The Food and Drug Administration (FDA) has updated the fact sheet for the Janssen COVID-19 vaccine to include information related to the potential increased risk of developing Guillain-Barré syndrome.

Guillain-Barré syndrome is a rare neurological disorder in which the body’s immune system damages nerve cells causing muscle weakness and sometimes paralysis. According to the Centers for Disease Control and Prevention (CDC), there were 100 preliminary reports of the syndrome among more than 12 million vaccine doses administered. Most of the cases occurred about 2 weeks following vaccination in men 50 years of age and older.

The Fact Sheet for Healthcare Providers Administering Vaccine now includes a warning stating that reports of adverse events following the use of the Janssen COVID-19 vaccine suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination. Moreover, the Fact Sheet for Recipients and Caregivers has been updated stating that the chance of having Guillain-Barré syndrome occur is very low.

The Janssen COVID-19 vaccine is currently authorized under the FDA’s Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. 


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References

Johnson & Johnson Statement on COVID-19 Vaccine (7/12). [press release]. New Brunswick, NJ: Johnson & Johnson; July 12, 2021.