Covid-19: EU regulators say AstraZeneca’s jab should come with warning of ‘very rare’ blood clots

EU health ministers could not agree on the best way through the Covid vaccine crisis last night after their own regulator’s verdict that the AstraZeneca jabs’s benefits outweigh the risk of blood clotting.

The European Medicines Agency (EMA) said the jab should come with a clear warning that clots were a ‘very rare side effect’, but stopped short of banning it for younger age groups. 

Some member states have been limiting the vaccine to older citizens, while others have suspended its rollout entirely.

Am extraordinary virtual meeting of the bloc’s health ministers was convened after the EMA’s afternoon press conference to take stock and thrash out a response.

But it broke up without agreeing a plan, despite urgings from Portugal, current president of the Council of the EU, that they should seek common ground

British health chiefs today ruled that people under 30 should be given an alternative to AstraZeneca where possible because the benefits of the jab do not clearly outweigh the risks, in a significant divergence from their colleagues in Brussels.  

The EMA refused to back EU heavyweights such as Germany which have banned the jab for under-60s, arguing that the risk posed by Covid is far greater than that of potential vaccine side effects.  

Sweden was among the first to give its backing to the EU regulator, agreeing that the benefits of the AstraZeneca vaccine ‘outweigh the risks.’

The World Health Organisation likewise sought to downplay fears, describing the blood clot link as ‘plausible but not confirmed’ and calling cases ‘very rare.’

But the EMA’s announcement sparked debate among medics, some of whom were concerned that it risked discouraging people from taking the vaccine by amplifying fears over the blood clots. 

The EU's medical regulators have said that Astra Zeneca's vaccine should come with a clear warning that blood clots are a 'very rare side effect'. Pictured: European Medicines Agency executive director Emer Cooke at a press briefing this afternoon

The EU's medical regulators have said that Astra Zeneca's vaccine should come with a clear warning that blood clots are a 'very rare side effect'. Pictured: European Medicines Agency executive director Emer Cooke at a press briefing this afternoon

The EU’s medical regulators have said that Astra Zeneca’s vaccine should come with a clear warning that blood clots are a ‘very rare side effect’. Pictured: European Medicines Agency executive director Emer Cooke at a press briefing this afternoon

At least 10 countries in Europe, joined by Germany last week, 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 week, 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 week, 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

A man is given the Pfizer-BioNTech vaccine in Cologne, Germany, yesterday after the country banned AstraZeneca's jab for under-60s

A man is given the Pfizer-BioNTech vaccine in Cologne, Germany, yesterday after the country banned AstraZeneca's jab for under-60s

A man is given the Pfizer-BioNTech vaccine in Cologne, Germany, yesterday after the country banned AstraZeneca’s jab for under-60s

WHAT ARE THE BLOOD CLOTS LINKED TO ASTRAZENECA’S VACCINE AND WHAT SYMPTOMS DO THEY CAUSE?

WHAT ARE THE BLOOD CLOTS LINKED TO ASTRAZENECA’S JAB? 

European health chiefs today ruled that AstraZeneca’s Covid jab should come with a warning that, in very rare cases, it may cause potentially deadly blood clots.

The EMA, which polices the safety of drugs used on the continent, spotted 169 cases of cerebral vein thrombosis (CVST) and 53 cases of splanchnic vein thrombosis (SVT), from 34million jabs. 

CVST occurs when a vein that drains blood from the brain is blocked by a clot. It can lead to a stroke.

SVT is the same type of blood clot but it occurs in the digestive system.

WHAT SYMPTOMS DO THEY CAUSE?

The EMA said symptoms of the two blood clots included:

  • Shortness of breath
  • Chest pain
  • Swelling of leg
  • Persistent stomach pain
  • Severe headache
  • Blurred vision
  • Skin bruising beyond the site of injection

IS THERE ANY PROOF THE JAB CAUSES THE BLOOD CLOTS?

Scientists have repeatedly insisted there is no proof yet that AstraZeneca’s coronavirus vaccine causes the blood clots.

But officials are still investigating the link and can’t rule it out completely.

Although there isn’t any evidence that the clots are developing because of vaccinations, some academics have a theory that it is the immune reaction making it happen.

Research teams in Germany and Norway claim the blood clotting issue may be caused by the jab, in very rare cases, making the body attack its own platelets.

Platelets are tiny chunks of cells inside blood that the body uses to build clots to stop bleeding when someone is injured. But they can also make unwanted clots.

Experts from Oslo and Greifswald University believe the jab could cause the body to produce antibodies – normally used to fight off viruses – which mistake platelets in the blood for foreign invaders and attack them.

To compensate, the body then overproduces platelets to replace those that are being attacked, causing the blood to thicken and raising the risk of clotting. 

The researchers say the phenomenon is similar to one that can occur in heparin-induced thrombocytopenia (HIT), when sufferers take a drug called heparin. 

HOW OFTEN ARE THE CLOTS OCCURRING? 

Figures presented by the EMA today — which took into account data up until April 4 — suggested the clots were occurring once in every 150,000 jabs. They also said most of the cases had occurred in women under 60.

The MHRA, which plays the same role in the UK, found 79 cases of clots in 20million doses by the end of March.

Officials said the risk was around one in every 250,000 doses.  

They also insisted the benefits of the vaccine outweigh the risks for the vast majority of people — but that the ratio was more ‘finely balanced’ in younger people.

EMA chiefs said that the clots were occurring more often than expected, prompting them to say the jabs need to come with the warning that it is a rare side effect. 

But it said the committee investigating the link did not conclude that age and gender were clear risk factors for the very rare side effects.

WHICH COUNTRIES HAVE ALREADY RESTRICTED THE JAB TO OLDER PEOPLE?

Germany last week temporarily banned the AstraZeneca vaccine for under-60s, while France took the same controversial move for under-55s.

Iceland has restricted it to over-70s, while Finland, Sweden and Lithuania all say it can only be given to adults over the age of 65.

Denmark, Norway, the Netherlands and Latvia have all suspended the jab completely, while regulators probe the link further.

But the EMA refused to back any of the nations in their age-restricted roll-outs. Last week it publicly said there was no evidence to justify sweeping bans for younger people. 

WHAT DOES BRITAIN’S DECISION MEAN?

The MHRA ruled that Britons under 30 should not be given AstraZeneca’s coronavirus vaccine due to mounting evidence linking it to rare blood clots.

More than 20million doses of the AstraZeneca vaccine have now been given in the UK, with the jab used as the main weapon in the UK’s arsenal.

The roll-out is unlikely to move on to under-30s for several weeks, perhaps months, meaning that supplies of the other jabs could be saved for younger adults.

But, given that AstraZeneca’s vaccine is the main driver of the campaign, the roll-out could be slowed if the change of heart on blood clots knocks public confidence in 30-50 year olds.  

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Jacques Battistoni, head of the French doctors’ union MG, said: ‘This time, the EMA confirms clearly that there is a link between vaccination and serious adverse effects. But these events are exceptional.

‘Other medications also pose such risks.

‘Will vaccination with AstraZeneca be harder? Most certainly. We will need to explain further and convince our patients that the benefits outweigh the risks, and that ‘zero risk’ just does not exist.

‘We have a lot work ahead of us. However, we cannot give up on the AstraZeneca, we do not have enough doses to allow that.’

Professor Frederic Adnet, head of A&E at Avicenne Hospital in Bobigny, France, said: ‘The EMA’s communication today will undoubtedly affect confidence further in AstraZeneca’s vaccine and have consequences on the vaccination deployment in France.’ 

The EU has ordered 400 million doses of AstraZeneca, and like the UK which is pencilled in for 100 million doses, any knock to confidence in the vaccines poses great risks to their respective programmes.  

The EMA said they had found 169 cases of the rare brain blood clots known as cerebral vein thrombosis (CVST) and 53 cases of a separate blood clot called splanchnic vein thrombosis, out of 34 million doses dished out by April 4.

This is the equivalent of one blood clot for every 150,000 doses. But many of these clots would have occurred naturally, meaning the true risk will be smaller, the EMA said.  

The EMA stated the risk of deadly side effects from AstraZeneca’s vaccine is far lower than the risk of death from Covid.

It suggested the vaccine comes with a warning and individual countries decide who is vaccinated with what company’s jab.  

Britain’s equivalent, the MHRA, said in its review it had found 79 patients who had suffered deadly blood clots in the brain or arteries out of 20 million Britons vaccinated by the end of March. This is a rate of around one in 250,000. 

Nineteen of the patients died and three were under the age of 30.

The MHRA insisted there was still no concrete proof that the British-made vaccine is causing the clots, but admitted the link was getting firmer.

The review prompted the Government’s vaccine advisory group, the JCVI, to recommend that people aged 18 to 29 be given an alternative jab, such as Pfizer or Moderna. 

EMA boss Emer Cooke, however, sought to downplay any concerns about blood clots.

She said: ‘These are very rare side effects. The risk of mortality from Covid is much greater than risk of mortality from these side effects.’

Dr Sabine Straus, the regulator’s chairwoman, said the available data found a ‘very rare event that might occur’.

She told a press conference: ‘The frequency is difficult to assess, but we feel if you state the reporting rate is approximately one in 100,000 or even a little bit higher, that would reflect the risk.

‘Based on that information we ask national vaccination authorities to make up their mind on who they would like to vaccinate with which kind of vaccine.’

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said the blood clots reported had been found in veins in the brain, the abdomen and arteries, combined with low levels of blood platelets and sometimes bleeding.

It said symptoms associated with the blood clots include shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin where the injection was administered.

Anyone who displayed them should seek medical attention, the EMA said.

The committee carried out an in-depth review of 62 cases of clots in the brain and 24 cases of clots in the abdomen as of March 22, with 18 of the combines cases proving fatal.

They came from reporting systems in the European Economic Area and the UK, from around 25 million people who had received the vaccine.

Ms Cooke said its review ‘confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects’.

She said: ‘Vaccination is extremely important in helping us in the fight against Covid-19.

‘This vaccine has proven to be highly effective. It is saving lives, vaccination is extremely important in helping us in the fight against Covid and we need to use the vaccine we have to protect us from the devastating effects.

‘We will continue to monitor the scientific evidence and issue further recommendations, if necessary, on the grounds of science and robust evidence.

‘When millions of people receive these vaccines, very rare events can occur that were not identified in clinical trials.

‘Our conclusion is that these clotting disorders are very rare side effects of the vaccine.’

Ms Straus said the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects.

She said: ‘This vaccine has proven to be highly effective, it prevents severe disease and hospitalisation and it is saving lives.

‘Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.

‘Prac, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination of the AstraZeneca vaccine should be listed as possible side effects of the vaccine.’

She added: ‘I think that the cases that we have evaluated, the 62 together with the expert group, those cases provided quite good and extensive information.

‘But nevertheless, the number is very limited. On the one hand, that’s of course very good and fortunate that the number of cases is limited. At the same time, that also makes it very difficult to find common factors.

‘And on the other hand, what we also know is a lot of cases that are spontaneously reported, they are not as complete as we would like to have them in order to further analyse them.

‘So I would like to repeat again, my kind request for people who suspect that they might have a side effect, please report it, and report it as extensively, and as complete, as possible.’

Some 34million AstraZeneca jabs had been dished out in the EU by April 4, with 169 cases of CVS and 53 cases of splanchnic vein thrombosis. This is the equivalent of one in every 150,000 doses, according to Google.

The EMA said the updated figures – which were slightly higher than the headline numbers in the main release – did not change the recommendations.

Scientists believe the combination of clots and low blood platelets could be caused by an immune response leading to a condition similar to those seen in heparin patients.

Patients who use the blood thinner sometimes fall into heparin induced thrombocytopenia — a condition involving thrombosis.

It comes as a review by the UK drugs watchdog found that 79 out of 20million Britons vaccinated with the AstraZeneca vaccine had suffered deadly blood clots in the brain or arteries by the end of March. 

The cases came at a rate of about one in 250,000. Nineteen of the cases died and three were under the age of 30. 

Officials insisted there was still no concrete proof that the British-made vaccine is causing the clots, but admitted the link was getting firmer. 

They reiterated that halting its use in under-30s was precautionary until they can sure-up the link between the vaccine and the clots.

Britons over that age are still being advised to get the vaccine because the risk of Covid far outweighs the chance of developing the extremely conditions. 

But regulators said the balance of benefits and risks was ‘more finely balanced’ in younger people.

The EMA presented its review at a press briefing this afternoon, chaired by Emer Cooke (right), its executive director, Sabine Straus (centre), chair of PRAC, Peter Arlett, Head of Data Analytics and Methods Task Force

The EMA presented its review at a press briefing this afternoon, chaired by Emer Cooke (right), its executive director, Sabine Straus (centre), chair of PRAC, Peter Arlett, Head of Data Analytics and Methods Task Force

The EMA presented its review at a press briefing this afternoon, chaired by Emer Cooke (right), its executive director, Sabine Straus (centre), chair of PRAC, Peter Arlett, Head of Data Analytics and Methods Task Force

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)

Leaked delivery schedules reveal the Government is expecting AstraZeneca’s vaccine to make up 75 per cent of its Covid jab supplies over the next two months. The document, published on the Scottish Government’s website in January and quickly taken down, showed Britain was anticipating about 29.4m doses of AstraZeneca’s jab between April and the first week of June. By comparison, officials expected just 8.5m of Pfizer’s vaccine in the next two months and 1m of the new Moderna jab, which is being rolled out for the first time in Wales today

Prime Minister Boris Johnson said he will carefully follow the advice on the Oxford/AstraZeneca vaccine from the MHRA and JCVI but does not believe he will have to alter the schedule for easing the lockdown.

During a visit to Cornwall, he told broadcasters: ‘I think the crucial thing on this is to listen to what the scientists, and the doctors, the medical experts, have to say.

‘The MHRA is meeting, the JCVI is meeting, they’ll be setting out the position and we will get on with rolling out the vaccine and obviously we’ll follow very carefully what they have to say.

‘I don’t think anything that I have seen leads me to suppose that we will have to change the road map or deviate from the road map in any way.’

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