Health Canada approves Covifenz for COVID-19.
Medicago and GlaxoSmithKline announced that Health Canada has granted approval for Covifenz, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted).
This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 to 64 years of age. Health Canada based its decision on scientific data shared by Medicago as part of their rolling submission that began in April 2021 under an Interim Order, and concluded with the filing of a New Drug Submission-CV.
Covifenz uses Coronavirus-Like Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs) co-administered with GSK’s pandemic adjuvant. The vaccination regimen calls for two doses given intramuscularly 21 days apart (3.75 micrograms of CoVLP antigen in combination with GSK pandemic adjuvant in the same injection). The vaccine is stored at 2 °C to 8 °C. Covifenz antigen will be manufactured in Canada and in North Carolina (US). Covifenz is not currently approved or authorized for the prevention of COVID-19 or any other indication anywhere other than Canada.
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