Canadian biopharma company Medicago, a subsidiary of Japan’s Mitsubishi Tanabe Pharma (TYO: 4508), and UK pharma major GlaxoSmithKline (LSE: GSK) have announced that Health Canada has granted approval for Covifenz, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted).

This vaccine, formerly dubbed MT-2766, is indicated for active immunization to prevent coronavirus disease 2019 (COVID‑19) caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18 to 64 years of age.

Medicago received C$173 million ($131 million) from the Canadian government to help develop its plant derived virus-like particle (VLP) vaccine, MT-2766.

“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 chief executive 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,” he added.

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.”

Government supply contract

The Canadian government has a contract with Medicago (the Marketing Authorization Holder) to supply the COVID-19 vaccine. Medicago says it is committed to fulfilling this order as soon as possible.

“As one of our government’s top priorities has been to reverse the 40-year decline faced by Canada’s biomanufacturing sector, we are pleased to see Medicago’s vaccine approval. It is a great milestone for Canada’s biotechnology sector and for homegrown innovation. We will continue to support companies that want to produce vaccines in Canada and join the growing national biomanufacturing sector.” said François-Philippe Champagne, Canada’s Minister of Innovation, Science and Industry.

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.

About Covifenz

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 (3.75mcg of CoVLP antigen in combination with GSK pandemic adjuvant in the same injection). The vaccine is stored at 2 °C to 8 °C.  Covifenz antigen will be manufactured in Canada and in North Carolina (USA).

Covifenz is not currently approved or authorized for the prevention of COVID-19 or any other indication anywhere other than Canada.

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