FDA Issues New Warning on J&J Vaccine

CDC says it has been linked to around 100 cases of Guillain-Barre syndrome
By Rob Quinn,  Newser Staff
Posted Jul 12, 2021 3:11 PM CDT
Report: FDA to Issue New Warning on J&J Vaccine
In this March 26, 2021 photo a member of the Philadelphia Fire Department prepares a dose of the Johnson & Johnson COVID-19 vaccine at a vaccination site setup in Philadelphia.   (AP Photo/Matt Rourke, File)

Another setback for the Johnson & Johnson COVID vaccine: The FDA has added a new warning to on the one-shot vaccine after reports of a rare side effect. The CDC says there have been around 100 reports of people contracting Guillain-Barre syndrome after receiving the J&J vaccine. Most of them were hospitalized and one person died, though regulators say it's not entirely clear whether the shot caused the problem, the AP reports. The CDC says around 12.8 million doses of the vaccine have been administered and there does not appear to be a similar increased risk of the autoimmune disorder with the Pfizer and Moderna vaccine, the Washington Post reports.

The CDC describes the syndrome as a "rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis." The CDC says most of the estimated 3,000 to 6,000 people who develop GBS each year in the US recover fully. People sometimes develop the syndrome after the flu or other infections, including COVID-19. The CDC says the cases linked to the J&J vaccine mainly occurred in men over 50 around two weeks after vaccination. Health officials describe the issue as a "small possible risk." The FDA says people who receive the J&J shot should seek medical attention if they experience symptoms including tingling sensations and double vision. (Read more coronavirus vaccine stories.)

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