Open war between AstraZeneca and the EU

BrusselsThe confrontation between the European Union and the pharmaceutical company AstraZeneca is already an open war. It is no longer just about compliance with a secret contract, but the tension has escalated to the point of making a mess of the third meeting scheduled for Wednesday at 6:30 p.m. to try to clarify why the laboratory cannot deliver the agreed doses. The day started in Brussels with the European Commission confirming that AstraZeneca was refusing to attend the meeting, which was promptly denied by the company. 

The meeting has taken place, but the atmosphere is more than tense. According to European sources, the company had cancelled attendance the day before, claiming it had no more information to give. However, in the end, this very morning it announced that it would send only one of the people summoned. An e-mail between the company and the commission's director general for health, Sandra Gallina, published by German broadcaster ZDF shows that AstraZeneca did indeed cancel the appointment.

But this mess is only a mere glimpse of the underlying problem: AstraZeneca announced last week that it would deliver only a quarter (according to EU sources) of the doses committed during the first quarter. Brussels is demanding explanations and those obtained so far are not satisfactory. In an interview granted to several media, the company's CEO, Pascal Soriot, assured that if they did not manage to deliver the doses it is because two of the four plants that have to produce their vaccine in Europe were showing a "low performance" and that, as the United Kingdom signed the contract three months earlier, they will receive all the doses ordered.

"We reject the logic of serving on a first-come, first-served basis. That may work in the neighborhood butcher shop, but not in contracts. There is no priority clause in any signed agreement," Health Commissioner Stella Kyriakides fumed. The Commission reiterates that these explanations are of no use because the EU agreed to finance the Oxford/AstraZeneca vaccine with €336m (not all of which has been paid yet) so that there would be a certain number of doses (nine figures according to EU sources) available as soon as the vaccine was licensed. The EU claims it assumed the risk of losing the investment if the vaccine was not licensed, but the company pledged to be prepared to have the agreed production capacity. Moreover, in the agreement (which is still not out in the open) Brussels assures that both the UK plants and the two plants in Europe (Germany and Belgium) were counted on. Therefore, it demands that if the European plants have not reached the expected production capacity, doses be sent from the UK. "There is no hierarchy between plants," the commissioner said.

Precisely, the commission suspects that while the pharmaceutical company claims that it cannot meet the agreed deliveries, it has sold doses to other countries and, therefore, has asked the Belgian authorities to cooperate to find out whether or not vaccines have been exported. For this reason, it wants to set up a transparency system that would oblige pharmaceutical companies to notify in advance if and where they plan to export doses. It is not a question of blocking exports but of being able to have the information, they stress. The opacity in all this affair is key, because only one of the contracts, that of CureVac, is public. The European Commission assures that it is the companies that have demanded strict confidentiality clauses that implied not making the agreements public. But now Brussels considers that, with Soriot's interview, AstraZeneca skipped the agreement and demands that AstraZeneca publish the entire agreement so that it can be checked who is telling the truth.

However, the Commission is clear about its intentions: it wants to settle the dispute as soon as possible and receive the agreed vaccines. The legal wrangling is secondary if it gets the doses the EU was counting on. "The disappointment is immense because AstraZeneca was going to be the first to obtain authorization and be able to produce the vaccines on a massive scale, then we were fortunate that Pfizer and Moderna had it before, but it is unacceptable that the distribution schedule is reduced to just a fraction," European sources have lamented.

In addition, AstraZeneca's vaccine has not yet received authorisation from the European Medicines Agency (EMA). The meeting at which EMA experts have to decide whether to give the vaccine the green light is scheduled for Thursday. On Tuesday, however, EMA director Emer Cooke opened the door to the possibility that the authorisation may not be complete, but only allow the Oxford vaccine to be given to people under the age of 65 because of a lack of data on its impact and efficacy in older people, precisely one of the risk groups that should be vaccinated as a priority.