(The Canadian Press)

By Justin Goulet

Moderna’s COVID-19 vaccine authorized by Health Canada

Dec 23, 2020 | 8:55 AM

OTTAWA, ON – Another COVID-19 vaccine has been approved by Health Canada.

The agency has authorized Moderna’s vaccine, the second authorized in the country following Pfizer-BioNTech’s vaccine.

Health Canada received Moderna’s submission on October 12, 2020 and following a thorough, independent review of evidence provided, the agency has determined that the vaccine meets stringent safety, efficacy and quality requirements.

The federal government noted that the different storage and handling requirements of the Moderna vaccine mean that it can be distributed to isolated and remote communities, including the territories.

Health Canada is publishing a number of documents related to its decision, including a “high-level summary of the evidence” that was reviewed to support the authorization of the vaccine.

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More details will be made available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.

Health Canada and the Public Health Agency of Canada will monitor the safety of the vaccine once it hits the market. The terms and conditions of Moderna’s vaccine authorization require the manufacturer to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure the benefits of the vaccine continue to be demonstrated through market use.

Additionally, the support the safe use of the vaccine, the National Advisory Committee on Immunization (NACI) will update its recommendations on the use of COVID-19 vaccines to inform federal, provincial and territorial immunization programs.

The vaccine is indicated for use in people who are 18-years or older. Moderna is currently doing studies in children from 12 years of age and older. This indication could be revised in the future to include children, if the data from Moderna’s studies support it.

The vaccine was authorized under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.