„Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation (CMA) and this has been requested from the company,“ the EMA said in a statement. „Further information from the ongoing clinical trials is also expected from January.“

The Amsterdam-based agency earlier told AFP that it had not yet received any formal marketing authorisation and that it had set no timetable for approving the vaccine.