FDA restricts use of Johnson & Johnson COVID vaccine due to blood clot risk

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FDA restricts use of Johnson & Johnson COVID vaccine due to blood clot risk
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The Food and Drug Administration put rigid limits on who can receive Johnson & Johnson’s one-dose COVID-19 vaccine on Thursday, saying the vaccine should only be given to people who cannot receive a different vaccine or those who specifically request it.

'THIS IS HAPPENING!':FDA vaccine chief Dr. Peter Marks said the agency made the decision after re-examining the data on the risks of life-threatening blood clots, concluding that they are limited to J&J's vaccine.

Out of the about 17 million Americans who received the J&J shot, federal scientists had identified 60 cases of the side effect, including nine that were fatal, as of mid-March. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was roughly 1 per million shots, according to Marks.

A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

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