Indonesia's BPOM Plans Joint EMA Review of M72 TB Vaccine and Is Drafting a Conditional Approval Rule

Indonesia's drug and food regulator, BPOM, says it is lining up a faster path to approve the M72 tuberculosis vaccine candidate. It has not yet decided to use it.

Tri Asti Isnariani, BPOM's Director of Drug Registration, spoke today, Thursday, Nov. 5, at the 40th Stop TB Partnership Board Meeting in Badung, Bali. She said BPOM has already coordinated with the European Medicines Agency (EMA) on a joint assessment of the vaccine.

"For the M72 vaccine, we have already coordinated with the European Medicines Agency. We will conduct a joint assessment to accelerate the process," she said.

Why the EMA matters

Tri Asti explained the logic. The World Health Organization's Prequalification decision, the endorsement that opens the door to bulk procurement by international health agencies, is expected to follow the EMA's assessment. A joint review with the EMA is meant to shorten the path to that decision.

She also pointed to BPOM's status as a WHO Listed Authority. Under that designation, BPOM's regulatory decisions can carry WHO's trust when products are assessed. BPOM has also placed two of its staff at the WHO, one working on marketing authorization and one on laboratory matters.

Conditional approval is still being written

BPOM is processing a regulation that would create a conditional approval mechanism, Tri Asti said. In her description, the scheme allows faster approval of certain products by weighing the scientific data against public health need.

She was careful on the key point. "After this meeting, I will report to leadership whether we can speed things up through conditional approval for M72 or not," she said.

That is where things stand. The regulation is in process, and the decision to apply it to M72 sits with BPOM's leadership.

What the data show so far

Tri Asti said M72 has completed Phase II clinical trials with early efficacy results of roughly 54 to 57 percent. That sits right around the 55 percent efficacy reference point she said WHO uses.

That is an early-stage number from a mid-stage trial, and it straddles the line. Phase 3 results are not yet in hand, according to Tech Times, which described BPOM's work as building the regulatory machinery ahead of those results.

A conditional approval means a product reaches patients on a narrower evidence base than a full approval. The rule being drafted will set the terms. Those terms have not been made public.

Manufacturing angle

Indonesia's state-owned vaccine maker PT Bio Farma is pursuing formulation partnerships for M72/AS01E on Indonesian soil, according to Tech Times. Bio Farma has said it is open to cooperation on formulating the candidate.

If a partnership materializes, Indonesia would be a trial site, an early regulatory mover and potentially a manufacturing node for the vaccine. None of those pieces is finished. No partner, timeline or production volume has been announced.

What comes next

The near-term question is narrow. Tri Asti will report to BPOM leadership on whether to pursue conditional approval for M72, and the conditional approval regulation still has to be finalized. BPOM has said it will pursue every regulatory pathway to move as fast as possible. The Phase 3 data will determine what the agency and the EMA are actually reviewing.