SII, Gates MRI partner to manufacture new TB vaccine, a first in a century
- Serum Institute of India and Gates MRI signed an agreement to manufacture an experimental TB vaccine.
- The vaccine candidate, developed by GSK, has completed successful Phase 3 trials.
- This is the first new TB vaccine in over a century since the BCG vaccine was introduced.
Historic pact for a century-old challenge
The Serum Institute of India (SII) has signed an agreement with the Gates Medical Research Institute (Gates MRI) to manufacture a novel tuberculosis vaccine candidate. The move comes after the vaccine successfully completed Phase 3 clinical trials.
This marks the first new TB vaccine in over a hundred years. The existing Bacillus Calmette-Guérin (BCG) vaccine, developed in the 1920s, remains the only approved jab against the disease.
A vaccine originally developed by GSK
The experimental vaccine was originally developed by the British pharmaceutical giant GSK. Under the new manufacturing agreement, SII will produce the candidate for global access, particularly targeting high-burden countries like India.
Officials have not yet confirmed the exact timeline for regulatory approvals or mass rollout. But the partnership signals a major push to address a disease that kills over a million people every year worldwide.
Why a new TB vaccine matters
Tuberculosis remains one of the deadliest infectious diseases globally. India accounts for the highest number of TB cases in the world, with nearly 26 lakh cases reported annually.
The BCG vaccine offers limited protection against pulmonary TB in adults. It is most effective in preventing severe forms of the disease in children. A new, more effective vaccine could dramatically alter the trajectory of TB control efforts.
Phase 3 success paves the way
The vaccine candidate has shown promising efficacy in late-stage trials, though full data has not been made public yet. The Phase 3 results were strong enough to convince both SII and Gates MRI to move forward with manufacturing plans.
The partnership aims to ensure the vaccine is affordable and accessible in low- and middle-income countries. SII’s manufacturing capacity, the largest in the world by volume, is expected to play a key role in scaling up production.
What lies ahead
Regulatory submissions are expected in the coming months. If approved, this could be the first new TB vaccine to reach the market since the 1920s.
The next steps will involve securing approvals from Indian and global health regulators, followed by large-scale production. Global health agencies are watching closely.