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The FDA and CDC’s call to pause Johnson & Johnson’s COVID-19 vaccine rollout is a “strong argument for safety,” Dr. Anthony Fauci, the White House’s chief medical officer, said during a press briefing Tuesday. Fauci said the agencies raising the red flag on the one-dose vaccine after six cases of a rare, severe blood clot were reported among the 6.8 million recipients was a “testament” to how seriously officials are considering patient safety.
When asked if the agency acted too quickly to call for a pause, Fauci said the agency is “internationally known for their capability for making sure we have the safest products out there,” which is why they acted out of “an abundance of caution.”
“This decision was made by the CDC and the FDA and that’s one of the things that’s such a good thing about our system here, is that we’re ruled by the science not by any other consideration so the decision was really thoroughly made by the FDA and CDC,” he said.
While some questioned whether the pause would contribute to vaccine hesitancy, Fauci noted the tens of millions of Moderna and Pfizer doses that have been administered without any issues, and said that the FDA’s swift action on Johnson & Johnson “shows they are indeed the gold standard.”
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Full Transcript
James S. Brady Press Briefing Room 4/13/2021 12:47 P.M. EDT
Psaki: Good afternoon, everyone. Well, today I’m joined by, of course, Jeff Zients, our COVID Coordinator, and Dr. Fauci to talk about the news from the FDA this morning. They’re also going to be able to take some questions. I will keep an eye on the clock.
And, with that, I will turn it over to Jeff.
Zients: Well, first, thank you, Jen, and thank you to all of you. Good afternoon.
As you all know, the FDA and CDC announced earlier today that, out of abundance of caution, they’ve recommended a pause in the use of Johnson & Johnson vaccine as they review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine.
Let me start by saying that this announcement will not have a significant impact on our vaccination program. The J&J vaccine makes up less than 5 percent of the more than 190 million recorded shots in arms in the United States to date.
The President has always said that this is a wartime effort. We’re at war against the virus. And as such, we’ve mobilized a wartime effort so that we’re prepared for a wide range of scenarios. And that’s why the President took action earlier this year, before the J&J vaccine was even authorized, to secure enough Pfizer and Moderna doses for 300 million Americans by the end of July.
Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each and every week. In fact, this week, we will make available 28 million doses of these two vaccines. And as we’ve done since we took office, we will continue to get the supply out the door as soon as it’s available.
So we have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day. And that puts us well on pace to meet the President’s goal of 200 million shots by his 100th day in office and continue to reach every adult who wants to get vaccinated.
We’re now working with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine. And we’re actually already seeing this happen today at sites across the country where J&J appointments are being adjusted, that were for today, to actually get Moderna and Pfizer today. So that’s happening in many places across the country.
The President has committed to the American people that his administration will always lead with science, tell the truth, and give Americans the facts as we know them. CDC and FDA will continue to do just that and provide regular updates to the public, and they will do so as they continue their investigation.
With that, let me hand it over to Dr. Fauci, and then we’ll take questions.
Fauci: Thank you very much, Jeff. Just to follow up a bit and maybe fill in a couple of points from what Jeff said and what our colleagues in the FDA and the CDC said earlier this morning at the press conference.
A couple of issues come up of the importance of — of calling this pause, because people say, “What does a pause mean?” It really allows both the FDA and the CDC to further investigate these cases to try and understand some of the mechanisms of what it is, some more details about the history of the individuals who were involved that might shed some light on, looking forward, what will happen and what we will do. That’s the first thing.
The other thing is to make physicians out there aware of this. And there are some clinical implications of that that I believe are important.
For example, if someone comes in with this really rather rare syndrome of thrombotic thrombocytopenia, where you get thrombosis — and when you have thrombosis, the most common way to treat that is with heparin. That would be a mistake in this situation because it could be dangerous and make the situation much worse. So there’s a clinically relevant reason why you want to make this known to people.
Also, when individuals, particularly younger women, who might come into a physician with a particular thrombotic phenomenon — which is things that happen for other reasons all the time — that we want to alert physicians to take a history of a recent vaccination. That would be important.
So the pause not only allows us to take a look at the cases and learn more, but it is also a signal out there to help the physicians.
A common question — and I’m sure we’ll have a number of questions which Jeff and I will be happy to answer to you. But one of the questions that comes up, already, rather frequently: Does this have anything to do with the efficacy of the vaccine?
So we know that there have been 6.85 million doses of J&J distributed in the United States thus far. So someone who maybe had it a month or two ago would say, “What does this mean for me?” It really doesn’t mean anything; you’re okay. Because if you look at the frame — the timeframe when this occurs, it’s pretty tight from a few days — 6 to 13 days from the time of the vaccination.
The next question is one that we’re all, obviously, aware of: “What impact is this going to have about people’s attitudes about vaccines in general?”
So you might know that there have been now 120 million people that have received at least one dose of a vaccine. Most of that — subtract the 6.85 million — is in the messenger RNA from Pfizer and from Moderna. There have been no red-flag signals from those. So you’re talking about tens and tens and tens of millions of people who’ve received vaccine with no adverse effect.
This is a really rare event. If you look at what we know so far, there have been 6 out of the 6.85 million doses, which is less than one in a million. So, remember, this is something that we always — out of a — really, out of an abundance of caution, as Jeff said, to give us the time to take a good look at it and see if we can get further information.
So I’ll stop there. Jeff and — we could obviously take some questions.
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Psaki: Okay. Mary, do you want to kick us off?
Question: You have described this as a “really rare event,” but this does seem like a pretty drastic step. Do you believe that the scientists sufficiently weighed the benefits of this pause against the damage or risk that this could do to the broader effort and the impact it could have on vaccine hesitancy?
Zients: Well, Dr. Fauci, maybe you’ll go after me. But I want to say that we have plenty of supply. So, I’d mentioned that we, for the last several weeks, have been sending 25 million doses out. And while we’re averaging 3 million shots in arms per day, the 25 million supports actually that level and even accelerating. And we just sent out 28 million doses today — or announced 28 million doses will be sent this week to states, Tribes, and territories and through our federal channels. So we have plenty of supply to continue our vaccination program and to hit our goals.
But over to Dr. Fauci.
Fauci: Yeah. I believe your question is: Did we pull the trigger too soon on this because it was such a rare event? Well, you know, the — our FDA is internationally known for their capability of making sure that we have the safest products out there. And that’s what I meant when I said “an abundance of caution.” You want to make sure that safety is the important issue here.
We are totally aware that this is a very rare event. We want to get this worked out as quickly as we possibly can. And that’s why you see the word “pause.” In other words, you want to hold off for a bit, and it very well may go back to that, maybe with some conditions or maybe not. But we want to leave that up to the FDA and the CDC to investigate this carefully. So I don’t think it was pulling the trigger too quickly.
Question: And just a logistical question more so than anything: The Advisory Committee on Immunization Practices is meeting tomorrow —
Fauci: Right.
Question: — to discuss this. Why not try to meet today? I mean, is this not a moment to sort of drop everything and focus on this?
Fauci: You know, I think you have to get people pulled together. I think tomorrow is not such a long wait. I mean, I’m sure they want to get everybody. There may be people who are not available — they want to get the full component of it.
Psaki: Alex.
Question: Can you talk a little bit about the process in both deciding for this pause and, sort of, what comes next? First off, did the White House have any advance notice of the issues with the J&J vaccine, and was there involvement from the White House in deciding this? And how do you evaluate when to pause vaccines? Are we going to see more of these pauses in the future if more issues pop up?
Zients: Why don’t you do the first part and I’ll do the second part.
Fauci: This decision was made by the CDC and the FDA. And that’s one of the things that’s, I think, such a good thing about our system here, is that we’re ruled by the science, not by any other consideration. So the decision was really thoroughly made by the CDC and the FDA.
Zients: And staying consistent with following the science, we were notified last night that there would be an announcement this morning, and therefore had no other involvement other than knowing last night that there would be an announcement this morning from the FDA and the CDC.
Question: And, in this review, what — what’s going to happen? What are they looking for? What are they evaluating? When should we expect to be a conclusion?
Fauci: Well, they want to see if there’s any clues of other things going on. Were there any underlying — for example, if they’re going to — just a hypothetical — if they’re going to make a decision to go forward and say, “You know, we looked at this.”
If they find some common denominators among the women who were involved that might be synergizing and, essentially, enabling this type of an adverse event, they may know that for those who don’t have that it may be much safer. There may be clues when you go down and really get granular about every single case.
In addition, they want to look at what some of the mechanisms are. The mechanisms may give some insight as to what is going on.
Question: And should we expect to potentially see further pauses in the future? I mean, could this keep happening with the vaccines because they’re so new?
Fauci: Well, you know, if you look at the history of — take a look at what has gone on with the Moderna and the Pfizer, where you have, you know, literally tens and tens and tens of millions that’s watched as carefully — there have been no red flags.
When you have a red flag of something that is as serious as thrombotic thrombocytopenia — particularly when you have an individual, one of whom died — you take that seriously. So I don’t think that minimal things — that very likely have nothing at all to do with the vaccine — that we’re going to pull the trigger so quickly as to keep stopping and stopping and stopping.
I think this is an unusual occurrence of a serious, adverse event that you want to make sure, before you go forward, you investigate it thoroughly. And that’s exactly what they’re doing. They’re pausing so that they can look at it more carefully.
Psaki: Weijia.
Question: Thank you. A couple for Dr. Fauci, first. It’s great to see you back at the podium, Dr. Fauci. Given that the impacted patients were all women between the ages of 18 and 48, should women under 50 be excluded from getting the J&J vaccine?
Fauci: The question you’re asking gets back to the several of the questions here. That’s the reason why the CDC and the FDA want to take a look at this and say: “Is there — are there some categories now where people outside of that categories don’t have any of the factors, so it’ll be okay to go on.”
It is entirely conceivable — making no predictions — that there may be some restriction in an age group or not. We don’t know that now. That’s the reason why they’re working very hard to answer the question you’re asking.
Question: And what’s your medical advice for people who have recently received the J&J vaccine and may be concerned about blood clots?
Fauci: Well, I mean, if someone recently — within days — I would tell them to just — first of all, don’t get an anxiety reaction because, remember, it’s less than one in a million.
However, having said that, pay attention: Do you have symptoms, headache? Do you have shortness of breath, chest discomfort? Do you have anything that resembles a neurological syndrome? And, obviously, if you have something as serious as a seizure, I mean, you know, that’s pretty clear.
But the manifestations of this are that headache is the very common component of it, because the sinus thrombosis that they have is the draining of the blood in the brain, and it will cause enough symptomatology to make you notice it. Just tell people to just watch out for not feeling very well.
Question: Thanks. And one for Jeff. Officials from different states told us, this morning, that they were really caught off guard by this announcement. They were ready to put shots into people’s arms and had to scramble. Can you explain that chain
of communication? When and how did you notify states that they might have to pause?
Zients: Right. Well as I said, we didn’t know about anything, in terms of the announcement, until last night. And we didn’t even know the content of the announcement until this morning when everyone else read it. As soon as we got that, we — our team farmed out and started contacting folks to make sure that everyone knew that that was now announced by the FDA and CDC.
Tuesday is the day that I have my regular governors call. So that was fortunate that that was at 11:00 a.m. So we had all the governors already lined up with their teams, and we had Dr. Fauci and Dr. Walensky join that call. And the teams will continue to support the statewide efforts, the federal channels, the community health centers to make the adjustments.
So I think the message got out very clearly and quickly. The — there was no heads up here. The announcement was made this morning.
Question: Thank you.
Question: Thanks, guys. Just two quick ones. First one — and you might not have the answer to this: Do we have a timeline in terms of how long this is going — are we talking days before it might get flipped back on or a week?
And second one for Jeff, if you don’t mind. I understand what you’re saying on the macro level related to supply, but when you talk to local officials, the J&J shot — because of storage, because it was one shot — it was considered a crucial component in rural areas and, kind of, underserved communities. How does that not affect the timeline that you guys are on, in terms of actually getting shots in arms?
Fauci: During one of the questions which was asked, I believe, of the CDC, the — the question was just yours. And I don’t know what they’re going to be doing. What I heard from the previous press discussion was it’s going to be more like days to weeks, rather than weeks to months.
Zients: We have plenty of supply and we have plenty of vehicles for delivering that supply — whether it’s through the federal pharmacy channel, whether it’s mobile units, community health centers — and all of those are equipped to deliver the Moderna and Pfizer vaccine. So we’ll make sure that those units continue to grow in number. Because you’re right, we need to reach people where they are. And the mobile units and the community health centers are particularly essential for those. And they have been receiving Moderna and Pfizer doses since we began both those programs.
Question: So you — it’s no different — you just swap out the vaccine if it was a mass vaccination center or if it was a mobile unit going to a rural area to (inaudible).
Zients: Yeah, the Moderna and Pfizer vaccines, as you know, are two-dose vaccines.
Question: Right.
Zients: So it’s important that people come back for their second dose three weeks post their first dose of Pfizer and four weeks post their first dose of Moderna.
But all — all of our units, all of our delivery channels are equipped to deliver both Pfizer and Moderna.
Question: And just real quick, how does this not contribute to — those of the very areas where hesitancy, I think, is most predominant at this point in time, based on what you guys have seen. Do you have to change your message? Do you have to do something different to address hesitancy in the wake of something like —
Zients: No, I think you need to continue to be transparent about what the science is telling us. This is what brings us here today. There’s — as Dr. Fauci said, there’s been tens of millions of doses of Pfizer and Moderna administered over the last several months, and millions of people, both in the U.S. and around the world, have been safely vaccinated.
I think it’s important that — you know, we have here the FDA, and the FDA is the gold standard for ensuring the safety and the effectiveness of the vaccines. And today’s action, I think, is clear evidence that they’re taking every step necessary to ensure the American people have clear and transparent information about the safety and effectiveness of these vaccines.
So, the bottom line is the vaccines — Moderna and Pfizer — that are now being administered are clearly safe and are saving lives, and every American should get vaccinated when it’s their turn.
Psaki: Jordan.
Question: Thanks. Jeff, is the — is J&J production going to continue during this pause? And secondly, is the Biden administration considering ordering more doses of Pfizer/Moderna given — just in case this problem with J&J becomes prolonged?
Zients: So, the J&J production issues in Baltimore — obviously, a completely separate set of issues, and those are being worked out through the FDA process with the company. And production of those vaccines can begin if and when the FDA authorizes that facility.
Your second question was — you know, we really have thought of this as a wartime effort from the beginning, which is why we purchased excess supply so that we’d be ready for any contingency. And we’ll continue to look at every possibility, in terms of making sure that we always have enough supply for the American people.
Question: But just to clarify, on the J&J production — not related to the Baltimore plant, but just overall J&J production — is that going to pause while this pause on administering doses occurs or is the production going to continue?
Zients: Well, the production is really centered around that Baltimore facility. The vast majority of the production is that Baltimore facility.
Psaki: Andrea.
Question: I just want to — Jeff or Dr. Fauci — I want to just ask you very directly: Are you ruling out the possibility that the vaccine could be removed from the market? I mean, are you ruling out that — are you expecting it to be reallowed?
Zients: Dr. Fauci.
Fauci: You know, I think it would be premature to comment on that. And that’s the reason why the pause was done, so that they can take a good look at it very carefully, look at every different factor.
I wouldn’t want to speculate as to what — what would happen. Often, when you see things like this — that you pause and come back. Whether or not that happens now, I can’t guarantee it, but I can tell you that’s exactly what the CDC and FDA people are going to be deciding on and looking at very carefully.
Question: And then if I could just ask you on this outreach question. So, you know, this is the problem that you’ve been struggling with — the, sort of, vaccine hesitancy. This obviously is a setback. How — what — do you have to, sort of, ramp up into an additional war-type effort to really ensure that this message gets out there? Do you personally go to place — states like Mississippi, where the vaccine vaccination rate is really low?
Zients: Well, let me answer your first question, and then I’ll — you know, we — consistent with it being a wartime effort, we’ve planned for different scenarios and different contingencies.
So, we have enough supply of Moderna and Pfizer to hit the targets that we’ve set: the 200 million shots in 100 days and to head toward the Fourth of July that we’ve talked about as a country — a more normal Fourth of July.
Clearly, part of that is making sure that when it’s an American’s turn to get vaccinated, they get vaccinated, and we do need to continue to build confidence. And that’s done at the community level. People are trusting of their local doctors, their faith leaders, their neighbors. The why — which is why it’s important when people do get vaccinated, they not only get themselves vaccinated, but they spread the word about the safety and effectiveness of the vaccines.
Psaki: Steven.
Question: Just to nail it down, Jeff, one of the goals that you haven’t mentioned today is the hope that there’ll be enough supply on hand for the country by the end of May. Is that still operative now, in the wake of this pause?
And the second question is, it’s a bit surprising to learn that you only, yourself, learned about this this morning. Do you wish you had heard sooner?
Zients: I learned about it last night that there would be an announcement, not the specifics of the announcement. No, because that’s to the science, and we want the science agencies to lead with science, and there’s no reason for us to be involved in any of the scientific decisions. We bring nothing to the table. That is the FDA’s role; that is the CDC’s roll. And they’re led by terrific leaders with great teams to do the science, and this administration will be led by science.
And as to your first question, we believe there’s enough vaccination — there’s vaccine in the system, Moderna and Pfizer — for all Americans who want to get vaccinated by May 31st to do so.
Psaki: Hans.
Question: Jeff, I feel like we’re kind of dancing around the hesitancy question here, and so I just ask you directly: Do you think the announcement of this pause will increase or decrease vaccine hesitancy?
Zients: Look, hesitancy amongst a group of people is a challenge, and we need to be addressing it — and we are, as I talked about — by going to meet people where they are, to follow all that we’ve learned about who people trust: doctor — their local doctor, their nurse, their faith leader.
And I think that, you know, there’s tremendous track record, as Dr. Fauci has talked about, with tens of millions of doses of Pfizer and Moderna. The FDA, acting the way they did today, shows that they are indeed the gold standard. And I think that should reassure the American public that they will be very diligent and conservative in how they approach the vaccines.
Question: So the argument is that because the FDA — this tripwire was triggered, that should give Americans more confidence in the overall vaccination plan?
Zients: Certainly about — around how safety and efficacy are being monitored by the gold-standard folks at the FDA.
Psaki: Okay, let’s do these three more, and then we’ll let them go back. Go ahead.
Question: Jeff, you said the FDA is the gold standard for ensuring the safety and efficacy of vaccines. To what extent does today’s news add urgency to the effort of getting a permanent nominee confirmed to head the FDA? You know, clearly, it’s always an important post, but how much of a spotlight does this news now (inaudible)?
Zients: I have no personnel announcement to make today. The FDA has an extraordinary group of scientists and experts that lead these types of efforts.
Question: How helpful would a permanent director be in those efforts though?
Zients: I think that the FDA does an extraordinary job, and the teams that are — that are addressing these issues are experienced teams. In fact, the acting director is a very experienced leader. So I would — I think the experience at the FDA and the expertise at the FDA is indeed the gold standard.
Psaki: Go ahead.
Question: Are there any immediate plans to accommodate the states because of this pause? And can you guarantee that every person who had a reservation cancelled will get rescheduled in a matter of days?
Zients: Yeah, as I said, there’s — I think there’s already, in certain locations, people who are scheduled for today are already rescheduled. So we’ll do anything we can to support the states on the logistics of rescheduling.
And, you know, at the same time, the most important thing is that the supply exists to continue to vaccinate 3 million Americans a day. And there’s enough supply to actually accelerate that. There’s tens of millions of doses in the system. And as I said, today we announced 28 million more Moderna and Pfizer doses are available to be ordered this week.
Psaki: Last question.
Question: Dr. Fauci, you said that there was no red flags with the other two vaccines. This might — this question might be asking you to state the obvious, but can you verify that means that there were no developments of blood clots — symptoms in the recipients of those vaccines?
Fauci: There have been no serious events to call attention to anything that would relate to a pause.
Question: And why would it be in — why would (inaudible) one vaccine, but not the other two? And how does that speak to the safety of the other two vaccines?
Fauci: I think, you know, when you examine everything in general, the fact that you’ve — have, you know, 120 million doses — individuals have received at least one dose, and as you subtract, out of that 121 million, 6.85 [million], you’re talking about, you know, 114-or-so million individuals have received at least one dose and no negative red fails [sic] — red flag signals, that tells you you’re dealing with a really safe vaccine.
And I think, you know, apropos of several of the questions that people asked about hesitancy, you know, when you want to talk about safety, this is an extraordinary safety record that the others have. And the fact that a pause was done I think just is a testimony to how seriously we take safety and why we have an FDA and a CDC that looks at this very carefully.
And hopefully, we’ll resolve it pretty soon — within days to weeks apropos of your question. So I think it’s a very strong argument for safety, actually.
Psaki: Thank you, Dr. Fauci. Thank you, Jeff. Really appreciate you taking the time.
Zients: Thank you. Thank you, everybody.
Question: Thanks, guys.
Question: Thank you.
Zients: Thank you.
Question: Come back again soon.
Psaki: (Laughs.) They’re always welcome. Always welcome.