Health Canada begins first authorization review of a COVID-19 vaccine submission, Report

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Health Canada begins first authorization review of a COVID-19 vaccine submission, Report
Health Canada begins first authorization review of a COVID-19 vaccine submission, Report

Yesterday, Health Canada received its first submission for authorization of a COVID-19 vaccine developed by AstraZeneca in partnership with the University of Oxford. This is an important step for Canada in its response to the pandemic, but it is just one step on the road to obtaining safe and effective vaccines.

Health Canada will be doing a rolling review of AstraZeneca’s vaccine data to make sure it meets the Department’s rigorous safety and efficacy requirements.

In September 2020, the Minister of Health signed an Interim Order allowing companies to submit safety and efficacy data and information as they become available. Often referred to as a rolling review, this allows the Department to start its review right away, as information continues to come in, to speed up the review process. The Department will not make a decision on whether to authorize this or any other vaccine until it has received the necessary evidence to support its safety, efficacy and quality. Following the authorization of any vaccine submission, Health Canada will publish the evidence it reviewed in making its decision for transparency.

The Department will continue to work closely with international regulators to ensure aligned approaches and high standards. This collaboration will make our review more efficient and robust.

Earlier this month, the Prime Minister announced that Canada has signed an agreement with AstraZeneca to buy 20 million doses of its COVID-19 vaccine, should that vaccine successfully complete clinical trials and be authorized by Health Canada.

The Department is in active discussions with several vaccine manufacturers and expects to receive more COVID-19 vaccine submissions for authorization in the coming months.

Notice to Media: Health Canada’s expedited regulatory process is complex and multi-faceted. The Department intends to host a technical briefing for media in the near future to provide more information on its processes.

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