In a few weeks, a potential COVID-19 vaccine developed in Quebec will become the first Canadian candidate vaccine to enter human trials. Nathalie Landry, executive vice president of scientific and medical affairs for Medicago, the biopharmaceutical company behind the vaccine, told CTV News that they “had completed the preclinical development of this vaccine” and that they were “only” a few weeks [from] initiate our first clinical trials in humans. ”
Research teams from Laval University have collaborated with the company to develop the candidate vaccine. Both the federal and Quebec governments have contributed to the development of the vaccine.
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 previous tests on the animal vaccine, which is produced in tobacco plants, mice began to produce 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 start the human trials, and that Health Canada is currently reviewing it.
“If we get approval in time, we will recruit subjects and start this study by mid-July,” she said.
The first phase is “designed to assess the safety and immunogenicity of the vaccine,” she said. It will welcome adults aged 18 to 55 and will take place in a clinical site in Montreal.
“If all goes according to plan, this first phase will produce results by the end of August and by September, we will select the best vaccine treatment option,” said Landry.
Phase two of the trials is expected to start in October.
The company has two main facilities that could produce the vaccine itself if it were allowed to go into production. A facility is located in Quebec, but they also have a larger facility in North Carolina.
“This is a commercial facility that can produce a higher dose volume,” said Landry. “So the production will go to both places. ”
So far, the company has only used the Quebec facility to produce the vaccine.
She said that in future trials, once the safety of the vaccine is assured, they would like to have a “global study” of the vaccine in order to properly test its effectiveness.
“We need to have global distribution to make sure we are in a region that [is] unfortunately COVID-19 cases, ”she said.
Landry says that to get an officially licensed vaccine for commercial production, “you have to prove that the vaccine is safe, immunogenic and effective. ”
It is difficult to determine when the vaccine could be made available to the public, as it all depends on the duration of subsequent trials to study the efficacy. In special cases, where there is sufficient data on the efficacy and safety of the vaccine from phase two trials, the government can intervene and consider speeding up production by authorizing it for emergency use, a said Landry.
A decision could also be made to make a vaccine available to certain segments of the population from the start, Landry said. But assuming the vaccine goes through the normal process, it should go through a third phase first.
“Hopefully around the same time next year, we will be close to this end,” she said.