AstraZeneca submits EMA application for Covid vaccine
Tuesday, 12 January 2021
The European Medicines Agency, EMA, announced Tuesday that it has received a conditional EU marketing authorisation application from AstraZeneca for the Covid-19 vaccine developed by the group in collaboration with the University of Oxford.
The application was expected, and the EMA has already indicated that it could give its opinion before the end of the month if all goes well.
The EMA will now evaluate the data at its disposal and its Committee for Medicinal Products for Human Use (CHMP) could make its decision as early as its 29 January meeting, providing no problems arise, the agency said.
If signed off on by the EMA, the European Commission will then decide whether or not to authorize the product to be placed on the European market.
If conditional marketing authorization is granted, this would be the third coronavirus vaccine to be used in the European Union, following on from the BioNTech-Pfizer and Moderna vaccines.
The first deliveries of Moderna’s vaccine to the EU took place this week, while BioNTech-Pfizer’s vaccine has already been in use for several days in the vaccination campaigns that have started in all 27 Member States.
Belgium is expecting more than 7.5 million doses of AstraZeneca’s vaccine for its own territory under the European Advance Purchase Agreement (negotiated by the Commission).