FDA Requires New Warning of Link Between Neurological Disorder, RSV Vaccines

WASHINGTON, D.C. — The Food and Drug Administration is requiring Pfizer Inc. and GlaxoSmithKline to include a new warning that their respiratory syncytial virus (RSV) vaccines can cause a rare neurological disorder known as Guillain-Barré Syndrome.

In a Jan. 7 alert, the FDA cites postmarketing data suggesting an increased risk of GBS within 42 days of vaccination with Pfizer’s Abrysvo and GSK’s Arexvy.

GBS is a rare neurological disorder that occurs when the body's immune system attacks the peripheral nervous system, causing muscle weakness, tingling, and sometimes paralysis. While GBS can affect people of any age, but it's more …