Korea's First COVID-19 Vaccine Likely to Get Approval within This Week

The birth of a Korean COVID-19 vaccine is imminent. Korean public health authorities are expected to approve SK Bioscience’s SKY Covione (candidate substance GBP510) as early as this week. If the final approval is given as expected, Korea's first and only COVID-19 vaccine will be used at vaccination sites from the second half of this year.

The Ministry of Food and Drug Safety said on June 27 that the Central Pharmaceutical Review Committee concluded on June 26 that SK Bioscience’s SKY Covione could be approved. The approval process for COVID-19 vaccines and treatments will be completed after a review by the Final Inspection Committee.

SKY Covione is part of a global infectious disease response project supported by the Bill & Melinda Gates Foundation (BMGF) and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine was jointly developed by SK Bioscience and the Institute for Protein Design (IPD) at Washington University College of Pharmacy, and is powered by GSK’s immune enhancers.

This vaccine should be injected twice, four weeks apart. Unlike the messenger ribonucleic acid (mRNA)-based COVID-19 vaccine, which must be stored at very low temperatures, it can be refrigerated and distributed at two-eight degrees Celsius.

The results of a comparison between SKY Covione and AstraZeneca’s Corona 19 vaccine, Vaxzevria also showed SKY Covione’s superiority in both immunogenicity and safety. In an immunogenicity evaluation, the titer of neutralizing antibodies, which can neutralize the COVID-19 virus and prevent infection, was 2.93 times that of the control group when two SKY Covione shots were given to adults with an interval of four weeks. The seroconversion rate stood at 98.06 percent in the vaccinated group, 10.76 percent higher than 87.30 percent in the control group.

SK Bioscience requested approval only for primary and secondary vaccinations for COVID-19, and a clinical trial for additional vaccinations is currently in progress.

SK Bioscience will also proceed with approval reviews of SKY Covione at the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom and the World Health Organization (WHO). If SKY Covione is registered with the WHO as an official COVID-19 preventive vaccine, it will become the ninth approved global COVID-19 vaccine after mRNA vaccines from Pfizer and Moderna and Russian and Chinese vaccines.