The European Medicines Agency (EMA) gave its approval on Thursday for children aged 5 and above to receive the Pfizer/BioNTech vaccine against the coronavirus - making it the first to be green-lighted in the European Union for children under 12.
The move still requires the official approval of the European Commission, but that is considered a formality.
Children aged 5 and above would receive a third of the adult dose of the Pfizer/BioNTech vaccine, followed by a second injection three weeks later.
The EMA stressed that studies showed the vaccine to be safe and effective. No serious side effects had been detected to date, at most mild reactions such as pain at the injection site, tiredness and headaches.
The experts began examining studies conducted by the drug manufacturers in October.
In Europe, the Pfizer/BioNTech vaccine has so far only been approved for people aged 12 and older. But in Israel and the United States, children as young as 5 can be vaccinated with it.
It is very rare for children to contract Covid-19, but they can also fall seriously ill, according to the EMA's medical experts. They concluded that the benefits of vaccination outweigh the risks.
A national decision
The EMA's approval does not mean that the vaccine is now recommended for children, the agency stressed, noting that this was a national decision.
In Germany, the standing vaccination committee (Stiko) is due to issue its recommendation on vaccinating children aged 5-11 before year end.
Acting Health Minister Jens Spahn has said that 2.4 million Pfizer/BioNTech doses will be available for children from December 20.
EMA could soon green-light a second vaccine for children. Its experts are currently evaluating an application from the US manufacturer Moderna.
