J&J shot gets FDA warning for link to terrifying immune syndrome


J&J shot gets FDA warning for link to terrifying immune syndrome

Despite being associated with some Guillain-Barré syndrome cases, FDA insists benefits outweigh risks

Fiona Rutherford and Riley Griffin

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 US immunisation effort.

The Food and Drug Administration said in a statement on 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 hospitalisation 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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