Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease Caused by 15 Serotypes

July 19, 2021 Auto Bot approval, Biotech, FDA, Merck, regulatory, Vaxneuvance 0

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

Click here to­ read the full press release/ article | Ref: Merck | Image: Shutterstock

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