Health Canada authorizes Pfizer-BioNTech COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant


September 28, 2023 | Ottawa, ON | Health Canada

Health Canada has authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant for individuals six months of age and older.

Health Canada received Pfizer-BioNTech's submission on June 29, 2023. After a thorough and independent review of the evidence, Health Canada has determined that the vaccine meets the Department's stringent safety, efficacy and quality requirements.

As per the product label, the vaccine is authorized as a one-dose vaccine for individuals five years of age and older, regardless of their COVID-19 vaccination history. Infants and children between six months and less than five years of age, who have not previously received a complete COVID-19 primary series should receive three doses. If they have completed a primary series, they should receive one dose.

Earlier this month, Health Canada authorized Moderna's COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant, and Health Canada is currently reviewing a submission from Novavax for its COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant for people 12 years of age and older. This submission is being reviewed on a priority basis by dedicated scientific teams.

The National Advisory Committee on Immunization (NACI) is evaluating COVID-19 vaccine options and schedules, with consideration of age and other risk factors for vaccinated and unvaccinated individuals, and is anticipated to provide guidance in the coming months.

Canada will have ample supply of the new formulation of mRNA vaccines available in fall 2023.

Vaccination continues to be one of the most effective ways to protect ourselves against COVID-19. Evidence indicates that vaccines approved for use in Canada are effective at preventing severe illness, hospitalization and death from COVID-19.

For more information on COVID-19 vaccines, visit our website.


Media Relations
Health Canada

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