The Food and Drug Administration (FDA) will now require labeling changes for 2 respiratory syncytial virus (RSV) vaccines to warn of the potential risk of Guillain-Barré syndrome (GBS) associated with the vaccines. Postmarket observational studies suggest there is an increased risk of GBS during the 42 days following vaccination with Pfizer’s Abrysvo vaccine for RSV and GSK’s Arexvy vaccine for RSV. Both were approved by FDA in 2023, so they are relatively new in the market. Clinicians may report suspected adverse events to the national vaccine adverse event reporting system here.
Rare condition: In 2019, there were 150,095 (95% uncertainty intervals 119,924 to 188,309) total cases of GBS globally, according to the Journal of Neuroinflammation. It is considered rare with an incidence rate of 1–2 cases per 100,000 people per year worldwide, and more than 80% of those diagnosed experience a complete or nearly complete recovery.