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

SK Bioscience 'Skycovione'

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience's 'Skycovione,' the first domestically produced COVID-19 vaccine, is accelerating its entry into the global market.

On the 29th, SK Bioscience announced that it has applied for Conditional Marketing Authorization (CMA) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the global approval of Skycovione.

Since March, Skycovione has been undergoing rolling review by the MHRA for expedited approval. With the recent acquisition of Phase 3 clinical trial data, the company will now proceed with the formal conditional approval review process. Rolling review is a system that allows the sequential submission of efficacy, safety, and quality data before the final approval application to rapidly evaluate promising vaccines and therapeutics.

Alongside this, SK Bioscience plans to quickly obtain conditional approval from the European Medicines Agency (EMA) and listing on the World Health Organization (WHO) Emergency Use Listing (EUL), thereby introducing the domestically produced vaccine to the global COVID-19 vaccine market.

Jae-yong Ahn, CEO of SK Bioscience, stated, “With this approval application, we have taken the first step to introduce a domestically produced COVID-19 vaccine with excellent safety and immunogenicity to the global COVID-19 vaccine market, which is dominated by major global pharmaceutical companies. Starting with the UK conditional approval application, we will showcase South Korea's technological capabilities to the global vaccine market through Europe and WHO EUL listing, and do our best to help restore safe daily lives worldwide through initiatives such as the COVAX Facility.”

Skycovione is a COVID-19 vaccine developed independently by SK Bioscience based on its global network. Through Phase 3 clinical trials conducted in South Korea and five other countries involving 4,037 adults aged 18 and over, it demonstrated excellent immunogenicity and safety during primary vaccination, proving its competitiveness. Additionally, in an extended Phase 1/2 clinical study of Skycovione, analysis of the cross-neutralizing ability of homologous booster shots against COVID-19 variants showed a strong immune response to the Omicron variant (BA.1).