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