
FDA's Peter Marks to Congress: Youngest kids vaccine won't need to hit 50% efficacy mark
The FDA’s top vaccine leader told a congressional committee on Friday afternoon that although the adult vaccines had to meet a 50% threshold for efficacy against Covid-19 infections, that same standard will not need to be met for the vaccines for the youngest group of children, for which a vaccine is not yet available.
The agency is currently reviewing data from Moderna’s two-shot vaccine for this youngest group as it awaits further data from Pfizer on its potential three-dose shot. Moderna has said its vaccine is 51% effective in children 6 months to 2 years of age and 37% effective in 2- to 5-year-olds. The agency also previously scheduled and then canceled an adcomm to review data on two doses of Pfizer’s vaccine for children under the age of 5.
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