SK Biosciences and the International Vaccine Institute (IVI) announced today that the typhoid conjugate vaccine developed by SK Biosciences with technology transfer from IVI has achieved World Health Organization prequalification (PQ) and has been recognized by the United Nations agency as a vaccine. It was announced that the path has been opened to public procurement. Promote his TCV supply worldwide.
WHO PQ certifies the safety, efficacy, and GMP of vaccines by evaluating their manufacturing processes, quality, and clinical trial results according to strict standards. The WHO PQ is essential for participating in international tenders organized by UN agencies such as UNICEF and the Pan American Health Organization (PAHO), proving the quality of the vaccine and the competitiveness of the technology in the global market.
The new vaccine SKYTyphoid™, which has now been approved by the WHO, is a typhoid conjugate vaccine jointly developed by SK Bioscience and IVI with technology transfer from IVI with financial support from the Bill & Melinda Gates Foundation. SK Biosciences was the manufacturing partner, and IVI led the clinical trials in the Philippines and Nepal.
The vaccine utilizes the “purified Vi polysaccharide/diphtheria toxoid conjugate'' method, in which diphtheria toxin protein (diphtheria toxoid), which serves as a carrier, is conjugated to the polysaccharide of Salmonella typhi, which serves as an antigen. Employing conjugate technology, the vaccine can be safely administered to infants and young children aged 6 months to 2 years and produces a sufficient immune response with a single dose compared to existing oral live vaccines or polysaccharide typhoid vaccines. and long-term protection is expected.
Based on clinical results, SKYTyphoid™ received an export license from the Korean Ministry of Food and Drug Safety in 2022. A phase 3 clinical trial conducted by SK Biosciences and his IVI in Nepal on 2,160 healthy individuals aged 6 months to her age of 45 years demonstrated the excellent immunogenicity and safety of the vaccine. In a comparative study with a conventional WHO-PQ polysaccharide-protein conjugate typhoid vaccine, SKYTyphoid™ demonstrated comparable immunogenicity and safety in all age groups with no noticeable side effects after administration. The results of this study were published in The Lancet Infectious Diseases, a sister journal of The Lancet.
Additionally, results from a Phase II clinical trial of the SKYTyphoid™ booster shot published in the international NPJ (Nature Partners Journal) Vaccines show that two doses of TCV are highly effective in infants aged 6 to 23 months. It was shown that an immune response was induced. The antibody titer in the body has increased significantly compared to before vaccination.
The WHO authorization of SK Bioscience's TCV represents the successful conclusion of a global public-private partnership to bring to market a novel vaccine of critical importance to global public health. SKYTyphoid™ will help diversify and expand the supply of his TVC and improve vaccine access in endemic countries. With SK's commitment to manufacturing vaccines for global public health at competitive prices, SKYTyphoid™ will play an important role in global typhoid prevention. ”
Dr. Sushant Sahastrabudde, IVI Typhoid Program Director
Given the high demand for typhoid vaccines around the world, especially in low-income countries, SK Bioscience plans to begin supplying the vaccine as soon as possible and expand global supply through public procurement markets, including in typhoid-endemic countries. According to the WHO, an estimated 11 million to 20 million people worldwide are infected with typhoid fever and 120,000 to 160,000 people die from the disease.
“Typhoid fever is more prevalent in warmer temperatures, and climate change and the alarming rise in antimicrobial resistance will only increase the threat of this disease,” said Dr. Jerome Kim, IVI Executive Director. “This is critical for effective prevention and control.” IVI will continue to work with SK Bioscience and other partners to make this vaccine available to those who need it most. ”
“We are pleased that our global collaboration to address global vaccine supply imbalances and improve public health has been recognized through the WHO PQ,” said Ahn Jae-young, President of SK Biosciences. In addition to PQ, additional country-specific approvals are required to enable rapid supply of vaccines.'' With the addition of SKYtyphoid™, SK Biosciences now has two influenza vaccines and one varicella vaccine. WHO PQ was achieved for four types of vaccines, including the
sauce:
International Vaccine Institute
