The European Medicines Agency, the EU’s regulator for medicinal products, on Thursday approved the BioNTech-Pfizer vaccine, also known as Comirnaty, for children aged 5-11. It’s the first vaccine approved for children under 12 in the EU.
The vaccine has already been approved in the EU for use in people between the ages of 12 and 17 years since May.
The EMA said the vaccine should be given to children in two doses of 10 micrograms three weeks apart as an injection in the upper arm. Adult doses contain 30 micrograms.
The companies have said a clinical trial of children aged 5 to 11 has shown their vaccine to be 90.7% effective against the coronavirus.
The approval comes as Europe battles another massive surge of coronavirus infections. Authorities in Austria, which is seeing a very high rate of COVID cases, did not wait for the EMA approval and have already begun vaccinating the 5 to 11 age group.