SK Bioscience wins marketing license for Korea's first COVID-19 vaccine

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, SKYCovione, 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 four weeks apart. 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. Messenger ribonucleic acid (mRNA) vaccines must be stored at an ultracold temperature such as minus 70 degrees Celsius or below.

Since the early stage of the vaccine's development, SK Bioscience has built its global R&D network supported by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI). The biotech has evaluated the vaccine’s efficacy and safety through 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 those approved by the World Health Organization (WHO) for Emergency Use Listing (EUL). Once the vaccine is registered on EUL, SK Bioscience will be able to supply it to developing countries via the COVID-19 Vaccines Global Access (COVAX), a worldwide initiative for equitable access to vaccines. The Korean biotech is also conducting a clinical trial of a booster dose of the SKYCovione vaccine, 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 SKYCovione, Korea has become the third country to have both a 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 biotechs are developing COVID-19 vaccines and another 18 are developing COVID-19 treatments in Korea.

Write to Ji-Hyun Lee at bluesky@hankyung.com
Jihyun Kim edited this article.