EuBiologics secures WHO prequalification for typhoid vaccine

EuBiologics said Friday its typhoid conjugate vaccine has received prequalification from the World Health Organization, opening the door for the Korean vaccine maker to bid for international public procurement programs.

Prequalification means the WHO recognizes the vaccine's safety, quality and efficacy, and clears the way for UN agencies and other international organizations to buy them for global health programs.

This is EuBiologics’ second WHO-prequalified vaccine, following its oral cholera vaccine Euvichol, which received the international certification in 2015.

EuBiologics said the typhoid vaccine demonstrated similar immunological effectiveness and a comparable safety profile to an existing WHO-prequalified vaccine in a clinical trial conducted in Kenya and Senegal.

The vaccine comes in a multidose formulation with a 2.5-milliliter vial providing five doses. EuBiologics said the formulation was designed with international public procurement campaigns in mind, as large-scale vaccination programs require efficient storage, distribution and administration.

According to EuBiologics, this was the first time an inspection by Korea’s Ministry of Food and Drug Safety was recognized as part of the WHO’s prequalification assessment of a new vaccine, and demonstrated the Korean regulator’s capabilities.

EuBiologics had previously submitted a proposal to UNICEF to supply the vaccine and the two sides agreed to resume discussions on after WHO prequalification was completed. The company plans to immediately seek follow-up talks with UNICEF and accelerate efforts to enter the international procurement market.