A made-in-Canada vaccine to protect against COVID-19 began human clinical trials Tuesday in Toronto, says the biotechnology company that developed the vaccine.
Toronto-based Providence Therapeutics said three shots will be given to 60 adult volunteers at a clinical trial site in Toronto in the first phase of the trial on Tuesday.
Fifteen of those volunteers will receive a placebo, and 45 will get the vaccine, called PTX-COVID19-B.
Brad Sorenson, the company’s CEO, said it’s the first time a vaccine designed and manufactured in Canada has begun clinical trials. The company has purchased a site in Calgary to mass-produce the vaccine.
The vaccine is designed to trigger an immune response in the body. Providence’s product is a vaccine with mRNA technology and is similar to that of Moderna that is being administered to people across Canada.
Quebec-based pharmaceutical Medicago began clinical trials last July of its coronavirus vaccine that is based on another technology. Unlike Providence, a large portion of Medicago’s vaccine doses will be manufactured outside the country, in North Carolina.
Medicago’s vaccine is currently in Phase 3 clinical trials — the last stage before it can apply for approval from Health Canada and other regulators to market the product.
Sorenson said Providence designed and built its vaccine last March.
The federal government provided financial sponsorship and support for the early phase clinical trial through the National Research Council of Canada’s Industrial Research Assistance Program.
Currently, Canada lacks the capacity to manufacture the millions of doses of coronavirus vaccines needed to immunize people outside of a clinical trial setting. It’s why the federal government struck deals with Pfizer-BioNTech and Moderna — both manufactured abroad — to obtain the vaccines being rolled out across Canada.
While the company was developing the vaccine in pre-clinical studies, Sorenson said it also started to build the infrastructure to manufacture the vaccine in Canada as well.
The company purchased a 20,000-square-foot facility in Calgary that includes 12,000 square feet of lab space to mass-produce the vaccine. The facility will be up and running in two months, Sorensen said.
Pending regulatory approval, a larger Phase 2 trial with adults over 65, youths under 18 and pregnant people could start in May, Sorenson said.
If the vaccine proves safe and effective in clinical trials and Health Canada approves it, the goal is to have it ready for the global market by January 2022.
Providence Therapeutics was founded in 2013 to focus on cancer vaccines.
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