FDA Updates J&J EUA with Guillain-Barré Syndrome Warning

On July 8, 2021, the FDA revised the Johnson & Johnson COVID-19 Vaccine Emergency Use Authorization fact sheet to include a warning related to Guillain-Barré Syndrome (GBS). GBS is an autoimmune disorder in which the immune system attacks healthy nerve cells in the peripheral nervous system, causing muscle weakness or paralysis.

According to the Centers for Disease Control and Prevention (CDC), around 100 preliminary reports of GBS have been reported to the Vaccine Adverse Events Reporting System (VAERS) after 12.8 million doses of Johnson & Johnson COVID‐19 Vaccine administered. Many of these cases have been reported about two weeks after vaccination and mostly in males, many aged 50 years and older. Importantly, available reports do not show similar patterns of GBS related to use of mRNA vaccines (Pfizer‐BioNTech and Moderna), after over 321 million doses of mRNA vaccine administered in the United States.

The risk of adverse events after COVID-19 vaccinations remains low. In line with the CDC, DSHS continues to recommend COVID-19 vaccination for everyone 12 years old and older given the risk of COVID-19 illness and severe complications, such as long-term health problems, hospitalization, and death.

As with any adverse events, please report cases of GBS following COVID-19 vaccination to the Vaccine Adverse Events Reporting System.