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US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic

Executive Summary

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.

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Sanofi and AstraZeneca’s antibody nirsevimab is still likely to reach the market first, but Pfizer could be close behind with superior efficacy results.

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