The Food and Drug Administration (FDA) has updated information about the Johnson & Johnson COVID-19 vaccine to include a warning about increased risk of Guillain-Barré syndrome.
FDA approved the requested changes to the fact sheets on the vaccine by the drugmaker Janssen Biotech. According to the new warning, reports of adverse events following use of the Johnson & Johnson vaccine “suggest an increased risk” of the rare neurological disorder during the 42 days after vaccination.
The fact sheet for recipients and caregivers now says the chance of having Guillain-Barré occur “is very low.” But recipients of the Johnson & Johnson vaccine should seek medical attention right away if they develop symptoms such as weakness or tingling sensations, “especially in the legs or arms,” that worsen and spread elsewhere on the body; difficulty walking; double vision; and difficulty with bladder control or bowel function.
Citing “people familiar with the decision,” The New York Times reported that although regulators found the chances of developing Guillain-Barré to be low, they “appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States.”
The warning is the second the company has issued after reporting an increased risk of blood clots back in April, but FDA maintains “the known and potential benefits of the product outweigh the known and potential risks of the product.”
Last Updated On
July 14, 2021
Originally Published On
July 13, 2021