MEDICAGO
Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to announce submission of the positive Phase 3 data for regulatory review by Health Canada as part of the New Drug Submission for COVID (NDS-CV) rolling review for Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant. Medicago is seeking review and approval for the vaccine candidate for indication in healthy adults, aged 18 years and above.
“We are pleased to submit our Phase 3 data as the final portion of the rolling submission for our COVID-19 vaccine candidate for review,” said Dr. Judith Atkins, Vice-President of Regulatory Affairs at Medicago. “We are grateful to Health Canada for their review, and we hope this brings Canadians and the world one step closer to having greater vaccine diversity.”
Thomas Breuer, Chief Global Health Officer, GSK, added: “We are one step closer to our goal of making this innovative adjuvanted, plant-based vaccine available. As a refrigerator-stable option that builds on our established adjuvant technology, we are hopeful it will play an important role in the efforts to overcome the COVID-19 pandemic.”
The New Drug Submission for COVID (NDS-CV) process allowed the submission of nonclinical sections, quality, clinical safety, and efficacy information as they became available for Health Canada’s immediate review to accelerate the overall review process. Submitting the Phase 3 data completes the submission process.
The regulatory filing process for the COVID-19 vaccine candidate has been initiated with the FDA (US) and MHRA (UK). Preliminary discussion is underway with the WHO for preparation of the submission. A Phase 1/2 trial has also been initiated in Japan where Medicago plans to submit for regulatory approval in combination with the Phase 2/3 global study results next spring. The vaccine candidate has not yet been approved by any health authorities.
“If authorized, Medicago’s COVID-19 vaccine would be the world’s first ever plant-based vaccine approved for human use,” said Takashi Nagao, CEO and President of Medicago. “It would also be the first Canadian vaccine approved in over 20 years, signaling a powerful step forward for Canada’s vaccine preparedness strategy.”
About 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) Group, 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 under its Medium-Term Management Plan 21-25 and is also working to develop new modalities of vaccines. MTPC Group 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. For further information please visit https://www.mt-pharma.co.jp/e/ .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216005780/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ahead of Holiday Season, Visa Identifies Five Transformative Forces Reshaping Global Payment Security20.11.2025 19:50:00 CET | Press release
New Biannual Threats Report Reveals Fundamental Shift in Fraud Operations as Criminals Adopt Industrial-Scale Tactics To celebrate International Fraud Awareness Week, Visa (NYSE: V) today released its Fall 2025 Biannual Threats Report, revealing five forces that are transforming the global payments security landscape. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120412198/en/ The report, produced by Visa's Payment Ecosystem Risk and Control (PERC) team, draws on intelligence from Visa's global network to identify how criminal operations are evolving with unprecedented speed, scale, and sophistication. "The payments ecosystem is experiencing a paradigm shift in how fraud operates," said Paul Fabara, Chief Risk and Client Services Officer at Visa. "Criminals are no longer working as opportunistic individuals-- they're operating like tech startups, building reusable infrastructure and deploying systematic, industrial-scale
Suzano Forms Partnership with Tencent and Ecofuturo Institute at COP30 for AI-Powered Conservation and Nature Education20.11.2025 18:25:00 CET | Press release
New agreement signed at COP30 will see organisations collaborating to use artificial intelligence tools for biodiversity monitoring and digital platforms to boost public engagement in conservation efforts. The world’s largest pulp supplier, Suzano, today announces the signing of a Memorandum of Understanding (MoU) with the multinational technology business Tencent and the Brazilian non-profit Ecofuturo Institute, to pioneer new digital approaches to drive public engagement in conservation. The collaboration will leverage Suzano’s expertise in sustainable forestry, Tencent’s cutting-edge digital technology, and Ecofuturo’s expertise in environmental education, to pilot joint initiatives in both Brazil and China. These include enhancing ecological awareness, accelerating biodiversity solutions, and leveraging digital platforms to foster public engagement in conservation. The partnership will result in a pilot project where advanced AI tools for species recognition developed by Tencent’s
EMVCo Working on How Global Specifications Can Support Agentic Payments20.11.2025 17:38:00 CET | Press release
EMVCo – the technical body that creates and manages EMV® Specifications and programmes that enable seamless and secure card-based payments worldwide – has announced that it is working on how global specifications can support innovation in agentic payment solutions by increasing trust and interoperability across the ecosystem. Agentic commerce is rapidly reshaping the shopping experience by enabling AI agents to act on the consumer’s behalf. This is driving significant momentum for agentic payments, which introduce AI agents as new actors that can initiate transactions with merchants – without requiring direct involvement from the consumer. While agentic payments have the potential to increase convenience and personalisation, they present unique considerations for how transactions are initiated, authenticated and secured. As industry adoption and innovation accelerate, a globally interoperable and scalable approach may be beneficial in realising trusted agentic payments for consumers, m
Université Paris-Saclay and Owkin: A Unique Alliance to Propel University Medical Research to the Top of the European Rankings Through AI20.11.2025 15:17:00 CET | Press release
Université Paris-Saclay and Owkin announce the signing of a memorandum of understanding to explore the potential of K Pro Free - Owkin’s AI co-pilot for biology - for use by Paris-Saclay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120130113/en/ K Pro Free will now be available to the entire Université Paris-Saclay community, and in particular teachers, researchers and doctoral students working in the biomedical sciences. The partnership includes workshops, training sessions and events designed to promote the discovery and adoption of K Pro Free, as well as the co-organization of communication and dissemination initiatives around the use of AI in health. In this way, the partnership will promote user training, but also enrich and continuously improve the co-pilot's models through feedback and use cases from the l’Université Paris-Saclay community. This partnership is part of Université Paris-Saclay’s strategy to integr
Frasca Advances Flight Training Technology with New Visual System Powered by Unreal Engine20.11.2025 15:05:00 CET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced the launch of VITAL FVS 100, the next evolution of its visual system technology. Building on the proven TruVision Global platform, VITAL FVS 100 was developed using Epic Games’ Unreal Engine and delivers unprecedented realism, scalability, and innovation in pilot training. The Unreal-powered VITAL FVS 100 system introduces major advancements in visual fidelity and training realism, further enhancing the capabilities of Frasca, a leading developer of flight simulators and training devices. The new system includes physically based renderings, advanced lighting effects, and a new volumetric cloud model that creates dynamic, weather-rich environments. Terrain imagery now includes one-meter resolution coverage for the contiguous United States and Hawaii, with expanded global datasets covering European buildings and tree covered regions. Additionally, enhanced particle effects re
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom