Johnson & Johnson, in a discussion with federal agencies, confirmed that its COVID-19 vaccine is linked to Guillain-Barré syndrome (GBS), a rare neurological disorder. Following this confirmation, on July 12 The Food and Drug Administration (FDA) announced that it will add a warning label to Johnson & Johnson’s COVID-19 vaccine via a fact sheet for providers and patients!

Key among the findings within the fact sheet were alarming data which showed that the chances of developing GBS without the J&J vaccine are low. However, recipients of the J&J vaccine are three to five times more likely to develop the neurological disorder. The federal monitoring system has identified 100 suspected cases of Guillain-Barre among those who received Johnson & Johnson’s one-dose shot.

The FDA provided a preliminary report which showed that 95% of the cases containing the rare neurological disorder associated with the J&J covid vaccine were considered severe and required hospitalization of those affected.