[ad_1]
“A formal marketing authorization has not yet been submitted to the EMA” for this vaccine, which means that, for now, no timetable can be established, “the Amsterdam-based agency told AFP.
EMA Deputy Executive Director Noel Wathion told Belgian newspaper Het Nieuwsblad on Tuesday that an authorization within the next month is “unlikely”, which was confirmed by the agency Tuesday night.
The AstraZeneca / Oxford vaccine is undergoing a “continuous review”, which allows the EMA to assess the levels of safety and efficacy, as they become available, even before the manufacturer submits a formal application for authorization.
This procedure makes it possible to speed up the evaluation of a marketing authorization application once it has been formulated.
The EMA approved the Pfizer / BioNTech vaccine on December 21, which the European Commission had previously authorized, and it is expected to respond to Moderna on January 6.
