EU Admits ‘CLEAR’ link between AstraZeneca jab & blood 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 it could stop under-30s getting the jab – which is the main one being deployed in Britain. But Government insiders told the Daily Telegraph that regulators were unlikely to impose any age-based ban.
Boris Johnson today called on Britons to still get AstraZeneca’s jab while on a visit to one of the firm’s 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.
It comes amid reports that thousands of doses of the AstraZeneca vaccine are being wasted in France following a ‘wave of panic’ triggered by its suspension.
And it was also claimed today that EU officials are confident they will have enough doses to immunize the majority of their citizens by the end of June. Britain is aiming to have offered a first dose to all adults by the end of July.
The World Health Organization still maintains there is ‘no link for the moment‘ between the Oxford AstraZeneca vaccine and blood clots.
Rogerio Pinto de Sa Gaspar, director of regulation and prequalification at the WHO, told a briefing today: ‘The appraisal that we have for the moment, and this is under consideration by the experts, is that the benefit-risk assessment for the vaccine is still largely positive.‘
He added: ‘For the time being there is no evidence that the benefit-risk assessment for the vaccine needs to be changed and we know from the data coming from countries like the UK and others that the benefits are really important in terms of reduction of the mortality of populations that are being vaccinated.‘
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 originally banned the jab for over-60s over the same blood clot fears — 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.
‘In the next few hours, we will say that there is a connection, but we still have to understand how this happens,‘ Mr Cavaleri told Italian newspaper Il Messaggero. ‘Among the vaccinated, there are more cases of cerebral thrombosis… among young people than we would expect.‘
Stella Kyriakides, the European Commissioner for Health and Food Safety, said the results of the EMA’s review of the AstraZeneca vaccine were expected tomorrow.
But France is already wasting thousands of doses of the AstraZeneca vaccine due to concern over the jab, even as the country battles against a third wave. Medics have reported people turning down the inoculation in droves, despite it being a key part of the country’s planned route out of the pandemic.
This is because President Emmanuel Macron has performed a series of U-turns over the highly effective vaccine, with critics suggesting the Brexit-critical leader had challenged the jabs safety and effectiveness to attack the UK.
European capitals have been told the EU has now secured enough doses for them to inoculate the majority of their citizens by the end of June, according to a briefing note seen by Bloomberg.
The forecast, however, assumes that some 70million AstraZeneca doses will be used, which could be put in doubt if regulators limit their use.
It also shows that some member states – including Austria, Croatia and the Czech Republic – are expected to lag behind.
EU Commissioner Thierry Breton, who is leading jabbing efforts, has previously claimed they will have the capacity to deliver enough doses to hit ‘herd immunity’ by July 14, which is Bastile Day in France.
Amid the MHRA’s safety review of the jab, two senior sources told Channel 4 news that the data is still unclear on the risks of the vaccine. But the insiders said 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 Neil Ferguson — the scientist whose grim modelling that 250,000 may die without restrictions scared ministers into imposing Britain’s first lockdown last March — said the jab may not be suitable for younger Britons, if a link is proven. ‘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 yesterday.
‘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, an infectious disease expert at the University of East Anglia, has also warned 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.‘
Although there isn’t any evidence that the blood 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. They admitted they ‘don’t know why this is happening‘.
But the researchers say the phenomenon is similar to one that can occur in heparin-induced thrombocytopenia (HIT), when sufferers take a drug called heparin.
It comes as No10’s vaccine minister today revealed 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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Barry
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And this is early times let us see where we are in a year or two.
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Doug Harrison
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‘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.‘
So says Professor Hunter an infectious disease expert from the notorious East Anglia University, home of climategate. It is patently nonsense when the risk to under 30s from covid19 is virtually nil. Has he never studied the statistics from his own country’s records?
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