FDA Adds Guillain-Barré Syndrome Warning to RSV Vaccines Abrysvo and Arexvy

The U.S. Food and Drug Administration (FDA) has mandated new safety labeling for the RSV vaccines Abrysvo, produced by Pfizer Inc., and Arexvy, developed by GlaxoSmithKline Biologicals. Both vaccines must now include warnings about a potential risk of Guillain-Barré Syndrome (GBS), a rare neurological disorder, following vaccination. The update follows findings from postmarketing studies that suggest an increased risk of GBS within 42 days of receiving either vaccine.

Abrysvo, initially approved in May 2023 for adults over 60, has also been authorized for use in individuals aged 18 to 59 who are at high risk for severe respiratory syncytial virus (RSV) infections. Additionally, the vaccine is approved for immunizing pregnant individuals between 32 and 36 weeks gestation to help protect infants from RSV-related complications during their first six months of life. Similarly, Arexvy, also approved in May 2023 for adults over 60, is now available for individuals aged 50 to 59 at increased risk of RSV complications.

Guillain-Barré Syndrome is a rare condition in which the body’s immune system attacks its own nerves, potentially causing muscle weakness or paralysis. The FDA’s decision to update the vaccines’ prescribing information follows reports linking the vaccines to a heightened GBS risk, emphasizing caution for healthcare professionals and patients.

Healthcare providers are urged to inform patients about the potential risks associated with these vaccines and to report any adverse events through the Vaccine Adverse Event Reporting System (VAERS). VAERS is jointly managed by the FDA and the Centers for Disease Control and Prevention (CDC).

Article by multiple RFHC contributors.

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