New typhoid conjugate vaccine from EuBiologics receives WHO prequalification
This important milestone could provide countries with an additional option for typhoid vaccination and can contribute to a sustainable supply of typhoid conjugate vaccines.
EuTYPH-C Inj.® Multi-dose, manufactured by EuBiologics in the Republic of Korea, is the fifth typhoid conjugate vaccine (TCV) to receive WHO prequalification. Photo credit: Courtesy EuBiologics Co. Ltd.
Seattle, United States and Seoul, Republic of Korea – EuTYPH-C Inj.® Multi-dose, a new typhoid conjugate vaccine (TCV) manufactured by EuBiologics in the Republic of Korea, has been prequalified by the World Health Organization (WHO). This brings the total number of WHO-prequalified TCVs to five and represents another important step toward expanding global access to typhoid vaccination.
Demand for TCVs is high in typhoid-endemic countries. TCVs, recommended by WHO, have several advantages compared to older typhoid vaccines; notably, they provide longer-lasting protection, only require one dose, and can be given to children as young as 6 months of age, allowing for inclusion in routine immunization. However, TCVs are not always affordable or accessible for low-income countries. Development of additional TCVs from diverse manufacturers can help strengthen supply, support greater affordability, and expand access for countries seeking to introduce TCVs as part of their typhoid prevention and control strategies.
“WHO prequalification of EuTYPH-C Inj.® Multi-dose is an important milestone in EuBiologics’ commitment to expanding access to high-quality vaccines worldwide,” said Howard Her, Clinical Development Team Leader at EuBiologics. “We are grateful to RIGHT Foundation, PATH, and all of our clinical and development partners whose collaboration made this achievement possible. We look forward to contributing to a sustainable global supply of typhoid conjugate vaccines and helping countries protect more children and communities from typhoid fever.”
WHO prequalification—a designation confirming that a vaccine meets strict international standards for quality, safety, and efficacy—was supported by rigorous clinical studies in the Philippines, Kenya, and Senegal that demonstrated strong safety and immunogenicity. Importantly, WHO prequalification enables EuTYPH-C Inj.® Multi-dose to be considered for procurement by United Nations agencies and for use in Gavi, the Vaccine Alliance-supported immunization programs. It is approved for use in children and adults aged 6 months to 45 years.
PATH supported the EuTYPH-C Inj.® Multi-dose Phase 3 clinical study in Kenya and Senegal, as well as supported EuBiologics through WHO prequalification pre-submission meetings and clinical assessment responses. PATH is now collaborating with EuBiologics on a follow-up study evaluating the persistence of immune responses approximately 3 to 3.5 years after vaccination among children who participated in the previous Phase 3 study. Final results from the study are expected in early 2027.
“The ongoing evolution of new TCVs onto the global market is crucial for establishing sustainable, accessible supply in the regions with the greatest need. Prequalification of EuTYPH-C Inj.® Multi-dose marks the moment when rigorous clinical research transforms into real, lifesaving protection for children in typhoid endemic regions,” said Dr. Emmanuel Mugisha, Global Director of Vaccine Implementation and Director of TyVAC at PATH, a consortium that aims to accelerate the introduction of TCVs in Gavi-eligible typhoid-endemic countries. “PATH congratulates EuBiologics on this milestone and is proud of the work we’ve done together to strengthen the TCV toolkit.”
Typhoid is a serious and potentially life-threatening illness that primarily impacts children younger than 15 years of age in Asia and sub-Saharan Africa. The Global Burden of Disease Study estimated that typhoid caused approximately 6.2 million cases and 72,000 deaths globally in 2023. While typhoid is treatable with antibiotics, drug-resistant typhoid is increasing, raising the urgency for preventative measures including TCVs and improvements to water, sanitation, and hygiene. Millions of children have already been reached through TCV introduction campaigns worldwide.
About PATH
PATH is a global nonprofit dedicated to achieving health equity. With nearly 50 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. For more information, visit https://www.path.org.
About EuBiologics Co., Ltd.
EuBiologics Co., Ltd., headquartered in Seoul, Republic of Korea, is a specialized developer of both preventive and therapeutic vaccines. The company is focused on building a diverse pipeline that includes bacterial and viral vaccines for infectious disease prevention, as well as personalized therapeutic vaccines. EuBiologics Co., Ltd. is a major supplier of WHO-prequalified oral cholera vaccines through UNICEF procurement, playing a key role in the global public health market. Leveraging its proprietary vaccine platforms, the company is also advancing premium vaccine development and provides customized contract research and manufacturing services for biopharmaceutical products. For more information, please visit the website (http://eubiologics.com/eng/).