EuBiologics secures WHO prequalification for typhoid vaccine

EuBiologics, a South Korean biopharmaceutical company, has secured prequalification from the World Health Organization (WHO) for its typhoid conjugate vaccine, EuTYPH-C Inj. Multi-dose (EuBiologics). This marks a key milestone in the company’s efforts to expand its presence in global health markets. The WHO prequalification process confirms that the vaccine meets international standards for safety, quality, and efficacy, enabling it to participate in international public procurement programs managed by UN agencies and other global health organizations. The prequalification was achieved through a clinical trial conducted in Kenya and Senegal, where the vaccine demonstrated similar immunological effectiveness and a comparable safety profile to an already WHO-prequalified typhoid vaccine. The trial results were crucial in supporting the application, which was reviewed by the WHO. The vaccine is formulated as a multidose product, with each 2.5-milliliter vial containing five doses. This design is intended to facilitate efficient storage, distribution, and administration during large-scale vaccination campaigns, aligning with the logistical requirements of international public health initiatives. EuBiologics is not new to WHO prequalification. The company previously received certification for its oral cholera vaccine, Euvichol, in 2015. This latest achievement solidifies its position as a reliable manufacturer of vaccines meeting global health standards. The WHO prequalification also represents a notable step for the Korean regulatory system, as it was the first instance in which an inspection by Korea’s Ministry of Food and Drug Safety was acknowledged as part of the WHO’s prequalification assessment for a new vaccine. This recognition highlights the growing capability of Korean regulators in ensuring pharmaceutical compliance with international benchmarks. The company had earlier submitted a proposal to UNICEF for the supply of the vaccine, and both parties agreed to restart discussions once the WHO prequalification was finalized. With the certification now in hand, EuBiologics intends to expedite follow-up negotiations with UNICEF and intensify its efforts to gain entry into international procurement markets. The vaccine’s potential inclusion in global health programs could significantly enhance access to typhoid prevention in regions where the disease remains prevalent. Typhoid fever continues to pose a substantial public health challenge, particularly in low-resource settings where access to clean water and sanitation is limited. The WHO estimates that approximately 116 million cases occur globally each year, with the highest burden in Asia and Africa. A safe and effective typhoid vaccine is therefore essential for reducing morbidity and mortality associated with the disease. EuBiologics’ vaccine offers a promising solution, especially given its compatibility with large-scale distribution strategies required for widespread immunization. Looking ahead, the company will likely focus on securing contracts with international buyers, including UN agencies and national governments, to ensure the vaccine reaches populations in need. The success of this prequalification underscores the importance of innovation and regulatory alignment in the global fight against infectious diseases. As EuBiologics moves forward, its continued engagement with international health bodies will play a critical role in shaping the future of typhoid prevention in vulnerable communities.