RSV Vaccines Get Guillain-Barré Warning

An FDA alert says the agency has required safety labeling changes about Guillain-Barré syndrome risks for Pfizer’s Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline Biologicals’ Arexvy (respiratory syncytial virus vaccine, adjuvanted). Guillain-Barré syndrome is a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.

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.