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13th Apr 2021

AstraZeneca 'safe and effective', says EU regulator

  • The AstraZeneca vaccine is safe and effective, the EU medicines regulator ruled on Thursday, after a week in which reports of fatal blood clots had caused 13 member states to suspend its use (Photo: European Commission)

EU regulators declared the AstraZeneca Covid-19 vaccine "safe and effective" on Thursday (18 March).

The announcement by the European Medicines Agency (EMA) came after 13 member states suspended its use over blood clot fears.

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But Dr Emer Cook, who heads the agency, told reporters that the vaccine's benefits far outweigh any risks.

She noted that the vaccine does not increase the risks of blood clots or thrombosis. The agency will, however, continue to study any such possible links.

Her views were echoed by Dr Sabine Straus, who chaired the committee overlooking potential risks.

Straus said "that there is no increase in the overall risks of blood clots with this vaccine". She also said it likely reduces the risks of thrombotic events overall.

AstraZeneca said it had received 37 reports of blood clots - out more than 17 million people vaccinated in the EU and UK.

Those reports triggered suspension of its use by 13 EU member states.

France, Germany and Italy earlier this week suspended the vaccine as a "precautionary measure" pending EMA's review.

Thousands of vaccine appointments have since been cancelled. The suspension has also added concerns to the already slow rollout of vaccines in the EU.

Last week, over 2,500 people died of Covid-19 in one day across the EU.

Meanwhile, other EU states like Belgium, the Czech Republic and Poland have continued to use AstraZeneca.

The World Heath Organisation also weighed in on Thursday.

It said the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue.

Following safety guidance from the European Medicines Agency, Germany, France and several other European countries have decided to lift suspensions on the AstraZeneca coronavirus vaccine on Thursday evening.

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