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Saturday, April 24, 2021 1:00 am

Paused J&J shot given OK to restart

Officials: Blood clot risk less than benefits

Associated Press

U.S. health officials lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson's single-dose shot Friday after scientific advisers decided its benefits outweigh a rare risk of blood clot.

The 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 age 50. Three died, and seven remain hospitalized.

But ultimately Friday, the Food and Drug Administration and Centers for Disease Control and Prevention 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.

“Above all else, health and safety are at the forefront of our decisions,” CDC Director Dr. Rochelle Walensky said in a statement. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses” of the J&J shot – and will continue to monitor them.

The U.S. decision – similar to how European regulators are rolling out J&J's shot – comes after CDC advisers earlier Friday voted 10-4 to resume vaccinations, but panelists made clear that they must come with warnings about the risk. The group debated but ultimately steered clear of outright age restrictions.

“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,” said 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.

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.”

European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J's shot. But how Americans ultimately handle J&J's vaccine will influence other countries that don't have as much access to other vaccination options.

Dr. Paul Stoffels, J&J's chief scientific officer, pledged that the company would work with U.S. and global authorities “to ensure this very rare event can be identified early and treated effectively.” J&J already was working with the FDA on a warning label for the shot.

The side effect debate isn't the only hurdle facing J&J. The FDA separately uncovered manufacturing violations at a Baltimore factory the company had hired to help brew the vaccine. No shots made by Emergent BioSciences have been used – J&J's production so far has come from Europe. But it's unclear how the idled factory will affect J&J's pledge to provide 100 million U.S. vaccine doses by the end of May and 1 billion doses globally this year.


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