And Publicprivate Partnership in the fight against covid19. [indistinct conversations] senator dont believe this. Now its on. Senator is it . Ok. The hearing of the health, labor, and Pensions Committee will please come to order. As we begin our hearing i would like to explain the changes we have made to address the health and safety recommendations made by the attending physician and sergeant at arms after they consulted with the department of health and Human Services at the centers for Disease Control and prevention. Seating has been spaced so we are six feet apart and we have made it possible for senators and witnesses to participate by Video Conference if they choose to do so, and several have. To maintain social distancing, we have very limited seating and dont have room formulas of the public to attend, however this hearing is available to watch a live online and a recording will be available on the committee health. Www. Senate. Gov. The hearing will be shown from gaveltogavel in its entirety, unedited by anyone from the moment that we start until the very end that we stop. Due to the limited seating, representatives of the press are working as a pool to relay observations to their colleagues and senators and staff present have been reminded about the safety guidelines put in place by the attending physician. We all wore our masks. Im not going to wear mine during the hearing, since we are six feet apart, but senators may do whatever they choose to do. I would like to thank the rules committee, the sergeant at arms, the architect of the capitol, capitol police, Nonpartisan Committee staff for all of their hard work to help keep us all safe as we conducted these important hearing. In april, the owners of a Senior Living facility gave of covid19 diagnostics test to 2500 at their and residents 26 communities in tennessee and kentucky and according to the there were very few who tested positive of the 2500 and those that tested positive were all without symptoms and they were all put in quarantine. This is what he told the newspaper from tennessee. Because of the fear we decided the only way to make sure residents didnt have the virus was to test them. There is no substitute for. Esting everybody all roads back to work and back to school lead through testing. Our country will soon be doing 2 million diagnostic tests for covid19 per week. An impressive number. But to contain the disease and give americans confidence that it is safe to go back to work and school, we will need tens of millions of tests. Many more than our Current Technologies can produce. First tos necessary identify the small number of us who have the disease or who have so that thoseo it americans can be quarantined so that we dont have to quarantine the whole country. Testing is important, secondly, because it will help americans who are traumatized by the daily reports of the virus. It will help us to gain the confidence necessary to go back to work and school. This hearing is about how we will find those new technologies that are needed to rapidly produce tens of millions of tests in one of the most ambitious Scientific Enterprises by onent memory, headed of our countrys most distinguished scientists. Looking ahead i want to mention two important oversight activities for the committee. Number one, next tuesday our hearing will examine how we are dealing with this pandemic covid19. Dr. Witnesses will be anthony fauci, director of the National Institute of allergy and infectious disease, dr. , the assistant secretary for health at the u. S. Department of health and human hahn,es, and dr. Stephen commissioner of the fda. The second oversight activity i would like to mention is that during the next few months, our committee will examine why are what our country needs to do for the next pandemic that will surely come. I think that congress should put in place the structures and the funding to be ready for the next pandemic during this year, while the Current Crisis is still on our minds. Over the last 20 years, the last and severalents congresses, including after sars,bird flu, katrina, and ebola, have passed several major laws that created a. Ational stockpile provided incentives for development manufacturing, diagnostics, treatments, and vaccines, strengthened the centers for Disease Control, and for the last five years thanks to the leadership of senators blunt, marie, and others, they have provided record funding for the National Institutes of health. We will talk about the importance of preparing for the next pandemic at the hearing next tuesday. As a result of all of that effort, with three president s and several congresses over the , the New York Times reported the following on , most experts agree that the United States is one of the countrys best prepared to prevent or manage such an epidemic. But i think we would all agree that we would have liked to have been even better prepared for covid19, as everybodys responsibility is to make sure we are even better prepared or the next infectious disease. I want to play for the record a remarkable speech by the former Senate Majority leader, bill thet, who saw clearly then problems we still have to do you with today. On april 19 they punt published his essay, storm that we were unprepared for, which i would also include in the record. The end of the crisis will be determined by three things, tests, treatments, and vaccines. There is promising news we are likely to hear more from today and treatments and therapies will be available this summer and the administrations warped speed pursuit of a vaccine has a goal of 100 million doses by the byl and 300 million doses january, a target much more ambitious than has ever been achieved before. The private sector has demonstrated a capacity to turn out quickly tens of millions of serology tests. The tests that determine whether you have had the disease and have the antibodies that might create some immunity for a time, although that is not proving yet. This week is taking aggressive steps to make sure these tests are accurate. After a bumpy start caused mainly by a faulty test , United Statesc is now conducting over one million diagnostic tests weekly. By mid june there will be two and a half million available to dr. Deborahng birx, coordinator of the Coronavirus Task force. As of yesterday, according to President Trump and john hopkins university, the United States has conducted over 7 million diagnostic tests. May 1, the wall street journal described the testing situation this way. Tests, have approved 70 more than approved for the flu virus of 2009. More tests per capita have been performed in new york city than in singapore, south korea, and australia. Hospitals and labs have performed 1. 6 million tests in the past week according to the covid tracking project and last week Governor Andrew Cuomo said the tests would be available through some 5000 pharmacies across new york state and abbott labs says they have shipped one million tests for their machines in the field that can return isults in five minutes and manufacturing 50,000 kits per day. U. S. Hospitals have more than 5000 fast testing machines that require no special training. Some 93 of the u. S. Population lives within 10 miles of a test site, according to the wall street journal. The testing has expanded the , where there is a shortage of nose swabs and chemical reagents, but the shortages are easing things like the resourcefulness of private prop , allowing polyester swabs, swap manufacturers can prioritize. Onavirus kits that is the end of the summary. The task force submits that dates have submitted their goals, testing from a, and the administration is working to help provide swabs that states are not able to obtain on the commercial market so that states can meet the goals. That is all very impressive. But not nearly enough. To test every nursing home, every prison, everyone in an operating room, and some entire classes, campuses, and factories , team sports events, to give those tests more than once, we will need millions more tests than we are producing today. The demand will only grow as the andtry goes back to work someone hundred thousand Public Schools and 5000 colleges plan to reopen this august. There are two ways to increase Testing Capacity and of course, the first is to squeeze every possible test out of Current Technologies. The second is to focus today on the need for new testing technologies. Throughout march and april, senator blunt of the Senate Appropriations subcommittee had many conversations with experts in the government and across the private sector and we couldnt find anyone who thought the Current Technology could produce the tens of millions of tests necessary to put the virus behind us. So, we worked to include in the 1. 5 recent legislation billion dollars for what we called a competitive shark tank. The name was described after the thatty Television Show pits entrepreneurs in a competition to see who can succeed. At the National Institutes of health would utilize the capacities of government itself in coordination with the private out all the stops in fasttrack new technologies designed to produce tens of millions of tests and by august, at least millions more tests by august and even millions more than that by the flu season. We allocated another 1 billion for medical advanced research of Development Authorities to work with the National Institute of health to accelerate production of those. Speaking the scientists across the country there are many ideas , some using crisper Gene Editing Technology and one of them allows you to use her cell test to photograph your swab results, send it to your doctor, several million incorporate wearable technology. Theres a lot of talk about antigen test. The nih only five days after the funding was signed into law announced the official start of its Shark Tank Program to boost the most promising testing technologies. There were 400 requests for applications in the first 24 hours as of may the fifth and im sure dr. Collins will update us on this, there were 800 and andxpressions of interest 50 applications have been submitted and reviewed. Many of these earlystage concepts wont work. Or they wont be able to be scaled up quickly enough. But thats ok. Thomas edison said he tried 10,000 times and made 10,000 mistakes before he produced the first incandescent lightbulb. We hope we dont have that many we need aret all two or three successes, or even one from the shark tank. The first place to find these technologies is at the National Institute of health, dr. Francis collins leads the nih, once led the effort to map the human genome, here to talk about the 1. 5 billion shark tank. The second place, a division of the department of health, working across government, the private sector invest in multiple innovative ideas to and easyccurate, fast, testing capabilities to build new capacity. Is acting director of barta here to talk especially about their role in scaling up whatever new innovative tests dr. Collins finds. They have another 1 billion for that purpose, agreeing to 2. 5 million in total effort for this acceleration of diagnostic tests. 80 years ago, in 1942, president Franklin D Roosevelt invited senator mckellar of tennessee, the chairman of the Senate Appropriations committee, to the white house for a private talk. Senator mckellar, president roosevelt said, i would like for 2 million in the appropriations bill to create a project to win the war. Senator mckellar said mr. President , that should be no problem, i just have one question. Where, in tennessee, where will the project be built . Well, that was oak ridge, tennessee. That 2 million funded the Manhattan Project that, in record time, produced to Nuclear Devices that one world war ii. World war ii. The greatest number of distinguished scientists working on one project in history. The shark tank is at least a mini Manhattan Project. It doesnt have to be in tennessee, but the tennesseans of the Oak Ridge National laboratory will be helping it to succeed with their supercomputers and other assets. 2. 5 billion does not go as far today as it did in 1942, but it is still a lot of money and it is likely that at this moment more scientists are working to create solutions for covid19 than on any other project in the world. Their success in delivering new technologies to create simple diagnostic tests with quick results and then safe and effective treatments for way thisis the only will happen. Forward to safe path combat the Novel Coronavirus without adequate trip adequate testing. Let us hope that out of dr. Collins shark tank will emerge one mighty great white shark that will help us to combat this disease. Senator murray . Senator murray thank you very much, chairman alexander. Good to be here today with you. I also want to thank the Committee Staff who help us to set up this technology to make this hearing possible and of course, thank you to the witnesses for being here today as well. Waslast hearing on covid19 march 3. Hearing i expressed my intense frustration at the administrations lack of preparedness and its failure to ramp up testing. The white house constant contradictions of Public Health expert guidance and more. 60 daysre more than later and i wish i could say that i have Better Things to say about the administrations response, but i do not. The only difference is that now over 800 people in my home state have died, nationwide now more than 73,000 are dead. Tens of millions are unemployed. Meanwhile, the president is still denying the severity of the crisis. Still insisting that it is not his problem and is increasingly attempting to control and silence those who want the truth to be told. The president is afraid of the truth, because here it is. He failed and continues to fail to protect lives, our economy, and our way of life. Which brings me to our Witnesses Today. I appreciate you being here and i expect you to tell the truth today. I will want to know your honest assessment of where we stand on Testing Capacity and whether we are preparing appropriately to have a safe, effective vaccine as soon as possible. I will want to understand how you are planning to prioritize Public Health over political influence and corporate profits. I will want your commitment that you will protect workers at hhs who will speak out when they see that Public Health is not being served. Dr. Driscoll, you are here instead of dr. Wright, who filed a complaint this week detailing a shocking culture of corruption that prioritize cronyism over Public Health, including at an agency critical for Vaccine Development and distribution. You can expect a question from me on that and i expect the truth from you. While i appreciate the interests in this Shark Tank Initiative to develop new tests, we have to remember that the fight against this virus, its reality, not Reality Television and it has to be led by scientists and prioritize Public Health. Not profit or politics. Innovation plays an Important Role in the development of vaccines and treatment, there is no silver bullet. In fact we have already innovated faster tests, at Home Collection tests, and critically there is much more in the pipeline. The problem is not lack of innovation, its lack of leadership and a plan from this white house. Carcan innovate the fastest in the world but it wont get you to where you are going without a good driver and directions. When it comes to testing, the administration has had no map and no one at the wheel. There is a reason, they say, that failing to plan is planning to fail. The fastest and most innovative work is not much use if we dont know how many tests we need or have a supply chain with the capacity to manufacture all the tests and devices that we need and we dont have the workforce or lab capacity to use the test. ,nd even if we had enough tests labs, and workers, it cant have the necessary impact if it isnt distributed widely across the country, if it doesnt reach a in other service communities, people with disabilities, homebound seniors, communities of color, and high risk populations. If tests dont become available to the asymptomatic or if we dont enforce current law that requires testing for everyone. Free testing for everyone. Addressing these issues wont be thegh without plans to use results as effectively as possible to fight the coronavirus like rapidly recruiting, training, supporting what we need for Public Health efforts like Contact Tracing, quarantine isolation, using data to surveillance and track within the community while protecting privacy. The administration finally told Washington State last week that it would be sending all states a significant number of supplies to help expand Testing Capacity. However, even if they finally deliver the supplies we have been asking for for months, that is still not a plan, its a piece of the puzzle. As long as the administration refuses to look at the full picture to develop a detailed, National Plan to rapidly ramp up testing, we wont make the to get peopleed back to school, work, and a sense of normal life on a national scale. Our experts wont have the visibility to transmission what they need for Public Health drives in our effort to reopen. That is exactly why i have fought to secure language in the package that Congress Passed requiring the administration to submit a strategic testing plan no later than may 24. I am going to be watching closely to make sure that their plan addresses all the questions we desperately need answered and i am going to be pushing for more resources to build and sustain the testing efforts we need to support Contact Tracing and support other Public Health efforts with a plan for vaccine production and distribution so that we have an effective vaccine and can scale it up quickly to make it available and free for everyone. The 25 million that we passed recently for testing was a start , it is going to take a lot more to get this job done. Yes, it will take determination and some semblance of leadership from the president. Because no matter how innovative we are, we cannot reopen the tests arefely until fast, free, and everywhere. No matter how hard frontline workers and governors and families work to do their part, we still need the federal government and its president to step up and kindly do its part. Thank you, mr. Chairman. Its great to be with you this morning. Let me make sure my microphone is on. Im pleased to what welcome our two witnesses. I want to give them a full introduction. After they give us their proceed backe will and forth from party senioritys. Technologically thats the way it is recommended we do it. We are very fortunate to have these Witnesses Today on the , of, how do we create new technologies for diagnostic testing so that we can have uslions more tests to help go back to work, school, and contain the disease . Our first witness is dr. Francis collins. I have asked him to take up to 10 minutes for his opening remarks. Hes the director of the National Institute of health and we are fortunate to have him in this position at this time. He oversees the work of the largest public funder of Biomedical Research in the world and is a physician geneticist by training, and prior to becoming the a at nih director of years ago in 2009, he served as the directors he Agencies National Human Genome Research from 1993 to 2008, during which he led the International Human genome project. Hes an elected member of the National Academy of medicine and sciences and was awarded the president ial medal of freedom in 2007 and received the national in 2009. Science so, we are looking for a distinguished scientist to head this program and i think we are lucky to have this graduate of the university of virginia who received a phd from yale and from the North Carolina school of medicine who plays the guitar very well. Dr. Gary,ll hear from who is broadly experienced as well. I have asked them to summarize his written testimony in five minutes. He is the acting director of the biomedical advanced Research Development authority and is responsible for making sure that barca is focused on innovation and advanced research and development. Such as diagnostic tests, the subject today, critical to preventing and combating covid19 and other Health Threats that we face. Ta has been at bar to bar for more than 10 years and started working on the smallpox effect seen program there and has served as the Deputy Assistant for preparedness response in the u. S. Department of health and Human Services. 2014, 2015, he was named the ebola incident coordinator for bar chat and played a key role in the efforts that led to the first license ebola vaccine. Prior to joining, he was an assistant professor of oncology and apology at the Georgetown University medical center, where andocused on back therapeutics and received an undergraduate from the university of rochester and a phd from georgetown. Welcome again to our witnesses, we begin with you, dr. Collins. Welcome. Dr. Collins thank you very much to everyone in the room and those of us joining virtually at this time. Im pleased to be her with my. Olleagues i want to thank you, senators, for your sustained commitment to the National Institutes of health, which enabled us to be the forefront of action at this time of National Health crisis and im grateful to have the opportunity to address how we at nih and scientists across the country are harnessing innovation to diagnose, treat, and prevent the Novel Coronavirus. Can you hear me all right . You are muffled either because of the mass for the microphone, im not sure which. Senator well, were dr. Collins well, we going to do an experiment here. I dont know if this is randomized, but it is at least a comparison. You are still pretty muffled. We did get advice from the attending physician of the that it was ok to not wear a mask we chose to when we are six feet apart. Dr. Collins i see that im a safe six foot distance from everyone and i want you to hear the testimony, so i will follow that direction. Nih has taken an all hands on deck approach to bringing the best and most innovative science to diagnosis, treatment, and prevention. If i could have the slide up that i would like to be showing, that would be great, thank you. And the genetic sequence of sars, when it was first released generate 10th sen. Alexander let me ask you to wait a moment to ask the technician to address your microphone. Dr. Collins its a static he thing, i think. Thing, i think. Sen. Alexander you are the principal witness, we want to hear you have to say. Dr. Collins i think the other microphone might have been better. Now that the mask is off, should we try that again . Sen. Alexander we will take just a moment for a technical adjustment to see if that makes a difference. Yes, sir . [inaudible] you like myer mask . Well, it did work for other things, i thought it might work for this. Yeah . Dr. Collins how is this one . Sen. Alexander a lot better. Dr. Collins sounding better . . O staticy ok, so when the genetic sequence of sars was first released, just you and you are 10th of this year, nih worked quickly to develop possible therapeutic agents and developing a fasttrack maxine. Within a month the National Institute of allergy and Infectious Diseases had launched on the gileadal drug remdesivir across the nation and internationally. As reported, they had preliminary results just last week showing that patients who received it had a faster time to receivedlive those who the placebo. Its not a home run, but it is a landmark, the first rigorous demonstration of efficacy for treatment for covid19. Just 63 days after receiving the viral sequence, they completed all the clinical evaluation of axing candidates and the first human patient was dosed in a phase one trial and it is happy and i am happy to tell you it is going well and im excited to see how the timetable for the retesting has been advancing. Information comes in from scientists and patients all over the world, we have been sifting, sorting, looking for , fundingideas everything from basic biology to Clinical Trials and closely watching private sector efforts and seeking ways to collaborate and it has been apparent that research is fully charged up to tackle the trials, with that expression of american creativity applying to the development of new and more powerful and accessible approaches. That is the main topic of our hearing and i will come to that shortly. First, if you will permit me i wanted to share a bit more about progress on their purex and vaccines for covid19. , nih announce the start of an Unprecedented Partnership that now includes 18 pharmaceutical companies, multiple academic experts, the , the european medicines agency, the department of Veterans Affairs and department of defense, a Partnership Im happy to cochair with johnson johnson. Accelerating covid19 therapeutic intervention. And vaccines. There is an incredible selection of organizations that have come together to speed progress. To conduct its work, activ has developed a select committee of Senior Leaders with four working groups, each cochaired by a Senior Scientist from industry and one from nih. I have just one example, the clinical Therapeutics Working Group has been conducting a rigorous review of the approximately 100 and 70 therapeutic candidates already , seeking to prioritize those of the greatest urgency to get into Clinical Trials. We cannot do 100 and 70, so we want to be sure to use the resources for those that have the greatest promise. Another active working group is hard at work to make sure the trial capacityl is assembled and used for this purpose to test the highest priority candidates with standardized evaluation methods. We have never done it like this before, to have this kind of coordinated approach across sectors and figure out how to get them into trials efficiently and quickly. To say a word about our Industry Partners here, within two weeks partnership, the made unprecedented commitments, agreed to abide by prioritization of candidates, no matter who owned the drugs and indicated their willingness to contribute their own capacity your to whether the drug being. Ested was one of their own a partnership in the truest sense. There is more, the most recent put inr of our efforts, in part by the congress and representing todays topic, the diagnostic innovation initiative. I want to turn to that. First, the National Cancer institute is using their expertise in the rolla g and lab medicine has supported by funding from this congress to evaluate and improve testing. Serology testing is based on the idea that we can look through your immune system playbook to see if your body has produced antibodies that respond to this virus. Such a test has the potential to tell generally how widespread it is has been and it is critical evaluated toest be make sure it is specifically sensitive and specific. The tests are Getting Better and better. At the moment we still dont know for sure however whether someone with a prior infection and who is antibody positive is completely resistant to longection and, if so, how that immunity would last. Questionss to those are being intensively studied and once the information is in hand we will be in a better position to advise people about the meaning of a possible Antibody Test. Second and most directly nihvant to the hearing, the launched the covid19 initiative called rapid acceleration of week. Stics just last we heard this from the chairman that most current testing for the virus depends on detection of the viral rna genome using the pcr chain reaction. A pcr test takes a small piece of dna or rna, amplifies it billions of times over so that it can be detected, but the amplification process is timeconsuming and requires a thermal cycling machine available only in Laboratory Settings in general and requires personnel who know how to run the test and troubleshoot the problem. This program, supported by toding from congress, seeks expand the range of diagnostic technologies to include a bunch of novel approaches that rapidly expand access to testing. It is engaging scientists across the country, from the basement to the board, in an effort to improve current tests and advance completely new technologies. As america moves back into public spaces but seeks to avoid further infections, tests have to be more accessible, ideally to people at the point of care, to make it easier for people to be tested. We need tests that dont require hours or days to determine results. The new kinds of tests need to be sensitive enough to flag asymptomatic individuals who may have just become effective but dont know it yet. They must be reliable, have a friendly design, and utilize different types of examples, including saliva, integrating with mobile devices to process and show results seamlessly. Above all, they need to be accessible to everyone. So, how should we inspire this new outpouring of technology . How can we unleash this ingenuity at this time a public urging . How do we provide the resources for scale up and deployment of powerful testing platforms. Our approach, which the senators recently compared to a sharp , was shark tank diagnosed on this slide, where you can see a bunch of light bulbs, a comment from Thomas Edison seeing the seeming , will this is what is going to be happening with this initiative. Occurs in three phases. First of all, theres a call for innovative technology. That went out last week. Phases zero requires that a on the call to make sure it fits the model and then its rapid evaluation of the technology. Over the course of a week by clinical, technical, manufacturing exports, review boards with scientific and business domains will rapidly evaluate the proposals that provide real promise. The promising earlystage technologies will in initially moved to phase one, where we will make a modest award of funding while supporting the inventor or company to address scientific or business weaknesses identified in the review. Welldeveloped technologies can go directly to phase two. We dont want to hold anyone back and it is possible that some of the shark tank arrivals are big enough fish in that they are ready to move on and we will support that as well, providing validation in tests, meaning regulatory requirements and working closely with colleagues. In that regard we are looking at some who have substantially increased substantial laboratorybased tests although developinge point is point of care. To tell you the update, it was Just Announced last week. We are allowing submissions of proposals on a rolling basis and i have to say that im delighted and somewhat astounded that as of new yesterday there were 1087 applications initiated, 79 of them already complete, they had to provide a lot of details. At nih and i have never seen anything with this quickly. The Expert Review Team has already identified those needed for the intense form of scrutiny, its going to be a wild ride. To tella close i want you about the third part of the initiative, the major focus on implementation of strategies for testing of rural, underserved, under resourced populations. Among the hardest hit by the coronavirus, and often those for which testing has been less available, the effort that we , as anling red x up underrepresented populations, will include the development of a Centers Program to roll up demonstrations projects to be put in place across the country in places where covid19 has hit hardest and where testing has thus far been successful, with a program focusing on the ethical, issuesand social associated with testing and ways to avoid the inequities associated with unequal access. To conclude, the goal of red x, to make millions more accurate and easy view tests per week available to all americans by the end of summer and even more in time for the flu season, i must tell you, senators, that this is a stretch goal that goes well beyond what most experts think will be possible. I have encountered some stunned expressions when describing knowledgeable individuals. The scientific and logistical challenges are truly daunting, but i remain optimistic that for the track record of American Ingenuity and the outpouring of what has happened for the great ideas coming into the shark tank , at nih we believe that putting the best scientists in the world together is really way to beat the challenge and bring the virus under control. Thank you for the opportunity to lead the initiative and i look forward to your questions. Sen. Alexander thank you, dr. Collins. Dr. [indiscernible] welcome. Thank you. Thank you for the opportunity to testify today. My name is dr. Gary distr [indiscernible] at acting director of barta the department of health and Human Services. Sen. Alexander could you put the slides back up for him, please . I want to highlight how we are developing a response to the pandemic. Alex as are declared with Health Emergencies generally first, 2020. We established an interagency call within the agency to highlight the establishment of strategies for therapies and diagnostics to address covid19. The same day, barta opened a medical counter portal to accept Market Research submissions from stakeholders receiving 2700 submissions to date. We are working with interagency prioritize and review all submissions. Prior to receiving those funds we modified solicitations for covid19 products and have received 210 submissions under the Broad Agency Announcements and 310 to the easy, the streamlined solicitation with a cap of 750,000 in funding. This is what we do, engaging innovative stakeholders, establishing partnerships, with countermeasures for the American People to save lives. Under the response structure taskforces were established to bring experts together for key challenges and finding solutions and one task force is the medical task force on this slide, including representation from working groups established to address vaccines, therapeutics, and diagnostics. We are a key leader in the groups and the goals are to prioritize and align shared information across a transparent manner with a track record of success for delivering effective countermeasures in response to Public Health emergencies, including h one and ebola. We have unique authorities allowing the organization to push candidates forward to the review, testing, and approval phase. We have leverage 3. 5 billion under the cares act covid19 supplemental and made investments in multiple therapeutic and vaccine candidates and, important for today, 19 diagnostic programs. The second slide shows diagnostic candidates supported a, cdc, and the department of defense with molecular at the top, then point of care, and the last is the highlight investments in antibody and antigenbased tests. The next slide shows the specific projects with emergency use authorization to support the need for expanded diagnostic capacity with investments into molecular tests for commercial labs and point of care tests for individuals who are affected. Labbased and near patient Molecular Diagnostics are on the left with point of care on the right and a green star indicating diagnostics being granted an emergency use by the fda and we have recent shifted focus to antigen tests, supporting a total of 19 diagnostic products. Our efforts have helped to ensure the availability of diagnostic testing in the u. S. , 2. 7 million tests shipped in the last seven weeks, we expect the barta funded partners to continue in the next few weeks and we are proud to collaborate multiple efforts. First, with dr. Collins under the accelerating covid19 vaccines, and the active partnership. Secondly, we are working with the radeks program at the National Institute of biomedical engineering. Will provide barda expertise as teams are assembled to shepherd development. The nah initiative and the barda efforts are complementary and together we will make the program a success. Barda has 300 Industry Partners, with 54 approvals. Our longstanding expertise and accelerating candidate diagnostics, therapeutics, and vaccines, its a testament to our dedicated team. This committee and congress at large have been various out of our mission and today more than ever we need your continued support and flexibility to make sure that we can focus on the task at hand. Thank you for passing the recent appropriations that will aid in the overall response effort. We couldnt do you our job without your partnership and support and i look forward to discussing how we can continue to Work Together on this issue. Thank you. You. Alexander thank we will now go to fiveminute rounds of russians in signorelli order, including the senators participating by, by video. I will begin. Dr. Collins, you said that you would define the tens of ,illions of tests that we need the first thing youre going to do is squeeze every test out of existing technology. Am i correct in that existing Technology Wont produce that number of tests, so we need a new technology . Dr. Collins i think it is both, and, not either or. I think existing technologies have a potential for further scaling up and we are interested in seeing that happen. Barda is very much in that space and we will work closely ofether on it, but most those existing technologies are done in central laboratories. They are not what we would call point of care and we want to see that feature heavily emphasized in what we do with the new technology so that they can be more successful with a rapid turnaround, for tests to be generally distributed to places without much access. It is definitely the case. Anything that we can do that will increase the number of tests available by a factor of five or even 10 is very worth what we would want to put into it but we also believe that it is not just a matter of taking what we have and making it a higher throughput, we need more new technologies. You ar let me ask question, first. Before i came in here i got off the phone with the chancellor of the university of tennessee at knoxville. They have invited their students to come back in august. Talked to the president of the University South of nashville and they have done the same. What can you tell University President s and principles . We have 5000 colleges with 100,000 Public Schools that would like to go back cool in august. What can you tell them about the availability of testing in august, including the possibility that there may be some of these new tests that would expand supply dramatically. That would very much be our goal and you have made the point repeatedly about how critical that will be in terms of us getting back to school and not having what would be a second or third wave of coronavirus at that vulnerable moment when the flu season is starting up as well. What you want to have at that point is the ability in the community to know if the virus is circulating, being able to do surveillance, finding out if the virus is around and if so, thediately identifying infected and getting them quarantined. Schools and colleges are a critical place. Having a great expansion in the number of point of care test at that point so that University President s and chancellors have a chance of knowing the risks bringing people back. Thats what we want to contribute to and that is what this project is all about. Sen. Alexander let me ask you about scaling up. Im not a scientist and i wont pretend to be one, but i have so much respect for the Scientific Community in the United States. I cant imagine that out of the 1000 applications are expressions of interest you have received that there wont come a few new ideas that would prevent quick,the kind of simple, inexpensive, easy to will beer tests that widely available in, we talking about tens of millions of tests. The question is, how do you manufacture all of those . When you select the survivors of your shark tank or your experiment, are you taking into account if you can scale them up . And let me ask, what will barda do, working with you, to scale up what you discover is a new technology to produce tens of millions of tests . Great question. Very quickly, the review group that will be looking at these thousands of applications are well populated with people who are experts in business, commute commercialization, and scale up. You have to get the resources together. They could come from small businesses. How do you provide the resources . Sparta is and a great spot to assist with the scale up. As dr. Collins mentioned, we envisioned this as a seamless transition. Partnering with industry, bringing together engineers so that ezell products are moving through the funnel you saw, it is a seamless transition, and we assist with finding we would have available to help scale up manufacturing. You would be involved in helping to identify promising technologies based upon their scalability . Then you would be coordinating with outside groups to see the scaling is done . Dr. Collins to help partner them, correct . Senator murray . Thank you, mr. Chairman, and thank you jar witnesses. President after the claimed to want to take a test can take a test, we have over one million covid19 cases. There more than 73,000 deaths, and no plan to bridge the huge gaps. States are left to respond with limited federal resort federal support, and fighting with each other for critical supplies. To address those failures, congress required the administration to submit a national, Strategic Plan to increase testing by may 24. Approximately 220,000 test were performed. Experts say we need between 500,000 tests per right now to 5 million a day or even more going forward. To reach those targets, states need more than musings from the white house. They need numbers, timelines, and clear expectations about how the federal government can get us there, but dr. Collins, yes or no, in order for that plan to ensure governors and Health Leaders have enough testing to begin state reopening, should that national, Strategic Plan on testing include specific,umeric target Testing Capacity supply chain capacity, and projections of shortages . Dr. Collins senator, it is not my sweet spot because of course, this is the job of the Coronavirus Task force and the cdc. I know states are looking for those kinds of specific guidelines, and i totally understand that. Plan detail how to best allocate different tests to for different settings tests for different settings, like at a workplace . Dr. Collins there are scientific reasons why those kinds of decisions ought to be nuanced based on the circumstances. They could be different from one environment to the next. Any plan would have that kind of specific recommendation about particular environments where testing is going to be offered. Ok, thank you. Soon you for testifying so and your tenure in this role. This week, your predecessor filed a complaint with special counsel detailing an alarming degree of corruption among Political Leadership across hhs, trump administration. We learned from dr. Bright that the white house largely ignored warnings about covid19, failed to take steps to adequately secure supplies of ppe and secure a. The white house failed to secure supplies for testing, they pushed untested and unproven drugs against the advice of experts, and political leaders in baditicians positions. Doctors, i expect you to cooperate fully with any investigation into dr. Brights complaint, and i will look into these allegations. Theres so many workers across the federal government trying to do the right thing. Help us generate a plan and distribute a vaccine, putting science ahead of politics, and refusing to put the Publics Health at risk. For those of you who were doing that and watching, thank you. Doctors, can you commit to me today, without resolution, that you will always prioritize the Publics Health hating never give in to pressure to do political favors, and you will speak out against corruption and incompetence, and miss in misconduct when you see it . Yes. Yes. Thank you. And i appreciate that. Do you both commit to doing everything in your power to protect hhs employees from political interference in doing their jobs, especially to protect those who speak out and make sure Public Health efforts are guided by science and not personal profit or politics . Yes. Yes. Do either of you have any that dr. Bright faced political pressure he set in his complaint . Personal, have any primary information, so im only going by the things i have read. It is not a circumstance i can form an opinion because i dont have the facts. Now that this is a Personnel Matter being handled by the special counsel, we cannot really comment. Ok. Well, you both commit to being transparent with congress and throughout the covid19 response, including what guardrails are in place to make sure government researchers researches yes. Yes. Did i hear yes from both of you . Yes, you did. Yes. Thank you. I have a few seconds left and i hope to ask a few more questions in the next round, mr. Jim carrey thanks in the next round, mr. Chairman. Senator ensley. Thank you, mr. Chairman, and thank you you senator murray for this hearing. I want to thank the witnesses were all of the information they have provided, and it is very critical thing for the nation. I hope this does not turn into the hearing about trump. [inaudible] announcedstration has the number public cloud partnerships bringing agencies nih is at the helm of most of these efforts. How is it agencys role [inaudible] fan ofre very much a partnerships to get science to happen. I had i learned how much can be gained by bringing groups together that have different skills and talents, and not worrying about will get the credit to get the job done. More recently, i have had the privilege of leading several of these partnerships focused on trying to develop the next generation of therapeutics for diabetes, alzheimers disease, rheumatoid of the right is, parkinsons disease, cancer, and those have turned out to be in no mostly productive by getting the best and brightest scientists around the same table and make sure the data is accessible. When the covid19 crisis came along, it was clear we might benefit from that same kind of model, and by talking to my colleagues from all sectors, we did decide this was worth a try. On april 3, 34 days ago, convened Senior Leadership of pharmaceutical companies, of fda, cdc, the nih and the european medical medicine agency, and came up with a series of things we thought could be done better as a partnership than either of the sectors or companies or institutions can do on their own. That is what active has become, and i must say, it has been astounding to see the way in which people have plunged into this effort to advance therapeutics and vaccines for covid19. Some of those Previous Partnership i mentioned partnerships i mentioned took a couple of years. This took two weeks. On a, we announced the launch of this enterprise, and it has been 24 7 for these working groups trying to knock down the barriers that might otherwise get in the way. The red x effort is not the same kind of partnership. I might call it a more bottomup kind of partnership in the sense that the talent and the innovation and the Creative Ideas about new testing platforms is largely coming from small businesses. So they become our partners because they are feeding these ideas into the shark tank of those 1087 that i told you we have already received as far as responsys to the solicitation. Responses to the solicitation. A few middle size businesses as well. That is the kind of thing you like to see for this kind of partnership, which will be intensely competitive. Nih, iime at nih at learned if you want to get something done, find all the potential contributors who have skills, talents, motivation, and resources, and lets do it together. That is what we have to do at a time like this with this Global Pandemic all around us. Thank you. I have a question about who is in charge. Arehaving to scramble we having to scramble to catch up. Anytime youre trying to move products to the advanced development stages, Public Health emergency, a Mission Statement identifies taking a lead role in the Early Research and barda has taken the lead goal advanced development and manufacturing. Where nih and barda have primary authority in development [inaudible] what we are talking about at this hearing, the handoff that we are making sure happens in this space, we are really good at getting those early ideas started, figuring out how technologically they can be advanced, but when they get to the point of being ready for a real commercialization scale out, barda steps in with all of their skills. Gary, you may want to say more. This is not the First Partnership between nih and barda. We have partnered over the past decade or more with the National Institutes of allergy and Infectious Diseases, transitioning vaccines and therapeutics for some of the greatest threats are nation faces like radiological threats and pandemic influenza. Building of that Natural Partnership that occurs. We work handinhand. Barda is integrated into the active partnership. You saw in the slide i presented that it is in the whole of government or everyone is working across governments, sharing information and helping to develop those medical thank you. The clock on my screen is behind. Thank you. Thank you, senator. Your timing is very good. Senator kason, who has done a lot of work in this area was senator burris especially. Senator kason . Can you hear me . Yes. Yes. We can hear you. Mr. Chairman, very much, and i want to thank our witnesses. I want to start with the reality that so many communities are facing now, that the case numbers and the deaths are overwhelming. We all know the national numbers. Those numbers translate in pennsylvania to something on the order of more than 51,000 cases. The death in our state one up recently. We are now over 3100 deaths. We are thinking of those families that are suffering in so many ways. I want to start by commending the frontline workers in this crisis. The Frontline Health care workers, as well as so many others. I will try to list all of the other occupations, all of the work being done on those front lines. Secondly, i want to commend those who are throughout our country, tens of millions who are doing their part by staying home and by socialdistancing, and wearing masks, and doing all the things the experts tell us we should do to stop the spread of the virus. We are grateful for that. I think the administrations response so far has been inadequate, and that might be an understatement. Is nowhere near the dedication of the frontline workers it is nowhere near the dedication of the frontline workers, or compliant Board Hearing to standards, like people are at home. I wanted to start with that in with onetesting entrance i think her failures, and try to mitigate in the short term to make a pledge never to have such failures in the future. I think there are at least three. The testing failure, the failure to deliver adequate supplies and personal protective equipment, and thirdly, the failure to effectively communicate over time. Sometimes, the administration has been guided by science and expertise, and then that expertise has undermined. Before i get to my questions, thesenate, as it has in four legislation, the response that, the families that, the cares act and the we have been focusing on stopping the spread of the virus, dealing with the Public Health challenge, but secondly, also helping those who are adversely impacted by the terrible economic consequences that flows in the wake of the virus. My say i say we should focus our work on oversight. Another chairman will be getting that, but we have to do a lot more oversight with the response of our. I want to pose a question about the next generation of ppe. Mission,well bardas and part bardas mission is that we have a pandemic, the agency for bart itself limits the hormone such a pandemic, and ppe is a part barda. You heard and read, and i am sure you are well aware of the that the ppe is meant for so many workers. Sometimes, personal protective equipment that is causing harm to those workers. We have to get to nexgen or a personal protective equipment, and i would hope you would work with us on preparing, not just the next couple of months, but preparing for the next 50 years. I hope we can have your commitment on that, both you personally as well as barda. Do we have a commitment from you . Yes you do. Thank you very much. Dr. Collins, and my remaining minute, let me get to a question about evidence and foreign policymaking. Fromve heard so much Public Health experts and scientists on how to stop the spread of the virus, and how to deal with this pandemic. I ask you, dr. Collins, do you agree that science and peerreviewed evidence should be what we implement by way of policy and our response to the pandemic . Dr. Collins i have built my whole career on science and evidence in rigorous ways to derive that in the hopes that would in fact be the way in which we as a society make decisions, so i certainly agree that ought to be the way in which we move ourselves forward in a fashion you can be confident as based on real facts. I hope you will continue to advocate for decisions we make in the senate based upon science, and based upon best, possible expertise. Not based upon arbitrary deadlines and politics or philosophy. So i thank you for that. Your grateful. Mr. Chairman, i might have followup questions in the next round. Thank you. Bewe will see if there will next round. We will try to end at 12 45 because the witnesses have to go on in we have votes at noon, i think. At 1 30, soe a vote we will see if there is time for a next round. Thank you. Has an important engagement and has asked to go kind and others have been enough to allow him to do that. Senator robert . Senator roberts thank you very much, and i apologize to my colleagues were going out of order. At 12 00, i have to speak on the floor of the senate, and it is in regard to the fact that the memorial has been delayed because of circumstances, and this is on behalf of the Eisenhower Commission in which i am pleased to be a chair. So for that reason, im going to proceed and i will try to make my remarks very assisting. Uccint. I want to talk about im about i want to talk ok. Reasonbe you heard the that im stepping forward here out of the recognition of the situation. Situationtalk about a that is unique that we are going through right now, and that is the packing plant situation, the meatpacking plant situation. Testing rates in kansas have largely allowed, or lied behind other states or lagged behind in the states in this crisis. We have 23 of the cattle market. Five in kansas. A break we have had down networkers at the meatpacking plants, where working with governor kelly of kansas, we made an early decision, and the governor concurred that we would try to keep these plants open. We dont need, not only a problem with our meat supply, but it was backing up the entire food chain. Other chairs on the committee can speak to that. And the same situation is happening in the pork industry in the poultry industry. At any rate, the ceos of the Packing Companies were very when and were very pleased an actsident initiated [inaudible] i shouldve just gone up and whispered in your ear and it wouldve worked out. To ceos of the packing have stepped forward. President initiated this fast production act and declared the meatpacking plants and national asset, not only in regards to meat or pork, which is a more serious issue, but the backing up of our entire food chain. Our consumers are discovering that finally, their food doesnt calm from grocery stores, comes from farmers and ranchers and growers. So, the ceos have stepped up, and they wanted to invest in this kind of a situation before, but now they are absolutely forced to, but it is a willing kind of situation. The problem is our workers. Just this morning, they showed up at the plant, not in the numbers we had hoped for, but we still hope to keep the meatpacking plant and what is happening is they are not catching the virus at the meatpacking plant. It is afterwards. And so, we have cdc, we have osk, iand we have nil fancy term to inform workers that the plant is safe and employee should practice socialdistancing. When they leave the plant, then head home. But that is not been the case, at least uptodate. I think we are in a situation where there is any need, that i could see for an immediate test right now, they are having their temperature taken paining when they their temperature taken, and on a rapid test, this is a kind of situation that demands an answer now. If in fact we had any kind of a situation where you could have an immediate test. Nice mostost meatpacking plants, there are many languages spoken, and to educate the workers and to alleviate their jobs as well. You can see the need for the tests. Have not left you any time to respond. Can we at least get something done on the Rapid Testing on Something Like this that is happening today . If i could take 10 seconds, this is a very good example of why we need exactly what is red s program is trying to put tests inhich are rapid any place that is been an outbreak to get people quarantined so they dont spread it to others. We know people who have no symptoms or no fever could be carrying the virus, and we need to have a test to identify. That is what we are trying to do with red x. Senator baldwin . Baldwin thank you, mr. Chairman. Think you are quite aware of how supportive federal investments in medical research, and it is encouraging to hear about the work of the nih during this really difficult time. You noted in your testimony, above all, tests need to be accessible to everyone. I agree, and that is why i introduced medical supply transparency and the delivery at with my colleague, senator murphy, who you will likely hear from shortly. Which requires the administration to develop a National Testing plan, and it unlocks full authority of the defense production act to increase the production of supplies needed for testing. Reddr. Collins, the goal of x is to develop and deploy for covid19. Each of the tests is likely to have supplies that will be needed in order to actually and get specimens for these tests. We also need to know whether we will need personal protective equipment, or swabs or reagents to actually conduct these tests. Can you describe sort of, with your crystal ball looking foward, to what might be red x and what supplies that will be needed to do these tests . Dr. Collins great question. Every one of these nominated platforms for technological advances is going to have a different set of requirements as far as those kinds of supply questions, and here again, we will be looking at that closely as we try to evaluate which ought to get done. Will requires lobster we do by the way many will require no swabs. Many will requires swabs and we also think saliva may turn out to be an attractive alternative, which might not require a swab at all if you have a way of collecting just a saliva sample, but all of those things have to be thought about hating certainly, we would not want to make a major investment to be thought about connie certainly, we would not want to make a major investment of what we got a clear sense of what that supply chain would be, if this will be implemented all across the country. We are working closely with barda this is where working with barda will be critical because this is a sweet spot for them in terms of keeping track of all the details you make sure you dont end up with a Success Story you cannot implement because you forgot about some part of the supply chain. So, i thank you for that seeing withi am already available testing platforms, each has a different swab, different reagent. This closed loop in many and if that is going to be the case in the future, we need to anticipate that as we try to ramp up and make sure we are supplying the reagents and the slops and the specimen collection for each of the various tests that will be out there. The second complication i see is if i look at wisconsin for example theres so many different entities that are trying to seek these tests for enhancing their Testing Capacity. The systems, employers who want to test employees before they reopen for business, and when , private andes Public Schools, higher nocation, etc. , there are logistics right now. I returned and this idea of having the full authority of the defense production act involved with you at nih and barda, in create amake, to streamlined system for testing. That it help you to know at your stage at nih, what sort of institutions will need testing and when so that you can identify the gaps and actually be looking at tests that are likely to fill those gaps . Yeah, of course, we want to have a full sense of the needs that are out there from multiple institutions and in places that are most vulnerable. Vulnerable. I mentioned these demonstration projects we will try to put in place for places they dont have ready access to testing for underrepresented groups. That is one example of what you are referring to. We need to have our finger on that pulse. Thank you very much, senator baldwin. Senator collins. Thank you, mr. Chairman. Let me start by saluting you for your extraordinary leadership in putting together this initiative that will make such a difference for the health of our country. Year, i introduced a bill after i reviewed alarming data our indicated how dependent countrys pharmaceutical market suppliers ofas active pharmaceutical ingredients, api. I discovered 72 of the facilities producing apis were over sent. 13 were located in china. In the midst of this pandemic, india took steps to restrict the apis to our american markets. Clearly we should not be so dependent on foreign nations for essential ingredients foro are medications. That will be really important as we develop treatments for the coronavirus. The development of promising new diagnostics, how will you ensure we have the capacity to manufacture and scale up these innovations right here in the United States . Thank you. The Global Pandemic has highlighted the vulnerabilities of the supply chains for many products. Ppes were one of the first things we saw. Now it is also Raw Materials and ingredients. Drugs, we are looking at advanced manufacturing technologies. We are evaluating ultimo using a much smaller footprint than you would for a traditional manufacturing facility to try to bring that back. For these Raw Materials for the diagnostics, partnering with u. S. Companies that have the experience and knowhow to scale up diagnostics. They have engineers. To acquire allem t materials so we can scale that up. Vaccine manufacturing is a very long process. We need to acquire those Raw Materials now so our manufacturers can manufacture on scale. Act it of the meds authored was included in the cares act, but i do think we need to do more work in this area. I appreciate the fact you are very aware of the problem and are working on it. Dr. Collins, let me turn to you next. We were just talking about swabs and how they are an essential part of diagnostic tests. I am proud of the fact one of the two leading manufacturers of swabs is puritan medical products, which is located in maine. Just last week, with support from the defense production act and private investment, puritan has teamed up with a large thnstruction company and ba fireworks to open a new facility in record time that will double the production of swabs. That obviously is very good news. In addition, we have a laboratory that is abbott labs in Southern Maine that has helped produce the rapid tests. My question to you is what more can we be doing this happen to the authority under the defense production act so that when you do get a winner we can be up and of a rapid, scale manufacturing of the new tests . What any of us have imagined four or five months ago we would be talking about swabs that is Senate Hearing . This has come at such an unexpected way but its absolutely critical for testing. This comes back to needing to think ahead. With any of these new kinds of technologies we are trying to encourage through the short tank shark tank, what will you be short of, have planned for and what will barda have to make to that happens . Deal with the supply chain and make sure it will not caught off by something international. If necessary, come up with ways as you have done in maine the double or triple production. We have to be thinking everything in advance and not get caught by surprise. We will not make that mistake. Thank you. Thank you, senator collins. Senator murphy. Thank you for being here today. A comment and then a couple of questions. We are so grateful for the work you are doing and your efforts to inform ss to some of these partnerships. You are only as good as the direction you are given by the president of the United States. What you have effectively told us today is that this new effort to try to find a widely available pointofcare test was launched eight days ago. Largely at the urging of members of the senate. If we had a president who truly prioritized testing, this effort would have been launched the thete we heard about prospect of coronavirus coming to the United States. Instead, literally in the middle of the epidemic, when some states have gotten through the worst of it, we are now launching this initiative. It should not be lost on us how far behind we are on testing. Frankly, it is not an accident. It is not an accident. The president told us he didnt want to bring folks to the United States from a cruise ship because they would drive up our numbers. Not because of any Public Health risk. Just yesterday he said by doing all this testing we make ourselves look bad. That is the president s belief. That the testing makes us look bad. If you dont think perception is important to this president , you have not been paying attention for the last three years. We are playing catchup. The question is how we do that most effectively. Dr. Collins, let me ask you a question. Not so much about the new active, theroject, project to try to develop a vaccine and treatment. Appreciate the fact he reached out to the European Partners to be a part of this effort. But there already is an International Effort designed to develop a vaccine. 70. It has been working on pandemic vaccines for three years. Week, lastf this week, the partners got together to try to rally the world to footwear money not into active but into sepi. My question is this. We should be running our own efforts to develop a vaccine, but why not also join . Why not also make sure we have a seat at the table when it comes to the biggest International Effort to develop a vaccine . Maybe it is not necessarily your policy decision as to whether to join. We could do both, right . We could be leading our own efforts to develop a vaccine and also be a member of this international group. Which, by the way, all of our allies are part of it. The europeans, the saudis, everyone is working on a vaccine together. We are not part of that effort. T is hard to understand ent at theres founding in davos. Not present in a direct way at this recent fundraising effort to try to put together Additional Support for areine development, we certainly connected in indirect ways. The companies that are part of active, many of them have strong european connections. Some are in fact european companies. In a position to contribute to the development of some of the vaccines we are talking about getting into this master protocol. Think, you are exactly right. This is a global crisis. We should approach it globally and not get wound up about what the obstacles are in the way. Im a scientist. I want to see this project succeed. One quick question. You referred to the allegations that dr. Bright made as a Personnel Matter. But it is not a Personnel Matter. He did not get fired for showing up late. He alleges he got fired because he was trying to talk to his superiors about a culture of corruption in which industry players and nonscientific input had influence over the decisions barda was making. That is not a Personnel Matter. That is a Public Policy matter. Would you agree that getting to the bottom of the allegations he ases is important for you the temporary or acting head of this agency . Do you have any opinion as to whether outside Industry Groups have too much sway inside this operation . I do think its important. Im sure there will be an investigation. I stand by i have been at barda for 13 years. All proposals that come and have to go through a scientific review. The review is based on science, technical merit, the feasibility of the program, and the ability of the company to potentially do the work. We review those by interagency partners through the Technical Evaluation process. They are then reviewed, make awards. I am still confident in the way we make our investment decisions, that they are based on science and based on the best technology we can bring forward. Thank you. Thank you, senator murphy. Senator cassidy . All three questions will be for dr. Collins. Thank you for your good work. I appreciate it. I was intrigued by your testimony but i would like to hear your further thoughts about the underserved Population Program in louisiana. Graham. In louisiana, we have been hard hit. I am working with my group with people back home as to how we address this. How we apply for it . What resources . You can reply to that is a qfr, too. This is a program because the funding just came along recently. It is still in the formative spaces but we will be soliciting applications for centers that could be placed in locations where underrepresented groups have been hard hit and not had access to testing in a way you would ideally want to see. That will be coordinated ethical, along with a legal and social Implications Program and a coordinating center. Who do i call . You can call me. Sounds great. Secondly, he spoke about having to look at the ability of antibodies to provide protection, and the duration, etc. It is like flu. Antibodies will be completely protective of some and mitigate the symptoms and others and if you may not have any effect whatsoever. We may not know the duration of the benefit until three years from now. I guess my question with all that, they will be uncertainty as we rollout this information. Are you suggesting we wait for absolute certainty before we begin to make policy decisions based upon how useful Antibody Testing is . Both in terms of looking at the spread of the disease, but more importantly as to its protection against reinfection . Thats a fundamentally important question. You have thought deeply about this as i have. We do know that coronavirus, covid19, is one that the immune system recognizes and eradicates the virus. We know you recover from it. Thats good. That tells you the immune system knows what to do with it. It is not like hiv. At the same time, this virus can mutate. We have been able to observe that. It is an rna virus. It does not mutate the way influenza does so we dont think it will have the very rapid seasonal change we have to deal with influenza. We really dont know the answer to a lot of your questions. They are fundamentally important. Can you get reinfected with this . There have been a few cases. They are not incredibly convincing. If you are reinfected, how long will that last . There is evidence in rhesus monkeys the antibody is protective, and from sars 1, immunity was 18 years. It does seem assess the Scientific Evidence is pointing in that direction. It is pointing in that direction and we are counting to that counting on that to be the answer. What is defined as knowing . Knowing may not be for one or two years but we have to make policy decisions before then. Indeed. At the present time to evaluate the meaning of a positive Antibody Test one should be quite cautious. I think it will help to see if anybody who has such an interbody test turns out to get infected again in the next six months or so, because the virus will be around, will start to get an Early Warning sign. We will not know if it is three years, five years, 10 years. We should be tracking who was positive so we can follow them longitudinally to see if they develop once more. With their appropriate consent, of course. This is the program we have talked about that is enrolled 300,000 americans that preconsented for this followup. Let me ask you as well, and to the chair i would like to enter an article for the record. Covid19 has shouted scientific labs, putting a generation of researchers at risk. So ordered. This is an issue when universities have told me that they just had a Research Project shut down. The article which i speak speaks about specially modified rats that had to be euthanized because of the inability to access the lab. Extendinge of programs in just one of my universities was 20 million for all the grad students to complete. Nih hasas left relaxed spending guidelines, but im told that probably will not be enough. Im asking you what is nih planning for these scientists. Im deeply concerned about that. This is a heartache seeing the scientific enterprise put on hold. My own laboratory has researchers who are at home trying to write papers and relators are but they are not to make experiments they would be doing on diabetes or aging. If you add up what this is going to cost in terms of the lost productivity and the need to keep people employed, the estimate theres nothing like 10 billion of nih funded research that will disappear because of the way in which this virus has affected everybody. Universities are very much hoping this is something that could somehow be ultimately compensated. I worry about trainees with lost time. We are concerned about what this does to their professional careers. We have to reassure them we will get through this and they will look back on this someday and say that was a pretty bad time but we all managed to figure out a way to cope with it. You put your finger on something that wakes me up at night a lot. What if we dont to the rest of the Research Enterprise because of covid19 . Im not sure you give me a plan. Im over my time. I yield back. Thank you, senator cassidy. Senator warren. Thank you, mr. Chairman. Three month ago, america saw its first taste of the virus. President trumps response has been a complete disgrace. Instead of using this time to drastically ramp up our testing to test asplan many as possible, he has peddled conspiracy 30s and brag on television u. S. Cases would soon be close to zero. Today, over 70,000 people are dead. 1. 2 Million People are infected and 30 millipeople have lost their jobs. Meanwhile, america is still racing to get its testing numbers up. I had a detailed plan for how to do it. Testing capacity and better reporting of demographic butrmation is already law, there is more we need to do to correct the president s failures, including the federal government to probably publicly manufactured supplies. You are the acting director of barda, which was set up to make sure the government has lifesaving drugs on hand in a crisis, even if it is not profitable for Drug Companies to make those drugs on their own. Does that mean the federal government is running drug factories all over the country with federal employees inside and on the production line . Thank you for the question. No. What we do is partnered with companies. We form these Publicprivate Partnerships to help develop lifesaving medical countermeasures. Vaccines, therapeutics, diagnostics. We provide. The companies we provide funding. The companies provide funding. We are providing the funds, and in particular for covid19, the government will take the risk for developing those vaccines, therapeutics and diagnostics because we need to expedite the vidal event element. Federal and expedite the development. We have a True Partnership with Industry Partners to bring medical countermeasures forward. Thank you. In other words, barda identifies , takeslic health risk drugs from concept to reality, and then contracts with private companies to make it happen. The power of the federal government to ensure what we probably need. Barda has already invested in makingof companies therapeutics and vaccines and diagnostics to fight covid19. Scientists are racing around the clock and they will get it done, but coming up with these lifesaving innovations is not the only challenge we face in this area. Scienceins, lets say delivers all the tests we need and eventually vaccine. What other basic medical supplies do we need to be able to actually produce and administer these tests and treatments . Again, i think we have to think about exactly what those supplies would need to be and whether that falls involves a swab to collect a sample and do the test, some sort of solution you have to transmit it to the laboratory. All those parts of the supply chain have to be thought about it for going to make this as successful as it needs to be. People are worried about if we have enough medical glass to put all these doses of the vaccine into vials so they can be administered. That is a serious issue to think about, even as we are anticipating that such vaccines may be available in millions of doses as soon as this fall. All that requires thinking forward. Thank you very much. I appreciate that. To put it bluntly, even if we come up with vaccines or better tests, if we dont have the right supplies, if we dont have enough cotton swabs or free glass,oral glass or it will not be able to do us much good. Let me ask you this. Is bardas job to supply the nation with cotton swabs in reagents. Barda will do what is necessary to get the job done to protect the nation. Barda is focusing on ancillary supplies. Making the vaccine, which is a liquid, is only one step. You need a vial, a stopper to close the vial, and needles and syringes. We are responsible for making sure all those ancillary supplies to develop and administer that vaccine are taken care of. In other words we can just wait for the cotton swabs to roll off the Assembly Line from the cotton swab factory. We have to be planning this out, as dr. Collins is saying. Correct. Do you believe congress should pass senator murphys and baldwins bill to use its authority under the defense production act and get private companies to make what we need . We can do more. Last week i announced the covid19 emergency manufacturing act. My bill establishes an office of manufacturing for Public Health that is modeled after barda. The office would publicly manufacture or entering Contract Manufacturing everything the country needs to fight covid19. Reagents, masks, face shields, intubation drugs. How much19 should be included in the next run a virus relief so we can save lives that are still being put at risk by the president . Thank you, senator warren. Senator murkowski. Thank you. Thank you for your leadership. I greatly appreciate it. A tv show. G is i have to stress test today. That stress test is cordoba, alaska. A small fishing community. Population about 2000 in the winter. It doubles in the summer when the fisheries come on. It is a strong fishing community. Seventh and volume of landings in alaska. 16th nationwide. About 50 million in revenue. Significant for us. I mentioned it is a small community. That means it has small hospital facilities. We have a license for 23 beds. 12 of those are longterm and are occupied. But basically have six available beds for the community. The fisheries, the big salmon season, the copper rivers are coming on and the season begins may 14. We are moving onto it very quickly. We have five processors that work in town. They bring in about 450 seasonal workers. The total workforce is about 55 0. Yesterday we had the first positive covid test that we have seen in cordoba. It was a worker who had flown in i begin the fisheries season want to share with you what the community and collaboration with the processors has done to make sure we keep this virus out. All outofstate workers are gathered in seattle. They are put up in a hotel room. There is security guards at the doors. They are tested. Then they wait until the tests come back. If they are cleared, they are put on an airplane, either a charter or alaska airlines, flown direct. They are met at the airport. They are put in a special bus. They go directly to the processing facility where they are again administered a second test. It was on that second test this individual tested positive. Yesterday. E results thematic al was a asymptomatic. We have a community cut off from the rest of the world. You only get in by airplane. There has been no fairies since ferries the entire winter. You have a situation where we have three id analyzers. We are waiting on it test. All the other tests are completed by swab and then flown to anchorage, an hours flight away. We have about 1300 tests available in the community now. I talked to the mayor. I was texting back and forth with him last night. Speaking with our chief medical officer last evening. What do you need . We have the shark tank going on. What does alaska need . We need to have at point testings. We have to recognize when you have these rural distances, it just does not work otherwise. It has to be easy to run. Dr. Collins, you mentioned the up demonstration. That sounds intriguing and i will probably be calling you along with senator cassidy, but you indicated it is intended for those areas that are hardhit. We dont want cordoba to be hardhit, because if it is hardhit, the fishery does not move forward. It is the bristol bay fishery coming up in another month that is going through these same protocols here to try to possible if it is even to open up a fishery. The National Council for history registration move their Conference Online because of the coronavirus outbreak. The session of next features yale history and history professor joanne freeman, the editor of the essential hamilton, letters and other rights. You want something that is affordable and highly accurate. It does have false negatives where you have somebody who probably is already infected but the test doesnt quite pick it up yet. We want to try that number up to 100 . That is what shark take aims to do for you. Special of providing attention of places where testing has not been available, you make a very good point. It means they are vulnerable to being hardhit if the testing is not accessible to one of them. Thank you. Thank you, senator makowski. Thank you, mr. Chair, for the hearing. Last time we were here as a committee was march 3. Occurred in the United States from coronavirus when we were last together. Is 74,000 665ber 74,665. Of 1126nche average deaths per day. Personally, i am a welloff u. S. Senator. I know four people who have died from coronavirus since we were last together. My brother steves motherinlaw , a friend of 25 years in richman who is married to one of my agents, gerald glenn, a bishop and active faith leader in the Richmond Community who was active and appointed by both democratic and republican governors to juvenile justice positions. And Lois Schaefer who is my wifes best friends mother who died here in a nursing home in fairfax county. My nextdoor neighbor died, and i store neighbor of 20 years, not of coronavirus but of a long battle with lung cancer. Because of coronavirus, he couldnt have visitors like you normally would, couldnt grieve with the family together, like family normally would, and i did not know lauren but i laurena. She is from charlottesville and was working in emergency medicine, trying to save as many people as she could. She got coronavirus and went home. When she was well, she came back to the hospital and found it overwhelming. She died 10 days ago by suicide. Was saidnow who it this brutal thing about one Million Deaths and one death is a tragedy. The numbers are large, but we cant forget each one is a tragedy. 3, we had nine deaths in this country. 28march 3, south korea had deaths on march 3. The total death toll in south korea from coronavirus is 256. 28, march 3,ry, 256 today. My question is you to you is why . South korea is a messy, robust mocker sarah robust democracy like us. It is packed with super pack ed metropolitan areas but also rural areas. Im assuming it has something to do with testing, but that is the only question i have. Why, from march 3 two today, has to today, as the south korean death toll gone from 28 at 256, and the u. S. Death toll has gone from nine to 74,665. This is very sobering. Im glad you started talking about specific individuals, but sometimes we get into these conversations as if it was an academic question or it is about statistics or about some fancy technology, which i confess i spend a lot of my time on that as well, but this is really about people, real people who have lost their lives, who have been terribly sick and whose families now have the chance degree but not in the usual way. My wife said to me, a couple days ago, she said, you seem so burdened about this particular priorities and projects. Youve done this before, and you seem to sail along. What is going on . I said when i was in charge of trying to lead the human genome project, it was incredibly competitive. It was incredibly exciting because it had this historic nature to it. This time, it is about People Living or dying. It is different. We have to think about that in every step of the conversation like this. South korea did amazing things. It is helpful for them that they are a smaller country than we are with a lot less population to try to manage. They did figure out how to do the distancing thing and a testing thing, and with great speed and rapidity. South korea, which i visited, is an amazing, technologically advanced country. It is pretty breathtaking when you see what they have been able to do. They jumped in on this in an effective way. Our sprawling country is another challenge. Obviously a challenge we now grieve to see what has happened with the more than 75,000 deaths , and we are not through this. We are nowhere near through this. Everything we have to do now is to try to look at that experience and say weve got to put everything weve got into keeping this terrible tragedy from getting any worse. That means testing and therapeutics, and vaccines. From me personally, that is what im doing, 24 7, and i will continue, as long as there is anybody still at risk. Thank you dr. Collins and mr. Chair. Thank you, senator. Senator scott . Thank you mr. Chairman and thank you to the panel for being here with us today. I know we have made significant progress over the last several weeks, and im excited to see that. Im also excited about the future prospects of your shark tank activities and efforts, so thank you for your willingness perpend, 24 7, seven days week on trying to find ways to strengthen americas health. Coming from a state like south assume there are probably over 50,000 infected in South Carolina, but we have not had the availability of testing, because, as you already know, South Carolina is a state considered on the low side of the number of cases, and therefore, the testing resources are going in other directions. As you think about our future, we really want to make sure, as we serve americas needs, that communities have more access to testing. That is why im encouraged by your prospects. I love to hear you talk about the radix prospects because in calhoun county, newberry, greenville county, or a larger county, the testing needs are very important in Rural America and South Carolina. I would love to have you eliminate that a little more for us. The second question i would have is about the vulnerable populations in Rural America, and rural South Carolina is a part of that. So are some minority groups like africanamericans and hispanics, alaskan, native americans as well. Native alaskans are all part of the same type of grouping as it relates to the Underlying Health conditions that may make you more predisposed of having a significantly harder road to the coronavirus. Love to have you talk about the importance of having folks in control groups, minorities in our country minorities in our country participating as well. It sounds like South Carolina and alaska are in the same situation of not having access to tests you need right now to try to keep people in your seat estate healthy. That is one of the main reasons we are proposing this program to try to put in places like that, where there are vulnerable populations, some of which are getting sick at an alarming rate , the access to testing particularly needs to be focused on there. Im particularly concerned when i look across the country at the statistics about what is happening with africanamericans , where clearly the burden of covid19, in terms of the most serious illness and deaths, fall disproportionately on the shoulders of black individuals. Look at georgia where Something Like 80 of the individuals with serious illness in hospitals are africanamerican. Torture is only 30 africanamerican, so that tells you there is something going on. Georgia is only 30 africanamerican, so that tells you there is something going on. It makes it more difficult for those societies to practice physical distancing because of social circumstances. And maybe they cant afford to stay home and stay out of the public circulation, because you have an hourly job, and if you dont show up, you dont get paid. This is one of those moments where Health Disparities, which in this country have been a problem for decades, a bright light is shone upon them, and we should not miss the chance to solution. This area ofn trying to make sure the testing is successful, maybe we can do something that has not quite been done this way before. We imagine 10 or 20 of these demonstration projects located in projects that are in particular need of access to these resources, populated by scientists who are dedicated to that goal, with a Strong Community outreach, to try to make sure the Community Embraces what it is, that this can represent, and recognize this can be a way in which, when vaccines come along, we can make sure the vaccines are distributed in a fashion that is not otherwise affected by going to the obvious places that have more resources. We want to work through the federally qualified Health Centers for testing and vaccine. Thank you. I think South Carolina is a place we can benefit from working with. I will make one comment. Maybe the chairman will allow you to answer this question. One of the things that i found quite interesting, when you look at the prevalence of the coronavirus in nursing homes, looking at the fact that the death rates are significantly higher there, couple that with the fact that, as i talk to the nursing home community, about 60 to 70 of their certified nursing assistants are africanamerican. About 80 female who have a very vulnerable population, serving another vulnerable population. If there is ever a case for more testing in nursing homes, not only for the residents but for the workers, this is a classic example. Final question to both panelists would be about crisper and Gene Editing Technologies to advance more testing and new types of testing. Any closing comments with my last 38 seconds . Could make your answers distinct assisting this Amazing New Technology that allows you to find a very specific dna or rnas beacons sequence of comingr of new protocols into the shark tank are based upon that, and some of the ones im most excited about, it is a totally different approach and could before very pointofcare and readily done without requiring special technology. I agree with that completely. It is a new technology i could look at a very low level of the virus and sample. I think that is the True Advantage of that and look forward to pushing that forward. Thank you for your indulge indulgence. There we go. Thank you, mr. Chairman and Ranking Member maury for holding this hearing. And, allowing for remote participation. Thank you to the witnesses for being here and your ongoing work and that of your entire Team Responding to this pandemic. We know how hard people are working. I will start by saying that, yesterday in new hampshire, a little under 1. 4 Million People of under one point 4 Million People, the death rate is eight per 100,000 from the coronavirus. The need for testing has never been more clear, and i think what is hanging over this entire hearing is that question that senator so eloquently asked. It is in the question we have all been really referencing, is what what our trajectory look had right now if we had more testing where and when we needed it, accurate testing that could be done rapidly, and why have some countries enabled to do that testing and we have not . We need to discuss the nearterm testing issues today, to be sure. The other issues the chair has talked about are also important, too. But, i would like to request that we also hold a hearing on covid19 vaccines as well. Because, this has already been discussed. We need to plan for the entire reduction and production and distribution of that. Rapidt these intense and goals for getting a vaccine up and operative. A my state, there is manufacturer of hypodermic needles who says they have not been receiving the kind of purchase orders from the federal government that will allow them to have the kind of volume of hypodermic needles on hand when we are hoping this vaccine might be ready. I hope very much that we will have a hearing just on vaccines and the manufacturing supply chain we will need to have up and running, because this administration has been slow to respond to the needs of testing and for personal protective equipment. We need to learn from those mistakes and avoid the situation in the future. Dr. Collins, a couple questions for you. Relatively few people can access testing. I would like if you talk about the rate of testing we are doing for population in this country, not just the wrong number. Potentialhose with covid19 symptoms cannot access testing. Though they have the virus, it has been an important part of our efforts. As states reopen, people are asked to return to work, it becomes harder to comply with this advice. The report suggests some diagnostic tests are returning inaccurate results 15 to 30 of the time. These quality issues may hinder containment of covid19 as individuals correctly believe they are not infected or incorrectly believe they were infected and they have developed immunity. Dr. Collins, the goal of the shark take initiative is to accelerate development and increase Testing Capacity. Reliable testing infrastructure depends as much on quality as it does on quantity. Do the nih do to ensure that they are producing highquality products . That is a critical question, senator. It is a critical step in the shark tank phase one two approach we are taking, that fairly early in the pathway, the technology has to be validated. At that is it has to be tested against a variety of Gold Standard samples, of varying degrees of the presence of the virus, to see if it is sensitive enough to detect to the virus when it is there and specific enough so it does not give a false positive on a sample that has no virus in it. That is essential. Anything that fails at that point will fall out of the tank and will not be taken forward, unless there can be a technical solution to deal with a performance issue. Once this does pass the gate and gets successfully moved forward into commercialization and scale up, the fda will be in the strongest position then and will look at this carefully to see whether it passes their muster. In this Current Crisis, fda has been authorizing tests with what is called emergency use authorization, but in the longerterm, they will be determined to make sure these tests pass all of the appropriate validation steps, so you can count on that coming in there as well. It is a critical question and we will make sure not to have this as an opportunity. It has to be not just out there but has to be accurate. Very quickly, and i know im over time, mr. Chair, but how would you ensure dr. Collins, that in order to receive federal funding, that these new diagnostic tests will represent a significant improvement over existing products to justify federal investment. That, again, will be something that will also be engaged in that they will be also engaged in. We dont want to put taxpayers money into something that does not represent a significant advance over what is already there. I dont think we will have to worry that there will be already enough testing that you dont want to think about bringing on board one of these new pointofcare platforms. If it is highly accurate and quick in giving a response, it seems likely we will want to invest in it. Thank you you, mr. Chair. Senator romney. Thank you, mr. Chairman. I appreciate you holding this hearing. My first question is for the doctor, a quick question, relating to probability. Those of us who have been in the Business World have to deal with probability. Probability we will have a generally available vaccine for the American Public by the end of the year . 5050, 90 , 20 . What is the likelihood . Im not a betting person, but if we dont set lofty goals, we will never achieve the goals. We are working hard across the federal government to make sure we are doing everything we can to expedite. I know that. I know we have lofty goals. Im not asking for goals, im asking for probability. 90 10, what is the likelihood we will have the vaccine available for the general public by the beginning of the year for the population of our country . I know what the goal is, 100 , but what is your success of probability . You have been in this for a long time, so what would you be thinking about . That is why i dont like to either set timelines ok, never mind. If you dont want to answer the question, we move on. My second question is to dr. Collins. The machine is already providing information i guess almost at a realtime basis. What is wrong with making a lot more of those and using that as a machine that can be available at most businesses, retailers, so for us. Is it just inadequate . Is it the false negatives . It strikes me that we already have a technology that works. Am i wrong on that . This is a great machine. It does provide you pointofcare, and it does it quickly in the space of 15 minutes. It requires having special machines, and there is a limited number of those machines out there. I think it is 18,000 or Something Like that. To really meet the need, that would have to go up sis day and chilly up substantially. The other concern has been that it does have about a 15 false negative rate. If you are in a circumstance where you really dont want to miss a diagnosis from somebody already carrying the virus, you would like to have something that has a higher sensitivity than that. I know they are working on how to make that happen, but so it is certainly one of the most exciting things we have right now, but we think we can do better. Better thanment is having this regard, but a test that works, it could be made more sensitive. If we devote a lot of resources to making a lot of these machines, perhaps having other people around the world or country making these machines that an accelerated pace, while we can fulfill the need that we are talking about with technology that already exist, the probability of planning a new technology, i hope we can find that. It strikes me this kind of lastne finally, the question for you, dr. Collins, i have been puzzled by the conflicting data i see, and im sure you see the same thing, the reports out of massachusetts that the number of people there that were a symptom attic, people that of course the testing in new york that suggested people already had covid19. The prison tests as well in five states of the south, which is as i recall 93 of the people testing positive never had symptoms. Week, they said we would not test everybody and let the economy keep going. Do we need to have the kind of testing we are talking about, or does this information suggest, given so many people that are a symptom attic, i was at a hearing with a symptom attic symptomatic, i was at a hearing that said between 50 and 90 of people with covid19 dont have symptoms. If that is the case, should we let this run its course through the population and not test everyone. Everyone . Im interested i am putting that forward as a strawman. A lot of people seem to get this virus without symptoms at all. About 60 of new cases are transmitted by such people. It is still the case that 74,000 people have died from this disease, so the people who are out there infected, who may not themselves be suffering, are passing themselves and becoming a vector to others who are vulnerable with chronic illnesses or in the older age group. Sometimes, you have people that, lets say are not immune, there are plenty of circumstances where young people who you wouldnt have not been hit hard by this have gotten sick or even died. I think it is an extremely it is extreme the unusual to have a virus so capable of infecting without symptoms and carrying it on to others. We have not encountered Something Like that before, but that does not mean it is a terribly dangerous virus for the people who end up in the icu and perhaps lose their lives. The only way we could put a stop to that is to know the person people who they are even if they have no symptoms, get the quarantine, find their contacts, and that all applies here too. Senator thank you senator romney. Senator jones. You, mr. Chairman. Thank you for having this hearing, you and Ranking Member murray. It is very important. Ive been monitoring this and decided to come down, but i have been listening to a number of things. First of all, i want to followup on what senator collins said and eluded to with regard to foreign dependence on vendors for health care equipment. She was talking more in terms of prescription drugs, but obviously we have seen a lot of problems with regard to ppe. Other Health Care Manufacturing or other Health Care Manufacturing. I hope to phyla built next week that gives tax incentives and other things to try to get those Health Care Manufacturing into those cut into this country, so that any future endeavors as we replenish the national stockpile, we can do so with american. Made americanmade goods. I would encourage my colleagues to look at that and join me on that. I look at senator scotts abouts r about theura the rural areas of the country. Senator scott stole my questions , dr. Collins, but i appreciated your answers very much. I would like to follow up a little bit on that, because, with all candor, we talk about rural areas but also vulnerable populations. That thisur word is pandemic has shown a spotlight on the Health Disparities in this country. It is a phrase i have been using as well in my home state. I dont think it is it is not lost on me that, ironically, we are having this discussion this week when this within the last 24 to 48 hours, the administration has issued briefs in the United States Supreme Court attempting to dismantle a Health Care Program that has given Good Health Care and insurance to millions of americans in this country. The exchangesgh but also through medicaid expansion, in any number of states. Of 14te of alabama is one states that did not expand medicaid. As part of the vulnerable , i have 326,000 alabamians without Health Care Care and without insurance. I find that appalling. When we have the opportunities. As we go forward, number one, i am hoping that the congress in its next package will consider ways to incentivize states to as we medicaid did under the aca. I hope the aca remains intact, but i would like you to comment a little bit. We have spoken a lot on your rat x up. I want to figure out what we can do, now that we have shined the spotlight, to make these vulnerable populations less vulnerable. Not just this not just to this pandemic but to the preexisting conditions we see in these populations. I would appreciate you commenting on that and how specifically we get some of these testings and distributions into those areas. Thank you, dr. Collins very much. I appreciate the question. This is a great passion for virtually all of the Institute Directors at and ih. We have the National Institute of Minority Health and Health Disparities, focused on this issue. Increasingly, the research we are doing is going beyond trying to identify what the factors are that are responsible for Health Disparities. We learned pretty much about those into what we could do about it in terms of interventions and demonstration projects. That is what we think of in this space, by having the demonstration projects where you introduce the access to testing, introduce their connection to vaccines. You can change the dynamic instead of studying it. We have studied Health Disparities a lot. We think it is the largest supporter of our medical research. We have an opportunity to learn what works and see if that is can be extrapolated to the entire country. Do you think of Something Like this happens in the future that one of the things we ought to focus on and use the spotlight to try to make sure that preexisting people with preexisting conditions, we reduce the number of vulnerable population, the number of folks with preexisting conditions by doing all we can to get good, Affordable Access to health care throughout this country. Thats what we need, along with a little all of the other things you need to do to reduce the incidence of obesity, diabetes, and cardiovascular disease. All of these take a heavy toll on people from certain subs group subgroups, and we ought to be preventing that. Thank you, dr. Collins and mr. Chairman. Thank you, senator jones. Senator braun . Patience pays off. I may be the last one. Im not sure. Testing, you hear it so often. To me it repeats what we all agree with. You said south korea kind of was the standard to maybe try to aspire to. If there is a test they use that was part of the protocol, was that a significant part of it, or was it their high gene, their hygene hygiene, their sheltering, etc. I dont recall the details of their particular technology, but i do not think it was anything out of the ordinary. It was based on using this pcr reaction to identify the presence of the viral rna genome, and certainly the tests we are doing, lots of those in this country as well. I think it was the speed at which they were able to set this up. To be able to test people quickly who had had any symptoms. And, their enforcement of such things as physical distancing, doing this in a country where people were also quite amenable to those recommendations. We be not quite as much in these american zones of not necessarily which tests and which company would be closest to what they used there that we have here . I think the kinds of ones you see now in Companies Like labcorp and qwest would be the sort of thing you have, where it is fairly high throughput if done in a central laboratory. Frame, andthe time talking to a pharmaceutical company, one of few headquartered in indiana, the ceo said about 40 companies hasss the country, that it been at a breakneck pace to get there. Especially for the one that is quick or a country our size that will have reliable results. We hear so often and heard it today that we dawdled, that we didnt get there. I like i would like your opinion. From when i heard from the people actually doing it, they ane working at this in entrepreneurial and feverish pace, and they didnt have the genome to work with until maybe four months ago. What is your comment on that . Ani think there has been incredible amount of energy put into trying to do this. Nih in bethesda, i have 25,000 employees and i want to be sure they are safe. We didnt have access to easy testing for our own employees, and we wanted to make sure if they came to work they were not infecting other people. I asked our laboratory in the clinical center, which is a research hospital, to set up a lab test. The most test we can do in a given day is in the hundreds, not tens of thousands. It is not simple to do this. So it is not that we dawdled, it is the fact that we have a country scaled much larger than south korea, and it will take a point to get to the equipment in place to do it. Is that fair . I think that is part of it, and part of it is bringing on board some of these new technologies, which is what radex is all about. That will take time in and of itself. But we have not had the need to do this kind of scale of testing. Even for Something Like hiv and hepatitis, it pales in comparison to what we need to this need for this. We didnt have in the laboratory, the cup kind of capacity to take on this number of tests, and all of a sudden, it was there. All of a sudden, there it was. A littleched on this bit. Senator romney, senator jones talked about it, an idea of the broad methodology, whether we took an approach similar to sweden, where you let heard immunity be the approach. Could we have built an iron dome around the most vulnerable, in some fashion, with better protocol, to where it would have been different from a onesizefitsall, blanket approach, that might have had difficulties in this country due to the nature of who we are as well. Could we have protected the most vulnerable, if we focused the available resources to where we could have contemplated a different approach. Since it seems to passover so many people in a way where they are a symptomatically. Im throwing that out there as a question. It would have had to been an iron dome pretty impenetrable, because it imagine because imagine if one case got in there. From the easy spread who dont have people who dont have symptoms, you have a nursing home situation in the iron dome. In a certain way, we have been doing a version of that with Vulnerable People staying at home, keeping physical distance, and making sure others around them are doing the same. It has been, i would say, a fairly successful enterprise when you see the fletching flattening of the curve happening in many places. Did not just happen because we got lucky. It happened because we went through considerable difficulties and it did damage to our economy, to try to save lives. By this is sequestering up people so they could not get fatal illnesses. What we really need is to get back to where we really want to be, a circumstance where you dont have to do that anymore. That is why the vaccine is so prominent in our minds. Until we have the vaccine, the testing to identify people and get quarantined if they are already incubating this virus, that has to be a mix. The vaccines dont let anybody tell you, if we did one, it would be all right. We have to do all three. Thank you, senator braun. Senator rosen. Can everyone hear me ok . Yes, we can hear you. Thank you. I think i get the luxury of being the last question. I hope it is a good one. I really appreciate the chairman, that you set up this hearing, and i appreciate the Scientific Research that the doctors are doing, and their teams. I know how important it is and i know you have been working aroundtheclock in nevada. Real, andic is very we have had lockdown orders, social distancing, and we are beginning to flatten our curve. Our hospitals are not overwhelmed, and we seem to be doing all right. Everyone has talked about how we reopen our economy in a way that is thoughtful, sciencebased, how many died not having diagnostic Testing Capacity and all of that. A senator and i have introduced legislation to start a longitudinal study on covid with nih, and the cdc, that will be reporting every three months and six months, further as we go down. So we can point scientists and policymakers with data into a direction as we collect that. Dr. Collins, have you seen any studies yet on your end, or are you doing any that will track those individuals we talked about that have the positive Antibody Tests, see how long it stays in their system, and what question. Is my first then, i will give them all to you and you can answer them. The Shark Tank Program does not include Antibody Tests. Are we going to add the Antibody Tests to that . Then, i am concerned about unintended consequences. You talk about the shark tank. Consequences when you talk about the shark tank. We need researchers to collaborate on round the world collaborate around the world. Are there unintended insequences, to put people silos for collaboration that we desperately need not to happen. Those are my three questions. Those are great questions. In terms of the need to track people and see what happens, particularly as was brought up earlier, is the presence of antibody, something can say makes you immune. I think may our best chance at this is the Program Congress has funded and part of 21st act. I have to specifically give a shout out to to this committee and the chairman. They have this program which is racking one Million People over time. We are up to 300,000 that have signed up. Those individuals answer lots of questions, their Electronic Health records are available for researchers to look at. They give blood samples over the course of time, so you can see, i didnt have the antibody then and now it does. What happened there . We should be able to utilize that for this and many other purposes to try to get those answers. I agree we need those. The second question about Antibody Testing, our sense was the commercial community has done a good job of getting Antibody Test out there. Our scientists at the National Cancer institute was asked by fda to do the validation, and they have been able to do so in a bunch of those and it was published a couple days ago. They are really good in terms ofs Committee Terms of sensitivity and specificity. I would say, if we have a new technology where you could get both a virus test and Antibody Test at the same time, for a really good price, that might be something we would be pretty interested in. Finally, in terms of the unintended consequences of shark we willulting in silos, do our darndest not to let that happen. Our kind of the shark tank discourages that kind of siloing, because the advisors helping each of these platforms, developers has a new technology to succeed, they are very wellconnected. They will be constantly looking for ways that that Technology Developer ought to meet this particular company that has the ability to do the scale up. And, we will not let those opportunities go by. We will watch that closely, and there will be competition, and the Successful Companies will want to be on top, and that is how american capitalism success, which is what we need in this space, but not in the point where it becomes destructive and people conceal information we could all learn from. I would yield my last few seconds. Thank you, senator rosen. Im going to call on senator murray in a moment for closing remarks, and i will wrap up the hearing. We told our witnesses they could leave by 12 40 1245 time. So ifators 12 45, senators could ask questions for the record. We have an opportunity tuesday because we have a hearing tuesday on back to school and work, which includes dr. Fauci from nih, dr. Redfield, the head of cdc, the head of the fda, and the admiral who is in charge of testing. The questions will be relevant to them. For those who might be watching, i want to ensure you that we are following the rules the intending physician told us. We are social distant, we have worn our masks, and he said we could take them off while we were asking questions. We will put them back on as we leave. I thank the senators who have joined by video, and i hope we have had an audience. This has been a very interesting time. It lets me call on senator murray, and after that, i will include that conclude the hearing. Mr. Chairman, thank you so much for doing the hearing. I have a number of other questions i especially wanted to ask dr. Collins about the racial and ethnic disparities and how he will ensure testing and diagnostics. Then, the Agency Partnerships that will be deployed to communities in need, and i will submit those for the record. I hope you and i can talk about that in the future. Thank you to both of our Witnesses Today. Mr. Chairman, i want to thank you and think our witnesses for coming in today. But, i also want to thank all of senate employees, especially those required to come to campus today. To you and your community sees taking adequate safety precautions. I also want to thank everybody who helped set up the technology to make this hearing possible. Our country has really grappled with a world of change since our last hearing on coronavirus. My gratitude goes out to our health care and Public Health heroes who are essential workers who are making sacrifices against malta help those affected by the spread of this. My heart goes out to anyone struggling with this awful disease themselves, the loss of a loved one, or their very real mental Health Crisis in isolation and trauma. One thing has not changed since the last hearing, even though it has been over two months, president said anyone who once a test can get one. It is still not true. The will not change if president continues to deny the severity of this crisis, insisted is not his problem, and silence those who want the truth to be told. While President Trump has yet to show the leadership detailed in the National Plan, i think we should i will not comment on it because our families across the country cannot afford to keep waiting to finally get our response to this crisis on the right track. Thank you very much for having this hearing, mr. Chairman, and i look forward to our next one as well. Thank you, senator murray, and thank you for your cooperation, your staff, and all of your employees for arranging the employees for arranging this hearing and the one on tuesday. Just a few comments as we wrap up. Hopkins, as johns well as President Trump, the United States has conducted 7 million diagnostic tests. That is more per capita than south korea, for example. That is a very impressive total. This hearing is about needing aliens of more tests. That is because of the uniqueness of the situation, not because we do not conduct a lot of tests today. In tennessee, the governor has been aggressive on testing. Tested everybody in the state prisons. He has drivethrough testing on the weekends in many parts of our state. I began my Statement Today with the nursing home in franklin, tennessee that had tested all 2500 of its residents and staff. We have been able to find that number of tests for those kinds of activities, yet it is not enough to me for me to assure the university of the president of tennessee, with whom i talked, that she will have enough test to ensure students and faculty that it is safe to come back. At thed to a Professor University of californias berkeley and he converted his own laboratory into a laboratory he believes can test everybody on the Berkeley Campus within a week, if they wish to be tested. Is caring about needing tens of millions more tests, already having 7 million test, no other country in the world has tested that many people for coronavirus. Also the emphasize effort that i know senator blunt, i, and many others we understand that, in your chart, there will be failures. If there are not failures, you are probably not doing your job, because failure can mean it does not work, or it doesnt work well enough to be scaled up fast enough to help the schools and to be ready for the education season and the flu season as it comes on. We understand that. We will support the idea. The idea that there may be failures. On the other hand, going to senator rosens comments, the closest thing to this i remember is, when i was education secretary and david kearns was the deputy under h w bush, we sent out a solicitation for new ideas for new american schools, and there was a lot of money available. We were deluged with good ideas. Only a few could win, but we gave a citation to so many others, and we may have gotten more bang for our buck out of the ones who did not win then the one to dead, because it unleashed so much enterprise and opportunity. It may be that will produce the tests or platform that can be used for the next virus, or maybe we will introduce a bright scientist to a manufacturing company, looking for such a person. I can see all sorts of dividends coming from this enterprise, other than the one or two, or three, or for new technologies that will allow us to produce tens of millions of diagnostic tests, so we can, number one, identify all of those with the disease. There are not many of us. Maybe it is 3, 5 maybe it is 3 , 5 , 7 , we really dont know. Those of us sick sick that are sick or exposed, that will allow us to quarantine and track that percentage of us. The rest of us can go back to work and school. Right now, we are quarantining the entire country because we are unable to identify those sick or exposed. It causes abut terrible price to pay on our economy. I would like to also mention that tests are free. Congress and the administration takemade sure that, if you a covid19 test, it is free. You are either either you will, the insurance company, or government will pay for it. The first test is whether you have it, the Antibody Test is whether you have had it. On those tests, at least in the conversations senator blunt and i have had with the conversations, sounds like the country is on the way, meaning we are likely not to have any problems with shortages over those over the next six months, though the fda has a job to do to make sure which ones are accurate and which ones are not. Withe conclude the hearing the appropriate words, or i will be in trouble. Remainring record will open for 10 days. I want to thank dr. Collins and the other doctor for being here. We are counting here to do something that does not always happen in government, which is unleashing the private sector, taking advantage of the best of it, and letting our agencies collaborate and Work Together, and not be sunk into their individual silos. We need for dr. Collins to find a new technology, with the help may sayistro, who that is a great idea but we may not we cant scale it up. Then we wait on him to make sure we can produce tens of millions of them to go back to work and school. Members may submit Additional Information for the record within the next 10 days, if they would like. 10 00 a. M. T again at on tuesday, may 12, for our hearing, covid19, safely getting back to work and school. Thank you for joining us today. The committee will stand adjourned. [gavel noise] [camera shutters] thank you, very much. Cspan has unfiltered coverage of the federal response to the coronavirus pandemic with white house briefings, updates from governors and congress and our daily callin program, washington journal. Hearing your thoughts about the Coronavirus Crisis and if you missed any of our live coverage, watch any time on demand at cspan. Org coronavirus. Coming up on todays washington journal, a look at the latest u. S. Response to the coronavirus pandemic with dr. Kristin englund from the Cleveland Clinic and later, author Rick Atkinson joins us to iscuss the 75th anniversary of ve day. [captions Copyright National cable satellite corp. 2019] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] host u. S. Workers continue to lose their jobs and file for Unemployment Benefits at a record rate. And in todays report on the overall jobs number for the month of april could be the worst since the great depression. It is friday, may 8, 2020. Good morning and welcome to washington journal. Well spend this first hour asking you how the coronavirus pandemic has impacted your job. Heres how to joins us. For those of you in the east and central time zones, 2027488000. In the mountain pacific time zones, thats 2027488001. You can also send us a text. That line,
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