POLITICO – The University of Oxford/AstraZeneca will submit their jointly-produced coronavirus vaccine to the European Medicines Agency next week — with a decision on approval for use across the bloc expected by the end of January.
The EMA already has the drug-makers’ phase 3 data as part of a rolling review, but the vaccine producers are yet to hand a formal submission for conditional marketing authorization from the EU regulator.
“Possible conclusion — end of [January], depending on data and evaluation progress,” the agency tweeted. The Commission would need to rubber stamp a recommendation from the EMA.
POLITICO
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