AstraZeneca's lower EU vaccine supply target hinges on factory approval: document

BRUSSELS: AstraZeneca's new aim of supplying 30 million doses of its COVID-19 vaccine to the European Union by the end March hinges on the bloc's drug regulator approving supplies from a factory 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, down from a contractual obligation of 90 million and a previous pledge made last month to deliver 40 million doses.

The new lower target for March deliveries, which confirmed an earlier report from Reuters, depends on the regulatory approval of a vaccine factory in Leiden run by subcontractor Halix, the internal document dated March 10 showed.

EU leaders have come under fire for rolling out vaccines at a far slower pace than neighbouring Britain due to a longer approval and purchasing process as well as repeated delays in supplies from AstraZeneca and other drugmakers.

AstraZeneca said in the document seen by Reuters that it is assuming the Halix factory will get the green light on March 25 and has pencilled in deliveries of nearly 10 million doses for the following week.

The European Medicines Agency (EMA) confirmed in a statement that the Halix factory had not yet been approved and declined to comment on when any authorisation might be granted.

An EU official close to EMA's decision-making told Reuters that a decision "might perhaps" come at the end of March.

It was unclear whether any delay in the plant's approval would also affect AstraZeneca's vaccine supplies to the EU in the second quarter.

A spokesman for AstraZeneca declined to comment on the factory's approval status nor on its production and stockpiling capacity. Halix declined to comment on its regulatory approval.

The Halix plant is one of four mentioned as manufacturers of vaccines 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 have said, noting that two plants in Britain 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 in the April-June period, despite contractual obligations for 180 million shots.

It said export restrictions had prevented it from boosting supplies to the EU from its global network to make up for production problems in the EU supply chain.

Shortly after Reuters reported in February that the company had told the EU it could deliver less than 90 million doses in the second quarter, AstraZeneca said it was still committed to meeting the 180 million supply target.

Overall, the company is now aiming to ship only 100 million vaccines to the EU by the end of June, instead of the 300 million foreseen in the contract.