Logo

Merck Reports the US FDA’s Acceptance of sBLA for Priority Review of Vaxneuvance for Invasive Pneumococcal Disease

Share this

Merck Reports the US FDA’s Acceptance of sBLA for Priority Review of Vaxneuvance for Invasive Pneumococcal Disease

Shots:

  • The sBLA is based on the P-II & III studies to evaluate Vaxneuvance in infants, children & adolescents aged 6wks. to 17yrs. with IPD
  • The studies will support the use of Vaxneuvance in clinical settings, including immunization along with patients who are at high risk for pneumococcal disease & also supports as part of a mixed dosing regimen following initiation of infant vaccination with PCV13 along with catch-up setting for older children who are pneumococcal vaccine-naïve or received a lower-valency pediatric PCV
  • If vaxneuvance is approved, it will provide an improvement in the safety or effectiveness for a serious condition with an anticipated PDUFA is April 1, 2022

Ref: Merck | Image: Merck

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions