SK bioscience will accelerate to apply for emergency use listing (EUL) to the World Health Organization (WHO)

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, today announced that the Company has submitted an application for a Conditional Marketing Authorization (CMA) of the COVID-19 vaccine, ‘SKYCovion™’ to the European Medicines Agency (EMA), following U.K. submission. SK bioscience also plans to quickly apply for Emergency Use Listing (EUL) to the World Health Organization (WHO). If the EUL is obtained, SKYCovion™ will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if required.

SKYCovion™ is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovion™ has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 Programme.

SKYCovion™ is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, and HPV vaccines. The results of the global Phase III clinical trial showed that SKYCovion™ induces neutralizing antibody responses and had an acceptable safety and the reactogenicity profile compared to the control vaccine, AstraZeneca’s Vaxzevria™, used in the study. The results of extended phase I/II clinical trials also showed that there was a high immune response to the Omicron variant BA.1 after a booster of SKYCovion™. The clinical trial was conducted in cooperation with 16 institutions, including Center for Vaccine of Korea National Institute of Health, International Vaccine Institute (IVI), and Korea University Guro Hospital.

Ahn Jae-yong, CEO of SK bioscience, said, "The repeated emergence of new COVID-19 variants are still threatening our daily lives,” adding, "Our aspiration remains to fulfill our role and responsibility as a global vaccine hub by entering overseas markets for self-developed vaccines and developing new platforms to respond to the pandemic."

Meanwhile, SK bioscience plans to develop a combination vaccine candidate that applies for both flu and COVID-19 at once using the SKYCovion™ platform, and a universal vaccine candidate effective against the Sarbecovirus group that includes COVID-19 and its variants to prepare for endemic COVID-19.