FDA warns on potential Johnson & Johnson COVID-19 vaccine link to rare disorder | Fox News

FDA warns on potential Johnson & Johnson COVID-19 vaccine link to rare disorder | Fox News: The Food and Drug Administration (FDA) announced a new warning on the Johnson & Johnson COVID-19 vaccine and a possible link to Guillain-Barré, a rare autoimmune nerve disorder. The agency revised the vaccine's accompanying fact sheets to reflect an increased risk of the disorder following vaccination. The warning comes after about 100 preliminary reports of Guillain-Barré cases against a backdrop of about 12.5 million Johnson & Johnson doses administered, the FDA said in a statement Monday. Of the total, 95 cases were serious and involved hospitalization, with one reported death. However, the FDA stopped short of pinning a causal relationship between the vaccine and the rare disorder.