BPOM Boosts National Vaccine Independence Through Bio-TCV Indonesia

The Food and Drug Authority (BPOM) is encouraging the realisation of national vaccine independence through the launch of Bio-TCV, a conjugate typhoid vaccine developed through collaboration between academia, industry, and government. Bio-TCV is the result of a partnership between the Faculty of Medicine, University of Indonesia (FKUI), Cipto Mangunkusumo Hospital (RSCM), and PT Bio Farma. This collaboration is considered proof of Indonesia’s ability to transform research results into health products ready for public use. Bio-TCV was developed as a vaccine to provide active immunisation against typhoid fever caused by Salmonella typhi infection. The vaccine can be administered from the age of six months to adults, strengthening the national immunisation programme whilst expanding protection for vulnerable groups. Furthermore, the vaccine is projected to enter the international market through the WHO Prequalification process. If this stage is successfully passed, Bio-TCV will not only meet domestic needs but also open opportunities for Indonesia to become an important part of the global vaccine supply chain. Head of BPOM, Ikrar Taruna, assessed that Bio-TCV is not just a conjugate typhoid vaccine resulting from domestic innovation, but a sign that Indonesia is entering a new chapter in health development. According to him, research, industry, and government are no longer moving separately but are mutually reinforcing within a single innovation ecosystem. In the launch process, FKUI and RSCM led the implementation of Phase I, II, and III clinical trials with strict scientific and ethical standards. Meanwhile, PT Bio Farma undertook a lengthy process of technology mastery through a partnership with the International Vaccine Institute (IVI) since 2010 and technology transfer in 2013, until it was finally able to produce the vaccine independently. Behind the entire process, BPOM played a role in overseeing every stage, from clinical trial assistance, product standardisation, and production process supervision, to the evaluation of the vaccine’s quality, safety, and efficacy. The entire assessment was carried out through an accelerated review mechanism, an approach that speeds up the regulatory process without reducing scientific rigour or public protection. Taruna Ikrar assessed that the presence of Bio-TCV is an important step in building national health sector independence through mastery of research, technology, production, and a credible regulatory system.