FDA, J&J Mull Guillain-Barré Warning on Vaccine

Johnson & Johnson says it is in discussions with FDA and other regulators about rare cases of Guillain-Barré syndrome which have been reported following vaccination with its Janssen Covid-19 vaccine. The discussions presumably will center around whether a Warning should be added to the product’s labeling.

“The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree,” a company statement says. “Any adverse event report about individuals receiving Johnson & Johnson’s single-shot Covid-19 vaccine, as well as our own assessment of the report, is shared with the U.S. Food and Drug Administration, the European Medicines Agency and other appropriate health authorities. We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.”