EU regulator endorses Pfizer-BioNTech Covid-19 vaccine for children as young as 12
The European Medicines Agency's endorsement comes weeks after it began evaluating extending use of the vaccine, developed with Germany's BioNTech, to include 12- to 15-year olds.
Europe's medicines regulator on Friday backed the use of Pfizer's Cov-19 vaccine for children as young as 12, paving way for a broader roll-out in the region after similar clearances in the United States and Canada.
The European Medicines Agency's endorsement comes weeks after it began evaluating extending use of the vaccine, developed with Germany's BioNTech, to include 12- to 15-year-olds. It is already being used in the European Union for those aged 16 and older.
The EMA said two doses were required in the 12-15 age group and should be administered with an interval of at least three weeks. It is now up to individual EU states to decide if and when to offer the vaccine to teenagers, it added.
Inoculating children and young people is considered a critical step toward reaching "herd immunity" and taming the pandemic.
However, giving vaccines to younger people in affluent countries while many parts of the world await doses for older and more vulnerable people has raised concerns.
Pfizer and BioNTech in March unveiled trial data showing their vaccine offered 100% protection against the infectious disease in a trial with 2,260 adolescents aged 12 to 15. It was also well tolerated.