Another potentially dangerous blood condition has been spotted in a handful of patients given the AstraZeneca coronavirus vaccine, the...
Another potentially dangerous blood condition has been spotted in a handful of patients given the AstraZeneca coronavirus vaccine, the EU's drug watchdog has announced.
The European Medicines Authority (EMA) said five cases of capillary leak syndrome had been reported in vaccinated patients on the continent.
The rare condition sees blood leak from tiny vessels into muscles and body cavities, resulting in a sudden drop in blood pressure. If left untreated, it can cause organ failure.
Data suggests the UK's regulator, the MHRA, had spotted three cases of capillary leak syndrome out of 20million people given the AstraZeneca vaccine by late March.
It is another blow for the British-made jab, which has been restricted for certain age groups in various countries around the world, including under-30s in Britain, after reports of rare blood clots in the brain and abdomen.
Officials insisted there is still no evidence the jab causes the blood conditions and stressed the benefits of vaccination far outweighed the risk.
Meanwhile, the EMA revealed it is also reviewing reports of rare clots involving Johnson and Johnson's Covid vaccine, which uses the same technology as AstraZeneca's.
Four serious cases of rare blood clots with low platelets were detected in people vaccinated with the jab, one of which died.
In the US, four clinics have had to pause J&J vaccinations, after eight people suffered 'adverse reactions' in the latest crisis, coming at a site in Cummings, Georgia.
Officials did not specify what types of reactions the eight people had to the shot, but said they were 'consistent with common reactions in adults being vaccinated with any vaccine,' and cited the number of cases as the trigger for the pause.
However, the eight people who had reactions were among 425 people who got the J&J shot at that site and, ostensibly, did not have any noticeable reactions.
The same thing has happened at clinics in three other states this week.
J&J vaccinations have now resumed at a Colorado site that reported 11 people had had bad reactions to the one-dose vaccine and two were taken to hospitals on Wednesday, as well as at a North Carolina site where 18 people had reactions. Four were taken to hospitals.
'The reactions people experienced today were consistent with known common side effects from receiving the vaccine,' Wake County officials said in a statement about the adverse reactions at PNC Arena in Raleigh.
Georgia officials said in a statement that there was a similar incident in Iowa, but no details have been released there.
The J&J jab, made by the US-firm's Belgium arm Janssen, had been earmarked by UK officials for young people because it is given as a single dose.
The vaccine has been approved in the EU and was due to be rolled out in the coming months. It is currently under review by the UK's medicines watchdog and the UK Government has ordered 30million doses.
The EMA has said that 'at this stage, it is not yet clear whether there is a causal association' between either vaccines and the reported conditions.
J&J said that it was aware of the reports of blood clots and is working with regulators to assess the data and provide relevant information.
'At present, no clear causal relationship has been established between these rare events and the Janssen Covid vaccine,' the company said in a statement.
The European Medicines Authority said five cases of capillary leak syndrome had been reported in people given the AstraZeneca vaccine
The EMA revealed it is also reviewing reports of rare clots involving Johnson and Johnson's Covid vaccine, which uses the same technology as AstraZeneca
It comes as Johnson & Johnson's COVID-19 shot was paused at the PNC Arena site (pictured) in Raleigh, North Carolina after 18 people had adverse reactions on Thursday. Four have been taken to area hospitals
Furthermore, a scientist advising the Government said today any blod clots associated with the J&J vaccine are 'extraordinarily rare events'.
The jab , also known as Janssen, is yet to be approved for use in the UK, but the Government has ordered 30 million doses.
Professor Peter Openshaw, a member of the Covid-19 clinical information network, told BBC Radio 4's Today programme: 'We still don't know whether they are directly related and caused by the vaccine but it seems possible that they could be.
'It wouldn't be surprising to find the J&J, the Janssen vaccine, also causes rare blood clots because it's based on an adenovirus technology which is not that far away from the technology being used in the AstraZeneca vaccine.'
Asked if he is concerned it could undermine public confidence in coronavirus jabs, Prof Openshaw said: 'These are extraordinarily rare events and there is no medicine that is going to be completely free of side effects but this is on the scale of the risk of adverse outcome you would expect if you get into a car and drive 250 miles, and many of us wouldn't blink before taking that risk.'
Stacey Beard, a spokesperson at the Raleigh site, also told WRAL that about 2,000 shots a day had been given out at the site, and only a 'handful' of the J&J shots it gave resulted in adverse reactions.
Generally, the shot is thought to have a milder side effect profile compared to vaccines made by Pfizer and Moderna.
Similarly, the reactions at the Colorado clinic represented less than one percent of the 1,300 shots it was giving a day.
Both AstraZeneca and the J&J vaccines are viral vector types, which use a weakened version of a different virus to deliver instructions to human cells.
So far over 20 million AstraZeneca jabs have been given out in the UK, and 5 million J&J vaccinations in the US.
They tell the cells to produce a harmless piece of Covid, known as a spike protein, so the body can recognise it if the real virus infects them.
Scientists are interested in whether the clotting issues are related to the engineered spike protein specifically, a senior SAGE source said today.
This could explain why clotting conditions have been widely reported in people who catch the real coronavirus.
However, the SAGE member said this would not account for why clotting issues have not been linked to the Pfizer or Moderna vaccines.
Those vaccines use different technology to deliver the genetic instruction to the cells but they also trigger the body to make and recognise spike proteins.
Meanwhile, it was claimed today AstraZeneca's Covid vaccine may also be restricted for under-40s when Britain's immunisation drive moves down to younger groups.
Medical watchdogs will assess data on the jab's links to extremely rare blood clots in 'scrupulous detail' in order to paint a clearer picture on the exact risk-benefit ratio.
They have already advised 18 to 29 year olds are given an alternative to the UK-made jab because their odds of falling seriously ill with Covid are so small that the benefits of AstraZeneca's do not clearly outweigh the potential clot risks.
Analysis of the UK vaccine rollout has found that younger people appear more prone to clotting after vaccination but there is no set cut-off age. Experts have told MailOnline there is a 'gradual age gradient of risk'.
Professor Jeremy Brown, a member of the JCVI, which advises No10 on jabs, told the Daily Telegraph: 'We're going to start vaccinating phase two healthy adults, starting with the 40 to 50-year-olds, and then we'll go to the 30 to 40-year-olds.
'When we are approaching that point we'll need to think about this a little bit more to be absolutely sure at what point in that age cut-off – given the situation we are facing at that time, and any more data that comes through on this rare complication, because more data will come through – then that might alter the age range.'
GPs have warned the announcements this week have unintentionally caused 'panic' and sparked a wave of cancellations for the AstraZeneca jab.
Doctors in Nottingham and Peterborough said they had also been inundated with calls from concerned patients who have already had their first dose.
Statisticians insist the risk of under-30s developing blood clots from AstraZeneca's jab is so tiny that if Wembley stadium was filled with people in the age group, only one would be struck down.
Britons still back the Oxford-AstraZeneca Covid vaccine - as 75 per cent tell pollsters (pictured) they consider it to be safe
For older adults, the risk of blood clots is even smaller - but their risk of dying from Covid is much higher, meaning the risks versus benefits swings heavily in favour of vaccination.
The move to recommend under-30s get a different jab does not mean it is unsafe for young people, with neither the UK's drug regulator or the EU's ordering the jab to be banned for certain age groups.
But both acknowledge cases of blood clots from the life-saving jab appear to be occurring slightly more often in younger adults.
EU nations - who have been embroiled in a stand-off with AstraZeneca for months - have defied guidance based on statistical analysis showing the vaccine's benefits outweigh the risks of the vast majority of adults. Germany has halted the jab for under-60s, while France has made the same move for under-55s.
France and Germany have both advised younger adults already given AstraZeneca's jab should get a second dose of Pfizer or Moderna's - taking the opposite stance to British counter-parts.
But the World Health Organization (WHO) today said there was 'no adequate data' on switching doses. The UK is currently trialling this dosing regimen, and scientists say it is likely to be safe and effective but results are not expected until later in the year.
Amid fears the guidance could scupper the UK's vaccination roll-out, which is heavily reliant on AstraZeneca's jab, ministers yesterday sought to dismiss blood clot fears. Health Secretary Matt Hancock compared the risk of blood clots overall - one in 250,000 - to taking a long-haul flight.
Nottingham GP partner Dr Irfan Malik told Pulse Magazine the new advice 'created panic' among patients.
He said: 'Patients and the public have become very concerned about the risk of clots with the Astra Zeneca vaccine – they are declining to have it. I'm afraid this has been badly managed and stopping the under-30s from having the vaccine has alarmed the public.
'The changes have led to a substantial increase in calls to practices creating a further huge increase in workload.'
Peterborough GP Neil Modha said the vaccine hesitancy was not just exclusive to under-30s, adding: 'It's not just under-30s who are calling, the person who I just spoke to was 53, so it's just general increased anxiety unfortunately about the vaccine programme.
'And then people have been signposted to their GPs for conversations and they're not easy and simple conversations, you need to give people time and space to have them.'
But polls show 75 per cent of the public still consider the jab to be safe.
Professor Anthony Harnden, the deputy chairman of the JCVI, said the public 'should remain confident' in the vaccine programme despite the changes to guidance.
He stressed to The Telegraph that the link with blood clots was a 'very, very rare, extremely rare safety signal'. However, he said the new advice that those under 30 should be offered an alternative to AstraZeneca – is unlikely to change.
Professor Harnden said his team was poring over data for other groups and that they will have a 'much more clear' view a by the time the programme moves to thirty-somethings.
Any decision to restrict AstraZeneca jabs to adults in their thirties could damage the UK's roll-out.
Ministers insist there is enough doses of Moderna and Pfizer to cover the remaining 8.5million under-30s who have yet to be jabbed.
But estimates suggest there is around 10million adults in the 30-39 age bracket - and most won't have been offered their first dose yet.
No10 has bought 40million doses of Pfizer's jab, but is rationing it for second doses to ensure the 11million people already given their first dose get their top-up within 12 weeks.
Britain has also purchased 17million doses of Moderna's vaccine. It means that if the UK was to completely reserve supplies, there would be enough of the alternatives for around 17.5million people - similar to how many under-40s still need to be jabbed.
But there is no guarantee all the supplies will come by July 31 - the date ministers have set for offering every adult their first dose.
Other jabs, including ones made by Novavax and Johnson and Johnson, are set to come on stream in the coming months, which could provide the roll-out a much-needed boost in the face of any other age-restrictions on AstraZeneca's.
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