WASHINGTON (AP) — U.S. regulators on Thursday sharply limited who can receive Johnson & Johnson’s COVID-19 vaccine due to a rare but serious risk of blood clots.
The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or who specifically request the Johnson & Johnson option. For months, U.S. officials have advised that Americans starting their COVID-19 vaccination series should opt for Pfizer or Moderna injections instead.
FDA officials said in a statement that they decided to restrict the Johnson & Johnson vaccine after reanalyzing data on the risk of life-threatening blood clots occurring within two weeks of vaccination.
The decision represents the latest restriction affecting the single-dose Johnson & Johnson vaccine, which for a long time has been eclipsed by Pfizer and Moderna’s two-shot regimens.
In December, the Centers for Disease Control and Prevention urged prioritizing Moderna and Pfizer vaccines over Johnson & Johnson because of safety concerns. Earlier, American officials had treated the three vaccines similarly, since each had been shown to offer strong protection.
But follow-up studies have consistently shown lower effectiveness for the Johnson & Johnson vaccine. And while the clotting events associated with the Johnson & Johnson shot are rare, officials say they are still occurring.
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