US health officials on Friday lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson’s (J&J) single-dose shot, after scientific advisers decided that its benefits outweigh a rare risk of blood clot.
The US government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot out of nearly 8 million people given the J&J shot. All were women, most under 50. Three died and seven remain hospitalized.
However, ultimately, federal health officials decided that J&J’s one-and-done vaccine is critical to fight the COVID-19 pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.
The US Centers for Disease Control and Prevention (CDC) said the J&J vaccine has important advantages for some people who were anxiously awaiting its return.
The US Food and Drug Administration (FDA) updated online vaccine information leaflets for would-be recipients and health workers, so that shots could resume as early as yesterday.
“This is not a decision the agencies reached lightly,” FDA Acting Commissioner Janet Woodcock told reporters late on Friday.
CDC Director Rochelle Walensky added that the pause should increase confidence in vaccine safety, showing “that we are taking every one of those needles in a haystack that we find seriously.”
The US decision — similar to how European regulators are rolling out J&J’s shot — comes after advisers to the CDC debated in a day-long meeting just how serious the risk really is.
Panelists voted 10-4 to resume vaccinations without outright age restrictions, but made clear that the shots must come with clear warnings about the clots.
“I think we have a responsibility to be certain that they know this,” said Sarah Long of Drexel University College of Medicine, who voted against the proposal, because she felt it did not go far enough in warning younger women.
The committee members all agreed the J&J vaccine “should be put back into circulation,” panel chairman and Arkansas Secretary of Health Jose Romero said in an interview after the vote. “The difference was how you convey the risk... It does not absolve us from making sure that people who receive this vaccine, if they are in the risk group, that we inform them of that.”
European regulators earlier this week made a similar decision, saying the clot risk was small enough to allow the rollout of J&J’s shot.
However, how Americans ultimately handle J&J’s vaccine will influence other countries that do not have as much access to other vaccination options.
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