Dr. Fauci, CDC Director Testify Before Senate on COVID-19 Guidelines Transcript

Patty Murray: (05:13) Good morning. The Senate Health, Education, Labor and Pensions Committee will please come to order. Today we are hearing the latest update from federal officials about our efforts to fight the COVID-19 pandemic. Ranking Member Burr and I will each have an opening statement and then I will introduce our witnesses, doctors Walensky, Fauci, Marks and Kessler. I'm glad to have you all back before our committee today and I know we will continue to hear from you as we work to end this pandemic. Patty Murray: (05:39) After the witnesses give their testimony today, each Senator will have five minutes for a round of questions. Before we begin, I want to again, walk through the COVID-19 safety protocols that are in place today. We will follow the advice of the attending physician and Sergeant at Arms in conducting this hearing. We're again, grateful to all of our clerks and everyone who's worked so hard to get this set up and help everyone stay safe and healthy. Committee members are seated at least six feet apart, and some senators are participating by video conference. Patty Murray: (06:09) While we are unable to have this hearing fully open to the public or media for in-person attendance, live video is available on our committee website at help.senate.gov. And if you are in need of accommodations, including closed captioning, you can reach out to the committee or the Office of Congressional Accessibility Services. Well, we are not yet through this pandemic. It is clear we are making significant progress. We administered well over 200 million COVID-19 vaccine in president Biden's first 100 days. Over half the adult population has gotten at least one dose. Patty Murray: (06:46) A third of the country is fully vaccinated. Schools, businesses and communities are working to safely reopen and the Food and Drug Administration has now authorized vaccines for adolescents. So we've come a long way in the last few months, but even as we are encouraged by the progress so far, we're all keenly aware more work lies ahead. This pandemic has touched every community in our country and every corner of the world. To truly end it, vaccines have to be just as widespread. And while some progress is being made, for example, in my home state of Washington, they've released a dashboard with vaccination data and the latest numbers from which show Washington State has vaccinated over five million people and we are vaccinating around 50,000 more a day. Patty Murray: (07:31) The data also shows vaccinations are lagging in some areas, especially for black, Latino, tribal, and rural communities and not just in my state, but across the country. In some states, we are still lacking key data on demographic characteristics including race and ethnicity. We have to address systemic inequities and tear down barriers that are making harder for some people to get vaccines. Everyone must have the opportunity to get vaccinated, regardless of race, zip code, disability, primary language, or internet access. Patty Murray: (08:04) We're also seeing vaccination rates slow. It is a reminder that making sure people can get vaccines is just half the battle. We need to make sure they do get them. To make that happen, we need to make sure people are getting reliable information about vaccines and hearing from voices they trust about why getting vaccinated is so important, not just to protect themselves, but to protect those around them and stop this disease from spreading or mutating into new deadly strains. Patty Murray: (08:36) I'm glad that Biden administration is continuing to release funds from the American Rescue Plan to help address some of these challenges including last week, when they announced almost a billion dollars to strengthen our response in rural communities and a quarter of billion dollars to develop and support a community-based workforce to help underserved groups get information about vaccines, schedule appointments, arrange transportation and more. As we work to get our nation vaccinated, we have to also acknowledge this is a global fight and do our part to lead on the world stage. Patty Murray: (09:11) The deadly outbreak in India is a heartbreaking reminder of what can happen when this virus spreads unchecked, when it mutates into more contagious, more deadly strains and when it overwhelms healthcare systems. It's a reminder this pandemic won't fully be over for our country until it is over for the world, which is why I'm glad the Biden administration is sending medical support to India, sharing some of our excess doses globally, and even considering other steps to remove barriers to vaccines for countries that need them including a targeted waiver of COVID-19 patent protections. Patty Murray: (09:46) These moves won't just save lives in India, they will ultimately save lives in Washington State, North Carolina, and across the country because people get that when there's a fire down the street, it's in their best interest to put it out before it gets to their family's home. Not to mention that helping your neighbor's always the right thing to do. I'm also hearing from lots of people in my home state who really feel we can't simply end this crisis and never look back. We have to learn from it. Patty Murray: (10:13) We have to be better prepared for the next public health emergency so that we are never, again, in a situation like this. Which is why ranking member Burr and I plan to develop bipartisan legislation to address and build on lessons learned from the COVID-19 response. Ensure robust public health and medical capacity to provide services to those most at risk, improving the supply chain for critical medical supplies, tackle the health disparities that afflict so many of our communities and strengthen the nation's public health infrastructure and medical preparedness and response programs at every level. Patty Murray: (10:51) I look forward to having more hearings specific to that work soon and hearing what our witnesses today have to say on that subject as well. As federal officials on the front lines of this pandemic, you all have an important perspective into the progress we are making today, as well as the lessons we must learn for tomorrow. Now I will turn it over to Ranking Member, Senator Burr for his opening remarks. Senator Burr: (11:13) Thank you, Madam chair. I'm glad we're holding another hearing to update us on the status of COVID-19 response and to our witnesses, thank you for the work you've done. More importantly, welcome back to the committee. It's been almost 18 months since the initial reports of severe pneumonia in Wuhan China surfaced. Since that time, we've tragically seen over a half million deaths in this country from COVID-19. Government back shutdowns have jeopardized the livelihood of millions of Americans, and we've spent more taxpayer money than I could have ever imagined in response this virus and the devastating effect it's had on our economy. Senator Burr: (11:58) But now more than ever, there's reason for hope. We're seeing the promise of vaccines and treatments in real time. A month ago, the case count in the United States was over 70,000 new cases per day. Today, we're down to roughly 40,000 and headed south. CDC is projecting continued declines in death and hospitalization rates. Because of Operation Warp Speed, Dr. Marks, Dr. Fauci, Dr. Hahn, and the FDA, we've fully vaccinated, 115 million Americans with roughly 44%, which is referred to 44% of adults and delivered almost 330 million doses to states. Senator Burr: (12:45) Operation Warp Speed and Barta spent more than $18 billion to make vaccines available to Americans, manufacturing vaccines at risk and the American people are benefiting from that today. Manufacturers were able to produce enough vaccines that the United States is now able to help provide vaccines to countries in need like India. Because of the collaborative efforts over the last year, we're ready to turn the corner. The partnerships developing and manufacturing the COVID-19 vaccines have been one of the biggest scientific success stories in generations. Senator Burr: (13:26) Industry answered the call at the start of the pandemic and partnered in an unprecedented way to bring us these life saving products. Intellectual property is part of the reason we have these life saving products today. If these protections are not in place for innovators of lifesaving medicines we'll not have them for the next pandemic. It's that simple. We held a hearing on the threat of China taking intellectual property from US research and now the Biden administration is agreed just to hand it over. Senator Burr: (14:08) There's a way to support the manufacturing of vaccines globally and help countries in need without acting in bad faith against innovators who stepped up when the world needed them the most. It's the partnership we're already seeing today that are saving lives, not silly ideas about socializing means of production. The action from the Biden administration to support waiving intellectual property rights will undermine the innovation we're relying on to bring this pandemic to an end and will leave us with a less prepared future. Senator Burr: (14:47) I'm encouraged that some of our European allies cautioned against this reckless action and I hope the adults in the Biden administration will realize that what sounds good and a grad school every tower thesis paper does not make sense in the real world. You four are the adults in the room. I urge you to think about the real consequences if we just give away this science and this technology. The next part of our job is going to be the difficult part. I've been looking to Israel to help predict the challenges that we may be in store within the US since they're ahead of us on vaccination rates today. Israel was able to vaccinate 40% of the adult population by the end of February. Their data shows that uptake stalled once they've vaccinated, about 60% of the adult population. While there are differences between our countries, we have to use the information we've got to best predict our road ahead. Every adult has the opportunity to be vaccinated and supply's starting to exceed demand. In other words, we have more shots than we have arms to put it in. We need to address vaccine hesitancy and it needs to be done now. I know this is the case in my state with recent reports from Wilmington, North Carolina, that local officials are changing their approach as vaccine demands slow. Senator Burr: (16:14) We must paint a picture for the American people, showing the benefits of both vaccination and a reopening of our country. This is a simple message for those in leadership positions. I got the vaccine, my wife got the vaccine, my sons got the vaccine, their wives got the vaccine. I've encouraged all my staff to take it as soon as it's available to them and I've gone through the last 24 hours with a real fear that I had a one and a half year old grandson who might have had COVID. Fortunately, it all came back negative and he'll hopefully leave the hospital sometime today. Senator Burr: (16:53) But I would guess that everyone in this room is vaccinated, which means if we follow the CDC guidelines, we can dispense with mask and social distancing. Tomorrow, I hope that we're going to have a vaccine that's approved for kids over 12 and ones younger, hopefully in the not too distant future. We must reassure Americans that COVID vaccines are safe. Vaccines save lives. I might've been naive when we started this, believing that staying out of the hospital and not dying might've been motivation enough to get people vaccinated. It clearly wasn't. And that's why we must reassure Americans that if you get a COVID vaccine, our lives can and will return to normal. But we can't assure without painting that picture for them what that looks like. Senator Burr: (17:53) Today's response is preparing us for tomorrow's threat. As Senator Murray said, we've launched a joint effort to strengthen our public health preparedness programs for the next threat, which we will inevitably face. That threat could be emerging today, or it could be a new virus, another curve ball for mother nature, or the result of deliberate manmade attacks on our country. Our framework has always been flexible and it needs to stay that way. There will always be lessons that we learn from each response and our threat landscape is constantly evolving. Our experience with this pandemic has made that even more clear. Senator Murray and I look forward to working with each of you and the members of the committee on this project to take stock of lessons learned and to actually put them into action. To our witnesses today, thank you for all you've done up to this point of the response, but know that the most challenging days may be the next several weeks and months ahead, as we attempt to get to a vaccination level that changes the glide path to one that's permanently in the decline. With that, I thank the chair. Patty Murray: (19:10) Thank you, Senator Burr and I look forward to working with you on that, and I wish your grandson well. Senator Burr: (19:14) Thank you. Patty Murray: (19:15) I will now introduce today's witnesses. 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. Walensky, welcome back. Thank you for joining us today. Next, I'd like to introduce Dr. Anthony Fauci who 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. Fauci, good to have you back before the committee as well. Thank you for joining us. Patty Murray: (19:47) Dr. Peter Marks is the director of the Center for Biologics Evaluation and Research for the Food and Drug Administration. Dr. Marks, we're glad to have you here again as well. Thank you. And finally, I would like to introduce Dr. David Kessler. Dr. Kessler is the Chief Science Officer of the Biden administration's COVID-19 response. Dr. Kessler, glad to have you with us as well. With that, we will begin our witness testimony. Dr. Walensky, we'll begin with you for your opening statement. Dr. Rochelle Walensky: (20:18) Thank you, chairwoman Murray, Ranking Member Burr, and members of the committee for the invitation to speak with you today. I last testified before this committee less than two months ago. Since that time, the dedicated professionals at CDC have been working diligently to provide additional resources to states, localities, territories, and tribes. Thanks to support from Congress. We are updating our guidance based on the latest scientific evidence and we are working with our partners around the country and the globe to reduce the burden of COVID-19. Dr. Rochelle Walensky: (20:50) I am pleased to report that since January, we have seen a consistent downward trend with daily averages of new infections dropping 76%, hospitalizations down 71% and reported deaths decreasing by 75%. This progress is also reflected in our data on the county level risk. Just a few months ago, 85% of all counties in the US were experiencing high COVID-19 transmission rates and increased community risk. This morning, that is down to 33% of counties. Dr. Rochelle Walensky: (21:23) These trends give me hope. And still I continue to emphasize that we must remain diligent and committed to our surveillance and prevention efforts because the emergence of variants could set us back. With your help, CDC is using the $1.7 billion Congress provided to expand nationwide genomic sequencing efforts. Since January, we have dramatically increased sequence output from 3,000 samples per week to approximately 35,000 samples per week. We are also keeping our commitment to prioritize health equity. Dr. Rochelle Walensky: (21:55) Since March, we have announced a number of investments that center in health equity. These include $2.25 billion to address COVID-19 related health disparities and advance health equity among high-risk and underserved populations. $3 billion to strengthen vaccine confidence with a focus on increasing uptake and equity and administration, particularly in communities hardest hit by the pandemic. $332 million in community health workers to support COVID-19 prevention and control, and $250 million to develop targeted strategies for vaccine education and outreach for uptake in specific communities. Dr. Rochelle Walensky: (22:36) In addition, CDC continues to update our guidance as we learn more. This includes a recent update outlining levels of risk of activities for fully vaccinated and unvaccinated people. We will continue to update this guidance to be clear that vaccines are a means of returning to activities we stopped as a result of the pandemic. I am so proud to report the administration of more than 261 million vaccine doses, including more than 133 million since I last testified before you in March. Over 84% of Americans age 65 and older, and over 58% of all adult Americans have now received at least one vaccine dose. Dr. Rochelle Walensky: (23:19) With these cases trending down in the United States and more people getting vaccinated, we are cautiously optimistic. However, globally, the pandemic is more severe than ever. India's surge of cases is tragic and a reminder that the virus can rapidly outstrip our efforts to contain it if we are not careful. We will not end this pandemic without working hand in hand with countries around the globe to fight COVID-19. Dr. Rochelle Walensky: (23:46) I want to take a moment to acknowledge that while we have made great progress over the last few months, more than 579,000 people in the United States have died from COVID-19 during this pandemic. And just since I saw you last in March, over 39,000 of our loved ones have died from COVID-19 in the United States. Every death is a stark reminder of why we must remain vigilant and focused to end this pandemic as quickly as possible. I want to close with a promise and an appeal to the American people. My promise is that CDC will continue to follow the science as our guide and my appeal is to implore everyone to get a COVID-19 vaccine as soon as possible as the fastest way to end this pandemic. Dr. Rochelle Walensky: (24:33) But even with this powerful tool, while we continue to have community transmission, we must also maintain public health measures we know will prevent the spread of this virus mask, hand hygiene, and physical distancing. Finally, as we get through this pandemic, we must work together over the months and years ahead to build on the investments, partnerships and innovations that we have created during this crisis. This includes achieving sustainable investments in public health infrastructure to be better prepared for whatever comes next. It is one way we can turn tragedy into lasting progress and improved health for all. Thank you, again, for the opportunity and invitation to testify today and I look forward to answering your questions. Patty Murray: (25:17) Thank you, Dr. Fauci. Dr. Anthony Fauci: (25:20) Madam chair, Ranking Member Burr, members of the committee, thank you for giving me the opportunity to discuss with you this morning the role of the National Institute of Allergy and Infectious Diseases and the NIH and research addressing the COVID-19 pandemic. As I had mentioned to this committee during the last hearing that we attended, we have a strategic plan that has four major components. Fundamental knowledge of the virus, diagnostics, therapeutics, and the development of safe and effective vaccines. Dr. Anthony Fauci: (25:51) For the purpose of today's discussion, I will focus on the issue of vaccines. We often get asked how it could be possible that the virus was discovered in January of 2020 and we had doses of vaccine going into the arms of individuals, a vaccine that was highly efficacious and safe 11 months later in December of 2020. Well, the story behind that has been the decades of investment in basic and clinical biomedical research that has led to our ability to accomplish this extraordinary feat. Just some examples, the basic preclinical and clinical research in developing vaccine platform technology, particularly the highly successful mRNA platform. In addition, scientists at the Vaccine Research Center at NIAID, as well as grantees and contract doors throughout the country developed the optimal immunogen, which is the confirmationly correct spike protein, which is used by virtually all the vaccines that are being tested right now. And finally the utilization of a clinical trial network that we had set up decades ago for Influenza and for HIV. Dr. Anthony Fauci: (27:16) When one thinks of ethicacy, it really is what are the results of a clinical trial? Often when you get into the real world, the effectiveness of vaccines falls short of the original efficacy. That is not at all the case with the vaccines for COVID-19 because the real world effectiveness is even more impressive than the results of the clinical trial. One example, the University of Texas looked at 23,000 of their employees and found that the incidence of infection was 0.05% markedly lower than non-vaccinated individuals. Dr. Anthony Fauci: (27:55) The CDC has multiple MMWRs reporting on various aspects of the real world effectiveness. Importantly, a recent paper in the Lancet reported on the experience in Israel, which is Senator Burr had mentioned, has done an extraordinary job of getting their citizens vaccinated. What we have seen is a remarkable diminution in the number of infections that reached a critical turning point when they reached a certain percentage of the individuals who were vaccinated. It wasn't only limited to Israel. Another recent paper in the country of Qatar showed a similar type of a result in which not only was the mRNA vaccine highly effective in over 300,000 individuals tested in preventing the original wild type virus. But it also had a very interesting capability of protecting against mild to moderate disease of a problematic variant from South Africa, the 351 and protected virtually 100% from severe disease including hospitalization and death. Dr. Anthony Fauci: (29:11) When the president makes the goal of 70% of adults receiving at least one vaccine by the 4th of July, we believe that that is an attainable goal. The reason we feel it's important is that I believe that we are about at that critical turning point when we get a certain percentage, we don't know exactly what it is, but clearly the majority of individuals in the country vaccinated, we will see a sharp turning point and a marked diminution in cases. As I said the last time I testified before you, we are in a race between the vaccine and the virus. If left to its own devices will continue to surge. Based on experience thus far in this country and globally, I feel confident that if we continue to vaccinate people at the rate that we're doing, that we will very soon have a situation where we will have so few infections in this country, we will begin to return to normality that all of us desire so much. Thank you very much. Patty Murray: (30:16) Thank you, Dr. Marks. Dr. Peter Marks: (30:23) Chair Murray, Ranking Member Burr, distinguished members of the committee, thank you for the opportunity to testify before you again, to describe FDA's continued COVID-19 response efforts and particularly our efforts on vaccines. First, yesterday evening, the FDA announced the expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents down to age 12 years. We know that this is a big step for our country as vaccinating a younger population can bring us closer to a sense of normalcy and to ending this pandemic. Dr. Peter Marks: (30:58) To look at the safety of the vaccine, the FDA evaluated a clinical trial of more than 2,000 adolescents age 12 through 15. Half of the participants received the Pfizer-BioNTech vaccine and half received a Saline Placebo. The side-effects experienced by those age 12 through 15 were similar to those experienced by individuals aged 16 and older. To look at effectiveness, the FDA evaluated data about how participant's immune systems responded to the vaccine comparing 190 individuals aged 12 through 15 to 170 age 16 through 25. Dr. Peter Marks: (31:35) The FDA also evaluated data on cases of COVID-19 among adolescents age 12 through 15 seven days after the second dose of vaccine was given. No cases of COVID-19 occurred among 1,005 adolescents who received the vaccine compared to 16 cases in 978 Placebo recipients, thus indicating the vaccine was completely effective in preventing COVID-19 in the trial that was symptomatic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available scientific data as we have with all of our COVID-19 vaccine authorizations and the CDC's Advisory Committee on Immunization Practices will next review the data tomorrow. Dr. Peter Marks: (32:25) Also, as we announced yesterday, we intend to convene a virtual meeting of the vaccines and related biological advisory committee on June 10th, 2021, during which we'll provide a status update on our approach to emergency use authorization in individuals age 12 through 17 years of age. We'll also discuss the data needed to support an emergency use authorization and a biologics license application in children less than age 12. Dr. Peter Marks: (32:53) Second, as COVID-19 vaccination expands into adolescents, we continue to work diligently with CDC and other partners on safety surveillance of the authorized vaccines. We're grateful to Congress for the American Rescue Plan funds, which are supporting expanded vaccine safety surveillance among other critical priorities. We've seen that our safety surveillance systems are doing what they're supposed to do and detecting important adverse events. Dr. Peter Marks: (33:18) Recently, our surveillance systems detected a safety signal for rare blood clots and low blood platelets known as thrombosis thrombocytopenia syndrome with the Janssen or Johnson & Johnson COVID-19 vaccine. Following a brief pause taken to evaluate the situation and educate providers based on the rare but increased risk of this adverse event mainly in women age 18 through 50 years of age. FDA modified the fact sheet for healthcare providers to include a warning pertaining to the risk of thrombosis with thrombocytopenia and the fact sheets for recipients and caregivers was also updated. We'll continue to diligently monitor the safety of all of these vaccines. Third, the CDC and FDA are working... Dr. Peter Marks: (34:03) ... Third, the CDC and FDA are working closely together to track the emergence and the spread of COVID-19 variance. Currently available evidence suggests that the three available FDA-authorized vaccines adequately address COVID 19 variants circulating in the United States. However, we're working with manufacturers and government partners to plan the composition of the vaccine so that we can administer booster vaccinations if necessary of inappropriate composition. Fourth, the FDA recently completed an inspection of Emergent BioSolutions, the proposed manufacturing facility for the Janssen COVID-19 vaccine. At the close of the inspection of Emergent BioSolutions, FDA investigators cited several observations concerning whether the facility's practices met our regulatory requirements and standards. We're now working with Emergent BioSolutions to address the conditions identified. It's been made public that no product has been released from this facility for use in the United States and will not agree to the release of any product from this facility until we're truly confident that it meets our expectations for quality. Dr. Peter Marks: (35:07) Additionally, moving forward, the agency is refining how to optimally evaluate the manufacturing quality during this and any future public health emergency. We're committed to maintaining the trust of the public in the vaccines and hope that every eligible individual consider getting vaccinated to help end this pandemic. Thank you. Patty Murray: (35:28) Thank you, Dr. Kessler. Dr. David Kessler: (35:32) Chair Murray, Ranking Member Burr, distinguished members of the committee, thank you for the invitation to provide an update on our COVID 19 response. Allow me to succinctly set out what we are focused on today. Dr. David Kessler: (35:48) First, we have delivered today 330 million doses of vaccine in the United States and have administered over 260 million of them. The most important thing we all need to do is to get a vaccine to everyone who wants to be vaccinated in the United States. The current vaccine supply exceeds demand. Nothing is more important than achieving the president's goal of having 70% of adults with at least one shot by July 4th. The long-term fate of many of our communities depends on getting people vaccinated. Dr. David Kessler: (36:37) There are many reasons why people have not yet been vaccinated. We need to recognize at the core for many is simply a fear of the unknown. All the data support the basic proposition that these vaccines are safe and effective. Getting vaccinated will prevent hospitalization and death. Dr. David Kessler: (37:05) Second, the FDA took a significant step yesterday in the fight against COVID-19 by expanding the Pfizer EUA to adolescents ages 12 to 15. Pending the recommendation of the ACIP tomorrow, we plan to offer the Pfizer vaccine to all young people, ages 12 to 15. Right now the Pfizer vaccine is available at many local pharmacies and larger health clinics. We are working to make smaller trays available so that the Pfizer vaccine can be administered by more pediatricians, family, doctors, and rural healthcare providers. By late fall, we expect to have data on the safety and effectiveness of vaccines for children under 12. Dr. David Kessler: (37:51) Third, we are planning, and I underscore the word planning, to have booster doses available if necessary for the American people. Increased age, the natural waning of antibodies over time and new variants all increase the probability that booster doses may be needed. Dr. David Kessler: (38:15) Fourth, it is absolutely essential that we begin sharing doses made in the United States with the rest of the world. Supplying other nations with vaccines is not just the right thing to do for lifesaving humanitarian purposes, it is also in the best interest of the United States to mitigate the risk of viral evolution. Dr. David Kessler: (38:38) Fifth, we need to hasten our search for an antiviral. I am concerned that even after we finish vaccinating most of the people who want to be vaccinated by this summer, there will still be a significant number of cases and an unacceptable number of deaths. People who are immuno-suppressed, who do not mount an immune response for a number of reasons, or choose not to be vaccinated will continue to be vulnerable and we need options for them. The antibody treatments are one approach, but a simple oral antiviral can add to our armamentarium to bring this epidemic under control. Dr. David Kessler: (39:20) Lastly, we need to build a program for vaccine preparedness for future pandemics. This will need to be done in partnership with the private sector and build on all the lessons we have learned today. Dr. David Kessler: (39:35) Thank you for the opportunity to testify today, and I look forward to your questions. Patty Murray: (39:40) Thank you to all of our witnesses for being here today and your testimony. We will now begin around a five minute questions of our witnesses, and I ask our colleagues, keep track of your clock and stay within those five minutes. We do have votes starting at 11:30 today. Patty Murray: (39:54) Dr. Fauci, let me start with you. The surge COVID-19 that is devastating India is a painful reminder, really, that we can't end the pandemic here until we end it everywhere. I'm glad that Biden administration is leading that global fight by rejoining the World Health Organization and funding global vaccine efforts and committing to donate 60 million AstraZeneca vaccines to other countries by July 4th. Patty Murray: (40:19) India's outbreak really underscores the need for a robust public health infrastructure in the US to respond appropriately to this pandemic and future outbreaks as well. I wanted to ask you today, Dr. Fauci, what can we learn from India's outbreak that we should apply to our response here in the US? Dr. Anthony Fauci: (40:40) Well, I think one of the important things is don't ever underestimate the situation. The reason that India is in such dire straits now is that they had an original surge and made the incorrect assumption that they were finished with it. What happened, they opened up prematurely and wind up having a surge right now that we're all very well aware of is extremely devastating. That's the first thing. Dr. Anthony Fauci: (41:05) The second thing is preparedness with regard to public health preparedness, which we, as a lesson learned for future pandemics, have to realize that we need to continue to build up our local public health infrastructure, which over the last decades we have let to actually, in many respects, go into disarray, likely because of our successes in controlling so many diseases. The other lesson that's learned Madam Chair is that this is a global pandemic that requires a global response, and we need to pay attention to the responsibility that we have, not only for our own country, but to join with other countries to make sure that we have the access to interventions, particularly vaccines throughout the world, because if it continues to have dynamics of virus anywhere on the world, we have a threat here in the United States, particularly with variants. There's one variant in India that is also a new variant, 617B617. Dr. Anthony Fauci: (42:09) Those are just a few of the lessons that I believe we can take from what's going on in India. Thank you. Patty Murray: (42:14) Thank you. Patty Murray: (42:16) Dr. Marks, I'm really encouraged by how the FDA has worked both quickly and carefully to get multiple COVID vaccines authorized. But having said that, I am very concerned about the reports involving Emergent BioSolutions, you mentioned it in your marks. It is a contractor that received $628 million to manufacture COVID vaccines and wanted to ask you to explain FDA's recent findings because after receiving reports of cross-contamination with another vaccine, FDA inspected the Emergent facility, as you said, and asked the contractor to pause manufacturing and the cross-contaminant needed vaccine was not distributed for any use. But Dr. Marks, what steps is FDA taking to make sure of the quality, safety and effectiveness of all COVID-19 vaccines? Dr. Peter Marks: (43:07) Yeah. Chair Murray, thank you for that question. We're currently, for the Emergent facility, we're actively working with all of the parties involved to ensure that the facility's deficiencies are all remediated so that before they actually are able to release vaccine, it meets all of our quality standards that Americans deserve from vaccines. Dr. Peter Marks: (43:27) Also, as we move on to other facilities that may be producing vaccines, we will take the approach of using all of our inspectional tools to ensure that the quality of those is the highest nature. As with all of our biologics license applications, we generally will be performing on-site inspections of those facilities to ensure the quality of those products. Patty Murray: (43:56) Thank you. I'm really deeply concerned about what happened. My expectation is in the future nothing like that happens again. Patty Murray: (44:04) Dr. Walensky, in my last minute here, let me just ask you, the CDC says that while fewer children have been sick with COVID-19 compared to adults, children can be infected, get sick and spread the virus. With the authorization of Pfizer yesterday for children 12 to 15, what would you say to parents who are considering getting their kids vaccinated now? Dr. Rochelle Walensky: (44:27) I would encourage all parents to get their children vaccinated. I know many parents are enthusiastic and have been texting me, can't wait to get their children vaccinated. I recognize that there some parents want to sort of see how it goes first, but I am encouraging all parents to get their children vaccinated. Some parents won't want to be first, but I'm also encouraging children to ask for the vaccine. I have a 16-year-old myself, and I can tell you he wanted to get the vaccine. He wants his life back. These kids want to go back to school. They want to go back to the things they love. Patty Murray: (44:56) Thank you. Senator Burr. Senator Burr: (45:00) Thank you, Chairman. Senator Burr: (45:01) Dr. Kessler, We've shipped 2.7 million doses of AstraZeneca, I think to Mexico, that's the only country we've shipped to. We've got additional doses of AstraZeneca in inventory in this country. We talked about July 4th, exporting more. Why have we not taken the AstraZeneca, which is not approved for vaccination in the United States, why have we not mobilized that to other countries in the world today? Dr. David Kessler: (45:33) Senator, it's a very important question. We have shipped a total of four million doses to date, including to Mexico and, I believe, 1.5 to Canada. We are ready to ship up to 60 million doses of AstraZeneca. But as the chair pointed out and as my colleague Dr. Marks responded, there are issues with Emergent that are under review by the Food and Drug Administration. If and when those issues are resolved and we can say that these are quality doses, we will do just as you say. Senator Burr: (46:30) Correct me if I'm wrong, I didn't think the Emergent Baltimore facility had anything to do with AstraZeneca production. Am I wrong, Dr. Marks? Dr. Peter Marks: (46:40) Senator Burr, no, the AstraZeneca vaccine was being produced in that facility. The FDA feels it's imperative that before vaccine can be shipped to any other partner, it has to meet the quality standards that it would meet for any American as well. Senator Burr: (46:57) How long do you anticipate that testing the AstraZeneca vaccines that's currently manufactured would take to verify? Dr. Peter Marks: (47:04) We are working on that as quickly as we can. We understand the imperative here. There is a working group across our office of regulatory affairs and our center and others at FDA that are working together to try to clear that, those doses, as quickly as we can. I can't give you an exact time, but we understand the imperative to be able to have them available so that Dr. Kessler can arrange for them to be shipped to those in need. Senator Burr: (47:31) Okay. Dr. Peter Marks: (47:32) Thank you. Senator Burr: (47:33) Dr. Kessler, one of the reasons we are as successful today is that partnerships have been leveraging vaccinations around the world and over 275 partnerships have been created to scale up vaccine production manufacturing. I guess I'm asking you this, if we wave intellectual property in the United States, do we not stand the risk of affecting innovation in the future? When, if we did it to scale up manufacturing capacity, the private sector has done that through partnerships already, and that's the reason that we've been so successful. Shouldn't we let the private sector continue to do something that I think Dr. Fauci and I have said in the past, we never anticipated this. This is novel that they would have the relationship to do it. Why mess with a good thing? Dr. David Kessler: (48:29) I applaud the actions of the pharmaceutical industry. Senator, this is a once-in-a-century pandemic. I think we all recognize that extraordinary circumstances call for extraordinary measures. We know, and I agree with you, Senator, that a waiver alone won't result in the scale and speed we need to make enough vaccines to end the pandemic. That's why we will continue to ramp up our efforts, working with the private sector and all possible partners to expand vaccine manufacturing and distribution around the world. I mean, our job is to do, as you say, to increase that supply, that's what we're focused on. We want to make vaccines available to the world. Senator Burr: (49:28) David, here's the reality. When Pfizer went to open up its Kansas plant to produce vaccine, it took them, I believe, seven months to retool and to get everything done. This belief that you can export intellectual property and you're going to have a stand up around the world instantaneously of vaccine production is a joke. Dr. Marks has already expressed concern over the backlogs for inspections and how long would it take for us to inspect foreign sites if in fact there was a vaccine pool that found its way in and out of the United States. Senator Burr: (50:04) Let me just get this before my time runs out. Can anybody give me the number, there's been 33 million Americans infected with COVID that have actually tested positive, how many of that 33 million have then been vaccinated? Does anybody know what that number is? Senator Burr: (50:27) Here's why I make the point, and here's why I think it's relevant. If we're looking at a certain number that we don't know exactly what it is, Dr. Fauci, that we want to get to and we vaccinated 115 million, it's important for us to know of the counted vaccine number, how many of those already had protection because they were COVID positive? If we're trying to reach a number when the president says 70% vaccination, if we get to 65 vaccinated and 5% got COVID and they have protection, isn't that like being at 70? Senator Burr: (51:05) I think one of the problems that the goalpost continues to be too far, and we've now got the harder part of how do we take the 40% that aren't real comfortable with getting vaccinated and at least have a shot at vaccinating 50% of that 40%. It may be that our number is higher today on the protected. I know it is. I don't think 33 million have all been vaccinated that were positive, but I think it's absolutely crucial that we figure out what that number is, not sure whose responsibility it is, that we figure out what that number is and put that into our formula of how many Americans have protections. Senator Burr: (51:45) I thank the Chair. Patty Murray: (51:47) Thank you, Senator Burr. Senator Casey. Sen. Robert Casey: (51:50) Chair Murray, thank you very much. I want to thank our guests, Dr. Fauci, Dr. Kessler, Dr. Marks and Dr. Walensky. I think I'll have at least one question for Dr. Walensky and one for Dr. Marks. Sen. Robert Casey: (52:03) I'm going to start with you, Dr. Walensky. I want to thank you for your leadership and the leadership of the CDC and your efforts to ensure that children and adolescents are up to date on vaccinations, particularly as students returned to in-person learning. You noted, you and others have noted, there over 11 million doses to the vaccines for children program that have been missed. These missed doses could seriously and negatively impact efforts to protect children and their families and communities from vaccine-preventable diseases and conditions. Of course, we're talking here about diseases other than COVID-19. Sen. Robert Casey: (52:46) At the same time, with 12 to 15 year olds now able to get vaccinated against COVID-19, there's an even greater need to ensure parents are aware of all the vaccines, all the vaccines that children should receive in order to remain healthy. The rescue plan contains funding to build vaccine confidence and specifically includes provisions to ensure funding is allocated towards increasing vaccination rates throughout the US. Sen. Robert Casey: (53:17) Here's the question, Doctor. In addition to the public awareness efforts that you and CDC have already undertaken, will the CDC be releasing the funding to both states and communities to ensure that children and adolescents are caught up on both routine and recommended vaccinations, particularly as children returned in-person learning? Dr. Rochelle Walensky: (53:41) Thank you, Senator, for that. You raise an issue that is near and dear to my heart and I'm very worried about. Dr. Rochelle Walensky: (53:46) More than 20% of our measles vaccines were not used this year. We have the same issue with meningococcal vaccines and especially among our adolescents. Unfortunately, we actually don't have data on whether we can co-administer the COVID- 19 vaccine and other routine immunizations and whether we'd get the same protection from the COVID-19 vaccines and the routine administration of other immunizations. That is one issue that the experts at ACIP are going to address tomorrow as to whether that can safely be done and that we could potentially get adequate protection. Dr. Rochelle Walensky: (54:19) You are right. We need to, as we're putting forward these efforts in vaccine confidence for the COVID-19 vaccine, we need to take this outreach and make sure that we are reaching these communities and not only conveying the importance of getting the COVID-19 vaccine, but if we are not able to co-administer them, to make sure we get back to these children and be able to administer the routine vaccines that they have lost before the school year. Sen. Robert Casey: (54:45) In terms of the funding, though, that will be released? Do you have any sense of the timing of that? Dr. Rochelle Walensky: (54:50) I do not, but we can get back to you. Sen. Robert Casey: (54:52) Okay. Thank you. Sen. Robert Casey: (54:53) Dr. Marks, I wanted to start with you regarding Pfizer. We've heard a lot this year about emergency use authorization and we know that Pfizer has recently filed their application for full licensure of their COVID-19 vaccine. I think we get a lot of questions at home on a range of these issues and, in particular, what does it mean? What does it mean? What does full licensure mean? One of the concerns that we've heard a lot about is the vaccines are provided this emergency use authorization, but what's the next step for a vaccine? Can you explain what it means to get full licensure. That's question number one. Sen. Robert Casey: (55:44) Secondly, what additional information would a company need to submit beyond what was required just for so-called EUA? Dr. Peter Marks: (55:55) Senator, thanks very much for that question. The full licensure is something that a manufacturer submits with a full data package, which I'll go into in a moment. But I just want to go back to pick up on something that Dr. Fauci said. Dr. Peter Marks: (56:09) These COVID-19 vaccines, they were expedited not by cutting corners, but by going through a development plan in which kind of empty space, space that would have been normally just not stuff happening, was taken away, so manufacturing was done while the clinical trials were done. The large clinical trial programs were of the size of normally-licensed vaccines in the United States. The one place where we're a little bit short was the duration of safety follow-up. But we are very confident from the amount of safety follow-up, at least a median of two months safety follow-up on this safety data set for the emergency use authorization, that the large majority of adverse events became apparent. We're very confident in recommending these vaccines for everyone, our families, all Americans. The difference that will happen with the biologics license application is that the manufacturers will be able to submit additional safety data, perhaps six months of safety data, rather than just the median two months safety data. Additionally, there are some technical things that will be there that many people may not care a lot about, but we do, that is manufacturing conformance lots, the formal facilities inspections will occur and additional ancillary studies will be put in that package. Dr. Peter Marks: (57:33) I think the main message to the American public is that for all intents and purposes, the vaccine that's being used is very close to what we would normally have in a biologics license application. There are some little things around the margins that will go into the biologics license application when we have a formal approval. Sen. Robert Casey: (57:54) Thank you. Thank you, Chair Murray. Patty Murray: (57:56) Senator Paul. Sen. Rand Paul: (57:58) Dr. Fauci, We don't know whether the pandemic started in a lab in Wuhan or evolved naturally, but we should want to know. Three million people have died from this pandemic, and that should cause us to explore all possibilities. Instead, government authorities, self-interested in continuing gain-of-function research say there's nothing to see here. gain-of-function research, as you know, is juicing up naturally occurring animal viruses to infect humans. To arrive at the truth, the us government should admit that the Wuhan Virology Institute was experimenting to enhance the coronavirus' ability to infect humans. Sen. Rand Paul: (58:36) Juicing up super-viruses is not new scientists in the US have long known how to mutate animal viruses to infect humans. For years, Dr. Ralph Baric, a virologist in the US, has been collaborating with Dr. Shi Zhengli of the Wuhan Virology Institute, sharing his discoveries about how to create super-viruses. This gain-of-function research has been funded by the NIH. The collaboration between the US and the Wuhan Virology Institute continues. Doctors Baric and Shi worked together to insert bat virus spike protein into the backbone of the deadly SARS virus and then use this man-made super-virus to infect human airway cells. Sen. Rand Paul: (59:22) Think about that for a moment. The SARS virus had a 15% mortality. We're fighting a pandemic that has about a 1% mortality. Can you imagine if a SARS virus that's been juiced up and had viral proteins added to it, to the spike protein, if that were released accidentally? Sen. Rand Paul: (59:43) Dr. Fauci, do you still support funding of the NIH funding of the lab in Wuhan? Dr. Anthony Fauci: (59:49) Senator Paul, with all due respect, you are entirely and completely incorrect that the NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology. Sen. Rand Paul: (01:00:06) Do they fund Dr. Baric? Dr. Anthony Fauci: (01:00:09) We do not fund gain- Sen. Rand Paul: (01:00:11) Do you fund Dr. Baric's gain-of-function research? Dr. Anthony Fauci: (01:00:13) Dr. Baric does not do gain-of-function research, and if it is, it's according to the guidelines and it is being conducted in North Carolina, not in China. Sen. Rand Paul: (01:00:24) You don't think concerning a bat virus spike protein that he got from the Wuhan Institute into the SARS virus is gain of function? Dr. Anthony Fauci: (01:00:30) That is not- Sen. Rand Paul: (01:00:31) You would be in the minority because at least 200 scientists have signed a statement from the Cambridge Working Group saying that it is gain of function. Dr. Anthony Fauci: (01:00:39) Well, it is not. If you look at the grant and you look at the progress reports, it is not gain of function, despite the fact that people tweet that, they write about it- Sen. Rand Paul: (01:00:50) Do you support sending money to the Wuhan Virology Institute? Dr. Anthony Fauci: (01:00:53) We do not send money now to the Wuhan Virology Institute. Sen. Rand Paul: (01:00:55) Do you support sending money? We did under your tutelage. We were sending it through EcoHealth. It was a sub-agency and a sub-grant. Do you support that the money from NIH that was going to the Wuhan Institute. Dr. Anthony Fauci: (01:01:08) Let me explain to you why that was done. The SARS-CoV-1 originated in bats in China. It would have been irresponsible of us if we did not investigate the bat viruses and the serology to see who might have been infected in China. Sen. Rand Paul: (01:01:29) Or perhaps it would be irresponsible to send it to the Chinese government that we may not be able to trust with this knowledge and with this incredibly dangerous viruses. Sen. Rand Paul: (01:01:40) Government scientists like yourself who favor gain-of-function research maintain the disease arose naturally. Dr. Anthony Fauci: (01:01:43) I don't favor gain-of-function research in China. You are saying things that are not correct. Sen. Rand Paul: (01:01:50) Government defenders of gain of function, such as yourself, say that COVID-19 mutations were random and not designed by man. But interestingly, the technique that Dr. Baric developed forces mutations by serial passage through cell culture that the mutations appear to be natural. In fact, Dr. Baric named the technique the "No See 'em" technique, because the mutations appear naturally. Nicholas Baker in the New York Magazine said, "Nobody would know if the virus had been fabricated in a laboratory or grown in nature." Government authorities in the US, including yourself, unequivocally deny that COVID-19 could have escaped a lab, but even Dr. Shi in Wuhan wasn't so sure. According to Nicholas Baker, Dr. Shi wondered could this new virus have come from her own laboratory. She checked her records frantically and found no matches. "That really took a load off my mind," she said. "I had not slept for days." Sen. Rand Paul: (01:02:46) The director of the gain-of-function research in Wuhan couldn't sleep because she was terrified that it might be in her lab. Dr. Baric, an advocate of gain-of-function research admits the main problem that the Institute of Virology has is the outbreak occurred in close proximity. What are the odds? Baric responded, "Could you rule out a laboratory escape? The answer in this case is probably not." Sen. Rand Paul: (01:03:12) Will you in front of this group, categorically say that the COVID-19 could not have occurred through serial passage in a laboratory. Dr. Anthony Fauci: (01:03:20) I do not have any accounting of what the Chinese may have done, and I'm fully in favor of any further investigation of what went on in China. However, I will repeat again, the NIH and NIAID categorically has not funded gain-of-function research to be conducted in the Wuhan Institute of Virology. Sen. Rand Paul: (01:03:44) But you do support it in the US. We have 11 labs doing it, and you have allowed it here. We have a committee to do it, but the committee is granted every exemption. You're fooling with Mother Nature here. You're allowing super-viruses to be created with a 15% mortality. It's very dangerous. I think it was a huge mistake to share this with China. It's a huge mistake to allow this to continue in the United States. We should be very careful to investigate where this virus came from. Dr. Anthony Fauci: (01:04:10) I fully agree that you should investigate where the virus came from. But again, we have not funded gain-of-function research on this virus in the Wuhan Institute of Virology. No matter how many times you say it, it didn't happen. Sen. Rand Paul: (01:04:23) You're parsing words. You're parsing words. There was research done with Dr. Shi and Dr. Baric. They have collaborated on gain-of-function research where they enhance the SARS virus to infect human airway cells. They did it by merging a new spike protein on it. That is gain of function. That was joint research between the Wuhan Institute and Dr. Baric. You can't deny it. Patty Murray: (01:04:48) Senator Paul, your time has expired. Patty Murray: (01:04:50) Dr. Fauci, I will let you respond to that. We need to move on. Dr. Anthony Fauci: (01:04:54) Excuse me? Patty Murray: (01:04:56) I will allow you to respond to that, and then we'll move on. Dr. Anthony Fauci: (01:05:00) Yeah. I mean, I just wanted to say, I don't know how many times I can say it, Madam Chair, we did not fund gain-of-function research to be conducted in the Wuhan Institute of Virology. Patty Murray: (01:05:10) Thank you. Senator Smith. Sen. Tina Smith: (01:05:13) Thank you, Chair Murray. Thank you so much to our panelists for being here today. Sen. Tina Smith: (01:05:20) I want to just, following up on that exchange, just ask Dr. Fauci a question. Dr. Fauci, what is the impact of conspiracy theories pedal by Senator Rand Paul and others on American's willingness to take this vaccine, a vaccine that by all accounts is remarkable for its safety and efficacy? Dr. Anthony Fauci: (01:05:51) Well, conspiracy theories certainly are not helpful in what we're trying to do. I guess I can say that with some degree of confidence. Sen. Tina Smith: (01:06:01) Well, I would agree. I think, in this moment, we are at a critical moment for our response to this pandemic. In only 14 months since this pandemic started, we are here today to acknowledge that we have 261 million doses of vaccine in people's arms, we have over 58% of Americans with at least one dose. I mean, this is an incredible accomplishment. We also know that we have more work to do. It seems to me that we ought to be focused on that work. We have to make sure that our comprehensive strategy that you have been working on, Dr. Fauci, for a long time, and I'm so grateful for the support that you're getting from the Biden/Harris administration, a comprehensive strategy that is around vaccinations, around surveillance testing, around treatment, social distancing, and masks, and also centering our work around health equity. I mean, this is what we need to be really focused on, it seems to me. Sen. Tina Smith: (01:07:03) I'd like to ask Dr. Walensky a question about how we go about this question of, on this issue of getting people getting vaccines into people's arms now. Vaccines and acceptance of vaccines seem to be really a spectrum from people that are gung-ho and ready to go, to people who have a serious resistance to taking vaccines. We're seeing some learning, it seems to me, about what works. I have a great example of that in Duluth, Minnesota, where public health nurses set up a pop-up vaccine clinic at the Duluth Transportation Center. Minnesotans who are taking their bus home or going to pick up their children at childcare, can go to that vaccine pop-up clinic, fill out their paperwork and get their shot all in one dose. It's breaking down some of the logistical challenges that a lot of Americans and Minnesotans still have. They're finding just great success. Sen. Tina Smith: (01:07:58) There was a story in Minnesota Public Radio just in the last couple of days about a woman- Sen. Tina Smith: (01:08:03) ... radio just in the last couple of days about a woman named Karen Moore, who was way they to get a vaccine and hoping that she would be able to get it at a convenient location and was able to do it all in one spot. And that made all the difference in the world to her in terms of overcoming her so-called vaccine hesitancy, which wasn't hesitancy, it was just the logistics challenges. So, Dr. Walensky, can you tell us a little bit about what the CDC is doing, working with states and localities to deploy methods like we're seeing in Duluth, Minnesota to help people get easy access to vaccines? Dr. Rochelle Walensky: (01:08:36) Thank you so much, senator. We have spent $3 billion getting money to states and localities to advance these efforts and trying to get vaccines into people and to enrich vaccine confidence. I would invite all of you to take out your cell phones and to text, GET VAX 43829. You put in your zip code, you get a list of all the places where vaccines are available to you. You can do that by an 800 number, or you can go to vaccines.gov and type your zip code and find out which vaccines are available nearby to you. So we're trying to make it, we're working to make it easy. We do have to do some of the pivoting as you discussed and ensure that places now have pop-up sites. They have mobile vaccination units. That we are reaching out to rural communities. That we're putting vaccines in federally qualified healthcare centers. That we can do this campaign. Now, a campaign with 5,000 community corps members from everyone, from NASCAR and NFL to Infectious Disease Society of America, to faith-based organizations, sending our messages, being the trusted messengers. Dr. Rochelle Walensky: (01:09:40) And we're starting to see the effects of this work. Just this morning, CDC released new racial inequity data on how we're doing in reaching racial and ethnic minorities with vaccines. The bar graph now shows not just our overall progress, but what we've done in the last two weeks. And in the last two weeks we've been really successful in reaching racial and ethnic minorities in ways we hadn't up until this time. So we have to do more. We recognize we have to do more. We have vaccine confidence consults that locals and states can call the CDC and say, we're having a hard time reaching people in this community, what are the things that we can do? This is just a brief list of the many, many activities that we are engaged with every single day to get vaccines into people for, and to recognize that all hesitancy is not the same flavor. Some people it's convenient, some people want to understand the science more, some people just need the time off. Sen. Tina Smith: (01:10:32) Thank you so much. Thank you, Madam Chair. I want to just say I appreciate the work of the CDC and others to support the innovative and strategic efforts of states like mine to overcome some of those barriers. Thank you. Chair Marie: (01:10:46) Thank you so much, senator. Senator Collins. Senator Collins: (01:10:48) Thank you. Dr. Walensky, I used to have the utmost respect for the guidance from the CDC. I always considered the CDC to be the gold standard. I don't anymore. And I want to give you three examples where I think the conflicting confusing guidance from your agency has undermined public confidence and contradicts the scientific guidance of many experts. The first has to do with school openings, an issue that we've talked about before. The New York Post reported that a powerful teacher's union, the AFT, successfully secured changes verbatim in draft guidance on school re-openings. This came about because of an outside group that did a FOIA requests that revealed extensive interactions between the AFT and the CDC. This has been described by Dr. Monica Gandhi, a professor who has written extensively about the coronavirus as very, very troubling. She's referring to the emails back and forth between the CDC and the AFT. Senator Collins: (01:12:19) And she says, "This is not how science-based guidance should work or be put together." My second example is from a New York Times story that appeared today. It talks about CDC guidelines on mask wearing, and where the CDC announced said less than 10% of COVID-19 transmission was occurring outdoors. The article points out that this is, "Almost certainly misleading," and goes on to say, "There is not a single documented COVID infection anywhere in the world from casual outdoor interactions such as walking past someone on a street or eating at a nearby table." The third example has to do with new guidance the CDC has issued for summer camps. And here are the reactions of two experts. One, a pediatric immunologists at Columbia referred to the recommendation as, "Senseless." The editor in chief of the Journal of the American Medical Association Pediatrics called the guidance, "Unfairly draconian." Senator Collins: (01:13:51) So here we have unnecessary barriers to reopening schools, exaggerating the risks of outdoor transmission and unworkable restrictions on summer camps. Why does this matter? It matters because it undermines public confidence in your recommendations, in the recommendations that do make sense, in the recommendations that Americans should be following. I'd like you to respond to why the CDC is not following the standard procedures. Why it's having offline secret negotiations with one stakeholder that was revealed only through reporting in a FOIA requests. Why it is exaggerating outdoor transmission. We know that masks make a big difference indoors, they don't outdoors. Dr. Rochelle Walensky: (01:15:02) Thank you for that question. Maybe if I could take each of your examples, one by one. First, the school guidance. As a matter of practice, the CDC engages with stakeholders, with consumers who take our guidance, who use our guidance before it is finalized so we can understand whether it addresses their needs. For our school guidance, we did that with 50 different stakeholders. Over 50, actually. I personally engaged with both parents and teachers and many different stakeholders to address what could be done to improve the draft guidance we had. One of those stakeholders recognized that in our guidance we had addressed what you do if you have immunocompromised children at risk of severe disease, but we had neglected, in our draft, to address what happens if you have immunocompromised teachers. Teachers who are getting chemotherapy, who have immuno-compromising diseases. Dr. Rochelle Walensky: (01:15:52) The request was that we add some language for what happens if you have immunocompromised teachers and how they should behave in school. That is what we did. We used CDC based science to make that addition, but the request was to address what happens if you have immunocompromised teachers. And that was an oversight in our initial draft. And we included a science-based response or a science-based language in our guidance. With regard to the New York Times piece this morning, there's a meta analysis from Journal of Infectious Diseases that was published in November, I believe, where the top line result of all studies that were included in the systematic review said less than 10% of cases were transmitted outdoors. It is that meta analysis that combined all different science from many different places. I think over 19 studies were included. Dr. Rochelle Walensky: (01:16:47) The top line result was less than 10% published in the Journal of Infectious Diseases. One of our top infectious disease journals. That is where that came from. It was a published study that synthesized study from many places. With regard to camp, I have a 16 year old, every year he comes home from camp and he writes the number of days until he returns to camp the next year. This year, it got to zero and I told him he wasn't going. I want our kids back in camp. We now have 38,000 new infections on average per day. Last May 11th, it was 24,000 and we sent a lot of kids home and camps were closed. The camp guidance is intended to get our kids to camp and allow them to stay there. Thank you. Senator Collins: (01:17:36) Madam Chair, I would just says unanimous consent that the full New York Times story dated today be placed in the record because it answers, I realize I'm out of time, it answers Dr. Walensky's response. Chair Marie: (01:17:55) So, Senator Kaine. Senator Kaine: (01:18:04) Thank you, Madam Chair. And thank you to the witnesses for your important testimony. Some of you have been before this committee so often. I can remember the first time you were before us on January 24, 2020, and so much has happened since then and there's so much to talk about. But my colleagues have done a good job already in addressing many of my interests. At the last hearing that we had together, which I believe was in March, Dr. Fauci, I talked to you a little bit about long COVID. When the day comes where the president declares that the national emergency is over, they're still going to be at least two challenges, long COVID, and then the mental health challenges that have resulted from a year of such loss. I want to ask Dr. Fauci and Dr. Walensky to dig into a little bit how you are using the funds that have been provided to deal with the long COVID issue for folks who are suffering symptoms after they've recovered from COVID. Dr. Anthony Fauci: (01:19:04) Thank you very much for that question, senator. This is really an important problem. The NIH has been given $1.15 billion to study this, and we're doing this in collaboration with CDC and other organizations. Long COVID is a real issue. Anywhere from 10, in one study, as high as 30% of individuals who recover from the acute manifestations of COVID-19, who have virologically no virus in them at all, and they should be on the road to an uneventful recovery. But unfortunately what we've been able to find out now, and we're going to be putting together a number of cohort studies to determine the extent, the duration, any possible underlying pathogenesis and any intervention. But the symptoms are somewhat common. There's a commonality among them. It's extreme, sometimes debilitating fatigue, muscle aches, temperature dysregulation. Dr. Anthony Fauci: (01:20:08) You feel hot or cold. Dysautonomia, which is related to that. Unexplained rapid heartbeat or tachycardia, neurological symptoms and what people refer to as brain fog, or the inability to focus or concentrate over an extended period of time. These are real symptoms and they can last for a long time. We have people that we follow now up to nine months or longer where this occurs. It's a very important problem. We take it very seriously. We have a task force at the NIH, multiple NIH institutes, not only my own, heart lung and blood, neurology and mental health, all of which are going to be looking at this over the next year or so, because it is something that we really do feel we need to find out what's the underlying cause and what we can do about it. Senator Kaine: (01:20:59) Thank you for that, Dr. Fauci. That's going to provide a lot of comfort to people who are grappling with these symptoms. Dr. Walensky, I want to shift to the second concern that I have. Again, we're not at a point yet where the emergency is over and yet even when we are at that point, the mental health impact of this very, very challenging time on the American public and people all around the world is very significant. I have worked closely with colleagues, including Senator Cassidy, really to pinpoint mental health impact on frontline healthcare workers whose experience of dealing with death and illness at such a massive scale, having to manage end of life conversations with people who would normally be having those conversations with their own family members. Senator Kaine: (01:21:42) This is a real significant concern. My colleagues supported inclusion of provisions of the Dr. Lorna Breen Act in the recent work that we've done. And I understand that CDC and NIOSH are starting to focus on public information campaign to frontline healthcare providers, to reduce stigma, to seeking mental health assistance. Should they need it? Could you talk a little bit about those efforts and more broadly the question of keeping our healers healthy? Dr. Rochelle Walensky: (01:22:12) Thank you very much for that question, senator, and for the resources. I think it would be hard to overestimate the trauma that our healthcare providers, our frontline workers have seen over this last year. Having been there before I was here, I can tell you, I'm pulling up to driveways in your hospital that have morgues in the parking lot. Is really a striking thing to find. I am grateful for the resources. NIOSH is collaborating with our injury prevention center within the CDC to create mechanisms and support tools to do outreach for our healthcare workers. And I would also mention that we saw mental health challenges ahead of COVID-19. So these are not just put mental health challenges because of COVID-19. Even among our youth between 2009 and 2019, before COVID ever started, we saw 40% increase in mental health challenges. So we need this, not just for our healthcare workers, but through, for the society at large. Senator Kaine: (01:23:10) Thank you very much. Thanks, Chair Marie. Chair Marie: (01:23:12) Thank you. Senator Cassidy. Senator Cassidy: (01:23:19) The doctors, thank you all for being here. I approach you now kind of as a physician who's done research in vaccines more so than I'm approaching as a senator. I was struck... and by the way, I'm incredibly frustrated and the American people are frustrated because they hear you're following science, but then they just have a sense that the lag time between the implementation of that and recommendations is far too long. It's not just the American people. I'll put it this way, not just the people in my state. Here's a stat article. CDC slow cautious messaging seems out of step with the moment. Want to go back to the office? Don't wait on the CDC. That's from Wall Street Journal. And the liberals who can't quit lockdown from The Atlantic. So first I was struck. When Senator Burr suggested that previous immunization actually confers immunity, did any of you agree with that? Dr. Fauci. Dr. Anthony Fauci: (01:24:14) Does previous immunization confer- Senator Cassidy: (01:24:16) Does previous infection confer immunity? Dr. Anthony Fauci: (01:24:18) It does. We don't know what the durability of it is, but it certainly does confer immunity. Senator Cassidy: (01:24:22) But we still recommend that they be vaccinated? Dr. Anthony Fauci: (01:24:25) Yeah, we do. Senator Cassidy: (01:24:25) That seems out of step. Dr. Anthony Fauci: (01:24:27) No, actually, senator, a study has shown very clearly that if you vaccinate someone who has previously gotten infected and recovered the level of neutralizing antibodies and T-cells are extraordinarily high, not only against the wild type virus, but also against the variants- Senator Cassidy: (01:24:49) [crosstalk 01:24:49] of that research, I've pulled some of that research which refers to that. My concern is that that would happen if you had another infection. All the immunization does is mimic a pre-existing infection. That is very well-established with other viruses. No one has not established it for this virus. And indeed some of this research shows that within four days, which is the window period, if you will, for an infection to become an illness, those antibodies rise quite precipitously, but we still recommend that they get two doses even though the same literature shows that there is an increase in side effects when someone gets a second dose and they've been previously immunized. So not life-threatening, but nonetheless an increase in side effects. But nowhere do I see a recommendation that, well, don't get the second dose because the literature shows that after one dose you've topped out your immunologic response and you're at an increased risk with the second dose. Would anybody like to speak to that? Dr. Peter Marks: (01:25:54) So there are studies ongoing to look at the first versus second dose. I agree with you, it is a very reasonable proposition for study. But the purpose of immunizing somebody who's been infected previously is to develop higher antibody titers. Those high antibody titers are what is so critical in preventing- Senator Cassidy: (01:26:13) If I may, again, the studies in other viruses show, hopefully we have research showing here, but it appears to that a re-immunization merely mimics what would happen if somebody were exposed to the virus. All it does is kind of mimic that which would occur. Dr. Peter Marks: (01:26:30) Senator, this is a different virus. Each virus is- Senator Cassidy: (01:26:33) This is a different virus, Dr. Marks, is the research going to explore that which I'm referring to because the research so far shows that within four days you get a significant increase in anybody titer? Dr. Peter Marks: (01:26:43) There's research that's been done to show that after vaccination, the nature of the immune response gives sufficiently high titer antibodies that the post-vaccination immune response- Senator Cassidy: (01:26:54) That's with every virus. That is not unique to this. Dr. Peter Marks: (01:26:57) It's likely superior to natural infection, in this case, in preventing against some of these variants. And I think that's what Dr. Fauci was getting to. Senator Cassidy: (01:27:05) And I'll also point out that the vaccines themselves and presumably the previous infection is also effective against the variants. By the way, can people go back to work if they've been vaccinated and not wear a mask, assuming they're not immunocompromised? Dr. Rochelle Walensky: (01:27:25) We have about a third of people in this country who are vaccinated. We have about a third of counties in this country that still have over 100 cases per 100,000. We are working to review our guidance and to update our guidance. We have put out three different- Senator Cassidy: (01:27:42) I'm sorry, let me just ask again. If I'm vaccinated and I have antibody and I'm exposed to somebody else, what is my risk of coming down with symptomatic infection? Dr. Rochelle Walensky: (01:27:52) 5%. Senator Cassidy: (01:27:53) 5% if I'm... No, that's overall, not if I've been vaccinated and if I have antibody, that's if I'm vaccinated overall, correct? Dr. Rochelle Walensky: (01:28:03) I don't think we have data on what you're looking at. We did not check antibodies on everybody who was vaccinated. Senator Cassidy: (01:28:08) But we could. Dr. Rochelle Walensky: (01:28:08) We absolutely could. But to date, we only have- Senator Cassidy: (01:28:11) And we do know that if we know that critical mass or if we know that herd immunity is somewhere north of 60 or 70%, if we go into a workplace where within that workplace, there is 100% immunization such as here, we've achieved herd immunity. Yeah, there's somebody in here that may not be responding to the vaccine, but because everybody else has, they're protected. That's nowhere reflected. And right now we have federal agencies which we've had employees not working for a year because the union says that they have to have special workplace precautions for them to return to work. There is consequence to this kind of delay as a stat article shows of the kind of updating of these recommendations. Senator Cassidy: (01:28:58) The American people are incredibly frustrated. And as Senator Collins says, they're beginning to disregard what you say that's true. Because so much of what you say is patently not true, I have to wear a mask when I'm outside and the wind's blowing at 20 miles an hour, that's been changed, but it was only changed recently. They seek not to believe those things which are true. You got to realize, you got to be more real-time. Let me finish with this. I don't know, there's was stat article in the New York Times that pointed on the HIV epidemic. The recommendations were much more kind of calibrated to real life. Senator Cassidy: (01:29:33) Listen, we know people are going to do this. If you're going to do it, please accept this recommendation. This is a blanket. Walk outside and wear a mask. You're vaccinated and everybody else's in the room is vaccinated, but you're wearing a mask. The American people just lost patience with us. With you guys. I just asked you to just kind of be aware of their frustration and get a little real-time into updating these things. I'm sorry to be so frustrated. I respect you all and thank you for your service. I yield back. Chair Marie: (01:30:07) Senator Baldwin. Sen. Baldwin: (01:30:12) Thank you, Madam Chair. Dr. Walensky, as you know, I led the effort to ensure that the American Rescue Plan included funding for CDCs work to address variants of the coronavirus, specifically through genomic sequencing. I am really encouraged to hear from your testimony that we are now sequencing 10% of our nation's weekly cases. And this is up from about, well, less than half of 1% in February when I introduced my tracking COVID-19 Variants Act. Couple of questions about what we're finding. Last month, the White House announced that it would provide initial funding to jurisdiction so that health departments could conduct, expand and improve activities to sequence genomes and identify mutations of the coronavirus. I'd like to have you describe how health departments are making use of this funding and how this investment will improve our response to future public health threats, but also any new new variants that we should know about, particularly anything troubling from the perspective of eluding the therapeutics and vaccinations that we have produced. Dr. Rochelle Walensky: (01:31:31) Thank you so much, senator. We are so grateful for those resources in our ability to scale up. As you know, we are now sequencing about 35,000 virus samples per week. That is a broad collaboration with commercial labs, with public health labs, with academic partners, and then with public health labs, sending samples to CDC so we can address them more completely. In terms of moving forward, I'm looking forward to bolstering the infrastructure, to be able to do these sequences at the local level, to producing the infrastructure within CDC, to be able to follow these in a pandemic related way, not just for this pandemic, but for future public health threats. And then further, to expand our ability and our workforce in genomic sequencing and analytics and bioinformatics, to be able to not just address COVID-19, but these are long standing things that we are going to need to address anti-microbial resistance and other infectious threats. Thank you. Sen. Baldwin: (01:32:30) Thank you. Last week, the administration announced support for the waiver of intellectual property protections on COVID-19 vaccines to help end the pandemic. I believe that this news is the beginning of our work to restore America's public health leadership on the world stage, but there's more to be done when it comes to addressing COVID-19 worldwide. Dr. Fauci, can you explain how increases in new cases of COVID-19 worldwide threaten the progress that we've made here in the United States and how can we avoid repeating history when it comes to combating infectious diseases worldwide? Dr. Anthony Fauci: (01:33:13) Thank you for that question, senator. Yes, indeed. As we've said so often, and it is true that a global pandemic requires a global response. And even if we successfully vaccinate our population and get the level of infection down to a very low level, as long as there's a dynamic of infection spread throughout the world, in any place in the world, there always is the danger that variants will be generated and ultimately will come to the United States because of the travel that we know makes no place in the world separate completely from any other place in the world. Dr. Anthony Fauci: (01:33:54) So that's something we really need to pay attention to. And it's for that reason that I keep saying, and many of my colleagues keep saying, we really do have a responsibility to the United States first, we do for sure, but we also need to take part in an effort, whatever effort. And it's going to be multifaceted effort to make sure that the rest of the world contains the outbreak. And that could be from some of the things we're doing right now with India, by giving them immediate help with oxygen and drugs and PPEs, but also to provide for the availability of doses of vaccine that we can make available to them, not alone, not just the United States, but the rest of the developed world. Sen. Baldwin: (01:34:32) Thank you. One quick last question to Dr. Kessler, in its first few months, the Biden administration has surpassed every goal and expectation it has set terms of getting shots in arms. Because of this effort we are moving into the next phase of our vaccination effort in which the focus is less on mass vaccination sites, and more about meeting folks where they are to get shots to hesitant and hard to reach individuals. As you know, these vaccines come with certain logistical challenges and limitations, including cold storage and use by requirements as well as specific numbers of doses in each vial. As we shift to a more individualized effort, how will the administration work to ensure that we are using our existing vaccine supplies effectively and minimizing the potential for wasted doses? Dr. David Kessler: (01:35:29) Senator, a very, very important question. Because as everyone on this committee has recognized and has been part of this heroic effort, initially certain decisions were made on how to maximize the number of doses produced. And the decision in order to get the hundreds of millions of doses that we've already administered, we've had to make certain trade offs. And that's why you see the packaging the way it is, which is in a considerable number of doses. And we have to reduce that packaging. But every day, senator, I am in awe of the contributions that many of our local community health professionals, community leaders, ordinary citizens are taking to be able to bridge the barriers that people are having. So I would like to get this eventually down into very small individual doses, but that's going to take time. And right now we're going to do everything possible to speed that up. Sen. Baldwin: (01:36:56) Thank you. Chair Marie: (01:36:58) Senator Murkowski. Sen. Murkowski: (01:37:00) Thank you, Madam Chairman. Thank you all for being here. A lot of frustration this morning, and I think as Senator Cassidy mentioned, it kind of reflects the frustration that Americans have with where we are. We're all tired with COVID, we're done with COVID, but as many have said, COVID is not yet done with us. But how we're able to make sense of the guidance that comes out of CDC is critically important. Alaska was very early on in making sure that the vaccine was available to all very quickly. And as a consequence, we were pretty proud of the fact that our numbers of vaccination were strong and we were number one in country. But when you start out first, you also then are the forerunner in demonstrating what it means to really see this vaccine hesitancy. And we're seeing that play out in different ways, in different shapes. Sen. Murkowski: (01:37:54) So I appreciated your comments, Dr. Walensky, to Senator Smith about the ways that we can address the concerns that have been raised. Whether it is where can I get the vaccine, is it safe, who do I look to for guidance. The State of Alaska did a survey that was released on Thursday that indicated that people are not looking to you all for guidance, they're not looking to our chief medical officer in the State of Alaska, they're looking to see what their friends and their neighbors do. They don't care what their senator or the folks from CDC do. So we've got a lot more work to be doing with regards to that. I want to speak to my particular frustrations, which you have had the benefit of multiple conversations with me. And that is how we can get our tourist sector back to work for even a small sliver of the season. Sen. Murkowski: (01:38:50) 1.3 million tourists come to the State of Alaska on a cruise ship. There were 48 tourists that came to Alaska on a cruise ship last year. And right now it doesn't look much better. We've been working back and forth with CDC, trying to deal with this conditional sale order. After many months of requests, we finally get to a place where we think we've got some guidance out there. I just, at 11:30, got new information that the CDC's last traunch of guidance still requires additional guidance to be published. And I say, yes, it's minor, but the fact of the matter is it is still yet one more gate that has to be gone through. And our reality is if you can't get ships turned North now there is no season, whether it is for one week or one month. Sen. Murkowski: (01:39:47) And so I guess, Dr. Walensky, I'm going to ask you one more time, can you give Alaskans any guidance at all with regards to the ability to finally get this guidance fully resolved? You've got cruise lines that are saying, we're going to require everybody be vaccinated. All of our crews will be 100% vaccinated. We will require that those who want to sail on our ships this summer be vaccinated. Those in the communities who are welcoming them are also equally committed to the vaccine. So should I just tell folks back home, don't even bother ramping up your seasonal operations because it's just not coming, we can't get that guidance from the CDC? Dr. Rochelle Walensky: (01:40:34) First of all, senator, let me congratulate you and Alaskans for getting vaccines into arms because have been a role model in being able to do that. With regard to sail, I was here in March. We were waiting on 2A guidance. That 2A guidance of working with ports has since come. We have been now engaging, as I noted we do with schools, with our consumers, with our key stakeholders. We have had twice weekly calls now with the cruise ship industry to understand how they are interpreting their guidance and what they need in order to be able to get boats back in the water. That is our goal for this season. Mid summer was our goal. 2A has been released, 2B has been released. Our guidance on how we get trial voyages into the water, as well as step three released, how you get conditional sail certificates. Dr. Rochelle Walensky: (01:41:23) All three of those have been released. We have been in this dialogue with the industry so that we can understand what are the challenges in the current guidance that are hard to be met. And we are actually having these conversations and then going back and addressing those challenges. We had a Dear Colleagues letter that went out after 2A, and we have others that are in the work. So we are working with those in the industry to do our best to get ships back in the water this season. And we have actually agreed to a five day turnaround when those proposals come to us. Sen. Murkowski: (01:41:54) Well, it was news to me to, again, just see that there is yet another thing that has come up just this morning. So I'd ask you to take a look at that. My time is- Sen. Murkowski: (01:42:03) ... come up just this morning, so I'd ask you to take a look at that. My time is expired here, but I must raise this fishing mask mandate. If you think about those mandates, they really don't make sense. The fact that the coast guard is requiring, because it's federal law out there, that persons traveling on a conveyance or at a transportation hub wear a mask for the duration of their travel. So I've got fishermen, commercial fishermen that are out there in the water. I've got crabbers and salmon fishermen and cod fishermen that are trying to deal with a mask because they're concerned about failure to comply. This is more of a safety hazard than anything. You're out on a boat, the winds are howling, your mask is soggy wet. Tell me, tell me how anybody thinks that this is a sane and a sound policy to do. Sen. Murkowski: (01:42:58) So we've got a situation right now where the fishermen are more concerned about the liability in failing to have the mask on rather than prudent marine safety protocols. This is absolutely, absolutely a crazy policy. I just don't understand. I don't understand how we put our coast guard men and women in a situation where they know that safety is at issue, a broader safety issue than the fear of transmission when you are outdoor in the elements and you are now being required to wear a mask. So I would hope that the CDC would reconsider this quickly, quickly, quickly. Dr. Rochelle Walensky: (01:43:47) We're in the process of finalizing industry specific guidance for exactly this reason. Thank you. Sen. Murkowski: (01:43:51) Thank you. Thank you, Madam Chairman. Patty Murray: (01:43:53) Thank you. We will turn to Senators Murphy, Marshall on Hassan. A vote has been called. I'm going to go over to the floor and vote. Senator Burr will preside and I will be back as quickly as possible. We'll go to Senator Murphy. Senator Murphy: (01:44:06) Thank you, Chairwoman Murray. Thank you all for the fantastic work you do to protect the country. Just a quick word on this frustration you're hearing regarding guidance from the CDC. I mean, listen, our witnesses today could sit here and claim that we have definitive information on risks or means of transmission or asymptomatic transmission, but they wouldn't be telling the truth. We suffered through four years with a president who literally made things up about this virus, who simplified the story over and over and over again because he thought simplifying things and being definitive would make him look good, including giving free medical advice to Americans on what therapies they should take, making claims that the virus would disappear after a matter of weeks. That wasn't good for the country. It didn't help us fight this disease. We still have a lot to learn. Senator Murphy: (01:45:05) And so I frankly appreciate the fact that we have leaders today who recognize that we still have gaps in information, who occasionally may err on the side of caution in order to save lives. And I share the frustration, but the frustration is rooted in the fact that we are still less than a year and a half into a virus that we're still beginning to understand. And so to that end, Dr. Walensky, on this question of outdoor transmission. So Senator Collins was asking you about a paper you put out suggesting that it could be 10% of cases. There's other folks that say it could be 1% of cases. There are some epidemiologists who say that it could be 0.1% of cases. That's a really important difference and I assume the difference between 5% and 0.1% would likely educate decisions you would make about what recommendations you make to summer camps. Senator Murphy: (01:46:16) How do we, on this question, close the gap in information that we have? Given that there are so many competing analysis out there of outdoor transmission, what do we do to try to make sure, especially heading into this summer that we have the best information possible? How do we solve for this problem? Dr. Rochelle Walensky: (01:46:39) Thank you Senator for that question. I think it's important to realize that we at CDC are responsible for putting out guidance for individuals as well as for populations for public health. We're responsible for putting out guidance for counties that have less than five cases per a hundred thousand and for counties that have greater than a hundred cases per hundred thousand, as well as for counties that have less than 10% of people vaccinated and counties that have more than 50% of people vaccinated. Our guidance has to be science-based for all of these situations. In our last iteration of what vaccinated people can do, safely do. We did update our guidance, not only for not wearing masks outdoors, but also for not wearing masks outdoors in certain settings for people who are unvaccinated. In those situations, we also said if people are gathered with other unvaccinated people dining with their masks off and close by, there may be a risk to that if they're dining close by. Dr. Rochelle Walensky: (01:47:34) Certainly this meta analysis that was put forward that demonstrated the top-line result of less than 10% transmission occurring outdoors was helpful scientific evidence and we are following the science as it continues to emerge. I think it's also really important to recognize that now with vaccination of 12 to 15 year olds, our summer camp guidance is probably going to have to change in those settings and we plan to do so. Senator Murphy: (01:47:58) Great. Dr. Kessler, question for you on booster shots. You've included in your testimony an expectation that we may be in the business of purchasing and distributing booster shots, maybe as soon as later this year. I asked a question the last hearing about the transparency of contracts with the companies that are supplying vaccines. I still think that we could do better in terms of letting the American public know and policymakers know about the financial terms of these contracts. But what do we expect when it comes to contracting for a booster shots? Are we going to go back to the same companies that provided the vaccine? Are we going to open that tender up to a broader set of companies? How do we expect the process of procuring booster shots to work and how do we make sure that it adequately protects taxpayer dollars? Dr. David Kessler: (01:49:02) Senator, thanks for the question. Very important. We're in that process now in order to plan because that's really what we're doing. If we want a vaccine, let's say both the duration of immunity, increase in age so there're less antibodies and the variants, we have to take all those things into consideration. And if we want vaccine end of the year, we have to do that now and we are in fact in those negotiations. The best science to date, I mean, the data we have, and I don't want to get too technical, but the question is, are we dealing with homologous boosts or heterologous boosts? Basically, are you going to boost with the same vaccine or can you switch that out and do mix and match? And that requires data where collecting that data and it's going to be the data that drives what we boost with. Dr. David Kessler: (01:50:22) But for planning purposes, I think the simplest and safest assumption, and I underline the word assumption, is that it may be for at least the short term, that homologous boosts with the same type of vaccine makes the most scientific sense. But I need a couple of more months in order to give you a definitive answer, but I have to plan now. So specifically to answer your question, we are dealing with the same companies because we want to continue with the safety and efficacy that we've seen in those vaccines. Down the road, that may change as we get other, for example, protein-based vaccines available senator. Senator Murphy: (01:51:10) I was just going to say I hope that this committee is actively involved with the administration on the construction of those contracts to make sure that we're adequately protecting our taxpayers investment. Thank you, Mr. Chair. Senator Burr: (01:51:25) Senator Braun. Senator Braun: (01:51:29) Thank you, Senator Burr. Dr. Walensky, think from the get go, there's been that uncertainty of when we arrive at the moment when many of us feel that this is truly in the rear view mirror. And from the early conversations I've had and being on this committee, it's always been interesting to understand I think if and when that comes with clarity, that's the only way I think we get true comfort back into the country. Senator Murphy, others have mentioned how things have changed, goalposts have moved. I think that's inherently confusing to people, especially ones that might have other reasons for not getting vaccinated. And I think that it's so important that we get there, everyone vaccinated. My question is I think on the education side of it, more emphasis and resources need to be put into rural America. Senator Braun: (01:52:24) I think along with the logistics that have been some effort made there to improve it. I think it's inherently more difficult to get vaccines in the arms when it's spread out in areas like that. But I'd like you to zero in on, it was three feet, it was six feet and then three feet, indoors and outdoors. So many things have evolved, and I think with something as uncertain as this, it's natural to have that dynamic. Where in time and does natural infection go along with vaccination to have some weight in that point in time where cases really start to fall off the chart? Dr. Rochelle Walensky: (01:53:13) Thank you so much for those questions, senator. Maybe I'll start briefly with the rural and say in our efforts over this last several weeks, resources have gone broadly to rural communities. We are now funding federally qualified healthcare centers, getting vaccines into areas in those centers. Over five million vaccine doses have been given through FQHC. So we know we need to do that outreach and that is part of this next chapter. In terms of the six versus three feet, I think from the school guidance, I know from the school guidance, the first iteration that was put out in February, the biggest challenge to getting children back to school was the six foot guidance. What happened soon thereafter is science emerged and because six feet proved to be such a challenge, within a month, we had three studies that demonstrated that three feet and six feet were equivalent for younger children, and so it was based on those science. Dr. Rochelle Walensky: (01:54:08) I would really like to say that we're in a static situation here and that the science isn't changing, but we are changing our guidance as the science evolves and as the science emerges, and we have to remain humbled to that science. With regard to your question regarding natural immunity, we have several challenges there. The CDC on its website has a map of presumed of seroprevalence by state as to how many people out there have antibodies. And of course, we don't know all of the infection that has happened, right? Because much of this infection has been asymptomatic. As Dr. Fauci has said, that prior infection likely confer some immunity. It might confer full immunity for some period of time. But I will say that we're still learning and being humble here. This past week, our genomic surveillance data demonstrated that 72% of our sequences are now the B117 variant. Dr. Rochelle Walensky: (01:55:02) What do we know about how long prior infection will last with regard to new infection and to B117 variant if you're not vaccinated. We don't have all of those data yet. We're doing studies, we're evaluating it. But I do think that we should continue to encourage vaccination of people who have had disease before. Senator Braun: (01:55:25) Thank you. Dr. Fauci, J&J vaccine, which I think for many people was a preference in terms of just being one shot and had a high efficacy rate to boot. Do you think it was a mistake in that we pulled it when statistically the rate of an incident was so, so low, lower than I think on many other drugs out there that seemingly have much higher side effect consequences? Was that a setback that put us in a place that has really hurt us or have we recovered from it? Dr. Anthony Fauci: (01:56:05) I don't believe it was a setback, senator, and I think if it was, we certainly have recovered from it because we now know when you ask people, there's a lot of people who really want to get a dose vaccine, waiting for the availability of this. What I do think it did that you don't fully appreciate is that it really underscored how seriously we take safety because to call a pause on a adverse event that as you mentioned correctly is really quite rare. Of course, at the time there were six cases in about 7 million people, which is less than one per million, which is really a very, very low around. The FDA and the CDC looked at the data. They wanted to find that if there are any more, they wanted to alert the physicians who might be out there seeing patients about what the proper way to treat them because there's one general way to treat that people might use that would actually be contra-indicated namely with heparin. Dr. Anthony Fauci: (01:57:12) So when the long run and the big picture, when all was said and done, I do not believe it was a setback. I think it really underscored how seriously we all take safety. Senator Braun: (01:57:22) How many vaccinations do we need to get fully in the arms to be at what the theoretical herd immunity would be and cases crash? Anybody. Dr. Anthony Fauci: (01:57:35) Yeah. I think that's going to be a difficult number to give because herd immunity as a concept means you get enough people vaccinated, enough people infected so that you have a core of protected people that's a blanket of protection over even the vulnerables who cannot. The threshold of herd immunity is a number we don't know yet for this particular virus. We know it for measles, but we don't know yet what that is. We can guess it's somewhere between- Senator Braun: (01:58:05) That uncertainty is probably the thing that is going to be the hardest thing to grapple with to get this fully in the rear view mirror. So thank you. Senator Burr: (01:58:13) Thank you, Senator Braun. Senator Hassan. Senator Hassan: (01:58:14) Well, thank you, Ranking Member Burr. Thank the chair for holding this hearing and really thank you to all of our witnesses today for not only being here, but for your service. Before I get to a question, Dr. Walensky, I just want to second what Senator Murkowski said about getting the guidance to the fishing industry out as quickly as you can. I just met with my fishermen at the Yankee Fishermen's Co-Op in New Hampshire this week, and we've got boats of fishermen who are fully vaccinated who see the coast guard coming, telling them they have to keep their masks on. Not only is a wet mask dangerous out on the open water, but because of the noise, both the wind and the equipment, these guys are used to relying on kind of sign language on the boat, and with a mask on, they really can't and it's a real safety issue. So I hope you will take this under advisement and get the guidance out as quickly as you can. Senator Hassan: (01:59:02) Dr. Fauci, I wanted to follow up a little bit. We've been talking about the very good news of the Pfizer authorization for 12 through 15 year olds and it looks like they may be seeking at least emergency authorization for two to 11 year olds in September. And that's really welcome news, but many families are still looking for guidance about how to protect children under the age of 12 from the virus until a vaccine is authorized for them, especially as public health restrictions are being lifted around the country. And I'm hearing some from parents that the schools are mostly reopened or hybrid reopened, but they're kind of nervous about sending their children to school. So what advice do you have for families about what steps they can take to protect their children from the virus while we await FDA authorization for use of the vaccine for kids? Dr. Anthony Fauci: (01:59:53) My recommendation, senator, would be really to follow the CDC guidelines. I mean, when the children are in the home with vaccinated individuals, the guidelines are clear what needs to be done. When they're outside, many things you can do without a mask outside, but if you're not vaccinated and you're interacting with people outside of the home from different locations, you want to be careful and have the children have masks. So I think a good following of the CDC guidelines, which as Dr. Walensky says, continue to evolve in real-time as they get more data, the guidelines get updated and upgraded. So that would be my recommendation. One other thing that I think is important is that there's a lot of work that we're doing now in clinical trials to get vaccinations for children younger than 12. Dr. Anthony Fauci: (02:00:40) So a bunch of companies, several of them are doing what's called age deescalation studies, where we're looking at children from 12 to nine, nine to six, six to two, and then six months to two years. We think by the time we get to the end of this year, that we will have enough information to vaccinate children of any age. Senator Hassan: (02:00:59) Well, that will be very welcome news to a lot of parents. So thank you. Dr. Kessler, I want to follow up on a line of questioning that Senator Murphy was following. We've heard encouraging news certainly that the protection from the COVID-19 vaccines remained strong for at least six months and likely longer, but also that Americans may need booster shots, as you all just discussed. It's going to be really critical that these vaccines remain accessible and that their price reflects the large investments that American taxpayers made in the research and development of the technology. So what steps should Congress take to ensure that COVID-19 vaccines, including booster shots if needed remain available to Americans even after the end of the public health emergency, and how can we ensure that pharmaceutical companies price these vaccines in a way that account for taxpayer investment? Dr. David Kessler: (02:01:56) Senator, a key question. Let me assure you that because of what this committee has done and your colleagues on appropriations, we do have the funds to purchase the next round again, if they are necessary. So we will be able to purchase the next round and to assure that if there are boosters, they are free just as the last round. I think you raised a very good question. Beyond that, beyond 2022, I look to your guidance and your colleagues on, at what point do you transition back to a commercial market? But I think for this coming round, we are going to proceed as we have proceeded and you've made those funds available. Senator Hassan: (02:03:00) Well, I look forward to continuing the discussion. I see that I am almost out of time here, but I did want to just ask Dr. Walensky quickly, can you speak to the importance of continued access to COVID-19 testing, even as we work to distribute the vaccine and we're building up our community and herd immunity. Dr. Rochelle Walensky: (02:03:22) Yes. Thank you very much for that question. First of all, we recognize that right now, we we've done an extraordinary job in getting vaccine to a third of Americans, and yet two thirds of Americans don't yet have vaccine. And in fact, our young children will not have access to vaccine for the rest of this year. We have put out $10 billion towards states to be able to do testing programs within schools. Some higher ed have been able to successfully engage in this past semester through testing programs on their college campuses. We're going to need to continue testing through our long-term care facilities, as well as our correctional facilities, our dense industries. And so, yes, I think there has to be a huge corner of what we are doing that is related to testing. Also, surveillance water testing, sewage testing to look for outbreaks. Dr. Rochelle Walensky: (02:04:11) So we're doing a lot in the testing area. We're really grateful for the resources to be able to do so. Once we have vaccine in the majority of people, we are still going to have disease out there and we're going to need to rapidly be able to detect it. Thank you. Senator Hassan: (02:04:24) Thank you very much. Thank you, Madam Chair. Patty Murray: (02:04:26) Senator Marshall. Thank you. Sen. Marshall: (02:04:27) Thank you, Madam Chair. Dr. Fauci, do you think it's possible that COVID-19 arose from a lab accident at a lab in Wuhan and should it be fully investigated? Dr. Anthony Fauci: (02:04:38) That possibility certainly exists and I am totally in favor of a full investigation of whether that could have happened. Sen. Marshall: (02:04:45) Great. Is it possible COVID-19 is not naturally occurring? Dr. Anthony Fauci: (02:04:51) Again, that is a possibility. I don't know if we're ever going to be able to approve that, but you always need to open up and leave all possibilities, which is the reason why I and so many of my colleagues are very much in favor of what the WHO said that they want to go back again and take another look in there and see what was going on in that lab. Sen. Marshall: (02:05:10) And will you commit to get this committee all the records, anything to do with any type of viral experiments, say from 2013 to the present so we can review those? Dr. Anthony Fauci: (02:05:21) Certainly. I would comply with any requests of the committee. Sen. Marshall: (02:05:25) Do you and other at NIH have a conflict of interest when determining that the labs and lab work you help fund should be investigated and how it's investigated? Dr. Anthony Fauci: (02:05:35) No, I don't think it's a conflict of interest. We're very open and wanting to make sure that everything that has any question is looked into at all. I have no problem with that. Sen. Marshall: (02:05:44) Okay. In 2013, President Obama placed a moratorium on viral gain-of-function studies with some loopholes, which you were able to use at certain times. I don't know if we disagree. We can discuss what's viral gain-of-function and what isn't. But in 2017, you had a long process and I assume it was you that decided to lift this moratorium. And my question is this, during the review, did you consider the risk of dual applications by military, terrorists or other foreign actors? Dr. Anthony Fauci: (02:06:18) I'm not sure what you mean by that, senator. Did I consider applications from dual actors? We- Sen. Marshall: (02:06:24) I'll say it again. Did you consider the risk of dual application, that there might be other folks that would use some of the GoF discoveries, that they might be used by military, terrorists or other foreign actors? Dr. Anthony Fauci: (02:06:40) Well, in any research that we do, we publish the research. It's available for anyone to use it in any manner in which they can. That's the modus operandi of the NIH. We fund research, the research is made public. Sen. Marshall: (02:06:55) Is there a national security consideration though in that type of decision, thinking that viral gain-of-function could be more powerful than the nuclear weapons? To share that information with a government foreign actor would have been like trying to do the Manhattan Project and nuclear energy, nuclear weapons, doing it with say Hitler or the Soviet Union. Dr. Anthony Fauci: (02:07:18) I'm not sure what you're getting at, senator, but we don't fund research. We have committees that look at that to make sure that research that is of any potential danger is not funded. So I'm not exactly sure what your point is. Sen. Marshall: (02:07:34) My point is, is there national security implications with something as theoretically lethal as viral gain-of-function? Dr. Anthony Fauci: (02:07:43) Sure, there is. That's why we have committees. We have a P3CO committee, which is the Potential Pandemic Pathogen Care and Oversight. And that's the committee separate from the NIH that looks at these types of grants to see if they need to be funded. So there is a considerable amount of oversight to make sure grants that are doing research that would obviously be of danger is not performed. Sen. Marshall: (02:08:13) So when you made the decision to stop the moratorium on gain-of-function, were there national security advisors in the room? Was there state department, was there defense department? Who were those people that might've been part of that decision? Dr. Anthony Fauci: (02:08:26) First of all, I did not make the decision to pause the gain-of-function. If one looks at what actually happened, we put a pause on and I was the one that was very much in favor of that pause in- Sen. Marshall: (02:08:40) [crosstalk 02:08:40] 2013. Dr. Anthony Fauci: (02:08:43) In 2014 to 2017. The pause was lifted because we established a committee that looked at what we called P3CO. Sen. Marshall: (02:08:55) I'm familiar with it. Dr. Anthony Fauci: (02:08:56) Right, exactly. And when that committee then was able to make decisions about granting a part from the NIH so that we would not have any decision and it would be a decision- Sen. Marshall: (02:09:06) I got one last question I want to sneak in. I still don't know that you answered, was there national security people in the room when that process, that if someone made the decision, I think you led that decision, but we'll come back to that. Here's my last question. If COVID-19 is indeed a product of lab manipulation, can you sit here and unequivocally say the viral studies that NIH helped fund could not be indirectly or directly related to this final COVID-19 virus? Dr. Anthony Fauci: (02:09:35) Yeah. Looking at the experiments that were done that we funded, there would not be that possibility. Sen. Marshall: (02:09:40) Unequivocally. Dr. Anthony Fauci: (02:09:41) Well, they're talking about a hybrid virus of a mouse virus that was adapted to a mouse that anyone that knows anything about virology would realize that that is not something that would infect a human, much less be pathogenic and transmissible. Sen. Marshall: (02:09:58) But we helped make the mouse that had the HLA receptor that this COVID-19 was specific for and NIH was involved in the development of that humanized mouse? Dr. Anthony Fauci: (02:10:09) Yeah. Yes, but as I mentioned in response to Senator Paul, the NIH and NIAID did not fund gain-of-function research to be conducted at the Wuhan Institute of Virology. Sen. Marshall: (02:10:24) But that's not my question. The question is, could some of the funding you did, you can call it gain-of-function or not, developing the HLA receptor, the mouse. I'm not sure if you're going to call that gain-of-function or not, probably not, but could some of the funding indirectly ended up to the contribution of COVID-19? Dr. Anthony Fauci: (02:10:43) I'm not sure exactly where that question is going. I mean, you could do research on something as benign as looking at something that has nothing to do with it, and it could indirectly, someday, somehow be involved. So if you want to trap me into saying yes or no, I'm not going to play that game. Sen. Marshall: (02:11:00) But we need to look at that very, very deeply and consider exactly... That's why you committed earlier to sharing all the [crosstalk 02:11:07]. Dr. Anthony Fauci: (02:11:07) I'd be happy to share any information you would like with the committee. Sen. Marshall: (02:11:10) Thank you so much. I yield back. Patty Murray: (02:11:12) Thank you. Senator Rosen. Senator Rosen, I believe you're on mute. We're going to hold one second for Senator Rosen's mute function to work. I believe they're trying to undo Senator Rosen's mute function from the studio. Senator Rosen, if you can just be patient with us for a minute while we get that fixed. I'm going to go ahead and ask a question, and Senator Rosen, if you can just hold for just a minute. I wanted to ask Dr. Walensky, there are variant strains of COVID-19 that threaten to disrupt progress made towards ending the pandemic. And the CDC reports that the B117 variant is now the predominant strain in the United States. We need to know which variants are out there and how they're spreading and who they're spreading to, which is why we approved $1.75 billion in the American Rescue Plan to help CDC shore up its genomic sequencing and surveillance activities. Do you have enough data? Do you have the right data and the right data systems to be able to track these variants as they spread? Dr. Rochelle Walensky: (02:12:53) Thank you, Senator. We have scaled up our sequencing dramatically as I have noted. And every two weeks or so, we get an update in data and we look at where these sequences are. Just yesterday, I believe, the most recent update that demonstrated 72% of our cases are now B117, 6% are now P1, and we're grateful for the resources to be able to do so. Generally, our ballpark was to have 10% of all circulating virus to be able to be sequenced. And so with cases coming down and our sequencing rising up, we've been able to reach about that 10% mark right now. That has required a lot of collaboration across, across government, across commercial labs and whatnot. The function and the impact of these, whether they are variants of concern, variants under investigation, how we understand these is related to an inter-agency collaboration with BARDA, NIH and CDC, in terms of seeing how transmissible they are, as well as how well they function against monoclonal antibodies in our vaccines. Patty Murray: (02:14:09) Thank you for that. Senator Rosen, do we have your back? Senator Rosen: (02:14:12) I think we're back. Can you hear me now? Patty Murray: (02:14:14) Yes, we do. Senator Rosen: (02:14:15) Oh, very good. Sometimes, Zoom happens. There you go. Well, thank you, Chair Murray. Appreciate your patience, appreciate you calling this hearing. Extremely important. And so for you, for all the scientists, the medical personnel, the frontline workers, I'm so grateful for what everyone's been doing to be sure that we can keep the American people, really people around the world safe, healthy and informed. So, Dr. Fauci, when we last spoke in March, you shared that NIH had just launched a billion dollar initiative to study the long-term effects of COVID-19 and identify potential of prevention and treatment measures for the long haulers. Because COVID-19 of course is a novel virus, there are so many gaps in our research and unknowns for the people who've been affected and are still suffering. And that's why I introduced bipartisan legislation that will ensure that NIH will continue to be able to work with the CDC on comprehensive and longitudinal studies of a diverse group of COVID-19 patients. Senator Rosen: (02:15:19) I know some of the research has already been done, it's going to go forward. So you shared earlier some updates along COVID. Could you speak to the research gaps that remain for learning more about the long-term effects, such as lung capacity, heart function, some of the things that people really seem to be struggling with once they've recovered from their initial symptoms? Dr. Anthony Fauci: (02:15:40) Well, thank you very much for that question. Yes, we have initiated a series of studies. First of all, building up cohorts so that we can get enough individuals in the cohort to be able to do the kinds of studies that you're going to do. As I mentioned in response to a prior question, it's a multi institute endeavor involving multiple NIH institutes with differences- Dr. Anthony Fauci: (02:16:02) ... involving multiple NIH institutes with different interests in different organ systems. Just as you said, the National Institute of Heart, Lung, and Blood is one that is looking at some of the issues that you raised in your question. The National Institute of Neurological Diseases and Stroke, the National Institute of Mental Health, and my Institute, the National Institute of Allergy and Infectious Diseases. We've also just now started the request for applications to be able to gather the cohorts and do those types of studies. So there's a considerable amount of interest in this and a major commitment on the part of the NIH to study this thoroughly, to fill in some of the gaps that still remain as to what the pathogenesis of this particular syndrome is, because it is a real syndrome that is very troubling to a large number of patients. Senator Rosen: (02:16:55) Thank you. I'd like to move to the other part of this equation, which is the therapeutic research and development. Because even though people are getting vaccinated, of course, there's still people getting sick, and there are people, like you said, still suffering chronic pain, chronic illness as a result of COVID-19. And so we have to be sure that we have those tools to continue to treat any cases that come forward. So could you give us any updates about what therapeutics might be in the pipeline? And do you think, is there a potential for any of these treatments to help some of the long haulers? Maybe it can treat acute and chronic illness as a result of the function of COVID? Dr. Anthony Fauci: (02:17:36) Senator, it's an excellent question, but it's almost impossible to talk about treatment when you don't know what the underlying pathogenesis is. So that's the reason why the studies are starting off by gathering the cohorts and trying to find out if there is a mechanism for some of the symptomatology. The profound fatigue, the muscle aches, the temperature dysregulation, the sleep disorder. The brain fog, as they call it. So we don't know exactly what the mechanism of this symptomatology is, and for that reason, it becomes very difficult to do anything other than symptomatic treatment for these individuals. That's why it's so important to do the studies that we're planning to do, so that hopefully when we understand the mechanisms, we'll be able to have some therapeutic intervention. Senator Rosen: (02:18:27) Well, thank you. I appreciate that, because it's really going to be important moving forward, it's going to be important to our health care workers, to our surging of hospital capacities, and actually globally around the world. So I just thank you for that. I look forward to reconnecting with you as we begin to see more results of this really important longitudinal research and the progress that it's making. Thank you, Madam Chair. I yield back. Dr. Anthony Fauci: (02:18:54) Thank you. Patty Murray: (02:18:54) Thank you very much. I wanted to ask, the pandemic's deadly impact on communities of color shows we have a long way to go to address systemic racism and health inequities in this country. Black and Latino people are receiving vaccinations at disproportionately low rates, and some of the systems that are designed to make vaccinations easier, like online registration for appointments, have actually made it harder for some, like our Native Hawaiian and Pacific Islander elders. Additionally, AAPI communities have experienced higher rates of discrimination and violence, as we know, since the start of this pandemic. So Dr. Kessler, I wanted to ask you, how is the federal government working to decrease COVID-19 related health inequities? Dr. David Kessler: (02:19:44) Senator, thank you for the question. Enormously important. There's some at least initial good news. We've seen the deaths are down dramatically since January, and we all know that they're down 80% among seniors, but that drop includes a drop among Hispanics of 80%, and among African-Americans of about 70%. And in the past two weeks, 55% of the people vaccinated were white, but 45% were non-white. That compares to the general population, that's about 60% white and 40% non-white. Dr. David Kessler: (02:20:32) We have much more to do, especially in the area of confidence. We do see that people's confidence in the vaccine is increasing. Black Americans' confidence increased by 24 points since January, and Latino Americans' confidence increased by 22 points since January, but outreach access is absolutely critical. These vaccines are free. Every adult in America is eligible in about 80,000 locations, but we have a lot more work to do, and we are keeping equity at the center of the response, and we will not leave anyone behind. Patty Murray: (02:21:23) Okay. Thank you so much for that effort, and I appreciate it. Senator Burr, do you have any closing questions or comments? Senator Burr: (02:21:31) Madam Chairman, thank you. Yes, I do. I've got a little bit of cleanup, if I can. What I've been able to piece together since we started, and this is to you, Dr. Marks, and maybe Dr. Kessler. BARDA signed a contract for $1.2 billion, for 300 million doses of AstraZeneca vaccine. That's currently authorized in 70 countries around the world, its manufacturing capacity in 15 countries and 25 sites. In addition to the Baltimore Emergent facility, two sites in the US manufacturing in Ohio and New Mexico of AstraZeneca vaccine. So here's my question. Of the stock that we currently have on hand, which I estimate to be about 60 million doses, is all of that being held because it came from Emergent? Or in that 60 million inventory that we have today, is some of that either foreign manufactured and-or Ohio or New Mexico, and would not have to be held up because of the current inspection concerns at Baltimore? Dr. David Kessler: (02:22:53) Senator, I have been talking to AstraZeneca, even last night. I've been talking to them regularly over the last several weeks. To answer your question very specifically, the 60 million that you referenced, all that drug substance was made at Emergent. There is another facility at Catalent that manufactures drug substance, but we've not contracted and we are not involved, and that's for global. There are two other facilities, one in Westchester that you referenced, that is for drug product, but everything that we have involvement is in that 60, that has been produced for that first initial 100, and they stopped at 60, when because of the problems at Emergent, are all being reviewed by our colleagues at FDA because of issues at Emergent. Senator Burr: (02:24:16) Follow-up question. Of the over two million doses that went to Mexico, a million and a half doses that went to Canada, have there been any indications from those vaccines if they have, one, I assume they have been used. Is there any reason to believe that they were reporting any adverse effects? Dr. Peter Marks: (02:24:38) Senator Burr, no, and those came from a time when that facility was not being used for more than one vaccine. To produce more than one vaccine, sir. Senator Burr: (02:24:54) So the fact they produce not only AZ, but J& J, now makes them susceptible? Dr. Peter Marks: (02:25:06) It's a matter of public record that the problem that occurred at the facility involved a contamination event between two vaccines. Senator Burr: (02:25:13) Okay. Dr. Peter Marks: (02:25:14) And that was the issue that we are dealing with. But I just should add that you have our commitment that we are going to work as quickly as we possibly can to get both clearance of the doses that are currently being held, because we don't have clearance of the safety of those doses yet, and also to get that plant back up and running in a matter that's fully consistent with what Americans expect from their pharmaceutical product. Senator Burr: (02:25:51) Okay. This question, I'm going to go to Dr. Fauci, Dr. Marks, and Dr. Walensky. What percentage of the employees in your institute, your center, or your agency, of your employees, has been vaccinated? Dr. Anthony Fauci: (02:26:13) I'm not 100% sure, Senator, but I think it's probably a little bit more than half, probably around 60%. Senator Burr: (02:26:19) Dr. Marks? Dr. Peter Marks: (02:26:21) I can't tell you the exact number, but it's probably in the same range. Some people vaccinated at our facility, and others outside of the facility. Senator Burr: (02:26:30) Dr. Walensky? Dr. Rochelle Walensky: (02:26:31) We're encouraging our employees to get vaccinated. We've been doing town halls and education seminars. Our staff have the option to report their vaccination status, but as you understand, the federal government is not requiring it, so we do not know. Senator Burr: (02:26:46) Okay. And listen, you're the face of why people should get vaccinated, and knowing, and promoting, and confidently giving numbers, percentages, I think is really, really important as we go into this last part. Now, if you tell me that there's some statute that says you can't require somebody to tell you, imagine being the parent of a school aged kid, who for generations has been required to have their kids vaccinated before they could start school. And the fact that even within our health organizations, we can't require that of people, we're going to have tough decisions to make. Employers are going to make those decisions. There have been decisions already made by colleges around the country that said, "If you're on faculty or you're a student, you're not coming next year if you're not vaccinated." Now, they have the ability to do that. These are tough questions with even tougher answers, but if we're going to get that last mile coverage, we're going to have to start portraying that we're willing to do to ourselves what we're asking the American people to do. Senator Burr: (02:28:04) Dr. Walensky, I think it's safe to say that the 21st century is something that CDC has not totally entered, but I'm confident that you're going to take them there. And especially as it relates to science and technology. My question is simple. Do you believe the CDC Director should meet with private industry and innovators who have new technologies that can help modernize the CDC? Dr. Rochelle Walensky: (02:28:31) Thank you. I think I have an extraordinary opportunity as being Director of the CDC during this period of time. I think that much of what we're going to need to do in public health is going to take collaboration with academia, with government, with private sector, with nonprofits, and I am looking forward to engaging in those in a transparent, open way so that we can have that dialogue and create those collaborations. Senator Burr: (02:28:57) So let me go back and ask you one more time. Do you believe that the CDC Director should meet with private industry and innovators that have new technologies? Dr. Rochelle Walensky: (02:29:06) I believe that I should be encouraging all of those collaborations, and I am relying on my senior leadership team, my subject matter experts to engage in many of those conversations. Senator Burr: (02:29:17) But not you. Dr. Rochelle Walensky: (02:29:18) If it's a subject matter where I'm an expert, I'd be happy to. Absolutely. Senator Burr: (02:29:25) I think in a question to your staff, they suggested that you couldn't, but I'll revisit that through my staff to yours. So I've got to say that I'm a little bit confused on the issue of CDC guidance after hearing my colleagues, Senator Collins and Senator Cassidy, about exactly who's involved in content and language. So I sent to CDC an oversight letter, and I got your response to it on 22 April, and I'll just highlight a few things. "CDC uses its emergency response clearance protocol to clear items during emergency responses. This emergency response clearance is applicable to all CDC authored, CDC branded information products with content related to an active or ongoing response, such as COVID-19 response. The clearance process consists of a series of formal reviews, approvals by relevant CDC subject matter experts, SMEs, and agency clearance officials. This typically consists of content development and review by CDC's relevant COVID-19 response task force, or SMEs, followed by additional review coordinated by CDC's Joint Information Center." Senator Burr: (02:30:54) At no point, given the opportunity, did the letter mention anything about people outside of government. Could be parents. It could be the National Education Association. It basically said this all happens within government. Now, that's not what I heard my colleagues say as it related to the guidance on schools, that there was input provided by outside entities. And as a matter of fact, I went ahead and pulled all the email chains that I think was accessed by the media outlets that made them write this story. And I'll just say that it's a little bit alarming, because it's all done on a timeline, and it suggests that AFT leadership, not sure what the issue was they raised, but they certainly changed the language of the guidance, because there's actually emails that thank them for the language that they provided. And when you look at the timeline between that and White House announcement, one would have a hard time believing that everything went through a clearance process that was described in the oversight response letter to me. So I'd ask you to clear it up for me if you would. Dr. Rochelle Walensky: (02:32:32) Thank you. Thank you for that question. So as I mentioned to Senator Collins, prior to our putting our guidance through a formal clearance process, we do an enormous amount of stakeholder engagement to ensure that the guidance can actually address the questions asked. In fact, I can tell you on the other side, when I was a healthcare provider at Massachusetts General Hospital, I would frequently call my colleagues at the CDC and say, "We need guidance on X. It needs to address X, Y, and Z." Dr. Rochelle Walensky: (02:33:02) In the stakeholder engagement for the schools, we did outreach with over 50 organizations. We spoke to teachers. We spoke to parents. We spoke to superintendents. We spoke to many different stakeholders to understand what it is that they needed from our guidance. As I mentioned previously, in doing so, we recognized in meeting with the teachers that we had actually failed to comment on what happened if teachers were immunosuppressed, if teachers were undergoing chemotherapy, if they had a family member with a transplant at home, how we were going to engage and provide guidance to those. It was the CDC scientists that provided the guidance, that provided the science around what we should do. It was the request from teachers to say, "You didn't address this issue." And we hadn't. Senator Burr: (02:33:53) So the first contact by AFT with your staff was on February 1. Monday, February 1. And your staff person wrote, "We were able to review a copy of the draft guidance doc." Or excuse me. Trautner with the AFT, "We were able to review draft guidance documents over the weekend. We were able to provide some initial feedback to several staff this morning about possible ways to strengthen the document." That's on February 1, in the morning. On February 2, your staff emailed to you that they had followed up with suggested language on accommodations per exchange, and on February 3, at a White House press conference, you say, "Schools can reopen without teachers being vaccinated." Would one reading this be concerned with this timeline, and what the oversight letter told me was the protocol that you went through to have guidance signed off on? Dr. Rochelle Walensky: (02:35:13) So in the February 3 press, first of all, in the February 3 press conference, that was before our guidance was released. That was speaking to science and studies that demonstrated that schools had effectively reopened without teachers being vaccinated, and keeping students and children safe. February 3 predated our guidance release, which I believe was February 12, although I'd have to confirm. You may recall at the time that in the media, I took quite a hit for commenting on that from teachers themselves. They were not happy with me at the time. Senator Burr: (02:35:48) And with the success of AFT, then NEA engages you, and you actually committed to do an NEA town hall meeting, is that right? Dr. Rochelle Walensky: (02:36:02) We were engaging at the time with over 50 organizations, teachers, superintendents, parents alike, at the time when our school guidance came out. As a matter of practice, in an unbiased fashion. Senator Burr: (02:36:14) Well, Madam Chairman, I'm going to ask that the letter and the emails be included as part of the record. Patty Murray: (02:36:26) Without objection. Senator Burr: (02:36:27) I only make this observation that I hope you can understand why members express frustrations on guidance that there's a chain of information that suggests people had preferred access to not only advice, but actual language that went into the guidance. I know what your answer to my last question is going to be because of I've stated it in one of the emails. Should CDC guidance suggest that all states should have required teachers to be vaccinated? Dr. Rochelle Walensky: (02:37:09) I would encourage all teachers to be vaccinated. We spent the month of March providing vaccines through our federal pharmacy programs, and we got over 80% of our teachers and educators vaccinated through that process. So I am certainly encouraging that all teachers be vaccinated. I think that the guidance with regard to mandatory vaccination in schools is going to be have to done at the local level. Senator Burr: (02:37:29) Would you provide guidance that suggested to schools that they vaccinate teachers? Dr. Rochelle Walensky: (02:37:38) We have been encouraging vaccination of teachers- Senator Burr: (02:37:41) All teachers? Dr. Rochelle Walensky: (02:37:45) We have been encouraging vaccination of all teachers, of all educators, of all parents, of all students. Senator Burr: (02:37:49) Is that in guidance? Dr. Rochelle Walensky: (02:37:53) I would have to confirm, because I don't know whether our most recent updated guidance for schools actually had widespread availability of vaccine. Senator Burr: (02:38:02) Okay. The Chairman's been awfully kind to me, and I'm not trying to pick. As I said when I started, the next several months are going to be extremely tough at getting people vaccinated. I don't want any of us to lose focus on what the mission is out there. I know for all of you, I'm stating the obvious, that we've got to stay focused on vaccines. But the confidence the American people have in you is a lot of what's going to make us successful, as Dr. Fauci and I have talked many times about. Thank god we had in place an architecture that we perfected over the last 20 years that allowed things to happen organically, like EUAs and this type of thing. It wasn't because we experienced anything. We went through little red flags, H1N1, SARS, Ebola, where we looked at it and said, "Boy, if this would have been the big one, what would we have changed?" And collectively we went through and changed them. Senator Burr: (02:39:11) And we were much better prepared a year ago, architecturally, and 80% of what we did was following the statutes that's out there, and the authorities that were given to many of your institutes or agencies, or in Dr. Marks' case, to the FDA. And I've got to tell you that I believe what the FDA has accomplished, I never dreamed they could do. My goal now is to make sure we don't roll back, because as we move into technology platforms, that's not something that is easy to go back and do clinical trials on, again, if you're just looking for a new indication. Senator Burr: (02:39:51) But I've got to tell you that I believe that schools going back in person in the fall is absolutely crucial to getting the majority of the parents who have yet to be vaccinated vaccinated. And knowing that at least by the end of this month, if we're not already there, every adult that wants to be vaccinated can be vaccinated, it's time for us to start setting the stage and paint the picture for what the fall looks like. That people can go on vacation this year, and they can eat in a restaurant,l in the Outer Banks of North Carolina, preferably. That they can plan their summer vacation, hopefully in a few more weeks or days. Maybe they can go to camp. That in the fall, we expect every school to be in person, short of some drastic change in the infection glide path. And next Thanksgiving, you ought to plan to have Thanksgiving with your family, and extended family. And Christmas, you ought to be able to enjoy. Senator Burr: (02:40:59) If we paint that type of picture, I believe, David, we're going to get people vaccinated. But if we continue to fail at the trust that they have in us, making the calls that are appropriate at the time, feeling like they're influenced in any way, feeling like we're not out there where we need to be, interpreting the science, we're going to fail. And we're going to fail for the American people, but more importantly, we're going to fail for the world, because the world right now is relying on us getting to that number and us providing the technology and the manufacturing capacity for them to be vaccinated. Senator Burr: (02:41:39) So we've got a big step ahead of us. I'm delighted that all four of you are here today. I thank you for the work that you've done up to this point, and more importantly, for the work you're going to do in the future. I thank the Chair. Patty Murray: (02:41:52) Thank you. That will end our hearing today. I want to thank all of our colleagues who are here. I especially want to thank all of our witnesses today. Thank you all, Doctors Walensky, Fauci, Marks, and Kessler for joining us to update on this fight against this pandemic. And to tell you thank you to all of those who work for you and have been diligent in trying to make tough decisions in a difficult time to help protect all Americans. So thank you very much to you and to all the people that work with you. Patty Murray: (02:42:19) For any Senators who wish to ask additional questions, questions for the record will be due in 10 business days on Tuesday, May 25, at 5:00 PM. Hearing record will remain open until then for members who wish to submit additional remarks and materials for the record. Patty Murray: (02:42:33) The Committee will next meet tomorrow, Wednesday, May 12, to mark up the nominations of Jocelyn Samuels to be a member of the Equal Employment Opportunity Commission, Jennifer Abruzzo to serve as General Counsel of the National Labor Relations Board, and [inaudible 02:42:46] to serve as Solicitor for the Department of Labor. With that, the Committee stands adjourned. Speaker 1: (02:43:06) [inaudible 02:43:06]. Dr. Anthony Fauci: (02:43:06) Thank you. Patty Murray: (02:43:06) Thanks again.