Serum Institute Propels Adult TB Vaccination Drive: Seeking Approval for Breakthrough Recombinant BCG Vaccine

Seeking approval for an adult tuberculosis (TB) vaccine, the Serum Institute of India (SII), headquartered in Pune, has applied for emergency use authorization to the Drug Controller General of India (DCGI). This move marks a significant step towards combating TB by 2025.

Traditionally, the BCG vaccine has been administered to infants in India, leaving adults without immunization. However, the development of a recombinant BCG (rBCG) vaccine by SII aims to address this gap. Prakash Kumar Singh, the Director of Government and Regulatory Affairs at SII, informed the Economic Times (ET) about the submission, following extensive phase-3 clinical trials involving 2,000 participants. Pending approval, a single dose of the vaccine is expected to offer adequate protection.

Aligned with the national goal to eradicate TB by 2025, the Indian government is prioritizing this initiative, surpassing the Sustainable Development Goal target. Upon regulatory approval, the National Technical Advisory Group on Immunisation (NTAGI) will finalize the vaccine’s integration into the national immunization program.

The potential recipient pool for the TUBERVAC-rBCG vaccine spans across age groups, encompassing children, adolescents, and adults. Determination of the target age demographic will be subject to expert evaluation.

The ambitious goal of a TB-free India, endorsed by the Prime Minister, echoes the urgency to eradicate TB ahead of schedule. Notably, government officials express optimism regarding the vaccine’s reception among adults, emphasizing the necessity for enhanced protection beyond childhood immunization with BCG.