EU agency says AstraZeneca vaccine is safe and effective.
A review by the EU’s medicines regulator has concluded the Oxford-AstraZeneca Covid-19 vaccine is “safe and effective”, and its benefits outweigh the risks.
The European Medicines Agency (EMA) conducted its review after 13 EU states suspended use of the vaccine over fears of a link to blood clots.
The EMA found the vaccine was “not associated” with higher risk of clots.
But it said it would continue to study the possibility of such links.
The EMA investigation focused on a small number of cases of unusual blood disorders. In particular, it was looking at cases of cerebral venous thrombosis – blood clots in the head.
Decisions to suspend use of the vaccine sparked concerns over the pace of the region’s vaccination drive, which had already been affected by supply shortages.
Much of Europe is struggling to contain a surge in coronavirus cases.
The World Health Organization (WHO) on Thursday called on countries to continue using the vaccine, and is due to release the results of its own review into the vaccine’s safety on Friday.
Emer Cooke, the agency’s executive director, told a news conference: “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.”
The EMA’s expert committee on medicine safety, Mrs Cooke said, found that “the vaccine is not associated with an increase in the overall risk of thrombotic events or blood clots”.
But the EMA, she added, could not rule out definitively a link between the vaccine and a “small number of cases of rare and unusual but very serious clotting disorders”.
Therefore the committee has, she said, recommended raising awareness of these possible risks, making sure they are included in the product information. Additional investigations are being launched, Mrs Cooke added.