Via Teleconference
12:33 P.M. EDT
MR. ZIENTS: Good afternoon. Thanks for joining us.
Our focus today will be the decision by the FDA and CDC to start providing booster shots to Americans 65 years and older and those at high risk of COVID-19.
This is a significant start to our boosters program, and a critical step forward in our fight against the virus.
As I will discuss, we have the supply. We are prepared and we’re ready to get booster shots in arms to tens of millions of eligible Americans.
First, let me turn to Drs. Walensky, Fauci, and Murthy. After which, I will expand on our operational readiness. And then, we’ll open it up for questions.
Over to you, Dr. Walensky.
DR. WALENSKY: Thank you, Jeff. Good afternoon.
As always, we are working across government and across the scientific and medical community to move us out of this pandemic, to stop the spread of infection, to keep people out of the hospital, and to save as many lives as possible.
This afternoon, I will talk with you about vaccine booster shots, but first I want reflect on where we are in the current state of the pandemic.
Yesterday, CDC reported over 120,000 daily COVID-19 cases, nearly 10,000 hospitalizations, and almost 2,000 deaths. The vast majority of these cases and deaths reflected in these reports are people who are unvaccinated.
Vaccination provides the best possible protection against COVID-19 infections, severe disease, hospitalization, and death.
CDC data continue to show the power of vaccination, with recent reports showing the fivefold reduction in risk of infection, tenfold reduction in the risk of hospitalization, and elevenfold reduction in the risk of death after vaccination.
Yesterday, we took an important first step in our vaccine booster program. As part of the process over the past few days, CDC’s Advisory Committee on Immunization Practices met to discuss the FDA emergency use authorization of booster doses of the Pfizer-BioNTech COVID-19 vaccine.
They met, as they often have during this pandemic, in a moment of great importance of health to many Americans, analyzing the complex, real-time data available to make concrete recommendations.
Their task was not easy and their resulting hours-long discussion reflected the tension of the moment between an individual calculation of risk and benefit, and the impact on society.
I listened intently to all of it. I heard a diversity of opinions and perspectives, and I applaud the committee’s commitment to an open and transparent scientific process.
Following their vote, I fully endorsed ACIP, the committee’s recommendation that all people 65 and older, and those 50 to 64 years old with underlying medical conditions should receive a Pfizer booster shot if they received a Pfizer primary series.
I also endorsed their recommendation to allow 18- to 49-year-olds with underlying medical conditions to receive a Pfizer booster shot.
These recommendations will help strengthen protection against severe disease and those populations who are at high risk of severe complications from COVID-19.
At the conclusion of the meeting, the advisory committee had a robust discussion about whether boosters should be available for those at high risk of COVID because of occupational or institutional risk — people like healthcare workers, teachers, frontline responders, essential workers, and those in congregate settings.
The result of their discussion was a close vote. Had I been in the room and on the committee, I would have voted “yes,” and that is reflected in my resulting decision to allow the use of Pfizer-BioNTech COVID-19 booster dose for those 18 and older at high risk of COVID-19 exposure and transmission because of occupational and institutional exposure.
As CDC Director, it’s my job to recognize where our actions can have the greatest impact. In a pandemic, we most often take steps with the intention to do the greatest good even in an uncertain environment, and that is what I’m doing with these recommendations.
Over the past 18 months, we have experienced a deadly pandemic that has had a disproportionate impact on parts of our country — those on the frontlines, in hospitals, and classrooms, and those in crowded settings who have put themselves in harm’s way on a daily basis. In an effort to protect those at greatest risk, our initial vaccine rollout prioritized these individuals — the everyday heroes of our society.
Our healthcare systems are once again at maximum capacity in parts of the country. Our teachers are facing uncertainty as they walk into the classroom, and I must do what I can to preserve the health across our nation.
I’m also aware of the disproportionate impact this pandemic has had on racial and ethnic minority communities. Many of our frontline workers, essential workers, and those in congregate settings come from communities that have already been hardest hit. Withholding access for boosters from these people and communities would only worsen the inequities that I have committed to fight against.
When we announced our booster plan in August, we said we would follow the rel- — regulatory and scientific processes. And over the last month, we have done exactly that. Scientists at FDA, CDC, and across the country and the world have poured over the data we have available.
FDA’s decision to authorize the Pfizer-BioNTech COVID-19 vaccine for those greater than 65, those at high risk for disease because of underlying medical conditions, and those at high risk of exposure and transmission because of occupational and institutional risk reflected a balance of the safety and effectiveness data we have available and the need to protect our society.
It was a decision about providing rather than withholding access.
I, too, thought of the stressors of the current moment of this pandemic and the principles of access and equity in my decision.
CDC is making boosters available to these eligible groups, and we will look at the data. We want to ensure people have the choice to take advantage of a tool that may be helpful to optimize their vaccine protection as the Delta variant continues to circulate and many face increased risk.
The interim guidance is for Pfizer booster vaccines for COVID-19. It is a first step, and we will continue to review new data on effectiveness and experience with the third shot as it becomes available.
We suspect what we are seeing with existing data for older people and those at greatest risk of severe outcomes or occupational exposure will not be unique to only those populations. I’m committed to updating and revising our guidance in real time and in collaboration with the scientific community.
Over the past two weeks, ACIP, our advisory committee, and the FDA only reviewed data for the Pfizer-BioNTech vaccine. CDC will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations to keep all Americans safe.
We will, with similar urgency, evaluate the available data in the coming weeks to swiftly make additional recommendations for other populations at risk and people who received Moderna and J&J vaccines.
While today’s action was an initial step related to booster shots, it will not distract us from our most important focus: to get as many people as possible vaccinated with a primary series.
I want to be clear: We will not boost our way out of this pandemic. Infections among the unvaccinated continue to fuel this pandemic rise — resulting in a rising number of cases, hospitalizations, and deaths where people are unvaccinated. The most vulnerable are those unvaccinated.
If you are not vaccinated and eligible, I encourage you to get vaccinated to protect your community, your family, and yourself.
Thank you. I’ll now turn things over to Dr. Fauci.
DR. FAUCI: Thank you very much, Dr. Walensky. Dr. Walensky has very clearly delineated the recommendations for a third-shot booster for people who’ve received the Pfizer regimen.
What I’d like to do over the next few minutes, as shown on this first slide, is to try to and answer the question: Is — what the third-shot booster of the mRNA vaccines do for both immune response and clinical effect.
So, let’s first look at the immune response with regard to neutralizing antibodies.
On this slide, this is what the booster does for neutralizing titers against the Delta variant. In green is the wild-type variant. For comparison, in blue is the Delta variant. And you’re looking at different age groups — 18 to 55 and 65 to 85.
Just concentrate for a moment on the blue. One month after dose two, the titer was 241. It went up dramatically after dose three to 1,321.
If one looks at the 65 to 85, it went from 123 to 1,479. That’s laboratory data. Let’s look at clinical data.
Next slide.
This is a study that was recently published in the New England Journal of Medicine — again, in Israel — from 1.14 million people aged 60 years or old who received a second dose of mRNA at least five months earlier. Twelve months — twelve days or more after the third-shot booster dose, the rate of confirmed infection was lower in the booster group than in the non-booster group by a factor of 11.3, and the rate of severe illness was lower by a factor of 19.5.
Let’s take a closer look at that in that paper.
Next slide.
As you can see, going from left to right are the days since the booster vaccination. And as you can see, somewhere around 12 days from that third-shot booster, you see an increase in protection against confirmed infection in the booster group compared with the non-booster group.
Next slide.
What about severe disease? Here again, in a study from Israel in individuals age 60 or older in a per-100,000 population.
On the left part of the slide, unvaccinated in red; those who have two doses of the mRNA — 37 — compared to those who got two doses, plus the booster — down to 4.
This is more dramatically demonstrated on the righthand side of the slide. When you look at the months of infection with severe disease: 175 unvaccinated, 37 of the people who got two doses, and 4 with those who got the third boost.
Next slide.
What about reactogenicity — the kinds of effects you get when you get an injection of a vaccine? As shown, highlighted in yellow, in this observational study of over 1,600 individuals, again in Israel, the local and systemic reactions following the third dose was similar to those reported following the second dose, which is always more than the first dose, but quite similar following the second dose.
Next slide.
To reiterate what Dr. Walensky said, we’re talking about boosters, but the fact is it’s still extremely important for the unvaccinated individuals to get vaccinated. And as Dr. Walensky said — I will repeat it because it’s worth repeating: After Delta became the most common variant, a fully vaccinated person had a reduced risk of infection by fivefold, hospitalizations by greater than tenfold, and death by greater than tenfold.
With that, I’ll hand it over to Dr. Murthy.
DR. MURTHY: Well, thanks so much, Dr. Fauci. And it’s good to be with all of you again today.
As public health officials, our highest commitment is and has always been to protect the American people from COVID-19 and its many consequences for our health. And we all know that COVID-19 has cost us lives; it’s led to hospitalizations; it’s taken people out of work and school for weeks; and it’s led to prolonged symptoms, also known as long-COVID syndrome.
This week, the FDA and CDC gave us one more tool to protect the health of Americans, and that tool is the booster shot. Data indicates that boosters will extend and enhance protection against COVID-19 for people who are six months past their last dose of the vaccine. This is especially important for those who are at increased risk of bad outcomes with COVID.
So, here is what you need to know: Starting today, if you are six months out from your last dose of the Pfizer vaccine, you are eligible for a booster if you fall into one of three high-risk groups.
Number one, you are 65 or older. Number two, you have a medical condition that puts you at high risk of severe illness with COVID, and these conditions include obesity, diabetes, high blood pressure, chronic kidney disease, and others. And number three, you work or live in a setting where you’re at increased risk of exposure to COVID. This includes healthcare workers, teachers, those living in shelters and prisons, and grocery store workers.
Just as before, you can go to Vaccines.gov to find some of the thousands of places around the country where you can get a shot.
Now, the CDC and FDA recommendations apply to Pfizer vaccine recipients, and I want to speak directly to those who received Moderna and J&J: Your health matters just as much as other vaccine recipients, and we want to make sure that your protection against COVID is strong and reliable as well. That’s why the FDA is working closely with Moderna and J&J to get and process their data as quickly as possible with a goal of making booster recommendations for Moderna and J&J recipients in the coming weeks. This is a high, high priority.
Finally, I want to add that while boosters are an important tool to add to our pandemic response, there are many Americans who still have not gotten their first or second shot.
Vaccinating the unvaccinated remains a high priority, and we must not lose sight of this goal with all the discussion around booster shots. That is why we will continue our efforts to reach those who are not yet vaccinated, using a combination of increased access and community-based information campaigns to help people get accurate scientific information from sources they trust. Getting our nation vaccinated remains our most important path out of this pandemic.
As we continue our vaccination efforts, we must also continue to use the many other tools we have to reduce the spread of COVID-19, not just vaccines: wearing a mask in public, indoor spaces; gathering outdoors or in well-ventilated spaces; and using testing in schools and other settings to identify and contain infection early. These measures will continue to be important in the days and weeks ahead.
You know, overall, we’ve come a long way during this pandemic. We’ve saved lives, and we’ve protected millions of Americans by working together, but we have more distance to travel.
Our approach going forward will continue to be grounded in data and guided by scientists and public health experts, as it has from the beginning. And we will continue to take all steps possible to protect our nation’s health and end this pandemic for good.
Thanks a lot. And I’ll pass it back to Jeff.
MR. ZIENTS: Well, thanks, Drs. Walensky, Fauci, and Murthy.
As the doctors just stated: Booster shots will provide enhanced protection and, based on the FDA and CDC’s decision, over 60 million Americans who are fully vaccinated with Pfizer will now be eligible for a booster once they hit their six-month mark.
Up to 20 million Americans have already hit their six-month mark and therefore are now eligible. So, as of today, up to 20 million Americans can get their booster shot.
We are ready to get booster shots in arms right away.
We saw what happened during the initial rollout of vaccinations in December 2020: The country lost precious time because the federal government had no plan to administer shots.
This time around, because we’ve been planning for this moment for weeks, we are prepared and ready to execute.
Thanks to the President’s actions, we’ve secured enough booster supply for every American. Boosters will be free for everyone, regardless of immigration or health insurance status — no ID or insurance required.
And we’ve worked closely with partners, including governors, pharmacies, doctors, long-term care facilities, and other providers so that eligible Americans are able to get a booster shot at roughly 80,000 places across the country, including over 40,000 local pharmacies.
Our message to our partners has been clear: We stand ready to help them in any way that we can as we get this booster program up and running and help them get the job done at the local level.
We’ve put a special focus on making sure those most vulnerable, particularly residents and staff in long-term care facilities, can get booster shots quickly and efficiently. Across the past several weeks, CDC contacted tens of thousands of nursing homes, assisted-living facilities, and other high-risk settings to ensure that they are ready. And CDC worked with states, Tribes, and territories to connect vaccination providers to the long-term care facilities that need help.
States, Tribes, and territories have also used the past several weeks to develop operational plans and get ready.
North Carolina has projections of week-to-week demand for boosters in each of the 100 counties across the state, and has worked with 3,000 provider partners to ensure county-by-county capacity to support increased demand.
Colorado has 9 mobile vaccination clinics ready to go to get boosters to where people are, and will double that number to 18 over the coming weeks.
And Colorado, along with New York, Ohio, and other states across the country are ready to activate large vaccination centers to get shots in arms as quickly as possible.
Thanks to the President’s actions, they will be able to do so with 100 percent reimbursement from the federal government.
Our pharmacy partners have also used this lead time to ensure they are ready for boosters, scaling up to handle the increased volume. HyVee has hired 2,000 pharmacy technicians across more than 275 pharmacies. CVS is hiring 25,000 workers, including pharmacists, pharmacy techs, and nurses. And Kroger’s ramping up its capacity to 1 million booster shots in arms per week. One million booster shots per week — that’s a double of Kroger’s previous weekly administration rate. Clearly, pharmacies are ready for boosters.
At the same time, pharmacies will continue to mount robust outreach and education campaigns to vaccinate the unvaccinated.
Importantly, we’ve also been working with roughly 1,400 community health centers so they are ready to get boosters to the hardest-to-reach communities as we ensure equity remains front and center of everything we do.
Bottom line, we have been preparing and we are hitting the ground running to get booster shots in arms. We will continue to lead with science and act aggressively to stay ahead of the virus, including preparing for potential boosters for additional populations and with additional vaccine types in the weeks to come.
And importantly, we will continue working to get unvaccinated Americans vaccinated because more vaccinations will accelerate the path out of the pandemic.
We’re making important progress on this front. Seventy-five percent of all Americans 12 and older — so, three out of four of all Americans 12 and older — now have at least one shot. And we’re getting nearly 800,000 shots in arms each day.
We are on pace to administer 24 million shots in September. And we remain laser focused on driving additional progress, including through the President’s old vaccination requirements.
I’ll close with a simple but important call to action: If you’re unvaccinated, go out and get a shot. It’s free, it’s easy, it’s safe, ind it’s never been more important to get vaccinated.
With that, let’s open it up for a few questions. Kevin.
MODERATOR: Thanks, Jeff. First question, let’s go to Nate Weixel at The Hill.
Q Hi. Thanks. Just how do you sort of avoid this confusion of people who are not eligible right now but are going to want to get a shot anyways? I mean, is there a way to stop them from just showing up at the pharmacy or their doctor’s office and getting a vaccine?
MR. ZIENTS: Dr. Walensky.
DR. WALENSKY: Thank you, Nate. As with the first rollout of vaccines in the primary series, what we are doing now is self-attestation. The FDA and the CDC advisory committees have reviewed the data — the efficacy data, the safety data, the waning data — for Pfizer and only Pfizer so far. And we will, with urgency, when we receive it and have it available, review the J&J and the Moderna.
So again, self-attestation, but the data that we have reviewed and the advice and recommendations we are given is — we have given is for Pfizer boosts with people who received a Pfizer primary series.
MR. ZIENTS: Dr. Murthy, do you want to add anything there?
DR. MURTHY: Yeah. Thank you, Jeff. You know, to build on what Dr. Walensky said, you know, making sure that people have clarity on these recommendations is extremely important to us. You know, we have been working for the last month, in the planning process, with state and local health officials. We will continue to do that to make sure they have the information they need to inform their communities.
We were also continuing our work with community organizations, in part through the COVID-19 Community Corps, in an effort to make sure that trusted messengers on the ground have the information they need to share with others.
All of us on this call, as well as other public health officials in the administration, will continue to go out and speak directly to the public to make sure people understand the new recommendations.
And finally, on Vaccines.gov, you can not only find places where you can get vaccinated, but you can get information on these new booster recommendations that will take you to the CDC site and resources, which lay out, in fact, for example, what conditions qualify as those which put you at higher risk for COVID-19.
So, we’ll continue to get information out through a variety of means to make sure people know how to put these recommendations into effect.
MR. ZIENTS: Next question.
DR. FAUCI: So, Jeff, if I might also —
MR. ZIENTS: Please — Please, Dr. Fauci.
DR. FAUCI: Yeah, one of the things people should also realize — I mean, there will be temptations, for example, for people who recently got vaccinated to not wait for the six-month period of time. There’s an immunological reason why it’s important to wait: Because, you know, if you allow the immune response to mature over a period of a few months, you get much more of a bang out of the shot, as it were an enhancement of your antibodies.
So, I think there might be a natural feeling, “Well, gee, I’m getting anxious. I really want to get my third shot right now as opposed to waiting for the timeframe that Dr. Walensky and Dr. Murthy just mentioned.” You want to make sure there’s an immunological reason for that timeframe. Thank you.
MR. ZIENTS: Next question.
MODERATOR: Meg Tirrell at CNBC.
Q Thank you. Dr. Walensky, I’m wondering if you can just talk a little bit more about your, sort of, deliberations over making this decision, which many of us in the media have portrayed as you overruling the Advisory Committee. And your press release came out after midnight last night suggesting, perhaps, this really was a tough decision. And some have said this could undermine confidence in the process, where we saw the advisors go one way and you go another.
I did just talk with one of the advisors who voted “no,” and she said she actually felt like you listened, and by putting the “may” language in there, that you really took what she was worried about, at least, into account. But are you worried about how this will appear and perhaps shake confidence in the process?
DR. WALENSKY: Thank you, Meg, for that question. I want to be very clear that I did not overrule an advisory committee. This was an — I listened to all of the proceedings of the FDA advisory committee and intently listened to this exceptional group of scientists that publicly and very transparently deliberated for hours over some of these very difficult questions on where the science was.
After those deliberations, I listened to the votes, I listened to the comments on the vote. And this was a scientific close call, and I think you could tell by the duration of the meeting and the discussions that this was a scientific close call.
In that situation, it was my call to make. In the — if I had been in the room, I would have voted “yes”, and that was — yes, how my recommendations came out after listening to all of their scientific deliberations.
To the extent that people are concerned about confidence, I would say they should listen to the deliberations themselves. We did it publicly. We did a transparently. And we did it with some of the best scientists in the country
MR. ZIENTS: Next question.
MODERATOR: Tamara Keith at NPR.
Q Thank you so much for taking my question. As more and more mandates go into place, is the White House or the administration ever going to weigh in and endorse any of the vaccine verification forms that private industry is starting to come up with, or is this going to be sort of a Wild West situation?
And one other question: What will the boosters mean for mask guidance? Will people who have gotten boosters potentially not need to wear masks in places where people who have not do?
MR. ZIENTS: Why don’t I take the first question, and then I’ll turn to Dr. Walensky.
Look, organizations are taking different approaches to vaccine verification, and they include the CDC vaccination cards, pharmacy and medical records, digital verification, state and local records. And there is no one size that fits all, and we support the innovation and know these advances will continue.
But we also, at the same time, believe that all systems have to have key standards, including affordability, being available both digitally and on paper, and protecting people’s privacy and security.
Dr. Walensky, to you.
DR. WALENSKY: Yeah, thank you for that question, Tamara. So, we have very little data in this moment to inform whether a third shot, a booster shot, will decrease transmissibility, especially in the context of the Delta variant.
Obviously, we recognize that this is going to be a critical clinical question, a critical public health and policy question that people are interested in. And we are already working on studies to examine this as boosters roll out here in the United States.
But I want to reiterate that the reason to get the vaccine — the primary series, the reason to get the boost is to protect yourself, your family, your community from transmit- — from disease and hospitalization.
MR. ZIENTS: Next question.
MODERATOR: Let’s go to Michael Erman at Reuters.
MR. ZIENTS: Michael?
Q Hi. Just wanted to know two quick questions quickly: Will the CDC change its definition of “fully vaccinated” to be those people who it has designated as needing a third shot?
And also, do you expect to have a similar process for Moderna and J&J with the ACIP and VRBPAC meetings for those approvals?
MR. ZIENTS: Dr. Walensky, the definition of “fully vaccinated.”
DR. WALENSKY: Yeah, so we are not changing the definition right now of “fully vaccinated.” I think we need to have more experience with our third shot and have more people eligible or recommended to receive it before we change that definition. That is something that we will be looking at in real time.
As to a similar process, I certainly don’t want to speak for the FDA and what they will do for their advisory panel, but we intend to have numerous advisory panels at the CDC to examine many upcoming decisions, including Moderna, J&J, as well as pediatric vaccination.
MR. ZIENTS: Next question.
MODERATOR: Shira Stein at Bloomberg.
Q Hi, thanks for taking my question. Why are you recommending boosters for people under 65 when there is next to no long-term evidence they will help and a very low rate of breakthrough hospitalizations in this age group?
MR. ZIENTS: Dr. Walensky and then Dr. Fauci, if you have anything to add.
DR. FAUCI: Yeah.
DR. WALENSKY: Our recommendations for under 65 and, in fact, our strong recommendation for those who are between the ages of 50 and 64 reflect the potential increase for severe outcomes for people who are sick, who get COVID, especially among those with underlying conditions.
We are starting to examine and see the data. The data are harder to parse out for those with underlying conditions. The data are harder to assess as you have multiple underlying conditions, teasing out which ones specifically. But we’re starting to see those data both here and in other countries, and it was for that reason why we came out with a strong recommendation for those between the ages of 50 to 64 with underlying medical conditions.
MR. ZIENTS: Dr. Fauci.
DR. FAUCI: Yeah, just — yeah, thank you, Jeff.
Just to add to that: You know, one of the things we should realize is that the primary endpoint for the approval of the vaccine was clinically recognizable disease; it wasn’t hospitalization.
So, the indication for the vaccine is you don’t really want people to get sick. You certainly don’t want them to go to the hospital and die. But I think that there is some misunderstanding that if you don’t get hospitalized, everything is okay. That’s really not the case.
There are many people who don’t get sick enough to go to the hospital who have a waning of immunity against symptomatic or moderately symptomatic disease, who have a rather major disruption in their life and in their responsibility.
So, we’ve got to be careful that we don’t so neatly break it up into: If you don’t get into the hospital, all is well. It may not be the case.
MR. ZIENTS: Last question, Kevin.
MODERATOR: Last question: Dan Vergano, BuzzFeed.
Q Thank you. Dan Vergano, BuzzFeed News. I’m wondering two things. One is: Can people really get boosters today if they go to their pharmacy, or is that something that waits on state health agencies?
And the other thing is that there was a discussion at the meaning from FDA of long COVID being a concern in the booster decision. I wonder if anyone can speak to what — how that played into maybe going beyond what the committee was interested, where they’ve seen hospitalizations to be their — their criteria? Thank you.
MR. ZIENTS: The — on your first question, as I said earlier, we are ready and we are prepared, and implementation is happening as we speak. So, there are people who will be getting booster shots as early as this afternoon.
Dr. Walensky?
DR. WALENSKY: Yeah, so this is an important question and was discussed with regard to long COVID. We don’t have a lot of data with regard to long COVID in the context of breakthrough infections after two doses are — of a vaccine or after full vaccination.
Early data suggests that there may be about half the risk of long COVID for people who’ve already been fully vaccinated, at least to date than for people who have never seen the vaccine.
But this would still be a high percentage of people who had — get long COVID — somewhere in the 10 to 15 percent range. And so, that was certainly softer scientific data to inform us, but among the things that people were considering.
MR. ZIENTS: Good. Well, thank you, everybody. We look forward to seeing you at next week’s briefing. Thank you and have a good weekend.
1:07 P.M. EDT
To view the COVID Press Briefing slides, visit: https://www.whitehouse.gov/wp-content/uploads/2021/09/COVID-Press-Briefing_24September2021.pdf
