Health Canada authorizes second bivalent COVID-19 booster targeting the Omicron BA.4/5 variants

On November 3, 2022, 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.4/BA.5) subvariants, and is authorized for use as a booster dose in adults 18 years of age or older.

November 3, 2022 | Ottawa, ON | Health Canada

Today, Health Canada authorized an adapted version of the Moderna Spikevax COVID-19 vaccine that targets the Omicron BA.4/BA.5 subvariants. It is authorized for use as a booster dose in individuals 18 years of age or older.

After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent Moderna Spikevax 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.

This adapted vaccine has a similar safety profile to the previously approved Moderna Spikevax boosters, 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.

Related Links

Moderna vaccine product page

COVID-19 vaccines and treatments portal

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