Washington, DC…Good afternoon, and thanks for joining us. Before I turn to Drs. Walensky and Fauci, I want to provide an important update on the progress we’re making across a number of fronts in our fight against the virus, starting with vaccinations.
We know vaccines are the very best line of defense against the virus, so our top priority remains getting shots in arms.
We’ve made tremendous progress across the past nine months.
Just today, we reported 1.14 million total shots in arms. Importantly, this includes almost 300,000 Americans getting their first shot. These are both the single-highest day totals in the last two weeks.
And today, we will hit 400 million shots in arms since the President’s first day in office — 400 million shots in arms in nine months.
And we remain laser focused on getting more shots in arms, including booster shots.
Following the FDA and CDC’s decisions last week, Pfizer, Moderna, and J&J boosters are now available for tens of millions of eligible Americans.
We have worked with governors, state and local health departments, pharmacies, doctors, community health centers, rural health clinics, and long-term care facilities to be ready for this moment. And thanks to our planning and preparation, boosters are off to a very strong start.
In just the first five days since their authorization, 1.5 million Americans got the enhanced protection of a Moderna or J&J booster shot. And 15 million Americans now have received an additional dose of Pfizer, Moderna, or J&J.
So, our booster program is off to a very strong start. And we’re working with states, pharmacies, and other partners to quickly, efficiently, and equitably get boosters to tens of millions of eligible Americans.
We are also planning for the rollout of vaccinations for kids. Twenty-eight million young Americans would become eligible for protection from COVID-19 should the FDA authorize and CDC recommend the vaccine for children ages 5 through 11.
States have now placed their initial orders of vaccine for kids. And upon FDA authorization of the vaccine, millions of doses will be shipped immediately to tens of thousands of pediatricians, family doctors, children’s hospitals, community health centers, rural health clinics, and pharmacies –– providers parents and kids know and trust.
The bottom line is that we will be ready immediately following FDA and CDC’s decisions so that parents can get their kids vaccinated quickly, easily, and conveniently.
Next, I want to highlight important progress we’re making in ramping up both the availability of testing –- particularly at-home testing -– and access to free testing.
We are on track to have more than 200 million rapid at-home tests available to Americans each month starting in December. That’s more than four times the level of supply in late summer. And we’re also on track to increase the number of places Americans can access free testing to 30,000 community-based locations.
And this week, the FDA and NIH took additional steps that will make even more tests available and help reduce testing costs.
First, FDA authorized another over-the-counter, at-home test — the ninth test to come to market in the last 10 months, giving consumers more choices.
Second, FDA announced that at-home tests will now be able to be sold in single-test packs, meaning Americans will have more options and no longer have to buy two-test packs. This will also make tests more affordable and accessible.
Third, to efficiently bring more tests to market, NIH is investing $70 million from the American Rescue Plan to establish an accelerated pathway to support FDA authorization of additional over-the-counter, at-home tests.
Together, these actions will benefit American consumers by increasing at-home testing options, adding to the number of tests on shelves, and reducing prices.
So, from vaccinating more unvaccinated Americans, to getting booster shots to tens of millions, to planning for vaccinations for kids age 5 to 11, to increasing at-home testing supply and making tests more affordable, we are making important progress.
The President’s plan is working. And we remain focused on the execution required to move us forward on our path out of this pandemic.
With that, I’ll hand it over to Dr. Walensky.
DR. WALENSKY: Thank you, Jeff. Good afternoon, everyone. It’s good to be back with you again today.
As always, I’m going to start with the data. And, today, I want to provide you a closer look at the current state of the pandemic.
Let’s start with cases. As of yesterday, the seven-day daily average of cases was about 65,900 per day. And this represents about a 16 percent decrease over the previous week.
Down from our peak and early September, we are now heading in the right direction and — but, with cases still high, we must remain vigilant heading into the colder, drier winter months.
As we look at hospitalizations, we also see week-on-week decreases with a 54 percent decrease from our peak the week of August 28th.
As of yesterday, the seven-day average of hospital admissions was about 5,500 per day, which is a decrease of about 12 percent from the prior week.
It’s important to note that the hospitalization rate among unvaccinated adults is 12 times higher than those who are vaccinated, again demonstrating the power and importance of vaccination.
While COVID-19-associated deaths have continued to decline, the seven-day average of daily deaths remains greater than 1,000 per day, with an average of 1,100 reported yesterday.
Understanding where we are in the current state of the pandemic allows us to look forward to what is on the horizon and to be clear in our efforts — as many people as possible to protect them against COVID-19. This includes protecting our children and understanding the risk that COVID-19 poses to them. The health and wellbeing of our nation’s children is of the utmost importance.
As Jeff laid out, the regulatory process is underway to make COVID-19 vaccines available for children ages 5 to 11. And I’d like to just step back and take a moment to put some of this into perspective. CDC’s data presented at yesterday’s FDA Advisory Committee showed that among all children ages 5 to 11, COVID-19 was one of the top 10 causes of death in the United States over the last year.
Since the start of the pandemic, there have been more than 8,300 hospitalizations among children aged 5 to 11 and there have been 745 deaths in children less than 18.
Hospitalization rates are three times higher for non-Hispanic Black, non-Hispanic African — American Indian and Alaskan Native, and Hispanic children compared to non-Hispanic white children.
Yesterday, an FDA Advisory Committee met and reviewed data from Pfizer that described COVID-19 vaccine efficacy in 4,500 children ages 5 to 11. The trial showed a vaccine efficacy rate of nearly 91 percent in preventing COVID-19 infection in children who did not have COVID-19 infection previously.
As we anticipate authorization for vaccines for children, I want to emphasize ways we contin- — can continue to protect our children today. Surrounding our children with people who are vaccinated helps protect them against COVID-19. It’s important that we continue to vaccinate as many adults as possible to provide protection to children in the community, especially those who may not be eligible for vaccination themselves.
We must continue to help our children follow the prevention measures we know will keep them safe: continuing to wear masks in schools and other indoor settings, choosing outdoor settings, avoiding crowds and poorly ventilated spaces, and washing our hands often.
Right now, there are over 60 million Americans eligible for vaccination who are not yet vaccinated, leaving themselves and children around them vulnerable. If you’ve not yet been vaccinated against COVID-19, I urge you to consider the many benefits of vaccination.
Thank you. I’ll now turn things over to Dr. Fauci.
DR. FAUCI: Thank you very much, Dr. Walensky. In line with the discussion of the importance of getting vaccinated that you just heard, I’d like to focus for the next couple of minutes on one of the reasons why it is so important. And that is — if I could have the first slide — what we refer to as “post COVID-19 conditions.”
Now, they can be divided into two general categories: one, that are readily explainable by organ system damage. For example, if you have acute respiratory distress syndrome with a considerable amount of damage to lung tissue, you can expect that it is likely that your pulmonary functions would have residual negative impact on them.
However, there’s another syndrome — a group and constellation of signs and symptoms — which are not completely explainable by readily apparent pathogenic processes. This has been referred to as “long COVID.”
And what we see is a constellation of signs and symptoms that range from profound debilitating fatigue, shortness of breath, chest pain, dysautonomia, any of a number of the signs and symptoms shown on this slide in combination. This has been unexplained thus far by any identifiable pathophysiological process.
So let’s take a look at the incidence of this. There have been a number of studies that have been published. This is just one representative six-month retrospective cohort of over 270,000 people who were infected and had COVID-19. The range of individuals ranges from anywhere from 10 to more than 35 percent who might have at least one symptom between three and six months following the diagnosis of COVID-19. So that’s the population in general.
What about children? It is very clear now that in certain cohorts that have been followed, that the cohort study in the UK indicate that a smaller percentage than the general population — which is obviously good news — namely around 4.4 percent –experience which would come under the category of long COVID.
What about the impact of vaccination? In this slide recently published in The Lancet Infectious Diseases, people who were fully vaccinated, namely breakthrough infections — when you look at them, they’re about half as likely as an unvaccinated person who then got infected to report long COVID symptoms, which is again, interestingly, another reason why it is so important to get vaccinated.
We are doing studies now that have key questions and gaps. We need to know more about the epidemiology, the phenotype or presentation of a person, the spectrum — hopefully understanding the pathophysiological mechanisms which would then lead to the possibility of intervention. Also, risk factors, and finding out interesting questions: whether infection triggers changes in the body that increase the risk of other conditions, such as cardiovascular disease and neurological disease.
So, on the last slide: What we’ve been doing right now is putting forth a program, which are referred to as “RECOVER” for “Researching COVID to Enhance Recovery.” It’s an initiative that seeks to understand, prevent, and treat the long-term effects. And it is a meta-cohort study. And hopefully, over the coming months to a year, we will give us more information made public as to this very perplexing symptom complex.
Back to you, Jeff.
MR. ZIENTS: Well, thank you, Doctors. Let’s open it up for a few questions.
MODERATOR: Thanks, Jeff. A reminder: one question per person. First, let’s go to Joyce Frieden at MedPage Today.
Q Yeah. Hi, thanks for taking my question. With the advent of all these increasing numbers of at-home tests, can you speak to the issues around accuracy in terms of false negatives and false positives? Has that been getting better?
MR. ZIENTS: Yeah, I’m going to see if Dr. Walensky or Dr. Fauci have anything to add, but my understanding is the accuracy of the antigen test is quite high. When people do receive a positive test, they’re recommended to go get a PCR test to have that confirmation of the antigen test, but the antigen testing has proven to be quite sensitive.
Dr. Fauci or Dr. Walensky, anything to add?
DR. FAUCI: No. I think you said it very well. We are having more tests. I think the thing that’s really important is the investment that’s being made so that we can have now on average of about 200 million tests per month available, which I think will be very, very important as part of the armamentarium that we use to get control of this.
So, the testing situation is certainly going in the right direction with regard to the availability of tests.
MR. ZIENTS: Next question.
MODERATOR: Josh Wingrove at Bloomberg.
Q Hi, there. Thank you for this. Can you give us an update on the OSHA rule or if you have any visibility on when that will kick in and, linked to that, whether you would consider the supply chain crunch in the determination of when to begin that?
Some of the transport companies and whatnot are saying that compliance with this will exacerbate their labor shortage. And I wonder if you have any response to folks saying that.
MR. ZIENTS: Yeah.
Q Thank you.
MR. ZIENTS: So, on OSHA, you know, the team has been working over at Labor to develop the emergency temporary standard that covers employers with over 100 employees to ensure that workers are fully vaccinated or undergoing testing on a regular, at least one time per week basis. That’s obviously critical to help stop the spread in the workplace.
As one of the final steps in the process. The agency — Department of Labor — has submitted the text of the emergency temporary standard to the Office of Management and Budget. And while we don’t have a specific time to provide today, Josh, the rule will be finalized soon.
But we know businesses are already acting. And we’ve seen, you know, major companies and small businesses and other organizations step up each and every day with vaccination requirements.
Your second question was about these mandates — the federal mandates and could they cause disruption to the economy or to the supply chain.
You know, to be clear, the requirements for federal workers and contractors will not cause disruption. And, you know, I think the first part of that is, these vaccination requirements, as we’ve talked about before, work. First, the doctors have seen very strong compliance: 99 percent at United Airlines; 99 percent at Houston Methodist, the health system, which was one of the early movers; 99.5 percent at Rutgers University. And just yesterday, Tyson’s Food announced that they’re at 96 percent of their workers who have gotten vaccinated, with still days to go before their deadline next week.
The other piece of this is that vaccination requirements for federal workers and contractors — there are still weeks until we reach those deadlines. And it’s important to remember that those deadlines are not cliffs. The federal worker deadline is the 22nd of November, and the federal contractor deadline is not until December 6th [8th].
But even once we hit those deadlines, we expect federal agencies and contractors will follow their standard HR processes and that, for any of the probably relatively small percent of employees that are not in compliance, they’ll go through education, counseling, accommodations, and then enforcement.
So, these processes play out across weeks, not days. And so, to be clear, we’re creating flexibility within the system. We’re offering people multiple opportunities to get vaccinated. There is not a cliff here.
And the purpose, I think, most importantly, is to get people vaccinated and protected, not to punish them. So, we do not expect any disruptions.
Next question, please.
MODERATOR: We’ll go to Cheyenne Haslett at ABC News.
Q Thank you. Given the concerns expressed about the potential for unknown side effects at yesterday’s meeting and given that cases are falling, as you mentioned, Dr. Walensky, should there still be as much urgency to get kids vaccinated?
MR. ZIENTS: Dr. Walensky.
DR. WALENSKY: Thank you, Cheyenne. So, you know, I think there’s urgency because we’re seeing disease in children and we’ve seen deaths in children and we’ve seen long COVID, as Dr. Fauci demonstrated, in children.
Certainly, we have seen cases come down before, and the way to prevent surges again is to get more and more people vaccinated and make sure that we have protection. So, I will look forward to the discussion of the Advisory Committee on Immunization Practices next week.
MR. ZIENTS: Wonderful.
To clarify one thing from the prior question from Josh: I think I misspoke and said that the deadline for federal contractors was — the correct deadline is December 8th. If I misspoke and said the 6th, that was a mistake. December 8th is the deadline for federal contractors.
Next question, please.
MODERATOR: We’ll go to Meg Tirrell at CNBC.
Q Thank you. I have a question about sort of “last-mile” assistance overseas. There’s been an increasing amount of discussion about the fact that it could be useful for the U.S. to help not just in donating doses of vaccine, but also help with administration of those doses. Andy Slavitt has been talking about potentially the troops from Afghanistan being deployed to places like Haiti and Africa.
Can you talk a little bit about what the U.S. is already doing in terms of assistance with “last mile” in other countries, and are there any plans to increase that assistance?
MR. ZIENTS: So, Meg, your — it’s a good question, and I want to start by reminding people of what the U.S. is doing on vaccine supply.
We’ve already sent over 200 million doses to over 100 countries and have committed to sharing — donating 1.2 billion doses in total across the next period of time. By the end of this time next year, we will have donated more than 1.2 billion doses.
You’re right to point out that vaccines are not the same thing as vaccinations and making sure — as we did when we came into office when there was vaccine supply ramping up, but shots weren’t getting into arms — that we are helping countries that need it to make sure that shots get into arms and people are protected.
And USAID, other agencies across the U.S. government, UNICEF, and other organizations are helping to do just that.
So, while we continue to ramp up supply across the world, through the U.S. leading the way having donated now more vaccines to the world than all other countries combined, we do need to continue to focus and make sure that those vaccines become vaccinations and shots in arms.
Dr. Walensky, anything?
DR. WALENSKY: If I —
MR. ZIENTS: Please.
DR. WALENSKY: Yeah, if I might chime in. So, CDC is working in over 60 countries and have been for many years, where we collaborate deeply with the ministries of health. We have longstanding personnel on the ground. We have trusted personnel in the communities in many of these countries — in most of these countries.
And so that is going to really be able to help leverage our vaccination efforts in those countries in terms of vaccine surveillance, in terms of vaccine efficacy studies, vaccine confidence, as well as making sure that there are adequate safety systems in all of these countries, and, absolutely, getting vaccines in arms as trusted people already.
So, that work is already underway in many, many countries.
MR. ZIENTS: Good. Thanks, Dr. Walensky. Why don’t we take one more question. Kevin?
MODERATOR: Let’s go to Sabrina Siddiqui at the Wall Street Journal.
Q Hi. Thank you as always for doing the briefing. You know, there are some recent surveys suggesting that it’s just over a third of Americans who plan to vaccinate their children right away. So, can you — I know you’ve talked about public education campaign, but can you give some more specifics on how you plan to address vaccine hesitancy among parents?
And do you have any updates on timing for other COVID vaccines for children, specifically those under the age of five?
MR. ZIENTS: So, Dr. Fauci, do you want to take the second part of the question — any update on kids under five?
DR. FAUCI: Yeah, those studies are ongoing right now — not only with Pfizer, but also Moderna, which has a study called KidCOVE, which is for younger children. There’s Teen COVE for those who were of the teenage level. We don’t have enough data now to present it for a regulatory approach. But right now, the data are being collected and analyzed.
So we will be able to answer the question, I believe, within a reasonable period of time regarding the safety and the immunogenicity among those lower than five years old.
MR. ZIENTS: So, in terms of confidence and families that have questions, I think there are many, many families across the country awaiting the opportunity to get kids 5 to 11 vaccinated. And at the same time, there are, as you point out, some families that have outstanding questions.
As we’ve seen with adults, confidence grows over time. At the start of the vaccination program last December, only 34 percent of adults were eager to get the shot. And today, nearly 80 percent of adults — those over 18 — have at least their first shot.
So, if the vaccine is authorized and recommended, we are — we will be ready. We’ve talked about being ready with supply in tens of thousands of locations across the country. But we’ll also make it for — convenient for and easy for parents to get their questions answered.
We’re building partnerships with the Children’s Hospital Association and the American Academy of Pediatrics. The Surgeon General, Dr. Vivek Murthy, is setting up the partnership’s leadership — sorry, the Parents Leadership Corps, a group of well-known medical experts, including pediatricians and family doctors, trusted parents, and other outside stakeholders who will amplify accurate information online and in media appearances.
You know, we’ve learned throughout that what matters most is local trusted messengers that, in this instance, parents and kids can turn to to get their questions answered. And we’ll also be out with a full range of channels of media, including robust paid media campaigns across television, radio, print, social, and digital.
So, we will be ready to answer questions and build confidence through local efforts and national efforts. And the bottom line is, we expect more and more kids to get vaccinated across time.
Thank you for today, and we look forward to the next briefing.