AstraZeneca’s goal of providing smaller vaccines in the EU 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 depends on the bloc’s drug regulator approving supplies from a Dutch factory, shows an internal document.

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

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

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

AstraZeneca said in a document seen by Reuters that it assumed that the Halix factory would receive the green light on March 25 and included in deliveries of almost 10 million doses for the following week.

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

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

EU leaders have been on fire for launching vaccines at a much slower pace than the UK due to a longer approval and purchase process, as well as repeated delays in the supply of AstraZeneca and other drug manufacturers.

CUTS 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 on when any authorization could be granted.

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

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

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

The Halix plant in Leiden is one of four mentioned as EU vaccine manufacturers in AstraZeneca’s supply contract with Brussels signed in August.

However, only one in Belgium has so far been used to supply the block, EU officials said, noting that two UK factories did not export 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 for 180 million photos.

He said export restrictions prevented him from boosting EU supplies from its global network to address 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 the 180 million supply target.

Overall, the drug company now aims to deliver only 100 million vaccines to the EU by the end of June, instead of the 300 million 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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