The laboratory maintains that it has fulfilled its contract with the EU and that the dispute is unfounded.
The European Commission has announced this Monday that it will take the Anglo-Swedish laboratory AstraZeneca in court for systematically failing to deliver vaccines against Covid-19 promised to the EU by contract. The decision was adopted last Friday and has the unanimous support of the 27 member states, according to Brussels. The laboratory replies that it has complied with its agreements with Brussels and that the dispute is unfounded.
“The Commission took legal action last Friday against the AstraZeneca company for the breach of advance purchase agreement. The reason is that some of the clauses of the contract have not been respected and the company has not been able to present a reliable strategy to guarantee the punctual delivery of doses “, explained the spokesman for Health, Stefan de Keersmaecker, at a press conference .
“What is important to us in this case is to make sure that there is a rapid delivery of a sufficient number of doses to which European citizens are entitled and which we had been promised by contract, “added the spokesman.
After learning that Brussels is going to court, the Anglo-Swedish laboratory has made public a community in which he regrets this step. “AstraZeneca has fully complied with the advance purchase agreement with the European Commission and will defend himself firmly in court. We believe that any litigation is unfounded and we welcome this opportunity to resolve this dispute as soon as possible, “the company maintains.
“Our company is about to deliver almost 50 million doses to European countries by the end of April, in line with our prognosis, “AstraZeneca continues. The laboratory justifies its problems by the complexity in the manufacture of vaccines and the shortage of supplies.
Delivered and planned doses
“We are making progress in addressing technical issues and our production is improving. But the production cycle of a vaccine is very long, which means that these improvements take time to result in an increase in finished vaccine doses, “the statement concludes.
The first hearing of the case will be held this Wednesday before the Court of First Instance in Brussels, since the contract with AstraZeneca is drawn up under Belgian law.
The decision to go to court comes after a long and bitter dispute with the company. The community Executive already activated a few weeks ago dispute resolution mechanism provided for in the contract by sending a letter of formal notice to AstraZeneca. Since then, the Commission and the laboratory have maintained high-level contacts in search of a negotiated solution that have also failed to solve the problem.
Under the contract with AstraZeneca, the Anglo-Swedish laboratory should have delivered 300 million doses to the EU between January and June of this year. However, instead of the 120 million vaccines promised for the first quarter, the company supplied only 29.8 million. For the second quarter, AstraZeneca was supposed to deliver 180 million doses, but has lowered its forecast to 70 million.
That is to say, in total only 100 million doses of the 300 million foreseen in the advance purchase agreement. Since the beginning of April, hardly any injections from this company have reached the EU.
European leaders exclusively blame AstraZeneca’s systematic non-compliance with the chaos and delays in the vaccination campaign in Europe. A chaos that has been aggravated by the rare cases of thrombosis associated with a low number of registered platelets among recipients of this vaccine.
The contract will not be renewed
In fact, the Community Executive has already decided not exercise the purchase option for 100 million extra doses (up to 400 million) foreseen in the contract with the Anglo-Swedish laboratory. In addition, Brussels rules out signing new agreements with AstraZeneca and has decided to bet in the future on vaccines based on messenger RNA technology, such as those from Moderna and Pfizer.
In fact, the president of the Commission, Ursula von der Leyen, has announced that it is negotiating a new contract with Pfizer to purchase 1.8 billion doses in 2021-2023. An agreement that would cover both booster injections and vaccines adapted to new variants of the virus.
For its part, the European Medicines Agency (EMA) issued precisely last Friday a new opinion reaffirming the AstraZeneca Covid-19 Vaccine Safety (called Vaxzevria) despite very rare cases of thrombosis. After reviewing all available data, the EMA has concluded that “Vaxzevria benefits outweigh risks for all age groups“.
Ursula von der Leyen visited the Pfizer plant in Puurs last Friday
Etienne Ansotte / CE
The European regulator also recommends managing the second dose of AstraZeneca to all peoplewho have already received the first injection, regardless of their age. The EMA rules out other options that the Spanish government is considering for those under 60, such as giving a messenger RNA vaccine as a second dose or leaving them without a second injection.
Specifically, the European Medicines Agency evaluated three alternative scenarios– delay the second dose of AstraZeneca beyond 12 weeks, do not give a second dose at all, or give as a second dose a vaccine based on messenger RNA technology, such as that of Pfizer-BioNTech or Moderna. All three alternatives have been rejected.
“Available data support continuing to administer a second dose of Vaxzevria vaccine 4-12 weeks after the first, in line with the product information. The data do not support delaying or avoiding the second dose of the vaccine. At the moment there is no available or very limited data on alternatives, “said EMA Deputy Director Noël Wathion at a press conference.
Based on the EMA’s analysis of all available data, rare cases of thrombosis affect 1 in 100,000 vaccinated people.