Quebec-based Medicago Preps its Homegrown Plant-based COVID-19 Vaccine for Canada Approval, Touting Promising Phase 3 Data

Quebec, Canada-based Medicago, a company affiliated with Japanese Mitsubishi Tanabe Pharma Corporation (MTPC) Group, has submitted Phase 3 data of its homegrown plant-based Covid-19 vaccine candidate for review to Health Canada, a company press release said. The submission feeds into expectations that the shot will soon become the first Covid-19 vaccine to use virus-like particle (VLP) technology and the first plant-based vaccine to be approved. 

Medicago is a pioneer of plant-based therapeutics and its 500 member team, with manufacturing facilities in the U.S. and Canada, have been working on delivering a plant-based solution to emerging global health challenges, such as Covid-19.

The biopharmaceutical company uses its proprietary technology to produce VLPs in plants. These VLPs mimic the structural properties of viruses. However, they do not contain any genetic material and therefore cannot replicate and are not infectious. This makes them ideal vaccine candidates since they can be used to stimulate the immune system. VLPs made by other processes have been used as vaccines for over three decades. Medicago’s plant-based sourcing makes it unique.

Medicago’s Covid-19 Vaccine Candidate

For its Covid-19 vaccine candidate, Medicago also uses 3.75 micrograms of its plant-based antigen along with GlaxoSmithKline’s pandemic adjuvant. The two-dose vaccine regimen is given 21 days apart and was tested in adults over 18 years of age in Canada and the U.S. during Phase II trials and in over 24,000 subjects in various countries as part of the Phase 3 trials. Overall, the vaccine efficacy rate was 71 percent against all variants, the company had said in a previous press release. Its efficacy against the globally dominant Delta variant was 75.3 percent and 88.6 percent against the Gamma variant. The Omicron variant was not circulating during the period the study was carried out.

No serious adverse events were reported during the trials and reactogenicity was mild to moderate with symptoms lasting one to three days. Even after the second dose, only 10 percent of recipients experienced mild fever, the company added in the press release.

Under the rolling review process, Health Canada accepts submission of nonclinical data such as quality, efficacy, and data about clinical safety as and when they are available. With the latest submission, Medicago has completed the submission process and following Health Canada’s approval, the vaccine will be available in Canada.

“It would also be the first Canadian vaccine approved in over 20 years,” said Takashi Nagao, CEO of Medicago, in the press release. “If authorized, it would (also) be the world’s first-ever plant-based vaccine approved for human use.”

The Road Ahead

Medicago has also confirmed that it has begun the regulatory filing process with the US FDA and the Medicines and Health products Regulatory Agency (MHRA) in the UK. A submission for approval to the WHO is also underway. In Japan, Medicago has begun a Phase 1/2 trial and the company will apply for regulatory approval next spring when the data from its global Phase 2/3 trial becomes available, the press release said.

The company plans to publish the full results of the Phase 3 study in a peer-reviewed publication as soon as possible.

Author

Ameya Paleja