Angela Merkel last night defended Germany’s decision to ban Oxford/AstraZeneca shots for under-60s as she and Emmanuel Macron made overtures to Vladimir Putin to get Moscow’s Sputnik V jab into the EU.
The chancellor insisted that ‘trust stems from the knowledge that every suspicion, every individual case will be examined’ after 31 cases of a rare blood clot were found among 2.7million people who have had the jab in Germany.
But surveys show that public trust in the vaccine has slumped in EU nations during a months-long back-and-forth over the jab, which experts from the UK, WHO and EU have found to be safe and effective in preventing Covid-19.
With the AstraZeneca roll-out once again mired in chaos, Merkel and Macron last night discussed co-operating with the Kremlin to produce Sputnik V within the EU in what would amount to a major propaganda coup for Putin.
Some politicians in Germany have already called for Sputnik V to be approved as the AstraZeneca row hampers a jab programme already struggling to pick up the pace across the EU.
Merkel, who is 66 and a trained scientist, said she is open to getting the AstraZeneca jab herself, adding that ‘the possibility of me being vaccinated is nearing’.
‘I have said when it is my turn, I will get vaccinated, including with AstraZeneca,’ she said.
Angela Merkel (pictured)last night defended Germany’s decision to ban Oxford/AstraZeneca shots for under-60s, prolonging the EU’s back-and-forth over the shots
GERMANY’S ASTRAZENECA FLOUNDERING
January 29 – UNDER-65s ONLY: When the EU’s medicines agency approves the AstraZeneca jab, German vaccine chiefs say there is too little data on older people to allow it for over-65s
March 4 – ALL AGE GROUPS: The ban on over-65s is lifted after data from England and Scotland shows the jab is highly effective in preventing hospitalisation in older people
March 15 – TOTAL SUSPENSION: Germany joins more than a dozen European countries in banning the shots altogether over sporadic reports of blood clots
March 18 – JABS RESUME: EU regulators give their verdict that the jab is safe and the benefits outweigh the risks, prompting Germany to resume injections
March 30 – OVER-60s ONLY: In a 180-degree U-turn from its earlier position, Germany is now only making the jab available for older people because most blood clots are in younger patients
France already limits the use of the AstraZeneca jab to those aged over 55 while Canada this week imposed a similar restriction.
But several EU nations are using the jab without such restrictions following the European Medicines Agency (EMA)’s ruling that it is safe, including Italy, Greece, Belgium, the Netherlands, Sweden and Portugal.
Asked if there was a need to look again at the use of the jab in the UK, cabinet minister Robert Jenrick said today that ‘no, we don’t, we’re 100 per cent
‘That’s borne out by study after study, by our own independent world-class regulators and by recent research, for example, by Public Health England that’s shown that thousands of people’s lives have been saved since the start of this year alone thanks to our vaccine programme,’ he told Sky News.
‘People should continue to go forward, get the vaccine, I certainly will when my time comes, it is a safe vaccine and the UK’s vaccine rollout is saving people’s lives right across the country every day.”
In Italy, Prime Minister Mario Draghi and his wife, who are both 73, have received their first dose of AstraZeneca to show confidence in the vaccine.
The new reports which have spooked German regulators consist of 31 cases of the unusual blood clot known as a sinus vein thrombosis, with nine deaths.
Out of these 31 cases, 29 were in women aged 20 to 63, while two of them were in men aged 39 and 56.
EU regulators say it is not proven whether such blood clots are being caused by the AstraZeneca vaccine, though they say it cannot be ruled out.
But Germany’s vaccine commission, STIKO, recommended that the jabs be halted for under-60s because of ‘currently available data on the occurrence of rare but very severe thromboembolic side effects’.
STIKO’s verdict was accepted by the German government and the health ministers of the 16 states on Thursday, after some areas including Berlin and Munich had already moved to limit jabs.
‘They are findings that STIKO and finally us, cannot ignore,’ Merkel said.
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
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.
Rudolf Henke, an MP in Merkel’s party and member of a health committee in the German Bundestag, told BBC Radio 4 that the commission was ‘checking the cases which have been reported’.
‘The reports have increased during the last two weeks and that is the reason of that intervention,’ he said.
‘We are looking at all the substances with the same kind of vigilance, we are vigilant to all cases.’
Asked whether the blood clot scares were specific to AstraZeneca’s jab rather than linked to other vaccines as well, he said: ‘That is our knowledge so far’.
One Berlin hospital, the prestigious Charite clinic, had earlier made an even more specific ruling by banning the vaccine for women under 55 because of the blood clot fears.
STIKO now intends to make another recommendation by the end of April on how to proceed with people under 60 who have already received a first dose of the vaccine.
Ministers said people who are due for their second jab can either choose to take it if cleared by their doctor, or they can opt to wait for the commission to deliver its verdict.
Other under-60s can still decide to take the vaccine following consultation with their doctor, the government says.
Health chiefs also looking into the possibility of administering a second shot with a different vaccine.
In Britain, which has been giving out AstraZeneca shots at full steam since December, Downing Street has stressed that the jab is ‘safe, effective and has already saved thousands of lives’.
But confusion has reigned across the EU, with France making similar U-turns to Germany and Spain last night making another change by expanding the use of the jab to over-65s.
With Brussels also complaining about a shortage of AstraZeneca supplies, some politicians in the bloc have warmed to the idea of reaching out to Moscow for its Sputnik V jab.
Named after the Soviet space satellites of the Cold War, the jab was widely ignored in the West after being prematurely registered last year but the tide has turned after clinical trials suggested it was highly effective.
In its readout of the call with Macron and Merkel, the Kremlin said the three leaders had talked about prospects for registering of Sputnik V in the EU and the possibility of joint production inside the bloc.
Merkel and Macron’s offices said they had discussed opportunities for co-operation in an otherwise frosty call, noting that Sputnik V would be evaluated by the same standards as other vaccines.
The EMA started a rolling review of Sputnik V earlier this month, but has yet to reach a conclusion.
Russia has been actively marketing Sputnik V abroad despite a slow pace of its rollout at home, in what was seen as an attempt to score geopolitical points.
Macron (left), Putin (right) and Merkel discussed ‘cooperation’, which would see the Sputnik jab made used in the European Union once regulators give it the go-ahead
The latest German U-turn comes with Merkel already under pressure over chaotic lockdown rules and spiralling infection rates in a country which was once seen as a star performer during the pandemic.
In the space of barely two months, Germany has banned the vaccine for over-65s, then cleared it for all age groups, then suspended it altogether, then resumed it again, only to now scale it back again.
British MPs called the German decisions ‘ludicrous’ and said they ‘reek of total confusion’, adding that regulators have repeatedly said the jab is safe and the rollout is urgent.
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’.
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.’
The 31 clots spooking German officials are the condition that first worried regulators, known as cerebral sinus venous thrombosis (CSVT).
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.
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 EMA found no proof the jab was causing it. Scientists and politicians slammed Germany’s move as a backwards step going over old ground.
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
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.
Spain extends AstraZeneca vaccine jabs to over 65s
Spain’s health ministry announced Tuesday that it was extending the roll-out of the AstraZeneca Covid-19 vaccine to the over-65s, after recent scientific reassurances about its safety.
The vaccine, restricted until now to the 55-to-65 age group, will now be made available to over-65s in priority groups such as health workers, police officers or teachers.
‘In respect of the AstraZeneca vaccine, given the new scientific evidence … the age limit is raised,’ said a ministry statement Tuesday evening.
Spain was among a number of European Union countries that suspended use of the AstraZeneca vaccine earlier this month after reports of blood clots in a very small number of people.
But they resumed its use last week after the both the World Health Organization and the European Medicines Agency gave the vaccine a clean bill of health.
Several countries are nevertheless taking precautions.
Germany said Tuesday it should only be in general use for the over-60s: anyone under that age could only take it after consulting with their doctor about the risks.
Spain has already cleared other vaccines for use among the over 65s.
Spain is one of the European countries hardest hit by the coronavirus, having suffered more than 75,000 deaths.
‘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 state 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.
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.’
A Government spokesperson said: ‘The Oxford/AstraZeneca vaccine is safe, effective and has already saved thousands of lives in this country. As the UK’s independent regulator has said, when people are called forward, they should get the jab.
‘Over 30million people have already received their first dose of a vaccine, and we are on track to offer jabs to all over 50s by 15 April and all adults by the end of July.’
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.
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.
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
Slovakian Premier and Government resign over Russian vaccine deal
Slovakia’s prime minister Igor Matovic and his government have resigned to ease a political crisis triggered by a secret deal to buy Russia’s Sputnik V coronavirus vaccine.
It is the first European government to collapse due to its handling of the pandemic but the move will keep the four-party coalition in power and avoid the possibility of an early election.
The coalition holds a comfortably parliamentary majority.
President Zuzana Caputova accepted the resignation and asked Eduard Heger from Mr Matovic’s Ordinary People party to form a new government.
Mr Heger served as finance minister and deputy prime minister in the outgoing government.
Mr Matovic, who had announced on Sunday that he would be making the move, is expected to assume the post in the new government.
The crisis erupted when a secret deal came to light at the beginning of March involving Slovakia’s agreement to acquire two million doses of Russia’s Sputnik V Covid-19 vaccine.
The populist prime minister orchestrated the deal despite disagreement among his coalition partners.
With few changes, Mr Heger’s cabinet is expected to be the same as Mr Matovic’s. The president could swear it in as soon as this week.
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 women-only ban included 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.
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.
‘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 Charite hospital in Berlin, a prestigious clinic which has previously treated Angela Merkel and Alexei Navalny among others, announced the ban on Tuesday
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 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.
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.’