FDA Will Add Warning of Rare Nerve Syndrome to J&J Vaccine

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The Food and Drug Administration intends to attach a warning about a slightly increased risk of developing Guillain-Barré syndrome, an autoimmune disorder that affects the nervous system, to the Johnson & Johnson COVID-19 vaccine, the New York Times reported Monday. A federal-government monitoring system that tracks vaccine side effects reportedly identified about 100 suspected cases of Guillain-Barré disease among J&J vaccine recipients.

Sources familiar with the FDA’s action told the Times that the chance of developing the syndrome, though already rare generally, is “three to five times higher” in those who opted for the single-dose shot from Johnson & Johnson compared to the U.S. population overall. The White House is expected to make an announcement about the added warning this week.

The Centers for Disease Control and Prevention describes Guillain-Barré syndrome as a “rare, autoimmune disorder in which a person’s own immune system damages the nerves, causing muscle weakness and sometimes paralysis.” The agency said in a statement on Monday that the reported cases of the syndrome among J&J vaccine recipients were mostly among men 50 and older.

This is not the first setback for the Johnson & Johnson vaccine. Fifteen million doses of the vaccine had to be thrown out back in March owing to contamination concerns at the Baltimore plant where they were manufactured. Emergent BioSolutions, the company that runs the plant, was told by the FDA in June that 60 million doses had to be disposed of for similar reasons.

There was also a brief pause in the distribution of the one-dose vaccine in April after a small number of women developed severe blood clots after receiving the shot. The pause was lifted after the CDC and FDA conducted a safety review and added a warning about the clots. As in that case, the FDA still concludes that the benefits of getting the J&J vaccine far outweigh the risk of developing Guillain-Barré syndrome.

FDA to Add Warning of Rare Nerve Syndrome to J&J Vaccine