For 4,037 adults over 18 years of age, GBP510(AS03) proves non-inferiority to an authorized COVID-19 vaccine
Full benefit risk profile of the vaccine to be confirmed when safety data is available in the coming weeks
SK will submit a biologics license application to the Korean Ministry of Food and Drug Safety within this month
SK will secure South Korea´s vaccine sovereignty while preparing the next pandemic with the GBP510 platform
SK bioscience´s COVID-19 vaccine candidate has secured a top-line immunogenicity result from its Phase III clinical trial meeting its primary endpoints. Safety data will be available soon. The full benefit risk profile of the vaccine will be confirmed soon once safety data is available. If a license is approved by domestic health authorities, South Korea is expected to achieve ‘vaccine sovereignty.’
SK bioscience (CEO Jae-Yong Ahn) announced that the company has confirmed positive immunogenicity in the results of a Phase III clinical trial of GB510/AS03, a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 Spike protein, jointly developed with the Institute for Protein Design (IPD) at School of Medicine the University of Washington with combination of GSK’s pandemic adjuvant, AS03.
SK bioscience announced that the candidate vaccine is non-inferior to AstraZeneca´s COVID-19 vaccine, Vaxzevria (control vaccine) in immunogenicity when injected twice with an interval of 4 weeks. Vaxzevria is a COVID-19 vaccine jointly developed by Oxford University in the UK and AstraZeneca. The vaccine has been authorized in over 50 countries around the world, including the WHO and EU.
The results of a Phase III clinical trial conducted with 4,037 adults who are 18 years old and older at 16 domestic clinical institutions and overseas institutions, has shown the higher induction level of neutralizing antibodies which prevent COVID-19 infection than the control vaccine two weeks after the shot of GBP510/AS03. In addition, the ‘antibody conversion rate’, which refers to the proportion of subjects whose neutralizing antibody level increased fourfold or more after vaccination, was also higher than that of the control vaccine, proving non-inferiority.
Jae-Yong Ahn, CEO of SK bioscience said, “The government, health authorities, international organizations and research institutes, global companies and Korean people have united to support us for this achievement. We will continue to fulfill our mission so that South Korea can establish itself as a nation with vaccine sovereignty.”