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Updated December 18, 2020. VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including primary analysis results from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). This was followed by the Prescription Drug User Fee Act (PDUFA) goal date in August 2023If authorized, the vaccine candidate would help protect infants through maternal immunization.

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