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

Rachna Singh, MLA for Surrey-Green Timbers, is the Parliamentary Secretary for Anti-Racism Initiatives. (Photo courtesy of flickr.com/photos/bcgovphotos)
A micro brewery is being eyed for Jordan River. However, the site where the brewery is proposed still needs to go through the rezoning process. (Black Press Media file)
Micro brewery proposed for Jordan River

Jordan River Brewing Company envisions to build wholesale, sit-in brewery along Highway 14

Traffic waits at the intersection of Highway 17 and Beacon Avenue. A study found failing levels of service at the intersection of Highway 17 and Sidney’s Beacon Avenue for multiple movements during morning peak traffic and for all left-moving traffic during afternoon peak traffic. (Wolf Depner/News Staff)
Province supports potential interim improvements to Sidney intersection

Province says interchange is the long-term plan for intersection of Beacon Avenue and Highway 17

Oak Bay local Lachlan Kratz (red, middle) has signed with pro rugby team NOLO Gold in Louisiana. (Contributed photo)
Oak Bay local signs with pro rugby team

Lachlan Kratz at 21 is now NOLO Gold’s youngest member

Vancouver resident Beryl Pye was witness to a “concerning,” spontaneous dance party that spread throughout social groups at Kitsilano Beach on April 16. (Screen grab/Beryl Pye)
VIDEO: Dance party erupts at Vancouver’s Kitsilano Beach to the dismay of onlookers

‘It was a complete disregard for current COVID-19 public health orders,’ says Vancouver resident Beryl Pye

Russ Ball (left) and some of the team show off the specimen after they were able to remove it Friday. Photo supplied
Courtenay fossil hunter finds ancient turtle on local river

The specimen will now make its home at the Royal BC Museum

Pall Bearers carrying the coffin of the Duke of Edinburgh, followed by the Prince of Wales, left and Princess Anne, right, into St George’s Chapel for his funeral, at Windsor Castle, in Windsor, England, Saturday April 17, 2021. (Danny Lawson/Pool via AP)
Trudeau announces $200K donation to Duke of Edinburgh award as Prince Philip laid to rest

A tribute to the late prince’s ‘remarkable life and his selfless service,’ the Prime Minister said Saturday

B.C. homeowners are being urged to take steps to prepare for the possibility of a flood by moving equipment and other assets to higher ground. (J.R. Rardon)
‘Entire province faces risk’: B.C. citizens urged to prepare for above-average spring flooding

Larger-than-normal melting snowpack poses a threat to the province as warmer weather touches down

Vancouver-based Doubleview Gold Corp. is developing claims in an area north of Telegraph Creek that occupies an important place in Tahltan oral histories, said Chad Norman Day, president of the Tahltan Central Government. (THE CANADIAN PRESS/HO)
B.C. Indigenous nation opposes mineral exploration in culturally sensitive area

There’s “no way” the Tahltan would ever support a mine there, says Chad Norman Day, president of its central government

Stz’uminus Elder George Harris, Ladysmith Mayor Aaron Stone, and Stz’uminus Chief Roxanne Harris opened the ceremony. (Cole Schisler photo)
Symbolic red dresses rehung along B.C. highway after vandals tore them down

Leaders from Stz’uminus First Nation and the Town of Ladysmith hung new dresses on Sat. April 17

A Western toadlet crosses the centre line of Elk View Road in Chilliwack on Aug. 26, 2010. A tunnel underneath the road has since been installed to help them migrate cross the road. Saturday, April 24 is Save the Frogs Day. (Jenna Hauck/ Progress File)
Unofficial holidays: Here’s what people are celebrating for the week of April 18 to 24

Save the Frogs Day, Love Your Thighs Day and Scream Day are all coming up this week

The Attorney General’s Ministry says certain disputes may now be resolved through either a tribunal or the court system, pending its appeal of a B.C. Supreme Court decision that reduced the tribunal’s jurisdiction. (AP Photo/Mark J. Terrill)
Court of Appeal grants partial stay in ruling on B.C. auto injuries

B.C. trial lawyers challenged legislation brought in to cap minor injury awards and move smaller court disputes to the Civil Resolution Tribunal

A vial of some of the first 500,000 AstraZeneca COVID-19 vaccine doses that Canada secured. THE CANADIAN PRESS/Carlos Osorio
Canada’s 2nd blood clot confirmed in Alberta after AstraZeneca vaccine

The male patient, who is in his 60s, is said to be recovering

Most Read