FDA Issues Safety Communication That Warns About Possible GBS With Certain RSV Vaccines

MedPage Today (1/8, George) reports, “The FDA issued a safety communication that warns about possible Guillain-Barré syndrome (GBS) with respiratory syncytial virus (RSV) vaccines manufactured by Pfizer (Abrysvo) and GSK (Arexvy).” The prescribing information for both of the vaccines “has been revised to say that a postmarketing observational study suggested an increased risk of GBS in the 42 days following vaccination.” Drug Topics (1/8, Nowosielski) reports, “As more research is conducted regarding immunization’s link to GBS, the FDA encourages any patients with adverse reactions to RSV vaccines to report them to the Vaccine Adverse Event Reporting System in the meantime.”