The European Union’s drug regulator has given approval to the Pfizer-BioNTech COVID-19 vaccine for administering to children aged between 5 and 1. The EU watchdog’s approval now means that children in Europe will now receive their first jabs against the coronavirus at a time when the continent is witnessing a resurge in cases.
The Pfizer BioNTech COVID-19 vaccine received approval for use in children 5-11 on Thursday, nearly six months after the vaccine was approved by the EU for usage in teenagers aged between 12 and 17.
The vaccine will be administered to children in two 10 microgram dosage and there will be a period of three weeks between the two doses, as recommended by the European Medicines Agency (EMA). The vaccine will be administered in the form of a shot in the upper arm.
The approval comes as Europe is again the epicentre of the pandemic again, accounting for about half of cases and deaths. The companies have said their vaccine, which is called Comirnaty, showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11. Adult doses of the vaccine contain 30 micrograms.
“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.
“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.
Countries will not be able to start rolling out the shots among younger children until next month. The first of the low-dose paediatric version will be delivered on Dec. 20, a spokeswoman for BioNTech said on Thursday.
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, the BioNTech spokeswoman said.
For paediatric shots, 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.
Surging cases in Europe have prompted new unpopular curbs on movement winter grips the region and people gather indoors for celebrations in the run-up to Christmas, providing perfect conditions for COVID-19 to spread. On Thursday, Slovakia started a two-week lockdown, following the example of neighbouring Austria, while the French and Portuguese governments were considering more restrictions.
Health experts have pushed the wider use of booster shots to try and avoid hospitals being overwhelmed as immunity from earlier vaccinations wanes.