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

The RCMP are reminding drivers to find alternative ways home if they have consumed anything that impairs their ability to drive. (Black Press file photo)
Impaired Ladysmith driver flees road check twice on the same night

The officer issued the driver numerous violation tickets, and a four-month driving suspension

Duck Paterson. (File photo)
Paterson’s Perspective: Maybe we’re not so different from the Americans

Columnist Duck Paterson shares his views on civil discourse in Canada and America

Rod Alsop and the LSS band had a great day holding class outdoors at Transfer Beach. (Cole Schisler photo)
Ladysmith Secondary School band takes class outside to mark the end of academic quarter

The band took advantage of a sunny January day to play outside

Jessica Lowry created a series of videos to engage Ladysmith Intermediate School students in mindfulness. (Submitted photo)
Ladysmith Intermediate teams up with local artist to introduce students to mindfulness

Ladysmith artist Jessica Lowry created a series of 36 videos to help students practice mindfulness

Luke Marston works on the seawolf mask for Canucks goalie Braden Holtby. (Mike Wavrecan photo)
Stz’uminus artist Luke Marston designs new mask for Canucks goalie

The mask features artwork inspired by the Coast Salish legend of the sea wolf

Maj.-Gen. Dany Fortin, vice-president of logistics and operations at the Public Health Agency of Canada, speaks at a news conference on the COVID-19 pandemic in Ottawa, on Friday, Jan. 15, 2021. THE CANADIAN PRESS/Justin Tang
B.C. records 500 new COVID-19 cases Wednesday, 14 deaths

Outbreak at Surrey Pretrial jail, two more in health care

A suspect has been arrested in connection with fires at Drinkwater Elementary (pictured) and École Mount Prevost. (Kevin Rothbauer/Citizen)
Arson suspect arrested after fires at Cowichan Valley schools

Drinkwater Elementary and Mount Prevost schools hit within a week

A woman writes a message on a memorial mural wall by street artist James “Smokey Devil” Hardy during a memorial to remember victims of illicit drug overdose deaths on International Overdose Awareness Day, in the Downtown Eastside of Vancouver, on Monday, August 31, 2020. THE CANADIAN PRESS/Darryl Dyck
B.C. paramedics respond to record-breaking number of overdose calls in 2020

On the front lines, COVID-19 has not only led to more calls, but increased the complexity

Nanaimo RCMP are seeking the public’s help after a man allegedly assaulted a clerk at James General Store on Victoria Road on Jan. 18. (Submitted photo)
Suspect screams at customer then assaults store clerk in Nanaimo

RCMP asking for information about Jan. 18 incident at James General Store

Chartwell Malaspina Care Residence in Nanaimo. (News Bulletin file photo)
Two Nanaimo care-home residents have died during COVID-19 outbreak

Death reported Monday was the second related to Chartwell Malaspina outbreak, says Island Health

Rod Bitten of Union Bay won $500,000 in the Lotto Max draw on Jan. 15. Photo supplied
Vancouver Island electrician gets shocking surprise with $500K Extra win

Rod Bitten has been hard at work with home renovations, which is… Continue reading

Eighteen-year-old Aidan Webber died in a marine accident in 2019. He was a Canadian Junior BMX champion from Nanaimo. (Submitted)
Inadequate safety training a factor in teen BMX star’s workplace death in 2019

Aidan Webber was crushed by a barge at a fish farm near Port Hardy

Oyster River Fire Rescue members were called out to a suspicious fire in Black Creek. Two vehicles parked at a private residence were destroyed by fire. Photo courtesy Oyster River Fire Rescue
Suspicious fire destroys two vehicles at Vancouver Island residence

Oyster River Fire Rescue personnel were dispatched to a fire at a… Continue reading

Members of the BC RCMP Explosive Disposal Unit (EDU) is on route to Drummond Park opposite of Fulford Habour on Saltspring Island after the discovery of a suspicious cylindrical-shaped device. (Google/Screencap)
Bomb disposal unit en route to Salt Spring Island after suspicious device found in park

Police say a resident discovered the device Wednesday morning in Drummond Park opposite BC Ferries terminal

Most Read