EU Regulator Approves Major Sites to Boost Vaccine Rollout

The European Medicines Agency granted regulatory approval to two vaccination plants in the Netherlands and Germany in a boost for the European Union’s sluggish inoculation campaign.

The Dutch Halix facility, based in Leiden, is manufacturing the drug substance for the AstraZeneca Plc vaccine and had been awaiting approval to distribute the doses amid a significant shortfall of the shot’s deliveries for the EU.

The second site, a BioNTech SE facility in Marburg, is a key piece of a plan by the German company and partner Pfizer Inc. to boost production of their shot to 2 billion doses this year. BioNTech said the approval makes Marburg “one of the largest mRNA vaccine manufacturing sites in Europe as well as worldwide.”

The European commissioner for health and food safety, Stella Kyriakides, welcomed the news, saying it was a welcome step in increasing production capacity in the bloc.

The distribution of Astra supplies from Halix has been at the center of talks between the U.K. and the EU in recent days, with both sides laying claim to its shots. The EU has exported some 21 million vaccine doses to the U.K. so far, of which more than a million were Astra shots, and has vowed to curb further shipments until the company meets its delivery targets to the bloc.

The EU expects Astra to deliver from the Dutch plant in order to meet its contractual obligations. EU officials are worried that the drugmaker may even fall short of delivering 30 million doses to the bloc this quarter, a target which is less than a third of the original commitment.

EU Regulator Approves Major Sites to Boost Vaccine Rollout

In a joint statement published on Wednesday, the British government and the European Commission said they were “working on specific steps we can take -- in the short-, medium - and long term -- to create a win-win situation and expand vaccine supply for all our citizens.”

A European diplomat told Bloomberg earlier this week that the most sensible solution would be to divide deliveries from the plant on some form of pro-rata arrangement based on population size.

The clearances will come as a relief to the companies and the EU amid delivery shortfalls that have stoked tensions between the region and its neighbors.

©2021 Bloomberg L.P.

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