Within days of AstraZeneca's surprise cut to first-quarter COVID-19 vaccine deliveries to Europe, a fierce debate between the drugmaker and government officials is playing out behind the scenes—and in the press.
CEO Pascal Soriot said the company has no legal obligation to deliver vaccines on a specific timeline. The EU maintains AZ’s new delivery schedule is “not acceptable.”
The sides were set to meet Wednesday, but an EU official told Politico the drugmaker had pulled out. AstraZeneca told Fierce Pharma via email it hadn't.
The back-and-forth comes as both sides seek to manage public opinion while salvaging their own relationship and getting deliveries back on track—and after AstraZeneca disclosed last week that a manufacturing problem would force a big reduction in Q1 supplies.
The company was originally set to deliver 80 million doses to Europe in the first quarter, but that number has been reduced to 31 million, according to Reuters. A spokesperson last week told Fierce Pharma the company plans to deliver "tens of millions" of doses to Europe in February and March.
In a statement Monday, European Commissioner for Health and Food Safety Stella Kyriakides said the EU "pre-financed the development of the vaccine and the production and wants to see the return." She wrote a letter to the company raising "important and serious" questions, she added.
Meanwhile, Soriot told AstraZeneca's side of the story in an interview this week with Italian newspaper la Repubblica. The company isn’t contractually obligated to deliver doses on a specific timeline under its EU agreement, he said. Rather, the deal called for AZ to make its “best effort” to deliver on its promise.
OK, then, EU officials said after the interview, AstraZeneca should publicly release its contracts, Reuters reports. An EU official told the news service that the details Soriot disclosed were supposed to be confidential and the “best effort” clause was standard for agreements centering on products that don’t yet exist.
Soriot also said AstraZeneca owed the U.K. first. Britain finalized its deal with AstraZeneca three months before the European Union struck its own, Soriot added, giving AZ a “head start” to work through potential manufacturing issues in that supply chain. Soriot has rejected calls to divert U.K. doses to Europe, The Guardian reports.
The source of the trouble in Europe is a Novasep factory in Belgium the Wall Street Journal reported, citing sources. The facility has only been able to turn out about a third of the yield AZ had been expecting, the Journal said. Meanwhile, in the U.K., AstraZeneca has partnered with at least one local manufacturer, Wockhardt, which is turning out doses at a plant in Wales.
"Governments are under pressure,” Soriot told the la Repubblica newspaper. “Everybody is getting kind of a bit, you know, aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe.”
AZ told Reuters in a statement that its COVID-19 vaccine supply chains were set up around individual agreements with countries or international organizations. Vaccines produced under the deals are "dedicated to the relevant countries or regions" and the deals rely on "local manufacturing wherever possible," the company said.
As if to support that argument, Serum Institute of India said its manufacturing is on track; it's set to supply multiple countries with vaccines, including its home country, Brazil and Saudi Arabia. Overall, AstraZeneca has set up deals with 20 different manufacturing partners around the world.
As AstraZeneca works through its manufacturing issues, the mRNA vaccine team of Pfizer and BioNTech are working to scale up their global supply chain—an effort that caused a temporary glitch in European and Canadian deliveries.
But on Tuesday, vaccine giant Sanofi said it's also stepping in to help. After the company's own vaccine took a hit in phase 2 testing, Sanofi approached Pfizer and BioNTech about a manufacturing partnership. Sanofi is now set to produce 100 million doses of the Pfizer/BioNTech mRNA vaccine for Europe this year.