Shomporko Desk:-Canadian trials have just begun for a potential COVID-19 vaccine however its Quebec-based manufacturer is now making light of its expected effect.
Dr. Bruce Clark, president and CEO of the biopharmaceutical company Medicago, alerts observers against holding unrealistic desires that his product – or any of the numerous vaccines being developed all around – will carry the pandemic to a dramatic stop.
“Whatever vaccine we get in this first round – unless it’s a miracle – it’s not going to be perfect,” says Clark, whose company started trials for its proposed vaccine Monday in Quebec City.
“It’s going to must undergo development, it’s going to take probably years to come up with a knowledge of the right vaccine, the correct methodology. It’s no longer the panacea.
“To assume that we can have, in 18 months, the solution to a pandemic that comes around once in a generation, is naive.”
So much is still unknown about COVID-19, notes Clark, including how it may manifest during the flu season later this year.
He suspects a more likely scenario is that a vaccine will offer only part of the solution, along with new therapeutics and ongoing public health interventions.
Medicago’s first phase of clinical trials will test a plant-based product on 180 healthy men and women, aged 18 to 55.
The randomized, partially blinded study uses technology that does not involve animal products or live viruses like traditional methods.
Clark notes that vaccine developers typically use chicken eggs to propagate a virus, but Medicago uses recombinant technology involving the genetic sequence of a virus, with living plants as the host.
The resulting virus-like particles mimic the shape and dimensions of a virus, which allows the body to recognize them and spark an immune response.
Clark says the plant-based approach is significantly faster and offers more consistent results than egg-based or cell-based methods.
While it takes five to six months to propagate a virus in eggs, the plant-based technique requires just five to six weeks, he says.
The trial will evaluate three different dosages alone, or with one of two adjuvants provided by GlaxoSmithKline and Dynavax. An adjuvant can boost the effectiveness of a vaccine for better immunological response, thereby reducing the required dose, Clark adds.
He hopes to know the effectiveness of the adjuvants and dosing by October, and then kick off a second, more targeted trial phase involving about 1,000 participants.
Clark says the third phase would involve about 15,000 to 20,000 subjects, and maybe a global study, depending on the circumstances of the pandemic.
If the vaccine is successful, Clark points to another uncertainty.
Clark suggested similar hurdles could impact vaccine distribution, putting immediate pressure on Medicago to complete the construction of a large-scale manufacturing facility in its home base of Quebec City.
“Certainly, we need a facility in Canada,” Clark says.
“There’s no guarantee on the easy flow of materials back and forth across the border should we have a successful vaccine. We have to keep the focus on completing the Canadian facility so that we have the domestic capacity. I think this is what most countries are concerned about.”
By the end of 2023, the Quebec City plant is expected to be able to produce up to one billion doses of the COVID-19 vaccine annually.
Until then, Medicago says it expects to be able to make approximately 100 million doses by the end of 2021, assuming its trials are successful.
Clark says countries must temper any nationalist agendas that might emerge with a viable vaccine and acknowledge that the fight against COVID-19 is global.
Photo credit: BUSINESS WIRE
News source: The Canadian Press