10:36 A.M. EDT ACTING ADMINISTRATOR SLAVITT: Good morning. Thank you for joining us. Today, I am joined by Dr. Walensky, Dr. Fauci, and Dr. Murthy to give you a thorough update on a busy week of activity fighting the pandemic across multiple fronts. You have heard our scientific and public health teams, led by Dr. Fauci and Dr. Walensky, talk in plain terms about the threat to ending the pandemic we face from more dangerous variants that emerge from COVID-19. Today, with their help, I want to lay out our strategy to tackle these variants. When we arrived in January, we put together a 200-page plan on how we would tackle every element of the pandemic -- from vaccinations, to inequities, to school re-openings, to testing. Part of any plan is tackling the things you can’t fully prepare for but which emerge as critical threats. All roads to defeating the pandemic go through the path of successfully and quickly vaccinating the country. To date, 125 million Americans have been vaccinated and millions more each day. But even as we accelerate our efforts to get shots in arms, more dangerous variants are growing, causing increases in cases with people without immunity. This increases the urgency for you to get vaccinated. But it also requires us to intensify our efforts to quickly test for and find the genetic sequence of the virus as it spreads. Now, we started in a hole. Despite having world-class researchers and dedicated state and local public health leaders, when we arrived, the U.S. was sequencing only a small fragment of what other countries were. This hampered our ability to find and react to these new variants. What we call surveillance -- our ability to spot variants as they emerge and spread -- is vital, particularly as we aim to get ahead of dangerous variances before they emerge, as they are in the Midwest right now. Today, we are announcing a $1.7 billion investment to bolster the ability of the CDC and state and local public health departments to monitor, track, and defeat emerging threats -- whether it’s COVID-19 variants today or other viruses in the future -- through a process known as genomic sequencing. This significant investment, which is made possible due to the American Rescue Plan President Biden signed into law last month, is critical in our fight against the new and potentially dangerous variants of COVID-19. Right now, these variants account for nearly half of all COVID-19 cases in the United States, and we need more capacity in our public health system to identify and track these mutations. State and local public health departments are on the frontlines of beating back the pandemic, but they need more capacity to detect these variants early on before dangerous outbreaks. This funding will enable CDC and states to do more genomic sequencing as we activate the nation’s great research capabilities to detect variants earlier and increase our visibility into emerging threats. This investment will give public health officials the chance to react more quickly to prevent and stop the spread. Today’s investment also builds on the major investments in testing and genomic sequencing that we made earlier this year. That includes $10 billion of American Rescue Plan funding to support COVID-19 testing in schools, another $2.5 billion to help state and local public health agencies increase testing capacity in underserved and high-risk communities, and nearly $200 million to begin to increase genomic sequencing capacity that this investment comes on top of. We’re doing a number of other things to work with individual states that are experiencing a rise in cases: providing more intensive support to get more shots in arms more quickly, more personnel to support vaccination and other public health efforts, and more testing and therapeutics. Additional sequencing efforts will be a vital tool in our battle against COVID-19. I have one further announcement. Today, we’re announcing another federally-run mass vaccination site in Bessemer, Alabama, that will have the capacity to administer 7,000 shots per week. Altogether, by next week, we will have opened 37 mass vaccination sites in 26 states, with a combined capacity of administering a total of 125,000 shots per day. We’re doing everything we can to put this pandemic behind us, and we stand ready to support states. But, before I turn it to Dr. Walensky, I want to reiterate the role all of us have to play. We need everyone to do their part. We need all Americans to take the steps we know work to stop COVID-19. So, please: Wear a mask, socially distance, and as needed -- socially distance, and get tested as needed, and also go get vaccinated. As of Monday, all adult Americans will be eligible. With that, I’m going to turn it over to Dr. Walensky. DR. WALENSKY: Thank you and good morning. As for my usual, I’ll begin with an overview of the data. Yesterday, CDC reported 73,622 cases of COVID-19. Our seven-day average is up to 69,500, nearly 70,000 new cases per day. I know case numbers may seem similar from day to day, but just four weeks ago, our seven-day average was only about 53,000 cases per day. In concert with the increase in cases, the seven-day average of emergency department visits, hospital admissions, and hospitalizations are all approximately 5 to 8 percent higher than they were in the prior seven-day period. And sadly, average daily deaths have increased for the third day in a row to over 700 per day. We are also getting vaccines into arms as quickly and as equitably and safely as possible. I am proud of the progress we've made. More than one third of the U.S. population has received at least one dose, and more than one fifth of the population is fully vaccinated. But we must continue to get many more people vaccinated. This -- the increasing trends in cases, hospitalizations, and deaths are very concerning, and they threaten the progress we've already made. As I've discussed, some of these increases are as a result of relaxed prevention efforts in states across the country, such as relaxed mask mandates or loosened restrictions on indoor restaurant seating. Another reason for these increases is the continued spread of highly transmissible variants -- more than 50 to 70 percent more transmissible -- which makes the race to stop the transmission even more challenging and threatens to overwhelm our healthcare system again in parts of this country. CDC data show that the B117 variant -- the variant originally identified in the United Kingdom -- represents 44 percent of the virus circulating during the week of March 27th. The prevalence of B117 since that time is certainly higher, and we are expected to have new data soon. The emergence of variants underscores the critical need for rapid and ongoing genomic surveillance. CDC has been acting on multiple fronts to increase our sequencing efforts in the United States to detect variants of the virus that causes COVID-19, and recently began receiving the sequence data from seven additional large commercial laboratories. As Andy just announced, the administration is investing $1.7 billion from the American Rescue Plan in an effort to more effectively track emerging and circulating variants across the country and to better prepare the country for the next pandemic. This includes surveillance of breakthrough infections, as well as more and more -- as more and more people get vaccinated. With this critical and substantial investment, CDC will fund the equipment, supplies, training, staffing, electronic infrastructure, partnerships, and innovation needed to build a robust national genomic-sequencing effort. In addition, $300 million will establish six Centers of Excellence in Genomic Epidemiology. These Centers of Excellence will operate as partnerships between state health departments and academic institutions, and today's funding will fuel cutting-edge research into genomic epidemiology. In this work, we will build our public health capacity to respond not just to COVID-19, but to future concerning emerging threats to public health. Yesterday, I testified before a congressional subcommittee, where I shared my commitment to working with the Biden administration and Congress to address longstanding vulnerabilities and core public health infrastructure that presents challenges in the nation's ongoing effort to successfully tackle COVID-19. Today's announcement and this investment substantially contribute toward that commitment. Finally, I want to comment on our ongoing surveillance of the safety (inaudible) with the Johnson & Johnson vaccine we discussed on Wednesday. After the press briefing on Wednesday, the Advisory Committee on Immunization Practices -- or ACIP -- met to discuss the six cases and provide recommendations. I want to thank the ACIP for their thoughtful discussion and their commitment to the science. The recommendation from this group of independent experts for a continued pause will allow additional time to review any additional cases that might come in, and for them to conduct a complete risk assessment and to evaluate the emerging science. ACIP will meet again this Friday, April 23rd, from 11:00 to 5:00 to provide further recommendations. Importantly, the vaccines produced by Moderna and Pfizer are still widely available, and we continue to work with pharmacies, states, and FEMA to make sure the vaccine supply remains robust across the country as we approach April 19th, when all Americans above age 16 or 18, depending on the vaccine received, will be eligible for vaccination. If you have not been vaccinated, I want to encourage you to do so with one of the available vaccines as soon as you can. Widespread vaccination is the only way we will ultimately move past this pandemic. Thank you. I’ll now turn things over to Dr. Fauci. DR. FAUCI: Thank you very much, Dr. Walensky. I would like to take this opportunity now to call your attention -- can I have the first slide? -- to the first -- soon to be first-year anniversary of the NIH-sponsored Coronavirus Disease 2019 Treatment Guidelines Panel. Next slide. This is a panel of individuals co-chaired by Dr. Cliff Lane, who is my Deputy Director of NIAID, but also the Clinical Director of the Institute; Henry Masur, who is the Director of the Critical Care Medicine Unit at NIH; and Roy “Trip” Gulik, who is the Chief of Infectious Diseases at Weill Cornell Medicine in New York City. As you can see from this group, the members -- some of you may recognize -- are people who are in the trenches every day, taking care of people with COVID-19. This panel was established to be able to work, literally in real time, updating guidelines for clinicians and healthcare providers throughout the country and the world on the latest information. And since information comes out not only in published work, but also the results that are pre-publication of either clinical trials or clinical observations, as well as expert opinion. Next slide. This is the list of the organizations that are represented on the panel by the people that you saw in the previous slide. Next slide. As I mentioned, the anniversary is next week on the 21st of April. Since we began, one year ago, there have been close to 4 million users in the United States, about 2,600,000 of which were international. So we are serving as a resource for clinicians throughout the world. Again, since the beginning, there have been over 14 million page views, and there have been 23 separate updates to the treatment guidelines. Next slide. This is an important slide. For those not used to looking at guidelines, there's varying degrees of strength of recommendation and what the evidence for that recommendation is. As you see on the left, there is "A,” a strong recommendation for a statement; "B,” moderate; "C,” optional. And on the right, it depends on what you're basing this recommendation. If you get a "1," that means there's one or more randomized trials without major limitations. "2A" is other randomized trials or subgroups. "2b" is non-randomized trials. And "3," you don't have a trial but there's expert opinion. So obviously, a "1" -- an "A-1" is a very strong recommendation based on good data, but you're going to see others, depending upon what the evidence has been. Next slide. So, let me just then show you an example. On April the 8th, eight days ago, there was an update on the recommendation of the use of anti-SARS-CoV-2 monoclonal antibodies. And the panel, after deliberation, recommended using one of the following combinations -- and I underscore "combinations" -- of anti-SARS-CoV-2 monoclonal antibodies to treat outpatients -- again, underscoring "outpatients" -- with mild to moderate COVID-19 at a high risk of clinical progression, as defined by the Emergency Use Authorization criteria. And these are the combinations listed there: bamlanivimab, etesevimab; or casirivimab and imdevimab. Number two, the treatment should be started as soon as possible after a positive result on SARS-CoV-2 antigen and nucleic acid amplification and within 10 days of symptom onset. Next slide. Now, the updated recommendations also have the following: Because the clinical outcome data are limited and there are concerns regarding the decrease of susceptibility of variants, the panel recommends against the use of bamlanivimab monotherapy. And that gets an "A-3" recommendation. The panel also recommends against the use of these antibodies in people who are hospitalized, except if it's in a clinical trial. However, the use should be considered for persons with mild to moderate COVID-19 who are hospitalized for a reason other than the underlying COVID-19 disease but who otherwise meet the criteria. And on the last slide. We often get asked, "If I have a patient coming into the office who I think I might want to give a monoclonal antibody to, how do I find out where and how to do that?" This is the information here. Contact the Combat COVID Monoclonal Antibodies Call Center at that telephone number and at that website. I'll stop there and hand it over to Dr. Murthy. SURGEON GENERAL MURTHY: Well, thanks so much, Dr. Fauci. And it's good to be with all of you this morning again. Today, I'd like to speak with you about two topics related to the national COVID-19 vaccination effort. First, American Indian and Alaska Native people are at higher risk for COVID disease and complications. And historically, we also know that they have faced more limited access to healthcare and great disparities in health. According to a recent CDC report, American Indians and Alaska Natives were 3.5 times more likely to get COVID than a non-Hispanic, white population. Native people are also more than four times likely to be hospitalized as a result of COVID-19. Despite these challenges, our colleagues working in the Indian health system have heroically administered more than 1 million doses of COVID-19 vaccines. That is a remarkable achievement and a testament to their dedication. Today, the Biden administration is doubling down on this critical work with a -- with a $4 billion investment from the American Rescue Plan to the Indian Health Service Tribal and urban Indian health programs. Specifically, these funds will support the following: expanded COVID-19 vaccinations, including mobile efforts, large-scale vaccination events, and public education and outreach campaigns; expanded testing, contact tracing, PPE access, and treatment; increased preventive health services for those at higher risk for COVID-19; and increased support for telehealth, the healthcare workforce, and the broader Indian healthcare system, which has been a hard hit during the pandemic due to lost reimbursements for care for both public and private insurance. Overall, we're committed to reducing health disparities and ensuring equity in our response to COVID-19. And today's funding announcement is part of a broader commitment to increase access to vaccines and reduce the spread of COVID-19 in hard-hit communities. Additionally, I want to emphasize one point in particular about vaccines which isn't always so obvious, and that's the following: Increasing access to vaccines is critical for increasing confidence in vaccines. And here's why: The more people see those around and get vaccinated, particularly family and friends, the more comfortable they become with getting vaccinated themselves. So the easier we make it to get vaccinated, the more people will get vaccinated, and that means more people around them would feel comfortable with getting vaccine themselves. And that's why access and confidence go hand in hand, and so does safety. Which brings me to the second topic. This week you've heard a lot from us about the pause with administering the Johnson & Johnson COVID-19 vaccine. These decisions are never simple, and this one was taken after a very careful assessment of the risks and benefits of calling for such a pause. But the actions taken by CDC and the FDA this week should give Americans confidence that our safety system is working for them. For some members of the public, uncertainty about getting vaccinated stems from questions about how safe the vaccines are. And this week is a reminder that safety is our top priority. Even when an extremely rare safety occurs, our scientific agencies will act with thoroughness and transparency so people can remain confident in the vaccines that are recommended to them. And as much attention as the J&J news has received though, what I'm most concerned about -- the numbers which are most on my mind are the rising cases in hospitalizations among those who are not vaccinated. Over the past year, the virus keeps reminding us that the risks of actually getting COVID are quite significant. It's cost us more than 500,000 friends and family members and has led to hospitalizations and prolonged symptoms for many, many more. We all want the same thing, which is to turn this pandemic around and protect ourselves and our loved ones. And to that end, our best path forward remains getting vaccinated and continuing to take the prevention measures that we know work: wearing a mask, washing our hands, and avoiding indoor gatherings with people outside of our household. We're really fortunate to have highly effective vaccines and a system that's working day and night to keep us safe. That gives me faith that we will make it through this pandemic together. Thank you so much, and we'll look forward to your questions. ACTING ADMINISTRATOR SLAVITT: All right. Thank you. I think we have time for a few questions. MODERATOR: We only have a few minutes for questions today, so please, please keep your questions to one question. First, we'll go to Weijia at CBS. Q Hi there. Thanks for taking my question. Can you lay out what the administration has done to (inaudible) Pfizer and Moderna vaccines? And did the trial include a booster shot so people know what to expect, medically, if they have to get one? ACTING ADMINISTRATOR SLAVITT: I think you're going to -- I'm going to ask you to repeat that because you cut out in the middle. Q Sure. I'm just looking for specifics about what the administration has done or is doing to acquire enough booster shots for people in the case that it -- that they need them for the Pfizer and Moderna vaccines, and whether the booster was part of the trial so people know what to expect, medically, if they get one in terms of the side effects. Thanks. ACTING ADMINISTRATOR SLAVITT: Got it. I'll take the first half of that. And then, in terms of side effects or anything like that, I'd just turn it to Dr. Fauci for that. So, look, we often get accused of being hyper-focused on preparation, preparing for multiple scenarios. We talk about that in here a lot. Requiring additional shots in the future is obviously a foreseeable potential event. I want to emphasize that while there is certainly speculation about this, that is far from saying that that is what's going to happen. I would, again, invite Dr. Fauci to comment on that. But I can assure you that when we do our planning, when we do our -- the President orders purchases of additional vaccines, as he has done, and when we focus on all of the production expansion opportunities that we talk about in here, we very much have scenarios like that in mind, as well as, obviously, vaccinating our teens and our children. So very, very important for all of us. Dr. Fauci, would you -- what would you add to that? DR. FAUCI: Yeah, regarding the clinical trials, in fact, ongoing already are clinical trials looking at a boost of the original wild-type virus vaccine, as well as a boost with a variant-specific -- in this case, the variant is 351, the problematic one from South Africa. So, in direct answer to your question, there are already clinical trial looking at both the safety of it, obviously, but as well as whether or not a boost of wild-type versus a boost of variant-specific increases the ability of the antisera to ultimately neutralize both the wild-type and the variant. ACTING ADMINISTRATOR SLAVITT: Thank you, Dr. Fauci. Next question. MODERATOR: Katherine Eban at Vanity Fair. Q Thank you for taking my question. What I would like to hear you all discuss is: If we are able to -- and it looks like we're right on track to do it -- vaccinate a solid majority of the country, what happens to the public health picture here if and when a large majority of the rest of the world remains unvaccinated? How will that impact the public health situation here at home or put pressure on us, medically? ACTING ADMINISTRATOR SLAVITT: So, Dr. Fauci, do you want to start with that? And, Dr. Walensky, Dr. Murthy, you're welcome to add if you have additional pieces. DR. FAUCI: Sure. Well, obviously, as we have said very often -- all of us on this call -- that a pandemic that is a global pandemic requires a global response. And even if we get good control in our country, which we feel that we will -- confident that we will, the fact is that as long as there's active dynamics of infection somewhere in the world, there always is somewhat of a threat that variants will emerge in those parts of the world and, because we're such an interconnected planet here, that it might actually be an issue that we will have to deal with as a challenge of keeping an eye on the possibility that variants will arise that we will have to make adjustments to, from the standpoint of vaccines as well as maintaining a certain degree of public health guideline control from a public health standpoint. I'd be happy to hear from Dr. Walensky if you have any other comments from that, Rochelle. DR. WALENSKY: Yeah, I would just say that I think we have a responsibility to vaccinate the rest of the world, both from a humanitarian standpoint as well as from a global health security standpoint, to ensure that we don't have further variants that threaten both the rest of the world as well as the United States. And I look forward to having CDC -- where we have partnerships across the globe -- to having a key role in providing technical assistance and support to make that happen. ACTING ADMINISTRATOR SLAVITT: Yeah, obviously a key priority of the Biden administration: to both vaccinate our own country, but also the leadership role we're taking in the world. I think we have time for one more question. MODERATOR: Let's go to Kaitlan Collins at CNN. Q Thanks so much. My question is on the J&J vaccine. Since you just announced that the vaccine advisors to the CDC aren't going to meet again until next Friday, that means this pause is now lasting more than a week. So aren't you concerned that the longer this pause lasts, the more damage it does to the reputation of the J&J vaccine and people's willingness to get it? ACTING ADMINISTRATOR SLAVITT: Dr. Walensky? DR. WALENSKY: Thank you for that question, Kaitlan. This was a really -- a meeting that we had with ACIP this week. The independent panel suggested that they needed more data; they needed time to look at both the risk and the risk-benefit analysis that has been -- that CDC is actively conducting, as well as to see if any further cases came in. We will meet next Friday. We recognize the critical importance of moving quickly. That's why we will have two unscheduled ACIP meetings in a 10-day period -- or 14-day period. And so, we are moving. And what I would say to the American people is that what we found is really extremely rare cases, through our vaccine safety monitoring system. And that we are transparently -- this meeting on Friday will be public. People can dial in. We are transparently conveying that science. We've reached out to over 10,000 providers to sort of, to ensure that they know what kinds of cases to look for and to do that outreach. And we want to convey to the American public: We have two vaccines that are readily available -- the Pfizer and the Moderna -- and people should continue to roll up their sleeves to get vaccinated. ACTING ADMINISTRATOR SLAVITT: Dr. Murthy, you made earlier comments about this safety priority that the country is placing and demonstrating. Do you want to reiterate some of your points. SURGEON GENERAL MURTHY: Sure. And, Kaitlan, let me just say: Look, when -- when events like this happen, when we take these kind of measures, we recognize that, for some people, it will raise questions. And we want to answer those questions, and that's why what you've seen just over the last few days is really concerted effort not only to do the safety investigation, but to communicate openly and transparently with people about what's going on. And that's why, in addition to the calls that Dr. Walensky mentioned with tens of thousands of healthcare professionals, we've also convened thousands of community organizations to talk to them -- faith organizations and sports organizations, other community-based organizations. We've also, you know, as you've probably noticed, had administration officials and others out in media to speak to people in national, regional, and local press. Again, use as many channels as we have to communicate with people. And we'll continue to do that because we want to be -- we want people to know what we know. And finally, let me just say this: Our message has been consistent, which is that, number one, this is -- this pause was about the Johnson & Johnson vaccine. If people have appointments to get the Pfizer and Moderna vaccine, we want them to keep those appointments. We have great faith in the effectiveness of those vaccines, and they have very strong safety profiles. Second, even if you've received the Johnson & Johnson vaccine, the vast and overwhelming likelihood is that you will be just fine. I know that people have questions about this given the cases they've heard about, but keep in mind that more than 7 million people have received the Johnson & Johnson vaccine, and we feel quite confident that the vast, vast majority of them, again, are just going to be fine. And third, just remember, this is your safety system working for you -- what you are seeing right now. A signal came up, the FDA and CDC jumped on it immediately to -- and decided to investigate thoroughly. And that's what's happening. And that, if anything, I believe, should increase people's confidence that they're being told what's going on and that any si- -- you know, signals are being investigated. We want people to have confidence the vaccines that we are recommending are safe and they're effective, and this is how we do that. ACTING ADMINISTRATOR SLAVITT: Kaitlan, I think this is the purpose of having the top clinical leaders in the country talking directly to you and to the public. The demonstration that incredibly rare events -- we also have to face the fact that we have lost 560,000 Americans and that vaccines save lives. 125 million Americans have gone and gotten vaccinated, and the results, as we can see, are quite incredible. So we hope Americans see that, in giving them the straight facts, we trust them to do the homework, make the decision to get vaccinated, and it's the right decision for them and their families. So, with that, I think we're going to close. And we will talk to you next week. Thank you. 11:08 A.M. EDT |
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