European Medicines Agency receives Oxford/AstraZeneca vaccine application
The European Medicines Agency (EMA) said Tuesday that it has received an application for conditional marketing authorization for the COVID-19 vaccine developed by England's University of Oxford and British-Swedish pharmaceutical giant AstraZeneca.
Conditional marketing authorization is the process used to speed up the approval of treatments and vaccines amid public health emergencies. The EMA said the assessment of the Oxford/AstraZeneca vaccine "will proceed under an accelerated timeline," and that an opinion on whether to issue an authorization could be announced by Jan. 29.
"If 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 agency said in a statement Tuesday. "The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days."