Medicago and GlaxoSmithKline announced that Health Canada has granted approval for Covifenz, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). This vaccine is indicated for active immunization to prevent COVID‑19 caused by severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18 to 64 years of age. The vaccination regimen calls for two doses given intramuscularly 21 days apart.
The Canadian approval of Covifenz was based on positive phase III data which showed that Covifenz demonstrated 71% efficacy against all variants of the virus. Against the Gamma variant, the vaccine was 88.6% effective, and 75.3% effective against the Delta variant. 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 companies said. The Omicron variant was not circulating during the time the study was being conducted, both GSK and Medicago said.
Medicago and GSK submitted data to Health Canada on a rolling submission beginning in April 2021.
Medicago and GSK partnered on this vaccine in July 2020. The collaboration was made after Medicago announced it produced a Virus-Like Particle (VLP) of the coronavirus and began to develop its vaccine candidate. GSK’s adjuvant technology is designed to both boost the immune response and reduce the amount of antigen required per dose. The adjuvant allows for more vaccine doses to be produced, which leads to the protection of more people from the threat of viral infection.Subscribe to the Trialsitenews “SARS-CoV-2” ChannelNo spam – we promise
Covifenz is an adjuvanted vaccine composed of plant-based virus-like particles (VLP) that closely mimics the native SARS-CoV-2 virus and activates local innate immune responses. The vaccine then elicits both neutralizing antibody and cellular immune responses to the spike antigen, which may contribute to protection against COVID-19.