The EMA’s expert panel found links between the AstraZeneca vaccine and cases of thrombosis, but said the benefits outweighed the risks.



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EMA Director Emer Cooke.  REUTERS / Yves Herman / Swimming pool
EMA Director Emer Cooke. REUTERS / Yves Herman / Swimming pool

The European Medicines Agency (EMA) admitted a link between thrombosis and AstraZeneca vaccine but he assured that the benefits of the inoculant outweigh the risks of side effects.

“The EMA’s Expert Committee on Drug Safety (PRAC) has confirmed that the benefits of the AstraZeneca vaccine for preventing COVID-19 generally outweigh the risks of side effects.”said the executive director of the agency, Emer cooke.

“The PRAC, after careful analysis, concluded that reported cases of unusual blood clots after vaccination with the AstraZeneca vaccine should be included as possible side effects.”Cooke added.

The director of the European Medicines Agency (EMA), Emer Cooke, during her digital appearance before the European Parliament's public health committee on Tuesday in Brussels.  HOSLET EFE / EPA / OLIVE TREE
The director of the European Medicines Agency (EMA), Emer Cooke, during her digital appearance before the European Parliament’s public health committee on Tuesday in Brussels. HOSLET EFE / EPA / OLIVE TREE

The head of the agency said they are in collaboration with the competent national authorities of the Member States of the European Union and the company AstraZeneca for “Ensure that these risks are proactively communicated to healthcare professionals”.

Cooke stressed the importance of both those vaccinated and healthcare professionals “Know the signs and symptoms of these unusual blood clotting disorders and detect them early to minimize the risks”.

The EMA said it will continue monitor all available scientific evidence on the efficacy and safety of all coronavirus vaccines authorized and “will issue further recommendations, if necessary, on the basis of solid evidence.”

For her part, the president of the EMA expert committee, Sabine straus, noted that they had carried out a detailed review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic venous thrombosis in the EU database on the safety of medicines (EudraVigilance) as of 22 March 2021, of which “18 were fatal”.

AstraZeneca coronavirus vaccine.  REUTERS / Yves Herman / File photo
AstraZeneca coronavirus vaccine. REUTERS / Yves Herman / File photo

“No specific risk factor could be identified on the basis of current data. The PRAC does not recommend any specific measures to reduce the riskStraus added.

Although most cases of thrombosis have occurred people under 60 and women, EMA experts could not conclude that “age and gender were obvious risk factors for these rare side effects”.

Further research and analysis will be carried out on this important topic.. The PRAC will continue to assess all available evidence on this issue as vaccination campaigns continue, ”added Straus.

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