Merck Applies in U.S., Europe to License V114 Pneumococcal Conjugate Vaccine
November 23 2020 - 7:30AM
Dow Jones News
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 robb.stewart@wsj.com
(END) Dow Jones Newswires
November 23, 2020 07:15 ET (12:15 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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