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INSERTING and REPLACING Health Canada Initiates the Review of the Rolling Submission for the First Canadian-Based COVID-19 Vaccine Candidate

April 23, 2021 Off By BusinessWire

QUEBEC CITY, Quebec–(BUSINESS WIRE)–Insert “adjuvanted” before “COVID-19 vaccine” in first and fifth paragraphs.

The updated release reads:

HEALTH CANADA INITIATES THE REVIEW OF THE ROLLING SUBMISSION FOR THE FIRST CANADIAN-BASED COVID-19 VACCINE CANDIDATE

Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to announce that Health Canada received for review the first portion of Medicago’s plant-derived adjuvanted COVID-19 vaccine candidate rolling submission on April 19, 2021.

The Interim Order (IO) rolling submission allows Medicago to submit nonclinical sections, quality and clinical safety, and efficacy information as they become available for Health Canada’s immediate review to accelerate the overall review process. Health Canada will not decide on whether to authorize any vaccine being considered under the IO rolling review until it has received the complete evidence to support the risk/benefit decision based on safety, efficacy and quality of the COVID-19 vaccine candidate.

“Health Canada’s decision to accept for review the IO rolling submission for Medicago’s vaccine, the first Canadian-based COVID-19 vaccine submission, meets an important milestone,” said Carolyn Finkle, Chief Operating Officer of Medicago. “We are grateful to Health Canada and look forward to continuing to work with them as they move forward with review of our COVID-19 vaccine IO rolling submission.”

In parallel with the review of the rolling submission, Medicago is conducting the Phase 3 trial. The last portion of the IO rolling submission will be filed after the COVID-19 vaccine efficacy and safety endpoint of the Phase 3 trial is reached.

“We are pleased with the interactions with the Canadian regulatory authority, and we appreciate their guidance and confidence in Medicago to pursue the IO rolling submission in Canada for our adjuvanted COVID-19 vaccine candidate,” said Judith Atkins, Vice-President Regulatory Affairs at Medicago.

Medicago has received regulatory approval to launch the Phase 3 portion of its Phase 2/3 clinical development in Canada, USA, UK and Brazil.

Medicago’s plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK’s pandemic adjuvant. Two doses of 3.75 micrograms of CoVLP are administered 21 days apart.

The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation, compared to placebo. The study will enroll up to 30,000 subjects initially composed of healthy adults (18y to 65y), followed by elderly adults (65y+) and adults with comorbidities. The trial will take place in 10 countries pending regulatory approvals, starting with Canada, the USA, the UK, and Brazil enrolling males and females from ethnically and racially diverse populations.

Information about how to participate in this clinical trial is available at http://www.CoVLPvaccine.com

About Medicago

Medicago is on a mission to 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-derived 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.

For more information: www.medicago.com