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AstraZeneca vaccine is “safe and effective,” says European regulator EMA

The European Medicines Agency (EMA) announced on Thursday evening that benefits of AstraZeneca vaccine against Covid-19  outweigh risks but also that it is continuing to study possible link with very rare blood clotting disorder.

The AstraZeneca coronavirus vaccine is “safe and effective” and its benefits outweigh the risks, Europe’s medicines regulator has said, but it would continue to study possible links between the shot and a very rare blood clotting disorder.

The director of the European Medicines Agency (EMA), Emer Cooke, said the agency’s safety committee had reached “a clear scientific conclusion” and had not found that the vaccine was associated with an increase in the overall risk of blood clots.

But Cooke said the agency’s review, launched after about 30 cases of unusual blood clots and low platelet counts in recipients of the vaccine prompted more than a dozen EU countries to suspend its use, had uncovered “a small number of cases of rare and unusual but very serious clotting disorders”.

She said the EMA still could “not rule out definitively a link between these cases and the vaccine”, and was therefore “recommending to raise awareness of these possible risks, making sure that they’re included in the product information”.

With several EU countries starting a third wave driven by more infectious new variants, many health experts have said the national suspensions risked harming public confidence in the much-needed vaccine and delaying the continent’s already sluggish rollout.

Investigations were continuing into the rare events, Cooke said, but “about 7 million people have now been vaccinated in the EU with the AstraZeneca vaccine, and 11 million in the UK … and I want to reiterate that our scientific position is that this vaccine is a safe and effective option to protect citizens against Covid-19”.

Britain’s MHRA medicines regulator also said on Thursday that the evidence did not suggest that the AstraZeneca vaccine caused blood clots, adding that it too was investigating a very rare and specific type of blood clot in cerebral veins.

It said there had been five cases of cerebral venous sinus thrombosis combined with a low platelets count in recipients of the vaccine in the UK, where more than 11m doses of AstraZeneca have been administered, and there was no need to pause the shot. (full story: theGuardian)

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