Friday, 08 January 2021
The European Medicines Agency (EMA) could make a decision by the end of January on whether to conditionally authorize the European market for AstraZeneca’s coronavirus vaccine, developed with Oxford University.
The EMA has received additional data from AstraZeneca, and expects a conditional marketing authorization application from AstraZeneca next week, according to Executive Director Emer Cooke.
The process could then lead to a decision by the EMA at the end of January, the executive director said at a public information session. However, the process depends, of course, on the assessment of EMA scientists, who must ensure the product’s efficacy and safety.
If successful, AstraZeneca and Oxford’s vaccine could then become the third to be licensed on the European market, after those of Pfizer-BioNTech and Moderna – which received the green light this week.
The Commission has entered into a pre-purchase agreement with AstraZeneca for 400 million doses, or 300 million base doses with an option to order an additional 100 million doses. The vaccine has the advantage that it can be stored in the refrigerator, unlike BioNTech-Pfizer’s vaccine, which requires freezing at -70°, and Moderna’s vaccine, which requires -20°.
The Brussels Times