EU drugs regulator says AstraZeneca vaccine is 'safe and effective'

·2-min read

The EU's drugs regulator said Thursday that the AstraZeneca vaccine doesn't increase the overall incidence of blood clots and that the benefits of using it outweigh the possible risks, paving the way for European countries to resume dispensing the shots.

European Medicines Agency (EMA) director Emer Cooke said the agency could not definitively rule out a link with 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.

France will resume vaccinating people with the AstraZeneca vaccine on Friday, French Prime Minister Jean Castex said at a press conference later on Thursday, at which he also announced a month-long limited lockdown for Paris and other regions.

Castex said that he will receive the vaccine himself on Friday afternoon.

“The AstraZeneca Covid-19 is effective, as underscored by the European regulator. It only has rare side effects," Castex said, noting that it has "a positive risk/reward ratio".

Sweden and Norway said they would continue to suspend the use of the vaccine despite reassurances by Europe's medical regulator, while Italy said it would resume its use on Friday.

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".

Other countries including Germany, Spain, Portugal, the Netherlands, Spain, Slovenia, Bulgaria and Lithuania said they 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 5 million people included 30 cases of unusual blood disorders in people in the European Economic Area (EEA), which groups 30 European countries.

The EMA's focus and primary concern has been on cases of blood clots in the head, a rare condition that is 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.