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
EsriIntroduces Latest ArcGIS Integrations for Microsoft Fabric18.11.2025 23:05:00 CET | Press release
Users Can Now Access a Powerful Combination of Spatial Analytics and Intelligent Mapping Esri, the global leader in location intelligence, today announced General Availability of ArcGIS GeoAnalytics for Microsoft Fabric. Also now in public preview is ArcGIS Maps for Microsoft Fabric, a mapping tool enabling users to easily add context with business, lifestyle, demographic, and environmental data to enrich enterprise data in Microsoft OneLake. “This integration makes some of Esri’s core capabilities accessible for data professionals directly from their Microsoft Fabric environment,” said Jack Dangermond, Esri president. “We are pleased to advance our long-standing strategic collaboration with Microsoft to help our shared customers unlock spatial insights and reveal unexplored patterns.” There has been growing market demand among data scientists, data engineers, business analysts, and their executive stakeholders for spatial analytics and mapping. Esri’s GeoAnalytics for Fabric will allo
Andersen Consulting indgår samarbejdsaftale med Business Meets Culture18.11.2025 22:18:00 CET | Pressemeddelelse
Andersen Consulting udvider sin globale rækkevidde gennem en samarbejdsaftale med Business Meets Culture (BMC), der er en global strategikonsulentvirksomhed med lokationer i Latinamerika, Europa og USA. Med afsæt i kulturel intelligens og indsigt i menneskelig adfærd specialiserer BMC sig i strategi, brandstrategi, kommerciel planlægning, innovation og altid transformation. Med deres egne metoder og tværfaglige teams hjælper BMC virksomheder med at knytte strategi tættere til mennesker ved at omsætte udvikling, adfærd og forretningsmæssige udfordringer til relevante muligheder for vækst. Virksomheden samarbejder med førende aktører på tværs af brancher som forbrugsvarer, finansielle tjenester, telekommunikation og teknologi. "Samarbejdet med Andersen Consulting giver os mulighed for at styrke rækkevidden og effekten af vores kulturelt forankrede strategiske arbejde," siger Fernando Parodi, som er CEO for BMC. "Sammen står vi endnu stærkere og kan tilbyde organisationer skarpere perspek
Finalists Announced for 2026 SPIE Startup Challenge, Showcasing Innovative, Investment-Ready Optics and Photonics Technologies and Applications18.11.2025 22:05:00 CET | Press release
The annual pitch competition final will be held at SPIE Photonics West Sevenearly-stage startup companies have been selected to compete for a top prize of $10,000 at the 16th annual SPIE Startup Challenge at Photonics West on 20 January. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118106028/en/ Eventual winner, Trey Daunis of Max-IR Labs, pitches their innovative technology during the 2025 SPIE Startup Challenge, engaging judges and a packed audience at SPIE Photonics West. The SPIE Startup Challenge is a competitive entrepreneurial platform for new businesses that utilize optics and photonics for innovative products or applications. Participating teams are competing for sponsored prizes, in addition to gaining increased visibility with potential investors and exposure to potential collaborators or partners. Cash prizes of $10,000, $5,000, and $2,500, provided by Startup Challenge Founding Partner Jenoptik, will be awa
Owkin Unveils Europe’s First Pan-European Agentic Infrastructure for Biology at the Franco-German Digital Sovereignty Summit18.11.2025 21:48:00 CET | Press release
At today’s Franco-German Summit on Digital Sovereignty in Berlin, Owkin, together with leading academic partners Gustave Roussy (France) and Charité Comprehensive Cancer Center (Germany), announced a landmark initiative to build the first pan-European agentic infrastructure to make biological data AI-ready, as a key step towards biological super intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118529021/en/ Thomas Clozel (CEO of Owkin) joins Emmanuel Macron, Friedrich Merz and others at the Franco-German Digital Sovereignty Summit The project aims to develop and deploy modern AI methods to support biological research and drug development. An initial focus will be on supporting the harmonization and structuring of biomedical data across Europe to enhance scientific collaboration. It will combine agentic AI systems and cutting-edge biomedical data structuring, to power a new reasoning model capable of automating
Reply at Microsoft Ignite 2025: Showcasing AI Innovation, Copilot Experiences, and Intelligent Enterprise Solutions18.11.2025 21:30:00 CET | Press release
Reply [EXM, STAR: REY] is taking part in Microsoft Ignite 2025, a premier event for technology professionals and decision-makers hosted by Microsoft, held from November 18 to 21 in San Francisco, California. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118836834/en/ A trusted Microsoft partner since 1996, Reply empowers organizations to innovate with Microsoft technologies, driving agility, intelligence, and sustainable growth. A trusted Microsoft partner since 1996, Reply empowers organizations to innovate with Microsoft technologies, driving agility, intelligence, and sustainable growth. With more than 2,000 Microsoft certifications across its network of companies – including Business Elements Reply, Cluster Reply, Solidsoft Reply, Light Reply, Root16 Reply, Valorem Reply, WM Reply and Zest Reply – the group has achieved all six Microsoft Solutions Partner designations. This year, Reply is also celebrating two major h
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