EU medicines regulator finds possible link between Johnson & Johnson vaccine and blood clots

Europe’s medicines regulator said it has found a possible link between the Johnson & Johnson Covid-19 vaccine and rare blood clots, but emphasized that the overall benefits of getting the shot outweigh the risks.

The news, announced Tuesday, threw another complicating factor into the European Union’s vaccination rollout and dealt a major blow to the company a week after its vaccine was paused in the United States.

The European Medicines Agency (EMA) concluded that “a warning about unusual blood clots with low blood platelets should be added to the product information” about the vaccine given to patients.

It said it had analyzed all currently available evidence including eight reports of serious and unusual blood clots from the United States, where more than 7 million Johnson & Johnson shots have been given. One of those cases was fatal.

“All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women,” the agency said. “Based on the currently available evidence, specific risk factors have not been confirmed.”

The EMA added that “the combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.”

The vaccine was paused in the United States last week after the reports came to light, and was delayed in the EU the same day.

This is a developing story. More details soon