Saturday, February 24, 2024
SK bioscience, a global biotech company dedicated to advancing human health through preventive measures and treatments, announced today that its typhoid conjugate vaccine (TCV), 'SKYTyphoid®' (project name NBP618), has received prequalification (PQ) certification from the World Health Organization (WHO). This marks the fourth WHO PQ certification for the company, following its influenza and varicella vaccines.
The WHO PQ process rigorously assesses a vaccine's manufacturing process, quality, and clinical trial outcomes against stringent criteria to ensure safety and efficacy. It involves meticulous scrutiny of technical documentation, including clinical and quality data, as well as testing of sample quality. Additionally, manufacturing facilities undergo thorough inspections to verify compliance with Good Manufacturing Practices (GMP) and quality control standards.
Developed in collaboration with the International Vaccine Institute (IVI) and supported by the Bill & Melinda Gates Foundation, SKYTyphoid employs the 'purified Vi polysaccharide-diphtheria toxoid conjugate' method. This innovative approach conjugates a polysaccharide of the typhoid bacteria to a diphtheria toxin protein, facilitating safe administration to infants and children aged 6 months to 2 years. It is anticipated to provide comparable immunogenicity and long-term protection with just a single dose, in contrast to existing oral live or polysaccharide typhoid vaccines.
SKYTyphoid's export license was granted by the Korean Ministry of Food and Drug Safety in 2022, based on compelling results from a global Phase III clinical study. Conducted in Nepal and enrolling 2,160 participants spanning toddlers to individuals aged 45 years, the study demonstrated positive immunogenicity and safety profiles for SKYTyphoid. Notably, compared to an existing WHO PQ-certified polysaccharide-protein conjugate typhoid vaccine, SKYTyphoid exhibited similar immunogenicity and safety across all age groups. These findings were published in The Lancet Infectious Diseases.
With WHO PQ certification secured, SK bioscience aims to target global markets with SKYTyphoid, particularly focusing on public procurement markets in major typhoid-endemic countries. The WHO estimates between 11 to 20 million cases of typhoid fever annually worldwide, resulting in approximately 120,000 to 160,000 deaths.
Jaeyong Ahn, CEO of SK bioscience, expressed satisfaction with the recognition of their efforts by WHO PQ certification, affirming their commitment to swiftly supplying SKYTyphoid by obtaining approvals in various countries. Dr. Jerome Kim, Director General of IVI, stressed the importance of vaccination in combating typhoid fever, particularly in light of climate change and the growing threat of antimicrobial resistance, pledging continued collaboration to ensure broad accessibility to the vaccine.
Source: prnewswire.com
