AstraZeneca’s lower target for EU vaccine supply depends on factory approval

BRUSSELS (Reuters) – AstraZeneca’s new target of delivering 30 million doses of its COVID-19 vaccine to the European Union by the end of March is dependent on the regulator’s approval of the d-block drugs ‘a factory in the Netherlands, according to 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, against a contractual obligation of 90 million and a previous pledge made last month to deliver 40 million doses.

The new lower target, which confirmed a previous Reuters report, is not guaranteed because it depends on a vaccine plant in Leiden run by subcontractor Halix to obtain regulatory approval, the internal document dated March 10.

AstraZeneca said in the document seen by Reuters that it assumed the Halix plant would get the green light on March 25 and had scheduled deliveries of nearly 10 million doses for the following week.

A spokesperson for the European Commission said on Saturday that the EU executive was in talks with the company to ensure it was doing everything it could to honor its commitments. He didn’t comment on Halix’s endorsement.

Asked about possible sanctions, he said: “What matters is that we ensure the delivery of a sufficient number of doses in accordance with the company’s previous commitments. We are looking at all options to achieve this. “

EU leaders have been criticized for rolling out vaccines at a much slower pace than neighboring Britain due to a longer approval and procurement process, as well as repeated delays in supplies AstraZeneca and other drug manufacturers.

SECOND QUARTER CUPS

The European Medicines Agency (EMA) said in a statement that the Halix plant has yet to be approved and declined to comment when an authorization could be granted.

An EU official close to the EMA’s decision-making process told Reuters that a decision “may” come at the end of March.

It was not clear whether any delay in plant approval would also affect AstraZeneca vaccine shipments to the EU in the second quarter.

A spokesperson for AstraZeneca declined to comment on the plant’s approval status, or its production and storage capacity. Halix declined to comment on its regulatory approval.

The Halix plant in Leiden is one of four named 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 block so far, EU officials said, noting that two UK factories have not exported vaccines to the EU.

In its statement on Friday, AstraZeneca also said it “aims” to deliver 70 million doses to the EU between April and June, despite contractual obligations of 180 million doses.

He said export restrictions had prevented him from increasing EU supplies from its global network to compensate for production problems in the EU’s supply chain.

Shortly after Reuters announced 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 determined to meet the target of 180 million doses.

Overall, the pharmaceutical company now aims to ship just 100 million vaccines to the EU by the end of June, instead of the 300 million planned in the contract.