Benefits of AstraZeneca Covid-19 vaccine ‘far outweigh the risks’, says European Medicines Agency

The benefits of the AstraZeneca Covid-19 vaccine outweigh its risks, the European Medicines Agency (EMA) has concluded.

Thursday, 18th March 2021, 4:45 pm
Updated Thursday, 18th March 2021, 5:25 pm
File photo dated 04/02/21 of a vial of the Oxford/AstraZeneca coronavirus vaccine. UK leaders and medical experts have defended the use of the AstraZeneca vaccine despite multiple European countries pausing its use due to concerns over possible adverse side effects. Issue date: Tuesday March 16, 2021.

It comes after more than 12 European countries paused their rollout of the vaccine as a precaution over several incidents of blood clots following vaccination.

Several countries, including Germany, Italy and France, say they would await results from an EMA investigation before deciding whether or not to resume delivery of the jag.

At a press briefing on Thursday, executive director Emer Cooke said the EMA committee had come to a “clear scientific conclusion”.

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“This is a safe and effective vaccine,” she said.

"Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.

“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events, or blood clots.”

She added that EMA had worked closely with European medical experts and the regulator’s UK counterpart the Medicines and Healthcare products Regulatory Agency (MHRA) during their work.

Dr Sabine Straus, head of the EMA’s Pharmacovigilance Risk Assessment Committee (Prac), said the number of blot clots reported after vaccination was “lower than expected in the general population”.

She said: “Prac has concluded that there is no overall increase in the risk of blood clots with this vaccine.”

Because the vaccine was effective in preventing Covid-19 – which can lead to blood clots – she said it “likely reduces” the risks of clots overall.

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However, she said there were still “some uncertainties” with a few cases where tiny clots had developed in multiple vessels or in vessels draining blood from the brain.

“The evidence that we have is at the moment not sufficient to conclude with certainty whether these events are indeed caused by the vaccine or not,” she said.

It comes after World Health Organisation regional director for Europe said on Thursday that the benefits of the vaccine outweigh the risks.

“The Covid-19 vaccination will not reduce death or illness from other causes,” Dr Hans Kluge said.

“As of now we do not know whether some or all of the conditions have been caused by the vaccine or by other coincidental factors.

“At this point in time, the benefits of the AstraZeneca vaccine far outweigh its risk and its use should continue to save lives.”

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