Statement on the U.S. authorization of the Moderna COVID-19 vaccine

December 18, 2020 | Ottawa, ON | Health Canada

Health Canada is aware that the U.S. Food and Drug Administration has issued an emergency use authorization for a COVID-19 vaccine manufactured by Moderna.

Health Canada has been reviewing Moderna's vaccine since it was submitted on October 12, 2020, and is expediting the review of COVID-19 vaccines. This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer. Rolling submissions allow for shorter review times without compromising safety, efficacy and quality, as part of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, which was signed on September 16, 2020.

There is still information and data to be provided by Moderna for review. Health Canada cannot provide a definite timeline for the completion of the review at this time, although it is expected to be completed in the coming weeks.

The Department is working closely with international regulators, including the U.S. Food and Drug Administration, to share information and data on vaccines currently under review.

Health Canada is working hard to give Canadians access to COVID-19 vaccines as quickly as possible and will not compromise its safety, efficacy and quality standards. Protecting the health and safety of Canadians is a top priority.