Health Canada is authorizing the Pfizer-BioNTech COVID-19 vaccine for children between the ages of 12 and 15. So now anyone above the age of 12 is approved for vaccination in Canada. Until now, the shot had only been approved for Canadians over the age of 16.
Pfizer Canada ULC and BioNTech SE today announced that Health Canada has expanded the Interim Order authorization for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group.
Health Canada based its decision on data from Phase 3 clinical trial in participants aged 12 to 15 years old. The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
In addition, the pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children six months to 11 years of age is ongoing.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
“Today’s expansion of our authorization 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,” said Fabien Paquette, Vaccines Lead, Pfizer Canada.
“We are proud that we are playing a part of the efforts to help protect adolescent Canadians in this devastating pandemic.”
“Since securing the Interim Authorization in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world in order to provide access to as many countries as possible,” said Özlem Türeci, Co-founder and Chief Medical Officer at BioNTech. “I am proud of today’s expanded authorization 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 pediatric populations.”