Canada Opts to Double Doses of Moderna’s COVID-19 Vaccine
The Canadian government initially signed on for 20 million doses of Moderna’s mRNA-based COVID-19 vaccine, but doubled its order as an approval draws near.
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By - Moderna recently announced that the Canadian Government will now acquire an additional 20 million doses of its mRNA COVID-19 vaccine, bringing the total to 40 million doses.
The updated agreement comes three months after Canada increased its initial commitment of the vaccine candidate to 20 million.
“This increased supply agreement from the Canadian government today reaffirms the confidence in our COVID-19 vaccine candidate and we appreciate our collaboration with the Canadian government as with many other governments and other key partners around the world,” Stephane Bancel, Moderna’s chief executive officer, said in the announcement.
“For ten years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. The recent positive efficacy analysis from our Phase 3 COVE study is an encouraging step in the development of mRNA-1273,” he continued.
Also last week, the Swiss Federal Government increased its confirmed order commitment from 4.5 million to 7.5 million doses of mRNA-1273.
Moderna stated that it is still on track to start the delivery of mRNA-1273 to help protect Canadians following regulatory approval by both the Canadian health authorities and the Swiss health authorities.
Additionally, if mRNA-1273 is approved by the FDA for emergency use, the company could begin shipping its COVID-19 vaccine in the coming weeks.
Moderna has already initiated the rolling review process with Health Canada and Swissmedic, and intends to seek prequalification or Emergency Use Listing (EUL) with the World Health Organization (WHO).
The Canadian vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner Lonza in Switzerland and ROVI in Spain for fill-finish services, the company said.
As one of the topmost promising COVID-19 vaccines, mRNA-1273 was found to be over 94.1 percent effective against the coronavirus, according to an analysis released earlier this month. The results were based on a total of 196 cases, of which 185 were in the placebo group and 11 were in the mRNA-1273 group.
A secondary endpoint analyzed 30 severe COVID-19 cases of COVID-19, all of which occurred in the placebo group and none in the group that received the mRNA-1273 injections.
Based on the prior analyses, Moderna stated that the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
Overall, COVE has enrolled over 30,000 participants in the US and is based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second dose of a vaccine.
Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB).
Moderna’s expertise lies in its messenger RNA therapeutics and vaccines to create medicines for patients.
But over the past six months, other top pharmaceutical companies, including Sanofi and Pfizer, produced promising mRNA COVID-19 vaccine candidates that are currently in clinical trials.
And at the end of October, Sanofi stated that its mRNA-based COVID-19 vaccine candidate, MRT500 induced “potent” neutralizing antibodies against COVID-19 in mice, with levels substantially higher than those previously observed in infected patients.
And Pfizer’s vaccine was found to be 95 percent effective in a Phase 3 study at the end of November.
FDA has granted the Pfizer vaccine emergency use authorization, but expects to issue an emergency approval to Moderna soon.
