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

OTTAWA, ON, Nov. 3, 2022 /CNW/ - Today, Health Canada authorized an adapted version of the Moderna Spikevax COVID-19 vaccine that targets the Omicron BA.4/BA.5 subvariants.

Metadata

Provider:

PR Newswire

Retrieved on:

Thursday, November 3, 2022

Information

Tags:

COVID-19, Clinical trial, Health Canada, Vaccine, Death, Hospital, Public Health Agency, Vaccination, Department, Safety, Public Health Agency of Canada, Severe acute respiratory syndrome coronavirus 2, Omicron

Geotags:

ONTARIO, CANADA

Organisation:

HEALTH CANADA, GOVERNMENT OF CANADA

Summary

Key Points:

OTTAWA, ON, Nov. 3, 2022 /CNW/ - Today, Health Canada authorized an adapted version of the Moderna Spikevax COVID-19 vaccine that targets the Omicron BA.4/BA.5 subvariants.
After a thorough and independent scientific review of the evidence, Health Canada has determined that the bivalent Moderna Spikevax booster is safe and effective.
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.
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.

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

OTTAWA, ON, Nov. 3, 2022 /CNW/ - 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. Clinical trial results showed that a booster dose of the bivalent Moderna Spikevax vaccine triggers a strong immune response against both Omicron (BA.4/BA.5) and the original SARS-CoV-2 virus strains.

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.

SOURCE Health Canada