KIRKLAND, QUEBEC and MAINZ, GERMANY, September 9, 2022 — Pfizer Canada ULC and BioNTech SE today announced that Health Canada has authorized COMIRNATY®, the companies’ COVID-19 vaccine, as a three 3-μg primary series for children 6 months to less than 5 years of age.
The 3-μg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.
“We know many parents in Canada have at heart to provide further protection for their children under 5,” said Fabien Paquette, mRNA Vaccines & Antiviral Portfolio Lead, Pfizer Canada. “With this Health Canada authorization, we have achieved another key milestone in our ongoing effort to help protect families and communities against COVID-19.”
“We are committed to providing access to our COVID-19 vaccine to all age groups,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “As of today, Canadian families have access to an authorized vaccine helping to protect their youngest children against COVID-19.”
Health Canada’s authorization is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to under 5 years of age. In the trial, children received the third 3-μg dose at least two months after the second dose at a time when Omicron was the predominant variant.
Pfizer and BioNTech will begin shipping 3-μg pediatric doses as directed by the Canadian government and public health agencies across the country.
COMIRNATY, also referred to as Pfizer-BioNTech COVID-19 Vaccine, is based on BioNTech’s proprietary mRNA technology. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, the United Kingdom and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
About the Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. The trial evaluated the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 μg each while children under age 5 received three 3-μg doses in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
AUTHORIZED USE IN CANADA
COMIRNATY 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 6 months of age and older. COMIRNATY must be injected intramuscularly only.
About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
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