
Jakarta (ANTARA) - The Food and Drug Monitoring Agency (BPOM) is actively monitoring the safety of Bio-TCV, Indonesia’s first locally developed conjugate typhoid vaccine.
The vaccine—born from a joint effort between the University of Indonesia (UI) and state-owned pharmaceutical giant Bio Farma—is being hailed as a critical milestone in strengthening national health resilience and ending its deep reliance on imported medicine.
BPOM Head Taruna Ikrar stated here on Friday that the partnership is a strategic response to Indonesia's high burden of typhoid fever cases.
It is also part of national efforts to break the country's 94-percent dependence on imported raw materials for medicines and vaccines.
“To ensure immediate access and protection, BPOM is fast-tracking the registration of this product through a special new drug development pathway, targeting a timeline of just 100 working days," Taruna noted.
Bio-TCV underwent a rigorous assessment of its safety, quality and efficacy before receiving its official distribution authorization number (NIE) in 2023.
It stands alongside Vivaxim and Typhim Vi as one of only three typhoid vaccines approved for use in Indonesia.
According to government database records from January 2025 to July 2026, Indonesia has produced two batches of the Bio-TCV vaccine, totaling 84,719 vials.
Meanwhile, Bio Farma data as of July 13, 2026, recorded a total production equivalent to 208,235 doses, of which 30,875 doses have been distributed to the public.
Taruna added that the domestic production of this vaccine can significantly reduce the threat of antimicrobial resistance (AMR).
Historically, high rates of Salmonella typhi infections have led to the widespread and sometimes excessive use of antibiotics in local communities. Preventing the infection entirely via immunization cuts antibiotic overuse off at the source.
Echoing this sentiment, Chair of the 2026 FKUI Med-Expo Committee, Mohammad Kurniawan, stated that strong cross-sector synergy is required to ensure domestic research directly benefits the public.
"Indonesia faces complex health challenges. No single sector can act alone. Today’s success is clear evidence of what happens when academia, government and industry unite,” Kurniawan noted at the launch of the One Health Indonesia Ecosystem.
He noted that clinical trial data for the vaccine demonstrated excellent efficacy and safety that meet international quality standards.
Nearly 100 percent of clinical trial subjects—including infants, children, and adults—exhibited a robust immune response, showing up to a fourfold increase in antibodies that persisted for at least a year post-vaccination.
The vaccine is approved for active immunization in infants aged six months and older, administered via a single 0.5 ml intramuscular injection. Side effects were reported as mild to moderate, including localized pain at the injection site, temporary fever and muscle aches.
Optimal protection is achieved three to four weeks after immunization, which is expected to provide robust protection for toddlers who have not previously received typhoid vaccines.
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Translator: Mecca Yumna Ning Prisie, Yashinta Difa
Editor: M Razi Rahman
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