Serum Institute of India Enters Global Effort for New TB Vaccine: Partnership Aims to Produce First New TB Shot in Over a Century

Serum Institute of India (SII) has taken a significant step in the global fight against tuberculosis by partnering to manufacture M72/AS01E, a promising vaccine candidate that could become the first new TB vaccine in more than 100 years.

The Pune-based company announced the agreement with the Gates Medical Research Institute (Gates MRI), marking an important milestone in efforts to address one of the world’s most persistent infectious diseases.

India’s Serum Institute joins global race for first new TB vaccine in a century. File/AFP | Firstpost

Partnership and Manufacturing Plans

Under the collaboration, Serum Institute will invest more than $100 million to scale up its manufacturing capabilities. Gates MRI will provide the necessary technology transfer for the vaccine antigen, while British company GSK will continue supplying the AS01E adjuvant component to enhance immune response. This preparation is intended to enable rapid production and distribution if the vaccine receives regulatory approval.

Importance for Global Health

Tuberculosis continues to pose a severe public health challenge worldwide. According to the World Health Organization, the disease caused approximately 1.23 million deaths and affected nearly 11 million people in 2024. Countries like India carry a particularly high burden. A successful new vaccine could substantially reduce infections, save lives, and ease the economic strain on affected communities.

Clinical Progress and Potential Efficacy

M72/AS01E has demonstrated encouraging results in earlier trials. In Phase 2b studies, the candidate showed around 50% protection against progression to active pulmonary TB over three years in adults with latent infection. The ongoing Phase 3 trial, involving thousands of participants across multiple countries, is expected to deliver critical data on the vaccine’s safety and effectiveness.

Strengthening India’s Role in Vaccine Development

This partnership reinforces India’s growing prominence in global vaccine manufacturing. Serum Institute, known for its large-scale production of affordable vaccines, was selected for its proven ability to meet international quality standards. The company also intends to work with partners in high-burden countries to improve long-term access and supply chains.

The MGMM Outlook 

India’s decision to take a leading role in manufacturing the M72/AS01E tuberculosis vaccine candidate reflects the country's expanding influence in global healthcare and vaccine innovation. Serum Institute of India has consistently demonstrated its ability to produce high-quality vaccines at scale, and this partnership further strengthens India's position as a trusted pharmaceutical and biotechnology hub. With tuberculosis continuing to affect millions, especially in high-burden countries like India, investing in advanced vaccine production before regulatory approval shows long-term planning and a commitment to improving global health outcomes.

The collaboration also highlights how India's manufacturing strength can contribute to solving some of the world's most pressing public health challenges. If the vaccine proves successful in ongoing Phase 3 trials, India will be well-positioned to ensure affordable and widespread access while supporting global immunization efforts. Such initiatives not only reinforce the country's reputation as the "pharmacy of the world" but also demonstrate how scientific innovation, strategic partnerships, and manufacturing excellence can work together to benefit both India and the international community.

(Sources: Firstpost, NDTV, Economic Times)