France and Germany threaten AstraZeneca over vaccine shortage

Warning of ‘legal commitment’ and concern that doses might have been diverted from the EU to the UK

France and Germany have raised the threat of legal action against AstraZeneca over a shortage of deliveries of coronavirus vaccines, even as an inspection of a plant in Belgium confirmed the company’s claims of production problems.

EU officials in Brussels have spoken of their suspicions that a shortfall in deliveries of the Oxford/AstraZeneca vaccine may have been due to doses being diverted from plants in Belgium and the Netherlands to the UK.

The European commission is demanding that AstraZeneca provide the EU doses from its two plants in Oxford and Staffordshire, warning that the company was contractually obliged to fulfil its advanced purchase agreement.

But on Sunday, Belgium’s prime minister, Alexander De Croo, said an initial inspection at AstraZeneca’s plant in Seneffe, 25 miles south of Brussels, had found evidence to back up the company’s claims of production issues at the site.

He said, however, that the investigation was continuing to ensure that the problems, described as a shortage of raw materials, were not a result of AstraZeneca allegedly favouring the UK’s order for 100m doses.

De Croo said: “AstraZeneca pointed to production issues at Seneffe. The federal medicines and health products agency has together with its European partners carried out checks at the site.

“It appears that there is a shortage of the raw materials needed to make the vaccines. The analysis of the situation there is still ongoing.

“Is it a typical production problem caused by having to very greatly increase production in a short time or is the problem due to others having been given precedence?”

De Croo said the commission’s new export authorisation system for vaccine suppliers gave the government a means to hit back but that he did not expect it to happen. “At first glance, that won’t be necessary,” he said.

“I hope that this won’t be necessary, and I don’t think that it is necessary,” De Croo added. “I presume that everyone is working with the best of intentions. However, if it becomes evident that the contract is not being respected, we have the means to hit back.”

AstraZeneca recently informed the commission that it would be able to deliver only 25% of the 100m doses expected in the first quarter of this year.

The continued assurance to the UK government that its doses would be delivered on time infuriated officials in Brussels who insisted that the sites in Britain should be used to meet the EU’s order.

In response, the Anglo-Swedish company’s chief executive, Pascal Soriot, said last week that this was not in the advance purchase agreement.

He insisted the company was obliged only to make “best efforts” to deliver doses “more or less at the same time as the UK” as the EU contract had been signed three months later.

Clément Beaune, France’s Europe minister, said on Saturday that the EU was investigating, but that the company could face “penalties or sanctions” if found to have given priority to British orders of the vaccine.

He said: “These are serious accusations, so it is not done lightly. I am not saying that there is a problem but if there is a problem and that [they] have favoured other destinations, other countries – for example the UK over us – then we will defend our interests. Our contracts need to be respected. Respecting contracts are not moral commitments, they are legal commitments. Penalties or sanctions can be triggered in every contract.”

In a sign that Brussels wants to dial down the rhetoric in the row, the EU’s ambassador to the UK, João Vale de Almeida, emphasised that the EU was not in dispute with the UK. “Our enemy is the virus,” he said. “Our contractual issues are with the vaccine producers. Britain is an ally of ours in the fight against Covid.”

The EU commission president, Ursula von der Leyen, said on Sunday AstraZeneca will deliver 9m additional Covid-19 vaccine doses in the first quarter, making a total of 40m doses to Europe.

AstraZeneca will start deliveries one week earlier than scheduled, Von Der Leyen said on Twitter. “The company will also expand its manufacturing capacity in Europe,” she said.

Speaking on German television later that evening, she rejected suggestions that Europe was in a race to vaccinate its population against the coronavirus faster than other countries, saying that it was important to cooperate at this stage of the pandemic.

“I think the only race we are in is with the virus and against time,” Von der Leyen said, adding that she had enjoyed “a very good conversation with Boris Johnson” the previous night in which she and the prime minister had agreed that factories in both the UK and EU would deliver doses to each region.

The EU has been criticised for investing too little in scaling up manufacturing in the early months of the pandemic.

According to the data analytics company Airfinity, the EU spent just €1.78bn (£1.58bn) in “risk money”, cash handed to pharmaceutical companies without any guarantee of a return, compared with €1.9bn by the UK and €9bn by the US.

The EU has a €336m advance purchase agreement with AstraZeneca to provide 400m doses of which a quarter was due before the end of the March. EU officials involved in the contract said that not all of the money had been paid to the company, describing the amount held back as “not pennies, not cents”. It is believed to in the region of €110m.

Given the company disputes the commission’s reading of the contract, such a move would probably end up in the courts, an outcome accepted in the commission, with officials insisting they are sure of their case.

Asked if the EU could refuse to make the final payment to AstraZeneca, Beaune said: “Yes, for example … by not ordering supplementary doses, or the penalties all which have been foreseen by the contract. But if it’s an industrial glitch, that results in a reduction in deliveries for Europe and not for the others, that’s a problem.

“I don’t want suspicion, [or] conspiracy, but we need clarity and transparency. At the moment, there is an investigation that is in the process of being finalised to see precisely what was delivered in Europe and to the UK from factories that produce in Europe. If there has been a preference granted to the British, then that’s a problem.”

The EU has introduced an export authorisation scheme to force vaccine suppliers to seek agreement on any doses leaving the bloc. It has also demanded disclosure of the last three months of exports.

The EU has been hit by a lack of supply after Pfizer also reported production problems in its plant in Belgium. The latest figures show that the UK has vaccinated 13.1% of its adult population. The EU has given a vaccine shot to 2.69% of its adult population, with the rollout of first jabs suspended in Paris and Madrid, among other regions.

The European Medicines Agency on Friday approved the use in the EU of AstraZeneca’s vaccine for people over 18 without an age limit.

The vaccine’s developers and regulators in the UK have strongly defended its efficacy in all groups.

Contributor

Daniel Boffey in Brussels

The GuardianTramp

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