The US will resume distribution of the Johnson & Johnson Covid-19 vaccine after an 11-day pause despite fears of the potential for extremely rare blood clots.
Scientific advisers decided its benefits outweigh the rare risk of adverse side effects.
The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly eight million people given the J&J jab.
All were women, most under 50, and three died while seven remain in hospital.
The Food and Drug Administration and Centres for Disease Control and Prevention (CDC) decided that J&J’s one-and-done vaccine is critical to fight the 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.
CDC Director Dr Rochelle Walensky said: “Above all else, health and safety are at the forefront of our decisions. Our vaccine safety systems are working.”
The US decision – similar to how European regulators are rolling out J&J’s shot – comes after CDC advisers earlier on Friday voted 10-4 to resume vaccinations but panellists made clear that they must come with warnings about the risk.
Dr Sarah Long of Drexel University College of Medicine, who voted against the proposal because she felt it did not go far enough in warning women, said: “This is an age group that is most at risk (of the clotting) that is getting vaccine predominately to save other peoples’ lives and morbidity, not their own.
“And I think we have a responsibility to be certain that they know this.”
The committee members all agreed the J&J vaccine “should be put back into circulation,” panel chairman Dr Jose Romero, Arkansas’ health secretary, 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.”
