AstraZeneca’s Covid vaccine is safe and there’s still no proof it causes blood clots, a British scientist insisted today as Germany banned the use of the vaccine in people under the age of 60.
Regulators in the UK and the World Health Organization insisted there was no proof of a link between blood clots and the jab and said as Covid was more dangerous the jab must be used.
It came as German health officials agreed to restrict the use of AstraZeneca’s coronavirus vaccine in under-60s amid fresh concern over unusual blood clots reported from those who received the shots.
German health minister Jens Spahn and state officials agreed unanimously today to only give the vaccine to people aged 60 or older, unless they belonged to a high-risk category for serious illness from Covid and had agreed with their doctor to take the vaccine.
The move, which follows the recommendations of Germany’s independent vaccine expert panel, comes after the country’s medical regulator released new data on the reported blood clots.
It showed a total of 31 unusual blood clots, including nine deaths, were reported by March 29 out of some 2.7 million doses of AstraZeneca administered in Germany.
Twenty-nine of the cases were in women aged 20 to 63 and two in men aged 39 and 56.
AstraZeneca’s Covid vaccine is safe and there’s still no proof it causes blood clots, a British scientist insisted today as German officials banned the use of the jab in those under the age of 60
German Chancellor Angela Merkel held a crisis meeting with state governors amid fresh concern over unusual blood clots last week
In a statement, AstraZeneca said that tens of millions of people worldwide have received its vaccines and noted the European Medicines Agency’s conclusion that the benefits of the shot outweigh the risks.
The company said it would continue to work with German authorities to address any questions they might have, while also analysing its own records to understand whether the rare blood clots reported occur more commonly ‘than would be expected naturally in a population of millions of people.’
Last Thursday German Chancellor Angela Merkel held a crisis meeting with state governors amid fresh concern over unusual blood clots.
Several German regions suspended the use of the shots in people under 60, and the country’s independent vaccine expert panel recommended restricting them to people above that age after reviewing the latest data on the rare side-effects.
Earlier today it was revealed Berlin, Munich and the eastern state of Brandenburg had stopped giving the vaccine to under-60s.
Hospitals in the major cities made the controversial move on their own after hearing about cases of blood clots in women who had received the jab.
However British MPs called the decisions ‘ludicrous’ and said they ‘reek of total confusion’, adding that regulators have repeatedly said the jab is safe and the rollout is urgent.
It marks a U-turn for Mrs Merkel’s government after it lifted an original ban on the jab when the European Medicines Agency declared there was no blood clot link, but has now gone back on this and suspended it again.
Scientists insist the risk of blood clots is no higher than in the general population but Canada has also pressed ahead with a surprise ban on giving it to under-55s.
Dr Simon Clarke, a microbiologist at the University of Reading, said: ‘There is no evidence that there is a problem but even if there was then you’re reducing what, at worst, is a tiny risk and imposing a bigger one by not giving people the protection of a vaccine.’
He added that people who were more worried about the minute possibility of a blood clot than they were of Covid-19 ‘have their priorities all wrong’.
This chart shows how Britain is still racing ahead of the EU in vaccinating its population against Covid-19, more than three months after the continent started its jab programme
Germany, as with many other countries on the Continent, has a spiralling infection rate amid a third wave of the virus
Deaths in Germany appear to still be declining from a second peak but are likely to tick up again within weeks in the wake of surging infection numbers
The 31 blood clots announced by German officials were its justification for the new vaccine ban.
Most of them have been in younger women but the AstraZeneca vaccinations have been stopped for both men and women. People can still get the Pfizer and Moderna jabs that are being used on the continent.
The 31 clots are the condition that first worried regulators, known as cerebral sinus venous thrombosis (CSVT).
WHAT NEW EVIDENCE PROMPTED GERMANY’S U-TURN ON ASTRAZENECA’S JAB?
German health chiefs based their vaccine ban on 31 reports of a rare type of brain blood clot called cerebral sinus vein thrombosis (CSVT).
Twenty-nine of the cases have been in women and two in men, all of them under the age of 65.
These clots are the same as the handful of cases that caused widespread European suspensions of the jab earlier this month and had a link to the vaccine ruled out by European regulators.
The Germans are not known to have any more evidence to suggest that the vaccine might be causing the clots, but appear to have been spooked by the cases appearing.
Cerebral sinus vein thrombosis (CSVT) 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 or a stroke.
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 CSVT is so rare they aren’t even sure how common it is in the general population.
CSVT is a rare clot in a vein draining blood from the brain that, left untreated, can cause a life-threatening brain haemorrhage or stroke.
It was this condition that panicked European drug regulators earlier in March but the European Medicines Agency found no proof the jab was causing it. Scientists and politicians slammed Germany’s move as a backwards step going over old ground.
Dr Clarke told MailOnline: ‘Whenever you do these things you need to have a reason to do them. It’s all a balance of risk.
‘There is no evidence that there is a problem but, even if there was, then you’re reducing what, at worst, is a tiny risk and imposing a bigger one by not giving people the protection of a vaccine.
‘People still get on airplanes and we know that there is a real risk of blood clotting if you’re sat on a plane for hours, but people still do it because they want to go on holiday.
‘So if people are more concerned about blood clots than they are Covid, I’d say they have their priorities all wrong.
‘You have to wonder what the thinking is. Are they being entirely up front? Because it just doesn’t make sense as it is presented. Maybe they know something they’re not letting on.’
Berlin’s health minister, Dilek Kalayci, said ‘everyone who has already received a first jab of AstraZeneca has very good protection’ but that there were new worries about possible side effects.
As a result, all upcoming appointments for the vaccine would be cancelled in Berlin for the coming days.
MPs in the UK said the move was ‘ludicrous’ and a repeat of what happened earlier in the month, which later turned out to be baseless.
Senior Tory backbencher Peter Bone said the decision to ban the drug ‘reeks of total confusion within the European Union’.
‘One thing is for sure, while the majority of our adult population has had its first jabs only a fraction in Europe have,’ he said.
‘None of it makes any logical sense, they seem to be in total confusion. The medical advice is that it does a great job.’
He added: ‘My constituents are very happy to have it and if the Germans don’t want it, send it over to us, we will use it, no problem.’
Another Tory MP said: ‘This is ludicrous. The WHO has said it is perfectly safe. The EMA has said it is safe. Our regulator has said it is safe.
‘It does look very much like a vendetta that the EU is maintaining both against AstraZeneca, because they are adhering to their contract, and the UK, out of spite.’
Vaccine regulators in the UK saw five cases after the first 11million people had been vaccinated – a rate of around one per 2.2million.
This was lower than an estimate by Johns Hopkins University in the US which suggests CSVT affects around five people per million each year.
Blood clots are reported as part of a routine system of logging every health problem that someone has after a vaccine to see if there are any trends.
Women under 55 will not get the AstraZeneca jab at a top German hospital because of fears of blood clots, despite EU regulators’ ruling earlier this month that the vaccine is safe
RESEARCHERS CLAIM IMMUNE SYSTEM REACTION TRIGGERS CLOTS
Research teams in Germany and Norway claim the blood clotting issue may be caused by the jab, in very rare cases, causing the body to attack its own blood platelets.
Platelets are tiny chunks of cells that the body uses to build blood clots when someone is injured, to stop them losing too much blood. But they are also components of 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, 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.
Experts say the condition has not been proven to be caused by the jab and may simply be showing up just because millions of people are being vaccinated and reporting their health conditions.
They added that, if spotted early, it could be diagnosed with a simple blood test and quickly treated with blood-thinners.
They stressed that even if the clots do turn out to be caused by the vaccine they are still extremely rare.
The Charite hospital in Berlin, which employs 19,000 people at its clinics, ordered the new ban along with a handful of other healthcare providers in Germany, including another Berlin hospital group which also operates care homes.
A Charite spokeswoman that none of their staff had suffered any complications after around 16,000 jabs were handed out to hospital workers, mainly AstraZeneca ones.
But the clinic nonetheless claims that the ban is ‘necessary because in the meantime further cerebral venous thromboses have come to light in women in Germany’.
One such case was a 47-year-old woman who reportedly died after developing a blood clot in the brain, although no link to the vaccine has been proven.
There was another case of a 28-year-old woman who developed a thrombosis after having the jab, but was said to be in a stable condition. Again no link to the vaccine was made.
Authorities in the district of Euskirchen said they had informed health authorities in Berlin about the two cases and stopped jabs for women under 55 in the meantime.
Others to have imposed the same new rule, including a university hospital in nearby Cologne, according to media reports.
EU regulators examined a series of reported blood clots across Europe earlier this month and found there was no increased risk, saying the number of clotting problems was actually lower than in the general population.
Safety experts at the European Medicines Agency said that ‘most of these occurred in people under 55 and the majority were women’.
But they did not recommend limiting use of the jab, saying the blood clots were ‘very rare cases’ and that the benefits of preventing Covid-19 were greater than the risks.
The blood clot issue mainly concerns a condition called cerebral sinus venous thrombosis (CSVT), in which a clot develops in the head and blocks a vein that drains blood from the brain.
If left untreated it can cause blood vessels to burst when pressure builds up, causing a haemorrhage and stroke.
Symptoms may include a severe headache, blurred vision, losing consciousness or seizures.
Experts studying the rates of CSVT in people who have had the AstraZeneca vaccine found that it didn’t appear to be happening more often than would be normal.
The EMA’s verdict prompted most European countries which had suspended AstraZeneca shots to start them up again soon afterwards.
That included Germany, which like France and several others had initially restricted the jab to under-65s because of limited trial data on older people.
The Charite hospital in Berlin, a prestigious clinic which has previously treated Angela Merkel and Alexei Navalny among others, announced the ban on Tuesday
France has since broken with the EMA’s guidance and banned over-55s from having the vaccine, in a 180-degree turn from its earlier position.
In addition, Canadian health officials said on Monday that they would stop giving the jab to under-55s and ordered a new analysis of the risks based on age and gender.
CANADA SUSPENDS ASTRAZENECA JAB
Canada is pausing its use of AstraZeneca’s Covid vaccine for people younger than 55, amid ‘safety concerns.’
The country’s National Advisory Committee on Immunization is recommended the pause, citing lingering worries over rare blood clots, and Health Canada officially called for the suspension on Monday.
So far, no cases of the rare but life-threatening clotting condition have been reported in Canada.
Canada is set to receive a shipment of 1.5million doses of AstraZeneca’s vaccine from the US, which has not yet authorized the shot.
It comes after European health regulators ruled that concerns that the shot might cause blood clots were unfounded. Before that, some European countries thought paused use of the shot in elderly people, due to claims it was ineffective.
‘There is substantial uncertainty about the benefit of providing AstraZeneca Covid-19 vaccines to adults under 55 given the potential risks,’ claimed Dr Shelley Deeks of Canada’s National Advisory Committee on Immunization.
The repeated U-turns and doubts raised by top officials have been blamed in part for the low uptake of the AstraZeneca shot, which was approved in the EU in January.
Germany has received more than 3.8million doses of AstraZeneca despite the EU’s ongoing row with the firm over supplies.
But only 2.7million of these have been used, with fewer than 1,000 getting two doses – leaving more than a million shots lying unwanted.
Recognising the jab’s poor image, German officials have sought to boost uptake by reassuring the population that the vaccine is safe and effective.
But a poll published last week showed that some 55 per cent of Germans regarded the AstraZeneca jab as unsafe in the wake of the blood clot row.
The position was even worse in France where 61 per cent said it was unsafe, weeks after Emmanuel Macron claimed it was ‘quasi-ineffective’ in older people.
By contrast, in Britain – which has never suspended use of the jab or limited it to certain age groups – only nine per cent said the AstraZeneca jab was unsafe.
The EU’s jab roll-out remains far slower than Britain’s more than three months after the bloc started vaccinating, leaving it vulnerable to a third wave.
Germany has given a first dose to barely 10 per cent of its population, reaching only 9.2million people compared to more than 30million in Britain.
While Germany has given higher priority to second doses than Britain, it is still barely ahead by that measure with 4.0million people fully vaccinated compared to 3.7million in the UK.
Germany’s slow vaccine roll-out and prolonged lockdown have piled pressure on Angela Merkel, pictured, who is set to leave office after September’s general election
The slow progress means that nearly 90 per cent of Germans remain unvaccinated as infections climb rapidly in a resurgence blamed partly on the British variant.
Millions of Germans are facing tough new restrictions as cases rise, although Angela Merkel is struggling to persuade regional leaders to implement the new rules.
The chancellor last week had to abandon plans for an ultra-strict Easter lockdown which had been widely criticised as impractical.
France is also seeing a rapid increase in cases, which has already forced ministers to throw the Paris region back into full lockdown after months of a nationwide curfew.
The number of patients in French intensive care units yesterday surpassed the worst point of the country’s last coronavirus surge in the autumn of 2020.
SHOULD PEOPLE WHO HAVE HAD THE OXFORD JAB BE WORRIED?
The UK has used more doses of AstraZeneca’s Covid vaccine than anywhere else – approximately 11million – and both officials and scientists say there is no sign that it causes serious health problems.
Side effects are normal, and around 53,000 changes in health or feelings have been officially reported across the UK so far, but the vast majority are mild and short-lived, such as headaches, muscle pains or fever.
The 53,000 side effects out of 11million suggest just 0.5 per cent of people get them – one in 200. The frequency of severe side effects is much lower. But not everyone records their mild side effects and not all of those reported are linked to the vaccine, many just happen by coincidence after someone has received the jab.
British drugs regulator the Medicines and Healthcare products Regulatory Agency (MHRA), which approved the vaccine, insists the jab is safe and says people should continue to take it.
Vaccine safety chief Dr Phil Bryan said: ‘We are closely reviewing reports but given the large number of doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause.
‘People should still go and get their Covid vaccine when asked to do so.’
The same message is being put out by the Joint Committee on Vaccination and Immunisation (JCVI), which advises the Government on its vaccine rollout.
Its deputy chairman Professor Anthony Harnden said on BBC Breakfast: ‘Safety is absolutely paramount and we monitor this data very carefully.
‘We have to remember that there are 3,000 blood clots a month on average in the general population and because we’re immunising so many people, we are bound to see blood clots at the same time as the vaccination, and that’s not because they are due to the vaccination. That’s because they occur naturally in the population.
‘One ought to also remember that Covid causes blood clots. So, the risks of not having the Covid vaccination far outweigh the risks from the vaccinations.’
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