SK bioscience has announced that, after entering into a license agreement with the U.S. Centers for Disease Control and Prevention (CDC), it has initiated process development for an injectable rotavirus vaccine candidate. Following successful process development, the company plans to advance the vaccine through subsequent clinical trials, regulatory approval, and ultimately, commercialisation.
Through the license agreement with CDC, SK bioscience has become the first Korean company to receive vaccine technology from the CDC. Previously, the CDC developed the injectable inactivated rotavirus vaccine technology and sponsored a phase I clinical trial. SK bioscience plans to rapidly implement this technology domestically, establishing a production process that simultaneously enhances vaccine efficacy and reduces costs, while advancing through clinical development and ultimately commercialisation.
The project is further supported by the Research Investment for Global Health Technology Foundation (the RIGHT Foundation). SK bioscience signed a research and development funding agreement with the RIGHT Foundation for the rotavirus vaccine process in June 2025.
The RIGHT Foundation is the first non-profit international public-private partnership funding agency in Korea, established through a three-way partnership between the Government of Korea, the Gates Foundation, and Korean life science companies. The foundation provides official development assistance that supports essential R&D to reduce the infectious disease burden in low- and middle-income countries.
Rotavirus is a leading infectious disease that causes severe diarrhoea and dehydration in children under five worldwide. According to Johns Hopkins University, approximately 24.4% of childhood deaths are due to diarrhoea caused by rotavirus infection. With the introduction of rotavirus vaccines, infection rates have declined significantly in high-income countries, resulting in 99% of global rotavirus-related deaths being concentrated in low- and middle-income nations.
The introduction of oral rotavirus vaccines has significantly reduced infection rates in high-income countries, achieving over 85% vaccine effectiveness. However, in low- and middle-income countries, the vaccine effectiveness falls below 50% due to challenging environmental conditions and poor nutritional status. Consequently, these countries are turning their attention to injectable vaccines, which are expected to deliver stronger protective effects than oral formulations.
According to Business Research Insights, the global rotavirus vaccine market is expected to grow from $8.12bn in 2024 to $13.9bn by 2033, representing a CAGR of 6.2% due to increasing demand for rotavirus vaccines.
In addition, UNICEF’s 2024 report shows that UNICEF procured a total of 329m courses (2-3 doses per course) of rotavirus vaccines between 2011 and 2023. Most were supplied to Gavi-supported low-income countries. The procurement volume increased from 0.9m doses in 2011 to 57m courses for 57 countries in 2023, and demand from Gavi-supported countries is projected to reach approximately 64m courses by 2028.
Jaeyong Ahn, CEO of SK bioscience, said, “We are pleased to collaborate with the CDC on the development of a rotavirus vaccine that has the potential to advance global public health. With the support of the RIGHT Foundation, we will continue to develop innovative vaccines to improve child health in low- and middle-income countries and fulfil our responsibility as a company contributing to a healthier future for people around the world.”