Canada obtains final data needed to make Moderna vaccine decision

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Moderna’s COVID-19 vaccine rolls out across the U.S.
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Canadians could see the highly anticipated Moderna vaccine approved for use “in the coming weeks,” as Health Canada officials now have the final documents needed to complete its review.

Still, Health Canada said on Friday that it cannot provide a “definite timeline” for the review to be finished, despite the United States’ recent approval of the vaccine.

The United States approved the emergency use of the Moderna vaccine on Friday as cases continue to soar within the country’s borders. Health Canada said it is “working closely” with international regulators, including the U.S. Food and Drug Administration, to exchange information on the vaccine candidates undergoing review.

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Last Tuesday, the chief medical adviser at Health Canada said things “look positive” with respect to the Moderna vaccine, and that Canada was on track to make its decision about the vaccine very soon. She noted that the only outstanding information Canada needed was the data on manufacturing plants – documents that were supposed to be delivered by the end of last week.

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On Friday, Health Canada said in a press release that it was still awaiting the arrival of those documents.

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“There is still information and data to be provided by Moderna for review,” read the Friday press release, which was sent to reporters again on Monday morning.

“Health Canada cannot provide a definite timeline for the completion of the review at this time, although it is expected to be completed in the coming weeks.”

Moderna’s new Canadian general manager told The Canadian Press in a Monday interview that “everybody worked really diligently all weekend,” as the documents were delivered to Canadian officials.

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

When Health Canada obtained all the data from Pfizer on its vaccine candidate, it took just five days for the vaccine to be approved. But Canada was more familiar with Pfizer’s manufacturing facilities, so a review of Moderna’s facilities – which Canada has never reviewed before – may take a bit longer.

Once that approval comes down, Trudeau said doses will begin to arrive within 48 hours – and Canada has inked a deal that would see 168,000 Moderna vaccine doses arriving before the end of the month.

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Moderna doesn’t require the same level of ultra-cold storage as the Pfizer vaccine, making its approval all the more important for Canadians living in remote regions. Because of these logistical struggles, Canada’s three territories have been promised enough Moderna vaccine doses to inoculate 75 per cent of their residents.

As they await the vaccine’s approval and arrival, however, the virus continues to spread. And while Nunavut had remained untouched by the virus until November, the territory reported its first coronavirus deaths on Sunday.

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Once the Moderna vaccine is approved, Canada will be firmly placed on a track towards attaining its projected vaccination timeline. While Canada has signed purchase agreements with multiple vaccine manufacturers, the agreements with Moderna and Pfizer alone should see 60 million doses arrive in Canada by September.

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That’s enough to vaccine 30 million Canadians, just eight million shy of the entire population.

Meanwhile, Health Canada says it’s working as fast as it can to ensure the Moderna vaccine doses – and any other vaccine candidates – are safe for use in Canada.

“Health Canada is working hard to give Canadians access to COVID-19 vaccines as quickly as possible and will not compromise its safety, efficacy and quality standards,” Health Canada wrote in its press release.

“Protecting the health and safety of Canadians is a top priority.”

With files from The Canadian Press

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