The European Union drug regulator Thursday approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11, opening the way for them to be given a first shot as the region battles surging infections.
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, the European Medicines Agency (EMA) recommended. 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 their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
Pfizer-BioNTech's vaccine has been approved for European Union use in teenagers between 12 and 17 years old since May. While final approval is up to the European Commission, it typically follows EMA recommendations.
It is not clear when countries may start rolling out the shots among younger children. Earlier this week, outgoing German health minister Jens Spahn said that EU-wide deliveries of the low-dose pediatric version would only begin on December 20.
The bloc joins a growing number of countries, including the United States, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for children in the 5-11 year age group and younger.
Tens of millions of children in this age group will be eligible for the shot in the EU.
For pediatric shots, the U.S. regulator authorized a new version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.