THE HAGUE (AFP) - The EU's drug regulator cleared Pfizer's Covid-19 vaccine for use in children aged five to 11 on Thursday (Nov 25), the first jab to be authorised for a cohort where the virus is rapidly spreading.
Only a handful of countries had previously given the nod for coronavirus vaccinations in younger children, including the United States, Israel and Canada.
The move paves the way for the 27-nation EU to extend its vaccination campaign as it battles a spike in cases.
Pfizer is currently authorised for people aged 12 and over in the bloc.
"I'm glad to tell you that Comirnaty from today has received approval for children five to 11 years of age," said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA), using the vaccine's brand name.
Children in the new age bracket will get one third of the dose that older people receive - 10 microgrammes compared with 30 microgrammes - with two injections, three weeks apart.
"Essentially, it's a much lower dose," Cavaleri told an online public meeting.
The European Commission must now sign off on the approval, which is usually a formality that happens within days, so that member states can decide themselves if they will give children the vaccine.
EU Health Commissioner Stella Kyriakides said the EMA "is clear the BioNTech/Pfizer vaccine is safe and effective for young children, and can offer them additional protection."
French Health Minister Olivier Veran, however, said that he had asked national health regulators to examine the issue before taking any decision on vaccinating children.
"This vaccination, if it is decided on in France, will not start before the beginning of 2022," Veran said.
'Rare in children'
Health authorities say children make up an increasing proportion of new cases and hospitalisations in Europe, which is back at the centre of the coronavirus pandemic.
Children are also considered key drivers of infections even when they themselves do not display symptoms.
The EMA said the vaccine was 90.7 per cent effective in a study of nearly 2,000 children of that age.
Side effects were usually "mild or moderate" lasting a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.
The EMA "therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19."
But the Pfizer jab's safety in children "will continue to be monitored closely".
"We know that severe Covid-19 and death remain quite rare in children. However, disease of all severity occurs in all the paediatric ages," the EMA's Cavaleri said.
Children were also at risk of so-called "long Covid" symptoms dragging on for months after infection, and multisystem inflammatory syndrome, he added.
The EMA is separately reviewing Moderna's coronavirus vaccine for children aged six to 11 and expects to reach a decision in January.
The regulator has so far approved four vaccines for use for adults in the EU: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.