AstraZeneca
vaccine not ready for quick European approval, watchdog official says
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[December 29, 2020]
AMSTERDAM (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.
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"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.
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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)
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