The EU’s regulator for medicinal products, European Medicines Agency (EMA), has approved BioNTech-Pfizer vaccine for children aged 5 to 11.
The BioNTech-Pfizer vaccine, also known as Comirnaty, is the first vaccine approved for children under 12 in the 27 EU member.
The vaccine has already been approved in the EU for use in people between the ages of 12 and 17 years since May and for adults since December 2020.
The EMA said the vaccine should be given to children in two doses of 10 micrograms three weeks apart as an injection in the upper arm. Adult doses contain 30 micrograms.
“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,” EMA said.
International news agencies report indicates that a clinical trial of children aged 5 to 11 showed their vaccine to be 90.7% effective against the Coronavirus.
However, the studies have not been large enough to determine whether the vaccine could produce rare side effects such as chest and heart inflammation that have been seen in mostly male older teenagers and young adults after the second dose.
The approval for younger children comes as the Ghana Health Service has also revised it guidelines to include children aged 15 and above to the eligible population to receive the Pfizer-BioNTech.