The European Medicines Agency (EMA) has approved the AstraZeneca vaccine for use after an emergency review found it is “a safe and effective vaccine," and not linked to a higher risk of developing blood clots.
In a highly anticipated verdict, Europe’s drug regulator said the benefits of the vaccine in combating COVID-19 far outweighed the risk of side effects.
“This is a safe and effective vaccine,” said Emer Cooke, the regulator’s chief executive.
But she said the agency "cannot rule out definitively a link" between the rare types of blood clots and the vaccine.
The EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware.
A number of countries including Cyprus paused the AstraZeneca rollout while EMA experts examined reports of blood clots in some recently inoculated people.
“We just have to continually remind ourselves of what a difficult situation we are in,” Cooke said.
“This pandemic is costing lives. We have vaccines that are safe and effective and can prevent deaths and hospitalisations. We need to use those vaccines.”
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