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

BRUSSELS (Reuters) – AstraZeneca’s new goal to deliver 30 million doses of the COVID-19 vaccine to the European Union by the end of March depends on the drug regulator of the block that approves a factory in the Netherlands, ‘ an internal document shown.

FILE PHOTO: A test tube with the caption “vaccine” in front of an AstraZeneca logo in this illustration, taken on 9 September 2020. REUTERS / Dado Ruvic / Illustration

The Anglo-Swedish drugmaker said on Friday that it would try to deliver 30 million doses to the EU by the end of March, compared to a 90 million contractual obligation and a previous promise made last month to deliver 40 million doses. .

The new lower target, which confirmed an earlier report by Reuters, can not be guaranteed, as it depends on a vaccine factory in Leiden run by subcontractor Halix, which receives the regulatory approval, the internal document of Shown March 10.

AstraZeneca said in the document seen by Reuters that it assumes that the Halix factory will get the green light on March 25 and provide delivery of nearly 10 million doses for next week.

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

Asked about possible sanctions, he said: “What is important is that we ensure the delivery of adequate doses in line with the company’s previous commitments. We look at all options to make it happen. ”

EU leaders have come under fire due to the introduction of vaccines at a much slower pace than neighboring Britain due to a lengthy approval and purchase process, as well as repeated delays in the stocks of AstraZeneca and other drug manufacturers.

CUTS OF THE SECOND TERM

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

An EU official close to the EMA’s decision told Reuters a decision could be made by the end of March.

It was unclear whether any delay in approving the plant would also affect AstraZeneca’s vaccine supply to the EU in the second quarter.

A AstraZeneca spokesman declined to comment on the factory’s approval status or its production and storage capacity. Halix declined to comment on the approval of the regulation.

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

However, EU officials have so far used only one in Belgium to supply the block, pointing out that two plants in Britain have not exported vaccines to the EU.

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

It said that export restrictions could prevent it from strengthening the EU’s supplies of its global network to compensate for production problems in the EU supply chain.

Shortly after Reuters reported in February that the company had told the EU that 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.

In general, the drug company intends to send only 100 million vaccines to the EU by the end of June, instead of the 300 million provided in the contract.

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

.Source