Health Canada Authorizes Pfizer and BioNTech's Omicron XFG-Adapted COVID-19 Vaccine

• 2026-2027 COVID-19 vaccine formula targets the XFG variant, in line with Public Health recommendations to more closely match contemporary circulating variants
• The vaccine will be available through various distribution channels in the coming days and weeks

KIRKLAND, QC, Sept. 17, 2026 /CNW/ -- Pfizer Canada ULC and BioNTech SE today announced that Health Canada has authorized the XFG variant-adapted COMIRNATY® for active immunization of individuals aged 6 months and older against COVID-19. The updated COMIRNATY® vaccine targets the Omicron XFG lineage, in alignment with public health recommendations for the 2026-2027 season.

The Health Canada 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 effectiveness of COMIRNATY ®.

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 the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, other countries, and the holder of emergency use authorizations or equivalents in other countries.

COMIRNATY®, including its updated formulation, may not protect all individuals and should be used per the guidelines in the updated Canadian Product Monograph.

"Today's announcement of the updated COMIRNATY adapted XFG vaccine provides Canadians and communities with an important protection tool as the virus continues to evolve," said Dr. Sean Gardiner, Country Medical Lead, Pfizer Canada. "Vaccination remains one of our most effective ways to help reduce the risks of serious illness from COVID-19, and this milestone underscores our commitment to bringing forward the latest science to support public health."

Commitment to Availability and Access

Pfizer Canada has secured sufficient inventory to fulfill all contractual commitments with federal and provincial vaccination programs and continues to carefully manage inventory and distribution to support equitable access across Canada. The vaccine will be available through various distribution channels in the coming days and weeks.

Individuals who are not eligible to receive COMIRNATY ® through a publicly funded vaccination program may still be able to purchase the vaccine through participating pharmacies. They may consult their provincial public health authorities for more information on eligibility criteria.

About COMIRNATY® in Canada

COMIRNATY® is an mRNA vaccine approved by Health Canada for active immunization against COVID-19 caused by SARS-CoV-2. It is indicated for individuals 6 months of age and older and uses mRNA technology to generate an immune response against the spike protein of the SARS-CoV-2 virus. The vaccine's formulations continue to evolve to address current variants in circulation following public health recommendations. As with any vaccine, COMIRNATY may not protect all vaccinated individuals. People in Canada should consult their healthcare professional to determine if this vaccine is appropriate for them.

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, visit www.pfizer.ca or follow us on LinkedIn, Facebook, and Instagram.

About BioNTech

BioNTech is a global next-generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

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

For more information:

Pfizer Canada:
Pfizer Canada Communications:
[e-mail]

BioNTech:
Media Relations
Jasmina Alatovic
[email protected]

Investor Relations
Douglas Maffei
[email protected]

SOURCE Pfizer Canada