Bharat Biotech starts clinical trials for TB vaccine

This is being viewed as a major leap in the battle against one of the deadliest infectious diseases globally, claiming over 1.6 million lives annually.

Developed through a collaboration between Spanish biopharmaceutical company Biofabri and Bharat Biotech, headquartered in Hyderabad, MTBVAC is derived from a strain of Mycobacterium tuberculosis found in humans, according to the release.

It holds potential as a more efficient and long-term alternative to the current tuberculosis vaccine, BCG, administered to newborns, which has been in use for over a century.

The BCG vaccine provides limited protection against pulmonary TB, the most prevalent and contagious form of the illness.

The trials aimed at examining the safety and immune response of MTBVAC have begun, with a crucial safety, immune response, and effectiveness trial scheduled to begin in 2025, as per the announcement.

Testing MTBVAC in adults and adolescents in a country where 28 percent of the world's tuberculosis cases are concentrated marks a big stride forward.

Before the clinical trials in India, the MTBVAC vaccine passed several critical milestones.

Following the recent conclusion of a Phase-2 trial to determine the optimal dosage, a double-blind controlled Phase-3 clinical trial in newborns commenced in 2023.

This trial aims to compare the efficacy of the MTBVAC vaccine with the existing BCG vaccine.

TB remains one of the world's top infectious causes of death, particularly in India, Esteban Rodriguez, CEO of Biofabri said.

Krishna Ella, Executive Chairman of Bharat Biotech said "Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today."

As many as 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated, the release added.