EuBiologics(206650) said on the 21st that its self-developed typhoid conjugate vaccine "EuTYPH-C Inj." has obtained World Health Organization (WHO) prequalification (PQ).
With this PQ, EuTYPH-C Inj. can participate in the international procurement market for typhoid vaccines led by international organizations such as the United Nations Children's Fund (UNICEF). EuBiologics secured its second WHO PQ vaccine after the oral cholera vaccine "Euvichol."
Typhoid is an acute systemic infectious disease transmitted through contaminated water or food, occurring mainly in Africa and South Asia. In particular, the importance of typhoid conjugate vaccines, which can be administered to infants and young children 6 months and older and elicit long-lasting immune responses, is growing.
EuTYPH-C Inj. is a conjugate vaccine that links a recombinant carrier protein (rCRM197™) to the surface antigen of Salmonella Typhi. It was developed for a single dose in people 6 months to 45 years old.
The company conducted clinical trials in the Philippines, Kenya and Senegal. In particular, in a multinational phase 3 trial of 3,219 participants in Africa, it confirmed immunological non-inferiority and safety compared with an existing WHO PQ typhoid conjugate vaccine. The study results were published in the international journal "The Lancet Global Health."
The clinical trial was conducted with support from the Right Foundation, which is also supporting a three-year persistence-of-immunity study currently underway in Senegal.
The product that obtained PQ is a multi-dose formulation that allows five doses from a single 2.5 mL vial. It was developed to suit the international public procurement market, where large-scale immunization is carried out.
In the PQ review, the Ministery of Food and Drug Safety's GMP inspection results were used in the WHO assessment. EuBiologics said this is the first domestic case in which the Ministery of Food and Drug Safety's inspection results were recognized in a WHO PQ review for a new product.
EuBiologics plans to use this PQ as a springboard to move forward with follow-up consultations and ramp up supplies to the international procurement market, having already submitted a supply proposal to UNICEF. For finished-product manufacturing, it intends to establish a stable supply system in cooperation with KOREAVACCINE, which has WHO approval.
A EuBiologics official said, "Having passed the key threshold of WHO PQ, we will proceed swiftly with follow-up discussions with UNICEF, and, based on the international procurement experience accumulated through Euvichol, we will do our best to ensure EuTYPH-C Inj. is supplied reliably to immunization sites in countries with a heavy typhoid burden."