AstraZeneca furiously deny reports in German media over ‘8% efficacy’

The EU’s vaccine regulator is reportedly set to reject the UK’s Oxford Covid jab for over-65s, according to reports in Germany. 

German federal chiefs expect the jab to be ‘8 per cent effective’ in people over 65 years of age, according to reports in newspapers Bild and Handelsblatt.

German officials fear that the AstraZeneca vaccine may now not be approved for those aged over 65 by EU medicine regulator, the European Medicines Agency (EMA), it is claimed. 

But the reports have sparked a furious denial by Oxford vaccine manufacturer AstraZeneca. The British-Swedish firm say the reports are ‘absolutely incorrect’.  

In a statement, they said: ‘Reports that the Astra/Zeneca Oxford vaccine efficacy is as low as 8 per cent in adults over 65 are absolutely incorrect’. 

German federal chiefs believe the jab to be less than 10 percent effective in people over 65 years of age, according to reports in newspapers Bild and Handelsblatt. But the reports have sparked a furious denial by Oxford vaccine manufacturer AstraZeneca 

‘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.

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. 

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‘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 anitbodies after the second dose.’ 

The EMA’s approval of the vaccine is expected to take place on Friday, according to reports.

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. 

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 when initial tests last year 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.’

The reports comes as EU leaders today voiced their fury after AstraZeneca said it could not meet the demands of a £300m vaccine deal following a weekend of riots in Europe over lockdown restrictions.

The vaccine makers have blamed the EU’s supply chain for their failure to deliver the promised 80million vaccines by the end of March as part of the deal.

AstraZeneca said they could only offer 31million vaccines in the first quarter, a cut of 60 per cent.

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: 

MODERNA (US)

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.

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The European Union’s Health Commissioner, Stella Kyriakides, tonight slammed the cut, warning it was ‘not acceptable’.

It comes after Eindhoven in the Netherlands saw its worst riots in nearly 40 years over the weekend, with Mayor John Jorritsma warning the country was ‘on our way to civil war,’ amid outcry over a new nationwide curfew.

Politicians pushed to tighten lockdown measures across the continent even after a weekend of rioting brought scenes of chaos to the Netherlands and Denmark.

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 rollout. 

The mayor of Eindhoven, the Netherlands, John Jorritsma, warned the country was 'on our way to civil war,' following riots at the weekend over a new nationwide curfew

The mayor of Eindhoven, the Netherlands, John Jorritsma, warned the country was 'on our way to civil war,' following riots at the weekend over a new nationwide curfew

The mayor of Eindhoven, the Netherlands, John Jorritsma, warned the country was ‘on our way to civil war,’ following riots at the weekend over a new nationwide curfew  

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

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

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

AstraZeneca is set to face further questions from the EU tonight, as Ms Kyriakides said: ‘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.

‘These questions were also discussed today in the joint Steering Board of the Commission and the 27 Member States with AstraZeneca.

‘The answers of the company have not been satisfactory so far. That’s why a second meeting is scheduled for tonight.

‘The European Union wants the ordered and pre-financed doses to be delivered as soon as possible. And we want our contract to be fully fulfilled.’

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.

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'

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'

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

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.

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'

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'

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’

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.’ 

Furious EU officials said they will investigate their claims and have questioned why Britain is not suffering from similar delays in the rollout. 

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.

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

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

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. 

The agreement for at least 300million shots was the first signed by the EU to secure Covid vaccines

The agreement for at least 300million shots was the first signed by the EU to secure Covid vaccines

The agreement for at least 300million shots was the first signed by the EU to secure Covid vaccines

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 on Monday.

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 chief executive Pascal Soriot denounced the 'me first' approach by some countries to obtaining doses

AstraZeneca chief executive Pascal Soriot denounced the 'me first' approach by some countries to obtaining doses

AstraZeneca chief executive Pascal Soriot denounced the ‘me first’ approach by some countries to obtaining doses

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.’

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