The approval is based on data from the Phase 3 clinical trial, which enrolled 2,260 adolescents aged 12 to 15 years in the US
Health Canada has expanded the interim order authorisation for the use of Pfizer-BioNTech Covid-19 vaccine, BNT162b2, in children aged 12 to 15 years.
With the approval, BNT162b2 becomes the first Covid-19 vaccine approved in the country for use in adolescents of this age group.
In December last year, Health Canada approved the vaccine to be used in people 16 years of age and older.
Based on BioNTech’s mRNA technology, the Pfizer-BioNTech Covid-19 Vaccine was developed by both BioNTech and Pfizer.
Pfizer Canada vaccines lead Fabien Paquette said: “Today’s expansion of our authorisation represents a significant step forward in helping the Canadian government broaden its vaccination program and begin to help protect adolescents before the start of the next school year.”
“We are proud that we are playing a part of the efforts to help protect adolescent Canadians in this devastating pandemic.”
BioNTech co-founder and chief medical officer Özlem Türeci said: “Since securing the interim authorisation in December for individuals 16 years and older, we have been working tirelessly to get our Covid-19 vaccine authorised around the world in order to provide access to as many countries as possible.”
“I am proud of today’s expanded authorisation of our Covid-19 vaccine, making it available for use in adolescents. Our work is not yet complete, as we continue our research into the use of our vaccine in paediatric populations.”
The Canadian regulator’s approval is based on data from Phase 3 clinical trial, which enrolled 2,260 adolescents 12 to 15 years of age in the US.
Pfizer stated that all participants in the study will continue to be monitored for long-term protection and safety for an additional two years after recovering their second dose.
Furthermore, the paediatric study is evaluating the safety and efficacy of the Covid-19 vaccine in children six months to 11 years of age.