Medicago & GSK start plant-derived COVID-19 vaccine trial
pharmafile | March 17, 2021 | News story | Research and Development | COVID-19, GSK
Medicago and GSK have announced the start of Phase III clinical testing of Medicago’s plant-derived COVID-19 vaccine.
The vaccine candidate will be used in combination with GSK’s pandemic adjuvant, and is on track to be the first plant-derived COVID-19 vaccine to market.
The Phase III clinical trial will enrol up to 30,000 healthy volunteers, taking place in 10 countries pending regulatory approvals, starting with Canada and the US.
The FDA granted Fast Track designation for the adjuvanted vaccine on 17 February, which will facilitate the jab’s development and expedite the review of the Phase III results.
Carolyn Finkle, Chief Operating Officer of Medicago said: “The FDA’s decision to grant Fast Track designation for Medicago’s vaccine candidate will help us expedite our efforts to bring the first plant-derived COVID-19 vaccine to market, subject to regulatory approval.”
Medicago’s plant-derived vaccine uses coronavirus-like-particle (CoVLP) technology co-administered with GSK’s pandemic adjuvant, in two doses, 21 days apart.
Takashi Nagao, CEO and President of Medicago said: “We are pleased to take the significant step of initiating the Phase III clinical trial at sites around the world.”
“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.”
In parallel with the Phase III trial, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “This advance to late stage clinical testing further reinforces our confidence in the adjuvanted vaccine candidate’s potential to make a difference in the continued fight against COVID-19. We look forward to sharing results later this year.”
Kat Jenkins
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