The Serum Institute of India and Gates Medical Research Institute have partnered to manufacture the M72/AS01E tuberculosis vaccine candidate, even as separate newborn trials for another vaccine, VPM1002, showed it failed to match the standard BCG vaccine’s effectiveness.
The global fight against tuberculosis is experiencing a dual-track moment of high-stakes clinical recalibration. While major international stakeholders move aggressively to secure manufacturing capacity for advanced adult vaccine candidates, recent trial data show that newer pediatric formulations face steep methodological and immunological hurdles.
VPM1002 Falls Short Against BCG in African Newborn Trials
A novel tuberculosis vaccine candidate designed for infants fell short of matching the standard bacillus Calmette-Guerin vaccine in a major double-blind, randomized phase 3 trial. Conducted across 14 sites in sub-Saharan Africa, the trial enrolled healthy newborns to receive a single dose of either BCG or VPM1002, a genetically modified recombinant BCG vaccine developed by the Serum Institute of India.
The study enrolled 6,897 newborns from Gabon, Kenya, South Africa, Tanzania, and Uganda between November 9, 2020, and June 21, 2002. Following a median follow-up of 35 months, QuantiFERON-TB Gold Plus conversion occurred in 5.3% of infants in the VPM1002 group compared with 4.3% in the BCG group. The trial investigators reported that efficacy endpoints consistently favored standard BCG over the candidate vaccine.
“The results favoured BCG over VPM1002 across the efficacy endpoints: there were more QFT conversion events (184 vs 150), more participants with confirmed tuberculosis (18 vs six), more participants with unconfirmed tuberculosis (92 vs 53), and more sustained QFT conversions (44 vs 33) in the VPM1002 group than in the BCG group.”
Study authors, via University of Minnesota reporting
The trial was terminated early in October 2024 after a review by the data safety monitoring board determined that fewer infections occurred than expected, leaving the study without sufficient statistical certainty to establish non-inferiority.
Serum Institute and Gates MRI Advance M72/AS01E Manufacturing Pact
While infant vaccine trials encounter complex endpoints, efforts targeting adolescents and adults are accelerating. The Serum Institute of India and Gates Medical Research Institute have entered an agreement to manufacture M72/AS01E, marking a pivotal industrial step for a candidate that could be a new tuberculosis vaccine introduced in over a century. GSK, the original developer, will supply the AS01E adjuvant for the vaccine.
The ongoing phase 3 trial for M72/AS01E reached full enrolment in April 2025, bringing together 20,000 participants across 54 sites in South Africa, Kenya, Malawi, Zambia, and Indonesia. Initiating manufacturing preparations ahead of final trial results is a deliberate strategy to guarantee immediate global distribution if regulatory approval is granted.
| Trial Metric | VPM1002 Newborn Trial | M72/AS01E Adult Trial |
|---|---|---|
| Development Stage | Phase 3 trial concluded early | Phase 3 trial fully enrolled |
| Participant Count | 6,897 newborns | 20,000 participants |
| Geographic Scope | Gabon, Kenya, South Africa, Tanzania, Uganda | South Africa, Kenya, Malawi, Zambia, Indonesia |
| Sponsor or Developer | Serum Institute of India | Gates MRI, GSK, Gates Foundation, Wellcome |
Financial Commitments and Global Supply Strategy
To prepare for potential future demand, the Serum Institute of India expects to invest more than US$100 million of its own resources into manufacturing readiness and capacity building. The collaboration also involves engaging local manufacturers in Indonesia and South Africa to support supply chain resilience over time in low- and middle-income countries where about 25% of the global population is infected with TB bacteria.
Earlier phase 2b data showed that M72/AS01E provided approximately 50% protection against progression to active pulmonary TB over a three-year follow-up period in TB-infected, HIV-negative adults aged 18 to 50 years. With the technology transfer process now underway between Gates MRI and the Serum Institute, stakeholders are balancing the methodological lessons learned from infant prevention trials against the industrial mobilization required for adult immunization pipelines.
