11:33 A.M. EDT

     MR. ZIENTS:  Good morning, and thanks for joining us. 

     Before I turn to Drs. Walensky and Fauci, I want to provide an update on vaccinations for kids. 

     On Friday, following a rigorous and independent scientific review, the Food and Drug Administration authorized Pfizer’s COVID-19 vaccine for kids ages 5 through 11.  This is an important step forward in our nation’s fight against the virus. 

     As Dr. Walensky will discuss, this week CDC will make its clinical recommendations on vaccinations for this age group. 

     As we await the CDC decision, we are not waiting on the operations and logistics.  In fact, we’ve been preparing for weeks.

     Thanks to the President’s actions, we’ve secured enough vaccine for all 28 million kids ages 5 through 11. 

     Governors and leaders of Tribes and territories have been working with their teams to ensure that doses are distributed efficiently and equitably across their jurisdictions through a range of channels — from pediatricians and family doctors’ offices, to school-based clinics, to community-based sites.

     Overall, more than 20,000 pediatricians, family doctors, pharmacies, and other providers parents know and trust are getting ready to administer vaccines. 

     Vaccines for kids ages 5 through 11 are specifically formulated for younger children, which means none of the vaccines already in the field can be used to vaccinate kids in this age group. 

     So, FDA’s authorization was also a critical operational milestone, allowing us to start packing and shipping kids’ vaccines for the first time.

     To get ready ahead of FDA’s decision, we asked states, pharmacies, and community health centers to place their initial orders and submit their detailed distribution plans.

     On Friday, within minutes of FDA’s authorization, we began the process of moving 15 million doses from Pfizer’s freezers and facilities to distribution centers. 

     There, millions of doses are being packed with dry ice and tracking labels before they are loaded into small, specialized shipping containers.  These containers are then placed onto trucks and airplanes, and shipped to vaccination sites across the country.

     Over the next couple of days, several million doses will start arriving at local pediatricians and family doctors’ offices, pharmacies, children’s hospitals, community health centers, rural health clinics, and other locations. 

     More doses will be packed and shipped and delivered each and every day over the next week or so, and more and more sites will come online as we ramp up. 

     Since FDA’s authorization last Friday, there hasn’t been a moment that teams have not been picking, packing, and shipping vaccines.  They have been working 24/7 and will continue to do so.

     I want to be clear about what this means for parents and guardians.  We know many families will turn to their pediatricians and family doctors.  And in addition, thousands of other trusted providers will also offer vaccinations for kids, including local pharmacies, health centers, and children’s hospitals.

     This will give parents a broad range of options to get their kids vaccinated and ensure all children, including those without primary care doctors — those most at-risk — have easy and convenient access to vaccines.

     Following CDC’s decision, parents will be able to visit Vaccines.gov and filter for locations offering vaccinations for children ages 5 through 11 so they can easily find a site nearby and schedule an appointment.

     While vaccinations may start later this week, the program will still be ramping up to its full strength, with millions more doses packed, shipped, and delivered, and thousands of additional sites coming online each day.

So, starting the week of November 8th, the kids’ vaccination program will be fully up and running.  Parents will be able to schedule appointments at convenient sites they know and trust to get their kids vaccinated.

And the number of sites will continue to increase throughout the month as more vaccine sites open their doors and administer vaccine.

Bottom line: We have been planning and preparing for this moment.  We are ready to execute, pending CDC’s decision.  And starting the week of November 8th, our vaccination program for kids ages 5 through 11 will be running at full strength.

We remain laser-focused on vaccinating unvaccinated Americans, those 12 and older, and getting booster shots to tens of millions of eligible Americans.

We’re making important progress on both fronts.  In fact, today, we hit two important milestones: 80 percent of adults now have at least their first shot, and 70 percent of adults are now fully vaccinated; 8 out of 10 adults with at least one shot, 7 out of 10 adults fully vaccinated.

On boosters, just over the past two days, about 2 million Americans rolled up their sleeves and got the enhanced protection of a booster shot.

And by day’s end, about 20 million Americans will have gotten an additional Pfizer, Moderna, or J&J dose.

So, our boosters program is off to a very strong start and continues to accelerate.

In closing, we know vaccines are the very best tool we have to accelerate our path out of the pandemic.  And we’re hard at working — at executing across a number of fronts, from vaccinating the unvaccinated, to getting booster shots to tens of millions of eligible Americans, to standing up our vaccination program for kids ages 5 through 11.

With that, over to you, Dr. Walensky.

DR. WALENSKY:  Good morning.  Thank you, Jeff. 

As per usual, I’m going to begin with providing you a closer look at the state of the pandemic. 

At the end of last week, the seven-day average of cases was about 69,000 cases per day, and that represents a decrease of about 3 percent over the previous week.

The seven-day average of hospital admissions was about 5,100 per day, and that’s a decrease of about 10 percent over the prior week.  And the seven-day average of daily deaths is about 1,100, a decrease of about 10 percent over the prior week.

Jeff shared with you the plans we have in place for distribution and administration of vaccines for children between the ages of 5 and 11. 

Today, I’d like to provide an update about where we are in the regulatory and recommendation process for pediatric COVID-19 vaccines.  There has been a great deal of anticipation for parents surrounding the authorization of vaccines for our children and the recommendations from CDC supporting our administration.  I deeply understand the urgency and concern over providing the best protection to our children against the virus.

When I spoke with you last week, the FDA Advisory Committee had just met and reviewed the data from Pfizer that described COVID-19 vaccine efficacy in children.  Pfizer submitted data on nearly 2,000 children between the ages of 5 to 11 years, and FDA reviewed effectiveness and immune response data. 

In the clinical trial, there were only 3 cases of COVID-19 in the over 1,300 children who received the vaccine and 16 cases in the 660 children who received placebo.  Similar to what we saw in the adult trials, the vaccination efficacy was nearly 91 percent in preventing COVID-19 vaccine.

The FDA Advisory Committee also reviewed safety data from an additional 2,000 children who received the vaccine and found no severe adverse events and reported post-vaccine symptoms, including soreness at the site, headaches, muscle aches, and low-grade fevers that were very similar to the adult population.

With the safety and effective — efficacy results, the FDA authorized the COVID-19 vaccine for children ages 5 to 11 on Friday. 

Tomorrow, CDC’s Advisory Committee on Immunization Practices will meet to have their transparent, open, and comprehensive discussion on the data for vaccine effectiveness, safety, and clinical need in children ages 5 to 11.

Throughout the pandemic, this committee has convened many times to review the latest data and provide their trusted expertise.  And I, along with many others, am looking forward to the scientific discussion and deliberation that will take place.

Following the committee’s meeting and votes on vaccine recommendations, CDC will release its recommendations for vaccination of children 5 to 11.

We know kids have different needs, and it’s critical to follow the scientific process and the due diligence required before we bring vaccine to children.  We know the possibility of vaccines for our children will be a welcome relief for many families.  And we also know parents will have a lot of questions, and I would encourage parents to ask questions as they consider the benefits of vaccinating their children.

As I’ve said before, vaccinating our children is one way that we can protect them from COVID-19.  We are eagerly awaiting vaccines for our children, but, while we do so, we must continue to do all that we can to protect them today in our homes, schools, and communities.  This means surrounding children with adults who are vaccinated to protect them against COVID-19 hospitalization and death.

Currently, over 60 million Americans who are eligible for vaccination remain unvaccinated.  If you have not yet been vaccinated, I encourage you to do so.

As we look forward to the fall and winter, it’s important to continue practicing prevention measures that we know work: wearing a mask in public indoor settings, staying home when you are sick, and washing your hands frequently.

For many families, the possibility of vaccines for our children will provide a great deal of comfort with every dose administered.  Parents should feel comforted not just that their children will be protected but that this vaccine has gone through the necessary and rigorous evaluation that ensures the vaccine is safe and highly effective.

Thank you.

I’ll now turn things over to you, Dr. Fauci.

DR. FAUCI:  Thank you very much, Dr. Walensky. 

Could I have the first slide, please?

Given the fact in the context that we now have eligibility criteria for the administration of booster shots for all three of the products that are available as vaccines in the United States, I thought I would take a moment or two just recapitulating what we know about boosters.

Next slide.

First, let’s take a look at the effect of booster shots on the level of neutralizing antibodies, which we know correlates very much with protection.

Next slide.

These are data from the Moderna product in which a third-shot booster was done on individuals who receive the primary, and a measurement was taken 28 days after the third booster shot.

Note the extraordinary increase from the light color blue to the dark blue, both in the younger individuals as well as in those older than 65.

For example, look on the righthand part of the slide.  The titer went from 32 to 706.

Next slide.

No different at all when one looks at the Pfizer-BioNTech.  For this slide, focus on the blue bars and look first at the younger group from 18 to 55 and see that the serum neutralization titer goes from 241 to 1,321, and from the elderly from 123 to 1,479. 

Next slide.

Next let’s take a look at the clinical effect of booster shots.  Most of these data will be coming from Israel because, as I’ve mentioned in previous briefings, they are generally a month or so ahead of us in the process of vaccination and booster.

Next slide.

So, this slide is pretty clear and pretty dramatic.  This is looking at confirmed infection per 100,000 risk days in Israel.  And as you can see across the age range, comparing non-boost in red with those who boost, you see a rather dramatic diminution in confirmed infections.

Next slide.

If you now look at protection across age groups of severe disease in a cohort of over four and a half million people in Israel, through July and August, there’s an 18-fold lower for ages 60-plus and a 22-fold lower for younger ages, 40 to 60, with regard to severe illness.

Next slide.

This is dramatically shown in this slide.  Again, data, as of yesterday, in Israel looking at severe cases per 100,000 population: 64 among the unvaccinated; as you might expect, a diminution dramatically down to 9.5 among those who are vaccinated.  And take a look at what you get when you get the extra third boost — down to 1.8 per 100,000 population.

     Next slide.

Now, if you want to look at the real-world data on effectiveness of a third doses of COVID-19 vaccine — next slide — a paper that just came out online three days ago looks at a cohort of over 720,000 individuals who received the third shot boost.  And again, the data are rather dramatic: a 93 percent lower risk of hospitalization, a 92 percent lower risk of severe disease, and an 81 percent lower risk of death. 

This is dramatically seen on the next slide, which is a series of Kaplan–Meier plots, looking at red, which is those who received two doses, and green — those who received three doses — in hospitalization, severe disease, and deaths. 

And so, on the last slide, one looks at the effect of boosters.  And one should ask oneself — which we do, as we look forward: Is the booster shot a regimen for waning efficacy, or is it really ultimately going to become actually part of the original vaccine regimen? 

We will only know this by following up individuals, which we are doing, who’ve received boosters to determine the degree of and durability of protection.

So, there’ll be more coming on that in the future. 

Back to you, Jeff.

MR. ZIENTS:  Okay, thank you, doctors.  Let’s open it up for a few questions.  Kevin?

MODERATOR:  Thanks, Jeff.  And since we started a few late, please keep your questions to one question. 

First, Anne Flaherty at ABC.

Q    Hi, thanks for taking my question.  So, Jeff, this question is for you.  Can you say exactly how many pediatric vaccine doses will be available, come Wednesday, if all goes as planned?  And if states were able to preorder as early as October 20th, can you explain why parents might have to wait until that week of November 8th for a full rollout, as you just suggested?

MR. ZIENTS:  So, the FDA — thank you for the question, first.  The FDA authorization was the trigger, regulatorily, that would allow — that allowed for the beginning of the picking, packing, shipping process.  And that started immediately within minutes of the FDA decision.  And as I said, people have been working 24/7.

We expect that several million doses are already en route to sites around the country.  And across the next week or so, 15 million or so doses will be around the country at convenient and trusted sites.  So, that’s why we are planning on some vaccinations towards the end of this week but the program for kids, ages 5 through 11, really hitting full strength the week of November 8th. 

Next question, please.

MODERATOR:  Meg Tirrell at CNBC.

Q    Well, thanks.  On kids, I’m wondering if you can tell us your thoughts about the (inaudible) vaccine for even younger kids.  We asked the FDA about this on Friday, and Dr. Marks suggested it would be a few months off, mainly because of when the kids were enrolled in the trial but also because the risk-benefit is different for younger kids, that they’re at even less risk of severe disease.  I’m just wondering the sense of urgency about a vaccine for kids under five.

MR. ZIENTS:  Dr. Fauci?

DR. FAUCI:  Well, it’s very clear that the data show that children — younger children who get infected, in general, do not have as severe disease as adults, particularly elderly adults.  We know that.

But I don’t think that that means that children are exempt from disease and even severe disease.  I think if one goes to pediatric hospitals, you’ll see that. 

Then again, you have to look at the role of children in the spread of infection.  You know, it was originally thought that children don’t spread infection and maybe don’t even get infected.  But the more we study it, we see that many of the younger children, possibly around 50 percent, who get infected get asymptomatic infection.

And there was a recent analysis of this in JAMA Pediatrics which indicated that it is likely that children equally spread infection, perhaps even in the hous- — in the household, as adults do.

So, I think we got to make sure that we don’t just diminish the impact not only on the individual child, but also on the spread of infection.  And for that reason, we feel it’s important to get children vaccinated.

MR. ZIENTS:  Next question, please.

MODERATOR:  Jeannie Baumann, Bloomberg.

Q    Hi, thank you so much for taking my question.  I was wondering if you could talk a little bit about the impact of the news on — you know, that Moderna is set back in terms of rolling out their vaccines for teenagers and just — and younger kids, and what that means for your ability to, you know, implement or get vaccines to younger kids.  Will that impact the rollout at all, or do you not see that having an effect?

MR. ZIENTS:  Dr. Walensky?

DR. WALENSKY:  Yeah, thank you for that question.  You know, all of these vaccines are thoroughly vetted and reviewed, and the data are publicly and transparently reviewed in the advisory committee meetings. 

The thing that’s most important is we have a vaccine for our adolescents — that is the age demographic under consideration with Moderna — and that is the Pfizer vaccine that has undergone that review.  And so we anticipate there shouldn’t be any challenges with regard to getting those adolescents vaccinated.

MR. ZIENTS:  Next question, please.

MODERATOR:  Nate Weixel at The Hill.

Q    Hi.  I’m wondering if you can talk a little bit about the mandate for federal employees.  There’s guidance out today on contractors, but I’m wondering about religious exemptions for federal employees.  Who is the one who decides that?  Is there a standard that they have to go through to — enable to get a religious exemption?  Thanks.

MR. ZIENTS:  Thanks.  So, religious exemptions are done through the agencies, through the HR departments of each agency, following processes with guidance across the federal government.  Religious exemptions are not new; they’ve been in place for other vaccines in the past.  And the agencies are following rigorous processes to evaluate religious and medical exemptions. 

More and more people are getting vaccinated in the federal government.  And the vaccine requirement is working, as it is across many sectors. 

Next question, please.

MODERATOR:  Last question.  Let’s go to Kellan Howell at Newsy. 

Q    Sorry, I had to figure out how to unmute.  Thanks so much for taking my question.  I have a question about the booster program.  It’s my understanding that, right now, specifically for folks who have gotten Pfizer or Moderna, there’s still a group of those people who are not eligible yet for a booster shot. 

And I guess this is really a question for Dr. Fauci.  It looks like, based on a lot of the data you’re looking at, that folks who aren’t getting a booster shot really aren’t as well protected as those who are getting a booster.  So, I guess, what’s your message to those people?  And is it likely that everyone will be able to get a booster soon?

MR. ZIENTS:  Dr. Fauci?

DR. FAUCI:  Yeah, the — I think the short answer to your question is that, yes, it will be very likely that everyone will be able to get a booster within a reasonable period of time. 

I want people to appreciate that when you’re looking at what the pace and the cadence of vaccinations and boosters in the United States, people who have a primary vaccination are still really quite protected against severe disease and hospitalization. 

As we’ve said very often, we want to stay ahead of the virus, and that’s one of the reasons why I showed you the data from Israel.  But I think, in due time, we will have equity so that people will be able to get vaccine in a booster situation as needed.

DR. WALENSKY:  And maybe if I could just add that the overwhelming number of new infections continue to be among people who are not vaccinated.

MR. ZIENTS:  Last question, Kevin. 

MODERATOR:  Let’s go to David Lim, Politico. 

MR. ZIENTS:  David?

Q    Hey, I was just unmuted.  I wanted to follow up on Jeannie’s question about Moderna and the FDA taking more time to evaluate its vaccine for adolescents and young children.  The company also said it was the delaying its emergency use authorization requests for kids ages 6 to 11 years of age.  How did these developments impact the rollout of COVID-19 vaccines for children in the U.S.? 

It sounds like the Biden administration is fairly confident that Pfizer will be able to supply an adequate number of appropriately sized doses.  But will all geography types for these populations be able to get enough vaccine while demand initially outstrips supply in the initial distribution period that you’re outlining?

MR. ZIENTS:  So, thank you for the question.  We have enough vaccine — Pfizer vaccine for every child age 5 through 11.  So the whole distribution plan that we’ve been talking about — 20,000 sites, millions of doses being shipped as we speak — is all Pfizer vaccine.  We do not have an EUA, as you know, for this age group for Moderna.  So, we have already plans and are in the process of shipping 15 million doses out nationwide, with millions of more doses available each and every week. 

States have chosen where, within their state to send vaccine supply.  And they’ll be able to get additional doses, as I said, each and every week. 

The federal government is also sending vaccines directly to pharmacies and community health centers, which will in turn administer vaccines to kids. 

And this is how we think is the best way to manage this supply chain of Pfizer vaccines with states having the benefit of seeing where the demand is strongest and allocating more and more to those locations going forward. 

So, we’re in great shape on supply.  And the whole plan is based on Pfizer vaccines.  So we have more than enough vaccine for every child 5 to 11 — specifically, the Pfizer vaccine. 

So the bottom line is: There’s plenty of supply of Pfizer vaccine and we look forward to parents having the opportunity to vaccinate their kids. 

Thank you for today’s briefing.  And we look forward to seeing everybody later in the week.  Thank you.

11:59 A.M. EDT

To view the COVID Press Briefing slides, visit: https://www.whitehouse.gov/wp-content/uploads/2021/11/COVID-Press-Briefing-1November2021.pdf 

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