Invasive Pneumococcal Disease Vaccine for Children Seeks FDA

Invasive Pneumococcal Disease Vaccine for Children Seeks FDA Approval

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for Merck's VAXNEUVANCE vaccine for the prevention of invasive pneumococcal disease in children six weeks through 17 years of age. The FDA set a Prescription Drug User Fee Act date of April 1, 2022.

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Roy Baynes , Merck Research Laboratories , Drug Administration , Precision Vaccinations , Priority Review , Biologics License Application , Prescription Drug User Fee Act , Jersey Based Merck , Merck Research ,

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