The European Union’s drug regulator has on Thursday approved the use of Pfizer-BioNTech’s COVID-19 vaccine for children between the ages of five and 11. The approval will now allow children in that age bracket to be given a first shot as Europe struggles to contain a surge in infections.
The European Medicines Agency (EMA) recommended that Pfizer-BioNTech’s vaccine, approved for European Union use in teenagers between 12 and 17 years old since May, be given as an injection in the upper arm in two 10 microgram doses, three weeks apart. Adult doses contain 30 micrograms.
The approval comes as Europe is again the epicentre of the pandemic again, accounting for about half of cases and deaths.
Inoculating children and young people, who can unwittingly transmit COVID-19 to others, is considered a critical step towards taming the pandemic. In Germany and the Netherlands, kids now account for the majority of cases.
Pfizer and BioNTech 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.
“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 and an EU source told Reuters that a decision would likely come on Friday.
“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.
Polish Health Ministry spokesman Wojciech Andrusiewicz told state-run news agency PAP that Poland would start vaccinating children aged 5-11 in December.
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 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. Germany will get 2.4 million doses with the first shipment, enough to inoculate about half the country’s children aged 5-11, the BioNTech spokeswoman said.
For paediatric shots, the U.S. regulator authorised a new version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.