South Korea-based SK bioscience has secured prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine, SKYTyphoid.
SKYTyphoid is the fourth WHO PQ for SK bioscience. Previously, the company received this certification for two influenza vaccines and a varicella vaccine.
The typhoid vaccine was developed under a collaborative effort between the company and the International Vaccine Institute (IVI). The project received support from the Bill & Melinda Gates Foundation.
SKYTyphoid uses the purified Vi polysaccharide-diphtheria toxoid conjugate method.
The South Korean vaccine and biotech company claimed that this conjugate technology enables safe delivery of the vaccine in infants and children between the ages of six months and two years.
The vaccine offers similar immunogenicity and long-term protection with a single dosage in comparison to the current oral live or polysaccharide typhoid vaccines.
IVI director general Jerome Kim 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.”
The Korean Ministry of Food and Drug Safety granted SKYTyphoid an export license in 2022 based on the findings of an international clinical trial.
The Phase 3 study in Nepal included 2,160 patients, ages ranging from six months to 45 years, and showed that SKYTyphoid had a positive immunogenicity and safety profile.
In comparison to the current WHO PQ-certified polysaccharide-protein conjugate typhoid vaccine, the vaccine demonstrated a similar immunogenicity and safety profile in all age categories.
The biotech company intends to use WHO PQ to target worldwide markets with SKYTyphoid, with a particular emphasis on public procurement markets.
SK bioscience CEO Jaeyong Ahn 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.
“We will make every effort to rapidly supply SKYTyphoid by obtaining approvals in countries.”
