SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced today that the 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.
The WHO PQ system evaluates the manufacturing process, quality, and clinical trial results of a vaccine according to strict criteria to certify its safety and efficacy. The tested vaccine must comply with stringent procedures, including: △examination of technical documents, including clinical and quality data, △testing of sample quality, △inspection of manufacturing facilities to ensure adherence to Good Manufacturing Practices (GMP) and quality control standards.
SKYTyphoid was jointly developed with the International Vaccine Institute (IVI) and is supported by the Bill & Melinda Gates Foundation. This vaccine utilizes 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. Compared to the existing polysaccharide-protein conjugate typhoid vaccine with WHO PQ certification, SKYTyphoid showed comparable immunogenicity and safety profile across all age groups. These findings were published in The Lancet Infectious Disease, a sister journal to Lancet1.
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.
Jaeyong Ahn, CEO of SK bioscience, said, "We are pleased that our global collaboration to address the global vaccine supply imbalance and improve public health has been recognized by the WHO PQ certification," adding, "We will make every effort to rapidly supply SKYTyphoid by obtaining approvals in countries.”
Dr. Jerome Kim, Director General of IVI said, “Typhoid fever is more prevalent in warmer temperatures, and climate change and the worrying rise of antimicrobial resistance are only adding to the threat of the disease. Vaccination is critical to effective prevention and control of the disease. In collaboration with SK bioscience and other partners, IVI will continue endeavors to make this vaccine accessible to people who need it the most.”