BPOM Boosts National Vaccine Independence Through Bio-TCV Indonesia
The Food and Drug Supervisory Agency (BPOM) is driving the realisation of national vaccine self-reliance through the launch of Bio-TCV, a conjugate typhoid vaccine developed through collaboration between academia, industry and government.
Bio-TCV is the result of collaboration between the Faculty of Medicine of the University of Indonesia (FKUI), Cipto Mangunkusumo General Hospital (RSCM) and PT Bio Farma.
The collaboration is seen as proof of Indonesia’s ability to turn research outputs into health products ready for public use.
According to an official statement received by CNNIndonesia.com, 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 infants aged six months through to adults, strengthening the national immunisation programme while extending protection to vulnerable groups.
Furthermore, the vaccine is projected to enter the international market through the WHO Prequalification process.
Should that stage be successfully completed, Bio-TCV will not only meet domestic needs but also open up opportunities for Indonesia to become an important part of the global vaccine supply chain.
The Head of BPOM of the Republic of Indonesia, Taruna Ikrar, regarded Bio-TCV not merely as a conjugate typhoid vaccine born of the nation’s own innovation, but as a marker that Indonesia is entering a new chapter of health development.
According to him, research, industry and government are no longer working in isolation, but mutually reinforcing one another within a single innovation ecosystem.
In the launch process, FKUI together with RSCM led the conduct of Phase I, II and III clinical trials under rigorous scientific and ethical standards.
Meanwhile, PT Bio Farma undertook a long process of technological mastery through a partnership with the International Vaccine Institute (IVI) dating back to 2010, followed by technology transfer in 2013, until it was finally able to produce the vaccine independently.
Behind the entire process, BPOM played a role in guiding every stage, from supporting the clinical trials, product standardisation and production process oversight, through to evaluating the vaccine’s quality, safety and efficacy.
All assessments were carried out through an accelerated review mechanism, an approach that speeds up the regulatory process without compromising scientific rigour or public protection.
Taruna Ikrar viewed the arrival of Bio-TCV as an important step towards building self-reliance in the national health sector through mastery of research, technology, production and a credible regulatory system.