First Approval of Domestic 'COVID-19 Vaccine' ... SK Bioscience's Full-Scale Entry into the Global Market

MFDS Secures Review Expertise and Transparency Through Triple Advisory Procedures

[Asia Economy Reporter Jo In-kyung] The COVID-19 vaccine developed by SK Bioscience has received final product approval. With the birth of the first vaccine developed using domestic technology, South Korea has joined the ranks of countries developing COVID-19 vaccines.

The Ministry of Food and Drug Safety (MFDS) announced on the 29th that it has decided to approve the COVID-19 vaccine "Skycovione Multi" developed by SK Bioscience, conditional upon the submission of the final clinical trial report for the manufacturing and sales approval application.

Skycovione Multi is a COVID-19 vaccine that induces an immune response by administering an antigen protein created using recombinant gene technology. It has been approved for the prevention of COVID-19 in adults aged 18 and over. A total of two doses of 0.5 ml each, mixing the antigen vial with the adjuvant (AS03) enclosed, are administered at 4-week intervals.

The MFDS conducted a triple advisory process before approving COVID-19 vaccines and therapeutics, including ▲ the COVID-19 Vaccine Safety and Efficacy Verification Advisory Group ▲ the Central Pharmaceutical Review Committee ▲ the Final Inspection Committee. The MFDS explained, "As a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), we reviewed the non-clinical, clinical, and quality data of Skycovione Multi under approval requirements and review standards equivalent to those of advanced countries such as the United States and Europe."

This approval is significant in that the MFDS evaluated the safety, efficacy (immunogenicity), and quality of the COVID-19 vaccine developed by a domestic company throughout the entire process from development, clinical trials, production management, to final approval according to international review standards. Simultaneously with the approval review, the MFDS established testing methods necessary for validation tests, and has prepared to supply the COVID-19 vaccine in a timely manner through rapid and thorough national lot release approval if SK Bioscience applies.

With the approval of Skycovione Multi, the global vaccine market entry of domestic companies is also expected. SK Bioscience plans to pursue listing on the World Health Organization (WHO) Emergency Use Listing (EUL) and prepare for vaccine supply through the COVAX Facility (international vaccine supply project).

In particular, this vaccine can be stored refrigerated (2~8℃), making it effective for use in countries that do not have ultra-low temperature distribution equipment for quarantine.

Oh Yu-kyung, head of the MFDS, said, "The MFDS approved SK Bioscience's 'Skycovione Multi' after thoroughly verifying safety and efficacy through a triple advisory process," adding, "We will continue to collaborate with various institutions to proactively respond to future infectious diseases."