EuBiologics' typhoid conjugate vaccine EuTYPH-C Inj. [EuBiologics]
EuBiologics' typhoid conjugate vaccine EuTYPH-C Inj. [EuBiologics]

South Korean vaccine maker EuBiologics said Friday its proprietary typhoid conjugate vaccine, EuTYPH-C Inj., has received prequalification from the World Health Organization.

The WHO prequalification formally qualifies EuBiologics to bid in global public procurement tenders for typhoid vaccines organized by international bodies including UNICEF. The certification makes EuTYPH-C the company's second WHO-prequalified product, after its oral cholera vaccine Euvichol series, extending EuBiologics' public vaccine portfolio into the typhoid space.

EuTYPH-C conjugates the Vi polysaccharide antigen of the typhoid bacterium with a recombinant carrier protein (rCRM197) produced in-house. The vaccine uses the company's proprietary protein-conjugation technology, EuVCT, and is designed for a single dose in individuals from 6 months to 45 years of age.

Clinical trials were conducted in the Philippines, Kenya and Senegal. A multinational Phase 3 trial involving 3,219 participants in Africa demonstrated non-inferiority in immunogenicity and a comparable safety profile against existing WHO-prequalified vaccines; the findings were published in The Lancet Global Health. The Phase 3 trial and an ongoing three-year immune-persistence study in Senegal were funded by the Right Fund, a global health research foundation.

The approved product is a multi-dose formulation — a single 2.5-milliliter vial providing five doses — optimized for large-scale public immunization programs. The review also marks the first time in South Korea that the Ministry of Food and Drug Safety's good manufacturing practice inspection results were officially recognized during a WHO prequalification assessment for a new product.

For commercial production, EuBiologics has partnered with Korea Vaccine, which received WHO approval last week for its finished-product manufacturing line, establishing an end-to-end supply chain from bulk production to final fill-and-finish. The company plans to move immediately into follow-up talks with UNICEF, to which it has already submitted a proposal, with the aim of securing a supply agreement.

The WHO prequalification is significant because it gives international recognition to EuBiologics' proprietary protein-conjugation technology while allowing the company to leverage the international procurement network it built through Euvichol to strengthen its position in the global public vaccine market.

"This achievement is the result of collaboration with public health partners including the Right Fund, the Ministry of Food and Drug Safety and Korea Vaccine," a company official said. "Drawing on the international procurement experience we have accumulated through Euvichol, we will do our utmost to ensure EuTYPH-C is supplied quickly and reliably to countries with a high typhoid burden."


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