Hope, doubt loom as human clinical trials begin on Calgary-made COVID-19 vaccine

Canadian vaccine developers are excited about starting human trials on a COVID-19 vaccine candidate from a Calgary company — but some think it’s too little, too late.

Sixty people are taking part in the trial for the vaccine developed by Calgary-based Providence Therapeutics.

Read more: Calgary company begins human clinical trials for its COVID-19 vaccine candidate

The first results are expected next month, and if they are promising, the Phase 2 trial could follow in May.

While Canada does not currently have the capacity to produce the millions of doses needed, Providence Therapeutics has partnered with another Calgary company, Northern RNA Inc., to build manufacturing infrastructure.

While that won’t help the current vaccine shortage, it could help down the road.

‘Ready to help fill a gap’

Providence Therapeutics CEO Brad Sorenson said if everything works out, the vaccine could be released by early next year.

“I hope that anybody who wants a vaccine has it by this fall,” he said.

“If that doesn’t turn out to be the case, we’ll be ready to help fill a gap if there is one. If we produce vaccines and Canadians don’t need them, there’s the worldwide supply, [which] is not even close to meeting worldwide demand. So we’ll be able to export that and help out wherever we can.”

Read more: Will Canadians get to choose which COVID-19 vaccine they get?

Brad Stevens, co-founder, president and CEO of Northern RNA, has about 23,000 square feet of manufacturing space at 335 25 St. S.E. for the collaboration.

“I thought, ‘Why do we have to buy everything from somewhere else? Why can’t Calgary get in this game?’ And so I did,” he said.

“Our Phase 1 is — we’re actually going to be manufacturing some of the components of the vaccine. Phase 2 — when we do an expansion of our facility or actually a restructuring of our facility, which is now going to be much faster than we had previously thought — that’s when we’re actually going to be manufacturing the vaccines.”

Read more: Alberta health-care workers receive province’s 1st COVID-19 vaccines Tuesday

Stevens said they are looking at supplying countries — nothing smaller than that.

“Providence is our first customer, and we’ll be looking for other customers around the world to make this out of Canada. So, yes, we will participate in the pandemic part,” he said.

“We will participate in the stabilization effort, and Northern will participate in the multiple applications that that messenger RNA will be used for in the future. I have no doubt.”

Instead of using the live virus that causes COVID-19, mRNA vaccines “teach our cells how to make a protein that will trigger an immune response,” according to the Canadian government.

Read more: Even with new COVID-19 vaccine approvals, rollout won’t increase before April

Sorenson said his company is ramping up the production of raw materials that will be used in the vaccine.

“We’ve got a lot of planning and collaboration that we have to do with Health Canada for our Phase 2 and Phase 3,” he said.

“We also expect that there’ll be an international component to that Phase 3 trial. So there’s a lot of work, a lot of planning that’s going to happen over the next couple of months.”

Read more: Coronavirus vaccine rollout: How Canadians will know it’s their turn to be inoculated

There is still a lot to learn. Sorenson said we don’t yet know how often will people need a booster, especially as new COVID-19 variants crop up.

“The one that’s most concerning right now is the South African variant,” he said, “and we’ve already designed that vaccine, so having that capacity in Canada is truly important for national security and for economic well-being.”

A medication vial is shown in this undated handout image provided by Providence Therapeutics. Human clinical trials have begun in Toronto for a proposed COVID-19 vaccine by a Canadian company. Providence Therapeutics of Calgary says 60 subjects will be monitored for 13 months, with the first results expected next month. THE CANADIAN PRESS/HO-Providence Therapeutics

‘Diversify the economy’

Stevens couldn’t contain his excitement with the idea of Calgary being involved in a global effort to battle the pandemic.

“I kind of think it would be cool for Calgary to be known as the messenger RNA capital of Canada,” he said.

“We’ve been able to go very, very quickly based upon our private investment to make this a reality here for Calgary, Canada and the world. But I’m excited. I’m a Calgarian, and I just can’t be more excited to do this in my home city.”

Read more: The U.S. is vaccinating nearly 1M people per day. How does Canada compare?

In addition to private funding, Stevens explained that they received a federal grant, adding that they can boost the economy in a short period of time.

“I think it will be important for Alberta to hear about our expansion plans, to be able to add jobs, add growth, diversify the economy here in Calgary,” he said.

“It’s really what we need right now.”

We need a ‘quick fix’

Amir Attaran, a University of Ottawa law and public health professor, called Providence Therapeutics’ announcement a “completely meaningless, unimportant development.”

“What this is, is a company that has never produced a vaccine, promising that they could get one out by next year, which is simply not timely and not a good use of the government’s resources to support it,” he said.

“I don’t even believe they’ll have it out by next year. I think that’s extremely unlikely.”

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Calgary-based company’s COVID-19 vaccine heading into human clinical trials

Trials are the fundamental problem in getting vaccines approved, Attaran said.

“Those trials typically enrol some 30,000, 40,000, 50,000 patients, in that range. Are you going to find volunteers in those numbers who are willing to try an untested, unproven, unknown vaccine if it means that they must sacrifice getting Pfizer’s or Moderna’s or somebody else’s that is tested and proven?” he said.

“People will simply not volunteer for the trial, and that’s a company problem, being this late. It’s a problem faced by many companies being this late.”

Read more: Johnson & Johnson says coronavirus vaccine data expected next week

We need vaccines urgently; Canadian pride isn’t a necessity right now, Attaran said.

“I know this isn’t very polite to say, but this is the worst part of being Canadian, of thinking that it’s only a solution if it comes from our country and is dipped in maple syrup first,” he said.

“With all due respect, what we need in this pandemic is a quick fix, meaning vaccines from anywhere in the world that are shown to work. A Canadian vaccine sounds lovely but it is not the priority of this pandemic.

Read more: AstraZeneca says reports of 8% coronavirus vaccine efficacy in seniors are ‘incorrect’

“The only vaccines we have the technology to make in Canada currently are those from AstraZeneca and Johnson & Johnson, and it is absolutely months late that the government is not manufacturing those in Canada. If we had, there would not be the shortage we’re experiencing today.”

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