It seems Astrazeneca and the MHRA29 Dec 2020 16:55
Have a lot to learn bout hoe to get a vaccine authorised widely - Guardian today
"European Medicines Authority unlikely to approve Oxford/AstraZeneca vaccine this month
The European Medicines Authority (EMA) will most likely not be able to approve the Covid-19 vaccine developed by AstraZeneca and the University of Oxford in January, the watchdog’s deputy executive director, Noël Wathion, said.
“They have not even filed an application with us yet”, he said in an interview with the Belgian newspaper Het Nieuwsblad on Tuesday. European regulators had only received some information about the vaccine, Wathion said.
“Not even enough to warrant a conditional marketing licence”, he added. “We need additional data about the quality of the vaccine. And after that, the company has to formally apply.”
This made it “improbable” that an approval could be granted next month, Wathion said.
The EMA could not be reached for comment.
AstraZeneca told Reuters last week that its Covid-19 vaccine should be effective against the new coronavirus variant, adding that studies were under way to fully investigate the impact of the mutation.
It had submitted a full data package about its vaccine to the British medicines regulator, the UK health secretary, Matt Han****, said."