U.S. FDA accepts for priority review the supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children

Merck/MSD

1 December 2021 - Merck today announced the U.S. FDA has accepted for priority review a supplemental biologics license application for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age. 

The FDA set a Prescription Drug User Fee Act, or target action date, of 1 April 2022.

Read Merck press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Paediatrics , Dossier