Plant-based COVID-19 vaccine approved
pharmafile | February 25, 2022 | News story | Medical Communications |
Medicago and GlaxoSmithKline (GSK) have announced the approval by Health Canada of COVIFENZ®, a COVID-19 vaccine manufactured in plants, with virus-like particles [VLP], developed in Canada. The vaccine is indicated for active immunisation to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) in individuals 18 to 64 years of age.
“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.”
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.
“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 the Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry.
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.
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.”
Discussions with other regulators, including the MHRA and WHO, are also underway to enable global supply of the vaccine.
Ana Ovey
