FDA limits use of Johnson & Johnson’s Covid-19 vaccine

FDA limits use of Johnson & Johnson’s Covid-19 vaccine, citing clotting risk.
Due to the ongoing concern of rare but serious blood clots, US regulators carefully limited who can receive Johnson & Johnson’s COVID-19 vaccination on Thursday.
The vaccination should only be administered to people who are unable to obtain another vaccine or who explicitly prefer J&J’s vaccine, according to the FDA. For months, US authorities have advised Americans to start their COVID-19 vaccinations with the Pfizer or Moderna vaccines.
“If we see deaths and there is an alternative vaccine that is not associated with deaths but is associated with similar efficacy … we felt it was time at this point to make a statement on the [product’s] fact sheet that this was not a first-line vaccine,” said Marks, who is director of the FDA’s Center for Biologics Evaluation and Research.
J&J’s vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.
In December, the Centers for Disease Control and Prevention recommended prioritizing Moderna and Pfizer shots over J&J’s because of its safety issues. Previously, U.S. officials had treated all three vaccines similarly because they’d each been shown to offer strong protection.
But follow-up studies have consistently shown lower effectiveness for J&J’s vaccine. And while the blood clots seen with J&J’s shot are rare, officials say they’re still occurring.
Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.

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