Global health receives a significant boost with the recent prequalification of the new typhoid conjugate vaccine, SKYTyphoid™, by the World Health Organization (WHO). This milestone achievement, announced by SK bioscience and the International Vaccine Institute (IVI), opens the doors for public procurement of the vaccine by UN organizations, marking a pivotal moment in the global supply of TCVs.
The WHO prequalification (PQ) process rigorously evaluates the safety, efficacy, and manufacturing standards of vaccines. It is a crucial step for participation in international tenders organized by UN agencies, ensuring the quality and competitiveness of the technology in the global market. The PQ certification for SKYTyphoid™ validates its adherence to stringent standards, certifying its safety, efficacy, and good manufacturing practices.
Developed through a collaboration between SK bioscience and IVI, with funding support from the Bill & Melinda Gates Foundation, SKYTyphoid™ represents a significant advancement in typhoid prevention. The vaccine, utilizing the ‘purified Vi polysaccharide-diphtheria toxoid conjugate’ method, offers a safe and effective solution for infants and young children aged 6 months to 2 years, providing long-term protection with a single dose compared to existing typhoid vaccines.
The successful licensure for export from the Korean Ministry of Food and Drug Safety in 2022 underscores the vaccine’s quality and safety. Furthermore, the Phase 3 clinical trial conducted in Nepal demonstrated the excellent immunogenicity and safety of SKYTyphoid™ across all age groups. The vaccine’s equivalent immunogenicity and safety, as compared to a conventional WHO-PQed polysaccharide-protein conjugate typhoid vaccine, were published in The Lancet Infectious Diseases.
Additionally, the Phase II clinical trial of SKYTyphoid™ booster shot revealed a strong immune response in infants aged 6 to 23 months, further affirming the vaccine’s efficacy and potential to contribute to global efforts in combating typhoid.
The achievement of WHO prequalification for SKYTyphoid™ marks a significant step forward in global health, offering a promising solution for the prevention of typhoid and contributing to the accessibility of life-saving vaccines for vulnerable populations worldwide.
