A Quebec-based biopharmaceutical company is beginning to recruit participants for its Phase 3 trial of a plant-derived COVID-19 vaccine.
In a Tuesday (March 16) news release, Medicago said that it had received approval from Canadian and U.S. regulators to begin enrolling adults into the Phase 3 portion of its trials based on positive interim Phase 2 results. That portion of the trial is almost complete, with results expected to be available publicly in April.
In parallel with the Phase 3 trial, Medicago said it has also started a feasibility study of a vaccine candidate to address emerging variants of concern.
The Canadian company is also partnering with GlaxoSmithKline, which is testing its vaccine adjuvant technology. According to the U.K.-based GlaxoSmithKline, the use of an adjuvant may reduce the amount of vaccine protein required per dose.
“We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world,” said Takashi Nagao, CEO and president of Medicago. “This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK.”
Phase 3 of Medicago’s vaccine trials will enrol up to 30,000 healthy adults between the ages of 18 and 65, followed by adults over the age of 65 and adults with comorbidities. The trial will take place across 10 countries, starting with Canada and the U.S., and seeks to enrol men and women from racially diverse populations.
Ottawa has signed a deal with Medicago to secure the rights to buy 76 million doses of its vaccine. The federal government has also pledged $173 million for the company’s vaccine research and development and for the construction of its Quebec City manufacturing facility.
According to federal government data, just over five per cent of Canadians have received their first dose of a COVID-19 vaccine as of March 6.
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