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AstraZeneca safe, effective, no causal link with clots-EMA

AstraZeneca safe, effective, no causal link with clots-EMA

Will delve deeper into rare cases of thrombosis says drug agency

ROME, 18 March 2021, 18:34

Redazione ANSA

ANSACheck

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European Medicines Agency Executive Director Emer Cooke said Thursday that the Oxford-AstraZeneca vaccine is "safe, effective, the benefits are higher than the risks and we can rule out any link between blood clots" and the administration of the jab, prompting Italian Premier Mario Draghi to announce that administaton of the ja will resume on Friday afternoon.
    EMA's clinical safety committee says the jab "cannot be linked to an increase in the events of thrombosis", said Cooke.
    She added "we will launch further investigations to better understand" the rare adverse events flagged up after the AstraZeneca vaccine was administered.
    Cooke said, however, that a link with the rare cases of blood clots cannot be ruled out and so this possibility must be flagged.
    Cooke said EMA had kept its promise to inform EU members on the issues so they can take the necessary steps after several countries including Italy suspended the jab pending Thursday's review.
    The incidence of blood clots after getting the vaccine is lower than in the non.vaccinated population, said Sabine Strauss, chair of EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
    She said "the benefits of the AstraZeneca vaccine continue to be much higher than the risks. The EMA safety committee has not found evidence of any problems in quality or in the batches".
    AstraZeneca vaccine leaflets will be updated to include information on possible side effects so that the public and health operators can mitigate them, said Strauss.

The administration in Italy of the Oxford-AstraZeneca jab will resume on Friday after EMA's review, Draghi said. "The Italian government welcomes EMA's pronouncement on the AstraZeneca vaccine," he said. "The government's priority remains that of achieving the highest number of vaccinations in the shortest time possible". The health ministry said vaccinations would resume at 15:00 Friday.


   

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