AstraZeneca’s lower EU vaccine offer focuses on factory approval

BRUSSELS (Reuters) – AstraZeneca’s new target to deliver 30 million doses of its COVID-19 vaccine to the European Union by the end of March depends on approval of deliveries from a factory in the Netherlands, an internal document found .

FILE PHOTO: A test tube labeled “vaccine” for an AstraZeneca logo in this image taken September 9, 2020. REUTERS / Dado Ruvic / Illustration

The Anglo-Swedish drug company said Friday it would try to deliver 30 million doses to the EU by the end of March, following a 90 million contractual commitment and a previous pledge made last month to deliver 40 million doses.

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

AstraZeneca said in the document seen by Reuters that it assumes the Halix plant will receive a green light on March 25 and that nearly 10 million doses have been delivered by the following week.

A spokesman for the European Commission said on Saturday that the EU director was in talks with the company to make sure it was doing everything it could to meet its obligations. He did not comment on Halix’s approval.

When asked about possible sanctions, he said: “The point 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 make this possible. “

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

EDITIONS IN THE SECOND QUARTER

The European Medicines Agency (EMA) said in a statement that the Halix plant had not yet been approved and declined to comment when authorization could be granted.

An EU official close to the EMA’s decision-making told Reuters a decision could be made in late March.

It was unclear whether a delay in the plant’s approval would also affect AstraZeneca’s vaccine deliveries to the EU in the second quarter.

An AstraZeneca spokesperson declined to comment on the plant’s approval status or its production and inventory capacity. Halix declined to comment on the regulatory approval.

The Halix plant in Leiden is one of four named as vaccine producers for the EU in AstraZeneca’s supply contract with Brussels signed in August.

Only one in Belgium has so far been used to supply the bloc, EU officials said, noting that two factories 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 between April and June, despite contractual commitments for 180 million shots.

It said export restrictions had prevented it from boosting supplies to the EU from its global network to offset manufacturing 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 determined to meet its 180 million delivery target.

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

Reporting by Francesco Guarascio @fraguarascio in Brussels; Additional reporting by Toby Sterling in Amsterdam; Editing by David Clarke and Mike Harrison

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