EU's Drug Regulator Backs AstraZeneca Vaccine After Safety Investigation

Reuters
Packages and a vial of AstraZeneca's COVID-19 vaccine.
Packages and a vial of AstraZeneca's COVID-19 vaccine.Credit: Thilo Schmuelgen/Reuters
Reuters

The EU's drug watchdog said on Thursday it is still convinced the benefits of AstraZeneca's COVID-19 vaccine outweigh the risks following 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.

The agency 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 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.

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