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EU regulator declares AstraZeneca vaccine 'safe and effective'

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LaToya Harding
·Contributor
·2-min read
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WATCH: European regulator says Oxford-AstraZeneca vaccine is 'safe and effective'

The European Medicines Agency (EMA) has concluded that the Oxford-AstraZeneca (AZN.L) COVID-19 vaccine is “safe and effective” for use.

The review from the medicines regulator comes after a string of European countries suspended their rollouts of the vaccine after fears it caused blood clotting.

The EMA said it would continue to study possible links between rare blood clots and the vaccine.

Several EU countries, including Germany, France and the Republic of Ireland, paused the use of the jab earlier this week.

Italy, Austria, Estonia, Latvia, Luxembourg and Lithuania also stopped using certain batches as a precaution after reports that a 50-year-old man had died in Italy after developing deep vein thrombosis (DVT).

Around 5 million Europeans have already received the AstraZeneca jab.

On Monday afternoon, the German government said it would temporarily halt the use of the vaccine. The country's health minister said the decision was taken on the advice of Germany’s national vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven reported cases of clots in the brains of people who had been vaccinated.

READ MORE: European Union turns to US for Oxford/AstraZeneca COVID vaccine

The decision was “a purely precautionary measure,” Jens Spahn said.

The Netherlands, Bulgaria, Denmark and Norway were also among the countries that paused its use, as well as Thailand, Iceland and Congo.

The review from the medicines regulator comes after a string of European countries suspended their rollouts of the vaccine after fears it caused blood clotting. Photo: Thilo Schmuelgen/Reuters
The review from the medicines regulator comes after a string of European countries suspended their rollouts of the vaccine after fears it caused blood clotting. Photo: Thilo Schmuelgen/Reuters

In a statement, AstraZeneca said there was no evidence of an increased risk of clotting due to the vaccine.

The company said that across the EU and the United Kingdom there had been 15 events of deep-vein thrombosis and 22 events of pulmonary embolism reported among more than 17 million people vaccinated.

Ann Taylor, the firm's chief medical officer, said on Monday: “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population.”

She added: "The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety."

Earlier on Thursday the World Health Organisation, which is set to release its own results of the vaccine’s safety, again backed the AstraZeneca jab after doing so on Wednesday.

WHO Europe director Hans Kluge said: "Benefits of the AstraZeneca vaccine outweigh any risks and its use should continue to save lives."

WATCH: What UK government COVID-19 support is available?