On May 5, 2021, Pfizer and BioNTech announced that Health Canada had expanded the Interim Order authorization for their COVID-19 vaccine to include individuals 12 to 15 years of age. This was 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 U.S. 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.