Health Canada approves Moderna COVID-19 vaccine

23 Dec 2020 | Canada | 351
Health Canada approves Moderna COVID-19 vaccine

Health Canada has approved Moderna's COVID-19 vaccine for use in this country, with 168,000 doses expected to arrive by the end of the year.

The regulator announced the approval on Wednesday after completing a review of the Massachusetts-based biotechnology company's clinical trial data.

"The data provided supports favourably the efficacy of the Moderna COVID-19 vaccine as well as its safety," Health Canada said in a notice authorizing use of the vaccine for people over the age of 18.

"There were no important safety issues identified and no life-threatening adverse events (AEs) or deaths related to the vaccine."

The authorization of a second COVID-19 vaccine comes as cases surge across the country. Quebec reported another new daily record Wednesday and Ontario saw its ninth consecutive day of more than 2,000 cases, even as it prepares for a lockdown starting on Boxing Day. 

Health Canada previously authorized the vaccine made by U.S. pharmaceutical giant Pfizer and German biotechnology firm BioNTech on Dec. 9, and it's already being administered in parts of the country to people in high-priority groups, including health-care workers and long-term care workers and residents.

Dr. Howard Njoo, Canada's deputy chief public health officer, said 240,000 of those doses will have been distributed to all provinces by the end of the day — enough to vaccinate 120,000 Canadians.

Moderna vaccine easier to store
The Moderna approval means vaccinations can soon begin in northern, remote and Indigenous communities, which haven't seen any doses of the Pfizer-BioNTech vaccine because they lack the freezer equipment necessary to safely store it at –70 C.

Moderna's vaccine, by contrast, can be stored at regular freezer temperatures.

"This authorization is a critical step in ensuring a COVID-19 vaccine is available to all Canadians in all parts of the country," Dr. Supriya Sharma, Health Canada's chief medical adviser, said at a press conference in Ottawa on Wednesday. 

"Since many Canadians live outside major urban areas, this vaccine can be used in communities that haven't had access to COVID-19-vaccines to date."

Patricia Gauthier, general manager of Moderna Canada, told CBC News that a shipment of 168,000 doses would arrive in the country within 48 hours.

Prime Minister Justin Trudeau praised the approval, and also announced that Canada had secured an agreement for delivery of an additional 250,000 doses from Pfizer next month, bringing the total number of doses expected to be delivered by Pfizer in January to 751,000.

"Between the early doses we have already received and the shipments now scheduled, we're on track to have at least 1.2 million doses from both Pfizer and Moderna delivered by Jan. 31," Trudeau said.

Canada has secured contracts with Pfizer-BioNTech for access to 20 million doses and with Moderna for 40 million doses by the end of 2021.

Distribution plans
Maj.-Gen. Dany Fortin, the military commander leading vaccination logistics at the national operations centre, said everything is in place for the rapid distribution of Moderna doses to designated sites in the provinces and territories, following a successful dry-run last week.

"We are ready to deliver up to 168,700 doses next week," he said. 

Fortin said the first vaccine doses will arrive in the territories on Dec. 28, unless weather becomes an issue. He also said the number of vaccine distribution sites in Canada would expand over the next few weeks, from 14 now to more than 100 next week.

Pfizer-BioNTech has chosen to ship doses directly to provincial sites using shipping company UPS, while the Public Health Agency of Canada is responsible for delivering doses of the Moderna vaccine.

PHAC has contracted FedEx to pick up doses in Europe and deliver them to a storage facility in Toronto, where logistics company Innomar will repackage the shipments into smaller amounts to be forwarded to provincial and territorial governments.

Clinical trial results 
Health Canada granted authorization to Moderna's vaccine after analyzing data from a Phase 3 trial that involved over 30,000 individuals in the U.S., half of whom received the vaccine while the other half received a placebo. 

The vaccine was found to be 94.1 per cent effective in participants with no prior COVID-19 infection and 86.5 per cent effective in people over the age of 65, Health Canada said. 

Data showed the vaccine's effectiveness and safety were consistent across age, sex and ethnicity.

Canada expected to receive 168,000 doses of Moderna vaccine by month's end, Trudeau says
Health Canada approves Pfizer-BioNTech COVID-19 vaccine
During the trial, 30 people in the placebo group experienced severe cases of COVID-19, compared with none from the vaccine group, Health Canada said.

Health Canada warned that people shouldn't take the vaccine if they are allergic to any of its ingredients, or if they currently have symptoms of COVID-19.

Moderna vaccine requires 2 doses
The vaccine is not yet recommended for use on children, as tests on adolescents only began in December and tests on children younger than 12 won't begin until next year.

Health Canada said in a statement that Moderna will have to continue to provide information to the regulator on the safety of the vaccine.

Like the Pfizer-BioNTech vaccine, Moderna's shot requires two doses to achieve maximum immunity.

It uses mRNA technology — a technology that directs cells to produce proteins that trigger an immune response to prevent or fight the virus that causes COVID-19.

The two doses should be taken one month apart.

Health Canada continues to review two other COVID-19 vaccines — one from U.K.-based pharmaceutical company AstraZeneca and another from Janssen Inc., a Canadian pharmaceutical subsidiary of Johnson & Johnson. Sharma said the regulator requires more data from both before it can make a decision.

Wednesday's approval comes as concerns grow about the emergence in the U.K. of a new, more contagious variant of the coronavirus that causes COVID-19, which has led to concern that it may reduce the efficacy of existing vaccines.

Chief Public Health Officer Dr. Theresa Tam said on Tuesday that there is no evidence to suggest that existing vaccines won't be effective against the new variant.

Infectious disease specialist Dr. Zain Chagla concurred. Even if the U.K variant does make its way to Canada, Chagla said mRNA vaccines like those made by Pfizer-BioNTech and Moderna can be reverse engineered to quickly counter new variants.

"This is what the benefit of this platform is — it's rapid to change. You only just need the sequence and within a week or two ... you could get a new vaccine out there," Chagla said. СВС