SK Bioscience Applies for WHO Emergency Use Listing of Korea's First Domestic COVID-19 Vaccine 'Skycovione'

[Asia Economy Reporter Lee Gwan-ju] SK Bioscience announced on the 8th that it has completed the application for Emergency Use Listing (EUL) of its self-developed COVID-19 vaccine 'Skycovione Multi (Skycovione)' to the World Health Organization (WHO).

WHO registers medicines that meet safety, efficacy, and quality standards on the EUL to rapidly supply vaccines and treatments during urgent health crises such as COVID-19. As of August this year, a total of 11 COVID-19 vaccines have been listed on the EUL.

Based on its own evaluation system, WHO strictly reviews clinical results, quality, and safety of vaccines and treatments to decide on EUL registration. EUL listing is mandatory to participate in international tenders organized by global organizations such as UNICEF, the Pan American Health Organization (PAHO), and GAVI, the Vaccine Alliance.

SK Bioscience plans to actively supply Skycovione to the global market through COVAX Facility and others once the EUL registration is completed within this year. Earlier in July, SK Bioscience also completed conditional approval applications to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

Skycovione was developed using a recombinant protein subunit (synthetic antigen) method and is expected to contribute to resolving global vaccine supply imbalances. It can be stored and distributed under refrigerated conditions (2?8°C), making it suitable for distribution in low- and middle-income countries lacking ultra-low temperature facilities.

Ahn Jae-yong, CEO of SK Bioscience, said, “We will take the lead in responding to the COVID-19 endemic and securing global vaccine sovereignty by swiftly obtaining approvals from global institutions and countries.”

This content was produced with the assistance of AI translation services.