BRIEF—First COVID-19 vaccine OKed for children aged 12 to 15 in EU

The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15.

Developed and marketed by BioNTech and Pfizer, the vaccine is already approved for use in adults and adolescents aged 16 and above, and was fully approved for 12-15 year-olds in the USA earlier this month.

The CHMP concluded that the benefits of Comirnaty in this age group outweigh the risks.

The use of the Comirnaty vaccine in children from 12 to 15 will be the same as it is in people aged 16 and above.

It is given as two injections in the muscles of the upper arm, given three weeks apart.

The effects of Comirnaty in children were investigated in 2,260 children aged 12 to 15 years.

This study was carried out in accordance with Comirnaty’s pediatric investigation plan (PIP), which was agreed by EMA's Pediatric Committee (PDCO).