“The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19,” the EMA said in a statement.
The COVID-19 vaccine developed by Pfizer and its German partner BioNTech called Comirnaty is already approved by EMA for use in adults and children aged 12 and above.
EMA recommending the Pfizer jab for young children marks the first time the EU regulator has cleared a COVID-19 shot for use in this age group. While final approval is up to the European Commission and is not confirmed yet, it typically follows EMA recommendations.
In children from 5 to 11 years old, a dose of the two-shot regimen is one-third lower than that used in people aged 12 and above. Just like in the older age groups, it is administered as two injections in the muscles of the upper arm three weeks apart.