The U.S. Food and Drug Administration on Monday added a warning to the fact sheet for Johnson & Johnson’s COVID-19 vaccine saying that data suggests there is an increased risk of a rare neurological disorder in the six weeks after inoculation. Bryan Wood reports.
The U.S. Food and Drug Administration issued a warning for Johnson & Johnson’s COVID-19 vaccine saying data suggests an increased risk of a rare autoimmune disorder called Guillain-Barré.
Also known as GBS, the syndrome is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers.
Most people fully recover.
In a Monday letter to the company, the FDA said the chances of getting GBS was “very low,” but still warned that recipients of the J&J vaccine should seek medical attention if they show symptoms within six weeks of inoculation, including weakness, tingling sensations, difficulty walking or difficulty with facial movements.
Most cases were in men over the age of 50.
Nearly 13 million people have received J&J’s one-dose vaccine in the U.S.
Out of 100 preliminary reports of GBS, the FDA says 95 cases have required hospitalization and one death has been reported.
The warning is another setback for the J&J shot, as its one-dose system was supposed to help vaccinate hard-to-reach areas.
Last week, European regulators issued a similar warning for AstraZeneca’s vaccine, which uses technology like J&J’s – a traditional, virus-based approach.
Meanwhile, the FDA has not linked GBS to the mRNA vaccines, Pfizer-BioNTech and Moderna.