F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

By Sharon LaFraniere and Noah Weiland

The Food and Drug Administration warned Monday that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndrome, another setback for a vaccine that has largely been sidelined in the United States.

Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision. The warning was attached to fact sheets about the vaccine for providers and patients.

Federal officials have identified 100 suspected cases of Guillain-Barré disease among recipients of the one-dose shot through a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines. Ninety five percent of those cases were considered serious and required hospitalization, the F.D.A. said. The reports are preliminary.

In a statement, the agency said 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.”

The agency added that it “continues to find the known and potential benefits clearly outweigh the known and potential risks” associated with getting the shot.

About 12.8 million people — or about eight percent of the fully vaccinated population in the United States — have received the Johnson & Johnson shot. By contrast, about 146 million have been fully vaccinated with Pfizer’s or Moderna’s vaccines, both of which require two doses.

Guillain-Barré syndrome occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis, according to the F.D.A. Several thousand people — or roughly 10 out of every million — develop the condition every year in the United States. Most recover from even severe symptoms.

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