Health officials are expected to warn that the one-dose Johnson & Johnson vaccine is linked to a small number of cases of a rare neurological disorder.
The U.S. Food and Drug Administration plans to add the warning to the shot’s label after finding some cases of Guillain-Barré neurological syndrome, the Wall Street Journal reports.
The syndrome is a rare one in which the immune system attacks nerves and causes temporary paralysis. The risk is somewhat common among vaccines.
Johnson & Johnson said Monday it has been discussing reports of Guillain-Barré with the FDA and that while the chances are low, it exceeds the rate of normally reported cases among the general population.
“Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protections against COVID-19 disease and prevents hospitalizations and death, including in countries where viral variants are highly prevalent,” the company said.
The risk is about three to five cases per million recipients, and according to the CDC, around 12.7 million people have received the J&J vaccine.