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EU medicines regulator says vaccine pauses could harm trust

Warning comes as many European countries stop using AstraZeneca Covid-19 vaccine pending a safety review

The head of the EU’s medicines regulator has waded into a row over the safety of the AstraZeneca Covid-19 vaccine, and warned that European governments that have paused its rollout risk undermining public trust in vaccination.

About 20 European governments including those of France, Germany, the Netherlands, Spain and Sweden have paused administration of the AstraZeneca jab, citing reports of blood clots in those who have received it.

The European Medicines Agency is now investigating these reports, while maintaining that the benefits of the vaccine outweigh any risks.

In a 16 March press conference, the agency’s executive director Emer Cooke said there was “no indication” that vaccination had caused the health problems but that the situation “needs a scientific evaluation”.

Cooke also sounded a warning over the pauses.

“Trust in the safety and efficacy of the vaccines that we have authorised is paramount for us…and we are worried that there may be an effect on the trust of the vaccines,” she said.

Troubled jab

The AstraZeneca vaccine has been dogged by controversy in recent months, including over the speed of its delivery to the UK versus the EU, and its effectiveness in older age groups. Several EU countries including Belgium, France, Germany and Italy initially approved it only for use in younger people, before changing their policies as more data accumulated.

The director general of Italy’s medicines authority, Nicola Magrini, told the Italian newspaper la Repubblica that the decision by governments to suspend the rollout of the vaccine was “political”.

A large number of medical researchers and AstraZeneca have said the evidence suggests the vaccine is very safe, including in those aged over 65, and that the blood clots seen recently are likely unrelated to vaccination.

Ann Taylor, the company’s chief medical officer, said: “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.”

Phil Bryan, vaccines safety lead at the UK’s drug regulator, said, “It is still the case that it has not been confirmed the reported blood clots were caused by [the AstraZeneca vaccine]. Blood clots can occur naturally and are not uncommon.”

The EMA expects to make public a recommendation on Thursday after its investigation is complete.

“A situation like this is not unexpected,” said Cooke. “When you vaccinate millions of people, it’s inevitable that you have rare or serious incidences of illnesses that occur after vaccination. Our role at the EMA is to evaluate these…so we can figure out if this a real side-effect to the vaccine, or is it a coincidence.”