Paul-Ehrlich-Institut

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EU Com­mis­sion Au­tho­ris­es In­di­ca­tion Ex­ten­sion of COVID-19 Vac­cine Comir­naty for 12- to 15-year-olds

On Monday, 31 May 2021, the EU Commission approved the marketing authorisation extension for BioNTech/Pfizer's COVID-19 vaccine Comirnaty. Prior to this, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the indication extension at its meeting on 28 May 2021. This means that BioNTech/Pfizer's COVID-19 vaccine can be used from the age of 12 years in the future.

EU flags in front of the European Commission building in Brussels (Source: NakNakNak/Pixabay.com)

Based on data from a randomised placebo-controlled clinical trial of just over 1,000 Comirnaty-vaccinated adolescents aged 12 to 15 years, titers of neutralising antibodies to SARS-CoV-2 were found to be equal to or higher after two vaccinations than in 16- to 25-year-olds. Analysis of common adverse events (reactogenicity) revealed a similar profile to adults, although the frequency of occurrence was slightly higher than in adults. Serious adverse events were observed in 0.4% of vaccinated subjects and 0.2% of subjects receiving placebo. None of these events were attributed to the vaccine.

In the overall view of the data collected on proven direct benefit, possible or probable indirect benefit, and known risks, there is a favorable risk-benefit balance. The best allocation is to be made by the member states depending on the respective vaccination strategy. In Germany, such trade-offs are made either politically or by the Standing Committee on Vaccination (Ständige Impfkommission, STIKO).

Updated: 01.06.2021