FDA adds new warning of rare nerve syndrome to Johnson & Johnson COVID-19 vaccine

The Food and Drug Administration on Monday updated its fact sheet for the Johnson & Johnson COVID-19 vaccine, saying that while the chance of developing Guillain-Barré syndrome is "very low" after receiving the shot, there is an increased risk.

Preliminary reports show that there have been about 100 suspected Guillain-Barré syndrome cases among people who received the one-dose Johnson & Johnson vaccine; the vaccine has been administered to more than 12.8 million Americans, the Centers for Disease Control and Prevention says. Among the people who developed the syndrome, the symptoms developed about 42 days after vaccination.

Guillain-Barré syndrome is a rare condition where the immune system attacks the nerves, and typically comes on after a person is infected with a virus. Every year, 3,000 to 6,000 Americans develop the illness, with most fully recovering. An FDA official told Axios that while the "available evidence suggests an association" between the Johnson & Johnson vaccine and increased risk of Guillain-Barré syndrome, "it is insufficient to establish a causal relationship."

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The FDA said there is no link between Guillain-Barré syndrome and the COVID-19 vaccines made by Pfizer and Moderna. Public health officials stress that the benefits of the vaccine vastly outweigh the risks, with the CDC saying on Monday that in the United States, "nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people. The risk of severe adverse events after COVID-19 vaccination remains rare."