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, paving the way for them to be given a first shot as Europe struggles to contain a surge in infections.
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.
Europe has become the epicenter of the epidemic, 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 epidemic. In the Netherlands and in Germany, kids account for the majority of cases.
Pfizer and BioNTech have said their vaccine, called Comirnaty, showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11 years old.
Comirnaty benefits children aged 5 to 11 outweigh the risks, especially in those with conditions that increase the risk of severe COVID - 19, the EMA said.
The European Commission is expected to make a decision on Friday, as final approval is up to the European Commission, and an EU source told Reuters that a decision would likely come on Friday.
EU health commissioner Stella Kyriakides said on Twitter that the BioNTech-Pfizer vaccine is safe and effective for young children, and can give them additional protection.
Countries won't be able to start rolling out the shots among younger children until next month. A spokeswoman for BioNTech said that the first of the low-dose paediatric versions will be delivered on December 20.
Wojciech Andrusiewicz, Polish health ministry spokesman, told state-owned news agency PAP that Poland would start vaccinating children aged 5 -- 11 in December.
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.
Hundreds 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 half of the country's children aged 5 -- 11, according to a spokeswoman for BioNTech.
The U.S. regulator 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.
As winter grips the region and people gather indoors for celebrations in the run up to Christmas, new unpopular curbs on movement have been set to be put in place in Europe, providing perfect conditions for COVID - 19 to spread.
On Thursday, Slovakia began a two-week lock-down, following the lead of Austria, while the Portuguese and French governments are considering more restrictions.
While health experts have pushed for booster shots to try and avoid hospitals being overwhelmed by earlier shots, vaccination of younger people is another tool in fighting the disease.
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 rare cardiovascular side-effects.
At least 10% of the 28 million eligible U.S. children have had a first dose.