EU sues AstraZeneca over failure to deliver expected vaccines

Pharmaceutical firm set to deliver just 100m doses by end June instead of expected 300m

The European Commission has launched legal action against pharmaceutical company AstraZeneca over shortfalls in deliveries of its Covid-19 vaccine, which had once been expected to form the backbone of the continent's inoculation strategy before falling starkly behind.

Under its contract with the EU, the British-Swedish company committed to make “best reasonable efforts” to deliver 300 million doses between December and June, but later revised this figure down to 100 million, a shortfall that slowed vaccine rollouts across the continent.

On Monday, the commission announced it had initiated legal action against the company for breach of contract, with a spokesman telling journalists that all 27 European Union member states had backed the move.

"The commission has started last Friday a legal action against AstraZeneca," said spokesman Stefan De Keersmaecker.

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“The company has not been in the position to come up with a reliable strategy to ensure the timely delivery of doses. What matters to us, in this case, is that we want to make sure that there’s a speedy delivery of a sufficient number of doses that European citizens are entitled to and which have been promised on the basis of the contract,” he added.

“So the commission has indeed started legal action on its own behalf and on behalf of the 27 member states that are fully aligned in their support for this procedure.”

The move follows months of difficult negotiations and public rows with AstraZeneca over the deliveries that sparked tensions with the United Kingdom as the EU became a rival for supply of the doses.

A link to rare side effects has clouded the rollout of the vaccine, which has been suspended for younger groups in several member states, though the European Medicines Agency deems it safe and effective in preventing Covid-19 and has repeatedly cleared it for use in all ages.

Strategy shift

Nevertheless, the EU has shifted its vaccine strategy to focus on the messenger RNA vaccines, particularly that of BioNTech-Pfizer, which have show high efficacy against variants. The EU is expected to conclude a fresh deal for a further 1.8 billion doses of the vaccines for booster shots up to 2023, and was able to increase its production to make up for some of the AstraZeneca shortfall.

Some member states were initially reticent to support the legal action against AstraZeneca, out of concern that it would not speed up the delivery of doses, but were ultimately won around according to diplomats.

The AstraZeneca vaccine was developed by scientists at the University of Oxford before a partnership was agreed with the pharmaceutical company to facilitate mass production, was constitutes the bulk of doses being sent to developing countries under the vaccine equity COVAX initiative. The company has promised not to profit from its production.

In a statement, AstraZeneca said it “regrets” the decision to pursue legal action, which it described as “without merit”.

“AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court,” the statement read.

"Vaccines are difficult to manufacture, as evidenced by the supply challenges several companies are facing in Europe and around the world. We are making progress addressing the technical challenges and our output is improving... We look forward to working constructively with the EU Commission to vaccinate as many people as possible."

Naomi O’Leary

Naomi O’Leary

Naomi O’Leary is Europe Correspondent of The Irish Times