Well being Canada has begun a rolling evaluation of the primary Canadian-based COVID-19 vaccine candidate.
Medicago, a biopharmaceutical firm headquartered in Quebec Metropolis, introduced on April 23 that Well being Canada had accepted its submission for a rolling evaluation of its vaccine.
The corporate’s COVID-19 vaccine makes use of “virus-like-particles,” a know-how that mimics the construction of the coronavirus however doesn’t really comprise any genetic materials from it, making it non-infectious.
It additionally comprises an adjuvant from pharmaceutical firm GlaxoSmithKline, which helps create a “stronger and longer-lasting” immunity than the vaccine would alone.
Medicago’s COVID-19 vaccine requires two doses that are administered 21 days aside.
The corporate has begun a Section 3 scientific trial of its vaccine, which can enroll as much as 30,000 people in as much as 10 international locations, together with Canada, the US, the UK, and Brazil.
The trial will initially give attention to wholesome people between the ages of 18 and 65, adopted by these over the age of 65 with comorbidities.
As soon as the “efficacy and security endpoint” of the trial has been reached, the final portion of the corporate’s rolling submission to Well being Canada will likely be filed.
Below an interim order issued in September 2020, Medicago can submit info to Well being Canada because it turns into out there, moderately than on the completion of all research, to speed up the evaluation course of.
Nonetheless, Well being Canada is not going to authorize any vaccine to be thought of beneath a rolling evaluation till it has obtained the “full proof” required to help its benefit-risk evaluation, together with the protection, efficacy, and high quality of the vaccine.
“We’re grateful to Well being Canada and look ahead to persevering with to work with them as they transfer ahead with evaluation,” stated Carolyn Finkle, Medicago’s Chief Working Officer.
Thus far, Well being Canada has authorised 4 COVID-19 vaccines from worldwide producers to be used.
The Moderna, Pfizer-BioNTech, AstraZeneca, and Janssen Inc. (Johnson & Johnson) vaccines are all made abroad, together with within the US and India, and shipped to Canada.