FDA Warns Johnson & Johnson COVID Vaccine Linked To Rare Autoimmune Disorder

The Federal Drug and Food Administration (FDA) announced a new warning would be added to the Johnson & Johnson COVID-19 vaccine after being linked to a rare autoimmune nerve disorder.

There have been about 100 preliminary reports of Guillain-Barré disease out of 12.8 million doses administered. Of those cases, 95 were considered severe and required hospitalization. One death was recorded. 

The majority of the cases were found by men and were recorded about two weeks post-vaccination. The individuals were typically over the age of 50.

Guillain-Barré is a rare disease in which the immune system attacks the peripheral nervous system and temporarily paralyzes parts or all of the body. Symptoms can last weeks or years. Symptoms typically level out after about four weeks. While most people diagnosed with the rare disorder recover, some are left with permanent nerve damage. Fewer than 20,000 cases are typically diagnosed yearly. 

“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship,” the FDA said in a statement. “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.”

Anyone experiencing side effects after vaccination should immediately seek medical care. Some symptoms include tingling, difficulty talking or swallowing, experiencing double vision, having trouble walking, and bladder or bowel control issues. 

Johnson & Johnson has been communicating with the FDA regarding the cases of Guillain-Barré, the company told the Daily Mail in a statement.

The issue has not been reported in either the Pfizer or the Moderna vaccines. Pfizer and Moderna require two doses to be effective, where the Johnson & Johnson vaccine only requires one dose.