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Former FDA Scientist Says More Data Is Needed On COVID-19 Booster Shots

MICHEL MARTIN, HOST:

We're going to spend a few minutes digging into the controversy over booster shots for the COVID-19 vaccine. Yesterday, a committee of experts appointed to advise the Food and Drug Administration voted overwhelmingly against recommending a third shot of the Pfizer vaccine for people aged 16 and up. The same advisory panel did recommend a Pfizer booster shot for those 65 and older as well as others considered to be at high risk of severe disease, including health care workers and people with underlying health conditions.

The panel's recommendation isn't binding, but it does cloud the way forward for the Biden administration, which last month announced a broad rollout of booster shots starting as early as Monday. The administration has committed to following scientific advice on such matters, so it would have to defend a decision to bypass these experts if it went ahead with its plan now. But the public health community is itself divided over all this, with some arguing the focus should remain on those who aren't vaccinated at all, including those around the world whose access to vaccines has been limited or nonexistent.

But others say boosters are warranted because the efficacy of these vaccines wanes over time. As we said, there's a range of opinion. But now, we're going to give the floor to Dr. Luciana Borio. She previously served as acting chief scientist at the FDA and is now with the Council on Foreign Relations.

Dr. Borio, welcome. Thank you so much for joining us.

LUCIANA BORIO: Thank you for having me. It's a pleasure to be with you today.

MARTIN: First of all, just - what's your take on the FDA advisory committee's recommendation yesterday? What do you think?

BORIO: Yeah. So the advisers made a very sensible decision by recommending that the vaccine - the boosters be made available to a subset of the initial population that was proposed, the elderly, the ones that are most vulnerable to complications from COVID. And I think it also shows that the process really worked, that there was a very fulsome scientific debate on the merits about the proposed plan. And I was really pleased to see that discussion taking place in a transparent public manner.

MARTIN: Can you just describe in layperson's terms what you think led the committee to this recommendation and to disagree for now with the idea of a broader rollout?

BORIO: Sure. So - and first, it's important to recognize that the number of studies and the nature of studies are really, really complex, these are complicated studies and that it's not unusual for experts to disagree. That's very natural and is the - that's how, you know, the scientific process works, that we have these debates. But the gist here is that these are observational studies, and they are really complicated to interpret.

And the studies that were - one of the big weighted study is the one coming out from Israel, very important study from Israel. And the conclusions from this study really is that one, well, maybe they are correct and maybe Israel is ahead of the U.S. and that we're going to be seeing here in the U.S. an erosion in the protective efficacy of the vaccines against severe disease and hospitalization or maybe the - studies in the Israel are really solid but there are fundamental differences between how our society behaves and interacts from Israel's. So maybe the studies there are not fully generalizable to the U.S.

The bottom line is that the data today do not support that boosters are needed for the general population, and the studies in Israel have a very, very short duration of follow-up, about two weeks of follow-up after the booster. So of course, it's very natural to see protection against infections shortly after a booster. But the advisers really want to see whether this protection is sustained. And importantly, they want to see whether the benefit is there for younger people, given the concerns for myocarditis that were revealed in the rollout of the vaccine, globally.

MARTIN: Well, so that the panel had a civil discussion. I mean, nobody was throwing pens at anybody or anything of that sort. But it seems that the debate has gotten fairly heated. Would you say that's a fair characterization? Or is it that debates over vaccines are normally contentious? We just don't focus on it. We just don't tend to see it.

BORIO: I think that's right. I think that the staff that does that day in, day out have worked together for decades. I began my career at the FDA in the Office of Vaccines. They're not experts in biologics and medical product and drugs. They're focused on vaccines, and there's a whole science around that. And they do take their jobs very, very seriously because we're giving a product to a population that is healthy to begin with, so safety considerations really matter. They're weighted heavily, and they expect to see, you know, very solid data that has been thoroughly reviewed and analyzed by their staff before making a decision that is so consequential.

MARTIN: Well, as I said earlier, President Biden - along with his advisers, like the surgeon general, for example - had put forward this plan to roll out booster shots before the FDA met to review the issue. Do you think that the president and his advisers kind of got over their skis on this as it were?

BORIO: I think that's the - a broadly accepted assessment of what happened. And I think they were right to, you know, plan with urgency for the potential rollout of boosters. I think that's very defensible. And also, there is a need to proceed urgently with collecting more data and to reviewing the data. But at this moment, there's no urgency to really roll out or deploy the boosters until there is more data and more thorough evaluation by the scientists at the FDA the CDC and their advisors.

MARTIN: You're saying earlier that there are discussions. There are rigorous debates about vaccines normally. But I'm wondering how you see all this talk about boosters in public. Is this a net positive or a net negative? On the one hand, as you said, people with expertise sometimes disagree. And you've applauded the transparency of it. On the other hand, we still have vaccine skepticism. So this a net positive or net negative that we're having this very public debate over the efficacy of a third booster shot?

BORIO: Yes, from experience, I learned that not having the transparent process, not airing the debate doesn't really help with vaccine hesitancy. It only increases. So we have a certain baseline of hesitancy, and it's only made worse if there's an attempt to have these discussions behind closed doors. And, you know, I think that the big message out of all of this is that these vaccines are incredibly safe and effective. And the best way to protect us all individually and collectively is to get more people vaccinated, especially the unvaccinated. They're driving this pandemic. And I fear that, you know, the discussion on boosters has somehow overshadowed the most important message, which is to get more people vaccinated here and globally.

MARTIN: That was Dr. Luciana Borio, former acting chief scientist at the Food and Drug Administration. Dr. Borio, thank you so much for sharing your expertise with us today.

BORIO: It's my pleasure. Thank you. Transcript provided by NPR, Copyright NPR.