- The EU is set to soon allow young children to get their first shot of a COVID-19 vaccine.
- Its drug regulator on Thursday recommended approval for Pfizer’s vaccine for kids aged five to 11.
- Europe is battling a surge in infections, and accounts for around half of global cases.
The European Union’s drug regulator recommended the use of Pfizer-BioNTech’s COVID-19 vaccine for children between the ages of five and 11 on Thursday.
Pfizer-BioNTech’s vaccine will be given in two 10-microgram doses three weeks apart as an injection in the upper arm, per the European Medicines Agency (EMA) recommendation. Adult doses of the vaccine contain 30 micrograms.
Final approval is up to the European Commission, which typically follows EMA recommendations.
The vaccine has been approved in the EU for people aged 16 and up since December 2020 and for young people aged between 12 and 15 years old since May of this year.
The recommendation comes as Europe is once again the epicenter of the pandemic, accounting for about half of new 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.
“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.
EU health commissioner Stella Kyriakides said on Twitter that it was “clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection.”
Countries will not be able to start rolling out the shots to young 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 US, Canada, Israel, China, and Saudi Arabia, which have cleared vaccines for children in the five to 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 pediatric shots, the US 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.