On 9 November 2021, the Committee for Medicinal Products for Human Use (CHMP) started evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11 years.
The CHMP at the European Medicines Agency (EMA), composed of experts from the medicines authorities of the EU Member States, will conduct an accelerated assessment of the data submitted by Moderna Biotech Spain, S.L., including results from an ongoing clinical trial in children and adolescents aged 6 to 11 years. This study was conducted in accordance with the Paediatric Investigation Plan (PIP) for the COVID-19 vaccine Spikevax (Moderna), which had been approved by the Paediatric Committee (PDCO) at the EMA.
An opinion from the CHMP on whether to recommend an extension of the marketing authorisation is expected in about two months, unless further data are needed. The European Commission will then make the final, legally binding decision on whether to approve a marketing authorisation extension. This decision will then apply in all EU Member States.
The vaccine Spikevax (formerly COVID-19 Vaccine Moderna) has already been authorised in the EU for persons aged 18 years and older in January 2021 and for children aged 12 years and older in July 2021.
Updated: 10.11.2021
