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

 
• By Bridget Silverman

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.

Scanning electron micrograph of human respiratory syncytial virus (RSV) virions (colorized blue) and labeled with anti-RSV F protein/gold antibodies (Alamy)
These RSV virions (colorized blue) are the target of many firms' vaccine development programs. • Source: Alamy

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