A Quebec-based biopharmaceutical company has submitted an application for a real-time review of its COVID-19 vaccine.
Medicago, which is headquartered in Quebec City, says Health Canada is currently reviewing data from the first portion of its plant-derived vaccine candidate
Under an Interim Order (IO) rolling submission, the company is able to submit findings in real time as it becomes available in order to to accelerate the overall review process.
Health Canada says it will not make a decision on whether to authorize the vaccine under the rolling review until it has received the complete evidence to support the safety, efficacy and quality of the COVID-19 vaccine candidate.
Health Canada has authorized four vaccines to be used in the fight against COVID-19.
Medicago’s plant-derived vaccine uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GlaxoSmithKline’s pandemic adjuvant. It requires two doses of the vaccine to be administered 21 days apart.
Medicago says it will begin conducting Phase 3 trials in 10 countries, starting with Canada, the U.S., Britain and Brazil involving up to 30,000 adults between the ages of 18 and 65 years. There are also plans to trial the vaccine in those 65 years-plus and adults with cormorbidities.