Biontech / Pfizer applies for EU approval for children

by time news

The pharmaceutical company is applying for approval of the corona vaccine for children aged five to eleven.

The German 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 that they had submitted the data on the clinical investigations to the EU medicines agency EMA in Amsterdam. The same data has already been submitted to the US FDA. An emergency admission for children was applied for there 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 4,500 children between the ages of six and eleven are taking part in the study; the data on five to eleven year olds are based on 2,268 participants. More than 90 clinics in the USA, Finland, Poland and Spain were involved.

(APA/dpa)

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