Editor’s note: This is an updated version of an article originally published in May 2023.
Typhoid is a persistent threat to the health and well-being of millions of people across the globe. In the low- and middle-income countries where the disease is endemic, there are approximately 6 million typhoid cases each year. The accuracy of this estimate, from the 2023 Global Burden of Disease, is difficult to determine, however; blood cultures, the gold standard for typhoid diagnosis, are difficult to perform and access, especially in high burden areas, leading to missed or even overdiagnosis and treatment. While there is urgent need for improved typhoid diagnostics, typhoid conjugate vaccines (TCV) are proven, effective public health tools that can reduce the burden of typhoid in the near term.
Of the five World Health Organization (WHO) prequalified TCVs, only two are eligible for introduction into routine immunization with support from Gavi, the Vaccine Alliance (Gavi). However, it is important to pursue additional vaccines to ensure supply is available to meet demand and to guarantee a healthy market. That’s why the recent prequalification of EuTYPH-C Inj.® Multi-dose, a new TCV from EuBiologics in Korea, marks a promising milestone for the overall typhoid prevention landscape.
From clinical trials to prequalification
EuTYPH-C Inj.® Multi-dose was shown to be safe and effective across multiple clinical studies. A Phase 2/3 clinical trial in the Philippines and a Phase 3 clinical trial in Senegal and Kenya—all areas in which typhoid is endemic—examined its performance in participants between 6 months and 45 years of age.
Both studies compared EuTYPH-C Inj.® Multi-dose to Typbar TCV®, a WHO prequalified and available vaccine; EuTYPH-C Inj.® Multi-dose demonstrated a comparable safety profile and was non-inferior to Typbar TCV. The Phase 3 study in Senegal and Kenya also assessed the performance of EuTYPH-C Inj.® Multi-dose when co-administered with measles-rubella and yellow fever vaccines at 9-12 months of age, the point at which these vaccines are typically administered in routine childhood immunization programs, and confirmed that it did not interfere with participants’ immune responses to either vaccine.
Based on data from the Phase 3 study in Africa, WHO granted EuTYPH-C Inj.® Multi-dose prequalification in August 2026. WHO prequalification confirms a vaccine meets strict international standards for quality, safety, and efficacy. It acts as a primary quality check so that international procurement agencies—such as UNICEF, the Pan American Health Organization, and Gavi—can safely buy and distribute the vaccine to low- and middle-income countries.
Investing in the future of TCVs
The EuTYPH-C Inj.® Multi-dose work doesn’t end here—it’s currently undergoing an observational study to evaluate the persistence of immune responses approximately 3 to 3.5 years after vaccination among children who participated in the previous Phase 3 trial in Africa. Final results from that study are expected in 2027. EuBiologics is also pursuing marketing authorization from the Ministry of Food and Drug Safety in Korea for a single-dose version of the vaccine.
Importantly, EuTYPH-C Inj.® Multi-dose prequalification and availability is just one chapter in the TCV story. The development of new TCVs can foster innovation, promote competition, and increase cost-effectiveness within the market. This can be achieved by improving accessibility, increasing supply, driving innovation, and enhancing effectiveness. Diversification of suppliers can increase the availability of TCVs to meet demand and reduce the risk of supply disruptions. The increase in supply can also drive down market prices by creating competition between manufacturers and enabling greater economies of scale.
TCVs are a safe, effective, and cost-effective method to prevent typhoid in children. Investing in the development of new TCV candidates such as EuTYPH-C Inj.® Multi-dose will provide additional options and greater supply. Ultimately, multiple TCV products will improve access and availability of these lifesaving prevention tools for the countries that need them most, saving more lives, and keeping children protected against typhoid.
