AZ shot not ready for approval in EU

Dec. 29, 2020

Although regulators in the UK and India are expected to grant an emergency approval to AstraZeneca’s coronavirus shot this week, officials in the EU say it may not be approved there until after January. 

According to the deputy executive director of the European Medicines Agency, AstraZeneca/University of Oxford have yet to submit an application or enough data for the vaccine to be reviewed. The agency’s deputy executive director said that the agency has not even received enough information to grant a conditional marketing license. Given the lack of information, the agency is unlikely to approve the vaccine in January. 

AstraZeneca has submitted a full data package to the UK. The company is not expected to submit data to the FDA until January. 

Read the full Reuters report.