First Shipment of Korea's First Domestic COVID-19 Vaccine... Significance of Securing 'Vaccine Sovereignty'

SK Bioscience Ships Initial Batch of 'Skycovione'
Gains Vaccine Production Experience for Future Pandemics
Global Network Secured During Development Also a Key Asset

SK Bioscience's COVID-19 vaccine Skycovione being shipped. [Photo by SK Bioscience]

[Asia Economy Reporter Lee Gwan-joo] On the 2nd, the initial shipment of SK Bioscience's 'Skycovione,' the first domestically produced COVID-19 vaccine, was completed. The significance of this shipment is special in that it secured South Korea's 'vaccine sovereignty' against COVID-19, which has spread worldwide for over two years. Even if another pandemic occurs in the future, South Korea now possesses experiential assets to produce vaccines using its own technology, and the numerous networks built during the development process are expected to serve as a foundation for strengthening the competitiveness of the bioindustry.

Fewer Side Effects... Sequential Supply of 10 Million Doses of Domestic Vaccine

The initial shipment completed at Andong L House consists of approximately 610,000 doses, and vaccinations will begin at public health centers nationwide and some designated medical institutions from the 5th. SK Bioscience plans to sequentially supply 10 million doses domestically according to the vaccination plan of the Korea Disease Control and Prevention Agency.

The distinctive feature of Skycovione is that it is a COVID-19 vaccine independently developed by a domestic company based on a global network. SK Bioscience received development funding from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), and co-developed it with the Antigen Design Research Institute at the University of Washington School of Pharmacy. To enhance immune response and induce neutralizing antibodies, GlaxoSmithKline (GSK)'s adjuvant AS03 was applied.

Skycovione attracted attention both domestically and internationally from the development stage. Unlike messenger RNA (mRNA) vaccines, it was developed using a synthetic antigen platform whose safety has been proven, resulting in fewer side effects. It also has the advantage of being storable and distributable under refrigeration, making it easier to supply to developing countries. Recently, conditional marketing authorization (CMA) applications have been completed with the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and applications for listing on the World Health Organization (WHO) Emergency Use Listing (EUL) are also being prepared, making overseas expansion of the domestic vaccine more visible.

Above all, the networks built during this process are expected to be of great help in responding to the post-COVID era. Choi Chang-won, Vice Chairman of SK Discovery, emphasized, "The success of Skycovione was possible thanks to the help of numerous domestic and international partners. Based on this valuable experience, we will further strengthen the global cooperation system, expand the technology platform, and enhance and sophisticate infrastructure. Through this, we will prepare for the next pandemic and contribute to protecting public health in South Korea and globally."

Packaging work for the COVID-19 vaccine Skycovione is being carried out at SK Bioscience L House in Andong-si, Gyeongbuk.
[Photo by SK Bioscience]

Confirmed Efficacy Against Omicron Variant... Accelerating Response to the 'Next Pandemic'

Skycovione demonstrated superior immunogenicity and safety compared to control vaccines during primary vaccination through global clinical trials conducted in South Korea and five other countries. The global clinical trials and analyses of Skycovione were supported by collaboration with the International Vaccine Institute (IVI), a non-profit international organization, and the Public Vaccine Development Support Center of the Korea National Institute of Health. Domestic clinical trials were conducted at multiple institutions, including Korea University Guro Hospital. Securing a global vaccine clinical network is also one of the major significances of Skycovione.

Recent clinical results showing expected efficacy against the Omicron variant have also drawn attention. The Korea National Institute of Health confirmed that additional doses of Skycovione induced neutralizing antibodies against BA.1 and BA.5 variants. Compared to before vaccination, neutralization capacity increased approximately 51.9-fold for BA.1 and about 28.2-fold for BA.5. Since the BA.5 variant is currently the dominant strain in South Korea, this confirms the potential for additional Skycovione vaccinations.

SK Bioscience is conducting extended studies on booster shots at domestic and international institutions to enhance the utility of Skycovione. Alongside this, using the technology developed for Skycovione, they are developing proprietary vaccines and pharmaceuticals such as ▲combo vaccines ▲universal vaccines ▲multivalent vaccines ▲nasal sprays, and are pursuing mergers and acquisitions (M&A) and technology transfers to expand into new areas including cell and gene therapy (CGT) and mRNA vaccines.