EMA begins evaluating use of Comirnaty COVID 19 vaccine in children aged 5 to 11

Amsterdam, The Netherlands: The European Medicines Agency (EMA) has started evaluating an application submitted by BioNTech/Pfizer to extend the use of its Covid-19 vaccine 'Comirnaty' for children in the age group of 5 to 11.

First approved in the European Union in December 2020, Comirnaty COVID-19 vaccine is currently authorized for administration in people aged 12 and above. Based on the mRNA (messenger RNA) technology, it produces spike protein on entering the body similar to that produced by the Covid causing SARS-CoV-2 virus. The vaccine administration thus enables the production of antibodies which prepares the body to defend itself against the SARS-CoV-2 virus

EMA’s human medicines committee (CHMP) will review the available data on the vaccine including the data obtained from ongoing clinical trials on children in the age group of 5 to 11 to decide whether it is safe and efficient for use in children below 12. The CHMP’s opinion will then be forwarded to the European Commission for the final decision on the vaccine administration. EMA is expected to declare the outcome of evaluation within a couple of months if no supplementary information for verification is needed in the process.