Peter Marks (Jim Lo Scalzo/Pool via AP Images)

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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