FDA Calls for Addition of Rare Side Effect Warnings to GSK and Pfizer Vaccines

Investing.com -- The U.S. Food and Drug Administration (FDA) announced on Tuesday that warnings regarding a rare neurological side effect should be included for vaccines developed by GSK and Pfizer against a common respiratory virus. The vaccines in question are GSK's Arexvy and Pfizer's Abrysvo, designed to combat respiratory syncytial virus. The FDA's directive followed a study conducted after the approval of the vaccines. In a safety notice, the FDA indicated that both Arexvy and Abrysvo could increase the risk of Guillain-Barré syndrome for up to 42 days post-immunization. Guillain-Barré syndrome is a rare illness where the body's immune system attacks its own nerves, potentially leading to muscle weakness and paralysis. The FDA noted that this condition typically occurs following an infection and there is currently no known treatment for it.