Health Canada says the Pfizer-BioNTech vaccine can now be given to kids as young as 12.
The vaccine was previously authorized for anyone at least 16 years of age or older.
A trial of more than 2,200 youth in that age group in the United States recorded no cases of COVID-19 among vaccinated kids.
Health Canada’s chief medical adviser Dr. Supriya Sharma says the evidence is there that the vaccine is safe and effective in that age group.
It is the first vaccine approved for children in Canada, and Sharma says it is a significant step forward in Canada’s fight against COVID-19.
The trial used the same size doses, and the same two-doses requirement, as the vaccine for adults.
Sharma said about one-fifth of all cases of COVID-19 in Canada have occurred in children and teenagers, and having a vaccine for them is a critical part of Canada’s plan.
She said while most kids don’t experience serious illness from COVID-19, protecting them with a vaccine also helps protect their friends and family, who may be at higher risk of complications.
“It will also support the return to a more normal life for our children, who have had such a hard time over the past year,” she said.
Pfizer CEO Albert Bourla said today the company expects to have data on trials in kids between two and 11 years old in time to apply for authorization in the United States in September.
The company has generally applied to Canada for approval around the same time but in this case Canada is ahead of the U.S.
The U.S. Food and Drug Administration expects to authorize the vaccine for 12 to 15 year olds next week.
The Canadian Press