Made-in-Canada coronavirus vaccine starts human clinical trials

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. 

Vaccines are designed to trigger an immune response in the body. Providence’s product is an mRNA vaccine and is similar to the Moderna coronavirus shot being given 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.

A vial is shown in this handout image provided by Providence Therapeutics. The company says it is the first fully made-in-Canada coronavirus vaccine to reach clinical trials in this country. (Providence Therapeutics/The Canadian Press)

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.

“We reached out to the Canadian government in April and said, ‘Hey, you’ve heard of Moderna. We’re doing the exact same thing,'” Sorenson said in an interview.

“We went from concept into the clinic in under a year without the same level of support as our peers had.”

Purchased Calgary site

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 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.

A typical vaccination station is seen at the COVID-19 vaccination clinic at the Health Sciences Centre in Winnipeg on Dec. 14. Currently, Canada lacks the capacity to manufacture the millions of doses of coronavirus vaccines needed to immunize people outside of a clinical trial setting. (John Woods/The Canadian Press)

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.

Initial focus was cancer research

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.

Sorenson founded Providence Therapeutics in 2013 to focus on cancer vaccines.

Several scientists contributed to the pre-clinical research on Providence’s vaccine, including those at the lab of Dr. Mario Ostrowski, a scientist at the Keenan Research Centre for Biomedical Science and an infectious disease clinician at St. Michael’s Hospital, Dr. Anne-Claude Gingras at Mt. Sinai Hospital, Dr. Samira Mubareka and Dr. Rob Kozak at Sunnybrook Research Institute, as well as Dr. Michael Pollanen, Ontario’s chief forensic pathologist.

In August, Ostrowski, whose laboratory performed the animal trials, said results were on par with tests of vaccines from Moderna and Pfizer-BioNTech at that stage.

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