Pfizer and BioNTech Receive Health Canada Authorization of COVID-19 Vaccine COMIRNATY in Children Ages 5 Through <12 Years

• With this authorization, COMIRNATY is currently the only COVID-19 vaccine available in Canada for use in this age group
• Authorization represents an important milestone with the potential to help protect school-aged children from COVID-19 infection

KIRKLAND, QC and MAINZ, Germany, Nov. 19, 2021 /CNW/ - Pfizer Canada ULC and BioNTech SE today announced that Health Canada has authorized COMIRNATY, the companies' COVID-19 vaccine for children 5 to under 12 years of age . For this age group, the vaccine is to be administered in a two-dose regimen of 10-μg doses given three weeks  apart. The 10-μg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in Canada for individuals 5 to under 12 years of age. 

"We are very proud to share this news with Canadians today. This is a day so many parents, eager to protect their young children from this virus, have been waiting for," said Fabien Paquette, Vaccines Lead, Pfizer Canada. "With this Health Canada authorization, we have achieved another key milestone in our ongoing effort to help protect families and communities, and to get this disease under control." 

"Today's authorization is supported by clinical data showing a positive benefit risk profile and high vaccine efficacy in children, underlining its potential to address a current public health need," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "As children 5 to 12 years are approaching the end of the year, both in and out of the classroom, our goal is offer a vaccine to help keep them safe and protected. We will continue to work towards broadening the access to our vaccine, also for younger age groups."

Health Canada based its decision on data from a Phase 2/3 randomized, controlled trial that included ~4600  children 5 to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). 

Shipping of 10-μg pediatric doses to Canadian immunization sites in partnership with the Public Health Agency of Canada will begin imminently (ages referred to as 5y to <12y on the vial and 5 years to <12 years on the carton). 

COMIRNATY (also referred to as Pfizer-BioNTech COVID-19 Vaccine), which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, and 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 or ongoing.  

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 5 years 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.

About BioNTech 
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, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de. 

SOURCE Pfizer Canada Inc.