RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.
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GSK has declared success for its RSV vaccine and will begin regulatory talks immediately – but the final efficacy level, as yet unrevealed, could be decisive in a competitive market.
Pfizer will acquire ReViral for up to $525m, adding a Phase II antiviral for respiratory syncytial virus (RSV), complementing its own work to develop a vaccine.
US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic
New breakthrough therapy designations bolster Pfizer’s maternal RSV vaccine and Bavarian Nordic’s older adult program, while Sanofi/AstraZeneca prepare to submit nirsevimab BLA and GSK deals with fallout of safety-driven Phase III trial pause.