AstraZeneca asks European regulator to approve its Covid-19 vaccine

  • 2021-01-12
  • LETA/AFP/TBT Staff

THE HAGUE - The European Medicines Agency (EMA) said Tuesday that AstraZeneca and Oxford University had filed a formal bid for authorization for their coronavirus vaccine and that a decision could come by January 29.

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

If the EMA approves the vaccine, it will still need authorization from the European Commission for use in the European Union (EU), but this is seen as a mere formality.

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

"An opinion on the marketing authorization 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.

Two vaccines have so far been approved for use in the EU - Comirnaty, a vaccine developed by US pharmaceutics giant Pfizer and Germany's BioNTech, and a vaccine made by US company Moderna.