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

L.V. Rogers student Nicolaj Bucher plays the trumpet as part of five-piece jazz ensemble LVJ5. Unable to perform live, the group recorded an album instead. Photo: Tyler Harper
Unable to perform live, L.V. Rogers jazz group instead records debut album

LVJ5 has released Lockdown Fever on streaming services

Grand Forks Fire/Rescue volunteers doused a hillside fire late Monday night, May 17. Photo: Laurie Tritschler
Grand Forks Fire/Rescue puts out hillside fire

No one was injured after a campfire got out of control below Columbia Drive

Michelle Jacobs receives her first dose of the COVID-19 vaccine at the Coast Capri Hotel on April 28, 2021. The pop-up clinic was hosted by the First Nations Health Authority. (Aaron Hemens/Capital News)
126 new cases of COVID-19 in Interior Health over the weekend

There are 22 individuals hospitalized due to the virus, and 13 in intensive care

Faye Petersen (left) and Emma LeCouffe have set up a STEAM fair for J.V. Humphries’ students. Photo: Submitted
Kaslo students plan school-wide STEAM fair

Emma LeCouffe and Faye Petersen have organized the event at J.V. Humphries

Map: BCWildfire Service
UPDATE: Human-caused wildfire burning near Castlegar

The McCormick Creek fire started Sunday

An avalanche near Highway 1 in Glacier National Park. Avalanche Canada will benefit from a $10 million grant from the B.C. government. (Photo by Parks Canada)
Avalanche Canada receives $10-million grant from B.C. government

Long sought-after funds to bolster organization’s important work

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

Abbotsford Regional Hospital. (Black Press Media files)
Canada marks 25,000 COVID-19 deaths since the pandemic began

The grim milestone means 6 in every 10,000 Canadians died of COVID-19 since March 9, 2020, when the country’s first COVID-19 death was reported

Staff-Sgt. Svend Nielsen, with the 100 Mile House RCMP. (Melissa Smalley - 100 Mile Free Press)
14-year-old boy killed in serious ATV crash near 100 Mile House

Youth was travelling with a group of peers when the incident occurred last Friday

Relief is coming for B.C.’s struggling tourism sector. (NEWS file photo)
B.C. officials set to announce more support for tourism sector hit hard by pandemic

Non-essential travel is restricted between three regional zones in B.C. until at least May 24

This image released by Universal Pictures shows Nathalie Emmanuel, left, and Vin Diesel in a scene from “F9.” (Giles Keyte/Universal Pictures via AP)
The blockbuster movie is making a comeback this summer

Excitement in the industry is growing again for a return to a big-screen normal

Grand Forks Fire/Rescue’s Dave Paulett hoses down a section of a wooden retaining wall which caught fire Monday, May 17. Photo: Laurie Tritschler
Fire starts in Grand Forks backyard after by oily rags left in sun

Flames put out before reaching home on 800-block of 72nd Avenue

Sicamous RCMP Sgt. Murray McNeil and Cpl. Wade Fisher present seven-year-old Cody Krabbendam of Ranchero with an award for bravery on July 22, 2020. (Contributed)
7-year old Shuswap boy receives medal of bravery for rescuing child at beach

Last summer Cody Krabbendam jumped into the lake to save another boy from drowning

B.C. Health Minister Adrian Dix and provincial health officer Dr. Bonnie Henry update the province’s COVID-19 vaccine program, May 10, 2021. (B.C. government)
B.C.’s COVID-19 infection rate stays below 500 a day over weekend

14 more deaths, down to 350 in hospital as of Monday

Most Read