SK Bioscience Applies for EMA Conditional Approval of Korea's First Domestic COVID-19 Vaccine 'Skycovione'

Researchers are conducting studies at the SK Bioscience Research Center in Pangyo, Seongnam-si, Gyeonggi-do, where the development of Korea's first domestic COVID-19 vaccine, 'Skycovione,' was achieved.

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience announced on the 1st that it has completed the conditional approval application to the European Medicines Agency (EMA) for 'Skycovione Multi', the first domestically developed Korean COVID-19 vaccine.

Skycovione is a COVID-19 vaccine jointly developed by the Institute for Protein Design (IPD) at the University of Washington School of Pharmacy and SK Bioscience. To enhance immune response and induce neutralizing antibodies, GSK's adjuvant 'AS03' was applied. From the early stages of development, funding was supported by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI). After being listed on the World Health Organization (WHO) Emergency Use Listing (EUL), it is planned to be supplied to the global market through the COVAX Facility.

Skycovione uses the 'synthetic antigen' method, which has been proven safe through long-term use in influenza and HPV vaccines. Through global Phase 3 clinical trials, it demonstrated superior immunogenicity compared to the comparator vaccine (AstraZeneca's 'Vaxzevria') after the primary vaccination series. Additionally, an extended Phase 1/2 clinical study confirmed a strong immune response against the Omicron variant (BA.1) when administered as a booster shot.

SK Bioscience plans to introduce a competitive domestic vaccine to the rapidly growing global COVID-19 vaccine market, starting with the UK and European countries. This year, the COVID-19 vaccine market is expected to grow to $84.9 billion (approximately 101 trillion KRW), a 29% increase from last year due to the prolonged pandemic. In particular, with the European Centre for Disease Prevention and Control (ECDC) and EMA, which oversee the EU's quarantine and health policies, lowering the target age for the fourth COVID-19 vaccine dose from 80 to 60 last month, the European market is expected to expand further.

Skycovione is also expected to reduce South Korea's dependence on imported vaccines. Before Skycovione was developed, the entire population was vaccinated with COVID-19 vaccines developed by foreign companies, increasing vaccine import dependence. According to Korea Customs Service import-export trade statistics, South Korea's vaccine import value last year was $2.35 billion, a sevenfold increase compared to $340 million the previous year.

Jae-yong Ahn, President of SK Bioscience, said, “With the repeated emergence of COVID-19 variants, people worldwide are still threatened in their daily lives. We will fulfill our role and responsibility as a global vaccine hub through overseas market entry of our domestically developed vaccine and development of new platforms to respond to the endemic.”