The Food and Drug Administration is adding a new warning for Americans who get the Johnson & Johnson coronavirus vaccine based on reports of a rare nerve disease in those who received the shots.
“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” the FDA said in a letter dated Monday to Janssen Biotech, the division of Johnson & Johnson that developed the vaccine.
About 100 preliminary reports of Guillain-Barré have been reported, according to the Centers for Disease Control and Prevention, The Washington Post reported.
Of those, 95 were serious and required the patient to be hospitalized, the FDA said. One person has died.
The FDA will stop short of saying the vaccine caused the disease.
NEW: The FDA warns that J&J’s coronavirus vaccine can increase the risk of Guillain-Barré syndrome. Risk is low but 3-5 times > than in general population. The neurological disorder was also linked to the 1976 swine flu vaccine. @SharonLNYT @noahweiland https://t.co/4B4WhASEmO
— Sheryl Gay Stolberg (@SherylNYT) July 12, 2021
The J&J #Covid vaccine may be linked to a small increased risk of developing Guillain-Barré syndrome, @US_FDA says. With the EMA saying last week that AstraZeneca’s vaccine may also trigger GBS, people will be looking to see if there’s a class effect. https://t.co/RLZdaNxeZ5
— Helen Branswell (@HelenBranswell) July 12, 2021
Existing evidence “is insufficient to establish a causal relationship,” the FDA said, according to The Post.
The FDA said it “continues to find the known and potential benefits clearly outweigh the known and potential risks” of the Johnson & Johnson vaccine.
In its reporting, The New York Times said that incidence of the rare nerve disorder “appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States.”
According to the FDA letter sent to Janssen, “Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. “
The FDA said symptoms of having Guillain-Barré include weakness or tingling sensations, especially in the legs or arms; difficulty walking or with facial movements; and difficulty with bladder control or bowel functions.
— Dr. Nina L. Shapiro (@drninashapiro) July 12, 2021
Most of those affected have been men aged 50 and older, according to the CDC.
The Post report said no such issues have been found with the Pfizer-BioNTech and Moderna vaccines.
This is the second major stumbling block for the Johnson & Johnson vaccine.
Three months ago, it was put on pause amid concerns the vaccine caused severe blood clots. The pause in its use ended after a warning was attached to the drug.
The Astra Zeneca vaccine, which is given in Europe and has not been approved for use in the U.S., has also been examined for a possible link to Guillain Barré.
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