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 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.”
This is the second COVID-19 vaccine to be approved by Health Canada.
The department approved Pfizer-BioNTech’s vaccine 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.
The Moderna approval means vaccinations can now begin in northern, remote and Indigenous communities, which lack the health care infrastructure to safely store the Pfizer-BioNTech vaccine at ultra-low temperatures.
The storage requirements of the Moderna vaccine are less onerous than those required for Pfizer-BioNTech’s vaccine.
Last week, Prime Minister Justin Trudeau said Canada would receive up to 168,000 doses of the Moderna vaccine before the end of December, and that 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.
Moderna vaccine requires 2 doses
The Moderna 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.
The data showed the vaccine’s effectiveness and safety was consistent across age, sex and ethnicity.
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.
Like the Pfizer-BioNTech vaccine, Massachusetts-based Moderna’s shot requires two doses to achieve maximum immunity.
It uses mRNA technology — a new vaccine 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.