Gates Medical Research Institute, Serum Institute ink agreement to manufacture novel TB vaccine

CAMBRIDGE, MA / PUNE – In a landmark development for global health, the Gates Medical Research Institute (Gates MRI) and Serum Institute of India Private Ltd (SII) have forged a critical agreement to manufacture M72/AS01E, a groundbreaking tuberculosis (TB) vaccine candidate. This partnership, announced on July 16, 2026, involves a substantial investment of over $100 million from SII to bolster manufacturing readiness and capacity, ensuring that if successful, the vaccine can be produced at scale and made accessible to populations in high-burden countries. Tuberculosis remains a devastating infectious disease, claiming over a million lives annually worldwide and disproportionately affecting low- and middle-income nations. Zambia, unfortunately, is no stranger to this crisis, ranking among the 30 high TB burden countries globally. With an estimated incidence of 283 cases per 100,000 people in 2023, and approximately 5,000 deaths annually, TB continues to be one of the deadliest diseases in the country. The current BCG vaccine offers limited protection for adolescents and adults, who are primarily responsible for transmission, underscoring the urgent need for new, more effective interventions. M72/AS01E, currently undergoing Phase 3 clinical trials, represents a beacon of hope. If approved, it could be the first new TB vaccine introduced in over a century, specifically targeting adolescents and adults to prevent the progression to active pulmonary TB. Previous Phase 2b trials demonstrated approximately 50% protection against active pulmonary TB over three years in HIV-negative adults. The World Health Organization estimates that such a vaccine could prevent 76 million new TB cases, save 8.5 million lives, and avert $41.5 billion in costs for affected households over 25 years. The strategic decision to initiate manufacturing preparations ahead of Phase 3 results highlights a proactive approach to ensure rapid deployment upon regulatory approval. For Zambia, the impl