Posted by Michael Wonder on 01 Apr 2022
Merck provides update on FDA review of supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1, 2022.
The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA. No new studies have been requested by the FDA.
