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

Saanich police used a drone to investigate 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 West Saanich Road crash

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

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 number drops below 10 for second time in 2021

Province reports 8 new COVID-19 cases on Vancouver Island

This rendering shows the proposed warehouse for lands under the authority of the Victoria Airport Authority near a Sidney residential neighbourhood. (York Realty/Submitted)
Sidney asked to show patience about identity of would-be warehouse operator

President of York Realty says nobody is trying to hide anything

Saanich police reported an increase in violent crimes and a drop in traffic incidents in the first three months of 2021 compared to the final quarter of 2020. (Black Press Media file photo)
Saanich police report increase in violent crimes during first quarter of 2021

More domestic violence, less property crime and distracted driving compared to end of 2020

Marc Kielburger, screen left, and Craig Kielburger, screen right, appear as witnesses via video conference during a House of Commons finance committee in the Wellington Building in Ottawa on Tuesday, July 28, 2020. The committee is looking into Government Spending, WE Charity and the Canada Student Service Grant. THE CANADIAN PRESS/Sean Kilpatrick
BREAKING: Trudeau didn’t violate conflict rules over WE Charity, watchdog says

Federal ethics commissioner Mario Dion found that former finance minister Bill Morneau did violate the rules

Pixabay
Island Health: two doctors, new clinic space to avert Port McNeill health crisis

Island Health has leased space to use as an immediate clinic location to avert health crisis

Police investigate a fatal 2011 shooting in a strip mall across from Central City Shopping Centre, which was deemed a gang hit. The Mayor’s Gang Task Force zeroed in on ways to reduce gang involvement and activity. (File photo)
COVID-19 could be a cause in public nature of B.C. gang violence: expert

Martin Bouchard says the pandemic has changed people’s routines and they aren’t getting out of their homes often, which could play a role in the brazen nature of shootings

A poignant Pandemic Postcard Project submission has led Lesley Wright and Graham Hughes of Literacy Alberni on a new path toward anti-racism education. (SUSAN QUINN/ Alberni Valley News)
‘I am not a virus’: How one postcard sparked a Vancouver Island pushback against racism

Literacy Alberni receives $50K in funding to create web-driven system for reporting racism

Tinder, an online dating application that allows users to anonymously swipe to like or dislike other’s profiles. (Black Press Media files)
B.C. man granted paternity test to see if Tinder match-up led to a ‘beautiful baby’

The plaintiff is seeking contact with the married woman’s infant who he believes is his child

Nurse Tami Arnold prepares to administer a COVID-19 vaccine. (Kareem Elgazzar/AP)
B.C. adults 30+ now eligible to get vaccinated against COVID-19

Health officials made the announcement Wednesday afternoon

Ancient Forest Alliance campaigner Andrea Inness walks beside an enormous western red cedar stump in a BCTS-issued cutblock in the Nahmint Valley. (PHOTO COURTESY TJ WATT)
Watchdog: logging practices put Vancouver Island old growth, biodiversity at risk

Forest Practices Board has issues with BC Timber Sales practices in Nahmint Valley near Port Alberni

Erik Christian Oun, who worked for the Coquitlam school district, has had his teaching licence suspended for half a year. (Pixabay)
B.C. teacher suspended after calling students ‘cutie’ and ‘sweetheart’ in online messages

Erik Oun’s licence has been suspended for half a year, a decision made by the B.C. Commissioner for Teacher Regulation

Most Read