Health Canada authorizes first bivalent COVID-19 booster for adults 18 years and older

Statement

September 1, 2022 | Ottawa, ON | Health Canada

Today, Health Canada authorized an adapted version of the Moderna Spikevax COVID-19 vaccine. This vaccine (known as a "bivalent" vaccine) targets the original SARS-CoV-2 virus from 2019 and the Omicron (BA.1) variant, and is authorized for use as a booster dose in individuals 18 years of age or older.

This is the first bivalent COVID-19 vaccine authorized in Canada and marks a milestone in Canada's response to COVID-19.

After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent Moderna Spikevax booster is safe and effective. Clinical trial results showed that a booster dose of the bivalent Moderna Spikevax vaccine triggers a strong immune response against both Omicron (BA.1) and the original SARS-CoV-2 virus strain. It was also found to generate a good immune response against the Omicron BA.4 and BA.5 subvariants, and is expected to extend the durability of protection.

This adapted vaccine has a similar safety profile to the previously approved Moderna Spikevax booster, with the same mild adverse reactions that resolved quickly.

Vaccination continues to be one of the most effective ways to protect families, communities and ourselves against COVID-19. Evidence indicates that the vaccines used in Canada are very effective at preventing severe illness, hospitalization and death from COVID-19. Keeping COVID-19 vaccinations up-to-date, including getting booster doses as recommended, will help protect an individual against serious illness and other complications of COVID-19 infection.

Health Canada has placed terms and conditions on the authorization requiring Moderna to continue providing information to Health Canada on the safety and efficacy of the 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, and will take action if any safety concerns are identified

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

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