SKYCovione filed in South Korea for COVID-19

SK bioscience conducted a Phase III clinical trial in 4,037 adults over 18-year-old across 6 countries (Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea). The vaccine candidate demonstrated superior neutralizing antibody titres over AstraZeneca's Vaxzevria (control vaccine), a currently authorized COVID-19 vaccine. SKYCovione vaccine candidate showed a clinically favorable safety profile. The results of the Phase III clinical trial show a superior neutralizing antibody response of SKYCovione against SARS-CoV-2 parental strain, 2.93 times that of a control vaccine 2 weeks after the second dose. In addition, the proportion of participants who seroconverted, (with a greater than four-fold increase in neutralizing antibody titres compared to baseline), was 98.06% in the SKYCovione group and 87.30% in the control group. Both immunological superiority and non-inferiority of SKYCovione was demonstrated compared to Vaxzevria (control vaccine).

Even in subjects aged 65 or older, the antibody conversion rate of those vaccinated with SKYCovione was over 95%, when compared to the control vaccine (about 79% for the same age group). In terms of safety, overall, SKYCovione showed a clinically acceptable safety profile?. Most of the adverse reactions that occurred after injection were mild or moderate.