Health Canada has granted approval for GlaxoSmithKline and Medicago’s Covifenz vaccine, a plant-based virus-like particles (VLP), recombinant, adjuvanted vaccine, for active immunization to prevent COVID‑19 caused by SARS‑CoV‑2 in individuals 18 to 64 years of age.
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).
According to the companies, 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.
“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.”
The Government of Canada has a contract with Medicago (the Marketing Authorization Holder) to supply the COVID-19 vaccine.
“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.”
“Today is a great day for Medicago as Covifenz becomes its first approved vaccine. I’d like to thank the Clinical Investigators involved in our trials as well as Medicago’s passionate and curious team of over 500 scientific experts and employees. Today only reinforces our commitment to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide.” said Yosuke Kimura, Chief Scientific Officer at Medicago.