Brussels The meeting between the EU Commission and Astra-Zeneca because of the delivery difficulties with the vaccine ended on Wednesday evening without any concrete result. EU Health Commissioner Stella Kyriakides praised the “constructive tone” in the exchange of views with Astra-Zeneca CEO Pascal Soriot. “The EU remains united and strong. The contractual obligations have to be fulfilled, the vaccines have to be delivered to the EU citizens, ”said Kyriakides. “We regret that there is still no clarity about the delivery schedule and ask Astra-Zeneca for a clear plan for the fast delivery of the vaccine quantities that are reserved for the first quarter.”
Similar to the EU Commission, the British-Swedish pharmaceutical company spoke of a “constructive and open discussion”. Astra-Zeneca promised closer cooperation.
The dispute between the pharmaceutical company and the EU had previously escalated. On Wednesday there was confusion as to whether the Anglo-Swedish vaccine manufacturer would cancel a meeting with the Commission and Member States on the same day. “Astra-Zeneca has informed us that they will not be attending the meeting,” said a commission spokeswoman.
A spokesman for Astra-Zeneca said the company was planning to participate. The EU then gave this signal: According to later information from Brussels, Astra-Zeneca withdrew the rejection. The EU leaders had criticized the British-Swedish group unusually harshly because of its delivery problems with the vaccine against Covid-19.
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Instead of the planned 80 million vaccine doses, Astra-Zeneca may only deliver 31 million units in the first quarter – 60 percent less than planned.
In an interview with European newspapers, Astra-Zeneca CEO Soriot rejected the sharp criticism of the EU: his company had agreed on a best-effort solution, according to the CEO. In other words: No fixed amount is contractually agreed, but “we have promised our best effort that we will do our best”.
The reason, according to Soriot: Brussels wanted to be supplied at around the same time as the British, who had, however, “signed three months earlier. So we promised to try, but we didn’t commit, ”said Soriot. “We like ambitious goals, but we haven’t given any guarantees.”
So far, the EU has invested 2.7 billion euros in development and production
In total, the EU has so far invested 2.7 billion euros in the development and production of vaccines against the coronavirus. At the end of August last year, Health Commissioner Stella Kyriakides had already signed a contract with Astra-Zeneca for 300 million vaccine doses and an option for a further 100 million.
The EU Commission had recently increased the pressure on the vaccine manufacturer.
Ursula von der Leyen also expressed sharp criticism: “The EU and others helped with money to build research capacities and production facilities. Europe invested billions to help develop the world’s first Covid-19 vaccines. To create a truly global common good. And now companies have to deliver, ”said the EU Commission President at the virtual world economic forum in Davos on Tuesday.
“You have to meet your obligations. That is why we are going to put in place a mechanism to make vaccine exports transparent. Europe is determined to do its part. But it’s also about business, ”criticized von der Leyen. Brussels is now working flat out to introduce export controls on vaccines. In response to the difficulties with Astra-Zeneca, the Commission is proposing a transparency register for vaccines against the coronavirus.
By the end of the week, the commission intends to make a detailed proposal to the member states. “We want to create clarity and transparency,” said the Vice President of the EU Commission, Dubravka Suica, this Wednesday.
“In future, all companies that manufacture vaccines against Covid-19 in the EU must inform them in good time if they want to export vaccines to third countries,” said Health Commissioner Kyriakides. Pharmaceutical companies should therefore register all of their exports of vaccines.
EU commissioner contradicts Astra Zeneca boss
With a register the EU wants to get a better overview of the production of vaccines in the 27 member states. “It’s about finding out what companies are exporting outside the EU,” said a Commission spokesman. This is owed to the European public in view of the huge investments in the development of vaccine production.
At the beginning of the Health Commissioner Kyriakides again insisted on strict compliance with the delivery contract. The 27 member states agreed that Astra-Zeneca had to meet its delivery obligations.
The statement made by Astra Zeneca CEO Soriot about a best effort agreement is not correct. “We reject the ‘first come, first serve’ principle,” said Kyriakides. “Our contract does not state that the UK should receive vaccines before us.” The native Cypriot appealed to Astra-Zeneca before the meeting of the steering committee that evening to restore the lost confidence.
Commission circles said that the EU had pledged Astra-Zeneca a total of 336 million euros. But all the money has not yet flowed.
In international comparison, the EU is a giant in vaccine production, it was said in Brussels. That is why the Commission only wants to buy vaccines in the EU. With this purchasing policy she wants to get around export restrictions like in the USA. Astra-Zeneca’s vaccine is produced in both Belgium and the UK.
Ema could approve Astra-Zeneca vaccine on Friday
The Commission does not accept the accusation that the EU is taking protectionist measures. EU Commission Vice-President Valdis Dombrovskis said the proposed register will not restrict exports of vaccines produced in the EU. “We do not intend to impose an export ban or export restrictions,” said Dombrovskis.
It is eagerly awaited whether the European Medicines Agency (Ema) will grant Astra-Zeneca’s vaccine conditional marketing authorization on Friday. Astra-Zeneca puts indirect pressure on the Amsterdam EU authority.
“As soon as we receive approval in the next few days, we will deliver three million cans. Then more every week until we’re at 17 million. They are distributed according to the size of the population, for Germany about three million in a month, ”said the Astra-Zeneca CEO of“ Welt ”. The EU lags far behind the US and UK when it comes to vaccinating the population.
The Ema Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has been reviewing the vaccine developed by Astra-Zeneca and Oxford University since Monday. It remains to be seen whether the vaccine will be approved. “We do not comment on ongoing reviews,” said a spokeswoman for the Amsterdam authority on request.
“An opinion on the approval could be submitted by January 29th at the meeting of the CHMP that started on Monday, provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently reliable and complete and all additional information necessary to complete the assessment are required to be submitted immediately, “said an Ema spokeswoman on request.
The recommendation of Ema must be confirmed by the EU Commission.
Market approval expected for Friday
The health policy spokesman for the EPP group and MEP, Peter Liese (CDU), expects the Ema to grant marketing authorization on Friday. “I believe that there will also be market approval for people over 65,” the doctor told the Handelsblatt in Brussels.
He suggests that the Standing Vaccination Commission (Stiko) in Germany re-examine whether the vaccine is actually used for people over 65 or whether younger people at risk and the medical staff can be vaccinated with this vaccine instead.
Liese also criticized Astra-Zeneca’s communication: In a press release in November, the group gave the impression that the vaccine was 90 percent effective. However, this 90 percent apparently only applied to a small portion of the study participants who accidentally only received half a dose.
“That was a serious mistake in the conduct of the study and in communication, but that’s not why the vaccine is bad,” Liese told Handelsblatt. The mistake has now been corrected. The data had been analyzed more closely. Since November, many new patients have been vaccinated in clinical trials and beyond.
In the UK, emergency approval has been in place since the end of December. “I don’t see any reason to wait. However, the experts have to comment on whether the vaccine should be used for people over 65 or only for those under 65, “said Liese.
In the European Parliament, expectations for today’s meeting between Astra-Zeneca and the Commission are high. “The exchange with Astra-Zeneca has to bring clarity. We don’t have time for games now. If the manufacturer delivers 60 percent fewer vaccine doses for the EU than agreed, full transparency about the causes and problem solving is required, ”said Tiemo Wölken, health policy spokesman for the SPD MEPs.
European politicians also demanded that the EU Commission inspect the contracts with all pharmaceutical companies. “We don’t know the Astra-Zeneca contract. That is the political scandal on this subject, which of course is of extremely high public interest, ”criticized Wölken.
Members of the European Parliament have written a letter to the Commission. In the letter they request access to the contracts with the pharmaceutical companies. “Unfortunately, both the EU Commission and most vaccine manufacturers refuse full access to the contracts for the purchase of Covid 19 vaccines. We urge them to publish all contracts unredeemed, “said Rasmus Andresen, budgetary spokesman for the Greens in the European Parliament.
“In addition, we need access to all other relevant documents that are related to the vaccine procurement. This also applies, for example, to meeting minutes from the contract negotiations and internal preparation rounds. Only then can we assess who is responsible for delivery bottlenecks, what role the German government is playing and what options the EU Commission has to sanction the unacceptable behavior of Astra-Zeneca. ”
So far, only the contract with the German pharmaceutical company Curevac has been disclosed. Andresen calls for all legal remedies, even an export ban, to be prepared in order to increase the pressure on Astra-Zeneca.
More: Controversy over Astra-Zeneca vaccine