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The benefit-risk balance of the AstraZeneca vaccine remains “positive”, according to the EMA

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The European Medicines Agency ruled on Wednesday on the formation of blood clots recorded after the injection of the AstraZeneca vaccine against Covid-19. If the latter considers that these clots should be listed as a “very rare” side effect, she considers that the benefit / risk balance of this vaccine remains “positive”.

The European Medicines Agency (EMA) spoke out on Wednesday April 7 on the cases of blood clots found after injections of the AstraZeneca vaccine against Covid-19. At a press conference, she announced that the said clots should be listed as a “very rare” side effect of the vaccine. However, the EMA believes that the benefit / risk balance of this vaccine remains “positive”.

“A possible link with very rare cases of unusual blood clots with low blood platelets” has been established, the Amsterdam-based agency said in a statement.

No risk factor identified

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.

With AFP

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