Merck Inc., submits applications for licensure of V 114, an investigational 15-valent pneumococcal conjugate vaccine to the FDA and EMA.

Merck has announced the company has submitted applications to the FDA and European Medicines Agency (EMA) for licensure of V 114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older for prevention of pneumococcal disease. The company awaits acceptance of the submissions by the U.S. and European regulatory authorities The regulatory applications for licensure of V114 include 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.