The Phase 3 trial studied the two-dose regimen of Covifenz given 21 days apart versus placebo in over 24,000 subjects aged 18 and above.
Common side effects in the vaccine group included injection site pain, headache, fatigue, fever, muscle aches, and chills.
Covifenz is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 to 64 years of age.
The safety and efficacy of Covifenz in individuals younger than 18 years of age or 65 years and older have not been established.
Covifenz has not yet received approval in other jurisdictions.
Covifenz was authorized for use by Health Canada on February 24, 2022. This is the first authorized COVID-19 vaccine developed by a Canadian-headquartered company, and the first that uses a plant-based protein technology.
Medicago is on a mission to help improve global public health using the power of plants.
Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-based therapeutics.
Mitsubishi Tanabe Pharma Corp., the majority parent company of Medicago, is one of the large Japanese pharmaceutical companies, with its headquarters in Osaka, Japan.
It positions vaccines as one of its key R and D areas and is also working to develop new modalities of vaccines.
MTPC will further contribute to the prevention of infectious diseases which is one of the world's important social issues, by delivering a new option of plant-based VLP vaccine as a new type of vaccine. MTPC is a member of Mitsubishi Chemical Holdings Group.
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