Statement on the U.K. authorization of the AstraZeneca's COVID-19 vaccine

Statement

December 30, 2020Ottawa, ONHealth Canada

Health Canada is aware that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an authorization for a COVID-19 vaccine manufactured by AstraZeneca.

Health Canada has been reviewing AstraZeneca's vaccine since it was submitted on October 1, 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 AstraZeneca for review. Health Canada cannot provide a definite timeline for the completion of the review at this time.

The Department is working closely with international regulators, including the U.K. MHRA, 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 without compromising its safety, efficacy and quality standards. Protecting the health and safety of Canadians is a top priority.

On December 9, Health Canada authorized the Pfizer-BioNTech COVID-19 vaccine. Health Canada subsequently authorized a second COVID-19 vaccine, on December 23, manufactured by Moderna.

Contacts

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

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