FDA to warn on potential Johnson & Johnson COVID-19 vaccine link to rare disorder, report says

The Food and Drug Administration is reportedly expected to administer a new warning on the Johnson & Johnson COVID-19 vaccine and a possible link to Guillain-Barré, a rare autoimmune nerve disorder.

The Washington Post, citing four individuals familiar with the matter, said the warning is expected after about 100 cases of Guillain-Barré occurred against a backdrop of nearly 12.8 million Johnson & Johnson vaccine recipients. The Post reported the cases occurred about two weeks post-vaccination, mostly among men, with many aged over 50.

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Johnson & Johnson, the FDA and the Centers for Disease Control and Prevention (CDC) did not immediately respond to Fox News’ requests for comment.

According to the CDC, Guillain-Barré occurs when a person’s immune system damages the nerves, spurring muscle weakness and in some cases, paralysis. Symptoms can last for several weeks to years, and while most will go on to fully recover, some are left with permanent nerve damage. Triggers for the rare syndrome include recent respiratory illness or diarrhea weeks before symptoms, or viral infections like the flu and Zika virus.

“Very rarely, people have developed GBS in the days or weeks after receiving certain vaccines,” the agency states. The syndrome is estimated to affect about 1 in 100,000 people, and in the U.S. it is more common among men and individuals above age 50. It is not contagious but outbreaks of germs linked to GBS can result in clusters. Treatments include plasma exchange and antibody infusions.

Fox News’ Alexandria Hein contributed to this report.

This is a developing story, please check back for updates.