A vial of Moderna’s COVID-19 vaccine is seen at Hartford Hospital, Monday, Dec. 21, 2020, in Hartford, Conn. THE CANADIAN PRESS/AP /Jessica Hill

A vial of Moderna’s COVID-19 vaccine is seen at Hartford Hospital, Monday, Dec. 21, 2020, in Hartford, Conn. THE CANADIAN PRESS/AP /Jessica Hill

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

Documents being reviewed as fast as possible

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.”

Eric Morrissette, a spokesman for Health Canada, said the documents are being reviewed as fast as possible.

The U.S. Food and Drug Administration issued an emergency authorization for the Moderna vaccine late last week, becoming the first country to approve it. The COVID-19 vaccine is also the first Moderna product ever authorized for use.

The company was established about a decade ago specifically to work on messenger RNA technology, or mRNA.

The final documents Health Canada needed 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 within 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 initially contracted to buy 20 million doses from Moderna, but exercised an option to buy 20 million more earlier this month, for a total of 40 million.

Gauthier said that is enough to vaccinate two-thirds of the Canadian adult population, and that there are still 16 million doses remaining for Canada to potentially buy as part of the contract. Sources not authorized to speak on the matter tell The Canadian Press a decision on whether to buy those extra doses will likely be announced this week.

The Moderna vaccine is only recommended for use on adults over the age of 18. Gauthier said clinical trials on adolescents began earlier this month and the vaccine will be tested on younger children in 2021.

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.

The vaccines from Pfizer and Moderna both use messenger RNA technology, which sends a genetic code to human cells to train them to create an immune response to COVID-19. Both drugmakers say the vaccines were more than 94 per cent effective at preventing infection.

But Pfizer’s technology requires the vaccine to be kept frozen between -60 C and -80 C until just before use, requiring complex shipping processes, dry ice and ultra-low-temperature freezers.

Moderna’s product can be kept stable at only -20 C and can be at room temperature for almost a month. The company said last week that where it is necessary, the vaccine can be shipped at temperatures between 2 C and 8 C.

It means Moderna’s vaccine can be more easily deployed wherever it is needed, including to the North, remote Indigenous communities and long-term care homes.

Moderna will be picked up by FedEx in Europe and shipped in freezers to Toronto, where logistics company Innomar Strategies will take possession of it.

Innomar president Guy Payette said the company will be the importer of record, run a quality assurance check on the vaccines, and then repackage the shipments into smaller amounts to be forwarded to provincial and territorial governments.

“We’re working on the assumption that it is imminent, and that we need to be ready when the vaccines get approved,” Payette told The Canadian Press.

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.

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

Coronavirusvaccines

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Many students and staff at St. Joseph High School are in COVID-19 quarantine. (File photo by JeffAdvocate staff)
St. Joseph High School students return to at-home learning today

Majority of students under COVID-19 quarantine

President Donald Trump speaks with reporters as he walks to board Marine One on the South Lawn of the White House, Wednesday, Jan. 20, 2021, in Washington. Trump is en route to his Mar-a-Lago Florida Resort. (AP Photo/Alex Brandon)
Supreme Court ends Trump emoluments lawsuits

Outcome leaves no judicial opinions on the books

Health-care workers wait in line at a UHN COVID-19 vaccine clinic in Toronto on January 7, 2021. THE CANADIAN PRESS/Nathan Denette
Military to support vaccination efforts in northern Ontario Indigenous communities

Canadian Armed Forces to support vaccine efforts in 32 communities of the Nishnawbe Aski Nation

Terrance Josephson of the Princeton Posse, at left, and Tyson Conroy of the Summerland Steam clash during a Junior B hockey game at the Summerland Arena in the early spring of 2020. (John Arendt - Summerland Review)
QUIZ: How much do you know about hockey?

Test your knowledge of Canada’s national winter sport

A Shell logo is seen at a petrol station in London on January 20, 2016. THE CANADIAN PRESS/AP, Kirsty Wigglesworth
Shell buys European electric car charging firm ubitricity

Experts say easier access to charging facilities key to successful rollout of electric vehicles

FILE— In this Feb. 23, 2019, file photo, Vashti Cunningham poses for photographers after winning the women’s high jump final at the USA Track & Field Indoor Championships in New York. Cunningham is one of the athletes who will be competing in the American Track League, which opens a four-week-long series on Sunday, Jan. 24, 2021 in an indoor setting at the University of Arkansas. (AP Photo/Julio Cortez. File)
Back on track: Competing, not cash, lures big names to meet

American Track League begins a four-week indoor series at the University of Arkansas

Eugene Levy, left, and his son Dan Levy accept the Best Comedy Series Award for ‘“Schitt’s Creek” at the Canadian Screen Awards in Toronto on Sunday, March 13, 2016. THE CANADIAN PRESS/Peter Power
Dan Levy to make ‘Saturday Night Live’ hosting debut on Feb. 6

‘Schitt’s Creek’ co-creator to host show

Toronto Maple Leafs' Alexander Kerfoot, centre, tries to get the puck past Calgary Flames goalie Jacob Markstrom, right, as Noah Hanifin looks on during first period NHL hockey action in Calgary, Sunday, Jan. 24, 2021.THE CANADIAN PRESS/Jeff McIntosh
Morgan Reilly’s three assists lifts Maple Leafs to 3-2 win over Flames

Leafs 3 Flames 2 CALGARY — Morgan Reilly’s three assists helped the… Continue reading

Green Bay Packers' Adrian Amos (31) reacts after intercepting a pass intended for Tampa Bay Buccaneers' Mike Evans during the second half of the NFC championship NFL football game in Green Bay, Wis., Sunday, Jan. 24, 2021. (AP Photo/Jeffrey Phelps)
Road warriors: Bucs win 31-26 at Green Bay, reach Super Bowl

GREEN BAY, Wis. — Tom Brady and the Tampa Bay Buccaneers’ road… Continue reading

People arrive to be tested for COVID-19 at a clinic in Montreal, Sunday, January 24, 2021, as the COVID-19 pandemic continues in Canada and around the world. THE CANADIAN PRESS/Graham Hughes
Too soon to know if Canada’s COVID-19 case decline will continue, Tam says

MONTREAL — It’s still too soon to know whether the recent downward… Continue reading

Most Read