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.
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 epicenter 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 percent efficacy against the coronavirus in a clinical trial of children aged five 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.
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Countries will not be able to start rolling out the shots among younger children until next month. The first of the low-dose pediatric version will be delivered on December 20, a spokeswoman for BioNTech said on Thursday.
The EU joins a growing number of countries, including the United States, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for children in the five-11 year age group and younger.
Tens of millions of children in this age group will be eligible for the shot in the EU. Germany will get 2.4 million doses with the first shipment, enough to inoculate about half the country's children aged five-11, the BioNTech spokeswoman said.
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.
Surging cases in Europe have prompted new unpopular curbs on movement as winter grips the region and people gather indoors for celebrations in the run-up to Christmas, providing perfect conditions for COVID-19 to spread.
On Thursday, Slovakia started a two-week lockdown following the example of neighboring Austria, while the French and Portuguese governments were considering more restrictions.
Health experts have pushed the wider use of booster shots to try and avoid hospitals being overwhelmed as immunity from earlier vaccinations wanes.