The European Union’s medicines regulator has recommended authorising Moderna’s COVID-19 vaccine for use in children aged between 12 and 17, marking the first time the shot has been approved for people under 18.
In a decision on Friday, the European Medicines Agency (EMA) said research in more than 3,700 children of 12 to 17 years of age showed that the shot produced a comparable antibody response to that seen in 18- to 25-year-olds.
Use of the vaccine, Spikevax, will be the same in adolescents as in people over 18, the EMA said.
Formal approval by the European Commission – the EU’s executive arm – is needed to start rolling out the vaccine for teenagers. The body typically follows EMA recommendations.
Until now, the vaccine made by Pfizer and its German partner BioNTech has been the only option for use in children as young as 12 in North America and the EU.