FDA Pushes Merck's Pneumococcal Vaccine Decision Date Into July For Expanded Use In Kids

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental marketing application for Merck & Co Inc's  MRK pneumococcal 15-valent conjugate vaccine in infants and children to July 1, 2022.

• The FDA requested additional data analyses from the pediatric studies, which Merck has submitted to the FDA. The FDA has asked for no new studies.
• Also See: Related: Merck's Next-Gen Pneumococcal Conjugate Vaccine Shows Efficacy In Pediatric Trials.
• In December 2021, the FDA granted priority review for the Company's application for VAXNEUVANCE to prevent invasive pneumococcal disease in children 6 weeks through 17 years of age.
• See here Benzinga's Full FDA Calendar.
• Price Action: MRK shares are up 0.09% at $82.09 during the market session on the last check Friday.