Bharat Biotech Begins Clinical Trials of TB Vaccine in India

Hyderabad-based Vaccine Maker Bharat Biotech Starts Clinical Trials of TB Vaccine

In a major milestone towards finding a vaccine for tuberculosis (TB), Hyderabad-based vaccine maker Bharat Biotech has announced the commencement of clinical trials in India for MTBVAC, the Spanish tuberculosis vaccine. This live attenuated vaccine of Mycobacterium tuberculosis, isolated from a human, is being developed to be more effective and potentially longer-lasting than the current BCG vaccine.

Collaborating with Biofabri, a renowned vaccine developer from Spain, Bharat Biotech will conduct phase 3 trials in India, following the completion of phase 1 and 2 trials by Biofabri in other countries. The objective of these trials is to study the safety, immunogenicity, and efficacy of MTBVAC in the most populated country, which also has the highest number of TB cases.

Bharat Biotech’s Executive Chairman, Krishna Ella, expressed enthusiasm about the progress, stating, “Our quest for a more effective vaccine against tuberculosis received a big boost today with clinical trials in India. The MTBVAC vaccine has passed several milestones before entering clinical trials in India.”

Esteban Rodriguez, CEO of Biofabri, emphasized the significance of testing the vaccine in adults and adolescents in a country where 28% of the world’s TB cases accumulate. He highlighted that the current BCG vaccine, which is over a century old, has limited effectiveness against pulmonary tuberculosis, the primary mode of transmission for the disease.

The trials, conducted by Bharat Biotech in collaboration with Biofabri, will evaluate the safety and immunogenicity of MTBVAC. A pivotal trial to assess its safety, immunogenicity, and efficacy is planned to commence in 2025.

This important step in the development of a new TB vaccine brings hope for a more effective solution to combat the disease, especially for newborns, adults, and adolescents who currently lack an effective vaccine.