The European Medicines Agency (EMA) on Friday approved the Pfizer-BioNTech coronavirus vaccine for 12 to 15-year-olds, the first vaccine to get the green light for children in the EU.
The drugs regulator said there were no major concerns over side effects, adding the vaccine was "well tolerated" in children.
EMA head of vaccine strategy Marco Cavaleri said data from clinical trials showed the vaccine was “highly preventative" for young people.
Europe has three deals with the vaccine provider, most recently one securing 1.8 billion doses.
Until now, the vaccine had only been approved for use in people aged 16 and over, although the US and Canada have already authorised the vaccine for children over 12.
Fast-tracked
Originally expected in June, approval for the Covid vaccine in young people had been fast-tracked by the EMA.
Following the authorisation, Germany has said it will start vaccinating children over the age of 12 from 7 June.
Chancellor Angela Merkel said that vaccination would not be compulsory and would have no bearing on whether children could attend school or go on holiday.
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Approval for the two-dose vaccine comes after Pfizer and BioNTech in March said it had shown to be safe and effective in a trial of 2,260 12 to 15-year-olds.
Meanwhile Moderna, which uses the same Messenger RNA technology as Pfizer, has said its vaccine was 96 percent effective in people aged 12 to 17 according to early clinical trials.
(With wires)
