BFF-30 AstraZeneca files bid for EU vaccine approval

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BFF-30

HEALTH-VIRUS-EU-VACCINE LEAD

AstraZeneca files bid for EU vaccine approval

THE HAGUE, Jan 12, 2021 (BSS/AFP) – AstraZeneca and Oxford University have
applied for authorisation for their coronavirus vaccine in the European Union
with a decision possible by January 29, The European Medicines Agency said on
Tuesday.

The jab would be the third available for the 27-nation EU after the
Pfizer-BioNTech and Moderna drugs, as the bloc struggles to speed up the
rollout.

“EMA has received an application for conditional marketing authorisation
for a COVID-19 vaccine developed by AstraZeneca and Oxford University,” the
Amsterdam-based regulator said in a statement.

The EMA said its assessment would “proceed under an accelerated timeline”.

“An opinion on the marketing authorisation could be issued by 29
January… provided that the data submitted on the quality, safety and
efficacy of the vaccine are sufficiently robust and complete,” it said.

The EU and the EMA have been under pressure to speed up the approval of
new vaccines against the virus, which has claimed the lives of more than
620,000 people across the continent.

BSS/AFP/FI/ 1444 hrs