The EU’s medical regulators have said that AstraZeneca’s vaccine should come with a clear warning that blood clots are a ‘very rare side effect.’
But the European Medicines Agency (EMA) refused to back banning the jab for younger age groups despite noting that most of the cases have occurred in women under 60.
British health chiefs today ruled that people under 30 should be given an alternative to the AstraZeneca vaccine 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 like 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.
EU health ministers were invited to an extraordinary virtual meeting this afternoon to be held immediately after the EMA’s ruling.
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.’
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
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
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 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.’