Via Teleconference

3:14 P.M. EST

MR. ZIENTS:  Good afternoon.  And thank you for joining us.

Today, Dr. Walensky will share the latest on the Omicron variant and discuss how people can stay safe over the holidays.  And Dr. Fauci will provide an update on the latest science.

First, I want to underscore the President’s message yesterday.  Due to Omicron, we expect a significant rise in cases.  Fully vaccinated people, particularly those with a boost, are highly protected.

But due to Omicron’s highly transmissible nature, we will see fully vaccinated people get COVID.  They’ll likely be asymptomatic or will feel under the weather for a few days.

Let’s be clear: Unvaccinated people are at a higher risk of getting severely ill from COVID, getting hospitalized, and dying.

We are prepared for this moment.

Yesterday, the President announced new actions the administration is taking to protect families, communities, and hospitals as we face Omicron.  These steps include:

  • More support for hospitals, including 1,000 military troops deployed, hundreds of ambulances, and help for hospitals to ensure adequate supplies, equipment, and beds.
  • More testing, including new federal sites and half a billion tests that will be free to all Americans.
  • And more capacity to get shots in arms, including new mobile clinics, hundreds of additional vaccinators in the field, and tens of thousands of new appointments.

Let me reiterate what the President said yesterday: This is not March 2020.  We have more tools than ever before to protect people: vaccinations, boosters, testing, and treatments.

Today, I want to give an update on treatments.

From day one, our strategy has been to fill the nation’s medicine cabinet with a diverse set of options to treat people.

Let me walk through the three types of treatments, starting with monoclonal antibody treatments, which have proven to be highly effective.

Since July, we have deployed 2.7 million monoclonal antibody treatment courses to help keep people out of the hospital and save lives.

From the moment we learned of Omicron, we began assessing our existing monoclonal antibody treatments, and we learned that two of the three existing treatments are not effective against the new variant.

Fortunately, GlaxoSmithKline’s monoclonal antibody treatment is effective, so we acted quickly to secure more supply of it.

We’re doubling — more than doubling the supply of GSK’s monoclonal to more than 1 million treatment courses, with 300,000 treatment courses available in January.

And we’ve already begun making this drug available to every state and territory.

Next, let me touch on a preventive treatment from AstraZeneca, which is especially important for certain immunocompromised individuals at high risk.  Many of these immunocompromised people are not able to get the level of protection they need from a vaccine alone.

We will have more than half a million doses of AstraZeneca’s monoclonal antibody treatments on hand in January, and we’re preparing to purchase significantly more across the next three months. 

And finally, let me provide an update on antivirals.

We got good news today with the authorization of Pfizer’s antiviral.  Merck’s pill, if authorized, along with Pfizer’s newly authorized pill, add oral treatment options to our nation’s medicine cabinet.

As soon as emerging science showed the promise of these antivirals, we acted quickly and aggressively to pre-purchase 10 million treatment courses of Pfizer and 3 million courses of Merck.

For Merck, by end of January, we anticipate about 3 million treatment courses available to send to states if FDA authorizes.

The Pfizer team has a very promising and now authorized treatment: a pill that dramatically reduces the risk of hospitalizations and death for those at risk. 

We’ve purchased 10 million courses, more than anyone else in the world.

According to Pfizer, the complex chemistry involved in creating the active ingredient in the pill means production takes about six to eight months.  So, supply of this product will ramp up over the next several months.

Knowing that these pills take time to manufacture, Pfizer continues to increase their production plans.

And now that the pill is authorized, we will have discussions to explore how we can help them improve their manufacturing capacity even further by providing any resources needed.

We will have 265,000 treatment courses of Pfizer available in January, with monthly totals of pills ramping up across the year and all 10 million treatment courses delivered by late summer.

As quickly as Pfizer gets the pills manufactured and delivered, we will immediately provide them to states and jurisdictions for distribution.

Just as we’ve done with vaccines and monoclonal antibody treatments, we will ensure equity is at the center of antiviral distribution.  We are not only urging states to ensure equity in their own distribution plans, but we are also distributing antivirals directly to community health centers across the country.

This will help ensure these lifesaving antivirals are available to the most vulnerable communities and hard-hit populations across the country.

In closing, as we face Omicron, the nation’s medicine cabinet of treatments gives us more options to protect the American people.  It’s yet another reason this moment is much different than March 2020.

We have tools to keep people safe, and we will continue using them to do so.

With that, over to Dr. Walensky.

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

The current seven-day daily average of cases is about 149,300 cases per day, an increase of about 25 percent over the previous week.

The seven-day average of hospital admissions is about 7,800 per day.

And the seven-day average of deaths are about 1,200 per day, which is an increase of about 3.5 percent over the prior week.

Over the past several weeks, CDC has continued to closely monitor the emergence of the Omicron variant. 

Currently, over 85 countries have detected Omicron.

And on Monday, we released updated data for the United States, which estimates that the Omicron variant represents approximately 73 percent of COVID-19 cases in the United States.

And in some areas of the country, Omicron has increased even further, accounting for an estimated 90 percent of cases in the Eastern Atlantic states, parts of the Midwest, South, and Northern Pacific states.

This rapid increase in the proportion of Omicron circulating around the country is similar to what we have seen around the world.  Although this is a reminder of continued threat of COVID-19 variants, this increase is Omicron proportion is what we anticipated and what we have been preparing for.

I know there are a lot of questions about the Omicron variant: how to protect yourselves, our loved ones, how to safely gather with our families and friends over the holidays.  And you have heard me say before, we know what works against COVID-19, and it is critically important that we implement our proven multi-layer prevention strategies.

Let me reiterate those four prevention measures for you: Get vaccinated, get boosted, wear a mask in public indoor settings in areas of substantial and high-risk community transmission, and take a test before you gather.

I know many parents are wondering how they can keep their children safe for the holidays. If your child is five or older, get them vaccinated.  And if they are younger than five years, surround them with adults and siblings who are vaccinated, boosted if eligible, and masking in public indoor settings.

I also want to be sure people understand the risks around holiday travel.  Holiday gatherings and risk of travel really has less to do with the airplane or car ride and much more to do with how people from different households behave in the weeks to days before meeting up.  Importantly, consider gathering with family and friends who are also practicing similar proper prevention measures.

And as we have said before, those who remain unvaccinated are the most vulnerable to COVID-19.  CDC data now updated through November, when Delta was the predominant strain circulating, demonstrated that an unvaccinated person has a 10 times greater risk of testing positive for COVID-19 and a 20 times greater risk of dying from COVID-19 when compared to those who were fully vaccinated and received their booster dose.

Although every day we are following more and more studies emerging about the Omicron variant, early data on the vaccine is promising against Omicron, especially when people are boosted.

COVID-19 vaccines, especially when accompanied by a booster dose, are likely to protect against severe disease, hospitalization, and death. 

Still, we know we will continue to hear more about people who get infected who are vaccinated.  These people may get mild or asymptomatic infections and could unknowingly spread those infections to others. 

Again, this means it is important for everyone, regardless of vaccination status, to wear a mask in public indoor settings in communities of substantial or high transmission.

And I would encourage people to take an at-home COVID-19 test ahead of time to help protect you and your family and friends who may be at greater risk for COVID-19 or severe outcomes.

Evidence has repeatedly shown that these prevention measures, when layered together, work. 

So, again, if you are wondering how to stay healthy and protect your loved ones this winter, please get vaccinated, get boosted, wear a mask in public indoor settings, and take a COVID-19 test before gathering with others.

We are at a critical point, and how well these measures are implemented by all of us, caring for ourselves and for one another, will largely determine the outlook of the coming weeks and months ahead.

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

DR. FAUCI:  Thank you very much, Dr. Walensky.  What I’d like to do now is spend just a few minutes on underscoring and reiterating some of the important principles that Dr. Walensky had mentioned.

I’m going to touch on four areas very quickly: transmissibility, severity, the evasion of immunity by vaccines, and the potential impact on therapeutics.

I will point out that there is a relationship between interpreting the relationship between transmissibility and severity, and I’ll explain what I mean in a moment.

Next slide.

No doubt, this is a highly transmissible infection.  These are the latest data that we get from the CDC about the Omicron variant that is sequenced in the United States isolates.  It is now about 73-plus percent.  And speaking to governors from other regions of the country — in some, they’re even as high as 80 to 90 percent.

So, there is no doubt that we are dealing with a highly transmissible virus for the reason, as Jeff mentioned just a moment ago, that we expect that they will be continuing to have a substantial increase in cases.

Next slide.

Now we get to the idea of severity.  These are data from our South African colleagues, who have clearly been showing now — in conversations we’ve had and now in this recent publication — that, in fact, it appears that in the context of South Africa, there is a decrease in the severity compared to Delta, both in the relationship and ratio between hospitalizations and the number of infections, the duration of hospital stay, and the need for supplemental oxygen therapy. 

Recently — literally, yesterday — there was another paper that came out from Scotland, which appears to validate and verify the data that are in South Africa.  This is good news; however, we must wait to see what happens in our own population, which has its own demographic considerations. 

I would point out that even if you have a diminution in severity, if you have a much larger number of individual cases, the fact that you have so many more cases might actually obviate the effect of it being less severe.  And that’s one of the reasons why the President in his remarks yesterday spoke about how we are going to supplement the capability of hospitals to respond to the possibility that there might be a run on the need for hospitalization. 

Next slide. 

Now let’s talk about some of the immune evasion.  We’ve mentioned this in different briefings before, but just to reiterate: There’s no doubt that there’s a marked reduction in neutralizing activity against Omicron — when you look at the two-dose mRNA vaccines, when you compare Omicron to earlier variants, such as Delta. 

However — and here, again, why we emphasize the importance of booster shots — the anti-Omicron activity is about 20- to 40-fold higher in sera from boosted vaccinees versus the peak in individuals who had a two-dose vaccine. 

This is validated by the clinical data, which shows that the vaccine efficacy, as we all know from previous studies, of a symptomatic infection of a two-dose mRNA wanes over time.   However, there’s a moderate-to-high effectiveness — about 75 percent — seen in the early period after a booster dose — and very likely higher when it comes to hospitalization and severe disease. 

Next slide. 

A quick word now on something that Jeff mentioned — is namely the treatments that are available: Unfortunately, but understandably, with the degree of mutations that we have with Omicron, some of the monoclonal antibodies — shown on the slide here — very likely will not work against Omicron.  And those are shown in the first two, under “monoclonal antibody.”

Fortunately, the GSK/Vir product, Sotrovimab, looks like it is well positioned to be used as a treatment against Omicron.  And then, the AZ product also is likely.

Small-molecule antivirals are available now.  You heard the recent approval of an EUA of paxlovid.  Of note and underappreciated is: Remdesivir is already fully approved and is available in a three-day course, which in a recent study showed to dramatically diminish the need for hospitalization.

Guidelines on this will be now reexamined by the NIH Guidelines Committee, and you’ll be hearing more about recommendations — how to utilize these. 

If I can have the last slide. 

I want to again just reiterate what Dr. Walensky said about prevention, which is a multi-layered, comprehensive process, the hallmark of which is vaccination. 

Now, one of the questions that Dr. Walensky and I and Dr.  Murthy and others get asked very frequently is that, right now, as we get to the Christmas holiday and the New Year’s, would it be safe for individuals who are vaccinated, who are boosted to get together with family in the setting of the home?  The answer to that is: Yes.  An extra level of protection would be the testing that Dr. Walensky mentioned. 

But I want to make sure this is not confused with going to a large gathering — and there are many of these — parties that have 30, 40, 50 people in which you do not know the vaccination status of individuals.  Those are the kind of functions — in the context of COVID and particularly in the context of Omicron — that you do not want to go to. 

So, to the extent possible, we urge you to stay away from those situations that could put you at a higher risk. 

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

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


MODERATOR:  Thanks, Jeff.  Let’s try to get through as many questions as we possibly can. 

First, let’s go to Peter Sullivan at The Hill.

Q    Hi, thanks.  I wanted to ask on the supplies of the new Pfizer treatment pill.  There have been some experts calling for the administration to just do more to increase supply — for example, enlisting other manufacturers the way Merck is helping to make the J&J vaccine — so you’re not just relying on Pfizer’s capacity alone.  Have you considered that at all?  Or is there more steps, you know, the administration can take to boost the supply?

MR. ZIENTS:  Yeah.  And I might also have Dr. Fauci talk some about the synthesis process, which takes months to do.  But we know the Pfizer team is hard at work, ramping up production.  And everyone agrees this is a very promising antiviral and, therefore, we want to make sure that production is ramped up as quickly as possible.  According to the company, the complex chemistry involved in creating the active ingredient in the pill means the production takes, as I mentioned, about six to eight months. 

Now that the pill is authorized, we will have discussions to explore how we can help them improve their manufacturing capacity even further by providing any resources that they need.  As quickly as Pfizer gets the pills manufactured and delivered, we will immediately be — we will be immediately providing them to states and jurisdictions for distribution. 

So, the bottom line is: Today is an exciting development and we applaud the American company for their innovation.  We do have 10 million doses ordered, which is the largest amount of any country in the world, and 265,000 treatment regimens will be available to us in January.

Anything you want to add there, Dr. Fauci?

DR. FAUCI:  Well, Jeff, just what you said.  I mean, the very good news is that we have a product now that has about a 90 percent efficacy in preventing hospitalization.

But the sobering news is: Unfortunately, it is really a quite complicated and complex synthetic process, which we will be working with the company to figure out how we can help alleviate the stress of the long duration that it takes to make it, and hopefully we’ll be able to shorten that process by working closely with them.

Mr. ZIENTS:  Next question.

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

Q    Thank you so much for taking my question.  I’m wondering — the WHO is telling people to curtail their holiday plans.  Why isn’t the U.S. government doing that also?

And also, where is the CDC on modifying the definition of “fully vaccinated” to include boosters?

MR. ZIENTS:  Dr. Walensky on holiday and modifying the definition.

DR. WALENSKY:  Yeah, I think that you just heard from Dr. Fauci as to how we are recommending people modify their holiday plans.  Certainly we’re not advocating for large events, as — and so I think that this is a modification.

We also have given clear guidance as to what we believe is a safe way to gather.  We do want families to be together — to be able to be together this holiday season.  And so, to do so, we’re really encouraging people to be vaccinated, to be boosted, and to practice all of those prevention strategies before they gather so they can maximize the safety of their holiday gathering as well as that reassurance of a test.

With regard to your second question, our guidance right now is very clear: CDC recommends — strongly recommends that people who are eligible for a booster go get a booster.  That is everyone above the ages of 16.  Boosting at greater than six months if you’re — if you’ve received the Pfizer or Moderna vaccine, and of course, greater than two months if you received the J&J vaccine. 

We’re looking at the definition right now, and, you know, more to come there.  But just to be very clear, our recommendations are to get boosted.

MR. ZIENTS:  Next question, please.

MODERATOR:  Let’s go to Jeff Zeleny at CNN.

Q    Thank you for taking my question.  I was wondering if Jeff or the doctors could point to one thing in the last month that you could have done differently to avoid where the nation is right now on the cusp of Christmas.

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

DR. FAUCI:  Well, I don’t think I can pick out one thing that we could have done.  Any time that you put the effort that we’re putting in, we always are the strongest self-critics of “could we have done something better; could we have done something more quickly or more thoroughly.”

And, you know, when you say I can’t think of anything, I don’t want anyone to think that we think we’ve done everything perfectly.  But I don’t think I could point one thing out in the last month. 

I think we’ve been intensively involved in getting the response to the Omicron variant.  We jumped all over it.  All of us spent the entire Thanksgiving weekend getting enough information to be able to respond in an appropriate way to Omicron.

So, again, admittedly, we can always do better, but I can’t think of something specifically that we would have done differently.

MR. ZIENTS:  Next question.

MODERATOR:  Let’s go to Meg Tirrell at CNBC.

Q    Well, thanks.  Going back to the Pfizer drug, I’m wondering if you can walk through how patients should try to get this drug.  The fact that they have to get a test result quickly and take the drug within five days of symptoms, a lot of folks don’t have primary care doctors.  So will there be telemedicine or some way to get it through the pharmacy?  How do you look at that?

And then, with the sort of limited supply of it at the beginning, it is indicated just for high-risk people, but should there be prioritization, even within those groups, like by vaccination status?

MR. ZIENTS:  Why don’t I talk for a second about the distribution plan and then over to Dr. Fauci for the medical questions.

As we’ve done with vaccines and monoclonals, we’ll distribute these treatments, these pills, in a fair and equitable way, now that they’ve been authorized by the FDA.

The antivirals will be provided to states and jurisdictions at no charge, on a pro rata basis, to quickly — to get that supply in the field.

As I mentioned in my comments: As part of the administration’s commitment to equity, we are also distributing antiviral pills — Pfizer — directly to federally qualified community health centers across all 50 states.  And that will ensure that these lifesaving antivirals are available at some of the most vulnerable — in some of the most vulnerable communities and hard-hit populations across the country.

Over to you, Dr. Fauci, for the medical part of this.

DR. FAUCI:  Yeah, Jeff.  And it is a — obviously, a very difficult situation when you have a limited supply.

For that reason, we’ve asked the NIH Guidelines Committee to put together a recommendation of when someone comes in with an acute infection and is in a risk group, which is what you want this to be for since we have a limited supply, that we would have a prioritization of what the best approach would be.

It almost certainly will be a physician writing a prescription for someone who within the first three days of notable symptoms of COVID and is in a high-risk group to get it.

But those guidelines — which will not only be limited to what you would do with paxlovid, but also whether or not it would — might be more appropriate to recommend remdesivir, which can be given in a three-day course, or one of the monoclonal antibodies that work.

So, stay tuned.  This will be coming out shortly from the Guidelines Committee.

MR. ZIENTS:  Next question, please.

MODERATOR:  Let’s go to Ricardo at the AP.

Q    Can you hear me?


Q    Okay.  Thank you for taking my question, and it’s for Dr. Walensky.  And my question is — the President flagged that we’re going to see more and more cases involving unvac- — I’m sorry — vaccinated people in every workplace, he said — even in the White House.

And anecdotally, people are seeing that with various political and sports celebrities who are vaccinated getting COVID.

Can you tell us what proportion of cases currently are represented by vaccinated people?  In other words, what proportion of COVID cases are vaccinated people — how that compares with what proportion on hospitalized patients and deaths? 

And can you give us a timeline for a decision on making the definition of “fully vaccinated” to mean “boosted” as well?  Because it seems like that’s an urgent question for the average American.

DR. WALENSKY:  Yeah, thank you for that question, Ricardo.  So, what I can tell you is that you are 10 times more likely to have a case of COVID if you are unvaccinated compared to if you are vaccinated and boosted.  You are 20 times more likely to die of COVID if you are unvaccinated compared to if you’re vaccinated and boosted.

And, yes, we know with Omicron — that has more mutations and is able to evade our vaccines better — that we are going to see vaccinated and even boosted people have breakthrough cases, and they will have breakthrough cases with mild disease or perhaps even asymptomatic disease.  And what I would say is: That is those vaccines working and working well, because those vaccines are working to prevent, really, severe disease and to prevent hospitalizations and deaths.

As for your second question, that evaluation is currently underway and, you know, more soon.  But to be very clear: Our recommendations are to get boosted.

MR. ZIENTS:  Next question.

MODERATOR:  Let’s go to Maureen Groppe at USA Today.

Q    All right.  I want to ask Jeff about the guidance coming out next month on how insurers will pay for at-home COVID tests.  Does the administration have the ability to require health plans to work with the pharmacies to make these tests free to consumers at the counter so that you don’t have to file for reimbursement after buying the test?

MR. ZIENTS:  Yeah, so that’s very much — it’s a good question.  That’s very much work in process, and all ideas — like the idea that you mentioned — are on the table.  And that’ll be worked through across the next couple of weeks with clear guidance on how American consumers with private health insurance can be easily reimbursed for their test.

Next question.

MODERATOR:  Sheryl Stolberg, New York Times.

Q    Hi, thank you for taking this question.  This is directed at Dr. Fauci.  Dr. Fauci, I wonder if you could address this idea that somehow Omicron is a blessing in disguise.  A South Korean health official said, “Omicron could be viewed as a signal of this pandemic nearing its end if it is proven to be more contagious, but less deadly.”  And I’m wondering, in the context of the data that you presented from South Africa today, what is your view of that?

DR. FAUCI:  Well, I think that’s a supposition that might — I would hate to say “a blessing in disguise.”  I’ve never thought of a virus ever, that can infect and kill people, to be a blessing in any way. 

But if you’re talking about, would it be preferable to have Omicron be totally pervasive and be relatively low degree of severity, yes, obviously, that would be preferable.  But it’s dangerous business to be able to rely on what you perceive as a lower degree of severity.

Having said that, it is conceivable, Sheryl, that if Omicron takes over and you get a good immune response to Omicron and you do not wind up getting severity as much as with Delta — that we can wind up with a virus that’s pervasive, that does not cause severity, and that people would get enough immune response to — that you would then wind up having a lesser degree of morbidity and mortality.

That is conceivable, but you don’t want to count on it.  You can’t count on anything when you’re dealing with a virus that has fooled us so many times before.

MR. ZIENTS:  Next question.

MODERATOR:  Last question.  Let’s go to Josh Wingrove at Bloomberg.

Q    Thank you very much.  Jeff, France said today that they’re not going to use Merck’s pill and are going to wait for Pfizer’s pill.  If the FDA does authorize Merck, will you use it?  In other words, will you follow the FDA, or is there any review that would happen afterwards about whether one pill would be better than the other? 

And, Dr. Walensky, we reported on the weekend that the data on vaccine counts are off nationally because of a range of factors.  But, essentially, we’re underestimating both the fully vaccinated and boosted but also the unvaccinated.  I’m wondering if you have any idea how big the gap is.  In other words, do you know what the true number is?  Thank you.

MR. ZIENTS:  Well, you know, obviously, on the Merck antiviral pill, we will follow the FDA’s lead and, as Dr. Fauci talked about, the NIH guidance on how the pill would be used if authorized by the FDA. 

And as I mentioned earlier, we have purchased 3 million of the Merck pills. 

Over to you, Dr. Walensky. 

DR. WALENSKY:  Yeah, thank you for that question, Josh.  So, we work with states, local governments, local jurisdictions, and work to get the best data that are possible from those local jurisdictions, and compile the immunization data from many different places — from pharmacies, from healthcare providers, from large database, large electronic health records — and do so from all different states and jurisdictions. 

We work closely with those states and jurisdictions to update and provide us the best possible data that they can.  And then we compile it to give you, the American people, the best reporting that we can. 

What I can say is that there’s one better way to get the data better, and that is: If people can bring in their vaccination cards, that really does help us to record what dose they are on.  And when they are not able to provide those vaccination cards, it makes it harder for local jurisdictions to assess that. 

So, we’re working with local jurisdictions and governments and healthcare providers in order to do so.  And we’d ask the American people to help us by — improve our data by bringing in their vaccination cards. 

MR. ZIENTS:  The one thing I’d add there, Josh, is, you know, as you said, there may be some situations where shots are misclassified — a first shot as a booster shot was, I think, an example you gave.  But I think the topline number, 475 million total shots in arms administered — I think it’s actually higher than that at this point, approaching 500 million — that reflects the total, tremendous progress that we’ve made. 

And what we know, most importantly, is getting more and more people vaccinated, more people boosted is the most important thing to do. 

So, I know CDC is making progress on the data.  But that topline number, approaching 500 million total shots in arms, is very encouraging.  We need to continue to grow that each and every day. 

So, I want to thank everybody.  And I hope everybody has a safe and happy holiday.  Thank you.

DR. WALENSKY:  Thank you.

3:39 P.M. EST

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