Health Canada authorizes COVID-19 vaccine booster targeting the Omicron BA.4/BA.5 subvariants

October 7, 2022 | Ottawa, ON | Health Canada

Today, Health Canada authorized a second bivalent COVID-19 vaccine booster. This is an updated version of the Pfizer-BioNTech Comirnaty COVID-19 vaccine, targeting the Omicron BA.4 and BA.5 subvariants, and is authorized for use as a booster dose in individuals 12 years of age and older.

Health Canada has authorized this vaccine after a thorough and independent scientific review of the evidence that has determined that this booster is safe and effective. The booster is expected to trigger a strong immune response against both the original SARS-CoV-2 strain as well as the Omicron BA.4/BA.5 subvariants. It is expected to have a similar safety profile to the original Pfizer-BioNTech Comirnaty vaccine, with mostly mild side effects.

Vaccination continues to be one of the most effective tools to protect families, communities and ourselves against COVID-19. Evidence indicates that all mRNA COVID-19 vaccines authorized for use in Canada continue to be very effective at preventing severe illness, hospitalization and death from COVID-19. Keeping up-to-date with COVID-19 vaccines, including getting booster doses as recommended, will help protect individuals against serious illness and other complications from COVID-19 infection.

Health Canada has placed terms and conditions on the authorization, requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the BA.4/BA.5 bivalent vaccine. This will provide the Department with more data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential new safety signals.

Health Canada and the Public Health Agency of Canada will continue to closely monitor the safety of this vaccine in Canada and internationally.