Health

First New TB Vaccine in a Century: Serum Institute to Mass-Produce Groundbreaking Shot

By GS Team
17 Jul 20262 mins read
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Historic TB vaccine breakthrough! Serum Institute of India partners with Gates MRI to produce M72/AS01E, the first new TB vaccine in over a century. Targeting adolescents and adults, this vaccine could prevent 76 million cases and save 8.5 million lives globally, especially in high-burden nations like India. SII invests $100M+ in manufacturing, pending regulatory approval.

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First New TB Vaccine in a Century: Serum Institute to Mass-Produce Groundbreaking Shot
TB Vaccine

The global fight against tuberculosis is on the verge of a historic breakthrough. The Serum Institute of India (SII) has signed a major agreement with the Gates Medical Research Institute to manufacture an experimental TB vaccine, M72/AS01E. If approved by regulators, it will become the first new vaccine for tuberculosis in over 100 years.

To prepare for large-scale production, the Serum Institute has committed over $100 million to build dedicated, state-of-the-art manufacturing facilities.

Bridging the Century-Old Gap in TB Defense

For over a century, the world has relied on the Bacille Calmette-Guerin (BCG) vaccine. While BCG is effective in protecting infants and young children against severe forms of the disease, it offers notoriously weak protection for adolescents and adults.

The new M72/AS01E vaccine specifically targets adolescents and adults, aiming to shield them from pulmonary tuberculosis the most common and highly contagious form of the disease.

The Stakes: Tuberculosis remains one of mankind's deadliest infectious diseases. World Health Organization (WHO) data reveals that nearly 11 million people contracted TB in 2024, resulting in roughly 1.23 million deaths. India currently bears the highest burden of TB cases globally.

A Global Collaboration

The vaccine's journey to the production line spans several major global health organizations:

  • Original Developer: GlaxoSmithKline (GSK), which will continue to supply the critical AS01E adjuvant an ingredient that boosts the body’s immune response.
  • Clinical Testing: The Gates Medical Research Institute, backed by the Bill & Melinda Gates Foundation and Wellcome.
  • Manufacturing Powerhouse: Serum Institute of India, tasked with scaling the vaccine for global distribution.

The vaccine is currently undergoing rigorous Phase 3 clinical trials. Large-scale manufacturing will commence immediately upon receiving regulatory approval.
If successful, public health models project that M72/AS01E could prevent 76 million TB cases, save 8.5 million lives, and dramatically slash global healthcare costs over the next 25 years.