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DISCLOSURE NOTICE: The information contained in this release is as of May 18, 2023. The vaccine candidate is currently under FDA review for both an older adult indication, as well as recently published in The New England Journal of Medicine. VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including primary analysis results from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) announced in November 2022. After this important discovery, Pfizer tested numerous versions of a stabilized prefusion F protein and identified a candidate that elicited a strong anti-viral immune response in pre-clinical evaluations. Rainisch G, Adhikari B, Meltzer MI, Langley G. Estimating the impact of multiple immunization products on medically-attended respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis.

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VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including primary analysis results from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) announced in November 2022. Updated December 18, 2020. Centers for Disease Control and Prevention.

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