Dr. Fauci & Dr. Walensky Testify on COVID-19 Response, Vaccines Full Senate Hearing Transcript

Sen. Murray: (00:00)
… if you are in need of accommodations, included closed captioning, you can reach out to the committee or to the Office of Congressional Accessibility Services. A few months ago, President Biden announced his plan to respond to the Delta variant, which was surging and jeopardizing our hard-won progress against COVID-19. And while our work continues, the president’s decisive action and the hard work of experts and public health officials across the country have put us in a stronger position to end this pandemic. Right now, cases, hospitalizations, and deaths are once again trending down, and the vaccination rate is continuing to go up. Nearly 80% of people age 12 and older have gotten their first dose of COVID-19 vaccine. Nearly 70% have been fully vaccinated, and inequities in vaccination numbers have been narrowing. We are also already seeing how requirements for vaccines or testing, like President Biden has called for and which a clear majority of Americans support, can bring vaccination rates even higher.

As of last month, vaccine requirements had increased vaccination rates by over 20%. United Airlines has seen their vaccination rate for employees go from 57% to 99% since they announced their vaccine requirement. Tyson Foods went from less than half of its workers vaccinated to over 96%. In my home state of Washington, 15 and 16 of our state’s workers have already complied with Governor Inslee’s vaccine requirement. And across the country, healthcare facilities, universities, and other employers are seeing similar results. And I expect that progress to continue now that the Department of Labor has put forward an emergency temporary standard on this issue. We’re also seeing progress on booster shots, with three different booster shots authorized and over 13 million already administered, and on shots for children younger than 12, with the FDA authorized vaccines for children ages 5 to 11 last week, and the CDC issuing its decision on this recently. But even with all the progress we’ve made so far, we must not take our foot off the gas.

Last winter, we saw this virus push our hospitals to the brink. We saw it infect and kill hundreds of thousands of people, including essential workers and healthcare workers, and we know it led to burnout among so many more. Vaccines are one of our best tools for making sure that does not happen again, and making sure we can build back from this pandemic stronger and fairer. In fact, as the White House noted in its report on vaccination requirements, an outside economic analysis found that increasing vaccination and reaching near full vaccination in workplaces could encourage millions of people to return to the workforce. Tests also continue to serve a critical role in stopping the spread by informing our ongoing response, which is why we need to plan to scale up testing even more. And in a larger sense, we must learn the lessons of this pandemic, not only so we can prepare for the winter ahead, but so we can finally bring an end to this pandemic and be better prepared for the next public health crisis, whatever it may be.

I’ve been pressing to get that done at every possible opportunity, and it’s why Senator Burr and I continue to work on bipartisan public health and preparedness legislation. And it’s also why I’m pushing for critical steps in Build Back Better to strengthen our public health infrastructure. Among other things, Build Back Better will help public health department across the country increase their testing and tracing capacity, train and retain public health workers, upgrade to more modern, inclusive, and interoperable data systems, communicate with the public and address misinformation about issues like vaccines, and address health inequities and build partnerships in hard- to-reach communities. It would also help our federal public health agencies like the FDA, CDC, and the Assistant Secretary for Preparedness and Response take action to increase lab capacity so we can sequence viruses and identify variants quickly, facilitate the development of new treatments and tests and vaccines, and improve the supply chain of medical supplies like syringes, ventilators, and personal protective equipment.

This pandemic has been long, and it has been deadly. It has hurt our economy, our communities, and our families beyond measure. But if we continue to take bold action, if we continue to follow the science and experts, if we continue to get people vaccinated and take steps to keep ourselves and those around us safe, we will get through this. And if we learn from this pandemic, if we finally end a cycle of crisis and complacency for public health funding and ensure we have an economy that works for everyone, not just those at the top, we can rebuild our country stronger and fairer, and we can make sure we are never in a situation like this again. With that, I will turn it over to Ranking Member Burr for his opening statement.

Sen. Burr: (05:13)
Thank you, Madam Chairman. To our witnesses, welcome back to the Health Committee. I get the feeling that we may need to send smoke signals to you. I’m not sure we could have gotten you further away from us and everybody. But we’re grateful to you, and we thank you for your service to the American people. Each time you’ve all come before the committee, I charged you to look ahead the next 30, 60, and 90 days, and figure out where we needed to be and what we need to do to keep up with this virus. I’ll say it again: You are the adults in the room, and you need to look around the corner to anticipate what we will need. More than 90 days from our last hearing, and we still have much to do to ensure that we’re better prepared, and better at responding than we’ve been in previous weeks and months.

Sen. Burr: (06:05)
As we get closer to the two-year mark of living with COVID-19, we need to take stock of the current state of our response and identify the next critical steps that will lead us out. Senator Murray and I have been working closely together to develop a pandemic bill, and at some point in the near future, Senator Murray and I will release a discussion draft of the reform. And we believe this is needed for our country’s future response. I very much appreciate the ability to work together on an issue so important to our national security. We’ve obviously delayed from our previous schedule, but given the [inaudible 00:06:46] appear on other big legislation, it is impossible for us to get that draft out until that’s concluded. We need to use all the tools at our disposal to keep pace with the virus, which continues to evolve.

Sen. Burr: (06:59)
Recent reports have surfaced of a new sub-variant that some are calling Delta Plus, which has accounted for an increasing portion of cases in the UK in the past month. I hope to discuss that in person when I leave Sunday for the UK, and spend some time in London next week to look at in fact what Delta Plus has done there. Cases and hospitalizations are down in the United States, but the administration cannot declare premature victory like we did in the summer. The mistake only brought us to a place we are today, with shortages of tests, therapeutics, and continued lag in extremely important data about the disease. In September, even CDC warned of shortages in point-of-care and over-the-counter tests, and to expect increased demand for lab-based testing.

Sen. Burr: (07:52)
To state the obvious, we need more rapid tests that are available and in stock. North Carolinians are calling my office desperate for help in accessing therapeutics. And even with new announcements on oral therapeutics, Americans are waiting for these drugs. This administration bears 100% of the responsibility for the lack of testing and the lack of therapies. You got complacent. You let your foot off the gas. You didn’t order enough tests. You didn’t purchase enough therapeutics, and now we’re rationing. The private sector will respond to purchasing agreements in the contracts. They cannot and will not produce things that customers are not ordering. Congress has given billions of dollars and billions of more of dollars. We’ve demonstrated bipartisan commitment to giving you the cover to purchase vaccines, test therapeutics even if we don’t use them. The administration squandered time and resources you’ve already had available to you, and the American people are suffering as a result. As we look ahead, we need plans in place to handle COVID as an endemic disease that will be part of our lives for the foreseeable future.

Sen. Burr: (09:03)
So my question in the headline for this hearing is simple: What’s the plan? We need to take stock of lessons learned to strengthen our ability to be ready for the next threat that we may face, but also learn from successful approaches and put those into everyday practice. We need to identify information gaps and map out how we’re going to address them so that we can make the best decisions based on sound science and sound data. Most importantly, we need strong leadership. We need a nominee for the FDA commissioner, and this administration cannot drag its feet on a new leader at the NIH. Both nominees will have challenging missions to complete under difficult circumstances, and nearly impossible shoes to fill. Qualified nonpartisan leadership at these agencies is paramount. Dr. Woodcock, I’m still rooting for you. We must leverage the laboratory community and test developers to bring more innovative, rapid, at-home, and point-of-care tests to market.

Sen. Burr: (10:05)
We need not let our guard down as we did this summer. We’re reaching the time of the year where we’re all looking forward to spending time with loved ones, and access to testing will help this happen safely, but we’re still behind. These tests, which we need to keep our businesses and schools open and families safe, are still far too difficult to find for most Americans. Testing shortages and delayed test results are keeping children out of school, parents away from the office, and limiting our understanding of where virus is circulating in our communities. The administration had to scramble to order 200 million at-home tests per month, many of which won’t even be ready until December. And that’s not enough. In early October, FDA announced that it authorized new tests to expand access to reliable at-home testing. Europe’s been using these same tests for seven months.

Sen. Burr: (11:02)
Just this past weekend, my two-year-old grandson was notified on Friday that his teacher tested positive. Teacher of a preschool class, masked 100% of the time that they were there. They did the appropriate thing. They shut the class down for a week. The problem was that his siblings could no longer go to school. School not only required him to be tested before his sister could return to school, but didn’t accept an at-home test for a negative test for the two-year-old. They required a PCR test. It’s confusing. America does not understand the standards that we’ve set. And in that case, she lost three days of school. Even though they could afford the PCR test, how many families can’t? The American people are tired of accepting “better late than never” from our public health agencies. And the testing shortage will only get more pronounced if the Department of Labor issues its threatening temporary standard, which it did right before we came in, which will create an even larger demand for tests for those who don’t choose to get vaccinated.

Sen. Burr: (12:26)
One recent survey found that 59% of unvaccinated workers are still not likely to get vaccinated, despite the mandates from this administration. With the heavy-handed vaccine federal mandates on employers, this administration completely disregards the legitimate question raised by many Americans, and specifically [Dr. Pauline Marshall 00:12:46]: What role does natural immunity play in protecting against this virus? I’ve said before that I did not believe that the federal government mandates will solve our problem. We’re seeing cops and firefighters quit, and pilots engage in sick-outs. The nation’s military and contractors worry about our preparedness of personnel, or fired over these mandates. And just this morning, a mandate from CMS to all healthcare providers that accept Medicare and Medicaid, that if they don’t mandate to their workforce, they’re no longer participants in Medicare or Medicaid, will only suggest to doctors not to accept Medicare or Medicaid patients if in fact they choose as a medical professional not to be vaccinated.

Sen. Burr: (13:33)
So there likely will be controversies over whether to require the vaccine for children, when even your own experts raise great concerns about mandating children get vaccines. I urge all of you back away from mandates, and instead use your platforms to educate, encourage, inform. Don’t be divisive. While more therapeutics and more tests are the tools that we need to manage the constant demands of the virus, we also need better information to make the best decisions. We need real-time data to understand and get ahead of COVID today and to detect the next emerging infectious disease or public health threat in the future. So far, Congress has dedicated $1.1 billion to improve our public health data sharing, and turn it into an actionable information through our surveillance system. But we still do not have the up-to-date and actionable data we need to answer some of the most common questions from the American people.

Sen. Burr: (14:48)
Effective communication of information and data is the best way for the public health officials to win back the trust of the American people, and it’s clear to me that the CDC has lost the trust of the American people. Show Americans the evidence for why the tough choices are the right ones, and don’t just expect that compliance gets you there. Use the best information available at the time, even if it isn’t perfect, and update action as the information evolves. This is a particular challenge for what is supposed to be our leading public health agency, the CDC. An agency that I have watched agonize over having perfect, clean data to make decisions for Americans. By the time we get their data, it’s too late. We still don’t have the answers to basic questions. We need real, usable information about masks. How well do different types of mask work? When should we use them? The CDC continues to change its posture on the collection of information on breakthrough cases. How many breakthrough cases result in hospitalization? How many do not? CDC’s not in a place where the nation looks for real-time data, and we need to change that.

Sen. Burr: (16:10)
The CDC’s too focused on writing academic papers about something that happened weeks or months ago. When Americans want real data, they’re forced to look elsewhere, like John Hopkins University or HHS Protect. I worry the new approach to HHS Protect will not be able to overcome the complacent academic culture of CDC without serious reforms, so I’ll be watching very carefully. We must all come to terms with the reality the virus is here to stay. It’s vital that the four of you sitting here today take the initiative to lead, empower Americans with data, tools, and clear and actionable guidance needed to get back to normal. The more people that get vaccinated to protect against COVID, the better. The more tests available to Americans to detect and diagnose COVID, the better. The more therapeutics we have to rapidly treat COVID, the better. The more we can continue to learn from this experience, the better prepared we will be. I thank the chair.

Thank you, Senator Burr. I will now introduce today’s witnesses. Again, thank you for joining us today. Dr. Rochelle Walensky is the director of the Centers for Disease Control and Prevention, and the administrator of the Agency for Toxic Substances and Disease Registry. Dr. Anthony Fauci is the director of the National Institute of Allergy and Infectious Diseases, and the chief medical advisor on President Biden’s COVID-19 response team. Dr. Janet Woodcock is the acting commissioner of the Food and Drug Administration, and Dawn O’Connell is the Assistant Secretary for Preparedness and Response. Dr. Walensky, Director Fauci, Acting Commissioner Woodcock, and Assistant Secretary O’Connell, thank you all for joining us once again. We look forward to your testimony. And Dr. Walensky, we will begin with you.

Dr. Walensky: (18:11)
Good morning, Chair Murray, Ranking Member Burr, members of the Senate Health Committee. I’m honored to join you today to provide an update on the COVID-19 pandemic. Since I last testified before this committee on July 20th, we have witnessed a steep increase in COVID-19 cases, hospitalizations, and deaths around the nation, largely fueled by the Delta variant. The Delta variant reminded us we need to be humble in our response to this virus, and to follow the science as we modify guidance and address the pandemic. Here are a few things we’ve learned over the last four months. First, the Delta variant is notably more contagious and spreads faster than previous variants. Second, though breakthrough infections are infrequent, vaccinated individuals who are infected with Delta are able to transmit the virus. And third, while we have seen waning vaccine-induced immunity in certain populations leading us to recommend the rollout of booster shots, COVID-19 vaccines are still highly effective and provide strong protection, particularly against severe disease, hospitalization, and death.

While we are once again pleased to see downward trends in cases, this decline seems to be slowing, and deaths are not falling nearly as fast as we would like. On average, we still see over 1,000 deaths every day, and tragically, there have been more than 138,000 deaths since I last spoke here. As we look towards the coming weeks and months with some optimism, we must remember what the Delta variant did to this country: erasing weeks of prior progress and long downward trends, and reminding us that this novel coronavirus is unpredictable. In addition, we’re entering the winter season, where we are predicting an increase in influenza and other respiratory viruses. We are concerned about this year’s flu season, has the potential to be severe. It’s just as important as ever to get vaccinated for COVID and for influenza. We’ve made incredible strides in vaccinating the US population against COVID-19. As of November 3rd, we have vaccinated about 85% of the United States population 65 years and older, 70% of those 18 years and older, 68% of those 12 years and older, and nearly 58% of the entire United States population.

Some of our latest data only reinforced why vaccination is so very important, showing that unvaccinated people have six times greater risk of testing positive for COVID-19, and 11 times greater risk of dying from COVID-19 than people who are fully vaccinated. Importantly, we now have data showing that the Pfizer vaccine is nearly 91% effective in preventing COVID-19 infection in children ages 5 to 11 who did not have COVID-19 infection previously. Why is this such important news? Case surveillance data indicate that there have been 9,000 hospitalizations among children ages 5 to 11 since the beginning of the pandemic. Mortality data have recorded more than 97 deaths in this age group. There are now well over 5,000 children diagnosed with MIS-C and living with complications of this disease. As a mother, I know that no parent should have to see their child face long-term complications of an infection, or be hospitalized.

And we now have a highly effective tool to prevent this disease in our children. Following FDA’s authorization, I endorsed CDC’s Advisory Committee on Immunization Practices’ recommendation that children ages five and up should receive a COVID-19 vaccine. I strongly encourage parents and their children to get vaccinated. And if you have any questions about the vaccine, please talk to your child’s pediatrician, a school nurse, your local pharmacist, or a trusted medical professional. In addition to the critical work to get out of this pandemic through vaccination and other prevention strategies, we need to better prepare for future outbreaks and pandemics.

One of the most important steps we can take to support these efforts is to support sustained disease-agnostic funding for public health. This is how we will accomplish our goals to rebuild our public health workforce, invest in our public health laboratory infrastructure, ensure rapid response readiness, and improve our ability to collect and use data. I hope these bipartisan goals for members of this committee, and I look forward to continuing to work with you to achieve these investments. Before I close, I want to emphasize that the work we’ve done collectively to invest in and distribute vaccines has given us our most powerful tool to get out of this pandemic. Data show again and again that vaccines work. They are safe, and they can save your life. Thank you. I look forward to your questions.

Thank you. Dr. Fauci.

Dr. Fauci: (23:20)
This doesn’t seem to work.

It works. We can hear you.

Dr. Fauci: (23:31)
Madam Chair, Ranking Member Burr, members of the committee, thank you for giving me the opportunity to discuss with you the role of the National Institute of Allergy and Infectious Diseases in the conduct and support of research addressing our nation’s response to COVID-19. In previous hearings before this committee, I’ve discussed the critical role of NIAID in the development of COVID-19 vaccines, their testing in clinical trials, as well as the proof of their real-world effectiveness. Today, I would like to focus my remarks on studies aimed at optimizing the degree and durability of protection offered by these vaccines. In addition, I will mention our recent work in the development of effective therapies to prevent the progression of COVID-19 disease, and I’ll close by briefly mentioning our involvement in preparedness for future pandemic threats.

Dr. Fauci: (24:25)
It has become apparent as we follow cohorts of vaccinated individuals over time that the durability of protection afforded by the vaccines, both against infection and the development of severe disease, gradually wanes over time. This has led to a considerable amount of activity aimed at optimizing protection by boosting with an additional dose of vaccine several months after the primary regimen. One can gauge the effect of these booster shots by measuring the induction of high levels of neutralizing antibody, as well as the clinical effect of enhanced protection. And in this regard, it has become clear that giving a third boost of an mRNA vaccine approximately six months or more following the original primary regimen provides a dramatic enhancement of protection against infection, as well as severe disease. And in the studies from Israel, this is beginning to be seen across all age groups. In this regard, certain subsets of individuals who have received any of the three vaccines available in this country are now eligible for booster shots.

Dr. Fauci: (25:39)
Importantly, to increase the flexibility of the administration of boosters, NIAID has conducted a critical study, which is called Mix and Match, in which individuals are divided into three groups representing each of the three available products. These individuals were then boosted with a product other than the original one with which they were vaccinated. Data clearly indicated that boost with a different product than the original was both safe and indeed induced a robust immune response. Thus, although we recommend that people boost with the original product of their vaccination, this study adds a degree of flexibility by allowing a choice of booster shots if it is difficult for one reason or another to receive the original product. Let me now move on to a brief discussion of the NIAID research approach to therapeutics, particularly in the context of treating an individual early in the course of infection to prevent progression to severe disease.

Dr. Fauci: (26:47)
The NIAID has initiated a program called the Antiviral Program for Pandemics, which is aimed at catalyzing the development of new medications to combat COVID-19, as well as to prepare for future pandemic threats. The program has two pillars. One takes existing drugs and accelerates their clinical testing and advanced development, and the other pursues the discovery of new molecules aimed at various vulnerable components of the SARS-CoV-2 replication cycle. One compound in particular, molnupiravir, developed by Merck and Ridgeback companies, has shown considerable promise in a recently conducted clinical trial in which the drug was administered early in the course of infection. And it decreased hospitalization and death by 50% in the treated individuals compared to the placebo group.

Dr. Fauci: (27:50)
I bring this to your attention because the very early work on this molecule was the result of NIH grant support to academic institutions for the fundamental basic research which led to the discovery and the development of this molecule. Finally, I would like to close by looking forward to how we might best enhance our preparedness for what will be the inevitable future pandemics. In this regard, the NIH has already initiated its plans for the rapid development and implementation of successful countermeasures against several prototype pathogen families of viruses that threaten the health and safety not only of our nation, but of the entire world. I look forward to describing these plans to you in more detail. Thank you for your attention, and I would be happy to answer your questions following the presentation.

Thank you. Dr. Woodcock.

Dr. Woodcock: (28:58)
Having the same… There we go. Great. Good morning, Chair Murray, Ranking Member Burr, and members of the committee. Thanks for the opportunity to testify here today, and for the continued bipartisan efforts of your committee to address the COVID-19 pandemic. FDA appreciates the productive discussions, and we look forward to continuing our partnership on these legislative efforts. FDA has achieved some of the most impressive scientific-based regulatory advances I’ve seen during my entire career at the agency during this pandemic, driven by our mission to protect public health. I know the American public has been eager to hear about getting their children vaccinated, what they can do if they get sick with COVID-19, and how they can further protect themselves and their loved ones against the virus. Let me provide a brief update on the actions the agency has taken to protect public health in three key areas since I last testified before this committee.

First, regarding vaccines, FDA has authorized three COVID-19 vaccines and approved one vaccine. These have met FDA’s expectations for safety and effectiveness, appropriate either for authorization or approval in preventing COVID-19. In the last few weeks, the agencies made additional critical decisions about the use of these vaccines. FDA authorized booster doses for use in certain populations for all three authorized vaccines, as you’ve just heard from our other witnesses. As more data became available, the data suggested the effectiveness of the initial doses had started to wane, meaning that use of a booster dose would be important in bolstering protection for these populations. And the agency also authorized the use of mix-and-match booster doses for COVID-19, using data from NIAID as was just mentioned. This means eligible individuals can get any of the three authorized vaccines as their booster dose, and really simplifies availability for the public.

Also, FDA authorized the Pfizer vaccine for use in children ages 5 through 11. I know, because I’ve had many messages on this, many parents have been waiting impatiently for months for this authorization. And I’m happy to say as we speak here today, young children across the country are starting to get vaccinated against COVID-19. And to be clear, FDA is confident in the safety and effectiveness data behind these decisions, and the American public can and should feel confident in receiving any of these vaccines. They will help bring this pandemic to an end, and I strongly encourage all eligible Americans to get vaccinated and to get their children vaccinated. We all have an important role to play here. Second, diagnostic tests are a key line of defense in the pandemic, and will become increasingly important, I think.

Increasing access to accurate rapid at-home tests is a priority for FDA. We prioritize the review of at-home rapid antigen tests, and we’re actively engaging with test developers to increase their availability. Last month, the agency authorized additional over-the-counter at-home tests, which we expect to significantly increase the availability of rapid tests to the public. These authorizations add to a growing list of tests that can be used at home without a prescription in the US. Additionally, last week, FDA provided recommendations for labeling updates to facilitate better over-the-counter single-use testing for symptomatic people. In tests currently, they’re only authorized for serial testing. This change allows tests to be sold as single tests, meaning greater availability of more individual tests. FDA remains focused on speeding the process to get appropriately accurate and reliable tests in the hands of all Americans who need one.

Third, there’s a need for medical products to treat and prevent COVID-19, especially for those unable to get vaccinated or who don’t develop an immune response. We continue to carefully evaluate the data on any promising therapeutics, and our priority is to have fast discussions between FDA and drug sponsors. We are hoping that we’ll see more therapeutics authorized soon to treat COVID-19 in the future as another weapon in our arsenal. And finally, I want to stress that all of FDA’s work and effort is toward the goal of protecting the public. It’s a responsibility we take seriously, and we rely on science. This is what allows us to expedite development and availability of medical products to address COVID-19. Thank you, and I look forward to your questions.

Thank you. Assistant Secretary O’Connell.

Ms. O’Connell: (34:24)
Chair Murray, Ranking Member Burr, and distinguished members of the committee, it is an honor to testify before you today. I am pleased to have this opportunity to provide a few key updates that have occurred in ASPR since I last testified before you in July. Ensuring the nation has the necessary vaccines, therapeutics, and diagnostics to respond to COVID-19 remains a primary focus of ASPR’s response. To date, BARDA has supported 77 medical countermeasure projects. This includes 15 therapeutics, 55 diagnostics, and 7 vaccine candidates.

Of diagnostics and seven vaccine candidates. Notably, as part of the counter measures acceleration group effort with DOD, BARDA has placed 1.5 billion doses of vaccine under contract, distributed over 4.88 million doses of monoclonal antibodies and shipped more than 144 million diagnostic kits. Accelerating the supply of available rapid point-of-care and over-the-counter tests has been another important focus of ASPR’s work. While there is currently enough testing capacity across all types of tests, we have seen a growing preference for rapid tests, especially those that can be used at home.

Over the last few months, ASPR has invested over $3 billion to bring additional rapid point-of-care and at-home tests to market, with $1 billion of that going specifically to at-home tests. As production has ramped up since September, these investments put us on pace to quadruple, by December, the number of at-home tests available each month to nearly 200 million. Supporting hospitals and healthcare systems that are overwhelmed by COVID-19 patients is another important focus of ASPR’s response. Since July, 27 national disaster medical system teams, nearly 600 team members, have deployed to support sites in 12 separate states.

We currently have teams in Wisconsin, New Mexico and Montana. For these deployments, NDMS personnel support a range functions, including hospital augmentation and decompression, setting up medical overflow centers for patients and offering mortuary support. Ensuring our healthcare providers and first responders have the necessary medical supplies they need, remains a focus of ASPRs efforts. As of October 1st, the Strategic National Stockpile, or SNS, shipped more than 250 million items, to aid the national response over the course of the pandemic. Including deploying more than 3000 ventilators to 17 jurisdictions since I last testified.

We continue our work to replenish the SNS to levels at or above pre-COVID-19 amounts. Thanks in large part to the supplemental funding Congress has provided, the SNS has spent approximately $11.9 billion to replenish the inventory. Including purchasing from domestic manufacturers whenever possible. While replenishing the SNS is essential, we continue to address the root cause of why public health supply chains were so strained in the first place.

We are investing critical funding and expanding domestic manufacturing, including investments of 250 million in PPE manufacturing, 268 million in manufacturing of testing consumables, 14.8 million in vaccine raw material manufacturing. 160 million in fill/finish capacity, 65 million in vaccine biomanufacturing, 186 million in manufacturing capacity for at-home and point-of-care tests and 53.8 million in testing raw materials. With additional funds going out the door every day.

I firmly believe that running all this from D.C. without the view from the states and regions is unwise. I’ve made it a priority, in my first few months, to get out to our regional offices. To meet with those teams and local leaders and understand the unique challenges they face. So far, I’ve been to four out of 10 regions, with plans to get out to all of them in the coming months. I’ve met with an NDMS team in New Orleans, as it was decompressing a pediatric ICU unit this summer. I have also hosted for three tribal consultations, to ensure that tribal nations and urban Indian organizations are able to access the SNS.

I’ll continue to review, analyze and adjust our response efforts, based on what I’m seeing and hearing in the field. Welcome any feedback you are hearing from your constituents and seeing when you are home. Thank you again for inviting me to testify before you on efforts within ASPR to support the COVID-19 response. I look forward to answering your questions, working with the team at ASPR and our colleagues across HHS, to end the pandemic. Thank you.

Thank you very much to our witnesses. We will now begin a round of five-minute questions of our witnesses. I, as always, ask my colleagues, please keep track of your clock and stay within those five minutes. The FDA’s emergency use authorization of the Pfizer vaccine for children 5 to 11-years-old is really a big step in the pandemic response, that will make 28 million children eligible to receive a vaccine. Given the spread of variants, getting kids vaccinated is really critical to protecting them, while also protecting our educators and our parents and other caregivers. Dr. Woodcock, I wanted to ask you, can you describe FDA’s thorough review of scientific evidence in making this decision, as well as your advice to parents who are hesitant to get their children vaccinated?

Yes, certainly. The FDA first reviewed the manufacturing of a new dosage form, because the children need a lower dose. That was very carefully reviewed, as well as the stability of the new dose, to make sure that it was appropriate. Then, all the data on the children were reviewed at the patient level. In other words, we went to the raw data and re-reviewed that and made sure that the evidence that was presented to us accurately reflected both the data on effectiveness, on efficacy, on the immune response and on safety.

We looked at all the adverse events, to make sure that they were properly reported and that we understood the magnitude of those events. So, in this trial, where thousands of children received the vaccine, ages 5 to 11, we saw mostly very mild to moderate flu- like symptoms. Primarily after vaccine. Or sore arm, which people can expect after getting a shot. But, we did not see any serious adverse events and the vaccine was over 90% protective. So, we feel very confident, along with all the adolescent data that we have on this vaccine and all the data and administration to adults, that this vaccine is safe and appropriate for children. It will protect them from severe COVID.

Thank you. Dr. Walensky, this morning, OSHA released an emergency temporary standard, to protect workers against COVID-19. This is a critical step to reducing workplace transmission and making workplaces safer nationwide. Especially for our frontline workers, who are at high risk of COVID-19. Can you just speak to us, from a public health perspective, about the urgent need to get more Americans vaccinated and the importance of implementing measures to protect people from infection in higher-risk settings like our workplace?

Yeah, thank you so much. We’ve had 745,000 deaths from this disease and we’re continuing to have about 75,000 cases, every single day. We know the most disruptive thing in a workforce is to have a COVID outbreak and to have workers in that workforce come down with COVID infection, severe disease and in some cases, death. Vaccination, as we have seen, decreases your risk of infection by sixfold. Decreases your risk of hospitalization and death by tenfold, even during this Delta surge. So, there is absolutely a public health priority, to get people vaccinated and to continue the important prevention and mitigation strategies, including masking, to keep them safe. Thank you.

Thank you. This is a question for the whole panel and I don’t have much time left, but I would use my Chair prerogative to ask all of you, because it’s an issue we are all concerned about. Senator Burr mentioned it. That is the issue of testing. We know diagnostic testing is critical, but we have continued to experience critical challenges with testing. Shortage of rapid tests, not enough locations to get tested, supply chain issues and more. So, I’d like to ask all of you, quickly, to respond. What is your agency doing to make sure our country is well equipped to handle current and future testing needs? I will begin with Dr. Walensky.

Yes. Thank you so much. So, we are working with states and jurisdictions, to make sure we can provide technical assistance on how best to utilize these tests. This is important in the school districts as well, $10 billion in school districts, to utilize testing. We provide technical assistance as to how to utilize it and peer-to-peer, school-to-school advice on how best to utilize the testing program. As well as the hiring of school nurses, in order to use the testing program.

Thank you. Dr. Woodcock?

We have streamlined, recently, our standards and approach for over-the-counter tests. So, as I said in my testimony, so that we hope they should get out more quickly, we prioritize testing where there’s a public health need. Which, right now, is the over-the-counter tests. We also try to move very quickly those manufacturers that can make large supply of tests, because there is still an unmet need there. We think, we have authorized 11 over-the-counter tests and expect more to come, between that and what ASPR is doing, that the supply should increase rapidly.

Miss O’Connell?

Thank you, Chair Murray. We’ve invested $3 billion in the last two months, on increasing production and supply of rapid point-of-care and at-home tests. 1 billion of that focused exclusively on at-home tests. So, we continue to try to get those out. We also, through HRSA, started a pilot program, which would provide free at-home tests through their federally-qualified health centers. So, for those families that aren’t able to afford the test in the pharmacies, this would allow free access.

Dr. Fauci?

Dr. Fauci: (45:53)
Yes, thank you. Madam Chair. The NIH is prioritizing the development of affordable at-home tests, through a program called the Independent Test Assessment Program, or ITAP, which we will provide reliable, independent laboratory and clinical tests to the FDA, for the manufacturers, so that they can scale up quickly. If the tests meet the FDA’s performance and quality standards, the FDA, hopefully, will then give an emergency use authorization. So, we’re providing data for the companies to be able to expedite the availability of tests that are rapid, efficient and point-of-care.

Thank you. Senator Burr?

Sen. Burr: (46:36)
Thank you, Chairman. This question is directed at Doctors Fauci and Walensky. In January, an NIH study found that 95% of people who had recovered from COVID had at least three out of five components needed to recognize the virus up to eight months after infection. In August, Israeli researchers found that the natural immunity can confer longer-lasting and stronger protections against infection, severe disease and hospitalization resulting from the Delta variant.

Sen. Burr: (47:06)
Rockefeller University found that, while vaccination induces memory B cells to evolve over the course of a few weeks, natural infection produces memory B cells that improve for up to one year after infection. This is likely because remnants of the virus remain in the body for longer than a vaccine would, which gives the body more time to adapt to it. I understand that it’s not all black and white. U.K. researchers released studies, results suggesting that fully-vaccinated individuals who had COVID-19 have the highest immunity.

Sen. Burr: (47:39)
Additionally, last week, CDC published a new report that found unvaccinated people who had previously been infected were five times more likely to test positive for COVID-19 than people who were fully vaccinated with an MRNA vaccine. My question is simple, what does the science say about the durability of natural immunity? When can we expect answers on its benefit?

Thank you so much, Senator Burr. The CDC did publish a 96-page paper review in a scientific brief on Friday. I want to be very clear. After review of that scientific brief, the CDC continues to recommend that people who have been previously infected get their COVID-19 vaccine. We know, in our vaccine studies, our vaccine effectiveness studies, with dates certain when people were vaccinated and we can prospectively follow them through our effectiveness studies and our effectiveness cohorts. Through that, we can see the durability with a date certain in vaccines.

The data on the infection-induced immunity, some of which you quoted, are murkier. They rely on retrospective studies, observational studies and studies where we can’t do a prospective study. We are following these people, we are following people who’ve been previously infected in our infection cohorts, but the data and the science are harder. You talked about infection-induced immunity with memory B cells and antibodies, but another arm of the immune system, the T cells, are harder to study and harder to evaluate to try and do this in a commercial-type fashion.

What I would say is, the final study that you cited, which is the study from the CDC, that retrospectively looked at a cohort of people who have been previously infected and those who had been previously vaccinated. As you noted, there was a five-and-a-half-times fold more likely chance of being diagnosed with COVID if you had infection-induced rather than vaccine-induced immunity. That is among the studies that we reviewed that led us to our current recommendations.

Sen. Burr: (49:48)
Dr. Fauci?

Dr. Fauci: (49:49)
Just to add a little bit to that. Senator Burr, the studies you refer to were NIH-funded studies about B cell and T cell responses by NIH grantees. It is true that, as a matter of fact, both from natural infection, as well as from vaccine-induced immunity, you have not only antibody responses, but you have the development and the maturation of memory B cell responses and T cell responses.

Dr. Fauci: (50:17)
One of the goals over the next several months, which are currently being done via grantees, is to determine the clinical correlation between the development and maturation of B cell and T cell responses and clinical effect. We’re looking at that both post-vaccination, post-boost and in individuals who’ve been infected. Hopefully, we’ll get more definitive information over the next several months.

Sen. Burr: (50:41)
Should an individual who has recovered from COVID be exempt from the mandate to be vaccinated, given that they have natural immunity?

CDC recommendations suggests that you have both more durable and robust and known immune response if you are vaccinated after you’ve been previously infected. Those are our recommendations.

Sen. Burr: (51:02)
The children 5 to 11 who have recovered from COVID, should they be vaccine-exempt?

Our guidance continues to recommend that children who’ve been previously infected actually get vaccine. As data are emerging on the impact of natural infection in adults, our data are still even sparser among children.

Sen. Burr: (51:24)
How does the concentration of antibodies in a recovered COVID-positive patient compare to an individual six months after they’ve had a vaccination?

Dr. Fauci: (51:40)
It really varies from study to study. The one thing that we do know that’s very important when you talk about post-infection immunity, is that when you vaccinate a person following recovery from infection, the level of antibodies are considerably higher than post-infection alone. Higher than vaccination alone. So, the best combination of high degree, of laboratory-related protectiveness, is if a person who gets infected and recovers, ultimately gets vaccinated. That looks like the most powerful of the protective responses.

Sen. Burr: (52:21)
Clearly, I understand that from the data. My question on whether a COVID-positive recovered patient should be mandated to take a vaccine. If they’ve not had COVID, then you take a vaccine to boost your immunity level to a certain degree. COVID-positive patients have already done that. I’m just telling you, it’s a hard sale to tell people who have had COVID that they’re now under a mandate, mandate by the federal government, to be vaccinated. I think you’ve got an extremely tough sale to a healthcare professional, doctor, nurse, who had COVID, might have a hesitancy about the vaccine.

Sen. Burr: (53:07)
I look at what ASPR is required to do, to fill in for the healthcare vacancies that exist out there and surge people to it. You start doing this to people, Medicare, Medicaid providers, community health centers, we’re not going to have the people to surge [inaudible 00:53:24] from the healthcare professionals that make a decision. “I had a natural immunity. I’ve got some protection, but I don’t yet believe I need to be vaccinated.” I think we need to think about this. Thank you, Chair.

All right. Senator Kane?

Sen. Kane: (53:38)
Thank you, Chair Murray, and thank you to the witnesses, the ranking member. I’m going to ask about two topics supporting the mental health of our frontline healthcare workers, that has been such a challenge in this time, and long COVID. So, to Dr. Walensky, I’ll address you first. We’ve talked about this before, the pandemic has taken a huge toll on frontline healthcare workers. This committee has come together in a bipartisan way to help pass the Lorna Breen Healthcare Provider Protection Act. Passed the Senate in August and it’s actually being marked up in the House today, the health subcommittee.

Sen. Kane: (54:10)
I’m happy about that. We’re proud to have worked together with folks in this body, to get $140 million of funding for this initiative in the American Rescue Plan. Dr. Walensky, we worked closely with Dr. Breen’s family for over a year. To build support for the work, introduce the legislation, get funding in the American Rescue Plan. We’re encouraged by progress that’s being made on this bipartisan initiative.

Sen. Kane: (54:35)
As the CDC works to implement this bill and use these funds to promote education and awareness campaigns, what can those of us who have worked on this bill, who care very much about this issue, do to help the CDC effectively communicate with our frontline healthcare workers, that there are resources and help available for them?

Thank you so much, Senator Kane, and thank you so much for your leadership in this very much needed bill and these resources. First, let me just give you a sense of the scope of the challenges and the problems that we face. CDC published an MMWR several weeks ago, not just in healthcare, but also in our public health workforce. Half of the people surveyed had more than one mental health challenge in the year prior. A third reported depression, a third reported anxiety, 8% of our public health workforce reported suicidal ideation in the past year.

When we talk about our healthcare workers, yes, we’re hearing about our places that are stressed with COVID surges, but we’re not hearing about our healthcare workers who are left after those surges. Who are taking care of people where amputations are higher rates than we’ve ever had before. Missed cancer diagnoses because of missed care. This is what is impacting our public health, our healthcare workers. Some of these resources are now with NIOSH, so that we can provide them for mental health, for resources, for support, for to research what it is that they need, so that we can provide this healthcare workforce as well as our public health workforce, the resources that they desperately need. I’m very grateful, thank you.

Sen. Kane: (56:17)
Thank you. Dr. Fauci, on long COVID. I’ve had COVID and I’m still dealing with nerve-tingling issues, 18 months after having had it. They’re mild, thank goodness, but others who are dealing with long COVID effects, they aren’t so mild. Fatigue, respiratory, cardiac, other issues. What updates can you provide about NIH research on efforts to better understand the symptoms of long COVID and how to expand treatment options for patients who have this condition?

Dr. Fauci: (56:48)
Yes. Thank you very much for that question, Senator. This is a very important problem, which we take very seriously. At NIH, since our last hearing when you also brought up that very important question, we have now, in full implementation of a program called Recover Program. Which is about a $1.5 billion program, looking at the formation of large cohorts of individuals. To be able to study them from the standpoint of the incidents, the prevalence and, importantly, what the pathogenic mechanisms of symptoms such as your tingling. But, even as you mentioned correctly, so many people have much more severe, in the sense of almost-incapacitating fatigue, sleep abnormalities, a variety of other things.

Dr. Fauci: (57:38)
There’s three components to the program that we’ve just recently awarded. One is a significant amount of resources to the NYU Langone center in New York, which takes the scientific lead for the program. The data collection will be led by Massachusetts General Hospital and Harvard Medical School. The repository for specimens will be led by Mayo Clinic. Since we last spoke, all three of those have now become operable. Hopefully, the next time we speak in a situation like this, I’ll be able to give you some scientific data that resulted from those studies. Thank you.

Sen. Kane: (58:18)
Thank you very much for that answer. I yield back, Chair Murray.

Senator Paul?

Sen. Paul: (58:24)
Dr. Fauci, I don’t expect you today to admit that you approved of NIH funding for gain-of-function research in Wuhan, but your repeated denials have worn thin. A majority of Americans, frankly, don’t believe you. Even the NIH, now, admits that EcoHealth Alliance did perform experiments in Wuhan that created viruses not found in nature, that actually did gain in lethality. The facts are clear. The NIH did fund gain-of-function research in Wuhan, despite your protestations. You can deny it all you want, but even the Chinese authors of the paper, in their paper, admit that viruses not found in nature were created. Yes, they gained in infectivity.

Sen. Paul: (59:07)
Your persistent denials though, are not simply a stain on your reputation, but are a clear and present danger to the country and to the world. As Professor Kevin Esvelt of MIT has written, “Gain-of-function research looks like a gamble that civilization can’t afford to risk.” Yet, here we are again, with you steadfast in your denials. Why does it matter? Because gain-of-function research with laboratory-created viruses not found in nature could cause a pandemic even worse the next time.

Sen. Paul: (59:39)
We’re suffering today from one that has a mortality of approximately 1%, that are experimenting with viruses that have mortalities of between 15 and 50%. Yes, our civilization could be at risk from one of these viruses. Experiments that combine unknown viruses with known pandemic-causing viruses are incredibly risky. Experiments that combine unknown viruses with coronaviruses that have as much as 50% mortality could endanger civilization as we know it.

Sen. Paul: (01:00:10)
Here you sit, unwilling to accept any responsibility for the current pandemic. Unwilling to take any steps to prevent gain-of-function research from possibly unleashing an even more deadly virus. You mislead the public by saying that the published viruses could not be COVID. Well, exactly no one is alleging that. No one is alleging that the published viruses by the Chinese are COVID. What we are saying is that this was risky type of research. Gain-of-function research, it was risky to share this with the Chinese. That COVID may have been created from a not-yet-revealed virus.

Sen. Paul: (01:00:47)
We don’t anticipate the Chinese are going to reveal the virus if it came from their lab. You know that, but you continue to mislead. You continue to support NIH money going to Wuhan. You continue to say you trust the Chinese scientist. You appear to have learned nothing from this pandemic. Will you, today, finally take some responsibility for funding gain-of-function research in Wuhan?

Dr. Fauci: (01:01:15)
Senator, with all due respect, I disagree with so many of the things that you’ve said. Again, first of all, gain-of-function is a very nebulous term. We have spent, not us, but outside bodies, a considerable amount of effort to give a more precise definition to the type of research that is of concern, that might lead to a dangerous situation. You are aware of that. That is called P3CO.

Sen. Paul: (01:01:45)
We’re aware that you deleted gain-of-function from the NIH website.

Dr. Fauci: (01:01:49)
Well, I can get back to that in a moment, if we have time. But, let’s get back to the operating framework and guide rails of which we operate under. You have ignored them. The guidelines are very, very clear, that you have to be dealing with a pathogen that clearly is shown and very likely to be highly transmissible in an uncontrollable way in humans. To have a high degree of morbidity and mortality. That you do experiments to enhance that. Hence the word EPPP, enhanced pathogens of potential pandemic-

Sen. Paul: (01:02:29)
So, when EcoHealth Alliance took the virus [crosstalk 01:02:32].

Dr. Fauci: (01:02:31)
Well, I would love to finish-

Sen. Paul: (01:02:34)
Combined it with WIV1 and caused a recombinant virus that doesn’t exist in nature and it made mice sicker, mice that had humanized cells, you’re saying that that’s not gain-of-function research?

Dr. Fauci: (01:02:45)
According to the framework and guidelines of EPPP-

Sen. Paul: (01:02:48)
Som what you’re doing is defining away gain-of-function.

Dr. Fauci: (01:02:51)
No.

Sen. Paul: (01:02:51)
You’re simply saying it doesn’t exist, because you’ve changed the definition on the NIH website. This is terrible and you’re completely trying to escape the idea that we should do something about trying to prevent a pandemic from leaking from a lab. The preponderance of evidence now points towards this coming from the lab and what you’ve done is change the definition on your website, to try to cover your ass, basically. That’s what you’ve done.

Sen. Paul: (01:03:14)
You’ve changed the website, to try to have a new definition that doesn’t include the risky research that’s going on. Until you admit that it’s risky, we’re not going to get anywhere. You have to admit that this research was risky. The NIH has now rebuked them. Your own agency has rebuked them. But the thing is, is you’re still unwilling to admit that they gained in function when they say they became sicker. They gained in lethality. It’s a new virus. That’s not gain-of-function?

Dr. Fauci: (01:03:41)
According to the definition that is currently operable. You know, Senator-

Sen. Paul: (01:03:46)
The new one.

Dr. Fauci: (01:03:46)
Let’s make it clear for the people who are listening. The current definition was done over a two-to-three-year period by outside bodies. Including the NSABB, two conferences by the National Academy of Science, Engineering and Medicine on December, 2014, March, 2016. We commissioned external risk benefit assessment. Then, on January of 2017, the Office of Science and Technology Policy of the White House issued the current policy-

Sen. Paul: (01:04:23)
Coincidentally, the definition-

Dr. Fauci: (01:04:24)
I have not changed any definition.

Sen. Paul: (01:04:25)
Appeared on the same day the NIH said that, yes, there was a gain-of-function in Wuhan. The same day, the definition appeared, the new definition, to try to define away what’s going on in Wuhan. Until you accept it, until you expect accept responsibility, we’re not going to get anywhere close to trying to prevent another lab leak of this dangerous sort of experiment. You won’t admit that it’s dangerous and for that lack of judgment, I think it’s time that you resign.

Sen. Murray: (01:04:50)
Thank you, Senator Paul. I would like to give the time to Dr. Fauci.

Dr. Fauci: (01:04:54)
Yeah. Well, there were so many things that are egregious misrepresentation here, Madam Chair, that I don’t think I’d be able to refute all of them. But, just a couple of them for the listeners to hear for. You have said that I am unwilling to take any responsibility for the current pandemic. I have no responsibility for the current pandemic. The current pandemic, okay? Number two, you said the overwhelming amount of evidence indicates that’s a lab leak. I believe most card-carrying viral virologists and molecular virologists would disagree with you. That it’s much more likely, even though we leave open all possibilities, it’s much more likely that this was a natural currents. Third, you say we continued-

Sen. Paul: (01:05:44)
You tested 80,000 animals and no animals have been found-

Sen. Murray: (01:05:48)
Senator Paul, please. Senator Paul, the time is deferred. [crosstalk 01:05:50]

Dr. Fauci: (01:05:51)
Third, you made a statement just a moment ago that’s completely incorrect. Where you say we continue to support research at the Wuhan Institute of Virology, which is completely-

Sen. Paul: (01:06:03)
You approved it in August of last year.

Dr. Fauci: (01:06:06)
No, no. Your statement says, quote, I wrote it down as you were writing. “You continue to support research at the Wuhan Institute of Virology.” Which is completely-

Sen. Paul: (01:06:16)
Your committee a month ago said you still trust the Chinese scientists and you still support the research over there. You said it a month ago in your committee.

Sen. Murray: (01:06:22)
Senator Paul, I have allowed Dr. Fauci to respond. You’ve had your time. I’m going to give him one more minute.

Sen. Paul: (01:06:27)
If he’s going to be dishonest, he ought be challenged.

Sen. Murray: (01:06:29)
Senator Paul, we will allow Dr. Fauci to respond after you’ve given accusations like that. Dr. Fauci?

Dr. Fauci: (01:06:35)
Well, I don’t have any more to say, except to say that, as usual, and I have a great deal of respect for this body of the Senate and it makes me very uncomfortable to have to say something, but he is egregiously incorrect in what he says. Thank you.

Sen. Murray: (01:06:50)
Thank you.

Sen. Paul: (01:06:52)
History will figure that out on its own.

Sen. Murray: (01:06:54)
We will turn to Senator Hassan. Thank you.

Sen. Hassan: (01:06:57)
Thank you, Madam Chair and Ranking Member Burr. I want to thank all the witnesses too, for being here today and for your work. I want to start with a question to Assistant Secretary O’Connell. Last month, I sent a letter to Health and Human Services Secretary Becerra, highlighting the difficulty that some [inaudible 01:07:15] have faced in accessing COVID-19 rapid tests and urging the secretary to take action. These tests are essential tools to help ensure that people can stay safe, kids can stay in school and we can keep our economy open. So, Assistant Secretary O’Connell, what will the department do to address the issues raised by my constituents in New Hampshire, about access to COVID-19 rapid tests?

Ms. O’Connell: (01:07:42)
Senator Hassan, thank you so much for the question. Of course, thank you for the letter. Your letter raised two key points. One, the amount of time it was taking for some of your constituents to get the results. The other was the lack of the over-the-counter tests in New Hampshire. So, we responded to both, the ASPR testing team reached out to the state health official to understand the delay and learned that the average turnaround time, right now, is about 1.1 days.

Though it sounds like your constituents had some different experiences. We’ll continue to watch that. The second issue was about the lack of over-the-counter tests. The team reached out to Abbott and they have now secured the 60,000 tests that New Hampshire has ordered. They will come in 10,000 increments for six weeks. So, you should have 60,000 tests in New Hampshire by Christmas.

Sen. Hassan: (01:08:33)
Thank you very much. I appreciate that. I know my constituents do too, especially parents of school-aged children who want to get those results quickly so the kids can get back into the classroom. Dr. Fauci, as I think probably some colleagues have already noted, but I wanted to talk about the availability of vaccines for younger children. I think all families in New Hampshire were relieved when the Food and Drug Administration and the Centers for Disease Control signed off on Pfizer’s COVID vaccine for children ages 5 to 11 last week. At a hearing earlier this year, I asked when you anticipated that vaccines would be available for children of all ages. You told me that you thought vaccines would be ready for children of any age by the end of the year. Do you still anticipate that vaccines will be available for children under age five by the end of the year?

Dr. Fauci: (01:09:27)
I don’t know. When you say available, Senator, that’s the difference between the clinical studies that are done to show the data. Currently, as we are speaking now, the age deescalation studies are part of a spectrum. One of the spectrum was what you’ve just heard of, 5-to-11. The data were convincing, you’ve heard of the results from Doctors Woodcock and Dr. Walensky. The studies are ongoing now, from six months up to two years. Two years to five years. I would anticipate, I would’ve hoped that the data might be available by the end of-

Dr. Fauci: (01:10:03)
I would’ve hoped that the data might be available by the end of the year. I would say, and again, it’s very difficult to make predictions, because you don’t want to get ahead of the data. And you don’t want to get ahead of the FDA’s analysis-

Senator Hassan: (01:10:13)
But you’re thinking… I’m just trying to get a sense of timeline.

Dr. Fauci: (01:10:16)
Yeah. I would think it might be towards the beginning of the coming year or the end of this year, I hope.

Thank you very much. Right. Dr. Woodcock, I wanted to shift to another issue, because of course, while we’re dealing with the pandemic, we also continue to deal with the opioid epidemic. I recently sent you a bipartisan letter about the consulting firm, McKinsey, which simultaneously worked for both opioid manufacturers, such as Purdue Pharma, and for the FDA on a variety of projects, including a track and trace system to monitor dangerous prescription drugs. The FDA response to my letter stated that McKinsey never disclosed these potential conflicts of interest, and that the FDA only learned about them earlier this year, nearly a decade later, through media reports. McKinsey’s work for Purdue Pharma was made public in a major news story last year, and McKinsey issued a public apology for its actions last year as well. So why wasn’t the FDA aware of McKinsey’s work for Purdue last year when it was front page news and McKinsey was speaking publicly about it?

Dr. Woodcock: (01:11:22)
Well, at least speaking for myself, I was aware of that. At that time, McKinsey was only doing consulting work of a administrative nature for the FDA. And so there was nothing that had to do with any product or any standard or anything like that. It had-

Doctor, I’m sorry to interrupt, but I’m almost out of time. I just want to point out that they were consulting on a track and trace system to monitor dangerous prescription drugs. That your response to my letter also says that since finding out about McKinsey’s work for Purdue quote, “No additional contract reviews or outreach to McKinsey has occurred.” So because my time is about to, or has expired, I will follow up with you and the FDA. It seems to me, we have a major conflict of interest between McKinsey’s work for McKesson and Purdue. At the same time, it was working for the FDA on track and trace system. And it’s something we really have to get to the bottom of it, because I think it helped fuel the opioid epidemic, which has devastated my state.

Happy to work with you.

Thank you, Madam Chair.

Senator Murray: (01:12:37)
Thank you. Senator Collins?

Senator Collins: (01:12:39)
Dr. Fauci, first let me make clear that I believe in the efficacy of vaccines and have encouraged my constituents to become vaccinated. But I’m hoping you can explain what appears to be a contradiction when I look at the data for the state of Maine. Maine ranks in the top five states in the percentage of people who have been vaccinated. In fact, 95% of those over age 65 have been fully vaccinated. And yet, Maine has the 15th highest confirmed deaths from COVID on a per capita basis. Our hospitals are overwhelmed. We’ve seen a 6% increase in hospitalizations, 18% increase in people in the ICU, a 37% increase in people on ventilators recently. And while it’s largely individuals who are unvaccinated, there are some that are breakthrough cases, and all of us know individuals who, despite being fully vaccinated, have experienced COVID. Can you explain to me why a state that has done a terrific job in getting people vaccinated is seeing this surge in cases that is overwhelming our hospitals and causing great fear and pain and loss?

Dr. Fauci: (01:14:33)
Well, thank you for that question, Senator. Well, first of all, I think you did say something just a moment ago that I think is part of the explanation. You said that most of them are among people who are unvaccinated. However, and it’s quite true, that there are breakthrough infections, because no vaccine is 100% protective. And you will always get breakthrough infections. In general, for the most part, breakthrough infections for people who have been vaccinated, all other things being equal, are usually less severe, don’t lead as much to hospitalizations, and don’t lead to as much as death. The data though, in general, as was mentioned, I think specifically, the numbers that were given by Dr. Walensky, are incontrovertible, that a vaccinated compared to an unvaccinated person, has a multifold less likelihood of being infected, a multifold less likelihood of being hospitalized or dying. So I think there are probably confounding, multiple factors going into the difficult situation that your citizens in your state are going through. But there’s no doubt that the vaccines, clearly much, much better in the sense of protecting you from infection, hospitalizations, or death compared to the unvaccinated.

Dr. Walensky, parents, teachers, and pediatricians have all talked to me about the learning loss, the emotional and behavioral health problems that have occurred among children due to their not being in school. And in contrast to the quarantining option, the test to stay approach allows asymptomatic students who test negative for COVID to remain in school rather than quarantining after another student or staff member has tested positive for the virus. A Lancet study shows that case rates were not significantly higher at schools that use the test and stay approach versus schools that require students to miss school and quarantine at home. And indeed, your home state of Massachusetts has adopted a test to stay strategy.

Brown University professor Emily Oster has expressed great frustration with the CDC as being slow to take a stronger position in favor of test to stay, asking, “What evidence are they waiting for?” She says school quarantine should end and be replaced with test to stay or nothing. Another public health expert said simply, “It’s madness to quarantine school children.” The CDC policies hinder learning and provide no meaningful reduction in COVID transmissions. My question for you is why doesn’t the CDC issue guidance or recommendations to encourage school districts to adopt test and stay in order to avoid these highly disruptive quarantines of students who are asymptomatic and could be tested?

Dr. Walensky: (01:18:14)
Thank you, Senator. Thank you for that question. When you and I spoke in this room, or in this venue, in July, we shared the priority of getting our children back to school. I’ve said it’s the first place that should be open and the last place to close. In that context, we have studies just this school year that have demonstrated that we have 96% of our schools open, for which I’m very pleased. And still, we have 4% of schools, over a million children, who’ve been impacted by COVID related outbreaks. And those schools have had to be closed. Our data also demonstrate that our prevention measures have been working. In schools that are practicing the prevention measures, including masking, they’ve been three and a half times less likely to close because of a COVID related outbreak than those who have masked. But your question is important.

These are new data out of the UK that have demonstrated this new test to stay strategy. That is a strategy after a child is exposed in a classroom, that they stay in that classroom with sequential tests every day, every other day, to demonstrate that they are negative so that they can stay in school. We have updated our frequently asked questions, that this is a promising practice, and we’re actually working with local jurisdictions now to demonstrate the domestic data here in the United States. That this practice works, it’s safe, it’s effective. It gets our children back to school. And importantly, we recognize that jurisdictions are actually doing this, and other jurisdictions may want to. And in that context, we’re doing peer-to-peer matching of schools that are interested in doing the test to stay practice and having them talk to schools that are also doing it so that they can use the implementation strategies that a school has already used. So we’re actively studying this so that we can provide the data on it working, and we’re actively encouraging it as a promising practice. Thank you.

Thank you.

Thank you. Senator Smith?

Senator Smith: (01:20:06)
Thank you, Madam Chair and Ranking Member Burr. And thank you so much to our panelists for being with us today. So I just want to start by highlighting that we have made major are steps forward in getting Americans vaccinated. Vaccine requirements are working, I believe, to encourage people to get these highly effective vaccines. We’re also seeing progress with children. It is great news and a big deal that children age 5 to 11 can now get their shot. So clearly we have more work to do, but this is progress. So I’d like to spend my time focusing on the trajectory of this pandemic and what normal is going to look like going forward. Starting out, it seems to me that people thought of COVID 19 as something like polio, for example, where we could develop a vaccine. And then we could control, or even potentially eradicate, this disease.

Now, it seems that COVID 19 will be more like an influenza, an infection that will recur for the foreseeable future, though hopefully with less and less severity. So Dr. Fauci and Dr. Walensky, can you help us understand how we should be thinking about the path of this pandemic over the next couple of years? Dr. Fauci, understanding that we don’t have crystal balls and this is an unpredictable virus, what do you think the next six months to two years are going to look like? And do you expect that COVID is going to become more endemic and less pandemic as we move forward? And what does this mean for how people are going to be living their lives?

Dr. Fauci: (01:21:38)
Yeah. So let me just put a very brief perspective of it, Senator. When you think about pandemics, you’re in the pandemic phase. And then you have a deceleration phase. Then you have a control phase. Then hopefully you’ll have elimination and maybe eradication. I think eradication is out. We’ve only eradicated one virus in history for humans, and that’s smallpox. We’ve eliminated certain infections by very good vaccination programs, such as eliminating polio from the United States, eliminating measles, except for some pockets of under vaccinated group. So what we’re really to talking about is control, and control has a wide bracket. You could have it under control, where you have enough infections in the community where it isn’t a pandemic phase, but it still is interfering with what we would like to get back to, what we used to know as normal. What we hope to get it as it’s such a low level, that even though it isn’t completely eliminated, it doesn’t have a major impact on public health or on the way we run our lives.

Dr. Fauci: (01:22:42)
We would hope that as we get people more vaccinated, not only in this country, but throughout the world, that the level of viral dynamics will be so low. I can’t predict for you today when that will be. Because as we see, we now have a situation, we’re entering the winter. The good news is we’re continuing to come down, and hopefully we’ll go further and further down, but what happens globally will impact us. So if we get more people vaccinated globally and more people vaccinated now, hopefully within a reasonable period of time, we will get to that point where it might occasionally be up and down in the background, but it won’t dominate us the way it’s doing right now.

Thank you for that. I appreciate you bringing in the issue of global vaccination rates and how that affects our health here at home. And I hope, Madam chair, that this is a topic that we can devote a little bit more time to in this committee, because I think it is very salient to our work to protect Americans. Dr. Walensky, let me turn to the question of data and metrics. You and I had a great discussion last week about what is the most useful data to track the course of this pandemic as it evolves and how difficult it is for people to assess their own relative risk, especially now that we have a vaccine that provides such strong protection against serious disease. So Dr. Walensky, in this phase of the pandemic, what are the best metrics for us to pay attention to? For example, should we be paying more or less attention to positivity rates, case rates, or should we be paying more attention to breakthrough infections that cause serious illness and hospitalization, more like we track influenza outbreaks for example?

Yeah, thank you for that question and for that conversation earlier this week. We’ve been thinking a lot about what an endemic phase looks like and with the data that were needed to during that phase. Certainly, right now we are collecting data on cases, hospitalizations, deaths. We know that not all of our case data is 100%, because not every rapid test is being reported. And importantly, as we do with flu, we collect death data. We collect hospitalization data. We absolutely need to know how our healthcare systems are doing, and we absolutely need to know how deadly a flu season is. We also collect data on influenza-like illness, what is presenting, and we’re currently collecting data now on COVID-like illness.

So we are working towards those metrics of what we need. Some of them are already… In fact, all of them are already collecting, and the question is what are going to be our best metrics moving forward, and probably modeling it on flu. The other metric that I think is critically important is vaccination rates. And one thing that we haven’t really touched on, just in this conversation, but we are absolutely working on and doing much better, is our race and ethnicity data, our equity data. Because if we are not following how we are doing in these communities with regional and ethnic minorities, we are not going to understand the impact of this pandemic on all of the communities in this nation. We’ve actively worked on making sure that those are up to speed as well. Thank you.

Well, thank you. Thank you very much. As we move forward, I think it is crucial that we are tracking the right metrics so that Americans have a useful understanding of relative risk and better understand the steps that they can take to limit their own risk. Just as you say, including these vaccines, that work, that are safe, and that save lives. Thank you.

Thank you. Senator Braun?

Senator Braun: (01:26:15)
Thank you, Madam Chair. First question will be for Dr. Fauci. I was watching the interchange between you and Senator Paul, and that is always entertaining. And I think what I’m interested in today, because it was back on May 26th that we had a hearing. And what’s happened at the Wuhan Institute of Virology, there’s a debate out there. And it’s not clear what happened. And the thing I remember at the tail end of our conversation, because the merits of the case, either way… Senator Paul makes it one way. You make it the other way. Eco health comes into play in terms of what happened there. Transparency, and you were on record as saying you like it, you love it, you believe in it.

I pressed you that day, well, on something I’ll get to in a moment. But what about releasing all the information that you do have under your control? Because I think as long as the American public can’t see it, with all the mystery surrounding what happened in terms of its origin, and I think then you said, well, you could maybe suggest it to President Biden on declassifying information when it comes to the subject I’m going to get to in a moment. Will you agree, liking transparency to get all of the information out there, as it relates to the origin, so we can all see it, here in the Senate, across the country.

Dr. Fauci: (01:27:47)
Thank you for that question, Senator. I have always been, am now, and will always be very, very much for total transparency in everything we do. So as far as I’m concerned, what you’re saying resonates very strongly with me. I do want to make one point, because it gets confusing to people. One of the things that’s very, very clear, irrefutable, that the NIH funding of grants in Wuhan and the viruses that were discussed, including the viruses that Senator Paul mentioned, would be molecularly impossible to have resulted in SARS-CoV-2. And that sometimes gets conflated.

Dr. Fauci: (01:28:31)
When they talk about your funding research there, where people can argue about the definition of gain of function or not. I gave you the process whereby that definition was established. But what gets confused and conflated is that any of the card carrying molecular virologists will tell you, that not withstanding the debates about definitions, the funding by the NIH of the grant and the viruses that were worked on, could not possibly have turned into SARS-CoV-2, because there are evolutionarily so distant that nothing anybody could have done could have done that. And I really feel I need to say that. But getting back to your question, I’m all for transparency-

I’m talking about, so has all the information, period, been released that pertains to that subject? Because that looks like it would be under your control to do that. So isn’t out there publicly?

Dr. Fauci: (01:29:33)
I’m not sure exactly what you mean by all the information. But I can tell you, anything that is under my control, that is legally able to be released, I am all for 100% releasing. I promise you that.

Well, we’re going to make sure that all of that is out there, because one of the most difficult things about this whole navigation is that there are varying opinions. Not everybody is going to agree with you. We’d like to see it so we can sort through it, where other experts look at it and the American public. Now, let’s get back to the whole housing that we have within our own departments. Josh Hawley and I had a bill that passed by unanimous consent through the Senate to declassify that information. And again, you said you were for transparency. You were hesitant about that not being your bailiwick. Is that something you would want to go on record with, to advise the president to get that declassified, so that we can see it, the American public can see it. And that was discussed, and you thought you might be willing to do it back on May 26th. Do you want to publicly say do it?

Dr. Fauci: (01:30:53)
To be quite honest with you, I don’t really know when you say, classified information, what information are you referring to? Because the NIH, the information that we involved with, is not classified at all.

No, this would be stuff that we hold within our intelligence departments. Senators have been able to look at it. It’s not been released. Department of Homeland Security, that’s not. Not what you house within the NIH. And that is you being the main advisor to the president on this issue, why wouldn’t you say declassify it so we can look at it?

Dr. Fauci: (01:31:31)
Well, I would have to find out, Senator. When you’re talking about classified information, that’s certainly above anything that I do, because I want to reiterate for the record, that the NIH does not do any classified anything. Everything we do [crosstalk 01:31:46]-

All 100 senators were for doing it. Many of us had the ability to look at it. You or others, Dr. Walensky, it may be a big deal to do it. Real quickly, thank you for those answers. I got a question about, and this is aimed at Dr. Walensky. What about the importance of therapeutics? And I asked you this back on May 26th. Where is that in the whole journey, in terms of having another tool, and prophylactics as well? Because there’s a lot, all of us acknowledged that a vaccine was a miracle to get. You’re seeing where you’re running into some that simply won’t get it. It’s hard for me to imagine that you’ll vaccine the rest of the world. When do you put the same amount of enthusiasm on the other two tripods of the stand to actually put every tool in the tool chest, aimed at getting rid of this, or at least treating it?

Thank you, Senator. I’m absolutely for using therapeutics, but I think they should be used after we use vaccination, because vaccination… Certainly, we have seen that the therapeutics that are out there, the remdesivir, the dexamethasone, the molnupiravir is a promising new therapeutic that Dr. Fauci just mentioned a few minutes ago. All of those would be at after you’re infected. They prevent. They work to prevent severe disease and death. They’re not foolproof. So, certainly my first tool in the toolbox would be for vaccination. And then, of course we would need testing, because most of these therapeutics actually work best, especially the oral one, the molnupiravir, work best if you can give them early. So I do think we need as many tools in this toolbox as possible. I would also say that the best public health intervention here would be vaccines.

You’ve said that before, and thanks for reiterating.

And Senator, you are over your time.

I just ask you to put that same enthusiasm and speed behind the other things that might be out there to help us. Thank you.

Thank you. I’m going to go vote. As senators know, a vote is open. The next two senators will be Senator Murphy and Senator Murkowski. I hope to be back by the end of that.

Senator Murphy: (01:34:01)
Thank you very much, Madam chair. Thank you to all of you for your service to this country during an incredibly trying time. I thought the Senator Collins line of questioning deserved a follow up. She asks a good question. She says we’ve got high vaccination rates in Maine, and so why do we still have so many deaths? But I think it’s important to sort of step back and look at the national data here. I’ll direct this to you, Dr. Walensky. I was looking at a survey of national data that was published, now back in the spring, so it’s a few months old.

But in it, it suggested that if you look at the 10 states with the lowest rates of vaccination versus the 10 states with the highest rates of vaccination, it’s black and white. You are four times more likely to be hospitalized if you live in one of those states with the lowest rates of vaccination. You are five times more likely to die if you live in those states. And so each individual senator will have their own experience, but tell us what the story is now that we have will lots of variation amongst states when it comes to vaccination rates, and what that tells us about your likelihood to ultimately end up in the hospital or end up dying from COVID.

Thank you for that question, Senator. So yes, we have about 75,000 cases a day right now, and there are states that are highly vaccinated, and they’re still having cases that Senator Collins has commented on. This is going to be very local, very community-based. This virus is an opportunist. It is rapidly transmissible. And if you have communities that are under-vaccinated, even if a state averages at 70%, this virus is going to go to those communities. Importantly, we have actually looked during the Delta surge at three states with high vaccination rates, Connecticut being one of them, and three states with lower vaccination rates.

And we can see, even just in this Delta surge, just since June, that the death rates in the under vaccinated states, in the states with vaccination rates that are 10, 20% lower than the highly vaccinated states, the death rates are five to tenfold higher. So we absolutely can see the impact of this. There are cases that occur in vaccinated people. They, for the most part, don’t lead to death. Sometimes they do, but for the most part, they don’t. These vaccines are preventing disease. They are preventing, tenfold, more likely to be hospitalized. If you are unvaccinated versus vaccinated, 11 fold, more likely to die if you’re unvaccinated versus vaccinated.

I think Senator Collins’s question was a good one. And I’m glad to get the true story of what the overall national data is here, because it’s compelling. But there are other senators who are deliberately trading in just dangerously false information. It’s stunning that the misinformation about COVID is not just coming from purveyors of propaganda online. It is often coming from our colleagues here in the Senate. I was on the floor a few weeks ago, listening to Senator Johnson who suggested sort of transparently that there was a correlation between those who got vaccinated and post vaccination deaths, noting that 5,000 deaths were reported on the adverse event system happened one or two or three days following a vaccination, suggesting that there was a correlation. I’ll ask this to Dr. Walensky, is there any increased risk of death to individuals who get a vaccine? Is there any data to back up the claim that Senator Johnson was making, that there’s some correlation between risk of death and vaccination? Isn’t it exactly the opposite?

For COVID, it is in fact, exactly the opposite. Our vaccine adverse event system collects all deaths after vaccination. That means if you were hit it in a motor vehicle accident and succumb to that event, that would be reported in our vaccine safety system. Clearly, that is not a causal effect from a vaccine. And yes, these vaccines are working to prevent death from COVID 19. And what I would just say, when people ask me all the time what they can do, what Congress can do, what senators can do for us as a country, for me at the CDC, it is to encourage your constituents to get vaccinated. Thank you.

One of the things I hope this committee will work on, in the middle of this pandemic and following, is health literacy, is helping Americans understand where good sources of medical information are and where the dark spots are, where you’re listening to political actors who have their own agenda, not one based in science. And I think this is, frankly, a place where Republicans and Democrats can collaborate, because I think we have found a general lack of health literacy during this pandemic. But it was a problem that existed beforehand. And so while it pains me to know that some of our colleagues are the purveyors of this misinformation, it’s a project that probably should be able to be bipartisan moving forward. I appreciate you all being here. Thank you, Mr. Chair.

Speaker 1: (01:39:17)
Senator Romney?

Senator Romney: (01:39:18)
Thank you, Mr. Chairman. I appreciate your service and the information you’re providing this morning. Just following up on Senator Murphy’s question. There is a perception that side effects adverse effects from the vaccine are not being gathered, that they’re not being made available to the public. Are the side effects and adverse effects, dr. Walensky, being captured? Are they available to the public? Is there a place we can go to see what the likelihood is of various side effects based upon getting a vaccine?

We have the most robust vaccine safety system than we have ever had in this country, in the roll out of this vaccine. Our vaccine adverse events reporting system, as Senator Murphy just described, has over 600,000 reports publicly available. We have a new V-safe system, which is developed specifically for the COVID 19 vaccine program. It uses a text message system, web surveys, to get people to provide their symptoms after they’ve been vaccinated. It includes over nine and a half million people and over 12 million health surveys. We have a pregnancy registry where we survey pregnant women. We are getting their information during their vaccine, after their vaccine in their first trimester. We call them in their second trimester, their third trimester, after their baby is born, and at three months. We’ve registered over 5,000 women in that. And we have over 24,000 who have been contacted. And we have a vaccine safety data link, which is collaboration with our academic institutions, which includes over seven and a half million people who initiated vaccination. This is the most robust vaccine safety system that’s ever been documented.

And where might the public go to see what the probability is of various side effects or adverse effects from the vaccination?

On our CDC website.

Thank you. Appreciate that. Dr. Fauci, a number of us are concerned about mandates, obviously. The question, I sent you a text just to prep you for the question, but the question in this regard is, if we do have a mandate… And I’m thinking now of the mandate for private companies. If we do have a mandate, will it save lives? And is there an estimate of the number of lives that might be saved by virtue of having our private companies that have over 100 employees, either having their employees receive a vaccination or get a weekly test? If that occurs, will it save lives? And do you have an estimate of the number of lives that might save?

Dr. Fauci: (01:41:51)
I have a very firm and confident answer to your first question, Senator. And I don’t have one of your second. But let me just explain very briefly. We know that vaccines absolutely save lives, and we know that mandates work. If you look at, for example, the percentage of people in United Airlines or in the Houston Medical Association, or in other organizations that have mandated, it works 99 plus percent. For example, with United airlines. So if you take the fact that mandates work and vaccines absolutely save lives, the answer to your question is, yes, it does save lives. What that number is, you’d have to do modeling, Senator, that I don’t have in front of me right now, to determine when people get vaccinated in a certain area, what is the chance of their having gotten infected? And given their underlying condition, what’s the chances of their having died or not? That information can likely be modeled, but I don’t have that for you right now.

Yeah. I would think that given the information you do have, if you extrapolate from the information you have, as to where mandate have been imposed, such as United Airlines, and you apply it, you can calculate what the number of lives saved might be. I would think that would be helpful for me and for others who are concerned about mandates. We’re also concerned about lives lost and protecting human life. We also had a question from Senator Kaine about the long haulers, if you will, the long COVID. How serious are these long haul cases and what proportion of those that have COVID? Do you have a sense? Do we know the number? What proportion of those that have had COVID are subject to, if you will, serious long COVID conditions?

Dr. Fauci: (01:43:45)
A very good question, Senator, that we are now actually finding out more definitive data. There have been a number of published papers from different, smaller cohorts. We’re now putting a massive cohort study. And among the smaller of cohorts, it ranges from 10 to up to 30, 35% of people have varying degrees of prolonged symptomatology following the so-called resolution of the acute disease. Some of them can be relatively minor, but some of them can be incapacitating. For example, there are some individuals who have truly incapacitating fatigue. Where they were pretty healthy, athletic, and then following COVID, they never get back to their baseline. There are sleep disturbances. There are a thing called brain fog, which can be very disturbing to people where they can’t focus or concentrate. So the spectrum is wide. It can go from something that just is modestly bearable to something that incapacitates you. And that’s the reason why we have this study right now, looking at it, that’s about a $1.5 billion investment to try and sort that out.

I know my time is up, but I would just note that it would be helpful for those of us that are concerned about-

Just note that it would be helpful for those of us that are concerned about our children or grandchildren, to have a sense, not just of the number of deaths associated with COVID in children, but also the number of long COVID cases, severe long COVID cases because it would be my estimate that that probably substantially exceeds the number of deaths among young people. That information I think would be helpful for parents and grandparents like myself. Thank you

Senator Hickenlooper

Senator Hickenlooper: (01:45:30)
There we go. Sorry about that. Once again, I want to thank each of you for, not just for your testimony today, but for all the work that you have done over this entire, and it is a campaign. It’s very similar to a war. We’re seeing a COVID surge right now in Colorado that has led to emergency capacity issues in our hospitals. That’s not just in certain parts, it’s pretty much across the state. Just about 80% of those in the hospitals are unvaccinated. Dr. Fauci, I guess my question, my first question would be in a state like Colorado where we have made real progress, I mean great strides in vaccination rates, how should we be thinking about this recent surge? Just that it’s still the tail of the unvaccinated?

Dr. Fauci: (01:46:35)
Yeah. Yeah. That is not unexpected when you get into, for example, the situation where the weather starts to get colder, and people do things more indoor, but as you said quite correctly, when you see surges, they are very, very heavily weighted towards the unvaccinated. Not only in the incidence of infection, but also in the incidence of severe disease that might lead to hospitalization. I believe that’s a pretty obvious type of an explanation for that, which is the reason why we continue to push to get as many people vaccinated as we possibly can.

Senator Hickenlooper: (01:47:15)
Right. Dr. Wolinsky, I thought that Senator Romney’s comments about his children and grandchildren, and I think soon, if not already his great-grandchildren, that’s what we’re seeing more questions every day. And so, this week’s vaccine approval for five to 11-year-olds, I think one question we’ve heard is how is that going to affect this rising, this increase in infection rates? How do we do everything we can to make sure these kids get vaccinated of those who want to be vaccinated?

Yeah. So thank you, Senator. First, let me go back to Senator Romney’s question on percent of children who get long COVID. We’ve had about 1.9 million children between the ages of five to 11. We’ve seen a long COVID rate in those children of about 4.5%. It’s less than adults, but it’s still high and it’s still… We should note it. We’ve also seen in that demographic 5,000 cases of MISC this multisystem inflammatory syndrome that can be devastating. We’ve had 46 deaths from MISC alone, and nearly a hundred children in the demographic between ages five to 11. We have a lot of work to do to reach out to our pediatricians, to reach out to our parents, to make sure that we have the communication, the education, the information that parents need.

This is a new vaccine to them. They’ve perhaps received the same Pfizer vaccine themselves, but for their children, it’s a new vaccine. One thing I think is really important and is probably worth grounding people on is we have a lot of vaccine-preventable diseases for our children now, varicella, hepatitis A, meningococcus, just to name a few. The death rates from varicella are about 16 per year before vaccination, for hepatitis A, about three per year, for meningococcus about eight per year. The death rate for COVID in this age demographic was 66.

Wow, very sobering. I am fully aware of the high levels on vaccinated kids in certain, especially in certain geographic areas. My son, Teddy, who’s now off at college, but when he had just turned four months, he was about to get his second whooping cough shot, and he got infected by an unvaccinated kid who we were… Well, it’s about the most terrified. It’s the most terrifying experience I think I’ve ever been into where you just can’t stop him from coughing, and you’re in a hospital, and you have to blow oxygen on his face to try and shake him out of the coughing. It’s absolutely terrifying. It was amazing. It took us a long time to get a doctor to diagnose it because, at that point, we were just beginning to see whooping cough again because everyone was in the habit of getting their children vaccinated, and suddenly that changed. Ms. O’Connell, I also worry that the recent surge is further stretching the situations around our frontline workers after already the last couple of years, tremendously difficult. We hear that in Colorado. Is that happening across the country as well?

Senator, yes. Thank you for that question. We have sent 27 different teams out to augment hospitals that were overrun by COVID patients, about 600 team members to 12 different states, so we are seeing that.

Great. How do we address burnout among healthcare workers? What advice can you provide?

Well, we’ve been happy, of course, to go in and help where we can, but we know that we’re not the sustainment. One of the things that the American Rescue Plan provided was funding for the public health workforce. And so, we’re continuing to look for ways to invest in a long-term public health workforce to support these first responders and healthcare workers that are burned out and worn out from this pandemic.

Wow. Again, I’ll just finish by saying thank you to each of you. One of the most amazing things to me as a scientist who recognizes the importance of data, that your ability, and your vision to start collecting data from the very beginning, and make sure that we take the lessons that we learn in this situation, where so often people are making decisions without enough data, is really going to inform our pandemic preparedness and help this, not just our country, but the world as we go forward and battle, not just this virus, but the others to come. Thank you.

Thank you.

Yield back.

Senator Tuberville.

Senator Tuberville: (01:52:10)
Thank you very much, Madam Chair. Thank you for being here today. I know it’s hard work and you need to get back to work. You know, in my former job I had to win games and in your business, we got to win and right now we’re not winning John Hopkins University just made a report last week that this year we’ve lost 353,000 people. And to this point last year, that’s how much we lost the entire year. It’s a little perplexing that we’ve got two vaccines, boosters, and we got masks and all that. We still got to win. We got to win this fight. I mean, I think everybody understands that. I recently wrote an [inaudible 01:52:59] talking about how we need an all above approach. We need every tool in a toolbox to be used, been talking to doctors all over Alabama. We’ve had a tough problem.

They’re very upset that they don’t have the freedom to treat like they should have the freedom to treat. They’re being told by officials in their hospital that they can’t use certain drugs such as ivermectin or whatever. They know that it works. That’s what they tell me. I’m not a doctor. Monoclonal antibodies, we ran out in Alabama because for some reason we’re starting to ration those in the last few months. I think I could ask all of you what you think about monoclonal antibodies, and I think you’d all say, to some degree, they work, but this specific question is for Ms. O’Connell. I want to ask you this. Congress gave money through the Cares Act to help with the development of production of therapeutics. Within three months of being in office, President Biden’s administration decided not to buy, or they declined to exercise contract options on monoclonal antibodies.

Now, I know you weren’t there at the time. They inherited these contracts from the Trump administration. Those decisions caused a shortage, especially for us in Alabama. At the same time, the Biden administration was ramping up monoclonal production as we’re trying to get back to it, HHS turned and gave $142 million non-compete contract to an accounting firm to market these treatments to the public. The administration hired KPMG to promote a therapeutic that the government stopped buying. That makes no sense. I looked at the website and my son and I could probably put it together for $10,000. We paid $142 million. I’m just asked you, Ms. O’Connell, I understand that HHS is currently reviewing this. I just would hope that you would commit to reprogramming some of that money to monoclonal’s if there’s any left. Could I get a commitment on you for that?

Senator, thank you so much for the question. We have seen a change in the monoclonal landscape when the Asper therapeutics team began looking at the distribution models in February, a lot different than we experienced during the Delta surge. A 20-fold increase in demand for monoclonal’s. We went to a state distribution system. And so, you’re absolutely right. It’s time to reevaluate whether we need this distribution help to get to the harder hit communities. That review is underway right now. I’m expecting a memo any day with the team’s recommendations on whether to keep that funding going.

Thank you. We just need to get more of them. I know we’re trying to do that, and we’re all trying to do our best, but we just got to try to do it the right way. Dr. Fauci, you talked a lot about gain of function research and whether or not the US funded it. I’m not a doctor. I’m not a scientist, so I’m not going… I’m going to just ask you straight forward here. What kind of biological research is China actually conducting, as we speak, that we know of?

Dr. Fauci: (01:56:20)
Yeah. Well, right now, when you say China, China is well beyond the Wuhan situation. There’s research that goes on collaboratively with the United States, not only with NIH but with any of a number of organizations, including the CDC where have Chinese researchers. The funding that goes on right now that was just mentioned with Dr. Paul, we are not funding the Wuhan Institute anymore. That’s for sure. I can’t testify to the scope of research that goes on beyond what the NIH.

So, the WHO, they don’t communicate with us because we’re paying them four or $500 million.

Dr. Fauci: (01:57:03)
Yeah.

Surely the goodness, they have something to do with what China’s doing.

Dr. Fauci: (01:57:07)
Yep, for the most part, the research that comes out of China, if you look at the things over the years, I’m talking, not in this capsule of period where it’s all focused on China, anti-China, I’m talking about decades of collaboration, particularly in the arena of influenza and other diseases. There’s a lot of research going on. I don’t think I can tell you what all the research is going on because I don’t have eyes on all the research.

Are we communicating with them though, somehow some way with China?

Dr. Fauci: (01:57:38)
Well, yeah, we communicate a lot with them. Certainly, there’s been a lot of stress and strain right now when you talk about the Wuhan situation, but our colleagues in Shanghai, our colleagues in Beijing, we communicate with them all the time. The Chinese have a very, very fine centers for disease control and prevention modeled against our own CDC. Our CDC is in very good collaboration and cooperation with them.

I just think that if they had let us in early, that we may have not been in this situation, maybe the world in this situation that we’re in. I hope you would agree with that and they just kind of shut us off.

Dr. Fauci: (01:58:15)
No, absolutely. We want to find all the information we can, and the NIH and the entire HHS has been very much in favor of all transparency and getting to know all the information of what’s going on in China. We’re all very much in favor of that. We want more transparency.

Thank you.

Thank you. Senator Casey.

Senator Casey: (01:58:35)
Chair Murray, thank you. I would ask first, unanimous consent that the statement from the Alzheimer’s Association and Alzheimer’s Impact Movement be submitted for the record.

Without objection.

Thank you, Chair Murray. I wanted to start with Assistant Secretary O’Connell, about in particular the hospital preparedness program. It’s a program I’ve long supported aggressively and so many others have as well. For those listening, this is a program that supports hospitals and other healthcare facilities, and the providers who work at those facilities, in preparing for public health emergencies. As we all know, COVID 19 has taxed the healthcare system like never before, and at various points in the pandemic as surges have hit communities across the nation at different times. These hospitals and ICUs have been overrun with patients, most recently as a result of the Delta variant. So, Assistant Secretary O’Connell, I’ve got three questions. First, what role have the local healthcare coalitions, which are the core element of the program, what have those coalitions played in responding to the surges and hospital admissions?

Senator, thank you so much for that question. You’re absolutely right. The HPP program that you referenced is the only federally funded program to help healthcare systems and hospitals prepare for emergencies It’s critical and we’ve seen it play a significant role in this pandemic response. The local coalitions were very important because as we were seeing hospitals overrun with COVID patients, they were able to work with their coalition members to move patients to ICUs that actually had beds, so we did see that play a significant and important role.

Second question is, are you planning any after-action review to incorporate lessons learned from the pandemic with regard to the hospital preparedness program?

Absolutely, Senator. One of the things as I’ve been out in the regions, meeting with local leaders and coalition leaders, I’ve seen there’s been an uneven use and success of the HPP program based on regional strengths, based on state situations. I think one of the things I’d like to do as we look at lessons learned, is figure out how to have a more uniform, successful model for the HPP program.

How about the third question, How about goals for the program in the near-term?

Well, a couple of things that we’ve learned in the near-term, the need to secure PPE within healthcare systems and coalitions. We have also learned the value of telehealth and how important it was for systems to be ready to do some care remotely. We’re going to take these near-term goals and begin applying them for longer-term preparedness.

I appreciate those answers. I wanted to move to Dr. Wolinsky on a broader question about public health infrastructure. One of the challenges in the response has been building the systems that we need to track information necessary to manage everything from hospital capacity, and ICU bed availability, to critical medical supplies, vaccine components, you know the long list that that is. The concern, of course, is that we’re going to reach a point where we all start saying the pandemic’s over and we move on. We’ve got to finally, at long last, invest in our public health infrastructure. How would you leverage any tool that we have now, especially the existing data systems that’s been created for COVID 19, to ensure that we’re prepared for the next major public health emergency?

Yes. Thank you so much for that question, Senator Casey, My hope and I’m grateful for the support to date for long-term disease, agnostic, public health infrastructure investments that are bipartisan so that we don’t find ourselves in this situation again. We need to be prepared for this, for any pandemic to come, and we need to get out of the current pandemic. As you know, this is multi-pronged in my view. We need a public health workforce that is upskilled, that is trained, that is diverse as the communities from which they come. We’ve lost 60,000 jobs in the last decade and thousands more since the pandemic started. We not only have to work to rebuild that public health workforce but actually to skill up in ways that can be empowered to prevent the next pandemic. Laboratory infrastructure is going to be key. We’ve built up genomic sequencing. Now we’re doing tens of thousands a week. This was something that we weren’t even doing much of prior to the beginning of this pandemic, but we again need the workforce.

We need the machinery. We need the tools and the collaborations with our public health labs in order to place these all across the country. And then, of course, you note data monitorization. We absolutely need interoperable data. We’ve been able to scale this up enormously over the last year during this pandemic. We have tens of thousands of electronic health records that we’re now accessing in a HIPAA compliant way, where we were doing just a hundred before this pandemic. It needs to be interoperable and we need to invest in it. To get a full-scale hospital system up on Epic, for example, is over a billion dollars for a single health system. So, when we scale that nationally to what we need for our public health workforces across all of our states, and territories, and tribes, and localities, the investment is so very needed. Thank you.

Thank you, Doctor.

Thank you.

Thank you, Madam Chair.

Thank you, Senator Cassidy.

Senator Cassidy: (02:04:43)
Thank you all for being here. Dr. Wolinsky, a couple of things. As I walked in, I came in late, one of either you or Dr. Fauci was saying that the reason that we’re not saying that natural immunity is protective as is a vaccine, even though there’s recent publications showing that six to eight months out, 92% of those with natural immunity have T-cells, B-cells, and antibodies that would be considered adequate to protect, and indeed B-cell continues to climb, that we don’t and have data. Now, in your response to Mr. Casey, you just mentioned that CDC has access to tens of thousands of EHR’s. I’ve been told that HHS or CDC has access to patient identifiable data, as to who test positive. I do that as a prologue. If we don’t know that natural immunity confers protection against future infection, it’s because we’ve decided not to look because I’ve learned that there is a cohort of people that we know have been previously infected. We’ve got the bench research showing that the triad of antibodies T-cells and B-cells are there and that 92% of them are still there at six months out, so why have we not done the research showing that natural immunity confers protection against recurrent infection?

Yeah. Thank you so much for allowing me to clarify this point because I understand the question. First of all, let me just reiterate that our current stand after reviewing 96 papers and the scientific brief on this issue, is that everyone who’s been previously infected should be vaccinated.

But that’s not my question.

Right. Agreed. Part of the challenge here is, as you know, the infection-induced immunity and the biases associated with retrospectively looking at the data, several of those papers that we reviewed for that brief, have demonstrated that the kind of disease that you had at the time you had it matters. Did you have disease a year and a half ago? Did you have… Were you an older person?

Can I stop you for a second? We could do this prospectively because you know who is actually, apparently, I’m told you’ve got patient identifiable data, and you would be able to say okay, six months ago, we’re going to start everybody infected within the last six months, and be able to follow their EHR prospectively to see this. I mean, theoretically, CDC has the ability to do this right now.

Yeah. That too would have its own biases. One of the things that we have demonstrated in the scientific brief is that asymptomatic and mildly symptomatic people who might not present to their providers might present to an urgent care clinic, who might not be recorded in their own EHR, likely have less robust protection than those who’ve been severely infected.

But that could be established prospectively if using the data that you have, and you could even say, if you had symptomatic infection, you don’t need to be vaccinated. We would consider you immune. You don’t have to be subjected to the mandate.

If we had data that demonstrated a correlation of protection, Dr. Fauci already mentioned data that they’re working on to look at correlates of protection, not just in antibodies, but as you noted in T-cell function as well. So, if we were able to document a correlate of protection, we absolutely could prospectively follow.

But this paper that I’m reading from NIH, speaks that there is durable memory of the virus up to eight months after infection, in 95% of the people who recovered, including B-cells, which continue to climb, T-cells, and antibody. I’m also saying you could do it clinically because we have data that’s patient identifiable, that we could go back and look and see if they were exposed. They could be in a hotspot like Louisiana, where you know they’re being exposed, and then you would see. Not just by lab data, but empirically I can tell you the American people intuitively understand this, and they feel a little bit like we are being willfully blind to it. I have limited time. Let me just ask you something else. What percent of CDC employees are vaccinated?

We’re actively encouraging vaccination in all of our employees, and doing a lot of education, and outreach in order to get our agency fully vaccinated.

But the percent?

I don’t have that for you today.

I’m told that 75 to some north of 75% of CDC employees at headquarters are still working remotely. Is that correct?

We are following regulations through HHS and the federal government.

No, that’s not my question. I apologize to be rude, but I’m asking a very straightforward question. I’ve been told that north of 75% of employees that at CDC headquarters are working remotely. Is that correct?

Senator, I don’t actually know the number off the top of my head, so I’d have to-

When you look down the hallway, are there empty desks? Are over 50% of the desks empty?

Senator, I don’t have the numbers off the top of my head. What I will tell you is that we’re working closely within HHS and the administration to follow the governmental rules for return to work.

There’s a recent GAO report that shows, and was released in the last two weeks, that there’s been no coordinated response from the federal government to get people back into work. Now, if there’s any agency that, since we have teachers in Fulton county are back at work, that the caseload of COVID in Fulton county is about 88, at its peak, it was 606, if what I’ve been told by someone who, frankly, kind of knows, that people in laboratories are not showing up. I have no clue how laboratory workers who presumably are vaccinated, wearing PPE, would consider themselves eligible to stay at home. I say this because I just want to echo, we got to lead by example in the federal government. If our public health agencies don’t have enough confidence in the immunization, and in the PPE to go back to work fighting infectious diseases, there’s going to be a lot of undermining of a willingness to further fund public health.

We absolutely have our essential labs back at work conducting their essential research towards this response. We are following the regulations, and providing technical assistance, and technical support to the federal government for return to work policies.

One more thing. I had asked, Angus King and I had sent a letter dated February the 25th, asking about genomic surveillance. We’ve still not received a response. You referenced it in your early remarks. Both Senator King and I would appreciate a response.

We’ll get back to you. Thank you very much.

Thank you. I yield.

Thank You. I’m going to go vote. The next four senators I have in my order are Senator Baldwin, Marshall, Rosen, and Murkowski. I will return.

Senator Baldwin: (02:11:18)
Thank you, Madame Chair. We’re here today to discuss the road ahead on the pandemic response. I fear that that road will be a rocky one if we forget the lessons that we’ve learned thus far, particularly when it comes to our ability to make critical supplies like PPE in this country. A New York Times headline this summer declared, I quote, “A glut of Chinese masks is driving US companies out of business.” In response, I joined several of my colleagues in writing to the US Trade Representative, Catherine Tai, to urge her to let tariff exclusions on Chinese PPE expire. The US Trade Representative is currently weighing that decision. One reason these Chinese masks may be so cheap is that they are counterfeit, some of them. In fact, the FDA has pulled emergency use authorizations from several Chinese mask manufacturers, so I’m pleased that Asper plans to use the Defense Production Act funds to procure masks and the raw melt-blown material needed to make N95’s from domestic sources.

I worked to include that funding in the American Rescue Plan. However, government procurement can only support so much American industry. To retain a strong base of medical supply manufacturers and to reduce our reliance on foreign manufacturers as a whole, we need to prevent dumped and knockoff Chinese PPE from driving American manufacturers out of business as well. First, Ms. O’Connell, are you concerned about the practice of dumping PPE from China, undermining the ability of domestic manufacturers to remain competitive in the US? And if so, have you conveyed these concerns to the US Trade Representative?

Senator Baldwin, thank you so much for this important question. We do participate in an inter-agency process where various departments have had the opportunity to share our support. So yes, we have conveyed.

Okay. Dr. Woodcock, the FDA has revoked authorizations for certain Chinese masks. Are you concerned that increased reliance on Chinese PPE will threaten the safety of the US healthcare workers? And if so, have you conveyed that concern to the US Trade Representatives?

Yeah. Well, I can’t answer the last part of your question. I don’t know. I will look into the US Trade Representative. We are concerned about lower quality PPE coming from anywhere. We have, of course, put in import alerts. We have chased down and identified suppliers who have sent in counterfeits. We have tried to do recalls throughout the United States to get these off the market. We are interested in increased authorities because we do not have seizure authority for devices and several other authorities that we have been talking to staff about that would improve our ability to interject these counterfeits.

Thank you. For Dr. Wolinsky, throughout the pandemic, we’ve heard about how gaps in the clinical and public health workforce have significantly hampered our response. In particular, we’ve long faced significant recruitment and retention issues among infectious disease, clinical workforce, and with health professionals who conduct outbreak preparedness and response activities. As this committee considers policies to better prepare for the next pandemic, I’m more working to introduce the Bio Preparedness Workforce Act with senators, Colin, Collins, Rosen, and Murkowski, which would create a new provider loan repayment program focused on encouraging students to pursue careers as infectious disease clinicians and bio preparedness professionals. Dr. Wolinsky, as an infectious disease physician and public health leader, I know that this issue is particularly important to you, and can you share your perspective on some of the serious workforce challenges I mentioned, and how proposals to bolster this workforce might make a difference in responding to future outbreaks?

Thank you so much for those efforts for your support and for that question. We know that about 80% of people leave medical school now with debt. About half of those actually have undergraduate debt as well. The debt for an average medical student is about $215,000. In terms of going into the field of infectious diseases, it is one of the lowest paying fields for all of medicine, all of the subspecialties. In fact, in most hospitals, if you are an infectious disease provider, versus a generalist, your salary is less as an infectious disease provider. If we are going to bolster the public health workforce with infectious disease physicians, this kind of support will be essential.

Thank you.

Speaker 2: (02:16:52)
[inaudible 02:16:52]

Senator Marshal: (02:16:52)
Thank you, Mr. Chairman, and thank you for being here this afternoon, or this morning. 11th hearing, this is the 11th hearing that this committee has had on the COVID pandemic. We had all, of course, hoped that we would be well beyond this, but instead we are well in the middle of it, and we see it changing. I talk to folks back home and they really wonder aloud, what’s the path out of this. Right now, my state is we’re four times the national average, in terms of number of positive cases. Our hospitals are still overwhelmed. For the past month, we have been number one in the country. Nobody wants to be number one here and we’re going into the winter season. It’s kind of discouraging right now. We’ve talked about the strength of the vaccines that have been developed through Operation Warp Speed, but I think everyone would acknowledge that the pandemic that we encounter in March of 2020 is different than where we find ourselves today with a Delta variant.

Senator Marshal: (02:18:07)
We’re talking about vaccine hesitancy, very, very real in my state. We still don’t have a highly effective vaccine that is stable without refrigeration, or a nasal, an oral vaccination option. I’m worried that we are prioritizing vaccine technology that may not necessarily be feasible to bring this pandemic to a close globally. And so, a question to you, Dr. Fauci, and then to you, Dr. Woodcock, do you think, Dr. Fauci, that what we have today, the existing vaccine technology that’s currently authorized by FDA, is truly sufficient to bring us out of this pandemic, not just the United States, but globally? And what then, is the administration doing to support and to accelerate development of the next phase of vaccines that could offer longer and broader immunity to the COVID19 and, of course, all of its variants?

Dr. Fauci: (02:19:17)
Thank you for that question, Senator. First, the vaccines that are currently available, particularly the ease of use of the mRNA and the extraordinary effectiveness of both the Moderna and the Pfizer’s RNA, are if properly utilized, we believe would have a much, much better control of this outbreak as we have right now. But to your specific question, we are also supporting the development of other platforms of vaccines. For example, the soluble protein, recombinant protein together with an adjuvant, is something that traditionally has been vaccines that have used in other diseases and have much less stringent require-

Dr. Fauci: (02:20:03)
… other diseases and have much less stringent requirements for cold chain and other things that might logistically get in the way of getting it more widely distributed. In specific answer to your question, even though we have very effective and very safe vaccines that are being implemented now, we’re not stopping there. We’re making investments in the development of other platforms, some of them are already well on their way.

Sen. Murkowski: (02:20:27)
But I think it’s important to hear that because I think part of what we’re dealing with with this vaccine hesitancy is people are saying, “Well, okay, you got your vaccine. And believe me, I got my vaccine and I got my second vaccine and I’ve now gotten my booster.” And I’m hearing from people that are much more hesitant than I, it’s like, “Well, if you’re going to have to keep getting one of these every six months, how really effective is that?” Dr. Woodcock, let me ask you, I’ve spoken to some researchers that are working on these next generation of vaccines. They’ve told me that FDA is not prioritizing new vaccine technologies now, but rather they’re focusing on therapeutics and existing vaccines. Is this accurate and can you speak to that?

Well, the group that regulates therapeutics is different than the group that regulates vaccines within the FDA. They’re not competing within each other. As far as vaccines, we have been prioritizing the ones we could get out immediately because of the public health emergency. However, I think there will be new forms of vaccines. As Dr. Fauci said, there may be new vaccines that don’t require the cold chain. Manufacturers may be able to modify the current vaccines to what are called lyophilized formulation that doesn’t require refrigeration. That would be good.

And people are looking at different types of vaccines such as oral, nasal and so forth. It’s just taking longer. I don’t think the FDA is not standing in the way of that development. It is the fact that the tried and true platforms are easier to get a new vaccine up and running, and we had to do that in the middle of this emergency to get things done as quickly as possible, but certainly, there’s a lot of research going on in additional vaccines and FDA’s not impeding that.

Sen. Murkowski: (02:22:28)
Mr. Chairman. I have additional questions that I’ll submit to the record. I would certainly hope that we’re going to have an opportunity to hear a little bit more from the administration though about the mandates that have been put in place, this newly released emergency temporary standard from OSHA. I think these are areas where when we’re talking about vaccine and vaccine hesitancy, we need to be talking to those who are putting in place some of these standards that in my state are causing an extraordinary issue and problem within our workforce.

Sen. Burr: (02:23:13)
Senator Rosen.

Sen. Rosen: (02:23:13)
Thank you, Chair Burr. And of course, Chair Murray and Ranking Member Burr, thank you. And I want to thank ever everyone for being here today and for your lifelong commitment to saving lives and protecting us. It is something that people don’t realize as you go into these careers, what the motivation is and I thank you for that.

Sen. Rosen: (02:23:33)
I want to talk a little bit today about the supply chain, because as we’ve seen throughout the pandemic, American… our reliance on just in time supply chain for essential goods, especially emergency medical supplies, it really leaves us vulnerable to critical shortages. When we were experiencing acute shortages of essential supplies like masks and gowns, many small manufacturers in the United States, while they stepped up to change what they were producing to meet this public need, like Polar Shade, a Las Vegas company that switched from making window coverings to PPE during the crisis. My office heard from a number of companies looking for federal guidance to receive technical assistance on quality standards where the essential goods were needed most, but there was no system in place to handle this type of situation.

Sen. Rosen: (02:24:26)
That’s why I introduced with Senator Cassidy, the bipartisan Strategic Planning for Emergency Medical Manufacturing Act. It’s going to create a voluntary domestic backup manufacturing network, a process for manufacturers to plan ahead, prepare, receive this guidance and federal contract opportunities before a disaster strikes, so they’re ready to go when needed. And of course, we heard from Senator Baldwin about people dumping supplies that are not quality. Ms. O’Connell, how did the gaps in our domestic supply chain, how do they hinder COVID… the initial response last year and what gaps remained today? And can you… I want to work with you on advancing a bipartisan solution to strengthen our networks.

Senator Rosen, thank you so much for this important… for bringing up this important topic and I would really look forward to working with you as well. When the pandemic first started, we experienced something where the whole world wanted and needed the same supplies at the exact same time, and many of them were being made overseas. In that time, thanks to a lot of funding that’s come from Congress, we’ve been able to invest a billion dollars in various domestic manufacturing efforts.

Now, that doesn’t fill all the gaps yet, but we’re continuing to look at various projects and send money out the door. One of the things we’re doing that I think you’ll be interested in is creating a domestic warm base. We’re starting to see and we experience that even at some phases in the pandemic where demand for certain supplies increased and then immediately decreased, and what we need is to have this warm base. We, for example, are putting out a statement of interest in having 140 million N95s capacity to manufacture those per month and having that warm base capacity, we’re investing $115 million in that effort. We’re trying to fill some gaps and we’re continuing to look for opportunities.

Sen. Rosen: (02:26:33)
Great. I look forward to working on that with you and Dr. Fauci in that same vein, where we had critical supply shortages as we think about PPE and other things, what about critical supplies of equipment and things for our research labs? How does that impact our ability to do the research, to advance the latest treatments and how can we overcome those challenges? We had reagents, I know, that we were trying to get, a lot of different things.

Dr. Fauci: (02:27:01)
Yes, that is an issue in some circumstances, Senator, where we have certain reagents, as you mentioned, that are not immediately available because of supply chain issues and that’s the reason why we get concerned when we have supply chain interruptions, which could impact what we do at NIH, which is research.

Sen. Rosen: (02:27:21)
Well, thank you. I hope… look forward to working on that and Dr. Walensky, testing, testing, testing. It’s the key to moving forward through a lot of this, whether you have vaccination treatments or not, we need robust testing. And a lot of people can’t pay for the out-of-pocket. The turnaround be slow. What support is the federal government providing to help states increase their ability to have fast, reliable, and free testing when it comes to labs and staffing that is critical for our economy, people to go back to work?

Absolutely. And we’ve been working very closely with states and jurisdictions in order to roll out testing, free testing, and free testing support. We are working closely with states and schools. We’ve rolled out $10 billion thanks to you in the American Rescue Plan to provide testing in schools and importantly, personnel, school nurses as well as the technical assistance as to how… and toolkits for our schools as to how we use these tests, where best to use which tests, and then peer-to-peer school advisors. If a school wants to roll out a testing program, how you might do that and how they might work with another school to understand what the challenges are and how to overcome them.

Sen. Rosen: (02:28:29)
Yes, schools are key. Well, I see that my time has expired. Thank you all again. Appreciate it, and Madam Chair.

Sen. Murray: (02:28:36)
Thank you, Senator Marshall.

Sen. Marshall: (02:28:37)
Thank you, madam Chair. I want to start by asking unanimous consent to submit several documents. The first are 40 publications that support natural immunity, 40 publications. The next I want to submit is CDC briefing that Dr. Walensky was kind enough to bring to our attention. It was dated October 29th of this year. Science Brief: SARS-CoV-2 Infection-induced and Vaccine immunity, and want to call to everyone’s attention as the CDC points out here, the immunity provided by vaccine and prior infection are both high, but not complete.

The immunity provided by vaccine and prior infection are both high, but not complete. And for now, the last, what I’d like to submit is something, the CDC’s MMWR Release, Volume 7, October 29, 2021 Laboratory-Confirmed COVID-19 Among Adults Hospitalized. Along with that, a review by Dr. Martin Kulldorff as well as some comments from some 20 physicians. I ask just to look at the study, just with concerns about that particular study.

Sen. Murray: (02:29:51)
Without objection.

This morning, I’d like to focus on immune versus non-immune as opposed to conflating those who have natural immunity plus the vaccination. I will give you, there’s some studies that would support some benefit to giving a vaccine to those who are already immune from natural immunity. I give you that, but the issue today I want to really lock in on is natural immunity versus vaccination immunity.

We could have a frank debate, I’m sure, all day long about the pros and cons. And I would think that if we were given the lecture to our medical students, we would probably say the jury’s still out and here’s all the information and the data, and I think that’s why we have physicians to be able to look at this data and look at this particular person’s medical history about, do we feel the benefits of this vaccine outweigh the risk.

And Dr. Walensky, I just… My question for you is going be, are you so convinced that this data is so much in favor that the vaccine by itself is better than natural immunity by itself? Are you so inclined to give that advice to the White House and separate the Navy SEAL that I talked to yesterday from the military? A young, healthy Navy SEAL, he’s probably got, oh my goodness, if he gets COVID, a one out of a million chance of having a serious hospitalization, at the same time, he has a 50 out of a million chance of getting heart swelling, which knocks him out of being a Navy SEAL at least for six months and probably forever.

Are you so convinced that the data is so compelling that natural immunity isn’t as good as vaccination? Again, don’t conflate the two together. Are you so convinced that the nurses I worked with in liberal… when this epidemic was roaring, the union worker at Wolf Creek Nuclear Plant that kept the electricity on months ago that we held as heroes, that now, we’re going to punish them and separate them from the job. We took an oath to do no harm. Are you so convinced, is the data so compelling that you think that’s what we should do?

Thank you, Senator, for that question. First, let me just go back to the initial point, which I don’t want to conflate them, but let me just say, I think the studies are uniform that vaccination after…

That’s not my question.

Right, I understand.

That’s not my question.

I want to make sure that we correct the record because I do believe that you said some-

We that three times.

I think that’s uniform. If we’re looking at infection-induced immunity versus vaccine- induced immunity, and we did transparently put a full review of the literature that’s out there, 96 studies. I think if we were talking to our medical students, we would tell them that we do not have a correlate of protection. We can’t measure whether you are protected or not. And we do know by virtue of the fact that our vaccine-induced immunity studies know for certain a date that we can follow what those correlates of protection are in effectiveness studies and we don’t have the capacity, not only do we not have a correlate of protection and an antibody-

I apologize. I need to move on. I apologize. Next, I want to submit for the record, ask unanimous to consent, first of all, there’s an email from Peter Daszak dated July 11, 2016. It says, “Dear Jenny, this is terrific. We’re very happy to hear that our gain-of-function research funding pause has been lifted.” Our gain-of-function funding pause has been lifted, along with of course, the studies that go along with that. Dr. Fauci, who reviewed the grant proposal? And this is, of course, the one that’s in the news. 1R01AI110964, project title, Understanding the Risk of Bat Coronavirus Emergence. Who reviewed the grant proposal? Who made the decision that the grant would not be subject to the pause of gain-of-function? Who came up with the language allowing exemptions to be made? Was it the awardee or EcoHealth?

Dr. Fauci: (02:33:55)
Senator, I’m not so sure what you’re asking. Did you say that I do that?

No, I’m asking who. Who would make that type of decision?

Dr. Fauci: (02:34:05)
As to what?

Who would decide to make a pause in the bio gain-of-function decision for this particular research policy, this research request, again, from EcoHealth that’s dated 5-27-2014, that Peter Daszak would respond, “This is terrific. We’re very happy to hear that our gain-of-function research funding pause has been lifted.” Who would make that decision?

Dr. Fauci: (02:34:32)
I think conflating the words gain-of-function research pause, the question is it was asked of the trained staff at the institute if this research would fall under the pause for gain-of-function, and it was determined by trained staff that it did not, because at that time, there were two components of guardrails. There’s the guardrail of prior to 2017, which is whether or not an experiment is designed to enhance the transmissibility or the-

We understand that. We’ve been through the-

Dr. Fauci: (02:35:11)
No, well-

So that didn’t rise to your level?

Sen. Murray: (02:35:14)
Senator Marshall, your time has expired. We have two additional senators plus closing remarks-

I think these are very important questions that America would like to know the answer to.

Sen. Murray: (02:35:23)
And if you could submit them for the record, we could get a-

Will you commit, Dr. Fauci, to answering our questions that we’re going to submit for the record?

Dr. Fauci: (02:35:31)
We always answer questions that are submitted to the record, of course.

Thank you.

Sen. Murray: (02:35:35)
Thank you. Senator Lujan.

Sen. Lujan: (02:35:39)
Thank you very much, Chair Murray and Ranking Member Burr. And I very much appreciate my colleagues’ comments and attention to ensuring maximum vaccination in the United States, especially ensuring all American children who are eligible get vaccinated. Because of that line of questioning, I’m able to turn my attention in another area that has been talked about a bit today, but I hope we can dig a little deeper.

Sen. Lujan: (02:36:10)
Although the United States is making progress vaccinating people, I’m concerned about the low level of vaccination in low and moderate income countries. For interconnected border states like New Mexico, our physical and economic health depends on international cooperation. Much of the world remains unvaccinated and that puts Americans’ health and prosperity at risk. Though 49.6% of the world’s population has received at least one dose of COVID vaccine, only 3.7% of people in low-income countries have. And yet in the United States, 15 million vaccines have been thrown away since March 1.

Sen. Lujan: (02:36:49)
Dr. Fauci, I appreciate your comments to Senator Smith on this topic, and again, I’d like to dig in a little more. Dr. Fauci, do low vaccination rates concentrated in parts of the world allow COVID to spread unchecked?

Dr. Fauci: (02:37:06)
Yes, Senator. And that’s the reason why, as I’ve stated publicly very often, that a global pandemic requires a global response because when you have vaccine dynamics that are rather robust in countries that are under-vaccinated, then what could conceivably happen may be likely, certainly there will be mutations and sometimes mutations aggregate to the point that they lead to a new variant, which would be of concern particularly if that variant has the potential of evading the vaccines that we already have.

Sen. Lujan: (02:37:41)
Dr. Fauci, you anticipated both of my follow-up questions, which were asking about the concerns with new variants and evading vaccinations that are currently available. Now, I opened this question up to the panel, yes or no, do low vaccination rates in large swaths of the world put the United States health and economic recovery in jeopardy? Dr. Walensky?

We absolutely need a global response. I think that the line is no one is safe until everyone is safe.

Sen. Lujan: (02:38:10)
Dr. Fauci?

Dr. Fauci: (02:38:11)
Definitely, yes.

Sen. Lujan: (02:38:13)
Dr. Woodcock?

Yes.

Sen. Lujan: (02:38:17)
Ms. O’Connell?

Yes.

Sen. Lujan: (02:38:18)
Dr. Woodcock, the more attention that is brought to this area, my question is what more can be done or can we be doing in the United States to ensure countries have the data they need to approve vaccinations in country? During a recent visit with other colleagues, we found out that some countries had not yet approved vaccines that were available across the United States in many parts of the world.

Well, we post as much information as we can. We post our reviews, which have a large amount of information. The material that goes before the advisory committees is all posted. And also, we participate in an international collaboration called ICMRA. That often, I’ll be on a call, there’ll be representatives from 90 to 100 different countries. It’s only regulators, and we talk about the challenges and how we can overcome them, and specifically as a vaccine area. The FDA is very happy to collaborate to the extent we can, by law, with any country, to help them with the regulators and getting information that they need.

Sen. Lujan: (02:39:34)
You said something very key there that the FDA’s happy to work with others as long as the law allows. And one of the areas that I’m very interested in pursuing is what is not allowing the United States to fully work with other countries in this space. The United States has actively engaged in international efforts like COVAX and other regulatory harmonization efforts, but the reality is that low-income countries remain largely unvaccinated.

Sen. Lujan: (02:40:01)
While the amount of discarded vaccines is a small percent of vaccine doses successfully administered, each wasted dose represents a missed opportunity to protect the health of a person and stop the spread. And so, how can we maximize that? I’m very interested in pursuing what is standing in its way, how can we increase those efforts, what’s required for us to work with countries so that they have a rapid response ready to go. I learned that that exists in Ecuador, even in areas of indigenous communities where they’ve proven that if they can get the vaccine, they can get into people’s arms relatively efficiently.

Sen. Lujan: (02:40:39)
And so, Madam Chair, I want to be respectful of my other colleagues. I’ll submit the remainder of my questions into the record. I want to thank each of the experts that are here today and I look forward to working with each and every one of you to get more people vaccinated and stop the spread of COVID. Thank you so much.

Sen. Murray: (02:40:53)
Thank you. Senator Moran.

Sen. Moran: (02:40:56)
Chairwoman, thank you. You and Ranking Member and witnesses, thank you for joining us now this afternoon. First, Dr. Walensky, I’m interested in learning what the administration’s plan may be in regard to vaccination mandate. Just days ago, you signed off on the emergency use authorization for pediatric COVID-19 vaccine. The issue of mandates is roiling across the country. And while there are many parents who are interested and willing to get their young children vaccinated, there are also other parents who still question the pediatric use… emergency use authorization and are concerned about a potential federal vaccine mandate.

Sen. Moran: (02:41:46)
I share the concern about federal vaccine mandate. I urged the CDC and the administration against implementing a vaccine mandate for students. Forcing parents to vaccinate their children as a requirement to attend public school would be, without a doubt, a federal overreach. Federal government mandates for children to attend school that would represent an extreme departure from our educational system’s historic longstanding reliance upon local and state control. And in my view, the decision to vaccinate a child should be left to the parent and their trusted physician. It’s a private relationship. The federal government should not be inserting itself into with a mandate.

Sen. Moran: (02:42:33)
Perhaps all that commentary is unnecessary and you can just assure me that that is not what is the next step in mandates from the Biden Administration. And if, just, you can only answer, maybe perhaps you can can’t answer what the Biden Administration is going to do, but what is your thoughts and what would your recommendation be?

Thank you, Senator Moran. I am delighted that this week, we were able to strongly recommend that 28 million children received a COVID-19 vaccine to prevent infection, to prevent severe disease, lung COVID, multisystem inflammatory syndrome, as well as death in the children that we have seen between the ages of 5 and 11. Those recommendations are strong. They are after endorsement of the FDA’s emergency use authorization. Vaccine requirements for schools are left to the local jurisdiction. And so, we will leave those to the local jurisdiction to make those decisions.

Sen. Moran: (02:43:32)
So, Kansas parents who may have concerns about whether or not their children will be able to attend school, that will not be a decision that’s made… without a vaccine, that’s not a decision that will be made by the CDC or the Biden Administration, but remain a local decision to be made by a local board of education?

I will always encourage that parent to get their child vaccinated and speak to them about the information and communication and education that they need in order to get their children vaccinated. Right now, at this moment, those decisions are made at the jurisdictional level as they are for vaccination of other vaccine-preventable diseases among children.

Sen. Moran: (02:44:10)
I felt better when you said… before you said right now, and that just causes me to, again, ask, is there any intention to change that longstanding practice?

Not to my knowledge.

Sen. Moran: (02:44:20)
Thank you. Let me call on Ms. O’Connell. Ms. O’Connell, I’ve been a supporter and seen the value a long time ago as a house member, I offered a Moran 10-Point Plan on saving healthcare costs, of reducing healthcare costs. One of those components is the value of community health centers. And I’d like to give you the opportunity to tell me what it is that can be done, should be done to continue to include those community health centers who have played an integral part in combating COVID-19 that they’re capable, more capable and prepared should there be another pandemic.

Well, Senator Moran, thank you. This is one of the things that you and I have in common, strong supporter of our federally-qualified community health centers, our rural health centers in the program that HRSA runs to support both. We’ve seen the FQHCs play a significant role in distributing vaccine. We’re also running a pilot program right now, which allows them to distribute free at-home rapid tests to families. And I think that’s another important way in which they can contribute to this response. We’re hoping to scale that up by Thanksgiving. Right now, it’s in eight states.

We’ve also been able, through the FQHCs and rural health centers, distribute masks to families that might need them, high-quality masks. And of course, they continue to provide clinical care to families that seek their care there. Continue to see them play a significant role and we’re always looking for opportunities to increase the impact they can have in this pandemic.

Sen. Moran: (02:46:08)
I thank you for that answer. And I want my community health centers to know how valuable they are, not just in a time of a pandemic, but throughout the daily life of lots of Americans. I just visited one in Kansas City, Kansas last week. Again, reminded that they serve a very valuable purpose and a way for those who might not otherwise access the opportunity to have a consultation with a healthcare provider to be able to do so and to make a decision about how to care for themselves and their families. Thank you very much. Thank you, Chairman.

Sen. Murray: (02:46:42)
Thank you. Senator Burr, any closing remarks?

Sen. Burr: (02:46:45)
Thank you, Madam Chairman. To all four of our witnesses today, thank you for the job you do. And more importantly, would you go back to the host of people that are behind you in this work and thank them on behalf of the committee. Dr. Walensky, I didn’t have this on my list today, but the questions have precipitated. Do you really not know the answer to the number of vaccinated individuals at CDC or did you just not want to answer Senator Cassidy’s question?

We’re still actively working on collecting those data and those data are updated in real time.

Sen. Burr: (02:47:20)
Could you provide that for the committee by Monday of next week?

We are working towards updating those data and I would have to speak with my staff about where we are and whether those numbers are going to be available on Monday.

Sen. Burr: (02:47:32)
Dr. Walensky, I just remind you that there’s an executive order in place for all federal agencies that vaccinations for federal workers be concluded by November 22nd. And it says that actual date is November 8th, which is next Monday because disciplinary actions have to begin on November the 9th. If the collection is still in process, how are you going to start disciplinary actions based upon the executive order?

We’re actively updating those data. I just don’t know exactly when they will be fully in, but certainly, we will have those data by the appropriate deadlines.

Sen. Burr: (02:48:12)
Well, if CDC doesn’t have to live by the rules, why should employers have to live by the mandate rules?

As I mentioned, we will actively make sure that we are complying with the rules because we want everybody else to as well.

Sen. Burr: (02:48:22)
Let me ask one last question, because I think what you’ve heard is a frustration by members about confusing messages that go out. It’s confusion when somebody has to be vaccinated though they’ve got natural immunity. It’s confusing when this policy is in place for mask and then over here, it’s changed. And I realize this is an evolving thing. But correct me if I’m wrong, the CDC website currently says that if you have had COVID in the last 90 days and you leave the country and you come back in, you’re not required to be tested before you come to the United States.

Sen. Burr: (02:49:02)
The website says, we recommend that within three to five days of returning to the United States, you should have a COVID test. I’ll leave on Sunday. I have double vaccination, I have a booster. Next Thursday in London, I’ll be required to have a COVID test in London before I can fly back into the United States. The CDC’s own website puts more value on natural immunity than they do on two vaccine shots and a booster shot.

Our guidance is intended… First of all, let me just say, I think our guidance is very simple when it comes to vaccination. It has nothing to do with whether you’ve been infected or not. We recommend everybody in this country to be vaccinated with either two doses of a Pfizer or Moderna vaccine or a single dose of a Johnson & Johnson vaccine. It couldn’t be more simple. Everyone should get vaccinated who is eligible to be vaccinated. With regard to our [inaudible 02:49:58] travel, our travel guidance and our travel restrictions are to keep Americans safe, to keep people traveling to the United States safe and to keep our local communities safe.

Sen. Burr: (02:50:10)
Let me repeat what the guidance is, that if I leave the country and I’ve been infected and recovered from COVID in the last 90 days, I can come back in the country without a requirement to be COVID tested before I come in the country, though, I’m recommended once I get in the country to have a test within three to five days. If I’m vaccinated and I’m boosted, if I leave the country, I’ve got to physically be tested outside the United States before I can return to this country. I’m not asking a question. I’m making a point.

Senator, may I just-

Sen. Burr: (02:50:47)
That is so confusing that there’s every reason to believe that the American people can look at this and say, “What the hell are you guys doing? What are you judging this based on? It’s not common sense. And it’s certainly not science.”

The scientific ground for these tests is that these PCR tests can stay positive up to 12 weeks. And so, what we’re working to prevent is that people who would have a persistently positive test from prior infection, not be confused with people who are newly infected in that country. They actually have to prove that they’ve had a positive test so we’re not looking and misdiagnosing them as newly infected. It’s the science that’s informing that policy.

Sen. Burr: (02:51:27)
Your stated policy suggests that you put more value on natural immunity. It does. It does.

It’s the performance of the diagnostic tests, unfortunately.

Sen. Burr: (02:51:38)
Thank you, Madam Chairman.

Thank you.

Sen. Murray: (02:51:41)
That will end our hearing today. And I want to thank our panelists, Dr. Walensky, Dr. Fauci, Dr. Woodcock and Assistant Secretary O’Connell. You’ve all been very patient and we appreciate a very thoughtful discussion about our ongoing response to this pandemic and the path forward and I really do appreciate all of you being here today. For any senators who wish to ask additional questions, questions for the record will be due in 10 business days, November 19th, at 5:00 PM, and with that, the committee stands adjourned.

Dr. Fauci & Dr. Walensky Testify on COVID-19 Response, Vaccines Full Senate Hearing Transcript

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