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Medicago/GSK COVID-19 vaccine positive Ph3 data
Medicago/GSK COVID-19 vaccine positive Ph3 data.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8512U\n GlaxoSmithKline PLC\n 07 December 2021\n \n \n \n \n Issued: 7 December 2021, London UK and Quebec City, Canada\n \n \n \n \n \n Medicago and GSK announce positive Phase 3 efficacy and safety results for adjuvanted plant-based COVID-19 vaccine candidate\n \n \n · \n Primary endpoints and secondary endpoints for which data are available were met in trial dominated by COVID-19 variants\n \n \n · \n Efficacy demonstrated against all variants seen in the study, including 75.3% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant \n \n \n · \n Vaccine candidate was well-tolerated, with no related serious adverse events reported in the vaccine group\n \n \n · \n Final regulatory submission to be filed with Health Canada imminently\n \n \n \n \n \n \n \n \n Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline plc (GSK) today announce positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago's plant-based COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, conducted in over 24,000 subjects (adults 18 years and above) across six countries. \n \n \n \n \n \n Vaccine efficacy was demonstrated in an environment dominated by SARS-CoV-2 variants, \n unlike most published Phase 3 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% (95% CI: 58.7, 80.0; Per Protocol Analysis: PP). \n The corresponding number for people with an initial seronegative status indicating no previous exposure to COVID-19 was 75.6% (95% CI: 64.2-83.7; PP). The vaccine candidate demonstrated efficacy of 75.3% (95% CI: 52.8, 87.9; PP) against COVID-19 of any severity for the globally dominant Delta variant. Efficacy was 88.6% (95% CI: 74.6, 95.6; PP) against the Gamma variant. Although only a small number of severe cases occurred in this study, none occurred in the vaccinated group. No cases of the Alpha, Lambda and Mu variants were observed in the vaccinated group while 12 cases were observed in the placebo group. The Omicron variant was not circulating during the study.\n \n \n \n \...