FDA Issues Warning on Johnson and Johnson Vaccine

The FDA has issued a warning about a potential rare neurological complication with the Johnson and Johnson vaccine. Yesterday the U.S. Food and Drug Administration updated the label on Johnson and Johnson’s Coronavirus vaccine to warn of the possible increased risk of the complication known as Guillain-Barré syndrome. It’s a disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. Each year in the U.S. an estimated 3,000 to 6,000 people are diagnosed with the syndrome. The FDA says 100 preliminary reports of Guillain-Barré syndrome had been filed with the U.S. government’s Vaccine Adverse Event reporting system out of 12.8 million doses given. In most of the cases, symptoms began about two weeks following the initial shot and mostly within males older than 50. 95 of the 100 reports involved people who needed hospitalization and one person died. If people who’ve gotten the Johnson and Johnson shot notice symptoms such as weakness or tingling in the arms and legs, especially if it spreads, they should seek medical attention. Other symptoms include difficulty walking, speaking, chewing or swallowing, double vision and bowel or bladder control issues. The CDC and FDA are monitoring cases of the syndrome that have been reported.