Prognosis
J&J’s Covid Shot Gets FDA Warning About Rare Immune Disorder
- One death reported among 100 cases of Guillain-Barré Syndrome
- U.S. says benefits top risks, but link adds to J&J’s obstacles
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The fact sheet for Johnson & Johnson’s Covid-19 vaccine was revised to warn of the risk of a rare immune-system disorder, adding new headwinds for a shot once expected to be a linchpin of the U.S. immunization effort.
The Food and Drug Administration said in a statement Monday that it was adding the warning after 100 reports of Guillain-Barré Syndrome, a rare condition in which the immune system attacks the nerves, among people who had received the shot. So far, about 12.8 million Americans have been given the one-dose vaccine.