The US Food and Drug Administration (FDA) has issued a new warning that the one-dose COVID-19 vaccination from Johnson & Johnson (Janssen) may raise the risk of Guillain-Barré syndrome (GBS) rare neurological condition. On Monday, the Food and Drug Administration updated the vaccine’s fact sheet to include the warning. In addition, an Food and Drug Administration official tells Health in an email an analysis of data from the Vaccine Adverse Event Reporting System (VAERS).
A national early warning system for detecting possible safety problems in vaccines licensed in the United States revealed that 100 people reportedly developed GBS after receiving the Johnson & Johnson COVID-19 vaccine. Ninety-five of the 100 cases were classified as severe, necessitating hospitalization; one individual died.The Food and Drug Administration says, “Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship.” Still, the Food and Drug Administration has issued the warning. So, too, has Johnson & Johnson itself. Here’s everything you need to know about GBS, including whether the new sign should influence your vaccination decision.
GBS is highly uncommon, both in the general population and among those who have received the Johnson & Johnson COVID-19 vaccine. GBS affects roughly 1 in 100,000 people worldwide, with 3,000 to 6,000 people developing the disease each year in the United States. When only looking at persons who have received the Johnson & Johnson vaccine, the 100 preliminary GBS reports are among over 13 million people in the United States who have received the vaccine.