The U.S. Food and Drug Administration (FDA) on Monday warned of an increased risk of Guillain-Barre (GBS), a rare neurological disorder, following vaccination with the Johnson & Johnson vaccine after 100 preliminary cases of the syndrome were reported among the 12.5 million doses given.
Most of the cases required hospitalization and one person died, according to the Washington Post. There does not appear to be a similar increased risk of the autoimmune disorder with the Pfizer and Moderna vaccine.
The FDA is updating its vaccination materials for healthcare providers to note an “association” between the vaccine and a risk of GBS, according to ABC News. The agency said the data are “insufficient to establish a causal relationship.”
“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 FDA stated.
The CDC describes the syndrome as a “rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.”
Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from GBS, but some have permanent nerve damage. Some people have developed GBS after a bout with the flu or other infections, including COVID-19.
The CDC also notes that the cases of GBS seem to be affecting men over the age of 50 years, occurring about two weeks after vaccination. Health officials describe the issue as a “small possible risk.”
According to the FDA, patients should seek medical attention if they experience a weakness or tingling sensation, especially in the legs or arms, and that might worsen or spread to other parts of the body.
Other telltale symptoms include difficulty walking, speaking, chewing, or swallowing; double vision; and bowel or bladder control problems.
