Via Teleconference

1:46 P.M. EDT

MR. ZIENTS:  (Inaudible) — and thank you for joining us.  I’ll turn to Doctors Walensky, Fauci, and Murthy after I provide a brief update.

We have made remarkable progress on vaccinations in just seven months, with more than 200 million Americans now with at least their first shot and 171 million Americans fully vaccinated.

But we can’t and we won’t let up.  We’re now in a pandemic of the unvaccinated, and the way to end this pandemic is more vaccinations.  More vaccinations — that’s exactly what we’re getting done.

Nationwide, we’ve gotten a total of 6 million shots in arms in the last seven days.  That’s the highest seven-day total in over a month and a half.

And at the end of last week, for three straight days, we got more than 1 million shots in arms each day.  That’s the first time that’s happened since June.

Importantly, we’ve dramatically increased the number of people getting their first shots each day.

Back in mid-July, we were averaging 260,000 first shots in arms per day.  Today, we’re getting 450,000 first shots a day — more than a 70 percent increase.  And we’re seeing the greatest increases in states that had been lagging on vaccinations.

In Alabama, Arkansas, Louisiana, and Mississippi, more people got their first shots in the past month than in the prior two months combined.  This is critical progress.

In the face of the Delta variant, more and more Americans are stepping up each day to get vaccinated. 

We’re working to encourage more vaccination, including through vaccination requirements.  Over the past several weeks, we’ve adopted vaccination requirements for federal workers, the armed forces, and healthcare personnel at both the Department of Veterans Affairs and the Department of Health and Human Services.

And just last week, the President announced that nursing homes serving residents covered by Medicare and Medicaid will be required to have vaccinated staff.

Yesterday, after a thorough, independent, and rigorous scientific review process, the FDA gave full and final approval to the Pfizer vaccine, reaffirming its findings that the vaccine is safe and effective.

As Dr. Murthy will discuss, this is a key milestone that will help get more shots in arms.

We know that there are Americans who have been waiting for the FDA process to be completed before getting a shot.  For those Americans, the wait is over.  Now is the time to join the more than 200 million Americans who have already rolled up their sleeve and gotten vaccinated.

It’s free, it’s easy, and it’s never been more important to protect yourself, your loved ones, and your community.

It’s not just individuals; institutions must step up too, and many are.

In just the past 24 hours, CVS, Chevron, Texas Instruments, Ochsner — that’s a health system that’s one of the largest employers in Louisiana — all of them have stepped up to cover their workers.

New Jersey and New York City have stepped up to cover teachers and school staff.  And the University of Minnesota, Centre College, and State University of New York have stepped up to cover students.  We expect more and more to follow.

If you’re a business, a non-profit, a state or local leader who’s been waiting for full and final FDA approval before you put vaccination requirements in place, now is the time.

You have the power to protect your communities and help end the pandemic through vaccination requirements.

Let me be very clear: Our wartime response will continue to deploy every tool at our disposal to get more people vaccinated.

Just today, HHS announced that it’s changing its reimbursement policies so pharmacies and other vaccination providers have additional support and incentives to administer vaccines in smaller long-term care settings.  This will help ensure long-term care residents have greater access to COVID-19 vaccines.

At the same time that we drive more progress on vaccinations, our COVID-19 Surge Response Teams continue to work with states to respond to Delta outbreaks.

We are working with 17 states and have deployed over 700 federal personnel; surged hundreds of ventilators, ambulances and other critical assets to support hospital systems; and established dozens of free testing sites.

Importantly, since July 1st, we have shipped over half a million lifesaving therapeutics to treat COVID patients — half a million therapeutics that are preventing hospitalizations and saving lives.

We continue to accelerate the use of these treatments.  In fact, in just the first two weeks of August, we shipped more than 10 times the amount of treatments we shipped to states in the entire month of June.

We are acting aggressively to stay ahead of the virus and are planning for booster shots starting the week of September 20th, pending FDA and ACIP approval.

We expect the rule will be simple: Get your booster shot eight months after you’ve got your second shot.

We’re working closely with states, pharmacies, and others who will get the job done at the local level.

Earlier today, we convened two meetings — one with governors and their teams and one with pharmacy CEOs — to discuss their operational planning so they’re ready to hit the ground running.

Our message is clear: We will mobilize the unprecedented level of federal support we have provided states, pharmacies, and other partners since the President took office, and help in any way that we can to get booster shots in arms.

I’ll end with this: The President’s whole-of-government effort continues full speed ahead across all fronts to defeat this virus.

And as we have said from the start, we need everyone — governors, leaders of educational and healthcare institutions, employers, small and large businesses, and all Americans — to do their part to defeat this virus.

With that, let me turn it over to Dr. Walensky.

DR. WALENSKY:  Good afternoon.  Let’s begin with an overview of the data.  Last Friday, CDC reported 157,000 new cases of COVID-19.  Our seven-day average is about 137,000 cases per day.  This represents an increase of nearly 12 percent from the prior seven-day average.

The seven-day average of hospital admissions is about 11,000 per day, similar to the previous seven-day period.  And the seven-day average of daily deaths have also increased to 739 per day, an increase of 23 percent from the previous seven-day period.

As cases, hospitalizations, and deaths continue to rise, I want to reemphasize the serious risk of COVID, especially to the unvaccinated, and the importance of vaccines to prevent severe illness and save lives.

This slide shows data on hospitalizations among the vaccinated and unvaccinated reported to CDC’s COVID-NET.  This is a nationally representative sample of hospitals that covers approximately 10 percent of the U.S. population. 

Based on these data from January through July, represented on the horizontal axis, COVID-19-associated hospitalization rates were 17 times higher in unvaccinated, shown by the blue line compared to vaccinated adults, shown by the green line.  These data have been submitted to a preprint server and anticipate they will be posted online in the next few days.

Additionally, today, in CDC’s MMWR, we published a report examining data from Los Angeles County between May and July, which found that people who were unvaccinated were nearly five times more likely to be infected and about 29 times more likely to be hospitalized with COVID compared with people who are vaccinated.

These data remind us that if you are not yet vaccinated, you are among those highest at risk.  The Delta variant of SARS-CoV-2 virus is highly transmissible, represents over 98 percent of COVID cases here in the United States, and is driving up infections, hospitalizations, and deaths across the country.

Please, do not underestimate the risk of serious consequences of this virus.

Vaccines are the best tool we have to take charge of this pandemic.  We continue to see more and more data on the safety and effectiveness of the vaccines authorized in the United States, and now we have full FDA approval for one vaccine and extraordinary safety and effectiveness data for the others.

If you are unvaccinated and ready to revisit your decision to get vaccinated, or if you still have questions, talk to your physician or a trusted source to get the information you need to get vaccinated. 

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

DR. FAUCI:  Thank you very much, Dr. Walensky.  I’d like to spend the next couple of minutes in addressing a much-underutilized intervention for COVID-19, and that is the use of monoclonal antibodies for the treatment and prevention of SARS-CoV-2 infection and COVID-19 disease. 

Next slide. 

For those not totally familiar with this, monoclonal antibody is an antibody that’s produced by a single clone of B cells or a cell line, and consists of identical antibody molecules that can actually be produced in the in-vitro situation in unlimited quantities. 

Next slide. 

If you look at the virion on the upper-left part of the slide and you look up the blown-up spike protein — the red molecule on the right upper panel — when you talk about polyclonal antibodies, which result from infection or vaccination, it’s a group of antibodies against every aspect of the spike protein, which is the good news.  However, the concentration and the affinity of those antibodies can be markedly improved if you get a single cloned antibody — hence the word “monoclonal” — that’s against the very specific part of the spike protein that can have a major effect in prevention and treatment. 

Next slide. 

So, let’s look at what we have.  We have three anti-SARS-CoV-2 monoclonal antibody products that have currently had Emergency Use Authorization from the FDA.  And the EUAs here are for adults and children 12 years of age and older who weigh at least 88 pounds.

There are three of them.  There’s the Lilly product — the bamlanivimab plus etesevimab.  There’s the Regeneron project — product, referred to as REGEN-COV.  And then there’s the GSK and Vir product.  Each of these products targets the spike protein of SARS-CoV-2. 

Next slide. 

So, you can do an indication for these antibodies that are twofold.  The first is to treat infection with SARS-CoV-2. 

Next slide. 

And in this regard, clinical trials have demonstrated that early treatment with anti-SARS-CoV-2 monoclonal antibodies can reduce the risk of COVID-19 hospitalization or death by 70 to 85 percent. 

It is important to emphasize that this must be done early in infection and not wait, of course, until a person is sick enough to be hospitalized.  That’s when you get the best effect. 

And again, being an underutilized intervention, we want people out there, including physicians, as well as potential patients, to realize the advantage of this very effective way of treating early infection. 

Next slide. 

Now, if you look at the people who should benefit from this, this is a list from the FDA and the NIH treatment guidelines about all of the people who may have significant benefit from this type of therapy if given early in their infection. 

I’m not going to go through each and every one of them, but as you can see, there are a number of conditions on this slide that could benefit from the monoclonal antibody treatment after infection. 

Next slide. 

But there’s also the benefit of prevention using monoclonal antibodies. 

Next slide. 

And we know now that the FDA, just a couple of weeks ago, authorized the Regeneron monoclonal antibody for post-exposure prophylaxis, namely for the prevention of COVID-19 after someone has been exposed to a documented case of SARS-CoV-2. 

And even now — and I won’t show the data because of lack of time — there are now studies in pre-exposure prophylaxis, as well as other studies in treatment. 

So, I’ll have on the last slide — next slide — the treatment guidelines panel.  We can give you all the information, and it’s accessible on the website shown here.  And for physicians, patients, and others who want to know how you can get monoclonal antibodies administered, this is the call center and this is the online way to approach it. 

So, bottom line is: This is a very effective intervention for COVID-19.  It is underutilized, and we recommend strongly that we utilize this to its fullest. 

Back now to Vivek Murthy — Dr. Murthy. 

DR. MURTHY:  Well, thanks, Dr. Fauci.  And it’s really good to be with all of you again virtually today. 

Yesterday’s FDA approval of the Pfizer COVID-19 vaccine is a new milestone for our country’s vaccination efforts.  We know that some people have been waiting for this next step to be complete before they choose to get vaccinated.  And if that’s you, the time to get vaccinated is now. 

I want to talk about what approval will mean for three major groups that have played a key role in getting people vaccinated to date. 

First, the approval will help doctors and nurses instill even more confidence in the vaccine among their patients.  More and more, clinicians are talking to their patients about vaccination, recognizing that they are among the most powerful voices in helping people understand the lifesaving benefits of the vaccines. 

They’re also administering the vaccines in their clinics and hospitals.  According to one estimate, the number of primary care practices which administer vaccinations in their offices jumped from less than 40 percent in April to over 75 percent in mid-July, which means that it’s a lot easier now for patients to get vaccinated during routine visits. 

In addition, four of the country’s largest health systems, representing 315 hospitals and more than 30 million annual patient encounters, have just committed to making vaccination more convenient by vaccinating in primary care offices, hospital discharge points, and emergency departments.  And an additional 29 healthcare networks have committed to proactively reach out to their unvaccinated patients to make vaccines available at more primary care offices and to arrange transportation to vaccination sites.

Second, the approval will also support employers and educators in their efforts to vaccinate their workers and students.  As our kids and young people return to the classroom, we know that many schools and universities and businesses have established vaccination requirements in order to create safer places for people to work and to learn. 

Yesterday’s approval by the FDA will help nudge organizations who may have been on the fence about vaccine requirements to move forward with such plans.  It will give these institutions one more reason for their students and employees to get vaccinated. They’ll be able to tell them that the FDA approval represents the gold standard for vaccine safety and effectiveness.  And they’ll be able to tell them the FDA didn’t cut any corners to approve the COVID-19 vaccine.  What they did do is work around the clock reviewing hundreds of thousands of pages of data and inspecting the facilities where the vaccines were produced. 

After all that, the Pfizer vaccine passed the FDA’s rigorous review — yet another reason to feel confident that getting vaccinated is the right thing to do. 

And third, the approval will embolden and equip our COVID-19 Community Corps with even more tools to talk to their communities about vaccination.

Since the spring, we’ve been building this people-powered movement of individuals and organizations across the nation based on our belief that health information is best when it comes from local trusted sources.

The thousands of conversations that our Community Corps members have had in recent months has led more people to get vaccinated, and those conversations have saved lives.  Now they have yet another tool to help people understand the safety and effectiveness of the vaccines. 

You know, at the end of the day, the reason we are making progress and increasing vaccination rates is because, in the face of the Delta variant, everyday Americans are doing their part to talk with each other about getting vaccinated. 

We’re making progress because so many doctors and nurses and other health professionals are taking time to have these conversations with their patients, even while they work around the clock to care for the thousands of people hospitalized with COVID-19. 

So, if you are not vaccinated, the FDA announcement gives you one more reason to get vaccinated.  Please do it.  Please get vaccinated.  Do it for your own health.  Do it for our children who aren’t able to get vaccinated and rely on the rest of us to shield them from infection.  Do it for our healthcare workers who are running on fumes as they struggle to care for COVID-19 patients in overflowing hospitals for the fourth time during this pandemic.  And do it for your community, which needs more people like you to get vaccinated in order to return to normal. 

If you are already vaccinated, this is the time for you to talk to your family and your friends and urge them to get vaccinated. 

The Delta variant continues to spread, and everything we have learned until now has told us that the vaccines are the best way to save lives and keep people out of the hospital.

Thanks for your time.  I’ll pass it back to Jeff.

MR. ZIENTS:  Thank you, Doctors.  Let’s open it up for a few questions.  Kevin?

MODERATOR:  First question, let’s go to Kristen Shamus at the Detroit Free Press.

Q    Thanks so much for taking my question.  I wanted to ask a little bit about the CDC recommendation for masking in K-to-12 schools.  Many school districts have opted not to require them despite that recommendation.  And given that COVID-19 case rates, hospitalizations among children are climbing, is it now time for the federal government to ask governors to put in place statewide mask mandates for K-to-12 schools, especially given that kids at the elementary level where they’re not yet eligible for vaccines?  And if not, why not?

MR. ZIENTS:  Dr. Walensky, do you want to go first there?

DR. WALENSKY:  Yeah, I will just say it’s critically important that we get our children back to school.  We have seen over the last year and a half now the implications of not having our children in in-person learning.  We know that most of the disease that comes into the schools comes in from communities.  And we have high rates of the communities now, so we want to decrease the rates of community — of disease in communities by surrounding children with people who are vaccinated. 

And then, of course, to following our prevention guidance for schools — which we have provided: layered mitigation strategies, including masking, as well as cohorting, ventilation, and distancing, and screening to keep our children safe in the school environment.

MR. ZIENTS:  Yeah, just to — just to add a little bit to what Dr. Walensky said: You know, the President’s message to those educators who are stepping up right now to protect their students when their governor will not is clear, and that is that we stand with you and are ready to support you in any way. 

As Dr. Walensky said, the bottom line is: We know what works.  The vaccines work, masking works, prevention and mitigation strategies work.  And there’s plenty of funding that’s been made available thanks to the American Rescue Plan. 

Unfortunately, some school districts are being forced with difficult choices: defy their governors or hurt their students.  No school should have to make that choice.  Governors and other leaders must put politics and their own political self-interests aside. 

The President has directed Secretary Cardona to look at everything that can possibly be done to protect students and help local leaders do the right things to keep kids safe and in the school.  And one of the options that the Secretary has laid out is out of his office of Civil Rights Investigations.

So we’ll continue to use every tool available to support efforts to protect students and bring them back to school safely. 

Next question. 

MODERATOR:  (Inaudible.)

Q    Hi, can you hear me? 

MR.  ZIENTS:  Yes, we can.  

Q    Great.  Can you talk about — I just came out with story yesterday about the problems that pregnant people in the U.S. are facing: Only — 76 percent of pregnant people in the U.S. are unvaccinated, and we are seeing rises in pregnant people who ended up hospitalized with COVID-19.  What are you going to do to try and get more pregnant people to get vaccinated, especially in light of the CDC’s recommendation to do so, a few weeks ago?

MR. ZIENTS:  So, Dr. Walensky, why don’t you review that recommendation, and, Dr. Murthy, you could talk about efforts to get the word out.

DR. WALENSKY:  Right.  Thank you.  So, last week, we reiterated and strengthened our guidance for pregnant people to get vaccinated.  We have data on CDC website talking about pregnant women who have gotten vaccinated during pregnancy.  However, there are a lot of more vaccinated people who were vaccinated prior to their pregnancy. 

We do know that SARS-CoV-2 — COVID — leads to increased severity of outcomes in pregnant women and increased severity of outcomes in their unborn babies.  And so, we are advocating, suggesting, highly recommending — as is the American College of OBGYN — to vaccinate people before pregnancy or during pregnancy.

DR. MURTHY:  Thanks, Dr. Walensky.  And what I would also say is: We believe this issue is so important that we have mobilized a number of assets to help get the information out.  We’ve been working with the medical community, with the American College of Obstetricians and Gynecologists, with family medicine doctors and other primary care providers to make sure that they are talking to their patients. 

We’re also doing sessions where we’re talking directly to communities, hosting community town halls.  And we’re also working with our trusted messengers to make sure folks are talking to people in communities — whether that’s in churches or synagogues or other settings — to get this information out.

What people also — it’s so important that they understand is that the risks of getting COVID during pregnancy are significant.  There’s a significant increased risk of hospitalization, of ICU stay, of preterm labor and preterm birth.  These are not insignificant risks.  And the best way to reduce your risk, to take care of, you know, yourself during pregnancy is to get vaccinated.  That’s why we’re working hard to get that message out. 

MR. ZIENTS:  Next question. 

MODERATOR:  We’ll go to Sasha Pezenik at ABC News.

Q    Hey, guys.  Thank you for taking my question.  It’s a two-part one.  The first is for Dr. Fauci.  You’ve given the timeline that Americans could see the light at the end of the tunnel in the pandemic by the spring of 2022, and to get there, a lot more eligible unvaccinated people will have to step up for their shot.  But what happens if, after this full approval of Pfizer, we still don’t see the vaccination numbers budge significantly?  So what’s the administration’s plan at that point to get us where we need to be?

And that leads me to part two for Jeff Zients.  The vaccines’ full licensure may pave the way for further vaccine mandates.  Is the administration prepared to go to bat legally for businesses or schools that mandate vaccines?

DR. FAUCI:  Well, let me take —

MR. ZIENTS:  Dr. Fauci.

DR. FAUCI:  Yeah, thanks, Jeff.  Let me take the first part of that question.

You know, you really have to be careful when you ask for projected timelines, because the fact is, the most prevailing issue involved here is that if we can get as many people vaccinated as we possibly can, as quickly and as efficiently we can — particularly in the context of the BLA now that has come out from Pfizer and the availability of other vaccines on EUA — we can end this as a pandemic even sooner than that. 

So rather than focus on the situation of getting a specific timeline, I would like to appeal to this country — to the people in the country who are not vaccinated — to realize that we have the capability among ourselves to essentially cut down the timeframe to getting the end of this pandemic very, very clearly by just listening to everything you’ve heard on this press conference.  Get vaccinated and the timeframe will be truncated dramatically.

MR. ZIENTS:  So on the second part of your question, in terms of vaccine requirements, I think we have a strong track record that shows that we’re willing to pull lever after lever, and we’ll continue to look for additional measures we can take to require vaccines.

Over the past several weeks, we’ve imposed a series of new requirements: first, federal workers who must show proof of vaccination or undergo rigorous testing and masking; second, the armed forces who require COVID-19 vaccinations now for all 2.1 million troops and National Guardsmen and women; third, people who work in federal medical facilities, including the VA, Indian Health Services, and the Public Health Service Corps.  And just last week, using the power of the federal government as a payer of healthcare costs, we’re requiring nursing home workers to be vaccinated. 

We’ll continue to look at every possible lever the federal government can pull to help curb this virus.  And as to your question as to the private sector and public sector and not-for-profit leaders, we expect more and more vaccination requirements.  They can help us end this pandemic.  And, you know, we certainly have their backs.  And the Justice Department has already said that vaccine requirements are indeed legal.

Next question.

MODERATOR:  Let’s go to Sarah Karlin-Smith.

Q    Hi, thanks for taking the question.  You talked about the plan for boosters again today.  I was curious if you could comment on why the White House is sort of getting in front of CDC and FDA here in terms of them actually reviewing applications and having data and, you know, the necessary evidence to recommend boosters.  Couldn’t it create some public confusion if, once the FDA and CDC do their work, it doesn’t quite align with what the White House has been saying?

MR. ZIENTS:  Well, good question.  Thank you for that question.  As our medical experts laid out last week, having reviewed the data, it was, in their clinical judgment, the time to lay out a plan for COVID-19 boosters. 

We announced our approach in order to stay ahead of this virus, give states and pharmacies time to plan — I mentioned the planning meetings that we had this morning with governors and pharmacy CEOs — and to give Americans time to prepare for their planned eight-month booster.

So, we’ve also made it very clear — starting last week and we continue to reiterate — that our plan is pending the FDA conducting an independent evaluation and the CDCs panel of outside experts, the ACIP, issuing a booster dose recommendation — or a booster recommendation.

You know, this virus has proven to be very unpredictable, and we’ve been planning for every scenario.  And we want to make sure we stay ahead of the virus. 

Next question. 

DR. MURTHY:  Jeff, can I just add one thing to that?

MR. ZIENTS:  Please. 

DR. MURTHY.  Yeah, so, I mean, Sarah, it’s a great question, and one thing I want to emphasize: A key piece that went into this decision making was the commitment to transparency. 

If you recall, we had been saying — myself, Dr. Fauci, Dr. Walensky, Dr. Collins, and others — other scientists and public health experts in the department — we’ve been saying for weeks that we are looking closely at the data to look for evidence that breakthroughs are increasing, any evidence that boosters may be needed.  And if and when we see that, we will tell you.

When we came together and looked at the data that finally gave us a sense that there was a signal, or that it was important to act on, we wanted to tell the public as soon as possible because that was a commitment that we made.

In no way does this actually bypass the integrity of the FDA and the CDC Advisory Committee processes.  In fact, if you look at the letter that was signed and the statement that was put out from us, it is from not anybody else but the scientific experts in the department, from Dr. Walensky; Dr. Fauci; myself; from Dr. Janet Woodcock, the head of the FDA; from the head of the NIH, Dr. Collins; and other medical professionals who drove in this decision making. 

So, we can preserve integrity of process while still being transparent with the public, while still planning ahead and giving people a sense of what may come.  And that’s what we were doing with that announcement. 

MR. ZIENTS:  Thanks, Dr. Murthy.  Next question. 

MODERATOR:  Last question.  Let’s go to Erin Billups at Spectrum News. 

Q    Hi.  Thank you so much for taking my question.  You know, many parents are under the impression that young children do not spread the virus as effectively as adults, but there have recently been studies that challenge that.  But as more and more schools are requiring vaccinations of everyone eligible — all staff, teachers — I’m wondering if you could paint a picture for parents as to why their younger children should still need to be masked.  What is the risk of young kids contracting the virus and spreading it to other people?

MR. ZIENTS:  Dr. Walensky. 

DR. WALENSKY:  Yes, thank you for that question.  I think our data have demonstrated that in — with Alpha, certainly, we saw less transmission in schools among childr- — between children and between children and staff than we saw between staff to staff.  It’s not that there was none; it was that there was less. 

We also know now we’re dealing with a much more transmissible virus.  And we have, of course, seen outbreaks where children are transmitting to other children, so — and certainly with the Delta variant, that we know that that transmissibility is increased somewhere around twofold. 

So, the reason to mask in schools is not necessarily only to protect our adults but also to protect our children from transmissibility from one child to another, and then, of course, from children going home to perhaps unvaccinated or immunocompromised or at-risk adults who might have waning immunity. 

MR. ZIENTS:  Wonderful.  Well, thank you, everybody.  We look forward to the next briefing. 

2:19 P.M. EDT

To view the COVID Press Briefing slides, visit: https://www.whitehouse.gov/wp-content/uploads/2021/08/COVID-Press-Briefing_24August2021_for-transcript.pdf

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