Following different concerns raised over rollout of AstraZeneca vaccine, the European Medicine Agency, the EU’s drugs regulator has certified the vaccine as “safe and effective”.
The body on Thursday also clarified that the vaccine was not linked to an increased risk of blood clots.
“The committee has come to a clear scientific conclusion: this is a safe and effective vaccine,” the agency’s Chief, Emer Cooke, told a press conference after a probe by the body’s safety committee.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
Furthermore, Cooke said that it was still convinced the benefits of AstraZeneca’s (AZN.L) 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.
He added that 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 have 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).