AstraZeneca’s lowest vaccine supply target in the EU depends on factory approval

BRUSSELS (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 approval of the regulator for drugs in a factory block in the Netherlands, an internal document showed. .

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 lower target, which confirmed an earlier Reuters report, is not guaranteed as it depends on a vaccine factory in Leiden run by subcontractor Halix to obtain regulatory approval, the internal document of March 10 showed.

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.

A spokesman for the European Commission said on Saturday that the EU executive was in talks with the company to make sure he would do everything he could to honor his commitments. He did not comment on Halix’s approval.

Asked about possible sanctions, he said: “What matters is that we guarantee the delivery of a sufficient number of doses in line with the company’s previous commitments. We are analyzing all the options for that to happen ”.

EU leaders have been criticized for launching 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.

SECOND QUARTER CUTS

The European Medicines Agency (EMA) said 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 or on its production and storage capacity. Halix declined to comment on his regulatory approval.

The Halix plant in Leiden 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 between April and 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.

Overall, the pharmaceutical company plans to send only 100 million vaccines to the EU by the end of June, instead of the 300 million provided for in the contract.