Key components of Pallister's 'made-in-Canada' vaccine sourced from U.S. and Switzerland
Providence Therapeutics says it will deliver before the end of the year, critics not convinced
When Premier Brian Pallister plunked down a $7.2-million, non-refundable down payment on a yet-to-be approved COVID-19 vaccine from a Calgary pharmaceutical company, he justified the expense as a way of breaking Canada's dependency on foreign vaccines.
It turns out key components of the vaccine will be produced in the United States and Switzerland, according to Brad Sorenson, CEO of Providence Therapeutics, which is in the process of finalizing a $36-million deal to supply the province with two million doses of vaccine this year.
Sorenson says his company is on track to produce 50 million doses of the vaccine before 2021 is over, but that will entail sourcing the RNA from an undisclosed manufacturer in the U.S. and nanoparticles from a company in Switzerland.
Providence has no choice but to source the materials from outside of Canada for its first production run slated for this summer but Sorenson says as of 2022, all the vaccine's components will be made in Canada.
The ingredients will be shipped to Emergent Biosolutions' Winnipeg plant which will formulate and fill individual 10-dose vials. Two doses will be required for full vaccination, according to Sorenson.
"We're going to begin production out of the facility in Manitoba in July. And once that production begins, we will be producing 50,000 vials a day," he said.
Some experts believe getting that first shipment of doses to market before the end of the year would be a stretch, if not downright impossible.
"The best case scenario? Probably early in the new year," said Prof. Mahesh Nagarajan, who specializes in supply chain management at the UBC Sauder School of Business.
"I base that assessment on the fact of how long it took for a very large company like Pfizer, and Moderna, to do it, and all the hiccups that they encountered before they could actually scale up," said Nagarajan, adding he hopes Providence will succeed in the end.
Providence delivering a vaccine by Dec. 31 is so improbable as to belong in the realm of fantasy in my opinion.- Prof. Amir Attaran, University of Ottawa
University of Ottawa School of Epidemiology and Public Health Prof. Amir Attaran is more skeptical.
"Providence delivering a vaccine by Dec. 31 is so improbable as to belong in the realm of fantasy in my opinion," said Attaran.
He doubts Providence will be able to enrol sufficient participants in its Phase 2 and Phase 3 trials, which have yet to be approved by Health Canada.
He also questions the company's ability to compete with Pfizer, the maker of one of the two approved vaccines in Canada.
"How is Providence, which is operating out of a minuscule office in Calgary, going to go up against that?" said Attaran.
Providence is admittedly lean, with 30 employees, although it is planning to hire more. It recently moved into an 8,000-square-foot office in Calgary and has space in the Mars Discovery District — a startup incubator — plus offices and labs at Sunnybrook Research Institute in Toronto, according to Sorenson.
He says the next trial is estimated to cost $22-24 million. The trial design, which will be submitted to Health Canada for approval in the coming weeks, would involve 2,500 to 3,000 participants in a comparative trial, in which half would receive the Providence vaccine and the other half would get an already approved vaccine.
Dr. Michael Gardam, an infectious disease and infection control expert overseeing Health PEI, said Providence may struggle to get unvaccinated volunteers as people line up for the already licensed product.
"If you have a product that works really, really well, people tend to want that product."
The people farther down on the vaccine priority list, though, may find this vaccine trial attractive, Gardam said.
'Negligible' federal support: CEO
Sorenson says Providence expects to complete all of the clinical trials in September or early October at which point it will file with Health Canada for emergency use authorization.
"We've spent just over $13 million to date on our program," said Sorenson who anticipates bringing in an additional $30 million through a convertible debenture that will be made available to existing shareholders.
Providence has received some funding from the federal government. A spokesperson from the National Research Council's Industrial Research Assistance Program says it has committed to provide up to $4.7 million to Providence for Phase 1 clinical trials.
"You know how much money I've received from the federal government to date? Just over $2 million," said Sorenson.
"And quite frankly, I could give it back tomorrow. I have received negligible support from the federal government."
He says the money he is receiving from the province is a down payment for a product, one that he is not sure will still be needed by Manitoba 10 months from now.
"I hope that by then, the federal government has been able to come through on its promise and that Canadians are all vaccinated. If that's the case, we'll sell these vaccines into the international marketplace and Manitoba will be able to recoup its costs. It's insurance," said Sorenson.
With files from Ian Froese