The European Medicines Authority (EMA) will most likely not be able to approve the Covid-19 vaccine developed by drugmaker AstraZeneca and the University of Oxford in January.
"They have not even filed an application with us yet", the watchdog's deputy executive director Noel Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday.
European regulators have only received some information about the vaccine, Mr Wathion said.
"Not even enough to warrant a conditional marketing licence", he said. "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 already be granted next month, Mr 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 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.
