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