Senator blunt the appropriation subcommittee on labor, health and Human Services, education and related agencies will come together. Im glad to be here this morning with my colleagues, some offices or from some other location. This is the first appropriations hearing being held in person and virtually and want to thank 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 Development Authority 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 each week. In fact, i would say maybe more than a million more each day. But its not enough to diagnosis the disease. We must treat it as soon as possible to prevent it. To the end, on your next page, youll see n. I. H. Has launched the accelerating covid19 therapeutic interventions and vaccines. That will be an acronym, activ, initiative. This initiative is shown here in is shown here and the handout provides a highlevel overview of the organization of this remarkable and unprecedented Publicprivate Partnership involving 18 biopharmaceutical companies, academic experts and multiple federal agencies. In two short months, activ has developed five master protocols that will hasten f. D. A. Review and possible approval. These will rigorously test a series of antivirals, montical antibody treatments in both inpatient and outpatient settings. Supported by operation warp speed, we expect four treatment trials to get under way in the next six weeks and were quite excited about their potential for success. But still the ultimate tool that , we need to end the covid19 pandemic is a vaccine. Operation warp speed is working together on Vaccine Development. A scientific review of more than 50 candidates has already been conducted. The furthest along in u. S. Testing, shown on page 5, is an experimental vaccine from n. I. H. s Vaccine Research center in partnership with moderna. This vaccine features a small, noninfectious snippet of messenger r. N. A. Injecting this m. R. A. Into muscle spurs a persons own body to make the viral spike proteins, which in turn will encourage the production of productive antibodies against sars cov2. Phase two began on may 29. This month, we plan to launch phase three, which will seek to enroll 30,000 volunteers with resulted expected in a few months. So clearly, weve already learned much about this devastating virus and weve made significant strides at unprecedented speed in developing diagnostics, therapeutics and vaccines. Yet, far more work is needed to end this global crisis. With your support, n. I. H. Is on the case. So thank you for this opportunity and i look forward to your questions. Senator blunt thank you, dr. Collins. Dr. Redfield. Dr. Redfield good morning, chairman blunt. Ranking member murray, members of the subcommittee. Im pleased to be here with my h. H. S. Colleagues. Together were working on the , Critical Issues related to covid19 Vaccine Development, manufacturing distribution under the auspices of operation warp speed. Vaccines are one of Public Healths greatest scientific achievements. With the support of congress, investments in c. D. C. s domestic and global immunization programs continue to diminish disease threats and advance the human condition. Most importantly, vaccines save lives. Preparing for the implementation of the safe and effective covid19 Vaccine Program is a critical next step. Through our existing influenza Vaccine Program, c. D. C. Continues to work with state, tribal, local Territorial Health partners to prepare and maintain Public Health distribution pipeline. This includes training personnel, building strategic relationships, utilizing data systems, identifying the resources to sustain an efficient and effective immunization infrastructure. Leveraging the existing systems, c. D. C. Stands ready to support our partners with the distribution once a Covid Vaccine is available. Each year, c. D. C. Safely distributes vaccine from manufacturers to nearly 40,000 public and private Health Providers across the nation. And in a typical year, we provide vaccine for more than 80 million individuals. During an emergency, this system has the ability to scale and capacity to manage and distribute up to 900 million vaccine doses. This is possible because c. D. C. s established an extensive integrated network inclusive Public Health departments, Public Health providers and Community Groups that extend far and wide. Drawing on the lessons from the 2009, h1n1 pandemic, we began new covid19 strategy. Strategies will be based on many factors. One strategy likely will be prioritizing who is vaccinated. The goal is to ensure that Vaccine Access for all americans who can benefit from vaccination. To do this we must consider the , logistic aspects of where vaccines are administered and who is administering. We need to manage inventory, gauge vaccine supply nationwide. C. D. C. Currently manages the supply through its vaccine system and collects vaccine data from jurisdictions to help them make informed decisions. C. D. C. s Immunization Safety Office has a longstanding history of monitoring the safety and efficacy of vaccines and will continue to provide leadership in this area. Scientifically based vaccine policies are the foundation of the u. S. Immunization system. These policies are formulated by recommendations from the Advisory Committee on immunization practice, or acip, and then provided to me as c. D. C. Director. Another key component is the efficient Distribution Strategy to ensure people have clear and accurate and ample information on vaccines so they can make informed decisions about getting vaccinated. Experience has shown us that vaccines are powerful tools and reaching every individual who could benefit from immunization is an important goal. Successful Vaccine Program will require a combination of traditional and new innovative approaches to how to administer and deliver vaccines. Pharmacies and other complementary Community Locations will be more important during our response to this pandemic. Finally, Public Health considerations have to look at the management of the vaccine itself. Every vaccine has requirements for storage and handling that must be addressed for the vaccine to be effective when delivered. Ensuring the chain, from when the vaccine is manufactured to when its administered. To meet these aggressive goals will be important to enhance our nations infrastructure. In the coming months, we will be confronted with the confluence of covid19 and seasonal flu. C. D. C. Is working to encourage the americans to embrace flu vaccination with confidence. This is an important Public Health goal and serves two important purposes for covid19. First, increasing flu Vaccine Coverage can reduce the strain on our health system, which we have already seen in some areas from covid19. Second, the flu vaccine takes another opportunity to test our systems and infrastructure that will need to be leveraged during a covid19 vaccine delivery program. As we confront the fight the confront to fight the pandemic its important that all , americans have confidence in all vaccines. Through the cares act, c. D. C. Was provided 140 million in funding to support states and local departments for early planning of the flu influenza season and to enhance these immunization programs across our nation. Covid19 is the most significant Public Health challenge that our nation has faced in more than a century. In the absence of a vaccine and countermeasures, today we are implementing effective Public Health measures and encouraging the adherence to what i referred to as the powerful weapons of social distancing, face coverings and hand hygiene. In doing so, im confident that we will emerge from this pandemic united together, stronger than ever. I encourage you to see the i encourage you to see the possible as both the public and private sectors pursue a vaccine and that we as a nation confront this pandemic globally. Thank you and i look forward to your questions. Senator blunt thank you, dr. Redfield. Dr. Disbrow. Dr. Disbrow thank you, chairman blunt, Ranking Member murray, members of the committee. I want to tell you how barda is responding to the covid19 pandemic. Barda is a unique Government Organization created to bridge the valley of death between basic research and latestage developments of products, vaccines, therapeutics and diagnostics, called countermeasures to address security threats. In the brief 13year existence, barda has got 55 f. D. A. Approvals. They are experts in Government Contracting and pharmaceutical and diagnostic development, many with 25 Years Experience working in the pharmaceutical industry. Barda has a track record of success in response to Public Health emergencies. One is had h1n1, ebola. Bardas long standing expertise in accelerating the advanced research and development of candidates, diagnostics, therapeutics, vaccines shows the dedication of the team. I want to thank my barda colleagues as they work long hours and weekends to support this response. In typical fiscal year, they invest 1. 6 billion to address chemical, biological, Nuclear Threats and pandemic influenza. This year in addition in just three months, we have obligated over 3. 5 billion as part of the covid19 response. Barda has leveraged funds provided under the cares act and funds from h. H. S. To invest in multiple vaccine candidates, programs, diagnostics. 12 diagnostics have been granted emergency authorization by the f. D. A. The portfolio now supports over 40 projects. When h. H. S. Secretary azar declared a Public Health emergency, we highlighted our strategy for development of vaccines, therapeutics. That same day barda opened a portal to accept Market Research submissions from stakeholders seeing over 3300 submissions to date. Prior to receiving supplemental funds, we allowed for submissions for covid19 specific products. We received over 267 submissions under b. A. A. And 426 to the easy b. A. A. This is what we do. We engage innovative stakeholders, establish partnerships, develop medical countermeasures and bring them to the American People to save lives. Early in the outbreak, barda strategies to engage with vaccine manufacturers, developing different platform technologies, some already licensed by the f. D. A. Or near licensure and had established Manufacturing Processes to manufacture large quantities of vaccines. Our therapeutics was similar. Invest in multiple technologies to increase our chances of success. Four diagnostic it is to invest in many areas. We used our existing funding and authorities. This early strategy has partially served as the basis for operation warp speed strategy or o. W. S. O. W. S. Is an unprecedented collaboration between the department of health and Human Services and the department of defense to expedite vaccines, therapeutics and bring them to the American People. O. W. S. Aims to bring up to 300 million doses for safe and effective vaccines in early 2021 as part of a broader strategy to develop, manufacture, distribution of covid19 vaccines, therapeutics to the American People. We work with the n. I. H. , d. O. D. The prior goal of o. W. S. Is to produce safe countermeasures. We need to take Financial Risks to expedite the vaccines and therapeutics. The key to success is to invest in multiple candidates and support parallel development activities. The risk is purely financial. A financial risk of manufacturing large amounts of medical countermeasures while were still determining the safety and efficacy. We will not risk the safety of these products. This financial risk is necessary to ensure m. C. M. s are available for use as soon as the f. D. A. Has deemed them safe and effective. Some of the investments will be in products that do not make it. This is the financial risk we must take because the risks and lives lost and the impact to our community is far greater. This committee and congress at large has been very supportive of barda in our mission and were very thankful. Today more than ever, we need your continued support and flexibility to ensure our staff can stay focused on the issue at hand. Senator blunt thank you, dr. Disbrow. We will stick to five minutes every member has. There will be a second round and everybody will be dissatisfied at the end of their first five minutes what they didnt get to ask. The person that follows them will be particularly satisfied they stayed close to the five minutes. Dr. Collins, dr. Disbrow said there would be no product even produced would be available and safe, do you have any concerns on the vaccine side that f. D. A. Is not going through every safety step they wouldnt normally go through . Dr. Collins mr. Chairman, i have no concerns and im deeply engaged working in this process with operation warp speed. I think the ability to do things quickly is not compromising safely. Its safety. We can speed things up even though it may involve doing manufacturing at risk when we dont know yet whether that vaccine will work and ultimately throw out a lot what gets manufactured if it doesnt work. But there will be no compromise on the safety and efficacy standards. Thats clul. Senator blunt dr. Disbrow, you mentioned the risk factor. Dr. Collins said well throw out anything thats produced that doesnt go through the final certification of safety and efficacy. Tell us a little more about that process. I also noticed you said were engaged in review, testing and the approval phase. Are we engaged with anybody in the manufacturing phase . Dr. Disbrow were engaged. Were investing in a diverse array of technologies, different technologies because were uncertain which Vaccine Technology may produce a safe and effective vaccine. Were doing, as dr. Collins mentioned, manufacturing at risk. This is a risk that we have to take if we want to expedite the timeline. So there is reason the f. D. A. Is not part of operation warp speed. They are an independent regulatory body and they will review the safety and efficacy. But we will manufacture at risk large volumes of vaccine and there is the potential that if those vaccines do not prove to be efficacious in phase three studies we will not move forward with that study. Senator blunt every time i hear at risk and i am pretty comfortable with vaccine, people hearing at risk, i dont think we can emphasize enough what were risking is losing some money that we invested to move multiple products forward so that when the products that did get through the whole process would be available at maybe roughly the same time theyre finally approved for use. Nothing will be more frustrating in this moment than for f. D. A. To certify a product and then hear its going to be months before that vaccine would be available. And am i right in believing thats what youre those months with what youre trying to avoid through barda . Dr. Disbrow yes. Barda is investing in multiple vaccine candidates and youre exactly right. It is a financial risk. Its not a safety risk. And we are manufacturing in the government and the government is assuming that financial risk. Senator blunt im sure youll talk about specific money later. We already invested 3 trillion to try to fight the virus and save the economy. If somehow we lose 3 billion in an effort to get both of those fights in the right place quicker, i think we all ought to be willing to eagerly talk about the fact frankly if we didnt lose money we didnt try hard enough. If you choose six vaccines and they all make it, i think the question will be, well, why didnt you choose eight vaccines . Because, again, dr. Disbrow pointed out, all of these vaccines will be slightly different than the other vaccine. When you get a vaccine for covid, am i right in assuming that people will not all get the same vaccine for the in all likelihood for their Covid Vaccine . Dr. Disbrow were hoping to develop one or more safe and effective vaccines. If there are one or more safe and effectively vaccine, there is the potential one vaccine may work better in a certain population than the other. Well continue to evaluate those. Senator blunt who is responsible for the plan for distribution in the current structure . Dr. Redfield thank you for the question, mr. Chairman. This is really the center space for the c. D. C. As i mentioned before, were currently involved in the distribution of a variety of Vaccine Programs throughout this nation. So this is really the prime responsibility of the c. D. C. To work in coordination to take advantage of some of the logistical capabilities of the department of defense. But this is really c. D. C. s primary responsibility. Senator blunt thank you, dr. Redfield. Senator murray. Senator murry thank you to all our Witnesses Today. Dr. Redfield, this crisis we will know will not end until we have a safe and effective vaccine that can be widely and equitably distributed. On tuesday, you agree that we need a comprehensive national plan, implementation will hinge on Public Health agencies to deploy vaccine to every community once it is available. C. D. C. s decades of experience managing a National Immunization program has to be central to that planning. I think i just heard you answer chairman blunt. But under operation warp speed, does c. D. C. Leave the planning for immunization infrastructure and distribution or is in that in any way the department of defense responsibility . Dr. Redfield thank you very much for the question, senator murray. Again, its leveraging were going to leverage the logistical capability of d. O. D. With obviously the experience and essential role that we play in distribution with the state, local, tribal, territorial partners around the nation. Again as i said to the chairman, this is c. D. C. s lead with the Logistical Support of the department of defense. Senator murry so has the d. O. D. Ever managed that same distribution at this kind of scale before . Dr. Redfield i would have to refer that question to the department of defense, but i can just reiterate which i mentioned that c. D. C. Has a system in place that we use routinely. Senator murry ok. I am going to move on. Thats a question thats important here. Let me ask. C. D. C. Hasnt used funding for any of the supplemental bills can you tell us why that is . Dr. Redfield sorry, senator. I didnt quite understand. Senator murry c. D. C. Has not used any of the funding of the supplemental appropriations bill that youve been given to prepare for a mass Vaccine Distribution campaign. And i want to know why that was. Dr. Redfield senator, id have to have our group get back to you. Weve expended a substantial amount of the money that congress has provided us. I know i moved over 12 billion to state and local, territorial, Tribal Health department to augment their capacity. I would need to get our team get to the specifics of it. We senator murry yeah. You used that for flu vaccine. Important. The lack of preparation for covid19 Vaccine Distribution is concerning to me. And it doesnt sound to me like c. D. C. Is given that effort. Chairman, i do need an answer. I think we all do to that question. Dr. Disbrow, last month, h. H. S. Announced a 628 million deal with Emergent Biosolutions to help manufacture the eventual covid19 vaccine. The largest award, that deal at the highest paid contractor for the h. H. S. Office for assistant secretary of preparedness and response. A Washington Post investigation revealed before the pandemic, after they doubled more than any other contractor of a biodefense company as founder and chairman, a connection by the way he fails to disclosed to the senate during his confirmation process in 2017. So dr. Disbrow, this is my question to you today. Can you say with 100 confidence that companies are awarded barda contracts based solely on scientific merit and not their personal relationship . Dr. Disbrow yes, i can. Senator murry it was reported yesterday 30 Companies Making coronavirus drugs and vaccines removed standard language from their contracts with barda that give the government rights to intervene in cases of unreasonable drug prices. I am very concerned that pharmaceutical companies have dictated the terms of barda contracts and watereddown the governments marching right protection. At a time when were spending billions of dollars in Vaccine Development, why did we weaken our ability to ensure fair vaccine pricing . Dr. Disbrow for the u. S. Government to use marching rights requires a very high threshold. The u. S. Government can ask the holder of the i. P. To grant a nonexclusive, partial exclusive or exclusive right to the license. However, the contractor has to show that they are not or expected to not, within reasonable time, achieve practical application. That is not occurring. We are all working very quickly to push forward with the development of vaccines and therapeutics. Action is necessary to alleviate health or safety needs, not reasonably satisfied by the contractor. I also do not believe that threshold has been met. So, again, under barda contracts, we work under the federal acquisition regulations. We do have some contracts of which are called other transactional agreements which are outside of the far. But we always everything is based on science and to protect the federal governments investment. Senator murry i just want to say this. We are spending billions of dollars in Vaccine Development. We should not be weakening our ability to ensure fair vaccine pricing for the people of this country. Thank you. Senator blunt thank you, senator murray. Senator shelby. Senator shelby thank you. Ill address this to all three of you. Where are we today . The American People are watching this hearing. We believe that we have sent you enough money. If we havent, tell us why not. But tell us where we exactly are, if you can be exact, on coming up with a vaccine . I know the vaccine, i know youre trying every approach in the world. You know, logical approach. You got a lot of people working on it. But the American People are dying and getting sick and theyre looking for results and we know you cant wave the magic band. Dr. Collins, ill start with you. What do you say to the American People today where we are and when the timeline and what do you think we will be where . Dr. Collins mr. Chairman, this is the right question and something i think all of us working on covid19 are obsessed about night and day because this is one of those crises where science is not only important, its crucial, and ever mistake we make would set us back and every wasted opportunity would have a consequence for somebodys life. So i want to tell you, we are all in. Everybody working on this warp speed team. Where we are with the vaccine, remember generally it takes five to 10 years to develop a vaccine from a new infectious agent. We dont have that time. So in record time, the very first vaccine went from knowing what the sequence of this viral genome was to injecting the first patient in a phase one trial in 63 days. Thats a world record by a long shot. Because of new technologies that made that possible. And then going quickly from the phase one which looks very promising to phase two, which started on may 29, and phase three, which will begin this month. And how long will that take . We need to enroll 30,000 volunteers and that should take a matter of some month. We are all optimistic that the goal we have set to have a vaccine that works and is safe by the end of 2020 will be met. By one of the vaccines i just mentioned but there are several all being conducted side by side. And that we would then have by early 2021, 300 million doses of a vaccine thats safe and effective. So all that is where were putting ourselves on the line and i think everybody at this table would agree thats really a stretch goal but its the right goal for the American People. Senator shelby dr. Redfield. Dr. Redfield thank you, chairman. Two comments. First and foremost, the most important thing as we move forward with these vaccines, as was said before, is that our role at c. D. C. , again, along with others that are here in f. D. A. Is to ensure theyre safe and efficacious. Where we are right now, the two areas where we have the most Important Role is to figure out how to get that vaccine into the individuals that would benefit from there. Two things there. Building vaccine confidence. Senator shelby thats presupposing you come up with a vaccine, right . Dr. Redfield we have to work on that right now, chairman, just because the complexity of giving a new vaccine to the American Public as we learned during the h1n1 in 2009, its seriously complicated. So we are working on that, if you will, distribution mechanism now, and were working on building the confidence of the American Public now with the is up position that our supposition that our colleagues are evaluating the vaccine itself between the seven shots on goal or many vaccines theyre developing now that one of those vaccines will come and show an adequate safety and efficacy profile to go forward and be distributed. Senator shelby dr. Disbrow. Dr. Disbrow building on the previous comments, we look at incremental success as were moving along. You saw some results yesterday. Pfizer. Those are important to get out to the American People. Phase three Clinical Trials, thats been reported by one of the companies we are working with. Theyll energyefficient theyll initiate their phase three trial. In july there are phase three trials that are staggered later in the summer. Those are important milestones to let the American People know we are making progress. In addition is the scaleup in manufacturing and validating those process. That is a critical milestone as well. So where we are right now is were in the phases of the different Clinical Trials. Phase one, phase two, phase three, and were ramping up manufacturing. Senator shelby dr. Collins, how much cooperation around the world since so many nations, so many people are affected do researchers collaborate on and what are they getting . Dr. Collins science has always been an International Effort and never more so than were faced with a Global Pandemic. I think a collaboration and cooperation is really excellent. One of the vaccines were talking about actually was originally developed in the united kingdom. Has now been embraced in a way that the u. S. Can take advantage of it. Also with support from bardas very Excellent Way of doing those negotiations. So, yeah, we are looking in every nook and cranny for the kinds of collaborations that will go faster. That is our scientific tradition. Senator shelby thank you, mr. Chairman. Senator durbin i want to follow up on senator murrays question. We are in the national of a national pandemic. We are in the middle of a National President ial campaign. And i think her question goes to the fundamental basic desire for testimony here on where we stand in terms of the political world before we address the medical world. Id like to ask the three witnesses here if any of them have felt any pressure, political pressure from the white house or other agencies in terms of the selection of the companies to develop a vaccine, the timing of the Vaccine Development, the announcement of a vaccine or any other aspect that is part of your responsibility on the medical side . Dr. Collins no. Lots of internal pressure as a physician and a member of the world to try to find the answers. Dr. Redfield senator, my answer is no. Dr. Disbrow the answer is no. I am a scientist, not a politician. Senator durbin thank you. Thats the answer i was hoping for and what the American People are looking for. Let me go to the next question on the medical side and heres where i think we need to have some candor. When i am told that the phase three Clinical Trial of the Moderna Vaccine thats been conducted by the university of illinois at chicago will kick off in about a week and they anticipate that it will last years before two years before they completed it, collecting information from all of the people who volunteered for the test, blood samples and the like to determine the safety and effectiveness of that vaccine, i find it difficult to square that reality thats been announced in their phase three Clinical Trial with the promises that im hearing over and over again that within 12 months were likely to have a vaccine. It suggests to me that the phase three Clinical Trial, which ordinarily takes two years, is going to be somehow abbreviated. Now, i understand the emergency use authorization at f. D. A. That may be utilized to choose a vaccine and going to production, distribution of such a vaccine. But that has had at least some mixed results recently when it came to the hydroxychloroquine that was announced. So how do we maintain the confidence of the American People of the safety and effectiveness of vaccine if it appears that we are shortcutting this phase three Clinical Trial thats usually required in these vaccine circumstances . Dr. Collins senator, maybe i can explain why that twoyear interval was there in terms of the assessment of the vaccine. We need to know as soon as possible is, does this vaccine, when administered to people who currently are not infected but are likely to get exposed, does it protect them from becoming infected . So each of the vaccine trials will aim to enroll 30,000 participants. Half of whom will get the vaccine. Half of whom will get a placebo. Well watch, then, as these individuals, and they are going to be particularly recruited in areas where the vaccine is currently spreading, either get infected or dont. It will only take about 126 episodes where somebody with the placebo gets infected and somebody with the vaccine doesnt to know this has worked. That will be the point where you would be happy to say this now has efficacy and, of course, youll have a lot of people to see if there is safety. The reason to prolong the study after that has been achieved is longterm side effects that werent anticipated . We dont think so but you want to be able to follow. Also, how durable is this particular immunity . Is this vaccine will be something that will work for life or will you need a booster in a year or two, hence the timetable. Senator durbin if im going to make a decision, good news, 126, whatever it happens to be, in the span or three, four months, heres your vaccine. If im going to make that decision, what youre telling me the phase three Clinical Trial still has important elements in my decisionmaking process to be resolved, which are going to take time in terms of longterm impact of the vaccine, is that correct . Dr. Collins thats the way we do a lot of trials of drugs, not just have a scenes. Whether you assess the drug is safe or effective. Then you dont stop looking once f. D. A. Has given an approval. You carry out longterm studies to make sure there is not some unexpected result or the drug stops working. Thats basically the plan here with vaccines. We dont want to miss the chance to collect that downstream data. Senator durbin dr. Collins, are you familiar with the cutter vaccine issue . Polio vaccine . Dr. Collins yes. Senator durbin did you respect on that for a moment what the world of Vaccine Development looks like today compared to then . Dr. Collins yes. That was a terrible tragedy and circumstance where a vaccine actually turned out not to be fully inactivated and created the illness it was supposed to prevent. I think i could reassure you and the American People that that strategy of trying to administer a killed vaccine is not currently being pursued for sars cov2. Because of the risks. Instead the vaccines choose to produce just a small component of the virus. These proteins, these pike proteins that sit on the surface. Thats what the vaccine produces. There is no intact virus there at all. The cutter experience, a terrible tragedy, is not possible with the way these vaccines are being designed. Senator durbin thank you. Chairman blunt senator alexander. Senator alexander we have been talking about vaccines. Next year id like to talk about tests and treatments this fall which is only a few weeks away. Lets start with tests. Dr. Collins, with all the depressing news we hear about covid19 for the last several months, americans are hungry for sports. Will there be enough covid19 tests so we can watch some football this fall . Or some basketball this winter . I notice the National Hockey league said it was going to test every player every day. The president of Brown University told our committee she wanted to test every opportunity before they come back. Its been said the country will have 40,000 to 50,000 test capacity by september. That will probably be enough to have widespread testing to go back to school and work. But will it be enough for sports teams to take the field . Probably the answer lies with your red x effort to make a new way of creating quick, reliable, diagnostic tests that can be administered frequently, maybe even every day. Well be able to watch some football and some basketball this year. Or do we have to wait until next year . Dr. Collins im probably the least qualified sports fan but i do appreciate this is important to a lot of people. We want to see americans have a chance to have some normal experiences of enjoying life. I do believe this should be possible. What is being done and appreciate the strong support from this congress to make this possible is to speedily put together these kinds of point of care tests that can be done on site, can give you a result within an hour, and can tell you immediately whether that person is actually infected with the sars c 06789 v2 virus which they can be immediately quarantined. The general sense is for athletic teams you need to know that. Otherwise you will have an out that will wipe out the entire team. Senator alexander your goal is to have these tests available this fall. September . Thats your goal. Dr. Collins that is the goal. The path we are on right now and again this is a White Knuckle goal because its never been done in anything of this timetable before would be to have one million tests per day available for the kind of point of care on the spot testing thats very much needed for going back to school and going back to sports events. Senator alexander these would not be the tests that have to be shipped to a lab. Dr. Collins thats our goal. If they are going to be shipped to the lab the lab needs to be nearby. We are aware there are places where there are labs that have instruments that could be brought to wear on this widely distributed already but havent been adapted to this purpose. That would be a next best thing to have them in your own local arena. The best is to have your gadget right there at the front desk when somebody shows up for practice and find out is this person somebody who is safe to send to the field. Senator alexander threats go to treatments and medicine. Senator kennedy may be here. He said in his way that he thinks what people are really afraid of with this virus is not just getting it but they might die. They might die or have a very severe illness because there is no medicine for it. Except you mentioned two that have been approved by the f. D. A. So as we go back to school, for example, 75,000 students going back to elementary and secondary school we are happy that covid19 doesnt seem to affect children very much. Or even College Students very much. But there is the danger that there this might i effect their teachers or older administrators or they go home to their parents or grandparents and might infect them. What can you say to the teachers and administrators and parents and grandparents about medicines this fall will help them not die and not have a severe illness . What will be available this fall when the kids go back to school . Dr. Collins there are intense efforts to expand that territory from the approved drugs to other kinds of ways to do effective treatment. A big promise here is the use of what you might call passive immunization where you basically provide to somebody who is ill antibodies derived from somebody who has survived already. This is the idea behind convalescent plasma being rigorously studied and right now analyzed by the f. D. A. To see the results. More than that one could develop antibodies senator alexander this is the antibody cocktail developed and approved by the f. D. A. With ebola. Dr. Collins exactly. It worked really well. You have these antibodies taken from somebody who has survived the disease and you turn that into a product. Those trials are going to get started this month. Senator alexander thank you, mr. Chairman. Chairman blunt thank you, senator alexander. Senator shaheen. Senator shaheen thank you for being here and your testimony and service to try and address what is obviously the worst threat to americans in my lifetime. Im concerned about the impact on Older Americans and those in longterm care facilities in New Hampshire 80 of our covid19 deaths have been in longterm care facilities. Thats the highest percentage in the country. Im concerned as you talk, dr. Redfield, about how you prioritize who gets the vaccine when we have one. How do you prioritize these residents and those with underlying conditions like diabetes . Dr. Redfield thank you very much, senator. Very, very important question. Obviously this is going to be discussed through our Advisory Committee on immunization practices. Clearly the most vulnerable and those individuals at greater risk for mortality have to be highly considered. As well as those individuals at great risk for infection because of what they do. Turns out among Health Care Workers that get i effected we recently looked at it, turns out the most common Health Care Workers who got infected were the nonnurse, the sort of the caregiver in the nursing home. These are going to be critically important. I will say one thing. Depending on which virus vaccine is approved, it may have particular characteristics that make it more or less appropriate to begin with in different populations. This is why i think its hard for us to know exactly until we know which of the virus clearly the vulnerable will be, if not the top priority, one of the top priorities. Senator shaheen do you have a timetable when you make those decisions . Obviously things are moving rapidly. Dr. Redfield there is discussions already going on. But as i mentioned at the end of the day its going to be dependent on the characteristics of the particular vaccine product we are now planning to do. Senator shaheen staying with you, dr. Redfield, last month the agency for toxic substances and disease registry issued a statement expressing concerns about the relationship between exposure to pfas chemicals and the risk for covid19 infections and complications. In New Hampshire and in communities across this country we have a number of people who have been exposed to pfas who are very concerned about this statement. Can you tell us what the agency is doing, what c. D. C. Is doing to assess the impact of pfas exposure on covid19 risks . Dr. Redfield we are currently working, both of our agency for toxic substances and flu division, are working together in a study to try to learn better about the interrelationship between the pfas certificate yum concentrations and the association between symptomatic covid infections. We do have a study ongoing to try to understand that association. Senator shaheen do you have a timeline for that study . When you expect to have data that could give us some insights on that . Dr. Redfield i think i really learned that i have to be careful in trying to predict. As my colleague, dr. Collins said, science has its own timeline. Senator shaheen do you think we are talking months, years, decades . Dr. Redfield we are not talking decades. But obviously we are trying to get that information as soon as we can. I really am not able to commit how fast the science will be done, senator. Senator shaheen seems to me that would speak to trying to address pfas exposure wherever we can. I think this is for you, dr. Disbrow. As we are talking about the challenge in this pandemic, one of those testing, at least, has been trying to provide access to all of the ancillary supplies that are required. I think that is probably going to also be true as we think about the vaccination plan and distribution. We have heard from one manufacturer in New Hampshire who makes syringes that they need some certainty so they can order the equipment they are going to need to make those syringes that are going to be available for vaccinations. So can you give us any details on the anticipated timeline for the award of contracts for production and supplies . Dr. Disbrow thank you for that question. As Everybody Knows making a vaccine is more than just making the bulk vaccine. There are multiple steps involved. You have to have finish capacity. Barda is working hard with our partners, the joint Program Executive office, as well as under o. W. S. To reserve excess capacity for fill finish so you cannot overwhelm make the vaccine by fill it. We are working with j. P. O. To expand capacity for vials. You need the vials for the vaccine. We have awarded contracts for needles and syringes acquiring needles and syringes. We are working with j. P. O. To expand capacity for needles and syringes so there are sufficient needles and syringes when the vaccine becomes available of the we are working on all aspects of the vaccine. There is also kitting, when you send out a vaccine you have to have the needles and syringes, alcohol wipes, bandaid. And then there is the distribution. As dr. Redfield mentioned, it was important the people developing the vaccine and under warp speed we are tied in with the group talking about distribute and kitting because they have to know what that vaccine will look like. Is it a single dose, multidose vial . What is the cold chain requirement . We are working across operation warp speed and multiple different work streams that are fully integrated. Blood pressure senator moran. Senator moran thanks to you and the Ranking Member for having this hearing. Thank you for joining us. Dr. Collins let me thank you for joining me on a phone call with the university of Kansas Health system in which report on a vaccine was the highlight of the day, month, and year. So im pleased to hear medical researchers and practitioners in kansas heard what you said and found it to be very pleasing kind of optimistic note. Let me ask something that is covid19, or is a virus so unique that there are not things that can be done to better prepare us for the next virus . The next pandemic . So that a Vaccine Development is developed, the development occurs in a shorter period of time . Or is it just starting i dont know scratch is the right word, but starting from scratch each time . Dr. Collins its a great question, senator. Yes, i enjoyed talking to the folks in kansas. Wonderful bunch of scientists and physicians. Coronaviruses of which this is one have been around a long time. Some of them cause the common cold. We still havent cured that one, but it hasnt been such a high priority. And sars and mers were also coronaviruses. We learned something from them. If we not had already an effort to try to develop vaccines for sars and mers, we wouldnt have been able to jump on sars cov2 quickly. Every time do you this you get better at it. Plus the Overall Technology for how we develop vaccines has been advancing. The lead vaccine now in terms of its earliest out of the gate, which is the Moderna Vaccine, and the fisa one announced yesterday, utilizing r. N. A. As the thing you inject so you ask the body to make the protein which then backs the antigen your immune system reacts to. Thats pretty new. We would not have done that years ago. Well keep Getting Better at new ideas. I do hope, maybe this is part of the question, we learn from this experience when we get through this, because we are going to get through this, we dont then go back into some complacency and say thats it. We wont ever have another one like that again. Because we all know we will. What will it be . Will it be another coronavirus . Will it be that influenza epidemic we are worried we are overdue for coming out of somewhere that will be very dangerous . We should never again step back into the point of complacency with these kinds of emerging infections. I hope we will, therefore, from what has been built to deal with covid19, sustain that. Senator moran i want to follow up on that but i want a question to dr. Redfield. Ill try to get back to dr. Collins. Dr. Redfield, thank you for the telephone conversation we had several months ago. I would highlight for you and others who might be listening that the issue of p. P. E. , personal protection equipment, is back front and center. Seemed to me in my life it had diminished a bit. In conversation with Community Leaders, including hospital and Public Health officials, the concern is the supply is short once again as the numbers increase. And the potential of greater circumstance is more challenging circumstance comes in this fall. Any suggestions that anyone who hears this statement of mine has on how i can get additional p. P. E. To kansas Public Health hospitals and employers i would welcome that. Let me ask you, one of the things i take away from whats transpired is the importance of Public Health departments. I think generally we have until i served on this committee, i didnt realize the significant role that c. D. C. Plays in support of our community and Public Health departments. What is it that needs to take place so that when the vaccine is developed our Public Health departments are prepared to administer that vaccine in the distribution . How can c. D. C. , this Committee Help make certain that occurs well . Dr. Redfield thank you very much, senator. I think you heard me say before we had decades of underinvestment in our Public Health departments across this nation. This is the time now to correct that. You all have made great support, c. D. C. Has already awarded 12 billion with a b to the local, state, territorial, Tribal Health departments in the last eight weeks or so to begin to give them the resources they need to begin to build up their capacity. Human capacity usually takes longer than weeks to build up. We are obviously as you know c. D. C. Has over 650 people embedded in the local Health Departments to help with that human capacity. Well continue to work with them. Recently with the resources did you with the carrots act, we were able to get a little over with the cares act, we were able to get a little over 10 billion for plans how to expand their testing, contact tracing, Public Health infrastructure. We are doing it on the run. I think you have heard me say before when it comes to Public Health, when it comes to Public Health, this is something we as a nation should plan to be overprepared not underprepared. And i do believe this is the moment in time when this nation can actually help put the Public Health infrastructure across this nation not only that we need but this nation deserves. As you mentioned, most of c. D. C. s money actually gets distributed to the local, state, territorial, Tribal Health departments. Some of these Health Departments were 70 of their overall funding. We are the nations funder through you of the Public Health infrastructure of this nation. We need to augment that to where we are now overprepared for the next pandemic. Senator horan mr. Chairman, if you have a second round. Blood pressure senator merkley. Senator merkley thank you very much, mr. Chairman. Dr. Collins, i wanted to get some sense from you of our understanding in a short and simple version of whether this coronavirus is such that we anticipate that its mutations will mean different vaccines may be effective against some versions of the disease but not others . And whether it means we will likely have to have an annual production of modified vaccines based on those mutations like we had with the flu . Dr. Collins thank you. Thats a very important scientific question that many of us are wrestling with to collect as much data as we k i think the somewhat reassuring news is that this particular virus, which is an r. N. A. Virus, does not have a rapid mutation rate. Its not like influenza or h. I. V. Where you know you have a tough time getting a vaccine to work or to stay effective. But it does change over time. There is at least one significant variant in the virus thats already happened since it originally appeared about six months ago that may have made it somewhat more infectious than the original strain coming out of wuhan. We are not absolutely sure of that, but it looks like that might be the case. The good news is that though variants we detected do not seem to be those that would interfere with the effectiveness of the current vaccines being designed and tested. Nor with the antibody strategies also being tempted. We are going to watch that carefully. The big question well have is whether this is a circumstance where once vaccinated you are basically protected for life or whether over the course of time this virus will change its coat enough that you will need to have a booster thats slightly better in its design for whatever it is that this turns into next. We dont know the answer to that. But i think the good news is this is not like h. I. V. This is not like influenza. Its a fairly well behaved virus we think we ought to be able to tackle effectively with a vaccine strategy. Mr. Senator merkley thank you very much. I want to turn to the question that senator murray raised about the elimination of the safeguards. Those safeguards for reasonable pricing when the government has invested in the development have never been implemented. Many people feel they serve as an effective instrument of leverage should the American People be gouged after investing millions or now perhaps billions of dollars. Was n. I. H. Consulted about removing the safeguards from the contracts . Dr. Collins we were not asked about that. We have been asked about those safeguards in other circumstances. Senator merkley do you support inclusion of those safeguards to keep the American People from price gouging after we invest in development of drugs . Dr. Collins i certainly think the American People ought to have access to vaccines they are helping to pay for. I think the plan has been nicely made to be sure that is the case so nobody would be denied access to this regardless of their health care. The issues are complicated when you look at the original language. It does seem as dr. Disbrow said earlier these were intended to allow the government to step in when there was a company that basically refused to try to produce a product to benefit the public. It does not look as if those particular parts of the bill were intended to do something where the price was considered to be unacceptable. We have been caught in this many times before and thats what the lawyers tell me. In this circumstance i have to defer to barda, but my understanding understanding was there was no likelihood the product wouldnt be pursued. Senator merkley it would be ok to leave them in the contract. But it still has the marching rights and n. I. H. Claims joint ownership of the Moderna Vaccine. I find it interesting that n. I. H. Wasnt consulted over the difference between that contract and some of these other contracts. Dr. Collins i have to be careful here because its possible somebody at n. I. H. Was consulted. I was not made aware of it. I have to check on that. Senator merkley thank you. Dr. Redfield, the c. D. C. Consulted over the contract and designed to ensure fair pricing . Dr. Redfield not to my knowledge, sir. Senator merkley thank you. Dr. Disbrow, why suddenly eliminate this language in some of these contracts but not others . Who was it who asked you to do this . And what did you include language in some contracts and not others . Dr. Disbrow some of the confusion is in our far base contracts it is in there. Some of the documents requested by the group that asked for them under foia, freedom of information act, were other transactional agreements which are outside of the far. These are research and development contracts. We are not acquiring product under these contracts. Senator merkley recognize, too, its rich and development being funded by the American People with the vast potential for profit for the companies. So the American People have a stake in fair pricing. I think the American People are aware that they are gouged on drugs routinely. That we pay more than citizens in any other developed country. 80 of americans routinely respond they want fair pricing. They shouldnt be charged more than the citizens of other countries because we spend more in the development of the products. I think that plays double here. The reason im emphasizing this is we are going to spend billions of dollars in this development. And we should absolutely use that investment to make sure we are not gouged on the back end. So i just want to say this conversation that murray initiated and im following up on here is an important one. I hope you are going to take thoughtful consideration of how to make sure that the americans do not pay more for these drugs through the government payment or through citizens having to pay for them, than do the citizens of any other developed country. In fact, i hope youll make sure thats the case. Blood pressure thank you, senator merkley. Senator capito. Senator capito thank you, mr. Chairman. Thank you for not just being here today. I know you have been on political many times but thank you what you have done and going to do to meet this crisis. Dr. Disbrow, i have a question. Many of my questions i had initially youall have answered on that. Efficacy and safety issues around the vaccine. As i recall back when we first started we had an issue with china making the p. P. E. , with italy having the swabs. I might have had a little long. But the reagents in germany. There was a competition globally for all of these supplies. I imagine there is going to be a competition globally for the Vaccine Supplies and the vaccine itself. Dr. Collins mentioned that they have been working with u. K. In a collaborative way. How much of what youre seeing the development is actually manufactured in this country where we can sort of control our own destiny . Dr. Disbrow thank you for the question. This Global Pandemic has highlighted the vulnerability in our supply chains for medical devices, Raw Materials, and active pharmaceutical ingredients for drugs. I cant give you the specific number of what percent of the products are manufactured here in the United States. What we are doing as i mentioned responded to one of the earlier questions is we are working for a needles and syringes and vials to expand domestic capacity so we dont have to worry about this in the immediate future and near future. We are also working with all of our manufacturers to make sure they acquire the Raw Materials needed to manufacture vaccines and or therapeutics because therapeutics are also important. So that they can manufacture at scale. Senator capito is this a question you ask when you are looking at giving contracts whether its produced in the United States, where you can control your own destiny . Dr. Disbrow we look at the raw supply material chain. We do that for all our manufacturers to identify risks early on and address those risks early on. Senator capito i would like to dig down on that. I think that thats concerning. Obviously because this is a global issue. I think it sort of shook the American Public when we realized we werent controlling the ability to have testing supplies or the ability to produce our own p. P. E. Dr. Collins, a question i have a little off topic but equally as important. You know that n. I. H. Is invested heavily, so we hear on the opioid epidemic. But the latest stats coming out of our state of West Virginia, senator manchin is here, and across the country is there has been a big spike in overdoses during this covid epidemic. Im wondering i know youre fast at work on this in a lot of different various ways, how are you seeing that . And how might having a vaccine or having Better Therapeutics be able to help us meet this challenge of folks that are in therapy for addiction or had this addiction issue to be able to cope during these very stressful times . Dr. Collins senator, i appreciate you bringing this up. Its not off topical all. Its a sear ewes National Tragedy that has gotten even worse because of the coalescence of the covid19 crisis and the opioid use disorder crisis. I have seen those same statistics about maybe a 42 increase in overdoses in just the last three months. And deaths associated with that are going up. After we had started to make headway with this crisis, with all of the things that had been done with various programs and use of medications we know can work and yet now prescriptions for those medications have plummeted because people arent able to get into treatment programs. We are doing everything we can at n. I. H. With supplements to some of our Research Programs to try to understand how best to intervene. How to provide people with support even if it has to be done remotely by telemedicine kind of interventions. We have been supporting the idea that methadone, which traditionally required people to show up every day in a crowded location, could actually be done in a fashion where people could receive this at home because otherwise the dangers are too great and people were simply dropping out. I cant tell you how desperately we need to get back in a place where people can congregate together that. Will require effective treatments and vaccines. Thats on my mind every day as we are trying to accelerate that progress. This is a very serious situation, indeed. Senator capito really the counseling going on by telehealth initially was actually having greater they were staying more true to their appointments and going well and then it has gone back down. Dr. Collins people need interaction more than just through a zoom call. Thats hard to do right now. Senator capito dr. Redfield, four seconds. Our vaccination rate in West Virginia is falling. How are we going to do a p. R. Campaign that this is important . Dr. Redfield its a critical point, senator. I always look at the consequences of covid as the second said. Health versus health. 85 decline in pediatric vaccinations in individuals under 5. We are obviously we are in the process of making a play with the Miles Per Hour academy of pediatrics to respond to that. Its really important. Globally its a big issue, too. I try to say in subsaharan africa, where covid is a significant problem. A much bigger problem is there is 120 million children who havent gotten the measles vaccine. Chairman blunt thank you, senator. Senator baldwin. Senator baldwin thank you, mr. Chairman. I have a couple of i hope quick questions. Dr. Disbrow, can you quickly list for me the vaccine prospect that are being invested in right now . You have narrowed it from many who have come forward first it was 14, now fewer. Can you list them and what type of vaccine it is . Dr. Disbrow i appreciate the question, senator. Can i not specifically mention some of the companies we are in active negotiation was many of them. One i can mention is astrazeneca where we already have a contract. We are in the process of moving forward with Large Manufacturing contracts and acquisition of vaccine for multiple other candidates. Senator baldwin those Company Names in terms of the vaccine prospects are not public . Dr. Disbrow some of the companies originally funded by barda for advanced research and development, those are public who we invested in. I think your specific question may be the composition of the portfolio under operation warp speed. That can i not today talk about. But we are very quickly moving and negotiating contracts and hopefully in the very near future well be able to make an announcement with the entire portfolio under operation warp speed. Senator baldwin how many have been finalized right now versus how many are you still in negotiations with . Dr. Disbrow i already told you about the one which is the astrazeneca. And we have others we are working with. Senator baldwin how many do you think youll have in total . Dr. Disbrow more than one. Sorry. It really is procurement sensitive. These are market moving negotiations that we are having with these companies. I just need to be careful about that. Again, we are happy to publicly announce. You will see the press releases when we award these contracts so that everybody is aware of whats being supported. Senator baldwin to have the intellectual property of prospect you also have the manufacturing you want to make sure to fit timelines youll be able to have [no audio] dr. Disbrow im sorry you cut out for a little bit. Is manufacturing going to be u. S. Based . Senator baldwin yes. Dr. Disbrow yes. 100 . Are you looking at any vaccine prospects that you [no audio] chairman blunt lets go to senator kennedy and well come back to senator baldwin once we think that we have this technical problem worked out. Senator kennedy. Senator kennedy thank you, mr. Chairman. Thank you, gentlemen, for being here. Gentlemen, id like your opinion on something. When the pandemic first became apparent in the United States, a number of busy and important people, senator people, in the federal government also in states state and local governments, told us, the American People, that we shouldnt wear a mask. That a mask would not protect other people. It wouldnt protect us. And in fact, in some case it is might actually hurt us. When i heard that i thought to myself, you know, this is odd. Because i turn on the television and i see doctors and nurses wear masks. When they are treating coronavirus patients. I remember thinking this is odd, i wonder where they went to med school or nursing school. Next we were told by these busy, important people we were told, well, you should wear a mask. The reason you should wear a mask is not for yourself but to protect other people who might get the coronavirus from you. Then i turned on tv again and i saw these doctors and nurses wearing masks, treating people with coronavirus. And i thought to myself, this is odd. Why are they trying to protect the patient . The patient already has a coronavirus, for gods sakes. Then it occurred to me that maybe these busy and important people were wrong and are wrong. So i talked to a lot of doctors and nurses, not the ones i saw on tv, others whose judgment i respect, and i read a little bit. And i came to the conclusion that a mask is very helpful. And it will protect us. It will protect other people, and it will protect you. And thats why i wear a mask. Because i dont want other people to die, and i dont want to die. Now, how come these busy important people who are smart people in the federal government told the American People this . Dr. Collins may i, as a busy person. Let me try as a physician to explain the history. Mask is not a mask is not a mask. The kind of mask im wearing that most people in this room are wearing, cloth masks or Something Like that, are pretty good at capturing any kind of droplets that might be coming out of your mouth while youre speaking, because im producing them right now. If i happen to have sars cov2 you dont want those droplets near you. Senator kennedy i get all that. Dr. Collins but we didnt really know that, senator, until march or thereabouts. This is a very unprecedented way for a virus to spread. To have asymptomatic people spewing out virus like this. Senator kennedy excuse me, but why were the doctors dr. Collins they were not wearing these masks. They are wearing n95s. Senator kennedy we didnt have enough n95s to go around. Dr. Collins they should have. Senator kennedy could have, would have. Dr. Collins this doesnt do a great job of protecting me guns somebody else who is near me. It still allows senator kennedy is some mask better than no mask . Dr. Collins in part because senator kennedy how come we didnt tell the American People that some mask is better than no mask . Dont you think it would have been better to convince people now to wear a mask . Dr. Collins at the beginning senator kennedy you happen to be here. Dr. Collins at the beginning, senator, i dont think we realized of asymptomatic people spreading this. We thought if you were around people who were healthy you werent going to catch this. If you went into a sickbed you might need to worry about it. Senator kennedy doctors and nurses on the frontlines got it. Let me ask you one other quick question. Give knee a yes or no. I think youall are going to say yes. Is the expedited process for developing and testing therapeutics and vaccines safe . That we are using right now . Dr. Collins yes. Dr. Redfield yes. Dr. Disbrow yes. Senator kennedy how come we dont always use it, then . Dr. Collins im not sure the question. Senator kennedy we are going faster than we normally do, right . How come we didnt always go faster . And will we go back to doing it the old slower way once we are past the pandemic . Dr. Collins we talked about we are spending a lot of money by going really fast and doing things that are probably ahead of where they should be and running the risk therefore of needing to throw out a lot of materials we dont use. We cant usually afford to justify billions of dollars in the circumstance. This time we can give the Public Health emergency and people are dying. Chairman blunt thank you, senator kennedy. Back to senator baldwin. About half of your time is still left, senator. Senator baldwin not sure what happened. I wanted to finish my question with dr. Disbrow and perhaps also address it to dr. Collins. Are we considering any vaccine candidates where the delivery method would be something other than syringe and needle . Dr. Collins not at the current time. But there are products. Senator baldwin let me move to dr. Collins. I know that a lot of the companies that are catching the most attention are very large with the capacity to produce in large quantities. Some innovation comes from very small companies. I know wisconsin has a number of small biotech companies. Working in both the vaccine space and the treatment space. What can you tell me about their opportunities to participate . Dr. Collins senator, there were more than 100 vaccine opportunities coming forward. Of course we had to because of the Public Health emergency choose the one that is had the best chance of being able to scale up really rapidly. But there are lots of great ideas out there about Vaccine Development which might not be the ones you want to bank in for sars cov2 right now because such a sense of urgency. This is not the last time we are going to face an infectious disease. I hope all of those ideas will continue to be developed for whatever comes next. Or perhaps if we end up in a circumstance where this vaccine is needed to help a booster down the road, this virus doesnt seem to be completely vanquished. Some of those ideas could be helpful. We just had to prioritize. Finally i would say in terms of Small Businesses, senator alexander was asking earlier about diagnostics. For the radx program which aims to try to bring on great ideas about new ways to do diagnostics at point of care, of the more than 560 applications we have gotten, 2 3 have been from Small Businesses virtually from every state in the country n that space theres been a wonderful opportunity for innovators to come in and have a chance to be scaled up rapidly. Senator baldwin final question for dr. Redfield. With regard to a master plan for Vaccine Development and production and prioritizing initial delivery, can you let me know how far along we are on a plan all of us will be able to review in writing . Particularly with regard to the tail end of when it is available, who will it first be made available to . Because i think that is something that we really need to see. I know there is an ongoing set of panels and experts who are tying themselves to these decisions. I want to know the timeline for such a written plan. Dr. Redfield thank you very much, senator. You are right. A number of us are working on this plan. Unfortunately at this moment i cant tell you exactly when we are going to have a plan released, but i can commit to you that we will, when we have completed the plan, have a plan that will be released. As i said, part of the nuances of it will depend upon the actual vaccines. But the background plan independent of that is being developed and working through and being coordinated through operation warp speed. As i mentioned c. D. C. Does have the lead on this distribution. As we get it completed we will make it available. Chairman blunt thank you, senator baldwin. Im going to ask a question on the ethics and that discussion later. So youall might be thinking about that as you try to determine a priority of who gets access as access is available. Go to senator murphy. Senator shotz, and senator manchin in that order. Then a second round. Senator murphy. Senator murphy thank you very much, mr. Chairman. Thank youall for being here. Being so attentive to our concerns and questions. First let me just follow up on a series of questions that senator merkley raised. I dont have a question connected to it. Puts me in an uncomfortable position with disagreeing with dr. Collins. But the United States government has never exercised marching rights under contract. It is true there is a lot of question and dispute regarding exactly what the government is allowed to do, but the language in the underlying statute is in fact very broad. It requires companies, contracted to the u. S. Government, to provide these drugs upon reasonable terms. And there are plenty of legal scholars who read into that term price. That if you are gouging consumers, then you arent offering the drug on reasonable terms. I would disagree with any guidance thats being given that said the government cannot use that underlying statute. As a mechanism to prevent price gouging. I think its been a real success of the pharmaceutical industry to get lawyers to make recommendations that provide that kind of limitation. I at this think its really concerning that that language is not in many of these contracts that are being sold, that are being signed by the government today. Its important to say. But, mr. Disrow, one particular question that arises out of concerns that have been presented to be by smaller and mediumsized Drug Discovery companies in and around the northeast, i have had a number of smaller companies, but companies with track records of success who have tried to be in contact with barda and have received absolutely no response. And given these concerns about cronyism and the potential track record that i think deserves investigation regarding companies that are big and multinational and have connections to people inside barda getting preference, do you think you have the resources to field inquiries and respond adequately to every company that may have a promising proposal to make to you . Because it does concern me to have heard from many very Good Companies in my state and my region who have been, frankly, completely unable to get any response from barda. Dr. Collins i appreciate the question and also the comment. Dr. Disbrow as the new acting director of barda, i am committed to doing a much better job. In a typical year we are able to interface with multiple companies. We hold approximately 150 to 200 tech watches each year where companies can come in and speak with us about their technologies. As i mentioned in my opening statement, to date we have received 3,394 submissions that we are trying to get through so that they receive a fair evaluation. And we are working as quickly as possible. So under normal circumstances i think the answer is yes, we are always looking to bring on new and bright and talented people. But we are a bit overwhelmed right now, but we are still working through the process. We have had over 391 tech watches. Corona watches where its a virtual tech watch not an inperson tech watch. We continue to strive to improve our best business practices. Senator murphy i appreciate that answer and i hope youll make recommendations to us on what Additional Resources we can give you. It would be absolutely tragic for a small or Mediumsized Company who might have the ski that unlocks treatment or vaccine to be left on the outside. In the remaining time, im going to take the bait from senator alexander. As he knows i care a lot about College Sports. As a fan. But also as someone who wants to make sure we Start Playing games in a way thats safe for, especially College Athletes who receive no compensation to go out there and make billions of dollars for other adults. My question is to you, dr. Redfield, has the c. D. C. Given recommendations regarding whether it is appropriate to have fans in attendance at either College Sports games or professional games this fall . I can see having enough resources to be able to test athletes, but we certainly dont have the resources to test every fan that walks into a crowded stadium. Even a College Stadium thats one quarter full still has tens of thousands of people in close proximity. Has the c. D. C. Any guidance with respect to attendance at sporting events . Dr. Redfield not directly. We have had interaction was most of the Sports Industries both at the professional, collegial level. Senator murphy why not . Thats a really important question. Should we put 20,000 people in a College Football stadium . Dr. Redfield i guess i misspoke then. I thought if you thought we directly recommended that we have fans. We have put our guidance several weeks ago on mass gatherings. Which would include obviously those events. We have commented directly in our guidance over the last three or four months on gathering size and precluded fans from going to being recommended in these sporting events. I was looking at the other way around. Did you think we made a positive recommendation to include them . Clearly our mass guidance and all our previous guidance to slow the spread for the 15 and 30 days we have not recommended these gatherings to be such that you would have fans in the stands. Chairman blunt thank you, senator murphy. Senator manchin. Senator manchin thank you for being here. Its good to hear from you. Im just trying to, dr. Disbrow, just a simple explanation of the money that we have invested so far, i know my tally shows Johnson Johnson got 456 million. Moderna has 483. Emergent biosolutions, 620. That was all for developing vaccines. That comes out to 2. 76 billion. And then for distribution and manufacturing, apple jack got 138. Mallard, 164. Sio2 Materials Science 143. For a total of about 650 million. When you put it all together you are up around 3. 3, 3. 4 in that neighborhood. What do we get back as taxpayers when this vaccine when one of these companies or all of them have a proven vaccine . Are we a private investor . Do we get something in return . Do we get this value back as far as in the vaccine that can be distributed to all our Health Centers . Now we have to buy it back . Dr. Disbrow there will be future procurements of the vaccine. To address your specific point, yes, we do receive when we are doing contracting for acquisition, we seek consideration to the u. S. Government for previous investment its more than just a dollar per dollar investment. It is also the cost of capital, because the u. S. Government took the risk to make that investment. Senator manchin we are taking the risk same as the private sector. So private citizen would take this risk, they get a bigger return for the risk. Dr. Disbrow right. Our investments would be taken off the senator manchin our investments would be dr. Disbrow no. If the company was going to charge 10 for a dose of vaccine, this is an arbitrary number. I dont think anybody is charging that. For sale outside the United States, in the United States the u. S. Government would buy it at a reduced price because we already invested 450 million to support senator manchin we are going to get our value back. Dr. Disbrow correct. Senator manchin are we able to control the pricing or put pressure on them not to gouge . Dr. Disbrow again, whenever we are negotiating, the best value to the u. S. Government we seek consideration. These are hard negotiations. Yes, we seek the best value. Senator manchin you already testified on. P. P. E. s didnt get out the way they were supposed to. And we are concerned about getting distribution. And i know youall spoke about the community Health Centers. Dr. Collins and all that. I appreciate what youall have done. I can tell you they are still hurting very much so because a lot of states have not distributed the money that they received as help from the cares package to keep them viable. Theres money there that hasnt been distributed properly. We should be putting pressure on our governors to do their job to make sure our First Responders and county Health Departments have the necessary funds. They are not getting it i can assure you. Rural health. Rural providers have been hit particularly hard by the epidemic across the United States. Covid19 are growing faster in rural areas at 13 than National Area of 9 for the second week in a row. Rural counties have the highest number of new cases of covid19 in a sevenday period since the pandemic began. West virginia saw a single day high just yesterday. We have 12 hospitals in all of our hospitals are rural. 12 hospitals already closed. Three in West Virginia, and we are concerned about the Rural Health Care that we have to distribute. Hows a vaccine going to be distributed in the rural areas to make sure we are able to meet the rising challenges that we have there . Rural providers have the necessary equipment where they have the personnel to administer the vaccine. Dr. Redfield thank you, senator. A really important question as you know. The broader question of how we maintain help capacity in Rural America. As i said there is going to need to be a variety of Innovative Strategies to ensure that we can get broad distribution particularly the groups that have been under vaccinated. You mentioned the rural. We had under vaccinations historically in africanamerican, hispanic populations. And we need to more aggressively and the h1n1 there was reluctance to fully engage the pharmacies. As vaccine outlets we need to expand that in this distribution. There is going to need to be clear linkage with the community Health Centers that will along the with the local Health Departments in addition to that i think there will need to be mobile units that are going to be able to go and provide broader vaccination access, particularly in Rural America. Senator manchin Rural America is getting hit hard now. We knew it would be a delayed reaction how they are getting hit. We are the most vulnerable population in the country of West Virginia because of our age and type of hard work they have done. They have Underlying Health conditions, too. If it hits, its going to be a disastrous proportions. We need to stay ahead of it. Right now we had a hard time getting everything else. We have a hard time getting a vaccine or antibody when it comes, we are really up the creek. We hope you put the attention towards rural and make sure that your associates understand the need for rural. Dr. Redfield we are committed to make sure that all those in need get access to this vaccine. Chairman blunt thank you, senator manchin. Dr. Disbrow, lets talk a little more about any obligation these companies we partnered with have to be sure that the vaccine is available at a reasonable price. If they fail, we underwrite their failure. Im for that. I want to get plenty of opportunities out there on the field advancing forward so that we have as many vaccines as we can have available as soon as of the individual vaccines available, as soon as we can. But if we are successful we basically get our money back plus interest. Are there surely there are other obligations here in that partnership of the privatepartner to make the vaccine available in a reasonable way. Would you expand on that a little bit. Dr. Disbrow sure. Thanks for the question, senator. Also remember that each of the companies that we are working with its a true partnership. The u. S. Government has assumed risk. Many of the contracts that we have are cost shared contracts. Meaning that the company also assumes risk. The companies while we are working on awarding the contracts that i mentioned earlier, are agreeing to proceed at risk under operation warp speed. Because they are committed to developing a vaccine. Yes, the goal is to negotiate the best price for the u. S. Government. We would probably have to pay a slightly higher price for Industry Partners who chose not to receive government funding because they assumed 100 of the risk. Senator blunt dr. Collins, and others can enter into this discussion if you want to, in terms of determining the Health Priorities, we should be doing this right now. We know were eventually going to have a vaccine. Therapeutics. Lets focus on where were going to be with the vaccine in terms of distribution an accessibility. Who is talking about Health Priorities or ethical issues that relate to the rapid opportunity for people who want a vaccine to get a chance to have the vaccination . Dr. Collins very important question. One that is occupying the minds of a lot of us thinking about this future that we hope to have as soon as possible. Youve heard bob redfield talk about what the c. D. C. s role is but i think there may be an opportunity before we get to that moment before we have a vaccine thats been proven safe and effective to have a broader discussion that bring into this ethics, experts in Public Health, people who are particularly aware of challenges for reaching out to those who have suffered from Health Disparities for a long time and are being hit particularly hard by covid19, another area where we want to be sure as far as priorities. Bob redfield and i talked a bit about this, this may be a moment to bring together a group of such big thinkers who could take a high level view of this and lay out a foundation of principles that could be utilized by his c. D. C. Committee, the acip, when the moment comes to turn that into an implementation plan. We think that might be something best done in a circumstance by an organization that is not itself governmental because its still the case, i think, that people are a little uneasy about the government calling the shots here. We are having a conversation very early on with the National Academy of medicine about whether they would be the place to convene such a discussion. We can keep you posted on that, it looks promising. I think that would be a really good step right now. To do that quickly and have those principles laid out, say, before labor day. Senator blunt im confident well hear from others about whether the National Academy of medicine is the best place to do this or not, and thats good, that input will be good to have, and you may hear it before we do, but it does seem to me that this should be happening right now. Just like every other plan about distribution of the vaccine, of therapeutics, of test, particularly the vaccine. I would think if were going to have this discussion, lets not have it after we have a vaccine and were waiting to distribute it because we havent had a discussion of the ethics or health care priorities. Dr. Redfield, do you want to talk about this . Dr. Redfield i want to make one comment, mr. Chairman, because i couldnt agree more. I want to say how important it is that we have it now because its not just about who is going to get the vaccine. Its also about, we have a requirement to study the safety and eff ka soif the vaccine in these populations. Historically if you have underlying me call conditions, significant, you dont get into vaccine trials. If you have pregnancy you dont get into vaccine trials. If youre a child you dont get into vaccine trials. Dr. Collins and i discussed this, theyre planning to make sure these populations are inclued because the last thing we want to be is trying to recommend who gets the vaccine and we dont have any data in how the vaccine works in the population that we really think this vaccine needs. Clearly right now theres really thoughtful thinking among the vaccine trialist, how do we make sure that we have good representation of africanamericans, hispanics, children, pregnancy, women, individuals that are elderly that have multiple chronic medical conditions. Because thats where this vaccine needs to go. And so i dont know if francis wants to comment anymore on it but i know they are thinking how to move those populations into the phase three trial efforts so that well have that data when we need it. Senator blunt dr. Collins, and then well go to senator murray. Dr. Collins the doctor has said it well. This may make it more challenging to run a phase three vaccine trial when youre trying to enroll a diverse set of volunteers, it would be easier to line up a bunch of 20somethings who happen to be from the white population, but thats not the only answer we need. We need to really have this diversity. Many of us are working hard to make sure as the trials get launched in the very near future they have that kind of outreach. Senator blunt lets be sure that the trials arent needlessly waiting because we havent had this discussion as quickly as we need to have it. Senator murray. Senator murray thank you, mr. Chairman, and thats exactly what ive been talking about, why we need a plan and why the public needs to see this plan. Even if everything goes well, and we have a vaccine and it is safe and effective to the best of everybodys knowledge it isnt going to be available for everybody september 1, and we need to know how its going to be distributed, where its going to go, what the priorities are. The public is good at dealing with facts. Theyre not good at dealing withvery expectations that have no chance of being met and then we run into all kinds of problems. Thats why ive been pushing for a public plan for us to be able to know how this is going to happen. Im in that game. Dr. Disbrow, let me ask you. Experts are saying Clinical Trials for treatment can move more quickly than vaccine trials and then an effective drug that renders the virus less deadly could allow us to begin to return to normal faster. So about the concern that barda notified researchers it was halting funding for treatment of severe lung ailments associate as well asvirus dampening the overall immune response that causes the body to turn on itself. I wanted to ask you, why did barda decide that the development of therapeutics for severe forms of covid19 is not a priority, and how did this how does it communicate that change . Dr. Disbrow thank you for the question. Two part response, and i promised to be very quick. Barda continues to invest in therapeutics, including the Large Program you heard about before. Over 25,000 people have been transfused. We are further supporting hyper immune globulin where you take pooled plasma and use that for antibodies. We are also supporting neutralizing antibodies. All of that is being done under operation warp speed similar to what were doing for vaccines. We did close the immunotherapeutics portion because at the same time under operation warp speed in collaboration with dr. Collins active program, what we were receiving were individual proposals with no clear identification that the products would work as an immune modulator but requesting very large phase two or three studies. Under the active partnership with o. W. S. , the decision was made to stand up large Clinical Trials, a Clinical Network under a master protocol where you can evaluate multiple candidates for immune modulators and they will also be looking at anticoagulants as well in a smaller cohort to determine if there is clinical benefits. If any of these drugs are run through active protocols show clinical benefit, were happy to engage with those developers to help them with manufacturing. Senator murray it was also reported that barda suspended applications for the development of treatment of covid19. Can you explain that. Dr. Disbrow i didnt hear the question, the last part . Senator murray it was reported recently that barda is suspending applications for the development of preventive treatment for covid19. Explain that. Dr. Disbrow preventive therapeutic treatments . Senator murray correct. Dr. Disbrow i will have to look into that and get back to you. I apologize. Senator murray ok. Vaccines are important and we all want that, but we dont want to put all our eggs in one basket. Especially since we know we have seen issues in the past where it is hard to develop. We all want it, but we cant put our eggs in one basket. So i will be following that. Dr. Collins, i want to direct a question to you. Given the devastating impact of covid19 on black, latino, tribal communities, its so important that we ensure equitable representation in our Clinical Trials for vaccines and therapeutics. There was an internal analysis on inclusion that shows that only 29 of participants in n. I. H. Funded Clinical Research were members of racial minority groups. Only 9 were ethnic minorities and initial reports suggest were still not achieving adequate enrollment for these groups in Clinical Trials for potential covid19 treatments and vaccines. Can you tell us what n. I. H. Is doing to reduce the barriers for participation and recruit people for these . Dr. Collins senator, i really appreciate this question. This is an extremely high priority. As has already been pointed out at this hearing, the burden that has been laid upon the shoulders of minority groups, particularly africanamericans, latinos, and native americans from covid19 has been extreme, with much higher rates of hospitalization an deaths in those groups. That means that the Health Disparities that we have known have been around for a long time have a very bright light being shone on them. This is our opportunity and responsibility to take this on and with the greatest seriousness. Certainly when it comes to running the Clinical Trial, both for vaccines an therapeutics, this will be the highest priority. We want to work with the parts of n. I. H. That have expertise in this space like the National Institute of Minority Health and Health Disparities, but we also want to work with institutions out there like the hbcus that have that kind of credibility and capability. Theres an irony here in that were also at a moment, i think, where there is perhaps more suspicion about government involvement in such things and yet this is the very moment where we need to have the trust of those communities to reach out to them. And that means we need to engage Community Leaders in that space. That means the churches, that means the heads of various organizations that represent these underserved populations. And we are building all those bridges as fast as we can and i totally agree with you. If we fail at this, at this moment, where Health Disparities have emerged in such a dramatic way, we will have really failed to live up to our responsibility as stewards of the public trust. Senator murray let me just ask one quick followup on that. Because there was a recent report from c. D. C. That pregnant women are more likely to be hospitalized with covid19 than nonpregnant women, and despite a lack of data its clear women of color are disproportionately at risk. So im concerned about the lack of inclusion of pregnant and lactating women in in Clinical Trials. Are you going to file the fda guidance by including them in Clinical Trials for covid19 . Dr. Collins absolutely. We have been looking at ways to include pregnant and lactating women and it applies very strongly in this place. This is another high priority at n. I. H. Dr. Diana binaki, who is our director, has been a leader in this space. Were trying to put together a way to improve the ability to do successful outreach safely to pregnant women and lactating women. We have to have that included as part of this mission. Senator murray thank you. Thank you for indulging me, mr. Chairman. Senator blunt senator alexander. Senator alexander thanks, mr. Chairman. Dr. Collins, i believe you said that youre considering involving the National Academy of medicine in determining the fairness of the distribution of vaccines. Is that correct . Dr. Collins that is correct. Senator alexander the National Academy describes itself this way, if i remember, it was founded by president lincoln, chartered by the United States congress, to attempt authoritative, objective, and scientificallybased answers to difficult questions of national importance. The New York Times called the National Academy of medicine the United States most esteemed and authoritative advisor on issues of health and medicine. So, put me down as thinking thats a good idea to involve. Because as people across the country look up at whats happening here theyll see agencies without the medical with, and agencies alphabetical names, and they may be greatly respected agencies or bodies, but i dont believe they have the prestige of the National Academy of medicine. So in terms of the fairness of the distribution, i think the only downside i can think of, because ive worked with the academies many times, you may have to speed them up a little bit because the academies are accustomed to not moving at warp speed and youre trying to move at warp speed. But were not talking safety, were talking about fairness. I think thats a good idea. I would endorse it. Let me move on to Something Else, dr. Collins. I want to pick up words that you or senator moran said, Something Like sustaining what weve built. We had a whole hearing about this in our committee that senator murray and i chair, the health committee. For 20 years, weve had four president s and several congresses pass nine laws and try to be prepared for pandemics and we thought we were, and then we get assaulted with this sneaky, dangerous, covid19 virus and we find gaps that didnt happen. Senator frist, the former majority leader, testified before our committee. He pointed out he made 50 speeches when he was majority leader, identifying what needed to be done, tried to do them but between pandemics we get our eye off the ball. We have other things to do. And we dont do the hard things. So it seems to me that what i im going to work hard with senator blunt, senator murray, anyone else, senator shelby, others, to try to make sure that we dont make that mistake this time. And that while weve got our eye on the ball, while were paying attention, while we have these lessons in front of us, that we do them. For example, manufacturing. Building up capacity. Were building up onshore capacity, barda says. Well, are we going to sustain that . Or are we just going to let happen to it what governor levitt testified happened with the last manufacturing plant . Stockpiles. We know what happened with stockpiles, they diminished. Hospitals and states sold them off. They didnt have the money to keep them up. Data. Were not all happy with the way data is being aggregated by c. D. C. And need to take a look at that. Are we going to wait until next year when were worrying about Something Else, or are we going to do it now . Hospital preparedness. Were getting our hospitals prepared again, but are we going to sustain that for the next pandemic . This is not the last sneaky, dangerous virus thats going to assault our people. State and local support for Public Health. Governor levitt, former secretary of health, former governor, said for 30 or 40 year, as dr. Redfield said, we have gradually underfunded Public Health. So were not as prepared as we think we are. When were assaulted by a virus like this. So i would like in my remaining moments, dr. Collins, to have your comment on the importance of in the middle of this pandemic sustaining what we built up for the next pandemic because im pretty sure based on my experience that if we wait six months and everything is over and were back to normal, well be worrying about Something Else and we wont make the difficult funding decisions, which most of them are, on manufacturing stockpiles, data, hospital preparedness, and state and local Public Health. Dr. Collins well, id love to capture the words youve just spoken and try to be sure that we all look at those every month or so after we get through this current crisis, which we will. But our track record is not so good here. We dont really think about this as sort of we need an insurance policy against the next pandemic. We would never think about going bare in terms of insurance for our homes or our cars, but we have gone bare too often in terms of insurance against pandemics, which requires that sustained investment. Youve enumerated quite nicely the areas that have been allowed to slip in between these episodes. We might have a covid23. Who know what is the next coronavirus is. Or we might have an influenza that comes, which is sort of overdue now. And my sincere hope would be given that this has been after all the most serious infectious threat in the lifetime of any of us that this time we would have a little sustained memory. I for one would like to help with that, too. Senator alexander thank you. Thank you, mr. Chairman. Senator blunt thank you, senator alexander. Senator moran. Senator moran mr. Chairman, thank you very much. I have been listening in my office to all of the hearing today, but im glad i was here in person to hear what senator Alexander Just said. And lamar, while your tenure in the United States senate is coming to an end, i hope your voice on this and many other things does not cease. What you just said is important for us and for the American People to hear and i appreciate what how you conducted yourself always, but what you had to say today was especially valuable. Dr. Collins, i promised i would come back to ask you a question and it deals with the consequences of the pandemic on research that was ongoing prepandemic. And so im worried, this subcommittee, this Appropriations Committee, n. I. H. , our colleagues in congress, have highlighted the importance of n. I. H. Research and in many instances have put our money where our mouths are. And im worried that we have set the stage for a step backwards rather than a step forward as a result of the virus. And so my question is, that you can discount that if thats the not true but my impression is that research that should be ongoing today is not, that laboratories are not at capacity. Many are shut down. People have not been able to come to work. I dont know how prevalent that is in University Research versus institutions in maryland. But what is it that we need to know to make certain that we provide the resources, perhaps in a phase four, that would quickly restart the capabilities of n. I. H. To be on the path toward finding the cures to all the things we want to cure . Dr. Collins senator, i really appreciate your asking the question. This is very much on my mind as i see the way in which by necessity for safety reasons so much of our research enterprise, not just at n. I. H. And our laboratories in bethesda, but all over the country since thats where most of n. I. H. s dollars go, has been very much scaled back. Many of the research that involves something other than covid19 was pretty much put into a very slow pace because people needed to head home to protect against the further outbreaks. And people were still able to do science, and many of them have worked incredibly hard doing what they can do, but if you need a lab bench and you need some equipment and some supplies, you cant do that in your dining room. So it is fair to say we have lost a lot of time with research that required that kind of action, whether its in Cancer Research or something to do with gene therapy or a Diabetes Project like in my lab because all my people had to go home too. This has been a major negative consequence among many others of covid19. We do not want to see that have a lasting impact. I will tell you, the universities who are major grantees are hurting bad right now because of the way in which this has hit them financially. They have both had the difficulty of not being able to conduct research they thought they were doing, but many of them have medical centers that have been hemorrhaging money pause of the inability to do elective surgeries and other procedures that would normally allow them to balance the books. Theyre in deep trouble. We have estimated just on the basis of the research thats been lost, something in the neighborhood of 10 billion of federal funds that may be necessary to recoup if were going to bring these institutions back up to where they need to be. On top of that, i think theres a wide variety of areas that n. I. H. Oh, my watch is talking to me, thinking im talking too long a wide variety of areas that n. I. H. Would like to put more effort into to compensate for this in terms of our efforts in covid19. So yes, we have been very interested in hearing what might be possible in terms of that compensation and i know institutions are who are grantees are particularly so, so probably including in kansas, i would be surprised if you have not heard from leaders there about the situation theyre in. Senator moran doctor, thank you. I dont know how many times ive asked you when will we be able to delay the onset . When will the research be sufficient to delay the onset of alzheimers . When are we going to be able to rid ourselves of diabetes . And you have, in your ways, have tried to tell us time frame on which things seem to be on, and i worry that if we ask the question today, it would have to be a time frame that is much shorter. And while the pandemic is certainly severe and serious, a crisis in many way, the cure for cancer, the ridding ourselves of diabetes and alzheimers is so significant as well that we cannot now allow this circumstance to keep us from being on the path necessary to do the things that we set out to do. Dr. Collins i want to assure you, n. I. H. Is doing everything within our power to allow flexibles among grantees in terms of ways to keep things going. Young investigators can have an extension on their timetable for their career next step and all of that, but it is still a heartbreaking situation to see the consequences. Senator moran since i used most of my time to brag on senator alexander, im going to try to get another question in. And that is, we see and hear dr. Fauci regularly. And tell me about the other institutes at n. I. H. I dont mean to discount him, my actual question is, what are the other institutes having to do with the pandemic . It wouldnt just be Infectious Diseases that are trying to help us solve this problem. I assume n. I. H. Across the board is engaged fully. Dr. Collins absolutely. I convened all the Institute Directors back in march and said what can we do collectively that one institute cant do, though certainly dr. Faucis is in the lead. And every single one of our 27 institutes have a role theyd like to play, some of which they dont have resources for but hope they can obtain them. The heart, lung and bachelors degree institute, since this is a lung disease, are running a trial of anticoagulants because that is the place, heart, lung, and blood, that is where they have the greatest expertise to help the most ill patients. The Genomic Institute to try to figure out whats the difference between individuals to predict who will get really sick after exposure and who will shrug it off. There is probably some big story to be learned there in terms of what could be useful including who would be highest priority to get a vaccine. I mentioned child health and the importance of worrying about kids but also about pregnant women. Certainly the Health Disparities issues you have heard about are absolutely pressing and we have expertise in that space as well. So it is all hands on deck with people designing programs, trying to figure out if there are ways they can reallocate dollars in the very rapid turnaround and hoping theres a way they can expand that because of the great needs. So thanks for the question. It is very important and very much on everybodys minds at n. I. H. Senator moran ive utilized more than my good will, so i cant ask any more questions, but dr. Disbrow and dr. Redfield, i have issues and things id like to discuss with you and i look forward to doing that when it becomes possible. Senator blunt senator kennedy. Senator kennedy thank you, mr. Chairman. Gentlemen, i want to thank you for being here today. I want to thank you for your hard work. I know youve been under a lot of pressure. And i know this has been a learning process. And were learning more each and every day. I dont know whether were in the middle of a new surge or the first surge never ended, doesnt really matter. But the American People are scared. Theyre scared not just about their health and their familys health, theyre not just scared about dying, theyre scared about their job. Theyre scared about their country, theyre scared about their world, theyre scared about their church. This is overwhelming for all of us. But they are really overwhelmed. And theyre not morons. Theyre very intelligent. They dont have time, of course, to because theyre too busy earning a living to read every day on the latest information. I want to echo my colleagues and strongly encourage you at some point to, if you havent already, prepare a report, but also with your other colleagues, perhaps dr. Birx, dr. Fauci, set aside some time to Talk Straight to the American People. Tell them the truth. As i know you will. Underpromise, overdeliver, no spin. Explain where we are on vaccines. Im encouraged by the progress thats been made. I think the speed is breathtaking. Im impressed that the whole world is working together. And explain where we are in terms of delivering that vaccine if we develop it. You may have to do this on several different reports or press conferences, and i know this is an easy thing for me to suggest. There are others that will have input in terms of you holding a press conference. But i would do the same thing about therapeutics. As ive said a number of times, people arent afraid of getting sick, theyre afraid of dying. Now, nobody wants to get sick but people would feel a lot better if they knew if they got sick theyre not likely to die. I know theyre not likely to die, but many people dont understand that. And thats where the therapeutics comes in. I would also encourage you to talk frankly to the American People about what they can do to make themselves as safe as possible. Theres been a lot of misinformation about social distancing and masks. I think the information has been pretty consistent about good hygiene. But you gentlemen and others have credibility. And i would strongly encourage you to do that. And i want to thank you for your service. I mean that. Give the American People some hope. But tell them the truth. And i think there is hope out there. The other issue i wanted to talk about but im not, well save it for another day, we got to get our kids back to school. Weve got to get our kids back to school. Weve got to do it. And we need your help figuring out how to do it safely. Thank you, mr. Chairman. Senator blunt thank you, senator kennedy. I did notice a major Pediatric Group came out yesterday talking about for nutritional reasons, for socialization reason, for the sanity of their parents, kids need to get back to school. Itll be the most likely touchstone that things are returning to normal if we can get that done. So, dr. Collins, on the testing area, im concerned the dates im hearing dont seem to quite match up with the millions of school kids and college kids taking tests multiple times, when school starts, that would be easily taken and quickly responded to. Do you want to talk about that for me just a little bit more . Dr. Collins ill try. So, currently the way that testing has been progressing, youve seen substantial increases across the country now to the point where more than 30 million tests have been administered and were at the point now where between half a million and a million tests are happening each day. But as i said earlier, many of those are circumstances that require a Central Laboratory and where the results may not come back for a day or two or three. What were trying to do with radx is to greatly enhance the ability for those kinds of tests to be there. We are both looking at platforms that go into the shark tank and then have the opportunity for rapid expansion. Were also looking at a few things that are a little more advanced, but not advanced enough. They could sort of bypass the shark tank and go to the next phase in a program called radx atp, for advanced technology program. Some of those are also looking promising. And were doing everything we can to pull them up into a high throughput space. Again, we have said if this went really well wed have millions more tests per week by the end of the summer, beginning of the fall. Im talking to bruce stromberg, whos the director of radx, a very gung ho engineer as you know, from having met with him. He believes that we could get to the point of an extra million tests per day just from the radx program by the first of september, by labor day. Thats a heck of a stretch since we started this program at the end of april, but thats the trajectory were on. That would go fairly steadily upward then over the course of the next two or three months, so it might be more in the neighborhood of five million to 10 million additional tests per day by december. Thats our current projection. Again, taking the exhortation from senator kennedy about underpromise and overdeliver, im not trying to tell you what i think the absolute most amazing outcome would be, im trying to tell you what we could achieve and then hold us accountable and see if we can do it. Senator blunt from elementary senator blunt from Elementary School to Big University to an employer, are you thinking about cost as one of the things youre looking at . I dont think these can cost 50 a test or 120 a test. I think weve got to be very cost conscious here in what we encourage. Dr. Collins that is absolutely part of the way each one of these platforms is being assessed. If you have something thats really cool technologically, but is not clear, it to me thats what we should be investing in right now. Sometimes people say it will cost 100 bucks but then the shark tank folks get involved and drive that price down. Heard dr. Unt i disbrow brought up the reality that when you have a vaccine, you have to have a package to house the vaccine that will be administered. I cant imagine the outrage if we had a vaccine and we need, lets say, a handful of items to be able to give that vaccine and we only have four of them. I cant imagine how aggravated people would be starting right here if somehow were not totally prepared for that. Tell me whose job that is to be sure we have all of that in line so that not only can the vaccine be developed and delivered, but we have everything we need to be sure it can be administered. Dr. Disbrow it is important to have an endtoend plan for vaccine, development and delivery. Right now the Strategic National stockpile is working on the kitting of the vaccine, sorry the components. Senator blunt go ahead. Dr. Disbrow theyre the ones doing it, but again under operation warp speed, it is a continuum. The people who are developing the vaccines, those working groups are letting them know, its going to be a fivedose vial, so youd need to send out seven needles, seven syringes, seven alcohol wipes. Because you have to have excess. And were all working together on that. Is putting together those kits. Senator blunt who is doing that . The hhs . Disbrow under operation warp speed, they are under the table. Senator blunt were going to ask questions of them about this topic, then. Dr. Redfield, do you want to add anything to that . Dr. Redfield the only thing i would add, because it is important, weve done pandemic exercises to prepare for pandemics and identified, as you pointed out, that everything was fine but we didnt have enough needles, or everything was fine but we didnt have enough vials. Thats been taken into account here. Senator blunt i hope so. Dr. Redfield but the other area i want to emphasize is dont underestimate the importance that we have the chain capability depending on what the restrictions are of the product, that that product needs to be handled within that cold chain for that distribution. Senator blunt right. I believe i understand what were trying to accomplish here, these various vaccines would have Different Levels of what they need to have to maintain their efficacy . Dr. Redfield that is correct. Some of them will require minus 80, a higher level cold chain requirement. Some may require less. I think its important that we are preparing to make sure we have redundancy in our cold chain capability. Senator blunt there may be more than one more covid bill. I think we should assume that between now and sometime late this year, theres probably one more chance to get this right funding wise. How much money do you need . Dr. Disbrow i cant say how much we need on the record, but we will work with congress and our colleagues at hhs to identify our budget needs and bring those to you. Senator blunt you will work through the secretary . We need to know that number. We need to be thinking about that. Dr. Redfield, do you want to talk about this topic . What do you need to enhance the flu vaccines at a level we have not been able to encourage people to take before . Plando you need for your 60 days later for a vaccine network, what resources do you need that you will not have unless we provide them . Dr. Redfield thank you, mr. Chairman. I want to echo the sentiments of chairman alexander, just to go back to my view that now is the time to make the investment in the core capabilities in Public Health that this nation needs and deserves, its a broad issue in terms of daytoday modernization, the ability to have predictive data analysis, laboratory resilience in the Public Health work force. In terms of distribution of the vaccine, largely one of our key responsibilities, i think its important for people to realize that distributing a new vaccine to everyone in this nation is a complicated process and it is going to take resources. Its not measured in the millions, its measured in the billions. Its not like were just going to send a vaccine off to a bunch of doctors offices and its all going to happen. I think its important that we make that investment so that just like were developing the vaccine at risk right now, if it when its finished, the company is going to have enough to actually start to give it to the American Public. We need the exact same thing for the Distribution Strategy, commented by senator murray and others. That process has to happen now. It is going to take resources to build it. Senator blunt we have confidence we need a vaccine. We need to know what the plan is. There is no reason to wait any longer than we have to. We ought to have that plan put together right now that has the flexibility that allows you to deal with different vaccines from different locations in different ways. But this is, right now is the time that ought to happen. Whoever you need to work through to get the information we need about what thats going to cost, we need to know that in the next couple of weeks. Dr. Redfield yes, sir. Senator blunt dr. Collins, i think we put a billion dollars in shark tank and other money in substantial money at n. I. H. For all of these various divisions to be looking at what they need to be what do you need next . Dr. Collins i appreciate the question. Ill consider this that youre asking for my professional judgment. Senator blunt i am. Dr. Collins i mentioned in response to senator morans question, the desperate need our forting institutions have the result of covid19 and the loss in Research Capabilities adds up to about 10 billion. Thats part of it. We do have transn. I. H initiatives developed over the course of the last few weeks that i think would make major contributions to our advances here. Theres about 1. 6 billion in those projects that involve multiple institutes and another 2. 2 billion for specific institute initiatives that i think have very high value. Then on top of that, we also are thinking about whether there are ways we could help with the economic difficulties in the country, because n. I. H. Every dollar we give out we know has a stimulus for the economy and we have an additional set of ideas there for things that would be shovel ready that add up to another 5 billion. Those are things we have been thinking about. Senator blunt i think on the grantee front, i know weve been talking about the grants that were going to run out this year, basically they lost this year an extension of those grants, some money to start laboratories back up. And some absolute authority that the grants you didnt get to determine this year dont get lost in this process and you have more time to do that. Would those three things all be correct . That is very much correct. Appreciate you being so on top of those things. Theyll matter a lot. Senator blunt senator alexander. Senator alexander thanks, mr. Chairman. Its been a helpful hearing for me, learned a lot. Dr. Collins, Nashville Metropolitan schools start august 4. So do a lot of other schools in the south. They start i know in the north they think thats uncivilized, but thats what we do. So the relevance of that is to test and treatment. As i said earlier, we had a lot of talk about vaccines down the road. Tests and treatments are upon us. And i get a sense i cant prove it but were going to really need those point of care tests youre working on and were going to need them quickly. I hear lots of anecdotal stories about Lab Technicians that are overworked, machines that are overworked, about people who can, even in our state where the governor has said if you want a test go down to your Public Health department and get it. I get conflicting rumors that some Public Health department s say only if the doctor says so. I hear stories of delays, of three, four, five days before the diagnostic test comes back and of course its not very useful when it comes back several days late. What im getting around to is i want to underscore the importance of your point of care tests and i hope you will let senator blunt and the rest of us know if theres anything that we can do to accelerate your radx effort, because creating millions of new tests a day that are point of care, rapid, quick, reliable, as senator blunt said, our surest path toward normalcy is when 75 Million Students go back to school and college. And it will make it will build a lot of confidence in those schools and colleges if the schools and colleges can test as frequently as they want to. Randomly, or every class, or every floor in a dorm, or as the Brown University president said, she wants to test every student before they come back. Ok. Most campuses arent going to do that, but she want to. So if thats what builds the confidence to come back, your project is the answer to that. It seems to me. I have the same confidence in it that i did earlier when senator blunt and others worked on it. Let me my final my other question is treatments. We talk about going back to school. Having the point of care tests so you can test any student, any class, any teacher, whatever you want is one thing. To say in the preliminary meetings, come back to school. Were going to try to be open five days a week and we want to assure that teachers, administrators and parents and grandparents at home, that when you come back, there are some specific medicines that are going to be available that will help make sure that your illness is not as severe and that youre less likely to die. Could you take a minute and quickly list those . Two or three of them are already approved, two or three like the antibody cocktails are very promising, and what would those things do . I mean like, remdesivir, if ive said that right, did i hear someone say that increase decreases by 32 the amount of time to recovery. Thats important specific information to someone. Dr. Collins i totally agree with you this is critical. Its a major part of operation warp speed. Im glad to say Janet Woodcock is now the leader of the therapeutics for operation warp speed, a very experienced scientist who knows how to get things done. Its a privilege to work with her. Yes, remdesivir has been approved. It does reduce hospitalization. Senator alexander if im a parent and my kid comes home sick, is that available to me to help make my hospital stay shorter . Collins remdesivir is produced by gilead, the u. S. Government has acquired large numbers of doses. It is intravenous, so its for people who are in the hospital and are pretty sick. We know it works. Senator alexander what else would reassure me . Shownllins a steroid was in a study in the u. K. U. K. , we worked with them all along, it showed a significant improvement in survival of those on ventilators and those not on ventilators, but were on oxygen. We have those too, but that is not nearly enough. We need to push forward all these other things quickly that look like they could have promise. The active partnership that i described, Publicprivate Partnership, looks hard to see. What would be the most important therapeutics to get prioritized because there were hundreds of ideas out there. Then try to get those into Clinical Trials. There is a trial coming soon of other immunomodulators. Things to damp down the overreaction of the immune system that seems to happen in people who are very sick, particularly those in i. C. U. s. There is a trial Getting Started soon on anticoagulants, its clear this virus does something that makes the blood overly clottable, it clots in the lungs and other places, that can be a fatal outcome. We need to figure out how that works. Then there are all of these immune systems, the antibody cocktail, the convalescent plasma, all those now being subjected to rigorous testing this summer as well in the United States. Senator alexander theres a possibility or a likelihood that some more of those will be available for parents, grandparents, teachers, administrators who might be infected . Dr. Collins were going to push hard to get those trials to a point where you can draw a conclusion about their effectiveness by the end of summer, early fall. That is the goal. I think the antibody cocktails have a lot going for them because we know they worked for ebola and all kinds of reasons to think this is the kind of virus it should work for too. Senator alexander and you have several Companies Making those, right . And if they work and are safe, you should be able to produce a lot of those . Dr. Collins that will be the challenge, producing them. Having warp speed involved and thinking about the manufacturing so we dont have a successful trial and have to wait to scale it up. These have to be done in big fermenters. Barda is very enganged in that, as is n. I. H. , as is the whole warp speed team. We want to be sure if we have something that works, theres a lot of it out there. Senator blunt thank you, senator alexander. Thanks to our witnesses. Weve take an lot of your time today. Its been helpful to us. For people at hhs who are here, who are following this hearing, i think we need more clarity in 1950s and he said to them, youve got two jobs. One is your ship. And one ship and your reactor. Happens,r blunt we need to knw and we need to know in a hurry. We can be helpful if you dont tell us how to help. And we need these questions answered. Thank all of you. Thank you for sticking with me. Senator murray was with us right up until the end of this as well. The record will stay open for one week for additional questions. The subcommittee will stand in recess. [captions Copyright National cable satellite corp. 2020 chatter] [captions Copyright National cable satellite corp. 2020] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] crisis, people are losing their lives. With Police Reform taking center stage in congress, watch our live coverage of the latest developments, less the governments response to the coronavirus pandemic. From were going down 30,000 to 20,000, and now we stayed flat, and then we was started going up. And briefings on foreign affairs, health care, and insight. There is a line one should not cross where governmental power is used e
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