M72 tuberculosis vaccine approval in Indonesia: BPOM weighs a fast track

BPOM, Indonesia’s national drug and food authority, is preparing a conditional approval route and a joint review with the European Medicines Agency (EMA) that could speed up M72 tuberculosis vaccine approval in Indonesia. The announcement came at the 40th Stop TB Partnership Board Meeting in Badung, Bali.

Two tracks for M72 tuberculosis vaccine approval in Indonesia

The first track is a joint assessment with the EMA. Tri Asti Isnariani, BPOM’s Director of Drug Registration, said: “For the M72 vaccine, we have already coordinated with the European Medicines Agency. We will conduct a joint assessment to accelerate the process.” The second is a conditional approval mechanism, which BPOM is processing as a formal regulation.

No decision has been taken. BPOM has already approved the Phase 3 trial in Indonesia, but not the vaccine.

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The efficacy figures so far come from Phase 2 work. In a Phase 2b study, M72/AS01E showed approximately 50 percent efficacy against progression to active pulmonary TB over three years. Tri Asti cited preliminary Phase 2 efficacy of approximately 54 to 57 percent. The Phase 3 trial, NCT06062238, enrolled 20,000 participants across 54 sites, Indonesia among them. Gates MRI expects results in late 2028.

Why it matters

Indonesia ranks second in the world for TB burden, with more than 1.06 million cases a year and more than 130,000 deaths.

A conditional route only pays off once the Phase 3 data arrive, and those results are years away. The joint review may matter most for procurement. TechTimes notes that WHO prequalification, which UNICEF and Gavi need before buying, typically follows EMA’s conclusions, so an overlapping review could shorten the sequence. Bio Farma, the state-owned vaccine maker, is seeking a domestic formulation partner for M72.

Source: TechTimes, 5 November 2026