Health Canada approves use of AstraZeneca’s COVID-19 vaccine

Health Canada has approved use of the COVID-19 vaccine from AstraZeneca, clearing the way for millions of more inoculations in Canada.

Canada’s regulatory experts had been assessing the submission from AstraZeneca and Oxford University for safety and efficacy since October, and announced their approval Friday morning.

“AstraZeneca COVID-19 Vaccine is indicated for active immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019,” reads their website.

“The efficacy of the vaccine was estimated to be 62.1 per cent. Overall, there are no important safety concerns and the vaccine was well tolerated by participants.”

Canada has secured access to 20 million doses of the AstraZeneca vaccine.

Some jurisdictions, notably France, have restricted the vaccine to people under the age of 65 despite the World Health Organization’s insistence that the product is safe and effective for all age groups. Health Canada said it has no immediate safety concerns for those 65 and older.

‘Potential benefit’

The regulator said the clinical trial results “were too limited to allow a reliable estimate of vaccine efficacy in individuals 65 years of age and older.”

“Efficacy in individuals 65 years of age and older is supported by immunogenicity data, emerging real world evidence and post-market experience in regions where the vaccine has been deployed, which suggest at this point in time a potential benefit and no safety concerns,” said the approval.

“Efficacy in this age group will be updated as additional data becomes available from currently ongoing trials.”

Health officials are expected to give a technical briefing on the approval at 10 a.m.

Prime Minister Justin Trudeau, members of his cabinet along with Chief Public Health Officer Dr. Theresa Tam and her deputy Dr. Howard Njoo will give an update at 11:30 a.m. ET. CBC News will carry it live.

Regulator still reviewing 2 other vaccine candidates 

Earlier this week, Dr. Supriya Sharma, Health Canada’s chief medical adviser, told the House of Commons health committee that the regulator has received all the necessary scientific information from the company but was still looking into questions about labelling and the product monograph — the information disseminated by Health Canada to medical professionals about how and when a vaccine should be administered and in what groups.

Health Canada has approved the Pfizer and Moderna vaccines, which are already being rolled out in Canada.

Unlike those two shots, which are based on mRNA technology, the AstraZeneca uses more conventional viral vector technology.

Health Canada is reviewing two other vaccines: one from Johnson & Johnson and another from Novavax.

Other countries — notably Australia, the European Union and the United Kingdom —  have already authorized AstraZeneca for use in their jurisdictions.

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