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FDA Approves Prefilled Syringe Format for GSK’s Shingrix Vaccine

Eliminating manual reconstitution simplifies delivery of the proven recombinant zoster vaccine.

Signage is pictured in the main lobby of GSK offices in London, Britain, February 20, 2025. REUTERS/Chris J. Ratcliffe/File Photo

Overview

  • The FDA granted approval on June 17 for a prefilled syringe presentation of Shingrix, removing the need for healthcare providers to mix separate antigen and adjuvant vials.
  • The vaccine’s core components — the glycoprotein E antigen and AS01B adjuvant system — remain unchanged in the new format.
  • Since its US launch in 2017, more than 90 million doses of Shingrix have been administered to adults 50 and older and to immunocompromised adults aged 18 and above.
  • Shingrix is indicated for adults aged 50 years or older and for those 18 and older at increased risk due to immunodeficiency or immunosuppression.
  • Shingles affects about one million Americans each year, with postherpetic neuralgia emerging as the most common severe complication.