Investing.com — The US Food and Drug Administration (FDA) on Tuesday directed that vaccines for a common respiratory virus developed by GSK and Pfizer (NYSE:PFE) must include warnings about a rare neurological side effect.
The vaccines in question are GSK’s Arexvy and Pfizer’s Abrysvo, designed to combat the respiratory syncytial virus.
The FDA’s directive comes in the wake of a study conducted after the vaccines were approved.
Both Arexvy and Abrysvo could increase the risk of Guillain-Barré syndrome for up to 42 days after immunization, FDA said in a safety notice.
Guillain-Barré syndrome is a rare disorder where the body’s immune system attacks its own nerves. This can result in muscle weakness and may lead to paralysis.
The FDA has noted that this condition is often seen following an infection and currently, there is no known cure.
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