The European Union’s drug regulator cleared a Covid-19 vaccine fromAstraZeneca Plc and the University of Oxford for all adults as a shortfall in expected deliveries raises tensions between the company and the bloc.
The go-ahead Friday clears the way for the European Commission to issue a conditional marketing authorization. The decision to include older adults in the approval comes after Germany’s immunization commission issued a preliminaryrecommendation Thursday that the inoculation be authorized only for people between the ages of 18 and 64 due to a lack of trial data in older groups.
The European Medicines Agency said that while most trial participants were between 18 and 55-years-old, and there wasn’t enough data to know the efficacy of the vaccine in older adults, an immune response had been seen in the older age group and the vaccine shown to be safe.
The agency said the vaccine doses would be given four to 12 weeks apart, which is in line with the recommended dosing gap in the U.K. The EU has agreed to purchase as many as 400 million doses.
The clearance follows a tense week between the bloc and the vaccine makers after Astra said it couldn’t deliver the number of shots expected over the coming months due to production issues. That prompted the EU to impose regulations on vaccine exports. The region, along with the U.K., is also facing delays for a shot from Pfizer Inc. and German partner BioNTech SE as the companies renovate a factory in Belgium.
The Astra-Oxford vaccine will be the third available in the EU after the regulator approved the shot from Pfizer and one from Moderna Inc.
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