E.U. demands answers on AstraZeneca delay and releases contract before likely approval.
The European Commission’s president has demanded that AstraZeneca provide a transparent and plausible explanation for why it will not be able to meet the delivery agreement of pre-ordered doses of its Covid-19 vaccine that is expected to be approved for use across the European Union on Friday.
The comments, by Ursula von der Leyen, come amid a dispute between the bloc and the pharmaceutical company, and hours before the commission made public a copy of its contract with AstraZeneca.
“There is a binding order, and the contract is crystal clear,” Ms. von der Leyen said in an interview with a German radio station earlier in the day. The contract includes language on two production facilities that can be used for making does intended for E.U. countries, she said, adding, “How they manage that is their affair.”
The comments come a week after AstraZeneca told the bloc that it would not be able to meet its commitment to begin deliveries of the 300 million doses of the vaccine. In the days since, a dispute between the British-Swedish pharmaceutical company and the bloc has escalated. The disagreement is fueled by concerns over a sluggish start to the vaccination campaign in its 27 member states, and has pitted Britain against the bloc, which it fully quit on Dec. 31 after years of wrangling.
The copy of the AstraZeneca contract that the European Commission released, which was heavily redacted, was largely similar to other industry contracts, including one that the bloc signed with CureVac. Although the AstraZeneca document includes legal language that protects the company over failures to deliver vaccines according to an agreed schedule, it also includes a clause saying that vaccines for this contract should be produced in factories within the European Union and in Britain.
The contract also says the company should make its best reasonable efforts to ensure the supply, or even switch to production outside the bloc and Britain if necessary. A detailed schedule of deliveries was redacted from the contract, which is under Belgian law.
The European Union has had several problems since it approved its first coronavirus vaccine, made by Pfizer and BioNTech, in December and then began a vast immunization campaign. It was already trailing weeks behind rich nations like the United States and Britain, and vaccine supplies have dwindled in recent days.
AstraZeneca’s plan to cut its deliveries as much as 60 percent deepened the troubles.
“What we want is a plausible explanation why there were these difficulties at the start,” said Ms. von der Leyen, herself a trained doctor.
She acknowledged that difficulties could happen in the highly complicated process of producing a safe vaccine under heightened time pressure, but noted that the European Union had invested a six-figure sum in AstraZeneca and other European pharmaceutical companies to enable pre-production.
“We wouldn’t have the possibility of the vaccine now had the E.U. not invested in these companies,” Ms. von der Leyen told Germany’s Deutschlandfunk radio on Friday. Other companies that received similar pre-orders, including for the Pfizer-BioNTech vaccine, have also faced production delays, but have offered reasonable explanations for the causes, Ms. von der Leyen said.
“What bothers us — by that I mean all 27 E.U. members,” she said, “is that AstraZeneca, unlike the other companies, cut supplies with very little notice and has not offered a plausible explanation of why the doses cannot be delivered.”
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