The Hague, Netherlands:
The coronavirus vaccine created by AstraZeneca and Oxford University, which was authorized Wednesday in Britain, is unlikely to get a green light in the European Union in the subsequent month, according to the European Medicines Agency (EMA).
The regulator, charged with overseeing vaccines’ authorisation in the EU ahead of they can be marketed, authorized the Pfizer-BioNTech vaccine on December 21. It is anticipated 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-primarily based agency told AFP.
The regulator’s deputy executive director Noel Walthion told Belgian newspaper Het Nieuwsblad on Tuesday that a achievable approval in January is “unlikely,” a statement confirmed by the agency late Tuesday.
The AstraZeneca-Oxford vaccine is presently undergoing a “rolling review” which makes it possible for the EMA to examine security and efficacy information as they are released, even ahead of a formal application for authorisation is filed by the manufacturer.
This process speeds up the evaluation of a promoting authorisation application when it is created, the EMA mentioned.
Britain on Wednesday became the very first nation in the globe to approve the vaccine, which is less expensive to generate and less complicated to shop and transport than the Pfizer-BioNTech jab.
For EU nations, it is up to the European Commission in Brussels to concern the final green light immediately after EMA approval.
Inoculations with the Pfizer-BioNTech vaccine started in the 27-member bloc more than the weekend.
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