J&J COVID-19 Vaccine: FDA Adds New Warning About 'Increased' Guillain-Barré Syndrome Risk

The U.S. Food and Drug Administration (FDA) updated the fact sheets for the Johnson & Johnson (Janssen) COVID-19 vaccine Monday, adding the possible risk for a rare condition called Guillain-Barré syndrome (GBS).

"Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination," the updated label for the J&J vaccine read.

Out of the 12.8 million Janssen vaccines given, there have been 100 preliminary reports of GBS in the government's Vaccine Adverse Reporting System, the FDA said as per CNN. Of the 100, 95 reportedly needed hospitalization while one died.

GBS is an auto-immune disorder in which a person's own immune system damages the nerves and causes muscle weakness and sometimes even paralysis, the Centers for Disease Control and Prevention (CDC) said. The condition is said to be "rare," and the symptoms can last from several weeks to years. Most people are said to fully recover from it, others incur nerve damage and some die, the agency noted.

In the updated label for patients and caregivers, the FDA noted that the chances of this happening are "very low," but people should immediately seek medical attention if they develop symptoms such as having difficulty walking and struggling with bowel function or bladder control after getting the Janssen vaccine.

"Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine," a spokesperson from the CDC told CNN.

In a statement, J&J noted that it has been discussing "rare" cases of the condition with the FDA and other regulators.

"We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated," the company said, adding that evidence still shows the single-shot vaccine can protect against COVID-19.

Further, the FDA noted that the vaccine's known benefits still outweigh the known risks.

"A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic," J&J noted.