Update on FDA review of sBLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for infants and children.- Merck Inc.,
Merck Inc., has announced that the 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. In December 2021, Merck announced that the FDA accepted the company’s application for Vaxenuvance for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age and it was granted Priority Review.
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