Jeff: (
02:45) ... [inaudible 00:02:45] to help systems, expanded testing capacity, and importantly, expanded the use of life-saving therapeutics. In fact, in the month of August, we shipped more than 670,000 courses of therapeutic treatments, that's six times as many as we shipped in July. These therapeutics prevent hospitalization and save lives. Our message to all states, tribes and territories is clear, we stand ready to help you in any way we can to respond to the Delta variant. As we respond to surges we remain laser focused on getting more shots in arms, and we continue to build momentum. Back in mid-July, we were averaging 500,000 vaccinations per day, today we're averaging 900,000. That's an 80% increase in the number of shots we're getting into arms each and every day. Last week we got over six million shots, the biggest weekly total since July 5th. Jeff: (
03:54) Importantly, we've accelerated the pace of first shots. In August, we got over 14 million, that's almost four million more first shots in August compared to the prior month, July. We continue to push for more vaccination progress, including through vaccination requirements. The President first adopted vaccination requirements for federal workers last month, and now over 800 colleges and universities, over 200 healthcare employers, small and large businesses across the country and dozens of state and local governments and school districts have stepped up to follow the President's lead. Tens of millions of Americans are now covered by vaccination requirements, and these requirements are already working to get more people vaccinated. In Washington State, the weekly vaccination rate jumped 34% after the state announced vaccination requirements for state employees, teachers, and school staff, healthcare workers and colleges and universities. Businesses are seeing strong results, on August 3rd when Arkansas based Tyson Foods announced its employees would need to be vaccinated no later than November 1st, only 45% of its workforce had gotten a shot, today that number stands at 72%. That's a 60% increase in less than a month. Jeff: (
05:35) Notably the share of job postings that require vaccinations are up 90%, according to indeed.com, a popular job search site. The bottom line, vaccination requirements work, they drive up vaccination rates and we need more businesses and other employers, including health care systems, school districts, colleges, and universities to step up and do their part to help end the pandemic faster. We need more individuals to step up too. As people across the country prepare for Labor Day weekend, it's critical that being vaccinated is part of their pre-holiday checklist. Getting vaccinated is free. It's easy and convenient, it's safe and effective, and it's never, ever been more important. So please, if you are not fully vaccinated, don't put it off any longer. Visit vaccines.gov or text your ZIP code 438829, 438829, that will enable you to find a site near you. Do your part, get your shot today for yourself and your loved ones, for your community and our country. With that, I'll turn it over to Dr. Walensky. Dr. Walensky. Dr. Walensky: (
07:03) Thank you, Jeff. And good afternoon, let's begin with an overview of the data. Our seven-day average of cases is about 129,000 cases per day. Our seven day average of hospital admissions is about 11,500 cases per day. And our seven day average of daily deaths has increased to 896 per day. As we prepare for more of our children to return to school after Labor Day, the CDC has strong and detailed guidelines that should be implemented to promote our children's safety in the classroom, let me reiterate what they are. Most importantly, the CDC recommends that everyone eligible for vaccination be vaccinated before school starts. If you or your vaccine eligible child is not yet vaccinated, it is never too late to begin your vaccine series. Dr. Walensky: (
07:52) Next, universal masking is critically important in schools for students, teachers, staff, and visitors, regardless of vaccination status. The CDC also recommends school employ additional key strategies in school to keep kids safe, including improved ventilation, physical distancing, and establishing screening programs for students and teachers. Federal resources have been made available to help schools implement these recommendations. Dr. Walensky: (
08:22) Parents should educate themselves on the CDC recommendations for K through 12 school operations. Parents can ask questions of their school administrators and learn how these steps will be implemented in their district. Parents should encourage their children to wear masks when in public indoor settings. And finally, and perhaps most importantly, parents can protect their children by getting vaccinated themselves, this will create a protective bubble around their children who are not yet eligible for their own vaccine. Dr. Walensky: (
08:54) As we approach the Labor Day holiday weekend, I want to share ways that Americans can keep their families and themselves safe over the long holiday weekend. First, if gathering with family and friends, remember that spending time outside with others who are vaccinated will help to prevent transmission. Throughout the pandemic we have seen that the vast majority of transmission takes place among unvaccinated people in closed indoor settings. Dr. Walensky: (
09:19) Second, when in public indoor settings, please wear a mask, vaccinated or unvaccinated. As I've said before, masks are not forever, but they are for now. Given the high transmissibility of the Delta variant and the significant community transmission in this country, wearing a mask is the easiest way for anyone, regardless of your vaccination status, to slow the spread of disease. Dr. Walensky: (
09:43) Third, talk with family and friends who are still unvaccinated about the benefits of the vaccine and consider taking them to get vaccinated over the long holiday weekend. Just yesterday the CDC's advisory committee on immunization practices reviewed the recent FDA decision to approve the Pfizer COVID vaccine, and we have updated our recommendations. I'm delighted to say that we now have a fully FDA approved CDC recommended vaccine available. For anyone who's been waiting to get vaccinated until we had more evidence on safety and effectiveness, I hope yesterday's announcement will have you join the more than 170 million people who have decided to protect themselves against COVID-19 by getting vaccinated yourself. Thank you. I'll now turn things over to Dr. Fauci. Dr. Anthony Fauci: (
10:33) Thank you very much, Dr. Walensky. I would like to now update you on COVID-19 vaccination in pregnancy. Next slide. It is very clear now, as I'll show you in a moment, that there are severe adverse outcomes for mother and baby during COVID-19 infection, therefore it is extremely important for pregnant women and women planning to get pregnant, to get vaccinated. Next slide. Dr. Anthony Fauci: (
11:03) Let's look at these adverse events that I mentioned a moment ago. From this CDC MMWR from over a year ago, if you look at an analysis of about 400,000 women and look at the risk ratio of things like intensive care admission, invasive ventilation, extracorporeal membrane oxygenation, or ECMO, or death, they all have an increased risk ratio. Next slide. If you look at total numbers, the total number of cases of pregnant women with COVID-19 from January, 2020 to August, 2021, there have been about 110,000 cases, about 19,000 hospitalizations and 131 deaths. Indeed, COVID-19 in pregnancy is serious. Next slide. Dr. Anthony Fauci: (
11:57) Let's take a look at some of those risk factors which increase the possibility and probability of severe illness. One is age, 25 years of age and older, occupation, pre-pregnancy obesity and chronic diseases like lung disease, hypertension, and pregestational diabetes mellitus. Next slide. What about the safety of COVID-19 vaccines in pregnant women? In over 35,000 participants that were followed in the v-safe, there were no obvious safety signals among pregnant women who received an mRNA COVID-19 vaccine. Next slide. And if you look at the immunogenicity in pregnant and lactating women, you see potent antibody and T-cell responses, as well as cross-reactive immune response against a number of areas. Next slide. Dr. Anthony Fauci: (
12:57) If you look then at breast milk, another advantage of getting a pregnant woman vaccinated is that when that woman breastfeeds it passes by passive immunization specific IgA and IgG antibodies in breast milk that were seen in a study with a six week follow up period. Again, antibodies found in breast milk show strong neutralization of virus protecting your newborn baby. Next slide. Dr. Anthony Fauci: (
13:29) And so if you look at the strong statement of 23 leading organizations who strongly urge all pregnant individuals, as well as recently pregnant, planning to become pregnant or lactating and other eligible individuals to be vaccinated. The bottom line, get vaccinated. Back to you, Jeff. Jeff: (
13:51) Wonderful. Thank you doctors. Let's open it up for a few questions. First question. Speaker 4: (
13:55) We'll go to Yamiche Alcindor at PBS. Yamiche Alcindor: (
14:06) Hi, thanks so much for taking my question. I have a question about, in some ways, the worries that you have with back to school children. Is there anything that you're seeing now in the states, given parents apprehension to send their kids back to school? [inaudible 00:14:21] you could talk about it's bubbling up, given that some medical professionals are saying that they're seeing more children be hospitalized. And I'm also wondering if you can speak at all to the idea that some states are seeing ICU bed shortages because of COVID, is there any sort of resources being shared to try to figure out what's going on there and to address it? Jeff: (
14:43) Dr. Walensky. Dr. Walensky: (
14:45) Sure, absolutely. Thank you, Yamiche. First of all, we have, as I mentioned in my remarks, strict and detailed guidance as to how to keep our children safe in school, this includes vaccination of everybody who is eligible, wearing masks in school. And we are seeing in some schools, as well as distancing and screening protocols, we are seeing schools that are not following these guidance, specifically, not masking, having lower rates of vaccination are dealing with outbreaks, especially in the context of this very transmissible Delta variant. And we are encouraging those schools to follow our guidance and to follow our assistance as they manage those outbreaks to get their kids safely back into school. Dr. Walensky: (
15:30) With regard to pediatric hospitalizations, we know that there's an absolute number of children, that because of this highly transmissible variant, an absolute number of children that are infected now with SARS-CoV-2, and because of that absolute number, there's a larger number of children in the hospital. We're also simultaneously dealing with an RSV outbreak that is occurring in children now that's atypical for this season, but is also leading to some more occupancy of those pediatric hospital beds. Thank you. Jeff: (
16:03) I would say on hospital capacity, in the last part of your question, our surge response teams are in constant communication with governors, states and local health officials. And as I mentioned, we've deployed 700 federal personnel to support states in their surge response and in their hospital staffing capacity. This includes doctors, nurses, EMS, and others, and we stand ready to provide states with additional resources, medical support teams, technical assistance, more supplies, and as we've talked about, lifesaving therapeutics that can keep people out of the hospital and save lives. Next question. Speaker 4: (
16:41) Let's go to Zeke Miller at the Associated Press. Zeke Miller: (
16:47) Thanks for taking my question. You mentioned the upcoming holiday weekend, given the surge in cases, should Americans reconsider travel this holiday weekend? And then more broadly, we've seen from the State Department and the CDC new travel warnings for countries that are doing better against COVID than the United States, why hasn't the administration taken a tougher stance in terms of advising Americans not to travel the same way as advising them not to travel to countries like Canada or places like Puerto Rico? Jeff: (
17:18) Dr. Walensky. Dr. Walensky: (
17:19) Yeah, we receive travel health notices and carefully watch those daily. [inaudible 00:17:29] look at testing capacity as well as case rates, and we update our travel guidance by country in real time. We have actually articulated that people who are fully vaccinated and who are wearing masks can travel, although given where we are with disease transmission right now, we would say that people need to take these risks into their own consideration as they think about traveling. First and foremost, if you are unvaccinated, we would recommend not traveling. Jeff: (
18:03) Next question. Speaker 4: (
18:03) Let's go to Meg Tirrell at CNBC. Meg Tirrell: (
18:09) Thank you. I'm hoping you can comment on these reports we've seen today, and the FDA confirming that two of the top regulators in the vaccine unit, they are retiring in October and November, Marion Gruber, and Phil Krause. A number of organizations are reporting that, in part, they're resigning because the FDA hasn't been as involved in the booster discussion that the CDC in some ways is front running them, and in some ways the White House is front running a booster discussion. I know you've addressed this before Jeff, but if you could tell us, are you concerned in general about these resignations affecting trust in the FDA and the vaccine process, and also about the ability for the FDA to quickly review vaccines, especially as the review of for kids is coming up around that time? Thanks. Jeff: (
18:56) Yeah, okay. Thank you for the question. As the President said last week, the FDA is the gold standard and we are all grateful for the tireless work of the senior team and the whole staff at the FDA, especially during the pandemic. The FDA has strong leadership in Dr. Woodcock and Dr. Peter Marks at the Center for Biologics Evaluation and Research and their critical work continues as we work to get safe and effective vaccines to the American people. The booster decision, which you referenced, as we've talked about, that decision was made by and announced by the nation's leading public health officials, including Dr. Walensky, Dr. Fauci, the Surgeon General, Vivek Murthy, Dr. Janet Woodcock, the FDA acting commissioner, Dr. Francis Collins, Dr. Kessler and others. Jeff: (
19:51) And as our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot. We announced our approach in order to stay ahead of the virus, get states and pharmacies time to plan, and to be transparent with the American people as the latest data and expert clinical judgements from the team to give them time to do their own planning. We have also been very clear throughout that this is pending FDA conducting an independent evaluation and CDC's panel of outside experts is showing a booster dose recommendation. So bottom line, this virus has proven to be unpredictable, and we want to stay ahead of it and plan for every scenario, and that's been our approach from day one and will continue to be our approach. Next question. Speaker 4: (
20:45) Cheyenne Haslett, ABC. Cheyenne Haslett: (
20:50) Hi, thanks for taking my question. There were comments at yesterday's ACIP meeting that the administration doesn't seem to have enough data to recommend boosters, I'm wondering if you're confident that enough data will be available by September 20th to reassure and back that decision? Jeff: (
21:06) Dr. Walensky. Dr. Walensky: (
21:08) Yeah, happy to take that. So the ACIP review data yesterday, that was the data that we reviewed just a few weeks ago that looked at increased waning with regard to the vaccine effectiveness for infection, and some suggestion that there was increased waning of vaccine effectiveness against hospitalization, the ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease and death. They will be reviewing that as well, but it is our own data as well as international data that has led us to be concerned that the waning we're seeing for infection will soon lead to a waning that we would see for hospitalizations, severe disease and death, which is why it's so critical now, to plan ahead, to remain ahead of the virus. Jeff: (
22:03) Next question. Speaker 4: (
22:03) This will be our last question, we'll go to Jeannie Baumann at Bloomberg. Jeannie Baumann: (
22:11) Hi, thank you so much for taking my question. I'm wondering if you have any idea how many unused doses there are in areas that have been impacted by Ida, and what the plan is to either prevent or minimize those doses from spoiling due to power outages in the cold storage requirements? Thank you. Jeff: (
22:30) The number one concern right now, as we talked earlier, is about those who have suffered losses and are in danger from the hurricane, so our thoughts go out to them. I know our operations team's working very closely with all of the states to provide any support they can, including to make sure that the vaccines continue to be stored safely and administered where appropriate. So the team is all over that, doing anything we can to help with the hurricane, including protecting the vaccines, and where appropriate, continuing to administer vaccinations. Thank you for today, we'll look forward to a briefing later in the week. Thank you everybody.