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EMA unlikely to recommend AstraZeneca vaccine in January

Credit: Belga

It’s unlikely that the AstraZeneca / Oxford coronavirus vaccine will be recommended for approval by the European Medicines Agency (EMA) in January, an EMA official said on Tuesday.

EMA does not have enough information about the vaccine, said the Agency’s Deputy Executive Director, Noël Wathion. “At the moment, AstraZeneca has only provided data on their clinical trials to the European Medicines Agency,” he told Het Nieuwsblad.

Such data is not enough to grant a conditional marketing authorisation, Wathion explained. “We need additional data on the quality of their vaccine.”

In addition, AstraZeneca has yet to submit a formal application, which is another necessary condition for the vaccine to be recommended.

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Meanwhile, the United Kingdom plans to roll out the AstraZeneca / Oxford vaccine from 4 January. As for why it would be authorised there, “we’re in the dark, because we don’t know what data AstraZeneca has submitted to the British authorities,” Wathion said.

“But it could well be that the British agency is granting a provisional authorisation,” which would only allow for certain batches of the vaccine to be distributed. “We don’t do that, because the company first needs to demonstrate that all vaccines will be of high quality,” he added.

As of 21 December, only the Pfizer / BioNTech vaccine was recommended for a conditional marketing authorisation by EMA and was approved by the European Commission the same day.

On Monday, the first Belgians received their first dose of the coronavirus vaccine on Monday, though Belgium’s official vaccine rollout is set to begin on 5 January.

AstraZeneca was the first pharmaceutical company to sign a contract with the European Commission, for a total of 300 million doses, with an option for an additional 100 million.

Jason Spinks
The Brussels Times