The International Vaccine Institute (IVI) is pleased to congratulate SK bioscience, the Coalition for Epidemic Preparedness Innovations (CEPI), and other partners for the June 29, 2022 approval of SK bioscience’s COVID-19 vaccine (SKYCovione™) by the Ministry of Food and Drug Safety, Republic of Korea.
SKYCovione™ is Korea’s first homegrown vaccine to achieve licensure among multiple vaccine candidates under development. IVI and SK bioscience jointly conducted a global phase III clinical trial of the vaccine in 4,037 adults in six countries—Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.
IVI also analyzed clinical samples from the trial in collaboration with the National Institute of Health under the Korea Disease Control and Prevention Agency to evaluate the vaccine’s efficacy. With the vaccine now approved for use, IVI will work with SK bioscience to seek the vaccine’s WHO emergency use listing (EUL) to help ensure its global use.
SKYCovione™, a recombinant protein-based vaccine, is the result of a global partnership between SK bioscience, Institute for Protein Design (IPD) at the University of Washington School of Medicine, and GSK and IVI, as well as CEPI, the Bill & Melinda Gates Foundation, the government of Korea and other partners. The vaccine is expected to give a new vaccine option to people around the world in addition to other currently available COVID-19 vaccines. SKYCovione™ can be refrigerated at 2 to 8 degrees Celsius and stored for a long time, unlike the existing mRNA vaccines that require ultralow temperature storage. Due to these advantages, the vaccine may play a key role in increasing vaccination rates in low-income countries where uptake has been low.
IVI is proud to have contributed to the successful clinical development of this vaccine and is committed to supporting its WHO EUL and global use. We will continue endeavors to accelerate the development of vaccines against COVID-19 and other diseases of global health significance, particularly the world’s neglected diseases to help ensure vaccine access and equity for all.