The first made-in-Canada COVID-19 vaccine will begin human clinical trials on Tuesday, according to a Toronto-based biotechnology company.
Providence Therapeutics said 60 volunteers between the ages of 18 to 65 will be divided into three groups, and three different dose levels of the vaccine and a placebo will be administered to each group. These volunteers will be monitored for a total of 13 months, but enough data will have been collected by April 2021 to move on to Phase 2 in May 2021.
“Having a made-in-Canada solution to address the global COVID-19 pandemic will augment the reliability of vaccine supply for Canadians, contribute to the global vaccine supply, and position a Canadian company on the global stage as a contributor to the solution,” said Brad Sorenson, founder and CEO of Providence Therapeutics.
The vaccine, known as PTX-COVID19-B, is an mRNA vaccine similar to the Moderna COVID-19 vaccine which now being distributed in Canada.
Once Health Canada deems the vaccine to be safe and effective, the company estimates it will be ready for the market at the end of 2021 or early 2022.
The federal government has provided $4.7 million in financial sponsorship and advisory services for Providence Therapeutics’ Phase 1 trial through the National Research Council of Canada Industrial Research Assistance Program.
In October 2020, the government of Canada also provided $173 million in funding for Medicago, a biopharmaceutical company in Quebec. Medicago agreed to supply 76 million doses of COVID-19 vaccine, which is subject to Health Canada approval.
Medicago began Phase 1 clinical trials in July 2020. While traditional vaccines are made from animal products or live viruses, Medicago’s COVID-19 vaccine uses a plant-based technology, which allows the company to easily increase production volume.
Unlike Providence Therapeutics, Medicago’s vaccine manufacturing facilities are largely based in North Carolina.
“We need to know that in a crisis, we can take care of ourselves. We need to be able to produce vaccines for ourselves. We don’t need to always buy them from overseas,” Sorenson said in a company introduction video.
Scientists from a number of institutes and laboratories have contributed to the pre-clinical research of Providence Therapeutics’ vaccine, including those at the lab of Dr. Mario Ostrowski at the University of Toronto, Dr. Anne-Claude Gingras at Mt. Sinai Hospital, Dr. Samira Mubareka and Dr. Rob Kozak at Sunnybrook Research Institute, and Dr. Michael Pollanen, Ontario’s chief forensic pathologist.