hankyoreh

An individual receives a COVID-19 vaccine. (Kim Hye-yun/The Hankyoreh)

The Ministry of Food and Drug Safety announced that it will be making a decision on the item approval of SKYCovione, South Korea’s first domestically developed COVID-19 vaccine from SK Bioscience, before July. The vaccine was recommended for approval by the ministry’s Central Pharmaceutical Affairs Council, making it through the most challenging hurdle in the item approval process. The final decision will be made through the consultation of the Final Inspection Committee, and item approval is likely.

The Hankyoreh compiled answers to some questions about the vaccine’s efficacy, significance, and introduction schedule based on statements from the Food and Drug Safety Ministry and SK Bioscience.

A: The vaccine was co-developed by SK Bioscience and the University of Washington in the US. It’s the first COVID-19 vaccine to be made entirely in South Korea, from raw material sourcing to the manufacturing of the final product. The South Korean Ministry of Food and Drug Safety is the first in the world to be deliberating on its item approval. Like Novavax, it was made through gene recombination, which is why safety is anticipated to be its strength.

A: Adults receive two doses with a four-week interval between doses. Clinical trials are testing whether mixing and matching with other types of vaccines will be possible.

Q: The vaccine was evaluated to result in greater immunity compared to the COVID-19 vaccine from AstraZeneca. Adults who received two jabs with a four-week interval between doses were found to have 2.93 times the amount of neutralizing antibodies that can prevent COVID-19 infections that were found in those who had received the AstraZeneca vaccine.

The seroconversion rate (the rate of trial participants whose antibody level multiplied by four times or more after vaccination) for the SK Bioscience vaccine group was 98.06%, higher than the seroconversion rate for the control group, which was 87.30%. Receiving three doses of the vaccine is expected to help prevent infections of the Omicron variant.

A: The ministry’s Central Pharmaceutical Affairs Council concluded that the vaccine is safe enough to approve. However, adverse side effects anticipated to affect the injection site and the entire body occurred in significant numbers among young adults more so than seniors, and after the first dose more so than the second dose.

For this reason, the council was of the opinion that guidance will be needed before the administration of the first dose. Anticipated side effects include fatigue, muscle pain, headache, chills, fever, joint pain, nausea, vomiting, and diarrhea.

A: The Ministry of Food and Drug Safety anticipates that the final decision regarding the vaccine’s item approval will be made within the month. Considering the Korea Disease Control and Prevention Agency’s vaccine introduction schedule, once the vaccine is approved, it’s expected to be available to the public in the second half of this year. SK Bioscience signed a contract with the agency in March to provide 10 million doses of the vaccine domestically.

A: Having experience with large-scale clinical trials is very important in vaccine development. Having this kind of experience at the national level allows a country to develop its ability to respond to other infectious diseases.

A: Clinical trials were conducted in six countries including New Zealand and the Philippines to prepare for distribution overseas. Emergency use authorization from the World Health Organization is also being pursued. If the WHO authorizes the vaccine for emergency use, the Korean-made vaccine may be supplied to low-income countries through COVAX, an international project for the group purchase and distribution of COVID-19 vaccines.

By Park June-yong, staff reporter

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