EU regulator says AstraZeneca vaccine is “safe and effective”

The EU’s drugs regulator said on Thursday that the AstraZeneca vaccine was “safe and effective” and was not linked to an increased risk of blood clots. This followed an investigation into reports of blood disorders that prompted more than a dozen nations to suspend its use.

The news came as the European Medicines Agency (EMA) director Emer Cooke said the agency could not definitively rule out a link to blood clot incidents and the vaccine in its investigation into 30 cases of a rare blood clotting condition.

It will however update its guidance to include an explanation about the potential risks for doctors and the public, she said.

Sweden’s Health Agency chief Johan Carlson said it would continue to suspend the use of the vaccine, but Italy said it would resume its use on Friday.

Italy’s Prime Minister Mario Draghi said in a statement that it remained the government’s priority “to carry out as many vaccinations as possible in the shortest possible time”.

Lithuania said it would also resume vaccinating with AstraZeneca shots.

The EU regulator has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who have received the shot.

The agency’s review covering five million people, included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which links 30 European countries.

The EMA’s focus and primary concern has been on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT) or a subform known as cerebral venous sinus thrombosis (CVST).More than 45 million of the shots have been administered across the EEA. (France24)

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