The agency said Thursday that it was making the move after confirming a total of 60 cases, including nine deaths, of the clotting condition known as thrombosis with thrombocytopenia syndrome, or TTS, among the millions of people who got the J&J shot.
The change will likely sharply scale back use of a vaccine that health authorities had once hoped would be a convenient option for many people, but has become a third choice for most people because of the emergence of the risk for the rare but life-threatening side effect.
Due to the risk, the Centers for Disease Control and Prevention in December recommended that patients opt for one of the other vaccines over the Johnson and Johnson shot.
“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,” said Peter Marks, who leads the FDA division responsible for regulating vaccines.
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