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The US FDA Approves GSK’s Shingrix Prefilled Syringe Presentation to Protect Individuals Against Shingles

Shots:

  • The US FDA has approved prefilled syringe formulation of Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster)
  • Approval was supported by data demonstrating its technical comparability to the existing format, which incl. 2 separate vials, a lyophilised antigen & a liquid adjuvant, combined by healthcare professionals before use
  • Additionally, Shingrix prefilled syringe formulation is under the EMA review following filing acceptance in Jan 2025, with submissions to other markets underway

Ref: GSK | Image: GSK | Press Release

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