Medicago, Maker of First Canadian COVID Vaccine Candidate, Submits Final Application to Health Canada

Medicago, Quebec’s maker of a plant-based COVID-19 vaccine, has submitted its final test data to Health Canada, leaving the ball in the court of the federal regulator, as Canada gets one step closer to having a vaccine from homegrown.

Earlier this month, the biopharmaceutical company announced that its dose was 71 percent effective against most variants of the virus, although its tests were completed before the appearance of the Omicron variant.

Now that all of your safety, efficacy, and manufacturing data has been released to Health Canada, federal experts will review it before making a decision on whether to approve the vaccine for use.

“If licensed, Medicago’s COVID-19 vaccine would be the world’s first herbal vaccine approved for human use,” said Takashi Nagao, Medicago CEO and president, in a statement.

“It would also be the first Canadian vaccine approved in more than 20 years, signaling a powerful step forward for Canada’s vaccine preparation strategy.”

A green light from Health Canada would make the Medicago dose the first COVID vaccine developed primarily in this country. (The company partnered with pharmaceutical giant GlaxoSmithKlein, which provided an adjuvant, a substance designed to make a vaccine more potent.)

The federal government has already signed an advance purchase agreement for the dose, meaning Canada is entitled to 20 million initial doses, with options to buy up to 56 million more. The company received $ 173 million in federal funding to accelerate the development process and help build a large-scale vaccine production facility in Quebec City.

It is on track to begin manufacturing vaccines in late 2024.

Medicago has also started the regulatory process in the United States and the United Kingdom, but given the public funding provided by the federal government, Canada would have been concerned about dosages, a company spokesperson previously told the Star.

Medicago dosing is a different “platform” than all currently available vaccines and does not use mRNA like Pfizer and Moderna. Instead, the company is using a cousin of a tobacco plant to produce what are called virus-like particles, which trick the immune system into generating a response that can then fight the actual virus.

The latest news comes as concern over the vaccine supply has been revived by the Omicron specter, as medical authorities across the country scramble to get the third vaccine, or booster, in arms. Multiple prime ministers have urged the federal government to begin importing more than the currently authorized doses to meet that demand.

While Medicago’s current application is to use its injection as a regular two-dose vaccine, the company’s plans said it plans to begin testing it as a booster shot in the next few weeks.

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