SK Bioscience said Wednesday that the Ministry of Food and Drug Safety approved the use of SKYCovione, the country's first homegrown Covid-19 vaccine.
SKYCovione has applied GSK's immune enhancer AS03 to strengthen immune response and induce high levels of neutralizing antibodies, the company said. SK Bioscience jointly developed the vaccine with the Institute for Protein Design at the University of Washington.
SK Bioscience explained that Bill & Melinda Gates Foundation and the Coalition for Epidemic Prevention and Vaccine (CEPI) had supported the development of SKYCovione from the initial development stage, helping to make the treatment an innovative product resulting from a global R&D network.
The company stressed that it had designed the vaccine so recipients could receive two doses in four weeks.
With the approval of SKYCovione, Korea has secured both a vaccine and a treatment, Celltrion's Regkirona, for Covid-19 when the government prepares for the endemic era and builds a national quarantine system in anticipation of another pandemic.
Korea is the third country worldwide, after the U.S. and the U.K., to have a homegrown Covid-19 vaccine and treatment.
Minister of Food and Drug Safety Oh Yu-kyoung also evaluated that SKYCovione, a vaccine developed by a Korean company following international review standards throughout the entire process from the development stage to clinical trials, production management, and final approval, has once again confirmed that Korea's license review capability is at an international level.
The company received approval for the vaccine after conducting a phase-3 clinical trial on about 4,000 adults in six countries -- Thailand, Vietnam, New Zealand, Ukraine, the Philippines, and Korea.
When the company administered SKYCovione twice, the neutralizing antibody, which can induce a prophylactic effect by neutralizing the virus infectivity, was about 33 times higher than before the injection and three times higher than the control vaccine. The company had used AstraZeneca's vaccine as a control vaccine.
The antibody conversion rate, which refers to subjects whose neutralizing antibodies increased more than four times after vaccination, was also 98.06 percent.
Even in adults 65 years and older, SKYCovione's neutralizing antibody titer was 2.7 times higher than the control vaccine, and the antibody conversion rate exceeded 95 percent.
SK Bioscience plans to apply for emergency use approval to other countries to release SKYCovione in global markets.
The company also plans to prepare for the supply of vaccines through the COVAX Facility by promoting listing on the WHO Emergency Use List (EUL).
The company expects low- and middle-income countries to use SKYCovione actively, as it can be stored at 2-8 degrees Celsius for a long time, not requiring cryogenic facilities.
"The development of Korea's first Covid-19 vaccine owed to the efforts of the government, health authorities, global organizations and companies, research institutions, and our employees who have worked tirelessly to develop the vaccine," SK Bioscience CEO Ahn Jae-yong said. "We will continue working with various organizations based on our technology and production capacity to respond to new pandemics preemptively."
However, as the ministry has approved the vaccine for basic vaccination, it is currently uncertain whether Korea will be using the vaccine as a booster shot in preparation for a possible resurgence of the virus this fall.
“Clinical trials for booster vaccination are currently in progress, and we will develop a booster vaccination plan by comprehensively determining clinical effectiveness, safety, and need for booster vaccination in consultation with the health authorities,” Minister Oh said.
Oh also stressed that research is still ongoing as to whether this vaccine is effective against the Omicron variant.
The Ministry of Food and Drug Safety announced that it plans to use the vaccine under future vaccination plans in Korea and utilize it abroad after receiving approval from the World Health Organization (WHO).