Via Teleconference 

3:05 P.M. EDT

MR. ZIENTS:  Good afternoon.  And thanks for joining today’s briefing.  I’ll turn to Drs. Walensky and Fauci after a brief update.

We know more vaccinations are the way to end the pandemic, and that’s exactly what we continue to see: more vaccinations.  Importantly, as of today, 175 million people have been fully vaccinated, up over 10 million from just a month ago.  A hundred and seventy-five million fully vaccinated Americans — that’s a major milestone in our vaccination effort.

We are laser-focused on getting more Americans vaccinated.  At the same time, we’re doing everything we can to help vaccinate the world.  It’s the right thing to do.

This virus knows no borders, and stamping out the virus everywhere protects our health and our economy here at home.  That’s why we’ve already committed to sharing over 600 million doses globally — far and away the largest contribution made by any country.

And in just the past 10 days, we’ve shipped millions of doses internationally, including to Mexico, Vietnam, Honduras, South Africa, and the Philippines.

In total, we’ve now shipped over 130 million doses to 90 countries.  According to the U.N., the United States has donated more doses than all other countries in the world combined.

We can and we will do even more.  And to that end, an important part of our efforts is increasing vaccine manufacturing capacity here at home and in other countries around the world.

Increasing vaccine manufacturing requires investing across the whole supply chain, from lipids to bioreactor bags to vials to syringes.  Over the past several months, we have done exactly that.

Thanks to the actions we’ve taken, including the President’s use of the Defense Production Act, we have significantly accelerated production of critical vaccine manufacturing equipment, inputs, and supplies.  And we have expanded fill-finish lines at factories so we can get vaccine doses into vials faster and at a larger scale.

These actions have paid off as American companies have significantly increased their capacity to produce vaccines for the U.S. and for the world, including those 500 million doses of Pfizer we have pledged to purchase and donate to the lowest-income countries in the world. 

Today, we’re taking another step to expand U.S. manufacturing of critical vaccine inputs, a nearly $3 billion investment in the vaccine supply chain.

This funding, which will start going out in the coming weeks, will enable companies that manufacture and produce vaccine inputs to add new production lines and facilities and to also expand fill-finish capacity.

This $3 billion investment in our vaccine supply chain will create thousands of good-paying American jobs, help us deliver on the President’s commitment to be the arsenal of vaccines for the world, and strengthen our long-term capabilities to respond to future threats.

I want to close with this thought: We’re doing everything in our power to ensure everyone, both here at home and around the world, has access to vaccines because more vaccinations are how we end this pandemic.

So, if you are unvaccinated, our message is simple: Don’t wait any longer.  Do your part.  Visit Vaccines.gov or text your ZIP Code to 438829 to find a site near you.  And please, please go get vaccinated today.

With that, over to Dr. Walensky.

DR. WALENSKY:  Thank you, Jeff.  Good afternoon.  Let’s begin with an overview of the data.  Our seven-day average is about 149,000 cases per day.  And the seven-day average of hospital admissions is about 12,000 per day.  Our seven-day average of daily deaths has increased to 953 per day. 

Today, I want to focus on COVID-19 and children and, importantly, what we can do to protect them.  As a mother of three and as a physician, I deeply care about keeping our children safe at home and at school. 

Tomorrow, CDC will publish two new studies in the MMWR that specifically look at COVID-19 and children.  These studies compare pediatric cases, emergency room visits, and hospitalizations during the prior winter surge, when vaccination rates were low, with this summer, when adults and adolescent vaccination coverage has increased and the Delta variant is the dominant variant. 

Both studies — one thing is clear: Cases, emergency room visits, and hospitalizations are much lower among children in communities with higher vaccination rates.  Vaccination works. 

The first study analyzed data from hospitals in 99 counties across 14 states and found that the hospitalization rate against — among unvaccinated adolescents, those aged 12 to 17, was nearly 10 times higher than that among fully vaccinated adolescents during the month of July. 

The second study looked at national cases, emergency room visits, and hospitalizations and found that in August 2021, the rate of hospitalization for children was nearly four times higher in states with the lowest overall vaccination coverage when compared to states with high overall vaccination coverage. 

Both of these studies included data from the past two months, when the Delta variant became the predominant variant across the country.  As cases were increasing throughout July and August, the number of children getting sick with COVID was also increasing.  From late June to mid-August, in the context of low community vaccination coverage and the rapid spread of the Delta variant, cases for children and adolescents 17 and under increased by nearly tenfold, which aligns with the increase seen for the general population. 

And although we are seeing more cases in children and more overall cases, these studies demonstrated that there was not increased disease severity in children.  Instead, more children have COVID-19 because there is more disease in the community. 

What is clear from these data is community-level vaccination coverage protects our children.  As the number of COVID-19 cases increase in the community, the number of children getting sick, presenting to the emergency room, and being admitted to the hospital will also increase. 

I want to emphasize three important points to protect our children.  First, we continue to vaccinate — we must continue to vaccinate all of those who are eligible to protect our younger children from disease.  Communities with high vaccination coverage are seeing lower pediatric cases and hospitalizations. 

Second, wearing a mask in public, indoor settings and continuing to practice the prevention strategies we know work are important to prevent further increases in cases and hospitalizations, especially for those children too young for the currently available vaccines. 

And third, with case rates in children high, it is important for schools to follow CDC guidance and ensure that all students, teachers, staff, and visitors to schools wear masks and that there are additional layers of protection in school. 

We know what we need to do to protect our children: get vaccinated, wear masks, and follow CDC guidance.  We must come together to ensure that our children, indeed our future, remain safe and healthy during this time. 

Thank you.  I’ll turn things over to Dr. Fauci.

DR. FAUCI:  Thank you very much, Dr. Walensky.  I’d like to spend a couple of minutes now going over recent data from Israel supporting the rationale for COVID-19 booster shots. 

So, on the next slide, we see new PCR-positive infections and new severe COVID cases in fully vaccinated people during the Delta wave in Israel from June 1st up to, in this case, August the 1st.  So clearly, Delta is dominant and is responsible for new cases, including severe disease. 

Next slide. 

However, in a study that began two days before the August 1st deadline I showed you on the prior slide, a study of a third booster of the Pfizer vaccine was approved for individuals 60 or older, and 1.1 million who were eligible for the dose got it between July 30th and August the 22nd.  And a rather substantial positive impact was seen 12 days or more after the booster dose.  There was a greater than tenfold diminution in the relative risk of both confirmed infection and severe disease. 

And in this paper by Bar-On et al. — on the next slide — the individual data are shown.  So if you go from left to right, the bottom dotted line is the dashed line represented no additional protection. 

On the vertical access axis is the fold reduction in risk of three doses compared to two doses.  So the numbers one, three, five, seven — that would be seven-fold reduction in risk or nine-fold reduction in risk.

And if you eliminate the one and the two, which is probably bias there — psychological bias — and look at what happens from day 3, 4, 5, 6 and on — when you get to day 12, you see a substantial diminution in risk of infection.  And, in fact, that represents here about a million individuals who received their third dose.  And if you look all the way on the right, you see about a 10, 11 or 12 percent reduction. 

Next slide. 

Looking at it in another way: In a different study, when you looked at the reduction in the odds of testing positive, comparing two doses versus three doses of the — of the Pfizer vaccine.  And in this study in a — one HMO in Israel — the Maccabi Healthcare Services — looking at more than 150,000 people in the first three weeks of August, they compared the two dose with the three dose and they found, after 7 to 13 days, up to 68 percent reduction in the risk of infection.  And after 14 to 20 days, a 70 to 84 percent reduction in the risk of infection. 

There’s no doubt from the dramatic data from the Israeli study that the boosts that are being now done there and contemplated here support, very strongly, the rationale for such an approach, based on the very favorable data associated with boost. 

I’ll stop there.  And back to you, Jeff.

MR. ZIENTS:  Thank you, Doctors. 

Why don’t we open it up for a few questions.  First question. 

MODERATOR:  We’ll go to Tamara Keith at NPR. 

Q    Thank you.  A little delay on the unmuting.  Two quick questions.  Is there any thought of doing a meeting connected to the U.N. General Assembly to try to encourage other countries to sort of amp up their vaccine donations globally? 

And then, I know there’s been some question about whether the FDA approval — full approval of the Pfizer vaccine has actually had a measurable impact on people getting their first doses.  And I’m wondering if you have any newer additional data on that.

MR. ZIENTS:  Dr. Walensky, on the second question, and then I’ll come back to UNGA.

DR. WALENSKY:  Yeah, that’s a great question.  We are seeing an uptick in vaccinations, generally, as Jeff has mentioned.  You know, we’re seeing now vaccination rates of around 900,000, a million a day, and vaccination rates of first doses that are about half that.  So all of that is really good news. 

Can we directly attribute it to the FDA approval?  I do think some — it has motivated some, but a lot of other things are happening at the same time, with regard to disease and people’s concern about that.  So I think that that definitely had some impact.  Whether it’s solely the only reason that we’re — the vaccine numbers are going up, I think, is hard to say.

MR. ZIENTS:  Yeah, I think on UNGA, you know, given the significance of COVID around the world, it’s clearly going to be a topic of discussion at the — at the U.N. 

Next question, please. 

MODERATOR:  We’ll go to Sheryl Stolberg at the New York Times.

Q    Hi.  Thanks for taking my call.  I have two questions.  First, for Dr. Walensky: State health officials had a call earlier today and they proclaimed the United States a hot zone unto itself.  They said the entire country was a hot zone.  And I wonder if you agree with that.

And then separately, for Jeff, can you talk a little bit more about the $3 billion investment?  What companies are involved?  How many doses will be produced over what time period?  And where will they go?  Is this exclusively for global donations?  How will that work?

MR. ZIENTS:  Dr. Walensky?

DR. WALENSKY:  So — yeah, so to start, the important thing that I will say is: Where we have more vaccination, we have less disease.  That’s very clear.  Certainly, the Delta variant is more transmissible, but in areas of the country where we have less vaccination, we absolutely have seen less disease.  There’s a lot of disease going on right now, but the way out of that is vaccination.

MR. ZIENTS:  So, Sheryl, you know, we’ve — as we’ve talked about, across the last six months, we’ve seen a significant increase in manufacturing in expanded fill-finish factories here in the U.S.  The investments we’re making with the $3 billion are in U.S. companies. 

However, that will expand their capacity for critical supplies — you know, things like lipids, bioreactor bags, tubing, needles, syringes, new plants for rubber and protective gloves.  So, we’re also looking at PPE.  The specific companies have not been chosen; that’ll be done through the contracting process, which we’ll start across the next several weeks. 

Next question, please. 

MODERATOR:  We’ll go to Jon Cohen at Science magazine.

Q    Hi.  Thanks for taking my question.  I just want to follow up on the question of boosters and the impact that the U.S. government decision might have on other countries.  Obviously, the U.S. government is donating a tremendous amount, but there’s a concern that other countries are going to use boosters widely, following the lead of the United States, and they’re not going to be donating much of anything.  Do you have any concern that the U.S. government is sending a message to other countries that will widely use boosters — even in groups younger than 60 — and not be increasing donations at all?

MR. ZIENTS:  Dr. Fauci?

DR. FAUCI:  Well, Jon, I would hope that the countries that are boosting their populations similar to what we are, understand the importance of the global necessity to essentially suppress this at a global level.  And that’s the reason why the United States is setting the example. 

As Jeff had mentioned, you know, we have given 130 million doses to 90 countries.  We will be giving 200 million before the end of the year, and another 300 million by June of 2022.  And we will continue to help increase the capacity of companies to be able to produce doses for the rest of the world. 

So, I understand your concern, but I hope that the example that the United States is showing will in fact be followed by other developed nations that do have the capability and the resources to contribute to the doses for the rest of the world.

MR. ZIENTS:  I think that captures it well.  I think what — we can do both: We can protect the American people and contribute to the world as we are leading the world in vaccine doses donated. 

And to go back to Sheryl’s previous question: The investments we’re making — the $3 billion — will expand U.S. manufacturing both for doses here in the U.S. and to give to the world and export to the world.

Next question. 

MODERATOR:  We’ll go to Zeke Miller with AP.

Q    Thanks for doing this.  Regarding — this is for Dr. Fauci.  You mentioned the studies in Israel.  We’ve seen the Israeli government require people to get a third dose of the vaccine to be considered fully vaccinated.  They’re — do you expect a similar change the United States that — you know, that if the third dose after that eight-month waiting period will be required to be, quote, unquote, “considered fully vaccinated” and enjoy the privileges of the freedoms that that provides? 

And then, sort of a broader question — and maybe for Jeff: Should we expect the same level of national campaign to give people that third dose of those two-dose vaccines?  That — we saw so much over the last year, reminding people that even just one dose of those shots wasn’t enough; you needed the second.  Should we expect sort of the same level of engagement to encourage people to get the third?

DR. FAUCI:  Well, regarding your first question: The determination whether something is now — constitute “fully vaccinated,” I will leave that up to the FDA when they get the data on the three doses to make that determination — and then, ultimately, a recommendation from the ACIP to the CDC so that it’s recommended. 

But I must say, from my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses.  And the reason I say that is that it is very clear, when you give a prime and maybe a second shot as a boost — but give the immune system enough chance to mature, in both affinity maturation and maturation of the B cell repertoire, it is entirely understandable why the results that I’ve just reported from the Israeli boosters are so dramatic. 

And we all hope — and I believe we have good reason to believe — that that only will not be a strong response, but that it will actually be durable.  And if it is durable, then you’re going to have — very likely — a three-dose regimen being the routine regimen. 

But we’ll just have to wait to make sure that that’s the case when the data get presented to the FDA.

MR. ZIENTS:  And, Zeke, on your question about the national campaign, working with our partners at the state and local level, the Federal Pharmacy — that intensity of the operation to get people their first dose, their second dose, and — there still are tens of millions of people who haven’t started their vaccination regimen.  And you know how important that is.  And we talked about it all the time. 

Same as Dr. Fauci just said, once the FDA and ACIP make their recommendations on boosters — that same intensity of operations and coordination and partnership will be applied to the booster campaign. 

Next question. 

MODERATOR:  Our last question will go to Carl O’Donnell at Reuters.

Q    Hi.  Thanks so much for taking my question.  So, I wanted to ask about the new variant of concern, identified on Tuesday by the WHO, the Mu variant — M-U — which some people are saying is less — or is more resistant to vaccines than other variants so far.  I just want to see if that’s something that you guys are concerned about; if you have, you know, any plans should that start to spread in the U.S.; and whether you think that by getting the booster shots out there that it reduces the risk?

MR. ZIENTS:  Dr. Fauci.

DR. FAUCI:  Well, yes, we certainly are aware of the Mu variant.  We’re keeping a very close eye on it.  It is rarely seen here, but it is not at all even close to being dominant.  As you know, the Delta is more than 99 percent dominant. 

Even though it is not — in the essence — taken hold to any extent here, we always pay attention to, at all times, variants.  This variant has a constellation of mutations that suggests that it would evade certain antibodies — not only monoclonal antibodies, but vaccine and convalescent serum-induced antibodies — but there isn’t a lot of clinical data to suggest that.  It is mostly laboratory, in vitro data.  Not to downplay it; we take it very seriously. 

But remember, even when you have variants that do diminish, somewhat, the efficacy of a vaccine — the vaccines still are quite effective against variants of that type. 

Bottom line: We’re paying attention to it.  We take everything like that seriously.  But we don’t consider it an immediate threat right now.

MR. ZIENTS:  Dr. Walensky, anything to add there?

DR. WALENSKY:  Nothing to add.  We’re watching it carefully.  There have been sequences here, but, again, as Dr.  Fauci said, over 99 percent of the sequences we’re seeing right now are Delta.

MR. ZIENTS:  Good.  Well, thank you for today’s briefing. 

We’ll look forward to seeing you early next week.  Thank you.

3:28 P.M. EDT

To view the COVID Press Briefing slides, visit: https://www.whitehouse.gov/wp-content/uploads/2021/09/COVID-Press-Briefing_2September2021-_transcript.pdf

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