The European Medicines Agency (EMA) has initiated an accelerated assessment of the COVID-19 vaccine developed by AstraZeneca and Oxford University, having received an application from the manufacturers for marketing authorisation in the European Union (EU) and the European Economic Area (EEA). A decision could be announced by 29 January, the EMA says.
In a statement issued today (12 January 2021), the EMA announced that it has received an application for conditional marketing authorisation for the vaccine and that the assessment will now proceed under an accelerated timeline. A decision could be issued by 29 January during the meeting of the EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete, and that any additional information required to complete the assessment is promptly submitted by the manufacturer.
If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting a conditional marketing authorisation. The European Commission will then fast-track its decision-making process with a view to granting conditional authorisation which will be valid in all EU and EEA Member States within days.