Serum Institute, Gates MRI tie up to produce experimental TB vaccine
- Serum Institute of India and Gates MRI have partnered to produce an experimental TB vaccine.
- The vaccine is still in development and has not yet received regulatory approval.
- The partnership aims to leverage Serum's manufacturing capacity for large-scale production.
Partnership announced for TB vaccine manufacturing
Serum Institute of India, the world’s largest vaccine manufacturer by volume, has entered a partnership with the Gates Medical Research Institute (Gates MRI) to produce an experimental vaccine against tuberculosis. The collaboration, announced on Thursday, aims to develop and manufacture a new candidate that could address one of the world's deadliest infectious diseases.
The experimental vaccine is still in clinical trials. No regulatory approvals have been granted yet. The companies have not disclosed the financial terms of the deal or the specific trial phase the vaccine is currently in.
Why this matters
Tuberculosis kills over 1.3 million people globally each year, with India accounting for roughly a quarter of all cases. The only licensed TB vaccine, BCG, is nearly a century old and offers limited protection against pulmonary TB in adults. A more effective vaccine could be a game-changer for public health.
The Gates MRI, a nonprofit biotech organization funded by the Bill & Melinda Gates Foundation, has been working on several TB vaccine candidates. Serum Institute’s involvement brings massive manufacturing capacity — the company can produce over 1.5 billion doses of vaccines annually. That scale could help ensure rapid, affordable supply if the vaccine succeeds.
What the partnership entails
Under the agreement, Serum Institute will handle process development, technology transfer, and large-scale manufacturing of the vaccine candidate. Gates MRI will provide the technology and oversee clinical development. The goal is to have a product ready for regulatory review and potential distribution once trials conclude.
Serum Institute CEO Adar Poonawalla said in a statement that the partnership aligns with the company's mission to make essential vaccines accessible to low- and middle-income countries. Gates MRI officials have not yet commented on a timeline for trial results or potential filing for approvals.
Challenges ahead
Developing a TB vaccine has historically been difficult. Many candidates have failed in late-stage trials over the past two decades. The bacterium that causes TB is complex, and previous attempts have struggled to trigger a strong enough immune response in adults. The current experimental vaccine aims to overcome these hurdles, but success is far from guaranteed.
Regulatory pathways also remain uncertain. Indian drug authorities and the World Health Organization will need to review safety and efficacy data before any rollout can begin. The companies have not specified which countries they would target first if the vaccine is approved.
What to watch: The next few months could bring updates from ongoing clinical trials. If data proves promising, the partnership could fast-track manufacturing and set the stage for one of the largest TB vaccine campaigns in history. If trials fail, the search for a breakthrough will continue.