Via Teleconference
11:03 A.M. EST
MR. ZIENTS: Good morning. Thank you for joining us. We got very good news over the weekend: The Food and Drug Administration issued an emergency use authorization for a third safe and effective vaccine, the Johnson & Johnson vaccine, which will help us defeat the pandemic.
While we have much work ahead of us on so many fronts, this is certainly a very encouraging development.
Today, we’ll get a state-of-the-pandemic update from Dr. Walensky. Dr. Fauci and Dr. Nunez-Smith will discuss the recently authorized J&J vaccine. And I’ll close with an update on our planning, logistics, and distribution of the J&J vaccine. And then we’ll open it up to questions.
With that, I’ll turn it over to Dr. Walensky.
Dr. Walensky.
DR. WALENSKY: Thank you, Jeff. I’m delighted to be back with you today. Let’s get started with the current state of the pandemic.
I remain deeply concerned about a potential shift in the trajectory of the pandemic. The latest CDC data continue to suggest that recent declines in cases have leveled off at a very high number. The most recent seven-day average of cases — approximately 67,200 — represents an increase of a little over 2 percent compared to the prior seven days.
Similarly, the most recent seven-day average of deaths has also increased more than 2 percent from the previous seven days to nearly 2,000 deaths per day.
These data are evidence that our recent declines appear to be stalling — stalling at over 70,000 cases a day. With these new statistics, I am really worried about reports that more states are rolling back the exact public health measures we have recommended to protect people from COVID-19.
I understand the temptation to do this. Seventy thousand cases a day seemed good compared to where we were just a few months ago. But we cannot be resigned to 70,000 cases a day, 2,000 daily deaths.
Please hear me clearly: At this level of cases, with variants spreading, we stand to completely lose the hard-earned ground we have gained. These variants are a very real threat to our people and our progress. Now is not the time to relax the critical safeguards that we know can stop the spread of COVID-19 in our communities, not when we are so close.
We have the ability to stop a potential fourth surge of cases in this country. Please stay strong in your conviction. Continue wearing you well-fitted mask and taking the other public health prevention actions that we know work.
Ultimately, vaccination is what will bring us out of this pandemic. To get there, we need to vaccinate many more people. Yesterday, the CDC’s Advisory Committee on Immunization Practices, or ACIP, endorsed the safety and efficacy of Janssen’s COVID-19 vaccine. After the ACIP met, I was heartened to sign their recommendations for use of this vaccine in people 18 or older.
This means we now have three safe and highly effective vaccines that prevent serious illness, hospitalization, and death from COVID-19. Importantly, ACIP does not state a preference for a particular COVID-19 vaccine; rather, they recommend that individuals can get any of the ACIP-recommended COVID-19 vaccines, and they encourage individuals to receive the earliest vaccine available to them.
The Janssen vaccine is a much-needed addition to our toolbox and increases the number of vaccine doses available, and makes it possible for people to get — for more people to get vaccinated and protected from COVID-19.
It also offers several unique benefits. It’s a single-dose vaccine that provides COVID-19 protection with just one shot. That can help fully vaccinate people who may have difficulty, or who are not interested, in returning for a second dose. For those administering the vaccine, this vaccine is also easier to store and transport since it does not need to be kept in a freezer. This will make it easier to provide vaccine in community settings and mobile sites as supplies scale up.
Having multiple types of vaccine available, especially ones with different dosing regimens and different storing and handling, offers more flexibility. For example, clinics and mass vaccination sites that do not have freezer capacity may be able to use the Janssen vaccine, increasing access to more communities.
I know that many Americans look forward to rolling up their sleeves with confidence as soon as a COVID-19 vaccine is available to them. We are working hard to get and distribute these vaccines to your communities. I also know that some people may not be there today and may still have questions about these vaccines, including wanting more information about the process for developing and authorizing them. That’s natural. And I know that some people have had experiences that may have diminished their confidence in the health system. That’s also understandable.
I want to emphasize several important facts about these vaccines. We have conducted the largest-scale clinical trials of any vaccine, and what made that possible so quickly was the high amount of disease in the community and the fact that so many people were interested in participating. All of the available data show that these vaccines are safe and are highly effective.
Over 100,000 people participated in clinical trials to evaluate the safety and effectiveness of these vaccines, and they have all met rigorous FDA scientific standards. Equally importantly, as of today, nearly 50 million people in the United States have received at least one dose of a COVID-19 vaccine. We have put in place the most intensive vaccine safety monitoring systems in U.S. history, and we are actively monitoring for any new safety signals.
CDC’s new V-safe smartphone-based health checker has now enrolled approximately 4.5 million people to capture patient-reported side effects in real time. These results are all reassuring. Some people have no side effects after vaccination. Many people have reported mild side effects like pain, swelling at the injection site, and headache and chills or fever. These are common with all vaccines and should go away after a day or so. Serious, generally reversible reactions remain exceptionally rare.
For those who have — still have questions about the vaccines, I encourage you to visit the CDC COVID-19 website for more information. Our decisions today as a unified nation, and as individuals, including whether and when to get vaccinated, will determine how quickly we can stop this pandemic and what life will look like in the coming months ahead.
The most important thing you can do is to be ready to get the vaccine that is available to you. It will help protect us all from COVID-19.
Thank you. I look forward to your questions. And with that, I’ll turn things over to Dr. Fauci.
Dr. Fauci?
DR. FAUCI: Thank you very much, Dr. Walensky. I’m going to just talk a little bit more now about the Janssen COVID-19 vaccine.
If I could have that first slide. Let’s move on to the second slide. We get questions — just move on to the second slide.
We get questions regarding the various percentage numbers that people see. And I know most of you are aware of them, but let me just clarify a few things. The 66 percent vaccine efficacy that we have is really against all of the countries involved. You must recall that this vaccine trial was done on three continents — the United States, South America, and South Africa — with varying degrees of infection dynamics, as well as varying strains, variants, or lineages. That is the 66 percent. The 72 percent is the vaccine efficacy against moderate to severe critical infection in the United States.
I want to point out again a question we often get asked. In order to try — we always say: What vaccine is better than the other vaccine? In order to be able to determine that, you would have to compare them head to head. This was not done. We have three highly efficacious vaccines that also, as Dr. Walensky says, has a very good safety profile.
A very important number, but I want to reemphasize, is that there’s 85 percent efficacy against severe COVID-19 globally, including the United States. This is very important because if you look at other countries, such as South Africa — if you go to the next slide — where you have the B1351, you can see that the efficacy against severe critical disease was 82 percent there. That’s really very important, because even though the vaccine itself — the spike protein that was used and expressed in that vaccine was the spike protein against wild-type virus, namely the virus that is the D614G, not against the B1351. So even though the vaccine itself was not specifically directed against those variants, it did extremely well when it came to preventing severe critical disease. And as we’ve heard many times now, there were no hospitalizations or deaths in any of those studies.
Next slide.
I want to just spend a minute now telling you the difference between the mRNA and the Ad26, because we often get asked that question. As we’ve said on previous briefings, the mRNA that’s injected into the muscle codes for the spike protein in the proper configuration. The body sees that and makes an immune response against that, giving you the protection that has been shown with both of the mRNA vaccines.
Next slide.
In contrast, the Janssen COVID-19 vaccine approach is to take a common-cold, harmless, non-replication, competent virus called Adeno26, in which the DNA of the SARS spike insert was given into the genome. That virus is then injected into an individual. The DNA then transcribes the RNA; the RNA then gives you the spike protein.
The ultimate end game is that both of the viruses — excuse me, both of the vaccines ultimately result in a spike protein in the right conformation that gives the body the opportunity to feel that this is the actual virus that it’s seeing when it’s not; it’s the protein.
Next slide.
And so just to put everything into perspective — we’ve shown this slide before — we now have, again, the third vaccine that is highly efficacious, as shown here, which has been granted an EUA, as has been described by Dr. Walensky.
Let me go to the last slide and just make a comment that I think people do not seem to appreciate, and it has to do with what goes into making these vaccines successful.
I have as the title of the slide, “The Role of the NIH and the U.S. Government in the Development and Testing of J&J.”
I think what people don’t appreciate is that there have been decades of investment in basic preclinical and clinical research to actually develop the adenovirus 26 vector. A lot of work done by Dr. Dan Barouch and his colleagues up at Harvard.
The development of the stabilized prefusion spike protein was done by scientists at the NIAID Vaccine Research Center. The utilization by J&J of the extensive domestic and international clinical trials network, that was established for — actually, for HIV and influenza.
Also, the NIAID-funded CORE lab at the HVTN, at the Fred Hutchinson Cancer Research Center, performed all the immunological testing. The Data and Safety Monitoring Board was established by NIAID, and there was extensive support from BARDA at ASPR of HHS to conduct the trial and to pre-purchase hundreds of millions of dollars’ worth of vaccines by BARDA.
So it’s a complicated process. So even though it looks like it was quick and it was done in a very relatively short period of time, there was a lot of effort, including fundamental, basic preclinical and clinical research that went into that.
I’ll stop there and hand it over to Dr. Nunez-Smith.
DR. NUNEZ-SMITH: Well, thanks so much, Dr. Fauci. This is all very, very good news. You know, all three vaccines are safe and highly effective at preventing what we care about most, and that’s very serious illness and death.
So all of the authorized vaccines will be distributed across states and jurisdictions and across all of our federal vaccination channels.
That doesn’t mean that every vaccination site will have every vaccine, but it means that all vaccines will reach all communities — so all three authorized vaccines available in the suburbs, all three available in the cities, all three available on the coast and in the Heartland.
So I just want to briefly talk about some of the clinical benefits of the J&J vaccine from a healthcare provider’s perspective. Having these different types of vaccines available for use — you know, ones that have different storage requirements, different handling requirements, different dosing recommendations — that will bring more options and more flexibility to healthcare providers.
You know, it could absolutely allow for expanded availability of vaccine, you know, in some temporary clinics, some pop-up mobile sites, and those locations that do not have cold storage capacity. The overall increased vaccine supply creates greater opportunity for people to get vaccinated.
We also recognize some individuals may have a preference for a single dose vaccine — so those who do not want to return for a second dose or who would have difficulty returning for a second dose. We understand that.
Still, as a physician, I strongly urge everyone in America to get the first vaccine that is available to you when it is your turn. If people want to opt for one vaccine over another, you know, they may have to wait. Time is of the essence; getting vaccinated saves lives.
No doubt, communities across the country have been devastated by this pandemic. The vaccines and vaccinations are a critical tool in bringing this unprecedented pandemic to an end. And now we have three.
And so, for that, in addition to the scientist, I want to thank all of the clinical trial participants for their contributions to scientific discovery.
You know, for this vaccination campaign to be successful, vaccines will have to reach everyone. And so kudos to those states and jurisdictions who are already working closely with trusted leaders in the hardest-hit communities to ensure fair and equitable access to vaccinations. This is best practice.
So, again, all three vaccines have been proven safe, highly effective at preventing severe disease, hospitalization, and death from COVID-19 after full immunity.
And if I could leave people with one message, it is this: Get vaccinated with the first vaccine available to you. Protect yourself, your family, and your community from COVID-19.
And with that, I’ll turn it over to you, Jeff.
MR. ZIENTS: Well, thank you, Dr. Nunez-Smith. I’ll provide an update on our planning, logistics, and distribution of the recently authorized Johnson & Johnson vaccine before we open it up for questions.
For the last several weeks, we’ve been working with governors, state and local health officials, and pharmacies and community health centers to ensure we were ready to roll out the J&J vaccine immediately after FDA approval and CDC recommendations.
Starting yesterday, we began executing on our plans by distributing 3.9 million doses of Johnson & Johnson to states, tribes, and territories, and also to pharmacies and community health centers.
Johnson & Johnson doses will be delivered as early as tomorrow. We’re allocating the J&J vaccine the exact same way we allocate Pfizer and Moderna’s vaccine: proportional to a state, tribe, or territory’s population.
So, for example, if a state represents 2 percent of the U.S. population, it receives approximately 2 percent of the Pfizer allocation, 2 percent of the Moderna allocation, and will now receive 2 percent of the J&J allocation that is made to states, tribes, and territories.
We have directed states to manage distribution of all three vaccines in a fair and equitable way. And we will continue to monitor that closely.
As part of that work, the CDC is tracking distribution of vaccines across a range of equity metrics, including zip codes and Social Vulnerability Index data.
We have three very effective vaccines, and all communities should have equitable and even access to each vaccine.
As to the expected supply of Johnson & Johnson vaccine, this week we’ll distribute 3.9 million doses. That is the entirety of Johnson & Johnson’s current inventory. We’re getting these doses out the door right away to ensure vaccines get into arms as quickly as possible.
J&J has communicated that the supply will be limited for the next couple of weeks following this initial distribution of nearly 4 million doses. The company then expects to deliver approximately 16 million additional doses by the end of March.
However, as we have discussed with governors and their teams and with federal partners, we know that J&J distribution and delivery will be uneven across these early weeks in March, and the company expects the delivery to be predominantly in the back half of the month.
Overall, in the J&J vaccine, we’ve done the planning, we have the distribution channels in place, and we’re getting doses out the door as quickly as possible to get shots in arms. So we’re focused on execution, and that includes the important work of ensuring that we continue to increase overall vaccine supply, increase the number of vaccinators, and increase the number of places Americans can get vaccinated.
Next, I want to provide an update on the pace of doses being administered. As you can see on our weekly vaccination report, the current seven-day average is 1.7 million shots per day. Given that the first couple of days in this seven-day period included the storm impacts, 1.7 million actually understates the current pace.
Over the weekend, we experienced new record levels of daily vaccinations. That said, we have much more to do on all fronts in our war on this pandemic.
There is a path out of this pandemic, but how quickly we exit this crisis depends on all of us. And that’s why I encourage everyone to take the advice of Doctors Walensky, Fauci, and Nunez-Smith.
Follow the public health guidance. Get vaccinated when it’s your turn. And continue to wear masks and social distance to protect yourself and your fellow Americans. We will continue doing everything we can, as a federal government, to defeat this virus, but it’ll take all of us, stepping up to do our part.
With that, let’s open it up to questions.
MODERATOR: Great. And a reminder to please keep your questions to one question only. First up, we’ll go to Elizabeth Wise at USA Today.
Q Hi, thank you so much for taking my question. You didn’t say how many doses are being shipped this week. I think, usually, you’ve had that.
My question, however, is: So, appointment systems seem to be the rate limiting factor for getting people vaccinated in a lot of the country, and in some cases this is frustrating people who aren’t coming back because they couldn’t get through. As states move into phase 1B and 1C, and we get tens of millions of more Americans who are eligible, how is the system going to cope? And what are you doing to strengthen it?
MR. ZIENTS: So the number of doses is 3.9 million. So that was the entire J&J inventory, and all of those doses are being shipped this week.
You know, I think scheduling an appointment is too difficult and remains too difficult in too many places. You know, in some states or in some locales, things have gotten better. The pharmacy systems are often better at scheduling appointments. But overall, too many Americans are suffering frustration, taking up way too much time to schedule an appointment.
And we have addressed some of those root causes as we’ve increased the vaccine supply, as we’ve put more vaccinators in the field, as we’ve increased the number of places. But now we really need to make sure the systems can handle not only the current demand, but the projected demand for people being vaccinated.
So we’re working with states to improve their health sites so that they can handle this capacity. We’re also looking at lower-tech solutions that the federal government might be able to provide, whether those are call centers or people to help navigate the system.
So I think, overall, scheduling remains, for far too many people, too frustrating, and we need to make it better.
Next question.
MODERATOR: Next we’ll go to William Joy with WFAA Dallas.
Q Thank you for taking my question. So this has to do with equity, for either Dr. Nunez-Smith or for Jeff. So, at least here in Dallas-Fort Worth, the gap between vaccinations in affluent zip codes versus underserved zip codes is actually getting worse. So how specifically are you grading yourself when it comes to equity? And what’s that grade right now?
MR. ZIENTS: Dr. Nunez-Smith?
DR. NUNEZ-SMITH: Yeah. No, thanks for the question. We’re absolutely 100 percent committed to equitable vaccine access. And, you know, the statistics that you share are very concerning to us. We know that we still have a challenge in term of — in terms of data. The data quality are not exactly where we’d like them to be as far as race, ethnicity. But even the data that we have do suggest this pattern.
You know, we are already, in the federal programs, prioritizing equity. We have been committed to this from the very beginning, in the launch of those programs, using metrics such as the CDC’s Social Vulnerability Index to help guide where resources should go.
You know, ultimately, we do believe that people should be vaccinated at the rates — and different groups should be vaccinated at the rates in their population. And that’s — that’s our target and our goal.
We’re already working closely with states to provide technical assistance where needed. We will continue to do so.
MR. ZIENTS: I think Dr. Nunez-Smith has captured it well. I will add that the President has been crystal clear that, as important as speed and efficiency in vaccinations, equity and fairness are as important, and we need to make sure that we execute on a strategy that ensures equity and fairness.
MODERATOR: Great. Next question will go to Laurie Garrett.
Q Sorry, had a moment of unmuting. Thank you very much. Yes, I have a question regarding the variants, and this would go to both Doctors Fauci and Walensky. We have this new New York variant that jumped from 0.2 percent of identified viruses in early November to now about 28 percent in New York. And it seems to have arisen in an HIV/AIDS patient, indicating the possibility that we could see variants arising in highly immunosuppressed individuals. And they’re warning that it may be colonizing nasal cells with very high, like tenfold affinity, for H2 receptors. And that’s a site pretty privileged in terms of IgG neutralizing antibodies.
So, I wonder — my question is: How worried should we be about this particular variant? And is it possible that vaccinated and COVID-surviving individuals who have neutralizing antibodies in their blood systems could still harbor and colonize and transmit from their noses to other individuals? Thank you.
MR. ZIENTS: Let’s start with Dr. Fauci, and then we’ll go to Dr. Walensky.
Dr. Fauci.
DR. FAUCI: Well, we certainly are taking the New York variant, the 526, very seriously, Laurie. You know, as you know, it started off in what is likely in the Washington Heights section, and then has gone through multiple boroughs, and is now gaining. Work done by David Ho has shown that we have to really keep an eye on that for its ability to evade both monoclonal antibody and, to a certain extent, the vaccine-induced antibodies. So it’s something we take very, very seriously.
The idea about the accessibility of antibody to the nasopharynx — I mean, that’s obviously a good point. It’s a theoretical, but it can be a real issue. So I’m sure that’s going to be something that is going to be looked at and studied about the degree of not only the viral load, but also the persistence of the viral load in the nasopharynx.
So, good points. All unknown right now, but something that we’re going to be looking at very carefully.
MR. ZIENTS: Dr. Walensky, anything to add there?
DR. WALENSKY: I would just say we know that early studies actually show that these variants could emerge in a single host — in a single immunocompromised host, as well. And it’s our reason to decrease circulating virus everywhere, but in the community, as well as in individuals.
DR. FAUCI: What I think is important — because we often get asked the question that’s a reasonable question: “Should people who are immunocompromised get vaccinated?” And the answer is, “Absolutely, yes.” Absolutely, yes. Because that’s not only important for them for their own health, but that could be the breeding ground of the emergence of variants for the simple reason that, if you don’t clear the virus rapidly, you’re going to have immunological selection within a given individual. And as Laurie said correctly, that was probably how all this started with 526.
MODERATOR: Next question will go to Jeremy Diamond at CNN.
Q Hey, thanks for taking the question. Sorry, let me just mute the (inaudible) here. Apologies. I’m hoping you could address some of the concerns that the more easily deployable nature of the Johnson & Johnson vaccine will make it the go-to vaccine for marginalized and harder-to-reach communities.
I know you guys have said that, you know, that’s something that you’re monitoring and you want states to distribute these shots equitably. But beyond monitoring, what more can the administration do to not only avoid this perception that, you know, you have different vaccines for different classes of Americans, but also to make sure that you’re getting the most bang for your buck from an epidemiological perspective, given the limited supply?
MR. ZIENTS: Dr. Nunez-Smith?
DR. NUNEZ-SMITH: Absolutely. Thank you for the — for the question. So, you know, we shouldn’t lose sight of the very good news that we have: we have three authorized vaccines. That’s tremendous. We do expect that they be distributed evenly for all communities to benefit.
There are clinical benefits to J&J that we talked about briefly — in terms of the cold storage capacity, the single dose — that might make it very useful for healthcare providers in their toolkit, as they’re thinking about things like some pop-ups.
But overall, you know, we do think that the distribution, again, should be should be even across communities. So, importantly, providing that guidance upfront — we are modeling that within the federal programs. And then, you know, as we said, we will be tracking biometrics, such as zip code and social vulnerability, to see where vaccines are going.
And should certain vaccines go consistently to certain communities, we will be able to intervene. And, you know, we’re here to provide support and technical assistance to pivot and intervene and correct, if and when needed.
MODERATOR: Last question will go to Zeke Miller at the Associated Press.
Q Thank you all for doing the call. Two questions. First, just to follow up on what Dr. Nunez-Smith just said: What would that intervention look like? Would that be a reduction in a state’s allocation?
And then, more broadly, for Doctors Walensky and Dr. Fauci, what is the current timetable in terms of federal guidance on what people who have been vaccinated can and shouldn’t do in this moment? Is it safe for them to go out to dinner right now? Can they start to travel? And are you worried that the delay in getting that sort of guidance is having some — a downward pressure on demand?
MR. ZIENTS: So, Zeke, I’ll go first here, and then over to the doctors.
You know, if we were to see that vaccines were going to certain communities, we will take action, as Dr. Nunez-Smith said, to ensure supply is distributed evenly. And first actions would include obviously the communication of our standards and our insistence that people adhere to the standards, and then we would begin by providing technical assistance to the state or other providers.
Second question over to you, Dr. Fauci.
DR. FAUCI: Yes. So this is something that the team — the medical team talks about all the time. Ultimately, the CDC will be coming out within a reasonable period of time; I’ll let Rochelle give you that timeframe in a moment. But, you know, I have been asked and have said publicly that, you know, as we get more and more people vaccinated, the logical question that was just asked by Zeke is an important question. And that is: What happens if you get doubly vaccinated people with the Pfizer and Moderna, for example — members of family, people coming in — like, I use the example of a daughter coming in from out of town who is doubly vaccinated, and a husband and wife doubly vaccinated, and maybe a next-door neighbor who you know are doubly vaccinated. Small gatherings in the home of people, I think you can clearly feel that the risk — the relative risk is so low that you would not have to wear a mask, that you could have a good social gathering within the home.
Beyond that is going to be based on a combination of data, a combination of modeling, and a combination of good, clinical common sense. And the CDC is working on that right now. And we’ll all be together with a good message hopefully soon.
So, Rochelle, why don’t you take it from there?
DR. WALENSKY: Yeah, I don’t have much to add, except to say we’re actively working on this guidance. We’re looking forward to releasing it soon.
At the same time — and I would agree with all that Dr. Fauci has said — at the same time, I want to really keep our eye on the fact that we are — our cases are increasing right now, slightly, and — but they are. And so, you know, the goal is not to sort of open up travel, open up all of, you know, things because people — you know, we’re scaling up vaccination. The goal in those first 100 days has always been to sort of make sure that we are in a place to be out of this pandemic. At 70,000 cases per day, we’re not in that place right now.
So while we may have, you know, guidance at the individual level, as Dr. Fauci has suggested, I think we all need to keep our eye on the fact that we’re not out of the woods here yet.
DR. FAUCI: Yeah. The environment of, as I just mentioned, the setting in a home of a small group of people having dinner together, all of whom are vaccinated, is very different when you step out the door and go into a society that has 70,000 new infections per day. So, amen to what Dr. Walensky just said.
MR. ZIENTS: I want to thank everybody for joining today. We’ll be back together on Wednesday. Thank you.
11:37 A.M. EST
To view the COVID Press Briefing slides, visit https://www.whitehouse.gov/wp-content/uploads/2021/03/COVID-Press-Briefing_1March2021_For-Transcript.pdf
