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).
Mainz - 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.
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Biontech: vaccination effective and safe in younger children
According to the two companies, the corona vaccine from Biontech / Pfizer has proven to be well tolerated in children aged five to eleven and elicits a stable immune response.
The data from the clinical trial are to be submitted to the European Medicines Agency (EMA) and the US FDA as soon as possible, the two vaccine manufacturers announced on Monday.
Biontech: vaccination effective and safe in younger children
Biontech: vaccination effective and safe in younger children
So far, there is no corona vaccine in Germany that is approved for children between the ages of five and eleven.
Biontech is now presenting study data for the immunization of the youngest.
Biontech: vaccination effective and safe in younger children
Biontech plans to apply for vaccine approval for children soon
Will the corona vaccination be available for under-12s soon?
At least Biontech would like to apply for approval soon.
Initially, however, only a certain group of children could possibly benefit.
Biontech plans to apply for vaccine approval for children soon
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
