TORONTO —
In a couple weeks, a potential COVID-19 vaccine developed in Quebec will become the first Canadian-made vaccine candidate to enter human trials.
Nathalie Landry, executive vice president of Scientific and Medical Affairs with Medicago, the biopharmaceutical company behind the vaccine, told CTV News that they “have completed preclinical development for this vaccine,” and are only “a few weeks away [from] initiating our first clinical trials in humans.”
Research teams with Laval University worked with the company to develop the vaccine candidate. Both the federal government and the Quebec government have contributed funds towards the vaccine’s development.
Landry describes the vaccine as “a virus-like particle, […] produced in our unique manufacturing technology that uses plants.” It was developed after receiving the SARS-Cov-2 gene, which is the technical name for the virus that causes COVID-19.
In earlier animal testing of the vaccine, which is produced in tobacco plants, mice began producing a positive antibody response within 10 days of receiving a single dose, researchers said in May.
Landry said the company has submitted the vaccine for approval to begin human trials, and that is currently being reviewed by Health Canada.
“If we get approval in time, we will be enrolling subjects and beginning this study by mid-July,” she said.
The first phase is “designed to evaluate the safety and immunogenicity of the vaccine,” she explained. It will enrol adults aged 18 to 55, and will be conducted at a clinical site in Montreal.
“If everything goes as planned, this phase one would provide results by the end of August, and by September, we’ll be selecting the best vaccine treatment option,” Landry said.
Phase two of trials would launch in October.
The company has two main facilities that could produce the vaccine itself if it was cleared to go into production. One facility is located in Quebec City, but they also have a larger facility in North Carolina.
“That is a commercial facility that can produce a higher volume of doses,” Landry said. “So, production will go in both places.”
So far, the company has only used the Quebec City facility to produce the vaccine.
She said that, in later trials, after the safety of the vaccine has been assured, they would want to have a “global study” of the vaccine in order to properly test how effective it is.
“We need to have global distribution to make sure that we are in region that [is] unfortunately experiencing COVID-19 cases,” she said.
Landry says that to get a vaccine officially cleared for commercial production, “you need to prove that the vaccine is safe, immunogenic and effective.”
It’s hard to pinpoint when the vaccine could be available to the public, as it all depends on how long later trials to study efficacy take. In special cases, where there is enough data on how effective and safe the vaccine is from phase two trials, the government can step in and consider speeding up the production by authorizing it for emergency use, Landry said.
A decision could also be made to make a vaccine available early to certain sections of the population, Landry explained. But assuming the vaccine goes through the normal process, it would need to go through a third phase first.
“Hopefully around the same time next year, we will be close to that completion,” she said.
Source: – CTV News
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