US Food and Drug Administration is expected to make an announcement regarding a new warning on Johnson & Johnson's Covid-19 vaccine. It is related to autoimmune disorder, the Washington Post reported on July 12. It cited four people familiar with the matter.
FDA has added a warning to Johnson & Johnson's vaccine fact sheet after receiving preliminary reports of patients developing the rare neurological condition Guillain-Barré (GBS) syndrome post receiving the shot, the agency said on July 12. One hundred suspected cases of GBS, among the 12.8 million people who have gotten the J&J shot, have been identified in the federal government's database for adverse side effects after taking the dose, FDA and CDC said. Of those, 95 were serious enough to require hospitalisation, and one person died, FDA said. J&J acknowledged in a statement on July 12 that it's been talking with regulators "about rare cases of the neurological disorder" following vaccination and that the reported case rate "exceeds the background rate by a small degree.”