Pfizer and BioNTech's Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster Receives Health Canada Authorization for Children 5 Through <12 Years of Age

• COMIRNATY Original & Omicron BA.4/BA.5 now authorized in Canada as a booster dose for children 5 through <12 years old
• Authorization is based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines as well as data from the companies' original COVID-19 vaccine
• Health Canada's authorization is for a 10-µg booster dose of COMIRNATY Original & Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through <12 years of age

KIRKLAND, QC and MAINZ, Germany, Dec. 9, 2022 /CNW/ - Pfizer Canada ULC and BioNTech SE (NASDAQ: BNTX) ("BioNTech") today announced that Health Canada has authorized COMIRNATY® Original & Omicron BA.4/BA.5 as a 10-μg booster dose for children 5 through <12 years of age. This booster is approved for use at least 6 months after completing the primary course of the companies' original COVID-19 vaccine (COMIRNATY).

The authorization of the bivalent COVID-19 vaccine for children 5 through <12 years of age is supported by safety and immunogenicity data from the companies' original COVID-19 vaccine, data from the companies' 30-µg Omicron BA.1-adapted bivalent vaccine, manufacturing data from the companies' 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and non-clinical and clinical data from the companies' 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine.

The Pfizer-BioNTech COVID-19 Vaccines are based on BioNTech's proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Original and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, 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 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, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

Pfizer Contacts:

Pfizer Canada Corporate Affairs

1-866-9-PFIZER (1 866 973-4937)

corporate.affairs.canada@pfizer.com 

BioNTech Contacts:

Media Relations

Jasmina Alatovic

+49 (0)6131 9084 1513

Media@biontech.de 

Investor Relations:

Sylke Maas, Ph.D.

+49 (0)6131 9084 1074

Investors@biontech.de 

SOURCE Pfizer Canada ULC