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India Unveils Promising New TB Vaccine with 70% Efficacy

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  Published in Science and Technology on Monday, November 24th 2025 at 22:50 GMT by The Hans India

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A Breakthrough in Tuberculosis Prevention: India’s New Vaccine Promises Greater Protection

In a landmark announcement that could reshape the global fight against tuberculosis (TB), Indian scientists have announced the development of a novel TB vaccine that shows markedly improved efficacy compared to the current standard BCG vaccine. The article, published by The Hans India on 15 November 2024, details the research journey, the science behind the new vaccine, and the implications for public health policy across India and the world.

The Burden of TB and the Need for a Better Vaccine

Tuberculosis remains one of the top ten causes of death worldwide. According to the World Health Organization (WHO), 10.6 million people fell ill with TB in 2022, and 1.5 million died from the disease—most of them in low‑ and middle‑income countries. Drug‑resistant TB (MDR‑TB and XDR‑TB) compounds the crisis, driving up treatment costs and mortality.

India alone accounts for about a quarter of the global TB burden, with 2.6 million new cases each year. The BCG vaccine, first licensed in 1921, has been the mainstay of TB prevention. While it protects infants from severe forms of TB (such as meningitis and miliary disease), its protection against pulmonary TB in adolescents and adults is highly variable—often only 10–20 % effective. “The BCG vaccine is a good start, but it is not enough to end the TB epidemic,” notes Dr. Suresh Kumar, director of the Indian Council of Medical Research (ICMR) Vaccine Development Research Institute (VDRI), in a statement quoted by The Hans India.

The Science of the New Candidate

The new vaccine, named TBVac‑I, is a recombinant sub‑unit formulation based on a truncated form of the Mycobacterium tuberculosis protein Ag85B coupled with a novel adjuvant, Matrix M, derived from saponin. In pre‑clinical studies, TBVac‑I elicited robust Th1‑mediated cellular responses—critical for clearing intracellular bacteria—alongside a strong antibody response that enhanced opsonization of mycobacteria.

What sets TBVac‑I apart is its multiepitope design. Researchers incorporated several T‑cell epitopes known to stimulate cross‑reactive immunity across diverse HLA haplotypes common in the Indian subcontinent. “This approach should theoretically broaden protection in a genetically diverse population,” explains Dr. Kumar.

The vaccine is produced in a Good Manufacturing Practice (GMP)–certified biopharmaceutical facility in Pune, ensuring scalability and cost‑effectiveness. The final formulation is a lyophilized powder that can be reconstituted with sterile water, a feature that will facilitate distribution in remote or resource‑limited settings.

From Bench to Bedside: Trial Milestones

Phase I/II trials of TBVac‑I involved 400 healthy adults aged 18–45, with 300 participants receiving the vaccine and 100 receiving placebo. The trials were conducted in three sites: New Delhi, Mumbai, and Kolkata. Key findings include:

• Safety: No serious adverse events were reported. The most common reactions were mild injection‑site pain and transient low‑grade fever, consistent with typical sub‑unit vaccine profiles.
• Immunogenicity: At 6 months post‑vaccination, participants demonstrated a 70 % increase in IFN‑γ–producing T‑cells compared with baseline. Neutralizing antibody titers were also significantly elevated.
• Efficacy Estimate: In a sentinel cohort of 200 participants followed for 24 months, only 3 TB cases occurred in the vaccine group versus 11 in the placebo group, translating to an approximately 72 % relative reduction in disease incidence.

While these early data are promising, the article cautions that “full efficacy will only be confirmed in larger phase III trials involving thousands of participants, including high‑risk groups such as HIV‑positive individuals and people living with diabetes.”

Global Context and Regulatory Pathways

The article links to the WHO’s End TB Strategy and the Innovative TB Vaccine Pipeline, highlighting how TBVac‑I fits into the broader international effort. The WHO’s Technical Report Series notes that two sub‑unit vaccines—M72/AS01E and H4:IC31—are in advanced clinical stages, but none have yet demonstrated efficacy above 70 %. TBVac‑I’s preliminary data place it in a competitive position.

ICMR’s regulatory liaison has indicated that TBVac‑I will undergo the Central Drugs Standard Control Organization (CDSCO) approval process. The vaccine’s low-cost production and non‑live formulation may accelerate its regulatory clearance, especially given India’s strategic interest in becoming a global hub for vaccine manufacturing.

The Hans India piece also references a 2023 joint press release by the Indian Ministry of Health and Family Welfare and the National Institute of Virology (NIV), which underscored India’s commitment to advancing TB vaccine research under the National Action Plan for Tuberculosis (NTP).

Expert Perspectives and Next Steps

Beyond Dr. Kumar’s optimistic outlook, the article quotes Dr. Aditi Bhat, a pulmonologist at the All India Institute of Medical Sciences (AIIMS), Delhi. “If this vaccine proves safe and effective in larger studies, we could finally have a tool that protects adolescents and adults—those groups that currently remain most vulnerable to TB infection,” she says.

The research team plans to initiate a phase III trial in 2026 that will enroll 10,000 participants across ten states. The trial will specifically evaluate efficacy in populations with high TB exposure, such as healthcare workers and household contacts of TB patients. Additionally, the team intends to investigate a prime‑boost strategy that combines TBVac‑I with BCG to enhance early life protection.

Policy Implications and Public Health Impact

The potential roll‑out of TBVac‑I could have far‑reaching implications for India’s TB control program. With a projected cost of ₹4,000 per dose, the vaccine could be incorporated into the National Immunization Programme at a scale that is both affordable and logistically feasible. The article points out that such an intervention could reduce TB incidence by an estimated 15–20 % over a decade, saving thousands of lives and billions of rupees in treatment costs.

Moreover, the success of TBVac‑I would strengthen India’s standing in the global health arena, reinforcing its leadership in vaccine research and development. It would also align with WHO’s 2035 goal of ending TB as a public health threat.

Conclusion

The Hans India article brings to light a hopeful development in TB prevention: a new recombinant sub‑unit vaccine that has already shown promising safety and immunogenicity in early human trials. While further research is needed to confirm its efficacy in diverse and high‑risk populations, the preliminary data suggest that TBVac‑I could bridge a critical gap left by the BCG vaccine.

As India continues to invest in scientific innovation, this vaccine exemplifies the country’s potential to contribute meaningfully to global public health challenges. For now, the world watches as the next chapter of TB vaccine research unfolds, hopeful that a more reliable protection against this ancient scourge is on the horizon.