The European Union has sued AstraZeneca over what the bloc has described as delays in shipping hundreds of millions of doses of coronavirus vaccines, a sharp escalation of a longstanding dispute between the bloc and the maker of one of the world’s most important vaccines.
AstraZeneca has said that it would be able to deliver only a third of the 300 million doses that European officials had been expecting by the end of June. As a result, European officials said on Monday that they believed AstraZeneca had broken its contract, and that they were seeking speedier deliveries than the company said it could muster.
The two sides’ relationship had grown acrimonious in January when AstraZeneca slashed its expected deliveries for the first quarter of the year, setting back the bloc’s vaccination campaign by weeks as cases picked up across the continent and political leaders faced scorching criticism for inadequate planning.
For AstraZeneca, whose cheap and easy-to-store shot is being used by 135 countries, the lawsuit could create further difficulties in a bruising stretch. No company had been as instrumental in the race to vaccinate poorer countries around the world, but AstraZeneca has been buffeted in recent weeks by the discovery of an exceedingly rare, though serious, side effect that has prompted restrictions on its use in parts of Europe.
At issue in the legal dispute was whether AstraZeneca had done everything in its power to meet its delivery schedule. Pascal Soriot, the company’s chief executive, has said that the contract required only that it make its “best efforts” to deliver the purchased doses on time.
Vaccine production is a notoriously fickle science, with live cultures needing time to grow inside bioreactors, for instance. In an effort to supply doses not only to richer nations that had purchased them well in advance, but also to poorer nations, AstraZeneca had partnered with manufacturing sites around the world, rather than relying on only a few factories, as Pfizer and Moderna have.
AstraZeneca, which developed the vaccine with the University of Oxford, has also said that the European Commission, the bloc’s executive branch, finalized its contract months after Britain did, giving the company less time to iron out any manufacturing difficulties.
Legal experts said that the “best efforts” language in the contract raised the burden on the Europeans to prove that AstraZeneca did not act diligently enough to supply the promised doses. But they also said that it did not entirely insulate the company from being deemed in breach of contract.
Geert Van Calster, a law professor at Leuven University specializing in contracts, said that the accelerated timetable of the legal proceedings — the European Union said it expected a judgment in three to seven weeks — meant that the courts would consider only what was apparent from an “immediately obvious reading of the contract.”
- On April 23, a Centers for Disease Control and Prevention panel of advisers voted to recommend lifting a pause on the Johnson & Johnson Covid vaccine and adding a label about an exceedingly uncommon but potentially dangerous blood clotting disorder.
- Federal health officials are expected to formally recommend that states lift the pause.
- Administration of the vaccine ground to a halt recently after reports emerged of a rare blood clotting disorder in six women who had received the vaccine.
- The overall risk of developing the disorder is extremely low. Women between 30 and 39 appear to be at greatest risk, with 11.8 cases per million doses given. There have been seven cases per million doses among women between 18 and 49.
- Nearly eight million doses of the vaccine have now been administered. Among men and women who are 50 or over, there has been less than one case per million doses.
- Johnson & Johnson had also decided to delay the rollout of its vaccine in Europe amid similar concerns, but it later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, also suspended use of the vaccine but later moved forward with it.
That could make it more difficult for European officials to demand faster shipments. But Belgian courts, like many in continental Europe, consider not only the wording of a contract, but also its genesis, which could work to the advantage of the European Union.
“A European judge looks at the good faith or lack of it that the parties brought into the contract, at the way in which the contract was negotiated, the general atmosphere,” said Professor Van Calster. “I think that the commission probably hopes that the judge will be able to determine that AstraZeneca, in particular, has failed to supply a number of vaccines which they could have reasonably supplied to the European Union.”
He said that the court could rule that AstraZeneca must surrender a certain number of doses, but that the outcome was uncertain.
AstraZeneca said on Monday that it “regrets the European Commission’s decision to take legal action over the supply of Covid-19 vaccines,” describing the lawsuit as “without merit.”
It said that it would deliver almost 50 million doses to the bloc by the end of April, and that it had “fully complied with the advance purchase agreement with the European Commission and will strongly defend itself in court.”
Stefan de Keersmaecker, a spokesman on health issues for the European Commission, said that the bloc had begun legal action because it believed the purchase agreement had been breached.
“The reason indeed being that the terms of the contract, or some terms of the contract, have not been respected,” he said, “and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses.”
Mr. de Keersmaecker said that all the 27 E.U. member countries supported the move.
The two parties had been engaged in an arbitration effort, but the European Union decided to move ahead with a legal case. The contract is under Belgian law, and legal proceedings would happen in Belgium.
The European Union’s vaccine contract with AstraZeneca, a British-Swedish company, was the first it signed, in August last year.
Whereas Brussels was desperate for AstraZeneca doses earlier this year, it has since put itself in a stronger position: European officials have pivoted to Pfizer’s vaccine, indicating that they would not seek further doses from AstraZeneca beyond those they had already purchased. The bloc is negotiating a contract with Pfizer for 1.8 billion doses over the next two years.
Ursula von der Leyen, the president of the European Commission, told The New York Times on Sunday that AstraZeneca had squandered the bloc’s trust.
“The noncommunication of AstraZeneca of the problems made it like pulling a chewing gum, because you never knew what was going on,” she said. Ms. von der Leyen added that the delivery shortfalls were too steep to ignore.
“At the moment, the company has a delay in delivering 200 million doses of vaccine by the end of the second quarter,” she said. “The number speaks for itself.”
AstraZeneca’s vaccine is being widely used across Europe, though some countries have curbed its use in younger people because of the risk of very rare blood clots. The European Medicines Agency, the bloc’s drug regulator, said this month that the shot’s benefits still outweighed its risks, but that it should carry a warning.
The vaccine is not yet authorized for use in the United States. American officials have given a few million doses that were manufactured there to Canada and Mexico.