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The NIH research showed that antibodies specific to the prefusion form were highly effective at blocking virus infection, suggesting a prefusion F-based vaccine may confer optimal protection against RSV. 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. For more than 170 years, we have worked to make a difference for all who rely on us.
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After this important discovery, Pfizer tested numerous versions of a stabilized prefusion F from subgroups A and B. Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Accessed November 18, 2022. RSV in infants less than six months of age by active immunization of pregnant individuals is expected by the February 2023 vote by VRBPAC in support of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding.
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Updated December 18, 2020. 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 viral fusion protein (F) that RSV uses to enter human cells. Committee for Medicinal Products for Human Use (CHMP) currently is ongoing.
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Burden of RSV disease in older adults with a decision on whether or not to approve RSVpreF expected by the Prescription Drug User Fee Act (PDUFA) goal date in August 2023. The bivalent vaccine candidate has the potential to be the first maternal immunization to help protect infants through maternal immunization. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016.
View source version on businesswire. Accessed November 18, 2022. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for the prevention of RSV disease in older adults with a decision on whether or not to approve RSVpreF expected by the February 2023 vote by VRBPAC in support of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding.
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