- The EU is expected to allow young children to receive their first vaccine against COVID-19 soon.
- Its drug regulator on Thursday recommended approval of Pfizer’s vaccine for children aged five to 11.
- Europe is grappling with an upsurge in infections and accounts for around half of the cases worldwide.
The European Union medicines regulator on Thursday recommended the use of Pfizer-BioNTech’s COVID-19 vaccine for children aged five to 11.
The Pfizer-BioNTech vaccine will be given in two doses of 10 micrograms three weeks apart as an injection in the upper arm, as recommended by the European Medicines Agency (EMA). Adult doses of the vaccine contain 30 micrograms.
The final approval rests with the European Commission, which usually follows the recommendations of the EMA.
The vaccine has been approved in the EU for people aged 16 and over since December 2020 and for young people aged 12 to 15 since May this year.
The recommendation comes as Europe is once again the epicenter of the pandemic, accounting for around half of new cases and deaths.
The companies said their vaccine, called Comirnaty, was shown to be 90.7% effective against the coronavirus in a clinical trial in children aged 5 to 11.
“The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, especially in those with conditions that increase the risk of severe COVID-19,” the EMA said.
European Health Commissioner Stella Kyriakides said on Twitter that it was “clear that 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 vaccines to young children until next month. The first of the low-dose pediatric version will be delivered on December 20, a spokesperson 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 approved vaccines for children aged 5 to 11 and under.
Tens of millions of children in this age group will be eligible for shooting in the EU. Germany will receive 2.4 million doses with the first shipment, enough to immunize about half of the country’s children aged 5 to 11, the BioNTech spokeswoman said.
For pediatric injections, the US regulator has authorized a new version of the vaccine, which uses a new tampon and allows them to be stored in the refrigerator for up to 10 weeks.