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
Binarly to Unveil “Broken Trust” Research: Firmware Bypass Chains, BMC Persistence, and EDR Evasion15.1.2026 23:04:00 CET | Press release
Binarly, the industry leader in software and firmware supply-chain security, today announced an upcoming DistrictCon presentation “Broken Trust: Firmware Bypass Chains, BMC Persistence, and EDR Evasion.” The session will detail how firmware-level attack chains observed in shipped enterprise devices can effectively undermine modern endpoint defenses, enabling stealthy compromise and long-lived persistence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115834965/en/ Binarly Unveils Broken Trust Research: Firmware Bypass, BMC Persistence In this presentation, the Binarly REsearch team will dismantle the assumption of hardware trust by presenting multiple real-world firmware bypass chains. Alex Matrosov and Fabio Pagani will provide a deep dive into the specific vulnerability classes and exploitation primitives that make these attacks reliable in practice. The team will also deliver a live demonstration compromising a fully
Coolbrook Named on the 2026 Global Cleantech 10015.1.2026 18:14:00 CET | Press release
Coolbrook, a transformational technology and engineering company on a mission to decarbonise major industrial sectors like petrochemicals and chemicals, iron and steel, aluminium, and cement, has been named on Cleantech Group’s 2026 Global Cleantech 100. This annual list recognizes companies poised to deliver market-ready solutions that advance a cleaner, more resilient global future. The report highlights innovators addressing some of the world’s most urgent environmental and infrastructure challenges. The complimentary report introduces you to innovators advancing groundbreaking technologies and business models to enable us to act on the ever-increasing climate and environmental crisis. Following a 2025 marked by geopolitical volatility and shifting economic signals, the global cleantech ecosystem enters 2026 with slightly greater certainty - yet heightened competitive pressure. Growth is concentrating around two dominant themes: AI infrastructure and critical minerals. “The 2026 Glo
World Economic Forum and Salesforce Empower Global Leaders With First-of-its-Kind Agentic Assistant for the 2026 Annual Meeting in Davos15.1.2026 18:01:00 CET | Press release
The Forum activates its vast data stores through Agentforce 360, enabling a level of preparation and decision-making for its over 3,000 attendees previously unachievable by human processing alone Salesforce (NYSE: CRM), the world’s #1 CRM, today announced the activation of the World Economic Forum’s institutional knowledge powered by Agentforce 360 to support over 3,000 of the world’s most influential leaders at the 2026 World Economic Forum Annual Meeting. The Forum has launched a new proactive, high-precision concierge app, “EVA,” built on the Agentforce 360 Platform, Salesforce’s agentic platform. EVA will empower attendees to move beyond traditional information access, with an AI agent that doesn’t just answer questions, but can reason, prioritize, and act on a leader’s behalf for the 2026 Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115571119/en/ Scheduled for January 19–23 in Davos, Switzerland, th
Frasca to Supply Four New Flight Training Devices to Global Medical Response15.1.2026 16:05:00 CET | Press release
New Level 7 FTDs will support pilot training for emergency medical operations Frasca International, Inc., a FlightSafety International company, today announced it has signed a contract with Global Medical Response (GMR) to supply four new Level 7 Flight Training Devices (FTDs). The new devices include an Airbus EC135, a Pilatus PC-12, a Beechcraft C90, and a Beechcraft B200. Each FTD will feature Frasca's unique motion system to provide enhanced realism in training. The devices will be installed at GMR’s new training facility currently under construction in Denton, Texas. Frasca has supported GMR’s pilot training efforts for nearly two decades, beginning with the delivery of their first device in 2005 for Air Evac Lifeteam, a GMR company. Since then, Frasca simulators have played a central role in preparing GMR’s flight crews for the complex and high-stakes environments they encounter in emergency medical operations. With the delivery of these new devices, GMR will operate a total of 1
illumynt Reports 60% Revenue Growth and Launches Global Innovation Center to Meet Rising Enterprise Security and Sustainability Demands15.1.2026 15:11:00 CET | Press release
illumynt an intelligent, security-first technology lifecycle partner, today announced significant growth and innovation milestones that position the company as a leader in the next evolution of the IT Asset Disposition (ITAD) industry—an industry increasingly shaped by artificial intelligence, accelerated hardware refresh cycles, and heightened regulatory scrutiny. Under the leadership of CEO Joerg Herbarth, illumynt continues to execute its mission to deliver intelligent, technology-driven lifecycle solutions that maximize sustainability, security, and recovery value for the world’s most compute-intensive organizations. In 2025, ITAD became a strategic imperative. AI-driven workloads have dramatically compressed infrastructure lifecycles, while updates to NIST SP 800-88 Rev. 2, adoption of R2v3, and the expansion of global privacy frameworks have raised expectations for auditability, transparency, and verified data security. As a result, ITAD has evolved from a back-end operational fu
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