The European Union's pharmaceuticals regulator approved Pfizer's coronavirus vaccine for use on children aged 5 to 11 years old on Thursday, paving the way for doses to be given to millions of elementary school students across the continent amid a new wave of infections.
The European Medicines Agency has approved a COVID-19 vaccination for use in young children for the first time.
"An expansion of the indication for the COVID-19 vaccination Comirnaty to cover usage in children aged 5 to 11," the FDA said.
The EMA estimated that the vaccination was roughly 90% effective in avoiding symptomatic COVID-19 in young children after analysing a research involving more than 2,000 children, and that the most common side effects were pain at the injection site, headaches, muscle soreness, and chills. The two-dose schedule should be given to children three weeks apart, according to the government.
At least one country dealing with an outbreak of diseases did not wait for the EMA to give its permission. Authorities in Vienna, Austria's capital, have already begun immunising children aged 5 to 11. The pandemic is presently centred in Europe, and the World Health Organization has warned that unless immediate action is taken, the continent's death toll might reach 2 million by the spring.
Before health authorities in member states can begin distributing shots, the EMA green light for the vaccine developed by Pfizer and German business BioNTech must be rubber-stamped by the EU's executive branch, the European Commission.
Jens Spahn, Germany's health minister, announced earlier this week that shipping of vaccines for younger children in the EU would begin on December 20.
Pfizer's kids-sized doses were approved by the US earlier this month, and other nations, including Canada, followed suit.
For elementary school-aged children, Pfizer tried a dose that is a third of the amount given to adults. Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press in September that youngsters aged 5 to 11 years old acquired coronavirus-fighting antibody levels that were just as high as teenagers and young adults who received the regular-strength doses.
However, the tests on Pfizer's vaccination in youngsters were not large enough to discover any rare side effects after the second dosage, such as chest and heart inflammation, which has been reported primarily in older male teenagers and young adults.
COVID-19 has caused more deaths in children aged 5 to 11 than some other diseases, such as chickenpox, did before children were routinely vaccinated, according to American officials.
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