BRIEF—Canada to start rolling review of a COVID-19 vaccine submission

Hot on the heels of a planned rolling review of AstraZeneca’s COVID-19 vaccine candidate AZD1222 by the European Medicines Agency, medicines regulator Health Canada says it has received a submission from the UK-based drug major’s product being developed 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, ie, a rolling review, which allows the Department to start its review right away, as information continues to come in, to speed up the review process.

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.