Medicago and GlaxoSmithKline (GSK) have announced positive efficacy and safety results from the global Phase III placebo-controlled efficacy study of Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant.
Vaccine efficacy was demonstrated in an environment dominated by SARS-CoV-2 variants, unlike most published Phase III efficacy trials for currently licensed COVID-19 vaccines that were conducted when only the ancestral virus was circulating, making direct comparisons impossible. The overall vaccine efficacy rate against all variants of SARS-COV-2 was 71%. The Omicron variant was not circulating during the study.
Based on the results, Medicago will imminently seek regulatory approval from Health Canada as part of its rolling submission. If approved, it will be the world’s first plant-based vaccine for human use.
Medicago has been developing its plant-based technology for the past 20 years, using unique technology to produce Virus-Like Particles (VLP) for its protein vaccines. VLPs are designed to mimic the native structure of viruses, allowing them to be easily recognized by the immune system. Because the VLPs lack core genetic material, they are non-infectious and unable to replicate. VLP vaccines developed by other technologies, have traditionally been used worldwide for more than 30 years.
Takashi Nagao, CEO and President at Medicago said: “This is an incredible moment for Medicago and for novel vaccine platforms. The results of our clinical trials show the power of plant-based vaccine manufacturing technology. If approved, we will be contributing to the world’s fight against the COVID-19 pandemic with the world’s first plant-based vaccine for use in humans. I want to thank everyone who participated in our clinical trials, our collaborators at clinical trial sites, our partners at GSK, the Government of Canada and Government of Quebec, Mitsubishi Tanabe Pharma Corporation, and all of our employees and our shareholders, for their commitment to advancing vaccine science when the world needs it.”
Thomas Breuer, GSK’s global COVID-19 adjuvanted vaccines lead and Chief Global Health Officer, said: “These are encouraging results given data were obtained in an environment with no ancestral virus circulating. The global COVID-19 pandemic is continuing to show new facets with the current dominance of the Delta variant, upcoming Omicron, and other variants likely to follow. The combination of GSK’s established pandemic adjuvant with Medicago’s plant-based vaccine technology has significant potential to be an effective, refrigerator-stable option to help protect people against SARS-CoV-2.”