FDA panel green-lights Moderna COVID boosters for risk groups


Vaccine advisors for the Food and Drug Administration (FDA) today unanimously approved a third and smaller dose of Moderna’s COVID-19 vaccine for vulnerable groups.

Today’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) was the first of two days of booster-dose deliberations, which tomorrow will cover the Johnson & Johnson vaccine and mix-and-match strategies.

In advance of tomorrow’s VRBPAC meetings, a research team based at the National Institutes of Health (NIH) yesterday released a preprint study suggesting that all vaccine combinations were well tolerated and immunogenic, but Johnson & Johnson recipients got a bigger immune response from an mRNA vaccine booster than a second dose of their original vaccine.

Approval aligns with Pfizer risk groups

In their vote, the 19-member group said the available data support the safety and efficacy of a booster dose of the Moderna vaccine, under emergency use authorization (EUA), in the same groups as for the Pfizer-BioNTech booster: those ages 65 and older, those ages 18 to 64 who are at risk of severe COVID-19, and those ages 18 to 64 whose frequent exposure in institutional or occupational settings put them at high risk for serious COVID-19 complications.



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