Therapy Areas: Vaccines
Merck Submits Applications in US, Europe for Licensure of Investigational 15-valent Pneumococcal Conjugate Vaccine
27 November 2020 - - US-based pharmaceutical company Merck (NYSE: MRK) has submitted applications to the US Food and Drug Administration and European Medicines Agency for licensure of V114, Merck's investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older, the company said.

The company awaits acceptance of the submissions by the US and European regulatory authorities.

The regulatory applications for licensure of V114 include results from Phase 2 and Phase 3 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.

V114 is Merck's investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of pneumococcal disease in adults and children.

V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.

An overview of the late-stage development program for V114 is available here.

V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.