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J&J’s Covid Vaccine Gets FDA Warning About Rare Immune Disorder
Posted
July 13, 2021
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0:51Now PlayingThe 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.
The agency said that 95 of the cases required hospitalization and that one person had died. While the available evidence suggests a link between the shot and the syndrome, the agency said that the data was insufficient to be able to say definitively it had caused the illness.
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