The FDA is reportedly planning to warn J& J coronavirus vaccine linked to serious Guillain-Barré syndrome

US health officials plan to warn of a rare but serious neurological disorder linked to Johnson & Johnson’s coronavirus vaccine, The Washington Post reported on Monday, citing four people it didn’t identify.

About 100 cases of Guillain-Barré syndrome have been reported among people who received J&J’s vaccine, the newspaper said, citing the US Centers for Disease Control and Prevention. Still, health authorities plan to say that the vaccine is safe, and that its benefits outweigh the risks, the Post reported.

The CDC and Food and Drug Administration did not immediately respond to requests for comment. J&J did not immediately respond to Insider’s inquiry.

Vaccines from Moderna and from Pfizer-BioNTech are being used much more frequently in the US, and those shots haven’t been linked to the condition. About 12.8 million doses of J&J’s shot have been administered.

About 3,000 to 6,000 people develop Guillain-Barré each year, according to the CDC. The disorder often follows infections with a virus or bacteria. The syndrome causes muscle weakness and sometimes paralysis, which is usually temporary, and it is more common among older men.

The warning would be a second black mark for J&J’s shot. The vaccine has also been connected to cases of rare but serious blood clots.

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