![]() ![]() The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains. ![]() ![]() ▪ In August 2022, Pfizer announced positive top-line data from the Phase 3 clinical trial RENOIR ( R SV vaccine E fficacy study i N O lder adults I mmunized against R SV disease) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. If approved, PF-06886992 could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine. ![]() Submissions to additional regulatory authorities outside the U.S. Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application (BLA) to the FDA in the fourth quarter of this year. The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease. ▪ PF-06886992 (Pentavalent (MenABCWY) Meningococcal Vaccine Candidate) - In September 2022, Pfizer announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. ![]()
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