SK bioscience, a South Korea-based vaccine and biotech company, has obtained prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine (TCV), ‘SKYTyphoid’ (project name NBP618). This the fourth WHO PQ the company has received following its two influenza vaccines and varicella vaccine.

SKYTyphoid was jointly developed with the International Vaccine Institute (IVI) and is supported by the Bill & Melinda Gates Foundation. This vaccine utilises the 'purified Vi polysaccharide-diphtheria toxoid conjugate' method, which conjugates a polysaccharide of typhoid bacteria, serving as an antigen, to a diphtheria toxin protein (diphtheria toxoid), that acts as a carrier. Utilizing this conjugate technology, the vaccine can be safely administered to infants and children aged 6 months to 2 years.

It is anticipated to offer comparable immunogenicity and long-term protection with a single dose, compared to existing oral live or polysaccharide typhoid vaccines.

SKYTyphoid has received an export license from the Korean Ministry of Food and Drug Safety in 2022, based on the results of a global clinical study. The Phase III study, which enrolled 2,160 participants ranging from toddlers aged 6 months to individuals aged 45 years in Nepal, demonstrated a positive immunogenicity and safety profile of SKYTyphoid. 

With WHO PQ, SK bioscience plans to target global markets with SKYTyphoid, focusing on public procurement markets, including major typhoid-endemic countries with high demands. According to the WHO, there are between 11 to 20 million typhoid fever cases reported worldwide each year, resulting in approximately 120,000 to 160,000 deaths.