On Jan. 12, 2021, Merck announced the FDA accepted for priority review a Biologics License Application (BLA) for V114, Merckﾒs investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of Jul. 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.