FDA Adviser: Vaccine To Be OK'd In Days, But 'Normal' May Not Return Until Next Fall

Dec 11, 2020
Originally published on December 14, 2020 6:27 am

The Food and Drug Administration's authorization of a COVID-19 vaccine could come within a day or two, a member of an FDA panel of experts that recommended an OK for the vaccine said Friday. But Dr. Paul Offit, a member of that panel, cautioned it could be next fall before life gets back to normal after the pandemic.

That fall prediction would depend on two-thirds of the American population getting the vaccine, he told NPR's Morning Edition.

"The problem is logistics," Offit said. "It's a matter of making the vaccine and distributing it. It's making sure people get it, that they aren't sort of swayed by ... what is a lot of misinformation that surrounds not only this vaccine but all vaccines. That's going to be the hang-up.

"I probably shouldn't make any predictions because you're invariably wrong with this virus when you make predictions. But I really do think that by next fall we could have life back to normal," said Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

On Thursday, the advisory panel voted 17-4, with one abstention, to recommend that the COVID-19 vaccine being developed by Pfizer and BioNTech be authorized for emergency use.

Offit, who was one of the yes votes, said there is "clear evidence that the vaccine is highly effective." But he said a closer look is needed into what is causing allergic reactions to the vaccine in some people who have begun receiving it in the United Kingdom.

Here are highlights of the interview, edited for length and clarity:


Interview Highlights

Why did you vote to recommend this vaccine be authorized?

Because I think we have clear evidence that the vaccine is highly effective at least three months after getting the first dose. And then given the other data they presented, I think it's likely to be effective for much longer. We know that the vaccine's been given to tens of thousands of people safely. So we can say, at least with comfort, that it doesn't cause an uncommon, serious side effect. And that doesn't mean it doesn't cause a very rare serious side effect. We'll find that out post-approval. But I think we know enough. When you agree to move forward with a product, it's not whether you know everything. It's whether you know enough to say that the benefits outweigh what at this point are theoretical risks.

Two people in Britain who got the vaccine had allergic reactions and they recovered. Britain's medical regulators told people with a serious history of allergic reactions that they should avoid the vaccine while officials investigate what happened. What should we make of that news?

I think we need to look a little closer at those; I think now three people in the United Kingdom had a serious allergic reaction following the vaccine. I think we need to figure out what specifically about that vaccine was causing them to have a problem. Was there anything specifically in their history that would give us a clue as to why they had a problem? I think by the U.K. public health group saying that anyone with a serious allergic reaction shouldn't get this vaccine, I think that was a little premature. There are tens of millions of people in the United States who carry EpiPens because they have allergies to, say, peanuts or to eggs. And I think this probably doesn't apply to them. And so I think we need to know more first.

We've also heard reports of short-term side effects from the vaccine. These are brief symptoms. They can last about 12 hours or so. What would you say to people who might be concerned about those symptoms?

Be honest. Tell them that they could have fever, including rarely high fever, fatigue, headaches, chills, muscle aches, joint pain, enough so that one could miss a day of work. Very similar, actually, to the shingles vaccine Shingrix, which also has a similar side-effect profile. But that's just your immune system being vigorous and working for you. In many ways it's a good thing. But you can't have people surprised by this because it is actually a fairly common problem. And as much as half of the recipients, especially after dose two, and more common in people less than 65.

You are the co-inventor of a rotavirus vaccine that took 26 years to develop. If you look at the speed at which this vaccine was developed — less than a year — are there drawbacks to that? Are there things about this that worry you?

Well, the world came together and got it done. I mean, what the United States did was they took the risk out of it for pharmaceutical companies. The United States government was willing to put forward [billions] to take the risk out of it for pharmaceutical companies by saying we'll pay for phase three trials, we'll pay for mass production at risk — meaning not knowing whether it works or not knowing whether it's safe. No pharmaceutical company would ever do that. ... The only thing that that's different now in terms of these big phase three trials is that you don't have a long time of follow-up for efficacy. So you can only say that this vaccine is effective for three months. And I think it's 95% effective after three months. It's extremely likely it's going to be highly effective after six months or a year or two years.

One of President-elect Joe Biden's goals is to distribute 100 million vaccine shots in the first 100 days of his administration. Does that sound doable to you?

It's going to be up to the companies. You know, it's not easy to mass-produce these products. It's not so much the messenger RNA, per se, which is synthetic and can be fairly easily scaled up. It's the lipid nanoparticle, that so-called little fatty droplet in which the messenger RNA sits. It's not easy to scale that up. And I think that's when there [are] hang-ups, and there was a recent hang-up with Pfizer, that's usually the problem.

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NOEL KING, HOST:

Eleven months ago, Pfizer and BioNTech started work on a COVID-19 vaccine. Yesterday, a group of experts looked at the data about that vaccine and considered this question - do the benefits of the vaccine outweigh its risks for use in people aged 16 and older? Now, those experts voted yes by a 17-4 margin. One abstained. The FDA will now consider whether to move forward with emergency use of the vaccine for a virus that has killed more than 1 1/2 million people around the world.

Dr. Paul Offit is one of the experts who's advising the FDA. He's the director of the Vaccine Education Center at Children's Hospital in Philadelphia. Good morning to you, sir.

PAUL OFFIT: Good morning.

KING: You were one of 17 yeses. Why did you vote to recommend this vaccine be authorized?

OFFIT: Because I think we have clear evidence that the vaccine is highly effective at least three months after getting the first dose. And given the other data they presented, I think it's likely to be effective for much longer. We know that the vaccine's been given to tens of thousands of people safely. And so we can say at least with comfort that it doesn't cause an uncommon, serious side effect. And that doesn't mean it doesn't cause a very rare serious side effect. We'll find that out post-approval. But I think we know enough. You know, when you agree to move forward with a product, it's not whether you know everything. It's whether you know enough to say that the benefits outweigh what, at this point, are theoretical risks.

KING: A question that has everyone on a knife's edge at this point - and I do mean everyone. How long do you think it will take the FDA to make a decision to authorize this vaccine and to get it out there to the American people?

OFFIT: I would think it would be in a day or two.

KING: A day or two. OK. I want to ask you about some of the concerns. Four people did vote no yesterday. And I don't know why exactly, but I'll tell you some of the concerns our science correspondents here at NPR have brought to our attention. Two people in Britain got the vaccine. They had allergic reactions, and they recovered. Britain's medical regulators told people with a serious history of allergic reactions that they should avoid the vaccine while officials investigate what happened. What should we make of that news?

OFFIT: I think we need to look a little closer at those, I think, now three people in the United Kingdom who had a serious allergic reaction following the vaccine. I think we need to figure out what specifically about that vaccine was causing them to have a problem. Was there anything specifically in their history that would give us a clue as to why they had a problem? I think by the U.K. public health group saying that anyone with a serious allergic reaction shouldn't get this vaccine, I think that was a little premature. There are tens of millions of people in the United States who carry EpiPens because they have allergies to, say, peanuts or to eggs. And I think this probably doesn't apply to them. And so I think we need to know more first.

KING: Do you think additional studies on the vaccine are needed, maybe just targeting those millions of people who carry EpiPens?

OFFIT: Yes, I think that's where so-called post-marketing or phase four studies - you need to take a group of people, say, who have severe egg allergies or severe peanut allergies and, in a controlled way, see whether there's any component to that vaccine that they would have an allergic reaction to. And if they don't, then you can make those people feel much better 'cause you're talking about tens of millions of people not getting this vaccine under that current recommendation.

KING: OK. We've also heard reports of short-term side effects from the vaccine, including fever, aches and fatigue. Now, these are brief symptoms. They can last about 12 hours or so. What would you say to people who might be concerned about those symptoms?

OFFIT: Right. Be honest. I mean, tell them that they could have fever, including really high fever, fatigue, headaches, chills, muscle aches, joint pain - enough so that one could miss a day of work - very similar, actually, to the shingles vaccine Shingrix, which also has a similar side effect profile. But that's just your immune system being vigorous and working for you. In many ways, it's a good thing. But you can't have people surprised by this because it is actually a fairly common problem in as much as half of the recipients, especially after dose two, and more common in people less than 65.

KING: Let me ask you a bigger-picture question. You're a vaccine expert, and I read that you are the co-inventor of a rotavirus vaccine that took 26 years to develop. I wonder if you look at the speed at which this vaccine was developed, less than a year. Are there drawbacks to that? Are there things about this that worry you? Or can we look at this and say, the world came together and got it done?

OFFIT: Well, the world came together and got it done. I mean, what the United States did was they took the risk out of it for pharmaceutical companies. The United States government was willing to put forward roughly $24 billion to take the risk out of it for pharmaceutical companies by saying, we'll pay for phase three trials; we'll pay for mass production at risk, meaning not knowing whether it works or not knowing whether it's safe. No pharmaceutical company would ever do that. So I think that's why it's safe. As long as you do a big phase three trial, which was done in this case, for Pfizer, 44,000, for Moderna, 30,000, that's good.

The only thing that's different now in terms of these big phase three trials, which are as big as any pediatric vaccine, is that you don't have a long time of follow-up for efficacy. So you can only say that this vaccine is effective for three months. And I think it's 95% effective after three months. It's extremely likely it's going to be highly effective after six months or a year or two years.

KING: One of President-elect Joe Biden's goals for the first 100 days of his administration is to distribute 100 million vaccine shots. So 100 million vaccine shots in 100 days - does that sound doable to you?

OFFIT: That's going to be up to the companies. You know, it's not easy to mass produce these products. It's not so much the messenger RNA, per se, which is synthetic and can be fairly easily scaled up. It's the lipid nanoparticle, that so-called little fatty droplet, in which the messenger RNA sits. It's not easy to scale that up. And I think that's - when there's hang-ups - and there was a recent hang-up with Pfizer - that's usually the problem. It's this so-called lipid nanoparticle.

KING: OK, OK. So it will depend on what the companies can do, not necessarily the logistics.

The data shows that this vaccine is 95% effective. When you think about what kind of difference this could make in the pandemic, what comes to your mind? Do you envision, as we've heard other health experts say, potential return to normal life by this summer, summer of 2021?

OFFIT: If we can vaccinate about two-thirds of the American population with this vaccine, I think that we can be back to normal by sort of next fall. That's what I would say. And the problem is logistics. It's a matter of making the vaccine. It's distributing it. It's making sure people get it, that they aren't sort of swayed by, you know, what is a lot of misinformation that surrounds not only this vaccine, but all vaccines. That's going to be the hang-up. But I'm going to predict that by - and I probably shouldn't make any predictions because you're invariably wrong with this virus when you make predictions. But I really do think that by next fall, we could have life back to normal.

KING: And as we close in on this milestone of getting a COVID vaccine, having done it with historic speed, what message do you have for Americans, many of whom are sad, depressed, isolated, financially strapped? It seems like this is an opportunity to see a silver lining. What do you want to say to people?

OFFIT: I think help is on the way in a couple of ways. First of all, this vaccine, I think, is going to be a powerful tool in stopping the spread of this virus. We now have an administration that is embracing science, that's embracing another powerful tool we have, which is masking and social distancing. And I think those two things together make me see the light at the end of the tunnel. I think the next two months are going to be hard with, you know, the weather being what it is, which is dry and cool, which allows for easy spread of this virus, Christmas coming up, the fact that it's going to take a while for vaccines to get out there. I do think it's going to be a rough couple of months, but I think we are going to emerge from this, I do.

KING: Thanks, Dr. Offit.

OFFIT: Thank you.

KING: Dr. Paul Offit is a member of the FDA's vaccine advisory panel, and he's director of the Vaccine Education Center at the Children's Hospital of Philadelphia. Transcript provided by NPR, Copyright NPR.