Prime Minister Justin Trudeau announced today that the promising COVID-19 vaccine candidate from Massachusetts-based Moderna will be available in Canada by the end of the month if the shot secures the necessary regulatory approvals.
Health Canada regulators are in the final stages of the review process for this vaccine. A final decision on authorization could come as early as this week.
If it’s approved, Trudeau said, Canada will receive up to 168,000 doses of the two-dose Moderna vaccine before the end of December. Trudeau said deliveries are slated to begin within 48 hours of Health Canada’s authorization.
“As with the early shipments of the Pfizer vaccine, this moves us even further forward on getting Canadians protected as quickly as possible,” Trudeau said. “We are very, very well positioned.”
With recent polls showing that a sizeable number of Canadians will refuse a vaccine altogether, or will wait some time before lining up for a shot, Trudeau said he wants Canadians to be assured that the science will not be rushed and Canada’s regulators will only approve a product that works.
“The approval of vaccines is not a political issue. Experts at Health Canada will do their jobs, and this is what they do for all drugs and vaccines in normal times,” he said in French. “The work has to be done without being compromised.”
The U.S. Food and Drug Administration will hear Thursday from an outside advisory panel on whether the vaccine is safe for use in the United States. FDA’s own scientists today endorsed it as safe and effective.
The Pfizer-BioNTech vaccine was approved by Health Canada regulators last week and vaccinations started in some provinces yesterday — but its stringent temperature requirements for storage mean the shot isn’t the best fit for much of the country.
Northern, rural and remote communities simply don’t have the health care infrastructure to safely store the Pfizer vaccine at ultra-low temperatures.
The Moderna product must be kept at -20 C — many degrees above the -70 to -80 C range that Pfizer demands for its shot — and there are more commercial-grade refrigerators on hand across the country that can store this vaccine.
Because the territories will not receive the Pfizer vaccine, Trudeau said the first Moderna doses will be directed to northern regions, remote and Indigenous communities. He said this vaccine is easier to ship over long distances in winter conditions.
“We are working to ensure the logistics planning is ready when vaccines are available, and have already shipped medical-grade freezers to the north. As soon as we get the green light, we’ll be ready to go,” Trudeau said.
Trudeau also said today that Canada will receive about 200,000 more Pfizer shots next week, while the number of sites where this temperature-sensitive shot can be administered will increase from just 14 this week to 70.
In August, Canada placed an order for 20 million doses of the Moderna product. Earlier this month, Public Services and Procurement Minister Anita Anand announced the government would exercise its contractual options for 20 million more shots in 2021. Canada could still buy up to another 16 million doses.
Trudeau attributed the December shipments of the Moderna vaccine to Canada’s early commitment to buy the product.
“Like the co-founder of Moderna pointed out a few weeks ago, Canada was among the first to pre-order their vaccine. That, combined with our solid plan on vaccine rollout, is why we have an agreement for early doses,” he said.
Health Canada has been reviewing Moderna’s clinical trial data on a rolling basis since Oct. 12.
The rolling review process — a policy shift implemented because of the urgency of this pandemic — allows drug makers to bypass the lengthy timelines they normally face when launching a new vaccine.
The company’s final clinical trial data are encouraging, demonstrating that the vaccine is 94.1 per cent effective at preventing COVID-19 and 100 per cent effective at preventing severe cases of the disease.
In July, Moderna began administering its vaccine and a placebo to 30,000 clinical trial participants in the U.S.
Of the 15,000 people who received the vaccine, only 11 developed COVID-19. None of those 11 people became severely ill. Among the 15,000 people who received the placebo — a shot of saline that does nothing — 185 developed the novel coronavirus. Thirty of those 185 patients reported severe illness and one died.
Health Canada is currently reviewing other vaccines from companies like AstraZeneca and Johnson & Johnson’s pharmaceutical division, Janssen.
In total, Canada has ordered roughly 418 million doses of COVID-19 vaccines from seven different companies — an insurance policy against the risk that some of the vaccines in development prove to be ineffective.