11:04 A.M. EST ACTING ADMINISTRATOR SLAVITT: Thank you for joining us. Before I turn to Dr. Walensky and Dr. Fauci, I wanted to give a quick update. Yesterday, Jeff Zients, our COVID Coordinator, announced yet another supply increase. Pfizer and Moderna’s vaccine supply will now increase to more than 20 million doses going out to states, tribes, territories, and pharmacies. That's double the number going out every week before we came into office. This presents an opportunity for everyone to increase their vaccinations, even as that supply and supply of Johnson & Johnson vaccine ramp up even further. The country must quickly work through this additional supply. Today, President Biden will direct Jeff and the Health and Human Services team to procure an additional 100 million doses of the Johnson & Johnson vaccine. This order allows for the President to plan for the future in the latter part of the year. This is war time. And as facts still emerge, it gives us maximum flexibility for our upcoming needs. So to review some of our progress from the vaccination program over the first 49 days: We've released vaccine supply. The President has ordered enough vaccine doses for every adult in the U.S. We’ve more than doubled the number of vaccines going to states. We've improved the efficiency of the vaccination process. When we arrived, less than half of vaccines distributed to states were administered; today that number is approximately 75 percent. We worked with the vaccine manufacturers to speed up their delivery to May 31st. And as you'll hear about later today, we led a historic partnership between two rival drug companies to scale manufacturing and speed delivery. We've surged the number of vaccinators. The President has deployed 3,500 federal personnel, in addition to providing federal funding for members of the National Guard, to serve as vaccinators with many more to come. We've signed an order to allow our nation's doctors and nurses to give shots. We've mobilized more than 2,000 military men and women to support community vaccination sites. We've also dramatically increased the number of places to get vaccinated. We've provided federal support for over 500 community vaccination centers. We've launched a program to directly send vaccines to more than 9,000 local pharmacies. We've opened or are ramping up 20 high-volume, federally run sites that will be able to deliver 70,000 shots a week in some of America's most disadvantaged neighborhoods; 16 sites are operational now. Those sites have already delivered more than 500,000 shots. We're ramping up a program that directly sends vaccines to more than 1,300 community health centers to reach hard-hit communities. We're launching mobile sites to help vaccinate the hardest-to-reach communities. And this is leading to results for the American people, most importantly. More than 91 million Americans have received a shot: at least one dose, 61 million Americans; fully vaccinated, 32 million Americans. America leads the world in total vaccinations. On June -- January 20th, there was a seven-day average of 890,000 shots per day. And today, we're averaging above 2 million shots per day. On Saturday, we set an all-time, single-day record: nearly 3 million Americans vaccinated -- a pace seen nowhere else in the world. In terms of protecting the most vulnerable -- our core duty as a nation -- when we came into office, 8 percent of people over 65 were vaccinated. Today, 60 percent are vaccinated. And according to the CDC’s new guidance, vaccinated parents can now visit and hug their grandchildren -- and, in most circumstances, without wearing a mask. This is an accomplishment every American going through the difficult process of waiting for the vaccine can take pride in. And as more people get vaccinated, more people will become eligible. Yesterday, Alaska became the first state to make vaccines available to all people over the age of 16. There are many steps left in the path, but we are making progress. With that, I will turn it over to Dr. Walensky. DR. WALENSKY: Thank you, Andy. It's a pleasure to be back with you today. Let's take a look at the current state of the pandemic. CDC’s most recent data indicate that the recent plateau of cases may be again starting to trend downward, with a seven-day average now of 56,000 cases per day. We also continue to see decreases in new hospital admissions for the most recent week. An average of 4,900 patients with COVID-19 were admitted per day in the most recent week. And while we have seen deaths hovering around 2,000 deaths per day in recent weeks, the latest seven-day average is now down to 1,600 deaths per day. Earlier this week, we saw the number of deaths per day drop below 1,000 for the first time since November. All of this is really good news. And while these trends are starting to head in the right direction, the number of cases, hospitalizations, and deaths still remain too high and are somber reminders that we must remain vigilant as we work to scale up our vaccination efforts across this country. We must continue to use proven prevention measures to slow the spread of COVID-19. They are getting us closer to the end of this pandemic. As I discussed on Monday, CDC released initial guidance on activities fully vaccinated people can resume safely while limiting risks to themselves and others. To help this important information out to the medical community and to the public, today the Journal of the American Medical Association published a scientific commentary from CDC. In the commentary, we again summarize the new recommendations from CDC: that fully vaccinated people can visit with other fully vaccinated people in small gatherings without wearing masks or physical distancing; that fully vaccinated people can also visit with unvaccinated people from one other household without wearing masks or distancing, as long as no member of the unvaccinated household is at high risk of severe illness from COVID-19; and that fully vaccinated people do not need to quarantine or get tested following contact with someone who has COVID-19, as long as the fully vaccinated person is asymptomatic. We also reiterate that in other scenarios, including public settings and travel, people who have been fully vaccinated should continue to wear masks and practice safe public health prev- -- precautions, just like people who have not yet been vaccinated. In addition, the commentary includes information about the scientific basis for CDC’s new recommendations that balance the risk of fully vaccinated individuals with the risk of infection and spread among the still 90 percent of the American public not yet protected by a COVID-19 vaccine. The commentary also describes the outstanding scientific questions we are working to answer to inform future guidance and get people back to their everyday activities. Key among them are questions about the risk of vaccinated people transmiss- -- transmitting the virus to others if they have a vaccine breakthrough and become infected; how long protection from vaccines lasts; and how well the vaccines work against the circulating virus variants. While we are starting to see emerging evidence that the vaccines remain effective against circulating variants and that the risk of breakthrough infections in vaccinated persons and spreading the virus to others is low, we must be resolute in our efforts to fully answer these critical questions. When answered, they will inform the future guidance that will enable us to safely resume activities, while also protecting others who remain vulnerable to this disease. We are working across the government and with many scientific partners to answer these questions as quickly as we can. And I'm committed to updating our guidance as new scientific information becomes available and, importantly, as more people get vaccinated. I want to close by reiterating that our actions this week represent a first step, not our final destination. We are at a critical point in this pandemic and on the cusp of having enough vaccine to protect every adult in the United States. We ask for your patience in practicing proven prevention measures for just a little while longer. We ask for your participation by rolling up your sleeve when it is your turn to be vaccinated. And we ask for your leadership in helping others do both of the same. With the above actions -- we are so very close -- we can turn the tide on this pandemic. Thank you. I look forward to your questions. And I'll now turn things over to Dr. Fauci. DR. FAUCI: Thank you very much, Dr. Walensky. What I'd like to do over the next couple of minutes is talk a bit about what we refer to as "special populations." So if I could have the first slide. Many of you are very familiar with this slide. It is a slide of the phased vaccine distribution that has been put out by the CDC. If you look at these -- from the phase 1A, B, C; and 2 -- what is not specifically mentioned here are pregnant women and pediatric individuals, namely people from age six months to 16 to 18. Also, in the third panel on phase 1C, we refer to as high-risk conditions. So I'm going to get a little bit more granular on that with you. If I could have the next slide please. First of all, let's take a look at what we mean by "special populations." First of all are pregnant individuals. There are about 3.7 million births in the United States in 2019. Then there are adolescents and children -- a very important topic when we think in terms of schools and the protection of children. There are about 73 million individuals between the ages of birth and 18 years. And then, importantly, there are immunocompromised individuals -- those who have immunosuppressive medical conditions, either primary immunodeficiencies or acquired immune deficiencies, such as HIV -- or individuals who are receiving immunosuppressive treatment or chemotherapy. That could be either due to an underlying neoplasm or, maybe even more frequently, to individuals with one form or another of an autoimmune disease requiring suppression of a hyperactive immune system. It's estimated that about 3 percent of U.S. adults fall within that category. Next slide. So what is some of the questions that we ask of these special populations? The obvious ones are: What is the safety and immunogenicity profile of vaccines in these populations? And as I mentioned on a previous presentation, it is unlikely that we will require a full efficacy study involving tens of thousands of individual volunteers. What we almost certainly will do is determine safety and do immunogenicity to determine if special populations -- be they pregnant women, be they pediatric cases -- that these individuals make a comparable immune response to that which we know, actually, is associated with the high degree of protection that we're seeing in our vaccines. Next is: What is the duration of the immune response to vaccination in certain special populations? Take, for example, individuals who have immunodepression either by a disease or iatrogenically by a drug. We may show that the level of immune response is good, but that the durability of that might be different because of the compromise of the immune system in these individuals. And then, we want to know: What is the efficacy of vaccination on reducing disease and transmission in certain special populations? There may be a difference between them and individuals in what we refer to as the "normal adult population." Next slide. So let's take a quick look at the pregnant individuals. The American College of Obstetrics and Gynecology -- ACOG -- recommends that vaccines of SARS-CoV-2 should not be withheld from pregnant individuals and that pregnant individuals may choose to receive a COVID-19 vaccine, and they should have a conversation with their clinicians. As I mentioned on a previous briefing: Although they were not specifically looking at pregnant women in the studies which led up to the EUA, since the EUA, several thousands of pregnant individuals have actually gotten vaccinated. And the CDC has established a V-safe pregnancy registry to follow the outcomes among vaccinated pregnant individuals. Specifically, in one case, Pfizer-BioNTech has launched a randomized placebo-controlled study to do just what I said a moment ago: to evaluate safety and immunogenicity in pregnant individuals. Also, as I mentioned in a previous briefing when we discussed J&J, the J&J adeno 26 vector has considerable experience with Ebola, in Africa, in individuals who are pregnant and or lactating. And on the final slide -- excuse me, not yet final -- the adolescents and children. The age range that is currently authorized for the SARS-CoV vaccination, as you well know, is 18 and older from Moderna, 16 for Pfizer, and 18 for J&J. There are vaccine safety and immunogenicity studies in adolescents and children that are either ongoing and/or planned. For example, Pfizer-BioNTech’s study in persons aged 12 to 15 is fully enrolled, as is the teen COVE study from Moderna in individuals 12 to 17. This led me to tell you last time that we would know, likely by the beginning of the fall, whether or not we can -- and I believe we will be -- able to vaccinate children of high school age. Now, there are also trials in younger children which will follow -- referred to, for example, as the Moderna “Kid-COVE” study. And as I mentioned previously, J&J is also planning studies in pediatrics. Next slide. And then on this last slide, just a couple of other considerations. People with HIV -- questions we get asked all the time. People with stable HIV infection are included in the trials, although the data are limited. The HHS guidelines for HIV recommend that people with HIV should receive the SARS-CoV-2 vaccine because the potential benefits certainly outweigh the potential risks. And remember, although people with HIV -- persons living with HIV are often considered to be immunocompromised, many of them, in fact, who have normal CD4 counts, who have their viral load suppressed by combination antiretroviral therapy, have relatively intact immune response. So we would expect that they would do quite well. And then finally, studies on highly allergic individuals are planned, and we will keep you up to date as we get data from these studies. I'll stop there. And now back to Andy. ACTING ADMINISTRATOR SLAVITT: Thank you. Let's take some questions. MODERATOR: Great. First question, we will go to Cheyenne Haslett at ABC. Q Hi, thanks for taking my question. Two questions for Dr. Fauci and Dr. Walensky. First, the CDC has said antibodies, after a COVID infection, can fade after three months. Should vaccinated people be concerned about their -- that their immunity might fade in such a short period of time? And then the second question is how concerned people should be about breakthrough infections. DR. WALENSKY: Thank you for that question. DR. FAUCI: Go ahead. DR. WALENSKY: You know, our current guidance says that -- you know, three months is the data that we have so far, so we are waiting for data to emerge about how durable your protection is beyond three months. And so this is exactly among the reasons why we want to be cautious as we take these first steps in our guidance post-vaccination. The durability and the protection, in the context of variants, are among the areas we're watching the evidence very carefully. DR. FAUCI: Yeah. One of the things we want to emphasize is that there is not a direct linear correlation between the level of antibody and the degree of protection, as Dr. Walensky says. Also, measuring antibody does not necessarily get the entirety of the immune response. We know now, and we're learning more and more, that the T-cell responses -- both CD4 and CD8 -- may also contribute significantly to the durability of protection. ACTING ADMINISTRATOR SLAVITT: Dr. Fauci, do you want to comment on the role, in the case of Moderna and Pfizer, of a second shot, in your view of durability? DR. FAUCI: Yeah. I mean, obviously, we've been talking for some time now about why we feel very strongly that we need to go with the science in showing that with Moderna, 28 days later, and with Pfizer, 21 days later, you get the maximum protection of 94 to 95 percent efficacy. But importantly, if you look at the titers of the antibody following the first dose, they may be good enough to do a degree of protection, but we don't know what the durability is. Also, when you're dealing with variants, you want a considerable cushion of antibody response, if in fact, when you look at the variants, it diminishes by several fold the efficacy of vaccine-induced antibodies. And if it diminishes it by several fold, you want to still stay within the range of protection, as opposed to essentially falling off the grid, as it were, if you get it so low. So that's the reason why we continue to maintain that recommendation. ACTING ADMINISTRATOR SLAVITT: Thank you. Next question, please. MODERATOR: Next, we’ll go to Kaitlan Collins at CNN. Q Thank you, and thank you for doing this briefing. My question is for Dr. Walensky, regarding the new CDC guidance on what vaccinated people can do. We know that the risk of infection during air travel is low when everyone is wearing a mask. So wouldn't it be lower for people who are fully vaccinated? And, if so, why did you not change the travel guidance for vaccinated people? DR. WALENSKY: Thank you for that question, Kaitlan. What we have seen is that we have surges after people start traveling. We saw it after July 4th. We saw it after Labor Day. We saw it after the Christmas holidays. Currently, 90 percent of people are still unprotected and not yet vaccinated. So, we are really looking forward to updating this guidance as we have more protection across the communities and across the population. ACTING ADMINISTRATOR SLAVITT: Next question, please. MODERATOR: Next, we'll going to April Ryan with TheGrio. Q Thank you so much. I have a couple of questions -- one dealing with the vaccination of pregnant women. Once the pregnant women are vaccinated, will the vaccination, by any chance, transfer into the unborn child and give them antibodies? Have you found that, as well? And also, on the issue of herd immunity -- Dr. Fauci, I would like to get this from you if possible -- what is the anticipation, in the midst of all of these vaccines flooding the zone, of herd immunity? What's the timetable? And do you think that you will reach that timetable, as you have certain communities that still are not participating in the majority way for this effort? Thank you. DR. FAUCI: Thank you, April. Very quickly, with regard to your first question, you would definitely expect -- and we've seen this with many other vaccines -- that when you vaccinate a mother during pregnancy, that there's transplacental transfer of antibody IgG from the mother to the baby, and also in breast milk if a mother decides that she wants to breastfeed. So that is a very good way where you can get protection of the mother during pregnancy and also get a transfer of protection to the infant, which will last for a few months following the birth of the infant. With regard to your question about herd immunity, as I mentioned, you can only make a calculation of what the percentage of the population that would have to be vaccinated, plus those who have been infected and would assume to be protected for at least for a limited period of time. We don't know what that number is, but you can calculate based on, for example, extrapolations from diseases like measles and the vaccine protection of measles and the transmissibility of measles -- which is very, very high. The herd immunity level for measles is around 90 percent. Once you get into the 80s, then you could start getting into trouble. We anticipate -- and again, it's purely a speculation -- that the herd immunity level will be about 70 to 85 percent. And that's the time that we believe, if you look at the planned rollout of the vaccines, that we would hopefully get to that point somewhere by the end of the summer and the early fall. You're absolutely correct: If a significant number of people do not get vaccinated, then that would -- that would delay where we would get to that endpoint, which is the reason that I underscore what Dr. Walensky said about the importance, in every aspect of what we do, of getting more people vaccinated -- just as many people as we possibly can. I want to also mention that we don't want to get too hung up on reaching this endgame of herd immunity because every day that you put 2 million to 3 million vaccinations into people makes society be more and more protected. So you don't have to wait until you get full herd immunity to get a really profound effect on what you could do. For example, as Dr. Walensky said, she keeps her eye on that very carefully as they reevaluate the guidelines, so you can get 20, 30, 40, 50 percent of the people vaccinated and not yet quite meet the empiric number that we're talking about and still get a very favorable effect from vaccines. DR. WALENSKY: Maybe I'll just add that the point of -- incredibly important that these are local rates as well, so if you have a population rate that is 85 percent protected across the country but a community that's only 50 percent protected, you can have outbreaks in that community. And so really we need this level of protection pervasive across all communities across the country. ACTING ADMINISTRATOR SLAVITT: Thank you. Let's take another question. MODERATOR: All right. Last question: We'll go to Shannon Pettypiece at NBC. Q Hi. First of all, I was wondering if you could give a bit of the timeline on these new J&J vaccine doses that you're talking about. Is that going to -- when would you get those? Is that going to speed how quickly we can get every American vaccinated? And secondly, I know you guys have talked before about when we're going to get to the point where we have more supply than demand for the vaccine, and I wondered if you are seeing any areas yet where we are approaching that. I know there's been reports from places like Louisiana, and Alabama, some of the Carolinas, where there seems to be more supply than demand in the states than have been expanding their population of who's eligible. So I'm wondering what you guys are seeing and then, of course, what you're doing to try to address that. ACTING ADMINISTRATOR SLAVITT: Sure. And maybe, for your second question, I'll also invite Dr. Walensky to add a comment about how she's thinking about this at the CDC. And, of course, Dr. Fauci, if you want to add as well. The Johnson & Johnson 100 million doses that -- that we discussed this morning was a recent order given by the President to the COVID Coordinator, Jeff Zients. So, that is -- that is a directive. And so, more details about that -- it's too -- it's too premature to provide you more details about what the content of that is going to be. With regard to your second question, maybe I'll just kick it off by saying that I completely agree with the premise of your question, which is that there is not a magic date where the entire country moves from needing more vaccinations to having too many vaccines for the population. And, point of fact, this is a journey that we're working on together. And as you suggested, community by community around the country, they’re going to reach that spot in different places. We are working through the CDC and directly with state and local officials, to continue to make that assessment. But important for you to know that, we are working on both sides of that equation, helping people get straight answers to their questions about vaccines, as well as increasing vaccine production, which we spent a lot of -- more of our time talking about here. Dr. Walensky, what would you add? DR. WALENSKY: Yeah, I would add several things. We are working now with 9,000 pharmacies across the country. We know that 90 percent of the population lives within five miles of a pharmacy. We are now rolling out to 250 Federal Qualified Health Centers across the country. We're working with our state and local partners to provide toolkits and assistance to ensure that they can reach -- reach all of their populations. We're doing vaccine confidence consult: if people have challenges, in terms of vaccine hesitancy, how can we address those challenges. There's a lot of work going on so that we can actually delay the period of time where people don't want the -- you know, where we have that inflection point. We want to have a lot of vaccine out there and we want to have a lot of people who want it. ACTING ADMINISTRATOR SLAVITT: Yes, and I would add that the -- the track record of these vaccines is so good, from a safety and efficacy standpoint, that simply making sure people have access to correct information and not misleading information is the most important thing, and making sure that local, trusted people have access to that information as is -- we continue to make vaccines more broadly available. Dr. Fauci, is there anything you wanted to add on that? DR. FAUCI: No, no further comment, Andy. Thank you. ACTING ADMINISTRATOR SLAVITT: Okay. Great. Okay, well, with that, we’ll wrap up. We will be back on Friday. And thank you all for your attendance. 11:33 A.M. EST |
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