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EMA says there is ‘no indication’ AZ/Oxford’s COVID-19 vaccine causes blood clots

Agency’s safety committee added vaccine’s benefits continue to outweigh risks

The European Medicines Agency (EMA) has said that there is currently ‘no indication’ that reported blood clots in people who have received the AstraZeneca/Oxford University vaccine were caused by the jab. 

In a statement, the EMA said that it is ‘aware’ that the Danish Health Authority has halted its AZ/Oxford COVID-19 vaccination campaign, after reports of blood clots in people who had received the vaccine. This includes one case in Denmark, where a person died.

In addition to Denmark, Norway and Iceland have also temporarily paused the rollout of the AZ/Oxford vaccine.

Other EU member states – Italy and Austria – have suspended vaccination from certain batches of the vaccine, although the suspensions in each country involves different batches.

According to the BBC, Estonia, Latvia, Lithuanian and Luxembourg have stopped using vaccines from the same batch (number ABV5330) as Austria, while Romania has suspended use of 4,200 doses from the same batch of vaccines currently suspended in Italy.

The suspensions come as a ‘precautionary measure’, the EMA said in a statement, while a full investigation is conducted into the reports.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has maintained that the benefits of the AZ/Oxford vaccine continue to outweigh the risks.

It added that the vaccine can still be administered while the ongoing investigation into the cases of thromboembolic events continues.

PRAC is already reviewing all reported cases following vaccination with the AZ/Oxford vaccine, as announced on 10 March.

It added that the number of thromboembolic events in vaccinated individuals is no higher than the general population.

‘As of 10 March 2021, 30 cases of thromboembolic events had been reported among close to five million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area,' the EMA said in a statement.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also responded to the precautionary measures undertaken by the Danish, Norwegian and Icelandic authorities.

“It has not been confirmed that the report of a blood clot, in Denmark, was caused by the COVID-19 Vaccine AstraZeneca,” said Phil Bryan, vaccines safety lead, MHRA.

“Blood clots can occur naturally and are not uncommon. More than 11 million doses of the COVID-19 Vaccine AstraZeneca vaccine have now been administered across the UK. Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population.

“The safety of the public will always come first. We are keeping this issue under close review but available evidence does not confirm that the vaccine is the cause. People should still go and get their COVID-19 vaccine when asked to do so,” he added.

Article by
Lucy Parsons

12th March 2021

From: Research

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