Pfizer Canada and BioNTech Receive Health Canada Approval of Omicron KP.2 Variant Adapted COVID-19 Vaccine

• Omicron KP.2 variant adapted vaccine COMIRNATY is now authorized in Canada for individuals 6 months of age and older. It is expected to be available in Canada in the coming weeks.
• The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage.

KIRKLAND, QC, Sept. 24, 2024 /CNW/ - Pfizer Canada ULC and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced today that Health Canada has authorized the KP.2 variant adapted COMIRNATY^® COVID-19 vaccine for ages 6 months and older. The updated COMIRNATY^® vaccine targets the Omicron KP.2 variant, one of the most recently circulating SARS-CoV-2 lineages.

The adapted COVID-19 vaccine will be available in Canada as a single dose for individuals 5 years of age and older, regardless of prior COVID-19 vaccination history. For children 6 months through 4 years of age, COMIRNATY^® is authorized for administration as a three-dose series in those without a history of completion of a COVID-19 primary vaccination course, or as a single dose for those with a history of completion of a COVID-19 primary vaccination course.

The newly formulated vaccine will be available in pharmacies and vaccination centers across the country in the fall. Each province and territory will have its own pathway for accessing the vaccine, and individuals are encouraged to refer to their provincial/territorial authorities for more information.

The COVID-19 Vaccines (COMIRNATY^®) by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines 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.

About Pfizer Canada

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, X, Instagram or YouTube.

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech 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 (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as 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 and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.

For more information, please visit www.BioNTech.com.

SOURCE Pfizer Canada

CONTACTS: Pfizer: Pfizer Canada Corporate Affairs, 1-866-9-PFIZER (1 866 973-4937), [email protected]; BioNTech: Media Relations, Jasmina Alatovic, [phone], [email protected]; Investor Relations, Victoria Meissner, M.D., [email protected]