Typhoid vaccine(Emergent BioSolutions, Inc.)

SKYTyphoid is jointly developed with the International Vaccine Institute, supported by the Bill & Melinda Gates Foundation. WHO PQ paves the way for public procurement by UN organizations. SK bioscience plans to target global markets with SKYTyphoid by seeking approvals in various countries. SEONGNAM, South Korea, Feb. 23, 2024 /PRNewswire/ -- 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. Continue Reading SK bioscience receives WHO prequalification for typhoid conjugate caccine. SK bioscience plans to target global markets with SKYTyphoid by seeking approvals in various countries. 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 Lancet[1]. 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." About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed in vaccine development and manufacturing to enable more equitable access of vaccines in the world. In leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin([email protected]) Jeannie S. Pak([email protected]) SOURCE SK bioscience

Researchers can accurately track where typhoid fever cases are highest by monitoring environmental samples for viruses called bacteriophages that specifically infect the bacterium that causes typhoid fever. Researchers can accurately track where typhoid fever cases are highest by monitoring environmental samples for viruses called bacteriophages that specifically infect the bacterium that causes typhoid fever. Senjuti Saha of the Child Health Research Foundation in Bangladesh and colleagues report these findings in a new study published February 15 in the open access journal PLOS Neglected Tropical Diseases. Typhoid fever is a common infection in many low- and middle-income countries and causes an estimated 135,000 deaths and 14 million infections globally each year. The World Health Organization has prequalified two typhoid vaccines, but for policymakers to plan effective vaccination strategies, they need accurate, high-resolution estimates of where the burden is highest. Traditionally, people have cultured the bacterium that causes typhoid fever from blood samples to determine where the infection is most common, but in the new paper, researchers tried a more cost-effective surveillance approach. They tested environmental water samples from sewage and other locations to detect bacteriophages specific to the water-borne pathogen that causes typhoid fever, Salmonella Typhi. The team tested 303 water samples from two locations in Bangladesh: the urban capital city, Dhaka, and a rural district, Mirzapur. They found that bacteriophages specific for Salmonella Typhi were present in 31% of environmental samples in Dhaka, compared to just 3% of samples from Mirzapur. This corresponds to results from more than 8,400 blood cultures, in which 5% of cultures from Dhaka and 0.05% from Mirzapur tested positive. The new results suggest that detecting bacteriophages specific for Salmonella Typhi may be a rapid environmental surveillance method that could help decision makers understand the presence of typhoid fever in the community. The researchers propose that environment monitoring of bacteriophage could be a simple, cost-effective and scalable tool to assist policy decisions on typhoid control. The authors add: ""Looking for bacteriophages in wastewater is a low-cost method for identifying typhoid hotspots without doing expensive blood cultures on thousands of people."