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

• COMIRNATY Original & Omicron BA.4/BA.5 now authorized in Canada as a booster dose for individuals 12 years of age and older
• Authorization is based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines as well as data from the Monovalent ("original" vaccine)
• COMIRNATY Original & Omicron BA.4/BA.5 combines 15-?g of mRNA encoding the spike protein of the wild-type of SARS-CoV-2 and 15-?g of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants

KIRKLAND, QUEBEC and MAINZ, GERMANY, Oct. 7, 2022 /CNW/ - Pfizer Canada ULC and BioNTech SE today announced that Health Canada has authorized COMIRNATY Original & Omicron BA.4/BA.5 as a 30-?g booster dose for individuals ages 12 years and older. An application for an Omicron BA.4/BA.5-adapted bivalent vaccine for children 5 through 11 years of age is also being planned for submission to Health Canada for review.

The authorization of COMIRNATY Original & Omicron BA.4/BA.5 is based on clinical data from Pfizer and BioNTech's Monovalent ("original" vaccine), Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. A clinical study investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is currently underway. This data will be provided to the authorities in the coming months.

Pfizer and BioNTech's bivalent COVID-19 vaccine contains 15-?g of mRNA encoding the spike protein of the wild-type of SARS-CoV-2, and 15-?g of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 variants contain identical spike protein amino acid sequences, both can be targeted with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.

"As we head into another fall and winter with COVID-19, we are pleased to offer Canadians our Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine," said Fabien Paquette, mRNA Vaccines & Antiviral Portfolio Lead, Pfizer Canada. "This is another important milestone in our ongoing efforts to provide protection against this virus. Pfizer will be making significant volumes of the vaccine available in the coming days."

"Today's approval allows us to make our Omicron BA.4/BA.5-adapted bivalent vaccine available to the people in Canada to support the continued vaccination program in advance of the winter season," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "The bivalent BA.4/BA.5 vaccine aims to provide broader immunization against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern. It marks a further milestone in addressing this continuously evolving virus."

COMIRNATY and COMIRNATY Original & Omicron BA.4/BA.5, which are based on BioNTech's proprietary mRNA technology, were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2- in Canada, the United States, the European Union, the United Kingdom 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.

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.

Pfizer Contacts:
Pfizer Canada Corporate Affairs
1-866-9-PFIZER (1 866 973-4937)
[email protected]

BioNTech Contacts:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
[email protected]

Investor Relations:
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
[email protected]

SOURCE Pfizer Canada ULC