Canadian biopharmaceutical company Medicago and its partner GSK have received Health Canada approval for Covifenz, their plant-based adjuvanted Covid-19 vaccine.

The plant-based vaccine is indicated for active immunisation to prevent Covid‑19 in individuals aged 18 to 64 years.

It leverages Coronavirus-Like Particle (CoVLP) technology and comprises recombinant spike (S) glycoprotein, co-administered with GSK’s pandemic adjuvant.

Covifenz is administered as a two-dose regimen, given intramuscularly 21 days apart.

Medicago intends to manufacture the antigen required for the vaccine in Canada and in North Carolina, US. The vaccine is stored at 2°C to 8°C.

Medicago president and CEO Takashi Nagao said: “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.

“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.”

GSK Vaccines president Roger Connor said: “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.”

Health Canada’s approval was based on scientific data shared by Medicago as part of their rolling submission commenced in April last year, and filing of a New Drug Submission-CV.

Established in 1999, Medicago is a biotechnology company focused on the discovery, development, and marketing of plant-based therapeutics vaccines and medications.

The company has a team of more than 500 scientific experts and employees, dedicated to using our technology to provide rapid responses to emerging global health challenges.

Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation, a large-scale pharmaceutical company based in Osaka, Japan.

The company has reached a contract with the Government of Canada to supply its plant-based Covid-19 vaccine.

Medicago chief scientific officer Yosuke Kimura said: “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.”