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BRUSSELS, Nov 26 (Reuters) - Europe's drugs watchdog said on
Thursday it expects to receive the first application for
conditional marketing approval for a COVID-19 vaccine "in the
coming days", the latest step towards making a shot available
outside the United States.
The European Medicines Agency (EMA) did not name the company
it expects to file the application, but Pfizer Inc and
BioNTEch are the most advanced in the regulatory
process among the three companies that have published late-stage
trial data for their vaccines.
The companies applied on Nov. 20 for U.S. approval and the
UK said it has asked its medical regulator to assess the vaccine
for its suitability.
Asked about its co-operation with the U.S. Food and Drug
Administration (FDA), it said in an email the agency may not be
able to synchronise the decision making process with other
international regulators.
The EMA started a real-time review of the Pfizer-BioNTech
vaccine on Oct. 6 to speed up the process of approving a
successful vaccine in the bloc, by allowing researchers to
submit findings in real time, without waiting for studies to
conclude.
(Reporting by Francesco Guarascio in Brussels;
Writing by Josephine Mason in London
Editing by David Goodman and David Evans)
Astrazeneca (AZN)
