Health Canada authorizes the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent-adapted COVID-19 booster for children 5 to 11 years of age

On December 9, 2022 (TBC), Health Canada authorized the Pfizer-BioNTech Comirnaty bivalent booster that targets the original COVID-19 strain and the Omicron BA.4/BA.5 subvariants for use in children 5 to 11 years of age.

December 9, 2022 | Ottawa, Ontario | Health Canada

Today, Health Canada authorized the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent-adapted booster for use in children 5 to 11 years of age. This is the first bivalent COVID-19 booster authorized for use in this age group that targets the original COVID-19 strain and the Omicron BA.4/BA.5 subvariants.

Health Canada previously authorized this bivalent booster for use in individuals 12 years of age and older on October 7, 2022. While the formulation for children 5 to 11 years of age is the same, the dose is one-third of that authorized for individuals 12 years of age and older.

After a thorough and independent scientific review of the evidence, Health Canada has determined that the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent-adapted booster vaccine for children 5 to 11 years of age is safe and effective and that its benefits outweigh any potential risks.

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 Comirnaty Omicron BA.4/BA.5 bivalent-adapted booster 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.

Contacts

Media Relations
Health Canada
613-957-2983
media@hc-sc.gc.ca