Via Teleconference

11:04 A.M. EST

MR. ZIENTS: Good morning, and thanks for joining us. Today, Dr. Walensky will provide an update on Omicron and the state of the pandemic, and Dr. Fauci will discuss the latest research on development of pan-coronavirus vaccines.

First, I’ll provide a brief operational update. We have more tools widely available for the American people than ever before: vaccines and booster shots, convenient testing options free high-quality masks, and effective treatments.

We remain laser-focus on deploying these tools to help protect people and to keep schools and businesses open.

Vaccines remain our single-most powerful tool. And just this week, we hit important milestones. Seventy percent of eligible seniors — those most at risk and most vulnerable — have now gotten their booster shot. And half of all eligible adults are now boosted. This is significant progress.

As the doctors and data have made crystal clear, vaccinations and boosters provide the best protection. And so, we keep driving more progress, with millions of shots going into arms each week.

In addition to driving vaccination progress here at home, the U.S. continues to lead the effort to help vaccinate the world.

At President Biden’s direction, we’re donating 1.2 billion vaccine doses — the largest commitment in the world. And today, we will hit a major milestone in our global effort: 400 million vaccine doses shipped to 112 countries. Four hundred million doses shipped for free, with no strings attached.

To put America’s leadership into perspective, we have shipped four times more free doses to the world than any other country.

Our tools are working, even in the face of a highly transmissible variant. And we continue to move toward a time when COVID won’t disrupt our daily lives — a time when COVID is no longer a crisis, but rather something we protect against and treat.

With that, over to Dr. Walensky. Dr. Walensky.

DR. WALENSKY: Thank you, Jeff. Good morning, everyone. I’d like to start by walking you through today’s data.

The current seven-day daily average of cases is about 692,400 cases per day, a decrease of about 6 percent over the previous week.

The seven-day average of hospital admissions is about 19,800 per day, a decrease of about 8 percent over the prior week.

And the seven-day average daily deaths are about 2,200 per day, which is an increase of about 21 percent over the previous week.

Yesterday, CDC released a new report that details the severity of Omicron in comparison to other variants.

Similar to our prior report, these data demonstrate that COVID-19 disease severity appears to be lower with the Omicron variant than with prior variants.

On this slide, you can see relative rates of cases, shown in purple; hospital admissions, shown in orange; and COVID-19-related deaths, shown in blue.

This figure compares these outcomes during the three periods of high COVID-19 transmission.

The peak last winter is shown in the green shaded section, when vaccination rates were low and cases, hospitalizations, and deaths were high.

The peak during the summer months was when the Delta variant was dominant — is in the yellow shaded area — when nearly 50 percent of the country had been vaccinated with a primary series.

And the third shaded section in orange represents the past month, when cases dramatically increased due to the Omicron variant.

Right now, nearly 64 percent of the country has received a primary series and about 50 percent of eligible people over 18 are boosted.

When you look at the Delta period and last winter, as cases increase, hospitalizations and deaths increased in a similar pattern.

Strikingly, when we compare the past month, when Omicron was the predominant variant, we see a clear separation between cases, hospital admissions, and deaths.

And while cases have dramatically increased and are five times higher than they were during the Delta wave, hospitalizations have not increased at the same rate and deaths remain low in comparison to the case counts.

When looking across these three periods, though, of high transmission in the pandemic, you can see that while the number of hospitalizations is higher now than we have ever previously seen, the ratio of hospitalizations to cases remains lower than prior peaks.

When we look at other disease severity indicators measured among people who are hospitalized with COVID-19 — such as hospital length of stay, ICU admissions, and deaths — these indicators are lower with Omicron than during previous periods of high transmission.

And this is likely attributable to two key factors: First, many people in our country have some level of immunity from vaccination and boosters or from previous infection. And second, it’s likely that Omicron is less severe than prior variants.

Although it’s encouraging that Omicron appears to be causing less severe disease, it’s important to remember that we are still facing a high overall burden of disease.

Hospitalizations have rapidly increased in a short amount of time, putting a strain on many local health systems.

Importantly, “milder” does not mean “mild.” And we cannot look past the strain on our health systems and substantial number of deaths — nearing 2,200 a day as a result of the extremely transmissible Omicron variant.

Please remember the importance of our prevention measures, including vaccination and boosters.

Last week, I highlighted three publications that described the effectiveness of booster doses in protecting against the Omicron variant. It is of critical importance that the people remain — that people remain up to date on CDC’s recommended COVID-19 vaccinations.

It’s vital that we all remain vigilant in the face of this virus. I know many people are tired, but many of our hospitals are still struggling beyond capacity. It’s been a long two years. However, please now do your part to lean into this current moment. Now is the time to do what we know works: Wear a mask, get vaccinated, and get boosted.

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

DR. FAUCI: Thank you very much, Dr. Walensky. I’d like to spend the next few minutes talking about our plans for the future and our current activities on the development of a universal coronavirus vaccine.

First slide, please.

A little bit over a month ago, my NIH colleagues and I wrote a perspective in the New England Journal of Medicine talking about the urgent need of a universal coronavirus vaccine.

The reason we did this perspective was to bring to the attention of the public — next slide — the fact that, in reality, over the past 20 years — since 2002 — we’ve had three coronavirus major disease outbreaks: SARS, MERS, and COVID-19, which we are currently experiencing.

However, since September of 2020, there have been five SARS-CoV-2 variants of concern: Alpha, Beta, Gamma, Delta, and now the current Omicron. And so obviously, innovative approaches are needed to induce broad and durable protection against coronaviruses that are known and some that are even at this point unknown. Hence, the terminology “pan-coronavirus vaccine.”

But I want to explain why this is somewhat of a complicated issue.

Next slide.

This is what we call a “phylogenetic tree” of the coronaviruses. If you look in the center of the circle, that’s the original source. And like a tree, it has many, many branches. And as you can see, there are many different types of coronaviruses. Those that have affected humans are in red font.

If you look at the Alpha coronaviruses — the two there with yellow — were really part of the four common cold coronaviruses that we each get challenged and infected with usually in the winter months. But if you look among the Beta coronaviruses, you see the three that have caused pandemic threats in reality.

Next slide.

So let’s put a circle on the SARS-CoV-2, where we are. We’ve had now five different variants — Alpha, Beta, Gamma, Delta, and Omicron — that have impacted us here in the United States.

Also, if you go to the next slide, you see that there’s a good relationship — next slide, please — between the SARS-CoV-1 and CoV-2. They are both what we call sarbecoviruses, which are a subset of the Beta coronaviruses.

The reason I say this is that, looking at the entirety of the coronavirus phylogenetic tree, it would be unreasonable to think we’re going to get a pan-coronavirus for all of them. But we can focus in on some of the subsets, particularly the SARS-CoV-2 and the entirety of the sarbecovirus, which includes SARS-CoV-1.

Next slide.

Having said that, what are we doing? The NIH, particularly NIAID, has invested a little bit more than $3 billion overall on coronavirus research since the pandemic began. A subset of that is coronavirus vaccine research — thus far, about one and a half billion dollars — with investments in basic and clinical biomedical research, particularly recent awards of about $43 million to four academic institutions to do specific research to develop these types of vaccines which I just mentioned.

But already, there have been results from funding that has been gone on over the past couple of years.

Next slide.

These are just a few of the scientific reports of examples of promising candidates that are at pre-clinical, namely in a mouse or another small animal, as well as non-human primates, as well as getting ready — already in phase one trials.

Next slide.

These are based on a concept of looking at a vaccine construct. I had said in a previous White House press briefing, when I described the mRNA, that one can look at it as a vaccine platform and a vaccine immunogen. The platform currently now that we talk about a lot is the mRNA (inaudible) vector, whereas the vaccine immunogen is, for example, that spike protein in its prefusion stabilized form that serve as the basis for the mRNA and other vaccines.

So, here’s two examples of what is going on now.

Next slide.

For example, a number of groups have used the nanoparticle approach, which is the platform. The immunogen of the different spike protein fragments, which, when put in a vaccine, would lead to a diverse antibody response — hence, covering a broad array of a particular virus.

Next slide.

Another example is an inactivated whole virus vaccine where you have different versions of the coronaviruses that are delivered by an intranasal mist. And this is important because this will go a long way to protecting against infection and spread of infection.

I just give those two examples because they’re two of many that are now currently being produced.

Next slide.

The final slide is some key points. I don’t want anyone to think that pan-coronavirus vaccines are literally around the corner in a month or two. It’s going to take years to develop in an incremental fashion.

Some of these are already in phase one clinical trials. Don’t forget, however, that our current vaccine regimens do provide strong protection, particularly when used with a booster, against severe coronavirus disease and death.

So, do not wait to receive your primary vaccine regimen. And if you are vaccine [vaccinated], please get your booster if you are eligible.

Back to you, Jeff.

MR. ZIENTS: Thanks, Doctors. With that, let’s open it up for some questions. Kevin.

MODERATOR: Thanks, Jeff. First question, let’s go to Nate Weixel at The Hill.

Q Hi, thanks for taking my question. Wondering about tests. Is there any effort underway at the administration to get Medicare to cover some of these tests — reimbursement — like private insurance is doing right now?

MR. ZIENTS: Thanks for the question. Yes, on Medicare. The program, as you know, already covers lab-based tests. And CMS, over at HHS, is exploring the best way to provide more testing options to Medicare beneficiaries.

I want to emphasize that currently, Medicare beneficiaries can get free tests. There are 20,000 free testing sites around the country, including at over 10,000 local pharmacies and other local convenient locations.

HHS is actually providing 50 million free tests — free at- home tests to community health centers and Medicare-certified health clinics. And as you know, the website is up and running for free tests for all Americans.

So, yes, the answer to your question is the program already does cover lab tests, and I mentioned the other convenient places for Medicare beneficiaries to get tested. And CMS is exploring the best way to provide more testing options to Medicare beneficiaries.

Next question.

MODERATOR: Let’s go to Victoria Knight at Kaiser Health News.

Q Hey, thanks, Kevin. Thanks for taking my question. So, a couple of questions about the specifics of the N95 mask distribution program. So, when are these going — masks going to arrive in the community health centers? How many of the 400 million from the Strategic National Stockpile are going to community health centers? And then why are these masks not being shipped directly in the mail with the rapid test kits that are being sent in the mail via the U.S. Postal Service?

MR. ZIENTS: Good. Thank you. So, last Wednesday, a week ago, we launched the program to make 400 million N95 masks available. This is the largest deployment of PPE — personal protective equipment — in U.S. history. We just determined that the fastest way to get masks out was through the channels that we use for vaccines, including community health centers and local pharmacies. We’ve already shipped masks out. And we’re beginning to see people pick up these high-quality masks at locations across the country.

They came online at several locations across the country through retailers like Hy-Vee, Walmart, and Meijer last Friday — so just 48 hours after we announced the program. So, the program is off to a very fast start. I think the decision to use those channels to get masks out immediately is the right decision.

Across the next couple of weeks, the program will hit full strength. So, Americans will be able to pick up free masks, as I said earlier, at tens of thousands of convenient sites, including, as you mentioned, community health centers around the country and local pharmacies.

Next question.

MODERATOR: Let’s go to Tamara Keith at NPR.

Q Thank you for taking the question. At the top of the briefing, you talked about moving to a place where COVID won’t disrupt our lives and it won’t be a crisis. And I — I wanted to get you to tease out that messaging a little bit more. What does that look like? How do we get there?

And, relatedly, what’s the status of delivery of the antiviral pills from Pfizer? How soon are you expecting to have those tens of millions of pills?

MR. ZIENTS: Okay, why don’t I have Dr. Fauci start on the first, and then I will talk about the delivery of the Pfizer pills.

Dr. Fauci?

DR. FAUCI: Yeah, thank you very much for that question. Yes, well, people ask that all the time: “What is an acceptable situation with regard to SARS-CoV-2 and COVID-19 and, in this case, Omicron that we are willing to live with, in the sense of not having it disrupt our lives?”

Well, first of all, the important point to make is that we are not there right now. As Dr. Walensky said, when you have over 2,000 deaths, 150,000 hospitalizations, and you have people who are now getting infected to the tune of somewhere around 700,000 a day, we’re not there yet.

Where we want to be is that sufficient control — and “control,” we mean not eradication like we did with smallpox — that’s unreasonable; not necessarily elimination, like we’ve done with polio and with measles by mass vaccination campaigns; but a level of control that does not disrupt us in society, does not dominate our lives, does not prevent us to do the things that we generally do under normal existence.

That would be a level of infection, but more importantly, concentrating on the severity of disease, hospitalizations, and deaths that fall within the category of what we generally accept — we don’t like it, but we accept it — with other respiratory viruses: RSV, para flu, and even influenza.

And if the degree of immunity in the general community population — either through infection plus boosting, either vaccine plus boosting, or just vaccine alone — those are the things that will hopefully get us to the point when we have antivirals to be able to treat people who are at high risk — that we no longer are in a situation of threat — threat to our equanimity, threat to our economy, the threat to allow us to live a normal life.

We believe we can get there because we have the tools with vaccines, with boosts, with masks, with tests, and with antivirals. That’s what we talk about when we get to the point where we can, quote, “live with the virus.” But, as Dr. Walensky emphasized, that is not where we are at this point. So, we still have a way to go.

MR. ZIENTS: So, on Pfizer, we’ve purchased — we’ve purchased 20 million treatment courses of the Pfizer pill, and we accelerated the delivery of the first 10 million from September to the end of June. We have hundreds of thousands of pills across the first quarter of 2022, per month, and that moves to — moves to millions in order to complete the 10 million first half of the 20 million by the end of June.

I want to remind everybody that that is one of five Pfizer pills — one of five effective treatments that we have in our nation’s medicine cabinet and that we have more treatments between the Pfizer pill; the Merck pill; GSK’s monoclonal antibody, which is effective against Omicron; AstraZeneca’s preventive therapy; and remdesivir. We have more available than we’ve had at any point in the pandemic, and we’re using every tool at our disposal to keep people safe.

Next question.

MODERATOR: All right, let’s go to Alex Tin at CBS.

Q Hi, thanks for taking my question. Drs. Walensky and Fauci, can you tell us — how do we know that Johnson & Johnson recipients who are up to date on their vaccines are protected against Omicron and severe disease? And do you expect we’ll see a change to that regimen for those recipients anytime soon? Thanks.

MR. ZIENTS: Dr. Fauci?

DR. FAUCI: Yeah, well, I mean, if you look at the data that we’re getting on vaccinations and boosters, it is very, very clear — I mean, obviously we have a lot more data in this country on mRNA vaccines, either the Pfizer or the Moderna, than we do on J&J.

But there’s no reason to believe — given the parallel protection that we have seen with J&J that is boosted or the mRNAs that are boosted, as well as the mix and match, which have been done, where you can vaccinate with one platform and boost with the other. We have found very interestingly that it works quite well — that they do boost each other rather well.

So, in that regard, we feel that the situation that we’re seeing with the mRNAs is really quite parallel with the boosted J&J — not the first dose, but the boosted J&J.

MODERATOR: All right. Next, let’s go to Cheyenne Haslett at ABC.

Q Thanks, guys. For Dr. Fauci, I had a question for you. If you could talk a little bit about this next age group waiting for vaccines, kids four and younger. Any updates on when we will hear from Pfizer on data? I think you talked about that coming in the next month or so.

And if you could clarify if this will be for a two-dose or a three-dose vaccine. Which is expected to be sufficient?

And then on Paxlovid, do you think the rollout to patients is going well, or are there things the government could be doing to make it easier to obtain?

DR. FAUCI: Well, I’ll answer the first question, and then turn to Jeff to ask — answer the second question.

With regard to the clinical trials that are being done in children from 6 months to 24 months and from 24 months through 4 years: As you probably know, the original data that was done was determine if the doses that were given to those children reached what we call “non-inferiority” with a more adult or adolescent population.

And in the original data that was put forth, it looked like the dose and the regimen for the children who were 6 months to 24 months worked well, but it turned out that the other dose — namely the other group, from 24 months to 4 years — did not yet reach the level of non-inferiority.

So, the studies are continued. It looks like it will be a three-dose regimen. I don’t think we can predict when we will see an EUA with that, because the company is still putting the data before the FDA. And I certainly don’t want to get ahead of the FDA, because I’m not privy to the data. And even if I were, I wouldn’t want to anticipate what the FDA would do.

I think we just need to be patient and know one thing for sure that that’s why the system works. Because the FDA is very scrupulous in their ability and in their effort to make sure that before something gets approved for people at any age — including and especially children, because of the special vulnerability of the children — that when these vaccines become available for children at those age, we can be certain that they will be safe and that they will be effective.

Bottom line: I can’t give you a timetable on that. We’ll just have to wait and see.

MR. ZIENTS: So, on the pills distribution: First of all, the FDA and NIH have provided guidelines on which patients should be eligible first for those pills. And then 85 percent of the pills have been distributed to the states, the same way we’ve distributed vaccines, for them to then put the pills in the most important places within their states — at local hospitals and health systems and other caregivers.

And 15 percent is going directly to community health centers around the country so that we’re making sure that we’re reaching those who are harder to reach, in more vulnerable locations, and that our response is fair and equitable.

I think it’s important to note that as soon as we get monoclonal treatments or pills, we distribute them out to the states so that they can get to patients as quickly as possible.

Next question.

Q Let’s go to Josh Wingrove at Bloomberg.

Q Hi, there. Thank you very much. Jeff, you said last week you might have an update this week on how many orders have been placed for those tests. I’m wondering if you perhaps have that?

And for Drs. Fauci and Walensky, I was hoping twofold — number one, do you know why we’re seeing the cases fall as much as we are, as quickly as we are, particularly in these big, urban settings? Is it that we assume everyone was or many people were more or less exposed and it’s running out of people to expose to? Or did people just clamp down on their behavior?

And forgive me for adding on: Last night, Tucker Carlson’s show advised viewers to stop using mRNA shots entirely, and I wondered if you want to respond to that. That show, of course, has a pretty significant viewership, and that’s a message that was sent out last night. Thank you.

MR. ZIENTS: Okay, Josh, I think that was three questions. Let me go first. And, you know, as we said last week, we will have an initial report on orders by the end of this week, so that will be coming. We’ve seen strong demand, and the website has worked very well — taking in orders quickly and efficiently.

Importantly, you know, already tens of millions of tests have gone out the door and are arriving — and many have arrived — at people’s mailboxes and doors.

So, we look forward to getting more and more Americans free tests directly to their doorstep in the days and weeks ahead.

Dr. Walensky, do you want to take the second question on the steepness of the decline?

And then, Dr. Fauci, if you want to make any comments on mRNA vaccines?

DR. WALENSKY: Happy to. Thanks, Josh. So, you know, the shape of the increase — the slope of the increase and the steepness of decline is what has been mirrored in other countries as well; South Africa and UK have seen similar trends.

I think it’s a combination of what you’ve been — what you commented on. First, that people are behaving differently in the context of Omicron. Many are, you know, masking up. Many are doing more distancing than they had before in the — while we’re in the middle of this surge.

I also think that there’s a large component of people who are vaccinated, people who are getting boosted, and some who are — who have been previously infected now — many who have been previously infected now, either with Omicron itself or with prior variants where they have some enduring protection.

Maybe — if I could just comment on the mRNA vaccine and just say that, last week, CDC put out data that demonstrated that if you are boosted, you are 68 times less likely to die than if you are unvaccinated.

Our hospitals are full of people who have not been vaccinated, and I would encourage people to go get vaccinated.

See if Dr. Fauci has anything to add.

DR. FAUCI: Yeah, I think the data speaks for themselves. We make recommendations based on the scientific data and the observations, particularly those that Dr. Walensky has just mentioned.

The overwhelming proportion of people in this country who are vaccinated have gotten mRNA vaccinations, either the Moderna or the Pfizer. And if you look at the data, you can’t walk away from the facts. And the facts are stunningly obvious when you look at the hospitalization and deaths among unvaccinated versus vaccinated versus vaccinated and boosted.

So there really isn’t much to say about that except that the facts speak for themselves.

MR. ZIENTS: Kevin, next question.

MODERATOR: Let’s go to David Lim at POLITICO.

Q Hi, thanks for taking my question. Senators Patty Murray and Richard Burr yesterday released draft legislation calling for the CDC director job to be subject to Senate confirmation.

Does the Biden administration support this proposal? And directly, Director Walensky, do you believe that this will strengthen accountability during future public health responses? Or do you think that the idea has downsides?

MR. ZIENTS: Let me — let me take this first. So, first of all, I want to say we look forward to reviewing the bill and appreciate the senators’ focus on pandemic preparedness and making sure that we never, ever face a pandemic of this magnitude again.

You know, I think that we’ll leave it to Congress to sort through the CDC director status of confirmation. And overall, we look forward to, you know, engaging with the Senate on — as the bill comes together.

I don’t know if, Dr. Walensky, you have anything to add there.

DR. WALENSKY: No, I don’t have much to add. I just will echo the gratitude and say, right now, my focus is on — we’ll certainly review the bill, but also focusing on, you know, the pandemic that we have on our hands right now.

MR. ZIENTS: Kevin.

MODERATOR: All right. Last question. Let’s go to Zeke Miller.

Q Thanks again for doing this. I just wanted to follow up on Dr. Fauci’s comments in response to Tam’s question regarding living with COVID.

Is it your sense, Doctors, that this is the last disruptive surge of COVID-19, given all of the tools — you know, vaccines, boosters, antibodies, and the like? You know, is there a light at the end of the tunnel that you see now?

And what metrics are you looking for — for to start, you know, giving people hope to, you know, book travel and, you know, take off masks and return to normal life — to normalcy?

MR. ZIENTS: Dr. Fauci.

DR. FAUCI: Yeah. Well, Zeke, there’s — we tend to explain it in the terms of a best-case scenario and a worst-case scenario. We all are hoping for and I believe we likely would get more towards a best- than a worst-case scenario, but we don’t know.

You’ve got to be prepared for the worst but anticipate and look at the data as it’s evolving and what the best-case scenario.

And it really relates, just to very briefly reiterate what I said before, where if you get enough protection from either infection-plus-boost or infection-plus-boost-again or vaccination with boosting, hopefully — because we know how important boosting is — that you will get a level of protection in the community that even if you get another variant, that you will not see a surge associated with that variant but you’ll have enough background immunity to protect against it.

The level that we want to so-called “accept” living with it is what I mentioned in answer to a previous question: We want to make it low enough so that it doesn’t disrupt our capability to function in society in a relatively normal way.

We do that with other respiratory viruses. We know that we get RSV, particularly against vulnerable — the elderly and children. We get parainfluenza. We get influenza. These are important. We try our best to contain them, but they don’t disrupt us with regard to challenging our hospital system, with regard to challenging the entire healthcare delivery system.

That’s where we want to be, and I believe that we will get there, hopefully sooner rather than later. But as I say that, I say we still will always be prepared for the possibility that there may be a variant that will make that timetable turn around.

And so, that’s the reason why we’re doing all of the things that we’re doing, including my presentation a little bit ago about a pan-coronavirus vaccine.

Thank you.

MR. ZIENTS: Yeah, I would just add to what Dr. Fauci said. You know, it’s stark contrast to where we were a year ago. We now have the tools to protect ourselves, our communities, our schools, and our businesses — the vaccines, the boosters, the tests, the masks, the treatment — that makes this response so different and our situation in our country so different than it was a year ago.

And going forward, as Dr. Fauci said, we’ll continue to have those tools, and we’ll continue to innovate to ensure that we protect people and we can begin to be on our path to managing this virus so that it’s no longer a crisis but something that we protect against and treat.

Thank you for today’s briefing. Look forward to the next one.

11:38 A.M. EST

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