated with website rumorsebrity espoused making false claims that shots are not necessary or cause autism. She continues, at best navigating this landscape can be confusing but when weighing the risks of encountering lifethreatening disease against the benefits of receiving a vaccine, there is no contest. The vast majority of children do not experience anything worse than shortlived redness or edging at the spot of the injection. And then, are the effective . There is an evidence of smallpox that was ravaging humans as early as the third century bce. The disease killed three out of 10 people who were affected. And then an english doctor saw that those who had gotten cowpox seemed to be immune from smallpox. He published his results in 1801 leading to the development of mankinds first ever vaccine and no one on earth has naturally since 1977. Llpox it has been officially eradicated. Polio was one of the most dreaded childhood diseases following introduction of vaccines specifically, the vaccine in 1955 and another in 1963. The number of polio cases fell rapidly to less than 100 in the 1960s. Fewer than 10 in the 1970s according to the cdc. Thanks to a Successful Vaccination Program the United States has been poliofree since 1979. Diphtheria terrified patients in the 1920s. Today there are only a few cases a year according to aap which tributes the change to which contributes the change to vaccinations. And then, is the Doctors Office safe . The pandemic has made some folks leery of the Doctors Office. An analysis of patient records according to the wall street journal chose that the immunization rate for recommended childhood vaccines has declined about 40 from late february through mid april. So for parents who are worried about taking their children to the doctor, the American Academy of pediatrics says pediatricians are working to make their offices as safe as possible. They say they are among the safest places you can be. Do not be afraid to take your child to see your doctor. I started my statement with comments from Jared Diamond and i will end with a warning he wrote recently. On june 23 this Committee Held a hearing on preparing for the next pandemic. One member asked, why would we worry about the next pandemic when we have not conquered this one yet . In the wall street journal on may 23, Jared Diamond provided an answer to that comment. He says that in this age of jet planes with millions of people carrying infections from one place to another overnight, the next pandemic could be next year and we would be wise to prepare for it. Congress tried to do that in response to the other new diseases that have emerged over the last 40 years, hivaids, sars, mers, ebola, but good intentions often evaporated as the epidemics ended. One example in 2012, congress created three manufacturing plants so that when the next epidemic arrived, we could introduce vaccines rapidly. Fortunately, two of those plants are playing a role in manufacturing hundreds of millions of those is a fact for covid19. Senator bernhard and i took a tour of one of them not long ago. There is still a need to improve and sustain these types of facilities so they are able to pivot more quickly to the next threat when it emerges. In a similar way stockpiles were , created and then depleted. Former hhs secretary told his committee that Public Health programs had been underfunded for the last 30 to 40 years. The nation goes, he said, from panic to neglect to panic. Fortunately, thanks to an unprecedented effort by the private sector in our government as well as scientists around the world, there is likely to be a covid19 vaccine ready for the most vulnerable citizens by the end of the year and hundreds of millions of doses available in 2021. Some of the challenges apart of finding a vaccine are how to distribute it, to whom should it go first, and how to persuade americans that it is safe to take. But while we are in the midst of dealing with this pandemic, it would be wise to remember in any legislation that Congress Passes this year to make sure that onshore manufacturing plants are functioning, stockpiles are full, Public Health is properly funded and states have the right tools and resources. The reason to do that now while our eyes on the ball is that the next pandemic, as Jared Diamond wrote, could be next year. Senator murray. Thank you very much, mr. Chairman. While you still have a few more hearings, i want to start off by saluting you for your many years of service to the country. I know my democratic colleagues and i will miss you next year. On the topic of todays hearing, mr. Chairman, our country is in the middle of a painful crisis. The covid19 pandemic has crowded hospital intensive care units, it has emptied schools and shuttered businesses. It has deepened Damaging Health disparities among black, latino and tribal communities, people with low incomes and people with disabilities. It has ravaged prisons and Nursing Homes and other congregant care facilities. It has strained our economy, our Mental Health and more. It has claimed around 190,000 lives so far and more each day. Unfortunately, instead of leading in the war against this virus and fighting the pandemic, President Trump is fighting Public Health experts. Instead of supporting facts and science, he is supporting conspiracies. He has spread absurd false , theories about fda officials being deep state agents and cdc overstating the death toll. He has promoted unproven treatments. He has called for less testing which he blamed for the rising number of covid19 cases, wrongly claimed kids are not likely to transmit the virus, and has repeatedly insisted this would all go away. The list of inaccuracies and outright lies at a time when truth is a matter of life and death goes on and on. Unfortunately, trump is not alone in his response. In july after months of delay and inaction, republicans put forward a proposal that did not come close to addressing the harsh realities of this pandemic. Now we are hearing their new plan is to force a vote on a proposal that does even less. I hope that republicans will sit down with democrats to work on a package that helps our economy and keeps our American Families safe. A package that actually increases testing and access to healthcare, that actually supports our schools and addresses the childcare crisis and protects workers. And what is relevant to this hearing today, helps make sure we get safe, effective trusted vaccines that are widely and equitably distributed and administered. Vaccines have long been a critical Public Health tool and even before this crisis, it was important that we encourage vaccines easier to keep people safe, to make sure vaccines are available and administered to kids across the nation including through efforts like the vaccines for Children Program and build Vaccine Confidence while combating misinformation. This pandemic has made the challenge more urgent than ever. I am glad we have Surgeon General adams and dr. Collins to share their expertise. But i am also frustrated that despite my request to the chairman, the fda commissioner and cdc director dr. Redfield were not invited to testify today. Those agencies play a very Critical Role in developing and distributing vaccines and should be here today. Hearing from them is even more urgent in light of recent political interference. By waiting to bring them before the committee, we are losing valuable time to avoid costly mistakes. In the past few weeks, we have not only watched President Trump directly promote conspiracies about the fda and the cdc, we have seen reports that he has asserted political pressure on the fda to issue an emergency use authorization for convalescent plasma and on the cdc which changed testing , guidelines to be more restrictive with no justification and running counter to the consensus of Public Health experts across the country. These are not the first reports of political interference. The Trump Administration had previously promoted unproven treatments like hydroxychloroquine and blocked cdc guidance for community reopenings. Recently the fda commissioner announced he was prepared to authorize a covid19 vaccine before phase three trials were complete but without providing any guidance about when that would be appropriate. When it comes to a covid19 vaccine, we cannot allow President Trump to repeat his maligning pattern of putting politics ahead of science and Public Health. Fda scientists efforts to ensure the safety and efficacy of vaccines must not be undermined by political meddling. Cdcs role in distributing a vaccine and prioritizing who receives the first doses must not be supplanted by politicians or Campaign Strategists or corporate lobbyists. If we are going to turn the page on this pandemic, people across the country must not have any doubt in this process or in the final product, which is why we need to hear directly and immediately from our Public Health agencies about how they will prevent political interference and why we need to push for the transparency required to hold this administration accountable. We need the fda to be transparent by issuing an official guidance with standards for granting any vaccine in emergency use authorization including standards for the , independent review of phase 3 data. By waiting for the completion of these Clinical Trials before moving on any candidate and by committing to make public any data used to greenlight a vaccine. We need transparency from the cdc about how it plans to handle s expertsion, how it will drive the progress devised the illadvised decision to have the cdc lead this effort and who will get priority when the first doses are available. We also need transparency on operation warp speed contracts and how it is addressing any potential conflicts of interest. In short, we need transparency from top to bottom. Of course in addition to transparency, we still need a comprehensive National Vaccine plan, one of several steps i have called for in the vaccine papers i put out on vaccines months ago. We have seen with testing how many problems the Trump Administration caused by refusing to develop a plan and leaving our states to fend for themselves. Testing is an ongoing catastrophe and we can not risk a repeat performance when it comes to vaccines. The Administration Must develop an end to end National Vaccine plan that addresses how we make sure vaccines are safe and effective, how we produce, distribute and administer hundreds of millions of doses, how we alleviate rather than deepen the Health Disparities we know exist, and how we overcome barriers to access like cost and proximity to providers and how we promote Vaccine Confidence and information especially when there is so much misinformation coming from the president of the United States. Developing and distributing safe effective vaccines is a huge , undertaking. It is one that cannot be accomplished without a strong sciencedriven leadership from the federal government. I really am glad we have the opportunity to talk about the challenges that lie ahead, but there are more questions we need to answer and so many more witnesses we need to hear from. I will absolutely keep pushing to make that happen. Thank you, mr. Chairman. Thank you, senator murray. As usual you are having some considerable effect. We have announced our next Health Hearing which will be in two weeks. Dr. Redfield from the cdc will be a witness. Admiral gerard will be here. Dr. Hahn, the head of the fda will be here. And dr. Anthony fauci will be with us. Today we have two witnesses. We welcome them. Dr. Francis collins is the director of the National Institutes of health and overseas the largest public funding of Biomedical Research in the world. He is a physician geneticist, becoming the nih director in 2009. He served as director of the agencys Human Genome Research institute from 1993 to 2008 and he led the International Human genome project. He is a member of the National Academy of medicine, sciences, was awarded the president ial medal of freedom and received the National Medal of sciences. He is a graduate of virginia and yale, university of North Carolina school of medicine. He is the only National Institute Health Director i know who has ever played the guitar at the bluebird cafe in nashville and played it pretty well, i might say. Next we hear from vice admiral jerome adams, Surgeon General of the United States. He oversees u. S. Public Health Service commission core, a group of Public Health professionals working for the advancement of Public Health. He previously served as the Indiana State Health commissioner. He led that states response to ebola, hiv and zika. He was staff anesthesiologist and assistant professor at the Indiana University school of medicine. He has been at the university of maryland in Baltimore County where he obtained a degree from berkeley and Indiana University where he completed his residency. Welcome to both witnesses. Dr. Collins, let us begin with you. Dr. Collins thank you very much and perhaps we could get the visuals on the screen if that is possible. Chairman alexander, Ranking Member murray and distinguished members of this committee, thank you for inviting me to discuss operation warp speed and the importance of developing safe and effective vaccines. I am grateful for your longstanding support of nih and for this opportunity to address how we are working with other parts of the government and with Industry Partners to prevent, diagnose and treat novel coronavirus. Let me provide a metaphorical illustration of how vaccines work. Your immune system is like an antibody factory. Yes, you have a sophisticated Biotech Company in your body. When your body sees an invader like these three viruses, it designs an antibody, a protein that can counter that specific threat. It may take a week or two for the factory to make that new product, but then it keeps the blueprints on file for every antibody it has ever made. The goal of a vaccine is to present a harmless part of the virus to your body, allowing your factory to work out an effective production strategy. If at some time in the future, the actual virus enters your body and your factory can quickly pull out the blueprint and ramp up production wiping out the virus before it has a chance to multiply and make you sick. For covid19, there are six vaccine candidates engaged in a u. S. Trials. Each vaccine has already undergone rigorous testing in animals followed by phase one safety testing in a small group of humans. For three of the six vaccines, we are already in phase 3 of testing where the goal is to inject 30,000 volunteers located in areas where the virus is actively spreading. Half of them are injected with the vaccine in half with a placebo and nobody knows which is which. Over the next week they are followed closely to see if infections occur. A successful vaccine should have fewer cases of covid19 in those who got the vaccine versus those who got the placebo. We will follow them for as long as two years to assess safety. We expect the other candidates to enter phase 3 in the coming weeks and months. These six vaccines represent three different scientific approaches. Having this mix of strategies is the best insurance against some unexpected problem with safety or efficacy. We hope and expect that more than one of these will succeed. They all have one thing in common, the initiation of immune responses against a spike protein of the virus, and you have seen this picture so many times. We know that people who have survived covid19 make neutralizing antibodies so we want the vaccine to do the same. The first scientific approach is a very traditional method. Recombinant protein technology. Basically you purify the spike protein in the laboratory and you inject that purified protein and the antibody factory goes to work. This process means this approach, although it is triedandtrue, is on a slower trajectory than the other candidates. Novavax plans to initiate their phase 3 trial in midoctober. Others announced their phase one Clinical Trial last week. If results are positive of phase three would start by the end of year. The second scientific approach also uses a wellknown technology, harnessing a virus and using it as a delivery truck. The other virus is modified by inserting a gene with the spike protein. Once it enters the cell, it is produced triggering an immune response. A phase three Clinical Trial of this approach was launched by astrazeneca on august 31 , although it is now on clinical hold and a similar phase 3 trial will be launched later this month. Finally the newest Platform Technology is one that was developed at nih using supplemental funds from the ebola epidemic a few years ago. In this approach which is now being pursued separately by pfizer and moderna, a small noninfectious snippet of mrna is prepared. Injecting this mrna will spur a persons own cells to make that protein and encourage the production of those protective antibodies against sars cov2. Before i conclude i want to , address safety. This is foremost in all our minds. We cannot compromise here. The announcement yesterday about the astrazeneca vaccine is a concrete example of how even a single case of an unexpected illness is sufficient to require a clinical hold in multiple countries. There are ways we have developed operation warp speed can move in quickly while maintaining those standards and i think you would want us to do that. People are dying. The delays have to be addressed. In some instances we have done that by carrying out steps in parallel that are traditionally done in sequence. We have limited downtime by moving into new phases before the previous phase is complete completely is completely analyzed. We have started to manufacture doses of all of these vaccines before we know if they work, understanding that we are spending hundreds of millions of dollars for vaccine doses we may have to throw away if they dont work. Please hear me now. The rigor of the scientific evaluation on safety and efficacy will not be compromised. As a scientist i am excited that this is allowing us to respond to this crisis in record time. As a physician, i am hopeful for the millions of lives that have been saved from other diseases through vaccination and the millions more we can save by developing a safe and effective vaccine for covid19. Thank you again for your support. I look forward to your questions. Thank you, dr. Collins. Dr. Adams, welcome. Dr. Adams thank you, Committee Members for allowing me to address the importance of childhood and adult immunizations in the context of covid19. My central message is this. Equitable vaccination of americas children and adults against preventable diseases is safe, smart, good for the economy and critical in our fight against covid19. The science is clear. Vaccines save lives and the u. S. Vaccine supply is the safest in history and in the world and they are a great value as every dollar invested in the measles vaccine saves society up to 20. This is because vaccines prevent disease keeping people out of the hospital and clinics and keeping employees and parents in the workplace. Yet, despite these benefits, less than half of adults get a yearly flu vaccine. Flu vaccines reduce a pregnant womans risk of hospitalization by 40 and a newborn babys risk by 72 . However only half of all pregnant women get recommended flu and whooping cough vaccinations. Pregnant africanamericans have even lower vaccination rates, a fact which may contribute to higher infant and maternal mortality. In fact, vaccination among ethnic and minority adults lags behind already Poor National averages. 37 hispanic. Native americans and African Americans get their flu shot compared to 40 of whites. Some vaccinations exceed 70 in whites but just over 50 in blacks and hispanics and these disparities persist for tetanus, and others. I want to move to Childhood Vaccinations. It is important to note that the Childhood Vaccination rate remains high nationally. One in 10 parents refuses at least one childhood vaccine and almost one third delay a vaccine. We know that unvaccinated children are more likely to be uninsured, to live below the Poverty Level and we live in rural areas. Unfortunately, the fear and access issues induced by covid19 has put additional children and adults at risk for vaccine preventable diseases. To ensure the benefits of vaccines for all americans, we must acknowledge obstacles of vaccination and in particular those encountered by racial and ethnic minority communities. These obstacles which i think are also opportunities include Public Education and rebuttal of misinformation, addressing practical issues related to access, and increasing engagement and trust at the final decision point. Realizing these opportunities will not only save lives, prevent suffering, and make wise use of resources now, but will further serve millions of americans when we get a safe and effective covid19 vaccine. And with both covid19 and the flu circulating this fall, this will be the most important flu season of our lifetime. Less flu and fewer hospitalizations will help to preserve Precious Health care resources. The best way to prevent the flu is to get the vaccine and i hope all of you here today will get your flu vaccine early and publicly. That is why my fall covid19 prescription is twofold. First we must all practice the three ws. Wash your hands, wear your mask and watch your distance. We must use every level to ensure all ethnicities receive vaccinations. In my written testimony i underline efforts to boost vaccination rates and i will finish by highlighting a few. Cdc works with providers that vaccines for children under section 317 immunization programs to provide over 80 million doses of vaccines annually and they have increased their flu vaccine purchase 20 fold this year. You can find out where to get vaccination online. Hhs recently launched catchup to get ahead, informing parents that it is important for children to get vaccinated during covid19. The catchup to get ahead toolkit is available on vaccines. Gov and to you senators out there, i would encourage you to send your staff there because there are great documents to help people understand that vaccines are safe and effective. Through a recent amendment, hhs authorized pharmacists to administer vaccines for children aged three through 18 during the covid19 pandemic and breaking news that i just got the ok to tell you before i came in, today hhs will be issuing guidance to expand access to safe and effective covid19 vaccines when they are made available. State licensed pharmacists will be able to administer vaccinations for covid19 to persons age three and older. Office of Minority Health is working with morehouse on a plan to engage and inform racial and ethnic minority communities about covid19 vaccinations. Finally, the Public Health Service Commissioned Corps which i helped lead works with underserved populations including indian Health Services and bureau of residents leading efforts to increase acceptance of an uptake of the flu vaccine. Ths officers are also working with racial and ethnic communities to engage them in culturally competent ways and to increase access through partnerships with states and qualified health centers. I want to close with calls to as senators,you your families, your staff and your constituents. Number one, your flu shot. Ideally before the end of october. We want everyone to have theirs by halloween. Second, catch up on childhood and adult immunizations right now. Pharmacies around the country are safe, open and ready to vaccinate. Number three, stop covid19 by ws washingy three , your hands, wear your mask and watching your distance. Use your bully pulpit to tweak, text and shout that vaccines are safe, effective and more important now than ever. Finally, go to vaccines. Gov for more information. I just want to throw in a personal note. We are in the midst of a social Justice Movement the likes of which we have not seen since the 1960s in my lifetime. As Surgeon General, i want you to hear me say that achieving Health Equity is necessary to achieving social justice. Vaccines are the quickest and easiest way for minorities and atrisk populations to protect their health. Now more than ever we need to help people understand vaccines are safe, vaccines are effective, vaccines are how we achieve Health Equity and social justice. Thank you and i look forward to your questions. Thank you, dr. Adams. We will now begin a round of five minute questions. I will ask that you try to keep the questions and answers within five minutes so all have the chance to participate with the votes coming up. Dr. Collins, lets take the announcement to which you referred about astrazeneca slowing its trials this morning or stopping it. What does that do to the effort, to the goal of producing hundreds of millions of vaccines by the end of the year . We have always said that a a vaccine is not safe, we will throw it away. Lets say astrazeneca or one of the others is not safe, will we still have enough vaccines . Dr. Collins thank you, senator. The reason we are investing not in one but six different vaccines is because of the expectation that they wont all work, although it would be lovely if they did. To have a clinical hold as has been placed on astrazeneca as of yesterday because of a single serious adverse event is not at all unprecedented. This happens in any largescale trial where you have tens of thousands of people invested in taking part and some of them may get ill and you always have to figure out is it because of the vaccine or where they going to get that illness anyway. With an abundance of caution at a time like this, you put a clinical hold you investigate , carefully to see if anybody else who received that vaccination or any other might have had a similar finding of a spinal cord problem. This ought to be reassuring to everybody listening when we say we are going to focus first on safety and make no compromises, here is exhibit a about how that is happening. If it turns out that is a real consequence of the vaccine, then all of those is currently being manufactured will be thrown away. We do not want to issue something that is not safe. As i understand your description, when i take a covid19 vaccine shot, it does not give me covid. At one time in the history, i guess that was the way. With smallpox, you gave someone a mild case of smallpox and hope they recovered. But when you take a vaccine for covid, you are not given me covid, correct . Dr. Collins absolutely. The old way of making vaccines is to take the actual virus and activated in a certain way or kill it and use that as the way of inducing an immune response hoping that you were completely successful in that inactivation. None of the vaccines i am talking about today are done that way. They are taking a small bit of the virus, namely that spike protein, and putting it into a fashion that the body can raise an antibody to it. That is all you are getting is that little bit of the virus. Youre not going to get infected by covid19 by any of these, i promise you. The cdc said that last year the flu vaccine was 39 effective and that last year between 24000 and 52,000 americans and 24000 and 62,000 americans died of the flu. On the other hand, the polio vaccine seems to be 100 effective. If you get the vaccine, you dont get polio. Will the covid19 vaccine be more like the flu vaccine or more like the polio vaccine in terms of effectiveness . Dr. Collins what a great question. I wish i knew a crisp answer to that. That is why we are doing large scale trials to look at safety and efficacy to see how protective this will be at how long the protection lasts. If i had to guess, i would say this is a better virus for a vaccine to really work well than the influenza virus which is a tough one because it is changing every year and that is why we have to get a new shot every year. Will it be as good as polio or 98 les, which is 95 , effective . I would love it, but we will not know until we get through these trials. Mr. Chairman, can i jump in quickly . Let me finish my questions, if i may. 24,000 and 52,000 62,000 americans died of flu last year. Is it possible that the handwashing, masking and six feet staying apart practices will mean that we will have fewer deaths from flu this year . Dr. Collins it is entirely possible and that would be the silverlining of this very difficult year we are living through. It is already been observed in the Southern Hemisphere that is going through their flu season already that they had a lower number of cases of influenza by far than usual and they have been practicing the same kind of measures we are talking about. We might benefit that way. But that is no reason for anybody to say, oh we will be fine. Get your flu shot, everybody. This is a really important year to do that as the Surgeon General has emphasized. Thank you very much. Senator murray . Thank you very much, mr. Chairman. Dr. Collins, as i said i have , been concerned about political interference and decisionmaking we have seen in the administrations response and the impact it might have on the acceptance of a vaccine. I want to ask you what steps you think federal agencies should be taking right now to build trust with the American People and develop airtight processes to make sure science and Public Health, not political interest dictate decisionmaking for covid19 vaccines. Dr. Collins thank you, senator. I am a scientist, and i believe the best way we can engender that kind of trust is by being as transparent as possible and you used the same word in your opening statement, so that people can see the facts. There are so many conspiracy theories out there right now. Even before we have a vaccine that has come anywhere near to being effective. Some of those are breathtaking in terms of their stretch of the imagination and sometimes people seem to attach themselves to those. Our best antidote is to say exactly what we are doing. I am reassured i hope it will be , and reassuring to you that there are a number of steps in terms of how vaccines will be evaluated. They are going to give the sense of scientific objectivity. First of all none of these trials will go even to an fda review until the data and safety monitoring board, which is the only group that gets to see what happened as far as protection, as far as safety events, looks at the data. These are very experienced qualified scientists. Only when they Say Something is happening here that looks like it might actually be worth reviewing, does this get brought forward. I hope you all the nine ceos of the Companies Involved in Vaccine Development all signed a statement that they will put they will not put forth something until they are convinced it meets the highest standards of safety and efficacy. The fda has its own advisory process and commissioner hahn , who will speak to you in two weeks has already said that he will use this vaccine and , related biological Products Committee to advise about any idea of using an emergency use authorization for this purpose. You can be confident in this as well. If we can put all of that information forward in a way that is digestible, i am hoping it will help turn the tide in what is right now a troubling situation where a lot of people are quite skeptical about this vaccine. What a heartbreak that would be if we go through all of this, we come up with a vaccine that is safe and effective, we have already lost 190,000 people and we can prevent more deaths and people are afraid to use this. We cannot let that happen. Let me ask you, dr. Adams. About 35 of americans would not get a vaccine even if it were fda approved and available at no cost. What impact would that have on a successful covid19 Vaccination Campaign as well as those in years to come . Dr. Adams thank you for that question. I think it is important that we start understanding that we have unprecedented levels of Vaccine Hesitancy in our country and globally. The World Health Organization has called this one of their top 10 Public Health threats. I think it is important to understand that we have a once in a Century Global pandemic superimposed on top of a president ial election and that makes messaging even more difficult and concerning. Here is what i can tell you. As a member of the Coronavirus Task force, there have been no politicization of the vaccine process whatsoever. We have a process in place that i trust as a doctor, as a dad, i get vaccinated every year. I get my family vaccinated every year. I am running out of time so i just wanted to say, we need Vaccine Confidence and it is really important and political interference can be a huge detriment to that, so can misinformation. Are you making sure the president understands that risk . Dr. Adams im using my bully pulpit to make sure that everyone understands vaccines are safe and effective. Im trying to focus on the process over the politics because the process is what will assure us that these are safe. Sen. Murray you mentioned the monitoring board. Im concerned about the lack of transparency around the world of the board in evaluating. Who sets the standards for the dsmb to determine whether a vaccine is safe and effective enough to end the trial early . Dr. Collins when the trial as a is first proposed, the demonstration of safety and efficacy will meet a certain standard and that means you have to have proof and the fda has already said this. If the vaccine is at least 50 effective, if it is less than that, it does not meet the standard. They have those parameters in front of them and they sen. Murray who sets those standards . Dr. Collins im sorry . Sen. Murray who sets the standards . Dr. Collins the fda. Sen. Murray do we have access to those . Dr. Collins we are consulted, but it is fdas responsibility to set those standards. Sen. Murray i hope the nih has that critical information. It is alarming if they dont. Dr. Collins we are not the deciders when it comes to what is acceptable. That is the fdas congressional authority. Sen. Murray thank you. Thank you, senator murray. Thank you, mr. Chairman. Thanks to testify great information. I really enjoyed watching dr. Collins and fleming last night use all of their talents in a marvelous performance at the white head awards. It is good to see you this morning in your normal role. I appreciate the questions that senator murray asked about the people worrying about fasttrack and accelerated approval and the fda shortchanging the safety. One of the things that worries me is what we can do to make sure that the Health Professionals that may be helping the patients to make their decisions about a covid19 vaccine understand the regulatory terminology and then feel comfortable communicating that to the patient about what it means. Dr. Collins, i am very appreciative of your explanation of how vaccines work and the charts that you have. That was very helpful. Will you be involved in some of these communication things for when the vaccine is available to help people understand how it works and why it works . Dr. Collins thank you, senator. And yes, nih has a role in terms of the communication and education about the Science Behind all of this working closely with our colleagues in the department of health and Human Services and especially with cdc in terms of clinical guidelines. In terms of ethical guidelines we have a role there that is , already helpful in providing physicians with information about how best to treat patients who have fallen ill with covid19. When it comes to the vaccines in terms of information, we will try to help in that space as well. Along with their professional societies who will be very important in terms of educating their own members about what are the pros and cons of a particular approach. Yes we will be right in the , middle of that. I am appreciative of that and have more confidence in it because of that. Vice admiral dr. Adams, you mentioned Childhood Vaccination. I know that plays an Important Role protecting age groups and limiting the spread of the disease and helps kids get back to school, which is back to normal which helps to reassure adults and also allows adults to go back to work. There are unique challenges in pediatric Vaccine Research because of the safety and ethics concerned about enrolling kids in trials. There can be differences in how they are manufacturing immune systems work. What do we know about the natural immune response that kids have to covid19 and when start the companys developing these Pediatric Products . Dr. Adams great question. Thank you for that. It is important to understand that the vaccine trial will be on people age 18 and up and we will make sure, and this is the way we have done it for other vaccines developed in the past. We will make sure it is safe and effective in adults and then we will slowly start to move down in age. The next round i anticipate will be aged 12 to 18 and then after that, if it continues to be safe and effective, we will test in people younger than that. That is the way we have done it for every vaccine because we cannot just assume that something is safe and effective in an adult will be safe and effective in a child. That is why it is even more critical that we work to ensure Vaccine Confidence and that all adults who can get a vaccine to do get a vaccine because it will be more important that we have a higher percentage of adults getting vaccinated to get closer to that level of herd immunity we need to break transmission of disease knowing , that the initial round of vaccinations will not be available for children. Dr. Collins, anything to add about testing in kids . Dr. Collins i think there is maybe an effort in one of the trials to begin to enroll children in the next month or so. Again, as the Surgeon General accurately said we generally want to wait until you are sure it looks safe and effective in adults before you take that next step. It should not be a lot longer. So you are working with the process for getting that Development Started as soon as possible, dr. Collins . Dr. Collins yes, again with a clear sense of wanting to have the safety and efficacy reviews through the dsmbs and the fda before deciding it is time to move downward in age. We dont want to make any risks to children in particular that we can avoid. We want the data from the adults first. You mentioned a Covid Vaccine. It is important that folks go to vaccine. Org. We have the catch up get ahead campaign. Over 400 million children are behind on Childhood Vaccinations. We want to prevent the disease we can prevent right now and every child should get their flu vaccine this year. Thank you both. Thank you, senator. Senator sanders . Let me thank dr. Collins and dr. Adams not only for being here for the years of Public Service. Thank you very much. You seem to have covered a lot of the territory. But i want to ask two questions. Number one, the taxpayers of our country have already spent billions of dollars, many billions of dollars on research and development for this vaccine. It seems with that type of development and with the fact that we have some 90 million americans today who are uninsured or underinsured, it seems clear to me and other senators that we must make vaccine free of charge to all people if we want to maximize the number of people who will get it and given the fact that we have already paid for it. This is something im going to be working very hard on. Other senators will as well. Will you join us in the effort to make sure that this vaccine will be distributed free of charge for all americans . Dr. Adams senator sanders, this is Surgeon General adams here. Thank you for bringing that up. I will give you a very direct answer. Yes. I Surgeon General i promise you , we will use every federal tool that we have to make sure that cost is not an obstacle for people receiving what will perhaps be the most important vaccine of our lives. And highly anticipated dr. Collins i share that 100 . Thank you both for that very definitive statement. Is that the posture of the administration right now . Is the administration saying that the vaccine will be free of charge . Dr. Adams i asked the question right before i came in to make sure. I feel strongly about this. The most honest answer i can give you is to the extent that we can ensure that from it federal perspective, yes. As you know there are things we , can do in the executive branch, there are things you can do through the legislative branch. Every tool that we have we will bring to bear to make sure that cost is not an obstacle. Thank you very much, for that answer. Let me ask about another issue. An issue that senator murray touched on. President we had the of the United States telling us this vaccine would be ready to go or developed before election day. Not a week after, not a month dayr but before election because of his great leadership and it would have taken president obama years more to develop that process. Assurance from scientists and doctors like yourself and not the administration to make it clear that this president is not speaking for the scientists of believe,try, that you i believe, that every member of congress believes we need to get that vaccine out to the American People as quickly as possible. Whether it is a week after election day, six months, or before election day, but what is most important is that vaccine is safe and ready to go. Is difficult given the political moment and the nature of that administration. Will you join me and many others in telling the president of the United States to get out of science and let the scientists do their job is moving as rapidly as possible in getting a safe vaccine out to the American People . I have had the privilege of serving as the nih director for 11 years. I cannot say strongly enough, that the decisions about how this vaccine is going to be evaluated and assessed will be based on science. I know i speak for my colleagues certainlyernment and for the Scientific Community broadly, that that can be the only basis on which this decision is made. Otherwise the public would not be expected to trust us. So that will be the only measure. Will it be done by a certain date . I could not possibly tell you right now because i do not know what is going to happen in the coming months. I have cautious optimism that by the end of 2020, one of these vaccines will have emerged and turned out to be safe and effective. Even that is a guess. Predict a particular week or after a particular date is well beyond anything any scientist right now could tell you and be confident that they know what they are saying. Yes science and science along , will be the way this decision is made. Otherwise, i will have no part of it. Dr. Adams senator some people , still care about what the Surgeon General has to say [laughter] jerome, i care what you have to say, please. Dr. Adams i want the American People to hear me say this. There will be no shortcuts. This vaccine will be safe. It will be effective or it will not be moved along. When a vaccine is either approved or authorized by fda, i and my family will be in line to get it. Sen. Sanders thank you, gentlemen. That is the kind of answer the American People are looking forward to hearing. Thank you very much. Thank you, senator sanders. Senator burr. Sen. Burr thank you, mr. Chairman, and the witnesses for the long hours you have devoted to try to come up for solutions for the American People and health care of the world, really. Admiral, i may have a question for you if i have got time. I think this is a good Inflection Point to talk about how we got to where we are. Decades we ho changing statutes to allow processes we have seen enacted through covid, not the first an agency that looked at novel threats. They were the first ones to look at how we stack some of the processes, the data, that we do not wait until the end of the second dump to process it realtime. ; we have seeneen congress, this legislative body, every so many years change that legislative statute to allow emergency youth authorization emergency use authorizations. In consultation with nih, cdc, to provide testing in realtime, which is the American People, which is what the American People wanted. Production, historically has taken tens of years to actually happen. Now we are trying to do it in one. We have not rewritten the protocols. Operatenot said fda, outside the powers we have given you. We have given you these new authorities. Use them. For the first time, we have seen Clinical Trials stacked. If at any point data does not support, they are stopped. As we saw with the astrazeneca, oxford trial. Collins,estimony, dr. You talked about nihs efforts to partner with private sector for adaptive protocols for Clinical Trials. Are we doing something novel or exactly the same as we have always done it . Dr. Collins we are doing something novel. I appreciate you raising the background and senator, your role in getting barta to where it is right now has been critical for operation warp speed and doing things in a business friendly way to get the tools we need in place. The other thing i had the privilege of helping make happen in late march april, was to go to the pharmaceutical companies we knew had something to offer; instead of saying, lets go off in our own direction, lets see if we can do something together. Active came about. 24 7, 100 people, mostly highranking scientists in Public Private sector designed protocols to launch trials without the process it come and out of that have series of trials on antibodies, anticoagulant, immunomodulators. Hat has gotten us much further emboldened by the Scientific Community. You have the statute to do that . Dr. Collins it helps that no one was feeling, we have to do six months of consultation. We see the u. S. Government functioning. [indiscernible] we have not changed the rules or protocols. We have exercised latitude in statute for incidents like this. Admiral, one question. Quarantine of our younger population over the past seven months, we have infants to oneyearolds that have not been exposed to the normal things they would have been had they not been quarantined. Dr. ,r Public Health entity what concerns do you have about the normal exposure they have not had and how that will affect us . Especially as we determine, do they need a covid test . Is this a normal thing they are running into . Dr. Adams im incredibly concerned about the fact, 5 million children are behind on vaccinations because of covid. The regular vaccinations. I am concerned about the levels of herd immunity among the populace. Adults and children have not gotten vaccinations they normally would have. That lowers the level of herd immunity. You need 93 of people in a community to be vaccinated to have herd immunity and prevent outbreaks, like in new york. It is critically important to protect our youngest, most vulnerable, that everyone who can catch up on vaccinations, get caught up. We have to move on. Thank you. Thank you, senator booker. Senator casey. Mr. Chairman, thank you for the hearing. Murrayto thank senator as we start this new work period. I want to thank the doctors for their appearances. Their testimony and their Public Service. While it is encouraging [indiscernible] the pace of the work being done to develop vaccine candidates, we still have vaccine willut how be manufactured distributed. Many americans have real aboutns, grave concerns how the Trump Administration appears to be interfering with fdas review process for political gain, as some see it. Ust in Public Health and expertise has been undermined by a history of institutional racism injustice in our Health Care System as well as by misinformed, antiVaccination Campaigns. It is imperative, it bears repeating, imperative that any Covid Vaccine authorized or approved by fda and recommended for widespread dissemination be both safe effective of course, as evidenced by reliable data from randomized controlled Clinical Trials. It is also imperative the president , Vice President , White House Covid Task force must a, tell the truth all the time. Not play political games. Lead by example. I understand there will be recommendations from Public Health experts on who should receive the vaccine first and what we should do. All of us should follow the recommendations. I also believe the American People should see that any Covid Vaccine is safe and effective and essential for ending the pandemic. Americans have to see it. They have to see others taking the vaccine. I asked both of you, starting with dr. Adams, will you commit to receiving the Covid Vaccine in public view once a vaccine becomes available as authorized or approved by the fda . Yes or no . Dr. Adams absolutely. Thank you. Dr. Collins i am to roll up my sleeve as soon as they say it is safe and effective. Senator it is important to practice what we preach. Important for the American People to see this. I want to move to a question, more focused on immunization info systems with dr. Adams. This is a question i hoped to ask dr. Redfield. Mentioned theder chairman will testify in two weeks. Given that most vaccine candidates tested will require two doses, it is essential to track which vaccines people are getting. We understand who receives a each personerstand receive the correct number of doses. Over vaccination or cross estimation could further stress the short supply. Immunization info systems already exist at state level. They do exactly this type of tracking. I am concerned the Administration May be planning or not use existing systems. An article in usa today of september 6 of ac dc document saying people getting vaccinated will get a record card that will tell them which vaccine they got, when they got it and when they should get their neck shot next shot. Support tovided any state immunization info systems . How are you integrating capabilities in your planning for Vaccine Distribution . Dr. Adams we are working with committees and organizations to figure out distribution of what will be the most logistically difficult vaccine ever deployed. We recognize infrastructures are in place at state level. Were going to lean on that existing infrastructure. We will promise with the partnerate we will with the appropriate partners. Senator thank you. Thank you very much, senator casey for sticking to time. I appreciate that. So your colleagues. Senator paul no one disputes the medical miracle of vaccines. We have discussed contributions. 70 years prior we were doing inoculation and several hundred years prior they were inoculating with live virus and antibodies in the mix. They did this because the disease was deadly. 20 of the public, 30 got it. Not every disease is the same. That is what annoys me about discussion. We think everything is smallpox. Submit or else. You cant go to school unless you get this. This is the debate we are going to have. What are we going to do to people . There is a difference between smallpox. 20 , 30 mortality. Children with covid, cdc website,. 68 per million. We are talking about a different disease. Recommendation on vaccines may be appropriate. Each individual needs to make their decision. If we are prioritizing it, the death rate for those in their 80s, those in Nursing Homes is incredibly high, 20 fold maybe 100 fold higher. Significant. That is where the priority should go. Each individual in a free society should assess the risks of the disease versus the risk of vaccine. It is not, it is important we should not get carried away, we will ostracize you if we dont take it. Lets try to persuade people about it. We have vaccines we have recommended for certain age groups. Pneumovax is recommended for those over 65. I have added. I have had all my vaccines. I am still for choice. Doesnt mean we turn our brains off and say blindly, everyone must submit, or else. I had part of my lung removed. I took the pneumovax. Even that, there was an absolutely recommended. Vaccines used to be recommended for those in risk categories. Flu vaccine was recommended over 50 at one time. Now it sounds like it is more extensive. That is fine. The vaccines are incredibly safe. At the same time, we need to really think through our fervor here before we mandate and make people take tests. My question to dr. Collins is, considering the death rate for covid among children is. 68 per million, are you in favor of adding a School Mandate . You cannot go to school unless you get a Covid Vaccine . Dr. Collins it would be premature for me to make a statement about what would be appropriate since we do not know to what extent vaccines currently study will be safe, effective in adults and we wont know is a later how they were for children. Are, areaul if they you in favor of mandating . Dr. Collins i would have to understand what the consequences would be. Im not ready to answer that. There is an issue about children getting infected and infecting others around them that may have an immune system that cannot handle it. That is one of the reasons we are so concerned about having children vaccinated, to avoid the kind of terrible circumstance where a child getting chemotherapy for cancer, gets sick and gets more sick. Senator paul that was always true, hundreds of thousands of people a year on chemotherapy and we have never decided to vaccinate everyone. Traditionally, those on chemotherapy tried to protect themselves from others, acknowledging the common cold could be devastating to someone on chemotherapy with low immune response. It is important we think about that. Works,ave a vaccine that by all means, lets try to vaccinate everyone willing. Particularly in Nursing Homes. The elderly. We should prioritize that. We should acknowledge there is extraordinary difference in website, less cdc than one per million children die from this. That has to be weighed in to the fact of whether you will mandate. Youre going to tell every kid in america that was a big deal. The death rate is less than one per million. If we are going to mandate you cannot go to school . Look at Contact Tracing studies in china, the netherlands, bermuda, england we find very little transmission. I talked to a gentleman who runs a school in North Carolina. 6000 students teachers. Zero cases, eight weeks open. Lots of schools have been open. It is a question we need to discuss and have it not be fear, fear, fear. Kids dont get it as often, dont transmit it as often and rarely die from it. We need to tell the truth about stats and not over blow them into telling people something that is not true. Decisionmaking should be decentralized. Every thinking individual in a free society gets to make those choices. Senator baldwin. [no audio] senator baldwin thank you, mr. Chairman. This is for dr. Collins. Ask about the importance of having diversity in the Clinical Trials taking place for a vaccine. I want to note the context. Last month, university of wisconsin announced it had been selected as one of the first sites in the country to participate in phase three Clinical Trials for astrazenecas Covid Vaccine candidate. Importancet into the of including a diverse thelation, i want to note views you have commented on pausing astrazeneca is investigate whether an unexpected medical event in one of their eligible candidates, which related to the vaccine. If i ask you about the importance of diversity, i just note, we have already enrolled in wisconsin, many participants in trials. Others,uld you and ,verlooking project work speed telling these folks who are already participating in this phase three trial . I imagine some of them are concerned. Dr. Collins i agree. This is fresh info. Connections who has and knows who the individuals are, are in the best position to let them know why there is a hold. This is based on a single severe adverse event which may or may not have anything to do with the vaccine but it is the best cautious approach to quickly stop and see if there is other evidence to be concerned about. I can check and see if this is the case. Not much time to go by until all the people involved get direct communication from the company about the fact that it is on hold and this is why and more info will be forthcoming. Senator i appreciate that. I will get constituent feedback on that issue. Wisconsin has announced it will a diversensuring population takes part in trial and develop recourses in spanish to address language barriers. Theyre going to have qualified interpreters available to speak to participants in 240 different linkages. Researchers are working to enroll a diverse Patient Population across gender, age, race, ethnicity. I would like for you to describe how a lack of diversity in Clinical Trials undermines our efforts to develop a safe, effective vaccine. Given the disproportionate impact covid has had on communities of color, what should Clinical Trials take into consideration as they work to recruit participants . Dr. Collins thank you. This is something i am passionate about. We have to work especially hard to achieve that diversity in participants in trials. Particular groups have been hit hard. Africanamericans, latinos, native americans. We want to know, does the vaccine provide benefit to those groups . They may benefit the most. Doubt, there are concerns in those communities whether this is something they should trust to be in their best interest. There is skepticism, distrust. We are and a time of considerable social people. Recruiting efforts have to be done with intention with Community Outreach engagement that might not happen. I appreciate what is going on in wisconsin. My hat is off, the way in which you describe the outreach you are doing, including with other languages. We are trying to do that same thing across other trials. Nih has a long history of doing this Community Engagement or other things like hiv. We are tapping into that. Couple days ago, you might now see Public Service announcements in the areas where vaccine trials are happening, that are particularly reaching out to africanamericans to explain why this might be something to look at and think about seriously getting engaged with and we know that that is a steep hill to climb. We are trying to climate. If we dont succeed in having her city in diversity, that takes away scientific value and it makes people wonder, was this really something that was safe . Why should we think about getting engaged when you say you have succeeded . We have to do this altogether. Senator thank you. Chairman thank you, senator baldwin. Senator collins. Sender collins thank you, mr. Chairman. Dr. Adams, in my state, the three groups of people disproportionately affected by frontlineas been Health Care Workers, black residents of my state and nursing home residents. Who is going to make the ofision on the allocation vaccine once it becomes available . Who will decide who gets the vaccine first . Dr. Adams thank you. You hit on the key points. Health care workers, nursing home workers, people of color disproportionately hit. With the National Academy of sciences, engineering and medicine, with other advisory groups, to come up with an answer to this difficult question about who gets the vaccine first. Some principles we agree on; there are no final recommendations yet but Health Care Workers and frontline workers should be first. They are most likely to be exposed. Behind them, who is most vulnerable, using a data driven process to determine who is most vulnerable and where that vaccine will have the biggest impact. But the American People need to know is we are thinking about this. We are working with partners to make sure it makes sense and is ethically appropriate to distribute vaccine in a way we ultimately will have the largest impact. Dr. Collins, a major Health Care System in maine, has contacted me to express concern about equipment they may need to store vaccine safely. They have already bought additional refrigeration units in order to store the flu vaccine. They are stocking up on that. At least some of the vaccine presentations understudy would require subzero refrigeration. Particularlysive, for rural hospitals in a state like maine, already struggling financially. If we are going to ensure access to groups i mentioned with dr. Adams, how can we do so, how can we ensure we are not creating inequities and uneven access unless we are helping with purchase of very expensive refrigeration units . Dr. Collins great question. There is intense effort underway to figure out how to address this. The Surgeon General and i have been engaged in those discussions. This is operation warp speed component done in a way that has never been done before. To imagine distribution when we are not sure yet which vaccines will be distributed. One, the one being produced by pfizer require storage at 70 celsius. That is a challenge for refrigeration situations. Warp speed is in the space of trying to figure out, with cdc, how to make sure that does not become deterrent to distribution. If that becomes the vaccine that to geteds, we want maine it, and rural areas, not just the big cities. I have been very pressed with the general, leading this, part of the effort for operation warp speed. A guy who knows how to do supply chain. That is being intensively pursued. Senator thank you both. Chairman thank you, senator collins. The voting has begun. I will vote in a few minutes. Senator burr will preside while i am gone. [no audio]ren senator warren i couldnt hear you either. Thank you very much. The pandemic has claimed the lives of 190,000 people. Safe,st hope is a effective Covid Vaccine. Vary but, estimates some epidemiologist believe 70 population will need to be immune to covid for taking vaccine in order to provide herd immunity necessary to end this pandemic. Dr. Adams yes, maam. 90 . Stimates range 60 to we need to get over half the population vaccinated to achieve herd immunity and stop transmission of the virus. Target our minimum would be 70 , give or take. Can we do that . The last flu season, for which data, lessomplete than half of u. S. Adults got a vaccine. Shows 21 a cbs poll surveyed would take Coronavirus Vaccine as soon as available. Convincing enough americans to take a Covid Vaccine is a big job. Lets talk about what makes it harder and what makes it easier. People are more likely to be vaccinated if they trust officials are basing the decision on science data and not on politics or selfinterest or conspiracy theories. Unfortunately, President Trump has undermined this trust. He has overruled science, pressured the fda into a product has spreadducts, he dangerous misinformation about covid, that other republicans have parroted and he has appointed a former drug executive with financial ties to vaccine makers to run the vaccine efforts. Said het days, he has will deliver a vaccine before the end of october they claimed that Public Health experts is driven not by Scientific Evidence but to boost chances of winning the election in november. It has gotten so out of hand, Companies Making vaccine put out a Public Statement promising to standardshi ethical and sound scientific principles when seeking vaccine approval. And researchers across government are working night and day to produce a safe, effective vaccine for the American People. We are deeply grateful for that. Dr. Collins, let me ask, the president s actions encourage public trust in vaccines or do they discourage americans from getting vaccinated for covid . Dr. Collins i am not sure i know the answer. I am more focused on what we can do in the Scientific Community to try to explain how it is these decisions get made. Certainly working with the Surgeon General trying to be sure that messages out there. I am hopeful those scary numbers, 21 saying they would not get this vaccine, that that is based on not knowing the facts. We are going to work really hard in the coming months to get the facts out about how decisions will get made and how once we have, and i hope we will by the end of 2020, at least one safe, effective vaccine what is the evidence for people to make their decision, discounting whatever conspiracy theories popped up in their facebook feed, ok, lets see what the doctors say. I hope we can enlist trusted voices in the community, not just in the government, the physicians, other Community Leaders who also get informed about this and share that info, that america, which always after a while, figures out how to do the right thing, will do it again. Respect, ith all due appreciate everything you are doing. Lots of people will. The question i asked is about what the president is doing. Weeks, the few president has accused fda officials of being deep state operatives. He has tweeted conspiracy theories about covid deaths. He has implicitly tied Vaccine Development to his reelection campaign. Americans who are watching this hesitate to take the vaccine because of what he has done. Does that help us get to the levels we need to create herd immunity . Dr. Collins i hope americans would choose to take the info they need from scientists physicians and not from politicians. Senator i hope youre right. The American People deserve a safe Coronavirus Vaccine. Lying if it pretends the president cares about anything other than his own political survival when it comes to Vaccine Development. It is time to take profits and politics out of the vaccine effort and let science to the work. Time has expired. Senator cassidy . He is on. Senator can you hear me . Yes. Senator great. To make your answer shorter, it is not out of rudeness. , there is at least one selective outd, of new york city suggesting 20 americans, new yorkers had already been exposed. Whether or not they have antibodies the whole point of immunization is to prevent natural infection, it is best to assume they are in the case of people being reinfected after initial infection occurs, they occur as rare as [indiscernible] thet seems we will resume natural infection [indiscernible] has there been any thought as to how to figure out who has already been exposed, thereby protected naturally and does not need the vaccine as opposed to everybody . [indiscernible] officials ofg companies producing the vaccine, said that would be very helpful. He said if we have a shortage of vaccine and a problem of hadvery, knowing that 30 already been exposed in certain areas would whittle down those who need to be vaccinated. Dr. Adams great question. I will be brief. We have antigen testing. Pcr testing. Antibody testing. Antibody is how we figure out who has been exposed. That is one of the questions about who gets vaccinated first. If you or someone who has been proven to have coronavirus in the past by Antibody Testing or diagnosis, that is someone who we would not put necessarily at the front of the line to get vaccinated until we get to the point where we have enough for everyone. This virus has fooled us many times. We still dont know what we dont know in terms of how long immunity will last. [indiscernible] it is rare a vaccine is more effective in terms of natural infection in reducing immunity. [indiscernible] let me return to what senator casey asked. It is related. Regarding, are you going to continue to use registries to document who has been vaccinated . [indiscernible] hand, it is important to know, this person has previously been diagnosed [indiscernible] how will we restore that info . [indiscernible] quickly, we work with Territorial Health officers, city, county officers, institutions with infrastructure in place. These discussions are occurring right now. Senator [indiscernible] indirect conversations with cdc, my understanding, for registries to address this, they would have to get appropriation from federal government. They would have to get software fixed. [indiscernible] obviously, 60 something states territories. There would be a backlog. Any effort made already to have these registries to take info as regards Covid Vaccination or preexisting immunity . Dr. Adams we will have cdc follow up with you. Yes, these conversations are occurring. The other answer in general, Public Health has been long underfunded, including surveillance and registries. We would be happy to work with you. Senator as we move beyond the conversation [indiscernible] in order for these registries [indiscernible] dr. Adams i did not hear the question . Could you repeat that . Senator is it still in the conversational phase . [indiscernible] dr. Adams dr. Redfield will be here in two weeks. I will followup up with you. Senator dr. Collins, there has been question [indiscernible] dr. Collins yes. It might be useful therapeutically. And as prevention. It is like passive vaccine. We have trials ongoing for people in Nursing Homes and people in families where there have been other infections. Et how thatow y will work in a preventative mode. Senator [indiscernible] [no audio] dr. Collins i did not hear your question . Senator [indiscernible] is that the case . Transverse myelitis. I dont have any other details. [indiscernible] kaine first,ator since there is about going on, the majority side, senator murkowski, scott, romney, in that order. Senator kaine recognized senator kaine great hearing. Observation and topics for question. We had a hearing in this committee may 12, safely getting back to work and school. I have been critical of administration for not Setting National testing goals, numerical, that we should be achieving us tests i was asking questions during the hearing to the admiral and what he said was this by september, taking every aspect into consideration, we project our nation will be capable of performing 50 million tests per month if needed at that time and as new tech is authorized like genome sequencing or Novel Solutions uncovered by nihs new diagnostics initiative, that number will be much higher. Month,ion tests per that number is not accepted by all at harvard. They indicate they think we need 1. 2 million tests per day to bump along or suppress coronavirus. 900,000 tests. Of the hight 52 range of what he said we should do by september. 69 low range. We are still dramatically behind what the administration suggested we should be doing in terms of testing to safely open for schools and workplace. I will have a chance to talk to him about that at the next hearing. Is there any benefit to the u. S. Not participating in kovacs project at who . Dr. Collins the u. S. Is engaged for covidbal stage and that is for me, personally, important. How vaccinested in can get manufactured and distributed. All our global Health Experts are deeply engaged, communicating and working with colleagues in other countries. You heard from the administration your sense, if we are able, the next 69 months, to have hundreds of millions of doses of vaccine, we want to make sure those are available to those countries that need the most and do not have their own resources. Senator kaine i recognize we are engaged at international level. I understand you appreciate it. I can see no tangible benefit to the u. S. Not participating in kovacs, as we look at multiple vaccines. There may emerge contenders. Diversification a portfolio would suggest we would have nothing to gain from withdrawing. Element requiring two doses of vaccine. Building on this, maybe your advice on this we know they percent of the people have said they will not get a vaccine. We have to educate people. We also know, other vaccines that require two doses, in this case, the leading contenders would require 28 days between doses. Dr. Collins that is right. Senator significant percentage of people, 40 to 65 in some studies, who get the first dose, will knock at the second. A significant percentage of people who get the second dose, do not get it in time. They will get it many months later after they are able to. What is the effect on a two dose vaccine if you just get the first and not the second . Dr. Collins we know little about that from the fact we have run phase one trials. You can look and see what happens as far as production of antibodies after first dose, which is our best way of assessing how it works. It looks as if the first dose does give some response but not the level you would like to see. The second dose, you are in the range of antibodies people have developed who got natural infection from covid. If you want to be as effective as possible, you go to the second dose. It is not ideal. Dosely, we want a single not requiring for duration, totally safe and effective. We may not be lucky enough to get something quickly to have something with her for parameters. Perfect parameters. Record,kaine for the and to our next panel, i will ask questions about how to educate people on the need to get that second dose in a timely fashion. I have a question about pregnant women i will save for the record. Chairman senator murkowski. Senator murkowski thank you, gentlemen for your comments and leadership in this. I take particular interest in this discussion about vaccines. Historicallygged in terms of vaccination rate. We have chronically been last among the 50 states. My understanding, we are in compared tout 74. 2 the 50 states. Massachusetts is the highest at 92 . Alaska has a long way to go. Unfortunately, we have been this way a while. When we talk about Vaccine Hesitancy in alaska, we know we get it. I am very concerned about where we are moving forward with this vaccine. I recognize we have some of the most vulnerable populations in alaska with our alaska native people. We have limited health care facilities. Opportunity in this hearing to hear all about it. Where exactly the type of state that needs that assurance that yes, this vaccine will be safe, this vaccine has not been initiativesolitical that would speed it up anyway that would cause it to be less effective. We have every interest to make campaigne is education people can believe in. Working with several of my colleagues on this committee on the save act, the safe authorizations for vaccine during emergencies, basically are ensuring a level of public independent expert review of the vaccine candidates. Tonow you may not wish comment on specific legislation. Dr. Collins, you have spoken in your initial remarks to the chairman and the Ranking Member about the assurance we must in fact make sure that this process is true, honest and is going to result in a level of trust and credibility. Inould ask you to help me encouraging alaskans and other americans on how we build this trust for a vaccine. What can you give me . Do we need more than just the save act . To build the credibility and trust . Otherwise, i am fearful the rates we have seen with our vaccinations generally, what we have seen just this year, compared to april last year, we saw 48 decrease in total vaccines administered instate this past may june, we have seen a slight improvement. We are in a tough spot right now. Give me some level of assurance. Dr. Collins we have a tough situation for the nation. I am sympathetic with your particular circumstances. With a history in alaska of hesitancy being even greater. Deckwill be all hands on for leaders in congress, the local communities have to get together to figure out how to convey this message. The Surgeon General is in the middle of trying to organize efforts. Maybe i should ask him to speak. Senator do we need a Public Relations campaign that is amped up . Who is the right messenger . The Surgeon General . Who is it . Right now, it is not working. Dr. Adams when it comes to vaccines and most health advice, people will trust their local provider more than anyone else. We are trying to arm local providers with facts. The cdc campaign has talkdsheets to help people frequently asked questions. We have been engaging with social media influencers. Rs, the sanbout rappe francisco 49ers, lady gaga, for instance, someone i never thought i would invoke in congressional testimony, but i gave her a shout out because she had a mask at the video music awards. People will listen to her before they will listen to the Surgeon General. We also need to encourage people to stop attacking the assess. Process. People dont like one party or the other. I want people to understand protections are built in, the process is strong. If you follow the process, they will have confidence. Everyone who says, i wont take this vaccine or i dont trust it, is instilling further hesitancy. Senator that is important. Thank you. Chairman senator. You, mr. Chair, the Ranking Member and our witnesses today. Thank you for your service. Your shop isone in working aroundtheclock we are grateful to you and them. We have been talking today about public trust in the vaccine approval process. We all agree it is critical. People are concerned. Youve heard the senators reference the cbs poll. Two thirds of americans would think the process was rushed if we got a vaccine this year. One in five plan to get vaccinated asap. Lets drill down on what the process is so we can provide confidence to the American People. Last week, you told abc news you have confidence in the review process because data safety monitoring boards would not allow a product to move over unless there is good evidence these vaccines are efficacious. In addition to ensuring a vaccine is effective, we have to ensure it is safe. Dr. Adams, what protocols are in place to ensure these boards do not stop Clinical Trials until they also collect sufficient data and what specific steps have been taken to ensure these decisions will not be subject to political influence from the white house . Dr. Adams this is more in dr. Collins lane. To exceedlly advises 3000 patients. These trials have 30,000 patients. This is about events. We have so many more people, tenfold involved in trials that we have the potential to recognize a safety and efficacy signal sooner. We have a higher incidence of background and age prevalence. That is a bad thing. In terms of getting signal, there are valid scientific reasons to expect we get a safety signal in short order. Senator hold on. Look, i appreciate that. What people are looking for is administratively, what systems to be have . If this review process is as evidencebased and free from political influence as you both suggest, why do you believe the leading Covid Vaccine manufacturers took the unprecedented step of jointly releasing a public pledge yesterday committing to an evidence based vaccine review process focused solely on safety and efficacy . Dr. Adams dr. Collins and i have been on the phone with them putting forward a full court press to help instill confidence in the vaccine process that we know has been wavering long before covid. Senator i will move onto another topic. Touch on the save act senator murkowski was talking about. If we expect the American Public to have confidence in products, we need to ensure they have full confidence in the review process. In addition to the general meeting in october, do you believe fdas biological products at Advisory Committee should hold public meetings, review Clinical Data and released their findings to the public before fda approves authorizes any vaccine product as they normally would . Dr. Adams i think we need to follow the process. The process works. We need to be careful about inserting new barriers in the process. Senator because time is limited , this is not a new barrier. This is the existing process. Dr. Adams we need to follow the existing process. Senator do you believe the cdc Advisory Committee should meet publicly, review data and issue public recommendations for each vaccine that enters the market so Health Care Providers across the country are confident giving these vaccines to patients . Dr. Adams yes. Senator the vaccine is only effective if people are willing to use it. I want to touch on the save act. This is Bipartisan Legislation that would improve Public Confidence in the vaccine process by helping to ensure that these independent fda and cdc reviews take place in a transparent way. Free from political influence without slowing down the development of safe and effective vaccines. I just want you to know that is what this is about. Experts arehese used to doing this work. They are independent. Im going to continue to push for this legislation to be included in the package and i look forward to working with you with ideas about other ways we can strengthen the transparency of this process and again, help the American People understand what the processes are, why you are so confident that scientists will be able to do their work. Going to let dr. Collins, if you had something to add, i will give you the time. Thank you. You asked about the statement by the nine ceos and i think they were responding out of their that there is this strong public distrust, skepticism, and they wanted to cannot and say very clearly we are not trying to pull something here, we dont believe in putting forward anything that is not absolutely safe and effective, we are pledging this in writing. I hope that add some confidence to the people are still looking at this. Send a romney. Thank you, mr. Chairman. And i want to thank the members of the panel for your testimony today. In particular, dr. Collins for the slides, the description of the process that is leaning toward a vaccine was most informative and colorful. I want to pick up on a line of questioning that senator murkowski described and that is the growing sentiment across our country of people who are, if you will, antivaxxers. People who are avoiding vaccines and i have been approached during business to my state by people who have books that are written describing why vaccines are bad, why they are made from adulterated sources, i wont go into other details. It is not just a social media phenomenon, there are literally books out there written to describe why vaccines are bad. Does not makeit sense for our government to have a very comprehensive effort to dispel this growing sense of vaccines being bad. And i dont know how you do that, but it would come to mind that you are doing that with regards to tobacco and advertising on tv, you could have debates, you could call these people, write these books, and have discussions with them which are politicized. Publicized. You could have a much more Aggressive Campaign on social media. Asking,the question im should we be doing more than we are doing, and what can we be doing to resolve the debate, the uncertainty that so Many Americans have about the wisdom of receiving a vaccine . I will ask dr. Collins and Surgeon General if you would both respond to that. Im sorry, i have a lot to say about this. This has been an issue for our country not just in this season of covid19, but before that. One has seen the consequences of that with measles. In the year 2000, the u. S. Succeeded in getting rid of measles and last year we had more than 1000 cases. People have forgotten that kids die of that disease and continue to die in other parts of the world. I think we have benefited from the success of vaccines so that a generation has lost track of the fact that these are preventing diseases that take lives. I just saw an estimate that if you look at all the children born in 2009 and you ask what would have happened if none of these vaccines had been available, 42,000 of them would have died. Imagine 42,000 kids dying from preventable conditions. They are available now but if they are not getting used, we are facing that same kind of terrible concert wentz and it is heartbreaking and i must say, frustrating. This kind of misinformation is still readily spread about people who have another agenda and we have a hard road to go to try to counter that when so many people dont see in their own experience, the reason why this is such a lifesaving vaccine. But i am going on a bit. Please, say what should do about it. I will very walk through. Approacha threetiered to improve x incompetence for research and valuation, collaboration and partnership, communication strategy and knowledge dissemination. Working with platforms like twitter and facebook to there is appropriate and Accurate Information displayed prominently when people do a search. Framework to strength index incompetence. Were working with medical schools. You mentioned that seeing resistance in the antivaccine immunity. It is important to understand that 90 of parents out there are actually doing the right thing and then when you look at the 10 who arent, most of those are not in that that iscine category, we really need to work on. We need to work on educating them and engaging them and being compassionate with them and patient with them to answer their questions. I went out to washington when they had a Measles Outbreak and i found that when they had afterhours conversations with parents, they come back 2, 3, sometimes four times. Thank you, general. Just one more comment for dr. Collins with regards to the russian announcement of a vaccine. Clearly, very little data. The promise ofng vaccine efforts in other countries and do they have much prospect for being a value to us . They certainly are to the extent that the information is being made available an obviously what you like to see is a publication that has been peerreviewed and some of that is starting to come from the vaccines that are being developed in china and russia. I must say, the way in which the russians rolled its outcome of declaring victory before they had gone much the on the phase one trial did not earn them a lot of confidence in the Scientific Community. We really have to be insistent that somebody is going to say this vaccine is safe and effective, that they have lived up to that very High Standard and i think our country establishes those standards and others generally follow them. Yes, we are watching, but some might have said that the effort put forward was putting a lot of people at risk, asking them to take a vaccine that had not gone through yet. Some even call that russian roulette. Centered around the, your time has expired. Senator smith. Senator romney. To first thank dr. Collins and dr. Adams for everything that you are doing. I know that everybody on this committee is dedicated and ofimistic about the goal having a safe and effective vaccine being distributed at scale for everyone. I want to just touch on that for a minute. Last month i introduced my covid19 treatment to ensure that folks get coverage through medicaid or people who dont have Health Insurance at all able to get the vaccine. This field on actions we have toeady taken in congress ensure that those who have coverage through medicare can have free vaccines. I just want to understand a little bit about how we can make sure folks are not stuck with outofpocket costs that are not expecting. You just confirm that the supplies thisment vaccine and the supplies that are needed to administer the vaccine at no cost. Yes, i can confirm that as part of operation work speed, as these various vaccines are chosen to be put forward, deals are negotiated that allowed the government to buy and own doses that can be provided for free to providers and along with that, all the other materials we need like syringes and vials and ppe is part of the package. The only thing that needs to be dealt with is any kind of charge that the provider might get for administering the dose and i know the administration is committed to making sure that does not become a barrier to anybody and you can get is completely for free. That is what you need to do. Right, that was my next question. Would that also be reimbursed by the federal government so that folks get stuck with something they are not anticipating . I think the administration has made it clear that no one should be denied this vaccine it needs to be completely free. And that we thought that we needed a booster, some sort of a booster shot, like we do for other Infectious Diseases over time. Those boosters at no cost to folks . I dont know that ive heard that conversation going on yet because we really dont have the data to know whether such boosters would be needed and if so, how frequently with the booster have to be provided. Course,ll hopeful, of that this vaccine will produce longlasting immunity but that is not always going to be the case. I think that is a downstream discussion, at least for me. I think it is important that we operate on the underlying belief that all vaccines should be provided at minimal cost to people because they save lives and they are costeffective. This is really a matter of Public Health but also a matter haveuity because we now black and brown, Indigenous People more likely to be and more likely to be facing this struggle. Its just extremely important. Ask all of my colleagues on the committee, i would be so grateful if you auld join me on this, to make very important step toward assuring that this vaccine, when it is available and we are optimistic about that and eager to make sure that that vaccine is available. I think i just have a couple more questions. I want to just ask you one question. I think people are so concerned. Bout this can you just explain to us a little it about how an event what would be the endpoint for when we know that this vaccine and trials should be completed . What is the endpoint . Let me quickly explain how that works. Have 30,000 people involved in the trial which is the number we are aiming for for all of these trials. Half of them receive the vaccine, half of them receive an injection of a placebo. Nobody knows whether they got the vaccine or the placebo. Then you track those individuals and you look to see who, in fact, gets infected. For, ofre looking course, is a circumstance where those who got the vaccine had significantly fewer cases than the folks who got the placebo. That tells you the vaccine is working. As it turns out, by the time 2,ing 150 cases of sarscovi if youre vaccine is at least 50 effective, you are going to know it because youre going to see a big skewing in terms of who got the disease and who did not and that is basically what we say this is an advanced decision process for designing efficacy. You count those advanced and you know whether it works or not. Smb, which is the part of his enterprise that is looking at this see that, then they raise their hand, assuming theyve also looked at safety and found it acceptable and say ok, fda, it is time to have a look. That is how it works. Thank you very much. Senator leffler . Senator jones. Chairman, thank you both for your service and for being here. Specifics one some some of these theories out there. I appreciate dr. Adams saying that 10 of parents out there, only 10 are not doing the right thing by getting vaccinations. Has been withs smallpox and measles and other things with which we grow enough. Now we are in the age of social media and the sea facebook, we see twitter, we see the internet over these conspiracy theories. I want to give both of you an opportunity right now because one of the things im not seeing from nih or from the federal governments efforts to really debunk these theories as opposed to just giving positive information out there. Adams, telland dr. Us what you have heard or what is the most outrageous thing and debunk it for us as quickly as you can so that the American People right here on the record fallthat they should not for the absolutely crazy theories about vaccines. Ill take the first one. Vaccines do not cause autism. People need to understand that. We look at the trials, we looked at the studies, vaccines do not cause autism. I will play the craziest one ive heard which is this is all designed by bill gates and when you get the vaccine it has a chip in it that is going to get stuck into your system and watch everything you are doing. People believe that stuff. None of the vaccines are ,esigned to be big brother their design, i take it, to save lives, correct . Thats exactly right. To save lives and to save money. Offer 1. 5 trillion in societal cost and that is just the vaccine every single year. That i wouldeacher like to wear sometimes and it has three words on it. It says vaccines cause adults. Very good. I would encourage both of you with your respective positions to do a little more in terms of actually debunking. I appreciate all that you are doing to share Accurate Information out there. I think doing a lot of Facebook Live every week with a Health Care Professional to try to get Accurate Information out there, but still, debunking the theories is also important, so i would encourage you to do that on your websites and do that with information, not just trying to get the accurate, but to debunk some of the garbage we are hearing. Dr. Adams, i want to follow up i want to knowe your position about encouraging minority participation in some of these Clinical Trials. We know that minority participation in Clinical Trials is down. We know on the flipside that minority populations are being disproportionately affected by covid19, and unfortunately, the United States has somewhat of a sordid history when it comes to minorities in Clinical Trials. Bet can you do, what would your voice to encourage more minority participation and how can we in Congress Help get that voice out there because i believe it is so important to get us a back effective vaccine for everyone. One of the things you can do is to support the institution right in your own community. I was there just two weeks ago and they have done a tremendous amount of work in terms of engaging the local Africanamerican Community in cardiovascular and hypertension research. Number one, we need to knowledge past wrongs that have occurred and you are my be surprised to hear me giving a shout out to bill clinton, bill clinton apologized for the tuskegee experiment several years ago. We need to acknowledge that, we need to acknowledge these wrongs occurred, and then we need to address the situations that cause them to happen. Again, we talk about the process, phase one, base to come based three. Agencyees and the whole should make sure these types of things never, ever happen again. And then we need to engage, and that is what youre talking about. We need to get out there were the people are and use trusted advocates. Ive been working with faith communities, i spoke to rabbis last week, ive spoken to a pastor of one of the largest megachurches in the country. We are talking to social media influences like kylie jenner and lady gaga. My kids will do something because they say it before dr. Collins or i say it. That is kind of the approach we are taking to engage with people. Acknowledge, address, and engage. Thank you, dr. Adams, and thank you for coming down to birmingham. We very much have appreciated your visit and hope it will be very successful. Thank you for this opportunity. Thank you senator jones. Senator rosen . Can you hear me . I can come welcome. Thank you comes to chairman. Thank you for holding this hearing, thank you to all the doctors for being here today, i really appreciate your testimony. I really want to raise the importance of assuring that we how thisst studies on impacts in wide range of patients in short and longterm including what treatments are most i would introduce a bipartisan understanding of to make sure that this Critical Research happens and that it is approved in the very first set of patients. I asked for my colleagues and his committee to ensure it is included in the next package passed by the senate that will determine future issues. I would like to move on now to rural access to vaccines. The cdc has asked the states to be ready to follow this vaccine industry plans in less than two months. Last month i was on a statewide virtual tour. A huge issue, particularly in rural towns. Access to regular primary health care. Across the country, rural areas are continuing to struggle with the pandemic and access to adequate medical care. With this in mind, what recommendations to you have for that we are not left out of the clinical Vaccine Distribution . Are we actually looking at the Vaccine Information that we should receive . Our communities who have no hospitals, no clinicians offices with the closees as medical Services Potentially 100 miles away. Multiple clinics, perhaps . Will we have to figure it out on her own . The Surgeon General might want to add something because it is even more in his domain. The distribution issues are critically important and are under intense planning processes right now. Speed hasg that warp not just the role of trying to encourage the Clinical Trial but also the manufacturing and distribution, and how do you actually get these doses to places with any to be, recognizing that we are going to need to do this in a priority way so that the most suitable people get them first . That means thinking about Rural Communities and all the ways that could happen but its going to be working with the states and the cdc is already deeply engaged in that. I think they got a little misunderstood when they say we need to be ready by november 1 just in case. I think they were trying to save us be prepared here and not wait until the last minute. That is very much the conversation that is going on. The Surgeon General may want to say a little bit more about rural areas in particular. I want to be sure that i will be very brief. I grew up in April Community in Southern Maryland where the nearest hospital was quite far away, and i ran the state department of health and indiana which is a most liberal state for three years. Weve utilized the vaccines for childrens program, weve utilized the section 370 and immunization program. We have infrastructures in place to get vaccines after those territories, but youre right, we have to challenge that we still have done a poor job of making sure we have equitable distribution of vaccines before there was a Covid Vaccine in those communities and we need to double up on those efforts. We are working with state and local Health Departments to make sure that occurs and i stand ready to work with you to make sure people know vaccines are safe and effective and we are addressing the practical issues. Service quality and satisfaction, making sure that people can get it easily and they are happy with the way they perceive it. These are all issues that are on my radar and that we are working with local partners to try to figure out before we get a vaccine. Left,nly have a moment seenor the record, we have a troubling decline in vaccination rates overall during the pandemic. Majored vaccinations were down by approximately 54 which is extremely concerning. Dr. Collins, have you explain that current how do you think that current drop in vaccinations were impacting getting a covid19 vaccination out . Would you recommend that, or how do you think we could bring our general vaccination rates back to where they should be . The general vaccination rate is a crisis right now that alter the intended to write now. There is no reason to have to wait until we see what happens with the current covid19 covid19 vaccine. All of those folks who might be listening to this who fell behind on childhood immunizations because of concerns about going to the Doctors Office, those offices has figured out how to make themselves about the safest place you can be. It is time to catch up. I know your positions will be very willing and interested to help you do so. Happening this fall as well as everybody getting their flu shots which is another vaccine whose appropriateness and urgency is going to be even more the case than ever. Thank you, my time has expired, i really appreciate your service. Thank you, senator rosen. We will rapidly or hearing of now, we have votes going on on the senate floor. I got a couple of questions in conclusion. Collins, there was some talk earlier during the hearing about multiple shots for a vaccine. If i remember right, we already do that, dont we . Some vaccines require more than one shot. For instance, the hpv vaccine which is saving lives from Cervical Cancer in prodigious numbers started out as a threesoaw. It is looking good that too will do, but we are not down to one yet. That is clearly something that motivated parents as i think it should. This is not the first time. I believe taking tetanus booster shots every 10 years. Mentioned the problem. Made insenator burr interesting point which was that a lot of the statutes Statutory Authority to do all the extraordinary things that the administration is doing right now is already on the books. In other words, congress after the last several pandemics took giving the fdaps more authority, giving the National Institutes of Health Additional funding and more flexibility. Management,tockpile creating manufacturing plants that would be ready in case we needed them. How valid is that point that, in fact, as we think about preparing for the next pandemic which could be next year in this age of jet planes, that a lot of good work has already been done by the last three or four president ial administrations of both parties, and members of congress of both parties, and that this Administration Simply is using to a full extent the Authority Congress has given you russian mark i think that is very true. It is traditional right now to bemoan that we were not ready for covid19, we were not perfectly ready, thats for sure. There were some things that probably could have been in better position to be ready, but there were things that congress had done over the past couple of possible to made it move more swiftly. Now we need to learn from this one and of course, this is the worst pandemic weve had in more than a century, so maybe we will learn even better this time to be prepared so that as we get through this, and we are going to get through this, and covid19 will slip into the rearview mirror, that we dont imagine we are done with pandemics. Or whatever the next thing might be is out there lurking and we should learn from the lessons and not do anything other than prepare. Governor the lessons, leavitt, a number of others who preceded both of you in your positions, said we go from panic to neglect to panic. And even though we have taken some sick it can steps to be better prepared, and you are taking advantage of those, theres no way you could have vaccine developing a this rapidly, this safely, this effectively without these steps. Still, we are not as prepared as we should be because in between epidemics, we lose our focus, which is why im urging that on onshore manufacturing that we make sure we keep those plants ,arm as governor leavitt said that we make sure the stockpiles stay full and are not depleted because of budget problems at the state or in the federal government, and governor leavitt said we had underfunded Public Health in this country for the last 30 or 40 years. And the time to be prepared for that is now. My strongterated feeling, and i hope you agree with it, that the time to sustain our preparedness is now while our eyes on the ball and while were dealing with pandemic, we should make sure we are prepared for the next one. Do you agree with that . Ive been in Public Health my entire life and as you mentioned , we chronically underfunded Public Health. Ive been coming to d. C. Every year for the last 20 years asking for funding for basic Public Health. The problem with Public Health is that it is like the oil change in your car. You wait until the engine blows up before you decide you need to check the oil. Health,to fund public we need to fund the vaccinations and i want to thank you for being a strong advocate knowing that this may be the last time i , your stronge you advocacy not just for the state of tennessee but for the United States in terms of making sure we have the resources that we need at the federal level and we are our tools to protect the American People. One other thing, the phrase has come up. There is another phrase that has been thrown around inelegantly in the news media and i think it is misunderstood. The way im hearing you talk is that developing herd immunity is a good thing, right . You want to get to a point where populationber of the has some form of immunity from a disease. Herd immunity by itself, nothing wrong with it. How you get there is the question. There is the old way to get ,here which is just let it rip just let it pour through the whole population, killing people until everybody is either killed or recovered with some form of immunity, or we have vaccines, which is the way we get there. I think its very important that the American People understand we want immunity, but we cant do it by locking everybody in their room the way they used to do with leprosy, put everybody with leprosy in a leper colony. But that doesnt get rid of the disease necessarily. What we can do today, we believe, and our testimony has been consistently, that every one of the Public Health experts in this administration and most out side are cautiously optimistic that we can have a safe vaccine that is also effective by the end of the year. Cautiously, at least for the most vulnerable, and by 2021, there should be hundreds of millions of doses of this. There is no guarantee of that. Youve told us we have six tracks of vaccines already moving. We dont necessarily expect everyone to work. Though dont work, even we are manufacturing them ahead of time even while were testing them, we will throw them away and they will never be distributed. You will be first in line to take a safe and effective vaccine as senator casey, i believe asked. To me, it seems important to say to the American People that immunity is what we want. We won most americans to be immune to covid19. And if that happens, the infection rate will go down, the disease will gradually become a minor event in american society. But there are only two ways to get there. One is to let it through the population, killing people until we have killed enough or enough have recovered to have immunity. Or, much preferable way is the vaccine that has a good prospect of being available by the end of the year. I thank you and your colleagues for what youve done and are doing. I know how hard your work. Dr. Collins, i cant let you get away without asking you one last action. You have headed up the socalled shark tank which weve funded. That i knowke sure what is the output right now. As the shark tests tank produced that people can take to determine whether they have covid19, and do you have the funding you need to get done what we ask you to do . I really appreciate your leadership in making it possible. Just beginning on april 25 for us to ramp up something that has never been done before. We invite a lot of Small Businesses and academics who have really Creative Ideas about how to do testing to come forward. Do and gett they can a lot of advice, and sometimes some difficult criticism and see whether they were ready for the big time. They actually expand their capacity to develop a significant validation and get deployed . Just as of last week, we are now up to 16 of these technologies that have been through this process. They are interesting technologies. Collectively, now, those at up to roughly 2 million per day that would not have been there before all this came along. Are based on genome sequencing, some of them are pointed care. Collectively, they are moving along. Together with what admiral gerard has been doing which is also a dramatic in terms of this expansion with things like that, i think we are on that pathway toward getting to enough cast that almost anybody would say. Unfortunately, increasingly, many of them are point of care test. Im also glad to say a lot of the test that were written by slow turnaround times have now gotten down to the point were 97 of all the test are returning to result in three days or less which is where we needed to be and were not, frankly, a few months ago. We are in a much better place. Dressing 2 million per day simply from those that come out of shark tank . That is 2 million times 30, that is a lot. You add to that what was already happening. You add to that the avid test test in october. Said your. Adams, you gave a number for up to september and october that was in the neighborhood of 100 million tests, which is twice as many as he testified here a few weeks ago when he estimated that we would have 40 million to 50 million tests in september or october. My own view is when we have an oversupply of fast tests, testing the ceased to be an issue. Knows theyeverybody can get it quickly if they want one, they will probably not want as many. Scarcity causes people to want more. On the other hand as you are talking about the university of illinois testing students twice a week, they are able to do that. And that is great. How many students and faculty are at that university . Tens of thousands. We are moving to the point where there are many different strategies, and no one is saying you have to test everybody everyday or twice a week or whatever, but different colleges, different schools, different workplaces will develop different strategies and if they know that employee comes up and says i feel worried working here, im afraid i might can coded, covid, you say come right in here, we will tell you whether you do or not. That will help give people the confidence to go back to work, backtoschool, back to childcare and until we have vaccines broadly available and distributed and administer which surely will be sometime next year if we are successful, between now and then, that sort of testing plus the treatment that we could discuss in our next hearing are a very impressive story. Just before you close down, i want to add to thank you for your leadership. Youve just been pointing out a beentic example, you have a clear, compelling, authoritative, evidencebased source of information for all of us and a remarkable voice of leadership. It has been a great pleasure and a privilege to have the chance to work with you. In settings like this, but in other settings as well. I just want to say you are going to be sorely missed. At the very generous and it is a privilege to work with both of you and im not gone yet. On that note, the hearing record will remain open for 10 days. Members may submit Additional Information for the record within that time if they wish. I want to thank senator murray and her staff are working with us on this hearing. One of the senators said to me on the floor this is the most civil hearing that he had attended in the senate in several weeks and most of their hearings are pretty simple. We each get her points and including our political points, but we do have respect for those of you who work for the American People like dr. Adams, and i thank senator murray and a democrat colleagues for allowing us to conduct hearings in that way. Our committee will meet twice next week, we will meet again at 10 00 a. M. On tuesday for a hearing entitled compensating college athletes, examining the potential impact of athletes and institutions. As the Congress Committee is the lead committee in the senate on that, we are looking into that in cooperation with them because this makes a difference to students, to student athletes, and the American People who like to watch sports. And then on thursday, we will have a hearing on something that this committee has been working on in a bipartisan way for six years, which is simplifying the fafsa, the federalaid Application Form of 20 million families fill out every year. Weve made progress on that in the obama administration, we made progress in the Trump Administration. Senator murray and i introduced and Congress Passed a bill making important steps earlier recently when we properly funded historically black colleges, but we would like to finish the job and we will have a hearing on that next thursday with the same four who got uslus one involved in it in the first place six years ago. Thank you for being here today, the committee will stand adjourned. Cspans washington journal, every day, we are taking your calls live on the air on the news of the day and discussing policy issues that impact you. Talkg up thursday morning, about the approval process for solutions. Ovid19 of theiscussion International Effort to develop a covid19 vaccine with dr. William moss, executive director of Johns Hopkins Bloomberg School of Public Health interNational Vaccine center. Watch cspans washington journal, live at 7 00 eastern. Be sure to join the discussion with your phone calls, facebook comments, Text Messages and tweets. Here is a look at our live coverage on thursday. House Speaker Nancy Pelosi holds her Weekly News Conference at 10 40 5 p. M. Eastern. At noon, the governors of new mexico, minnesota, kansas and guam testify before the House Financial Services committee about providing Financial Aid to states and u. S. Territories during the coronavirus pandemic. On cspan two, the senate is back to vote on whether to move forward with the scaleddown Economic Relief bill that republic is introduced in response to covid19. Anyone watching the senate yesterday so another installment in an ongoing series that has become somewhat familiar, the publicans rule out yet another