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The European Commission is making preparations for a lawsuit against COVID-19 vaccine maker AstraZeneca, according to multiple news outlets.
The potential suit, reported Thursday by Politico, then Reuters and AFP, is about AstraZeneca’s repeated failure to make good on EU deliveries of its vaccine. The Commission itself said Thursday that “all options” are still on the table when it comes to getting AstraZeneca to live up to its promises.
Beginning what is by now a long-running saga, AstraZeneca in January infuriated European officials by telling them it could deliver less than half of its agreed first-quarter deliveries. A couple of months later, the company said it would actually be delivering only around a third of its Q1 commitments, and only a third of Q2’s doses too.
This is when the Commission—the body that has been dealing with vaccine makers on EU countries’ behalf—got the legal ball rolling. It sent AstraZeneca a letter asking for informal discussions, thus triggering the dispute resolution process described in the contract. The deadline for AstraZeneca’s reply expired this month.
Commission noncommittal
Thursday’s reports indicate that the Commission discussed a lawsuit yesterday, at a meeting of EU member states’ ambassadors. Reportedly, most of the diplomats indicated support for the Commission’s plan, though Germany and France apparently want more time to think about it.
“It is about fulfillment of deliveries by the end of the second quarter,” an unnamed EU official told Reuters.
Per the Commission and AstraZeneca’s advance purchase agreement, the drugmaker was to make “best reasonable efforts” to deliver 300 million doses in the December-to-June period, with 180 million arriving in Q2. It has blamed production problems for the shortfall.
The Commission has not publicly committed to a suit. “What matters is that we ensure the delivery of a sufficient number of doses in line with the company’s earlier commitments,” said spokesman Stefan de Keersmaecker Thursday. “Together with the member states, we are looking at all options to make this happen.”
AstraZeneca said in a statement that it is “not aware of any legal proceedings and continues to hold regular discussions on supply with the Commission and member states.”
Clotting fallout
Even before this week, AstraZeneca’s future as an EU vaccine supplier was already looking shaky. Because of the possible links between AstraZeneca and Johnson & Johnson’s adenovirus-based vaccines and very rare and unusual blood clots, the Commission has recently been hinting that its next round of contracts will favor the rival messenger RNA (mRNA) technology offered by BioNTech/Pfizer and Moderna.
Many European countries paused their AstraZeneca rollouts, then limited the jabs to older people, because of the clotting risk. Dozens of people in Europe, mainly women below the age of 60, fell ill after receiving their AstraZeneca shots. Some have died, and Reuters reports this is one reason why the Commission has not taken up a contractual option for another 100 million doses.
However, as with J&J’s vaccine—which has caused similar symptoms in a handful of people in the U.S.—Europe’s top drug regulator has repeatedly said the benefit of getting the AstraZeneca vaccine vastly outweighs the risk, and rollouts should continue unabated.
Germany was the most influential country in restricting AstraZeneca’s rollout, with others such as France and Italy having followed its lead. On Thursday, Berlin became the fourth German state (after Saxony, Bavaria, and Mecklenburg-Vorpommern) to reopen AstraZeneca access to all adults.