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European regulator: ‘No indication’ Oxford jab is cause of blood clots

The European Union’s medicines agency has said there is “no indication” that Oxford-AstraZeneca’s coronavirus vaccine is the cause of reported blood clots.

The European Medicines Agency (EMA) has been carrying out a case-by-case evaluation of incidents and was expected to complete its review on Thursday, said executive director Emer Cooke.

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The review began after a report from the Norwegian Medicines Agency revealed blood clotting events in four adults who had the COVID-19 jab.

But on Tuesday, the EMA said it was “firmly convinced” the vaccine’s benefits outweighed the risk of side effects.

Ms Coke said: “I want to also stress that at present, there is no indication that vaccination has caused these conditions (blood clots).

“They had not come up in the clinical trials, and they are not listed as known or expected side events with this vaccine.”

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She said that in clinical trials, both the vaccinated people and the people who received the placebo had in fact shown some very small numbers of blood clot developments – indicating that it was nothing to do with the vaccine.

She added: “The number of thromboembolic events in the vaccinated people, overall, seems not to be higher than that seen in the general population.”

And in a statement, a University of Oxford spokesperson agreed.

It read: “Both the MHRA and EMA have said the vaccine’s benefits continue to outweigh any potential risks, and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing, a stance also supported by the WHO.

“What we know for certain at present from real-world data is there is a clear impact of the vaccine on public health – with far fewer cases, hospitalisations, and deaths from coronavirus in those who have been vaccinated. “

Blood clots and the Oxford-AstraZeneca jab: What does the data say?

Prime Minister Boris Johnson holding a vial of the Oxford/AstraZeneca vaccine
Image: Boris Johnson has said there is ‘no reason at all’ for the UK to discontinue the AstraZeneca vaccine

The World Health Organization (WHO) had earlier added its weight behind the debate, urging countries to continue using the jab.

And UK leaders and medical professionals joined in their defence of the Oxford-AstraZeneca vaccine after some European countries – including Germany, Italy, Spain, the Netherlands, France and Sweden – paused its use due to concerns over clotting.

Prime Minister Boris Johnson said there was “no reason at all” to stop the vaccine’s rollout and Scottish First Minister Nicola Sturgeon said she would accept her jab “without hesitation” when called on.

Now, France has said it expects inoculations there to resume after the agency meets and issues its recommendations.

Nicola Magrini, the director general of Italy’s medicines authority AIFA, told its daily newspaper La Repubblica he believed the choice to suspend the AstraZeneca shot was “political”.

He said it was safe and its benefit-to-risk ratio was “widely positive”.

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Vaccine suspension: What’s the science?

The EMA has said “many thousands of people” develop blood clots every year in the EU and “the number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population”.

In the EU’s largest member states – including Germany, France, Italy, the Netherlands and Spain – AstraZeneca has accounted for about 13-15% of shots administered since the rollout started almost three months ago.

The Pfizer-BioNTech vaccine makes up the majority, according to official bloc data.

Sky News science correspondent Thomas Moore said that out of the five million people who have had the vaccine across the continent, there have been 30 reports of blood clots.

He added: “In a population of that size, you’d expect one in 1,000 or around 100 a week developing a blood clot, even without vaccination.”

Both the WHO and the EMA are meeting separately on Tuesday to discuss the issue.

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‘Don’t panic’ over vaccine side effects says WHO

The EMA has been working closely with AstraZeneca, experts in blood disorders, and authorities including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and will report those findings in preparation for an extraordinary meeting on Thursday to consider any further action that may be needed.

Mr Johnson described the MRHA as “one of toughest and most experienced regulators in the world”.

“They see no reason at all to discontinue the vaccination programme… for either of the vaccines (the other being Pfizer) that we’re currently using,” he said.

And Dr Soumya Swaminathan, WHO’s chief scientist, told a media briefing “we do not want people to panic”, as she said no association has been found so far between blood clots and COVID-19 vaccines.

She said the rates at which blood clots have occurred in people who received the AstraZeneca vaccine “are in fact less than what you would expect in the general population”.

A woman receives an injection of the Oxford/AstraZeneca vaccine
Image: The EU medical regulator insists the vaccine’s benefits outweigh the risk of side effects

Clinical epidemiologist Dr Deepti Gurdasani said she believed the European countries’ decision to pause the AstraZeneca rollout was out of “an abundance of caution”.

Dr Gurdasani told Sky News there is no evidence so far of a link, but that because public confidence has “taken a hit” it is “important” the concerns are investigated “thoroughly but quickly”.

However, she added that even if the vaccine is found to cause a small number of incidents, people should still take the jab.

“The benefit of taking the vaccine far outweighs the risk, even if these events were linked to the vaccine – which we don’t know that they are at the moment,” she said.

“The risk of dying from COVID and the vulnerability of the age groups currently taking the vaccine is very high.”

Analysis: Oxford jab had troubled rollout in the EU from the start
By Michelle Clifford, Europe correspondent in Brussels

People need confidence going for a vaccine and the news that more countries are halting the rollout of the Oxford-AstraZeneca jab won’t instil that.

The vaccine has had a troubled start in the EU with delays to orders and Germany and France initially deciding not to give it to the elderly. That made many ask why, and in both countries I found many pursuing for the Pfizer-Biontech vaccine instead. Even many health professionals rejected the AstraZeneca jab because of some evidence of side effects.

So reports of blood clots in some people who received the vaccine will have created huge alarm. Not just in the EU but in the UK where the jabs are still being given to people. How many of us have thought in recent days we’d prefer to have an alternative vaccine?

But the regulators on both sides of the channel insist there is no cause for concern. There is no evidence of a causal link between the blood clots and the AstraZeneca vaccine. And the number of blood clots reported are tiny compared to the millions of jabs administered.

Still, governments deal with politics and public confidence and need to reassure their populations they are doing everything they can to ensure safety.

President Macron of France said the rollout would be suspended until the European Medicines Agency carries out a review which starts today. But his vaccines’ minister has said he believes the suspension will only be temporary suggesting a confidence in what the regulator has said.

No leader will want the legacy of delivering a vaccine which isn’t safe. But the evidence for now is that the AstraZeneca one is. Reviews by the European Medicines Agency and the World Health organisation-which has already said there is no evidence the blood clots were linked to the vaccination-will hopefully give more clarity. And confidence.

Without it, the EU is in trouble. It was relying heavily on the AstraZeneca vaccine to accelerate what was a sluggish start to its rollout. The European Commission announced today a major boost of its Pfizer-Biontech supply. But with millions still waiting for jabs, the union needs every vaccine it can get its hands on.

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