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AstraZeneca-Oxford vaccine approval unlikely in January: EU regulator

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(FILES) An undated handout picture released by the University of Oxford on November 23, 2020 shows a vial of the University’s COVID-19 candidate vaccine, known as AZD1222, co-invented by the University of Oxford and Vaccitech in partnership with pharmaceutical giant AstraZeneca. – Britain on December 30, 2020 became the first country in the world to approve the coronavirus vaccine developed by drug firm AstraZeneca and Oxford University, with a mass rollout planned from January 4, 2021. (Photo by John Cairns / University of Oxford / AFP) / 

The coronavirus vaccine developed by AstraZeneca and Oxford University, which was approved Wednesday in Britain, is unlikely to get a green light in the European Union in the next month, according to the European Medicines Agency (EMA).

The regulator, charged with overseeing vaccines’ authorisation in the EU before they can be marketed, approved the Pfizer-BioNTech vaccine on December 21. It is expected to rule on Moderna’s vaccine on January 6.

“No formal marketing authorisation has yet been submitted to EMA, therefore EMA’s committee for human medicines has not yet set a timetable” for approving the AstraZeneca-Oxford jab, the Amsterdam-based agency told AFP.

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The regulator’s deputy executive director Noel Walthion told Belgian newspaper Het Nieuwsblad on Tuesday that a possible approval in January is “unlikely,” a statement confirmed by the agency late Tuesday.

The AstraZeneca-Oxford vaccine is currently undergoing a “rolling review” which allows the EMA to examine safety and efficacy data as they are released, even before a formal application for authorisation is filed by the manufacturer.

This procedure speeds up the evaluation of a marketing authorisation application once it is made, the EMA said.

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Britain on Wednesday became the first country in the world to approve the vaccine, which is cheaper to produce and easier to store and transport than the Pfizer-BioNTech jab.

For EU countries, it is up to the European Commission in Brussels to issue the final green light after EMA approval.

Inoculations with the Pfizer-BioNTech vaccine began in the 27-member bloc over the weekend.

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