EU Going Ahead With AstraZeneca Lawsuit

27.04.2021 - The European Commission has confirmed rumors that it has initiated legal action against AstraZeneca for failing to meet contractual obligations for deliveries of Its Covid-19 vaccine. Health commissioner Stella Kyriakides said the action is being taken jointly with all 27 member states.

AstraZeneca had initially pledged to deliver 120 million doses to the EU in the first quarter but supplied only 30 million. For the second quarter, 180 million doses had been advised, but the company’s most recent advice was for only 70 million.

On top of the originally ordered 300 million total, the Commission had an option to take 100 million more doses but has now said it will not exercise this. Rather it will focus efforts going forward on the mRNA-based shots produced by Pfizer/BioNTech and Moderna and the CureVac candidate still in Phase 3 clinical trials.

The Commission’s health spokesman, Stefan De Keersmaecker, said that “some terms of the contract have not been respected” and that “the company has not been in a position to come up with a reliable strategy to ensure a timely delivery of doses. What matters to us in this case,” he said, “is that we want to make sure that there is 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."

At the heart of the ongoing dispute is the question of how watertight the volumes set down in the EU supply contract actually were. The Commission and the company have argued over whether AstraZeneca’s “to the best of its ability” meant development, manufacture or distribution of the vaccine. According to British politicians, the UK’s contract is more precise, calling for binding delivery terms – something the drugmaker has not confirmed publicly.

In March, European Commission President Ursula von der Leyen said AstraZeneca had “unfortunately under-produced and under-delivered. And this painfully, of course, reduced the speed of the vaccination campaign.”

Also slowing the speed of the campaign was the discussion of blood clots seen in people who received its shot, which was recently given the name Vaxezevria. Initially more than half of all EU member states paused their rollouts due to safety concern. Meanwhile, all but the Scandinavian countries have resumed vaccinations full speed. Denmark has announced it will stop using the AstraZeneca shot, and its doses may be up for grabs.

Commenting on the lawsuit, AstraZeneca said it has “fully complied” with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. “We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible,” the company added.

Sanofi comes to Moderna’s rescue

In a move that could help speed up the rollout of Moderna’s Covid vaccine, potentially in Europe and other world regions, Sanofi has again stepped in to offer manufacturing help. The French drugmaker said this week it would help fill and finish as many as 200 million doses of the Moderna vaccine at its Ridgefield, New Jersey, facility, starting in September. 

At a virtual pandemic summit held Apr. 23, Moderna CEO Stephane Bancel said the US biotech’s production had slowed, due to bottlenecks at Switzerland’s Lonza, its principal European supplier. The bottlenecks were reportedly due to the company’s difficulty in hiring enough qualified workers for its plant at Visp. Swiss press reports suggested that the recruiting efforts were being hampered by the company’s restrictive issue of work permits to foreign citizens.

The deal with Moderna is Sanofi’s third such agreement this year. In January, it promised to help supply more than 125 million doses of the Pfizer/BioNTech Covid-19 vaccine starting this summer. The drugmaker also has offered it to fill and finish 12 million doses per month of Johnson & Johnson’s single-dose vaccine.

Author: Dede Williams, Freelance Journalist