No Additional Orders for Korea's First Domestic Vaccine... How Will SK Bioscience Break Through?

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)

[Asia Economy Reporter Chunhee Lee] The market expansion of 'Skycovione,' a domestically developed COVID-19 vaccine by SK Bioscience, is facing difficulties. With the overall demand for vaccinations sharply declining and no additional government orders being placed, it is reported that the production of finished products is currently not taking place.

According to the related industry on the 23rd, Skycovione is currently only producing the active pharmaceutical ingredient (API), and the production of finished pharmaceutical products (DP), which involves actual filling, packaging, and shipment, is not being carried out.

Skycovione was initially shipped with 600,000 doses in September under a pre-purchase contract of 10 million doses with the government. However, as breakthrough infections continued, overall vaccination demand significantly decreased, and with vaccines targeting the Omicron variant being released one after another, preference for Skycovione has relatively declined, resulting in fewer vaccinations.

According to the Korea Disease Control and Prevention Agency, since the first vaccination of Skycovione on September 5, only 3,787 doses have been administered over about three months until the day before yesterday. This means only 0.6% of the supplied quantity has been used. Although extended studies have confirmed neutralizing efficacy against the Omicron variant BA.1, showing effectiveness against variants, actual vaccine recipients strongly prefer bivalent vaccines developed to target variants. Since the start of winter vaccinations on the 11th of last month, Moderna's BA.1-targeting bivalent vaccine has been administered 1.53 million times, Pfizer's BA.1 and BA.4/5-targeting vaccines 310,000 and 440,000 times respectively. In contrast, Novavax, which like Skycovione targets the original Wuhan strain, has only been administered 23,156 times.

Regarding this, SK Bioscience explained, "The reduced demand for vaccinations itself and the fact that we are a latecomer played a role," adding, "Since it is not the vaccine used for the first and second doses, there is an aspect of not overcoming path dependency."

SK Bioscience's recombinant protein COVID-19 vaccine 'Skycovione Multi (GBP510)'

Exports, which SK Bioscience initially proposed as an endemic exit strategy, have not yet been realized. Although applications for approval have been submitted to the UK, the European Medicines Agency (EMA), and the World Health Organization (WHO), related approvals have not yet been granted. For exports to low-income countries in Africa and Latin America, listing on the WHO Emergency Use Listing (EUL) is essential. The company is reportedly expecting EUL listing to be completed within this year.

SK Bioscience stated that it is ready to develop variant-targeting vaccines but is cautious about selecting the exact target variant due to the rapid progression of COVID-19 variants. Previously, SK Bioscience disclosed a plan, in cooperation with the Coalition for Epidemic Preparedness Innovations (CEPI) and others, to develop a vaccine within 100 days for the next pandemic.

A company official explained, "The 100-day strategy applies not only to the next pandemic but also to the COVID-19 vaccine, for which basic technology has already been developed through Skycovione," adding, "However, since variants are rapidly changing, predicting the next variant is difficult, but from a technical perspective, we are sufficiently prepared."