AMSTERDAM, Dec 29 (Reuters) - The European Medicines
Authority (EMA) will most likely not be able to approve the
COVID-19 vaccine developed by drug maker AstraZeneca and
the University of Oxford in January, the watchdog's Deputy
Executive Director Noel Wathion said.
"They have not even filed an application with us yet",
Wathion said in an interview with Belgian newspaper Het
Nieuwsblad published on Tuesday.
European regulators have only received some information
about the vaccine, 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, 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.
(Reporting by Bart Meijer; Editing by Giles Elgood)
Astrazeneca (AZN)
