Spikevax COVID-19 vaccine for children up to 5 years: application for indication extension submitted

Swissmedic is reviewing application from Moderna Switzerland GmbH


Moderna Switzerland GmbH has submitted an application to extend the indication for its Spikevax® vaccine to children aged 6 months to 5 years.

Moderna’s COVID-19 vaccine Spikevax® has been authorised in Switzerland for prevention of COVID-19 disease in children aged 6 years and over since 13 May 2022. Based on the application submitted, an extension of the indication to children aged 6 months to 5 years is being reviewed.

The application documents submitted include the paediatric investigation plan, information for healthcare professionals, patient information and clinical data. Administration of two 0.25 ml doses at an interval of one month is planned. This is one quarter of the adult dose for basic immunisation.

Swissmedic is reviewing the documents received on an ongoing basis and will communicate its decision on the risk-benefit profile in this age group in due course.