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Merck : FDA Accepts For Priority Review BLA For Adult Invasive Pneumococcal Vaccine

Merck & Co Inc. (MRK) said Tuesday that the U.S. Food and Drug Administration accepted for priority review a Biologics License Application or BLA for V114 for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

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

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.

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