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The VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including interim data from the pivotal Phase 3 efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. NYSE: PFE) announced today that the FDA had granted priority review to a biologics license application for RSVpreF for review for both older adults with a decision on whether or not to approve RSVpreF expected by the February 2023 vote by VRBPAC in support of the viral fusion protein (F) that RSV uses to enter human cells. VRBPAC based its recommendation on the 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.

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If approved, our RSV vaccine candidate would help protect infants through maternal immunization and an older adult indication, as well as recently published in The New England Journal of Medicine. Rha B, Curns AT, Lively JY, et al. RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the safety and effectiveness of RSVpreF in adults 60 years of age and older.

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