Senate Hearing on COVID-19 Vaccine Development Transcript September 9

Senator Alexander: (00:00) Dr. Collins and Surgeon General Adams are participating in person. Some senators are in person. Some are participating by video conference. The office of attending physician has advised that senators or witnesses may remove their masks to talk in the microphone, since our chairs are six feet apart or more. So that's why my mask is off. I'm more than six feet apart. When I'm in the hall or when I'm walking on the Senate floor, I wear my mask. So we're grateful to the rules committee, the Sergeant at arms, the press gallery, the architect of the Capitol KA Chung [Schick 00:00:38] and Evan Griffis, all who've helped us maintain a safe environment for this hearing. Senator Alexander: (00:43) I'd like to say, too, that there are votes that began at 11:15, but we'll continue the hearing so that all senators will have a chance to participate. And if necessary, I'll leave and I'll ask someone else to preside during the time that I'm voting, and then I'll come back. Senator Alexander: (00:58) 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'll ask each senator questions of five minutes, of up to five minutes. Senator Alexander: (01:22) I've been reading, I was saying to Senator Tin Kaine and Maggie Hassan, that I've been reading Guns, Germs, and Steel, the book that Jared Diamond wrote, that won a Pulitzer prize in 1977. He wrote that there nothing new about epidemics that cause mass deaths and social upheaval. And there's nothing new about where most of the infectious disease come from. Over the last 10,000 years, he says humans have acquired most of our infectious diseases from animals. During most of history, there were basically three ways to deal with these epidemics. One was to isolate the infected. Leper colonies, for example. Senator Alexander: (02:14) Two, according to Jared diamond was that over thousands of years, there've been genetic changes in human populations in response to infectious diseases that cause major outbreaks like smallpox, but that didn't help the Native Americans who had no resistance when European settlers arrived here, wiping out 90%, for example, of a native tribe by handing them a blanket with smallpox on it. Because the tribe had not previously been exposed to the virus. Senator Alexander: (02:45) And then there's a third way that was most common throughout most of history, and that was really the let her rip. Let the virus run its course through the population until everyone had either been killed or recovered and developed some immunity. Diamond says that the Black Death killed about one third of Europe's population between 1347 and 1351. Senator Alexander: (03:08) What's new about epidemics is modern medicine, including the ability to diagnose the disease and create treatments to 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's why today in all 50 States and the District of Columbia, schoolchildren are required to take vaccination for the following diseases: diptheria, tetanus, the whooping cough, polio, measles, rubella, 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's caused these diseases eventually to disappear. Senator Alexander: (03:53) Americans of my generation remember how polio terrified our parents in the early 1940s and '50s. Many saw their children die or be left dependent on an iron lung to breathe for the rest of their lives. Of those who contracted polio, the lucky children were like Senator Mitch McConnell, the majority leader, who is left only with the limp. The disease terrified Americans until Dr. Jonas Salk developed the polio vaccine in the 1950s. After the vaccine was developed, the United States undertook a large scale vaccination program, and polio was declared eradicated from the United States in 1979. Senator Alexander: (04:35) So the purpose of this hearing is to explore the remarkable progression that science is making toward a COVID-19 vaccine, to remind parents to have their children to get their childhood vaccines, and to encourage as many Americans as possible to get the flu vaccine this fall. Senator Alexander: (04:52) First, the progress toward 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, effective vaccine to hundreds of millions of Americans. Senator Alexander: (05:11) Some people incorrectly believe that warp speed means cutting corners, but it refers to the extraordinary investment in research, development, and manufacturing scale up for the COVID-19 vaccine. Perhaps most significantly, the Biomedical Advanced Research and Development Authority, we call it BARDA, has taken up the unprecedented step to help speed up manufacturing for hundreds of millions of doses of the vaccine early in the process, so they can be ready as soon as the new vaccines are approved by the Food and Drug Administration. In other words, they're being manufactured before they are approved. And if they're approved, they'll be ready to distribute. And if they're not approved, they'll be thrown in the dumpster. Senator Alexander: (05:58) Despite the speed with which scientists are developing a COVID-19 vaccine, Dr. Hahn, the commissioner of FDA, said the administration is not, or his agency "is not skimping on its review of safety and efficacy. This is going to be a science medicine data decision. This is not going to be a political decision," Dr. Han said. That means that if the FDA determines that a vaccine is not safe or effective after reviewing the science and clinical trial results, the vaccine will not be distributed. At the same time, CDC is working on a plan to distribute the vaccine, as soon as they are authorized or approved, prioritizing vaccines for healthcare workers and vulnerable populations. CDC's plan will be a fair system informed by nonpartisan health experts from the national academies of science, engineering, and medicine, and the advisory commission on immunization practice. Senator Alexander: (06:53) As inevitably happens, some have suggested, well, you're speeding up the vaccine because an election is coming, and you've asked states to get ready to distribute it because an election is coming. Well, I was thinking this morning, what if Dr. Collins showed up and Dr. Adams saying, "Well, it'll be five years before we're going to get a vaccine." I think we'd probably throw them out of the room and ask the President to try to find some more effective people. Or what if we didn't ask states to get ready to distribute the vaccine and show that we hadn't learned our lesson from what happened with the H1N1 virus, when the vaccine was ready, but the states weren't ready to distribute it. So we should move as rapidly as we can, both to develop the vaccine and to be prepared to distribute it. Senator Alexander: (07:39) So why are some Americans saying they're not persuaded to take the vaccine? Well, there are three reasons. One is, are they safe? Vaccines are approved and reviewed by the Food and Drug Administration. FDA can either license a vaccine or authorize it for use during a public health emergency. And the FDA stringent approval process is the world's gold standard. The vaccines are routinely, that are given to children, are specifically recommended by the advisory committee on immunization practices, an outside group of health experts that looks at all available scientific information about each vaccine. And then medical associations, like the American Academy of Pediatrics, the American Academy of Family Physicians, work with that agency to develop these recommendations. Senator Alexander: (08:28) In a 2015 article in Scientific America, Dena [Fanmeron 00:08:32] writes, "By age two, most children will receive almost 30 shots designed to boost the child's natural defenses against disease. Yet at the same time, parents who take their children for those recommended vaccinations might be inundated with website and celebrity espoused rumors, 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 life threatening disease against the benefits of receiving a vaccine, there's no contest. The vast majority of children do not experience anything worse than short-lived redness or itching at the spot of the injection." Senator Alexander: (09:18) And then are they effective? According to CDC, there's evidence a smallpox was ravaging humans as early as the third century BCE. The disease killed three out of 10 people who were affected. Then in 1796, an English doctor named Edward Jenner, saw that milkmaids who had gotten cowpox seemed to be immune from smallpox. So he scratched some puss from a cowpox blister on an eight-year-old boy, and the boy became immune to smallpox. Jenner published his results in 1801, leading to the development of mankind's first ever vaccine. And no one on earth has naturally acquired smallpox since 1977. It has been officially eradicated. Senator Alexander: (10:04) Polio was one of the most dreaded childhood diseases. Following introduction of vaccines, specifically the vaccine in 1955 and then 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 CDC. Thanks to a successful vaccination program, the United States has been polio free since 1979. Senator Alexander: (10:32) Diptheria terrified patients in the 1920s. But today, they're only a few cases a year, according to AAP, which attributes the change to vaccinations. Senator Alexander: (10:44) And then is the doctor's office safe? The pandemic has made some parents leery of the doctor's office, but analysis of patient records, according to the Wall Street Journal, shows that the immunization rate for recommended routine 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're among the safest places you can be. Don't be afraid to take your child to see your doctor. Senator Alexander: (11:23) I started my statement with comments from Jared Diamond. I'll end with a warning he wrote recently. On June 23rd, this committee held a hearing on preparing for the next pandemic. One member of the committee asked, "Why would we worry about the next pandemic when we haven't conquered this one yet?" Well, in a Wall Street Journal essay on May 23rd, Jared Diamond provides 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. Senator Alexander: (12:04) Congress tried to do that in response to the other new diseases that have emerged over the last 40 years. HIV AIDS, SARS, MERS, Ebola, but good intentions often evaporated as the epidemics ended. As 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 doses of vaccine for COVID-19. Senator Burr and I took a virtual tour of one of them not long ago. Senator Alexander: (12:43) However, there's still a need to improve and sustain these types of facilities, so they're able to pivot more quickly to the next threat when it emerges. In a similar way, stockpiles were created, and then stockpiles were depleted. Former HHS secretary and governor Mike Leavitt told this committee that public health programs have been underfunded for the last 30 to 40 years. "The nation goes," he said, "from panic to neglect to panic." Senator Alexander: (13:11) Fortunately, thanks to an unprecedented effort by the private sector and our government, as well as scientists around the world, there's likely to be a COVID-19 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 from finding a vaccine, are how to distribute it, to whom should it go first, and how to persuade Americans that it's safe to take. Senator Alexander: (13:41) While we're 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 eye is on the ball, is that the next pandemic, as Jared Diamond, wrote could be next year. Senator Alexander: (14:13) Senator Murray. Senator Murray: (14:17) Well, thank you very much, Mr. Chairman. And while you still have a few months left, as well as a few more hearings, I do want to start off by saluting you for your many years of service to this country, including as senator and chairman of this committee. I know my democratic colleagues and I will miss you next year. Senator Murray: (14:35) On the topic of today's hearing, Mr. Chairman, our country is in the middle of a painful crisis. The COVID-19 pandemic has crowded hospital intensive care units. It's emptied schools. It's 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 congregate care facilities. It has strained our economy, our mental health, and a lot more. It has claimed around 190,000 lives so far and more each day. Senator Murray: (15:17) Unfortunately, instead of leading us 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 and junk science. He's called for less testing, which he blamed for the rising number of COVID-19 cases. Wrongly claimed kids aren't likely to get her transmit the virus. And has repeatedly insisted this will just all go away. The list of inaccuracies and outright lies at a time when truth is a matter and life and death goes on and on. Senator Murray: (16:05) And unfortunately, President Trump is not alone in his deeply flawed response. In July, after months of delay and inaction, Republicans put forward a proposal that didn't even 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, instead, 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 actually protects workers. And most 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 uptake of flu vaccines each year 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. Senator Murray: (17:24) But this pandemic has made these challenges more urgent than ever. So I'm glad we do have Surgeon General Dr. Adams and NIH director Dr. Collins, here today to share their expertise. But I'm also frustrated that, despite my request to the chairman, FDA commissioner Dr. Hahn 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've not only watched President Trump directly promote conspiracies about FDA and CDC, we've also seen reports that he exerted political pressure on FDA to issue an emergency use authorization for convalescent plasma, and on CDC, which changed testing guidelines to be more restrictive with no justification and running counter to the consensus of public health experts from across the country. Senator Murray: (18:39) And these aren't the first reports of political interference. The Trump administration has previously promoted unproven treatments like hydroxychloroquine and blocked CDC guidance for community reopening. Recently, FDA Commissioner Hahn announced he was prepared to authorize a COVID-19 vaccine before phase three trials were complete, but without providing any guidance about when that would be appropriate. When it comes to a COVID-19 vaccine, we cannot allow President Trump to repeat his alarming pattern of putting politics ahead of science and public health. Senator Murray: (19:18) FDA scientists' efforts to ensure the safety and efficacy of vaccines must not be undermined by political meddling. CDC's role in distributing a vaccine and prioritizing who receives the first doses must not be supplanted by politicians or campaign strategists or corporate lobbyists. And if we are going to begin 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. Senator Murray: (20:06) We need the FDA to be transparent by issuing an official guidance with standards for granting any vaccine and emergency use authorization, including standards for the independent review of phase three data, by waiting for the completion of phase three clinical trials before moving on any candidates, and by committing to make public any data used to green light a vaccine. We need transparency from CDC about how it plans to handle distribution. How its experts will drive the process, despite the ill advised decision to have the Department of Defense, rather than CDC, lead a lot of this effort, and who will get priority when the first doses are available. We also need transparency on Operation Warp Speed's contracts and how it is addressing any potential conflict of interest. In short, we need transparency from top to bottom. Senator Murray: (21:06) And 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 white paper I put out on vaccine months ago. We have seen with testing how many problems the Trump administration caused by throwing up its hands and refusing to develop a plan and leaving our states to fend for themselves. Testing is an ongoing catastrophe, and we cannot 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 fight misinformation, especially when there's so much misinformation coming from the President of the United States. Senator Murray: (22:15) Developing and distributing safe, effective vaccines is a huge undertaking, and one that cannot be accomplished without a strong, science driven leadership from the federal government. So I really am glad we have this opportunity to talk about the important challenges that lie ahead, but there are many more questions we need to answer and so many more witnesses that we do need to hear from. And I will absolutely keep pushing to make that happen. Thank you, Mr. Chairman. Senator Alexander: (22:46) Thank you, Senator Murray. And as usual, you're having some considerable effect, as we've announced our next health hearing, which will be in two weeks, Dr. Redfield from CDC will be a witness. Admiral [inaudible 00:23:02] will be here. Dr. Hahn, head of FDA, will be here. And Dr. Anthony Fauci will be a witness. Senator Alexander: (23:11) Today we have two witnesses. We welcome them. Dr. Francis Collins is director of the National Institutes of Health. He oversees the largest public funding of biomedical research in the world. He's a physician geneticist. Prior to becoming the NIH director in 2009, he served as director of the agency's National Human Genome Research Institute from '93 to 2008. And he led the International Human Genome project. He's a member of the National Academy of Medicine, National Academy of Sciences, was awarded the Presidential Medal of Freedom and received the National Medal of Sciences. Is a graduate of Virginia and Yale, University of North Carolina School of Medicine. And he's the only National Institute of Health director I know who's ever played the guitar at the Bluebird Cafe in Nashville, and played it pretty well, I might say. Senator Alexander: (24:07) Next, we hear from Vice Admiral Jerome Adams, Surgeon General of the United States. He oversees US Public Health Service Commission Corps, group of over 6000 public health professionals working throughout the federal government for the advancement of public health. He previously served as the Indiana State Health Commissioner. He led that state's response to Ebola, HIV, and Zika. He was staff anesthesiologist and assistant professor at the Indiana University School of Medicine. He's been at the University of Maryland Baltimore County, where he obtained a degree, masters from University of California at Berkeley, an MD from Indiana University, where he completed his residency. Welcome to both witnesses. Senator Alexander: (24:53) Dr. Collins, let's begin with you. Dr. Collins: (24:58) Well, thank you very much. And perhaps we could get the visuals up on the screen, if that's 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'm grateful for your longstanding support of NIH and for this opportunity to address how we are working tirelessly with other parts of the government and with industry partners to prevent, diagnose, and treat the novel coronavirus, SARS-CoV-2. Let me provide a metaphorical illustration of how vaccines work. Your immune system is like an antibody factory. Yes, you have a very sophisticated biotech company inside your body. When your body sees an invader like these three viruses, it designs an antibody, a Y-shaped protein, that could 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's ever made. Dr. Collins: (26:04) The goal of a vaccine, therefore, is to present a completely harmless part of the virus to your body, allowing your factory to work out an effective production strategy. Now, if at some time in the future, the actual virus enters your body, your factory can quickly pull out the blueprints and ramp up production, wiping up that virus before it has a chance to multiply and make you sick. Dr. Collins: (26:27) For COVID-19, there are six vaccine candidates engaged in large scale US 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 three of testing, where the goal is to inject 30,000 volunteers, located in areas where the virus is actively spreading. Half of the volunteers are injected with the vaccine and half with a placebo, and nobody knows which is which. Over the next weeks, they are followed closely to see if infections occur. Dr. Collins: (27:04) A successful vaccine should have many fewer cases of COVID-19 in those who got the actual vaccine, versus those who got the placebo. We will also follow all of them for as long as two years to assess safety. We expect the other three candidates to enter phase three in the coming weeks and months. Dr. Collins: (27:22) Now, 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 the spike protein of the SARS-CoV-2 virus. And you've seen this picture so many times, but that's the protein you want to raise that antibody against. We know that people who have survived COVID-19 make neutralizing antibodies to this spike. So we want the vaccine to do the same. Dr. Collins: (27:59) Now 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. The laboratory process to produce and purify the protein means that this approach, although it's tried and true, is on a bit slower trajectory than some of the other candidates, but not much. Novavax plans to initiate their phase three trial in mid-October. Sanofi and GSK announced their phase one clinical trial last week. If results are positive, a phase three would start, for them, by the end of the year. Dr. Collins: (28:38) The second scientific approach also uses a well known vaccine technology, harnessing a harmless viral vector called an adenovirus and using it basically as a delivery truck. The adenovirus is modified by inserting a gene for the spike protein. Once the virus enters the individual cells, the spike protein is produced, triggering an immune response. Dr. Collins: (29:02) A phase three clinical trial of this approach was launched by AstraZeneca on August 31st, though it is now, as of yesterday, on clinical hold. And a similar phase three trial will be launched by Janssen later this month. Dr. Collins: (29:15) Finally, the newest platform technology is one that was developed at NIH, using, actually, supplemental funds from the Ebola epidemic a few years ago. In this approach, which is now being pursued separately by Pfizer and by Moderna, a small non-infectious snippet of messenger RNA or mRNA from the genome of SARS-CoV-2 is prepared. Injecting this mRNA, which codes for this spike protein, into muscle will spur a person's own cells to make that protein and then encourage the production of those protective antibodies against SARS-CoV-2. Dr. Collins: (29:51) And before I conclude, I want to address concerns about 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 for the trial in multiple countries. And that is what's happening. There are ways, however, that we have adopted in Warp Speed to move quickly, while retaining those most rigorous scientific standards. And I think you would want us to do that. People are dying. Dr. Collins: (30:25) Delays that traditionally require many years for a vaccine to be developed, had to be addressed. In some instances, we have done that by carrying out steps in parallel that are traditionally done in sequence. We've eliminated downtime by moving into new phases before data from the previous phase is completely analyzed. We have, as the chairman said, started to manufacture doses of all these vaccines before we know if they work, understanding that we are spending hundreds of millions of dollars for a vaccine doses that we may have to throw away if they don't work. But please hear me now, the rigor of the scientific evaluation of safety and efficacy will not be compromised. Dr. Collins: (31:02) ... of safety and efficacy will not be compromised. As a scientist, I'm excited that the pace of discovery is allowing us to respond to this crisis in record time. As a physician, I'm hopeful when I think of the millions of lives that have been saved from other diseases through vaccination and the millions more that we can save by developing a safe and effective vaccine for COVID-19. Thank you again for your support. I look forward to your questions. Senator Alexander: (31:27) Thank you, Dr. Collins. Dr. Adams, welcome. Dr. Adams: (31:31) Well, good morning. And thank you, Chairman Alexander, Ranking Member Murray and committee members for allowing me to address the importance of childhood and adult immunizations, particularly in the context of COVID-19. My central message today is this, equitable vaccination of America's children and adults against preventable diseases is safe, smart, good for the economy and critical in our fight against COVID-19. And the science here is clear, vaccines save lives and the US vaccine supply is the safest in history and the safest in the world. And they are great value as every dollar invested in the measles' vaccine, for instance, saves society up to 20. This is because the vaccines actually prevent disease, keeping people out of the hospital and clinic 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 woman's risk of hospitalization by 40% and a newborn baby's risk by 72%. Dr. Adams: (32:38) However, only half of all pregnant women get recommended flu and whooping cough vaccinations. And pregnant African-Americans 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 far behind already poor national averages. 37% of Hispanics, native Americans and African Americans get their flu shot versus 48% of whites. Among adults, rates of pneumococcal vaccination exceeds 70% in whites but is just over 50% in blacks and Hispanics. And these disparities persist for tetanus, zoster and Tdap as well. I want to move the childhood vaccinations. And it's important to note that childhood vaccination rates remain high nationally. But one in 10 parents refuses at least one childhood vaccine and almost a third delay a vaccine. We know that unvaccinated children are more likely to be uninsured, to live below the poverty level and to live in rural areas. Dr. Adams: (33:39) Unfortunately, the fear and access issues induced by COVID-19 have put millions of additional children and adults at risk for vaccine preventable diseases. So to ensure the benefits of vaccines for all Americans, we must acknowledge and address obstacles to vaccination. And in particularly, 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 provider 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 COVID-19 vaccine. And with both COVID-19 and the flu circulating this fall, this will be, in my opinion, the most important flu season of our lifetimes. Less flu and fewer hospitalizations will help conserve precious healthcare resources. Dr. Adams: (34:38) So let me be clear, the best way to prevent the flu is to get the flu vaccine. And I hope all of you here today will get your flu vaccines early and publicly. That's why my fall COVID-19 prescription is twofold. First, we must all practice the three Ws; wash your hands, wear your mask and watch your distance. And second, we must use every lever to ensure all ages, races and ethnicities receive recommended vaccinations. In my written testimony, I outlined efforts underway across HHS to boost vaccination rates and I'll finish by highlighting just a few. CDC works with providers through the Vaccines for Children or VCF, and the Section 317 immunization programs to provide over 80 million doses of vaccines annually. And they've increased their flu vaccine purchase 20 fold this year. You can find out where to get vaccinated using CDC's vaccinefinder.org. HHS recently launched Catch-Up to Get Ahead informing parents that it's important to and safe for their children to get vaccinated during COVID-19. Dr. Adams: (35:41) The Catch-Up to Get Ahead toolkit is available on vaccines.gov. And again, to you senators out there, I'd encourage you to send your staff there because there are great printable documents and digital documents to help people understand that vaccines are safe and effective. Through a recent amendment to the PREP Act, HHS authorized licensed pharmacists to administer routine vaccines for children aged three through 18 during the COVID-19 pandemic. And breaking news that I just got the okay to tell you all about right before I came in, today HHS will be issuing guidance to expand access to safe and effective COVID-19 vaccines when they are made available. State licensed pharmacists will now be able to administer COVID-19 vaccinations to persons aged three and older. Office of Minority Health is working with Morehouse School of Medicine on a $40 million plan to help engage and inform racial and ethnic minority communities about COVID-19 on vaccinations. Dr. Adams: (36:35) And then finally, the Public Health Service Commission Corps, which I helped lead along with Admiral Giroir, works with underserved populations including Indian Health Services and Bureau of Prisons, leading efforts to increase acceptance of and uptake of the flu vaccine. PHS 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 federally qualified health centers. So I want to close with calls to action to again, you as senators, to your families, to your staff and to your constituents. Number one, get your flu shot ideally before the end of October. We want everyone to get their flu shots by Halloween. Second, catch up on childhood and adult immunizations right now. Clinics and pharmacies around the country are safe, open and ready to vaccinate. Number three, stop COVID-19 in its tracks by practicing my three Ws; washing your hands, wearing your mask and watching your distance. Dr. Adams: (37:35) Fourth, use your bully pulpits to tweet, text, blog, and shout that vaccines are safe, effective, and more important now than ever. And then finally go to vaccines.gov for more information. And I just want to throw in a quick personal note, we are in the midst of a social justice movement the likes of which we haven't seen since the '60s in my lifetime. As Surgeon General of the United States I want you to hear me say that achieving health equity is necessary to achieving social justice. And vaccines are the quickest and the easiest way for minority and at risk populations to protect their health. So 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. Senator Alexander: (38:29) Thank you, Dr. Adams. We'll now begin a round of five minute questions. I'm going to ask senators and the witnesses to try to keep the questions and the answers within five minutes so all the senators have a chance to participate with the votes coming up. Dr. Collins, let's take the announcement to which you referred about AstraZeneca slowing its trials this morning or stopping it. What does that do to the goal of producing hundreds of millions of vaccines by the end of the year? We've always said that if a vaccine is not safe and doesn't work, we'll throw away the vaccines that are manufactured. But let's say AstraZeneca or one of the others doesn't work or isn't safe, will we still have enough vaccines? Dr. Collins: (39:21) Thank you, Senator. The reason that we're investing, not in one but six different vaccines is because of the expectation that they won't 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 certainly happens in any large scale 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 try to figure out, is that because of the vaccine or were they going to get that illness anyway? Dr. Collins: (39:56) And 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 vaccine or any other vaccines might've had a similar finding of a spinal cord problem. So 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 in practice. If it turns out that that is a real consequence of this vaccine and can be shown to be cause and effect, then all the doses that are currently being manufactured for that will be thrown away because we do not want to issue something that is not safe. Senator Alexander: (40:33) As I understand your description, when I take a COVID-19 vaccine shot, it doesn't give me COVID. At one time in the history, I guess, that was the way. With smallpox for example, you gave somebody a mild case of smallpox and hope they recovered, were inoculated. But when you take a vaccine shot for COVID, you're not giving me COVID, correct? Dr. Collins: (40:55) Absolutely. The old way of making vaccines and it is still done in some instances is to take the actual virus inactivated in a certain way or kill it and then use that as the way of inducing an immune response, hoping that you were completely successful in that inactivation. None of the vaccines I'm 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. But that's all you're getting is that part, that little bit of the virus. You're not going to get infected by COVID-19 by any of these, I promise you. Senator Alexander: (41:30) The Center for Disease Control said that last year the flu vaccine was 39% effective. And that last year, between 24,000 and 62,000 Americans died of the flu. On the other hand, the polio vaccine seems to be 100% effective. If you get the polio vaccine, you don't get polio. Same with some others. Will the COVID-19 vaccine be more like the flu vaccine or more like the polio vaccine in terms of effectiveness? Dr. Collins: (42:02) Senator, what a great question. And I wish I knew a really crisp answer to that. That's why we're doing these large scale trials to look at safety and efficacy, to see how protective this will be and how long the protection lasts. If I had to guess, I would say this is probably a better virus for a vaccine to really work well than the influenza virus, which is a tough one because it's changing every year and that's why we have to be getting a new shot every year. Will be as good as polio or as good as measles, which is 95, 98% effective? I would love it if that turned out to be the case, but we will not know until we get through these trials and see what really happens. Dr. Adams: (42:40) Mr Chairman, can I jump in really quickly? You mentioned- Senator Alexander: (42:42) No, let me finish my questions if I may. Between 24,000 and 52,000 or 62,000 Americans died of flu last year. Is it possible that the hand-washing, masking and six feet staying apart practices will mean that we'll have fewer deaths from flu this year? Dr. Collins: (43:08) It is entirely possible. And that would be, I guess, the silver lining of this very difficult year we're all living through. It's already been observed in the Southern hemisphere that's going through their flu season already that they had a lower number of cases of influenza by far than usual. And again, they've been practicing most of them, the same kind of measures that we're talking about. So we might in fact benefit that way. But that is no reason for anybody to say, "Oh, we'll be fine." Get your flu shot everybody. This is a really important year to do that as the Surgeon General has already emphasized. Senator Alexander: (43:39) Thank you very much, Senator Murray. Senator Murray: (43:43) Oh, thank you very much, Mr. Chairman. And Dr. Collins, as I said, I've been very concerned about political interference in decision-making we've seen in this administration's response and the impact it might have on the acceptance of a vaccine. I wanted to ask you what steps you think federal agencies should be taking right now to build trust with the American people and develop air-tight processes to make sure science and public health, not political interests, dictate decision-making for COVID-19 vaccines. Dr. Collins: (44:17) Well, thank you, Senator. I'm a scientist and I believe that 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's so many conspiracy theories out there right now, even before we have a vaccine that's come anywhere near to being drug safe and effective about what's going on here. Some of those are breathtaking in terms of their stretch of the imagination, and yet sometimes people seem to attach themselves to those. So our best antidote is to say exactly what we're doing. I am reassured, and I hope it will be reassuring to you that there are a number of steps in terms of how vaccines are going to be evaluated that are going to give that kind of sense of scientific objectivity. Dr. Collins: (44:59) First of all, none of these trials will go even to a FDA review until the DSMB, 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. And these are not federal employees, these are very experienced qualified scientists. Only when they say something's happening here that looks like it might be actually worth reviewing does this get brought forward. I hope you also saw the nine CEOs of the companies involved in vaccine development all signed a statement that they won't put forward something to FDA until they're convinced that it meets the highest standards of safety and efficacy. And then FDA has its own advisory process. And Commissioner Hahn who will speak to you all in two weeks has already said that he will use this Vaccines and Related Biological Products Advisory Committee, the VRBPAC to advise about any idea of using an emergency use authorization for this purpose. Dr. Collins: (45:57) So you can be confident in that as well. I think if we can put all of that information forward in a way that's digestible, I'm 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. And what a heartbreak that would be if we go through all of this and come up with a vaccine that is safe and effective. We've already lost 190,000 people. We could prevent many more deaths and yet people are afraid to use it. We can't let that happen. Senator Murray: (46:24) Well, Dr. Adams, let me ask you, because polls show that about 35% of Americans wouldn't get a COVID vaccine even if it were FDA approved and available to them at no cost. If confidence in COVID-19 vaccines is eroded by political interference or misinformation, what impact would that have on a successful COVID-19 vaccination campaign as well as vaccine confidence for years to come? Dr. Adams: (46:52) Well, thank you so much for that question. And I think it's 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's also important to understand that we have a once in a century global pandemic superimposed on top of a presidential election, and that's made messaging even more difficult and concerning. Now, here's what I can tell you. As a member of the Coronavirus Task Force, there has 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 and we will- Senator Murray: (47:45) I appreciate that. And I'm running out of time. So I just wanted to say, we need vaccine confidence and that's 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: (48:02) I'm using my bully pulpit as Surgeon General to make sure the entire country understands that vaccines are safe and effective. And this COVID vaccine, I'm telling people to focus on the process over the politics and the people, because the process is what will assure us that these are safe. Senator Murray: (48:17) Okay. And Dr. Collins, you mentioned in your answer to me, the Data Safety Monitoring Board, I'm concerned about the lack of transparency around the role of these boards in evaluating the safety and ethicacy of COVID-19. Who sets the standards for the DSMBs to determine whether the data from a phase three trial show a vaccine is safe and effective enough to end that trial early as some have said? Dr. Collins: (48:44) So when the trial is first proposed, the FDA has to review whether in fact, the demonstration of safety and efficacy is going to meet a certain standard. And that means you have to have a proof. And FDA has already said this, that the vaccine is at least 50% effective. If it's less than that, it doesn't meet that standard. The DSMB has those particular parameters in front of them, and they with very careful statistic- Senator Murray: (49:08) Who sets those standards? Dr. Collins: (49:10) Sorry? Senator Murray: (49:11) Who sets the standards DSMB uses? Dr. Collins: (49:14) The FDA. Senator Murray: (49:16) And does NIH have access to those? Dr. Collins: (49:19) We are certainly consulted, but it is FDA's authority and responsibility to set those standards. Senator Murray: (49:26) Okay. I hope that NIH has that critical information. It's alarming if they don't. Dr. Collins: (49:36) I would say yes, we do. I want to make it clear though that we are not the deciders when it comes to exactly what's going to be considered acceptable. That's FDA's congressional authority. Senator Murray: (49:46) Okay. Thank you. Senator Alexander: (49:51) Thank you, Senator Murray. Senator Enzi. Senator Enzi: (49:56) Thank you, Mr. Chairman, and ranking member. Thanks to the two who testified. Some great information. I really enjoyed watching Dr. Collins and [inaudible 00:50:10] last night use all of their talents or not in a marvelous performance at the Whitehead Awards. It's good to see you this morning in your normal role. I appreciate the questions that Senator Murray asked about the people worrying about fast track and accelerated approval and FDA perhaps short changing 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 patients to make their decisions about a COVID-19 vaccine, understand the regulatory terminology and then feel comfortable communicating that with the patients about what it means. Dr. Collins, I'm very appreciative of your explanation of how vaccines work in the charts that you had. 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: (51:30) Thank you, Senator. And yes, NIH has a role there in terms of 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. Just in terms of clinical guidelines, we do have a role there that has already been helpful, I think, in providing physicians with information about how best to treat patients who have fallen ill with COVID-19. And when it comes to the vaccines, in terms of information for physicians, we will try to help in that space as well. Along with their professional societies who will also be very important in terms of educating their own members about what are the pros and cons of a particular approach. So yes, we'll be right in the middle of that. Senator Enzi: (52:14) I'm 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 in protecting other age groups and limiting the spread of disease. It 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 that pediatric vaccine research. Because of the safety and ethics concerned about enrolling kids in trials, there can be differences in how their manufacturing immune systems work compared to adults. What do we know about the natural immune response that kids have to COVID-19 and when should the companies start the process of developing these pediatric products? Dr. Adams: (53:09) Great question. Thank you for that senator. Important to understand that the initial vaccine trials will be on people aged 18 and up, and we will make sure... and this is the way we've done it for other vaccines that have been developed in the past. We'll make sure it is safe and effective in adults and then we will slowly start to move down in age. So the next round, I anticipate, will be age 12 to 18. And then after that, if it's continues to be safe and effective, we'll test in people younger than that. And that's the way we've done it for every vaccine because we can't just assume that something is safe and effective in an adult will be safe and effective in a child. Dr. Adams: (53:51) But here's the important point, that's why it's even more critical that we work to ensure vaccine confidence and that all adults who can get a vaccine do get a vaccine because it will be even more important that we have a higher percentage of adults getting vaccinated to get closer to that level of herd immunity that we need to break transmission of disease knowing that the initial round of vaccinations won't be available for children. And Dr. Collins, anything that you'd add about testing in kids? Dr. Collins: (54:24) I think there is maybe an effort in one of the trials to begin to enroll children in the next month or so. But again, as the Surgeon General very accurately said, we generally want to wait until you are sure that it looks safe and effective in adults before you take that next step. But it shouldn't be a whole lot long. Senator Enzi: (54:42) So you're actually working with the process for getting that development started as soon as possible? To Dr. Collins. Dr. Collins: (54:53) Yes. Again, with a clear sense of wanting to have the safety and efficacy reviews through the DSMBs and through the FDA before deciding it's time to move downward in age. We don't want to make any risks here happen to children in particular that we could avoid. So first we want the data from the adults. Dr. Adams: (55:11) And you mentioned a COVID vaccine. It's important, again, that folks go to vaccine.org. We have a Catch-Up to Get Ahead campaign. Over 4 million children are behind on childhood vaccinations. So we want to prevent the disease that we can prevent right now, and every child should get their flu vaccine this year. Senator Enzi: (55:28) Thank you both. Senator Alexander: (55:30) Thank you, Senator Enzi. and Senator Sanders. Sen. Sanders: (55:37) Let me thank Dr. Collins and Dr. Adams, not only for being here today, but for the years of public service. Gentlemen, thank you very much. Senator Murray covered a lot of the territory that I was interested in, but I want to ask two questions. Number one, the tax payers of our country have already spent billions of dollars, many billions of dollars on research and development for this new vaccine. And it seems to me 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 I think a number of other senators that we must make that vaccine free of charge to all people if we want to maximize the number of people who will in fact get it, and given the fact that we have already paid for it. This is something I'm 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 to all Americans? Dr. Adams: (56:48) Senator Sanders, this is the Surgeon General Vice Admiral Adams here. Thank you for bringing that up. And I will give you a very direct answer. Yes. As Surgeon General of the United States, 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 and highly anticipated vaccine of our lives. Dr. Collins: (57:10) And I share that 100%. Sen. Sanders: (57:13) Okay. I thank you both for that very definitive statement. Is that the posture of the administration right now? Is the administration saying that that vaccine will be distributed free of charge to all Americans? Dr. Adams: (57:26) I asked that question right before I came in to make sure, because I feel strongly about this. The most honest answer I can give you is, to the extent that we can ensure that from a federal perspective, yes. As you know, there are things we can do in the executive branch, there are things that you all can do through the legislative branch. But every tool that we have, we will bring to bear to make sure that cost is not an obstacle. Sen. Sanders: (57:50) Good. Well, thank you very much for that answer, gentlemen. Let me raise another issue. And it's an issue that Senator Murray touched on. Recently we had the president of the United States telling us that this vaccine will be ready to go or developed before election day. not a week after the election day, not two weeks after, not a month after, but before election day because of his great leadership. And that it would have taken President Obama years more to develop that process. What we need is assurance from scientists and doctors like yourself and from others in the administration to make it clear that this president is not speaking for the scientists of this country. Sen. Sanders: (58:43) That you believe as I believe and I think 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 or six months after election day or before election day. But what is most important is that that vaccine is safe. It's safe and ready to go. Will you join me? And I know this is difficult given the political moment and the nature of that administration, but 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 in moving as rapidly as possible in getting a safe vaccine out to the American people? Dr. Collins: (59:33) Senator I'm a scientist. I've had the privilege of serving as the NIH director for 11 years. I can't say strongly enough that the decisions about how this vaccine is going to be evaluated and assessed is going to be based on science. And I know I speak for my colleagues in the government and certainly for the scientific community broadly, that that can be the only basis upon 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 don't know what's going to happen in the coming months. Dr. Collins: (01:00:10) I do have cautious optimism that by the end of 2020, at least one of these vaccines will have emerged and turned out to be safe and effective. But even that is a guess. And certainly to try to predict whether it happens on a particular week, before or after a particular date in early November, is well beyond anything that any scientists right now could tell you and be confident that they know what they're saying. So yes, science and science alone will be the way in which this decision is made. Otherwise, I'll have no part of it. Dr. Adams: (01:00:39) Senator, I know that some people still do care about what the Surgeon General has to say so I, [inaudible 01:00:44] Dr. Collins: (01:00:47) Jerome, I care what you have to say, please go. Dr. Adams: (01:00:49) I want the American people to hear me say this. There will be no shortcuts. This vaccine will be safe. It will be active or it won't get moved along. And when a vaccine is either approved or authorized by the FDA, I and my family will be in line to get it. Sen. Sanders: (01:01:07) Well, thank you gentlemen. I think that's the kind of answer that the American people are looking toward hearing. Thank you very much. Senator Alexander: (01:01:14) Thank you, Senator Sanders. Senator Burr. Senator Burr: (01:01:19) Thank you Mr. Chairman. To both our witnesses today, thank you for the long hours that you've devoted in this infection to try to come up with solutions for the American people and for the healthcare of the world really. Admiral, I may have a question for you if I've got time, but I think this is a good inflection point to talk about how we got to where we are. And I think Dr. Collins you know really well that we've spent two decades changing statute to allow some of the processes that we've seen and acted for COVID that aren't the first time. We created BARDA so that we had an agency that looked at novel- Senator Burr: (01:02:03) ... an agency that looked at novel threats. They were the first ones to look at how we stack some of the processes, the trials, how we process the data. That we don't wait until the end of the session dump, that we process it in real time. And what we've seen is we've seen Congress, this legislative body, every so many years change that legislative statute to allow emergency youth authorizations, not just from a president, from a secretary of HHS, down to the FDA itself. Senator Burr: (01:02:41) And Dr. Hahn has been unbelievable at how he used the emergency use authorizations in consultation with NIH, HHS, CDC to provide new testing out there in real time, which is what the American people wanted and needed. We haven't harmed anybody. In some cases, we found that the data didn't support the test that was out there, and they've been yanked from the marketplace. Senator Burr: (01:03:05) Vaccine production historically has taken, as you said, tens of years to actually happen, and now we're trying to do it in one. And what is important for the American people to understand is we haven't rewritten the protocols. We haven't said to FDA, "Operate outside of the powers that we've given you in statute," nor NIH, nor HHS, or CDC. But we've said, "We've given you these new authorities, use them." Senator Burr: (01:03:34) And for the first time, I think in development of drugs, vaccines, biologics, we've actually seen clinical trials that are stacked. If at any point the data doesn't support at the end of the day, they're stopped. As we saw with the AstraZeneca Oxford trial. Now, in your testimony, Dr. Collins, you talked about NIH's efforts to partner with the private sector to develop so-called adaptive master protocols for clinical trials. Are we doing something novel here or are we doing it exactly the same way we've always done it? Dr. Collins: (01:04:11) We're doing something very novel. And I appreciate your raising all of the background here about how we got here. And Senator, your role in getting BARDA to where it is right now has just been critical for where we are with Operation Warp Speed, and having that capability of moving quickly and doing things in a very business friendly way to try to get the tools that we need in place. Dr. Collins: (01:04:32) But another thing that I had the privilege of helping make happen back in late March and April, was to go to all the pharmaceutical companies that we knew had things they could offer here, both in therapeutics and in vaccines and saying, "Instead of all, going off in our own directions, let's see if we can do something together." And out of that came, this partnership called ACTIV, which stands for accelerating COVID-19 therapeutic interventions and vaccines. Dr. Collins: (01:04:54) That group rolled up their sleeves, 24/7, 100 people, mostly high ranking scientists in both public and private sector, designed these master protocols. To be able to launch clinical trials without the long process that it often takes to decide about the nitty gritty of protocol details. And out of that have come a whole series of trials on monoclonal antibodies, on anticoagulants, on immunomodulators. And all of that, I think, has gotten us much further than we would have been. If we hadn't decided, "Let's do it differently this time, let's really get everybody around the same table [crosstalk 00:01:05:29]- Senator Burr: (01:05:31) All driven by the scientific community Dr. Collins: (01:05:31) Absolutely. From both sectors. Senator Burr: (01:05:33) But you had the latitude and statute to do that. Dr. Collins: (01:05:35) We did, and it helped a lot that nobody was feeling like, "Oh my gosh, we've got to do six months of legal consultation," because we already had the framework to see how we could do that. Senator Burr: (01:05:43) I think the takeaway from today is we actually see the US government functioning. We see the process of development, partnership with the private sector in coordination with the government actually working. We haven't changed the rules. We haven't changed the protocols. We've exercised the latitude that was there in statute for an incident just like this. Senator Burr: (01:06:08) Admiral, I'll ask you one question as I end. With the quarantine of, especially our younger population over the past seven months, we've got a lot of infants to one year olds that have not been exposed to the normal things that they would be exposed to had they not been quarantined. As our public health entity doctor, what concerns do you have about the normal exposure that they haven't had and how that's going to affect us? Especially as we determine, do they need to go to get a COVID test? Or is this a normal thing that they're just running into? Dr. Adams: (01:06:50) Well, I'm incredibly concerned about, again, the fact that over four million, almost five million children are behind on their vaccinations because of the COVID-19 pandemic; the regular childhood vaccinations. I'm concerned about the levels of herd immunity amongst the populace, because adults and children now haven't gotten their vaccinations that they normally would have. And that lowers the levels of herd immunity. Dr. Adams: (01:07:14) For measles, for instance, we know you need 90 to 93% of people in a community to be vaccinated in order to have herd immunity and prevent an outbreak like we saw in New York. And so it is critically important to protect our youngest, and our most vulnerable that everyone who can catch up on their vaccinations, gets caught up on their vaccinations. We're focused on a- Speaker 1: (01:07:33) Admiral, we need to move on to the next- Dr. Adams: (01:07:35) Yes. Senator Burr: (01:07:35) Thank you. Dr. Adams: (01:07:36) Thank you. Senator Burr: (01:07:36) Thank you, Mr. Chairman. Speaker 1: (01:07:37) Thank you, Senator Burr. Senator Casey. Senator Casey : (01:07:42) Mr. Chairman, thank you very much for the hearing. I want to thank you and Senator Murray for having this hearing as we start this new work period, and I want to thank Dr. Collins, and Dr. Adams for their appearance. As well as their testimony and their public service. While it's encouraging, as I think all Americans are encouraged by the pace of the work that's being done to develop vaccine candidates. We still have a lot of questions. So many Americans have questions about how the vaccine will be both manufactured and distributed. Senator Casey : (01:08:15) Many Americans also have real concerns, grave concerns, about how the Trump administration appears to be interfering with the FDA's review process for political gain, as some see it. Also, Americans trust in public health, and in public health expertise has been undermined by a history of institutional racism, and injustice in our healthcare system. As well as by misinformed anti-vaccination campaigns. Senator Casey : (01:08:47) It is imperative, and I think this bears repeating, imperative than any COVID-19 vaccine authorized or approved by the FDA, and recommended for widespread dissemination, be both safe and effective, of course, as evidenced by reliable data from randomized controlled clinical trials. It's also imperative the President, the Vice President, the White House COVID-19 task force, must A, tell the truth all the time, not play political games, and lead by example. Senator Casey : (01:09:25) And though I understand as many of us do that, there will be recommendations from public health experts on who should receive the vaccine first and what we should do, and all of us should follow those recommendations. I also believe that the American people should see that any COVID-19 vaccine is safe and effective, and essential, for ending the pandemic. So Americans have to see it. They have to see others taking the vaccine. Senator Casey : (01:09:54) So I ask both of you, starting with Dr. Adams, will you commit to receiving the COVID-19 vaccine in public view once a vaccine becomes available, and is authorized or approved by the FDA? Yes or no. Dr. Adams: (01:10:12) Absolutely. Senator Casey : (01:10:14) Thank you. And dr. Collins? Dr. Collins: (01:10:16) I'm ready to roll up my sleeve as soon as they say it's safe and effective. Senator Casey : (01:10:20) Thank you. I think it's important. We practice what we preach. That means all of us in public office, in appointed office as well, because it's important for the American people to see this. Senator Casey : (01:10:33) I wanted to move to a question, a more focused question, on immunization information systems for Dr. Adams. And this is a question I had hoped to ask Dr. Redfield. I know as Senator Alexander mentioned, Chairman Alexander, that he's going to be testifying in two weeks, but I had hoped he would be here today. But given that most of the vaccine candidates being tested will require not just one but two doses, it's absolutely essential to track which vaccines people are getting. Senator Casey : (01:11:05) We have to understand who received a dose and ensure that each person receives the correct number of doses. Especially initially, where over vaccination or cross vaccination of different vaccine types could further stress the already short supply. We know that the immunization information systems already exist at the state level, and they do exactly this type of tracking. I'm concerned, however, the administration may be planning to not use these existing systems. Senator Casey : (01:11:39) An article in USA Today, on September the sixth cited a CDC document saying, quote, "People getting vaccinated will get a COVID-19 vaccination record card that will tell them which vaccine they got, when they got it, and when they should get their next shot," unquote. My first question for you, Dr. Adams is, has HHS, health and human services, provided any support to the state immunization information systems? And how are you integrating their capabilities into your planning for vaccine distribution? Dr. Adams: (01:12:14) Well, very quickly, we are working with States, with advisory committees, and with professional organizations to figure out the distribution of what will likely be the most logistically difficult vaccine that we've ever deployed. We recognize that there are infrastructures in place at the state level, through the Vaccines for Children's Program. And we're going to lean on that existing infrastructure. And so what I can promise you, is we're going to work with all the appropriate partners and we're not going to try to reinvent the wheel when we don't have to. Senator Casey : (01:12:43) I'll have some followup questions, but I'm out of time. Thank you very much. Speaker 1: (01:12:48) Thank you very much, Senator Casey for sticking to the time. I appreciate that, and so do your colleagues. Senator Paul. Senator Alexander: (01:12:58) No one disputes, the medical miracle of vaccines. In fact, we've discussed some of Edward [inaudible 01:13:04] contributions, but even 70 years prior to that, we were doing inoculation, and maybe even a couple of 100 years prior to that in the Middle East, there were inoculating with from live pustules basically, live virus with maybe some antibiotics in the mix. They did this though because the disease was incredibly deadly, 10%, maybe 20% of the public, 30% of those who got it, but not every disease is the same. And I think that's what annoys me some about the discussion is that we think everything is smallpox, and we say, "Submit or else, and you can't go to school unless you get this." And this is the debate we're going to have is how mandatory, and what are we going to do to people. Senator Alexander: (01:13:42) But there is a difference between smallpox. So you had 10 to 20%, maybe even 30% mortality, for children with COVID from the CDC website, it's 0.68 per million. So we are talking about a different disease here. And while the recommendation on vaccines may be appropriate, I think each individual needs to make their decision. If we're prioritizing it, the death rate for those in their 80s, or those in nursing home is incredibly high, 10 fold, 20 fold, maybe a 100 fold, higher. It's significantly higher. Senator Alexander: (01:14:16) And so that's where the priorities should go. But really, I think each individual, in a free society, should assess the risks of the disease versus the risks of the vaccine. But it's important that we not get so carried away with, "Oh, we have a vaccine, everybody's got to have it. And you, a kid, can't go to school, and we're going to ostracize you if you don't take it." No. Why don't we try through persuasion? I mean, it's worked for the most part, for most of our history. Let's try to persuade people about it. Senator Alexander: (01:14:39) Look, we have vaccines that we've recommended for certain age groups, Pneumovax is mostly recommended for those over 65, or those who have a significant comorbidity. I've had it. I'm 57. I've had all my vaccines. I've been to Central America, I've had all my vaccines, but I'm still for choice. It doesn't mean we just turn our brains off and say, blindly, " Every one must submit or else." I had Pneumovax, I had part of my lung removed. And I thought, well, maybe I'm at some risk for it. And so I took the Pneumovax. But even that it wasn't absolutely recommended. Senator Alexander: (01:15:11) Flu vaccines used to be a more recommended for those who were in risk categories, and those who were older. I think at one time, flu vaccine was recommended over 50. Now, it sounds like it's more extensive, and that's fine. The vaccines are incredibly safe. But at the same time, I think we really, really, really need to think through sort of our fervor here before we start mandating and making people take these tests. And so my question to Dr. Collins is, considering that the death rate for COVID among children is 0.68 per million, are you in favor of a adding a school mandate that you can't go to school unless you get a COVID vaccine? Dr. Collins: (01:15:50) Well, I think it would be premature for me to make a statement about what would be appropriate or not, since we don't even know to what extent the vaccines that are currently being studied are going to be safe and effective in adults. And as we've talked about, we won't know until later how they work for children. Senator Alexander: (01:16:04) Let's say they are safe and effective for children. Are you in favor of mandating that you can't go to school unless you take one? Dr. Collins: (01:16:12) I would have to really understand what the consequences would be. I'm not ready to give an answer to that right now. I do think there is this issue about children getting infected and then infecting others around them that may have an immune system that can't handle it. And that's one of the reasons I think we are so concerned about having children vaccinated, to avoid the kind of a terrible circumstance where a child who's getting chemotherapy for cancer, ends up getting sick and gets much more sick. And .68 is not zero. Senator Alexander: (01:16:38) But that was always true. We have hundreds of thousands of people every year on chemotherapy, and yet we've never sort of decided to mandate to everyone that they get vaccinated to protect those on chemotherapy. What we did traditionally is those on chemotherapy try to protect themselves from others, acknowledging that the common cold can be devastating to someone who's on chemotherapy and with very low immune response. So it's important that we think about that. And we not say that we're going to mandate to everyone because of a certain population. If we have a vaccine that works, by all means, let's try to vaccinate everybody that's willing to voluntarily take it, particularly in the nursing homes; those and the elderly. And we should prioritize that, but we should acknowledge that there is an extraordinary difference in mortality from the CDC website, less than one per million children die from this. Senator Alexander: (01:17:29) So that has to be weighed into the fact of whether or not you're going to mandate. If you're going to tell every kid in America, they can't go to school, and you're not willing to tell me you're not, that's a big deal. The death rate is less than one per million. And if we're going to mandate you can't go to school without that? Senator Alexander: (01:17:43) When you look at contact tracing studies in China, the Netherlands, Bermuda, and England, we find very little transmission. I just talked to a gentleman who runs a school called... Can't remember the name of the school in North Carolina. They have 6,000 students and teachers. They've been open for eight weeks, they have zero cases. Lots of schools have been open. It's a question we need to answer and we need to discuss, and not have it all be about fear or fear of fear. Senator Alexander: (01:18:09) The truth of the matter is kids don't get it as often. Don't transmit it as often, and rarely die from it. And so we need to tell the truth about the statistics and not over blow this statistics into telling people something that's not true. But that's also other decision-making ought to be decentralized where people in Washington don't get to tell everybody what to do. Every individual, every thinking individual in a free society gets to make those choices. Thank you. Speaker 1: (01:18:33) Thank you, Senator Paul. Senator Baldwin. Senator Baldwin: (01:18:45) All right. Thank you, Mr. Chairman. This first question is for Dr. Collins. And I'm going to ask a bit about the importance of having diversity in the clinical trials that are taking place for a vaccine. And I'm going to note this context; last month, the University of Wisconsin announced that it had been selected as one of the first sites in the country to participate in phase three clinical trials for AstraZeneca's COVID-19 vaccine candidate. Senator Baldwin: (01:19:25) And before I get into the importance of recruiting a diverse population, I want to just note the news that you've commented on already, that AstraZeneca is pausing their phase three to investigate whether an unexpected medical event in one of their eligible candidates was related to the vaccine. Senator Baldwin: (01:19:59) Before I ask you about the importance of diversity, I just want to note that we've already enrolled in Wisconsin, many participants in this phase three trial. What should you and others overlooking Project Warp Speed, be telling these folks who are already about to, or already participating in this phase three trial? I imagine some of them are very concerned. Dr. Collins: (01:20:35) Yes, I agree. They probably are. And again, this is very fresh information. But again, the company who has connections now and knows exactly who the individuals are, who've already been enrolled are in the best position to basically let them know why there is currently a clinical hold. Dr. Collins: (01:20:52) Again, this is based upon a single severe adverse event, which may or may not have anything to do with the vaccine, but it is the best sort of cautious approach to quickly stop and look and see if there's any other evidence to be concerned about. I assume, and I can certainly check and see if this is the case that not much time should go by until all the people involved in the trial get a direct communication from the company and the sites where they were enrolled, about the fact that it is on hold and this is why, and that more information will be forthcoming. Senator Baldwin: (01:21:23) Great. I appreciate that. And I'm sure I'll get some constituent feedback on that very issue. The University of Wisconsin has announced that it will focus in on ensuring that a diverse population takes part in the trial. And they've developed resources in both Spanish and Hmong to help address language barriers. And they're going to have a qualified medical interpreters available to speak with potential participants in 240 different languages. Senator Baldwin: (01:21:56) Researchers are also working to enroll a diverse patient population across gender, age, race, and ethnicity. I'd like for you, Dr. Collins, to describe how a lack of diversity in clinical trials undermines our efforts to develop safe, effective, and accessible vaccines? And given the disproportionate impact that COVID-19 has had on communities of color, what should a clinical trial sites take into consideration as they work to recruit participants? Dr. Collins: (01:22:34) Well, thanks for the question. Because this is something that I'm passionate about and where I think we have to work especially hard to try to achieve that kind of diversity in the participants in these trials. As you have said, particular groups have been hit hard by COVID-19; African Americans, Latinos, Native Americans. And we particularly therefore want to know, does the vaccine provide benefits to those groups? Dr. Collins: (01:22:59) Because they may be the ones who will benefit the most, if we can develop one that's safe and effective. But it's, without a doubt that there's also concerns in many of those communities about whether this is something they should trust to be in their best interest. There's skepticism, there's distrust. We are at a time of considerable social upheaval, which means that the recruiting efforts have to be done with particular intention to try to do the community outreach and engagement that might just not happen. Dr. Collins: (01:23:26) And I appreciate what you've said is going on in Wisconsin. And my hat is off the way in which you describe the kinds of outreach you're doing to communities, including those who speak other languages. We are trying to do that same sort of thing across other vaccine trials. The NIH has a long history of in doing this kind of community engagement for other things like HIV, for instance. We're tapping into that. Dr. Collins: (01:23:48) Just a couple of days ago, you might now see public service announcements in the areas where vaccine trials are happening, that are particularly reaching out to African Americans to explain why this might be something to look at and think about seriously getting engaged in. And we know that that is a steep hill to climb, but we're trying to climb it. If we don't succeed in having diversity and the participants in these trials, I think that takes scientifically away from the value of what we're trying to learn. Dr. Collins: (01:24:15) And it certainly makes people wonder, was this really something that I could say is about me and my community? If we weren't involved in the trial, why should we then think about getting engaged when you say you've succeeded? This has to be one of those things that we do all together. Senator Baldwin: (01:24:28) Thank you. Speaker 1: (01:24:31) Thank you, Senator Baldwin. Senator Collins. Senator Collins: (01:24:40) Thank you, Mr. Chairman. Dr. Adams, in my state, the three groups of people who have been disproportionately affected by COVID-19 have been frontline healthcare workers, black residents of my state, and nursing home residents. Who is going to make the decision on the allocation of the vaccine once it becomes available? Who will decide who gets the vaccine first? Dr. Adams: (01:25:20) And thank you for that question, Senator, and you hit on some of the key points; health care workers, nursing home workers, and people of color disproportionately hit by this virus. Important for people to know that we aren't just making this decision in a room. We're working with the National Academy of Science, Engineering, and Medicine, with again, professional organizations and other advisory groups to come up with an answer to this incredibly difficult question about who gets the vaccine first? Dr. Adams: (01:25:46) I can tell you some principles that we agree on. There are no final recommendations yet, but principles are that healthcare workers and frontline workers should be first in line because we know they're most likely to be exposed and most likely to spread. Behind them, it's looking at who is most vulnerable and using a scientifically driven and data driven process, to determine who is most vulnerable and where that vaccine will have the biggest impact. So what the American people need to know is we're thinking about this now. We're working with an array of partners to make sure it makes sense, and it is ethically appropriate to distribute vaccines in a way that we ultimately will have the largest impact. Senator Collins: (01:26:24) Thank you. Dr. Collins, a major healthcare system in the state of Maine has contacted me to express concern about the equipment that they may need to store the vaccine safely. They have already bought additional refrigeration units in order to store the flu vaccine. And they are stocking up on that. Senator Collins: (01:26:54) But at least some of the vaccine presentations that are under study would require a subzero refrigeration, that's expensive. Particularly for rural hospitals in a state like Maine, that are already struggling financially. If we're going to ensure that there is access to the groups that I mentioned with Dr. Adams, how can we ensure that we're not creating inequities and uneven access, unless we're helping with the purchase of those very expensive refrigeration units? Dr. Collins: (01:27:43) That's a great question, Senator. And I think there's an intense effort underway right now to figure out how best to address this. And certainly the surgeon general and I have been engaged in some of those discussions. This is an Operation Warp Speed component that is being done in a way that's never really been done before. To try to imagine how to do the distribution, when we aren't even quite sure yet, which vaccines are going to end up being the ones to distribute. Dr. Collins: (01:28:06) You're right, that one of the vaccines, the one that's being produced by Pfizer, requires storage at minus 70 degrees Celsius, which is, I think minus 94 Fahrenheit or some really low number. And that is a challenge for a lot of refrigeration situations. But I'd think Warp Speed is totally in the space here of trying to figure out with CDC, how to make sure that that doesn't become a deterrent to distribution. If that turns out to be the vaccine that Maine needs, then we want to be sure that's the vaccine that Maine can get. Dr. Collins: (01:28:36) And that includes in rural areas, not just in the big cities. So intense attention, I will have to say I've been very impressed with General Perna who is leading this part of the effort for Operation Warp Speed. Is a guy who knows how to do supply chain. And that's what we're going to be all about here. And that's being intensively pursued. Senator Collins: (01:28:56) Thank you both. Speaker 1: (01:29:03) Thank you, Senator Collins. The voting has begun and I'll go vote in a few minutes. Senator Burr will preside while I'm gone. Senator Warren. Senator Warren you're- Senator Warren: (01:29:47) Oh, thank you. Can you hear me, Mr. Chairman? Speaker 1: (01:29:50) Can now. Welcome. Senator Warren: (01:29:51) Okay, good. I couldn't hear you either. Thanks very much. So the coronavirus pandemic has claimed the lives of roughly 190,000 people. Our best hope to stop these deaths is a safe, effective COVID-19 vaccine. So Dr. Adams, let me start with you. Estimates vary, but some epidemiologists believe that at least 70% of the population will need to be immune to COVID-19 ideally through taking a vaccine, in order to provide herd immunity necessary to end this pandemic. Is that correct? Dr. Adams: (01:30:28) Yes, ma'am. The estimates that I've seen from experts range from 60% to 90%, but we certainly need to get over half of the population vaccinated so that we can achieve herd immunity and stop the transmission of this virus. Senator Warren: (01:30:43) Okay. So as I hear it, kind of our minimum target would be about 70% give or take. So the question is, can we do that? Now, the last flu season for which we have complete data, less than half of US adults, only about 45% got the flu vaccine. Currently a CBS news poll shows that only 21% of people surveying would take a coronavirus vaccine as soon as it became available. Senator Warren: (01:31:14) Convincing enough Americans to take a COVID-19 vaccine is a big job. So let's talk about what makes it harder and what makes it easier. People are more likely to be vaccinated if they trust that federal officials are basing a vaccine decision on science and on data, and not on politics or self-interest, or conspiracy theories. Unfortunately, President Trump has undermined this trust. He has overruled scientists and pressured the FDA into approving products based on weak evidence. Senator Warren: (01:31:48) He has spread dangerous misinformation about COVID-19, a practice that other Republicans have parroted. And he has appointed a former drug industry executive with financial ties to the vaccine makers to run the government's vaccine efforts. And now in recent days, he's hindered that he will deliver a vaccine quote, "Before the end of October," closed quote. A claim that public health experts fear is driven not by scientific evidence, but to boost his chances of winning the election in November. Senator Warren: (01:32:21) It has gotten so out of hand that companies making COVID-19 vaccines, put out a public statement promising to adhere, to quote, "High ethical standards and sound scientific principles when seeking vaccine approval." So, Dr. Collins, I know that you and the scientists at NIH, and the researchers across the federal government, are working night and day to produce a safe, effective vaccine for the American people. And we are deeply grateful for that. Senator Warren: (01:32:52) But Dr. Collins, let me ask, do the President's actions encourage public trust in vaccines and increase the number of people likely to get the vaccine? Or, do they- Senator Warren: (01:33:03) What's the number of people likely to get the vaccine or do they discourage Americans from getting vaccinated for COVID-19? Dr. Collins: (01:33:09) I'm not sure I know the answer to that question. I'm more focused on what we can do in the scientific community to try to explain how it is that these decisions get made and certainly working with the surgeon general, trying to be sure that that message is out there. Senator, I am hopeful that those scary numbers and you just quoted 121% people now saying they would accept this vaccine, that that's based upon not really knowing what the facts are going to be. Dr. Collins: (01:33:35) We're going to have to work really hard though in the coming weeks and months to get the facts out there about how the decisions are going to get made and how once we have, and I hope we will by the end of 2020, at least one safe and effective vaccine, what is the evidence that anybody would want to look at and making their own decision. Discounting whatever political words they heard, whatever conspiracy theories popped up in their Facebook feed and actually saying, "Okay, let's see what the doctors say." And I hope if we can enlist trusted voices out there in the community, not just people in the government like me, but people who are out there, the physicians in the community, other community leaders who also get informed about this and share that information that America, which always after a while, figures out how to do the right thing, will do it again and we'll take it back. Senator Warren: (01:34:22) Well, Dr. Collins, with all due respect, I really appreciate that you are doing everything you can and the scientists will continue to do that, and lots of people will. But the question I asked you is about what the president is doing here and whether what he's doing is helpful or not. Just in the past few weeks alone, the president has accused FDA officials of being deep state operatives. He's tweeted conspiracy theories about COVID-19 deaths, and he has implicitly tied vaccine development to his reelection campaign. If Americans who are watching all of this hesitate to take the vaccine because of what he has done, does that help us get to the levels we need to be able to create herd immunity? Dr. Collins: (01:35:09) I just hope Americans will choose to take the information they need from scientists and physicians and not from politicians. Senator Warren: (01:35:17) Well, I hope you are right. The American people deserve a safe, effective coronavirus vaccine, but Congress is lying to itself and to the public if it pretends that the president cares about anything other than his own political survival when it comes to vaccine development. It is time to kick profits and politics out of the vaccine effort and let the scientists do their work. Thank you Mr. Chairman. Senator Burr: (01:35:46) Senator Warren, your time has expired. Is Senator Cassidy on? I believe he is. Senator Casey : (01:35:48) Yeah, Senator Cassidy is on. Can you hear me? Senator Burr: (01:35:50) I can. Senator Casey : (01:35:51) Great. Thank you, gentlemen. If I occasionally ask you to make your answer shorter, it's not out of rudeness, it's just I have so much to ask. To Dr. Adams, Dr. Adams, there's at least one survey granted a little bit selected out of New York City suggesting the 20% of Americans, at least New Yorkers, had already been exposed. Now we can argue whether or not they have antibodies that are protective, but since the whole point of immunization is to mimic natural infection, I think it's best to assume that they most likely are and the case of people being reinfected after initial infection occur, but they occur about as rare as hen's teeth. So it does seem as if we're going to presume vaccines worked, we've presume that natural infection works. Senator Casey : (01:36:42) Has there been any thoughts as to how to figure out who has already been exposed thereby and protected naturally, and don't need the vaccine or at least lower priority, as opposed to no, let's just vaccinate everybody? I say this because this high ranking official of one of the companies producing a vaccine called to say that would be very helpful. He knew I was concerned about that and he said if we do have a shortage of vaccine and problems in delivering, knowing the 10 to 20 to 30% of who've already been exposed in certain areas would winnow down those who need to be vaccinated. What is your reply to all that? Dr. Adams: (01:37:24) Great question, and I'll be brief. We have antigen testing, we have PCR testing, and then we have antibody testing. And antibody testing is how we figure out who has been exposed to the virus. And that's one of the questions that's come up in conversations about who gets vaccinated first. If you were someone who has been proven to have had the coronavirus in the past by antibody testing or by a diagnosis, then 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 vaccines for everyone. But also important to remember this virus has fooled us many times and we still don't know what we don't know in terms of how long immunity will last for someone. Senator Casey : (01:38:04) I get that. If I may, but of course, it's rare that a vaccine is more effective than actual infection in terms of inducing longterm immunity. And so even if it's for the next three to four months, that would relieve the pressure. Let me return to what Senator Casey asked because it's related. Senator Casey asked regarding, "Are we going to continue to use our immunization registries to document who has been vaccinated?" Reply was "Not to reinvent the wheel." But on the other hand, if you're going to know, wait, this person has been previously diagnosed, previously infected and or has been documented to have antibody, how are we going to store that information and integrate it with the delivery of immunization, to those who are frontline. Dr. Adams: (01:38:47) And very quickly we work with ASTHO The Association of State and Territorial Health Officers, and NACCHO, the National Association of City and County Health Officers, these institutions that already have these systems in place, and these discussions that are occurring right now in anticipation of a vaccine. Senator Casey : (01:39:01) So let me ask you this, because I spoke to, I'm sorry, I had some indirect conversations with CDC. It's my understanding that for state immunization registries to be able to address this, they would have to get an appropriation from the federal government. They would have to get the vendor who does their software to fix it for them and that vendor, there's only four of them, and there's obviously 60 something states and territories. And so therefore there would be a backlog. Has any effort been made already to adapt these registries, to take the information as regards COVID vaccination and or preexisting COVID immunity? Dr. Adams: (01:39:41) To be brief, I will say that we will have CDC follow up with you. But the answer is yes, these conversations that are occurring right now. And the other answer that I have to say as surgeon general is that public health has been long underfunded, including surveillance and registries. And so we'd be happy to work with you to figure out how to- Senator Casey : (01:39:56) Has it moved beyond the conversations, do the actual implementation. For example, have RFPs been let in order for these immunization registries to be upgraded, or is it still in the conversation stage? Dr. Adams: (01:40:09) I'm sorry, I didn't hear the question. Can you repeat that? Senator Casey : (01:40:12) Is it still in the conversation stage or have contracts actually been let to upgrade the immunization registries or whatever system we use to document who is immune? Dr. Adams: (01:40:22) Dr. Redfield will be here in two weeks, but I will make sure we follow up with you and get you an answer to that question, sir. Senator Casey : (01:40:27) Sounds great. Dr. Collins, there's been some question as to whether or not monoclonal antibodies will work to prevent infection. Obviously, there's several ways that you could give monoclonal antibody, but one would be to give it to those who are vulnerable. Now, a monoclonal antibody is merely again, a mimicry of a vaccine. Has any thought been there to give monoclonal antibody to say a obese diabetic in order to prevent her from being infected initially? Dr. Collins: (01:40:59) Yes, there has. Monoclonals might be useful therapeutically for people already sick, but they might also be useful as prevention. And you say, yes, this is like a passive vaccine. And we do have trials already ongoing for monoclonal antibodies and for people in nursing homes and also for people in families where there've been lots of other infections to try to prevent them from getting sick. We don't know yet exactly how that's going to work in a preventative mode, but that is something we really want to know. It's a great question. Senator Casey : (01:41:25) Last question to AstraZeneca. Did they have Guillain-Barre? Because you suggested in your testimony, they may have had Guillain-Barre. Dr. Collins: (01:41:33) Sorry, I didn't hear your question, again. Senator Casey : (01:41:37) You suggested that the fellow who had the adverse event in the AstraZeneca may have had Guillain-Barre. Is that the case? Dr. Collins: (01:41:46) The word that we've had, and this was put in the New York Times is it's transverse myelitis, which is different than Guillain-Barre. Although sometimes confused for it at first presentation. I don't have any other details than that. Senator Casey : (01:41:58) Gotcha. Thank you very much. I yield back. Senator Burr: (01:42:02) I'm going to recognize Senator Kaine first. But just for the purposes, since there's a vote going on, on the majority side, it will be Senator Murkowski, Scott, Romney, in that order. Senator Kaine, Senator Hassan on the other side of people that I know that are here. Senator Kaine, you're recognized. Senator Alexander: (01:42:17) Thank you, and thank you to the witnesses. This is a great hearing. An observation, and then three topics for questions. Just an observation. We had a hearing in this committee on May 12th, the title was safely getting back to work and back to school. I have been critical of the administration for not setting a national testing goal, a numerical goal that we should be achieving as tests. And I was asking questions during the hearing to Admiral Brett Giroir. And what he said in the hearing was this, by September taking every aspect of development, authorization, manufacturing, and supply chain into consideration, we project that our nation will be capable of performing at least 40 to 50 million tests per month, if needed at that time. Senator Alexander: (01:42:59) And if new technologies are authorized, like whole genome sequencing approaches or any novel solutions uncovered by NIH's new diagnostics initiative, that number will be much higher. 40 to 50 million tests a month is 1.3 to 1.7 million tests a day. That number is not accepted by all. At Harvard, they indicate that they think we need 1.2 million tests a day to mitigate, to kind of bump along, or 4.3 million tests a day to suppress coronavirus. On September 4, we did 902,000 tests. That is about 52% of the high range of what Brett Giroir said we should do by September, or 69% of the low range. So we are still dramatically behind what the administration suggested we should be doing in terms of testing to safely open for schools and our workplace. And I'll have a chance to talk to him about that at the next hearing. Here's what I want to ask about first. Is there any benefit to the United States to not participating in the COVAX project of the World Health Organization, Gavi and CEPI? Dr. Collins: (01:44:17) I will say that the United States is engaged on the global stage in trying to see what can be done about COVID-19 and that's for me personally, a very important priority. We have invested and continue to in Gavi, which is a critical part of how vaccines can get manufactured and distributed. All of our global health experts are deeply engaged in communicating and working with their colleagues in other countries. And I do think you've heard from the administration, a clear sense that if we are able by the end of the next six or nine months, to have hundreds of millions of doses of vaccine, we would want to be sure that those become available now to those countries that need the most and may not have their own resources. Senator Alexander: (01:44:59) Dr. Collins, I recognize that we're engaged at the international level and there's good reasons for it as you state. I understand that you appreciate it. I can see no tangible benefit to the United States not participating in COVAX, just as we're looking at multiple vaccines on the theory that competition is good and then there may emerge the contenders that we want to. It seems like the diversification of portfolio would suggest we have nothing to gain from withdrawing from COVAX. That's my own opinion. I want to ask about a particular element of the leading contenders in the vaccine, which require two doses. I think there is at least one candidate that is a one dose vaccine. But building upon this and maybe get your guys' advice on this one. We know that a significant percentage of people have said they will not get a vaccine and that's for any vaccine, but in particular in this, and we have to educate people about it. Senator Alexander: (01:45:53) We also know that in other vaccines that require two doses, and in this case, the leading contenders would require at least 21 or 28 days between the doses is my understanding. In other vaccines that require two doses, a significant percentage of people, somewhere between 40 and 65% in some studies, who get the first dose will not get the second dose. And then a significant percentage of the people who get the second dose, don't get it in time. They will get it months or many months later, after they are able to get it. What's the effect on a two dose vaccine if you just get the first dose and don't get the second dose? Dr. Collins: (01:46:32) We know a little bit about that, Senator, from the fact that we've run these phase one trials. And again, you can look and see what happens after the first dose, as far as the production of antibodies, which is our best way of assessing whether it worked. I think with all of the two dose trials, it looks as if the first dose does give some response, but not at the level that you would really like to see. And then you give that second dose and you're up in the range of antibodies that people have developed who got actually natural infection from COVID-19. Dr. Collins: (01:47:01) Hence, if you want to be as effective as possible, you go to that second dose. It's not the ideal. I think ideally we'd love to have a single dose that didn't require refrigeration and was easily transported and was totally safe and effective. We may not be lucky enough in this very big push to get something quickly, to have something with the perfect parameters. But most important, I think we get something that works and saves lives. Senator Alexander: (01:47:25) For the record and to our next panel, I'll ask questions about what we will do to try to educate people on the need to get that second dose and get it in a timely fashion. I also have a question about a vaccine testing on pregnant women that I'll say for a question for the record. I appreciate your testimony today. Thanks Mr. Chair. Senator Burr: (01:47:42) Thank you, Senator Kaine. Senator Murkowski. Senator Murkowski: (01:47:45) Thank you, Mr. Chairman, and thank you gentlemen. Not only for your comments this morning, but just your leadership in this. I take particular interest in this discussion about vaccines because Alaska has lagged historically. In terms of our vaccination rate, we have chronically been last, last among the 50 States. It's my understanding that we are in there at about 74.2% compared to all the other 50 states. Other States, you've got some, Massachusetts is the highest at 92. So Alaska has a long way to go. And unfortunately, we've been this way for a while. So when we talk about vaccine hesitancy in Alaska, we know, we get it. And so I'm very concerned about where we are moving forward with this vaccine. I also recognize that we have some of the most vulnerable populations in Alaska with our Alaskan native people. We have limited healthcare facilities. You've had opportunity in this hearing to hear all about it. Senator Murkowski: (01:48:50) So we are exactly the type of state that needs to have that assurance that yes, this vaccine is going to be safe, that this vaccine has not been subject to political initiatives that would speed it up in any such way that would cause it to be less effective. We have every interest to make sure that there is an education campaign that people can believe in. I have been working with several of my colleagues on this committee, Senator Braun, Senator Hassan here, on the SAVE Act, this is the Safe Authorizations for Vaccines during Emergencies. Basically making sure that we are ensuring a level of public independent expert review of the vaccine candidates. I know you may not wish to comment on specific legislation. Dr. Collins, you've already spoken in your initial remarks to the chairman and to the ranking member about the assurance that we must in fact, make sure that this process that we have is true, is honest, and is going to result in a level of trust and credibility. Senator Murkowski: (01:50:15) I would just ask you to help me in 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 here, to build that credibility and trust? Because otherwise, I'm fearful that the rates that we have seen with our vaccinations, generally what we've seen just this year compared to April of last year, we saw a 48% decrease in total vaccines administered in the state. This past May and June, we've seen a slight improvement, but we're in a tough spot right now. Give me some level of assurance please. Dr. Collins. Dr. Collins: (01:51:02) I think we have a tough situation for the whole nation, but I'm sympathetic with your particular circumstances, with the history in Alaska, of hesitancy being even greater. This is going to be a need for all hands on deck, leaders in the Congress, people in the local communities, have to get altogether to figure out how to convey this message. The surgeon general is right in the middle of trying to organize a lot of this effort. So maybe I should ask him to speak as well. Senator Murkowski: (01:51:30) Do we need a public relations campaign that has really amped up? Messengers are important. Who's the right messenger? Is it the surgeon general? Who is it? Because right now it's not working. Dr. Adams: (01:51:42) We know that when it comes to vaccines and most health advice, that people will trust their local provider more than they will trust anyone else out there. So what we're trying to do is arm local providers with the facts. CDC's campaign really has scripts and sheets to help people talk about some of the frequently asked questions, we're engaging with social media influencers. So I was in Kotzebue and they knew about rappers, and the San Francisco 49ers. I remember there was a guy wearing a San Francisco 49ers hat. Lady Gaga, for instance, is someone who I never thought I'd invoke in congressional testimony, but I gave her a shout out because she had masks that she wore at the video music awards last week. And people will listen to Lady Gaga before they'll listen to the surgeon general. So we need to very much engage. Dr. Adams: (01:52:30) The other thing that I would implore you to think about is we need to encourage people to stop attacking the process. There's a lot of politics going on here. People don't like one party or the other, or one person or the other. The process is strong. And Dr. Collins and I have been adamant that we want people to understand, there are protections built in, the process is strong. If we follow the process and people understand the process, they will have confidence. But everyone out there who says, I won't take this vaccine if, or I don't trust this vaccine unless, is instilling further hesitancy and hurting us. Senator Murkowski: (01:53:03) I think that that's important. And that's exactly why the SAVE Act is there, is to focus on the integrity of that process. Thank you, Mr. Chairman. Senator Burr: (01:53:09) Thank you Senator Murkowski. Senator Hassan. Senator Hassan: (01:53:13) Well, thank you Mr. Chair and thanks to the ranking member as well. And to both of our witnesses today, thank you for your service and I'll let go of what other people have said. We know everybody in your shops are working around the clock here, and we are very, very grateful to you and all of them. We've been talking a lot today about public trust in the vaccine approval process, which we all agree is critical to achieving the widespread use of a vaccine. But right now, people are concerned as you've heard Senator Murkowski say, you heard Senator Warren reference, a CBS released this past weekend found that two thirds of Americans would think the process had been rushed if we got a vaccine this year, and only one in five plan to get vaccinated as soon as possible. So let's drill down a little bit on what the process is so we can provide some of this confidence to the American people. Dr. Adams, last week, you told ABC News that you have confidence in the COVID-19 vaccine review process because data safety monitoring boards would not allow a product to move forward unless there is "Good evidence that these vaccines are efficacious." But in addition to ensuring that a vaccine is effective, we also have to ensure that it is safe. So could you please tell us Dr. Adams, what protocols are in place to ensure that these boards do not stop clinical trials until they also collect sufficient safety data, including for high-risk populations and what specific steps have been taken to ensure that these decisions will not be subject to political influence from the White House? Dr. Adams: (01:54:51) I'll be very quick in my answer, because this is more in Dr. Collins lane. But as an example, the FDA generally advises a minimum population size for pre- licensure safety database for preventive vaccines, to exceed 3000 patients. These trials have 30,000 patients in them. This isn't so much about time as it is about events. And we have so many more people, 10-fold involved in these trials, that we have the potential to be able to recognize a safety and an efficacy signal a lot sooner. We also have a higher incidence of background disease prevalence. And that's a bad thing, but it means that in terms of getting a signal, there are valid, scientific reasons to expect that we will both get a safety and an efficacy signal in a very short order. Dr. Collins. Senator Hassan: (01:55:38) Hold on just a second, please. Dr. Collins. Look, I appreciate that. But what people are looking for is administratively, what are we doing? What systems do we have? Because look, if this administration's vaccine review process is as evidence-based and free from political influence as you both are suggesting, why do you believe the leading COVID-19 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: (01:56:09) I can give you at least part of that answer. And that's because Dr. Collins and I have been on the phone with them and really putting forward a full court press to help instill confidence in the vaccine process that we know, as Senator Murkowski just mentioned, has been wavering long before COVID. Senator Hassan: (01:56:24) Okay. And because my time is short, I'm going to move on to another topic. I understand you have something to say too Dr. Collins. But I want to touch again on the SAVE Act that Senator Murkowski was talking about. If we expect the American public, Dr. Adams, to have confidence in these products, we need to ensure that they have full confidence in the review process. In addition to the general meeting they are holding in October, do you believe FDA's vaccines and related biological products advisory committee should hold public meetings, review clinical trial data and release their findings to the public before FDA approves or authorizes any vaccine product as they normally would? Dr. Adams: (01:57:04) I think we need to follow the process because the process works. I think we need to be careful about inserting new barriers in the process, because it is just as unethical to prolong- Senator Hassan: (01:57:14) Excuse me, just because the time is limited. This isn't a new barrier or a new process. This is the existing process, right? Dr. Adams: (01:57:21) I believe we need to follow the existing process. Senator Hassan: (01:57:23) So you support that. Do you believe that the CDC's advisory committee on immunization practices should meet publicly, review data and issue public recommendations for each COVID-19 vaccine that enters the market so healthcare providers across the country are confident giving these vaccines to their patients? Dr. Adams: (01:57:41) Again, I believe we need to follow the process and engage healthcare providers so that everyone has confidence, yes. Senator Alexander: (01:57:45) Okay. Because a vaccine is really only effective if people are willing to use it. So I just want to touch on what the SAVE Act does a little bit. Working with Senator Murkowski and Senator Braun, for instance, we've introduced this as bipartisan legislation that would improve public confidence in the vaccine review 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. So I just want you both to know that's what the SAVE Act is about. We believe these processes are in place. These experts are used to doing this work. They're independent. I'm going to continue to push for this legislation to be included in the next COVID relief package and I look forward to working with you with ideas about other ways we can strengthen the transparency of this process, and really again, help the American people understand what the processes are and why you both are so confident that the scientists will be able to do their work. Senator Burr: (01:58:49) The senator's time's expired. I am going to let Dr. Collins, if you had something to add, I'll give you the time to do it. Senator Alexander: (01:58:56) Thank you. Dr. Collins: (01:58:57) Well, just very quickly. You asked about the statement by the nine CEOs, and I think they were responding out of their concern, which we very much share, surgeon general and I do, and I think all of you do, that there is this strong public distrust and skepticism. And they wanted to come out and say, very clearly, "Hey, we're not trying to pull something here. We don't believe in putting forward anything that's not absolutely safe and effective. We're pledging this in writing." I hope that added a little bit more confidence to the people who are still looking at this and wondering. I was glad to see this statement. Senator Burr: (01:59:30) Thank you, Dr. Collins. Senator Romney. Senator Romney: (01:59:34) Thank you, Mr. Chairman. And I want to thank the members of the panel for your testimony today. I have to thank in particular Dr. Collins for the slides so that the description of the process that's leading towards a vaccine was most informative and colorful. I want to pick up on a line of questioning that that Senator Murkowski described and that's with regards to the growing sentiment, I think across our country, of people who are, if you will, anti-vaxxers, people who are avoiding vaccines. And I have been approached during visits to my state, by people who have whole books that are written describing why vaccines are bad, why they're made from adulterated sources. And I won't go into all the details, but it's not just a social media phenomenon. There are literally books out there that are written to describe why vaccines are bad. And I wonder if it does not make sense for our government to put out a very comprehensive effort to dispel this growing sense of vaccines being bad. Senator Romney: (02:00:52) And I don't know how you do that, but it would come to mind that you're doing that with regards to tobacco and massive advertising on TV. You could have debates, you could call in these people who write these books and have discussions with them, which are publicized. You can have much more aggressive campaign on social media. I guess the question I'm asking is, should we be doing more than we're doing, and what could we be doing to resolve the debate, the uncertainty that so many Americans have about the wisdom of receiving a vaccine? And now I'll ask Dr. Collins and the surgeon general, both if you'll respond to that. Dr. Collins: (02:01:33) Well, I'll start, but the surgeon general will have a lot to say about this. This has been of course, an issue for our country, not just in this season of COVID-19, but before that. And particularly one has seen the consequences of that with measles, for instance, which in the year 2000, we declared that the US had succeeded effectively in getting rid of measles. And now last year we had more than a thousand cases. And 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 looked 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. Dr. Collins: (02:02:23) Imagine that, 42,000 kids dying for preventable conditions because vaccines were not available. Well, they're available now. But if they're not getting used, we're facing that same kind of terrible consequence, and it is heartbreaking. And I must say frustrating, and sometimes even causes you a little bit of anger and frustration that this kind of misinformation is so readily spread by people who have another agenda. And we have a hard, hard road to go to try to counter that when so many people don't see, in their own experience, the reason why this is such a life saving activity, but I'm going on a bit. Surgeon general, please say what we should do about it. Dr. Adams: (02:02:59) No, thank you, Senator. And I'll very quickly walk through. The Department of Health and Human Services is using a three tiered approach to improve vaccine confidence through research and evaluation, collaboration, and partnerships, communication strategies and knowledge dissemination. I put out an op-ed earlier this year with the secretary and with CDC Director Redfield. We're working with platforms like Twitter and Pinterest and Facebook to make sure appropriate and accurate information is displayed prominently when people do a search. CDC developed Vaccinate With Confidence, a strategic framework to strengthen vaccine confidence. We're working with minority medical schools like Morehouse and beyond. But you mentioned vaccine resistance and the anti-vax community. It's important to understand that 90 plus percent of parents out there are actually doing the right thing. And that when you look at the 10% who aren't, most of those 10% aren't in that anti-vaxxer, I say vaccine resistant category, they're in the vaccine hesitant category. And that's who we need to really work on. And we need to work on educating them and engaging- Dr. Adams: (02:04:03) ... that's what we need to really work on. And we need to work on educating them and engaging them and being compassionate with them and patient with them to answer their questions. And I went out to Washington when they had the measles outbreak last year, and I found that when they had after hours conversations with parents, they'd come back two, three, sometimes four times. But most of those parents when they got their- Senator Romney: (02:04:21) Thank you. Thank you general. I'll just make one more comment and that's for Dr. Collins and that's with regards to the Russian announcement of a vaccine. Clearly very little data, but are we evaluating the promise of vaccine efforts in other countries? And do they have much prospect for being a value to us? Dr. Collins: (02:04:44) We certainly are to the extent that the information is being made available, and obviously what you like to see is a publication that's been peer reviewed. And some of that is starting to come now from the vaccines that are being developed in China and Russia. I must say the way in which the Russians rolled this out declaring victory before they had gone much beyond a phase one trial, did not win them a lot of confidence in the scientific community. Dr. Collins: (02:05:07) And so we really have to be insistent that if 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 as well. So yes, we're watching, but some might have said that the effort that Russia had put forward was putting a lot of people at risk, asking them to take a vaccine that hadn't gone through that, some even called that Russian roulette. Senator Alexander: (02:05:31) Senator Romney, your time has expired. Thank you. Senator Romney: (02:05:33) Thank you. Senator Alexander: (02:05:35) Senator Smith. Senator Smith: (02:05:38) Great. Thank you so much, everyone. I want to first thank Dr. Collins and Dr. Adams for your service to our country and for everything that you were doing. I know that everybody on this committee is dedicated and optimistic even about the goal of having a safe and effective vaccine that can be distributed at scale and also can be free for everyone. Senator Smith: (02:05:58) And so I want to just touch on that for a minute. Last month I introduced my COVID-19 Treatment Act, which would ensure that folks that get their health insurance through Medicaid or CHIP or people who don't have health insurance at all, would be able to get a free COVID-19 vaccine. This builds on actions that we've already taken in Congress to make sure that folks that have private insurance or receive their insurance through Medicare, have a free vaccine. Senator Smith: (02:06:27) Dr. Collins, I want to drill in on this a little bit with you and just understand a little bit about how we can make sure that this happens and that folks aren't stuck with out of pocket costs that they're not expecting if they get their insurance through Medicaid or CHIP or if they're not insured at all. So first, can you just confirm that the federal government will buy this vaccine and also the supplies that are needed to administer the vaccine and make that available to providers at no cost? Dr. Collins: (02:06:55) Yes I can confirm that. And as part of Operation Warp Speed, as these various vaccines are chosen to be put forward and their deals are negotiated that allows the government to buy and own tens, or in some cases, hundreds of millions of doses that then can be provided for free to providers. And along with that, of course, all of the other materials you need, like syringes and vials and a PPE is part of the package. Dr. Collins: (02:07:20) The only thing that then needs to be dealt with is any kind of charge that the provider might give for administering the dose. And I know the administration is committed to making sure that that does not become a barrier to anybody, and you can get this completely for free if that's what you need to do. Senator Smith: (02:07:35) Great. That's perfect. That was my second question that there aren't hidden charges administrative costs, that that would also be reimbursed by the federal government so that folks don't get stuck with something they're not anticipating, which is of course, particularly a barrier, if you don't have any insurance at all, or if you have a Medicaid. Dr. Collins: (02:07:53) I think the administration has made it clear that no one should be denied this vaccine. It needs to be completely free. Senator Smith: (02:08:03) Let's say that we found out that we needed a booster, some sort of a booster shot, not like a two round vaccine, but you need to get a booster like we do for other infectious diseases over time. Would or should the federal government also cover the cost of those boosters at no cost to folks? Dr. Collins: (02:08:19) I don't know that I've heard that conversation going on yet because we really don't have the data to know whether such boosters will be needed. And if so, how frequently would the booster have to be provided? We're all hopeful, of course, that this vaccine will produce long-lasting immunity, but that's not always going to be the case. I think that's a downstream discussion, at least it is for me. Dr. Adams: (02:08:40) And we're talking about COVID, but I think it's important that we just operate under the underlying belief that all vaccines should be provided at minimal cost to people because they save live and they're cost effective. They're cost saving. Senator Smith: (02:08:54) Well, and Dr. Adams, the point here of course too, is that this is really a matter of public health, but it's also a matter of equity because we know that black and brown and indigenous people, people of color are more likely to be uninsured and are more likely to be facing a struggle. I think it's just extremely important. Senator Smith: (02:09:18) So I'm going to ask all of my colleagues on this committee, I would be so grateful if you would join me on this bill. I think it makes a very important statement and also makes a very important step towards ensuring that this vaccine, when it is available, and we all are optimistic about that, and eager to make sure that it is safe and effective, that that vaccine is available to everyone for free of charge. Senator Smith: (02:09:42) I think I just have a couple more questions. Dr. Collins, I want to just ask you one question. I think people are so concerned about this and how this process, which we have to trust and can be trusted. Can you just explain to us a little bit about what would be the end point for when we know that this vaccine trial should be completed and be done? What is the end point? Dr. Collins: (02:10:10) So let me quickly explain how that works. Let's say we have 30,000 people involved in a trial, which is the number we're aiming for, for all of these trials. Half of them received the vaccine. Half of them received an injection of a placebo. Nobody knows whether they got the vaccine or the placebo, but then you track those individuals and you look to see who in fact gets infected with SARS-CoV-2. Dr. Collins: (02:10:33) What you're looking for of course, is a circumstance where those who got the vaccine have significantly fewer cases than the well-matched folks who got the placebo. That tells you the vaccine is working. As it turns out, by the time you've seen 150 cases of SARS-CoV-2 in this group of 30,000 people, if your vaccine is at least 50% effective, you're going to know it because you're going to see a big skewing in terms of who got the disease and who did not. Dr. Collins: (02:11:00) And that's basically why we say this is an event based decision process for deciding about efficacy. You count those events and you know whether it worked or not. And if the DSMB, which is the part of this enterprise that's looking at this, sees that, then they raise their hand, assuming they've also looked at safety and found it acceptable and said, "Okay, FDA, it's time to have a look." That's how it works. Senator Smith: (02:11:25) Thank you. I know I'm out of time Mr. Chair. Thank you very much. Senator Alexander: (02:11:27) Thank you, Senator Smith. Senator Loeffler. Is Jones here? Senator Jones. Senator Jones: (02:11:50) Thank you, Mr. Chairman, and thank you both to our witnesses today for your service and for being here. I want to go at this a little bit. I want to get some specifics on some of these crazy theories out there. We talk about them and we see this. And I appreciate Dr. Adams saying that 10% of parents out there, only 10% are not doing the right thing by getting vaccinations. Senator Jones: (02:12:10) But all of this has been with smallpox and measles and other things, which we've grown up in a different era. Now we're an age of social media and we see Facebook, we see Twitter, we see the internet full of all of these conspiracy theories. I'd like to get both of you an opportunity right now, because one of the things I'm not seeing from NIH or from the federal government is efforts to really debunk these theories, as opposed to just getting positive information out there. Senator Jones: (02:12:36) So Dr. Collins, Dr. Adams, each take one or two of these theories, tell us what you've heard. What's the most outrageous thing and debunk it for us as quickly as you can so that the American people right here on the record know that they should not follow these absolutely crazy theories that are out there about vaccines. Dr. Adams: (02:12:56) I'll take the first one. Vaccines do not cause autism and people need to understand that. We've looked at the trials. We've looked at the studies. Vaccines do not cause autism. Dr. Collins: (02:13:07) And I'm agreeing with that one, but I'll tell you the craziest one I've heard, which is this is all designed by Bill Gates. And when you get the vaccine, it has a chip in it. That's going to get stuck into your system and it's going to watch everything you're doing. And people believe that stuff. Senator Jones: (02:13:23) So none of the vaccines are designed to kind of be big brother over people and to follow them. They're designed, I take it, to save lives, correct? Dr. Collins: (02:13:32) That's exactly right. Dr. Adams: (02:13:34) Exactly. To save life and to save money too. Vaccinations avert 402 billion in direct costs, and 1.5 trillion in societal cost. And that's just the flu vaccine, every single year. Dr. Collins: (02:13:46) I have a T-shirt I like to wear sometimes, although it isn't always well received and it has three words on it. It says, vaccines cause adults. Senator Jones: (02:13:57) Very good. I would though encourage both of you with your respective positions to do a little more in terms of actually debunking the theories. I appreciate all that you're doing to get accurate information out there. I've been doing a lot of Facebook live every week with a healthcare professional to try to get accurate information out there, but still debunking the theories is also important. So I would encourage you to kind of do that on your websites and do that in information, not just trying to get the accurate, but to debunk some of this garbage that we're hearing out there. Senator Jones: (02:14:31) Dr. Adams, I want to follow up with you a moment, because I really do think you're in a unique position about encouraging minority participation in some of these clinical trials. We know that minority participation in these clinical trials is down. And on the flip side, that minority populations are being disproportionately affected by COVID-19. And unfortunately the United States has somewhat of assorted history when it comes to minorities and clinical trials. So what can you do? What would be your voice to encourage more minority participation? And how can we in Congress help get that voice out there because I believe it's so important to get a safe and effective vaccine for everyone? Dr. Adams: (02:15:20) Senator, one of the things you can do is to support an institution right in your own community. University of Alabama at Birmingham, I was there just two weeks ago and they have done a tremendous amount of work in terms of engaging the local African-American community in cardiovascular, in hypertension research. But I think number one, we need to acknowledge past wrongs that have occurred. And you all might be surprised to hear me giving a shout out to Bill Clinton, but Bill Clinton apologized for the Tuskegee Experiment several years ago. We need to acknowledge Tuskegee. We need to acknowledge [Henry Aterlack 02:15:53]. We need to acknowledge these wrongs occurred and then we need to address the situation that caused them to happen. Dr. Adams: (02:16:01) Again, we talk about the process, phase one, phase two, phase three trials. Data safety monitoring boards. Committees and whole agencies at HHS that have been stood up to make sure these types of things never ever happen again. And then we need to engage. And that's what you're talking about, sir. We need to get out there where the people are and use trusted advocates. I've been working with faith community. I spoke to rabbis last week, I've spoken to a pastor of the largest mega church within the country. We're talking to social media influencers like Kylie Jenner and T.I. and again, Lady Gaga, because my kids will do something and believe it because they say it before they'll believe it because Dr. Collins or I say it, but that's kind of an approach that we're taking to engage with people. Acknowledge, address, and engage. Senator Jones: (02:16:51) Well, thank you Dr. Adams. And thank you for coming down to Birmingham for the opening of some of those free clinics. We very much appreciated your visit and those are being very successful. Thank you Mr. Chairman for this opportunity. Senator Alexander: (02:17:03) Thank you, Senator Jones. Senator Rosen. Senator Murray: (02:17:19) Can you hear me? Senator Alexander: (02:17:20) I can. Welcome, Senator. Senator Murray: (02:17:23) Perfect. Just having a little trouble unmuting. Thank you, Mr. Chairman. Thank you for holding this hearing. Thank you for both the doctors for being here today. I really appreciate your work and your testimony. But to begin with, I really want to raise again the importance of ensuring that we have robust longitudinal studies in how the virus impacts a wide range of patients in the short and the longterm, including what treatments are most effective. Senator Murray: (02:17:49) So I've introduced a bipartisan ensuring understanding of COVID-19 to protect public health act, to make sure that this critical research happens. And that it includes a very diverse set of patients. This bill was included in the House passed HEROES Act, and I ask support for my colleagues and especially on this committee to ensure it's included in the next COVID package passed by the Senate. That's going to help us determine future cures. Senator Murray: (02:18:17) But I'd like to move on now to rural access to vaccines and information. And so the CDC has asked the States to draft and be ready to follow vaccine distribution plans in less than two months. Our health departments, they're doing the work of heroes, but they're stretched thin and they still lack the robust federal support they need. Last month, I was on a statewide virtual tour. I heard how the need for basic healthcare services remains a huge issue, particularly in rural towns. In Baden, Nevada, they still lack access to regular primary health care. Across the country, rural areas are continuing to struggle as a pandemic exacerbates existing problems with access to adequate medical care. Senator Murray: (02:19:01) So with this in mind, Dr. Collins, what recommendations do you have for making sure that rural areas are not left out of the critical vaccine distribution, of the actual delivery of the vaccines, information about who should receive the vaccines. I have communities that have no hospital, no physician offices and no pharmacies. The closest medical service is potentially a hundred miles away. What is the national plan to deploy this vaccine across our states? Mobile clinics, perhaps. Can you tell us what's going to happen or will we have to figure it out on our own? Dr. Collins: (02:19:37) Well, I'll start, but I'm sure the surgeon general might want to add something because even more in his domain, but certainly the distribution issues are critically important and are under intense planning processes right now. Recognizing that Warp Speed has not just the role of trying to encourage the clinical trials, but also the manufacturing and then the distribution, everything like the cold chain. And how do you actually get these doses to the places where they need to be, recognizing that we're going to need to do this in a priority way so that the most vulnerable people get the doses first? Dr. Collins: (02:20:09) That means thinking about rural communities and all the ways that can happen, but it's going to be working with the states, and CDC is already deeply engaged in that. I think they got a little misunderstood when they said to the states, we need to be ready by November 1st, just in case. I think they were trying to say, let's be prepared here and not wait until the last minute. And that is very much the conversation that's going on. But the surgeon general may want to say a little bit more about rural areas in particular. Senator Murray: (02:20:34) Yes. I want to make sure that Congress is your partner and being sure that we leave no rural communities behind. Dr. Adams: (02:20:41) I'll be very brief. I grew up in a rural community in Southern Maryland where the nearest hospital was quite far away. And I ran the State Department of Health in Indiana, which is a mostly rural state for three years. We've utilized the vaccines for children's program, VFC. We've utilized the Section 317 Immunization Program. We have infrastructure in place to get vaccines out to those territories. But you're right, we have to acknowledge 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're working with state and local health departments to make sure that occurs. Dr. Adams: (02:21:24) I stand ready to work with you to make sure people know the vaccines are safe and effective. And that we're addressing the practical issue, the availability, convenience, cost, service quality, and satisfaction, making sure that not just it's there, but the people can get it easily and are happy with the way they received it. And these are all issues that are on my radar and that we're working with local partners to try to figure out before we get a vaccine. Senator Murray: (02:21:48) Thank you. I only have a moment left, but I'm going to submit this for the record. But we have seen a troubling decline in vaccination rates overall during the pandemic. It was reported that the rate of vaccinations generally were down by approximately 64%. This is extremely concerning, not just to me, but to everyone across our state. And I'm sure other states have similar statistics. Senator Murray: (02:22:12) And so, Dr. Collins, how do you think that current drop in vaccinations, the impact of getting a COVID-19 vaccination out? Could we pair up giving existing vaccinations to people along with the COVID-19 vaccination? Would you recommend that? Or how do you think that we can bring our general vaccination rate back to where it should be as well? Dr. Collins: (02:22:36) Well, the general vaccination rate is a crisis right now that ought to be attended to right now. There's no reason to have to wait until we see what happens with the current COVID-19 vaccines that are in clinical trials. So all of those folks who might be listening to this who fell behind on childhood immunizations because of concerns about going to the doctor's office, those doctor's offices have figured out how to make themselves about the safest place you can be. It's time to catch up. And I know your physicians will be very willing and interested to help you do so. And then that ought to be happening this fall, as well as everybody getting their flu shot, which is another vaccine whose appropriateness and urgency is going to be even more the case than ever. Senator Murray: (02:23:16) Thank you. My time is expired and I really appreciate your service. Thank you, Mr. Chairman. Senator Alexander: (02:23:26) Thank you Senator Rosen. We'll wrap the hearing up now. We have votes going on on the Senate floor. I've got a couple of questions in conclusion. Dr. Collins, there was some talk earlier during the hearing about multiple shots for a vaccine. If I remember right, we already do that, don't we? I mean, some vaccines require more than one shot. Dr. Collins: (02:23:52) So for instance, the HPV vaccine, which is saving lives from cervical cancer in prodigious numbers. It started out as a three dose. I think it's looking pretty good that two will do, but we're not down to one yet. And yet that is clearly something that motivated parents very much want their children to have as I would think they should. So yeah, this is not the first time. Senator Alexander: (02:24:13) And I believe I've taken tetanus booster shots. Dr. Collins: (02:24:16) Yes. Every 10 years. That's right. Senator Alexander: (02:24:21) That shouldn't be a problem. Senator Burr made an interesting point, which was that a lot of the 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 a number of steps, giving the Food and Drug Administration more authority, giving the National Institutes of Health additional funding and some more flexibility. Moving the stockpile management, creating manufacturing plants that would be ready in case we needed them. Senator Alexander: (02:25:04) How valid is that point? That in fact, as we think about preparing for the next pandemic, which Jared Diamond reminds us, 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 presidential administrations of both parties and members of Congress of both parties. And that this administration is simply using to a full extent the authority Congress has given you. Dr. Collins: (02:25:32) I think that's very true. I think it's traditional right now to bemoan that we weren't ready for COVID-19 that we somehow let things lapse. We weren't perfectly ready that's for sure. And there were some things that probably could have been in better position to be ready for this, but there were things that Congress had done over the past couple of decades, the creation of BARTA, other things that you've mentioned that made it possible to move more swiftly now. Dr. Collins: (02:25:54) Now we need to learn from this one. And of course, this is the worst pandemic we've had in more than a century. So maybe we'll learn even better this time to be prepared so that as we get through this and we are going to get through this and COVID-19 will slip into the rear view mirror that we don't imagine that we're done with pandemics, because COVID 23 or whatever the next thing might be, is out there lurking. And we should learn from these lessons and not do anything other than prepare. Senator Alexander: (02:26:20) Well, one of the lessons, and Senator Frist, Governor Leavitt, a number of others who proceeded both of you in your positions, have said we go from panic to neglect to panic. And even though we've taken some significant steps to be better prepared and you're taking advantage of those. I mean, there's no way you could be developing a vaccine this rapidly, this safely, this effectively, without these steps. Still, we're not as prepared as we should be, because in between epidemics, we lose our focus, which is why I am urging that on onshore manufacturing that we make sure we keep those plants warm, as Governor Leavitt said, on stockpiles, that we make sure the stockpiles stay full and aren't depleted because of budget problems at the state or in the hospitals or in the federal government. Senator Alexander: (02:27:12) 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. So I have reiterated my strong feeling and I hope you agree with it. That the time to sustain our preparedness is now where our eye is on the ball and that while we're dealing with this pandemic, we should make sure we're prepared for the next one. Dr. Adams, do you agree with that? Dr. Adams: (02:27:45) I've been in public health my entire life. And as you mentioned, we've chronically underfunded public health. I've been coming to D.C. every year for the last 20 years, asking for funding for basic public health. So the problem with public health is it's like the oil change in your car. You wait until the engine blows up before you decide you need to check the oil. Dr. Adams: (02:28:07) We need to fund public health. We need to fund vaccinations. And I want to thank you for being a strong advocate, knowing that this may be the last time I testify before you, for your strong advocacy, not just for the State of Tennessee, but for the United States in terms of making sure we have the resources we need at the federal level and are using our tools to protect the American people. Senator Alexander: (02:28:29) Well, thank you Dr. Adams. One other thing, the phrase herd immunity has come up. There's another phrase has been thrown around, let's just say inelegantly in the news media. And I think it's misunderstood by a lot of people. The way I'm hearing you talk is that developing herd immunity is a good thing, right? I mean, you want to get to a point where a large number, and I believe you used the number 60 to 90% of the population has some form of immunity from a disease. Herd immunity by itself, nothing wrong with herd immunity, right? Dr. Collins: (02:29:05) No, it's how you get there. Senator Alexander: (02:29:06) It's how you get there that's the question. And there's the old way to get there, which is just as Dr. Collins once said, let it rip, just let it roar through the whole population killing people until everybody's either killed or recovered with some form of immunity or we have vaccines, which is the way we get there. Senator Alexander: (02:29:26) I think it's very important that the American people understand we want herd immunity, but we don't want to do it. We can't do it by locking everybody in their room, the way they used to do with leprosy. You put everybody with leprosy in a leper colony. Well, that's a form of quarantine, but that didn't get rid of the disease, necessarily. What we can do today, we believe, the testimony has been consistently that every one of the public health experts in this administration and most outside, 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 that during 2021, there should be hundreds of millions of doses of this. And there's no guarantee of that. Senator Alexander: (02:30:20) You've told us we have six tracks of vaccines already moving that we don't necessarily expect everyone to work. That if they don't work, even though we're manufacturing them ahead of time, even while we're testing them, we'll throw them away. And they'll never be distributed. You've said you'll be the first of the 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 their herd immunity is what we want. We want most Americans to be immune to COVID-19. And if that happens, then the infection rate will go down and the disease will gradually become a minor event in American society, but there are only two ways to get there. And one is just to let it roar through the population, killing people until we've killed enough and enough have recovered, to have herd immunity, or the much preferable way is the vaccine that has a good prospect of being available by the end of the year. Senator Alexander: (02:31:26) So I thank you and your colleagues for what you've done and are doing. I know how hard you're working. Dr. Collins, I can't let you get away without asking you one last question. You've headed up the so called Shark Tank, the Red X Operation, which we funded. I want to make sure that I know one, what is the output right now? How many fast tests have the Shark Tank produced that people can take to determine whether they have COVID-19? And do you have the funding you need to get done what we asked you to do? Dr. Collins: (02:32:02) Well Senator, I really appreciate your leadership in making it possible. Just beginning on April 25th, for us to ramp up something it's never been done before and invite a lot of small businesses and academics who had really creative ideas about how to do testing for SARS-CoV-2, to come forward and jump into the Shark Tank and show what they could do and get a lot of advice and sometimes some difficult criticism and see whether they were ready for the big time. Could they actually expand their capacity? Develop a sufficient validation and get exported and deployed. Dr. Collins: (02:32:36) Just as of last week, we're now up to 16 of these technologies that have made it through this process. Very interesting technologies too. 16 different ones. And collectively now, those add up to roughly 2 million tests a day that would not have been there before all of this came along. Some of them are lab based tests. Some of them are based on genome sequencing. Some of them are point of care, but collectively they are moving along and together with what Admiral Giroir has been doing, which is also dramatic in terms of its expansion, with things like the Abbott by next test. Dr. Collins: (02:33:09) I think we are on that pathway towards getting to enough tests that almost anybody would say. Unfortunately, I think now, increasingly many of them are point of care tests. I'm also glad to say the lab based tests, which were afflicted by slow turnaround time have now gotten down to the point where 97% of all the tests are returning a result in three days or less, which is where we needed to be, and weren't frankly, a few months ago. So we're in a much better place. And we have- Senator Alexander: (02:33:34) So you're saying 2 million a day, simply from those that have come out of the Shark Tank? Dr. Collins: (02:33:39) That's right. Senator Alexander: (02:33:40) That's 2 million times 30. That's 60 million. Dr. Collins: (02:33:43) It's a lot. Senator Alexander: (02:33:43) A month. And then you add to that what was already happening, and then you add to that the Abbott test, which the Abbott says will produce 40 million tests a month in October. I think Dr. Adams, you said that Admiral Giroir gave a number for September and October that was in the neighborhood of a hundred million test a month. Dr. Adams: (02:34:08) Yes. Senator Alexander: (02:34:09) Which is twice as many as he testified here a few weeks ago, when he estimated that we'd have 40 to 50 million tests in September, October. My own view is when we have an oversupply of fast tests, testing will cease to be an issue. As soon as everybody knows they can get a fast test quickly if they want one, they'll probably not want as many. Scarcity causes people to want more. And then on the other hand, as you were talking about the University of Illinois testing students twice a week, they're able to do that? Dr. Collins: (02:34:50) And faculty too. Senator Alexander: (02:34:51) How many students and faculty at the university? Dr. Collins: (02:34:54) Tens of thousands. It's a lot. Senator Alexander: (02:34:56) Yeah. So we're moving to the point where there are many different strategies and no one's saying you have to test everybody every day, or- Senator Alexander: (02:35:03) No one's saying you have to test everybody every day, or twice a week, or whatever, but different colleges, different schools, different workplaces will develop different strategies. If they know that if an employee comes up and says, "I feel worried working here, I'm afraid I might have COVID." You can say, "Come right in here, in 15 minutes we'll tell you whether you do or not." Senator Alexander: (02:35:20) I think that will help give people the confidence to go back to work, back to school, back to childcare, out to eat. Until we have vaccines broadly available, distributed, and administered, which surely will be sometime next year, if we're successful, then that will... But between now and then that sort of testing, plus the treatments that we could discuss at our next hearing, are a very impressive story. Dr. Collins: (02:35:51) Senator, just before you close down, I want to add my voice to the Surgeon General, to thank you for your leadership. You've just been pointing out a dramatic example, which is this area of testing. But you have been a clear, compelling authoritative evidence-based source of information for all of us and a remarkable voice of leadership in the Congress. 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, even including the Bluebird Cafe. I just want to say, you're going to be sorely missed by all of us you've had the chance to work with you. Senator Alexander: (02:36:25) Well, that's very generous. It's a privilege to work with both of you. I'm 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 for working with us on this hearing. Senator Alexander: (02:36:44) 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. Most of our hearings are pretty civil. We each get our points in, including our political points, but we do that with respect for those of you who work for the American people, like Dr. Adams and Dr. Collins do. I thank Senator Murray and my democratic colleagues for allowing us to conduct hearings in that way. Senator Alexander: (02:37:09) Our committee will meet twice next week. We'll meet again at 10:00 AM on Tuesday for a hearing entitled Compensating College Athletes: Examining the Potential Impact of Athletes in Institutions. The Commerce Committee is the lead committee in the Senate on that, but we're looking into that in cooperation with them because this makes a difference to students, to student athletes, and to the American people who like to watch sports. Senator Alexander: (02:37:38) On Thursday, we'll 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 federal aid application form that 20 million families fill out every year. We've made progress on that in the Obama administration, we've made progress in the Trump administration. Senator Murray and I introduced, and Congress passed, a bill making important steps, I guess earlier this year, or recently, when we permanently funded historically black colleges, but we would like to finish the job. We'll have a hearing on that next Thursday with the same four witnesses, plus one who got us involved in it in the first place six years ago. Thank you for being here today. The committee will stand adjourned. (silence).