11:05 A.M. EST
ACTING ADMINISTRATOR SLAVITT: Morning. Thank you for joining us. Yesterday, you heard the President announce a new historic partnership to get Americans vaccinated more quickly. I want to provide background into how this came together.
Supported by the active involvement and leadership from the U.S. government, two of the largest U.S. healthcare and pharmaceutical companies, Johnson & Johnson and Merck, will enter into a historic manufacturing partnership to expand the production of Johnson & Johnson’s vaccine, as well as take on the complex and delicate process of putting those vaccines into the vials.
While these companies are competitors — most of the time — heeded by President Biden’s call, they are undertaking a wartime effort to come to the table for the good of the country. As many of you know, when we arrived in office on January 20th, we learned from Johnson & Johnson that they were behind on manufacturing.
We immediately got to work to fix this — to accelerate the process and to think big. We set out to do two things. First, increase the production of the vaccine itself, frequently referred to as the “drug substance.” And second, expand our ability to safely transfer the vaccine from drug manufacturing plants into the little vials that are shipped all over the country, a process called “fill and finish.”
Using the Defense Production Act, the Biden administration agreed to an initial investment of more than $100 million that will help expand the drug substance manufacturing and convert a Merck plant to perform the fill-and-finish production for the Johnson & Johnson vaccine.
With the encouragement and support of the administration, Johnson & Johnson and its manufacturing partners agreed to take several steps to increase production of the vaccine in the U.S. They’re now operating 24 by 7 across facilities to maximize production output. At the direction of the President, the Department of Defense is providing daily logistical support, and the administration deployed a team of global experts and equipment manufacturers to support faster ramp-up across all facilities.
I want to be clear: Both of these companies, Johnson & Johnson and Merck, deserve credit for this approach. They’ve stepped up as good, corporate citizens with the spirit of cooperation that the President has called for during this crisis.
Thanks to everyone’s collective actions, we’re now on track not only to catch up, but to have enough vaccine supply for every American adult by the end of May.
And over the course of the year, these actions will double Johnson & Johnson’s U.S. capacity to produce drug substance and increase the U.S. capacity for fill and finish.
Finally, I want to credit the execution of the men and women in government and the private sector who came together to work as a team to move this vaccine so rapidly from authorization into arms with incredible efficiency. This vaccine was approved on Saturday. The CDC reviewed it on Sunday. The same day, vaccines were packed and shipped from J&J facilities. Monday, the vaccines arrived at UPS and FedEx hubs and were delivered to vaccination sites so that, yesterday, Tuesday, the first vaccines were administered in states across the country.
Now, Johnson & Johnson and Merck are not the only ones and they’re not the only businesses stepping up. As I highlighted last Friday, U.S. companies are stepping up to help the country lead its way out of this crisis.
And this leads me to highlight a second announcement for this morning, aimed at improving the equitable distribution of vaccines.
Today, more than a dozen of America’s leading health insurance providers announced a new pilot program to get 2 million of the most vulnerable seniors vaccinated as fast as possible. Called the Vaccine Community Connectors pilot, the aim is to help vulnerable seniors overcome three of the most challenging current barriers: questions about the vaccine, scheduling, and transportation.
Health plans will make outbound calls to unvaccinated Americans of over 65 who live in areas of high social vulnerability. They’ll talk to them about vaccine efficacy, safety, and the value of vaccinations. Then they will facilitate vaccine registration and appointment scheduling for seniors. They’ll arrange transportation to and from a vaccination site and ensure seniors get back for a second shot. They’ll also look to deploy mobile vans into communities of need. Their goal again is to get 2 million of the most vulnerable seniors vaccinated as soon as possible.
This commitment came from organizations who have the call centers, technology, and community relationships to run a pilot program like this. And it comes on the heels of our call to action last week to the private sector to use their talents and resources to help bring a quicker end to this crisis.
With that, I will turn it over to Dr. Walensky and then to Dr. Fauci.
DR. WALENSKY: Good morning, and thank you. I’m delighted to be back with you today. Let’s get started with an overview of the pandemic.
We continue to see troubling signs in the trajectory of the pandemic in the U.S., with the most recent declines in cases and deaths continuing to show signs of stalling. We knew this could happen as variants emerged and reached more people in more communities, but we can still reduce their impact.
The most recent seven-day average of cases — 66,000 — is an increase of 3.5 percent from the prior seven days. The most recent seven-day average of deaths also increased 2.2 percent from the previous seven days to now slightly more than 2,000 deaths per day.
Today, we are at a critical nexus in the pandemic. So much can turn in the next few weeks. On the one hand, cases in the country are leveling off at rates just on the cusp of potential to resurge. And the B117 hyper-transmissible variant looms ready to hijack our successes to date. And on the other hand, stamina has worn thin, fatigue is winning, and the exact measures we have taken to stop the pandemic are now too often being flagrantly ignored.
All the while, we are just on the verge of capitalizing on the culmination of a historic scientific success: the ability to vaccinate the country in just a matter of three or four more months. How this plays out is up to us. The next three months are pivotal.
I’m asking you to reach deeply to protect our nation’s health and to protect your loved ones. Whether mandated or not, as individuals and as communities, we can still take the right public health action to protect ourselves and others: wearing a well-fitting mask, avoiding travel in crowds, social distancing, and practicing good hand hygiene. Now more than ever, we must do all we can to stop the spread of the virus.
As I said on Monday, we now have a third safe and highly effective vaccine, following the emergency use authorization by the FDA and the recommendations for use by the Advisory Committee on Immunization Practices, or ASIP [ACIP], of the Johnson & Johnson COVID-19 vaccine.
We saw footage of the first doses being administered yesterday, less than 48 hours after a ACIP recommended its use, just as Andy commented. This is a remarkable achievement.
With the additional vaccine, more vaccine doses are making their ways into communities, making it possible for more people to get vaccinated and protected from COVID-19. And because this vaccine is a single shot and is easier to store and transport, we can provide vaccines in more communities and mobile sites moving forward.
Yesterday, CDC released an MMWR article detailing the clinical trial data on the demonstrated safety and efficacy of this newly authorized vaccine. The report also provided important guidance for clinicians who will be administering it. The report reflects the in-depth discussions held during the emergency ACIP meeting this past Sunday and Monday.
CDC has now also updated its website to provide easy-to-find information for both healthcare providers and the public about the new Johnson & Johnson vaccine, including information people should know before getting a vaccine. I encourage you to check out our website to learn more.
But the message I want you to hear from me today is that we now have three COVID-19 vaccines that are all safe and highly effective, and the most important thing you can do is roll up your sleeve and get vaccinated with the first vaccine that is available to you.
Finally, I want to share how proud I am that CDC is taking a leading role in helping to achieve the President’s initiative to get educators and all school staff, including childcare workers, vaccinated.
I look forward to working with our pharmacies, state and local partners in the days ahead to move this critical work forward.
Thank you. I look forward to your questions. But, first, I’ll turn things to Dr. Fauci.
DR. FAUCI: Thank you very much, Dr. Walensky. I’d like to spend the next couple of minutes addressing the issue of the SARS-CoV-2 variants and what the multifaceted approach towards addressing these are.
If I could have the first slide.
This is a list of the variants that we have been discussing over the last several weeks. Just very, very briefly, you know the 117, which was originally in the UK, has the characteristic of increased transmissibility. It’s covered relatively well by our current authorized vaccines.
More problematic is the South African 351, which is moderately to severely reduced vaccine efficacy about fivefold or so.
There’s the P1, which originated in Brazil — again, some preliminary reports of increased transmissibility and antibodies elicited by previous infection or vaccine may be less effective.
In our own country, we have the 427/429 California variants, with preliminary reports of increased transmissibility and disease activity; and the New York 526, which recent studies show variable loss of neutralizing activity by some monoclonal antibodies as well as vaccine-induced antibodies.
So what is the approach? The approach that we have currently and for the future is really four-pronged. I’ll go very briefly through each of these to give you a sampling of the kinds of things that are going on and that you can expect.
The first being the ramping up of the vaccination with first and second doses of current EUA-approved vaccines. I can show you on the lext [sic] slide — the next slide.
And on the next slide is an example here of a Pfizer-BioNTech vaccine, namely looking at neutralizing antibody titers after the first and second dose.
If you look there at day 21, which is the time that you would be giving the second dose, the antibody titers that are there are good enough to suppress infection but to some extent — I mean, when you look at the data of the degree of efficacy that you do get after one dose. But take a look at what happens after the second dose. The degree of increase is at least tenfold in both of these age groups that was studied.
Now, the reason why this is important is that if you diminish it, as I mentioned on the previous slide — that if you get a variant that diminishes by maybe five- or sixfold, and you are in a level of antibody that’s as high as you see from day 28 through 35, you still have a considerable cushion to protect.
In fact, this was shown on a preprint server, where David Ho and his colleagues looked at the increased resistance of SARS-CoV variants 351 and 117. But particularly with the 351, he demonstrated a fivefold diminution of capability of blocking there, which tells you that a fivefold decrease still keeps you, with the second dose, well within the protective range.
The next approach is booster doses of the wild-type — against the wild-type virus, which is exactly what Pfizer has announced a bit ago and what other companies will also be doing, namely talking about a third dose of the original vaccine for those vaccine regimens that were a prime and a boost. And that’s going to be given to participants in a phase one trial to evaluate safety, tolerability, and immunogenicity. That study will evaluate up to 144 participants in two age group cohorts.
The next approach is one that we spoke about a week or so ago — was namely develop a variant-specific vaccine. So instead of boosting up against the wild type, which gives you the cushion effect against variants that I mentioned just a few slides ago, the approach that has been taken by some companies, in this case Moderna, is to begin clinical trials of a booster shot against the specific variant in question. And in this case, it’s the 351 from South Africa.
And, in fact, as I have mentioned previously, this is a planned study that will begin in the middle of this month, and it will be a study that it’s done in collaboration with our group at NIAID, in which we will look at both naïve and previously vaccinated adults.
And finally, the last is one that we look to the future, namely a universal coronavirus vaccine, one that would handle variants of SARS-CoV-2 and that would hopefully be able to address other pandemic coronaviruses in the future.
I’ll stop there and hand it back to Andy.
ACTING ADMINISTRATOR SLAVITT: Thank you. Thank you, Dr. Fauci, Dr. Walensky. Let’s take questions.
MODERATOR: All right. We have time for a few questions. And please keep your questions to one question.
My first one will go to Morgan Chalfant at The Hill.
Q Can you hear me?
ACTING ADMINISTRATOR SLAVITT: Yes.
Q Great. Thanks so much for doing this. I’m wondering if you can tell me how you came to the conclusion that there will be enough vaccine supply by the end of May to vaccinate all American adults and why it was important for the President to lay out that timeline yesterday. And also, just if there are any — if you’re worried at all about setting expectations too high on that.
ACTING ADMINISTRATOR SLAVITT: Thank you, Morgan. Well, look, we begin with: I don’t think it’s any secret that when we arrived here, Pfizer and Moderna were scheduled to deliver through — I think it was the end of September. Johnson & Johnson was well behind. And the President, as I think he’s guided, has committed to getting the country vaccinated as quickly as possible.
We got extreme levels of cooperation from private sector partners, and everybody, to say, “Let’s follow the President’s pledge. Move forward, and try to make sure we can get everybody vaccinated as quickly possible.”
We are not in the habit of over-promising. And therefore, even as of several weeks ago, before such time as the approval of Johnson & Johnson, the President was talking about moving up the date until the end of July.
All the while, though, we’ve been hard at work to try to take every idea we can, small or large, with Jeff Zients’s leadership, with Dr. David Kessler’s leadership, and the active participation of both Johnson & Johnson and Pfizer. And this is truly — I’m sorry, Johnson & Johnson and Merck. This is truly a story where there are no bad guys; there’s only good — only good actors here. Everybody got together and found ways to bring forward the timeline so we can get Americans fully vaccinated and into a very different place, in a very different part of that pandemic.
And I think the President has always said he’s going to lay it out straight for the public — good news and bad news. And when we have challenges, we talk about them; and when we have advances, we talk about them. So that’s how that came together.
MODERATOR: Great. And next we’ll going to Brenda Goodman with WebMD.
Q Hi, good morning. I have a question about Texas. Yesterday, Governor Greg Abbott said that he was going to lift the mask mandate and open the state up 100 percent, and we know that now that all the variants have been found in Houston, according to some researchers who were part of a large genomic sequencing effort there. So, I’m wondering, do you agree with the Governor’s assessment that it’s time to open the state up 100 percent?
ACTING ADMINISTRATOR SLAVITT: Well, let me begin with Dr. Walensky to talk about the CDC’s perspective, and then I’ll — I’ll add some comments.
DR. WALENSKY: Thank you for the question. I think, we, at the CDC, have been very clear that now is not the time to release all restrictions. I do think that, as I said in my remarks, the next month or two is really pivotal in terms of how this pandemic goes. As we scale up vaccination, we really do need to decrease the amount of virus that is circulating, as we’re trying to vaccinate all the public.
I will also note that, you know, every individual has — is empowered to do the right thing here, regardless of what the states decide for personal health, for public health, for their health of their loved ones and communities. I would still encourage individuals to wear masks, to socially distance, and to do the right thing to protect their own health.
ACTING ADMINISTRATOR SLAVITT: Let me just follow that up. You know, the President is committed to a few things. One is to follow the recommendation of the science and the scientists and wherever that goes, and so the President is 100 percent behind Dr. Walensky and the CDC’s recommendations.
I don’t think you could be any — possibly be any clearer about the importance and the need for masks. As a leader, it’s probably one of the topics he talks about most frequently. He models that behavior. He’s made the order on every possible area where we have federal control — all the federal sites and facilities, transportation.
And, of course, last week, we announced that we’re going to be distributing masks to community health centers and food banks. We think it’s critically important — critically important that, particularly over the next period of time — this is not forever, but the next period of time, when the President has called for this, we know that it can save tens of thousands of lives if people do this. And we strongly encourage people to continue to wear masks, and mayors, governors, and others recognizing that they have difficult decisions to make to keep the course.
MODERATOR: Next question, Sabrina Siddiqui at Wall Street Journal.
Q Thank you as always for doing the briefing. I wanted to ask if you have a sense of when Merck will actually be able to ramp up production in terms of helping with the J&J vaccine, given the time it will take for the company to convert its facilities. And do we know how many doses Merck will be able to help manufacture?
ACTING ADMINISTRATOR SLAVITT: Yeah, thanks, Sabrina. I think the answer is May. And, again, there are two elements: There is the substance of the vaccine itself, and then there’s the fill-finish. So it’s a bit more of a complex answer, but over time, we believe that Merck will be able to double the capacity that we’ve seen from Johnson & Johnson heretofore.
MODERATOR: Next we’ll go to Kristen Welker at NBC.
Q Hi, everyone. Thank you so much for doing this call. I really appreciate it. I wanted to follow up on the question about Texas. It’s not just Texas that is easing restrictions, it’s also other states like Mississippi, Arkansas, North Carolina, Virginia. So is there anything that the federal government can do? Is there anything that your team is looking to do to try to encourage, if not mandate, that these states reverse course?
And also, in terms of the May benchmark, as it relates to distributing the vaccine, what are the potential headwinds that could derail that timeline? In other words, what are you concerned about most when you look to that end-of-May goal?
ACTING ADMINISTRATOR SLAVITT: Thank you, Kristen. I think we have the same answer with regard to what our view on masks and what the President is saying and doing on masks. And so, you know, I think we are using the absolute full extent of all of the areas where we have federal control, and we are actively — actively being very, very clear on what we think needs to happen. And so we hope that other elected officials who have the authority in their domains will, in fact, listen.
We’re realistic enough to recognize that everybody is not going to pay attention everything we say, but we think this is very, very important.
In terms of Johnson & Johnson and Merck, I’m going to probably defer that question to the company. You know, I think we have a good plan. I will tell you we always worry about everything. I mean, that’s sort of part of our ethic around here — is execution mentality means that we are constantly worried. So anything that has yet to happen in the future, I can assure you we have world experts from manufacturing, from the Department of Defense, and from the companies all very focused on this. I don’t know that I can point to one specific thing.
MODERATOR: Last question will go to Raquel with TV Globo of Brazil.
Q Thank you so much. Can you hear me?
ACTING ADMINISTRATOR SLAVITT: Yes.
Q Thank you so much for this opportunity. My question is to Dr. Fauci, because Brazil is now having the worst time of the pandemic, and scientists around the world are warning that the COVID outbreak in Brazil is a global threat that could risk the progress here and in other parts of the world.
Dr. Fauci, do you agree with this assessment? And also, do you believe Brazil could be doing anything different to respond to this crisis, especially when it comes to vaccination? Are you having conversation or working with authorities from Brazil?
DR. FAUCI: Yeah. Well, thank you for that question. It is really a very difficult situation that Brazil finds themselves in because it is really difficult in the sense that even with infection from the original virus that was circulating — and recovery from that virus does not, in fact, protect you against reinfection from the circulating variant in Brazil.
The best thing one can do is to get people vaccinated as quickly as possible and as many people as possible. You have to get your scientists and your public health officials to take a close look at the match between the antibodies that are induced by the vaccine that you are using and what its efficacy against the P1 and P2 variant that is dominant in Brazil.
So that’s something that you — that I would imagine — and I’d be happy to be discussing this with your officials, if you’d like, to talk about what kind of options you might have.
The issue with the impact of what goes on in Brazil and the rest of the world: Obviously, when you have a variant that is in a particular country — and we already have the Brazil variant in a limited extent in our own country — that’s the reason why, as I mentioned literally just a few minutes ago, in our vaccination program we aim to get the highest titer of vaccination that would then be able to give a cushion of protection even against the variants.
And as I mentioned, the recent paper that came out from Dr. David Ho’s laboratory in New York indicated that there’s a diminution in the capability of vaccine-induced antibodies to protect, but it is a modest diminution, which means that it is likely that the cushion that you get from two doses of an mRNA vaccine would likely be able to protect reasonably well against that.
ACTING ADMINISTRATOR SLAVITT: Thank you.
Next question. Kevin, do we have any others?
MODERATOR: We can do one more. We’ll go to Chris Megerian at the Los Angeles Times.
Q Hi, everybody. One more question on the states that are reducing their own restrictions. Specifically, are you in conversations with these state leaders, urging them not to do this? Are they disagreeing in these conversations with you? I know there’s only so much the federal government can do to order states to do things, but, you know, what is happening behind the scenes to urge them to not do this?
ACTING ADMINISTRATOR SLAVITT: Well, I don’t have a hugely long answer for you. We are in constant conversation with the states. And I — suffice it to say that there are plenty of people — health officials, as you know — in every state who feel now is the wrong time to lift the mask mandate.
That it — I know it seems counterintuitive to folks to hear good news in the coming of vaccines and the acceleration of vaccines. We know, as Dr. Walensky said, that people are tired and eager for this to be over. But even though it’s counterintuitive, it’s actually the most important time for people to make sure we run through the tape and finish that up. I think that’s a commonly shared sentiment not just from us, but from public health experts everywhere. So hopefully the country will continue to rally together in this front.
I want to thank everybody for joining the call today, and appreciate all of the questions and the good work.
Talk to you Friday.