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With Two Firsts, Health Canada Approves Medicago's Covifenz COVID-19 Vaccine

This is the first authorized COVID-19 vaccine that was developed by a Canadian-based company, and the first that used a plant-based protein technology.

Quebec City-based biopharmaceutical company, Medicago, and GlaxoSmithKline (GSK) announced Health Canada approved the Covifenz COVID-19 vaccine today.

This makes it the first authorized vaccine developed in Canada and the first to use plant-based virus-like particles. The vaccine is indicated to prevent COVID-19 in adults 18 to 64 years of age. The vaccine calls for 2 doses administered 21 days apart, using 3.75 micrograms of Coronavirus-Like Particle (CoVLP) technology antigen in combination with GSK pandemic adjuvant in the same injection.

“The approval of our COVID-19 vaccine is a significant milestone for Canada in the fight against the pandemic. We appreciate Health Canada’s timely review,” Medicago President and CEO Takashi Nagao, said.

GSK is collaborating with companies and research groups who are working on COVID-19 vaccine candidates utilizing their vaccine adjuvant technology.

The Canadian health agency based its approval on 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.

The Vaccine and Plant Technology

The vaccine uses a CoVLP technology, and it’s composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs) co-administered with GSK’s pandemic adjuvant. The vaccine is stored at 2 °C to 8 °C. Covifenz antigen will be manufactured in Canada and in the US.

The CoVLP technology synthesizes the virus's genetic code so that its genetic instructions can be read by plants, according to the Health Canada website.

“The living plants are used as bioreactors in the vaccine development process to produce a non-infectious particle that copies the target virus. The plant-based technology is developed in carrier plants. These can include relatives to the potato, corn, tobacco or others. These plants are widely used in plant biotechnology as a host because of the large number of viruses that can successfully infect it. The technology uses the plant's natural cell process to produce protein virus-like particles (VLPs). The code containing the genetic instructions is inserted into bacteria, which then carry the information into the plant's cells. The plants quickly produce large quantities of these particles, which is the most important ingredient in the vaccine.The particles are injected into your body through a muscle. Once injected, they copy the structure of the virus. They do this so the immune system will recognize them as a virus that the body must protect itself against. The VLPs are non-infectious. Through this process, your body can mount a strong immune response against the spike protein without exposing you to SARS-CoV-2,” Health Canada wrote on its website.

The Canadian government has a contract with Medicago to supply their COVID-19 vaccine, and the company is already preparing vaccines for shipment. “We are manufacturing doses to start fulfilling its order,” Nagao, said.