The Food and Drug Administration (FDA) announced a new warning on the Johnson & Johnson COVID-19 vaccine and a possible link to Guillain-Barré, a rare autoimmune nerve disorder. The agency revised the vaccine’s accompanying fact sheets to reflect an increased risk of the disorder following vaccination.
The warning comes after about 100 preliminary reports of Guillain-Barré cases against a backdrop of about 12.5 million Johnson & Johnson doses administered, the FDA said in a statement Monday. Of the total, 95 cases were serious and involved hospitalization, with one reported death. However, the FDA stopped short of pinning a causal relationship between the vaccine and the rare disorder.
“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 statement reads, later adding, “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 updated warning advises seeking immediate medical attention upon symptoms post-vaccination like “weakness or tingling sensations (especially in the legs or arms) worsening or spreading to other parts of the body, difficulty walking, difficulty with facial movements including speaking, chewing or swallowing, double vision or inability to move eyes, or difficulty with bladder control or bowel function.”
Johnson & Johnson has been in talks with the FDA and other regulators over the rare cases, the company said in a statement on Monday.
“The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree,” reads the statement from Johnson & Johnson, which also urged awareness over signs and symptoms of rare adverse events for prompt identification and treatment.- READ MORE
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