(Writes through with new details)
Jan 12 (Reuters) - Europe's drugs regulator will review
AstraZeneca and Oxford University's COVID-19 vaccine
this month under an accelerated timeline, after the British
drugmaker submitted an application for conditional approval, the
watchdog said on Tuesday.
The European Medicines Agency (EMA) said it would fast-track
the assessment of the application and could issue an opinion on
a conditional marketing authorisation by Jan. 29 at a meeting of
its human medicines committee (CHMP). (https://bit.ly/2XuWmm3)
If endorsed by the EMA and formally approved by the European
Commission, the AstraZeneca vaccine would become the third
vaccine against the new coronavirus available on the continent
after Pfizer's and Moderna's.
The EMA also said that during its rolling review of the
vaccine, it had assessed data from ongoing trials in Brazil,
Britain and South Africa. It is also studying additional
information provided by AstraZeneca at the CHMP's request.
European Union conditional marketing authorisation allows a
treatment to be sold for a year in the 27-nation bloc before all
necessary data on its efficacy and side-effects are available.
AstraZeneca's vaccine has been approved in countries
including Argentina, Britain, El Salvador and India. Brazil is
expected to decide on approval this week.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by
Saumyadeb Chakrabarty and Barbara Lewis)
Astrazeneca (AZN)
