FDA Delays Decision on Merck’s Pediatric Pneumococcal Vaccine

The FDA has pushed back its decision date for Merck’s supplemental Biologics License Application (sBLA) for its 15-valent pneumococcal conjugate vaccine for pediatric patients by three months to July 1.

The requested indication for Vaxneuvance is for patients ages six weeks to 17 years old. The agency has asked for further analysis of data from pediatric studies of the multivalent vaccine, the company said.

Vaxneuvance is currently FDA-approved for adult patients who are 18 years and older. Merck said the agency has not called for any additional studies to support pediatric use.