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SKY Covione, SK Bioscience's COVID-19 vaccine (Courtesy of SK Bioscience) South Korea’s SK Bioscience Co., a biopharmaceutical unit of SK Group, has won marketing authorization for its COVID-19 vaccine from the Ministry of Food and Drug Safety (MFDS) of Korea on Wednesday. MFDS approved the vaccine, SKY Covione, under the condition that SK Bioscience will submit the final report on the clinical trials to the ministry.The COVID-19 vaccine will be used as a preventive measure for people aged 18 years and over in Korea. Two doses are set to be administered between four weeks. The vaccine prevents the original Wuhan strain, and the research on efficacy for omicron infection is ongoing, MFDS stated. The recombinant protein vaccine can be stored at between 2-8 degrees Celsius. It compares with messenger ribonucleic acid (mRNA) vaccines that must be stored at an ultracold temperature like minus 70 degrees Celsius or below.Since the early stage of the vaccine development, SK Bioscience has built its global R&D networks supported by Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). The biotech has evaluated the vaccine’s efficacy and safety through the phase 1 and 2 clinical trials in Korea and phase 3 trials in six countries, New Zealand, the Philippines, Thailand, Vietnam, Ukraine and Korea.In March, the biotech announced it has signed a contract with the Korea Disease Control and Prevention Agency (KDCA) for 10 million doses of the vaccine.SK Bioscience is working to add the vaccine to World Health Organization (WHO) Emergency Use Listing (EUL). Once the vaccine is registered on EUL, SK Bioscience will be able to supply it to developing countries via COVID-19 Vaccines Global Access (COVAX), a worldwide initiative for equitable access to vaccines. The Korean biotech is also conducting a clinical trial of booster vaccination of SKY Covione, as well as preparing for clinical trials for children under age 18.In addition, SK Bioscience and CEPI are jointly developing a vaccine against sarbecoviruses, such as severe acute respiratory syndrome (SARS). The firm also started developing nasal spray vaccines for COVID-19 in April.With the marketing license of SKY Covione, Korea has become a third country that has both homegrown treatment and vaccine for COVID-19, following the US and the UK. Korean pharmaceutical giant Celltrion Inc. won a marketing license for COVID-19 treatment Regkirona (regdanvimab) in February. In addition, six and 18 biotechs are respectively developing COVID-19 vaccines and treatments in Korea. By Ji-Hyun Leebluesky@hankyung.comJihyun Kim edited this article.
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