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Is The Pause In The Johnson & Johnson COVID-19 Vaccine Warranted?

STEVE INSKEEP, HOST:

Let's look more closely at the pause in giving the Johnson & Johnson COVID vaccine. Federal health agencies advised that pause after a rare clotting disorder, blood clots, were found in six recipients; one of them died. Those affected, all of whom were women, were among about 7 million people in the United States who have received the J&J shot, so these cases are very, very rare.

We've called Dr. Scott Gottlieb. He is a former head of the Food and Drug Administration and also, we should mention, a member of Pfizer's board. Of course, Pfizer has its own vaccine. Dr. Gottlieb, good morning.

SCOTT GOTTLIEB: Good morning.

INSKEEP: Was the pause on J&J the right call?

GOTTLIEB: Well, look; I'm not in possession of the information that the agency has, so I think that, you know, we have to give them the benefit of the doubt in terms of what they're seeing. And what they're seeing is cases that appear similar to what we observed with the AstraZeneca vaccine of a very rare clotting disorder where you basically get destruction of the platelets and you develop these rare clots. And so, obviously, the FDA thinks that there could be a relationship to the vaccine. And I think what they're aiming to do with this pause is elicit more reporting, gather more information if there are more cases out there, instigate doctors and patients to report those cases and, if this is related, not have more cases accrue because there's a lot of vaccine going into the market right now. And so you run the risk that as you're investigating this, more cases will accrue and more patients could potentially be harmed.

Now, I don't believe that this will be permanent. I think this is probably a temporary pause where the agency is going to evaluate the information it has, see if there is more cases out there to be reported to the agency, perhaps issue some guidance around the use of the vaccine and what doctors should be alert for and then allow the vaccine to continue to be distributed. And in fact, as you know, there's the advisory committee meeting today.

INSKEEP: Yeah, I'm thinking about the public health messaging here. Obviously, this sends a message that they are being very cautious and looking at even the smallest concern with these vaccines. And, of course, it's not a small concern at all for the six people who were affected, but it was literally a one-in-a-million event, a little less than a one-in-a-million event. And I assume this pause means that distorted message is going to get to some people that the vaccine is unsafe. When you're a public health official, as you once were, how do you weigh those factors to make sure you're not doing more harm than good?

GOTTLIEB: Look; it's very hard, but I think that we're in a different risk-benefit environment right now, at least from the agency standpoint. I think that's probably how they're looking at this in terms of a lot of Americans have been vaccinated. There's other available vaccines. You mentioned I'm on the board of Pfizer, which has one marketed vaccine. And so they're going to be aggressive when they see safety signals. I think that this is an indication that the agency is collecting information and valuing and acting on it very quickly. So that's probably reassuring to a lot of consumers. But you're right, the action could look dramatic to a lot of people, a pause as opposed to an advisory. They might have been able to accomplish some or a lot of the same things from just an advisory to physicians about the side effect. And so, you know, some people could look at this and feel that this is dramatic. But I think that the fact that they're bringing it quickly before the advisory committee, they're likely to issue some updated guidance today. And I think it's more likely than not that there's going to be a resumption in the use of the vaccine for some portion of the population. That should be reassuring to the public, that whole process.

INSKEEP: And is it likely that where we go with this then is that the vaccine use resumes but physicians are advised to keep an eye on this, patients are advised to keep an eye on this?

GOTTLIEB: I think that that's right. I mean, it depends, of course, on what additional information comes into the agency. And again, I think part of the exercise that they're going through, the effort that they're making here, is to try to elicit more reporting from physicians, as well as get more information out to doctors on what to be monitoring for and how to treat these conditions if they arise. But assuming they don't get, you know, a plethora of additional reports that could be related to this condition that they're monitoring, I think it's likely that this is going to go forward.

INSKEEP: Dr. Gottlieb, I got a chance to take somebody to a mass vaccination site yesterday. She got her shot. And it was one of those things that's set up, like, in a big kind of coliseum, an arena. And I don't want to say nobody was there. It was busy. People were coming and going, but it was a small fraction of the capacity of that particular location. How concerned are you - now that we're well past 100 million people who've gotten at least one shot, how concerned are you that the remainder of the population won't get there?

GOTTLIEB: I've been concerned for a while that we're going to have more supply than demand probably heading into the end of this month, certainly as we get into May. I think that there's probably 150 million Americans who are eager to get vaccinated. And as we expand into, you know, the younger age cohorts and a new eligible population, there's going to be some, you know, immediate demand. And we're seeing that right now. But after we work that off, I think when we start to get into younger people and we vaccinate a lot of the over-65 cohort - as we get into younger people, you're not going to see the demand be as brisk. I think we get to 150 million vaccines. I think we struggle to get to 160 million. Beyond that, I think it's going to be difficult. I'm not sure that you have the demand there. Remember last year, we delivered 125 million flu vaccines. That was an all-time record in terms of flu vaccination. That's really your target market. We're going to get beyond that with the COVID vaccines, but I don't think we're going to get measurably beyond that.

INSKEEP: Is 160 million, which is about half the population, enough for herd immunity?

GOTTLIEB: Well, it's not enough for classic herd immunity. I don't know that we ever get to herd immunity, but I think the combination of vaccinating that many people and having a lot of immunity in the population from prior infections, enough that the level of spread of this virus is going to be substantially reduced.

INSKEEP: You just said, I don't know if we're going to get to herd immunity, which is a discussion for another time. Wow. Dr. Gottlieb, thank you very much.

GOTTLIEB: Thanks a lot.

INSKEEP: Dr. Scott Gottlieb is a former head of the Food and Drug Administration. Transcript provided by NPR, Copyright NPR.