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 study are to be submitted to the European Medicines Agency (EMA) and the American FDA as soon as possible, as the two vaccine manufacturers announced on Monday.
"We are happy that we can submit the data for the group of school-age children to the regulatory authorities before the start of the winter season," said BioNTech boss Ugur Sahin, according to the announcement.
In contrast to the age group over twelve, the children from five to eleven years of age were only given a third of the dose for the phase 2/3 clinical study.
The two vaccinations were three weeks apart.
“Antibody responses in subjects who received a ten microgram dose were similar to those from a previous study by Pfizer / BioNTech in people aged 16-25 who received a 30 microgram dose “Announced the company.
The side effects were also comparable to those of the older group.
Results from two additional groups of participants aged two to five years and from six months to two years are expected for the fourth quarter.
According to the information, 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 United States, Finland, Poland and Spain are involved.