– Grant from the Bill & Melinda Gates Foundation will support additional supply of novel TCV at affordable cost for public sector markets
SEOUL, Korea –The International Vaccine Institute (IVI) announces receipt of a $15.7 million-dollar grant from the Bill & Melinda Gates Foundation to support late-stage development of a typhoid conjugate vaccine for public sector markets. This grant will fund Phase III trials of the Vi-DT typhoid conjugate vaccine (TCV) that are scheduled to take place in Nepal and the Philippines over the course of the next 2 years.
IVI developed the vaccine and transferred technology to its Korean partner SK bioscience, which produces the vaccine. SK bioscience has already completed process development and scale-up activities. The Phase I study has been successfully completed and a Phase II study in the Philippines is currently underway to provide longer term follow-up.
“The new grant will allow SK bioscience and IVI to complete clinical development of the Vi-DT typhoid conjugate vaccine,” said Dr. Sushant Sahastrabuddhe, Director of IVI’s Typhoid Program, “Phase III trials supported by this grant will bring the vaccine one step closer to licensure by the Korean Ministry of Food & Drug Safety and ultimately WHO prequalification, which would allow the introduction of another affordable TCV into the global market.”
Through the project, IVI and SK bioscience aim to ensure global supply of the vaccine at a predefined cost for populations in low- and lower-middle income countries where typhoid burden is endemic.
“We believe that both IVI and SK bioscience will continue successful collaboration for the development and global supply of TCV to protect and save millions of young lives at risk in low- and lower-middle income countries,” said Jaeyong Ahn, CEO of SK bioscience.
Typhoid is a poverty-associated infectious disease. Like cholera, the disease strikes the impoverished and frequently occurs in low-income settings where there is a lack of access to clean water, and where sanitation and hygiene are poor. Infants and young children are particularly at risk. Typhoid fever can be treated with antibiotics, however the WHO notes that the typhoid germ is becoming increasingly resistant to antibiotics and this poses a major threat to populations in developing countries.
“With the launch of Phase III clinical trials, we have reached the final milestone in our quest to develop an innovative typhoid vaccine that should be safe and effective in children 6 months and older,” IVI’s Director General Dr. Jerome Kim said. “This new vaccine will make a significant contribution to global efforts to reduce disease and death from typhoid infection among children in low- and middle-income countries.”
Typhoid is a life-threatening water-borne bacterial infection caused by Salmonella Typhi, which is contracted through oral ingestion of food or drink contaminated by bacteria shed by infected people. It is usually characterized by fever, headache, constipation, and malaise. However, it has few symptoms that reliably distinguish it from other febrile illnesses, which makes it difficult to diagnose and treat. Symptoms range from mild to severe, and it can even result in death. Because it is difficult to diagnose typhoid, estimates for the numbers of typhoid cases and deaths vary, but an estimated 10- 20 million get sick from typhoid and 128,000 – 161,000 die annually, according to the World Health Organization. Typhoid conjugate vaccines, which confer protection in children as young as six months of age and are thought to provide longer-lasting protection than the current live-oral or polysaccharide vaccines, have great potential in prevention of typhoid disease. The first typhoid conjugate vaccine was prequalified by the WHO in 2017 for use in children 6 months and older.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research in more than 30 countries throughout Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, Japanese encephalitis, MERS-CoV, and dengue fever, and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, please visit www.ivi.int
Tae Kyung Byun, Senior Manager of Communications, IVI
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