(Adds background)
DUBLIN, Nov 25 (Reuters) - The European Medicines Agency
(EMA) is "very hopeful" it will be able to give a positive
scientific opinion on COVID-19 vaccines seeking regulatory
approval before Christmas, the regulator's new chief said on
Wednesday.
"All going well we would be very hopeful that we could have
a positive opinion before Christmas," EMA Executive Director
Emer Cooke told RTE radio in an interview.
British drugmaker AstraZeneca followed U.S. rivals
Pfizer and Moderna on Monday in publishing
successful pivotal trial data for its COVID-19 vaccine, giving
the world's fight against the pandemic a third new weapon.
Cooke was quoted on Tuesday by the Irish Independent as
saying the EMA's aim was to reach a positive recommendation on a
similar timeline to the U.S. Food and Drug Administration (FDA),
which is expected to have a verdict in mid-December on Pfizer's
proposed vaccine.
"What we hear at the moment is the results coming out of the
clinical trials and these are very positive. But until we look
at the raw data and make sure that it is what is says on the
box, we can't recommend it for the European public," she said.
"Let me say that 90% effective is very, very good for a
vaccine, so the possibility that this will be supported in
practice by what we see in the dossier makes us look very
optimistically at this," Cooke said, when asked about data from
all three companies.
(Reporting by Conor Humphries, editing by Louise Heavens and
Mark Potter)
Astrazeneca (AZN)
