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The FDA is expected to add the Guillain-Barre Syndrome warning to the J&J Covid recording



FDA and J&J spokesmen did not immediately respond to requests for comment.

The Washington Post first reported on the FDA’s plans.

The significance: GBS is a rare disease in which the body’s own immune system attacks nerve cells. In the United States, about 3,000 to 6,000 people develop the syndrome each year; recover most fully, although paralysis can occur in the most severe cases.

GBS has been linked to other vaccines as a rare side effect, including a vaccine developed to fight the 1976 swine flu. Most vaccine-related undesirable side effects are noticed within two months of vaccination.

Most of the cases identified in the federal database were reported about two weeks after vaccination and were mostly seen in men aged 50 and over, the senior CDC official said.

“The data available does not show a pattern similar to that of Pfizer and Moderna vaccines,” said the official, which are made using a different vaccine technology. These vaccines have been linked to rare cases of myocarditis, an inflammatory disease of the heart, mainly in men under 30.

What’s next: The CDC’s vaccine advisory committee will discuss the issue at an “upcoming” meeting, the official said.

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