Medicago, a biopharmaceutical company headquartered in Quebec, and GlaxoSmithKline were granted approval for COVIFENZ COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted), by Health Canada. The vaccine is indicated for active immunization to prevent coronavirus disease caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18 to 64 years of age.
 
The Government of Canada has a contract with Medicago to supply the COVID-19 vaccine. Medicago is committed to fulfilling this order as soon as possible.
 
Health Canada based its decision 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.
 
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. The vaccine is stored at 2 °C to 8 °C.  COVIFENZ® antigen will be manufactured in Canada and North Carolina.
 
“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.”
 
Roger Connor, President of GSK Vaccines, added, “This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect people against COVID-19 disease. We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions.”