AstraZeneca vaccine linked to rare blood clots, says EMA official

The head of the European Medicines Agency’s vaccines strategy said there is a link between the Oxford/AstraZeneca coronavirus vaccine and a rare blood clot in the brain.

However, in an interview with Italian newspaper il Messaggero, Marco Cavaleri gave no indication that the EU regulator will at this stage change its recommendation that people continue to get vaccinated. The EMA has so far maintained the benefits of the AstraZeneca jab in protecting against the coronavirus outweigh any risks.

“We can now say, it is clear that there is a link with the vaccine,” Cavaleri said in the interview. “What causes this reaction, however, we do not know yet,” he said, adding the agency would announce this in a few hours.

Asked if the risk-benefit ratio was still in favor of the vaccine, Cavaleri replied, “Yes.”

The EMA’s safety committee PRAC is meeting this week to discuss the latest evidence of blood clots after vaccination with the Oxford/AstraZeneca jab, after which it is expected to make a fresh announcement.

On March 18, PRAC said the vaccine “may be associated” with very rare cases of blood clots associated with thrombocytopenia — low levels of blood platelets — including rare cases of clots in the vessels draining blood from the brain called cerebral venous sinus thrombosis (CVST).

After further reports of blood clots in Germany and France, the agency said on March 31 there was “no evidence that would support restricting the use of [the Oxford/AstraZeneca] vaccine in any population.”

Both countries however opted to limit the jab to older populations after concerns about blood-clotting incidents.

In Europe, the vaccine has also been restricted to older populations in the Netherlands, Sweden, Iceland, North Macedonia and Finland. Denmark and Norway have suspended its use completely. Elsewhere, it has been restricted to older people in Canada, while the U.S. has not yet approved the vaccine for use.

In the U.K., the Medicines and Healthcare Products Regulatory Agency is also reviewing cases of rare blood clots. The regulator said Sunday night that “no decision has yet been made on any regulatory action.”

Ashleigh Furlong, Carlo Martuscelli and Jillian Deutsch contributed reporting.

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