- India is testing two new TB vaccines developed by Cadila and Serum Institute of India
- The vaccines showed significant efficacy against extra-pulmonary TB in a large Phase III trial
- ICMR led and funded the trial, ensuring independent evaluation and minimizing commercial bias
Tuberculosis is a deadly disease. Every two minutes one person dies of TB in India. It is a complex disease to control. India's decades long battle against tuberculosis is entering a new phase, with the country gaining two potential new tools in the form of novel TB vaccines developed by Cadila Pharmaceuticals Ltd and the Serum Institute of India. Both vaccines are safe and can be used in the public health program once the drugs regulator gives an approval. While the vaccines are products of private sector innovation, their evaluation has been firmly anchored in public science, with a large, independent Phase III clinical trial led, funded and sponsored by the Indian Council of Medical Research (ICMR). The results, now published in the respected and peer reviewed journal The British Medical Journal (BMJ), add confidence that India's TB control strategy is expanding beyond treatment to prevention, especially against the more dangerous and often neglected extra-pulmonary form of the disease.
Tuberculosis remains one of the world's deadliest infectious diseases. According to global estimates, about 10.8 million people developed TB in 2023, and the burden has been rising in recent years after disruptions caused by the Covid pandemic. India accounts for the largest share of cases worldwide, carrying roughly one quarter of the global TB burden. Despite expanded diagnostics and free treatment under the national TB programme, the disease continues to claim lives and cause long term disability, especially among adults in their most productive years.
Speaking to NDTV Dr Soumya Swaminathan former Chief Scientist for the World Health Organisation (WHO) said "the two vaccines were tested for their efficacy in preventing pulmonary and extra pulmonary TB among household contacts of TB patients. VPM1002 was found to be effective in younger age groups and in preventing extra pulmonary TB. We need more research to identify the ideal timing of vaccination - possibly in school children aged 6 to 14 years." This could be of potential use in adolescents.
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India continues to shoulder the world's largest tuberculosis burden, with the WHO Global TB Report 2025 estimating about 27 lakh new TB cases in India in 2024, accounting for roughly one quarter of all TB cases globally. The disease also claimed over three lakh lives in the country, underlining its status as one of India's deadliest infectious killers. Despite this heavy burden, India has set itself an ambitious target to eliminate tuberculosis by 2025, five years ahead of the global goal of 2030. Elimination, as defined by the national programme, means reducing TB to fewer than one case per million population. Under the National Tuberculosis Elimination Programme, India has expanded diagnostics, improved treatment coverage and reduced TB incidence by about 21 percent since 2015, but experts acknowledge that new tools for prevention, including vaccines, will be critical if the country is to bend the TB curve faster and move closer to its elimination goal. At the heart of the challenge is the limitation of the nearly century old BCG vaccine, which remains the global gold standard. BCG protects infants and young children against severe TB forms such as meningitis, but it offers little sustained protection in adolescents and adults, where transmission and disease burden are highest. Adding to the complexity is extra-pulmonary TB, where infection spreads beyond the lungs to organs such as lymph nodes, bones, the abdomen or the brain. Extra-pulmonary TB , which constitutes upto 15-24% of TB in India, is difficult to diagnose, often requires costly investigations that are not routinely available free of charge, and is associated with high morbidity and mortality.
It is against this backdrop that the latest Indian trial assumes importance. The Phase III study assessed two vaccines, code named 'VPM1002' developed by Serum Institute of India and 'Immuvac' developed by Cadila, in over 12,700 participants aged six years and above. Participants were household contacts of recently diagnosed TB patients and included individuals with risk factors and comorbidities, making the trial reflective of real world conditions rather than ideal laboratory settings. The study was conducted at 18 sites across six Indian states, marking one of the largest TB vaccine trials undertaken anywhere in the world in recent years.
Crucially, while neither vaccine showed strong protection against all TB or pulmonary TB across the full population, VPM1002 demonstrated a statistically significant 50.4 percent efficacy against extra-pulmonary TB at the end of 3 yrs. For public health experts, this is a critical signal. Preventing extra-pulmonary TB could reduce deaths, disability and out of pocket expenditure for some of the most vulnerable patients. The study also reported encouraging protection in children, a group where breaking the transmission cycle can have long term population level impact.
The credibility of the findings is strengthened by the role of ICMR as the sponsor and funder of the trial. While the vaccines were developed by industry, the conduct and analysis of the study rested with a government research organisation, minimising commercial bias. Such an arrangement is rare globally and underscores India's growing capacity to independently evaluate complex health technologies at scale.
Another important aspect is cost. According to industry sources, the new TB vaccines could potentially be manufactured at less than one hundred rupees per dose with high volume, low cost production. If supported by policy and further evidence, this opens the door to large scale preventive vaccination in high risk groups, something that has long been considered financially out of reach for TB.
The study also highlights the biological complexity of the disease. Tuberculosis has a long latency period, meaning infection can remain dormant for years before progressing to active disease. This trial demonstrated that both vaccines demonstrated over 65% efficacy against extra-pulmonary TB in people with latent TB infection. In addition, both demonstrated an ability to prevent the progression to active TB in those who developed latent TB at 6 months wherein VPM1002 provided greater than 60% efficacy against all TB, Pulmonary TB and extra-pulmonary TB, while Immuvac provided greater than 50% efficacy against All TB and extra-pulmonary TB . The findings clearly indicate that the vaccines can play an important role in preventing progression. TB is not a simple infection where exposure quickly leads to illness. This makes vaccine development particularly challenging and explains why even partial protection, especially against severe disease, is considered a meaningful advance.
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India's engagement with TB vaccine science has a long history. The last major landmark trial was the Chengalpattu BCG trial conducted several decades ago, which evaluated the effectiveness of BCG in the Indian population. The findings from that trial shaped TB policy for generations. The current study, though different in design and scope, represents a similar moment in terms of scale, ambition and long term implications.
By being published in the The British Medical Journal (The BMJ), one of the world's most trusted medical journals, the study's findings are subjected to rigorous scientific scrutiny and global visibility. For India, this is not just about adding two vaccines to the toolbox, but about demonstrating leadership in tackling a disease that remains entrenched despite decades of effort.
While these vaccines are not a magic bullet, they signal progress. Combined with early diagnosis, effective treatment, nutritional support and social interventions, new vaccines could help tilt the balance in India's goal of controlling and eventually eliminating TB. For a country that bears the greatest burden of the disease, gaining credible, affordable and scientifically validated preventive tools marks an important step forward in a long and difficult fight.
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