mRNA-based COVID-19 vaccines are currently authorised in Switzerland for children and adolescents aged 12 years and over and recommended by the Federal Commission for Vaccination (FCV). Moderna has submitted an application to Swissmedic to extend the indication of the COVID-19 vaccine Spikevax® to children aged 6 years and older.
Swissmedic reviews Moderna Switzerland GmbH application for Spikevax®
Moderna’s COVID-19 vaccine Spikevax has been authorised in Switzerland for prevention of COVID-19 disease for adolescents aged 12 years and over since 9 August 2021. The extension requested would broaden the indication to cover 6 to 11-year-olds. The documentation submitted includes the initial results of an ongoing clinical trial with almost 5,000 participants in this age group. The subjects received two reduced vaccine doses compared to the adult dose 28 days apart.
Swissmedic is reviewing the application documentation, which it is receiving on an ongoing basis, in an accelerated process without compromising on the scientific review. When a decision on the benefit/risk profile in this age group will be possible depends on any necessary additional information on safety, efficacy and quality.