Pharmaceutical company GlaxoSmithKline (GSK) and their partner Medicago have announced that their plant-based COVID vaccine has reached a point where they can seek emergency approval for use.
If approved, it will be the world’s first plant-based vaccine.
According to a press release from GSK, the vaccine has an overall efficacy rate of 71 percent against all variants of Sars-CoV-2 other than omicron.
The global Phase 3 placebo-controlled efficacy study was conducted in over 24,000 adult subjects across six countries.
The pharmaceutical giant said that no serious adverse events were reported during the study.
“During the study, no related serious adverse events were reported and reactogenicity was generally mild to moderate and transient; symptoms lasting on average only one to three days,” the press release boasts. “To date, the Phase 3 results have confirmed the safety profile is consistent with Phase 2 results. The frequency of mild fever was low (<10%), even after the second dose. Full results of the Phase 3 study will be released in a peer-reviewed publication as soon as possible.”
Based on the results of their test, GSK and Medicago plan to “imminently seek regulatory approval from Health Canada as part of its rolling submission.”
“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,” said Takashi Nagao, CEO and President at Medicago, in the statement from GSK. “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, all of our employees and Mitsubishi Tanabe Pharma Corporation, 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.”