FDA delays review of Vaxneuvance sBLA for use in infants and children

US pharma giant Merck & Co (NYSE: MRK) on Friday announced that the US 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, from the previous April 1 date.

The FDA requested additional analyses of data from the pediatric studies, which Merck says has submitted to the agency. No new studies have been requested by the FDA.

In December 2021, Merck announced that the FDA accepted the company’s application for Vaxneuvance for the prevention of invasive pneumococcal disease in children six weeks through 17 years of age and it was granted Priority Review.