Health Canada in “Final Stages” of AstraZeneca COVID-19 Vaccine Review

Health Canada is in its “final stages” of reviewing the AstraZeneca COVID-19 vaccine candidate, according to the agency’s senior medical adviser Dr. Supriya Sharma.

On Tuesday during a technical briefing, Sharma said that Health Canada is currently going back and forth with the pharmaceutical company about what information the label will include.

“That’s what we’re in the process of doing right now,” she said, adding that this process can take “some time” before finalizing the review, which has been conducted in collaboration with the European Medicines Agency.

Health Canada’s regulatory experts have been assessing the submission from AstraZeneca and Oxford University for safety and efficacy since Oct. 1, 2020. It’s a two-dose vaccine, which several other nations have approved for use, including Britain, Australia, and South Africa.

Sharma said that the review of the AstraZeneca vaccine has been more “complicated” due in part to the way the clinical trials were set up, noting that there is a trial ongoing in the United States.

As well, in recent days and weeks questions have been raised about the efficacy of the vaccine in certain circumstances.

South Africa, for example, suspended a plan to vaccinate AstraZeneca to health workers after clinical trials showed it was less effective against the dominant variant strain in the country.

France has also not recommended the AstraZeneca vaccine be given to people over 65, citing a lack of data.

Sharma said that while this information is taken into account, it isn’t delaying Canada’s process.

The federal government has been aiming to have shipments of any newly-approved vaccines arrive in Canada as quickly as possible once Health Canada gives them the green light.

In the case of AstraZeneca, it’s possible that up to 500,000 doses of its vaccine could land in Canada before the end of March, according to Procurement Minister Anita Anand.

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