Chairman shelby and his staff for letting us try this and see how this kind of information gathering works for appropriators. Its not a markup. There will be no voting today, but were going to get some really important information. Yesterday, the new coronavirus cases passed 50,000 for the first time, making it a single day record. This morning, 128,000 americans have died and nearly 2. 7 million have tested positive for covid19. Of course, the thoughts of myself and everyone on this committee are with those individuals and those families whove been affected. I called this hearing really to look at an update on the efforts that the administrations put together and, frankly members of this committee were very involved in to see if we couldnt establish a new way to look at responding to pandemics. I think we have the chance to actually write a new important chapter in what that response looks like. Developing the right vaccine, the right therapeutics, the right testing is important. And i think were going to talk today about ways to try to have all of the safeguards in developing all of those things, but with a federal partner Going Forward more quickly than we would have ever gone forward today. I saw in reporting this morning pfizer just passed an important mark with the vaccine theyre working on. Maybe the most significant thing i saw in that article was that pfizer believes they may have 100 million doses of that vaccine available by the end of the year. That would be an extraordinary thing if it happens, and i think what were going to hear from our Witnesses Today is that there are other companies that would be developing different vaccines that also would add to that figure that might be available late this year or early next year. I think the administrations willingness to take this new initiative, the willingness of the administration and, frankly, our Appropriations Committee and the congress in what we did in the last covid act to put some money behind taking a chance, not a chance with an effective vaccine or a test but a chance we may move forward with something that doesnt work more to also allow us to move forward early with something that does work. This committee, the full committee and the congress has provided nearly 10 billion for this overall effort and the vast majority of this investment will support the research and development of vaccines and treatments. There are over 100 vaccines in development worldwide. Operation warp speed is focusing in on seven that we would encourage the advancement of and the Clinical Trials and further development. Importantly, as n. I. H. And the biomedical Research DevelopmentAuthority Continue to oversee the development of these vaccines, were also going to be talking today about how manufacturing for maybe the First Time Ever would begin while the vaccine is still going through the other process and maybe while tests are still going through the other process. As we saw earlier this year with diagnostic Testing Research at n. I. H. , the current processes can be streamlined to make them faster. Just because something is new doesnt mean its better. But this is a time to try things and to see what we can figure out to make work. Under the n. I. H. s shark tank program, program that particularly senator alexander and i spent a lot of time talking to people at this table about, principally dr. Collins, but people at this table, manufacturers and others, were hoping to fast track diagnostic tests to have tests that are easier to take with a quicker response that frankly millions of people can take dozens of times. Getting School Started in the fall at residential campuses and elementary and secondary schools and all other campuses having a test available will make a big difference. Some people have warned that the timetable to develop both tests and vaccines next year is far too fast. Others have said, maybe accelerating the process means that regulatory corners will be cut. Were going to be working really hard to be sure thats absolutely not the case and i think our leaders here today will help reassure us of what theyre doing to see that that doesnt happen. This is an opportunity for our witnesses to explain to our committee and the American People how the Development Process works, how theyll ensure the vaccine will be safe, and even with an accelerated research and Development Timetable how the vaccine will be distributed across the country as quickly as possible. I said to several people lately on the topic of vaccine and distribution that obviously developing the vaccine is the top priority, but right below that top priority is having a plan that distributes that vaccine in a way that people believe is fair and equitable and meets the standards that we should be establishing right now. There are clearly concerns about the vaccine. About half of americans are either reluctant. About one out of five americans say they are not going to take the vaccine. I certainly intend to. And i think most americans will. As we reassure people about this process, also think about small things. Polio and other in many cases vaccines have been , able to move outside the system because vaccines did their job and kids in the fourth and fifth grade dont line up any longer so that every Single Person takes their smallpox shot like they did when most of us were kids. I hope todays hearing really makes an impact on those concerns. I believe it will. And look forward to our witnesses. Senator murray is here and im going to recognize her for her opening statement. Senator murray, thanks for being with us today. Thanks for working together to have this hearing. Senator murray well, thank you very much, mr. Chairman. I really want to thank you and chairman shelby for allowing our Committee Members to participate in this hearing virtually today. I want to thank all our Committee Staff for setting everything up. I want to thank all of our witnesses who are joining us today as well. Your agencies play a Critical Role in the development of some of the most important tools against the covid19 pandemic. Safe and effective diagnostics to identify the cases, therapies to help patients and frontline workers to fight this disease, and ultimately a vaccine to move towards ending this crisis. That is why congress has appropriated more than 6. 5 billion to barda and 3 billion to n. I. H. For work on medical countermeasures against covid19. And we know well need more funding, particularly to distribute and promote a safe and effective vaccine down the line. And we also know were going to need to hold this Administration Accountable to avoid repeating the mistakes and delays. The Trump Administration put politics ahead of Public Health by promoting unproven treatments and steering p. P. E. Contracts to unqualified political allies. A plan in a comprehensive way likeationwide challenges scaling up testing and ignored and exacerbated existing Health Disparities that left black, latinos and tribal communities to face the worst of this crisis. If we want to get out of this mess anytime soon, the Trump Administration has to do better, particularly when it comes to developing a safe, effective vaccine thats widely available. What i hear from experts is that while we all want a vaccine fast, a vaccine that is fast but ineffective will fall sharp of will fall short of what it is needed to turn the tide on this pandemic. That is why its more than concerning that the Trump Administration sidelined our leading scientists at c. D. C. , removed the head of barda reportedly for putting science and Public Health over allegiance to President Trump, and took barda experts off leadership of contracts related to the search for a covid19 vaccine. I also have concerns about why barda has chosen to invest solely in new vaccine technologies that have only been studied experimentally and never made it to market while not pursuing older, proven technologies. Meanwhile, the Administration Still has not provided any explanation of how it is selecting vaccine candidates, what the risks are of narrowing down that short list, or address concerns about potential conflicts in contracts that predates this crisis. And it still has not provided a comprehensive National Vaccine plan. We saw with testing how the administrations stubborn refusal to plan led to totally avoidable delays. So congress clearly needs to act and hold President Trump accountable when it comes to vaccines or risk another inadequate plan that offer too little, too late, or offers no plan at all. That is why i am working on a proposal to require the Trump Administration to provide a comprehensive plan for how it will make sure we get a vaccine that is safe and effective, produced at scale, and distributed nationwide and free and available to everyone in a way that addresses the Health Disparities this pandemic has made worse. This plan has to ensure that research and development is rigorous, sciencedriven and inclusive, and it must lay out specific standards, timelines and milestones, a commitment to be fully transparent about the Clinical Trial data experts will use to evaluate safety and effectiveness and strategies for combating Vaccine Hesitancy and misinformation. When we finally develop a vaccine, we will need to safely manufacture hundreds of millions of doses for the u. S. Alone and billions globally as fast as possible. And that means just as many specialized glass vials, syringes, stoppers, and a lot more. Making all of that happen requires planning to manage the supply chain and navigate challenges like potential bottle necks. We also need a plan for when we begin to distribute vaccines. To guide critical decisions about who gets the vaccine first, like Frontline Health care workers, highrisk groups, and tackle barriers that could otherwise limit access by making sure the vaccine is free for everyone. And addressing Health Disparities which have already made this crisis so much worse for communities of color. And while we need this plan as soon as possible, we also need to be clear about what scientists and clinicians have cautioned, which is that while there is no guarantee a vaccine will be ready by the end of this year, much less by this fall, there are people suffering with covid19 right now who need proven therapeutics to help them beat this disease. While a vaccine is our best hope for stopping this virus, its not our only means of fighting it. Nor is it a panacea on us all. So i am alarmed that this administration is treating other priorities as an afterthought by investing far less in better diagnostics that can identify infections early in the course of the illness and prevent further spread. And pulling the plug on therapeutics that could provide lifesaving relief for hospitalizations at the greatest risk of dying or suffering longterm health effects. Congress provided funding for h. H. S. To invest in a spectrum of medical countermeasures to fight this virus, not just vaccines. We need to invest in every type of medical countermeasure and to do it in a way that benefits everyone in our country equitably because we know right now this virus is disproportionately impacting communities of color. For months now, i have been pressing for comprehensive Demographic Data on positive test results, hospitalizations, intensive care unit admissions, and fatalities. And im frustrated that we dont have all the data we need yet. But the picture we do have is alarmingly clear. People in the black community, latino community, and tribal communities are three to five times more likely to be hospitalized for covid19 than white people. And the death rate for people of color is two to three times that for white people. Those devastating Health Disparities are a symptom of a larger pattern of systemic racism and underinvestment in communities of color. And a warning that we need to work as fast as possible on an additional relief package to address those disparities before they get worse to protect our workers, our students, our families, and continue to support our communities as they fight this historic crisis. We cant know exactly how long until a safe and effective vaccine is widely available or how long before we can all safely go back to work, back to school, greet our friends with a handshake or a hug. We do know the decisions that we make today, whether we prioritize science or not, whether we plan ahead or not, whether we care for every community or not will make a huge difference in terms of where we are a year from now. So its absolutely critical we get this decision right. Thank you very much, mr. Chairman. I look forward to the testimony and to our questions today. Senator blunt well, thank you, senator murray. Got a great panel today. Dr. Francis collins, the director of the National Institute of health. Dr. Robert redfield, the director for the center for disease control. Dr. Gary disbrow, the acting director of the Biomedical Advanced Research and development authority. Usually referred to as barda. This is his first time to testify but our other two , witnesses have been before this Committee Many times. Its possible that dr. Collins may have set the record as a witness before this committee. Dr. Collins, why dont you start . We have your statements. Try to limit your opening comments to five minutes each. And you can do that however you want to. But were glad all three of you are here. As you can tell, were eager to ask questions. Dr. Collins well, thank you. Good morning, chairman blunt and Ranking Member murray and distinguished subCommittee Members. I want to thank you for your sustained commitment to the National Institutes of health. It has enabled n. I. H. To be at the forefront of research to address the covid19 Public Health emergency. Im grateful for this opportunity to update you on that work. You should have it in your place or if youre on the video connection, maybe an electronic version of a couple of images i want to point you to in a moment. Over the last six months, covid19 has spread around the world with frightening speed. To respond to this crisis, we need to find answers to many urgent questions about how to diagnose treat, and prevent. , at n. I. H. , we need to use the best science and technology in the world to find those answers. A critical question is to understand what we are up against. When it comes to new Infectious Diseases knowledge is power. , as you can see on the image on page 2 of your handout and also in this 3d printed model i brought along with me which , happily was not confiscated by the security people when i entered the building even though i guess you could say i brought virus to your hearing room, this one will not cause you illness. This model shows you the cause of covid19. Its this coronavirus called sarscov2. Notice the spiky things on the surface. Body,he virus invades the they open the door to infection. They act as keys that fit into specific cells. Once inside the cell, the virus takes over the machinery, begins replicating, producing thousands of viruses like itself and goes on to infect other cells. Work, we now have better means of treating covid19 than just a few months ago. Remdesivir and dexamethasone have proven beneficial in rigorous trials and are now standard of care for hospitalized patients, but we have much more to do. Let me Say Something about testing. Testing in the u. S. Has come a long way. More than 30 million tests for presence of the virus have been administered in the last few months. More than in any other nation. Yet, these tests, most of which rely on nasopharyngeal swabs and processing in centralized labs are not satisfactory for the needs at hand. Scaling to rapid routine point of care testing would be a major advantage but that requires new technology. With that in mind, congress, on april 25, provided Additional Resources for development of new covid19 tests. Just four days later, n. I. H. Launched the rapid acceleration of diagnostics, or radx initiative. If you turn to the next page, youll see an innovation funnel which includes a shark tank , component. This basically is an opportunity for those whove invested and invented new kinds of technologies to put their ideas forward and have them evaluated by a distinguished team of business, engineering, technology, and scaleup experts. In just two months, we have received more than 2,400 expressions of interest. And over 560 completed applications, most of these were most of these from Small Businesses. Many of these proposed tests use convenient samples like saliva, which would be better than a nasal swab because you can selfcollect. Of these 23 have already made it , through the shark tank and are undergoing intense validation and what you see here as phase one, preparing for possible massive scaleup in phase two and we expect to have at least one of these technologies in to phase within the next week. , we expect that the Winning Technologies will make it possible to deploy several million more tests ea