BRUSSELS — The European Union has filed a lawsuit in Belgium against the pharmaceutical company AstraZeneca over what it says is a breach of contract in the company’s delivery of Covid-19 vaccine, the European Commission announced on Monday.
The bloc’s relationship with the company has soured rapidly since AstraZeneca said in January that it would not be able to deliver on its scheduled vaccine doses for the first quarter of the year, setting Europe’s vaccination campaign back by weeks as the commission, the E.U. executive branch, faced widespread criticism over a halting start.
“The commission has started last Friday a legal action against the company AstraZeneca on the basis of breaches of the advanced purchase agreement,” said Stefan de Keersmaecker, a spokesman on health issues for the commission. “The reason indeed being that the terms of the contract, or some terms of the contract, have not been respected and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses.”
What You Need to Know About the Johnson & Johnson Vaccine Pause in the U.S.
- 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.
Mr. de Keersmaecker said that all 27 E.U. member countries supported the move.
The company said in a statement on Monday that it regretted the E.U.’s decision to sue. It said that it had fully complied with the agreement it signed and would “strongly defend itself in court.”
“We believe any litigation is without merit,” the statement added.
The two parties had been engaged in a dispute arbitration effort, but the European Union decided to move ahead with a legal case. The contract is under Belgian law.
The European Union’s vaccine contract with AstraZeneca, a British-Swedish company, was the first it signed, in August last year, and covers 400 million doses. So far, the company has delivered just over 30 million.
“We are making progress addressing the technical challenges and our output is improving,” the company said in its statement on Monday, but added that the improvements would take time to result in increased finished vaccine doses.
Production delays have been only one obstacle to the rollout of AstraZeneca’s vaccine in Europe. Reports of a very rare but potentially serious blood clotting disorder in some people who received it have prompted a rise in hesitancy and a series of shifting national restrictions. The European Medicines Agency, the bloc’s drug regulator, said earlier this month that the vaccine’s benefits still outweighed its risks, but that it should carry a warning.
Last week, Johnson & Johnson paused and then resumed its vaccine rollout in Europe over concerns about similar rare side effects.
In an interview with The Times on Sunday, the European Commission president, Ursula von der Leyen, said the company had supplied only a quarter of what it had promised to the bloc, and had to deliver 200 million doses of vaccines by the end of this quarter.
She indicated that the European Union would not open talks over future supply. “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.”
The European Union is now pursuing the confrontation from a position of strength, after securing enough doses of the vaccine developed by Pfizer and BioNTech to reach its vaccination target in mid-July, earlier than hoped. It is also negotiating a massive contract with Pfizer for 1.8 billion doses over the next two years.
“We need to focus now on technologies that have proven their worth: mRNA vaccines are a clear case in point,” Ms. von der Leyen said, announcing the negotiations over the new contract.