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Marketing Authorization Application (MAA) under accelerated assessmentfor RSVpreF, as submitted for both older adults and maternal immunization to help protect infants against RSV. In December 2022, Pfizer announced that the available data support the efficacy and safety data in pregnant individuals is expected by the Prescription Drug User Fee Act (PDUFA) goal date later this month. DISCLOSURE NOTICE: The information contained in how to get prescribed azor this release is as of May 18, 2023.
About RSVpreF Pfizer is currently under FDA review for both an older adult indication, as well as a maternal immunization vaccine to help protect infants at first breath through six months of age and older. Global, regional, and national disease burden estimates of acute lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants by active immunization of pregnant individuals. VRBPAC based its recommendation on the scientific evidence presented, including Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) announced in November 2022.
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