(Ottawa) Health Canada assures that it will be “soon” ready to announce whether it authorizes the second vaccine against COVID-19, after receiving the latest documents from the American company Moderna at the weekend.
Posted on December 21, 2020 at 6:42 p.m.
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Moderna’s new executive director in Canada – hired just three weeks ago to establish this Canadian branch – said the Moderna team was in constant communication with Health Canada. “Everyone has worked very diligently all weekend,” Patricia Gauthier said in an interview with The Canadian Press Monday. She contends that the process is proceeding its normal course.
A spokesperson for Health Canada, Eric Morrissette, said for his part that the documents are reviewed as quickly as possible.
The U.S. Food and Drug Administration (FDA) issued emergency clearance for the Moderna vaccine late last week, making the United States the first country to approve it. This vaccine against COVID-19 is also Moderna’s very first product to be licensed. The company was created about ten years ago to work specifically on messenger RNA technology.
The last documents Health Canada needed related to the manufacturing stage. Canadian doses of Moderna vaccine are manufactured in Switzerland and then shipped to Spain for the “fill and finish” process: six doses are filled into each vial, and the vials are placed in freezers for transport.
Up to 110,000 doses can be transported on a single pallet. Moderna intends to begin shipping its vaccine to Canada within 48 hours of Health Canada approval; up to 168,000 doses are expected to be delivered by the end of December, and two million by the end of March.
Health Canada initially signed a contract to buy 20 million doses from Moderna, but Ottawa exercised an option in early December to purchase 20 million more. According to Mme Gauthier, these 40 million doses will vaccinate two-thirds of the Canadian adult population.
In addition, the contract provides that Canada could purchase 16 million more doses. Sources not authorized to speak publicly have told The Canadian Press that a decision whether or not to purchase these additional doses will likely be announced this week.
Children in 2021
The Moderna vaccine is only recommended for adults over 18 years of age. Mme Gauthier explains that clinical trials in adolescents began earlier this month and that the vaccine will not be tested in young children until 2021.
Health Canada approved Pfizer-BioNTech’s vaccine on December 9, and vaccination began last week. Approximately five days elapsed between the receipt of final manufacturer documents by Health Canada and the green light given to Pfizer. Health Canada’s Chief Medical Advisor, Dr Supriya Sharma, however clarifies that Moderna’s production facilities are new to Health Canada, which may require a little more time before the decision is announced.
Both Pfizer’s and Moderna’s vaccines use messenger RNA technology, which sends a genetic code to human cells to “teach” them how to create an immune response to the SARS-CoV-2 virus, which causes COVID- 19. Both manufacturers claim the vaccines are over 94% effective in preventing infection.
In contrast, Pfizer’s technology requires that the vaccine be stored at very low temperatures – between -60 ° and -80 ° C – until the time of administration, which requires complex shipping processes, ice dryer and freezers outside the standards.
Moderna’s vaccine, meanwhile, can be kept stable at just -20 ° – and it can even be kept at room temperature for almost a month. The company said last week that if necessary, the vaccine could be shipped at temperatures between 2 ° and 8 °.
This means Moderna’s vaccine can be more easily deployed wherever it’s needed, including the North, in remote Indigenous communities, and even inside long-term care homes – no need to move people.
Moderna’s vaccines will be picked up by FedEx in Europe and shipped to freezers in Toronto, where logistics company Innomar Strategies will take possession. Innomar President Guy Payette said his company, the “importer of record,” will perform vaccine quality assurance checks and then repackage smaller shipments to send to provincial and territorial governments.
“We assume that (the decision) is imminent and that we must be ready when the vaccines are approved,” Payette told The Canadian Press.
Mme Gauthier is now helping to set up the Canadian division of Moderna, and plans to hire a team whose primary objective will be to help governments in Canada get the vaccine administered. She adds that her office will also be working to communicate information to Canadians on the safety and effectiveness of the vaccine.
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