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

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

Just Posted

Forward Elan Bar Lev Wise of the West Kelowna Warriors (right, shown playing for the Vernon Vipers in 2019) has been suspended nine games by the B.C. Hockey League for being the instigator and aggressor in an after-the-game fight with Vernon’s Kjell Kjemhus Monday, April 12, at Kal Tire Place. Kjemhus was given a two-game suspension for his role in the fight after the game was over. (Morning Star - file photo)
West Kelowna Warriors forward handed lengthy suspension

Elan Bar Lev Wise fought Vernon Vipers forward Kjell Kjemhus after BCHL game was over Monday, April 12; Kjemhus suspended two games

Vernon residents were able to bring propane fire pits down to Polson Park, between Jan. 25 - April 5 to enjoy with their family bubble, similar to those provided for residents at Predator Ridge. (Jennifer Smith - Morning Star)
Fire pits a flop in Vernon’s Polson Park

City spends estimated $2K on temporary program, few, if any take advantage; option closed now

Sheila Derbyshire dressed up as a scary clown to surprise her daughter, Talyn, at Len Wood Middle School in Armstrong April 12, 2021, for her 13th birthday. (Sheila Derbyshire - Contributed)
Armstrong mom sends in the clowns

‘Halloween freak’ celebrates daughter’s 13th birthday in style

Taxes are going up slightly for homeowners in 2021 to give businesses a break. (Jennifer Smith - Morning Star)
Tax shifts burden from Vernon businesses to homeowners

New rate for residential 2.67 per cent or $42 for average home

City of Armstrong community services manager and chief bylaw officer Warren Smith stands with the new food waste bin and garbage cart to be delivered to eligible residents later this month. (Brooke Hovey photo)
Armstrong changes waste collection system

Residents to be given new bins as part of the new system which goes into effect May 1

Burnaby MLA Raj Chouhan presides as Speaker of the B.C. legislature, which opened it spring session April 12 with a speech from the throne. THE CANADIAN PRESS
B.C. NDP promises more health care spending, business support in 2021 budget

John Horgan government to ‘carefully return to balanced budgets’

Protesters occupied a road leading to Fairy Creek Watershed near Port Renfrew. (Submitted photo)
B.C. First Nation says logging activist interference not welcome at Fairy Creek

Vancouver Island’s Pacheedaht concerned about increasing polarization over forestry activities

Skaha Lake Middle School. (File photo)
COVID exposure at Penticton middle school

Skaha Middle School is the latest in growing lists of exposure in the Okanagan

Flow Academy is not accepting membership applications from anybody who has received a dose of the vaccine, according to a password-protected membership application form. (Submitted image)
B.C. martial arts gym refusing patrons who have been vaccinated, wear masks

Interior Health has already issued a ticket to Flow Academy for non-compliance with public health orders

A five-storey, 60-unit building has been proposed for 8709 Jubilee Rd. E., Summerland. The proposal will be the subject of a public hearing on March 22. (Image by GTA Architecture)
Zoning, OCP amendments adopted for Summerland housing development

Additional variances will be needed for controversial five-storey, 60-unit housing development

Guinevere, lovingly referred to by Jackee Sullivan and her family as Gwenny, is in need of a gynecological surgery. The family is raising money to help offset the cost of the procedure. (Jackee Sullivan/Special to Langley Advance Times)
Langley lizard’s owners raise funds for gynecological surgery

The young reptile is scheduled for operation on Tuesday

Facebook screenshot of the sea lion on Holberg Road. (Greg Clarke Facebook video)
VIDEO: Sea lion randomly spotted on remote B.C. logging road

Greg Clarke was driving home on the Holberg Road April 12, when he saw a large sea lion.

Defence counsel for the accused entered two not guilty pleas by phone to Grand Forks Provincial Court Tuesday, Jan. 12. File photo
B.C. seafood company owner fined $25K for eating receipt, obstructing DFO inspection

Richmond company Tenshi Seafood is facing $75,000 in fines as decided March 4 by a provincial court judge

B.C. Finance Minister Selina Robinson speaks in the B.C. legislature, March 2, 2021. (Hansard TV)
B.C. NDP ministers defend ‘air tax,’ latest COVID-19 business aid

Empty home tax doesn’t apply to businesses, but space above them

Most Read