The European Union’s drug regulatory agency says experts have concluded the AstraZeneca vaccine is not linked to an overall increase in the risk of blood clots and that the benefits of use outweigh the risks.
The finding from the European Medicines Agency could open the way for European countries that had suspended use of the vaccine over the past week to resume dispensing the shots.
European Medicines Agency executive director Emer Cooke said the agency’s expert committee on medicine safety had come to a “clear and scientific conclusion”.
“This is a safe and effective vaccine. Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalisation outweigh the possible risks,” she said, in a virtual press briefing in the early hours of Friday morning.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
But she said the agency “cannot rule out definitively a link” between the vaccine and a small number of “rare and unusual but very serious clotting disorders” detected during the review.
The EMA recommended raising awareness by adding a description of these cases to vaccine leaflets so health workers and patients would be aware of the rare clotting disorders.
“Our scientific position is that this vaccine is a safe and effective option to protect citizens against COVID-19,” Ms Cooke said.
“It demonstrated that at least 60 per cent 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.”
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