AstraZeneca: vaccine delivery dates in EU were not guaranteed, says CEO Pascal Soriot



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“Pharmaceutical companies and vaccine developers have moral, societal and contractual responsibilities which they must assume,” European Health Commissioner Stella Kyriakides told reporters on Wednesday. “The opinion that the company is not obliged to deliver [vaccines] … is neither correct nor acceptable. “

“We are in a pandemic. We are losing people every day. These are not numbers, these are not statistics, they are people, with families, with friends and colleagues,” she added. .

Germany marked a year since the virus arrived on Wednesday, with the country showing no signs of reducing infections. Portugal has reported a record number of daily deaths in the past 24 hours. Strict lockdowns are in effect in the countries of the bloc.

The harsh reprimand from the European Union came after AstraZeneca CEO Pascal Soriot said the company agreed to do its “best effort” to deliver the doses that EU countries ordered but did not had not contractually committed to respecting a timetable. In a statement, AstraZeneca said it still intends to deliver tens of millions of doses to EU countries in February and March.

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Soriot told Italian newspaper La Repubblica on Tuesday that AstraZeneca was unable to guarantee the timing of deliveries to the EU because countries like the UK were faster to finalize orders. This “head start” has also given AstraZeneca’s UK operations more time to address the kind of supply chain issues now plaguing EU deliveries, the CEO said.

“We also had start-up issues like this in the UK supply chain. But the UK contract was signed three months before the EU vaccine deal. So with the UK we had three more months to solve all the problems that we have encountered … As far as Europe is concerned, we are three months behind in solving these problems, “he said.

EU officials declined to specify the extent of the vaccine deficit. But the shock came as they were still trying to gauge the impact of Pfizer (PFE) slowdown in deliveries of the vaccine developed with BioNTech last week, while a manufacturing plant in Belgium was modernized.

The double delays have sparked a strong backlash across the region, where governments are already under pressure for a slow rollout of vaccines. The highly unusual public dispute with AstraZeneca now threatens to undermine relations between Brussels and one of its main vaccine suppliers.

EU officials are threatening to tighten controls on vaccine exports and Italy has warned it could take legal action. European Commission President Ursula von der Leyen stepped up the pressure on Tuesday, saying the bloc “means business”.

“Europe has invested billions to help develop the world’s first Covid-19 vaccines, to create a truly global common good. And now companies must keep their promises. They must honor their obligations,” he said. she said at a virtual meeting of the World Economic Forum.

Starting problems

In his interview with La Repubblica and other major European newspapers, Soriot admitted that his company had encountered problems at a large manufacturing plant in Europe. He said the initial phase of vaccine production is often “complicated” and the company is “essentially two months behind” where it wanted to be.

“Would I like to do better? Sure. But, you know, if we deliver in February what we plan to deliver, it’s not a small volume,” Soriot said. “We are planning to deliver millions of doses to Europe, which is not small.”

He also highlighted the crucial differences in the agreements the company has made with the UK and the European Union.

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“The UK contract was signed first and the UK, of course, said ‘you provide us first’, and that’s fair enough,” he said. Three months later, when the European Union wanted to be supplied “more or less at the same time” as the United Kingdom, AstraZeneca was unable to make this commitment.

“Our contract [with the European Union] is not a contractual commitment. It’s a better effort. Basically we said we were going to do our best, but we can’t guarantee that we will be successful. In fact, to get there, we are a little late, ”he said.

The European Union acknowledged Wednesday that it had signed a “best effort” agreement with AstraZeneca. But a senior EU official said the bloc had already made part of a down payment of 336 million euros ($ 406 million) in an attempt to boost production, and Kyriakides rejected the logic of ” first come, first served”.

“We signed an advance purchase agreement for a product that did not exist at the time and that is not yet authorized to date. And we signed it precisely so that the company would strengthen its manufacturing capacity to produce the vaccine quickly, so that it can deliver a certain volume of doses on the day of its authorization, “the senior health official said. of the European Union.

The European Union has also said that doses produced at AstraZeneca’s factories in the UK should be used to fulfill its order, opening the door to a possible conflict with London.

“There is also no hierarchy of complete production plants mentioned in the advance purchase agreement. Two are in the EU and two are located in the UK,” Kyriakides said.

AstraZeneca said in its statement that it has built more than a dozen regional supply chains to produce its vaccine, working with more than 20 partners in more than 15 countries.

“Each supply chain has been developed with the contribution and investment of specific countries or international organizations on the basis of supply agreements, including our agreement with the European Commission,” the company said.

“As each supply chain has been set up to meet the needs of a specific agreement, the vaccine produced from any supply chain is dedicated to the countries or regions concerned and uses local manufacturing in the wherever possible. “

Ho-Yin Mak, associate professor of management science at Oxford Said Business School, said the AstraZeneca vaccine production delays are the result of a lack of slack in its supply chain.

“Part of this is inevitable … Production issues such as the performance issues reported by AstraZeneca are not uncommon, especially when manufacturers are trying to ramp up production rates quickly,” he said. .

Political firestorm

The EU’s vaccine efforts received a boost on Wednesday when the French drug maker Sanofi (CUT) said it would manufacture 125 million doses of the Pfizer / BioNTech vaccine for distribution in the block, with deliveries starting in the summer of 2021.

But European governments are demanding answers on the delays, stressing that the success of their vaccination efforts depends on the private sector.

“On the one hand, we can only welcome the result of science, and on the other hand, they have a monopoly and we are totally dependent,” Belgian Minister of Health Frank Vandenbroucke said on Saturday. “There may be production issues, but these uncertainties and announcements make it very difficult to organize the campaign.”

Sanofi participates in the production of 100 million doses of Pfizer / BioNTech vaccine

Kyriakides said on Monday that the bloc would now demand “full transparency regarding the export of vaccines” from the European Union.

“In the future, all companies producing vaccines against Covid-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries. Humanitarian deliveries are of course not affected by this. “she said on Twitter.

German Health Minister Jens Spahn said the checks were not meant to prioritize “the EU”, but to ensure Europe was getting its fair share.

“In my opinion, it makes sense that we have an export limit, which means that vaccines leaving the European Union have a license so that we know what is produced, what leaves Europe, where it is. comes out for a fair distribution. “, He declared to the German channel ZDF.

Soriot said he understood the frustration.

“Governments are under pressure. Everyone is getting a little, you know, aggravated or emotional about these things. But I understand because the Commission is managing the process for all of Europe,” said the CEO.

“As soon as we can, we will help the EU,” he added.

Single dose strategy

Soriot also offered his support for a strategy launched in the UK that could help accelerate vaccine deployment in the European Union.

In order to immunize more of its population more quickly, the UK is giving the first dose of Pfizer / BioNTech or AstraZeneca vaccines to as many people as possible, before giving a second dose up to 12 weeks later. .

“I think the UK single dose strategy is absolutely the right way to go, at least for our vaccine,” Soriot said, adding that the second dose is needed for long term protection.

There are no final clinical trial data on the efficacy of single injection administration of two-dose vaccines.

– Saskya Vandoorne and James frater contribution to reports.

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