The European Medicines Agency has delivered its conclusions on the links between thrombosis and the AstraZeneca vaccine against Covid-19.
At the same time, the EMA estimated that the benefit / risk balance remains "positive" with this product, of which several European countries have suspended the use.
The European Medicines Agency (EMA) announced on Wednesday that blood clots should be listed as a "very rare" side effect of the AstraZeneca vaccine against Covid-19, while estimating that the benefit / risk balance remains "positive".
The EMA has established "a possible link with very rare cases of unusual blood clots with low blood platelets," the Amsterdam-based agency said in a statement.
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No specific risk factor
No specific risk factors were identified, however, EMA Executive Director Emer Cooke said in a video conference.
"Specific risk factors such as age, gender or medical history could not be confirmed because rare events are seen at all ages," she explained.
"A plausible explanation for these rare side effects is an immune response to the vaccine," added Emer Cooke, noting that the vaccine is "very effective" and "saves lives".
Several European countries have suspended the use of the vaccine from the Anglo-Swedish laboratory AstraZeneca due to reports of blood clots among those vaccinated.
The European regulator had previously assured that the vaccine was not linked to a higher risk of blood clots, indicating, however, that it could not "definitively exclude" a link with rare bleeding disorders.
European Union health ministers are due to meet by videoconference from 6 p.m. to discuss the EMA's findings.