EMA has started evaluating an application to extend the use of BioNTech/Pfizer's COVID-19 vaccine, Comirnaty, to children aged 5 to 11.
Comirnaty is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 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 review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, in order to decide whether to recommend extending its use. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.
EMA will communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.
Comirnaty was first authorised in the EU in December 2020. More information about the vaccine is available on the EMA website.