The German company Biontech and its US partner Pfizer have applied for emergency approval for their corona vaccine for use in children between the ages of five and eleven with the US FDA.
The corresponding data had been transmitted to the authority, Pfizer announced on Thursday via the short message service Twitter. An FDA advisory body plans to deal with the application on October 26th.
Previously, clinical studies had shown that children in this age group tolerated the vaccine well and produced a stable immune response. In contrast to the age group over twelve, only one third of the dose was administered to the children aged five to eleven for the phase 2/3 clinical study. The two vaccinations were three weeks apart.
According to the companies, a total of 4500 children between the ages of six and eleven take part in the study; the data presented on the 5 to 11 year olds go back to 2268 participants. Over 90 clinics in the USA, Finland, Poland and Spain are involved.