The Food and Drug Administration is set to warn Americans that Johnson & Johnson’s coronavirus vaccine can lead to an elevated risk for Guillain–Barré syndrome. Regulators have said that chances for developing the rare neurological condition appear to be three to five times higher among those receiving doses of J&J’s vaccine compared to the general population in the United States. The Centers for Disease Control and Prevention called it a “small possible risk,” and officials believe the benefits of the vaccine still outweigh any potential side effects. Most people fully recover from the syndrome which causes muscle weakness and occasional paralysis. In rare cases nearly complete paralysis is possible.
Federal officials said that about 100 preliminary cases were reported in a federal monitoring system. The cases appearing in the Vaccine Adverse Event Reporting System have typically been reported about two weeks after vaccination and mostly in males, many aged 50 years and older, the CDC said in a statement Monday. The Biden administration is expected to announce the vaccine warning as soon as Tuesday. It comes after a manufacturing screw-up halted shipments and a temporary pause was slapped on the vaccine earlier this year due to concerns over potential blood-clotting problems. The syndrome has not been linked to coronavirus vaccines developed by Pfizer-BioNTech or Moderna.