What we know so far about Quebec-headquartered Medicago's plant-based vaccine candidate

Medicago, a Quebec City-based biopharmaceutical company has sent the first portion of plant-derived COVID-19 vaccine candidate rolling submission to Health Canada for review.The Interim Order (IO) rolling submission allows the company to submit relevant information as it becomes available to Health Canada to expedite the review process. "Health Canada will not decide on whether to authorize any vaccine being considered under the IO rolling review until it has received the complete evidence to support the risk/benefit decision based on safety, efficacy and quality of the COVID-19 vaccine candidate," noted a release from the company.Medicago is conducting the Phase 3 trial in tandem with the review of its rolling submission, after which it will submit the final portion of its IO rolling submission. The company has received regulatory approval for its Phase 3 portion of its Phase 2/3 clinical development in Canada, the U.S., the U.K. and Brazil."Health Canada's decision to accept for review the IO rolling submission for Medicago's vaccine, the first Canadian-based COVID-19 vaccine submission, meets an important milestone.," said Carolyn Finkle, chief operating officer of Medicago. "We are grateful to Health Canada and look forward to continuing to work with them as they move forward with review of our COVID-19 vaccine IO rolling submission."The vaccine candidate uses Coronavirus-Like-Particle (CoVLP) technology. The vaccine is comprised of "recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK's pandemic adjuvant."Two 3.75 microgram doses of CoVLP are administered 21 days apart. The Phase 3 portion of the trial is set to be an event-driven, randomized, observer-blinded two-way cross-over to analyze the formulation's safety and efficacy compared to a placebo. Initially, it will enroll up to 30,000 healthy subjects from 18 to 65 years of age, followed by adults over 65 and adults with comorbidities. The company intends to have the trial take place in 10 countries, pending regulatory approval, with Canada being one of the first.

What we know so far about Quebec-headquartered Medicago's plant-based vaccine candidate

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