Shots:

• The approval is based on seven P-II & III clinical studies involves assessing the safety- tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7-438 adults aged >18yrs. with IPD caused by 15 serotypes
• Results: Vaxneuvance showed a non-inferior immune response to PCV13 for 13 shared serotypes as assessed by OPA GMTs & superior immune responses for shared serotype 3- 22F & 33F based on greater OPA GMT ratio in P-III V114-019 study
• The approval follows the FDA’s Priority Review of Merck’s application granted in Jan’2021 and has also received BTD for Vaxneuvance to prevent IPD

  Ref: Merck | Image: Merck