The vaccine (called Comirnaty in the EU) was authorized in December for people aged 16+. On Friday, the CHMP recommended the extension of the vaccine to children aged 12-15.
Earlier this month, the US and Canada also authorized the vaccine for this age group.
75% to 100% efficacy
The EMA's CHMP based its decision on a study of 2,260 children aged 12-15 years old: carried out in accordance with Comirnaty’s paediatric investigation plan, agreed by the EMA’s Paediatric Committee.
The trial showed antibody response was similar in the 12-15 year old age group compared to that in 16-25 year olds. Of the 1,005 children who received the vaccine, none developed COVID-19. In the placebo group, 16 children out of the 978 developed COVID-19.
“This means that, in this study, the vaccine was 100% effective at preventing COVID-19 (although the true rate could be between 75% and 100%),” notes the EMA.
“The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and above. They include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These effects are usually mild or moderate and improve within a few days from the vaccination.”
Meanwhile, the EMA notes that cases of myocarditis and pericarditis reported following vaccination with Comirnaty are being assessed by its PRAC safety committee, although says there is ‘currently no indication that these cases are due to the vaccine’.
“Despite this uncertainty, the CHMP considered that benefits of Comirnaty in children aged 12 to 15 outweigh the risks, in particular in children with conditions that increase the risk of severe COVID-19,” it concluded.
In the EU, Member States compile their own vaccination policies, with most continuing to vaccinate older age populations first before opening up vaccination to younger people. France, for example, today starts offering a COVID-19 vaccine to anyone aged 18+.