HEALTH Canada on Thursday authorized Medicago’s Covifenz COVID-19 vaccine for the prevention of COVID-19 in adults 18 to 64 years of age.
After a thorough and independent scientific review of the evidence, the Department has determined that the vaccine meets Health Canada’s stringent safety, efficacy and quality requirements, and that the benefits of this vaccine outweigh the potential risks.
This is the first authorized COVID-19 vaccine developed by a Canadian-based company, and the first that uses a plant-based protein technology. Medicago’s Covifenz is authorized as a two-dose regimen of 3.75 micrograms per dose, to be administered 21 days apart.
In clinical trials, the vaccine was found to be 71 per cent effective against symptomatic infection and 100 per cent effective against severe disease caused by COVID-19. These studies were conducted while there were multiple variants in circulation. The data suggest efficacy against multiple variants, including Delta. Clinical trials with Covifenz showed efficacy against the Delta and Gamma variants, and data also suggesting efficacy against Alpha, Lambda and Mu variants. While additional confirmatory data are needed, preliminary and exploratory data shows that Covifenz produces neutralizing antibodies against the Omicron variant.
Health Canada has placed terms and conditions on the authorization. Medicago must continue to provide information to Health Canada on the safety and efficacy of the vaccine, including protection against current and emerging variants of concern as soon as it is available
The vaccine is authorized for use in adults 18 to 64 years of age, based on the data that was reviewed by Health Canada. There was limited enrolment of participants older than 65 years of age in the clinical trials because a large proportion of older individuals were already vaccinated. Medicago is currently gathering data in older individuals to support regulatory authorization for this age group.
In keeping with the Department’s commitment to openness and transparency, Health Canada said it is publishing multiple documents related to its decision, including a high-level summary of the evidence it reviewed to support the authorization of the vaccine. More detailed information will be available in the coming weeks, including a detailed scientific summary and the full clinical trial results that support the use of this vaccine.
Health Canada and the Public Health Agency of Canada will continue to closely monitor the safety of this vaccine, and will take action if any safety concerns are identified.
For detailed information on authorized vaccines and treatments in Canada, visit the COVID-19 vaccines and treatments portal.