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Home » FDA Open to Less Than 50 Percent Efficacy in COVID Vaccines for Smallest Kids
FDA Open to Less Than 50 Percent Efficacy in COVID Vaccines for Smallest Kids
In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection — a requirement that had been previously listed in FDA guidance.