Bharat Biotech begins clinical trials in India for MTBVAC TB vaccine

Hyderabad: In a significant stride towards combatting tuberculosis (TB), clinical trials have begun in India for MTBVAC, the pioneering tuberculosis vaccine. Developed as the first vaccine derived from a human source, MTBVAC marked a crucial milestone in the fight against one of the world’s deadliest infectious diseases.

Led by Bharat Biotech International Limited in collaboration with Biofabri, the clinical trials aim to evaluate the safety, immunogenicity, and efficacy of MTBVAC in the Indian population. With India being the most populous country and having the highest number of TB cases globally, these trials hold immense significance in advancing TB prevention strategies.

Importance of TB vaccine for India

Esteban Rodriguez, CEO of Biofabri, underscored the importance of testing MTBVAC in India, stating, “It is a giant step to test in adults and adolescents in the country where 28 per cent of the world’s TB cases accumulate.” He emphasised the need for continued efforts and funding to address TB, which remains a leading cause of infectious disease-related deaths, particularly in India.

Dr Krishna Ella, executive chairman of Bharat Biotech, expressed optimism about the vaccine’s potential, stating, “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India.”

Efficacy for children, adults

MTBVAC holds promise for both newborns and adults. It aims to surpass the efficacy of the current BCG vaccine, offering potentially longer-lasting protection for newborns and providing preventive measures against TB disease in adults and adolescents, for whom no effective vaccine currently exists.

The vaccine has undergone rigorous testing and development stages, including Phase 2 dose-finding trials and a Phase 3 clinical trial in newborns. Additionally, trials are underway to assess the vaccine’s safety and immunogenicity in HIV-infected adults, highlighting its potential for diverse populations.

Covid impacted TB control efforts

The global impact of TB cannot be understated, with over 1.6 million deaths annually. The Covid-19 pandemic has further exacerbated TB challenges, underscoring the urgency of developing effective preventive measures.

“MTBVAC represents a collaborative effort, bridging public and private sectors, national and international partnerships, to address a pressing global health issue. As the world commemorates World Tuberculosis Day, the commencement of clinical trials for MTBVAC offers hope for a future where TB no longer poses a significant threat to public health” concluded Dr Ella.