HYDERABAD, INDIA: Bharat Biotech, a research and pharmaceutical company based in Hyderabad, has initiated clinical trials for MTBVAC, the world’s first tuberculosis vaccine derived from a human source. The vaccine is intended to be more effective and potentially longer-lasting than the century-old BCG vaccine currently in use. Developed in collaboration with Spanish biopharma company Biofabri, Bharat Biotech holds exclusive global manufacturing rights for MTBVAC, which is aimed at protecting newborns, adolescents, and adults against tuberculosis.
MTBVAC differs from the BCG vaccine as it is based on a genetically modified form of Mycobacterium tuberculosis, containing all the antigens found in strains that infect humans. The current BCG vaccine, an attenuated variant of bovine tuberculosis, has shown limited efficacy against pulmonary TB, the main mode of disease transmission. As India is both the most populous country in the world and the one with the highest number of TB cases, conducting clinical trials in this region is vital for advancing research on the vaccine.
This groundbreaking initiative marks a significant step forward in the global efforts to combat tuberculosis. Dr. Krishna Ella, the executive chairman of Bharat Biotech, expressed optimism about the potential impact of the trials in India, emphasizing the importance of developing more effective vaccines to prevent this life-threatening disease in adults and adolescents. The ongoing research on MTBVAC has undergone over three decades of intensive study and development, with the aim of providing a more robust solution against tuberculosis.
Biofabri CEO Esteban Rodriguez highlighted the significance of testing MTBVAC in a country where a significant portion of global TB cases are concentrated. The collaboration between Biofabri, Bharat Biotech, and other research institutions in Spain and France has resulted in the development of a promising candidate vaccine that has shown potential in previous clinical trials. With the completion of a Phase-2 dose-finding trial and the commencement of a Phase-3 trial in newborns in multiple African countries, the progress of MTBVAC is closely monitored for its efficacy, safety, and immunogenicity.
The introduction of MTBVAC into clinical trials represents a critical juncture in the journey toward finding a more effective TB vaccine. With the emphasis on addressing the limitations of the existing BCG vaccine and the need for better prevention strategies against tuberculosis, the research team at Bharat Biotech is dedicated to advancing the field of vaccine development. As the trials continue to progress, the hope is to eventually offer a reliable and efficient vaccine solution to combat tuberculosis on a global scale.