'SK바사' First Domestic COVID-19 Vaccine to Be Approved This Week

Seokyeongwon, President of the National Institute of Food and Drug Safety Evaluation, is announcing the advisory results of the Central Pharmaceutical Affairs Deliberation Committee on SK Bioscience's COVID-19 vaccine 'Skycovione Multi' at the Ministry of Food and Drug Safety in Cheongju, Chungbuk, on the morning of the 27th.
[Image source=Yonhap News]

The birth of a domestically produced COVID-19 vaccine is imminent. Health authorities are expected to grant product approval for SK Bioscience's 'Skycovione (candidate substance GBP510)' as early as this week. Once final approval is obtained, the first and only domestically developed COVID-19 vaccine in Korea will be deployed at vaccination sites starting in the second half of this year.

According to the Ministry of Food and Drug Safety on the 27th, experts in biologics and vaccine review at the Central Pharmaceutical Affairs Deliberation Committee meeting held the previous afternoon concluded that SK Bioscience's 'Skycovione Multi-dose' can be approved. Although advisory from the final review committee in the approval process for COVID-19 vaccines and treatments remains, it appears that the overall review regarding the vaccine's efficacy, safety verification, and post-approval safety assurance measures has been virtually completed.

This vaccine is a recombinant protein-based COVID-19 preventive vaccine jointly developed by SK Bioscience and the University of Washington in the United States. It is administered twice at a 4-week interval. Unlike messenger RNA (mRNA) COVID-19 vaccines that require storage at ultra-low temperatures, this vaccine can be refrigerated and distributed at 2 to 8 degrees Celsius.

When compared to AstraZeneca's COVID-19 vaccine (Vaxzevria) as a control vaccine, it demonstrated superiority in both immunogenicity and safety. In the immunogenicity evaluation, adults who received two doses at 4-week intervals showed a neutralizing antibody titer capable of neutralizing the COVID-19 virus that was 2.93 times higher than that of the control group. The seroconversion rate was also confirmed to be 98.06% in the vaccine group, which is 10.76% higher than the control group's 87.30%.

This product approval application and review were conducted only for the primary COVID-19 vaccination series (first and second doses), and clinical trials for booster doses are currently underway.

Seo Kyung-won, Director of the National Institute of Food and Drug Safety Evaluation, stated, "SK Bioscience's Skycovione is the first COVID-19 vaccine for which our MFDS is conducting the world's first approval review, and it is the first domestically developed COVID-19 vaccine produced entirely in Korea from raw materials to finished product." He added, "We aim to make the final approval decision within June and are also targeting emergency use authorization from the World Health Organization (WHO), considering global supply."