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EU medicines regulator says benefits of J&J vaccine outweigh risks as it reviews rare blood clots


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Athens City-County Health Department Director of Nursing, Crystal Jones, 52, loads syringes with the vaccine on the first day of the Johnson and Johnson vaccine.

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LONDON — Europe’s medicines regulator on Wednesday said it still believes the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh the risks of side effects following reports of extremely rare blood clotting.

It comes shortly after the U.S. Food and Drug Administration asked states to temporarily pause using J&J’s vaccine “out of an abundance of caution” after six cases of a blood clotting disorder were detected among more than 6.8 million doses of the shot.

All six cases occurred in the U.S. in women, aged between 18 and 48, with symptoms developing six to 13 days after they received the shot. The FDA said one woman died as a result of blood clotting complications and another is in a critical condition.

The European Medicines Agency said it is currently investigating all the reported cases and will decide whether regulatory action is required.

“The EMA is currently expediting this evaluation and currently expects to issue a recommendation next week,” Europe’s medicines regulator said in a statement.

“While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.”

South Africa has halted its rollout of the shot, while J&J said it would “proactively delay” deliveries of its vaccine to Europe, which started last week.

The vaccine was authorized in the EU on March 11, but the widespread use of the shot has not yet started.

“Right now, these adverse events appear to be extremely rare,” the FDA said on Tuesday in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”

Last week, Europe’s medicines regulator said it found a possible link between the coronavirus vaccine developed by AstraZeneca and the University of Oxford and rare blood-clotting issues. AstraZeneca has not received authorization for use in the U.S.

The Oxford-AstraZeneca and J&J vaccines work in similar ways and both use an adenovirus, a common type of virus that typically causes mild cold symptoms.


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