EU regulator approves Pfizer/BioNTech vaccine for children aged 5-11

The European Medicines Agency (EMA) has approved the Pfizer/BioNTech Covid-19 vaccine for children between the ages of 5 and 11-years, Report informs referring to Irish Examiner.

Both the US and Canada have already authorized the use of Pfizer’s Covid-19 vaccine for children in the age grouping.

In children from 5 to 11 years of age, a study found that a lower dose of the Comirnaty vaccine was comparable to a larger dose used in people aged 12 and above.

Children in the group will be given two injections, three weeks apart, into the muscle of the upper arm.

“Of the 1,305 children receiving the vaccine, three developed Covid-19 compared with 16 out of the 663 children who received placebo. This means that, in this study, the vaccine was 90.7% effective at preventing symptomatic Covid-19 (although the true rate could be between 67.7% and 98.3%),” the EMA said.

The EMA’s human medicines committee (CHMP) therefore concluded that 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.