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. The agency previously scheduled and then canceled an adcomm to review data on two doses of Pfizer’s vaccine for children under the age of 5.

According to a readout of the meeting from the House select subcommittee on the coronavirus crisis, Marks explained that the FDA would not withhold authorization —…
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