Food & Drug Administration issues new warning on rare autoimmune disorder linked to J&J coronavirus vaccine

On Monday, the U.S. Food and Drug Administration (“FDA”) warned of an increased risk of Guillain-Barre, a rare neurological disorder, following the Johnson & Johnson vaccine after 100 preliminary cases of the syndrome were reported among the 12.5M doses administered. The agency noted that 95 of the cases were serious and required hospitalization, including one death. The FDA is updating vaccination materials for health care providers and patients to note an “association” between the vaccine and a risk of GBS, however, they said the data are “insufficient to establish a causal relationship.” Similar issues have not been reported tied to the Pfizer or Moderna vaccines.

The FDA still recommends the vaccine to prevent the serious health risks posed by COVID-19, stating:  “Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks. The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree.”

According to the CDC, the majority of people who develop Guillain-Barre report the symptoms after having a respiratory illness, including the flu or getting sick with diarrhea. According to the FDA, patients should seek medical attention if they experience a weakness or tingling sensations, especially in the legs or arms, and that might worsen or spread to other parts of the body. Other symptoms might include difficulty walking or making facial movements; double vision or inability to move eyes; or difficulty with bladder control or bowel function.

Editorial credit: Vladimka production / Shutterstock.com


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