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SK Bioscience’s COVID-19 vaccine SKYCovione (courtesy SK Bioscience)

The South Korean Ministry of Food and Drug Safety (MFDS) granted final authorization for the use of SK Bioscience’s SKYCovione, South Korea’s first independently developed COVID-19 vaccine.

The vaccine appears likely to be available for supply domestically and internationally as early as the second half of 2022.

The MFDS announced Wednesday that a final review committee meeting had been held, with SKYCovione, also known as GBP510, being granted product approval contingent on the submission of a report on the final results of a one-year tracking study of clinical research subjects.

The vaccine was previously approved by an MFDS expert advisory committee, which reviews clinical studies and quality, and by the Central Pharmaceutical Affairs Council before the final review committee issued its permit.

With this approval, South Korea joins the list of countries that have developed both vaccines and treatments (Regkirona) for COVID-19. The MFDS explained that it is the third country to acquire both vaccine and treatment development technology, after the US and UK.

Like the Novavax vaccine, SKYCovione was made with genetic recombination technology, in which antigen proteins are introduced directly to induce an immune response. Two doses are administered at four-week intervals to adults aged 18 and over. The vaccine can be stored for long periods and transported in refrigerated conditions at temperatures of 2–8 degrees Celsius.

Based on the results of clinical trials in South Korea and five other countries, the Central Pharmaceutical Affairs Council, an expert advisory body, determined that the vaccine met the efficacy and safety standards for a permit to be issued.

The vaccine was found to produce 2.93 times more titers for neutralizing antibodies, which prevent infection by neutralizing the COVID-19 virus, than the AstraZeneca vaccine. Examination for adverse reactions in clinical testing showed them to be at a permissible level.

Before the vaccine can be marketed, it will still need to go through manufacturing and national lot release authorization, which involves additional testing to determine whether the product was manufactured as permitted. It is likely to be made available for domestic supply by the second half of the year, based on discussions with the Korea Disease Control and Prevention Agency.

Clinical research is still underway on whether the vaccine can be administered as a booster shot to individuals who have previously been inoculated with other vaccines.

By Park June-yong, staff reporter

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