Merck's Pneumococcal Vaccine Lands FDA Nod, Just Few Weeks After Its Rival

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  • For the second time in five weeks, the FDA has approved a new pneumococcal conjugate vaccine, this time giving the nod to a shot from Merck & Co Inc MRK.
  • The vaccine, Vaxneuvance, is designed to protect against 15 strains of pneumococcal bacteria. That’s two more strains than Prevnar 13, a product from rival Pfizer Inc PFE.
  • But the total number of strains covered by Vaxneuvance is five shy of Prevnar 13’s successor, Prevnar 20, which the FDA approved in June.
  • The clinical studies were not designed to assess Vaxneuvance’s clinical efficacy compared to Prevnar 13. But in one of the strains, serotype 3, Merck said the immune response to its vaccine was superior to Pfizer’s.
  • Approval of Vaxneuvance covers the use of the vaccine in adults 18 and older.
  • Tests of the shot are still ongoing in infants, children, and teens.
  • Price Action: MRK shares closed at $78.02 on Friday.
  • Related content: Benzinga's Full FDA Calendar.
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