Shiloh
Editor, Senior Moderator
Source: https://www.bnnbloomberg.ca/busines...ots-to-warn-about-rare-neurological-disorder/
GSK, Pfizer RSV Shots Must Warn About Rare Paralysis Risk
By Antonia Mufarech
January 07, 2025 at 3:59PM EST
(Bloomberg) -- 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.
The analysis found nine excess cases of Guillain-Barré for every million doses given of Abrysvo, and an estimated seven excess cases per million doses of Arexvy in people who are 65 and older, the FDA said. 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.
GSK and Pfizer didn’t immediately reply to an emailed request for comment...
GSK, Pfizer RSV Shots Must Warn About Rare Paralysis Risk
By Antonia Mufarech
January 07, 2025 at 3:59PM EST
(Bloomberg) -- 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.
The analysis found nine excess cases of Guillain-Barré for every million doses given of Abrysvo, and an estimated seven excess cases per million doses of Arexvy in people who are 65 and older, the FDA said. 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.
GSK and Pfizer didn’t immediately reply to an emailed request for comment...