The EU's drug regulator approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11 on Thursday (Nov 25), paving the way for them to be given a first shot as Europe struggles with a surge in cases.
The European Medicines Agency (EMA) recommended that Pfizer-BioNTech's vaccine, approved for European Union use in teenagers between 12 and 17 years old since May, be given as an injection in the upper arm in two 10 microgram doses, three weeks apart. Adult doses contain 30 micrograms.
The approval comes as Europe is again the epicentre of the pandemic again, accounting for about half of cases and deaths.
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, kids now account for the majority of cases.
Pfizer and BioNTech have said their vaccine, which is called Comirnaty, showed 90.7 per cent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
"The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19," the EMA said.
While final approval is up to the European Commission, it typically follows EMA recommendations and an EU source told Reuters that a decision would likely come on Friday.
"Today's recommendation (...) is clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection," EU health commissioner Stella Kyriakides said on Twitter.
EU countries, including Austria, Poland, Hungary and the Czech Republic are now preparing nationwide inoculation programmes for younger children, although the first of the low-dose paediatric shots will not be delivered until Dec 20.
Portugal's President Marcelo Rebelo de Sousa welcomed the "good news", noting the rising number of infections among unvaccinated children.
In France, where the number of infections is doubling every 11 days, Health Minister Olivier Veran said he would ask health regulators to examine whether 5- to 11-year-olds should be able to be given the vaccine.
Norway was considering limiting its use to kids with serious underlying conditions, such as cancer and transplant patients, Geir Bukholm, infection control director of the Norwegian Institute of Public Health (NIPH), told Reuters.
The EU joins a growing number of countries, including the United States, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for children in the 5-11 year age group and younger.
Tens of millions of children in this age group will be eligible for the shot in the EU. Germany will get 2.4 million doses with the first shipment, enough to inoculate about half the country's children aged 5-11, a BioNTech spokeswoman said.
Polish Health Ministry spokesman Wojciech Andrusiewicz told Reuters the country is expecting a first batch of 1.1 million doses for the younger age group in December.
The Czech Republic said it expects to get 300,000 doses, which would cover about a fifth of its younger population.
In Austria, where the government has reimposed a nationwide lockdown, some provinces started vaccinating children of that age earlier this month even without official EMA approval.
After Thursday's announcement, Austrian Health Minister Wolfgang Mueckstein said the government would now prepare for a nationwide programme.
Surging cases in Europe have prompted new unpopular curbs on movement as winter grips the region and people gather indoors for celebrations in the run-up to Christmas, providing perfect conditions for COVID-19 to spread.
Slovakia started a two-week lockdown on Thursday, following the lead of Austria, while the Portuguese and French governments are considering more restrictions.
While health experts have pushed the wider use of booster shots to try and avoid hospitals being overwhelmed as immunity from earlier shots wanes, vaccinating younger people is another tool in fighting the virus.
However, the World Health Organization said on Wednesday that as children and adolescents are at lower risk of severe COVID-19, countries should prioritise adults and sharing doses with the COVAX programme aimed at supplying the world's poorest countries which have struggled to get vaccines.
Some countries have limited the use of COVID-19 shots based on the so-called mRNA technology used by Pfizer-BioNTech to younger people after reports of possible rare cardiovascular side-effects.
Top US infectious disease official Anthony Fauci told Reuters this week there had been no sign of any new safety issues since the rollout of vaccines for younger kids started earlier this month.
At least 10 per cent of the 28 million eligible US children have had a first dose.
No serious safety concerns related to the vaccine have been identified in trials, Pfizer and BioNTech said in a statement.
Some medics reacted with caution, saying that as children may not get as sick as adults, there was less urgency.
"There is great public, political, and social pressure for school children to be vaccinated to avoid outbreaks in schools, but the safeguarding of public health cannot be taken based on 'guessing'," Ana Rita Cavaco, head of Portugal's nurses association, said.