Pfizer Canada and BioNTech Receive Health Canada Approval of LP.8.1 Variant Adapted COVID-19 Vaccine

• LP.8.1 variant adapted COVID-19 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.

KIRKLAND, QC, Aug. 18, 2025 /CNW/ - Pfizer Canada ULC and BioNTech SE (Nasdaq: BNTX) "BioNTech" announced today that Health Canada has authorized the LP.8.1 variant adapted COMIRNATY^® COVID-19 vaccine for individuals aged 6 months and older. The updated COMIRNATY^® vaccine targets the Omicron LP.8.1 variant, one of the most recently circulating SARS-CoV-2 lineages.

This season's Pfizer and BioNTech COVID-19 vaccine will be available in pharmacies across the country in the fall. The public program operates according to the eligibility criteria determined by each province. If an individual meets these criteria, they will be eligible to receive the vaccine for free.

Efforts are ongoing in collaboration with private insurers and payers to streamline reimbursement processes within the private sector, for those who do not meet public program requirements.

Individuals are encouraged to consult their provincial or territorial health authorities for comprehensive details.

Health Canada's approval is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer and BioNTech COVID-19 vaccines.

The COVID-19 vaccines 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 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 investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and 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 Bristol Myers Squibb, Duality Biologics, 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 Inc.

CONTACTS: Pfizer: Pfizer Canada Corporate Affairs, 1-866-9-PFIZER (1 866 973-4937), [email protected]; BioNTech: Media Relations, Jasmina Alatovic, [email protected]; Investor Relations, Douglas Maffei, PhD, [email protected]