EU regulator says AstraZeneca vaccine is “safe and effective”

The EU’s drug 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 problems that prompted more than a dozen nations to discontinue its use.

The news came when the European Medicines Agency (EMA) Director Emer Cooke said the agency could not definitively rule out a link to thrombotic events and the vaccine in its investigation of 30 cases of a rare thrombotic condition.

However, it will update its guidance to include an explanation of the potential risks to doctors and the general public, she said.

The agency has been under increasing pressure to clear safety issues 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 of 5 million people covered 30 cases of unusual blood diseases in people within the European Economic Area (EEA), linking 30 European countries.

EMA’s focus and main concern has been cases of blood clots in the head, a rare condition that is difficult to treat called cerebral venous thrombosis (CVT) or a subform called cerebral venous sinus thrombosis (CVST).

More than 45 million of the shots have been administered throughout the EEA.


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