Message of the Day: Disease

Senator Lamar Alexander: (05:02)
The hearing may be watched online, an unedited recording will be available on the committee’s website, www.help.senate.gov. Witnesses are participating with the video conference in a one time exception. Some senators, including the chairman are participating by video conference. Senators we’ve been advised, may remove their masks, talk in to the microphone when they’re in the hearing room, as they’re six feet apart.

I’m grateful to the Rules Committee, Sergeant at Arms, the Press Gallery, the Architect of the Capitol, the Capitol Police, Committee Staff Chong Check and Evan Griffith all for their hard work to keep us safe.

At our hearing last Thursday, I said all roads back to work and back to school, run through testing. And then, what our country has done so far on testing is impressive but not nearly enough. Over the weekend Senator Schumer, the democratic leader, was nice enough to put out a tweet quoting half of what I said. He left out the other half, the impressive part. So let me say, again, what I meant by that. When I said impressive, I met that according to the Johns Hopkins University study, the United States has tested over 9 million Americans for COVID-19. That’s twice as many as any other country, we don’t know what China has done and it’s more per capita than most countries, including South Korea. Which, many members of our committee had cited as an example of a country that had tested well.

According to Dr. Deborah Birx, the United States were double testing the month of May, which should get us up to about 10 million tests conducted. Now, here’s what I mean by impressive. Here in Tennessee, where I am today. First anyone who’s sick, first responder or healthcare worker, can get tested. Our governor, Bill Lee is also testing every prisoner. Every resident and staff member in a nursing home is offered weekend drive through testing. He’s done specific outreach for testing to low income communities. A Tennessean can get a free test at the local public health department.

The governor’s slogan is, “If in doubt, get a test.” Governor Lee sent his testing goals in May to the federal government, as every state has done. Federal government is helping him make sure that he has enough supplies in case he has trouble getting them through the labs and the other commercial sources. As a result, our state is tested about 4% of the population. Governor hopes to increase that by 7% in May. That’s one of the best in the country.

This impressive level of testing is sufficient, we believe, to begin phase one of going back to work. Which as I said last week, it’s not nearly enough to provide confidence to 31,000 students and faculty members that we hope will show up at the University of Tennessee campus in August when school starts. Last week I talked with UT, Knoxville Chancellor Donde Plowman about that. We said, “What would persuade those 31,000 students, as well as the 50 million K-12 students in the country and the other 5,000 university students, what will persuade them to go back to campus in August?

That’s where the new Shark Tank comes in. Dr. Collins, at The National Institutes of Health calls it Red X. We had our hearing about that on Thursday. A really remarkable scientific exercise to take a few early stage concepts, that are swimming around and what we call that competitive Shark Tank, and see if Dr. Collins and his associates can find a few new technologies to create millions of new tests that will scale up rapidly and make it more likely that students will go back to school in August.

For example, the FDA authorized last week, its first diagnostic test using saliva that a person provides at home instead of a nose swab or blood. It authorized its first antigen test. We’re hearing a lot about those, like the ones used for flu or strep throat, which involves a swabbing of a nose and you can get the results in just a few minutes. Another proposal, not yet approved, is to put, in your mouth, a sort of lollipop sponge, take a photo of that with your cell phone and send that to your doctor, if it lights up you’re positive. Or, the university might send that saliva lollipop to a nearby laboratory, which could be a gene sequencing laboratory, which can deal with thousands of those samples overnight. That same process could occur at a middle school, it could occur at a factory.

Of course, anyone testing negative one day, can test positive the next. But, such widespread screening of entire campuses, schools or places of work will help identify those who are sick, trace down those who are exposed and that in turn should help persuade the rest of us to go back to school and back to work. In addition to more testing, I expect Dr. Fauci to talk to us about additional treatments that will be available to reduce the risk of death and the administration’s plan to do something that our country has never done before, which is to start manufacturing a vaccine before it actually has been proven to work, in order to speed up the result in case it does work.

Those vaccines, those treatments are the ultimate solution. But until we have them, all roads back to work and school go through testing. The more tests we conduct, the better we can identify those who are sick and exposed. Then we can quarantine the sick and exposed instead of trying to quarantine the whole country. Now in my opinion, this will require millions of new tests. Many from new technologies, some of these will fail but we only need a few successes to get where we want to go.

That’s why I said on Thursday, that what our country had done so far in testing is impressive but not nearly enough. First, squeeze all the tests we can out of current technologies. Next, try to find new technologies to help us contain the disease and persuade us to go back to work. Now one other thing, this is a bipartisan hearing to examine how well we’re preparing to go safely back to work and to school and to determine what else we need to do in the United States Senate.

Such an exercise sometimes encourages finger pointing. Before we spent too much time finger pointing, I’d like to suggest that almost all of us, the United States and almost every country so far as I can tell, underestimated this virus. Underestimated how contagious it would be, underestimated how it can travel silently in people without symptoms to infect other people. How it can be especially deadly for certain segments of our population, the elderly, those with preexisting conditions, minority populations.

Let me go back to the March 3rd hearing that we had in our committee on coronavirus. Six weeks after the first case was discovered in the United States, a day when only two deaths were recorded in this country, I read at that hearing this paragraph from the New York Times two days earlier on March the first. They reported this, “Much about the coronavirus remains unclear”, The Times reported. “And, it’s far from certain…”, This was March 3rd, that March 1, “that the outbreak will reach severe proportions in the United States or affect many regions at once. With its top notch scientists, modern hospitals and sprawling public health infrastructure, most experts agree, United States is among the countries best prepared to prevent or manage such an epidemic.” That was The New York Times on March 1.

A lot of effort has gone into trying to make our country well prepared. Over the last 20 years 4 presidents, several congresses, in response to 9/111, Bird Flu, Katrina, Ebola, H1N1, MERS, passed nine major laws to try to help get this country ready for what we’re going through today. These laws stood up to strategic national stockpile, created an assistant secretary for preparedness, it created incentives for the developments of vaccines and medicines that we’re using today. Strengthened the Centers for Disease Control, created ARDA.

Thanks to the leadership of Senator Blunt and Senator Murray for five straight years, we’ve significantly increased funding for the National Institutes of Health. All this was part of a shared goal, Democrats, Republicans, four presidents, several congresses, to try to get ready for what we’re going through today, whether it was known like anthrax or unknown, like COVID-19. But, despite all that effort, even the experts underestimated COVID-19.

This hearing is about how we improve our response to this virus, as well as the next. During the oversight hearing, I also intend to focus on, as I just said, the next pandemic, which we know is coming. What can we learn from this one to be ready for the next one? Can we… What can we learn from the fast tracking of vaccines and treatments that we’re about to hear about, that will make it even faster the next time? How can we keep hospitals in states from selling off protective equipment when their budget gets tight? How can we make sure Congress does our share of the funding responsibility? How do we provide enough extra hospital beds without canceling elective surgery, hurting other patients and bankrupting hospitals? Whose job should it be to coordinate supply lines, so that protective equipment and supplies get where they’re supposed to go, when they’re supposed to go? What’s the best way to manage the stockpile.

My preacher once said, “I’m not worried about what you do on Sunday, it’s the rest of the week that concerns me.” I’m afraid that during the rest of the week between pandemics, we relax our focus on preparedness. We become preoccupied with other important things. Our collective memory is short. Just three months ago, this country was preoccupied with impeaching a president. Now, that seems like ancient Roman history. Now, while this crisis has our full attention, I believe we should put into law, this year, whatever improvements need to be made to be well prepared for the next pandemic.

If there is to be finger pointing, I hope they’re pointed in that direction. We’re fortunate today to have four distinguished witnesses, with the heart of the response, the coronavirus. We’re grateful for their service to our country. I’ve asked them each to summarize their remarks in five minutes. Then, we’ll have five minutes round of questions from each senator. I’ve agreed, we’ll end our hearing about 12:30, after we have a full round of questions. Every senator will have a chance to have his or her five minutes.

Senator Murray will then have an opportunity to ask the last question or to close the hearing. And, I will then close the hearing. There will be other hearings to follow this hearing, like last Thursday’s hearing. And, senators may submit their questions in writing within the next 10 days.

Staying at home indefinitely is not the solution to this pandemic. There is not enough money available to help all those hurt by a closed economy. All roads back to work and back to school, lead through testing, tracking, isolation, treatment and vaccines. This requires widespread testing, millions more tests graded mostly by new technologies to identify those who are sick and who have been exposed so they can be quarantined. And, by containing the disease in this way, you give the rest of America enough confidence to go back to work and school.

For the near term, to help make sure those 31,000 UT students and faculty members show up in August, we need widespread testing. Millions more tests, created mostly by new technologies, to identify those who are sick and who have been exposed, so they can be quarantined by containing the disease in this way. You give the rest of America enough confidence to go back to work and back to school. Senator Murray.

Senator Patty Murray: (18:02)
Well, thank you very much Mr. Chairman. My thoughts are with you and your team right now, as you try to navigate the same challenge so many in our country are worried about. We all wish your staff member, a speedy recovery. And, as everyone works to take appropriate safety precautions, today I’d like to thank, not only our witnesses for joining us today, but also our committee staff for working to set up a safe format for members and witnesses and the public to participate in this hearing remotely.

Families across the country are counting on us for the truth about the COVID-19 pandemic. Especially, since it is clear they will not get it from President Trump. Truth is essential. So people have the facts, so they can make decisions for themselves and their families and their communities. Lives are at stake. If the president isn’t telling the truth, we must and our witnesses must. And, we’re counting on you today.

And, families need us to take this opportunity to dig into the facts about where things did go wrong, so we can finally get them on track because the Trump administration’s response to this public health emergency, so far, has been a disaster all on its own. Delays, missteps have put us way behind where we need to be on diagnostic tests and allowed inaccurate antibody tests to flood the market. Corruption and political interference have impeded efforts to secure desperately needed personal protective equipment and promoted dangerous unproven treatments. And, we recently learned that after experts at the Centers for Disease Control and Prevention spent weeks developing a detailed guide to help our communities understand how to safely reopen, when the time comes, the Trump administration tossed it in the trash bin for being too prescriptive. But, this is far from the first time this administration has silenced experts who were doing their job and putting public health first.

The fact of the matter is, President Trump has been more focused on fighting against the truth, than fighting this virus and Americans have sadly paid the price. Since this committee last heard from these witnesses on March 3rd, we have seen over 900 deaths in my home state of Washington, over 80,000 deaths nationally and the numbers continue to climb. Still, President Trump is trying to ignore the facts and ignore the experts, who’ve been very clear, we are nowhere close to where we need to be to reopen safely.

My hope today is that we can cut through this and have a serious discussion about what is needed to safely open. How close we are, as a country, to meeting those needs and how we actually get there. One thing that’s abundantly clear, we need dramatically more testing. It is unacceptable we still don’t have a national strategic plan to make sure testing is free, fast and everywhere. That is why I fought to make sure our last COVID-19 package included an initial $ 25 billion testing fund and a requirement that the administration submit a plan by May 24th.

And when I say a plan, I don’t mean a PR plan. I mean, the plan with specific timelines and numeric goals for supply and funding needs. One that actually addresses the issues we’re seeing on testing capacity and distribution and disparities and building out our public health system. And, makes clear to states and tribes and employers and the American people, what they can expect and what the administration will do to keep Americans safe.

But, testing alone won’t be enough to reopen our country. We still need far more personal protective equipment that has been available for our healthcare workers on the front lines. And, we will need far more for other workers as we reopen. So we desperately need this administration to step up and get that equipment to states, who are doing everything in their power to purchase supplies but simply cannot get nearly enough because the reality is unlike states, the federal government has the tools to actually fix the problem. If only the administration would use them.

And, we also need that equipment to actually work and for the FDA to act promptly if it does not, not weeks later when people may have already been exposed. And just as importantly, we can’t expect people to go back to work or to restaurants or to confidently send their kids to school, if there isn’t clear, detailed guidance about how to do that safely. Schools from early childhood through college, need to know how to keep their students, their staff and their educators safe. When should they wear masks? How do you run a school cafeteria or a school bus? And, if they can’t reopen classrooms, schools and families need to know we are working to ensure every student gets an education. Tools like online learning can only get us so far, if we don’t address the digital divide so that every student can access them. And, even then there will be learning loss that could deepen existing educational disparities among low income students, students with disabilities, English language learners and other vulnerable populations, if we don’t make sure they get equal access to resources and support.

And of course, schools aren’t the only workplaces we’ve got to be thinking about. We need to make sure that industries across the country know how to safely reopen and that people know their workplace is safe. Secretary Scalia needs to stop dragging his feet and do his job and have the Department of Labor set forward a rule that makes clear, worker safety is not optional. Mr. Chairman, I hope this committee can hear about those critical issues from Secretary Scalia and Secretary DeVos, as well as other experts in the space in the days ahead.

And, this is especially important to protect workers and residents at our nursing homes and other congregate care facilities, where we’ve seen some of the most deadly outbreaks. And, as the rash of outbreaks at meat packing plants shows, this isn’t just an issue for the healthcare industry. It is an issue for everyone. And, just as we need a plan before we can start to reopen, we also need a plan well before we have a safe and effective vaccine to guarantee that we can quickly produce and distribute it on a global scale. And, make it free and available for everyone.

So I’ll be asking about our progress on those issues today. Today safely reopening our country may be a ways off and the administration’s planning may be way behind but there’s still a lot that Congress needs to do. There isn’t time to spare. Some, including the White House, say we’ve already provided enough economic relief. Well, my question to them is, “What good is a bridge that only gets you to the middle of the river?” We don’t need to wait around to see if people need more help, we know they do.

We need to work quickly on another aggressive relief package and we need to make sure our priorities in that bill are protecting our workers, our students and our families. And, addressing this public health crisis, not bailing out corporations or protecting big business from accountability. People across the country are doing their part, they are washing their hands and wearing masks and social distancing and staying home. They need their government to do its part too. They need leadership, they need a plan, they need honesty and they need it now before we were open, so they can rest assured that we are doing things safely and competently with their health and wellbeing as a top priority. Thank you, Mr. Chairman.

It’s an important hearing and I know lots of people may be watching it for the first time. If they are, I hope they notice that we have 23 members of this committee, I believe one more Republican than Democrat. We have some very strong views but we’re able to work together and to express those views and respect each other and our witnesses and a big part of that goes to Senator Murray and her staff. So thank you for that.

Each witness will have up to five minutes to give his testimony. Thank you for making an exception and agreeing to testify by video because of these unusual circumstances. And, thank you for what you’re doing for our country. Our first with witnesses, Dr. Anthony Fauci. He’s Director of The National Institutes of Allergy and Infectious Diseases at The National Institutes of Health. He’s held that position since 1984, which meant he’s advised six presidents and worked on HIV AIDS, influenza, malaria, Ebola and other infectious diseases. He was involved in treating Ebola patients at NIH and also worked on vaccine trials for Ebola.

Next, we’ll hear from Dr. Robert Redfield. He’s Director of the U.S. Centers for Disease Control and Prevention, which has its headquarters in Atlanta. More than 30 years, he’s been involved with clinical research related to chronic human viral infections and infections diseases, especially HIV. He was the founding director of the Department of Retroviral Research with the U.S. military’s HIV Research Program. He’s spent 20 years with the U.S. Army Medical Corps.

Third, Admiral Brett Giroir. Admiral Giroir is Assistant Secretary for Health at The U.S. Department of Health and Human Services. That puts him in charge of development of public health policy recommendations. He’s taken on the responsibility for coordinating testing and focused on the increasing number of tests that we can do with existing technology. This federal service includes a variety of activities with our Defense Department in advanced research, threat reduction. He was part of the Blue Ribbon Panel to reform the U.S. Veterans health system.

And finally, we’ll hear from Dr. Stephen Hahn. He’s Commissioner of The Food and Drug Administration. Before joining FDA, he was the Chief Medical Executive of the University of Texas, MD Anderson Cancer Center. And, he was Chair of the Department of Radiation Oncology at the University of Pennsylvania. He was a senior investigator at The National Institutes of Health. Is Commander of U.S. Public Health Service Commission Corps in 2025.

Now, we’ll ask each of our witnesses to summarize their remarks in five minutes. Following that, each senator will have five minutes for questions and answers in order of seniority. Dr. Fauci, let’s begin with you. Welcome.

Dr. Anthony Fauci: (29:35)
Thank you very much, Mr. Chairman, Ranking Member Murray and members of the committee. Thank you for giving me the opportunity to discuss with you today, the role The National Institutes of Health and Research addressing COVID-19. The strategic plan that we have is fourfold. One, to improve a fundamental knowledge of the virus and the disease it causes. Next, to develop new point of care diagnostics. Next, to characterize and test therapeutics. And finally, to develop safe and effective vaccines.

First with regard to diagnostics, as you probably heard from Dr. Francis Collins last Thursday, the NIH has developed a rapid acceleration of diagnostics program called Red X, with an award to that specific program, up to a half a billion dollars, to support the development of COVID-19 diagnostics. It is a national call for innovative technologies, that will be evaluated in a Shark Tank like selection process, to get to either success or failure rapidly.

Moving on to therapeutics. I’ll talk a bit about the Remdesivir success antiviral in a moment. But, let me emphasize that there are a number of broad spectrum antivirals that are in various stages of testing. In addition, we will be looking at convalescent plasma, which is plasma from individuals…

… at convalescent plasma, which is plasma from individuals who have recovered from COVID-19 to be used in passive transfer either in prevention or treatment. In addition, hyperimmune globulin, which can be used as a gamma globulin shot. We’ll be looking at repurposed drugs as well as immune-based therapies and host modifiers, and finally, monoclonal antibodies.

Let me take a moment to describe the Remdesivir placebo-controlled randomized trial, which was done internationally with a power of more than 1,000 individuals in sites throughout the world. It was in hospitalized patients with lung disease. The endpoint was primarily time to recovery. The result was statistically significant, but really modest. We must remember it was only a modest result showing that the drug made a 31% faster time to recovery. We hope to build on this modest success with combinations of drugs and better drugs.

Moving on to vaccines, there are at least eight candidate COVID-19 vaccines in clinical development. The NIH has been collaborating with a number of pharmaceutical companies at various stages of development. I will describe one very briefly, which is not the only one, but one that we have been involved in heavily developing with Moderna. It’s a messenger RNA platform. You might recall in this committee that in January of this year, I said that it would take about one year to 18 months if we were successful in developing a vaccine.

The NIH trial moved very quickly. On January 10th, the sequence was known. On January the 11th, the Vaccine Research Center met to develop a plan. On the 14th of January, we officially started the vaccine development. 62 days later, we are now in Phase I clinical trial with the two doses already fully enrolled. There will be animal safety. The Phase I will directly go into Phase II-III in late spring and early summer. If we are successful, we hope to know that in the late fall and early winter.

There are some important issues, however, in COVID-19 vaccine development. We have many candidates and hope to have multiple winners. In other words, it’s multiple shots on goal. This will be important because this will be good for global availability if we have more than one successful candidate. We also, as the chairman mentioned, will be producing vaccine at risk, which means we’ll be investigating considerable resources in developing doses even before we know any given candidate or candidates work. I must warn that there’s also the possibility of negative consequences where certain vaccines can actually enhance the negative effect of the infection. The big unknown is efficacy. Will it be present or absent and how durable will it be?

Finally, I want to mention the NIH has launched a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines. The purpose of that is to prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential. Hopefully our research efforts, together with the other public health efforts, will get us quickly to an end to this terrible ordeal that we are all going through. Thank you very much. Happy to answer questions later.

Thank you, Dr. Fauci. Dr. Redfield.

Dr. Robert Redfield: (34:42)
Good morning, Chairman Alexander and ranking member Murray and members of the committee. Our nation is confronting the most serious public health crisis in more than a century, yet we’re not defenseless. We have powerful tools to fight this enemy. We have tried and true effective public health interventions such as early case identification, isolation and contact tracing combined with important mitigation strategy that include social distancing, frequent hand washing and face covering. These public health tools have and will continue to slow the spread of COVID-19.

I appreciate the opportunity this morning to provide a brief overview of some of CDC’s ongoing work in response to COVID-19. The CDC has been working 24/7 to combat the pandemic. CDC’s Emergency Operation Center is supporting state tribal, local, and territorial public health partners in building core capabilities, particularly workforce, laboratory and data and predictive analytics. Epidemiologists are conducting surveillance for COVID-19 as well as conducting health system surveillance.

Community mitigation teams are providing guidance on infection control and contact tracing. Our laboratory experts are performing serological testing to better define the extent of asymptomatic populations. As local leadership makes decisions to reopen, they’ll require varying degrees of federal support. Each location will be different and will face unique circumstances. CDC has conducted a state by state assessment of public health testing capacity and key contact tracing capacity as well as surge plans.

CDC is providing technical assistance and funding to the states provided through the Supplemental CARES Act and the Paycheck Protection Program and health care enhancement. We’re working directly with the state public health leaders to define their needs for testing and testing devices, supplies and manpower, surveillance, data collection and reporting, contact tracing, infection control and outbreak investigation.

I want to spend a moment to focus on several key elements. First testing, rapid, extensive and widely available timely testing is essential for reopening America. CDC’s role in testing continues to support diagnosis and contact tracing surveillance and outbreak when we work with the public health partners to define their particular testing strategy for their jurisdiction. Admiral Giroir will address the testing components of the response in greater detail.

Contact tracing, increasing state, tribal, local, and territorial contact tracing capacity is critical. It’s a critical part to stop the chains of transmission and prevent the occurrence of sustained community transmission. CDC’s role is to provide technical training, assistance and support to the states as they hire and build a workforce necessary to be fully prepared to effectively respond to the public health challenges posed by the ongoing COVID pandemic. This will be an expansive effort.

Surveillance, our nation surveillance program is built on a combination of systems, including existing syndromic influenza and respiratory viral disease surveillance systems have been combined with commercial and research lab platforms and our case reporting form system. CDC is adapting these and optimizing it to have a surveillance system in response to COVID-19. Importantly in light of the significant occurrence of asymptomatic infection, the surveillance for asymptomatic infection becomes an important public health tool for early case identification. CDC is working with each public health jurisdiction to develop a perspective surveillance program to include active surveillance among those that are most vulnerable, such as individuals in long-term care facilities, inner city clinics and homeless shelters.

We need to rebuild our nation’s public health infrastructure, data and data analytics, public health laboratory resilience and our nation’s public health workforce. Now’s the time to put it in place for the generations to come, not only for the public health system that our nation needs, but for the public health system that our nation deserves.

Before I close, I want to recognize the tireless commitment of the dedicated CDC staff who have deployed to every corner of this nation to fight COVID-19. More than 4,000 employees have deployed here and globally. Science and data continue with technical expertise and public source service to be the backbone of CDCs contributions to the US response. I extend my serious gratitude to the healthcare workers on the front lines, as well as their family and the essential emergency personnel. As well as the American people to say thank you for adhering to the stay-at-home guidelines and protecting the most vulnerable.

It’s important to emphasize that we’re not out of the woods yet. The battle continues, but we are more prepared. We need to stay vigilant with social distancing. It remains an imperative. We are a resilient nation. I am confident that we will emerge from this pandemic stronger together. Thank you.

Thank you, Dr. Redfield. Admiral Giroir, welcome.

Admiral Giroir: (40:09)
… be here to provide you with an update on the nation’s progress in testing for COVID-19. On March 12th, Secretary Azar requested that I lead the COVID-19 testing effort within HHS, including oversight and coordination of the FDA and CDC with regard to testing. Since then, the nation has performed more than 9 million COVID-19 tests, a number far greater than any other country and double the per capita tests performed to date in South Korea. To reach this point, we implemented a phased approach to meet testing needs during mitigation and now during phase one reopening of America.

Beginning March 20th, we pioneered 41 community-based drive-thru testing sites in locations prioritized by the CDC. These sites have been a profound success testing over 167,000 high risk individuals and demonstrating a prototype that is being duplicated multifold in nearly every state. Next, the administration leveraged trusted retailers, including CVS, Rite Aid, Walgreens, Walmart, Kroger, and Health Mart, who are now providing testing at 240 locations in 33 states, 69% of which are in communities with moderate to high social vulnerability.

To meet the need for collection supplies like swabs and media tubes, we first secured the global supply chain through a military air bridge. We worked directly with manufacturers to increase domestic production. We collaborated with the private sector and the FDA to validate multiple swab and media types that vastly expanded supplies while minimizing the need for PPE. Finally, we used Title III of the Defense Production Act to further invest in domestic manufacturing to prepare us for reopening. To support the need for surveillance testing during reopening, on April 27th we issued a new testing framework that also prioritized testing for persons without symptoms who are prioritized by health departments or clinicians for any reason, including screening of asymptomatic individuals according to state and local plans. Next, our federal multidisciplinary team conducted multiple calls with leadership from each state to set state-specific testing objectives.

Collectively, states and territories established an overall goal to perform 12.9 million tests over the next four weeks. The federal government is able to and will support the achievement of this goal. Specifically, the federal government is shipping to states 12.9 million swabs and over 9.7 million tubes of media in May alone. Last month, we also detailed the location and capacity of every lab machine in every state that could potentially run COVID-19 assays. Our team has worked with test suppliers to match reagents to these machines.

Looking forward between now and the end of 2020, the federal government will procure over 135 million swabs and 132 million tubes of media and distribute these to states as requested to supplement the now robust commercial supply. We anticipate marked increases in current tests, as well as the dramatic expansion of new point of care tests like the first in class Quidel antigen test authorized by the FDA just last Friday. Quidel anticipates being able to distribute 300,000 tests per day within just a few weeks.

By September, taking every aspect of development, authorization, manufacturing, and supply chain into consideration, we project that our nation will be capable of performing at least 40 to 50 million tests per month, if needed at that time. If new technologies are authorized like whole genome sequencing approaches or any novel solutions uncovered by NIH’s new diagnostics initiative, that number will be much higher.

Finally, I want to acknowledge and express my heartfelt gratitude to the officers of the US Public Health Service Commission Corps, the uniformed service I am honored to lead. 3,471 men and women have deployed in support of this pandemic. On the cruise ship in Japan to our military bases repatriating Americans to our community based testing sites and international airports to FEMA and our task forces to nursing facilities, including King County, Washington, and to field hospitals in hard hit communities across our nation, I thank each and every one of these officers and their families. On their behalf, I thank the members of this committee for supporting our training needs and the establishment of a ready reserve to supplement our ranks in future national emergencies. Thank you for the opportunity to provide these remarks.

Thank you, Admiral Giroir. Now Dr. Steven Han, our fourth and final witness.

Dr. Steven Han: (45:22)
Chairman Alexander, ranking member Murray and members of the committee, thank you for inviting me to participate in this hearing today. I first want to start by thanking the American people for their incredible efforts at mitigation and extend my condolences to those who have lost loved ones. From day one of this pandemic, the 18,000 FDA employees who are just incredible scientists, doctors and nurses have taken an active role in the all of government response to this pandemic. The FDA has worked to facilitate the development of medical countermeasures to diagnose, treat and prevent COVID- 19. We’ve worked closely with laboratories, manufacturers, academia, product developers, our federal partners and companies, companies that don’t even make medical products but want to pitch in, for example, by making hand sanitizer, personal protective equipment and ventilators.

Every decision we have made have been driven by data with the goal of protecting the health of the American people. In a public health emergency, however, our response has balanced the urgent need to make medical products available with the provision of a level of oversight that helps ensure the safety and effectiveness of those medical products.

I’d like to take a few minutes to tell you what FDA is doing to help the country at this point in which Americans should have a safe return to work and to school. It starts with testing as others have mentioned. FDA has worked with more than 500 developers who have or said they will be submitting emergency use authorization requests for COVID-19 tests. This includes some newer technologies that heretofore have not been used as part of diagnostic tests in response to a pandemic.

We have issued 92 individual emergency use authorizations for test kit manufacturers and laboratories. We’ve been informed by more than 250 laboratories that have begun testing under the regulatory flexibilities we outlined in March. We are conducting rolling reviews of EUA submissions so that we can quickly authorize tests, which the data support. In a public health emergency, the accuracy of diagnostic tests is important not only for the individual patient, but for the public at large.

FDA is helping to ensure the availability of tests that are providing accurate answers. We are also monitoring the marketplace for fraudulent tests and are taking appropriate actions to protect the public health. We are working to provide more clarity about which tests have been reviewed and authorized by the FDA and which have not.

Serologic tests will play a role in our recovery. Unlike diagnostic tests, which detect the presence of the virus, serologic tests measure the amount of antibodies or protein present in the blood when the body is responding to an infection like COVID-19. These tests can help identify individuals who can overcome an infection and have developed an immune response. We will continue working with labs and manufacturers and across the government to find a balance between the assurance that an antibody test is accurate and timely access to such tests.

Of course, the way we will eventually beat this virus is with a vaccine and FDA is working closely with our federal partners, including the NIH, vaccine developers, manufacturers and experts across the globe. We intend to use our regulatory flexibility to help ensure the most ensure efficient development of a safe and effective vaccine to prevent COVID-19. Until a preventative vaccine is approved, however, we need medical products to bridge the gap.

FDA has been working for several months to facilitate the development and availability of therapeutics as expeditiously as possible. We created an emergency program for this acceleration called the Coronavirus Treatment Acceleration Program, or CTAP. We have reassigned staff to work with urgency to review requests from companies, scientists, doctors who are developing therapies. We’re using every available authority and regulatory flexibility that’s appropriate to facilitate the development of safe and effective products to treat COVID-19.

A variety of therapeutic areas are being evaluated as mentioned by Dr. Fauci And others, including antiviral drugs and immunotherapies, as well as convalescent plasma, hyperimmune globulin and monoclonal antibodies. As Dr. Fauci also mentioned, we recently announced the positive results of the NIAID trial of Remdesivir and issued an EUA for the treatment of hospitalized patients with COVID-19.

Two other promising treatments that I mentioned are the antibody rich products, convalescent plasma and hyperimmune globulin. I am certainly willing to go into more detail if members of this committee have questions about this. But we are working very aggressively and closely with stakeholders to facilitate the development of monoclonal antibodies, which if shown to be safe and effective, could act as a bridge therapy to the development of a vaccine. We recognize that developing vaccines and therapies need to go hand-in-hand with ensuring that there will be sufficient supplies for our country. We’re also working with manufacturers to make sure that this supply chain is robust.

Mr. Chairman, ranking member and members of the committee, please know that in FDA, you have a dedicated team of some of the nation’s finest scientists, healthcare providers and public health professionals. We are guided by science and data and we won’t let up until we facilitate the development of products that our nation needs to get back to work. I look forward to your questions.

Thank you, Dr. Han. Thanks to all four of you for your expertise, for your dedication to our country and your hard work. We’ll now begin a round of five-minute questions from each Senator on the committee alternating between Republicans and Democrats. Each Senator has, if you’re a video conference, you have a little time clock at the bottom. I would ask you to try to stay within five minutes for your questions and answers.

I will start. I’ve got a question for Dr. Fauci and then Admiral Giroir. Doctor, let’s look down the road three months. There will be about 5,000 campuses across the country trying to welcome 20 million college students, 100,000 public schools welcoming 50 million students. What would you say to the chancellor of the University of Tennessee Knoxville or the principal of a public school about how to persuade parents and students to return to school in August? Let’s start with treatments and vaccines first. Dr. Fauci. If you can save about half of my five minutes for Admiral Giroir for testing, I would appreciate it.

Thank you very much, Mr. Chairman. I would be very realistic with the chancellor and tell him that when we’re thinking in terms-

It’s a her in this case.

I would tell her … I’m sorry, sir, that in this case that the idea of having treatments available, or a vaccine, to facilitate the re-entry of students into the fall term would be something that would be a bit of a bridge too far. As I mentioned, the drug that has shown some degree of efficacy was modest and it was in hospitalized patients not yet or maybe ever to be used either yet as prophylaxis or treatment.

If the issue is that the young individuals who will be going back to school would like to have some comfort in that there’s a treatment, probably the thing that would be closest to utilization then would likely be passive transfer of convalescent serum. But we’re really not talking about necessarily treating a student who gets ill, but how the student will feel safe in going back to school.

If this were a situation where we had a vaccine, that would really be the end of that issue in a positive way. But as I mentioned in my opening remarks, even at the top speed we’re going, we don’t see a vaccine playing in the ability of individuals to get back to school this term. What they really want is to know if they are safe. That’s the question that’ll have to be due with what we discussed earlier about testing. I’m about halfway through the remarks. I’d like to just pass the baton to Admiral Giroir who will address the question of the availability of testing and what role that might play in returning to school. Thank you, sir.

Thank you, Dr. Fauci. Admiral Giroir, you said that while we’re doing about 10 million tests this month, that we might be as high as 40 or 50 million by September in a month, which is a significant increase. If I’m chancellor of the University of Tennessee, could I develop a strategy where I’d say to all my students, “We have, for example, an antigen test, which is quick and easy. We want everybody on campus to come by and take it once before you begin school. That will at least let everybody know that on that day, we’ve isolated anybody who’s positive and then we can continue to monitor.” Is that strategy possible in August and September?

Thank you, Mr. Chairman. I may reserve 20 seconds for Dr. Redfield as well. The strategy that’s going to be employed really depends heavily on what’s the community spread at that time. If there’s almost no community spread, your strategy will be different. If there’s high community spread, it will also be different.

But yes, technically we will have the ability and your chancellor will have the ability. We expect there to be 25 to 30 million point of care tests per month available. It is certainly possible to test all of the students or it is much more likely that there would be a surveillance strategy done where you may test some of the students at different times to give an assurance that there’s no circulation. That would be done in conjunction with the CDC and the local health department.

There’s also strategies that are still needing to be validated, but of pooling samples. We know in some experimental labs as many as 10 or 20 samples can be pooled. Essentially one test could test 20 students. Finally, there are some experimental approaches that look interesting, if not promising, that for example wastewater from an entire dorm or an entire segment of a campus could be tested to determine whether there’s coronavirus in that sewerage, the waste water. There are other strategies being developed. I’d like to at least give 20 seconds to Dr. Redfield who really will be working on the strategy of how to employ that given different community spread.

Dr. Redfield?

Yeah, just some quick comments, sir. I mean, first I think it’s really important to evaluate critically the role of changes in social distancing on college campuses and in schools and the situation, not to forget the importance of what we’ve learned. Clearly also developing an aggressive program for wellness education, making sure people understand when they’re symptomatic they need to seek evaluation.

I think that you are going to have to look at the role of testing. I think there is going to be an important role of testing in these circumstances. I think it will be individualized based on where these different schools are, how much infection is in their [crosstalk 00:56:59]-

I’m going to wrap it up there so I can set a good example for the other senators with their five minutes. Senator Murray.

Senator Murray: (57:08)
Thank you very much, Mr. Chairman. Thank you to all of our witnesses. Dr. Fauci, you have warned of needless suffering and death if we push to reopen too soon, but the President has actually been sending the opposite message. I want to ask you today, what is the most important message you have for communities and states that are reopening even as our public health experts make it clear it’s too soon? Tell us what the consequences are.

Thank you very much for that question, Senator Murray. As I’ve said many times publicly, what we have worked out is a guideline framework of how you safely open America again. There are several checkpoints in that with a gateway first of showing, depending on the dynamics of an outbreak in a particular region, state, city, or area, that would really determine the speed and the pace with which one does re-enter or reopen.

My word has been, and I’ve been very consistent in this, that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14-day decrease that would allow you to go to phase one. Then if you pass the checkpoints of phase one, go to phase two and phase three. What I’ve expressed then, and again, is my concern that if some areas, city, states, or what have you, jump over those various checkpoints and prematurely open up without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn into outbreaks.

Therefore I have been being very clear in my message to try to the best extent possible to go by the guidelines, which have been very well thought out and very well delineated.

Senator Murray: (59:10)
If a community or a state or a region doesn’t go by those guidelines and reopens, the consequences could be pretty dire, correct?

The consequences could be really serious. Particularly, and this is something that I think we also should pay attention to, that states, even if they’re doing it at an appropriate pace, which many of them are and will, namely a pace that’s commensurate with the dynamics of the outbreak, that they have in place already the capability that when there will be cases, there is no doubt even under the best of circumstances, when you pull back on mitigation, you will see some cases appear. It’s the ability and the capability of responding to those cases with good identification, isolation and contact tracing will determine whether you can continue to go forward as you try to reopen America.

Dr. Anthony Fauci: (01:00:10)
It’s not only doing it at the appropriate time with the appropriate constraints, but having in place the capability of responding when the inevitable return of infections occur.

Senator Murray: (01:00:23)
Thank you for that. It’s very clear in order to do that we need knowledge, which is about testing. For months, this administration’s approach to testing has really been plagued by unrealized goals and disregard for systemic problems within that supply chain. Last week, an average of just 250 tests per day were performed in the United States. That is a small fraction of what we need. Yesterday, President Trump had the gall to declare the US had “prevailed” on testing in a press conference that was filled with misinformation and distortions.

Dr. Giroir, public health experts do not think the US has prevailed. I’m glad you finally committed that states, including my home state of Washington, will receive enough tests to meet their goals for May and June. But this administration has had a record of giving us broken promises that more tests and supplies are coming and they don’t.

We know by the way the testing needs will persist long past June, long past June. I wanted to ask you today, will the administration’s forthcoming strategic plan that is now required under the COVID package that was just passed and signed into law, will that strategic plan on testing include specific numeric targets for testing capacity, supply chain capacity and projection of shortages?

Admiral Giroir: (01:01:52)
Thank you for that question and statement, Senator Murray. Yes, we are as I’ve stated, we continue to have a work in progress as we build the testing capacity.

…. in progress. As we build the testing capacity, we have established the targets with the states of over 12 million tests over the next four weeks. We think those targets are going to be good in May, in June. But as Dr. Fauci said, we really have to be evidence based. We expect those targets to go up as we progressively open, as communities go through phase one and then into phase two. And certainly those numbers will need to go up significantly again in the fall when we potentially have influenza circulating with COVID. So yes, there will be targets. The targets will need to change based on the evidence that we see. But we are highly committed to securing the supply chain. We’ve worked daily with every manufacturer. And I’m just pleased we’re, in May and June, able to get ahead of the states so that we can supply them what they need so they have those assurances. So there’s not going to be any doubts about that.

Senator Patty Murray: (01:02:56)
So my question to you is when you put out that specific plan that you were required to do, we will see numbers that you are going to tell us that you will reach, targeted for testing and supply chain capacity and production, instead of just saying, “We hope to have a million this week, next week.” So you will give us the specific targets, correct?

I’ll say yes, ma’am, we know the specific amounts of tests we have over the summer.

Not have, how many we need.

So yes, ma’am. We developed the need statements by working with the states individually, with epidemiologists, with the CDC, so that overall in May, we’ll be testing about 3.9% of the overall US population.

Okay, fine. But what I’m telling you-

Chairman: (01:03:47)
Well over time, Senator Murray.

… how many we have, but how many we will need, not just for May, but in the coming months, so that we can be prepared to have them.

Yes, ma’am. And not to be repetitive, but we need to be evidence and data driven, because what we may see in May or June will drive differences in the amount of tests goals we have. So we really just need to be very humble about this. We need to look at the data. We know that the testing needs will go up over May and June as we progressingly open. And we will do our best to predict that. But you have to understand, we have to see what the data and the evidence show at that time.

Okay. I appreciate that. Mr. Chairman, again, what our strategic plan requires is, what is the goal? Not how many we have, but how many we need, and that’s what we’ll be looking for. Thank you.

Thank you, Senator Murray. Senator Enzi.

Mike Enzi: (01:04:39)
Thank you, Mr. Chairman. I particularly appreciated your opening statement where you had a very succinct list of preparations we need to learn from this pandemic for the next one. Not only should we be working on this and preparing, but we need to look at future too. And I think we’ve learned a lot. We’re fighting a virus at the same time that scientists are learning about it, so we need to be nimble. We also need to be sure that we are prepared for a second wave of outbreaks. It could coincide with the start of the flu season, potentially stressing our healthcare system even more than it already has been.

Mike Enzi: (01:05:20)
Admiral Giroir, I thank you for your comments. I think they’ve been comforting about what has been done and what can be done. I agree with Senator Murray that we need to have some specific goals. As an accountant, that’s always one of the things that I’m looking for.

Mike Enzi: (01:05:39)
For questions, Dr. Hahn, our understanding of the clinical picture of COVID-19 continues to evolve. What first looked like a respiratory illness now seems much more comprehensive, potentially affecting the heart, the brain, the kidneys, and other organs. How does this evolving picture impact the ability to evaluate the appropriate clinical or surrogate endpoints for review of vaccines and treatments?

Dr. Stephen Hahn: (01:06:10)
Thank you, Senator, for that question. The evolving clinical picture, and obviously the way this is manifesting around the country clinically, does in fact inform the endpoints that we will work with developers of therapies on so that we can get the absolute most efficient, but also the most accurate information and appropriate endpoints to make the necessary authorizations and approvals. We have set up this program called the Coronavirus Treatment Acceleration Program, where our top scientists and clinicians have been at the table, consulting with our colleagues at NIH and CDC to actually address those questions. What are the appropriate end points?

I’ll give you an example. We do know that in some circumstances, patients who’ve had severe COVID disease have developed thrombotic or clotting type episodes. And so we prioritized a review of agents that we think might be beneficial. And obviously, the clinical end points for those trials will be different than an agent that’s an antiviral like remdesivir where, as Dr. Fauci mentioned, we’re looking at time to recovery. So we want to adapt it to the clinical circumstance as well as to the type of therapy that’s put before us.

Mike Enzi: (01:07:29)
Thank you. Another question to Dr. Hahn. We have made a lot of progress in vaccine development already, but BARDA has identified that domestic manufacturing of needles and syringes is a significant gap in pandemic preparedness. What has HHS done in advance of potential national vaccination campaign to ensure that we have sufficient capacity to administer a vaccine?

Senator Enzi, thank you for that question. This is a really important point, because as you mentioned, it’s not just about the vaccine, or hopefully vaccines, that are developed. It’s also about the supplies that are needed as well as an operational plan for administering the vaccine. So this is an all of government approach. There is a program that’s been set up called Operation Warp Speed that includes Dr. Collins, Dr. Fauci, his colleagues at NIH, the Department of Defense, as well as other members of HHS and FDA. Dr. Peter Marks from our Center for Biological Evaluation Research has been helping coordinate that. He’s working very closely with Dr. Fauci and his team. And we’ve created what’s called a Gantt chart to look forward. What are the necessary supply chain issues, syringes, needles, et cetera, depending on the various vaccines that are being developed, how many times they have to be administered, and the route of administration. So we’ve been leaning in on the supply chain to ensure that when a vaccine is ready to go, we will have the necessary supplies to actually administer it and operationalize the vaccination.

Mike Enzi: (01:09:06)
Thank you. I have a couple more questions, but again, the clock’s not visible there, so I suspect I’ve used up my time. I’ll submit those in writing.

Thank you, Senator Enzi. Senator Sanders.

Senator Bernie Sanders: (01:09:24)
Thank you very much, Mr. Chairman. And let me thank all of the panelists for the hard work they’re doing and for being with us today. It is sad to say that we have a president of the United States, the leader of our country, who from day one downplayed the dangers facing this country from the pandemic. Who told us that the crisis would be over in a few months, that we did not have to worry. Who fired those members of the government who wanted to act aggressively. And among other things, the time when we need international cooperation, cut funding for the World Health Organization. But let me also say that I think we understand that facts are terribly important. That we don’t fully understand all of the ramifications of the COVID-19 epidemic. But let me ask Dr. Fauci a few questions, if I might. For a start, the official statistic, Dr. Fauci, is that 80,000 Americans have died from the pandemic. There are some epidemiologists who suggest the number may be 50% higher than that. What do you think?

I’m not sure, Senator Sanders, if it’s going to be 50% higher. But most of us feel that the number of deaths are likely higher than that number because given the situation, particularly in New York city, when they were really strapped with a very serious challenge to their healthcare system, that there may have been people who died at home who did have COVID, who were not counted as COVID because they never really got to the hospital. So in direct answer to your question, I think you are correct, that the number is likely higher. I don’t know exactly what percent higher, but almost certainly it’s higher.

Dr. Fauci, let me ask you this. In the terrible pandemic of 1918, the virus exploded in the fall. It came back with a vengeance. Are we fearful that if we don’t get our act together, as bad as the situation is now, it could become worse in the fall or winter?

Well, Senator, thank you for that question. It’s a frequently asked question, and I think that possibility does exist. However… And the reason I say that is that when you talk about, will this virus just disappear? And as I’ve said publicly many times, that is just not going to happen because it’s such a highly transmissible virus. And even if we get better control over the summer months, it is likely that there will be viruses somewhere on this planet that will eventually get back to us.

So my approach towards the possibility of a rebound and a second wave in the fall is that, A, it’s entirely conceivable and possible that it would happen. But B, I would hope that between now and then, given the capability of doing the testing that you heard from Admiral Giroir, and the ability of us to stock up on personal protective equipment, and the workforce that the CDC under Dr. Redfield will be putting forth to be able to identify, isolate, and contact trace, I hope that if we do have the threat of a second wave, we will be able to deal with it very effectively to prevent it from becoming an outbreak, not only worse than now, but much, much less.

Okay. Well, let me ask, we’ve heard a lot of discussion about vaccines. Obviously everybody in Congress and in this country wants a vaccine. We want it as quickly as possible, as effective as possible. Let me ask the honorable FDA Commissioner. Sir, if, God willing, a vaccine is developed, and if we’re able to produce it as quickly as we all hope we can, I would imagine that that vaccine would be distributed to all people free of charge. We’ll make sure at least that everybody in America who needs that vaccine will get it, regardless of their income. Is that a fair assumption?

Senator, I certainly hope so. FDA is very committed to making sure that all populations in the United States, including those most vulnerable, are included in the clinical trials.

Well, that’s not what I’m asking. What I’m asking is if and when the vaccine comes, it won’t do somebody any good if they don’t get it. And if they have to pay a sum of money for it in order to profit the drug companies, that will not be helpful. Are you guaranteeing the American people today that that vaccine will be available to all people, regardless of their income?

So the payment of vaccines is not a responsibility of the FDA, but I’m glad to take this back to the task force. I share your concern that this needs to be made available to every American.

Does anybody else want to comment on that? Mr. Giroir, do you think we should make that vaccine, when hopefully it is created, available to all regardless of income? Or do you think that poor people and working people should be last in line for the vaccine?

I’m sorry, Senator, were you asking me?

Yes, I was, sir. Yes, I was.

My office is one of the offices committed to serving the underserved, and we need to be absolutely certain that if a vaccine or an effective therapeutic or preventative’s available, that it reaches all segments of society, regardless of their ability to pay or any other social determinants of health that there may be.

Good. So you’re telling the American people today that regardless of income, every American will be able to gain access to that vaccine when it comes.

They should gain access to it. I don’t control… You know, I think that-

Well, you represent that administration that makes that decision.

I will certainly advocate that everyone is able to receive the vaccine, regardless of income or any other circumstance.

All right. Let me just-

We’re at time, Senator Sanders.

All right. I’m sorry. Thank you, Mr. Chairman.

Those are important questions. I don’t want to cut senators off, and it’s hard to see the time clock. But if we could stay as close as possible to five minutes, then all the senators can get their questions in. Thank you, Senator Sanders. Senator Burr.

Senator Richard Burr: (01:16:25)
Thank you, Mr. Chairman, and thank our witnesses today for what you’ve done for the people in this country and their safety in people around the globe. Let me ask you, Dr. Fauci, because you’ve been in the task force and at a majority of the press conferences. Has anybody in this administration ever asked you or any member to take the foot off the gas of trying to find a cure or any type of counter measure?

No, Senator, not at all. As a matter of fact, we at NIH, as you know, have right from the very beginning put our foot right on that accelerator in every aspect, including the development of vaccines and therapeutics. And as I described my opening statement, we actually started that in January, literally days after the virus was known and its sequence was published. So no, I have never been told by anyone to hold back on the development of any countermeasure or any basic research project that we’ve been involved in.

Thank you, Dr. Fauci. This question is for Dr. Redfield. Dr. Redfield, we have authorized in this committee and appropriated out of Congress multiple times over the last few decades, money for biosurveillance, and you talked about it. In the past four years, from FY16 to FY20, it’s been $23 million a year. And with the Cares Act, it’s over $1 billion in biosurveillance. We’ve seen the private sector go out and use data available to track the progress and spread of coronavirus around the world. Why has CDC not contracted with private sector technology companies to try to use their tools for biosurveillance?

Dr. Robert Redfield: (01:18:13)
Senator, thank you for the question. This is a critical issue, as you know, and also comes into one of the core capabilities I talked about, data analytics and data monitorization, which we’re appreciative of the additional funding Congress has given. I can tell you that this is under critical review now. We do have contracts with some of the private sector groups now to try to make the type of availability of data that we’ve seen with Florida available in all of our jurisdictions across the country. And in the process of making that happen.

Dr. Redfield, in June of last year, we reauthorized the Pandemic and All-Hazards legislation, which authorized at that time 30 new employees at CDC, specifically in surveillance. Now, I asked Dr. Schuchat in March, how many of those 30 had been filled? She said zero. As of mid April, zero of those 30 billets had been filled. How many of those 30 employees that this committee authorized CDC to bring on for biosurveillance have been filled today>

Sir, again, thank you for the question. I know our staffs have been in discussion since Dr. Schuchat’s testimony, and I know we’re in the process of continuing to try to figure out how to move that forward, sir. I can get back to you on it as I discuss what progress has been made since we had that discussion post her hearing with you when you brought that to light.

Well, I brought it to light the 1st of March, and now we’re in mid May. So I’m hopeful that we won’t just talk about surveillance, we’ll actually execute it, and will focus the unbelievable amounts of money that we’ve provided for you, that they will show some benefit to the American people.

Dr. Fauci, let me come back to you. This is one of the fastest development timelines we’ve ever seen for vaccines. And the American people, and hopefully people around the world, will be the beneficiary of what you find and the eventual licensure of that product. What are the biggest unknowns with this particular virus that can affect the development process? And dr. Hahn, if you’ve got anything to add after that to this, please do. Dr. Fauci?

Yeah. Thank you very much, Senator Burr. Well, there are a couple of things that I think are inherent in all vaccine development. First of all, there’s no guarantee that the vaccine is actually going to be effective, as you well know, because we’ve discussed this many times in the past. You can have everything you think that’s in place, and you don’t induce the kind of immune response that turns out to be protective and durably protective. So one of the big unknown is, will be effective? Given the way the body responds to viruses of this type, I’m cautiously optimistic that we will, with one of the candidates, get an efficacy signal.

The other thing that’s an unknown that’s of concern, but we’ll be able to get around that by doing the tests properly, is that, do you get an enhancement effect? Namely, there have been a number of vaccines, two in particular, dengue and respiratory syncytial virus. When the vaccine induces a suboptimal response and when a person gets exposed, they actually have an enhanced pathogenesis of the disease, which is always worrisome. So we want to make sure that that doesn’t happen.

Those are the two major unknowns. Putting all those things together, Senator Burr, I still feel cautiously optimistic that we will have a candidate that will give some degree of efficacy, hopefully a percentage enough that will induce the kind of herd immunity that would give a protection to the population at whole.

Dr. Hahn, anything to add to that?

Yes, sir. Thank you for the question. The obstacles from a regulatory point of view, I think are being met by the approach that’s being taken out of HHS and led by Peter Marks. And that is a common pre-clinical development pathway, so that we can appropriately assess one vaccine against the other. And then a master protocol that allows for a common control group and an assessment of very common endpoints. That’ll let us be as efficient as possible for the development of vaccine. We will evaluate approximately 10 candidates pre-clinically, and then in the phase one and phase two studies, and then take four to five into phase three studies in this HHS effort. So I think those are the obstacles that can be broken down to speed the development, but also allow us to ensure safety and effectiveness.

Mr. Chairman, yesterday the state of North Carolina started to publicize the recovered numbers. Those individuals who had coronavirus, but have recovered. It’s my hope that nationally, we will start reporting the recovered numbers. I think that’s important for the American people to hear. I yield back.

Thank you, Senator Burr. Senator Casey.

Bob Casey: (01:23:22)
Mr. Chairman, thank you for the hearing, as well as Ranking Member Murray. Mr. Chairman, I wanted to start today with a question regarding nursing homes. In particular, across a state like ours, we’ve had, as you might know, a high number of cases in Pennsylvania. At last count, over 57,000 cases. The number of deaths have gone above 3,700. And of course, a lot of those deaths are in nursing homes. We’re told that nationally, more than a third, as high as 35%, of all deaths have been in nursing homes, either the death of a resident of a nursing home or a worker.

Bob Casey: (01:24:04)
So I want to start today with a question for Dr. Redfield. Doctor, when we consider this challenge in our longterm care facilities, when we look at the number of deaths in nursing homes, I think a lot of families want basic transparency. And that’s one of the reasons why Senator Wyden and I sent you a letter dated April the 2nd. It was directed to you as well as the administrator of the Centers on Medicare, Medicaid services, Seema Verma. And in that letter, we asked for basic information about what the administration was doing to track the outbreaks in nursing homes, to provide basic information to the families of residents in nursing homes, surely to the workers, as well as to the community and public health professionals.

Bob Casey: (01:25:05)
Now, it took you about a month to respond to that. But in your response, you didn’t give us any information about the timeline. These families need this information. And now we’re told by the CMS administrator, after pressing her, Senator Wyden and I did, that this information may not be available until the end of May. I need to hear from you today, why has there been a three month delay in basic information that families and people within a community need about the outbreaks in nursing homes, the number of cases, what is happening in nursing homes. Tell us when we’re going to see that information.

Well, thank you very much, Senator. And you’ve highlighted one of the great tragedies that we’ve all experienced together. Clearly, the longterm care facilities have been particularly hard hit by this pandemic. Several things. I know that, again, the CMS who has oversight, several things have been done. And I could get back to you in terms of where they’re at in terms of activation. But clearly, all nursing homes now are required to report cases in either their individuals that are patients there or staff to the CDC. Secondly… Verma has put a policy in place that all nursing homes are required to notify the members of that nursing home of the existence of COVID in that nursing home to include family members… verify in terms of if that’s operational as of today or last week and I will get back to you with that.

One of the most important things we have decided as we talked about key and reopening, as Tony mentioned, we need… symptomatic cases. We need to be here to do… tracing. But the other thing that we really need to do is to do surveillance, because this virus does appear to have high propensity for asymptomatic infection, which means our traditional ways of identifying cases is going to be blunted. And so we’re developing a national surveillance system. And first, an important piece of that is to do a comprehensive surveillance in all the nursing homes in the United States. CDC will be doing that in partnership with the state and local territorial health departments. I think [inaudible 01:27:50] is going to have the responsibility to do it within the inner city clinics that are selected, and for the indigent health service clinics.

But this is critical we get in front of this and to do comprehensive surveillance of everybody in these nursing homes. We’ve also done aggressive outreach in all of them in enhancing infection control procedures, et cetera. CDC has been out to help these nursing homes with that, and to guidance, along with the CMS. But I’ll get back to you in terms of time. I’m pretty confident it’s already operational, but what I need to double check is to make sure, because I know Seema has announced it. They’re all reporting to CDC now, any infection in workers or patients, and that they are required now to notify other members in the nursing home as well as family members when COVID in one of those.

Bob Casey: (01:28:47)
And I, Mr. Chairman, just have one question for Dr. Fauci. Doctor, I wanted to ask you, in your testimony earlier in response to a question by Senator Murray, you outlined a basic concern you have with regard to states reopening. Can you restate that for us?

Yes. Thank you, Senator Casey. Yes. My concern is that as states or cities or regions, their attempt, understandable, to get back to some form of normality, disregard, to a greater or lesser degree, the checkpoints that we put in our guidelines about when it is safe to proceed in pulling back on mitigation. Because I feel if that occurs, there is a real risk that you will trigger an outbreak that you might not be able to control. Which, in fact, paradoxically, will set you back, not only leading to some suffering and death that could be avoided, but could even set you back on the road to trying to get economic recovery. It would almost turn the clock back, rather than going forward. That is my major concern, Senator.

Bob Casey: (01:29:55)
Thank you, Doctor. Mr. Chairman.

Thank you, Senator Casey. Senator Paul.

Senator Rand Paul: (01:30:01)
Dr. Fauci, scientists have shown that rhesus monkeys that are infected with COVID-19 cannot be reinfected. Several studies have also shown that plasma from recently infected coronavirus patients neutralizes the virus in lab experiments. In addition, infusion of convalescent plasma is based on the idea that recovering coronavirus patients are developing immunity and that it can be beneficial as donated. Studies show that the recovering COVID-19 patients, from the asymptomatic to the very sick, are showing significant antibody response. Studies show that SARS and MERS, also coronaviruses, induce immunity for at least two to three years. And yet the media continues to report that we have no evidence that patients who survive coronavirus have immunity. I think actually, the truth is the opposite. We have no evidence that survivors of coronavirus don’t have immunity, and a great deal of evidence to suggest that they do.

The question of immunity is linked to health policy, and that workers who have gained immunity can be a strong part of our economic recovery. The silver lining to so many infections in the meat processing industry is that a large portion of these workers now have immunity. Those workers should be reassured that they likely won’t get it again, instead of being alarmed by media reports that there is no evidence of immunity. You’ve stated publicly that you’d bet it all that survivors of coronavirus have some form of immunity. Can you help set the record straight that the scientific record, as it is being accumulated, is supportive that infection with coronavirus likely leads to some form of immunity, Dr. Fauci?

Thank you for the question, Senator Paul. Yes, you’re correct that I have said that given what we know about the recovery from viruses such as coronaviruses in general, or even any infectious disease, with very few exceptions, that when you have antibody present, it very likely indicates a degree of protection. I think it’s in the semantics of how this is expressed. When you say has it been formally proven by longterm natural history studies, which is the only way that you can prove, one, is it protected, which I said and would repeat, is likely that it is, but also what is the degree or type of antibody that gives you that critical level of protection, and what is the durability? As I’ve often said, and again repeat, you can make a reasonable assumption that it would be protective. But natural history studies over a period of months to years will then tell you definitively if that’s the case.

And I think that’s important, because in all likelihood is a good way of putting it. The vast majority of these people will have immunity, instead of saying there is no evidence. The WHO fed into this by saying no evidence of immunity. And in reality, there’s every evidence stacking up. In fact, a lot of the different studies have shown that it is very unlikely that you get it again in the short term.

Studies have shown that it is very unlikely that you get it again in the short term. With regard to going back to school, one thing that was left out of that discussion is mortality. Shouldn’t we at least be discussing what the mortality of children is? This is for Dr. Fauci as well, the mortality between zero and 18 in the New York data approaches zero. It’s not going to be absolutely zero, but it almost approaches zero. Between 18 and 45, the mortality in New York was 10 out of a hundred thousand. So really we do need to be thinking about that. We need to observe with an open mind what went on in Sweden, where the kids kept going to school.

The mortality per capita in Sweden is actually less than France, less than Italy, less than Spain, less than Belgium, less than the Netherlands, about the same as Switzerland. But basically, I don’t think there’s anybody arguing that what happened in Sweden is an unacceptable result. I think people are intrigued by it and we should be. I don’t think any of us are certain when we do all these modelings, there’ve been more people wrong with modeling than right. We’re opening up a lot of economies around the U.S. and I hope that people who are predicting doom and gloom and saying, “Oh, we can’t do this. There’s going to be the surge”, will admit that they were wrong if there isn’t a surge, because I think that’s what’s going to happen.

In rural States. We never really reached any pandemic levels in Kentucky and other states. We have less deaths in Kentucky than we have in an average flu season. It’s not to say this isn’t deadly, but really outside of New England, we’ve had a relatively benign course for this virus, nationwide. And I think the one size fits all, that we’re going to have a national strategy and nobody’s going to go to school is kind of ridiculous. We really ought to be doing at school district by school district and the power needs to be dispersed, because people make wrong predictions.

And really the history of this, when we look back, will be of wrong prediction, after wrong prediction, after wrong prediction, starting with Ferguson in England. So I think we ought to have a little bit of humility in our belief that we know what’s best for the economy. And as much as I respect you, Dr. Fauci, I don’t think you’re the end all. I don’t think you’re the one person that gets to make a decision. We can listen to your advice, but there are people on the other side saying there’s not going to be a surge and that we can safely open the economy and the facts will bear this out.

But if we keep kids out of school for another year, what’s going to happen is the poor and underprivileged kids who don’t have a parent that’s able to teach them at home, are not going to learn for a full year. And I think we’ve ought to look at the Swedish model and we got to ought to look at letting our kids get back to school. I think it’s a huge mistake if we don’t open the schools in the fall. Thank you.

Mr. Chairman, can I respond to that even though there are only 32 seconds left?

Mr. Chairman: (01:35:36)
Yes. And you might make it clear whether or not you suggested that we shouldn’t go back to school in the fall.

Well, first of all, Senator Paul, thank you for your comments. I have never made myself out to be the end all and only voice in this. I’m a scientist, a physician, and a public health official. I give advice, according to the best scientific evidence. There are a number of other people who come into that and give advice that are more related to the things that you spoke about, about the need to get the country back open again, and economically. I don’t give advice about economic things. I don’t get advice about anything other than public health. So I wanted to respond to that.

The second thing is that you use the word, we should be humble about what we don’t know. And I think that falls under the fact that we don’t know everything about this virus, and we really better be very careful, particularly when it comes to children. Because the more and more we learn, we’re seeing things about what this virus can do that we didn’t see from the studies in China, or in Europe.

For example, right now children presenting with COVID-19 who actually have a very strange inflammatory syndrome, very similar to Kawasaki syndrome. I think we better be careful if we are not cavalier in thinking that children are completely immune to the deleterious effects. So again, you’re right in the numbers that children in general do much, much better than adults and the elderly and particularly those with underlying conditions. But I am very careful and hopefully humble in knowing that I don’t know everything about this disease and that’s why I’m very reserved and making broad predictions. Thank you.

Thank you, Senator Paul, and Senator Baldwin.

Senator Tammy Baldwin: (01:37:23)
Thank you Mr. Chairman and ranking member Murray and our witnesses. I want to try to cover a lot of territory in my five minutes. So I’d certainly be appreciative of concise answers. But I want to start with Dr. Redfield. Dr. Redfield, I think that the testing protocols at the White House presents a model for other essential workplaces.

I’m sorry, Senator, you broke up at the beginning of your question. If you could just say it again. I’m sorry.

Yes. Dr. Redfield, do you think that the testing protocols currently in place in the White House present a model for other essential workplaces?

Well, I think, well, thank you for the question. I think one of the important things you bring up is the essential worker guidance that CDC put out. And I think it was originally modeled obviously on healthcare workers, where there were significant healthcare shortages and individuals that were…

I’m asking you, if you think that the White House protocols for testing are a model for other essential workplaces.

I would just say that I think each workplace has to define their own approach as how to operationalize our…

You’ve already had some considerable comment on the fact that OSHA has not stood up an enforceable, mandatory emergency temporary standard for workers in all sorts of work settings. But that aside, would you say that the PPE rules and protocols in effect right now in the White House are a model for other essential workplaces?

My own view, we would go back to the Guidelines that CDC has put out about essential workplaces for people, if they are an essential workforce that they go in public, they maintain six feet distancing and they wear face coverings.

Okay. Admiral Giroir, you have testified about how far you’ve come with regard to testing assessments. I want to ask you if you believe that we already have a national testing strategy today that spans from the nationwide testing needs assessment to the nationwide testing supply assessment. And a strategy to fill that gap. To procure domestically, what we need in terms of bridging that gap with testing platforms, swabs, specimen, collection media, and reagents, and the PPE needed to conduct those tests.

So thank you for that. We do have a strategy that spans us at least to the fall and beyond. As I mentioned, we’re working individually with every state. And I think Senator Paul is correct that Kentucky, Wyoming, or New Jersey, Rhode Island are different. And there are vastly different testing needs. The East Coast will have multiples of testing versus other states and we’re working those individually…

so I know you testified earlier that not only are you working with the States, but you’re working with every lab in every state…

Correct.

… to increase capacity. What about working with those who would need testing to say reopen their school, their university, their business. Each of them have identified what they think are their testing needs based on guidance, not mandatory enforceable rules, but are you in contact at that level? Does your dashboard have a visibility at that lowest level? Or are you mostly in contact with the states and with the labs?

So over the last few months, we’ve done a lot of individual work at nursing homes, at meat packing plants really down to the very granular level.

Okay.

Where we are right now, however, is we are really working with the state leadership, with the public health lab, the state epidemiologist, the SHOs, the state health officials, because they really need to understand what their sum is going to be in their state.

Okay. Thank you.

And then the funding we’re asking very specifically in the CDC funding for specific plans for schools, nursing homes, underserved, etc.

So I have two more points that I’m going to make. I don’t have time for questions. One is about the transparency of that needs assessment. Can the public see it? Can the state see it? Can the help committee members see it? Is it publicly available? And secondly, the delivery of this supply is a critical issue. And it seems to me that the logistics we’re getting this out, whether it’s PPE testing, or medical equipment is still extremely fragmented leading to price gouging, and many other inefficiencies. We need to stand up the full power of the Defense Production Act.

Would you like me to comment on that ma’am, I’m sorry.

I’m happy to have you comment with the indulgence of the chairman. We’ve gone over time and [crosstalk 00:10:13].

Try to give a succinct answer to the Senator please, Admiral Giroir.

Yes ma’am and yes, sir. Particularly for things like swabs and media, there is still a very, I would say, non-mature industry within the country. And that’s why we’ve made the decision to procure that all centrally through December and then distribute that to the state. Because there are just too many small companies, too many variables to control without a really heavy federal hand. That’s just an example of where we really moved into that and used the DPA for swab to help support American industry.

In more mature aspects of the industry, like some of the large test producers, we feel that by helping direct them to make sure that the states get what they need at the right distribution, that we’re not procuring them directly by us. But again, we’re going to be very evidence and data-driven as we move on. Thank you, sir.

Thank you very much, Senator Baldwin. Senator Collins.

Senator Susan Collins: (01:44:16)
Thank you, Mr. Chairman. Let me begin by first thanking each of our witnesses today for their expertise, their dedication and their hard work. Dr. Redfield, I want to start with you. I am hearing from dentists all over the state of Maine, that the fact that they can not practice center to stay, despite following very strict infection control protocols is causing growing health problems.

Dentists tell me that teeth with cavities that could have been filled are now going to need root canals. Teeth that could have been treated with root canals are now going to require extractions. People with oral cancers can not get the treatment, the cleanings that they need before beginning their treatment. Dental health is clearly so important and Maine state officials, as well as our dentists are seeking assistance in reaching the right decisions.

47 other states either have reopened dental practices, or have a day set for them to reopen. So my question to you is this, if dentists are following the American Dental Association guidelines, if they’re instituting strict protective measures for their patients, their staffs, their hygienists, themselves. And if they’re closely examining and seeing a decline in the number of COVID-19 infections in their county, are these reasonable factors for states to consider in reopening the practice of dentistry?

Yes, Senator, thank you for the question. We’ve been interacting and talking with dentists and working with the state and local public health officiants, to update our guidelines on reopening a variety of medical services, as you know. And I think you raise a very important point and I would not disagree with what you said about looking at the American Dental Association, as well as the reality of the outbreak in the area. But we are in the process of updating those guidelines and they will include direct guidelines for dental practices.

Thank you very much, doctor. Dr. Jarrah and Dr. Hahn, recently, there’s been a significant demand for remdesivir, I may be mispronouncing it, which transitioned to receiving an emergency use authorization. Last week, Maine’s two largest hospitals systems contacted me with questions about how this therapeutic will be allocated going forward. HHS finally released a statement on Saturday about allocations going to states, interestingly, not directly to hospitals.

But once again, the decision making behind these allocations is very unclear. HHS and the Assistant Secretary for Preparedness and Response say that each state is expected to receive an allocation, but no timetable has been provided. Beyond those who are being treated with this drug at Maine Medical Center through a clinical trial, I’m concerned that hospitalized patients in Maine will have little or no ability to be treated with this promising therapeutic for the foreseeable future.

As this and more therapeutics and ultimately a vaccine come onto the market place, how can these allocation and distribution issues be resolved so that patient care is not delayed? And so that it doesn’t depend on which state you live in whether or not you’re going to get access to these treatments, and ultimately a vaccine?

Senator Collins this… Oh go ahead, Admiral Giroir.

Go ahead. Go ahead, Commissioner.

Senator Collins. I think we completely agree with you that this has to be an evidence-based approach. Getting the medical therapeutics vaccines, remdesivir, whichever it happens to be to the people in need. I think we can all agree upon the fact that we’ve learned a lot of lessons from the remdesivir situation. And of course, as you mentioned, that’s being led by HHS.

And as for what you’ve seen in the most recent announcement is that what the test scores did was provide guidance to HHS regarding where the most significant outbreak occurred and where those hospitals, patient hospitalized patients were. This represented about a quarter of the supply of drug that we have and more will be allocated according to the methodology that gets drug to where those hospitalized patients are.

I think valuable lessons can be learned and will be learned with respect to other therapies and to vaccines in particular. And we must incorporate those into our operational plans moving forward.

Thank you, doctor. Admiral, do you have anything to add? I’m over time. Sorry. Thank you. If you have anything to add, if you do so for the record.

No, ma’am. No ma’am. I agree with commissioner. It’s, absolutely critical that it’s evidence-based, based on the people who could benefit from it and also fair and just throughout our country.

Thank you.

Thank you, Senator Collins. And Senator Murphy.

Senator Chris Murphy: (01:50:56)
Thank you very much, Mr. Chairman, thank you to you and Senator Murray for convening this. Thank you to all of our witnesses for your service. This is obviously an exceptional hearing today and that three of our witnesses are in quarantine. And so I just want to start by asking a pretty simple yes or no question that I think I know the answer to.

Dr. Fauci, Dr. Hahn, and Dr. Redfield, I’m correct that all of you are drawing a salary as you should during your period of quarantine. Is that correct?

Senator, let me start off. I think we better be careful about the issue of quarantine. We are essential workers as part of the essential infrastructure. And we, when needed, which is often, do our duties in our respective places at the White House. I was at the White House yesterday, and I will likely even, perhaps even be there today and in my office at the NIH.

So it is not really strictly speaking, a quarantine as we know it, but it is performing on duties as critical workers. And I’d be happy to have my colleagues also respond to that.

Senator Murphy. This is a Steve Hahn. I agree with Dr. Fauci and yes, I am drawing salary and I have continued to work during my quarantine. And as an essential worker will participate in meetings face to face when that attendance is considered critical.

My point here, listen, you all should draw a salary while you are taking precautionary steps because of the contacts you have made. My point is that quarantine is relatively easy for people like you and me. We can still work and get paid. We can telework, but there are millions of other Americans who work jobs that can’t be performed from home, or are paid by the hour.

And it’s just remarkable to me that this administration has not yet developed a mechanism for states to implement and pay for a quarantine system that will work for all Americans. Your plan to reopen America requires states develop that plan. And yet my state has no clue how to implement and pay for that system without help from the federal government. Which leads me to my second question.

Dr. Fauci, and Dr. Redfield, you’ve made news today by warning us appropriately of the dangers of states opening too early. But as Senator Murray mentioned, this is infuriating to many of us, because it comes hours after the president declared that we have prevailed over coronavirus. Which I’m just going to tell you is going to make it much harder on state leaders to keep social distancing restrictions in place. It comes days after the called on citizens to liberate their states from social distancing orders.

And I think you’re all noble public servants, but I worry that you’re trying to have it both ways. You say the states shouldn’t open too early, but then you don’t give us the resources to succeed. You work for a president who is frankly, undermining our efforts to comply with the guidance that you’ve given us. And then the guidance that you have provided is criminally vague. And I want to ask my last question on this topic. Obviously, the plan to reopen America was meant to be followed by more detailed nuanced guidance, right?

What does a downward trajectory mean? What happens if the trajectory is downward in some settings, but upward in others? What happens if you reopen and then there’s a spike in one location or another setting. And of course you knew this because you developed this guidance, this additional guidance that is site specific, that frankly is helpful. Some of this is on the CDC website, but some of it is not, and we need it. My state needs it. We don’t have all of the experts that you have. And so we rely on you.

So reporting suggests, Dr. Redfield, that this guidance that was developed by you and other experts was shelved by the administration. That it was withheld from states and the public because of a decision made by the White House. So my specific question is why didn’t this plan get released? And if it is just being reviewed, when is it going to be released? Because states are reopening right now and we need this additional guidance to make those decisions.

Senator, I appreciate your question. Clearly we have generated a series of guidances, as you know. And as this outbreak response has evolved from the CDC to an all of government response. As we work through the guidances, a number of them go for inner-agency review and inner-agency input, to make sure that these guidances are more broadly applicable for different parts of our society. The guidances that you’ve talked about, hae gone through that inner-agents review, their comments that have come back to CDC. And I anticipate they’ll go back up into the taskforce for final review.

But we’re reopening in Connecticut in five days, in 10 days. This guidance isn’t going to be useful to us in two weeks. So is it this week? Is it next week? When are we going to get this expertise from the federal government?

The other thing I will just say is that the CDC stands by to give technical assistance to your state in any state upon any request. I do anticipate this product guidance though, to be posted on the CDC website soon.

Soon.

I can tell you your state and reach out to CDC and we’ll give guidance directly to anyone in your state on any circumstance that your state desires guidance from.

Soon isn’t terribly helpful. Thank you, Mr. Chairman.

Thank you, Senator Murphy, Senator Cassidy.

Senator Bill Cassidy: (01:57:04)
Hey gentlemen, thank you very much for your service and I will have a set of questions. So if your questions can be brief, I appreciate it. Your answers can be brief. Dr. Hahn, in your testimony, you mentioned that the testing for the populations in the vaccine trials now includes older Americans. My question though, is what about children? Does it include children? Does it also include the obese, the diabetic, the immunocompromised, those who are at risk of having a non-response, or a mitigated response to vaccination? Can you comment on that please?

Yes, sir. Thank you, Senator Cassidy. When the phase two, phase three trials are in place, they will include our most vulnerable populations, including the individuals that you describe. We’re working very closely with…

So if I can interrupt…

Yes, sir.

Phase two would normally check for safety. You would not have to do a separate phase two in the patient who was younger? You follow what I’m saying? Or can you just assume the safety data from the adults applies to that of the children?

So, no, we would also want to assess safety, sir, as well in children.

So the current phase two trials, do they include children?

They’re in phase one studies right now, sir [crosstalk 01:58:17].

I thought Dr. Fauci said we had a phase two going on.

Well, I think it’s about to start for the Moderna vaccine. Perhaps, Dr. Fauci, you can answer that.

No Senator Cassidy. No, I did not say a phase two. I said we are in a second dose of the phase one and we will proceed when we finish the phase one to go into phase two. [crosstalk 01:58:37].

So I think I’m hearing the children will be included in phase two trials?

No, so that’s under discussion between FDA and NIH at this time, sir, because we do realize that it’s important [crosstalk 01:58:51] for us to understand what this is in children.

Dr. Redfield, to build back upon what Senator Murphy said, the published guidelines for school opening, obviously you’re about to modify, but I noticed as I read through them, there’s nothing about testing. So we speak about testing, targeted testing, how we use testing, but the guidelines for the school systems has nothing about how to integrate testing. Will these be in those guidelines that are being released?

Senator, thanks for the question. Clearly there’s going to need to be, as already been stated, an integration of a testing strategy that is going to be different, I think, for different school settings, as well as different jurisdictions, where the schools are setting. And that is going to have to be integrated into each of those. There’s a general overarching guidelines, and then as I say, I do think the testing strategy which is important, including the surveillance strategy needs to be individualized.

No, let me cut into that Dr. Redfield. Dr. Redfield and all due respect. I think children, whether you’re rural, frontier, suburban, or urban, is the one setting in which there is a remarkable commonality. And I will echo what Senator Murphy said. The resources that the federal government has greatly exceeds all but the most sophisticated populous, wealthy state. And even then it exceeds it by some extent. So I do think it would be good to have, okay, in a primary school setting, this is best practices are, these are three options and choose between one of these three. To say to each school district, or each private, or parochial, or independent school, “Work with your state board of health. Figure it out”, seems a wasted effort.

I say that because children play such a role in both protection of disease, the spread of disease, et cetera. So your thoughts on that, because it really seems that’s the one setting where you can have not cookie cutter, but certainly a pattern which can be followed.

Senator, I must have been misunderstood. When I was talking about differences, I was thinking of the difference between an elementary school, a high school, a college, and a trade school. There may be differences in how you integrate a testing strategy. But I do think having a testing strategy with different options for people to evaluate based on different principles will be important in terms of the guidance.

Dr. Fauci, you persuasively argue that the risk of reopening prematurely is great. But I think the frustration, if I think of children in particular, the risk-benefit ratio of a child being at home, potentially away from enhanced nutrition, without the parent able to work because school provides daycare. Without the monitoring that sometimes occurs for incidences, such as a child abuse. But perhaps most importantly, for all children, the opportunity costs of a brain which is forming not having access to the information that will help that brain form optimally.

Now, has there been any kind of risk-benefit ratio for the child? Yes, they are at risk for Kawasaki’s, but they are at particular risk for missing out on a year of education, particularly for those from less than rich backgrounds. I guess I’m very concerned about that tension. What are your thoughts on that?

you make a very good point, Senator Cassidy. That obviously very difficult of the unintended consequences of trying to do something that broadly is important for the public health, and the risk of having a return or resurgence of an outbreak and the unintended deleterious consequences of having children out of school. We fully appreciate that. I don’t have an easy answer to that. I just don’t. You just have to see, on a step by step basis as we get into the period of time with the fall about reopening the schools, exactly where we’ll be at the dynamics of the outbreak.

I might point out something that I think has been alluded to throughout some of the questions that we have a very large country and the dynamics of the outbreak on different, in different regions of the country. So I would imagine that situations regarding school will be very different in one region versus another, so it’s not going to be universally, or homogeneous. But I don’t have a good explanation, or solution to the problem of what happens when you close schools, and it triggers a cascade of events that could have some harmful circumstances.

Mr. Chairman, I’ll close by asking the permission of the chair to submit for the record article that just came out in the Journal of Pediatric Nursing. Children are at risk from COVID-19.

It’ll be included. Thank you, Senator Cassidy. Senator Warren.

Senator Elizabeth Warren: (02:03:54)
Thank you Mr. Chairman, and thank you to our witnesses for being…

Thank you, mister chairman, and thank you to our witnesses for being here today. I hope everybody’s staying safe and healthy. In the past 16 weeks over 1.3 million Americans have been infected with coronavirus. We now know that about 80,000 people have died and 33 million people were out of work. Dr. Fauci, you have advised six presidents, you have battled deadly viruses for your entire career. So I’d just like to hear your honest opinion. Do we have the coronavirus? Contained

Senator, thank you for the question. Right now it depends on what you mean by containment. If you think that we have it completely under control, we don’t. I mean, if you look at the dynamics of the outbreak, we are seeing a diminution of hospitalizations and infections in some places such as in New York City, which has plateaued and started to come down, New Orleans. But in other parts of the country, we are seeing spikes. So when you look at the dynamics of new cases, even though some are coming down, the curve looks flat with some slight coming down. So I think we’re going in the right direction, but the right direction does not mean we have, by any means, total control of this outbreak.

So right direction, as I understand it, we have about 25,000 new infections a day and over 2,000 deaths a day. I think those are the right numbers. Some are estimating we could be at 200,000 cases a day by June. Is that right, Dr. Fauci?

I don’t foresee that as 200,000 new cases by June. I am hoping and looking at the dynamics of things starting to flatten off and come down, that we will be much, much better than that, Senator. I mean, I think-

Just so I understand, we are right now at 2,000 new infections a day, and … 25,000 new infections a day and 2,000 deaths a day.

Right.

And that’s where we are right now.

Right.

Yeah. So let me just ask. We know that it is possible to get this virus under better control. Other countries have done it like South Korea, but we are now three months into this pandemic and basically we’ve continued to set records for the number of people who are diagnosed and the number of people who die. Dr. Fauci, you recently said that a second wave of coronavirus in the fall was, quote, inevitable, but that if, quote, America puts in place, all of the counter measures that you need to address this, we should do reasonably well. And the counter measures you identified are things like continued social distancing, significantly more testing, widespread contact tracing. You also said that if America doesn’t do what it takes, and this is your quote. We could be in for a bad fall and a bad winter. So right now we’re about 16 weeks away from Labor Day. That’s about the same length of time since the virus was first detected here in the US. Do we have enough robust measures in place that we don’t have to worry about a bad fall and winter?

Right now, the projection, as you’ve heard from Admiral Gira, with regard to the testing and other elements that would be needed to respond, the projection is that by the time we get to the end of the summer and early fall, that we will have that in place. That is the projection that I get.

We don’t have it in place now, but we are projecting that we’ll have in place. And let me just ask the other side of this. If we don’t do better on testing, on contact tracing, and on social distancing, will deaths from coronavirus necessarily increase?

Of course. If you do not do an adequate response, we will have the deleterious consequence of more infections and more deaths. And that’s the reason why you quoted me, senator, quite correctly, everything you said, and I will stand by that. If we do not respond in an adequate way, when the fall comes, given that it is without a doubt that there will be infections that will be in the community, then we run the risk of having a resurgence. I would hope by that point in time in the fall, that we have more than enough to respond adequately. But if we don’t, there will be problems.

I appreciate your hope. And I wish we could tell the American people that the federal government has this pandemic under control, but we can’t. In fact, we have said that the virus is not under control in the US, we haven’t yet taken the measures necessary to prevent a second wave of death. And we all know that the people who are going to be most affected are going to be seniors, essential workers, the people who are out on the front lines. The president needs to stop pretending that if he just ignores bad news, it will go away. It won’t. The time for magical thinking is over here. President Trump must acknowledge that the federal response has been sufficient and that more people are dying as a result. We are running out of time to save lives, and we need to act now. So thank you, Dr. Fauci for all you’re doing. You’re appreciated, but the urgency of the moment could not be clearer. Thank you.

Speaker 1: (02:09:49)
Thank you, Senator Warren, Senator Roberts.

Senator Roberts: (02:09:56)
Thank you very much, mister chairman, and thanks to all the witnesses. You all are like the fab four, I guess it was a fab five back in the day, but we’re shining the light of truth into the darkness with individual flashlights, for sure. Thank you, mister chairman, for emphasizing that we have to be bipartisan on this approach or we’re not going to get anywhere. And that obviously is in the eyes of the beholder. I’m happy to say that we have a very good relationship with Governor Kelly, who happens to be a Democrat, obviously I’m a Republican and her emergency management team is spot on. [inaudible 02:10:39] is doing an upstanding job. That’s the [inaudible 02:10:41] this morning, I talked to [inaudible 02:10:46] I’m reading here Kansas receives 7,000 new COVID tests [inaudible 02:10:51] with food processing facilities. You see this mural behind me, that’s a stage coach coming in to Dodge, as opposed to getting out of Dodge. Dodge city is my home town.

We are the hotspot in regards to Kansas, mainly because of two packing plants. We have five, that’s 26% of the cattle market. At any rate, Kansas is going through a tough time. We should be worried about the safety of the food supply chain, I think nationwide is under a great deal of stress. We see that in dairy, we see that in poultry, we see that in pork, they’re euthanizing pigs, and obviously the livestock industry. Sonny Perdue with the Department of Agriculture has stepped up, so has president, declaring that these packing plants are a national asset. With progress Dodge city, when we first started out, I had five tests, five, that’s between four and six, five. It’s not 50 million. As we hope to receive, that has been said by one of the witnesses. The reason I am really harping on all of the problems, we’re having in agriculture, on top of the fact that the relationship with China is such that even at first breakthrough with regards to trade to China, seems to be on hold.

That’s another price depressant. And this was going on five or six years where our prices had been below the cost of production. In result, our consumers are really figuring out that food doesn’t come from grocery stores. And I’m very worried that the harm to food value chain is very real, not to mention the financial situation that our farmers, ranchers, and our growers all take. Now having said all that I want to ask, Admiral Gira, you’ve spoken about the importance of having diversity in kinds of tests that are available. The five packing plants we have in Kansas, if we could get a rapid test and we could get it as we hopefully ask for it, because of the hotspots that are developing, not only in Kansas, but also doing great harm to the food value chain, that would be absolutely wonderful. And would you speak to that, sir?

Yes. Thank you, senator. Both Dr. Redfield and I have been very actively involved in getting strategies for the industry, particularly in Kansas, we are supplying very heavily the public health lab with rapid diagnostics, as well as surging them to areas like that. The one trade off, however, is that the, quote, rapid point of care diagnostics are very slow. So each machine can only do four per hour and that’s very, very slow. So it’s a mix of testing that you need at these kinds of situations on sort of the high throughput tests that are available at a major lab, a Quest Lab right there in Kansas, as well as a mix of the rapid testing. And that’s what we’re supplying in order to provide a comprehensive wholistic solution. And I believe CDC is on the ground as well in Kansas supporting that.

I appreciate that. If you’re only doing it for an hour, that’s not a rapid test. Maybe it’s a rapid slow test. I’m not quite sure how you define that. But I, for one think that as we reopen, and by the way, Governor Kelly started the opening process the first of this month, and May 18, and then we go to June and then the hope is we can open up. But we do have contingency plans that if that doesn’t work, as aptly described by Dr. Fauci, I think we’ll be right, but this is going to be a tough go. I have to tell you that in terms of agriculture, we’re not in good shape. I appreciate everybody, and the job that you are doing. We’ll stand beside you when you’re taking the boos and behind you when you’re taking the bows.

Speaker 1: (02:15:06)
Thank you, Senator Roberts. Senator Kaine?

Senator Tim Kaine: (02:15:10)
Thank you, mister chair to the committee, leadership and witnesses for calling this important hearing. The last time Dr. Fauci and Han were before us was March 3. I have a slide that I want to put up that shows what’s happened in America since then. The chart, which is here, compares to the experience of the United States and South Korea on three dates. On January 21, both nations experienced their first case of COVID-19. At that time, the unemployment rates in both countries were essentially identical. On March 3, when the witnesses were last here, South Korea had experienced 28 COVID-19 deaths, and the US had experienced nine. Again, the economies of both nations as measured by the unemployment rates were nearly identical. But now the story changes. As of yesterday, more than 81,000 Americans have died, and the US economy has experienced job losses not seen since the great depression.

Meanwhile, the economy of South Korea has not changed dramatically at all, and the death toll was now at 256. South Korea is smaller than the United States, one sixth of our population. But even if you bulk up the death toll to reflect the difference, the per capita death toll in the US is more than 45 times the rate in South Korea, and the healthcare carnage here is causing a near depression while South Korea has protected its economy by managing correctly. I could have done this chart with other nations. The US has the seventh highest per capita death rate in the world. Our death rate is off the charts higher than that in India, Australia, New Zealand, Japan, and Mexico. It’s nearly three times the death rate in Germany, twice as high as Canada’s rate. The question is why? If we want to open up our economy and schools, we have to learn the lessons of nations that have managed this well.

Here’s some things that don’t explain the difference. Our hospitals are as good or better than those in South Korea. Our healthcare providers, heroes, are as good or better than those in South Korea. Our research capacity is as good or better than that in South Korea. And we have more resources than South Korea. Our GDP is 12 times South Korea is, and our per capita income is 50% higher. So to Dr. Fauci, the death toll in the United States, the death rate in the United States, especially when compared with other nations is unacceptable. Isn’t it?

Excuse me, sorry, sir. Yes, of course. I mean, death rate that high is something that in any matter of form in my mind is unacceptable.

And Dr. Fauci, the experience of other nations shows that the US death rate is not only unacceptable, but it’s unnecessary. Isn’t that correct?

I don’t know if we can say that, senator.

But would you say that the U S has to do better?

Of course, you always have to do better. I mean, as a physician and-

And the experience of South Korea shows that how a nation manages the healthcare crisis has a huge impact also on its economic condition. Isn’t that the case?

That is the case, sir, I understand where you’re going with this, but I have to tell you that there is a big difference between South Korea and the United States and the outbreak.

And let me get to that. I want to get to factors that do explain the difference since we know it’s not resources or our health providers. First is testing. South Korea began aggressive testing much earlier than the US. Now in the fifth month of the pandemic, we’ve surpassed South Korea in per capita testing, but in the critical month of March, South Korea was testing its population at a rate of 40 times the testing in the US. Admiral Gira, Dr. Gira has set out the standard for us. When we get to September, he says the United States needs to do 40 to 50 million tests a month to be safe. That equates to about 1.3 million to 1.7 million tests a day. Yesterday, we did 395,000 tests. We’ve got a long way to go. A second factor is contact tracing. South Korea embraced a rigorous contact tracing program right from the beginning. The United States still has not engaged in a national contract tracing program. Isn’t that right? Would that be Dr. Fauci, Dr. Redfield?

So I think that question would best be directed to the CDC [inaudible 02:19:40].

When the outbreak started, sir, we had an aggressive contact tracing program, but unfortunately, as the cases rose, it went beyond the capacity, and then we went to mitigation, so we’d lost the containment edge clearly-

And that was key to the economy as well, because South Korea did testing, contact tracing, protect, serve, isolate the sick, and then they didn’t have to do the shutdowns, which helped their economy. Social distancing is a third factor. We’ve talked about it, but finally, the last one healthcare systems. Would you agree with me that it helps keep people safer either from serious conditions or death from COVID-19 if they have access to healthcare?

Yes, of course.

Of course that’s the case. In South Korea, 97% of the population have health insurance in the United States before COVID-19, millions didn’t have it and lacked access to healthcare. The massive job losses in the last months threatened to take health insurance away from millions more. And President Trump is doing all he can to dismantle the Affordable Care Act, which would take health insurance away from tens of millions more. Let’s learn the lessons from those who were doing this right. Thank you, mister chair, I yield back.

Can I make a clarification please, mister chairman? This is Brett [inaudible 00:02:21:00]. I just wanted to clarify that I did project that we will have the ability to perform 40 to 50 million tests per month in that timeframe. But I said, if needed at that time, I am not making a proclamation. We have to really understand where the epidemic is, what the community spread is, before we can estimate the number of tests that are needed. I was simply stating the fact that our combination of testing capabilities will be at that level, even barring new input from the NIH.

Speaker 1: (02:21:32)
Thank you very much, Senator Kaine, Senator Murkowski?

Senator Murkowski: (02:21:37)
Thank you, mister chairman and gentlemen, thank you for being here this morning, ritually, but also for all you have been doing for these many, many months. Alaska is doing okay right now from a numbers perspective. And quite honestly, we want to keep it that way because we know we have exceptionally vulnerable populations. We know we have a geography that is challenging. We know that we have facilities that are very limited. Last hearing we had an opportunity to hear from Dr. Collins and he shared where they are with the rad X, and also spoke to rad X up, which was very interesting about what we can be doing in rural areas. But focusing on hotspots, and as I reminded him, we don’t want to be a hotspot in Alaska. So every effort that we make to keep the virus out of Alaska is our lives that are saved.

I educated him on the community of Cordova that is just getting ready to open its copper river salmon fishery in two days, and was able to share that they had had one worker tested positive as he was coming in from the lower 48 to come to work. The good news on that is that all the protocols that we had put in place seem to be working. The quarantine, the isolation, not only for that individual, but for others that he had come in contact were secure. So I want to recognize the assistance that we have received from the administration. Dr. Eastman is in this state at this moment, the chief medical officer for the Department of Homeland security, going out to rural communities to really better understand our vulnerabilities, go to some of our fishing communities to, again, understand how we can successfully prosecute a fishery when you have to bring workers in from the outside.

We thank you for the assistance with regards to additional testing capacity. I’ve been in contact with our chief medical officer of the state this morning, and the mayor of Cordova, just better understanding again, do we have the tests that we need? What do we need on the ground? And one of the things that I would like to have clarified, and this is probably to you, Dr. [inaudible 00:02:24:00], because you have been so helpful in kind of shining the light on what we need to be doing in these rural areas.

But so much of the focus has been on hotspots and responding to the hotspots, but how do you keep those rural remote small communities from becoming the hot spots in the first place? Are we doing enough? And right now the strategy has been, we just lock it off. The travel restrictions that are in place are apparently working, but they’re also devastating our economy, whether it’s tourism, whether it’s our resource industries or whether it’s the potential for our fisheries. So admiral, if you might speak to that aspect of it. And then I have a very important question as it relates to contact tracing that I’d like to direct to either Admiral Gira or Dr. Redfield.

So thank you Senator. And as you know, you have an outstanding state health officer in Dr. Anne Zenkin.

We do.

I’ve had the privilege of working with her and you have a very good protocol in trying to keep Alaska safe by isolation over a period of time when you come in. As you know, we also work with the state to meet your very challenging testing requirements, because you can’t really send labs out 1,000 miles away. So we put a real customized mix of point of care and also the Cepheids machines. I think we sent nine or 10 new to Alaska and about 50,000 tests, which is about four times than you’ve done to date collectively in order to provide that support.

So again, I do think there’s a comprehensive strategy that you do have, but again, the mitigation to the degree that you can, given the circumstances, the face mask, the hand, washing the hygiene, we understand fully the challenges, particularly in the fishing rebar environment and the remote, but all these have to come together. The testing, the tracing, the mitigation, the hygiene factors, to try to keep your community safe. And we really understand culturally that many of your communities were almost annihilated in the 1918 influenza pandemic. And that memory is still very sharp and very hurtful to many of the citizens. So we want to do our best to assure them that we are giving them all the protection we can.

So Admiral, let me turn to Dr. Redfield because this relates to contact tracing. I think that this is a very, very key part of how we move forward into getting people back to work, getting people back to school. Right now, we have about a hundred people that are involved in CA in contact tracing in Alaska. That’s clearly not sufficient. There’s been talk about a national strategy, but I think we recognize that we have teams in place, whether it’s America or whether it’s Peace Corps, whether it’s our public health core, what more do we need to be doing to make sure that once you’ve been tested positive, you know then what happens after that. Who else needs to be brought into this? And I’m not convinced that we’re focusing enough on that aspect of how we move to reopening if we haven’t done the contact tracing,

Thank you very much, Senator. I want to just reemphasize what you said. I think contact tracing capabilities is critical. It’s going to be the difference from succeeding in containing this outbreak from [inaudible 02:27:49] using wide scale community transmission, or not. We’re positioned as you know, to deploy then redeploy the number of CDC, over 500 CDC individuals we have another over about 650 that we’re trying to put in through our foundation. But most importantly, we’re trying to work with your health department, with the resources that we’ve been able to give because of the Congress supplementals.

Also, as you mentioned with these other agencies, with Lab Corp, I mean with AmeriCorps, with the census bureau, to work together and have the state develop their [inaudible 02:28:26] capacity. Some states have reallocated state work. Some states have reallocated National Guard while they begin to do this. But I agree with you. And I said, it’s going to be a significant effort to build the contact tracing capacity that we need in this nation. It will be state by state, but it’s going to need to be augmented properly in your state from what you just said, five to tenfold. And we’re there to work with the states to help them accomplish. That needs to get in place before September.

Speaker 1: (02:28:59)
We need to move on to the next question.

Thank you.

Speaker 1: (02:29:03)
Thank you, Senator Murkowski. I don’t want to put any Senator off, but we have eight more senators who have five minute rounds, and it’s 12:30. So I’d like to request that the senators end the witnesses succinct questions and try to stay within five minutes would be appreciated. Senator Hasson?

Senator Hasson: (02:29:26)
Well, thank you, mister chair. Thank you and the ranking member for having this hearing and thank you to our witnesses today, and please pass our thanks along to all of the hardworking women and men in your agencies, who I know have been working virtually around the clock to try to improve our response and keep Americans safe. And mister chair, I hope you, and all the witnesses are healthy and safe today as is everybody on your team. I wanted to start by echoing the comments my colleagues have made about eating the leadership from the CDC and our public health experts on how you’re going to use facts and evidence as guidance so that our schools and our daycares and our businesses have the information they need to create safe and sustainable plans to reopen.

Of course that means too, that our testing capacity not only has to be enough, but it has to be flexible enough to meet our needs. The key distinction between South Korea and the United States is not how many tests per capita over a certain amount of time that we’ve done, but the fact that at the onset of this pandemic South Korea was much more able to do a lot more tests per capita than we were, and then follow that with all the other measures you’ve talked about. So that we continue to identify the need and then build our capacity towards the need. Not the other way around.

I wanted to start with a question to you, Dr. Fauci. First of all, thank you for your work and your expertise. I wanted to talk about nursing homes for a minute. In New Hampshire and across the country, a huge number of the deaths from COVID-19 that we are seeing have been in nursing homes. We all know people who have lost a friend or family member in nursing homes, and the grief compounded by the fact that you couldn’t be at the loved ones bedside if they die. Yesterday Dr. Birx said that all one million nursing home residents should be tested within the next two weeks, as well as all nursing home staff. Dr. Fauci, as a short term goal, that makes sense to me. But after that, what will the ongoing federal recommendations look like? How frequently do we need to test patients and staff on a continuing basis and what other measures will be necessary to keep our loved ones in these facilities safe?

Thank you for the question, Senator Hasson. The general plan, as you mentioned, that was recommended by Dr. Birx is a sound plan, as you said, in the immediate. Question is in the long range, we will have to have infection control capabilities in nursing homes that are really pristine and really unassailable. We have to do the kinds of surveillances and have to have the capability of when you identify someone you get out of that particular environment so that they don’t spread the infection throughout. General testing for all I think is a good start. But when you look, where are you going to go in the future? There has to be a considerable degree of surveillance capability.

Thank you, doctor. The White House is now requiring all staff to wear masks and anyone in regular contact with the president tested daily. Do you think nursing homes should implement those same measures to help make sure that our seniors can get the same level of protection?

I think there should be a system in place for the optimal protection of people in nursing homes. And that would be not necessarily testing every person every day. That’s one approach that might not be practical when you think of all the nursing homes in the country, but really strict regulations and guidelines about who is allowed to go into the nursing home and the staff, I believe, needs to be monitored very carefully with intermittent testing, to make sure that we don’t have introduction into the nursing home of infected individuals. I’m not sure you can practically do it testing every day, that I don’t think would be feasible. But something that is much more aggressive than has been in the past, I believe should be done.

Well, thank you. I have one last question for Dr. Fauci and dr. Redfield. I would also just say that if we are able to get masks to everybody in the White House, I hope we can get masks to every nursing home employee who needs it. Dr. Fauci and Dr. Redfield, US needs to be preparing now to ensure that we have the capacity manufacture and administer vaccines, something you’ve both touched on, both for an eventual COVID-19 vaccine, as well as other illnesses, such as the flu. The failure to ramp up production of testing and personal protective equipment early on during this crisis made things worse here, and those mistakes can’t be repeated when it comes to vaccine production and distribution.

We are already seeing reports that some children are not receiving routine immunizations, as it becomes more difficult to access in-person care. Dr. Fauci, what steps should we take now to ensure that we have sufficient manufacturing and distribution capacity for a COVID-19 vaccine without putting at risk our capacity to manufacture and distribute other important products such as the flu or measles vaccine. And my follow up question to Dr. Redfield would be what efforts are underway at CDC to ensure that all routine vaccines are accessible during the COVID-19 public health emergency?

Senator Hassan: (02:35:02)
… accessible during the COVID-19 public health emergency?

Thank you for that question, Senator Hassan. I’ll answer it as quickly as possible. I alluded to this in my introductory remarks when I was talking about vaccines for COVID-19, and what we said that as we do the testing on these vaccines, we are going to make production at risk, which means we will start putting hundreds of millions of dollars of federal government money into the development and production of vaccine doses before we even know it works, so that when we do, and I hope we will and I have cautious optimism that we will, ultimately get an effective and safe vaccine that we will have doses available to everyone who needs it in the United States, and even contribute to what is the needs globally, because we are partnering with a number of other countries.

The other part of your question about making sure that when we get into a situation like the so-called shutdown that we might be in now that we make sure that children get the vaccinations that they need because that would be an unintended consequence of shutting down as we are right now. It’s a very good point, and we want to make sure we don’t fall behind on that also. Thank you.

Senator Hassan: (02:36:12)
Thank you very much. And I’ll take my answer from Dr. Redfield offline. Thank you so much for allowing me go.

Senator Lamar Alexander: (02:36:18)
Thank you, Senator Hassan. Senator Scott?

Senator Scott: (02:36:21)
Thank you, Mr. Chairman. And to the panel, thank you all for being here virtually. Without any question, we find ourselves in a situation that we wish we were not, and I’m very thankful for folks like Dr. Birx, Dr. Fouci, and many others for your dedication 24/7. Without any question, our nation is safer because of your hard work. I’m going to direct my questions towards Dr. Fauci, really one specific question, Dr. Fouci.

And I’m thinking about the reopening of America and specifically the reopening of South Carolina, and I’m taking into consideration the fact that in South Carolina, I think overall, our cases are moving in the right direction. We have a little less than 8,000 cases. Unfortunately, 350 deaths. Our hospital capacity is actually better now than it was when the pandemic started. Our ability to isolate hotspots and mitigate the spread of the virus is, I think, where it needs to be.

With that in mind, I flew into Washington from South Carolina yesterday. We have plans to test additionally 220,000 more residents by the end of this month, focusing on at-risk populations. By the end of this month, we will have tested 100%, 100% of nursing home residents and the staff that takes care of them. And after increasing our contact tracing workforce 20 fold in a matter of weeks, our state’s health department announced yesterday that we’re going to increase it by an additional 1400 contact tracers.

We have built and we continue to build the tools necessary to better detect and isolate cases, to map their exposure, and to prevent substantial spikes moving forward. Most importantly, our healthcare system, thanks to in part to flexibilities from this administration, has the beds and the equipment necessary to address the most serious cases when they arise. Now, with these tools in hand, we have begun to reopen.

To be clear, we continue to scale up testing and to take measure to protect the most vulnerable. And the data points are increasingly clear. For older Americans and for those with chronic conditions like diabetes and high blood pressure, this virus remains a threat, a dangerous threat. A recent report suggests that in New York, roughly 90% of the fatalities had underlying issues, two thirds of fatalities were 70 years or older, 95% over the age of 50.

In South Carolina, the median age of patients who’ve died from the virus, 76 and a half. Nearly two thirds of fatalities have been patients older than 71, and nearly 90% were over the age of 60, and roughly 98% in South Carolina are over the age of 50. Contrast that with those age 20 and younger, where we’ve seen no deaths. Fewer than 1% of deaths in my state have been under the age of 40. Every single death is a tragedy. Every single one. And we mourn with our family members who’ve lost their loved ones.

We are taking every measure to protect our older South Carolinians, as well as those with underlying conditions. But when we set out to flatten the curve by taking aggressive, unprecedented measures, like staying at home orders and mass small business closures, we didn’t set out with a goal of preventing 100% fatalities. That would be unrealistic. It is impossible. And we didn’t set out to keep quarantines in place until we found a safe and effective vaccine. That would take too long.

Dr. Redfield, your agency put out a helpful graphic showing two curves. One was spiked quickly and peaked high, reflected daily cases without protective measures. The other, flatter curve showed cases with those measures in place, and the whole point, which the graphic illustrated, was to make sure that we did not exceed hospital capacity. So while I respect the need for caution, we are too often presented with a false dichotomy, either saving our economy or saving lives.

We’ve seen the goalpost around flattening the curve move, and I think that’s unfortunate, because at the same time we’re doing that businesses have collapsed, mental and physical health have declined, depths of despair escalate, educational outcomes nosedive, as we waited in our living rooms praying for some good news around therapies and around vaccines.

We’ve set out to flatten the curve, and I think we’ve done a pretty good job of that. We need to do better and we will do better. My question, Dr. Fauci, is, as we start the process of moving towards reopening South Carolina, what else would you suggest that we could do to protect our most vulnerable populations?

Thank you, Senator Scott. You gave a really very eloquent description of what I think is would be a model way where you approach this. I mean, you have put things in place that I think would optimize your capability of reopening. As I was thinking as you were speaking, I almost want to clone that and make sure other people hear about that and see what you’ve been doing.

The issue of your direct question to me about the vulnerable populations is that, as we have said in our guidelines, and it looks like you are ready to progress carefully because you put into place a very good system, that the vulnerables, the elderly and those with underlying conditions, should be those, who at the very last lifting of mitigations, should be those who are left in a situation where they might be in danger of getting infected.

In other words, protect them right up until the very end of the relaxation of your mitigation, because as you said very correctly, those are the individuals that are the most vulnerable to the morbidity and the mortality.

So those are individuals, particularly, I might say, sir, those in the minority group, the African American and Hispanics, who for a variety of situations that are the social determinants of health, have a greater likelihood of not only getting infected, but of also having the underlying conditions that would make their risk for a high degree of morbidity and mortality higher. So it looks like you’re doing things very, very well, and I would encourage you to continue and to follow the guidelines as you get closer to normalizing your state. Thank you.

Thank you, Dr. Fauci, and I’ll just simply close with this, this amount of time. Thank you for the many conversations that you and I have had about those vulnerable populations, to include minorities as well as our senior citizens. I will say that without any question, when you look at nursing homes, it’s typically African Americans and Hispanics are the certified nursing assistants who are providing care for the elderly population. So your focus on those two very vulnerable groups is much appreciated and thank you for your expertise.

Thank you, Senator Scott, and Senator Smith.

Senator Smith: (02:43:53)
Thank you so much Chair Alexander and Ranking Member Murray, and thanks to all of you for being here today and for your service. Dr. Fouci, I have to say, you are in the unenviable position of being the person that so many Americans and Minnesotans trust to give us the straight scoop and tell us what’s really happening. You’re about the facts and not about the politics, and that’s a really good thing. So I have to start by asking a question that I think a lot of Americans want to know, which is how are you doing? How are you holding up? It’s been an unbelievable effort.

I’m doing fine, Senator. Thank you very much for asking. This is such an important problem. It transcends all of us individually and has to be working as a team, and I enjoy very much working with your senators and the governors because it’s at the local level that we’re going to make this thing work. So I’m fine. I appreciate your concern.

Well, a lot of people are thinking about you and are grateful for your service as we are for all of you. So we’re gathered today to think about what we need to do to reopen our economy, and I think first about what’s happening in my home state of Minnesota, where agriculture is such an important part of how our state works. It’s a part of our history and our culture.

Pork processors right now are looking at the reality of euthanizing thousands of hogs a day because there is no place to process them because of what’s happening in the processing plants, and the working people who do the hard work in those processing plants are getting sick. So here’s one story. This is one worker, the Star Tribune wrote about this, named [foreign language 00:10:35] De Jesus. She’s an asylum seeker and a mom who works for a contractor that does the cleaning in the processing plants.

She works for $14 an hour, seven hours a day, five days a week, and her job is to sanitize the machines that process the meat into ground meat. And she started feeling sick on April 11th, but she kept going to work, and on April 21st, when one of her coworkers fainted, she told her supervisor that she felt sick, and so she was told to go home, but that if she didn’t show any signs of illness, she should come back.

She went to the doctor and she paid $115 to get a test and found out a few days later that she was COVID-positive. She’s still at home. She’s not getting paid and she doesn’t have health insurance. And nearly two weeks ago, President Trump deployed the defense production act to keep these processing plants open. But the USDA gave really limited guidance about what would be safe for those workers.

It said, for example, in response to testing, which has been such a big part of what we’ve been talking about today, they said, this is a quote, “Facilities should consider the appropriate role of testing in workplace contact tracing of COVID-19 positive workers in a work site and assessment.” So Dr. Fouci, as we think about how we move forward, we all want to open up the economy, what guidance would you give us in a situation like this here in Minnesota?

Well, I can give you my common sense guidance, although this is not the area of my expertise. It’s more in others, but it would seem that if you want to keep things like packing plants open, that you really got to provide the optimum degree of protection for the workers involved, the ability to allow them to go to work safely, and if and when individuals get infected to immediately be able to get them out and give her the proper care.

So I would think when you’re calling upon people to perform essential services, you really have almost a moral responsibility to make sure they’re well taken care of and well-protected. And again, that’s not an official proclamation. That’s just me speaking as a physician and as a human being.

Well, thank you, Dr. Fouci, And I think that you speak as a human being, but you also speak as the chief epidemiologist of our country and the person that we all trust. And this is the point that I want to make and drive home with everybody, which is this is the kind of guidance that we should be getting and following, and then these are the tools that we got to have in our country if we are going to reopen our economy, as we all want to do. If we move forward with reopening our economy, and yet we still have circumstances like we had in these processing plants and in other places around the state, we’re going to be right back where we started except even in a worse place, as I think you pointed out, Dr. Fouci.

Thank you, Senator. And again, it really does relate to one of the questions that one of your colleague senators asked me before, that one of the things that I keep emphasizing, and I’ll just repeat it again because it’s important, that when you are in the process of opening up and pulling back on mitigation, you really must have in place that capability of responding when you do have the inevitable upticks in cases that will absolutely occur.

It’s how we deal with it and how successful we are in putting the clamps on it that will prevent us from getting the kind of rebound that, not only from the standpoint of illness and death would be something that’s unacceptable, but it will set us back in our progress towards reopening the country.

Thank you very much, Senator Smith. Senator Romney.

Senator Mitt Romney: (02:49:41)
… and the participants in it. Admiral Giroir, I’m going to take off where Senator Hassan spoke. I understand that politicians are going to frame data in a way that’s most positive politically, but of course, I don’t expect that from admirals, but yesterday you celebrated that we had done more tests and more tests per capita even than South Korea.

But you ignored the fact that they accomplished theirs at the beginning of the outbreak, while we treaded water during February and March, and as a result, by March 6th, the U.S. had completed just 2000 tests, whereas South Korea had conducted more than 140,000 tests.

So partially as a result of that, they have 256 deaths and we have almost 80,000 deaths. I find our testing record nothing to celebrate whatsoever. The fact is, their test numbers are going down, down, down, down now because they don’t have the kind of outbreak we have. Ours are going up, up, up as they have to. I think that’s an important lesson for us as we think about the future.

On a separate topic, my impression is that with regards to vaccines, where I’m critical of what we’ve done on testing and vaccines, we’ve done a pretty darn good job of moving ahead pretty aggressively, and yet the President said the other day that President Obama is responsible for our lack of a vaccine.

Dr. Fouci, is President Obama, or by extension, President Trump, did they do something that made the likelihood of creating a vaccine less likely? Are either President Trump or President Obama responsible for the fact that we don’t have a vaccine now, or in delaying it in some way?

No. No, Senator, not, not at all. Certainly President Obama, nor President Trump are responsible for our not having a vaccine. We moved, as you said, because I described it in my opening statement, rather rapidly. No one has ever gone from knowing what the virus was to a phase one trial, as fast as we’ve done. So I don’t think that’s something that one should say anybody’s responsible for doing anything wrong on that. I think that’s right. That’s the correct way to do it.

Thank you. That was my impression. I was surprised by the comment, but that was my impression. Dr. Redfield, Senator Sinema and I wrote a letter to you expressing our dismay at the lack of real-time data at the CDC. I’m thinking about granular, demographic, hospitalization, treatment data. How is it possible in this day and age that the CDC has never established such a real-time system with accurate data? And what can Congress do to rectify that so we never have to look at something like this again? There you go.

There I go. Sorry. Senator, thanks for the question. I think you hit one of the … how important they are. The first one I focus on is data, data monitorization, data analytics, and predictive data analysis. Clearly, Congress has moved forward in providing funding for a data monitorization and we’re in the process of implementing that. The reality is, there is an archaic system, a non-integrated public health system. Each public health department has their own systems.

This nation needs a modern, highly capable data analytic system that can do predictive analysis. I think it’s one of the many shortcomings that have been identified as we went through this outbreak, and I couldn’t agree with you more, it’s time to get that corrected.

Thank you. Please help guide us as to what we need to do to make sure that happens, and I presume it’s not build it ourselves, but work with companies that have that capacity and use that capacity in our favor. Dr. Fouci, one last thing which relates to a virus, and I know I’m asking you the impossible question, but we’re all hoping for a vaccine, obviously.

It’s the objective of our administration to get it as soon as they can, and from what I can tell, they’re pulling out all the stops to do exactly that. Given our history with vaccine creation for other coronaviruses, how likely is it? I mean, is it extremely likely we’re going to get a vaccine within a year or two? Is it just more likely than not, or is it kind of a long shot?

It’s definitely not a long shot, Senator Romney. I would think that it is more likely than not that we will, because this is a virus that induces an immune response and people recover. The overwhelming majority of people recover from this virus. Although there is good morbidity and mortality at a level in certain populations, the very fact that the body is capable of spontaneously clearing the virus tells me that at least from a conceptual standpoint, we can stimulate the body with a vaccine that would induce a similar response. So although there’s no guarantee, I think clearly, much more likely than not, that somewhere within that timeframe, we will get a vaccine for this virus.

Thank you. Mr. Chairman, I yield.

Thank you, Senator Romney. I want to thank the witnesses for their patience. We have four more senators and we’d like to give them a chance to ask their questions. So, Senator Jones.

Senator Jones: (02:55:16)
Thank you very, very much, Mr. Chairman, and thanks to all our witnesses for your being here virtually and also for your incredible service during this time. I want to follow up real quick with an additional statistic that Senator Romney talked about with regard to South Korea. And that is the fact that we are a nation that has about six times the population of South Korea, but yet we have about 310 times the number of deaths from this pandemic. So I think we have to be very careful in making comparisons around the world, comparing the United States to other countries.

Dr. Redfield, I want to follow up just a little bit with what Senator Murkowski and I think Senator Kaine talked a little bit about contact tracing and where we’re going. I understand that you are working with states to try to develop plans for reopening. The testing is important. The contact tracing is important. But using that data as well is also going to be important in terms of the quarantine plans that Senator Murphy talked about, childcare facilities to allow people to put their kids in a facility while they go back to work.

All of those issues, including maybe even facilities like vacant hotels or motels that may be used for self isolation. How is this plan being developed within the CDC? Are those plans going to be individualized by state? Will we, as a member of Congress, have access to those plans? How our states going to pay for these? And I say that because my state’s already using the money that we’ve already given them as a wishlist.

I mean, they’re talking about building a $200 million state house as opposed to developing the test and doing the contact tracing. So I’d like if we just drill down a little bit on how these plans are going to develop, what access we will have to those plans, and be able to see them.

Thank you very much, Senator. Obviously, as I said before, this is a critical component of us taking this time that we have now to get prepared for next fall, the winter, and building that comprehensive contact tracing capacity. We’re working individually with the leadership of the state health departments, the local health departments, territorial and tribal to try to let them get us to understand what they think their capacity needs are.

And those discussions have already happened as Admiral Giroir said. There’s been a variety of federal agencies together on testing and contact tracing. CDC’s in position that we’ve reprogrammed our individuals that we have across the country, we’re 500, begin to help each of these states. We’ve augmented that with some additional personnel that we’re bringing on board state-by-state through our foundation. We’ve put about $106 billion of the money that Congress has appropriated into the states so they can begin to start thinking about how do they want to hire [inaudible 02:58:21] contact tracing capability.

And then of course, it was mentioned that other government programs like AmeriCorps or Peace Corps, so that each group is going to construct their contact tracing piece into what they think their needs are. And I do think it is going to be similar to what we heard from the Senator from South Carolina. These are significant increases. He said he increased 20 fold, and they’re going to increase again.

But the point you brought up is so critically important, and we found that as we already struggled through the repatriation of different Americans from around the country. Where we had to put many of these in quarantine, as you know, ended up using what military bases, because many of the state and local health departments really haven’t developed that system. Where do they put somebody who has to be in isolation, who’s homeless? How do you develop those systems?

So this has to be part of it too. Is it, there’s certain capacity that’s intrinsic or is it through hotels, as you mentioned? I think the point that was made by one of the other senators is so important about individuals that particularly like, say the meatpacking individual that has to go home and self isolate, but maybe they don’t have an ability to go home and self isolate because they live in a multi-generation house with about 12 other people.

There has to be mechanisms to be brought in, they have an effective way to identify cases, then trace contact, and then do the appropriate public health measure, and that these have to be comprehensive. It’s going to be developed one jurisdiction at a time. I see no reason why these are not transparent documents as they get completed.

And it really is a tribute to what the congressional support that you’ve all given so far. As I said, one point $1.6 billion got into the state, enough to begin to do this, in addition to the resources that we’ve gotten. But it is fundamental. People underestimate how important it is that we have a highly functional, comprehensive, aggressive contact tracing program so that the next phase of this outbreak we switch to containment, we don’t have to switch to mitigation.

Thank you, Dr. Redfield. I appreciate it. It sounds to me like we still got a lot of work to do. So thank you.

Thank you very much, Senator Jones. Senator Braun.

Senator Braun: (03:00:48)
Thank you, Chairman. There’s been so much discussion about testing in general, listened to Senator Romney earlier. I think Senator Kaine mentioned it. Everybody has. Dr. Hahn, if you remember, when we first met, I said, is the FDA going to be more entrepreneurial? Is the FDA going to kind of not be as stodgy? Talking then about how we fix the healthcare system in general. Now this has brought it into clear focus.

I’ve got a timeline that I’m going to submit for the record that shows from January 24th through March 5th, and I want to emphasize what Senator Burr asked earlier, has the administration ever put an impediment in front of trying to get to testing? And Dr. Hahn, this’ll end up in a question in a moment, but there was a span of time from January 24th through March 5th that I hope the American public looks at. And it gets back to what’s wrong with our healthcare system in general. Early testing, from what I’m seeing, was created by the fact that the CDC said it was going to do its own test.

The South Korean test that gets cited so often was not going to be looked at. We had to do our own. I know the FDA worked with the CDC, but the long and short of all of this is that for nearly a month, this was in that bureaucratic swirl. The FDA prevented private and academic development of tests for weeks. The CDC denied access to functioning tests, as I cited in South Korea.

This created, through all the red tape and bureaucracy, to where we had to come up with a one-size-fits-all approach, due to the uncertainty of the virus, and we are stuck with that now. I don’t want to dwell on that necessarily because I think those were mistakes that we made. I’m tired of having it heard that it’s the administration’s fault.

Dr. Hahn, I’d like to ask you this question. In that spirit of what we talked about during your nomination process, here going forward, will we shed some of that stodginess? Will we look to get therapeutics and vaccines through the system in a quicker method?

Because I fear if we don’t and if we treat through bureaucracy how we did the early period of testing, we can be belabor this into the distant future, and at that point there’s going to be not only the carnage from the disease itself, but from the economy to deal with. So I’d like your comment on that one-month stretch, what accountability the FDA and the CDC have, and then whether it looks better in terms of moving more quickly into the future.

Thank you, Senator Braun, for the question. Our timeline of that period demonstrates that we began working with test developers beyond CDC on January 24th and had double digit number of test developers working with us. One of the issues that we identified was in fact availability of the virus and other supplies to actually get that test development done in a timely fashion.

Senator, I completely agree with you that this is an opportunity for us to take the look and determine how we can do things better, and I think that’s a really important thing for all of us to do, and certainly the FDA can promise you we’ll do that. Looking forward, sir, I can commit to you that we will look at every one of our regulatory authorities.

We have done so during this outbreak. We have provided significant flexibility and have tried to provide the right balance between regulatory flexibility and enabling of the great test developers and therapeutic developers in this country with the need to ensure that our gold standard of safety and advocacy is in place.

We have leaned in with manufacturers. We’ve learned a lot from them as well as the other stakeholders, and we will continue to learn, and we will, I commit to you, sir, implement the changes that are necessary to make sure that we can act in a more nimble way, but still protect the safety and efficacy of medical products.

Thank you. Dr. Fouci, taking a page from your anti-AIDS playbook that implemented a formal, clearly-defined treatment review pathway, can we do that for COVID-19 in a similar, parallel track that you put into place back then in the ’90s? In fact, I’ve got a bill called The Promising Pathways Act, that is based upon that protocol you put into place. Can we do that to more quickly get through to therapeutics and vaccines here with COVID-19?

Well, it’s a different story.

Well, it’s a different story, but some similarities, if you’re referring to the parallel track that I put into place back in the late ’80’s, which was when there was no availability of drugs at all for HIV and when we were testing drugs within a protocol that we would make it available outside of the protocol in what has ultimately turned out to be compassionate use. So what we did is we didn’t want to interfere with the integrity of the protocol to determine in a controlled way what was safe and what was effective, but there was a dire need for some sort of accessibility to those drugs outside of a clinical trial, for those who might even have some chance of having it. And in fact, that was really in many respects, the birth of the really fern concept of a compassionate use.

And in fact, there is a version of that, which I’ll hand over to commissioner Hahn that is, when you have expanded access and emergency use authorizations for drugs that have not yet been fully proven in a clinical trial. So there is somewhat of an analogy in similarity between what I did in the 1980s and what is actually being done by the FDA now. So Steve, if you might want to comment on that.

I think that’s right Dr. Fauci, the emergency use authorization process by statute allows us to have flexibility and assess the risk benefit ratio in a public health emergency. And we’ve done that on the therapeutic side in three separate occasions and continue to look at those requests as they come in.

Thank you, Senator Braun, Senator Rosen.

Senator Rosen: (03:07:55)
Here I am. Thank you Mr. Chairman for bringing this hearing. And I want to thank the dedicated doctors today for their lifetime of work and study and passion. We are a grateful nation for all of your lifelong commitment in fighting disease and not just in the United States, but around the world. And as I talk to Nevadans about safely reopening the economy, one question that frequently comes up is when are we going to have a vaccine everyone’s talked about. In Nevada travel and tourism, of course, the lifeblood for us, and the jobs associated with those industries can only fully come back if we know it’s safe to travel and visit our work and our hotels, casinos, restaurants, and attractions. Ultimately to make this happen, we have to build confidence in our visitors that it’s safe. We need a vaccine. And that research is extremely important.

However, understanding that this takes time to develop and ensure both safety and efficacy, I’d like to hear more about what is happening regarding preventative medication research that could be helpful in the timeframe before a vaccine, and especially before one is widely available. So I’d like to ask if this could be part of the path in helping us begin to reopen our economy safely and bring visitors not only back to Nevada, but across our country. So Dr. Fauci, what research is currently happening to identify potential monoclonal antibody preventative treatments or other therapeutics? If the right antibiotic is identified or can be identified, would this be used as a preventative medication to block COVID-19 virus from latching onto those host cells, much like the treatments for rheumatoid arthritis, severe asthma, or other diseases? And secondly, would preventative medication options like this help compliment the effectiveness of a vaccine once it’s available?

Yeah, so thank you for that question, Senator Rosen. That’s an excellent question. And in all of the therapeutic interventions that we are developing, and you mentioned several of them, they could be direct antivirals along the line of Remdesivir, but that’s just one of a number of possibilities since there are several viral targets in the replication cycle. Using convalescent plasma in a preventive modality, as well as monoclonal antibodies in a preventive modality are in fact all feasible and will be pursued in parallel with the development of a vaccine. The model of using drugs and other interventions that are effective for treatment is really a great success story in the issue with HIV AIDS, because many of the interventions that were developed for the full treatment of an infected person are exquisitely effective in preventing infection of HIV. So that’s the kind of model that we work out in parallel. With treatment for disease, it’s the using as treatment as prevention. I believe that will be a part of our effort at the same time, as we’re putting a full court press on trying to get a vaccine. So it’s an excellent question, very relevant.

I know I have a short time left, so I’m just going to abbreviate this. The second most important question that I get, not just from our first responders or people worried about work, but generally what does the next generation of PPE need to look like for all of us as we go about our lives? Not just as workers, depending on your work, you may need something stronger, more specific, but as all of us as we want to go out and shop or out to eat or whatever those things are, get on an airplane, should mass be made of a certain material? Gloves, are handkerchiefs effective? Can you talk about PPE for the general public?

Well the best PPE for the general public, if possible right now is to maintain the physical and social distancing. But as we’ve said, and I think all of us would agree, there are certain circumstances in which it is beyond your control when you need to do necessary things like go to the drug store and get your medication, go to the grocery store and get your food. That in fact you need some supplementation to just physical distancing. And that’s the reason why some time ago the recommendation was made I believe it was Dr. Redfield at the CDC who first said that about getting some sort of a covering. We don’t want to call it a mask because back then we were concerned we would be taking masks the weight from the healthcare providers, but some sort of mask-like facial covering I think for the time being should be a very regular part of how we prevent the spread of infection.

And in fact, the more and more as you go outside right here and where I’m sitting in Washington DC, you can see many people out there with masks on, which gives me some degree of comfort that people are taking this very seriously.

Thank you.

Thank you Senator Rosen, Senator Leffler.

Senator Leffler: (03:13:15)
Thank you all for being here and for your service. Admiral Giroir, before I start my questions, I want to recognize your new role as the US representative to the World Health Organization. Mitigating a resurgence of this pandemic will take global cooperation. In order to do that, we need accountability and transparency at the WHO. This organization was established to ensure the timely flow of accurate unbiased information on global health emergencies, just as this. Reforms must be made in order to restore the trust that we need here. I hope you’ll work with our allies to push for these reforms. This question, I have two questions, the first one is for Dr. Redfield and Dr. Redfield, Georgians are wondering how we got here today. 1400 deaths, a third of Georgia’s workforce out of work. I’m incredibly concerned about the coverup and the misinformation coming from China and their efforts to suppress lifesaving information at the outset of this outbreak.

As we continue to reopen our economy safely, we have to take steps to ensure that another outbreak cannot take hold of the world in this way. I understand CDC has worked with the Chinese CDC on global health security for decades. Can you comment on the level and the timing of the information that you received and relied upon from your Chinese counterparts as this virus emerged?

Dr Redfield: (03:14:50)
Well thank you very much Senator, and I want to echo how important global health security is as a national security priority for this nation. And we’re going to need to be able to be able to respond to that as long as we are a nation. CDC has had relationships with countries around the world. We have offices in over 45 countries right now, people in over 60. And one of those happens to be China, where we have a US CDC that’s with the Chinese CDC. We’ve worked together for decades, particularly on influenza and emerging infectious diseases. And that has been a very productive, collaborative, scientific interaction. When this original outbreak of pneumonia of an unknown etiology came from the original seafood market. There were obviously discussions with us personnel, [inaudible 03:15:48] with the Chinese CDC, I personally had discussions as early. I think CDC did as early as January 2nd, and myself January 3rd, with the counterpart to discuss this. So at a scientific level, we had very good interactions. I think that’s different than the broader Chinese government level.

Thank you, Dr. Redfield. I have a final question for each of our great witnesses today, and it’s one that my constituents often ask me. The mainstream media, and indeed some of my colleagues in the Senate, seem to want to paint each of your relationships with our president during this war time effort as confrontational and lacking consensus. Can you categorically say here to the American people today, whether this is true or untrue. From your testimony today, I’ve seen a very coordinated effort to address this with the administration to combat this pandemic. Can you give me a sense of what the characterization is, whether it’s true or untrue? Thank you. I’d ask Dr Fauci to answer that first.

Yes, no, there is certainly not a confrontational relationship between me and the president. As I mentioned many times, I give advice and opinion based on evidence based scientific information. He hears that, he respects it. He gets opinions from a variety of other people, but in no way, in my experience over the last several months, has there been any confrontational relationship between us.

Thank you, Dr Redfield, Dr. Hahn?

Dr Redfield: (03:17:33)
Again, I would echo what Dr Fauci said, we’re there to give our best public health advice, and that’s what we do, it’s grounded in data and science. And I’ve always felt free to give the best public health advice that I think needs to be given at the time. And it’s always been done in a very professional way.

Senator Leffler, or this is Steve Hahn. I do not have a confrontational relationship, have not had a confrontational relationship with the president. He asks questions, I have given him my honest answers, rooted in data and science. And he’s listened respectfully to those, incorporating that into his decision making.

And Brett Giroir, why I have nothing else, but to echo my colleagues, we work very closely together. All the scientists, all the physicians, of course, Ambassador Burkes, other scientists within our group. We have a very productive working relationship with each other and also with the president and vice president, it would not be confrontational. And I certainly feel that we have the ability to honestly state our opinions and recommendations. And that’s been that way since the beginning.

Thank you, Senator Leffler, Senator Murray, do you have closing comments?

I do. And if it’s all right, I have two quick questions.

Sure.

Well, thank you. Dr. Fauci, while president Trump has claimed otherwise, there is no question that an essential part of reopening our economy safely is successfully developing and distributing a vaccine for COVID-19. We need to plan now to deploy a vaccine once it’s proven safe and effective, but it is absolutely crucial, this planning process, from the clinical trial to distribution and administration recognizes and addresses racial and ethnic disparities in our healthcare system that as we all know for too long have been overlooked and unacknowledged in this country. And we have to ensure equitable access to this vaccine for everyone. Dr. Fauci, let me start with you. What steps is NIH taking to make sure that clinical trials for COVID-19 vaccines and therapeutics account for racial and ethnic disparities?

Yeah, thank you very much. That’s a very relevant question, Senator Murray. And in fact, in the design of our clinical trials and the sites that we’ve chosen in our clinical trial network, it’s going to be very representative of being able to get minority populations and populations at most risk to be part of the trial so that we know during the trial, what the relative efficacy as well as potential adverse events is something we started back in the days of HIV when we tried to get good demographic representation. And we’re going to do that with these trial. Thank you.

Thank you. And Dr. Hahn, tell me what steps the FDA is taking now to make sure that the United States is prepared to produce a sufficient number of vaccines, including the necessary manufacturing, supply chain capacity for supplies like vials and stoppers and syringes.

Thank you, Senator. This is an effort that started as a partnership with the vaccine developers and the NIH and their efforts. So one of the most important things ma’am, has been the data transparency sharing of data, both with the agency, NIH, and with the manufacturers. So we can understand what the capacities are, what the needs are from the supply chain, and then how to actually share that so that if one manufacturers vaccine doesn’t go forward, we can use the capacity of that manufacturer for another manufacturer’s vaccine. I’m very happy to report that the work of Dr. Marx and Dr. Fauci has led to that sort of effort. We’ve developed, as I mentioned before, this Gantt Chart that describes all the steps that go forward with vaccination, including those supplies you described. It is somewhat complicated, ma’am in that we may very well have hopefully five to seven different candidate vaccines that may need different supplies associated with them, but we’ve been upfront identifying those supplies where they’re available and then working with the manufacturers to make sure that they are available.

Okay. Thank you. Thank you very much, and Mr. Chairman. Thank you. And thank you for all of our witnesses who are joining us today. It is really clear to me that we have more work to do before we can safely get back to work and school and some semblance of normal life in our country. We still need testing to be fast, free, and everywhere, and we need the white house to lay out a detailed national plan to make that happen. We still need adequate personal protective equipment, both for our healthcare workers and for workers at our businesses and at schools when the time comes. We still need guidance from our experts so our communities have the information that they need to reopen schools and businesses safely, confidently, and competently. And so public health workers and healthcare providers have the information they need to keep their patients and communities safe.

And well, experts have been clear that the day we can safely reopen may be a ways off, there’s plenty for us to do in the meantime, both to plan ahead, for example, to make sure that once we have a safe and effective vaccine, we can produce and distribute it to everyone quickly equitably at no cost and to address the immediate challenges. For example, making sure there are appropriate mental health resources for everyone who’s coping with the challenges that are presented by this virus, from the stress of physical isolation, loss of income, to the trauma and anxiety of patients and workers who’ve been on the front lines.

So I’m going to keep pressing Congress and the white house to provide the action and leadership that our communities need. And I hope Mr. Chairman, that we’ll continue to have the opportunities like this to hear directly from the experts and ask pressing questions about how to get our country through this crisis. It’s clear we’ve got a lot further to go, a lot more to do. And so I hope that as our efforts continue, we’ll be able to bring any of you back or witnesses for another hearing soon. And again, thank you to all of you for joining us today.

Thank you, Senator Murray. I’ve got a clarification question and a couple of quick comments and then we’ll thank the witnesses and wind up the hearing. My clarification is I want to make sure I didn’t create some confusion by the way I asked the question about going back to school. I asked Dr. Fauci first about treatments and vaccines and Dr. Admiral Giroir 2nd about testing. What I thought I heard was that Dr. Fauci said that vaccines are coming as fast as they ever have, but it’ll be later in the year at the earliest before we see that, but there’s some treatments that are modest, but are promising. There could be more, but that that doesn’t mean you shouldn’t go back to school. That would be more of a testing strategy. Am I right, Dr. Fauci? You didn’t say you shouldn’t go back to school because we won’t have a vaccine by the fall?

No, absolutely not Mr. Chairman. What I was referring to is that going back to school would be more in the realm of knowing the landscape of infection with regard to testing. And as Admiral Giroir said, it would depend on the dynamics of the outbreak in the region where the school is. But I did not mean to imply at all, any relationship between the availability of a vaccine and treatment and our ability to go back to school. You’re quite correct.

And what I heard from Admiral Giroir was that you’re ramping up current technologies. You are hopeful for Dr. Collins shark tank and the National Institutes of Health, but in any event, you would expect to have the capacity in the fall of 40 to 50 million tests a month. And that ought to be adequate for the principal of a middle school, or even the chancellor of a campus to design a testing strategy that could provide, for example, an antigen quick test to screen all the students in the school, if necessary. Is that correct?

Yes sir, Mr. Chairman. And again, we want to make as many tests available as absolutely possible. What I said is what I feel comfortable with knowing the production schedules being in the position of being able to work with the FDA and CDC that we should have 40 to 50. We will have 40 to 50 million tests available per month that need to be deployed in a smart, strategic way, depending on the dynamics in that area and in that region. Still having testing even widely does not nullify the need that we’re going to have to change our practices in terms of sanitation, personal cleanliness, distancing, face masks, things like that, given what the dynamics could be.

Well, thank you for those comments, because given that number of tests that will be available in say three months, or as we ramp up to that number three months from now, that should give every principal, every chancellor of every college campus and again, we have about 5,000 campuses and 100,000 schools, some reassurance that testing, as well as the common sense hygiene practices you talked about, could be used to develop a strategy for reopening for school in August. And then two quick comments. One is Senator Murray talked about the national plan, which was in the legislation that we all voted for. There’s a little bit of a push and tug between what’s national and what’s federal, what Washington should do and what the states should do. I’ve always thought it’s a mistake to say federal equals national.

In other words, COVID-19 is clearly a national problem, but that doesn’t mean the federal government’s supposed to do everything. For example, in testing, the law actually requires states to tell you Admiral Giroir, what their plans are, what their needs are. And then you said that during the month of May, you had a series of state plans that identified 12 and a half million tests, and you thought you could help meet that. On the other hand, you’ve also noticed a deficiency in the marketplace for some supplies. So the federal government is buying those and allocating them to the states. So we don’t want to get in a situation where Admiral Giroir is telling all the states what to do. Governor Lee in Tennessee doesn’t really want you to tell him what to do. He wants to tell you what he’s doing and let you comment on it.

I don’t think Governor Cuomo wants President Trump telling him what to do. So a push and tug between what Washington does and what the states do. I think we have a testing, contact tracing, isolating national strategy and plan led by the governors designed by the federal government as a national effort. And then the national effort clearly is to do the research for the treatments and the vaccines and what we’ve heard today is that’s coming along on a faster track than we’ve ever seen before. Finally, I want to reiterate, I thought this was a very helpful hearing. I thank the senators for their questions. I think anybody who took the time to watch would be impressed by the diversity of opinion and the honest answers we got from four really remarkable experts who are in the midst of this every day.

I want to reemphasize what I said earlier that I intend to make sure that we focus, Senator Murray suggested we need to have more hearings. I agree with her. And as we deal with this pandemic, we need to make sure we’re ready for the next one. What can we learn about faster treatments and vaccines for the next one? What can we learn about the stockpile? What ought to be in it? Who ought to be managing it for the next one? What can we learn? Can we learn anything about having hospital beds so we don’t have to shut down hospitals and bankrupt them and push patients out in order to create beds for sick people from the pandemic? What about states and hospitals that sell off their PPE in between pandemics? How do we keep our focus in between pandemics when we have so many important things to be worried about this country? How do we make sure that we in Congress sustain and fund all the things that we need to do?

And I want to make sure that we do that this year. Our collective memory is short. So while we’re all worried about this, we need to not only deal with this crisis, but get ready for the next one. I thank the witnesses for their extra time, I hope they get a sense that our job we see is to create an environment in which you can succeed. Because if you succeed, our country succeeds, which is what we desperately want. The hearing record will remain open for 10 days. Members may submit additional information for the record within that time, if they would like. Thanks to everyone for being here today, the hearing is adjourned.

Thank you very much, Mr. Chairman. Thank you, Senator Murray. Appreciate it.