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European Union Medicines Agency approves BioNTech-Pfizer vaccine for 5-11 age group

The European Medicines Agency, the EU’s regulator for medicinal products, on Thursday approved the BioNTech-Pfizer vaccine for children aged 5-11.

The European Medicines Agency, the EU’s regulator for medicinal products, on Thursday approved the BioNTech-Pfizer vaccine, also known as Comirnaty, for children aged 5-11. It’s the first vaccine approved for children under 12 in the EU.

The vaccine has already been approved in the EU for use in people between the ages of 12 and 17 years since May.

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,” the EMA said.

The companies have said a clinical trial of children aged 5 to 11 has shown 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 US, Canada, and Israel have already begun vaccinating children aged 5-11