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FDA limits approval of Johnson & Johnson COVID-19 vaccine

FDA limits approval of Johnson & Johnson COVID-19 vaccine
Boxes of Janssen (Johnson & Johnson) vaccines sit at a warehouse of Hungaropharma, a Hungarian pharmaceutical wholesale company, in Budapest, Hungary, on April 13, 2021. File Photo by Szilard Koszticsak/EPA-EFE

May 5 (UPI) -- The Food and Drug Administration on Thursday said it's limiting its authorization of the single-dose Johnson & Johnson COVID-19 vaccine to adults who can't receive other versions of the shot.

The federal agency said it's restricting the vaccine because of the risk of thrombosis with thrombocytopenia syndrome, which can cause rare but potentially life-threatening blood clots and low levels of blood platelets about one to two weeks after the administration of the shot.

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Despite the risks, the FDA said the known and potential benefits of the Johnson & Johnson vaccine outweigh the known and potential risks associated with the shot for adults. Therefore, the agency is still authorizing the vaccine for individuals 18 years old and older who can't receive other COVID-19 vaccines -- either because they're not accessible or clinically appropriate.

"We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,"

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The FDA temporarily paused the administration of the Johnson & Johnson COVID-19 vaccine last year after several reported cases of blood clotting. At the time, all six cases were found in women between the ages of 18 and 48. At least one died.

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