The European Medicines Agency (EMA), the EU's drug regulator, has approved the use of Pfizer (NYSE:PFE)-BioNTech's (Nasdaq:BNTX) COVID-19 vaccine for children between the ages of five and 11, Reuters news agency reported on Thursday.
The EMA has recommended that the vaccine, which is called Comirnaty, will be given in two doses of 10 micrograms three weeks apart as an injection in the upper arm. Adult doses contain 30 micrograms.
The EMA said: "The benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19."
According to the companies, their vaccine showed 90.7% efficacy against COVID-19 in a clinical trial of children aged five to 11.
While final approval is up to the European Commission, it typically follows EMA recommendations.
Tens of millions of children in this age group will be eligible for the shot in the EU, Reuters noted.
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