Approval requested for Korea's first Covid vaccine

SK bioscience's SKYCovione, the country's first homegrown Covid-19 vaccine [SK BIOSCIENCE]

SK bioscience said Friday it applied with the Ministry of Food and Drug Safety for use approval for GBP510, its Covid-19 vaccine candidate.

If approved, it will be the first homegrown Covid-19 vaccine. It will be sold under the name SKYCovione.

SK bioscience on Friday also released results of SKYCovione’s Phase 3 trials, the last round of clinical trials required for the drug. Trials were conducted on a total of 4,037 people aged 18 or older in 16 institutions in Korea and five other countries including Thailand, New Zealand and Ukraine. Divided into two groups, one group was administrated GBP510 and the other with AstraZeneca vaccines.

According to the results, SKYCovione showed 2.93 times more neutralizing antibodies titers against the virus than AstraZeneca's vaccine. It also demonstrated higher immunogenicity, SK said.

In regards to safety, the number of patients experiencing side effects was similar among the SKYCovione group and the AstraZeneca group. No significant side effects were observed during the trials.

SKYCovione is a recombinant vaccine that uses protein antigens. It is the result of recombinant DNA technology, which involves inserting an antigen onto the surface of a protein. Inside the body, that antigen stimulates an immune response that creates antibodies to fight off the virus in case of infection.

The vaccines can be stored in normal refrigerators at 2 to 8 degrees Celsius unlike Moderna and Pfizer vaccines, which use mRNA (messenger ribonucleic acid) technology and require extremely low temperatures to remain effective.

The convenience will play “a key role in distributing the vaccines in developing countries that do not have enough infrastructure to store them,” according to SK bioscience.

SK bioscience predicts authorization will be announced as early as June.

In March, the Korea Disease Control and Prevention Agency signed a 200-billion-won ($160 million) deal with SK bioscience for 10 million doses of SKYCovione to be administered domestically.

SK added that it will submit an application to the European Medicines Agency, as well as apply for emergency use approval from the World Health Organization within the first half of this year.

If commercialized, the vaccines will also be supplied to countries through the Covax Facility, a global vaccine distribution platform, SK said.

BY SARAH CHEA [chea.sarah@joongang.co.kr]