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The Food and Drug Administration is preparing to add a warning about a rare side effect that may occur after receiving Johnson & Johnson's COVID-19 vaccine. According to a report by the Washington Post, the FDA has received reports of 100 suspected cases of Guillain-Barré syndrome, a rare disorder in which the immune system attacks nerves cells, among the 12.8 million people who have received the pharmaceutical company's single-dose vaccine.
While health officials said the syndrome is rare, people who received Johnson & Johnson's vaccine are three to five times more likely to develop the condition compared to the general population.
The Centers for Disease Control and Prevention said that most of the cases were in men over the age of 50 and were reported within two weeks of receiving the vaccine.
The FDA still believes the benefits of the vaccine outweigh the risks that people may develop Guillain-Barré syndrome. Most people who contract the syndrome make a full recovery, though some people suffer permanent nerve damage.
"It's not surprising to find these types of adverse events associated with vaccination," Dr. Luciana Borio, a former acting chief scientist at the FDA, told the New York Times. "The data collected so far by the FDA, she added, suggested that the vaccine's benefits 'continue to vastly outweigh the risks.'"
Health officials have found no evidence that the vaccines made by Pfizer and Moderna increase the risk of developing Guillain-Barré syndrome.