Sunday, August 1, 2021

The EU’s vaccine bust-up with AstraZeneca is partly of its own making | Leo Cendrowicz


Last year AstraZeneca was heralded for its pioneering vaccine discovery. Yet today the British-Swedish pharmaceutical company is embroiled in a dispute with the European Union over claims that it is holding back vaccine deliveries for the bloc, while diverting supplies to Britain and other countries. But can AstraZeneca be blamed for the EU’s stuttering vaccine rollout, which is far behind Britain, the US and other countries?

Anger is certainly surging across the EU about the slow pace of vaccinations. The latest figures from Our World in Data reveal that just 2.1% of the EU population has received a vaccine, compared with 10.8% for the UK. The goal to vaccinate at least 70% of the EU’s population by this summer is wildly off – at the current pace, the bloc as a whole would reach only 15% by the end of September.

On the face of it, the EU has locked in far more vaccines than it needs: the European commission has secured a portfolio of more than 2.3bn doses, which is more than five times the EU’s 450 million population. It has contracts with five different vaccine makers: not only AstraZeneca, but Pfizer/BioNTech, Moderna, Johnson & Johnson, and CureVac. It has also wrapped up exploratory talks with Novavax and Valneva.

The commission negotiated the contracts on behalf of the EU as a way to avoid the ugly free-for-all that erupted last year, when national governments squabbled over orders of PPE and medical devices. The idea of a centralised procurement policy was not only to ensure a fair deal for all, but to leverage the collective negotiating weight of the 27 EU member states.

However, the EU approach came with strings. The commission, negotiating for the first time on vital medicines, felt that EU countries would demand value for money, so it dragged out the talks to secure better prices and product liability guarantees. That meant it signed the contracts with AstraZeneca in August, three months after the UK’s contract.

The EU’s joint approach may have secured lower prices and guarantees, but it came at the expense of speed – and at such a critical moment, it can only watch as the UK, which paid the full price, is benefiting from its early orders.

The approval process was also strung out. Last year, worried that vaccine scepticism might hamper the rollout, the commission and national governments insisted the Amsterdam-based European Medicines Agency (EMA) should not stint on its vital regulatory scrutiny. But that meant the first EU-approved vaccine, by Pfizer/BioNTech, was only offered from 27 December, some 16 days after the UK started to use it.

The AstraZeneca vaccine is yet to be approved by the EMA (this is expected on Friday) but it has already said production snags at its EU sites mean it will only deliver about 40% – or 31m – of its 80m promised doses to the EU in the first quarter. This shock setback has infuriated officials in Brussels and the EU member states, who have ordered a total of 400m doses.

The vaccine spat is, almost inevitably, charged with Brexit-tinged rancour. The fact that AstraZeneca, headquartered in Cambridge, seems to be favouring the UK market is seen by Brussels as undue bias, while British ministers counter that leaving the EU gave them the freedom to secure vaccines faster. Both the EU and the UK accuse one another of protectionism and vaccine nationalism.

However, AstraZeneca has not helped its case with what Brussels sees as indifference. In an interview with Italy’s La Repubblica newspaper, CEO Pascal Soriot effectively told the EU to calm down. Soriot said that his company only committed to meet demand to its “best effort” and added that the delays were due to startup issues in the European production sites. “Unfortunately, it’s really bad luck,” he said.

There is also a dispute about what the contracts say. Soriot says the British agreement prioritises supply coming out of the UK sites, while EU officials say they are not tied to any particular production facility. To prove its case, the commission called on AstraZeneca to publish the vaccine contract, which is currently restricted by a confidentiality clause.

The EU has issued threats over the delays. Ursula von der Leyen, the commission’s president, said the EU “means business” about getting its fair share of vaccines. The commission is now moving to set export controls on vaccines, insisting manufacturers with facilities in the EU should notify authorities of any shipments outside the bloc. “Which doses have been produced, where and to whom have they been delivered?” Stella Kyriakides, the EU health commissioner, said. Officials have damped down suggestions they could block exports, saying the “transparency mechanism” aims to ensure manufacturers meet their contractual obligations to the EU.

The forceful approach is backed by EU countries, with Angela Merkel, the German chancellor, calling on Tuesday for the “fair” distribution of doses, while the Italian government wants to take AstraZeneca to court to force them to fulfil their signed contracts.

But for all the EU seething, its leverage may be constrained by the contracts themselves. While the commission has not published its advance purchase agreements (APAs), partly redacted details of its deal with CureVac say that “the delivery dates set out in this APA are the contractor’s current best estimates only and subject to change”, adding that “the parties acknowledge that there is a risk that … the timeline for scaling up the production of the product may be delayed”.

There was good news for the EU when French pharmaceutical company Sanofi said it will help supply 125m Pfizer/BioNTech doses from July to help meet the huge demand. But that is little consolation now, as the EU waits for the rest of its vaccines to arrive.

• Leo Cendrowicz is a Brussels-based journalist who has covered Europe for more than two decades



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