SK Bioscience Typhoid Vaccine Obtains WHO Certification

Typhoid conjugate vaccine developed by SK Bioscience has received certification from the World Health Organization (WHO), raising expectations for global expansion.

SK Bioscience's typhoid vaccine SkyTyphoid
[Photo by SK Bioscience]

SK Bioscience announced on the 23rd that its typhoid conjugate vaccine SkyTyphoid Multi (project name NBP618), co-developed with the International Vaccine Institute (IVI), has obtained WHO’s prequalification (PQ) certification. This is SK Bioscience’s fourth WHO PQ certification following the influenza vaccines SkyCellflu trivalent and quadrivalent, and the varicella vaccine SkyVaricella.

WHO PQ is a system that certifies safety, efficacy, and compliance with Good Manufacturing Practice (GMP) by evaluating vaccine manufacturing processes, quality, and clinical trial results under strict standards. Passing the review grants eligibility for international procurement bidding. Obtaining WHO PQ certification is essential for participating in international tenders led by UN-affiliated organizations such as UNICEF and the Pan American Health Organization, and is regarded as a key factor demonstrating technological competitiveness in the global market.

SkyTyphoid is a typhoid conjugate vaccine jointly developed by SK Bioscience and IVI with support from the Bill & Melinda Gates Foundation. It uses a method that conjugates the polysaccharide of the typhoid bacteria, which acts as an antigen, to the diphtheria toxoid protein serving as a carrier. Compared to existing vaccines, it can be administered to infants aged 6 months to under 2 years, and a single dose is expected to provide sufficient immunogenicity and long-term preventive effects.

Based on global clinical results, SkyTyphoid obtained export product approval from the Korean Ministry of Food and Drug Safety (MFDS) in 2022. The company explained that early establishment of clinical design and quality data requirements through proactive consultations with the MFDS from the early stages of development laid the foundation for its success. Additionally, the MFDS’s inclusion in the WHO-listed regulatory authorities (WLA) at the end of last year and its global-level review process provided significant support during the rigorous WHO PQ evaluation.

SK Bioscience plans to expand its global market, including major typhoid outbreak countries, through public procurement markets, especially as demand for typhoid vaccines is high in underdeveloped countries. According to WHO, 11 to 20 million typhoid cases occur worldwide annually, with 120,000 to 160,000 deaths reported.

Jerome Kim, Director General of IVI, said, “Typhoid occurs more frequently in high temperatures and the risks are increasing due to climate change and rising antibiotic resistance. Vaccination is essential to effectively prevent and control typhoid. IVI will continue to work with partner organizations, including SK Bioscience, to ensure that those who need the vaccine most can receive it.”

Ahn Jae-yong, CEO of SK Bioscience, said, “We are pleased that global cooperation to resolve vaccine supply imbalances and improve public health has been recognized through this WHO PQ certification. Along with WHO PQ certification, we will obtain additional approvals by country to ensure the vaccine can be supplied promptly.”

This content was produced with the assistance of AI translation services.