Dhe 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. BioNTech and Pfizer applied for emergency approval of the corona vaccine for children aged five to eleven 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 aged between six and eleven took part in the study; the data on five to eleven year olds are based on 2268 participants. More than 90 clinics in the USA, Finland, Poland and Spain were involved.
Severe courses in children are rare
A member of the Standing Vaccination Commission (STIKO) does not yet assume that there is already sufficient data on rare vaccination side effects in children in the approval study. Because the test group is still too small for that, said the pediatrician Martin Terhardt of the newspaper Tagesspiegel. Such data will only be available after the vaccine has already been used. “This is different from the vaccine for those over twelve that was already being used in other countries when we made the first recommendation,” explained Terhardt.
The specialist in pediatric medicine said in a newspaper interview that he could imagine that the STIKO would initially make a recommendation for children with certain serious pre-existing conditions until there was a sufficient database. “Most of all I think of the clearly overweight children and adolescents.” Because they would definitely have a higher risk of contracting Covid-19.
As soon as the vaccine is approved in Europe, it can be used, said Terhardt. “Provided that the not yet easily assessable risk of vaccination is accepted by doctors and parents.”
Overall, children have a significantly lower risk of developing severe Covid-19 than adults. “It is true that large outbreaks are much less common in day-care centers and schools, but it does happen that children pass on the virus,” said Terhardt. If the numbers increased, so would the severe courses. “It’s all about them. We don’t worry about the common cold caused by Corona. “