As the EMA announced on Wednesday at the request of the RedaktionsNetzwerk Deutschland (RND), the schedule for the evaluation is about two months. Most recently, the authority assumed it would take several months until a possible approval. In mid-October, the EMA began testing the Biontech vaccine for children under twelve. The testing of the Biontech vaccine for under twelve year olds started on October 18th. According to the EMA, data from ongoing pediatric studies by Biontech and Pfizer would also be included in the assessment. These are expected in November.
A spokeswoman for the EMA assured that everything will be done to complete the evaluation within the shortest possible time. On the other hand, however, a careful and solid assessment of all available efficacy and safety data must be guaranteed. On Tuesday, an advisory body to the US FDA had spoken out in favor of emergency approval of the Biontech / Pfizer corona vaccine for children between the ages of five and eleven. The recommendation is not binding, but the FDA usually follows the experts. A final decision from the FDA is expected later this week.
