Brussels threatened to disrupt the supply of EU-made vaccines to the UK last night after it emerged the bloc’s regulator could reject giving Britain’s AstraZeneca jab to the Over-65s.
EU health chiefs demanded drug firms give them early warning when exporting Covid vaccines to countries outside the bloc – including to Britain.
The new edict means American firm Pfizer – which has a vaccine manufacturing plant in Belgium – will now need to tell EU chiefs when it wants to export its BioNtech jab to the UK, raising fears such exports could be blocked or delayed.
The move came as two German newspapers reported sources in Berlin saying EU experts have found the UK-made Oxford/AstraZeneca vaccine is only eight percent effective in pensioners. The drug firm furiously denied those reports.
AstraZeneca angered Brussels earlier yesterday by warning it would cut the number of vaccines it will deliver to Europe by the end of March from 80million to 31million.
But more concerning for EU health chiefs is their apparent discovery, the exact nature of which remained unclear today, that the AstraZeneca jab fails to adequately protect pensioners.
That would leave a large hole in the EU’s vaccine supplies as well as throwing into question the effectiveness of immunisation strategies in other countries including the UK, where getting AstraZeneca’s jabs in as many pensioners as possible is key to ending lockdown.
Well-respected financial newspaper Handelsblatt and tabloid Bild both quoted sources in the federal government as saying the AZ jab was less than 10% effective in over-65s.
The papers said German officials now fear the European Medicines Agency (EMA), the EU’s medicine regulator, may not approve giving the Oxford vaccine to such people.
The federal and state governments in Germany had planned to use the AstraZeneca vaccine for older people who live at home and cannot go to a vaccination centre due to age or illness.
However AstraZeneca last night branded the German reports ‘absolutely incorrect’.
Concerns over vaccine supply on the continent have prompted the European Union to tell pharmaceutical companies they can only export to Britain with explicit permission from the bloc. Pictured: Jenny Holland, 86, from Mansfield receives her injection of the AstraZeneca coronavirus vaccine at a former Wickes store in Mansfield, Nottinghamshire
All companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,’ EU health commissioner Stella Kyriakides warned last night, as Britain prepares to receive nearly 3.5m of the Belgian-produced Pfizer (pictured: The company’s production plant in Belgium) vaccine in the next three weeks
Stella Kyriskides, European Commissioner for Health and Food Safety, tonight warned delays at AstraZeneca were ‘not acceptable,’ and has scheduled for a second meeting after warning the vaccine developer’s initial excuses ‘have not been satisfactory’
AstraZeneca has blamed the EU’s supply chain for their failure to deliver the promised 80million vaccines by the end of March
The statement came after a weekend of protests over the tightening of lockdown rules in countries such as Denmark and the Netherlands (pictured: Protests in Eindhoven, the Netherlands, on Sunday)
Early figures show there were 220,000 vaccinations in the UK yesterday. The number will be updated later today by the Department of Health to include jabs in all settings
An AstraZeneca spokesperson said: ‘Reports that the AstraZeneca/Oxford vaccine efficacy is as low as 8 per cent in adults over 65 are absolutely incorrect.
‘In the UK the Joint Committee on Vaccination and Immunisation (JVCI) supported use in the population and the Medicines and Healthcare products Regulatory Agency (MHRA) included this group without dose adjustment in the authorisation for emergency supply.
‘In November we published details in The Lancet demonstrating that older showed immune responses to the vaccine, with 100 per cent of older adults generating spike-specific antibodies after the second dose.’
How does the Oxford vaccine work?
The vaccine – called ChAdOx1 nCoV-19 – uses a harmless, weakened version of a common virus which causes a cold in chimpanzees.
Researchers have already used this technology to produce vaccines against a number of pathogens including flu, Zika and Middle East Respiratory Syndrome (Mers).
The virus is genetically modified so that it is impossible for it to grow in humans.
Scientists have transferred the genetic instructions for coronavirus’s specific ‘spike protein’ – which it needs to invade cells – to the vaccine.
When the vaccine enters cells inside the body, it uses this genetic code to produce the surface spike protein of the coronavirus.
This induces an immune response, priming the immune system to attack coronavirus if it infects the body.
It was 62 per cent effective if given as two doses and 90 per cent when one half dose is given followed by a further full dose.
The EMA’s approval of the vaccine is expected to take place on Friday, according to reports.
Like in the UK, European vaccine drives are relying on shots from multiple suppliers to reach their targets.
Britain has so far ordered 40million doses of AstraZeneca’s jab – which was the first to be approved in the UK and is a so-called ‘work horse’ of the UK vaccine roll-out. The UK is expecting to receive nearly 3.5million Pfizer doses within the next three weeks.
But in a stern warning likely to raise eye-brows in Westminster, EU Health Commissioner Stella Kyriakides last night declared the bloc would take ‘any action required to protect its citizens’.
The row came after British-Swedish pharmaceutical firm AstraZeneca announced yesterday it could not meet the demand of a 300million dose vaccine deal it made with the EU in August – for which it was paid £298million upfront.
The move, described as ‘surprising’ by Ms Kyriakides, sparked fears of a vaccine shortage on the continent. EU bosses subsequently hit back, demanding ‘full transparency’ concerning the export of vaccines from the bloc.
In statement, she said: ‘Last Friday, the company AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced.
‘This new schedule is not acceptable to the European Union. The European Union has pre-financed the development of the vaccine and the production and wants to see the return.
‘The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered.’
Ms Kyriakides said the EU had asked AstraZeneca about the the change, but said the company’s answers had ‘not been satisfactory so far’.
She said: ‘We want our contract to be fully fulfilled. In addition, the Commission has today proposed to the 27 Member States in the Steering Board that an export transparency mechanism will be put in place as soon as possible.
‘We want clarity on transactions and full transparency concerning the export of vaccines from the EU.
‘In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries.
In a stern warning, she added: ‘The European Union will take any action required to protect its citizens and rights.’
HOW DO THE OXFORD, MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Oxford University has published the findings from its second phase, which show the jab provokes an immune response and is safe to use – it is not yet clear how well it protects against coronavirus in the real world.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
OXFORD UNIVERSITY (UK)
How it works:
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
Recombinant viral vector vaccine – a harmless cold virus taken from chimpanzees was edited to produce the ‘spike’ proteins and look like the coronavirus.
How well does it work?
94.5% effective (90 positive in placebo group, 5 positive in vaccine group) .
95% effective (160 positive in placebo group, 8 positive in vaccine group).
62% – 90% effective, depending on dosing. Average 70.4%.
How much does it cost?
Moderna confirmed it will charge countries placing smaller orders, such as the UK’s five million doses, between £24 and £28 per dose. US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose.
The US will pay $1.95bn (£1.48bn) for the first 100m doses, a cost of $19.50 (£14.80) per dose.
Expected to cost £2.23 per dose. The UK’s full 100m dose supply could amount to just £223million.
Can we get hold of it?
UK has ordered five million doses which will become available from March 2021. Moderna will produce 20m doses this year, expected to stay in the US.
UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.
UK has already ordered 100million doses and is expected to be first in line to get it once approved.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.
Oxford and AstraZeneca said there are no serious safety concerns about the vaccine. Phase three trial saw three out of 23,745 participants have ‘serious adverse events’ that were ‘possibly’ linked to the vaccine. All three have recovered or are recovering, and remain in the trial.
The statement came after a weekend of protests over the tightening of lockdown rules in countries such as Denmark and the Netherlands.
The jab has already been approved in the UK, as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco, while Canadian officials have asked for more data before approving the vaccine.
The Oxford jab is cheaper and easier to store than the rival Pfizer/BioNtech vaccine – which is also being used in Germany.
The Oxford vaccine can be stored, transported and handled at normal refrigerated conditions. This is unlike the Pfizer vaccine, which needs to be kept at minus 70C.
But the Oxford/AstraZeneca vaccine came under fire last year when initial tests showed the vaccine was 62 per cent effective when two full doses were given at least a month apart.
This was less than the Pfizer and Moderna vaccines, which were both shown to be 95 per cent effective.
However, the Oxford vaccine’s efficacy rose to 90 per cent when people were given half a dose followed by a whole dose at least a month later.
Pascal Soriot, chief executive of AstraZeneca, praised the results in a piece to the Sunday Times in December, saying: ‘We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else. I can’t tell you more because we will publish at some point.’
On the results, he said: ‘We would have preferred a simpler set of results, but overall we thought these are positive.’
Riots in the Netherlands (pictured) and Denmark come as EU chiefs voiced their fury after AstraZeneca said it would not be able to meet supplies set out in a £300m contract
A large group of young people clash with police on Beijerlandselaan in Rotterdam on Monday night amid growing anger over lockdown measures
Dutch policemen arrest a man during clashes with a large group of young people on Beijerlandselaan in Rotterdam, on January 25
Anti riot forces gather as groups of local youth gather on the streets of Schilderswijk, the Netherlands, for a second day on January 25
The deserted Avenue de l’Opera leading up to the Opera Garnier during a nationwide curfew, from 6pm to 6am, due to restrictions against the spread of Covid
The deserted Pont de Bir-Hakeim Bridge and the Eiffel Tower during a nationwide curfew, from 6pm to 6am, due to restrictions against the spread of the coronavirus
Politicians pushed to tighten lockdown measures across the continent even after a weekend of rioting brought scenes of chaos to the Netherlands and Denmark.
Matt Hancock reveals nearly 80% of UK over-80s have now had a Covid vaccine as NHS rollout reaches 6.6MILLION people
Health Secretary Matt Hancock last night announced that 78.7 per cent of Britons over the age of 80 have had a Covid vaccine as he confirmed 6.6million people have received their first dose.
That means nearly one in 10 people across the country has had at least one dose that could protect them against deadly Covid-19, and the Government is nearly halfway through its drive to hit 15million by mid-February.
Britain is ahead of all other countries in Europe in its vaccine drive and has one of the highest per-person rates in the world. But a Sunday slowdown meant that only 221,067 people received vaccines, down from a record high of 493,013 people on Saturday.
Department of Health figures showed 220,249 first doses and 818 second doses were administered across the country on January 24.
The Sunday slowdown is thought to have been triggered by fewer doctors and nurses being on shift on the last day of the working week, meaning fewer Britons could receive their jabs. The smallest number of cases and deaths is also generally recorded on Sundays, when more staff are off work and unavailable to tick off reports.
It comes as ministers battle to vaccinate the most vulnerable to the virus by mid-February. This includes the over-70s, vulnerable, care home residents and NHS frontline staff.
But the NHS appears to have already missed its internal target of reaching all care home residents by January 24.
The Health Secretary Matt Hancock said last Thursday they had already vaccinated 63 per cent of care home residents – leaving another 154,660 out of an estimated 420,000 residents waiting for their jabs. But ministers are yet to say whether the NHS target has been hit.
Britain last night recorded another 22,195 infections with the virus, a 41 per cent drop on last week, and a further 592 deaths, down one per cent on the same time last week.
France is due to decide whether to bring in a third national lockdown this week as Prime Minister Jean Castex warned the situation there is ‘worrying’, with Italy‘s top medic also calling for a month-long national shutdown.
The EU has not officially approved the Oxford/AstraZenecca jab yet but it is expected to give its assent on Friday, starting the mass roll-out.
Europe, which was initially praised for its tough response to Covid after most countries went into full lockdowns in March last year, has been hammered by a second wave that a mish-mash of measures has largely failed to control.
Those efforts have been complicated by the emergence of new and potentially more-infectious variants of the virus, including in the hard-hit UK, which is now back in full lockdown.
While many countries have announced new measures to try and bring infections down, case numbers have remained stubbornly high in countries such as France, Italy and Germany, causing hospitals to run out of space.
Meanwhile Spain and Portugal have both seen infections soar to record levels after a brief dip over the festive period, putting health services under strain.
The Netherlands, which had become one of Europe’s worst-affected countries with its light-touch lockdown approach, has seen cases fall dramatically in January but remain well above the lows seen during the summer.
As a result and amid fears the UK variant could cause cases to spike, new measures designed to bring the toll down were announced last week, including a 9pm to 4.30am curfew – the country’s first since World War Two.
The prompted protests in 10 cities on Sunday which turned violent, as protesters fought police, looted shops, and trashed police stations.
Authorities in Eindhoven announced on Monday that 62 people had been arrested and more are being sought, while officers in Amsterdam said 192 were arrested.
‘It is unacceptable,’ Prime Minister Mark Rutte said. ‘This has nothing to do with protesting, this is criminal violence and that’s how we’ll treat it.’
‘My city is crying, and so am I,’ Eindhoven Mayor John Jorritsma told media Sunday night. In an emotional impromptu press conference, he called the rioters ‘the scum of the earth’ and added ‘I am afraid that if we continue down this path, we’re on our way to civil war.’
Meanwhile, in locked-down Britain, it was announced yesterday that the UK had recorded the fewest coronavirus cases in a day since December 15 with 22,195 more people testing positive – a 41 per cent drop on last Monday – and new deaths remained level at 592, down one per cent in a week.
In further good news, Health Secretary Matt Hancock announced yesterday that 78.7 per cent of Britons over the age of 80 have had a Covid vaccine as he confirmed 6.6million people have received their first dose.
Boris Johnson sowed confusion today as he hinted that ‘some’ lockdown curbs could be eased in mid-February – but defied a growing Tory mutiny by refusing to guarantee that schools will be open by Easter
That means nearly one in 10 people across the country has had at least one dose that could protect them against deadly Covid-19, and the Government is nearly halfway through its drive to hit 15million by mid-February.
Britain is ahead of all other countries in Europe in its vaccine drive and has one of the highest per-person rates in the world – ahead of the Spain, France, Germany and Italy.
But furious EU officials have said they will investigate why Britain is not suffering from similar delays in the rollout as have been seen on the continent.
Peter Liese, an EU lawmaker from the same party as Angela Merkel, said: ‘The flimsy justification that there are difficulties in the EU supply chain but not elsewhere does not hold water, as it is of course no problem to get the vaccine from the UK to the continent.
‘AstraZeneca has been contractually obligated to produce since as early as October and they are apparently delivering to other parts of the world, including the UK without delay.’
The Anglo-Swedish drugmaker had received an up-front payment of 336 million euros (£298million) from the EU when they struck a deal in August, an EU official told Reuters.
Europe’s vaccine roll-out was already among the slowest in the world, but has been hit by further problems as France’s Pasteur Institute mothballed its jab on Monday and AstraZeneca cut supplies to the bloc by 60 per cent due to ‘supply issues’
EU executive Ursula von der Leyen had a call on Monday with AstraZeneca’s chief Pascal Soriot to remind him of the firm’s commitments
The agreement for at least 300million shots was the first signed by the EU to secure Covid vaccines.
Under advance purchase deals sealed during the pandemic, the EU makes down payments to companies to secure doses, with the money expected to be mostly used to expand production capacity.
But AstraZeneca said on Friday: ‘Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain.’
The site in question is a vaccine factory in Belgium run by the drugmaker’s partner Novasep.
A senior EU official said the bloc had a contractual right to check the company’s books to assess production and deliveries.
A Commission spokesman said: ‘We expect the company to find solutions and to exploit all possible flexiblities to deliver swiftly.’
EU executive Ursula von der Leyen had a call on Monday with AstraZeneca’s chief Pascal Soriot to remind him of the firm’s commitments, with a second meeting scheduled for the same day.
AstraZeneca was not immediately available to comment last night.
AstraZeneca chief executive Pascal Soriot denounced the ‘me first’ approach by some countries to obtaining doses
The first EU official, who has been directly involved in talks with AstraZeneca, said there were no high expectations about the meeting in which the company will be asked to better explain the delays, although its outcome is still unclear.
Earlier in January, Pfizer, which is currently the largest supplier of COVID-19 vaccines to the EU, announced delays of nearly a month to its shipments, but hours later revised this to say the delays would last only a week.
EU contracts with vaccine makers are confidential, but the EU official did not rule out possible penalties for AstraZeneca, given the large revision to its earlier commitments. However the source did not elaborate on what could trigger the penalties. ‘We are not there yet,’ the official added.
AstraZeneca’s vaccine is expected to be approved for use in the EU on January 29, with first deliveries expected from February 15.
On Monday, the boss of the pharmaceutical company denounced the ‘me first’ approach by some countries to obtaining doses.
AstraZeneca chief executive Pascal Soriot, speaking at a virtual event for the Davos World Economic Forum, also attacked a lack of global preparation for the deadly coronavirus pandemic.
The arrival of ground-breaking Covid-19 vaccines could have been grounds for celebrating, ‘but it unfortunately wasn’t because there was a little bit of ‘me first’ behaviour’, Soriot said.
‘Globally, it is fair to say we could and should have been better prepared for this pandemic,’ he added.
Soriot noted however that ‘things are changing and international collaboration is emerging’ over the coronavirus that has claimed the lives of more than two million people.
‘There are many good examples of tremendous public-private collaboration actually in many countries,’ he said.
Going forward, ‘the first thing to do is to invest in prevention and early detection and early treatment’, Soriot added.
He noted that among the world’s most industrialised countries, only three-percent of health expenditure is spent on prevention.
‘Twenty percent of this 3.0 percent… is spent on immunisation and early detections of disease.
‘So, essentially, we kind of tend to wait for people to become sick to try to address that, as opposed to early detecting (of) disease and preventing it.’