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

[Mary Wilson]

Content current as of: 01/07/2025

Purpose: To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Respiratory Syncytial Virus (RSV) vaccine. The Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section:

• Abrysvo- The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with Abrysvo.
• Arexvy- The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with Arexvy.

GBS is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.

New Warning about Risk for GBS Following Vaccination

FDA conducted a postmarketing observational study that assessed the risk of GBS following vaccination with Abrysvo and Arexvy. Based on FDA’s evaluation of data from clinical trials, reports to the Vaccine Adverse Event Reporting System (VAERS), and the postmarketing study, FDA has determined that the overall body of evidence suggests increased risks of GBS with Abrysvo and Arexvy, but that available evidence is insufficient to establish a causal relationship. ...

https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and