Covifenz, jointly developed by Canada's Medicago and British pharma giant GlaxoSmithKline, has become the world's first plant-derived Covid vaccine to get approval.
The two-dose vaccine, approved by Health Canada, uses Coronavirus-Like Particle or CoVLP technology.
The Government of Canada has a contract with Medicago, which is affiliated to Mitsubishi Tanabe Pharma Corp., to supply the COVID-19 vaccine. The Canadian plant-based therapeutics company expects to make the vaccine available in Canada as soon as possible and to progress further regulatory submissions.
COVIFENZ is not currently approved or authorized for the prevention of COVID-19 or any other indication anywhere other than Canada.
The adjuvanted Plant-based vaccine is composed of recombinant spike glycoprotein expressed as virus-like particles or VLPs. The vaccine also pairs with GSK's pandemic adjuvant, a substance that boosts the body's virus-fighting response.
For the vaccine, Medicago reportedly uses nicotiana benthamiana, a close relative to tobacco plants, to easily host genetic material and grow particles that mimic viruses.
It 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. The vaccination regimen calls for two doses given intramuscularly in 21 days interval. The vaccine is stored at 2 °C to 8 °C.
Health Canada's decision was based 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 reportedly demonstrated 71% efficacy against multiple variants of the SARS-CoV-2 virus in a study of 24,000 adults.
Medicago expects to manufacture COVIFENZ antigen in Canada and in North Carolina, U.S.
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