SKYCovione, Korea's first Covid vaccine, approved for use
The Ministry of Food and Drug Safety on Wednesday announced the approval of SKYCovione, a Covid-19 vaccine developed by SK bioscience, after the final review earlier in the day.
"The approval came after our thorough review on the safety and efficacy through a three-step consultative process," said Oh Yu-kyoung, minister of food and drug safety, during a press briefing held Wednesday afternoon.
The approval comes under one condition: SK bioscience must submit reports detailing people's health situations if they show any side effects after they get the vaccines.
Korea has become the third country in the world that has both a Covid-19 treatment and a vaccine, after the United States and Britain, according to the ministry.
The target of the vaccine will be adults aged 18 or older. People will receive two doses of 0.5 milliliters (0.017 ounces) at four-week intervals.
According to the results of Phase 3 clinical trials, SKYCovione had 2.93 times more neutralizing antibodies titers against the virus than AstraZeneca's vaccine. It also demonstrated higher immunogenicity. The trials were conducted on 4,037 adults in a total of six countries.
SKYCovione's trials were comparative-style trials, which compare the immunogenicity of an already-authorized vaccine with a candidate under development in order to prove its efficacy.
No serious safety issues were observed.
Co-developed with the University of Washington’s Institute for Protein Design and funded by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations, SKYCovione is a recombinant vaccine that uses protein antigens. Inside the body, the antigens stimulate an immune response that creates antibodies to fight off the virus in case of infection.
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 bioscience aims to apply for use approvals for the vaccine from global health authorities, including the European Medicines Agency and the World Health Organization, within the year.
If commercialized, the vaccine will also be supplied to countries through the Covax Facility, SK bioscience said.
The vaccines will be especially helpful for people in developing countries, SK bioscience added, as they 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.
SK bioscience also has a goal of making SKYCovione as a booster shot. The booster is currently in Phase 3 clinical trials, and a total of 750 people are participating in the trials.
BY SARAH CHEA [firstname.lastname@example.org]