Health Canada has approved Covifenz, an adjuvanted plant-based COVID-19 vaccine developed by Medicago, a Quebec biopharmaceutical company and GlaxoSmithKline.
Medicago
Covifenz, which is administered with an adjuvant from GlaxoSmithKline is based on Coronavirus-Like Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).
Health Canada has approved the vaccine to prevent COVID-19 in individuals 18 to 64 years of age.
The vaccination regimen calls for two doses (3.75 microgram of antigen in combination with GSK’s pandemic adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 °C to 8 °C.
The company, after the successful Phase III trial, had said that the vaccine had 75.3% efficacy against the Delta variant, and 88.6% against the Gamma variant. No cases of the Alpha, Lambda and Mu variants were observed in the vaccinated group while 12 cases were observed in the placebo group. The Omicron variant was not circulating during the study.
Health Canada in a news release said, “In clinical trials, the vaccine was found to be 71 per cent effective against symptomatic infection and 100 per cent effective against severe disease caused by COVID-19. These studies were conducted while there were multiple variants in circulation. The data suggest efficacy against multiple variants, including Delta. Clinical trials with Covifenz showed efficacy against the Delta and Gamma variants, and data also suggesting efficacy against Alpha, Lambda and Mu variants. While additional confirmatory data are needed, preliminary and exploratory data shows that Covifenz produces neutralizing antibodies against the Omicron variant.”
Medicago’s approach takes the leaves of a plant as a bioreactor to produce one of the three spike proteins of the novel coronavirus, the S-spike. The plant is a close relative to tobacco, known as Nicotiana Benthamiana. The plant has a weak immune system which makes it a good host for virus-like particles (VLP).
VLPs are designed to mimic the native structure of viruses, allowing them to be easily recognized by the immune system. Because the VLPs lack core genetic material, they are non-infectious and unable to replicate.
VLP vaccines developed by other technologies, have traditionally been used worldwide for more than 30 years.
Medicago has been developing its plant-based technology for the past 20 years, using unique technology to produce Virus-Like Particles (VLP) for its protein vaccines.
According to the news release, Covifen antigen will be manufactured in Canada and in North Carolina (US).
“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,” said Takashi Nagao, President and CEO at Medicago. “We’re also grateful for the Government of Canada’s support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order.”
The Government of Canada has a contract with Medicago to supply the COVID-19 vaccine.