European drug regulator warns there is a ‘CLEAR’ link between AstraZeneca’s jab and blood clots

Marco Cavaleri, vaccines head at the European Medicines Agency, said there is a ‘link’ between AstraZeneca jab and clots

One of the European drug regulator’s senior officials today claimed there is now a ‘clear’ link between AstraZeneca’s Covid vaccine and potentially deadly blood clots.

Marco Cavaleri, head of vaccines at the European Medicines Agency (EMA), said that CVST — a brain blockage that can lead to a stroke — was occurring more often than expected in younger people.

But he admitted that the body was still baffled about how the jab may trigger the rare complication.

EMA officials are already probing the link between the vaccine and CVST, which is more common in young women. Watchdog bosses are expected to make a formal announcement tomorrow.  

Despite his comments, Mr Cavaleri’s agency has repeatedly insisted AstraZeneca’s jab is safe and the benefits outweigh any risks. 

Last week it slapped down Germany for suspending its use in under-60s, arguing there was ‘no evidence’ to support age-based restrictions. 

But at the same time, the watchdog paved the way for a potential U-turn, warning that the rate of the complication did appear to be slightly higher than expected in vaccinated under-60s. 

Experts across the board say the evidence is now ‘shifting’ and that the jab is likely – in extremely rare cases – to cause the brain blockage.

The UK’s safety watchdog, the MHRA, has so far spotted 30 rare clotting events in 18.1million doses – around one in every 600,000. But the EMA believes it may occur in up to one in every 100,000 under-60s.

Britain’s medical regulator may also impose a German-style ban of AstraZeneca’s vaccine, it emerged last night. Sources told Channel 4 that it could stop under-30s getting the jab – which is the main one being used in Britain.

Boris Johnson today called on Britons to still get the jab while on a visit to an AstraZeneca factory in Macclesfield, saying the ‘best thing’ they can do is ‘look at what the MHRA say’. He added: ‘Their advice to people is to keep going out there, get your jab, get your second jab.’

But he glossed over questions about whether the UK could impose a ban on the jab for under-30s.  

UK regulators have now found 22 cases of cerebral venous sinus thrombosis (CSVT) in 18m people given the AstraZeneca jab

UK regulators have now found 22 cases of cerebral venous sinus thrombosis (CSVT) in 18m people given the AstraZeneca jab

 AstraZeneca is on track to roll out a new booster vaccine that will tackle coronavirus variants by autumn, the firm said

The risk of dying from Covid-19 is significantly higher than the rate of CSVT blood clots, which haven't even been definitively linked to the vaccines (Based on fatality estimates from Cambridge University and CSVT occurrences in Germany)

The risk of dying from Covid-19 is significantly higher than the rate of CSVT blood clots, which haven't even been definitively linked to the vaccines (Based on fatality estimates from Cambridge University and CSVT occurrences in Germany)

The risk of dying from Covid-19 is significantly higher than the rate of CSVT blood clots, which haven’t even been definitively linked to the vaccines (Based on fatality estimates from Cambridge University and CSVT occurrences in Germany)

More than 31million Britons have received at least one dose of a Covid vaccine in the UK

More than 31million Britons have received at least one dose of a Covid vaccine in the UK

More than 31million Britons have received at least one dose of a Covid vaccine in the UK

A TIMELINE OF THE ASTRAZENECA BLOOD CLOT SAGA 

March 7: Austria suspended the use of one batch of the vaccine after a woman, 49, who had been given it died of a ‘severe coagulation disorder’ and a 35-year-old developed a blood clot in her lung.

March 11: Authorities in Denmark, Norway and Iceland suspended all use of the vaccine following a 60-year-old woman in Denmark died of a blood clot after the reports emerged in Austria. Danish health minister Magnus Heunicke said: ‘It is currently not possible to conclude whether there is a link.’

March 11: European Medicines Agency’s safety committee began an investigation into the cases. It confirms 30 cases of ‘thromboembolic events’ – clots – were reported after five million vaccines in the EEA.

March 12: Thailand suspended the use of the vaccine off the back of European worries. Bulgaria also stops using it.

March 12: The European Medicines Agency, Britain’s Medicines and Healthcare products Regulatory Agency, Health Canada, the World Health Organization and AstraZeneca itself, all spoke out to defend the vaccine and say there is no proof it’s linked to blood clots. 

March 13: The Netherlands, Italy and Ireland temporarily stopped using the vaccine as fears about the cases in Austria and Denmark snowballed.

March 14: Germany and France suspended the vaccine.

March 15: Spain, Portugal and Slovenia suspended use of the jab. 

March 15: Professor Andrew Pollard, the Oxford expert who ran the clinical trials of the jab, insisted safety data are ‘reassuring’ and said ‘clearly those blood clots still happen’ as often as they would in unvaccinated people.

March 16: World Health Organization officials met to discuss the issue. European Medicines Agency is still investigating.

March 17: Scientists accuse governments of banning the jab on political grouns. AstraZeneca’s vaccine has been a flashpoint in the past.

March 18: European Medicines Agency holds a press conference on its investigation and rules that the vaccine is ‘safe and effective’. It said there wasn’t enough evidence to rule out a link to blood clots, but also not enough to prove one. On balance, it would be safer for countries to keep using the vaccine to stop Covid. The investigation would continue.

March 18: Germany, France and Italy resume use of the jab after the EMA’s conclusion. 

March 19: Finland suspends the jab after finding blood clot cases in its own population.

March 19: Bulgaria, Cyprus, Ireland, Latvia, Lithuania, Netherlands and Spain all confirm they will start using the jab again. Scandinavian countries did not follow suit and kept the ban in place.

March 22: A study is published that found public trust in the AstraZeneca vaccine collapsed in Europe at the time of the blood clot saga. A YouGov survey found more than half of people in Germany, France, Italy and Spain believed the jab was unsafe.

March 30: Germany bans the vaccine for people under the age of 60 after officials said they had found 31 cases of CSVT after 2.7million vaccinations. 

April 2: UK regulators announce a total of 30 blood clots, 22 in the brain, have now been discovered in Britons vaccinated with the AZ jab.

April 5: UK regulators begin reviewing their guidance amid concern the jab is considerably more likely among younger people.  

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In other Covid news:

  • Boris Johnson insisted there is ‘no reason’ to delay lockdown easing after SAGE doomsday third wave scenarios sparked Tory fury;
  • Aviation chiefs blasted ‘unfair’ plans to require holidaymakers to take two Covid tests for trips to green areas;
  • Proportion of adults refusing to have a jab has more than halved in four months to just six per cent, figures show;
  • The world’s Covid death toll has now passed three million – with the latest third recorded in the last three months;
  • Pub landlords said they were left with ‘impossible choice’ over vaccine passports.

Scientists insist the benefits of the AstraZeneca vaccine outweigh any risks for elderly people — who are most at risk of hospitalisation or death if they catch the virus.

But they warn that the picture is ‘more complicated’ for young people. 

Experts estimate the risk of dying of Covid for 25 to 44-year-olds is 0.04 per cent – or one in 2,500.

For comparison, the rate of CVST cases seen in Germany — which sparked fresh blood clot fears last week — is around one in 90,000.

It is not clear how many younger adults will suffer the blood clots naturally — but officials admit the risk is higher in women under the age of 50.

Officials are working round-the-clock to disentangle the statistical risk, analysing the background rate of CVST as well as the reported rate among people given AstraZeneca’s vaccine. 

Amid the MHRA’s safety review of the jab, two senior sources told Channel 4 that while the data is still unclear there are growing arguments to justify offering younger people – below the age of 30 at the very least – a different vaccine.

Both sources, however, emphasised their support for the Oxford jab and their concerns that any restriction of its roll-out could damage public confidence. 

Dr June Raine, the agency’s chief executive, said: ‘The benefits of Covid vaccine AstraZeneca in preventing Covid infection and its complications continue to outweigh any risks and the public should continue to get their vaccine when invited to do so.’

She added: ‘Our thorough review into these reports is ongoing. 

‘We are asking healthcare professionals to report any cases they suspect to be linked with Covid vaccination via the Covid yellow card website.’

The head of the EMA, Emer Cooke, has previously stressed there is ‘no evidence’ to support restricting the use of the jab across the continent.

She added a link between unusual blood clots in people who have had the jab is ‘not proven, but is possible’, but added that the benefits far outweigh risks.

The World Health Organization has also urged countries to continue using the ‘safe and effective’ jab, which offers a backdoor to get the world out of the pandemic.

Scientists have shifted their position in recent weeks, to indicate other vaccines against Covid may be better for young people. 

Professor Ferguson – who scared ministers into imposing Britain’s first lockdown in March with his prediction of thousands of deaths – said that should a link be identified then the jab may not be suitable for younger Britons.

‘In terms of the data at the moment, there is increasing evidence that there is a rare risk associated, particularly with the AstraZeneca vaccine,’ he told BBC Radio 4’s Today programme.

‘But it may be associated at a lower level with other vaccines, of these unusual blood clots with low platelet counts. It appears that risk is age related, it may possibly be – but the data is weaker on this – related to sex.

‘And so the older you are, the less the risk is and also the higher the risk is of Covid so the risk-benefit equation really points very much towards being vaccinated.

‘I think it becomes slightly more complicated when you get to younger age groups where the risk-benefit equation is more complicated.’ 

Professor Paul Hunter, a microbiologist at the University of East Anglia, has also warned that there may be a link between the AstraZeneca vaccine and blood clots.

He told the Today programme it is ‘not uncommon’ to get a cluster of rare events by chance. 

‘But once you find that cluster in one population and it then crops up in another – such as previously in the German and now in the English – then I think the chances of that being a random association is very, very low,’ he said.

‘Clearly more work needs to be done, but I think the evidence is shifting more towards it being causally related at the moment.’

‘(But) the chance of dying if you don’t have the vaccine is many times greater than the risk of dying from CVST after the AstraZeneca vaccine, even if it does turn out, as I suspect it will, that this link is causal.’

At least 10 countries in Europe, joined by Germany last night, have put some kind of restriction on the use of AstraZeneca's jab, mostly opting to give it only to over-60s because the CSVT cases seem to be happening in younger adults

At least 10 countries in Europe, joined by Germany last night, have put some kind of restriction on the use of AstraZeneca's jab, mostly opting to give it only to over-60s because the CSVT cases seem to be happening in younger adults

At least 10 countries in Europe, joined by Germany last night, have put some kind of restriction on the use of AstraZeneca’s jab, mostly opting to give it only to over-60s because the CSVT cases seem to be happening in younger adults

Vaccines minister Nadhim Zahawi pictured receiving his Covid jab. He said today they are expecting the first doses of the long-awaited Moderna jab to arrive this month

Vaccines minister Nadhim Zahawi pictured receiving his Covid jab. He said today they are expecting the first doses of the long-awaited Moderna jab to arrive this month

Vaccines minister Nadhim Zahawi pictured receiving his Covid jab. He said today they are expecting the first doses of the long-awaited Moderna jab to arrive this month

But confusion erupted over Moderna's supply today, after Scotland's First Minister Nicola Sturgeon revealed the first batch of doses arrived yesterday

But confusion erupted over Moderna's supply today, after Scotland's First Minister Nicola Sturgeon revealed the first batch of doses arrived yesterday

But confusion erupted over Moderna’s supply today, after Scotland’s First Minister Nicola Sturgeon revealed the first batch of doses arrived yesterday

WHAT IS CVST? 

Cerebral venous sinus thrombosis (CVST) is an extremely rare type of blood clot in the brain.

It occurs when the vein that drains blood from the brain is blocked by a blood clot, resulting in potentially deadly bleeding on the brain.  

Symptoms can quickly deteriorate from a headache, blurred vision and faintness to complete loss of control over movement and seizures. 

John Hopkins University estimates it affects five in a million people in the US every year, which would suggest 330 patients in Britain suffer from the condition annually.

According to the university, it can affect patients with low blood pressure, cancer, vascular diseases and those prone to blood clotting. Head injuries can also trigger the condition. 

Britain’s regulator said CVST is so rare they aren’t even sure how common it is in the general population.

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It comes as the vaccines minister reveals the long-awaited Moderna Covid vaccine will be dished out in Britain within the next two weeks.

Nadhim Zahawi said the first batch of the jab — approved by regulators in January — is set to arrive in the third week of this month, with ‘more volume’ expected in May.

Ministers had promised Moderna’s vaccine, which uses mRNA technology such as Pfizer’s, would arrive by the spring. Britain has ordered 17million doses.

But confusion erupted over Moderna’s supply today, after Nicola Sturgeon revealed the first batch of doses arrived yesterday. If Scotland’s First Minister is telling the truth, it means the UK is currently sitting on thousands of vaccines that are proven to work.

Announcing the impending arrival of the Moderna vaccine, Mr Zahawi told BBC Breakfast: ‘It will be in deployment around the third week of April in the NHS and we will get more volume in May as well.

‘And of course more volume of Pfizer and Oxford/AstraZeneca and we have got other vaccines. We have got the Janssen — Johnson and Johnson — vaccine coming through as well.

‘So I am confident that we will be able to meet our target of mid-April offering the vaccine to all over-50s and then end of July offering the vaccine to all adults.’

Despite Mr Zahawi saying the vaccine won’t be deployed until later this month, Ms Sturgeon said Scotland had already received its first batch of the jab.

Scotland is due to receive more than one million of the 17million doses ordered by the UK.

The First Minister also said that the doses have already been factored into forward planning for the vaccination programme, and will be delivered over the coming months.

Addressing today’s coronavirus briefing in Edinburgh, she said: ‘The arrival of this first batch doesn’t mean that we are able to accelerate the vaccination programme.

‘The speed of vaccination is already taking account of the expected Moderna supplies.

‘Nevertheless the fact that we now have three vaccines in use is clearly very welcome and it does give us additional security of supply, which is important.’

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