Sen. Murray: (00:00)
… and if anyone is in need of accommodations, including closed captioning, please reach out to the committee or the Office of Congressional Accessibility Services. We are at a point of great promise and peril in the fight against COVID-19. While I am encouraged by the fact that two thirds of adults in our country have received their first dose of vaccine, I am alarmed by how the rate of vaccination has been slowing, and how driven by the Delta variant rates of COVID-19 cases and deaths are once again on the rise.
Sen. Murray: (00:34)
Five counties in my state currently have high levels of transmission, according to the Centers for Disease Control and Prevention. For example, in Walla Walla County cases are up in July from June, and they were up in June from April and May. And even though 99% of the COVID deaths nationwide last month were among people who had not gotten vaccinated, we are still seeing fear and misinformation hold people back, huge disparities in vaccination rates, among communities of color and rural communities, skepticism about vaccines amongst some religious and conservative communities, and slow uptake among young adults. Vaccines are safe, effective, and free and easy to get. We need to make sure people know that.
Sen. Murray: (01:23)
We also need to make sure they understand choosing not to get vaccinated doesn’t just put themselves at risk, it puts the people around them at risk, including people who are immunocompromised like those fighting cancer and kids who are not yet eligible for vaccines. We also have to remember, vaccinations are just one front of this fight. Local health departments need the capacity to track emerging outbreaks quickly through contract tracing, sequenced virus samples to identify variants, help isolate ill people and track vaccination progress, and more.
Sen. Murray: (02:02)
Experts need to evaluate the longevity of immunity, especially in the face of new variants and the potential value of booster shots. Researchers need to study the long-term impacts of this disease and how to treat long haul COVID-19 or PASC. And perhaps most importantly, we as a nation need to fully learn the lessons of this pandemic and take action, so we are never in this situation again. That’s why Senator Burr and I have been working on bipartisan legislation and oversight to build the world-class public health and preparedness infrastructure our people deserve. It is my hope that through this work, we will not only address challenges we faced during this pandemic, but build on progress we saw in some states across the country.
Sen. Murray: (02:48)
In my home state of Washington, they worked to overcome challenges with sharing critical COVID data among health departments, labs, and hospitals to improve how data was used to allocate critical medical supplies like respirators and develop a more complete dashboard for demographic data that broke out numbers, for example, for the Pacific Islander community. Michigan created a task force on racial disparities early on in the pandemic to ensure they were reaching communities of color for testing and contact tracing. And Alaska literally employed every mode of transportation to deliver vaccines to hard to reach communities. One of the clearest lessons from this crisis is that you should have the same protection from a pandemic, chronic disease, or a public health threat, regardless of where you live, who you are, or what your income is. And one of the best ways of providing that level of protection is through strong public health infrastructure.
Sen. Murray: (03:48)
The stronger our health departments are at every level, the more effectively they can work to use sequencing technology and modern data systems to track the spread of diseases and monitor the success of vaccination efforts. Stand up testing and contact tracing to stop disease outbreaks, develop science-based guidance to address local needs, build partnerships in hard to reach communities and build trust as communicators and fight misinformation. There is a saying in healthcare, “An ounce of prevention is worth a pound of cure.” We need to have that same mindset when it comes to public health. That’s why I’ve pushed from our funding for public health departments throughout our COVID response packages. It’s why earlier this year I reintroduced legislation to end the cycle of crisis and complacency in public health funding by providing four and a half billion dollars in dedicated annual funding. It’s why I’m going to continue pushing for us to make these critical investments.
Sen. Murray: (04:48)
We all want this pandemic to end, and it is clear despite the incredible progress we have made in the last few months, we still have a lot more work to do. But even after we are through this crisis, our work won’t be done. We have to make sure we learn from this history and take action, so we never repeat it. This crisis has cost too much, has taken too many lives for us to do anything less. I look forward to hearing from all of our witnesses today. Thank you for being here. We want to hear about our response to this pandemic so far, the path forward and how we better prepare for threats like this in the future. With that, I will turn it over to ranking member Burr for his opening remarks.
Sen. Burr: (05:30)
Well, thank you Madam Chairman, I’m pleased that we’re holding this hearing today, our third panel with members of the administration, this Congress on COVID-19. To our witnesses, welcome. Welcome back. Some of you are old hands at this now, and others are relatively new. Dr. Fauci, Dr. Walensky, thank you for returning to the committee for the third time this year to discuss this pressing matter. Ms. O’Connell, welcome. This is your first hearing before the committee in your newly confirmed role as the ASPR. I’m glad that we’re able to get you confirmed so quickly. You have a lot of work in front of you, and all of us, Republicans and Democrats, are ready to help you and the fine folks at ASPR. Get the job done. Dr. Woodcock, welcome back to the HELP Committee. The FDA has benefited from your leadership and you are the right person at the helm as we continue to grapple with the pandemic. I hope that we’ll see you again at another hearing to talk about the great things that you’re doing at the FDA. Preferably a confirmation hearing.
Sen. Burr: (06:37)
I look forward to hearing from each of you on your perspectives of the current response to COVID-19 and where we should go from here. I’ve spent the better part of my career in Congress, working to prepare our country for the unthinkable and anticipating what we may need to respond to it. These early efforts had the support and leadership of many of my colleagues here now, including Senator Collins, our chair Senator Murray, Senator Casey, have all been important partners on preparedness with me working to reauthorize PAHPA and continue to keep a focus on these items during peacetime.
Sen. Burr: (07:14)
All of this effort was with the hope that we would never have to act on the authorities we provided, but it was also with an eye to what may be around the corner. Each law we wrote was designed to build on the lessons that we learned from each event. Zika, West Nile, SARS, and the anthrax attacks. We tried to anticipate what we didn’t think of last time around so that we could be better prepared for when the big one came. This committee has been holding hearings on COVID-19 response since March of 2020. At the very first hearing, I raised concerns with our ability to keep pace with the virus, to track its whereabouts and understand the impact that it would have on the lives of the American people. We have the authorities needed, but we were, and still are faced with many unknowns. Each step of the way, we need to look around the corner and ask ourselves, “What do we need to do today to keep us up with the virus 30, 60, and 90 days from now?”
Sen. Burr: (08:20)
The CDC estimated in mid-June, the Delta variant counted for more than 30% of all COVID infections. As of mid-July, the cases caused by Delta variant may be approaching 60% of all cases. The good news is, the cases are down significantly since the peak. The bad news is, the Delta variant is surging and vaccines have slowed because of hesitancy of resistance. I can tell you that the next few weeks and months will require us to answer some very difficult questions, especially as we work towards the last few miles of administering the vaccine in this country. COVID won’t just go away. We need all Americans who can get the vaccine to get the vaccine. If you won’t do it for yourself, do it for your friends, your families, for your neighbors and your local community. Do it for your grandchildren, so they can go back to school. Do it for your grandparents so they can finally go out and eat.
Sen. Burr: (09:21)
Not only is the Delta variant a concern, but we need to look around the corner to the next mutation of the disease. So I’d like to know if we’re performing enough sequencing, to be able to quickly detect the presence of variants, and are we tracking the right metrics to understand the shift and drift of the virus so that we can see in real time what new variants may mean for our response? Last week, one vaccine company announced it was ready to file for FDA emergency use for a booster shot. Do we need booster shots? When do we need them? What does this mean for widely available vaccine? Israel started offering booster shots last week. I’m worried that American leadership is no longer what it once was when it comes to public health and other countries are outpacing us. We have the same data as Israel. Why aren’t we making the same decisions? Messages from public health experts won’t be followed if Americans don’t believe in the experts.
Sen. Burr: (10:23)
The White House has the power to shape messaging, but it doesn’t, and shouldn’t shape science in any administration. The last administration lost the attention and trust of the American people with two hour press briefings. This administration shouldn’t lose theirs for the sake of the teacher’s union. We need to know what we’re being told by experts is the unvarnished truth. Don’t tell us what you don’t think we can handle. Don’t tell us what the administration thinks we should hear. Level with us. As we sit here today, we’re just months away from flu season. How do we get ready for the colder months ahead of us and the flu and cold season that it will bring along with it? Are the flu shots ready? Will we have enough? These questions should have been thought about weeks ago as they are already on our doorstep.
Sen. Burr: (11:15)
The same is true for our legislative efforts in the longterm changes we need to make, now. While lessons learned from COVID response are top of our mind, the ASPR must play a more prominent role, managing the threat landscape in peacetime and commanding the public health and medical response during the emergencies, with better coordination among federal agencies, better availability of data and public health surveillance, stronger partnerships with innovators in the private sector, building on the good work of BARDA, and visibility into our supply chain for critical drugs, supplies, which also need to be more sustainable. The CDC must be reformed to become a more focused, accountable, and transparent partner in public health and public health preparedness and learn to adopt and leverage 21st century technologies.
Sen. Burr: (12:11)
The NIH should build on its ability to accelerate basic research, leaning on its long expertise in partnering with academia to better understand the pathogens that pose the greatest risk and what tools we may have on the research bench to combat them. And the FDA should build on the great success that we’ve had. Staying the more nimble and creative agency it’s become during the COVID 19 response. This is especially important as the agency works to make final, it’s user fee agreements and transmit them to Congress for our approval next year. Now’s the time to anticipate what’s next. I encourage each of you, in this critical role that you play to engage with this committee to provide the insight into the COVID response as you have over the last 18 months, but more importantly, to look ahead. We have a window to update our public health and medical preparedness policies, taking into account lessons learned from COVID-19. And this committee intends to act before the attention of Congress turns to other matters.
Sen. Burr: (13:18)
It’s hard to believe, but memories will fade. I’ve had to fight to keep funding for pandemic and threat awareness too many times to count. I hope to pass that baton onto one of my colleagues to protect these important programs. But before I leave, I feel a great responsibility to make things better in one final bill. I’m glad that the chairman is an active and able partner in that effort. I appreciate her commitment to this bipartisan concern, and I think we have a real opportunity to make improvements. This effort will be our focus going into the fall, and we welcome your feedback, your insight, and most importantly, your expertise. There’s nothing more important than the health and security of our nation. With that, I thank the chair, and I yield.
Sen. Murray: (14:06)
Thank you, Senator Burr. With that, I will introduce today’s witnesses. We’ll begin with Dr. Rachelle Walensky. She’s 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. 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, it’s good to have you back before the committee. Thank you for joining us. Our next witness is Dr. Janet Woodcock. She’s the acting commissioner of the Food and Drug Administration. Dr. Woodcock, thank you for being here. I look forward to your testimony. Finally, we have the Assistant Secretary for Preparedness and Response, Dawn O’Connell. It’s good to see you Assistant Secretary O’Donnell. Thank you for joining us. I’m pleased to welcome you back to the committee, following your confirmation to this new role. With that, Dr. Walensky, You may begin your opening statement.
Dr. Walensky: (15:07)
Good morning. Chair Murray, ranking member Burr, members of the Senate HELP Committee, I’m honored to join you today to provide an update on the COVID-19 pandemic and our four priorities of CDC’s ongoing response tracking and preventing further spread of COVID, creating access to and confidence in vaccines, advancing health equity, and getting our children back to school. The current data reveal two divergent truths. Since the epidemic peaked in January, 2021, we have seen large reductions in COVID-19 cases, hospitalizations and deaths, and these trends are a testament to the success of our vaccination program and the tireless effort of professionals from across health, business and government sectors who have come together to respond.
Dr. Walensky: (15:54)
On the other hand, our progress across the country is not uniform. Vaccine coverage varies by state and by county. Communities where people remain unvaccinated are most vulnerable and most likely to experience increase in case counts. As of last week, nearly 50% of vaccine eligible population in this country is now fully vaccinated. 116 million people. And still nearly two thirds of counties in the United States have vaccine coverage less than 40%. In areas where vaccine coverage is low, cases and hospitalizations are starting to climb again. Over the last week, we have average 239 deaths per day, an increase of nearly 48% over the prior week. Each death is tragic and even more heartbreaking when we know that the majority of these deaths could be prevented with a simple, safe, available vaccine.
Dr. Walensky: (16:50)
Areas with limited vaccine coverage are allowing for the emergence and rapid spread of the highly transmissible Delta variant. CDC has released estimates of variants across the country and predicted the Delta variant now represents 83% of sequenced cases. This is a dramatic increase up from 50% for the week of July 3rd. In some parts of the country, the percentage is even higher, particularly in areas of low vaccination rates. To date, our data indicates that vaccines are available to neutralize the circulating variants in the United States and provide protection against severe disease, hospitalization, and death. The message from CDC remains clear, the best way to prevent the spread of COVID-19 variants is to prevent the spread of disease, and vaccination is the most powerful tool we have.
Dr. Walensky: (17:43)
We must continue to expand vaccine coverage by building trust and confidence in COVID-19 vaccines. And this is particularly important in communities of color, rural communities and other population groups at risk. CDC is engaging trusted community leaders to reinforce messages about the safety, efficacy and importance of vaccination. CDC remains committed to ensuring all of our work advances health equity. Thanks to supplemental resources, CDC has provided additional support to health departments to address health disparities and improve health equity among historically underserved populations at elevated risk. This includes, racial and ethnic minority groups and people living in rural areas. We are training and integrating community health workers into care teams, collaborating with partner organizations to improve vaccine access, and building vaccine confidence among medically underserved communities and disproportionately affected populations.
Dr. Walensky: (18:42)
As the director of the CDC, it is my priority to get our children back to school for safe in-person learning. Earlier this month, CDC released updated guidance to reflect the latest science on COVID-19 and the widespread availability of safe and effective vaccines for those ages 12 and over. We continue to recommend that schools implement layered prevention strategies to protect those who are not fully vaccinated and encourage vaccination for those who are eligible. Masks continue to be a critical part of these layered prevention strategies. Working together, school administrators and public health workers can carefully consider community transmission rates, local vaccine coverage, and occurrence of outbreaks, when deciding what strategies are needed to help prevent the spread of COVID-19 and safeguard in person education.
Dr. Walensky: (19:35)
In summary, the overwhelming majority of deaths from COVID-19 are now occurring in unvaccinated people. Vaccines are widely available across the country and this suffering and loss is simply and entirely preventable, nearly. For our entire nation to heal and move forward, we must do all our part to get our country vaccinated. Thank you and I look forward to your questions.
Sen. Murray: (20:00)
Thank you. Dr. Fauci.
Dr. Fauci: (20:02)
Thank you very much Madam Chair, ranking member Burr, members of the committee. Thank you for giving me the opportunity to discuss with you again, the role of The National Institute of Allergy and Infectious Diseases in the research response addressing COVID-19. As I’ve mentioned to this committee on prior hearings, the strategic plan for research for NIAID involves research on fundamental, basic knowledge regarding the virus, to development of diagnostics, therapeutics, and vaccines. For the purposes of today’s discussion, and my presentation, I’d like to focus on three vaccines that you know have been approved through the emergency use authorization for use in the United States. That is the two MRNA vaccines from Pfizer BioNTech and Moderna and the J&J vaccine, which is a human adenovirus vector vaccine.
Dr. Fauci: (20:57)
As I mentioned to this committee on prior hearings, the clinical trials that proved the extraordinary efficaciousness of these vaccines to the tune of 93% and 94%, are very, very clear right now. What I’d like to emphasize today is what has transpired since the last hearing. And that is the accumulation of data on the real world effectiveness of these vaccines in a situation we are confronted with a historic pandemic. And that is seen not only in the United States, but also in the UK, in the form of England and Scotland. In Israel ans Qatar and other places. When one looks at the data, and one good example is the cohort study from Israel, in which the MRNA vaccine used in that population was highly effective in the real world, beyond the clinical trial. Including, among asymptomatic, early symptomatic, advanced disease, intensive care, and even deaths. And if one looked across the cohort, you saw that it was effective in essentially every age group, from young individuals, middle-aged and even the elderly. That’s the good news.
Dr. Fauci: (22:16)
The sobering news that you’ve already heard of is the fact that we are now challenged with a very difficult and problematic variant referred to as the Delta variant. It is now been detected in at least 90-plus countries throughout the world. The reason it’s so formidable is the fact that it has the capability of transmitting efficiently from human to human in an extraordinary manner well beyond any of the other variants that we’ve experienced up to now, which has led to its becoming the dominant variant in this country. When I spoke to you last time, it was about 1% to 3% of the variant in the population. Right now it’s gone to over 80% and in some regions of the country, as high as 90%. that is the troubling news.
Dr. Fauci: (23:09)
The fact is that, however, and the importance of vaccination, is that our vaccines that we’re using in this country are very effective against this variant. Particularly, I point out, to the situation regarding advanced disease leading to hospitalizations and deaths, where it’s still well in the 90% of effectiveness. I’d like to close with just one or two comments that we’ve been hearing about regarding the situation of booster or an additional third dose superimposed upon the double doses of MRNA, and the single dose of the J&J. Right now we are doing studies to determine whether or not we will need boosters to increase the durability of protection. We don’t want people to believe that when you’re talking about boosters, that means that the vaccines are not effective. They are highly effective. We’re talking about the durability of that. And we’re doing studies now to determine that.
Dr. Fauci: (24:11)
In addition, there are individuals who are immunosuppressed. People who were on cancer chemotherapy. A variety of other individuals, transplant individuals, who may actually need a boost as part of their initial regimen, in the sense of getting them up to the point where they are protected. So in closing, I want to underscore with Dr. Walensky just said a few moments ago, the extraordinary importance of getting as many people vaccinated as we possibly can. We have the tools to end this epidemic. It is up to us to utilize those tools to their maximum. Thank you very much, Madam Chair.
Sen. Murray: (24:48)
Thank you. Dr. Woodcock.
Dr. Woodcock: (24:50)
Good morning, Chair Murray, ranking member Burr, and members of the committee. Thanks for the opportunity to be here today. I’m going to provide a brief update of what the agency’s been doing in our COVID-19 response. But first I want to start by recognizing the thousands of FDA employees who have really been working non-stop for the past year and a half. I really commend their efforts and thank them for their service to the country. It has been extraordinary.
Dr. Woodcock: (25:18)
From the earliest days of this public health emergency, there is a need for reliable diagnostics, as we all know. We began engaging developers in early January, 2020. And of last week, FDA has authorized nearly 400 tests and sample collection devices that provide a wide range of options for testing. Beyond diagnostics, we’ve evaluated emergency use requests for ventilators and novel devices, such as continuous renal replacement therapy products. We continue to review additional submissions for COVID medical devices and rigorously monitor safety signals and reports, including their performance against variants for the products on the market. This is in addition to addressing numerous device shortages that occurred during the pandemic, and working with our government partners to prevent counterfeit and substandard PPE and other products from entering the United States. Because of course people take opportunities to try to get substandard products into the country.
Dr. Woodcock: (26:24)
FDA has also supported development and availability of COVID therapeutics as expeditiously as possible. On March 31st, we announced the creation of an emergency review and development program, the Coronavirus Treatment Acceleration Program. We reassigned staff from other areas to review the hundreds and hundreds of requests from companies, scientists, and doctors who are working to develop treatments. As of June 30th, we’ve reviewed more than 460 trials for potential COVID therapies. These include anti-virals, neutralizing antibodies, cell and gene therapies, and combinations of these products. The diversity of therapeutic approaches that are being investigated is really critical to increasing our knowledge of this disease and its different stages.
Dr. Woodcock: (27:16)
These efforts have led to one approved drug therapy to treat COVID-19 and 10 therapeutics currently authorized for emergency use. In addition, FDA’s issued EUAs as you know, for three COVID-19 vaccines. These vaccines were authorized without cutting corners or sacrificing our rigorous standards. Intensive interactions between FDA and manufacturers minimize the time between different ordinary phases of the clinical development process and allowed for seamless movement through development, manufacturing, and our rigorous scientific review.
Dr. Woodcock: (27:54)
Throughout the vaccine authorization process, we took steps to facilitate transparency and trust by posting trial data, putting out guidances on what our standards would be, key decisional memoranda, and we held public advisory committee meetings. These vaccines have met the standards and quality to support an EUA and are helping, as you’ve heard, in our fight against the pandemic. Our work did not end with authorization of these vaccines though, we have to share as much information as we can with the public to help with trust and transparency. We’re also deeply involved with CDC on safety surveillance for the vaccines, as they go into millions of healthy people, to understand what adverse events might be related. And we continue to find that the known and potential benefits of these vaccines far outweigh the known risks, even as additional rare risks have been discovered. All this is in addition to the critical work we do to protect the nation’s food supply, which also-
Dr. Woodcock: (29:03)
… we do to protect the nation’s food supply, which also came into some jeopardy during this, and to interdict substandard medical products at our ports of entry, courier facilities, and international mail facilities. Since March, 2020, with coordination with customs and border protection colleagues, we’ve intercepted and destroyed almost 60,000 illegal and unapproved medical products that were attempting to get into the country. FDA has also played a major role in investigating the numerous shortages of medical products that have occurred during the pandemic. Partnering with our sister agencies represented here and far beyond, we’ve responded quickly and decisively, while maintaining our commitment to protecting the health of the American people. We look forward to working with the committee to address further issues. Thank you.
Sen. Murray: (29:55)
Thank you. Assistant secretary O’Connell?
Ms. O’Connell: (30:00)
Chair Murray, ranking member Burr, and distinguished members of the committee, I’m honored to testify before you today regarding efforts within the Office of the Assistant Secretary for Preparedness and Response to support the ongoing response to COVID-19. First, let me thank you for your support of my confirmation. It was just six weeks ago that I was before you as a nominee. And it has been just over three weeks since I was confirmed as the ASPR. I am honored that you have entrusted me with this important role, and I pledge to do everything I can to maintain your trust and confidence in my abilities to lead this office with vision, precision, and transparency. While I continue to assess ASPR’s work, one thing is abundantly clear. The ASPR team is working tirelessly to end this pandemic. And I am pleased to share some examples of the work that they are leading.
Ms. O’Connell: (31:02)
As you know, the Strategic National Stockpile, or SNS, worked to backstop state’s medical supply needs when the pandemic strained global supply chains. The SNS has deployed more than 200 million items, including personal protective equipment or PPE, ventilators, federal medical stations, and pharmaceuticals. ASPR has invested approximately $10 billion from COVID-19 supplementals to replenish the SNS to levels at or above pre-COVID-19 amounts. A new mission ASPR has taken on over the course of the pandemic is securing the medical supply chain. This work is complex and challenging, and has forced our organization to stretch in new ways. A secure and resilient medical supply chain is not only necessary for our current COVID-19 response, but will be critical for any nationwide response that follows. ASPR is investing in industrial base expansion efforts to reduce supply chain vulnerabilities and generate a domestic warm base for manufacturing that can be leveraged in a crisis. So far, ASPR has supported efforts for domestic manufacturing of PPE, active pharmaceutical ingredients, COVID-19 tests and supplies, such as reagents and resins.
Ms. O’Connell: (32:23)
In support of this work, ASPR is also leveraging the authorities delegated to the secretary under the Defense Production Act, to ensure that private sector partners making life savings products have the materials they need to deliver their product. So far, ASPR has priority rated 55 contracts to directly and indirectly support the COVID-19 response effort. ASPR will continue to leverage all of the tools we have at our disposal to ensure the supply chain is secure and that we are never again in the situation we found ourselves in last year. The National Disaster Medical System has completed nearly 5,400 mission assignments. The teams have brought surge capacity to ICUs and emergency rooms, established medical overflow centers, provided mortuary support in places like New York City, established sites to deliver therapeutics, and operated federal vaccination sites. They are currently standing by to participate in surge teams being stood up by the administration to respond to recent hotspots.
Ms. O’Connell: (33:27)
ASPR’s Biomedical Advanced Research and Development Authority, or BARTA, has supported over 65 medical countermeasure projects for the COVID-19 response. Most notably, BARTA led the vaccine development work for what was then known as Operation Warp Speed ,and is now known as the Countermeasures Acceleration Group, and advanced the development of the three vaccines currently authorized by the FDA. This was done, as you know, at historic speed, with less than a year between the identification of the virus and the authorization of the first vaccine. ASPR is also working with HHS leadership and the Department of Defense to transition the Countermeasures Acceleration Group to a long-term, sustainable management structure within HHS. Dr. Robert Johnson, a senior leader at BARTA, recently assumed the responsibilities as the chief operating officer of the mission.
Ms. O’Connell: (34:18)
I look forward to using this transition planning period as an opportunity to evaluate gaps and bring in the additional logistical capacity needed at ASPR and HHS to sustain the enduring mission for as long as it is required. As we move forward, I would like to build on this foundation to accelerate and recalibrate the work where needed, and continue to do all we can to bring an end to the pandemic as quickly as possible. Thank you again for inviting me to testify and allowing me to share these examples of the work ASPR is leading on behalf of the administration wide COVID-19 response effort. I look forward to answering your questions.
Sen. Murray: (34:57)
Thank you very much to all of our panelists today. We will now begin around a five minute questions of our witnesses. I ask all of my colleagues, please keep track of your clock. Stay within those five minutes. We do have votes starting at 11:30, and we have many members in attendance today. My first question is for the whole panel. We are at a pivotal point in this pandemic, and after weeks of declining rates of cases and deaths, we are now seeing a resurgence of COVID-19, in part due, as you all mentioned, to the circulation of variants. Vaccination rates are plateauing, and COVID fatigue is setting in around the country. So I want to ask each of you, what is the one thing everyone can do to help keep us from returning to the early days of this pandemic? Dr. Walensky?
Dr. Walensky: (35:44)
Get vaccinated and get your neighbors vaccinated.
Sen. Murray: (35:47)
Dr. Fauci: (35:54)
Sen. Murray: (35:54)
Dr. Woodcock: (35:55)
Couldn’t say it better.
Sen. Murray: (35:57)
Ms. O’Connell: (35:58)
Sen. Murray: (36:00)
Thank you to all of you. And I hope everyone heard that. Dr. Fauchi, the quick development of effective COVID vaccines has been a real success story during this pandemic. People getting vaccinated is really key to everyone’s ability to return to normal lives. With the spread of variants, as we all talked about, driving increases in cases and deaths now, I’m encouraged to see public health experts and vaccine developers are now considering the possible need for boosters. You mentioned this a bit in your opening remarks, but I wanted to ask you, how do you assess the duration of vaccine efficacy and the impact of variants on that efficacy?
Dr. Fauci: (36:41)
Thank you very much, madam chair. There are two ways that are actively being used now to assess the answer to your question. One is there are correlates of immunity which have been established. In other words, you have a level of measurable laboratory, for example, neutralizing antibody, which is the easiest to measure. There are also areas of immunity that are more difficult to measure, like T-cell responses. But the one that seems to be very well correlated is the antibody level. We know from studies from the clinical trials, as well as from animal studies, that there’s a baseline level, below which you go, you’re at much more vulnerable to getting a breakthrough infection.
Dr. Fauci: (37:23)
So the first is laboratory data. The second is watching and following cohorts of people to see if you have an increase in breakthrough infections. We know, according to the clinical trial, take for an example, the MRNA. They are 93-94% effective in preventing clinically recognizable disease. If you see a fall below that, into the eighties or even unfortunately, hope it never happens, into the seventies, then you know you’ve reached the point where the durability needs a boost. Those studies are ongoing right now.
Sen. Murray: (38:01)
So we don’t have any data yet about whether or not we’re seeing that?
Dr. Fauci: (38:04)
No, we don’t. There are some preliminary data that we’ve heard about from Pfizer, which studies that they did in Israel and in their own studies, which seem to indicate that there is waning immunity. We have a lot of cohorts that we’re following. The CDC is following at least 20 cohorts that’ll be able to amplify on that data and give us much more of a basis of making a decision.
Sen. Murray: (38:28)
How will the administration determine if booster shots are needed?
Dr. Fauci: (38:33)
Just by those very studies, just by following the cohort studies. And we’re waiting … maybe perhaps Dr. Walensky would like to comment, because she has in her domain of the CDC a number of cohort studies that will inform us. In the meantime, we at NIH are doing studies now to determine when you give a booster, how high up do you get it and what kind of a cushion do you get for antibody responses?
Sen. Murray: (38:59)
Okay. And Dr. Walensky?
Dr. Walensky: (39:00)
Yeah, thank you, senator. We have numerous cohort studies. They represent tens of thousands of people, and they’re represented across the United States. These include data from 14,000 nursing home facilities, long-term care facilities. We have a heroes cohort that is essential workers of over 5,000 people that are actually getting weekly PCR testing. We have healthcare worker cohorts. We have cohorts across the country where we’re following these data and really looking at it every several weeks to understand what the vaccine efficacy is. And it is among that and the laboratory data will be the decisions that we use. Fortunately, we’re anticipating that this will wane and not plummet. So as we see that waning, that will be our time for action.
Sen. Murray: (39:42)
Okay. Thank you very much. We really appreciate it. We’ll stay in touch on that. I will resend the balance of my time, since there’s many members here. Senator Burr?
Sen. Burr: (39:49)
Thank you, madam chairman. I’ve got to say, the last exchange was, ” Oh my God, we haven’t learned anything.” And let me just make this point. I remember early on in this, when the question of testing came up and CDC said, “We do testing,” and CDC demanded to do the test. And we lost weeks. And I’m not here to evaluate data. Tony, that’s your job and Rochelle and others, but to say, “We’re going to make this decision based upon the research we’ve got going on at CDC based upon the information that we’ve put out, and only our research counts,” and to basically ignore the Israeli data or the Pfizer data … and I’m not suggesting that we’re totally doing that.
Sen. Burr: (40:48)
I guess my question would be, has Israel given us transparency into their data? If Janet still lived in a world where we didn’t accept foreign data for applications, which FDA has had the authority to do since 1996 when I changed the law, but it took COVID to actually make that happen. So I realize that we want accuracy, but do we really have to wait for CDC to complete the data? Do you think you’re going to come to a different conclusion than Israel did? Share with me.
Dr. Walensky: (41:18)
Thank you for that question, Senator. Absolutely not. We have to have collaboration across the globe, because this is a global problem. So we’ve already had two conversations with Israel. We have data sharing from our cohorts, as well as from theirs. We’ve also been in discussions with the UK to see what data they have, because of course, they’re several weeks ahead of us in the Delta variant. So we intend to leverage all of the data we have around the world to share liberally with other countries, and in the hopes that they will share with us so that we can make the proper decisions here in this country and around the world.
Sen. Burr: (41:48)
Is there a reason to believe that the Israeli data is flawed?
Dr. Walensky: (41:53)
Sen. Burr: (41:53)
Is there a reason to believe that Israeli data is flawed?
Dr. Walensky: (41:57)
We are in discussions, epidemiologic discussions. There are numerous cohorts in Israel, those in the Ministry of Health, those in their healthcare systems. And we have seen some of their data, they’re actually continuing to analyze the data. So we’re in those active epidemiologic conversation.
Sen. Burr: (42:11)
My only point is they’ve made a decision to do boosters based upon their data. And we’re saying we’re still going to work out through our research to determine, and that’s where you begin to lose the trust of the American people in our healthcare experts. In April, the Biden administration announced a $1 billion commitment for sequencing at CDC. To date, only 844 cases from North Carolina have been sequenced according to CDC’s website. We had over a million cases. It seems there’s a major problem again at CDC. Let me just ask you, in CDC’s recent updated mask guidance for schools, it says communities should use local outbreak data to make decisions, yet I would challenge you that if only 844 cases have been sequenced, those local people don’t have the data they need to make that determination as to what the policy is going to be at a local level. Would you agree?
Dr. Walensky: (43:11)
That discussion is based on cases, not based on variants. So we are actually getting data from around the country based on variants as well, based from the local health departments within North Carolina and all of the states, as well as academic centers and commercial labs. And the recommendations for schools was based on test positivity and positive cases, not necessarily based on variants.
Sen. Burr: (43:36)
But shouldn’t transparency by the local health department about the variant in their community be important to their decision as to what they do in the schools?
Dr. Walensky: (43:47)
Absolutely. And we have data by region for variants that are posted on our website. They’ve been updated this morning with the 83%. So not only are we looking at test positivity, actually down to the county level, but variants that come in as well from each of the individual states, from the academic partners, from the labs.
Sen. Burr: (44:04)
Dawn, I know you’ve only been there three weeks. What are your plans to address the pressure that the flu is going to cause on the system?
Ms. O’Connell: (44:14)
Ranking member Burr, thank you for that question. That’s been something that the ASPR team has been considering and planning for over the last several months. There is now an inter-agency process set up by the White House supply chain coordinator that ASPR has been actively participating in, working with manufacturers of both flu vaccines and COVID vaccines to make sure that the supplies are there, so we have access to both vaccines as we head into the fall, but it is something that we will continue to monitor and recalibrate if needed. So we’re sure that we can do both at the same time. At this point, our planning assumption suggests that we can, but I will continue to monitor that.
Sen. Burr: (44:54)
Thank you. Thank you, chairman.
Sen. Murray: (44:55)
Senator Kane: (44:57)
Thank you, chairman Murray and ranking member. Thank you to the witnesses. I want to say worried about disinformation and then have some questions. Former President Trump was on television this weekend and he said one of the reasons people won’t get vaccinated is because “they don’t trust the election results”. And when I heard that, I sort of chuckled at that. I thought that was odd, to be connecting a big lie about the election to refusal to get vaccinated, but it caused me to do something that I hadn’t done, which is look at the vaccination rates in all 51 states, including the District of Columbia. The CDC data from yesterday morning shows the following: the 21 jurisdictions with the highest vaccination rates all voted for Joe Biden. 25 of the 30 jurisdictions with the lowest vaccination rates voted for Donald Trump. There’s a difference between causation and correlation, but possibly what the president said on television on Sunday, there may be something to it, that repeated disinformation about the election is now connecting in people’s minds with disinformation about willingness to take the vaccine.
Senator Kane: (46:04)
And it didn’t have to be this way, because one of the great things about President Trump and the Trump administration working with partners and funded by Congress was setting a world record in terms of developing really super effective vaccines in record time. President Trump had COVID in October. He decided to get vaccinated in January. He didn’t tout the vaccination. It came out months later, but he could still tout it. He could still say, “This is a Trump accomplishment,” and encourage people in these states who are lagging behind the national average to get vaccinated. That won’t solve all of the problem, because there’s many reasons people don’t get vaccinated, but I’m now convinced.
Senator Kane: (46:44)
I just came back from Latin America. In Latin America, they’re so thrilled at the US donation of vaccines. And they view our vaccines is state-of-the-art compared to the China and Russia vaccines. And they appreciate that we’re donating them rather than charging them, which China and Russia are doing. So around the world, people are beating a door down to try to get to US vaccines if they can. And here we have near universal availability. And again, I thought it was sort of comical, the president’s comments this past weekend, but as I look at the CDC data, maybe it’s not so comical, but it’s incredibly serious. Dr. Walensky, I wanted to ask you this question. I think you stated in your opening testimony that the overwhelming majority of deaths now are people who are not vaccinated. Now, when you say overwhelming majority, are you talking about 60%, 80%, 95%, 99%? What is the statistic?
Dr. Walensky: (47:40)
In a five month study from January to May in numerous states, five or six states, it was 99.5%.
Senator Kane: (47:46)
Now, obviously before the vaccine started, it was a hundred percent, right?
Dr. Walensky: (47:50)
Senator Kane: (47:51)
A hundred percent of people who died before we were vaccinating were unvaccinated, by definition. And since the vaccine has begun to be deployed, 99.5% of people who died are people who are unvaccinated. Those are very, very powerful statistics. As the administration has begun to say, this is now a pandemic of the unvaccinated. Dr. Walensky, I’m very concerned with the CDC press release, I guess from last week, about overdose deaths in the last calendar year, a 29% increase in overdose deaths. And it appears to be connected to the isolation substance use disorders often in a disorder of isolation. It appears to be connected to the intense isolation of the last year. Can you tell us what CDC and other partners are doing to look at this and work together with us to try to combat the resurgence of a scorch, which we had seen some positive movement on in the last few years?
Dr. Walensky: (48:52)
Yes. Thank you, senator. There’ve been two things in the last decades that have decreased life expectancy in this country. One is COVID-19, and the second is overdose. So we are now seeing a collision of those two things happening at the same time. And in fact, as you noted, the report demonstrated a 29% increase in overdose deaths year over year. We are actively working to not only study this issue, and not only study the overdose deaths, but the overdose hospitalizations, to look at surveillance, to look at the infectious diseases associated with injection drug use, to promote syringe services programs, Naloxone programs, as well as to provide services and toolkits around the country for not just substance use disorders, but for mental health, hear Her Now campaigns for maternal mortality, tool kits for suicide prevention for youth, parental toolkits. So we’re actively not only doing the surveillance and the studying of this, but also in the communities for the tool kits on the prevention side.
Senator Kane: (49:59)
Great. Thank you. I yield back, chair Murray.
Sen. Murray: (50:01)
Thank you, Senator Paul?
Seantor Paul: (50:05)
Dr. Fauci, as you are aware, it is a crime to lie to Congress. Section 126.96.36.199 of the US Criminal Code creates a felony and a five-year penalty for lying to Congress. On your last trip to our committee on May 11th, you stated that the NIH has not ever and does not now fund gain of function research in the Wu Han Institute of Virology. And yet, gain of function research was done entirely in the Wu Han Institute by Dr. Shi and was funded by the NIH. I’d like to ask unanimous consent insert into the record the Wu Han virology paper entitled Discovery of a Rich Gene Pool of Bat SARS Related Coronaviruses. Please deliver a copy of the journal article to Dr. Fauci.
Seantor Paul: (50:51)
In this paper, Dr. Shi credits the NIH and lists the actual number of the grant that she was given by the NIH. In this paper, she took two bat coronavirus genes, spike genes, and combined them with a SARS related backbone to create new viruses that are not found in nature. These lab created viruses were then to shown to replicate in humans. These experiments combined genetic information from different coronaviruses that infect animals, but not humans, to create novel artificial viruses able to infect human cells. Viruses that in nature only infect animals were manipulated in the Wu Han lab to gain the function of infecting humans. This research fits the definition of the research that the NIH said was subject to the pause in 2014 to 2017, a pause in funding on gain of function, but the NIH failed to recognize this, defines it away, and it never came under any scrutiny. Dr. Richard Ebright, a molecular biologist from Rutgers, described this research in Wu Han as the Wu Han lab used NIH funding to construct novel chimeric SARS related to coronaviruses able to infect human cells and laboratory animals. This is high risk research that creates new potential pandemic pathogens, potential pandemic pathogens that exist only in the lab, not in nature. This research matches … these are Dr. Ebright’s words. This research matches, indeed epitomizes the definition of gain of function research, done entirely in Wu Han, for which there was supposed to be a federal pause. Dr. Fauci, knowing that it is a crime to lie to Congress, do you wish to retract your statement of May 11th, where you claimed that the NIH never funded gains of function research in Wu Han.
Dr. Fauci: (53:05)
Senator Paul, I have never lied before the Congress, and I do not retract that statement. This paper that you were referring to was judged by qualified staff up and down the chain as not being gain of function. What was … let me finish!
Seantor Paul: (53:25)
You take an animal virus and you increase its transmissibility to humans. You’re saying that’s not gain of function?
Dr. Fauci: (53:30)
Yeah, that is correct. And Senator Paul, you do not know what you are talking about, quite frankly. And I want to say that officially, you do not know what you are talking about, okay? You get one person … can I answer?
Seantor Paul: (53:46)
This is your definition that you guys wrote. It says that scientific research that increases the transmissibility among animals is gain of function. They took animal viruses that only occur in animals, and they increased their transmissibility to humans. How you can say that is not gain a function –
Dr. Fauci: (54:06)
It is not.
Seantor Paul: (54:07)
It’s a dance, and you’re dancing around this because you’re trying to obscure responsibility for 4 million people dying around the world from a pandemic.
Sen. Murray: (54:16)
Let’s let Dr. Fauci –
Dr. Fauci: (54:17)
I have to … well, now you’re getting into something. If the point that you are making is that the grant that was funded as a sub award from EcoHealth to Wu Han created SARS- CoV-2, that’s where you were getting. Let me finish.
Seantor Paul: (54:34)
We don’t know.
Dr. Fauci: (54:35)
Wait a minute.
Seantor Paul: (54:35)
We don’t know that it didn’t come from the lab, but all the evidence is pointing that it came from the lab, and there will be responsibility for those who funded the lab, including yourself.
Dr. Fauci: (54:43)
I totally resent –
Sen. Murray: (54:44)
This committee will allow the witness to respond.
Dr. Fauci: (54:47)
I totally resent the lie that you are now propagating, senator, because if you look at the viruses that were used in the experiments that were given in the annual reports that were published in the literature, it is molecularly impossible.
Seantor Paul: (55:07)
No one’s saying those viruses caused it. No one is –
Dr. Fauci: (55:09)
It is molecularly –
Seantor Paul: (55:09)
– saying that those viruses caused the pandemic. What we’re alleging is the gain of function research was going on in that lab and NIH funded it.
Dr. Fauci: (55:18)
That is not –
Seantor Paul: (55:18)
You can’t get away from it. It meets your definition and you are obfuscating the truth.
Dr. Fauci: (55:22)
I am not obfuscating the truth. You are the one –
Sen. Murray: (55:24)
Senator Paul, your time has expired, but I will allow the witness to –
Dr. Fauci: (55:27)
Let me just finish. I want everyone to understand that if you look at those viruses, and that’s judged by qualified virologists and evolutionary biologists, those viruses are molecularly impossible to result –
Seantor Paul: (55:42)
No one’s saying they are. No one’s saying those viruses caused the pandemic.
Sen. Murray: (55:45)
Senator Paul –
Seantor Paul: (55:45)
We’re saying they are gain of function viruses, because they were animal viruses that became more transmissible in human and you funded it. And you won’t admit the truth.
Dr. Fauci: (55:54)
And you’re implying –
Sen. Murray: (55:55)
Senator Paul, your time has expired, and I will allow witnesses who come before this committee to respond.
Dr. Fauci: (56:01)
And you are implying that what we did was responsible for the deaths of individual. I totally resent that.
Seantor Paul: (56:09)
It could have been. It could have been.
Dr. Fauci: (56:09)
And if anybody is lying here, senator it is you.
Sen. Murray: (56:16)
Senator Smith: (56:21)
Thank you, Dr. Fauchi. And thanks to all of our panelists for being here today. And thank you, chairman and ranking member Burr. I just want to say, Dr. Fauchi, is there anything more that you would like to say to counteract these attacks on your integrity that we’ve all just witnessed?
Dr. Fauci: (56:39)
Well senator, thank you. I don’t think I have anything further to say. This is a pattern that Senator Paul has been doing now at multiple hearings, based on no reality. He keeps talking about gain of function. This has been evaluated multiple times by qualified people to not fall under the gain of function definition. I have not lied before Congress. I have never lied, certainly not before Congress. Case closed.
Senator Smith: (57:05)
Thank you. So we are 16 months into this pandemic, and I think we’re at a critical moment. Two thirds of adults have received at least one dose of the vaccine. And at the same time, we are seeing cases rising to about 41,000 a day. And as Dr. Walensky has said, we have an epidemic here of the unvaccinated, but of course this continues to affect every single one of us. So it seems to me that our actions and messages in this moment are going to make a huge difference in whether we move forward or backwards, not only here in the United States, but everywhere in the world. Today, as I was walking into this committee hearing, for the first time in months, I saw a line of people waiting outside of a pharmacy for testing and vaccines, and it made me wonder whether the recent surge of the Delta variant is –
Senator Smith: (58:03)
… whether the recent surge of the Delta variant is getting people’s attention and moving them from indecision to action, what a terrible way for this to happen. So I have a few questions, just to, I hope, clear up some of the misinformation and misunderstandings. Dr. Fauci, the COVID-19 vaccine protects against the Delta variant, is that correct?
Dr. Fauci: (58:25)
It protects against the clinically apparent disease and it protects extremely well against hospitalization and deaths.
Senator Smith: (58:35)
Right. So if you’re not vaccinated, given how contagious the Delta variant is, I mean, would it be fair to say you’re very likely to get this variant, to get the COVID-19 variant, would you say?
Dr. Fauci: (58:54)
Certainly when you look at the capability of this virus to transmit from people to people. I mean, obviously you have to be in an environment in which the virus is present. So if you are in for example, and I believe Dr. Walensky mentioned that in her remarks, if you are in a area, be it a state, a city, a county, or what have you, where you have a high level of infection in the community and a very low level of vaccinated people, the chances in that environment of getting infected are reasonably high.
Senator Smith: (59:28)
Right. And how do you compare, how do you think about the side effect risks of the COVID-19 vaccine compared to the risks of not being vaccinated? Because this is, I think, what people are struggling with.
Dr. Fauci: (59:41)
Right. It refers to the risk benefit ratio of getting a vaccination. And every time this has been evaluated, not only with this vaccine, but with so many other vaccines, there is no intervention that is without some time getting an adverse event. I mean, I don’t think I can think of one that hasn’t. So when you have that situation, you balance the rarity or the uncommon newness of a particular adverse event with the advantage that you would get from protecting yourself against the actual disease against which you’re vaccinated. And thus far, whenever this has come up about an adverse event, it’s been evaluated, perhaps even a warning has been given, but it’s always weighed on the part of saying that the benefit of the protection of the vaccine outweighs the risk of the adverse event.
Senator Smith: (01:00:37)
Thank you. Dr. Walensky, I have spoken with a lot of public health experts in Minnesota who tell me that they are still challenged getting, especially younger adults who are eligible to be vaccinated, getting them vaccinated. And part of it is the challenge, this perception that COVID is just not that big a deal for younger people, people who consider themselves healthy, and, “I’ve got a strong immune system,” and so forth. So let me ask you this. Are there a larger number of younger people getting hospitalized today versus a year ago or six months ago?
Dr. Walensky: (01:01:14)
We have seen hospitalizations go up for every age bracket recently, as cases go up. Proportionally, because there are more cases now among younger people, we’re seeing more of those people in the hospital. They still get hospitalized at a less frequent rate, given unvaccinated, than elderly patients. But in fact, because there are more of them now, that we are seeing more of them in the hospital.
Senator Smith: (01:01:35)
Okay. So another good piece of advice there about being aware of the risk, even if you see yourself as young and healthy.
Dr. Walensky: (01:01:43)
Senator Smith: (01:01:44)
Thank you, Madam Chair.
Senator Murray: (01:01:45)
Thank you. Senator Moran.
Senator Moran: (01:01:46)
Chairman, thank you. Thank you and Senator Burr for today’s hearing. Thank you to the witnesses for being here. Let me start with Dr. Walensky, please. Doctor, in May, the CDC announced new guidance for fully vaccinated individuals that they could resume activities without wearing a mask or staying socially six feet apart. (silence) It is a bit about the future, which you are fully engaged in. We need a better response to public health emergencies. A lot of confusion by health care providers, they’ve been reluctant to spend the money. It is… (silence)
Senator Moran: (01:04:43)
… that it’s in the works about assistance and care for facilities that care for our senior populations. And there’s still no answer in that. HHS is otherwise listening. There’s about $24 billion left unspent in the Provider Relief Fund. And we’ve been anxiously awaiting, always with the answer that it’s in the works, about assistance and care for facilities that care for our senior populations. And there’s still no answer in that regard. So I don’t know that you have a comment necessarily on that part of my commentary, but again, I’d utilize this as an opportunity to try to get more certainty at HHS on the spending of those dollars.
Ms. O’Connell: (01:05:26)
Senator Moran, thank you for your question, for both parts of it. And I certainly appreciate how frustrating it’s probably been not to have the clarity that you and your constituents have been seeking. And we’ll take the comments that you’ve made today and bring them back to the secretary and other parts of HHS senior leadership, to make sure that we understand how important it is that this money is moving quickly and that the guidance comes out expeditiously and that we can do all we can to support. I mean, we really want to do all we can to support your constituents. And so, it’s helpful to know that this has been a problem. And I look forward to working with you and your staff on it.
Senator Moran: (01:06:05)
If you can accomplish that, the purpose of my commentary will be satisfied. I would particularly ask that someone from HHS respond to us about the Provider Relief Fund, as it relates to senior care living circumstances.
Senator Moran: (01:06:17)
Dr. Fauci, in the 24 seconds I have left. I’ll just ask a quick question. You’ve talked about mental health, what are the necessary steps to mitigate a mental health and drug overdose crisis? What should Congress and American institutions be doing today for a future pandemic?
Dr. Fauci: (01:06:36)
Well, first of all, I think the lesson that we’ve learned from this, and we would hope in good preparation for what will inevitably be another challenge in the future, we can’t predict when, is to realize the important mental health impact that this outbreak has had, not only in the suffering from disease itself, but for the extraordinary disruption of our society. Which I think we’re going to have to realize that even when we get this under control, the mental health effects of this are going to be following this for months, if not years afterwards. We can’t forget that. When the outbreak is over, the mental health effects are not going to be over, they’re going to linger. And that’s what we really need to address.
Senator Murray: (01:07:21)
Thank you. Senator Rosen.
Senator Rosen: (01:07:24)
Thank you, Chair Murray, Ranking Member Burr for holding this vitally important hearing today. And I really want to thank all of the witnesses for helping to get our country vaccinated. It is so important to every person that we know and love in our community and our personal lives, that we do everything we can to save them and protect them. And I appreciate your hard work in this regard.
Senator Rosen: (01:07:48)
And so, I just want to speak a little bit about vaccine outreach because our country, we have made tremendous progress over the past several months in making the vaccine available to most individuals, to getting shots in arms. I’ve had the honor of going to some of the vaccine sites, of course, clinics in my home state of Nevada, our healthcare heroes. There are pillars of strength in our communities showing up day after day, to be sure that everybody that wants a vaccine can get one and we just can’t lose ground.
Senator Rosen: (01:08:20)
But unfortunately, Nevada, our cases are growing and we seem to be getting to the top of a list nobody wants to be in, the cases of the Delta variant. I’m extremely concerned about the lag in vaccination rates. In fact, last week, especially in nursing homes, Senator Cortez Masto and I, sent a letter to secretary Becerra to raise concerns about the low reported vaccination rates in Nevada nursing homes. And we have to find a solution to protect those most vulnerable, who can’t go out to a site and even their loved ones couldn’t take them.
Senator Rosen: (01:08:53)
So Dr. Walensky, are there any plans for the CDC, or in coordination with other agencies, to restart the pharmacy partner program that sent teams directly to every nursing home, perhaps for every facility with less than a 90% vaccination rate for residents and staff, and I might even say families of staff, who they go home to?
Dr. Walensky: (01:09:13)
Thank you for that question, Senator Rosen. And we recognize this challenge and we are with you in that in fact, we have 10 CDC people deployed to Nevada right now, working to assist. Part of the long-term plan in terms of working to vaccinate our long-term care facilities, not necessarily these staccato partnerships with the pharmacies, but to have a longitudinal plan. Because in fact, especially in our long-term care facilities, there’s quite a bit of turnover of the patients. And we want to make sure that there’s always vaccine available. Many of these long-term care facilities have access to pharmacies, and we want to make sure that there’s a vaccine actually active in the pharmacies, so that they can do vaccination when patients come in.
Dr. Walensky: (01:09:55)
I agree with you. And in fact, we need to work to get our staff vaccinated as well. In fact, staff in some of these long-term care facilities are 20% less coverage than the facility members themselves, the residents themselves. So we are working on confidence in those areas, but specifically strike teams with the long-term care facilities to assist in getting vaccine to those places. That’s not reliant on a one-time mass vaccination, but really has a longitudinal plan to make sure vaccine can be available in the long-term.
Senator Rosen: (01:10:27)
Yeah. And I would hope that you’d include the families of the staff because oftentimes, they have a high turnover too. They go home to their community and you’re just going to keep putting out that fire over and over.
Senator Rosen: (01:10:39)
But I’d like to switch now and talk a little bit about the research in vaccines, because obviously, we’re discovering more about COVID every single day. And I think for years to come, we’re going to continue to learn. And so now, is the time to take those additional steps, to see we don’t look back and find gaps in data that could have been prevented. Those gaps could have been prevented if we had acted sooner, speaking of longitudinal. And so data like this could save lives.
Senator Rosen: (01:11:04)
That’s why I introduce the Ensuring Understanding of COVID-19 to Protect Public Health Act. It’s bipartisan legislation that requires long-term, those longitudinal studies, on a variety of COVID patient population with regular public reporting. For example, some of the recent research is showing that COVID-19 vaccine may actually improve symptoms for some patients with long haul COVID. So Dr. Fauci, what do we know about this so far and how common is the vaccine to be a strong prevention tool, but also to work therapeutically in this case? And what else should we be studying?
Dr. Fauci: (01:11:44)
Very good point, Senator. And there has been anecdotal reports of people who have been infected, have developed long haul COVID, and their symptoms have been improved upon getting the SARS-CoV-2 vaccine. That has not been proven under the scrutiny of a clinical trial. So right now, we’re looking at individuals who actually have recovered and seeing if in fact vaccination does improve. Right now, although the anecdotal cases suggest that, I don’t think we can say anything definitively from a scientific standpoint, but that’s something that’s being looked at.
Senator Rosen: (01:12:22)
Thank you. I see my time is up. Thank you. Thank you.
Senator Murray: (01:12:25)
Thank you. Senator Romney.
Senator Romney: (01:12:28)
Thank you, Madam Chairman, and thank you to the members of our panel today for being here and responding to our questions. Thank you also to the teams of people that you work with, their tireless work over the last year and a half is something which many of us feel a great deal of gratitude for, for that effort.
Senator Romney: (01:12:46)
As we try and understand vaccine hesitancy, I’m sure some of that is due to spurious conspiracy theories. And I don’t know this, but social media may have been populated in part by enemies of our country that are putting out theories to try and get people not to take vaccines. But there’s also, I believe, another reason why some people who are not prone to believe those conspiracies don’t get vaccinated, and that’s because they don’t know what the data really suggests. And they wonder, “Okay, is this really a good thing for my 16 year old? What are the serious side effects of this vaccine for a 16 year old versus the probability of them getting very ill?” And I wonder, do we provide, or is there a place where people can go to find out what the data show for the side effects of vaccines by age group and how many serious complications there are for people of different ages. And then, compare that perhaps with the serious implications of getting COVID. And I’ll ask first Dr. Walensky.
Dr. Walensky: (01:13:57)
Thank you very much, Senator Romney. In fact, that’s exactly what we are doing. So one of the things I think that’s so important to understand is that when people don’t want to be vaccinated, it’s for a whole host of reasons. And until you start talking to them about what is their reason, is it, “I can’t take off work tomorrow and I may feel unwell”? Is it because, “I don’t understand these potential side effects for my 16 year old.” We at CDC have what we call vaccine confidence consults. So we have state departments, a local health department who can call into us and say, “These are the things that we’re hearing on the ground. What is the real data so that we can have trusted messengers providing that real data in real time to people and making sure that their questions are answered and that we can empower the people who are the trusted messengers on the ground with exactly those data?”
Senator Romney: (01:14:43)
And is that information being collected? Are our doctors and hospitals actually collecting the data that shows how many people are getting side effects by age group? Are you getting accurate information that people can rely upon? Because again, I see on social media and some broadcasters, a sense that somehow this is being hidden, that the side effects are being underplayed, that you have an incentive not to let people know what the kind of side effects might be and the seriousness of those side effects.
Dr. Walensky: (01:15:10)
And the answer is absolutely. We have numerous large scale mechanisms by which to collect these data. We have the first ever V-safe monitoring program, where people are giving their vaccine, how did they do today, how are they doing in a week. We have the Vaccine Adverse Event Reporting System. That’s a passive reporting system. Everything gets reported or is supposed to get reported, but we recognize it’s passive. Things may get missed. And then, we actually also have the Vaccine Safety Datalink, which is a link of nine academic centers. So we’re able to get real vaccine data as well as their denominators, which is hard to get in passive reporting. So we can check numerators and denominators and give us real estimates. We’re covering the gamut.
Senator Romney: (01:15:50)
The talk that Senator Burr described with regards to getting a booster, the suggestion from Israel, does it make sense? There are a number of us that would get in line to get a booster. How long is it going to take before we’re able to get sufficient information to allow Americans who want to get an additional vaccination, to be able to do so? Are we talking weeks? Are we talking months? I mean, I guess, given the fact that this is being done overseas, can we not use the data that’s come from those places to allow people in this country to get a third shot if they want to?
Dr. Woodcock: (01:16:32)
The agencies represented here are all monitoring this extremely carefully. As you’ve heard, 99.5% of all people who are being hospitalized now are unvaccinated. So at the moment, the people that are getting sick are the people who haven’t been vaccinated.
Senator Romney: (01:16:52)
I understand, but I’m looking at the data that’s coming from Israel and people who have double vaccinations are still susceptible to the Delta variant for serious disease and death. And they’re showing that if they get a booster, that dramatically is reduced. Why should we not allow people who are elderly or have other compromised conditions to be able to get that booster?
Dr. Woodcock: (01:17:14)
Certainly. We are looking at all that. Remember, this vaccine right now, the vaccines are under emergency use authorization. So we require an additional authorization for a booster.
Senator Romney: (01:17:27)
How long is that going to take? That’s the question. We have people who want to get that booster. And I’m hearing that from people who are at risk and concerned, they want to take that booster. They’re willing to take the additional risk of something that’s not been… They’ve already had two shots of it. They’re saying, “Give me the third, because I got this over a year ago. I got the vaccination over a year ago. I want to get that protection.” Why can’t they? I understand, you won’t let them yet, but when will you let them?
Dr. Woodcock: (01:17:53)
Well, Pfizer, at least has announced that it’s going to submit to their EUA data, both Pfizer data, and to Senator Burr’s early point, the other data that they have available to potentially make the case for a booster. So the FDA will be looking at that.
Senator Romney: (01:18:13)
I’m sure you will. I don’t like the timeframe, frankly, given the fact that this was being done elsewhere. My time is up. So I’ll turn back to you, Chairman.
Senator Murray: (01:18:21)
And Dr. Woodcock, for clarification, Pfizer has not requested the FDA to approve of a booster?
Dr. Woodcock: (01:18:31)
Of course, I can’t talk about that, but Pfizer has publicly announced that they’re going to submit an amendment to their EUA, to request for a booster dose.
Senator Murray: (01:18:40)
Thank you. Senator Hassan.
Senator Hassan: (01:18:44)
Well, thank you, Chair Murray and Ranking Member Burr. And thank you to all of our witnesses today for the work you do.
Senator Hassan: (01:18:51)
I want to just start to talk about a recent news item. It’s a deeply disturbing report, detailing dangerous inequities that USA Paralympians are facing at this year’s Tokyo Paralympics. Becca Meyers is a six time Paralympic medalist, who won three golds in Rio five years ago. She is deaf-blind, but in the past that hasn’t stopped her from competing and winning at the highest levels. This year though, she and other athletes from Team USA who experienced disabilities are being denied adequate access to personal care assistance, reportedly due to COVID-19 restrictions. Individuals who experience disabilities should not be forced to navigate the Tokyo Olympics without the support that they need in the midst of a global pandemic. Becca announced on Sunday that she is quitting the team because she is being denied a, and this is her quote, “reasonable and essential accommodation,” that would enable her to compete.
Senator Hassan: (01:19:55)
This is an outrage and a preventable situation that should never have gotten to this point. So I want the U.S. Olympic & Paralympic Committee to work immediately to address this issue. And I want them to ensure that all of our athletes are able to compete safely at this summer’s game, including by providing them the basic supports that they need just to navigate the world.
Senator Hassan: (01:20:19)
So I do have a question though, Director Walensky, because over the last year and a half, the CDC has provided guidance on how to mitigate the risk of COVID-19 in various activities, as well as special events, including sports. I have a question that you all could answer in writing. You can comment on it now, if you’d like, but what I’m interested in is your best guidance regarding COVID-19 mitigation, taking into account the needs of people with disabilities. So if you’d like to comment now, you can, or we can just do it in writing.
Dr. Walensky: (01:20:54)
Maybe I’ll just comment and say, I share your concern. We have dedicated resources specifically to disabled communities, especially those who are unable to come out and get vaccinated. I think probably that the individual sports, which we can do by writing, but I just want to echo your concern.
Senator Hassan: (01:21:09)
Yeah. And I just want to be clear that for some people with disabilities, the accommodation, the aid they need is another human being. And it really needs to be seen as the same kind of accommodations we would make in other situations. So I appreciate having an ongoing discussion with you about it.
Senator Hassan: (01:21:26)
Now, I’d like to turn to you, Ms. O’Connell. Last year, many states, hospitals, and first responders struggled to acquire personal protective equipment. And the federal stockpile did not contain the supplies needed to fulfill their requests for help. The stockpile also contained many expired and unusable products, which further limit its effectiveness. I recently introduced bipartisan legislation with Senator Cassidy, that would improve transparency into the stockpile, authorized transfers of expiring products and assist states in establishing and maintaining their own stockpiles in order to help avoid the kinds of challenges that we faced last year. What steps are you taking to improve the stockpile? And will you continue to work with us on this bipartisan legislation to make further improvements?
Ms. O’Connell: (01:22:13)
Senator Hassan, thank you so much for your question. This is a place where I tend to spend a lot of time in my new role. I’m pleased to report that ASPR has spent and invested over $10 billion in supplemental funds to restock the stockpile. We currently have 35 times the number of N95 respirators we had at the beginning of the pandemic. We have 17 times the number of gloves, eight times the number of masks. And of the N95 masks, all 12 contracts are with domestic manufacturers. So we’re beginning to see some progress.
Senator Hassan: (01:22:51)
And will you work with us on the bipartisan legislation that Senator Cassidy and I have introduced?
Ms. O’Connell: (01:22:56)
I would look forward to. Thank you, Senator.
Senator Hassan: (01:22:57)
Senator Hassan: (01:22:59)
Dr. Fauci, I have a question for you about pediatric vaccines. Many parents and family members are understandably eager for updates on the potential availability of COVID-19 vaccine authorized for use for children under 12. I’m encouraged that clinical trials for young children are underway and I’m hopeful that we will see the same safety and efficacy that we’ve seen from previously authorized COVID-19 vaccines. Doctor, when do you believe parents and families can expect trials to yield the type of data needed to pursue authorization for use in children under 12?
Dr. Fauci: (01:23:33)
Thank you for that question, Senator. From the standpoint of the data that would be required to make a decision, that very likely when you do the age deescalation study, so we’ve gone from 12 to nine, nine to six, six to two, and then six months to two years, likely by late fall, early winter, we’ll have enough data. But that doesn’t mean that then it’s all of a sudden going to be allowed to happen. That will be a regulatory decision that the FDA will have to make.
Senator Hassan: (01:24:00)
Well, thank you. And I see that I’m out of time. I’ll follow up with you in writing, because I’m also interested in what you think we could do now to help boost confidence and uptake for the pediatric population once the approval is authorized.
Dr. Woodcock: (01:24:14)
Thank you. Senator Marshall.
Senator Marshall: (01:24:16)
Thank you, Madam Chair. My first question for Dr. Walensky, as a physician, we always want to be able to know and discuss the benefits and risk of anything that we’re prescribing, including a vaccine. It’s estimated that 40% maybe 50% of children have already had the COVID virus. What are the additional benefits to the vaccine, to a child who’s already had the virus?
Dr. Walensky: (01:24:41)
I think it very much depends on what variant that child might have had, whether they could potentially be infected or reinfected. And one thing I just want to note with the children is I think we fall into this flawed thinking of saying that only 400 of these 600,000 deaths from COVID-19 have been in children. Children are not supposed to die. And so 400 is a huge amount for a respiratory season.
Senator Marshall: (01:25:11)
Thank you. And Dr. Woodcock, how many children under the age of 18 without a pre-existing condition, a significant health condition have died from COVID in this country?
Dr. Woodcock: (01:25:20)
I don’t have that at my fingertips. I’m sorry.
Dr. Walensky: (01:25:23)
Senator Marshall: (01:25:24)
Without health condition-
Dr. Walensky: (01:25:26)
Oh, that I don’t know. We’re not-
Senator Marshall: (01:25:27)
So I think the answer’s probably zero. So I think if you take a deep dive, most of the children that have died had some type of underlying health condition.
Senator Marshall: (01:25:35)
Dr. Fauci, in my hand is a three-dimensional printing of the COVID spike, something that’s certainly a scientific… Just baffles me in so many ways. It’s composed of two units. As you know, there’s an S2 subunit and an S1. And I’d like you to talk about the S2 subunit for a second. Can you explain the significance of the furin cleavage site, the double arginine CGG codon, if you would, and how that works clinically for us?
Dr. Fauci: (01:26:05)
Thank you for that question, Senator. The furin cleavage site is a site of a set of amino acids, which is at the point where the enzyme, furin, can cleave it so that the virus can then bind to the receptor cell and then enter the cell. So it is seen on a number of viruses. It’s on the SARS-CoV-2, and it’s also seen on other beta coronaviruses. You asked also about the double CGG codon. That is a codon, again, that is unusual, but it is also seen on a number of beta coronaviruses. It is not a very common codon for the amino acid in question, but it is seen in coronaviruses.
Senator Marshall: (01:26:52)
Dr. David Baltimore, a Nobel Laureate, I’ll quote him here, “When I first saw the furin cleavage site in the viral sequence, with its arginine codons, I said to my wife it was the smoking…”
Senator Marshall: (01:27:03)
With this arginine codons, I said to my wife, “It was the smoking gun for the origin of the virus.” These features make a powerful challenge to the idea of a natural origin for SARS 2. And again, this is Nobel Laureate Dr. David Baltimore saying this.
Dr. Fauci: (01:27:16)
Senator Marshall: (01:27:16)
Would you agree or disagree with Dr. Baltimore?
Dr. Fauci: (01:27:19)
Well, Dr. Baltimore, who is an extraordinarily accomplished scientist, has backtracked on that statement and says, “I wish I had not used the word smoking gun,” when it was pointed out to him that actually this is seen in a number of Coronaviruses, including one of the common cold Coronaviruses. So, I believe if you would ask.
Senator Marshall: (01:27:42)
So, you disagree with him?
Dr. Fauci: (01:27:43)
Well, I agree with his second statement where he backtracked and said he wished he had not used-
Senator Marshall: (01:27:50)
So, you disagree with his first statement though?
Dr. Fauci: (01:27:53)
And he disagrees with his first statement.
Senator Marshall: (01:27:55)
Okay. So, that can answer the question. We also have the S1 sub unit. And I refer to the timeline behind me here, that there was a moratorium placed for viral gain of function in 2014. And I think you’ll agree with me that the NIH funded research that led to an S1 spike that looks very similar, if not exactly, to what’s on the COVID-19 spike.
Dr. Fauci: (01:28:20)
What are you referring to, Senator? Can you please be more specific?
Senator Marshall: (01:28:23)
Yeah. So, I’m talking about the S1 sub unit of the current COVID-19 spike.
Dr. Fauci: (01:28:30)
What about it? I mean, are you talking about an experiment? Are you talking about a paper that was published?
Senator Marshall: (01:28:35)
So, I’m talking about viral research that was done using NIH funding with the North Carolina lab. And Dr. She developed to this S1 subunit spike that looks exactly like what we have on the current COVID-19 spike.
Dr. Fauci: (01:28:51)
Senator Marshall: (01:28:51)
Is that not true?
Dr. Fauci: (01:28:52)
No. I’m not sure exactly what you’re referring to. Are you referring to the paper of Barrack and She In Nature Immunology? Is that what you’re referring? I need to know specifically.
Senator Marshall: (01:29:03)
Yeah. So, Dr. Barrack and She printed studies on this S1 unit that was basically the development of the key to the door that specifically took the original SARS virus and made it so what would bond to the human lung cells.
Dr. Fauci: (01:29:18)
No. If you’re referring, Senator, to gain of function, by the definition-
Senator Marshall: (01:29:24)
Okay. I’ll have to pull the question.
Dr. Fauci: (01:29:26)
Senator Marshall: (01:29:27)
Would you agree that the spike that was developed there is what’s also on the current that’s COVID-19 virus?
Dr. Fauci: (01:29:31)
Yeah. But that’s irrelevant to anything until you have a context in which you’re putting it. You’re talking about an S1 and a spike. In what context? If you’re talking about a paper that was written by them-
Senator Marshall: (01:29:46)
But you would agree or disagree that it’s the same spike?
Dr. Fauci: (01:29:49)
I’m not sure what you’re talking about, Senator. I’m really not sure what you’re talking about.
Senator Marshall: (01:29:53)
Okay. Thank you.
Dr. Fauci: (01:29:54)
Chair Murray: (01:29:55)
Thank you. Senator Casey.
Senator Casey: (01:29:58)
Thank you, chairman. I want to thank the panel for being here today and for your public service at a challenging time for the country. I just wanted to make a couple of statements at the top. Assistant Secretary O’Connell, I want to ask you a question, but just wanted to note on pages four and five of your testimony about the information about the inventory that you’ve built up, we’re happy to read that. I won’t go through it all. And also the statement you made about “ensuring a safe and consistent supply chain for medical materials, ingredients, and supplies is critical for any national response to public health emergencies.” I couldn’t be… we couldn’t be, I should say, more pleased with that kind of a focus, because we’re going to need that in the future.
Senator Casey: (01:30:57)
Dr. Walensky, there was an earlier question, I think by Senator Hassan, talking about nursing homes and nursing home workers in particular. I want to ask you a question, because I’ve got a separate question. But the lower vaccination rate for a nursing home workers is of concern. We’re told by federal data that there are still 13 states where less than half, less than half of nursing home workers have been vaccinated. So, the message about vaccinations couldn’t be more important.
Senator Casey: (01:31:29)
And last thing I’ll say, Dr. Fauci, in reference to the questions by Senator Paul today and the accusation, I think it’s a widely shared view in both houses, in both parties that the integrity that you bring to your work and the knowledge you bring to your work on behalf of the nation, I think that sentiment is a broad and deep reservoir. And it is very, very much bi-partisan. I won’t ask you to comment on that.
Senator Casey: (01:32:05)
But I have a question for Dr. Fauci and Dr. Walensky about breakthrough infections. We know that even with the great success of the vaccines, there’s no 100% effectiveness. So, I wanted to ask about breakthrough infections. I haven’t seen, maybe it’s available, but I haven’t seen information about either breakthrough infections or enough information about cases of long COVID, I assume because of a lack of data. Dr. Walensky I would ask you, what types of data is CDC collecting to track breakthrough infections? And how are both CDC and the National Institutes of Allergy and Infectious Diseases, Dr. Fauci, using data to monitor outcomes in patients with breakthrough infections?
Dr. Walensky: (01:32:58)
Thank you, Senator. So, there are different ways that we are capturing these data. And I think all of them fit together in a puzzle. One is passive surveillance where we’re folks give us data when they break through. The hospital systems provide us data. They know that somebody is hospitalized and has a history of vaccination. We want to know about those cases. To the extent possible, we’d like to have a sample of the virus so that we can understand the viral load so that we can sequence it, we can understand their symptoms and their risks that potentially put them in that situation.
Dr. Walensky: (01:33:29)
However, that’s actually limited because it actually doesn’t give us the denominator. We don’t know who else would have been reporting or who we missed in that process. And, in order to do real effectiveness studies, we need to have both the numerator of the cases as well as the denominator. So, we’re doing many of those studies across the nation. We do have them geographically sampled. We have a long-term care facility study where we’re getting data from over 14,000 long-term care facilities. We have a health worker study. We have an essential worker study that’s 5,000 essential workers that are being tested by PCR every single week. And we have numerous other cohorts in 19 academic medical centers, 187 hospitals to monitor both the numerator, how many people are breaking through, how serious is their infection, as well as the denominator, how many people overall were vaccinated, so we can get a really good window as to the breakthrough, the percentage of people who are breaking through.
Senator Casey: (01:34:28)
Thank you. Dr. Fauci?
Dr. Fauci: (01:34:30)
Well, first, thank you very much for your prior comment, Senator. It’s much appreciated. With regard to your question, I think people need to appreciate, when you talk about breakthrough infections, that the original data from the clinical trial, the efficacy data was based on preventing clinically apparent disease, not preventing infection, such as asymptomatic infection. So, when you hear about a breakthrough infection, that doesn’t necessarily mean the vaccine is failing because it’s still holding true, particularly with regard to protection against severe disease leading to hospitalization and deaths. So, as per your question, what are we doing? We will be following for two years the people who were in the clinical trials, the 30,000 and 44,000 people, to be able to determine just what percent now in the context of the Delta Variant are actually breaking through to determine if it’s more than that original that we saw or, in the context of Delta, if it’s actually much more.
Senator Casey: (01:35:33)
Thank you, doctor. Thank you, Chair Murray.
Chair Murray: (01:35:36)
Thank you. Senator Cassidy.
Senator Cassidy: (01:35:37)
Hi. Thank you all. I’ll ask… if I cut you off, I’m not being rude. I’ve just got five minutes. Got to hustle. Ms. O’Connell, to follow up upon what Senator Hassan said, thank you for replenishing the strategic national stockpile. But one thing that troubled us is that there was no first in first out. There was no rotation of material before it expired. It was just dumped. Just yes, no, have inventory management systems been implemented to minimize the waste each?
Ms. O’Connell: (01:36:08)
Thank you, Senator. Yes. We are looking at that.
Senator Cassidy: (01:36:11)
Looking is a very vague term. If you were one of my medical students on rounds, I would say, what does that mean?
Ms. O’Connell: (01:36:16)
Well, one of the things we are pursuing is the model of the vendor manage.
Senator Cassidy: (01:36:20)
Wonderful. Thank you.
Dr. Walensky: (01:36:21)
Senator Cassidy: (01:36:22)
Secondly, related to that, I’m told there’s a lot of vaccine that’s about to expire. So, it’s six months from being expired in a state which is not completely using it. Unfortunately, that’s my state that’s among those. Ideally, from my perspective, we’d rotate that vaccine out to the border for those who were coming across as undocumented or down to Central America and Mexico, which is having these COVID outbreaks. I’m told there’s contractual issues with that. But is there any effort to rotate out soon to expire vaccine that doesn’t appear as if it’s going to be used into a setting which it could be used quite rapidly?
Dr. Woodcock: (01:36:59)
We have been working on this. And what we have been advising the states is, where they have repositories, to hold on to that vaccine. Because, unlike most medical products you’re used to, we’re making these stability determinations on the fly.
Senator Cassidy: (01:37:13)
So, Dr. Woodcock that’s news. You’re telling me that, even if it goes beyond the expiration date, that the vaccine can still be used?
Dr. Woodcock: (01:37:22)
No. I’m saying we’re telling people to hold on to it because, when the additional stability… because the companies are doing stability on the fly because we-
Senator Cassidy: (01:37:35)
Dr. Woodcock: (01:37:36)
Yeah. Yeah. So, we’ve extended the date once already for one of the vaccines. We may be able to keep extending as there is longer stability observed.
Senator Cassidy: (01:37:47)
But it still seems to me, inevitably sooner or later, you’re going to decide you’ve got to toss it. Now, just an inventory management system, it seems wise to be rotating that to a place where it would be taken up quickly, as opposed to a place where it’s being taken up quite slowly. Agree? Disagree? And, if you agree, any thoughts regarding that?
Dr. Woodcock: (01:38:10)
That’s really for probably Asper to talk about.
Senator Cassidy: (01:38:14)
And maybe for the State Department?
Dr. Woodcock: (01:38:15)
Yeah, and the international.
Senator Cassidy: (01:38:17)
But are there contractual obstacles to doing that? Because someone told me that the contracts with the drug companies would not allow the transfer of the product to another setting. We couldn’t give it to the Mexico, for example, because it just has to be tossed. Do you know about that?
Dr. Woodcock: (01:38:39)
Well, they aren’t the FDA has contracts. So, my understanding is that it’s possible under EUA to do exports, and that could be possible. But we can get back to you on that because it really isn’t an FDA issue.
Senator Cassidy: (01:38:53)
Sounds great. Next, as regards Dr. Fauci or Dr. Walensky, it does seem to me this issue… or Dr. Woodcock, of whether or not we need a booster would be ascertainable by whether or not we can see a response of antibody to rechallenge within the window period. It’s what, four days for the virus between exposure and an onset of infection? If the antibodies, after re-exposure to vaccine, if you will mimicking an infection, shoot up rapidly, we’ve got protection. Are any studies taking place along these lines?
Dr. Woodcock: (01:39:30)
Yeah. Absolutely, both within the government and within the companies. And the government as a whole, the agencies involved are monitoring this very carefully, and we’re sharing all the data. And we’ve heard from the many-
Senator Cassidy: (01:39:45)
Now, these are very simply done and don’t have a lot of timeframe. Obviously, the window period is only four days.
Dr. Woodcock: (01:39:51)
Senator Cassidy: (01:39:53)
And I’ve asked about this before, but it doesn’t seem as if there’s any answers. What is the delay in knowing this? Because that would answer Senator Romney’s question as regards to whether or not a booster is required.
Dr. Woodcock: (01:40:03)
Well, as Dr. Fauci said, there are two things going on here. One is, when does immunity wane to the point that you need to give a booster? Our populous is not going to… we can’t just boost them all the time. Right? We need to boost them when it’s appropriate.
Senator Cassidy: (01:40:18)
But isn’t there a subset of people whom you’re following longitudinally?
Dr. Woodcock: (01:40:21)
Senator Cassidy: (01:40:22)
That have negative antibodies. Their antibodies were initially a positive, and now they’ve gone down either very low or zero?
Dr. Woodcock: (01:40:27)
They’re waning. I wouldn’t say they’re negative. Obviously, Senator Dr. Cassidy, there are going to be people who don’t respond to vaccination primarily, right, because of some immunocompromise. However, what is being followed is the waning of humoral immunity, as Dr. Fauci described, over time. But it’s waning. It isn’t vanished.
Senator Cassidy: (01:40:52)
Dr. Woodcock: (01:40:53)
And that is clear because everybody who is getting hospitalized is unvaccinated, and they’re being exposed to the Delta Variant. So, the vaccination is holding right in the U.S.
Senator Cassidy: (01:41:05)
Okay. I thank you all.
Chair Murray: (01:41:08)
Thank you. Senator Lujan.
Senator Lujan: (01:41:10)
Thank you so much, Chairman Murray, for this important hearing and to all of our witnesses for being here today. While I’m encouraged that data shows vaccine rates are increasing across America, still less than half of Hispanics have been vaccinated, despite data showing that it is the least vaccine hesitant group. Dr. Walensky, federal investment in community health centers increased Hispanic vaccination rates. Yes or no, did this investment in this community save lives?
Dr. Walensky: (01:41:41)
I am grateful for collaboration with HERSA and the Federal Qualified Health Centers. And I absolutely think that being able to reach out to these communities has saved their lives, some of their lives.
Senator Lujan: (01:41:51)
Dr. Walensky, additionally, when Hispanic communities received outreach in Spanish, it increased vaccination rates. What is the plan to build on the success of using culturally appropriate outreach and messaging to boost Hispanic vaccination rates?
Dr. Walensky: (01:42:05)
I think we need to use culturally appropriate messaging in all of our vaccination efforts, and not just in our vaccination efforts, in all of our healthcare efforts. Our vaccination tool kits are available in more than 20 languages. So, it has worked in the vaccination of the Hispanic community, but also many of our other harder to reach communities. And yes, we are continuing to do outreach by trusted messengers in their own language in culturally sensitive ways. And in fact, we’re seeing that it’s working. We had a recent MMWR in North Carolina that demonstrated, when we did this outreach, we were able to reach Hispanic communities, increasing vaccination rates from eight to 19%.
Senator Lujan: (01:42:43)
And, Dr. Walensky, the nest question I have is along those lines. The administration has enlisted black owned barbershops and beauty salons, as well as faith-based community outreach, to promote the shots and even serve as vaccination sites to increase black vaccine rates, which is important. And I applaud. Does the administration have plans to employ similar targeted outreach to the Hispanic community?
Dr. Walensky: (01:43:05)
The administration is working to reach people where they are and to understand community by community what is it that that community needs to understand to have trusted messengers, whether it’s in barbershops, whether it’s in faith-based organizations, whether it’s in grocery stores. That’s what we’re working to do.
Senator Lujan: (01:43:22)
I’d be interested if you could submit to me or get to me what those plans are for outreach into the Hispanic community, similar to the plans I just described.
Dr. Walensky: (01:43:30)
Senator Lujan: (01:43:31)
I wish I could ask the panel similar questions about Native American vaccination rates. IHS is not sharing the data. With the exception of the good work that’s happening in Alaska, where Alaska is not depending on IHS to get vaccination rates, we do not have state-specific IHS data. Many officials have told me they’re going to fix this. It’s not been fixed. Please fix it. Let’s get IHS on board. Let me ask each of you a yes or no question. Has disinformation on tech platforms negatively impacted the response to the pandemic? Dr. Walensky?
Dr. Walensky: (01:44:09)
Yes. And, in fact, it’s propagated 70% more often.
Senator Lujan: (01:44:12)
Dr. Fauci: (01:44:13)
Yes, it has.
Senator Lujan: (01:44:14)
Dr. Woodcock: (01:44:15)
Senator Lujan: (01:44:16)
Ms. O’Connell: (01:44:17)
Yes, it has.
Senator Lujan: (01:44:18)
Assistant secretary O’Connell, viruses don’t respect international borders. And for interconnected border states like New Mexico, our physical and economic health depends on international cooperation. I very much appreciate the line of questioning from Dr. Cassidy. We need to do better in this space and look for every available tool that exists to make sure we’re helping get vaccine out, especially into neighboring countries across the Americas. What can the federal government do to decrease COVID infections in border communities?
Ms. O’Connell: (01:44:57)
Thank you, Senator, for that question. And I did want to follow up on what Senator Cassidy asked and Dr. Woodcock was responding to. It’s a question of liability, which is one of the things that we work through in these contracts that need to be worked through when vaccines are shared with other countries. And so, that’s the contracting issue that can be an impediment. But it is important, I think, that we offer tests and vaccines where we can to prevent the spread of COVID in the border communities.
Senator Lujan: (01:45:26)
I recently joined a CODEL to Latin America, and one of the countries we visited in Ecuador, where I found out that some of the vaccine formularies and samples have not been made available to local regulators to approve the vaccine. Anticipating if the United States can donate more vaccine or there’s more vaccine purchased, Dr. Walensky and Dr. Woodcock, and my time is about to expire, maybe submit this into the record. How can the federal government better coordinate internationally to ensure that foreign regulatory bodies have the data and vaccine supply that they can be approved locally? If you want to give maybe a quick response here, and then I can follow up into the record.
Dr. Woodcock: (01:46:06)
We have collaborations with regulators around the world through IMRG, which is the International Medicine Regulator Group, as well as other ways. So, we are actively reaching out to other foreign regulatory authorities to give them information about what we’ve done to review vaccines and what we know about them.
Senator Lujan: (01:46:27)
Thank you. And I want to thank this trusted panel. I certainly hope that we can stop the spread of misinformation, that we can listen to the experts and save more people across America. Thank you for your commitment to saving lives. I yield back.
Chair Murray: (01:46:42)
Thank you. Senator Braun.
Senator Braun: (01:46:42)
Thank you, Madame Chair. The question is for Dr. Fauci. I’m a strong believer in first amendment protections, and we’ve obviously seen, and coming from the business world as well, the tech industry carries so much clout. They are monopolies, as ones are defined. And, when you have markets, that is a lot of other power that goes along with it. When you have any case where the federal government gets in cahoots in any way with big companies like that, that is almost unheard of. And generally the government would try to do something about that. In February, Facebook included new criteria for removing misinformation and part of it was about the origination of the COVID virus, which now has gone from what they were declaring as misinformation to maybe the way we think it actually occurred. And Facebook has said that they’ve made consultations with leading health organizations. Was your organization, NIAID, one of the leading health organizations Facebook consulted with when deciding what speech to filter through?
Dr. Fauci: (01:48:05)
To my knowledge, Senator, that is not the case. When you say consulting with my agency regarding what speech to filter through, I don’t ever recall or have ever heard of any discussion about filtering speech.
Senator Braun: (01:48:22)
Did they consult with you on any topics, not necessarily whether you’d filter through it or not? Have you been in contact with them to give them your personal opinion on this or that?
Dr. Fauci: (01:48:39)
I don’t know what you mean by this or that. There was one communication or two, perhaps, with Mark Zuckerberg in which he emailed me and wanted to know if there’s anything that he could do. I believe it was promoting vaccination or making sure people do the right thing, wear masks. But it was mostly propagating a public health message. It had nothing to do with the origins of the virus at all.
Senator Braun: (01:49:05)
And then, do you on a very frequent basis consult with him, either via email or you have his cell phone number, for instance?
Dr. Fauci: (01:49:14)
No. I have exchanged a few emails. You probably know that, because you’re asking the question. About 10,000 pages of my email have been [inaudible 01:49:24]. And, in fact, there is an email exchange or two between myself and Mr. Zuckerberg. I don’t recall. I can look it up right now and see if I have a cell phone number. I’m not sure I do.
Senator Braun: (01:49:38)
Well, you can get back to me on that.
Dr. Fauci: (01:49:39)
Senator Braun: (01:49:39)
I’m guessing you might.
Dr. Fauci: (01:49:41)
Senator Braun: (01:49:42)
My point is an entity like that, and we’ve got 190 million users here in the U.S., and they are getting into the fray on so many things. And they are the classic example of where there’s too much concentration within one entity. And, in years past, we’ve done something about that, not just let it kind of run its course. And we’ve never had any of the big monopolies get involved with filtering or censoring speech to boot.
Senator Braun: (01:50:16)
Another question related to the White House has recently said that they are wanting to flag problematic posts. And, working for the president, would you be one that would try to come up with whatever posts that are out there that need to be flagged as misinformation?
Dr. Fauci: (01:50:42)
No. I have not at all been involved even indirectly in that.
Senator Braun: (01:50:45)
Do you think there’s a risk, even though you haven’t been involved, to the White House wanting to flag stuff that they think is problematic, and then have that same type of communication with entities like Facebook? Just get your opinion on that.
Dr. Fauci: (01:51:06)
No. Actually, this is beyond my area of expertise. I develop vaccines to save people’s lives. I don’t get involved in flagging things, Senator. Sorry.
Senator Braun: (01:51:15)
Okay. Well, let’s then pivot to speaking of vaccines.
Dr. Fauci: (01:51:18)
Senator Braun: (01:51:20)
When you enter grade school, there are many vaccines that are mandated and I think accepted over time. Would you, and I’d like Dr. Walensky to answer this as well. Would you be for mandating ever a vaccine for COVID-19 or any of the variants as mandatory for getting into grade school?
Dr. Walensky: (01:51:49)
I think first we need to see the data. I hope they are efficacious. First, we need to see the data, understand the risk benefit. So, I think that’s premature at this point.
Senator Braun: (01:51:58)
What data would you need, beyond what we’ve got, to go to that next step of making that a mandate along with some of the others that have been so for a long time?
Dr. Walensky: (01:52:07)
We don’t have clinical trial data in the grade school aged population yet.
Senator Braun: (01:52:15)
I think that means, for you, that you might considering further data.
Dr. Walensky: (01:52:17)
I think we need to see what the clinical trial data, see the risk benefits, see the long-term data.
Senator Braun: (01:52:23)
Dr. Fauci: (01:52:23)
I think the same thing. You have to make decisions based on data. We don’t have that data right now. When we do, then we could address the decision.
Senator Braun: (01:52:31)
Chair Murray: (01:52:32)
Thank you. Senator Baldwin.
Senator Baldwin: (01:52:33)
Thank you, Madame chair. So, I’ve been encouraged by this administration’s use of the Defense Production Act to produce more pandemic supplies in the U.S. And I was proud to be a part of the effort to secure ten billion dollars in the American Rescue Plan to increase the domestic supply of PPP and other medical supplies. In 2020, the U.S. was overly dependent on China, and we did not have sufficient domestic sources of very critical PPE, which was exacerbated by a shortage of raw materials. When the pandemic hit, there was a bottleneck in the global production of medical grade meltblown, a material that is essential for N95 masks. Today, Wisconsin manufacturers have the ability to provide the meltblowns to provide surge capacity required to produce billions of N95 respirator masks. This type American manufacturing is exactly what we need to be supporting.
Senator Baldwin: (01:53:48)
Ms. O’Connell, I know that Asper has used significant funding to increase its inventory of supplies, but I’m concerned that, if we don’t focus some of our expenditures on raw materials, we may remain dependent on China and other countries. How is Asper working to secure supplies of raw materials, like meltblown, to make us better prepared for the future?
Ms. O’Connell: (01:54:19)
Senator Baldwin, thank you so much for that question. And thank you for the work that you did to get that ten billion dollars in the American Rescue Plan. We just recently had released by OMB two billion dollars of that ten, which is going to go to, among other things, expanding manufacturing for raw materials for vaccines. So, that’s one of the first efforts that money will be used for. It will also go to make sure that we have enough full finish capacity, needles and syringes. And it’s just the start. We’re, of course, very anxious to get these contracts awarded and moving. But it’s the beginning of that ten billion dollars going to exactly what you had hoped it would go to. Of course, that’s not enough. We’ve got more to go. But I just wanted to share with you, that’s where we are right now. We’ve also spent, as I mentioned earlier, other supplemental funds on producing in the U.S. gowns and other PPE. So, we’re continuing to do that domestic manufacturing, but we do have this industrial based expansion for vaccine manufacturing capacity right now.
Senator Baldwin: (01:55:27)
Okay. Thank you. During this committee’s last COVID-19 hearing, I asked about the administration’s approach to reducing waste and better targeting vaccines, including by reducing the number of doses in each vile and the number of vials in each package. Experts believe that both of these steps would significantly aid vaccination efforts as doctor’s offices and community organizations could more easily give interested patients shots without worrying about spoiling additional doses. In that hearing, Dr.-
Senator Baldwin: (01:56:03)
… additional doses. In that hearing, Dr. Kessler expressed the administration’s strong desire and effort to move forward on both of those goals. But recent reporting suggests that this might no longer be the case. Dr. Fauci, can you assure me that the administration is doing all it can to encourage the production of smaller vials and smaller batches as soon as possible, and what steps are being taken and what is your anticipated timeline for changes like this?
Dr. Fauci: (01:56:34)
Well, thank you for that question Senator. That is not really in my area of activity. I believe that’s more of an FDA question.
Senator Baldwin: (01:56:41)
Well, Dr. Woodcock, please.
Dr. Woodcock: (01:56:43)
Certainly, and between us, or FDA, right? Basically, to do that, we need to get the manufacturers to change how they’re manufacturing the drug and what the storage conditions might be and things like that. I think heroic efforts are being made to try and get vaccines that don’t require deep freezing storage conditions,, and that could be then broken up into smaller groups and stored in say, a pediatrician’s office refrigerator.
Dr. Woodcock: (01:57:20)
I mean, that’s the ideal here so that pediatricians and others could … primary care, at the pharmacy, at the nursing home pharmacy, whatever, as new people come in, they could vaccinate them without wasting large amounts of vaccine or having to break into something in the deep freeze.
Dr. Woodcock: (01:57:41)
So those efforts are arduously going on. They are highly technical though, and they aren’t simple. I think the government and the manufacturers are both united in realizing this is necessary.
Senator Baldwin: (01:57:57)
Sen. Murray: (01:58:00)
Thank you, Senator Tuberville.
Senator Tuberville: (01:58:03)
Thank you very much. Thank you for being here today and testifying, Dr. Walensky, you’ve been in your current post since January, you’re in the top position, and you surely have heard critiques of the job the CDC has done so far in each, this administration, and even the last, you usually learn from some things that happened in the past. What would you say to those who look to the CDC and say that change is needed? That perhaps the agency needs a bit of restructuring?
Dr. Walensky: (01:58:37)
Thank you for that question. Certainly during-
Senator Tuberville: (01:58:41)
What would you do different?
Dr. Walensky: (01:58:42)
What would I do differently?
Senator Tuberville: (01:58:45)
Yeah, but go ahead.
Dr. Walensky: (01:58:45)
You know, certainly during the times of pandemic, I came in on January 20th, we had our pedal to the metal, shall we say, moving forward to try and do everything that we could to get us out of the pandemic. We’ve made a lot of progress. We’ve had to be humble about this virus can do and a lot has changed just in the last six months.
Dr. Walensky: (01:59:03)
We need a public health infrastructure in this country that allows CDC and our states and local health departments to be prepared for a pandemic. So in that process of restructuring, we need long-term disease agnostic funding that isn’t like a rollercoaster that comes with one pandemic and or one infectious disease threat and disappears when that threat is gone.
Dr. Walensky: (01:59:26)
We are going to be dealing with this when, God-willing everybody is vaccinated and people are well and the pandemic is largely behind us, we have long COVID, we will have boosters to be thinking about, we will be dealing with mental health issues for a very long time to come and we need the public health infrastructure to do so. That would be my biggest ask and change.
Senator Tuberville: (01:59:47)
Thank you, Dr. Woodcock, the FDA currently has emergency use authorization for three COVID vaccines, but they have not yet received the full FDA seal of approval. What would you say to the vaccine hesitant people who don’t feel comfortable taking a vaccine that hasn’t been fully FDA approved?
Dr. Woodcock: (02:00:11)
Well, first of all, I would say we did not cut any corners in these 30,000 patient trials and these 44,000 patient trials and all the surveillance you’ve been hearing about of potential rare side effects. So compared to other vaccines they’d be looking at, these have really gotten the full court press as far as evaluation and study and they’ve gone through the FDA process and they’ve gone to the ACIP, the CDC’s advisory committee, and it’s strongly recommended that people take them.
Dr. Woodcock: (02:00:45)
That said, it is public, that one of the companies put a marketing application before us, and we are going to do everything we can to review that in a timely manner. But of course, I can’t say anything more about it.
Senator Tuberville: (02:01:01)
What kind of timeline do you think that we’ll have full approval?
Dr. Woodcock: (02:01:04)
That’s the kind of thing I can’t talk about. Thank you.
Senator Tuberville: (02:01:07)
Thank you. Dr. Fauci, we’ve made this way to political. This has been tough on American people. We all know that. Everybody’s worked hard to try to get through this. Politics has played a huge role in this. We’ve all watched it from close and afar, but I think people need a unifying message from all of us, because in my state of Alabama, we don’t have everybody taking a vaccine and we’re having outbreaks as we speak.
Senator Tuberville: (02:01:40)
We’ve had Operation Warp Speed, General Perna in a committee here … not in this committee, but in another committee, he took a beating saying how poorly a job he did. The American people saw that. A lot of people voted for Donald Trump and a lot of people in the South, a lot of people in my state voted for Donald and We have to have a unified message.
Senator Tuberville: (02:02:01)
We can’t be blaming this or that. We’ve got to go north with this, we can’t go south. We can’t go the other direction. So Dr. Fauci, can you understand that unless this administration acknowledges the efforts of the last one, a large part of the Americans, they’re going to continue to feel like nothing’s positive. They’re not going to take the vaccine. You understand what I’m saying?
Dr. Fauci: (02:02:24)
I understand exactly what you’re saying, Senator, and thank you, that’s a very appropriate question that I would be pleased to answer. Having been present through the last year, which was the year when COVID began, the last year of the former administration, I can tell you that no doubt that the former administration deserves a considerable amount of credit for the effort that was put into Operation Warp Speed, that was able to allow, not only the rapid development and testing, but also the implementation of the vaccine. So there’s no doubt in my mind, as someone who has been on both sides of the fence, to say that’s the case.
Dr. Fauci: (02:03:07)
But with regard to your unifying message, if I might, sir, I think what we need to appreciate is that we are dealing with a common enemy and the common enemy is the virus. The virus doesn’t know if you’re a Republican, Democrat or independent. The virus just knows that it makes people ill and it kills people. We have an extraordinarily efficient tool against that common enemy. What I would hope the message would be, the unifying message is, let’s all pull together and utilize that tool, which is vaccination to really crush that common enemy. I think we have it within our capability to do it and I would hope that that would be the message.
Senator Tuberville: (02:03:55)
Positive attitude, plus effort equals performance. If we keep that positive attitude, we can get through this thing. We just need to quit fighting in the media and get everybody believing in the same thing. We’re all on the same team. Thank you very much.
Sen. Murray: (02:04:11)
Thank you, Senator Hickenlooper.
Senator Hickenlooper: (02:04:14)
Thank you, madam chair and ranking member. Thank you, coach. I appreciate that, the belief in the positive attitude. As someone who was a part of many scientific debates back in my solid days, it increases my respect beyond what I can say in words of how well you have gone through the intense debate, because these are life and death decisions you have to make, oftentimes where there was conflict among the science and we were trying to get the facts assembled and sorted and prioritized as quickly as we could.
Senator Hickenlooper: (02:04:58)
So before I even ask any questions, just let me say that my questions are always towards a unified future. But I want to make sure I recognized how well you have each served your country under very difficult circumstances. And I don’t know, Dr. Fauci, how many of these types of hearings have you been in so far?
Dr. Fauci: (02:05:20)
Close to 200.
Senator Hickenlooper: (02:05:21)
Yeah, so just to look at the intensity by which you focus on the answers is remarkably impressive and I wanted to express my gratitude and our gratitude. I guess, first with Dr. Walensky and Dr. Fauci together, we saw yesterday, the pediatrics academy talk about kids older than two wearing masks. We know that kids 12 and older should be getting vaccinated.
Senator Hickenlooper: (02:05:49)
Just quickly, just to give you a platform to talk about that unified message, what should schools be thinking about and who should they be talking to get ready? Obviously, the more kids we can get that are 12 and older, the more we get them vaccinated, they will be fully protected by the time they get to school in the fall, if we start now. What does that message look like? What would be a couple of what … Dr. Walensky, why don’t you start, and then Dr. Fauci can fill in.
Dr. Walensky: (02:06:20)
Thank you for that question, Senator. First of all, I want to lean in and say, I think it’s critically important that our schools be open for full in-person learning in the fall. We have learned enough over the last year to understand what we need to do to keep our children safe and we believe, based on the science, that we can keep them safe in those settings.
Dr. Walensky: (02:06:41)
How are we going to keep them safe? The first and foremost is the best thing would be to have everybody vaccinated who can be vaccinated, surround unvaccinated children who are not yet eligible with people who are vaccinated to protect them. So that is the highest and most important thing. For those children who are not able to be vaccinated, they can and should wear a mask in those school settings and we have said that in our guidance.
Dr. Walensky: (02:07:05)
I want to also comment on one other thing, and that I think is critically important in the school year coming ahead and that is the role of testing. Senator Burr has talked about the importance of other viral syndromes, flu, influenza. We are going to see upper respiratory infections in these schools in the fall. These kids have not been in school, they have not been with each other and I’m worried about the upper respiratory infections, and we are going to have to understand what is COVID and what is a simple cold among children. So those are among the things that I’m thinking about. Thank you.
Senator Hickenlooper: (02:07:36)
Great. Thank you. Nothing to add?
Dr. Fauci: (02:07:40)
Nothing to add. That was a very good explanation.
Senator Hickenlooper: (02:07:44)
You’ve become an admirable team. Dr. Woodcock, some of the FDA’s reports on … is it pronounced Aduhelm? Aduhelm? Biogen’s new Alzheimer’s drug, I think are very concerning. Last week, there was a extra panel convened by the Institute for Clinical and Economic Review, unanimously concluded that it wasn’t efficacious. It didn’t provide a benefit for patients with Alzheimer’s and certainly wasn’t worth the price tag.I know that I saw a couple … I was reading my briefs from my remarkable staff last night, that it could have been handled differently. How specifically differently should the FDA have looked at this?
Dr. Woodcock: (02:08:43)
Well, a lot of the confusion and controversy is simply what you said, this is an accelerated approval. That means it was approved on a surrogate endpoint that we believe is reasonably likely to predict clinical benefit. So the [ICE 02:09:03] conclusion that you just referred to, ICER, is not surprising because they haven’t definitively shown benefit.
Dr. Woodcock: (02:09:13)
Now, Congress has urged us to use the accelerated approval pathway for life-threatening diseases that don’t have any effective therapy. Alzheimers is one. I think part of the issue was it was brought to an advisory committee and proposed for a traditional approval, not on a surrogate endpoint. The advisory committee, more or less conclusively shot that down.
Dr. Woodcock: (02:09:38)
So the agency went back and looked at all the data on the surrogate endpoint, which is clearing out the Alzheimer’s plaque, the amyloid plaque from the brain, and they found that correlated with benefit, benefit, meaning slowing decline of deterioration of thinking. So with looking at other programs with other antibodies that do the same thing, they concluded that this clearing out of the plaque was reasonably likely to predict clinical benefit. But it doesn’t definitively mean that there’s a clinical benefit.
Dr. Woodcock: (02:10:20)
So I think with such a prevalent … it’s very common in cancer. It’s well accepted. That’s how we approved HIV drugs from the very beginning. All right. That was a very big success story. That’s how we approved many drugs for rare diseases, but this is a common disease and almost everyone, probably in this room, has had a relative-
Sen. Murray: (02:10:44)
Dr. Woodcock, thank you. We do have [inaudible 02:10:46] called and we have got to finish hearing. So I appreciate the response.
Dr. Woodcock: (02:10:48)
Long, I’m sorry.
Sen. Murray: (02:10:50)
Thank you, Senator Burr.
Sen. Burr: (02:10:52)
Thank you. Madam chairwoman, let me say, Dr. Woodcock, I think the decision that the FDA made relative to surrogate endpoints is exactly that forward leaning approach that we envisioned when we created that expedited pathway and I applaud the decision. I look back at HIV, who Tony Fauci was very involved in and had we not done similar things then, we wouldn’t have found the keys that unlocked doors that we needed.
Sen. Burr: (02:11:21)
I’m going to turn to Dr. Walensky for just a second. I just want to ask a quick follow-up on breakthrough, and Dr. Fauci, I understood what you said about the NIH following the clinical trials over a two year period, as it relates to breakthrough, that’s important. It’s not important from a standpoint of today and the decisions that we make. It’s my understanding that CDC is only tracking breakthroughs that result in hospitalization. Is that accurate?
Dr. Walensky: (02:11:53)
No, it’s not. So that’s in passive surveillance, which is, as I mentioned earlier, not the best way to track these breakthroughs and one of the limitations of our passive surveillance system, which is why we are collecting longitudinal data in tens of thousands of people, some of whom are getting weekly PCRs so that we can test for asymptomatic breakthroughs as well.
Sen. Burr: (02:12:12)
Okay. I think it’s extremely important that we be as specific on breakthrough exposures … One of the last tools that we have is, “Yeah, you may get vaccinated, but you may become infected and you’re going to have to prove the data that says, you probably won’t go to the hospital and you certainly won’t die.” So without that data, you’re in a very weak situation. So I would encourage you to build that database.
Sen. Burr: (02:12:43)
I’m going to take a couple of minutes to make an editorial, and it really gets to the heart of supply chain and Ms. O’Connell, this is going to fall in your lap. This is something that the chairman and I and the committee are going to deal with. You talked about a warm base. I know the target for what we want in the strategic national stockpile.
Sen. Burr: (02:13:09)
Here’s the reality. Federal purchases are 4% of PPE, and for us to set up a sustainable supply chain, it means that you have to compete with dumping practices of China on N95 masks, you have to compete with competition from around the world. I think, I know Janet and Tony understand that the memory span of a member of Congress is about 18 to 36 months.
Sen. Burr: (02:13:41)
After that, we sort of forget about the last incident that we went through and we look at it and say, “Well, why are we funding to keep the lights on this N95 mask facility? We don’t need any N95 masks.” The problem is that the 96% of the purchasers and providers across the country have now turned to the lowest cost competitor, which is probably not the warm base that we’ve got.
Sen. Burr: (02:14:08)
We’ve got to come up with a solution to this, and I want to work with you. I want to work with the White House because I’ve gotten to a point through a process of elimination as to what won’t work, faced with the realities of Congress’s inability to continue to fund indefinitely things that don’t produce something tangible. We’ve had to put BARDA on life support three different times because members didn’t see a need for it. Thank God we were able to keep it resuscitated.
Sen. Burr: (02:14:38)
I’m not sure that there’s a way to do this without creating an Americas trading block, where we incorporate North and South America together, where we incorporate the low cost, low labor areas of Central America, where textile companies already have a presence, where companies could move or to make N95 masks and not just warm base them, but actually let them compete with China in the open marketplace and sell to the rest of the world and invite the EU and invite Australia and invite Africa and India to be part of the America’s trading block, where we can expand.
Sen. Burr: (02:15:14)
As Janet knows, we’ve had problems with Brazilians on knocking off pharmaceutical manufacturing down there for years, let’s turn them into a part of our inventory of assets, where we can turn to vaccine production down there, pharmaceutical production down there, raw materials of South America.
Sen. Burr: (02:15:34)
If not, then show me something that is sustainable without the condition of Congress coming in and funding at the tune of hundreds of billions of dollars on an annual basis to keep that supply chain, for us as a purchaser of only 4%. Somehow we’ve got to present to the other 96%, a domestic manufacturing capability that makes them competitive against China, even with China’s dumping practices.
Sen. Burr: (02:16:07)
So I sort of lay that on the table. It won’t be the first time Tony has looked at me and said, “You’ve come up with something crazy.” But I’m in the business of trying to find solutions that are sustainable and it’ll only happen if we think outside the box on this. We thought outside the box with surrogate end points and Janet, were well down the road, people don’t die of HIV. They extend their lives.
Sen. Burr: (02:16:32)
Maybe the keys we find are actually cures in the future, mRNA technology platform, Tony, we may be cure cancer off of that platform, 2, 3, 4 years down the road. I wonder what the person who didn’t like mRNA for the vaccine for COVID is going to think when they’ve got prostate cancer and they’ve got a cure on an mRNA platform, I think they’re going to take it.
Sen. Burr: (02:16:57)
So everything’s going in our favor, but this is absolutely crucial to our assurance, to the American people and to the American economy and manufacturers that we’re going to put them somewhere, in a system that is sustainable for the future. I thank you for listening to me. I thank the chair. I yield back.
Sen. Murray: (02:17:15)
Thank you, Senator Burr. I appreciate that. That will end our hearing for today. I want to thank all of our colleagues, our witnesses, Dr. Walensky, Dr. Fauci, Dr. Woodcock, Assistant Secretary O’Connell for such a thoughtful discussion about our ongoing response to this pandemic and the path forward. With that, for any senators who wish to ask additional questions, questions for the record will be due in 10 business days, August 3rd, at 5:00 PM. The hearing record will also remain open until then for members who wish to submit additional material for the record.
Sen. Murray: (02:17:49)
The committee we’ll next meet tomorrow, July 21st for an executive session to consider the Family Violence Prevention and Services Improvement Act of 2021 and the nominations of Catherine Layman to be Assistant Secretary for Civil Rights at the Department of Education, Lisa Brown, to be General Counsel of the Department of Education, Roberto Rodriguez, to be Assistant Secretary for Planning, Evaluation, and Policy Development at the Department of Education, David Wilde, the Service Administrator of the Wage and Hour division at the Department of Labor, and Gwen Wilcox and David Prouty to serve as members of the National Labor Relations Board. Again, thank you to all of our witnesses.