Johnson & Johnson's Covid-19 vaccine about an observed "increased risk" of a rare and potentially dangerous neurological disorder called Guillain-Barre Syndrome (GBS).
However, the regulator said it's not entirely clear the shot caused the problem. In addition, health officials described the side effect as a “small possible risk" for those getting the shot.
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 them required hospitalization and one person died, the FDA said. GBS causes muscle weakness and occasionally paralysis that typically is temporary.