Why is AstraZeneca in dispute with EU and will it affect UK vaccines?

A row has erupted between the European Union, the United Kingdom and pharmaceutical company AstraZeneca over the supply of coronavirus vaccines.

The EU is frustrated at supply shortages and has demanded AstraZeneca doses be sent from British plants to make up for a shortfall.

On top of that, Germany’s vaccination advisory committee has now said there is insufficient data to recommend the jab for those over the age of 65.

Here’s everything we know about the dispute and its potential implications:

Why is the EU in dispute with AstraZeneca?

AstraZeneca has said initial deliveries to the EU will fall short because of a production glitch – reportedly at a hub in Belgium - and it will not be able to meet its supply targets for the first three months of this year.

The Anglo-Swedish company announced initial deliveries in the EU would total approximately 31 million doses, rather than the anticipated 80 million in the first quarter of the year.

With the speed of the UK's vaccine rollout outstripping other European countries, the EU has suggested doses produced in Europe have been directed elsewhere.

The president of the EU Commission, Ursula von der Leyen, has now called for an explanation from AstraZeneca for delivery hold-ups, as she insisted the supply orders are "binding" and "the contract is crystal clear".

While EU justice commissioner Didier Reynders has accused the UK of stoking up the row and trying to “start a vaccine war”.

The Commission on Friday, with AstraZeneca’s permission, made public a redacted version of the contract it agreed with the drugmaker in August 2020, which lies at the heart of the row.

EU officials pointed to a sentence in the contract in which the company says it is not under any obligation to others that would impede complete fulfilment of the agreement's requirements.

The contract mentions that the firm would use "best reasonable efforts" to use two UK plants as production sites for vaccines destined for the EU.

However, Ms Von Der Leyen said the best effort clause was only valid as long as it was not clear whether AstraZeneca could develop a vaccine.

Details about the price of the vaccine were notably redacted.

What has AstraZeneca said?

The company's chief executive Pascal Soriot said the contract only committed to meeting the EU's demands to its "best effort".

In an interview with Italy's La Repubblica newspaper, he reportedly said the “contract is very clear: Our commitment is, I am quoting, 'our best effort’.”

He explained that AstraZeneca and its partner Oxford University had signed a deal with the UK government for 100 million doses three months before the EU deal for 400 million doses was agreed.

Will the UK have enough doses?

The UK is concerned new powers coming into effect from Friday for the EU to block exports of pharmaceuticals to tackle Covid could interrupt its order for 40 million Pfizer vaccines, produced at a factory in Belgium.

The prime minister, Boris Johnson, said this week he is "very confident" about the UK's vaccine supply, while Cabinet Office minister Michael Gove insisted there "will be no interruption".

Mr Gove said the "first and most important thing" is that the supply schedule agreed with AstraZeneca is honoured so the domestic vaccine rollout can be delivered before neighbouring nations are aided.

And government vaccine tsar Nadhim Zahawi said he was "confident" supply of the Pfizer jab will continue.

But Downing Street declined to rule out vaccines being sent to the EU before everyone in the UK is vaccinated to help address supply shortages being faced by the bloc.

Will the EU take action to restrict supplies of EU-made doses to UK?

The European Commission on Friday announced it had adopted an export ban on some coronavirus vaccines.

Executive vice-president Valdis Dombrovskis told a Brussels press conference: "Today the commission has adopted an implementing regulation making the export of certain products subject to an export authorisation.

"This regulation concerns the transparency and export of Covid-19 vaccines."

It came after EU health commissioner, Stella Kyriakides, proposed forcing all drug-makers to register their Covid-19 vaccine exports in advance, so the bloc can keep track of what they are doing.

The majority of the AstraZeneca/Oxford vaccine supply for the UK is manufactured here rather than at the Belgium plant so it is not expected to be disrupted.

But there are concerns the new rules could affect access to the Pfizer vaccine, which is produced in Belgium.

The UK is scheduled to receive 3.5 million doses of the Pfizer vaccine over the next three weeks.

Germany's health minister, Jens Spahn, supported restrictions on vaccine exports, saying Europe should have its "fair share".

Asked if the EU could prevent Pfizer vaccines from being exported, Mr Zahawi, the vaccines tsar, told Sky News on Tuesday: "No, I'm confident that the Pfizer vaccine will be delivered.”

Is the vaccine safe for over-65s?

Earlier this week, a report in German business daily newspaper Handelsblatt said AstraZeneca's vaccine was thought to be only 8 per cent effective among the over-65s.

AstraZeneca and Mr Zahawi dismissed the report as "incorrect" and "untrue".

However on Thursday, a draft recommendation from Germany’s vaccination advisory committee said there was insufficient data to recommend the jab for those aged 65 and over.

Mr Johnson has said he is not concerned by the ruling, as he argued the evidence shows the vaccine "provides a good immune response across all age groups".

Dr Mary Ramsay, head of immunisations at Public Health England, said there had been "too few cases" of coronavirus in older people in Phase 3 clinical trial to determine efficacy in this age group, but other data on immune response had been "reassuring".

"Both the AstraZeneca and Pfizer/BioNTech vaccines are safe and provide high levels of protection against Covid-19, particularly against severe disease,” she said.

Responding to reports that Germany will limit the use of its vaccine to under-65s, AstraZeneca said in a statement: "The latest analyses of clinical trial data for the AstraZeneca/Oxford Covid-19 vaccine support efficacy in the over 65 years age group.”

A Phase 3 Lancet study published in December said older age groups had been recruited later into the study so "efficacy data in these cohorts are currently limited by the small number of cases, but additional data will be available in future analyses".

In that particular analysis, only 12 per cent of people given two doses of the vaccine in the UK arm of the trial (285 out of 2,377) were aged 56 to 69, while 9 per cent (213) were over 70.

Some 12 per cent of people in the control group (given a dummy vaccine) were also aged 56 to 69 while 9 per cent were over 70.

Previous work published in November included findings for 560 people. Of these, 160 were aged 18 to 55, 160 were aged 56 to 69, and 240 were 70 or older.

Those results found that all age groups, including older people, had an immune response to the vaccine after two doses.

Additional reporting by PA