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Benefits of AZ COVID-19 vaccine 'continue' to outweigh risks, says EMA’s executive director

EU regulator is expected to publish findings from its investigation on Thursday

The European Medicines Agency’s (EMA) executive director Emer Cooke has maintained that the benefits of the AstraZeneca (AZ)/Oxford University COVID-19 vaccine ‘continue’ to outweigh the risks.

Yesterday the EMA announced that its Pharmacovigilance Risk Assessment Committee (PRAC) had made progress in its investigation into reports of blood clots in people who had received the AZ/Oxford vaccine.

As announced earlier this week, the EMA is investigating 30 cases of thromboembolic events among approximately five million people who have received the AstraZeneca vaccine in the European Economic Area.

The regulatory agency noted that some of these cases had ‘unusual features’, including low numbers of platelets.

Although the investigation is ongoing, the EMA reiterated its previous position that the benefits of the vaccine outweigh the risks.

"[The EMA is] firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects,” added Cooke.

However, a total of 13 EU countries, including Germany, France, Italy and Sweden, have suspended the use of the vaccine while the EMA concludes its investigation into the reported blood clot cases.

The EMA's safety committee PRAC is expected to conclude and communicate its findings tomorrow, issuing any recommendations for further action if necessary.

The UK’s Health and Social Care Secretary Matt Hancock also maintained the safety of the AZ/Oxford vaccine yesterday, encouraging people to continue to receive the jab if they are invited to do so.

“We know that the Oxford/AstraZeneca vaccine is saving lives in the UK right now. So if you get the call, get the jab,” he said.

The EMA is working with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on its investigation, based on the British regulator’s experience with around 11 million administered doses of the vaccine.

In its own safety review, AZ said there was currently no evidence of a link between its COVID-19 vaccine and an increased risk of blood clots.

In a review of all available safety data from over 17 million people who have been given the AZ vaccine in the EU and UK, no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia was discovered.

This finding covered any defined age group, gender, batch and any particular country, AZ said in a statement issued on 14 March.

The World Health Organization’s (WHO) Global Advisory Committee on Vaccine Safety is also carefully assessing the blood clot reports.

“It is important to note that the EMA has said there is no indication of a link between the vaccine and blood clots, and that the vaccine can continue to be used while its investigation is ongoing,” said WHO director-general Tedros Adhanom Ghebreyesus.

Article by
Lucy Parsons

17th March 2021

From: Regulatory

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