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FDA advisers all voted to recommend clearance for a Johnson & Johnson boosterExBulletin

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The FDA advisory committee met to discuss the best way forward to improve immunity against the delta variant for people who have received the Johnson & Johnson vaccine.



AILSA CHANG, HOST:

I’m Ailsa Chang in Los Angeles with today’s boosters developments. FDA advisers have voted to recommend a booster dose for anyone who has received the Johnson & Johnson COVID vaccine. They say it could help improve the immunity of the 15 million people who received this injection. And here to tell us more is NPR health reporter Pien Huang.

Hi, Pien.

PIEN HUANG, BYLINE: Hi, Ailsa.

CHANG: Okay. So tell us more about this recommendation from FDA advisers today.

HUANG: Yes. So the 19 members of the FDA’s vaccine advisory committee voted to recommend a second injection of the J&J vaccine. And that’s for anyone 18 and over who’s ever had the vaccine, and it should happen at least two months after getting that first shot. Thus, a second injection was recommended because the J&J vaccine was less effective than the Pfizer and Moderna vaccines, and getting a second dose could bring it to a similar level.

Now there are open questions as to whether the second injection should be considered a booster injection or just part of the main course. For example, should the J&J vaccine just be a two-dose vaccine? There are also questions about the timing of this second shot. Like, maybe waiting up to six months later could boost immunity even more. But overall, the vaccines committee looked at the evidence and said people who have received the Johnson & Johnson vaccine should receive a second injection at least two months after so that they are better protected against COVID illnesses. .

CHANG: And what about the evidence these advisers looked at? Like, how did they come to that conclusion?

HUANG: Well, the decision ended up being unanimous, but there were some real twists in today’s meeting to make it happen. It started this morning with a presentation from Johnson & Johnson, and they argued that their vaccine was holding up well. Some studies, they said, show that the immunity is long-lasting and works against the delta variant. And then FDA official Peter Marks stepped in and said that wasn’t the whole story.

PETER MARKS: There is data to suggest that the efficacy of this vaccine is actually less robust than the company’s presentation here.

HUANG: CDC committee member Amanda Cohn says their data shows the J&J vaccine just wasn’t as protective as the Pfizer or Moderna vaccines, the so-called mRNA vaccines. In fact, in the United States, the J&J vaccine was only 68% successful in preventing people from being hospitalized with COVID.

AMANDA COHN: Which is both lower than what we saw in this presentation on real-world efficacy, and it’s also considerably lower than mRNA vaccines.

HUANG: By comparison, Moderna was over 90% effective. The bottom line here is that the J&J vaccine was less effective than Pfizer or Moderna to begin with, and there is still a gap. So the panel’s recommendation now is that anyone 18 years of age and over who has received one dose of the J&J vaccine should get another. Now that’s different from the recommendation they made yesterday for the Moderna booster. This was limited to those 65 and over and others at high risk of contracting COVID.

CHANG: Right.

HUANG: And that’s partly because the first two doses seem to hold up well in most people for the Moderna shot.

CHANG: I also understand that there was some discussion at today’s meeting about mixing and pairing boosters. Is it correct?

HUANG: Yeah, that’s right. There was the presentation of a government-funded study today which appears to show that following the J&J vaccine with one injection of mRNA, especially Moderna, might be better than receiving another injection of J&J and that it can sometimes produce high levels of antibodies. This is not a formal recommendation at this time. The caveat is that the study is small and ongoing. Still, committee member Ofer Levy, a professor at Harvard Medical School, says the results are important because they can help people make more informed decisions.

OFER LEVY: Many Americans are taking matters into their own hands. And I read in the media that people get boosters or mix different products. And so in the real world, all of those extra combinations or boosters are already happening.

HUANG: The committee didn’t vote on mix-and-match boosters today, but it looks like the FDA could give the CDC some leeway to make recommendations. So there’s more to come next week, especially next Thursday, when the CDC’s Vaccine Advisory Committee takes care of it.

CHANG: It’s NPR’s Pien Huang.

Thanks Pien.

HUANG: Thanks Ailsa.

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