BRUSSELS, March 13 (Reuters) – AstraZeneca’s new goal of delivering 30 million doses of its COVID-19 vaccine to the European Union by the end of March depends on the bloc’s drug regulator approving the supply of a factory in Netherlands, showed an internal document.
The Anglo-Swedish drugmaker said on Friday it would try to deliver 30 million doses to the EU by the end of March, ahead of a contractual obligation of 90 million and an earlier pledge made last month to deliver 40 million doses.
The new reduction target for March deliveries, which confirmed an earlier Reuters report, depends on regulatory approval for a vaccine factory in Leiden run by subcontractor Halix, the March 10 internal document showed.
EU leaders have been criticized for distributing vaccines at a much slower pace than neighboring Britain, due to a longer approval and purchase process, as well as repeated delays in the supply of AstraZeneca and other pharmaceuticals.
AstraZeneca said in the document seen by Reuters that it is assuming that the Halix plant will receive the green light on March 25 and has scheduled deliveries of nearly 10 million doses for the following week.
The European Medicines Agency (EMA) confirmed in a statement that the Halix plant had not yet been approved and declined to comment on when the authorization could be granted.
An EU official close to the EMA decision-making told Reuters that a decision “maybe” will come at the end of March.
It was not clear whether any delay in approving the plant would also affect the supply of vaccines from AstraZeneca to the EU in the second quarter.
An AstraZeneca spokesman declined to comment on the factory’s approval status, nor on its production and storage capacity. Halix declined to comment on his regulatory approval.
The Halix factory is one of four mentioned as vaccine manufacturers for the EU in AstraZeneca’s supply contract with Brussels signed in August.
However, only one in Belgium has been used to supply the bloc so far, EU officials said, noting that two factories in Britain have not exported vaccines to the EU.
In its statement on Friday, AstraZeneca also said that it “intends” to deliver 70 million doses to the EU in the period from April to June, despite the contractual obligations of 180 million doses.
He said export restrictions had prevented it from increasing EU supply from its global network to compensate for production problems in the EU supply chain.
Shortly after Reuters reported in February that the company told the EU it could deliver less than 90 million doses in the second quarter, AstraZeneca said it was still committed to meeting its 180 million supply target.
In total, the company now plans to ship only 100 million vaccines to the EU by the end of June, instead of the 300 million provided for in the contract. (Reporting by Francesco Guarascio @fraguarascio in Brussels; Additional reporting by Toby Sterling in Amsterdam; Editing by David Clarke)