The European Union drugs regulator has authorised Pfizer’s coronavirus vaccine for use on children aged from five to 11.
It clears the way for jabs to be administered to millions of school children on the continent amid a new wave of infections sweeping across Europe.
It is the first time the European Medicines Agency (EMA) has cleared a COVID-19 vaccine for use in young children.
The agency said it “recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged five to 11”.
The vaccine, called Comirnaty, will be given in two doses of 10 micrograms three weeks apart as an injection in the upper arm, the EMA recommended. Adult doses contain 30 micrograms.
EU health commissioner Stella Kyriakides said the recommendation made it “clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection.”
However, the French health minister Olivier Veran has asked the country’s medical ethics committee and health regulator to examine whether children as young as five should get a jab.
It is expected the rollout for primary-aged children will start in the new year.
Cases in Europe are surging, with countries introducing new lockdown measures and other restrictions.
Elsewhere, Israel started vaccinating five to 11-year-olds on Monday with the Pfizer jab. The United Arab Emirates and Bahrain have also approved the dose for the same age group.
Bahrain has also approved China’s Sinopharm jab for three to 11-year-olds.
China itself has approved two vaccines from Sinopharm and one from Sinovac for children as young as three.
Indonesia has approved the Sinovac dose from children aged six and over.
The US is jabbing children aged five and older, and Canada has also authorised the Pfizer dose.
Venezuela is using the Cuban Soberana 2 vaccine on children as young as two.
Ecuador is vaccinating children as young as six with the Sinovac jab.
Argentina is using the Sinopharm vaccine on children aged three and up, while Chile and El Salvador have started vaccinating six-year-olds.
In Costa Rica, vaccination is mandatory aged five and up.
Cuba has vaccinated children as young as two.
The World Health Organisation has criticised countries vaccinating children, saying: “As a matter of global equity, as long as many parts of the world are facing extreme vaccine shortages, countries that have achieved high vaccine coverage in their high-risk populations should prioritize global sharing of COVID-19 vaccines through the COVAX facility before proceeding to vaccination of children and adolescents who are at low risk for severe disease.”