GSK, Pfizer RSV Shots Must Warn About Rare Paralysis Risk
Live Mint-- GSK Plc and Pfizer Inc.’s vaccines for a common respiratory virus must carry warnings that they may be tied to an increased risk of a rare neurological side effect that can lead to paralysis, the US Food and Drug Administration said. A study done after the respiratory syncytial virus shots were approved suggests that people given GSK’s Arexvy and Pfizer’s Abrysvo may be at increased risk of Guillain-Barré syndrome for 42 days following immunization, the agency said in a safety communication issued Tuesday. While the data suggests an increased risk with the vaccines, there isn’t enough evidence to show the shots are causing the condition, the agency said. The potential risk of respiratory syncytial virus shots has been known, with the Center for Disease Control and Prevention’s vaccine advisory panel discussing the danger last year.