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Thursday, January 31, 2019

Merck Gets FDA Breakthrough Tag for Ped Pneumonia Vaccine

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age.
V114 is also under development for the prevention of IPD in adults. Both indications are currently being studied in Phase 3 clinical trials.

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