Merck : Applies in U.S., Europe to License V114 Pneumococcal Conjugate Vaccine

By Robb M. Stewart

Merck & Co. said Monday it has applied to U.S. and European regulators to license V114, its investigational 15-valent pneumococcal conjugate vaccine for use in adults.

The company said it is awaiting acceptance of applications submitted to the U.S. Food and Drug Administration and the European Medicines Agency.

The applications 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, Merck said.

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.

Write to Robb M. Stewart at [e-mail]

(END) Dow Jones Newswires

11-23-20 0715ET