The EU's drug regulator has approved Pfizer-BioNTech's vaccine for children aged 5 to 11.
In a statement, the European Medicines Agency (EMA) said the benefits of the drug “outweigh” the risks, particularly among clinically vulnerable children.
Pfizer and BioNTech have said their vaccine, called Comirnaty, showed 90.7 per cent efficacy against coronavirus in a clinical trial of children aged 5 to 11.
The EMA recommended the vaccine, which has already been approved for use in teenagers aged between 12 and 17, be given as an injection in the upper arm in two 10-microgram doses three weeks apart. Adult doses contain 30 micrograms.
The move paves the way for European countries to administer the shot to younger children in an attempt to stop a wave of infections that has threatened further Covid lockdowns across the continent.
Inoculating children and young people, who can unwittingly transmit Covid-19 to others, is considered a critical step towards taming the pandemic. In Germany and the Netherlands, children now account for the majority of cases.
While final approval is up to the European Commission, the body typically follows EMA recommendations. A decision is likely to come on Friday, reports suggest.
“Today's recommendation … is clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection,” Stella Kyriakides, the EU health commissioner, said on Twitter.
Countries will not be able to start rolling out the shots to younger children until next month. The first of the low-dose paediatric version will be delivered on December 20, a spokeswoman for BioNTech said.
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Polish Health Ministry spokesman Wojciech Andrusiewicz told state-run news agency PAP that Poland would start vaccinating children aged 5 to 11 in December when it receives the first batch of 1.1 million doses of the vaccine.
In addition to the EU, the US, Canada, Israel, China and Saudi Arabia have all cleared vaccines for children in the 5 to 11 year age group.
Tens of millions of children in this age group will be eligible for the shot in the EU. Germany will receive 2.4 million doses of the vaccine, enough to inoculate about half the children aged 5 to 11, the BioNTech spokeswoman said.
For paediatric shots, the US Food and Drug Administration authorised a new version of the vaccine which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.
The World Health Organisation said on Wednesday that as children and adolescents are at lower risk of severe Covid-19, countries should prioritise adults and share doses with the Covax programme, which aims to supply the world's poorest countries with vaccines.