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Earlier this month, Pfizer also announced it would be initiating multiple clinical trials evaluating RSVpreF in healthy children ages 5-18 with underlying medical conditions; and adults ages 18-60 at high-risk for RSV. 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). The positive vote is based on compelling scientific evidence shared by Pfizer, including interim data from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) announced in November 2022.
