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FDA advisory panel greenlights Moderna Covid-19 boosters for elderly & at-risk Americans

The Vaccines and Related Biological Products Advisory Committee voted on Thursday in favor of Moderna’s request for boosters, saying that adults 65 and older, as well as younger adults with health problems, jobs or living situations that put them at increased risk of the coronavirus should have access to them, at least six months after their initial two-shot regimen.

Moderna announced Tuesday that it had filed the request with the FDA for a decision on the boosters. The vote comes about three weeks after the committee approved the use of boosters for recipients of the Pfizer/BioNTech vaccine. The Johnson & Johnson application for boosters is on the agenda on Friday.

Though the Biden administration has announced plans to give boosters to everyone, the FDA advisory panel said there was no evidence it was yet time to do so. 

“I don’t really see a need for a ‘let it rip’ campaign for everyone,” said Dr. Michael Kurilla of the National Institutes of Health, according to AP.

The original regimen featured two 100-microgram injections, but Moderna says a single 50-microgram dose should provide a sufficient booster. Side effects and adverse events observed after the booster under trial conditions were similar to those observed after the second dose, Moderna told the FDA.

Halving the dosage would cut down on adverse effects and also leave more vaccines available globally, the company added.

As evidence for boosters, Moderna pointed to a study showing 36% fewer ‘breakthrough’ infections among the recently vaccinated, and a study of 344 people indicating that a 6-month booster increased antibodies.

“The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh, another member of the committee.

One lingering question was that recipients of the Moderna vaccine with severely weakened immune systems have already been recommended for a third full dose, which would make the boosters their fourth.

Assuming the FDA accepts the committee’s recommendations, Moderna and J&J boosters will have to be approved by the Centers for Disease Control and Prevention (CDC) panel, which meets next week.

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