Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults
The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
- The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
- V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
- V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.