Health Canada has final data it needs from Moderna to make a decision on vaccine

OTTAWA — Health Canada says it will “soon” be ready to announce if it can authorize a second COVID-19 vaccine after receiving final documents from U.S. biotech firm Moderna over the weekend.

Moderna’s new Canadian general manager — hired just three weeks ago to establish a Canadian office for the company — said Moderna’s team and Health Canada are in constant communication.

“Everybody worked really diligently all weekend,” Patricia Gauthier told The Canadian Press in an interview Monday.

She said the process is following the required course and “we’re hoping for a decision when Health Canada is ready.”

The final documents included data on manufacturing. The Canadian doses of Moderna’s vaccine are being made in Switzerland and sent to Spain for the “fill and finish” process, where six doses will be filled into each vial and the vials packed into freezers for shipping.

As many as 110,000 doses can be transported on a single pallet. Moderna intends to start shipping its vaccine to Canada with 48 hours of approval, with as many as 168,000 doses anticipated before the end of December, and two million by the end of March.

Health Canada approved a vaccine from Pfizer-BioNTech on Dec. 9 and vaccinations with that product began last week. It was about five days from the time the final documents were received until Pfizer got a green light, but Health Canada’s chief medical adviser Dr. Supriya Sharma has said Moderna’s production facilities are new to Health Canada and may take longer to review.

Moderna’s vaccine, which uses similar genetic coding technology to trigger an immune response, is a lot more flexible than Pfizer-BioNTech’s because it can be stored at less extreme temperatures.

Pfizer-BioNTech’s vaccine has to stay frozen between -60 C and -80 C until just before use, while Moderna can be kept stable at only -20 C, and can be at room temperature for almost a month.

Pfizer’s vaccine is being shipped by the company in special thermal boxes packed with dry ice, and only to delivery points in Canada equipped with ultralow temperature freezers.

Moderna will be picked up by FedEx in Europe and shipped in freezers to Toronto where logistics company Innomar Strategies will receive it, run a quality-assurance check, and then repackage it into smaller shipments to be forwarded on to each province.

It will also be the first vaccine shipped to the territories and to remote Indigenous communities.

Gauthier is now helping set up the Canadian division of Moderna, intending to hire a team of people whose first focus will be helping governments in Canada get the vaccine administered.

She says that includes efforts to communicate to Canadians the safety and effectiveness of the vaccine, which uses a novel genetic technology to train the immune system to fight off the virus that causes COVID-19.

This report by The Canadian Press was first published Dec. 21, 2020.

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