Belgian regulators have launched an investigation into AstraZeneca’s coronavirus vaccine production site near Brussels on the request of the European commission, in an escalation of the row over shortages within the EU.
A first visit by officials from the Belgian federal medicines agency was completed on Wednesday at the site in Seneffe, Hainaut, the health ministry in Belgium said. Samples and records were taken from the plant and a further inspection of the facility is expected in the coming days.
The investigation was requested by the EU’s executive branch due to doubts over AstraZeneca’s explanation of an expected shortfall in vaccine deliveries to the EU.
The Anglo-Swedish company has said it will be able to deliver to EU member states only about 25% of the 100m doses expected by the end of March due to a production problem at the Belgian site owned by the French life-sciences company Novasep. The vaccine is expected to be authorised by the European medicines agency on Friday.
At the same time, AstraZeneca has assured Downing Street that it will be able to produce 2m doses a week of the vaccine to the UK in order to successfully fulfil a total order of 100m jabs. The vaccine was authorised by the UK regulator in December.
The commission has questioned the company’s explanation for the expected shortfall in deliveries to the European Union, and wants to know whether doses produced on EU territory have been diverted to the UK in recent weeks.
The backdrop to the investigation is AstraZeneca’s insistence that it will not make up the shortfall in deliveries to the EU by diverting vaccine doses made in Oxford and Staffordshire and put into vials in Wrexham.
AstraZeneca’s chief executive, Pascal Soriot, had said that he was contractually obligated to fulfil the UK government’s order for 100m doses first from British-based production sites.
“The UK agreement was reached in June, three months before the European one,” he said in an interview on Monday. “As you could imagine, the UK government said the supply coming out of the UK supply chain would go for the UK first. Basically that’s how it is.”
EU health commissioner dismisses AstraZeneca contract argument – video
On Wednesday, the EU’s health commissioner, Stella Kyriakides, dismissed the company’s argument, insisting that millions of doses made in the UK should now be transported to the EU.
“We reject the logic of first come, first served,” the commissioner said. “That may work in a butcher’s shop but not in contracts and not in our advanced purchase agreements.”
The company, in response, insisted it had not offered any certainty that it would be able to deliver 100m doses in the first quarter of this year. The company has said it agreed to make “best efforts” given the vagaries of producing the vaccine.
A spokesperson for AstraZeneca said: “Each supply chain was developed with input and investment from specific countries or international organisations based on the supply agreements, including our agreement with the European commission.
“As each supply chain has been set up to meet the needs of a specific agreement, the vaccine produced from any supply chain is dedicated to the relevant countries or regions and makes use of local manufacturing wherever possible.”
On Thursday, the Cabinet Office minister, Michael Gove, said the UK would only help the EU with doses if there were spare vials.
“We will want to talk to and with our friends in Europe to see how we can help,” he said. “But the really important thing is to make sure our own vaccination programme proceeds precisely as planned.”
Germany’s health minister, Jens Spahn, said he feared “at least another 10 tough weeks” of shortages. “Making vaccines is very complex, and there can be a need for building work to increase capacity that leads to delays,” Spahn said on NDR radio. “But then it has to impact everyone in the same way and not just the EU.”
The UK plants have benefited from the supply contract being sealed three months before the one with the EU, allowing for early production glitches to be settled last year, Soriot has said.
A spokeswoman for the Belgian health ministry said Wednesday’s inspection at the AstraZeneca plant in Seneffe, 25 miles south of Brussels, had been conducted to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”.
The inspection was “was conducted in full transparency and objectivity”, the spokeswoman said. “Belgian experts are now examining the elements that were collected, together with experts from the Netherlands, Italy and Spain.”
A report on the findings is expected to take “a few days” with a follow-up visit expected.
The EU is investing €336m (£297m) in AstraZeneca in return for 400m doses of its vaccine. Not all of the money has been paid to the pharmaceutical company and EU lawyers are examining whether there has been a breach of their contract.
On Wednesday, Kyriakides, a Cypriot who studied in Britain, said AstraZeneca had a moral as well as contractual duty to treat the EU similarly to the UK.
She said: “We are in a pandemic. We lose people every day. These are not numbers, they’re not statistics. These are persons with families with friends and colleagues that are all affected as well.
“Pharmaceutical companies, vaccine developers have moral, societal and contractual responsibilities, which they need to uphold. The view that the company is not obliged to deliver because we signed a best effort agreement is neither correct, nor is it acceptable.”