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The FDA vaccine advisory board recommends booster shots of both the J&J and Moderna vaccines

J&J’s data showed that a second shot of its vaccine boosts protection to 94% against symptomatic moderate-to-severe infection when administered two months after the first dose

Johnson & Johnson

The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee has voted unanimously to recommend a second shot of Johnson & Johnson (J&J)’s COVID vaccine for the more than 15 million adults who have already received a dose.

While the FDA usually follows the advice of its advisory committee, a final decision cannot be made until the vaccine advisory group of the Centers for Disease Control and Prevention (CDC) has recommended the second jab, although this is expected within days.

“Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” said Paul Stoffels, chief scientific officer at J&J.

However, widespread concerns have been voiced about the real-world protection offered by the single-dose J&J vaccine, which has been shown to be comparatively less effective than the two-dose messenger RNA vaccines made by Pfizer-BioNTech and Moderna.

Paul Offit from the Children's Hospital of Philadelphia said: “This, frankly, was always a two-dose vaccine. I think it’s better as a two-dose vaccine, it’d be hard to recommend this as a single-dose vaccine at this point, given this two-month data.”

J&J’s data showed that a second shot of its vaccine boosts protection to 94% against symptomatic moderate-to-severe infection when administered two months after the first dose, similar efficacy to the mRNA vaccines.

The FDA panel also voted to recommend a booster shot of the Moderna vaccine to high-risk individuals, as it did several weeks ago for the Pfizer vaccine. However, some members of the panel felt Moderna’s data was weak; Eric Rubin, editor-in-chief of the New England Journal of Medicine, admitted that the data “is not perfect” but we live in “extraordinary times”.

The panel also looked at data from a mix-and-match study, especially the 76-fold geometric mean-fold rise (the ratio of post-vaccination to pre-vaccination titre values) for participants who received J&J’s single vaccine followed by a Moderna vaccine, compared to a 4.2-fold increase in those who received two doses of the J&J vaccine and a 35-fold rise in those who got J&J’s vaccine followed by a Pfizer/BioNTech vaccine.

One panel member, professor of paediatrics at Harvard Medical School, Ofer Levy, urged action. “In the real world, all these kinds of combinations or extra boosters are already happening. It’s a matter of some urgency for the FDA to help sort out what is admittedly a complicated and challenging scenario. We need to give guidance to the public.”

Article by
Hugh Gosling

19th October 2021

From: Research, Regulatory



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