The European Medicines Agency (EMA) has authorised the use of the Pfizer coronavirus vaccine for children aged 12 to 15.
Marco Cavaleri, who heads the EMA body that reviewed the vaccine, said the EU regulator had received the required data to approve the vaccine for younger teens and found it to be highly effective against Covide-19.
The EMA's recommendation to expand the vaccine to children was based on a study in more than 2,000 adolescents in the US that showed the vaccine was safe and effective.
Researchers will continue to monitor the shot's long-term protection and safety in the children for another two years.
The recommendation follows similar decisions by regulators in Canada and the US last month, as rich countries slowly approach their vaccination targets for adults and look to immunise as many people as possible.
The decision needs to be rubber-stamped by the European Commission and individual national regulators, Mr Cavaleri said.
The European Medicines Agency's endorsement comes weeks after it began evaluating extending use of the vaccine, developed with Germany's BioNTech, to include 12- to 15-year-olds. It is already being used in the European Union for those aged 16 and older.
It offers younger children in Europe the chance of access to a Covid-19 shot for the first time during the pandemic.
The vaccine, developed by the company’s subsidiary Janssen, has been approved by the UK medicines regulator and will be available later in the year.
The UK has ordered 20 million doses of the vaccine which has shown to be 67 per cent effective in preventing moderate to severe Covid-19.
It is also thought to be 85 per cent effective in preventing severe disease or admission to hospital.
Health and Social Care Secretary Matt Hancock said: “This is a further boost to the UK’s hugely successful vaccination programme, which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved to help protect people from this awful virus.
“As Janssen is a single-dose vaccine, it will play an important role in the months to come as we redouble our efforts to encourage everyone to get their jabs and potentially begin a booster programme later this year.”
Additional reporting by AP