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FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy

Last Updated: Jan 9, 2025

The FDA has required and approved safety labeling changes to the Prescribing Information for the following RSV vaccines:

  • Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc.
  • Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals

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