U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a potentially dangerous neurological reaction.
The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis.
The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of were hospitalized and one person died, the FDA said.
Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC.
J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world.
The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.
The new warning will be included in pamphlets given to people getting the J&J shot. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said.
The CDC and the FDA have been monitoring side effect reports submitted by physicians, drugmakers and patients to a federal vaccine safety database.