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FDA advisers recommend Moderna booster shot for at-risk adults

SARAH MCCAMMON, HOST:

Today, the FDA's vaccine advisers recommended that the agency authorize booster shots for the Moderna vaccine for people at high risk of COVID-19. The vote was unanimous, and it came after a full day of discussions on the safety and efficacy of booster shots. NPR's Pien Huang monitored the meeting, and she joins us now. Hello.

PIEN HUANG, BYLINE: Hey, Sarah.

MCCAMMON: So first, tell us about this committee and their decision today.

HUANG: Yeah, so this is a committee of outside advisers to the FDA. There are 19 voting members, mostly doctors, immunologist, infectious disease experts. And they were tasked today with looking into how safe and effective a Moderna booster shot would be. Their recommendation at the end of the day was to say, Moderna booster shots should be available to those 65 and older, those with underlying conditions and those whose jobs or living situations mean that they're going to potentially be exposed to a lot of COVID. They also said that it should be given at least six months after the last shot. This is basically the same recommendation they made last month for the Pfizer booster. And one difference between them is that the Moderna booster would be a half dose of the current shot - 50 micrograms instead of 100 - where Pfizer's booster is a full dose.

MCCAMMON: OK, so does this vote mean that everyone who got the Moderna vaccine now needs a booster shot?

HUANG: Well, it's not that clear-cut. I mean, most people who are fully vaccinated with the Moderna vaccine are still highly protected from getting hospitalized or dying from COVID. And what the panel saw today was that a Moderna booster might add some additional protection for getting breakthrough infections from the delta variant. This could be especially helpful for people who are older or at higher risk of severe COVID. Here's how committee member Eric Rubin, editor in chief for the New England Journal of Medicine, summed it up.

(SOUNDBITE OF ARCHIVED RECORDING)

ERIC RUBIN: The data are not perfect, but these are extraordinary times, and we have to work with imperfect data.

MCCAMMON: And so, Pien, how did these advisers come to this unanimous vote? What was this based on?

HUANG: Well, some of the most compelling evidence shared today was actually by researchers from Israel's Ministry of Health. They gave an update on their experience with the Pfizer booster. And I know that's not the Moderna vaccine, but it uses the same kind of mRNA technology. But Israeli researchers were totally convinced that giving out booster doses helped dampen infections and severe cases, effectively curbing their most recent wave of infections, which came from the delta variant. Now, here in the U.S., cases are declining without the widespread use of booster shots, but the panel's bottom line was that giving out a booster shot for the selected groups seems to be worth the risk. It might do some good in terms of preventing infections and disease spread, and so that's why they recommended - decided to recommend their use today.

There are still a few steps before Moderna boosters would be widely available. You know, the FDA still needs to accept this recommendation and authorize it. The CDC will meet next week and make their recommendations. So if all goes smoothly, Moderna boosters could be available by the end of next week.

MCCAMMON: Yeah, so that's Moderna. Pfizer boosters are already widely available. What about Johnson & Johnson?

HUANG: Well, Johnson & Johnson is what the FDA committee is all about tomorrow. The conversation could be pretty interesting because Johnson & Johnson wants to boost their one-shot vaccine with a second dose of the same shot, but there are some studies from the U.S. and Europe which show that it might actually be better for people who got the J&J vaccine to get a second dose of a different shot, like Pfizer or Moderna. That seems to lead to higher antibody levels and possibly better protection against COVID. So the question for tomorrow is - how will the FDA handle the J&J request? Will they try to limit the discussion to what the company has applied for? Could they recommend a different booster course? That's something I'll be watching for closely tomorrow.

MCCAMMON: Thanks so much for following all of this. That's NPR's Pien Huang. Thanks so much.

HUANG: Thanks for having me. Transcript provided by NPR, Copyright NPR.