FDA accepts for priority review the BLA for V114, investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older. - Merck Inc.

Merck announced the FDA accepted for priority review a Biologics License Application (BLA) for V114, Merck’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 July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults. The BLA and priority review designation are supported by results from Phase II and Phase III clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older. Additional studies in the BLA support the potential use of V114 in various real-world clinical settings, including in co-administration with the quadrivalent influenza vaccine and as part of a sequential administration with Pneumovax 23, and demonstrate equivalent performance among consecutive lots of V114. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition.