EU Approves AstraZeneca-Oxford Vaccine for All Adults Amid Shortfall
(Bloomberg) -- The European Union’s drug regulator cleared a Covid-19 vaccine from AstraZeneca 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 Astra-Oxford vaccine will be the third available in the EU after shots from Pfizer Inc. and Moderna Inc., and it could help alleviate the shortage of shots as the EU trails the U.K. and the U.S. in vaccinations.
The decision won’t immediately mean more shots for the elderly in Europe’s largest country. Germany’s immunization authority said the inoculation should be authorized only for people between the ages of 18 and 64, sticking with a preliminary recommendation. It cited a lack of trial data in older groups.
The European Medicines Agency said that while most trial participants were between 18 and 55 and there wasn’t enough data to pinpoint the vaccine’s efficacy in older adults, the shot has shown an immune response in the older age group and is safe.
The agency said the two-dose vaccine would be given in shots four to 12 weeks apart, in line with the recommended gap in the U.K. Despite varying intervals in trials, 86% of volunteers had a shot within that time frame, Bruno Sepodes, vice chairman of the EMA’s committee, said at a press briefing.
The clearance follows a tense week between the bloc and 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 the shot from Pfizer, developed with German partner BioNTech SE, as the companies renovate a factory in Belgium.
The agency focused on trial results showing that the AstraZeneca vaccine has an efficacy rate of about 60%, according to a statement. While the safety of the vaccine has been shown across four studies, authorities based their calculation on how well it worked in tests in the U.K. and Brazil only due to the infection rates in those studies.
AstraZeneca shares closed 2% lower in London.
The EMA committee excluded data in its assessment from an arm of the trial that received a lower first dose and had produced a higher efficacy reading of about 90% because there were ‘various confouders’ that made it difficult to know how accurate that efficacy number actually was, said Sepodes. The half-dose was only given to younger adults in the trials.
At this point, there’s no data to show whether the vaccine is effective against new variants of the virus that have caused alarm, EMA Executive Director Emer Cooke said at the briefing.
U.S. Trial Data
U.S. approval of the AstraZeneca shot remains a ways off. The EMA said it expects data from a U.S. trial that could shed more light on the vaccine’s effectiveness in the elderly at the end of the first quarter.
Although European approval of another vaccine is a step forward in the fight against the pandemic, immunization alone won’t stop the virus, she said, and each shot has some drawbacks. Although the AstraZeneca shot has shown lower effectiveness than those from Pfizer and Moderna, it’s easier to transport and store.
“None of them is perfect, none of them has all the characteristics that we might want to allow us to move completely forward, none of them is a magic wand on its own,” Cooke said.
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