Health Canada has approved Medicago and GlaxoSmithKline’s (GSK) plant-based virus-like particles (VLP), recombinant, adjuvanted Covid-19 vaccine, Covifenz.
Leveraging the Coronavirus-Like Particle (CoVLP) technology, Covifenz has recombinant spike (S) glycoprotein expressed as VLPs administered along with pandemic adjuvant of GSK.
According to the latest approval, the vaccine is intended for active immunisation to prevent Covid-19 in people aged 18 to 64 years.
Two intramuscular doses of Covifenz will be given at a gap of 21 days.
Medicago, which is the marketing authorisation holder of the vaccine, currently has a contract in place to deliver Covifenz to the Government of Canada.
Medicago noted that the company is committed to satisfying the order soon.
The regulatory agency based the latest approval on scientific findings submitted by Medicago as part of the rolling submission that commenced in April last year under an Interim Order.
The submission was concluded on filing the New Drug Submission-CV with Health Canada.
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.
“We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions.”
Manufactured in plants and developed in Canada, the vaccine can be stored at 2°C to 8°C.
The antigen for Covifenz will be produced in Canada, as well as in North Carolina in the US.
In July 2020, GSK collaborated with Medicago for the development and production of a plant-based adjuvanted Covid-19 vaccine candidate.
Under the partnership, GSK’s pandemic adjuvant system was integrated with Medicago’s recombinant CoVLP that imitates the structure of the new coronavirus. It also facilitates the detection by the immune system.