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

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

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.

READ MORE: Canada to receive early shipment of Moderna’s COVID-19 vaccine before year’s end

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.

Mia Rabson, The Canadian Press


Like us on Facebook and follow us on Twitter.

Want to support local journalism during the pandemic? Make a donation here.

Coronavirusvaccines

Just Posted

Nurses at the Cowichan District Hospital are thanking the community for following the health protocols during the ongoing COVID-19 pandemic. Pictured from left are nurses Jacqueline Kendall, Melissa Bustard and Heidi Ferris. (Robert Barron/Citizen)
Pandemic year like no other, Cowichan nurses say

May 10-16 is National Nursing Week

Island Health’s new Wellness and Recovery Centre at 5878 York Rd. is now planned to be open in the fall. (File photo)
Wellness and Recovery Centre now to open in the fall

Three community dialogues scheduled for May

B.C. Centre for Disease Control data showing new cases by local health area for the week of May 2-8. (BCCDC image)
Vancouver Island COVID-19 local case counts the lowest they’ve been all year

On some areas of Island, more than 60 per cent of adults have received a vaccine dose

A nurse gets a swab ready to perform a test on a patient at a drive-in COVID-19 clinic in Montreal, on Wednesday, October 21, 2020. THE CANADIAN PRESS/Paul Chiasson
Island’s daily COVID-19 case count drops below 10 for just the second time in 2021

Province reports 8 new COVID-19 cases on Vancouver Island Wednesday

Prince Rupert was one of the first B.C. communities targeted for mass vaccination after a steep rise in infections. Grey area marks community-wide vaccine distribution. (B.C. Centre for Disease Control)
B.C. tracks big drop in COVID-19 infections after vaccination

Prince Rupert, Indigenous communities show improvement

The bodies of Carlo and Erick Fryer were discovered by a local couple walking on a remote forest road in Naramata on May 10. (Submitted)
Kamloops brothers identified as pair found dead near Penticton

The bodies of Carlo and Erick Fryer were discovered by a local couple walking

Municipal governments around B.C. have emergency authority to conduct meetings online, use mail voting and spend reserve funds on operation expenses. (Penticton Western News)
Online council meetings, mail-in voting option to be extended in B.C.

Proposed law makes municipal COVID-19 exceptions permanent

Cannabis bought in British Columbia (Ashley Wadhwani/Black Press Media)
Is it time to start thinking about greener ways to package cannabis?

Packaging suppliers are still figuring eco-friendly and affordable packaging options that fit the mandates of Cannabis Regulations

A nurse prepares a dose of the COVID-19 vaccine in Kelowna on Tuesday, March 16. (Phil McLachlan/Black Press)
British Columbians aged 20+ can book for vaccine Saturday, those 18+ on Sunday

‘We are also actively working to to incorporate the ages 12 to 17 into our immunization program’

The AstraZeneca-Oxford University vaccine. (AP/Eranga Jayawardena)
2nd person in B.C. diagnosed with rare blood clotting after AstraZeneca vaccine

The man, in his 40s, is currently receiving care at a hospital in the Fraser Health region

Canada’s demo Hornet soars over the Strait of Georgia near Comox. The F-18 demo team is returning to the Valley for their annual spring training. Photo by Sgt. Robert Bottrill/DND
F-18 flight demo team returning to Vancouver Island for spring training

The team will be in the Comox Valley area from May 16 to 24

Saanich police and a coroner investigated a fatal crash in the 5200-block of West Saanich Road on Feb. 4, 2021. (Devon Bidal/News Staff)
Police determine speed, impairment not factors in fatal Greater Victoria crash

Driver who died veered across centre line into oncoming traffic for unknown reason, police say

Ladysmith RCMP safely escorted the black bear to the woods near Ladysmith Cemetary. (Town of Ladysmith/Facebook photo)
Bow-legged bear returns to Ladysmith, has an appointment with the vet

Brown Drive Park closed as conservation officers search for her after she returned from relocation

Most Read