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Canada’s challenges in procuring COVID-19 vaccines have led its researchers to look for homegrown alternatives to the Pfizer, Moderna, and, most recently, the Johnson & Johnson vaccines, which are in short supply across the country. The answer may come from a variety of sources, sparking hope that the country will soon improve on its fairly dismal national vaccination efforts.
According to the Financial Times , more than 225 million COVID-19 vaccination doses had been administered worldwide as of February 27. The world leader in doses per 100 residents as of that date was Gibraltar, with 99% of its population having received at least one vaccination dose; Israel was second, at 87.5%. Canada ranked 64th on the list, with 4.5 doses per 100 residents, a fact that has spurred the country to begin exploring proprietary approaches to vaccination.
One solution may come from Providence Therapeutics Inc, a small Canadian biotechnological firm. In late December, Providence received authorization from Health Canada to begin human clinical trials of its messenger RNA COVID-19 vaccine, PTX-COVID19-B. In preclinical studies at the University of Toronto, the vaccine proved highly effective at neutralizing the virus in multiple assays.
Providence began its phase 1 human clinical trial in late January. That effort will ultimately include 60 volunteers, of whom 45 will receive the vaccine and 15 will receive placebo. The company plans on moving on to a combined phase 2/3 trial involving 2000 to 3000 patients some time in late spring.
“We’re hoping that if things go well, we’ll have an approved vaccine by the end of this year,” Piyush Patel, MD, chief medical officer at Providence Therapeutics, told Medscape Medical News.
“It’s a bit of an accelerated program, obviously, because of COVID ― and that’s exactly what Pfizer and Moderna did. They combined phase 2 and 3 to get things done faster,” he added.
First Trial on “Home Soil”
According to Patel, the company’s vaccine is the first to be designed and manufactured in Canada and is the first for which clinical trials were initiated on home soil. What’s more, the company anticipates that it will not suffer the same delays that have plagued production efforts of other vaccines, because it will manufacture its own raw materials as well.
“So we won’t be competing with anybody else for raw materials,” Patel said.
The company is in the process of building a manufacturing facility in Calgary, where it will mass produce the vaccine. Providence is projecting output from that facility of as many as 50 million doses per year.
Providence is not alone in its efforts to bring a Canadian solution to the country’s vaccination challenges. Quebec City–based biopharmaceutical company Medicago is currently conducting phase 2/3 trials of its plant-based COVID-19 vaccine, which produces noninfectious versions of viruses called virus-like particles.
Medicago is also evaluating its vaccine candidate in conjunction with an adjuvant technology made by pharmaceutical giant GlaxoSmithKline. Unlike Providence, Medicago will manufacture a large percentage of its vaccine doses outside the country, in North Carolina.
Several other Canadian candidates are on the verge of initiating COVID-19 vaccine trials in the country, including the University of Saskatchewan’s Vaccine and Infectious Disease Organization. It received Health Canada approval in late December to initiate its own phase 1 clinical trial.
Prime Minister’s Response
In early February, Canadian Prime Minister Justin Trudeau announced a partnership between the federal government and American biotech company Novavax to produce tens of millions of its NVX-CoV2373 COVID-19 vaccine doses at a Montreal facility owned by the government. The company submitted the vaccine for regulatory approval shortly thereafter.
According to Novavax, its vaccine not only demonstrated an 89.3% efficacy rate in late-stage clinical trials but also offered strong protection against the COVID-19 variant first reported in the United Kingdom. That variant has proven to be more resistant to other vaccine candidates.
Canada’s efforts have not stopped there. The government recently pledged $25.1 million to Vancouver-based Precision NanoSystems Incorporated to support the development of the company’s self-amplifying RNA vaccine candidate through clinical trials. At the same time, the federal government announced that it will provide up to $14 million in support of Edesa Biotech Inc, an Ontario biopharmaceutical company working on a monoclonal antibody therapy for acute respiratory distress syndrome ― the leading cause of COVID-19 deaths.
“Since the beginning of the pandemic, our top priority has been the health and safety of all Canadians,” the prime minister said in a statement. “Today, we are investing in our biomanufacturing capacity so that we have the made-in-Canada vaccines and treatments we need to protect Canadians, now and in the future, and recover from the impacts of COVID-19.”
Those investments and alliances have proved irksome to executives at Providence Therapeutics. “To us, it is somewhat baffling,” Patel said. “I’m at a loss to figure out why that is considered a better route than backing a company that already has the vaccine in phase 1 trials.”
In a February 5 open letter to the prime minister, Brad Sorenson, CEO of Providence Therapeutics, asked the government for a $150 million investment to support its vaccination development efforts. Patel says the company will move forward whether or not it receives the funding.
“We have sufficient funding right now to finish our studies,” he said. “And we’re working with partners to raise additional funding for this. But governmental funding would obviously help speed up things and help us concentrate on getting the work done, as opposed to going out and fund-raising.” Either way, Providence is hoping to be able to produce as many as five million doses every month by the fall.
For some experts, however, having a made-in-Canada solution to the problem of worldwide vaccine shortages is less important than global cooperation.
“There are so many brilliant scientists all around the world. What we really need is a very robust collaboration,” Fiona Smaill, MBChB, professor in the Department of Pathology and Molecular Medicine at McMaster University, Hamilton, Canada, told Medscape Medical News.
“Not everybody has to invent everything from scratch, so I don’t think it’s critical. We don’t only need to address Canada’s problem, because we’re dealing with a worldwide pandemic. I believe that is the priority, rather than a Canada-only solution,” she said.
Smaill and her colleagues at the Fitzhenry Vector Laboratory at McMaster are working on their own vaccine, an adenovirus vector for COVID-19 that can be inhaled instead of injected. Ideally, the group would begin its own clinical trials in May.
“Our hypothesis is that we can immunize with a novel approach,” Smaill said. “This would include perhaps giving an intramuscular injection of one vaccine, and then boosting it a month later with one given into the lungs. And we’re hoping we can demonstrate an immune response which has a greater breadth, with the potential to deal with some of the variants or some of the other infections that may come along.
“But in the end, any vaccine is going to be good news,” she added.