Canada has become the first country in the world to authorize the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15 years.
Health Canada expands authorization to include adolescents aged 12 to 15
Pfizer Canada and BioNTech announced today that Health Canada has expanded the Interim Order authorization for their COVID-19 vaccine to include adolescents aged 12 to 15. This is the first-ever COVID-19 vaccine authorized in Canada for use in this age group. The jab was initially approved in December for those 16 and older.
Fabien Paquette, Vaccines Lead, Pfizer Canada stated:
“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. We are proud that we are playing a part of the efforts to help protect adolescent Canadians in this devastating pandemic.”
Özlem Türeci, Co-founder and Chief Medical Officer at BioNTech said:
“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. 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.”
Health Canada based its landmark decision on data from Phase 3 clinical trial in participants aged 12 to 15 years old. The trial enrolled 2,260 adolescents aged 12 to 15 in the US. All trial participants 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.
Authorised use in Canada
Pfizer-BioNTech COVID-19 Vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. Pfizer-BioNTech COVID-19 Vaccine must only be injected intramuscularly.
The use of Pfizer-BioNTech COVID-19 Vaccine is permitted under an interim authorization delivered in accordance with section 5 of the COVID-19 Interim order (IO). Individuals should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product.
For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
About the Pfizer-BioNTech COVID-19 Vaccine
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.