Tensions rise as AstraZeneca, EU spar over vaccine delays

The European Union and drugmaker AstraZeneca sparred Wednesday over a delay in coronavirus vaccine deliveries as the deepening dispute raises concerns about the increasing competition for limited supplies of shots needed to end the pandemic.

AstraZeneca Chief Executive Pascal Soriot addressed the dispute for the first time, rejecting the EU's assertion that the company was failing to honor its commitments. Soriot said vaccine delivery figures in AstraZeneca's contract with the 27-nation bloc were targets, not firm commitments, and they couldn't be met because of problems in rapidly expanding production capacity.

"Our contract is not a contractual commitment, it's a best effort,'' Soriot said in an interview with the Italian newspaper La Repubblica. "Basically, we said we're going to try our best, but we can't guarantee we're going to succeed. In fact, getting there, we are a little bit delayed."

AstraZeneca said last week that it planned to cut initial deliveries in the EU to 31 million doses from 80 million due to reduced yields from its manufacturing process in Europe. That drew an angry response from the EU, which says it expects the company to deliver the full amount on time. On Monday, the EU threatened to put export controls on all vaccines made in its territory.

Stella Kyriakides, the European Commissioner for health and food safety, rejected Soriot's explanation for the delays, saying that "not being able to ensure manufacturing capacity is against the letter and spirit of our agreement."

A third round of talks in as many days aimed at resolving the dispute is scheduled to take place Wednesday evening in Brussels.

"I call on AstraZeneca to engage fully to rebuild trust, to provide complete information and to live up to its contractual, societal and moral obligations," Kyriakides said at a media briefing in Brussels.

The EU, which has 450 million citizens and the economic and political clout of the world's biggest trading bloc, is lagging badly behind countries like Israel and Britain in rolling out coronavirus vaccine shots for its health care workers and most vulnerable people. That's despite having over 400,000 confirmed virus deaths since the pandemic began.

The EU has signed deals for six different vaccines, but so far regulators have only authorized the use of the two, one made by Pfizer and another by Moderna. The EU's drug regulator will consider the AstraZeneca vaccine on Friday.

AstraZeneca is setting up more than a dozen regional supply chains worldwide to meet regional demand for its vaccine. Overall, AstraZeneca plans to deliver up to 3 billion doses to countries around the world by the end of 2021.

However, establishing each facility is a complicated process that involves training people and ensuring each batch of vaccine is safe and effective. Sometimes this goes smoothly, but in other cases there are problems, Soriot said.

"We train them on how to manufacture,″ he said. "And then, you know, some people are new to this process. It's like they learn the process. They don't know how to make the vaccine and they're not as efficient as others.″

There are two basic steps in producing the vaccine. The first is a biological process that involves growing cells, which are injected with a virus, Soriot said. The second involves turning this "drug substance" into the final product, filling vials and testing each batch of vaccine.

Soriot said AstraZeneca had to reduce deliveries to the EU because plants in Europe had lower than expected yields from the biological process used to produce the vaccine. This has also happened in other regions as AstraZeneca sought to rapidly expand production capacity to meet demands from countries battling the pandemic.

"We've also had teething issues like this in the U.K. supply chain," Soriot said. "But the U.K. contract was signed three months before the European vaccine deal, so with the U.K. we have had an extra three months to fix all the glitches we experienced. As for Europe, we are three months behind in fixing those glitches."

An official from the European Commission, the EU's executive, said the bloc has agreed to give 336 million euros ($407 million) to AstraZeneca to develop its vaccine and deliver doses. The official, who wasn't authorized to speak publicly, said the commission would be entitled to recover part of the money if the company fails to live up to the terms of this advance purchase agreement.

If the company's U.K. plants are working more efficiently than those on the continent, the EU expects to receive doses made in Britain as provided in the contract, the official said.

"We reject the logic of first come, first served," Kyriakides said. "That may work at the neighborhood butchers, but not in contracts and not in our advance purchase agreements. There's no priority clause in the advanced purchase agreement."

The shortfall in planned deliveries of the AstraZeneca vaccine is coming at the same time as a slowdown in the distribution of Pfizer-BioNTech shots as Pfizer upgrades production facilities at a plant in Belgium.

"There are a lot of emotions running in this process right now, and I can understand it: people want vaccine," Soriot said. "I want the vaccine too, I want it today. But, at the end of the day, it's a complicated process.″