Corona vaccine from Moderna
Photo: Friso Gentsch / dpa
The European Medicines Agency Ema has recommended that Moderna's corona vaccine be released for children and adolescents aged twelve and over.
The authority announced on Friday.
Following Ema's recommendation, the EU Commission and the member states still formally decide on approval in the EU.
After the US company Moderna submitted the application for approval for 12 to 17-year-olds at the beginning of June, Ema had promised an "accelerated examination".
High effectiveness and tolerance
According to the US company, the basis of the application for approval was a phase 2/3 study with the mRNA vaccine in 2,500 adolescents between 12 and 17 years of age in the USA.
The effectiveness was 100 percent (read more here).
The safety and tolerability profile are the same as in the phase 3 study of adults, it said.
Overall, the vaccine was well tolerated by the participating children and adolescents, and there were no serious side effects.
The Moderna vaccine is the second vaccine that is also recommended in the EU for the age group of 12 to 17 year olds.
The vaccine from Biontech / Pfizer already has EU-wide approval for this age group.
In Germany, children and young people from the age of twelve can be vaccinated against the coronavirus since June 7th. The Standing Vaccination Commission (Stiko) does not generally recommend vaccination for this age group. According to Stiko, the benefit of the corona vaccination for healthy children and adolescents of this age is not generally given because the age group has a significantly lower risk of a severe or even fatal course of Covid-19 compared to older adults. In Germany, vaccination is therefore only recommended for 12 to 17-year-olds with certain previous illnesses and those around whom people live who have a high risk of a severe course of Covid-19.
However, the Stiko recommendation is not binding.
Children and adolescents in this age group can have themselves vaccinated if they and their parents have been informed by a doctor and accept the risk.
mar / kry / afp / dpa