SK bioscience's typhoid vaccine licensed for export by Korean Ministry of Food and Drug Safety

The International Vaccine Institute (IVI) and SK bioscience announced today that SK bioscience obtained an export license from the Korean Ministry of Food and Drug Safety for SK's typhoid vaccine 'SKYTyphoid' which they jointly developed.

SK bioscience and IVI started the development of the typhoid vaccine in 2013 by applying conjugate vaccine production technology. The vaccine received funding support from the Bill & Melinda Gates Foundation from the initial R&D stage, as SK bioscience led research and development and IVI was responsible for the conduct of global clinical studies.

SKYTyphoid is a polysaccharide-protein conjugate vaccine developed by conjugating the polysaccharide of typhoid bacteria, which acts as the antigen, to the diphtheria toxin protein (diphtheria toxoid), which acts as a carrier. Carrier proteins are known to play a role in inducing T-cell immune responses that affect long-term immunity. As a result, SKYTyphoid shows excellent immunogenicity even with a single dose inoculation and is expected to provide longer-term protection than the existing live oral or polysaccharide vaccines. Adopting conjugation technology, the new vaccine can be used in infants aged 6 months to up to 2 years as well as older populations.

IVI and SK bioscience confirmed the excellent immunogenicity and safety of SKYTyphoid in a phase III clinical trial conducted on 2,160 healthy individuals aged 6 months to under 45 years old in Nepal. In a comparative clinical trial with the existing typhoid conjugate vaccine that had obtained WHO PQ (Prequalification) certification, SKYTyphoid demonstrated equivalent immunogenicity and safety as the novel vaccine has not caused any notable side effects after administration in all age groups. Part of the research results were published in 'The Lancet Infectious Diseases,' a sister journal of The Lancet in December last year.

According to the results of the Phase II clinical trial of SKYTyphoid booster shot published in the international scientific journal 'npj (Nature Partner Journal) Vaccine' in January this year, two doses of SKYTyphoid in infants 6 to 23 months of age induced a strong immune response, with antibody titer in the body increasing 64 folds compared to before inoculation.

Based on these clinical results and licensure of the vaccine in Korea, SK bioscience will start the process to achieve WHO PQ for the vaccine. In collaboration with IVI, SK bioscience will seek to obtain WHO PQ certification for SKYTyphoid and start supplying the vaccine globally as early as next year. SK bioscience's vaccine plant, L House in Andong, Korea, will be solely responsible for both production and supply of the vaccine.

The Typhoid Program is one of the flagship programs at IVI since 1999 and the development of the conjugate vaccine was the cornerstone of this program. With the generous support from the Bill & Melinda Gates Foundation and the Government of Korea, we have conducted 4 clinical trials since 2015 in the Philippines and Nepal, and SKYTyphoid has shown good safety and immunogenicity profile. SKYTyphoid will play a major role in providing vaccine access in the endemic countries with support from Gavi, the Vaccine Alliance after its prequalification by the WHO."

Dr. Sushant Sahastrabuddhe, Head of IVI's Typhoid Program

"I am thrilled that our research conducted for over 10 years through global cooperation has resulted in an innovative vaccine," Ahn Jae-yong, CEO of SK bioscience, said. "We will seek to acquire WHO PQ for the vaccine speedily in order to contribute to making children in low- and middle-income countries free of suffering from typhoid."

"IVI is very pleased that SK bioscience's TCV has been licensed by the Ministry of Food and Drug Safety," IVI Director General Dr. Jerome Kim said. "This is the culmination of an exemplary global public-private partnership that has brought yet another vaccine against one of the world's neglected diseases. IVI is committed to collaborating with SK bioscience and other vaccine developers around the world to accelerate the discovery, development, and delivery of vaccines for global public health."

Typhoid is an acute febrile disease caused by salmonella typhi infection and is characterized by high fever and headache that emerges after an incubation period of 10 to 14 days. According to the WHO, an estimated 11 to 20 million typhoid cases occur every year around the world, mainly in developing countries, with 126,000 to 161,000 deaths every year.

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