Europe – EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17

EMA has started evaluating an application to extend the use of the COVID-19 Vaccine Moderna to include young people aged 12 to 17.

COVID-19 Vaccine Moderna is a vaccine for preventing COVID-19. It is currently authorised for use in people aged 18 and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein known as the spike protein, which is naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.

EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted in the application, including 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)…