Health Canada has authorized the use of the Medicago COVID-19 vaccine for adults 18 to 64 years of age.
Officials said Covifenz was approved after a thorough and independent scientific review of the evidence.
Health Canada reports the shot meets their stringent safety, efficacy and quality requirements, and that the benefits of this vaccine outweigh the potential risks.
In clinical trials, Health Canada said 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.
Health Canada said 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 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.
