Of the 100 preliminary reports of Guillain-Barré syndrome, 95 were serious.
The US Food and Drug Administration (FDA) has released a new warning that the one-dose Johnson & Johnson (Janssen) COVID-19 vaccine could increase people’s risk of developing Guillain-Barré syndrome (GBS), a rare neurological disorder.
The FDA added the warning to the vaccine’s fact sheet on Monday. The announcement comes after an analysis of the data from the Vaccine Adverse Event Reporting System (VAERS)—a national early warning system to detect possible safety problems in vaccines licensed in the US—showed that 100 people reportedly developed GBS after receiving the Johnson & Johnson COVID-19 vaccine, an FDA official tells Health in an email. Of the 100 cases, 95 were labeled as serious and required hospitalization; one person died.