Publication of phase III COVID-19 vaccine study results of Covifenz in New England Journal of Medicine.
Medicago announced the publication of the results from the Phase III study of Covifenz, COVID-19 Vaccine (plant-based virus-like particles [VLP], recombinant, adjuvanted), in the New England Journal of Medicine (NEJM). The Phase III trial studied the two-dose regimen of Covifenz given 21 days apart versus placebo in over 24,000 subjects aged 18 and above.
Common side effects in the vaccine group included injection site pain, headache, fatigue, fever, muscle aches, and chills.
Covifenz is indicated in Canada for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 to 64 years of age. The safety and efficacy of Covifenz in individuals younger than 18 years of age or 65 years and older have not been established. Covifenz has not yet received approval in other jurisdictions
GSK confirmed Medicago data from the Phase III trial of their plant-based COVID-19 vaccine candidate, in combination with GSK's pandemic adjuvant, demonstrated 71% efficacy against the main variants of SARS-COV-2 circulating at the time of the trial.
See-"Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine"- K.J. Hager, G. Pérez Marc, P. Gobeil, R.S. Diaz, G. Heizer, C. Llapur, A.I. Makarkov,et.al., for the CoVLP Study Team .This article was published on May 4, 2022, at NEJM.org. DOI: 10.1056/NEJMoa2201300.
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