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
New RSA Agent for Admin Threats Now Generally Available in Microsoft Security Copilot18.11.2025 19:07:00 CET | Press release
RSA Security today announced the general availability of its RSA Advisor for Admin Threats agent in Microsoft Security Copilot. “AI is the force multiplier for defenders, and when partners bring their agentic innovation into the Security Copilot ecosystem, the impact is exponential. Together, we’re not just building tools—we’re creating a new era of intelligent, collaborative cyber defense.” - Vasu Jakkal, Corporate Vice President, Microsoft Security. “We accelerated development of the RSA Advisor for Admin Threats agent to give security leaders the essential AI capabilities they need to quickly detect and resolve high-risk activity or insider threats in RSA ID Plus for Microsoft tenants,” said RSA President, Chief Product and Strategy Officer Jim Taylor. “In a recent RSA survey of more than 2,100 global security leaders, agentic AI emerged as the top cybersecurity priority, and 91% said they plan to integrate AI into their tech stack. We’re working with Microsoft to meet customers’ de
True Announces New Investment Partnership with Integrum to Redefine the Future of the Executive Talent Industry18.11.2025 16:33:00 CET | Press release
True, the premier global executive talent platform driving the industry’s tech evolution through data, AI, and expertise, today announced a new strategic investment partnership with Integrum Holdings LP (“Integrum”), a private investment firm focused on partnering with tech-enabled professional services companies. Integrum’s significant investment will power True’s next phase of growth as it helps clients solve their most pressing talent and leadership needs. Since its founding over 12 years ago, True has become a disruptive force in the industry, growing from a boutique into the sixth-largest executive search firm in North America with over $350 million in revenue. True’s organic growth has been fueled by its highly talented professionals and culture of innovation. With a tech-first and entrepreneurial mindset, and focus on transparency, True has reshaped the executive talent landscape. Brad Stadler, co-founder and CEO of True, said, “I knew during our first meeting, the group at Inte
Klarna now available on Apple Pay in Denmark, Spain, and Sweden with France to follow18.11.2025 16:22:00 CET | Press release
3 countries join the U.S., Canada, and UK in offering the ability to pay with installments when checking out online and in person with Apple Pay Klarna, the global digital bank and flexible payments provider, announced today that its flexible payment products are now available when checking out on Apple Pay in Denmark, Spain, Sweden. The launch brings even greater flexibility and transparency to Apple Pay customers in these countries, with Klarna available to eligible users checking out online and in-app with an iPhone or iPad, and in-store on an iPhone. The expansion builds on successful launches of this feature in the US, UK and Canada, where millions of customers have checked out with Klarna through Apple Pay. Klarna is one of the first buy now, pay later providers to be available on Apple Pay in these countries, offering consumers a seamless, flexible way to pay. Customers in France will be able to check out with Klarna on Apple Pay in the coming weeks. “After the fantastic respons
Bitfury Launches $1 Billion Initiative to Advance Ethical Emerging Technologies18.11.2025 16:11:00 CET | Press release
The company will begin deploying funds as early as Q4 2025 Today, Bitcoin miner turned technology incubator Bitfury announced its pivot to an investment firm with the launch of its $1 billion funding initiative, which seeks to back a new generation of ethical innovators. The firm’s new mission is to close the gap between the accelerating pace of technological progress and the slower evolution of ethical development — a disconnect it sees as a root cause of many global challenges. By supporting mission-driven founders, the company seeks to accelerate ventures that embed ethics, transparency, and human values at the core of emerging technologies. Bitfury’s new chapter as an investment firm builds on its pioneering legacy while expanding its role from technology provider to global catalyst for responsible innovation — ensuring the digital economy develops with integrity and long-term sustainability. Bitfury was originally founded in 2011 as a bitcoin miner, but over the past 15 years has
Interactive Brokers Expands Global Market Access with the Taipei Exchange18.11.2025 16:00:00 CET | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global electronic broker, announced access to the Taipei Exchange (TPEx), further expanding its global reach. Eligible clients of Interactive Brokers can now trade equities, ETFs, and Taiwan Depositary Receipts (TDRs) listed on TPEx, alongside products from over 160 global exchanges from a single platform. This extends the opportunity set available to global investors seeking Asian exposure, including the growth potential afforded by emerging small and medium-sized companies listed on the TPEx. Interactive Brokers is one of the few global trading platforms connected to TPEx, a leading Asian exchange for shares of small and medium-sized enterprises (SMEs). Through TPEx, clients can diversify their portfolios to include emerging, high-tech, and creative industries, as well as SMEs and micro-enterprises across Taiwan’s developing economy. To simplify trading, Interactive Brokers will facilitate TPEx trades with an automatic FX conversion be
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