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AstraZeneca vaccine not ready for quick European approval, watchdog official says

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AstraZeneca

The European Medicines Authority (EMA) will possibly not be ready to approve the COVID-19 vaccine developed by drug maker AstraZeneca. Which also partnered with the University of Oxford in January, the watchdog’s Deputy executive director Noel Wathion said.

“They haven’t even filed an application with us yet”, Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday.

However, European regulators have only received some information about the vaccine, Wathion said.

“Not even enough to warrant a conditional marketing license”, he said. “We need additional data about the standard of the vaccine. And afterwards, the corporate needs to formally apply.”

Therefore, this made granting of the vaccine this month “improbable”, Wathion said.

Nobody could reach EMA for any comments.

AstraZeneca told Reuters last week that its COVID-19 vaccine should be effective against the new coronavirus variant. Also, they added that studies were underway to completely probe the impact of the mutation.

It has submitted a full data package about its vaccine to the British medicines regulator, British health minister Matt Hancock said.

 

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