HYDERABAD: Bharat Biotech has partnered with Spanish biopharma player Biofabri to develop, manufacture and distribute a novel TB vaccine, MTBVAC, in more than 70 countries with a high TB incidence, primarily in Southeast Asia and sub-Saharan Africa.
The Phase III clinical trials of the vaccine are set to start in Senegal, South Africa and Madagascar in the second half of 2022, Bharat Biotech said on Wednesday.
Touted as one of the most promising vaccine candidates in the global TB vaccine pipeline, MTBVAC is a public private initiative that has been designed and discovered by the team led by Carlos Martín of the University of Zaragoza and is being manufactured and developed by Biofabri in collaboration with the university, IAVI and Tuberculosis Vaccine Initiative (TBVI).
Currently, the only available TB vaccine in the world — the Bacillus Calmette-Guérin vaccine (BCG) — was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease, it said.
Bharat Biotech chairman & MD Dr Krishna M Ella said Bharat Biotech opted for MTBVAC as it is in advanced stage of clinical development and also because of the extremely promising results from Phase I and II clinical trials. “TB is a highly contagious disease where vaccines are the best solution to prevent disease, reduce transmission and combat multi drug resistant strains,” Ella said.
Biofabri said the pact will help it place a globally accessible and affordable vaccine on the market in low- and middle-income countries. “For us, this agreement is a milestone in the MTBVAC project. The contract signed with Bharat Biotech ensures that our vaccine reaches countries such as India, Indonesia, Philippines, Pakistan and South Africa, among others where TB is a health problem,” said Biofabri CEO Esteban Rodríguez.