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J&J Vaccine Limits

The US Food and Drug Administration is limiting the authorized use of Johnson & Johnson's SARS-CoV-2 vaccine due to the risk of a rare blood clotting syndrome, CNBC reports.

The agency authorized J&J's SARS-CoV-2 vaccine in late February 2021 after a Phase 3 study indicated the one-dose regimen had a 66 percent efficacy rate in preventing moderate-to-severe COVID-19. The company later reported that two doses of their vaccine could further boost that protection. But the vaccine has also been linked to a rare blood clotting disorder as well as a rare neurological condition.

Because of the associated risk of thrombosis with thrombocytopenia syndrome — a potentially life-threatening condition in which individuals develop serious blood clots in combination with low blood platelet levels — the FDA now says the J&J SARS-CoV-2 vaccine should be limited to adults who cannot receive another SARS-CoV-2 vaccines for medical reasons, cannot access other SARS-CoV-2 vaccines, or would not otherwise receive a vaccination.

CNN notes that more than 18.7 million doses of the J&J vaccine have been given in the US.

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