FDA warns of potential rare neurological complication with J&J vaccine

FDA warns of potential rare neurological complication with J&J vaccine

 

The FDA on Monday updated the label on Johnson & Johnson's coronavirus vaccine to warn of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome.   While the FDA said it had not established the vaccine could cause the syndrome, it noted an increase in reports of the sometimes-paralyzing condition.   The FDA said 100 preliminary reports of Guillain-Barré syndrome had been filed with the US government's Vaccine Adverse Event Reporting System (VAERS), out of 12.8 million J&J vaccine doses administered.   "In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low," the FDA says in the label update for patients and caregivers.   Dr. Anthony Fauci stressed that the benefits still outweigh the risks. "You're always going to find some adverse event associated with vaccination," Fauci told CNN.   "When you vaccinate tens of millions of people, you will always find a rare event. You've got make a decision -- does the benefit outweigh the unusual risk of an adverse event? Thus far with the vaccines, it's always been decided that the benefit of the vaccine outweighs the risk of an adverse event," he said.