FDA Extends Review of Vaxneuvance for Infants and Children

The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for Merck’s Vaxneuvance (Pneumococcal 15-valent conjugate vaccine) in infants and children from 6 weeks to 17 years of age to July 1, 2022. The FDA has requested additional analyses of data from the pediatric studies. No new studies have been requested by the FDA.

Vaxneuvance is indicated for active immunization of adults 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes. It previously received breakthrough therapy designation and priority review from the FDA for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age.

The FDA had accepted Merck’s supplemental application in December 2021. The application was based on data from phase 2 and phase 3 studies in pediatric populations including infants, children, and adolescents