Paul-Ehrlich-Institut

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COVID-19 Vac­cine from 12 Years of Age - Eval­u­a­tion Pro­cess has start­ed for the Mar­ket­ing Au­tho­ri­sa­tion Ex­ten­sion of COVID-19 Vac­cine Mod­er­na

Ampoules COVID-19 Vaccine (Source: Torsten Simon/Pixabay.com)

The evaluation of the application to extend the use of Moderna's mRNA COVID-19 vaccine to children and adolescents aged 12 to 17 years started on 8 June 2021 at the European Medicines Agency (EMA).

The Committee for Medicinal Products for Human Use (CHMP) at the EMA will conduct an accelerated assessment of the data submitted by Moderna Biotech Spain, S.L., including the results of an ongoing clinical trial in children and adolescents aged 12 to 17 years. This study was conducted in accordance with the Paediatric Investigation Plan (PIP) for COVID-19 Vaccine Moderna, which was approved by the EMA's Paediatric Committee (PDCO).

The CHMP is expected to issue an opinion on whether to recommend an extension of the marketing authorisation in a few weeks' time. The European Commission will then make the final, legally binding decision on whether to authorise extension of the marketing authorisation. This decision will then apply in all EU Member States.

The COVID-19 Vaccine Moderna was authorised in the EU in January 2021 for people aged 18 years and older.

Updated: 15.06.2021