EU Commission wants answers from AstraZeneca on vaccine supply cuts

The European Commission is pressing British drugmaker AstraZeneca to provide immediate answers on the announced reduction of coronavirus vaccine deliveries to the EU.

Health Commissioner Stella Kyriakides sent a letter to the pharmaceutical company on Sunday demanding clarifications about its announcement late Friday that volumes of the Oxford/AstraZeneca vaccine will be “lower than originally anticipated.”

“We have serious questions, and we expect them to be answered on Monday,” one EU official said ahead of a steering board meeting between the Commission and representatives from EU countries Monday. Kyriakides tweeted Friday that the Commission and EU countries had reacted with “deep dissatisfaction” to the news.

“In this letter, the commissioner stressed the importance of deliveries in line with the schedules laid out in the agreements,” Commission spokesperson Stefan De Keersmaecker said Monday.

The contracts, which are confidential, include clauses that allow the Commission to terminate a contract with a vaccine producer. However, it’s too soon to take these kinds of steps, according to the Commission.

“At this stage, what’s important is that we have a discussion with the company, with the member states, and see how these deliveries which have to happen can take place in line with what was agreed in the contract,” De Keersmaecker added.

The cause of the issue is not entirely clear, as the Commission declined Monday to answer questions about the reason or whether they could get any vaccine supply from the U.K.

A senior EU official told Reuters on Friday that deliveries of the Oxford/AstraZeneca vaccine to the EU would be cut by 60 percent to 31 million doses in the first quarter. According to that report, AstraZeneca said that the cut was caused by “production problems” at a vaccine factory in Belgium run by its partner Novasep.

Another EU official told POLITICO that AstraZeneca is facing two issues: First, there was an issue with one of their batches that had to be thrown out. Second, the company is still sourcing raw material to ramp up manufacturing. Now, “it seems unlikely they will meet their first quarter target,” the official said.

“The shortage problem that they have will only be at the cost of EU,” EPP MEP Peter Liese told reporters Monday. He added that other markets such as the U.K. will continue to be served by AstraZeneca as planned.

While the company cites different supply chains between the EU and U.K. as reasons, “everybody understands that this is great nonsense,” said Liese. “If you have a contract, you have to deliver. It is very easy to ship vaccines from U.K., or wherever, to the EU.”

Commission chief spokesperson Eric Mamer said Monday that Commission President Ursula von der Leyen had a call with the AstraZeneca CEO Pascal Soriot Monday morning, “where she made it clear that she expects AstraZeneca to deliver on the contractual arrangements” and that “the EU has invested significant amounts in the company” to ensure manufacturing ramp-up.

How much the EU gave to the companies from its €2.1 billion Emergency Support Instrument is not public, but another EU official said this was a “three-digit million-euro amount.”

“Of course, production issues can appear with a complex vaccine, but we expect the company to find solutions and to exploit all possible flexibilities to deliver their doses as swiftly as possible,” Mamer said.

Frustration about AstraZeneca’s announcement is running high because the vaccine — which could receive its market approval by the European Medicines Agency as early as Monday — is expected to speed up the EU’s slow rollout of coronavirus inoculations. It’s cheaper and easier to roll out compared to the approved mRNA vaccines from BioNTech/Pfizer and Moderna.

The EU agreed last August to purchase 300 million doses with an option to purchase an additional 100 million of the Oxford/AstraZeneca jab, although the deal is based on quarterly deliveries.

News about reduced availability of the Oxford/AstraZeneca vaccine is also delicate for the Commission because it already faces pressure in many EU countries, particularly Germany, for allegedly having bungled the joint vaccine procurement process — an accusation that it firmly rejects.

EU leaders on Thursday voiced new urgency about accelerating the pace of vaccinations in Europe to avoid a further spread of the virus that could exacerbate economic damage and potentially close borders again.

Leaders already expressed concern last week after BioNTech/Pfizer said that deliveries of its vaccine have been reduced while it upgrades production facilities, which should allow the companies to increase its deliveries starting mid-February.

European Council President Charles Michel admitted Sunday that “it is going to be difficult” to reach the Commission’s target of vaccinating 70 percent of the adult population of EU countries by the summer.

AstraZeneca said in a statement Friday that “initial volumes” of its vaccine deliveries to the European Union “will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain.”

“We will be supplying tens of millions of doses in February and March to the European Union, as we continue to ramp up production volumes,” the statement added. The company declined to comment on the volume of the delivery shortfall, or which manufacturing plant is facing issues.