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FDA Advisors Recommend Moderna Recall For At-Risk AdultsExBulletin

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The Food and Drug Administration’s vaccine advisory committee met on Thursday to determine whether a Moderna booster is safe and helpful in the country’s fight against COVID-19.



SARAH MCCAMMON, HOST:

Today, FDA vaccine advisers recommended that the agency allow booster shots of 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 effectiveness of booster injections. Pien Huang from NPR monitored the meeting, and she is joining us now. Hello.

PIEN HUANG, BYLINE: Hi, Sarah.

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

HUANG: Yeah, so it’s a committee of external FDA advisers. There are 19 voting members, mostly physicians, immunologists, and infectious disease experts. And they were tasked today with determining how safe and effective a Moderna recall would be. Their recommendation at the end of the day was to say that Moderna’s booster shots should be available for people 65 years of age and older, those with underlying ailments, and those whose work or living conditions mean that they are potentially going to be exposed to a lot of COVID. . They also said it should be administered at least six months after the last stroke. 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 half a dose of the current shot – 50 micrograms instead of 100 – where the Pfizer booster is a full dose.

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

HUANG: Well, it’s not that clear. I mean, most people who are fully vaccinated with the Moderna vaccine are still highly protected against hospitalization or death from COVID. And what the panel saw today is that a Moderna booster could add extra protection to get breakthrough infections from the delta variant. This could be particularly useful for those who are older or at higher risk for severe COVID. Here’s how board member Eric Rubin, editor of the New England Journal of Medicine, summed it up.

(EXTRACT FROM THE ARCHIVED RECORD)

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

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

HUANG: Well, some of the most compelling evidence shared today was actually by researchers from the Israeli Ministry of Health. They took stock of their experience with the Pfizer booster. And I know it’s not the Moderna vaccine, but it uses the same type of mRNA technology. But the Israeli researchers were totally convinced that giving the booster doses helped alleviate infections and severe cases, effectively stopping their most recent wave of infections, which came from the delta variant. Now, here in the United States, cases are declining without the widespread use of booster shots, but the gist of the panel was that giving a booster shot to selected groups appears to be worth the risk. It could do good in terms of preventing infections and the spread of disease, and that’s why they recommended – decided to recommend their use today.

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

MCCAMMON: Yeah, so it’s Moderna. Pfizer boosters are already widely available. And Johnson & Johnson?

HUANG: Well, Johnson & Johnson is what the FDA committee will be tomorrow. The conversation might be quite interesting because Johnson & Johnson want to boost their single injection vaccine with a second dose of the same injection, but there are studies in the US and Europe that show that it might actually be better for people who have received the vaccine. J&J vaccine to get a second dose of a different vaccine, such as Pfizer or Moderna. This appears to lead to higher antibody levels and possibly better protection against COVID. So the question for tomorrow is: How will the FDA deal with J&J’s request? Will they try to limit the discussion to what the company asked for? Could they recommend a different booster course? This is something that I will be watching closely tomorrow.

MCCAMMON: Thank you very much for following all of this. It’s NPR’s Pie Huang. Thank you so much.

HUANG: Thank you for having me.

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