FDA Adds Guillain-Barré Warning to J&J COVID-19 Vaccine

The U.S. Food and Drug Administration issued a new warning for the Johnson & Johnson COVID-19 vaccine that says the shot has been tied to Guillain-Barré syndrome.

Officials said there is a "small possible risk" for the side effect, and said it is not entirely clear that it was caused by the vaccine, the Associated Press reported.

About 100 preliminary reports of Guillain-Barré have been detected after 12.8 million doses of Johnson & Johnson vaccine were administered, the U.S. Centers for Disease Control and Prevention said in a statement, The Washington Post reported. These cases have largely been reported about two weeks after vaccination and occurred mostly in men, many aged 50 years and older. Most people fully recover, but a few have permanent nerve damage, according to the CDC.

Available data do not show a pattern suggesting a similar increased risk with the Pfizer and Moderna mRNA vaccines. The Guillain-Barré cases will be discussed as part of an upcoming meeting of CDC advisers, the agency said, according to The Post.