Merck's Pneumococcal 15-valent Conjugate Vaccine Under Priority FDA Review For Use In Kids

The FDA has accepted for priority review Merck & Co Inc's MRK supplemental application seeking approval for Vaxneuvance (Pneumococcal 15-valent Conjugate 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 (PDUFA), or target action date, of April 1, 2022.
• Related: Merck's Next-Gen Pneumococcal Conjugate Vaccine Shows Efficacy In Pediatric Trials.
• In August, Merck posted encouraging topline results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety, and tolerability of Vaxneuvance in healthy infants enrolled between 42-90 days of age (n=1720). 
• In July, the FDA approved the pneumococcal 15-valent Conjugate Vaccine for adults 18 years of age and older for active immunization to prevent invasive disease.
• See here Benzinga's Full FDA Calendar.
• Price Action: MRK shares are up 0.77% at $75.45 during the premarket session on the last check Wednesday.