The clinical studies have applied to the EU Medicines Agency (EMA) for approval of their corona vaccine for children aged five to eleven.
Mainz – The Mainz-based pharmaceutical company Biontech and its US partner Pfizer have now also applied for approval of their corona vaccine for children aged five to eleven in Europe.
Both announced on Friday in Mainz and New York that they had submitted the relevant data on the clinical investigations to the EU Medicines Agency (EMA).
The same data has already been submitted to the US FDA. There, Biontech and Pfizer applied for emergency approval of the corona vaccine for children aged five to eleven on October 7th.
According to Biontech and Pfizer, the clinical studies show that the vaccine is well tolerated by children in this age group and elicits a stable immune response. In contrast to adolescents, children in this age group were given only a third of the dose. According to the companies, a total of 4500 children between the ages of six and eleven are taking part in the study; the data on the five to eleven year olds are based on 2268 participants. More than 90 clinics in the USA, Finland, Poland and Spain were involved. dpa
