[Edaily Reporter NA EUN-KYUNG ] Vaccine specialist EuBiologics Co., Ltd.(206650)announced on the 21st that its in-house developed typhoid conjugate vaccine, “EuTYPH-C Inj.,” has received Prequalification (PQ) from the World Health Organization (WHO).

WHO PQ is a procedure through which international organizations evaluate the quality, safety, and efficacy of vaccines when procuring them. With this PQ approval, EuBiologics Co., Ltd. has secured the qualification to supply “EuTYPH-C Inj.” to the typhoid vaccine procurement market organized by international organizations such as UNICEF. This is the company’s second WHO PQ-approved vaccine, following its “UbiCol” series of oral cholera vaccines.

“UTFC” is a conjugate vaccine that combines the Vi polysaccharide antigen of the typhoid bacillus with “rCRM197,” a recombinant carrier protein produced by EuBiologics Co., Ltd. It utilizes the company’s protein conjugation technology, “EuVCT,” and was developed for a single-dose regimen for individuals aged 6 months to 45 years.

EuBiologics Co., Ltd. conducted clinical trials for “UTFC” in the Philippines, Kenya, and Senegal. In a multinational Phase 3 clinical trial involving a total of 3,219 participants in Kenya and Senegal, the vaccine demonstrated immunological non-inferiority and safety compared to an existing WHO PQ typhoid conjugate vaccine. The study results were published in the international journal *The Lancet Global Health*.

The Phase 3 clinical trial was conducted with support from the Wright Foundation. The Wright Foundation is also supporting a three-year immunogenicity study currently underway in Senegal. The company plans to further verify whether antibodies are maintained over the long term to secure evidence for use in future actual vaccination programs.

The product that recently obtained WHO PQ approval is a multi-dose formulation, with one vial providing five doses. This design—allowing a total of five doses from a single 2.5 mL vial—was developed with the supply dynamics of the international public procurement market for large-scale vaccination campaigns in mind. The WHO plans to include this multi-dose formulation on its Prequalification (PQ) list.

The results of an on-site inspection conducted by the Ministry of Food and Drug Safety (MFDS) under the Good Manufacturing Practice (GMP) standards were utilized in this WHO PQ review. According to EuBiologics Co., Ltd., this marks the first instance in Korea where the MFDS inspection results were recognized in the WHO PQ review of a new product.

Prior to obtaining WHO PQ approval, EuBiologics Co., Ltd. submitted a proposal to UNICEF to supply “UTPC Injection.” At that time, the company agreed with UNICEF to continue discussions regarding a supply contract following the completion of the WHO PQ process, and plans to request follow-up consultations following this PQ approval to pursue supply to the international procurement market.

The company will collaborate with Korea Vaccine for the production of the finished product. Korea Vaccine recently received WHO approval for its “UTPC Injection” finished product production line. EuBiologics Co., Ltd. plans to meet future international procurement volumes by producing the bulk drug substance in-house while having Korea Vaccine handle the production of the finished product.

Typhoid fever is an acute systemic infectious disease transmitted through water or food contaminated with Salmonella typhi. It continues to occur in regions such as Africa and South Asia, and international organizations’ vaccination programs are centered on the typhoid conjugate vaccine, which can be administered to infants and young children and induces long-term immune responses.

A representative from EuBiologics Co., Ltd. stated, “This WHO PQ approval is not so much an achievement of our proprietary technology alone, but rather a result created in collaboration with our global public health partners.” The representative added, “Now that we have cleared the hurdle of WHO PQ, we will swiftly proceed with follow-up discussions with UNICEF and, drawing on the international procurement experience we have accumulated through ‘Yubicol,’ ensure that ‘UTFC Injection’ is stably supplied to vaccination sites in countries with a high burden of typhoid fever.”