Study results were included in the submission to Health Canada leading to Notice of Compliance
Quebec City, May 5th, 2022 – Medicago today announced the publication of the results from the Phase 3 study of COVIFENZ®, COVID-19 Vaccine (plant-based virus-like particles [VLP], recombinant, adjuvanted), in the New England Journal of Medicine (NEJM). 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.
“We are proud to have our Phase 3 clinical trial published in the esteemed New England Journal of Medicine to be shared with the larger scientific community. Medicago’s scientific team has dedicated decades to the development of our proprietary plant-based vaccine manufacturing platform, and we are thrilled to see our results disseminated in this way,” said Marc-André D’Aoust, Executive Vice President, Innovation, Development and Medical Affairs at Medicago. “We hope that this exchange of research and knowledge will encourage and inspire future innovation in biomedical science and clinical practice.”
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.
“The world needs a diverse range of vaccine options to continue to fight COVID-19, and we are proud to be able to contribute”, said Toshifumi Tada, CEO and President at Medicago.
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. We are proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Our passionate and curious team of over 500 scientific experts and employees are dedicated to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide. Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation. For more information: www.medicago.com
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), 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&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. For further information please visit https://www.mt-pharma.co.jp/e/.