Bharat Biotech, in collaboration with Spanish biopharmaceutical company Biofabri, has initiated clinical trials for MTBVAC, the world's first live attenuated vaccine of Mycobacterium tuberculosis isolated from humans, in India. This significant development aims to assess the safety, immunogenicity, and efficacy of MTBVAC in newborns, adolescents, and adults.

Hyderabad-based Bharat Biotech has secured exclusive global manufacturing rights for MTBVAC, which is positioned as a potential game-changer in the fight against tuberculosis (TB). Unlike the century-old Bacillus Calmette and Guérin (BCG) vaccine, MTBVAC offers the promise of enhanced effectiveness and longer-lasting immunity.

The trials, designed to evaluate the safety and immunogenicity of MTBVAC, have commenced in India, with a pivotal safety, immunogenicity, and efficacy trial scheduled to begin in 2025. MTBVAC holds potential not only for newborns but also for adolescents and adults, addressing the critical need for an effective TB vaccine in these populations.

Dr. Krishna Ella, Executive Chairman of Bharat Biotech, emphasized the significance of this milestone, stating, "Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India." He expressed gratitude for the partnership with Biofabri and underscored the noble effort to reinvent TB vaccines.

MTBVAC's development represents a culmination of over three decades of research, originating from Spain's University of Zaragoza's laboratory in collaboration with experts from the Pasteur Institute in Paris. Biofabri, serving as the industrial partner of the University of Zaragoza, has played a pivotal role in advancing the vaccine's development.

Esteban Rodriguez, CEO of Biofabri, highlighted the significance of conducting trials in India, a country bearing a substantial burden of TB cases globally. "It is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate," he stated, underscoring the importance of advancing vaccine research in high-burden regions.

MTBVAC's unique composition, derived from a genetically modified form of Mycobacterium tuberculosis isolated from humans, distinguishes it from the BCG vaccine. Recent trials, including a Phase-2 dose finding trial and a Phase-3 clinical trial in newborns, have demonstrated promising results, paving the way for further evaluation in diverse populations.