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Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.
Medicago and GlaxoSmithKline (GSK) announced on Feb. 24, 2022 that Health Canada has approved COVIFENZ, a plant-based, recombinant, adjuvanted COVID-19 vaccine. The vaccine is indicated for the prevention of COVID-19 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. Vaccination will consist of two doses administered intramuscularly 21 days apart.
The Government of Canada has a Marketing Authorization Holder contract with Medicago to supply the COVID-19 vaccine. Medicago is planning on fulfilling this order as soon as possible. Health Canada based its decision to approve the vaccine 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.
“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, in the press release. “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.”
“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,” added Roger Connor, president of GSK Vaccines, in the press release.“We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions.”