New typhoid conjugate vaccine Bio-TCV® approved in Indonesia

Published November. 29. 2023

In a significant development, the International Vaccine Institute (IVI) and Bio Farma, a biotechnology company based in West Java, Indonesia, proudly announced the licensing of Bio Farma’s Bio-TCV® typhoid conjugate vaccine (TCV) in Indonesia. The momentous occasion follows the marketing approval granted by Badan Pengawas Obat dan Makanan (BPOM), the national regulatory authority.

Bio-TCV® represents a Vi polysaccharide vaccine conjugated to the diphtheria toxoid carrier protein (Vi-DT), originally conceived at IVI and subsequently transferred to Bio Farma in 2014. This collaborative vaccine development initiative spanned preclinical development and Phase I-III clinical trials, with the ultimate goal of obtaining local licensure and prequalification (PQ) from the World Health Organization (WHO). The WHO PQ designation facilitates the vaccine’s global availability for public health use through entities like Gavi, the Vaccine Alliance. Notably, the project received financial support from the Bill & Melinda Gates Foundation.

Expressing his elation, Dr. Sushant Sahastrabuddhe, Acting Deputy Director General, Clinical, Assessment, Regulatory, Evaluation at IVI, described the achievement as a milestone after nearly a decade of collaboration. He expressed gratitude to the Bill & Melinda Gates Foundation for their funding support and acknowledged the partnership of project sites across Indonesia. Dr. Sahastrabuddhe emphasized the critical role of vaccination in typhoid control, especially in the face of challenges posed by climate change and increasing antimicrobial resistance.

Shadiq Akasya, President Director of Bio Farma, echoed the sentiment of successful collaboration with IVI in the development of Bio-TCV. The licensure of their typhoid conjugate vaccine marks a valuable addition to Bio Farma’s product portfolio. Akasya highlighted the importance of Bio-TCV in preventing typhoid infection, offering protection from as early as 9 months of age. The achievement underscores Bio Farma’s commitment to global health and the fight against infectious diseases through the provision of safe and effective vaccines meeting international quality standards.

Dr. Duncan Steele, Deputy Director and Strategic Lead of Enteric Vaccines at the Bill & Melinda Gates Foundation, celebrated the licensure of Bio-TCV in Indonesia. He commended IVI’s leadership in developing and transferring the technology to Bio Farma, emphasizing the impactful role of partnerships in advancing vaccines for public health use.

IVI and Bio Farma substantiated the safety and immunogenicity of a single dose of Vi-DT through a Phase III clinical trial conducted across three provincial capital cities in Indonesia. The results demonstrated non-inferiority to a control WHO-prequalified TCV, leading to BPOM’s approval of the vaccine for national use in individuals aged 9 months to 45 years. The next step involves submitting the dossier for WHO PQ, potentially adding an affordable TCV to the global public market, accessible to low-income countries through Gavi, the Vaccine Alliance.

Typhoid fever, a potentially life-threatening febrile illness caused by Salmonella typhi, disproportionately affects children and young adults, with an estimated 11 to 20 million cases annually in low- and middle-income countries. Vaccination has proven to be an effective preventive strategy, and IVI continues to collaborate with vaccine manufacturers worldwide to expand the availability of typhoid conjugate vaccines in the public market.

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