Montrealers are helping test the only Quebec-made potential vaccine
MONTREAL -- As seniors at two long-term care homes in Quebec become some of the first to receive an American-produced COVID-19 vaccine, research on a potential homegrown solution is advancing on the very same day.
Dozens of Montrealers volunteered to be part of the project and had to present themselves at the MUHC Vaccine Study Centre in the West Island on Monday
There, the first participants were scheduled to receive doses of an experimental COVID vaccine, developed by the Quebec City-based company Medicago, according to site director Dr. Michael Libman.
The 50 or so people are rolling up their sleeves for a critical part of the process - Medicago’s Phase 2 trial, which is beginning about a month after the company released the results of Phase 1.
In mid-November, the company said the Phase 1 data revealed that two doses of its adjuvanted vaccine spurred a significant antibody response in 100 per cent of the trial subjects.
Phase 2 will involve “a small number of mostly young and healthy people and it’s part of a safety check,” said Libman, an infectious diseases expert who is also the MUHC’s director of the Centre for Tropical Diseases.
All the Montrealers taking part are volunteers and they weren’t hard to find, since the vaccine centre has been in operation in the West Island for more than two decades.
“There’s a community there that knows we do vaccine studies,” Libman explained, “and quite a few of them have called and have asked, hey, are you guys studying one of the COVID vaccines?”
Everyone was pre-screened before being accepted into the study to ensure they don’t have any pre-existing illnesses, said Libman, that would “interfere and make it difficult for us to figure out that the vaccine really is safe,” and also produces antibodies as expected.
The McGill University Health Centre is one of 10 sites in Canada testing the vaccine, including CHU de Quebec. There are also five sites in the United States. In all, 600 people will get the vaccine candidate during Phase 2.
A much larger group composed of a greater variety of types of people (age, health status, etc.) will be recruited for the Phase 3 clinical trial.
In an interview on CTV Morning Live in Ottawa at the end of November, the company’s chief medical officer Dr. Brian Ward said he hopes to launch Phase 3 by the end of the year.
"We hope that will be completed by the late spring and then it's really up to the data and the regulators."
Phase 3 is when they’ll evaluate the efficacy of the vaccine. In generic terms, that means “how well the vaccine really works,” said Libman.
But he said that’s a far more complex task than it seems because efficacy can be defined in many different ways: Does the vaccine prevent symptoms, does it prevent transmission, does it prevent disease?
In the case of the COVID-19 vaccine, it’s the regulator - Health Canada - that defines what the “end-point,” should be, Libman said.
So far, the goal of the COVID vaccines is to prevent serious disease, so “we don’t really know yet if they prevent asymptomatic disease or asymptomatic spread.”
That information will only become available after many more people are inoculated and more research is done on outcomes.
It’s all the unknowns that underscore the need for Medicago to forge ahead with its own vaccine candidate, said the MUHC specialist - even though Pfizer’s product is already being administered, and other vaccines like Moderna’s are advancing through the government’s regulatory system.
“In the end, the more options, the better. There’s a reasonable chance we’ll find out the vaccines don’t all behave exactly the same. There may be some that are more suitable for one population than another.”
Should it be approved, the Medicago product would be one of the few vaccines that would be manufactured in Canada, uses technology that allows it to be produced quickly, and wouldn’t come with complicated transport and storage requirements.
THE MEDICAGO VACCINE
Medicago said its vaccine candidate uses "coronavirus virus-like particles" (CoVLP), which mimic the virus to encourage an immune response without introducing any form of the actual virus to the human body.
In order to make its vaccine, Medicago uses technology that transfers a genetic code to a plant - a member of the tobacco plant family.
The plant will then produce the antigen that spurs on the immune response as if it was its own