SK bioscience Achieves SKYCovione™ COVID-19 Vaccine Approval in Korea

SK bioscience has announced that SKYCovione™, South Korea’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant has been authorised by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.

SKYCovione™ 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 SKYCovione™ has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI).

The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione™ induced neutralising antibody responses, against the SARS-CoV-2 parental strain. The neutralising antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca´s Vaxzevria™, the control vaccine used in the study, 2 weeks after the second dose.

The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organisation.

SK bioscience will apply for authorisations at other selected regulatory agencies for distribution of SKYCovione™, including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).

SKYCovione™ is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione™ can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.

The market expects that SKYCovione™ will accelerate securing of Korea´s vaccine sovereignty and reducing dependence on vaccine imports.

Jaeyong Ahn, CEO of SK bioscience said: “The development of Korea’s first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organisations based on our own research and manufacturing technologies to preemptively respond to new pandemics.”

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