Health Canada approves Moderna COVID-19 vaccine

Health Canada has approved Moderna’s COVID-19 vaccine for use in this country, clearing the way for thousands of doses to arrive by month’s end.

The federal department announced the approval on Wednesday after completing a review of the Massachusetts-based biotechnology company’s clinical trial data.

“The data provided supports favourably the efficacy of the Moderna COVID-19 Vaccine as well as its safety,” Health Canada said in a notice authorizing use of the vaccine for people over the age of 18.

“There were no important safety issues identified and no life-threatening adverse events (AEs) or deaths related to the vaccine.”

Moderna’s is the second COVID-19 vaccine to be approved by Health Canada.

The department authorized a vaccine made by U.S. pharmaceutical giant Pfizer and German biotechnology firm BioNTech on Dec. 9, and it’s already being administered in parts of the country to people in high-priority groups, including health-care workers as well as long-term care workers and residents.

Moderna vaccine easier to store

The Moderna approval means vaccinations can now begin in northern, remote and Indigenous communities, which haven’t seen any doses of the Pfizer-BioNTech vaccine because they lack the freezer equipment necessary to safely store it at -70 C.

Moderna’s vaccine, by contrast, can be stored at regular freezer temperatures.

“This authorization is a critical step in ensuring a COVID-19 vaccine is available to all Canadians in all parts of the country,” Dr. Supriya Sharma said at a technical briefing in Ottawa on Wednesday. 

“Since many Canadians live outside major urban areas, this vaccine can be used in communities that haven’t had access to covid 19-vaccines to date.”

Sharma said Canada would receive up to 168,000 doses of the Moderna vaccine before the end of December.

Last week, Prime Minister Justin Trudeau said deliveries would begin within 48 hours of Health Canada’s authorization.

Trudeau is expected to address the approval at a news conference today at 1 p.m. Shortly after, government officials and public health officials will provide details on plans to distribute the vaccine. CBC News will carry those events live.

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Clinical trial results 

Health Canada granted authorization to Moderna’s vaccine after analyzing data from a Phase 3 trial involved over 30,000 individuals in the U.S., half of whom received the vaccine while the other half received a placebo. 

The vaccine was found to be 94.1 per cent effective in participants with no prior COVID-19 infection, Health Canada said, and 86.5 per cent effective in people over the age of 65. 

Data showed the vaccine’s effectiveness and safety was consistent across age, sex and ethnicity.

The storage requirements of the Moderna vaccine, just approved by Health Canada, are less onerous than those required for Pfizer-BioNTech’s vaccine. (Dado Ruvic/Reuters)

During the trial, 30 people in the placebo group experienced severe cases of COVID-19, compared to none from the vaccine group, Health Canada said.

Health Canada warned people shouldn’t take the vaccine if they are allergic to any of its ingredients, or if they currently have symptoms of COVID-19.

The vaccine is not yet recommended for use on children as tests on adolescents only began in December and tests on children younger than 12 won’t begin until next year.

Health Canada said in a statement that Moderna will have to continue to provide information to the regulator on the safety of the vaccine.

Moderna vaccine requires 2 doses

Like the Pfizer-BioNTech vaccine, Moderna’s shot requires two doses to achieve maximum immunity.

It uses mRNA technology — a technology that directs cells to produce proteins that trigger an immune response to prevent or fight the virus that causes COVID-19.

The two doses should be taken one month apart.

In August, Canada placed an order for 20 million doses of the Moderna product.

Earlier this month, Procurement Minister Anita Anand announced the government would exercise its contractual option for 20 million more shots in 2021. Canada could still buy up to another 16 million doses.

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