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EU drug regulator approves first COVID shot for 5-11 year olds

25 November 2021 17:09 (UTC +04:00)

The EU's drug regulator approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11 on Thursday, paving the way for them to be given a first shot as Europe battles a surge in infections, APA reports citing Reuters.

Pfizer-BioNTech's vaccine, which has been approved for European Union use in teenagers between 12 and 17 years old since May, will be given in two doses of 10 micrograms three weeks apart as an injection in the upper arm, the European Medicines Agency (EMA) recommended.

The approval comes as Europe is again the epicentre of the pandemic again, accounting for about half of cases and deaths.

The companies have said their vaccine, which is called Comirnaty, showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11. Adult doses of the vaccine 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.

While final approval is up to the European Commission, it typically follows EMA recommendations.

"Today's recommendation (...) is clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection," EU health commissioner Stella Kyriakides said on Twitter.

Countries will not be able to start rolling out the shots among younger children until next month. The first of the low-dose paediatric version will be delivered on Dec. 20, a spokeswoman for BioNTech said on Thursday.