‘No indication’ AstraZeneca vaccine causes blood clots, says EU medicines regulator

The EU’s review of the vaccine developed by the University of Oxford and AstraZeneca following an increase in blood clot concerns is an “ongoing process”, a top official has said.

Speaking at a 16 March press conference, European Medicines Agency executive director Emer Cooke said there was “no indication” so far that the AstraZeneca vaccine or any other jab has caused increased incidents of blood clotting.

The review comes after a spate of countries temporarily suspended vaccinations using the treatment, including Germany, France, Italy, Denmark and Norway. Sweden and Latvia became the latest nations to halt use of the vaccine earlier on 16 March.

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“A situation like this is not unexpected. When you vaccinate millions of people, it is inevitable that you have rare or serious incidences,” Cooke said. “Our role is to evaluate these to make sure any adverse reactions are rapidly investigated.”

AstraZeneca said a review of all available safety data from more than 17 million vaccinated people in the EU had shown “no evidence of an increased risk” of blood clots in any age group, gender, batch of shots or particular country.

The EMA is holding an urgent meeting of experts assessing the matter later on 16 March, and will provide a conclusion to the review with any recommendation on actions to be taken on 18 March.

“We need to have the facts first, we cannot come to a conclusion until we have had a thorough scientific analysis,” said Cooke. She noted that in clinical trials across both vaccinated and placebo patients for AstraZeneca’s vaccine, no increase in blood-clotting events were documented above that of what would be expected to occur naturally in the general population.

Thailand, which previously suspended use of the shot, has restarted distribution after assessing that the benefits outweighed the risks.

The UK’s foreign secretary Dominic Raab has repeated that the vaccine is “safe” for use, echoing the words of Prime Minister Boris Johnson.

“Different countries have different approaches, but I can tell you crystal clear that the UK regulator, the European EU regulator and the WHO all say that the AstraZeneca vaccine is safe and people should continue to take it,” Raab said, speaking to BBC Breakfast on 16 March.

“There is no extra risk on the evidence that we’ve seen, which is why they have authorised the vaccine and haven’t taken any further action.”

A spokesman for the Prime Minister said on 16 March that the UK is “guided by the MHRA” and encouraged people to come forward and take the vaccine when asked.

“The WHO has been clear that the AstraZeneca vaccine is both safe and effective and there is no reason for concern,” he said, adding that the Prime Minister would be “perfectly happy” to take the AstraZeneca Oxford University vaccine himself.

To contact the author of this story with feedback or news, email Emily Nicolle

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