EU regulator declares AstraZeneca safe for use

THE European Union’s medicines regulator has concluded that the Oxford-AstraZeneca Covid-19 vaccine is safe to use after several EU countries suspended their rollouts following reports that it could be linked to blood clots. 

The European Medicines Agency (EMA)’s executive director Emer Cooke said the agency had “come to a clear scientific conclusion: this is a safe and effective vaccine.” 

Cooke said the group did not find that the vaccine causes clotting, but added it could not rule out definitively a link to a rare blood clotting disorder, of which seven cases have been reported out of 20 million doses given in the UK. 

But she said the benefits of using the vaccine outweighed the risk. The agency’s decision comes after more than a dozen European countries halted their use of the vaccine, citing reports of a handful of patients across Europe who developed clotting after being inoculated. 

Most of the countries said they would await the EMA’s green light before resuming rollouts, but concerns remain about the impact of the suspensions on vaccine hesitancy across the continent. 

“I want to reiterate that our scientific position is this: this vaccine is a safe and effective option to protect citizens against Covid-19,” Cooke said at a press conference Thursday. 

“It demonstrated that at least 60% efficacy in clinical trials and preventing coronavirus disease, and in fact the real world evidence suggests that the effectiveness could be even higher than that.” 

The group said it recommended raising awareness of blood clot reports so that they could be further analyzed. 

But they said those reports were rare, and that more than 7 million people have received the vaccine in the EU. 

Countries should continue to use the AstraZeneca vaccine, the World Health Organization (WHO) has said, arguing its benefits outweigh any risks as the world continues to reel from the coronavirus pandemic. Hans Kluge, WHO director for Europe, made his appeal on Thursday after more than a dozen European countries stopped using the vaccine following scattered reports of blood clots as possible serious side effects, Aljazeera said. “As of now, we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors,” Kluge said.

 

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