Pfizer Canada, BioNTech receive Health Canada approval of LP.8.1 variant adapted COVID-19 vaccine

PFIZER Canada ULC and BioNTech SE “BioNTech” announced on Monday 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.