Filenews 8 June 2021
The European Medicines Agency, EMA, announced tonight that it has started evaluating the administration of the Moderna vaccine to young people aged 12 to 17.
The EMA will communicate the outcome of the evaluation in July, unless additional information is required.
The EMA recalls that the vaccine is currently approved for use in people aged 18 years and over. It notes that the vaccine contains messenger RNA (mRNA) with instructions for the production of a protein spike and prepares the body to defend itself against SARS-CoV-2.
The EMA Human Medicines Committee (CHMP) will carry out a rapid evaluation of the data submitted in the application, including the results of a large ongoing clinical study involving adolescents aged 12 to 17. This study was carried out in accordance with the Paediatric Research Plan (PIP) for COVID-19 Vaccine Moderna, agreed by the EMA Paediatric Committee (PDCO).
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 Commission, which will issue a final legally binding decision applicable in all EU Member States.
Cna
