Health Canada starts rolling review of CoVLP + pandemic adjuvant system for COVID-19.- Medicago

Medicago announced that Health Canada has received the first portion of Medicago’s CoVLP + pandemic adjuvant system (plant-derived COVID-19 vaccine candidate) rolling submission for review on April 19, 2021. The Interim Order (IO) rolling submission allows Medicago to submit nonclinical sections, quality and clinical safety, and efficacy information as they become available for Health Canada’s immediate review to accelerate the overall 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. In parallel with the review of the rolling submission, Medicago is conducting the Phase III trial. The last portion of the IO rolling submission will be filed after the COVID-19 vaccine efficacy and safety endpoint of the Phase III trial is reached.