EMA to assess whether COVID-19 Vaccine Moderna can be used in adolescents

COVID-19 Vaccine Moderna has been approved since January 2021 in the European Union for active immunisation to prevent COVID-19 in people aged 18 years and older. It is a messenger RNA (mRNA) vaccine, which delivers the mRNA instructing cells to produce the SARS-CoV-2 Spike (S) protein. SARS-CoV-2 is the virus that causes COVID-19, delivering the mRNA encoding this protein to human cells causes them to temporarily produce and express the S protein on their surface, presenting it for the immune system to detect and build up an immune defence against.

European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of data submitted in an application to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17. The data includes results from a large ongoing clinical study involving adolescents from 12 to 17 years of age. This study was carried out in accordance with the paediatric investigation plan (PIP) for COVID-19 Vaccine Moderna, which was agreed by EMA’s Paediatric Committee (PDCO). An accelerated assessment is a rapid evaluation of medicines that usually takes 150 days, rather than the 210 of the normal process.

The CHMP’s opinion on extending the use of the vaccine, together with any requirements for further studies and additional safety monitoring, will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

EMA will communicate the outcome of its evaluation, which is expected in July unless supplementary information is needed.