FDA issues new warning on rare autoimmune disorder linked to J&J vaccine

The FDA on Monday warned of an increased risk of Guillain-Barre following the J&J vaccine after 100 preliminary cases were reported among the 12.5M doses administered.

The U.S. Food and Drug Administration on Monday warned of an increased risk of Guillain-Barre, a rare neurological disorder, following the Johnson & Johnson vaccine after 100 preliminary cases of the syndrome were reported among the 12.5M doses administered. The agency noted that 95 of the cases were serious and required hospitalization. There was one death. While the FDA said it's updating vaccination materials for health care providers and patients to note an "association" between the vaccine and a risk of GBS, the agency said the data are "insufficient to establish a causal relationship." And, the agency added, it still recommends the vaccine to prevent the serious health risks posed by COVID-19. "Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks," the FDA stated.