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.

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-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.

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.

Several other Canadian vaccine candidates are poised to start clinical trials in Canada, including one from Saskatoon-based VIDO-Intervac that's currently recruiting volunteers for a Phase 1 clinical trial in Halifax.

Virologist Alyson Kelvin, an assistant professor at Dalhousie University and a scientist at the Canadian Centre for Vaccinology at VIDO-Intervac, is one of the many Canadian researchers involved in vaccine development and anticipating the results of clinical trials, including from Providence.

"The mRNA vaccines produced by Pfizer and Moderna have shown to have very robust immune responses, so perhaps this is a good strategy to be backing," Kelvin said. "Phase one clinical trials will help us determine if this mRNA vaccine is going into that same progression."

Michael Gardam, an infectious disease physician and chief operating officer at Health PEI, said the idea of having a domestic pandemic vaccine supplier makes sense. But Canada's plan was based on making more familiar influenza vaccines.

"If we're in Phase one, Phase two trials, by the time this Canadian vaccine may be approved, the pandemic may be largely over," said Gardam, who is not involved in vaccine development. "But the concept is a good one."

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.