On July 12, the Food and Drug Administration announced it is adding a warning label to the Johnson & Johnson COVID-19 vaccine, noting increased risk of a rare neurological syndrome called Guillain-Barré syndrome. The new warning label is based on preliminary data, after about 100 reports of GBS were detected in the Vaccine Adverse Event Reporting System, out of more than 12.8 million administered doses of the Johnson & Johnson vaccine administered.
The CDC continues to advise that everyone 12 years of age and older receive a COVID-19 vaccine. The risk of severe adverse events after any COVID-19 vaccination remains rare, far lower than adverse health outcomes associated with contracting COVID-19.
The CDC and FDA will continue to provide monitoring and treatment information to health care providers and vaccine recipients. Anyone with questions about which vaccine is best for them should speak to their healthcare provider.
Added July 13, 2021