Pfizer and BioNTech achieve Health Canada authorization for their vaccine to combat COVID-19

PfizerPfizer Canada and BioNTech SE (Nasdaq: BNTX) today announced that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations (NACI). BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.

"Today's decision from Health Canada is a historic moment in our collective fight against the COVID-19 pandemic and is a major step towards returning to normalcy in Canada. I'd like to acknowledge the tremendous efforts of Pfizer and BioNTech colleagues around the world who have contributed to the development of this vaccine," says Cole Pinnow, President, Pfizer Canada. "We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians."

"It is encouraging to see that our mRNA vaccine is now authorized in Canada. Following U.K. and Bahrain, it is the third country to approve use of our vaccine within a week," said Sean Marett, BioNTech's Chief Business and Chief Commercial Officer. "Together with our partner Pfizer, we are ready to ship the vaccines to Canada as soon as we receive the green light from the regulatory authority to start with the distribution."

Health Canada's decision is based on data that was filed through the rolling submission regulatory pathway, and includes data from the Phase 2/3 clinical trial, which began recruiting in late-July 2020, and enrolled approximately 44,000 people across approximately 150 sites in multiple countries.

Pfizer Canada and BioNTech will supply the Government of Canada a minimum of 20 million doses (and up to 76 million doses) of the vaccine through 2021.

Manufacturing and Delivery Capabilities

Pfizer and BioNTech continue to work in collaboration with governments and health authorities around the world to help ensure BNT162b2 can reach those most in need as quickly as possible, subject to country authorization or approval. The companies are taking a phased approach to quickly scale, manufacture and distribute large quantities of the vaccine at high quality, complementing the mRNA manufacturing expertise that BioNTech has gained over almost a decade. Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need. BioNTech will hold the regulatory approvals in the U.K. and Canada, and, if granted, in the U.S., the EU and other countries. Pfizer will have the marketing and distribution rights worldwide with the exception of China, Germany and Turkey.

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.

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.

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