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Pfizer and BioNTech Achieve Health Canada Authorization for COVID-19 Vaccine Booster

09/11/21

KIRKLAND, QUEBEC, CANADA and MAINZ, GERMANY, November 9, 2021—Pfizer Canada ULC and BioNTech SE today announced that Health Canada has granted authorization for the administration of COMIRNATY® (Pfizer-BioNTech COVID-19 Vaccine) as a booster dose at least six months after the second dose in individuals 18 years of age and older.

Health Canada’s authorization is based primarily on the clinical trial data filed by Pfizer and BioNTech. The data is from the clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY. The level of neutralizing antibody titers elicited by a booster dose of the vaccine was evaluated against SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, and compared with the levels observed after the two-dose primary series. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY.

In Canada, COMIRNATY is currently approved for use in individuals aged 12 and older. Canadians may find more information about the vaccine at www.pfizerbiontechvaccine.ca. Canadian Health Care Professionals can visit www.cvdvaccine.ca for more information.

COMIRNATY, 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.

About Pfizer Canada

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care 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, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

For further information

Pfizer Canada:

Corporate Affairs Canada

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

[email protected]

 

BioNTech:

Media Relations

+49 (0)6131 9084 1513

[email protected]