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Hyderabad: Bharat Biotech International Ltd announced on Sunday the commencement of clinical trials for the Tuberculosis vaccine Mtbvac on adults in India. This significant development marks a crucial step forward in combating Tuberculosis (TB), a disease that poses a significant health challenge globally, particularly in India.
TB continues to be a major public health concern, with India alone accounting for 28 percent of the world’s TB cases. Esteban Rodriguez, CEO of Biofabri, emphasized the urgent need for effective interventions against TB, highlighting the gravity of the disease as one of the leading infectious causes of death worldwide.
Mtbvac, developed by the Spanish biopharmaceutical company Biofabri, holds promise as a potential breakthrough in TB prevention. Bharat Biotech’s collaboration with Biofabri underscores a concerted effort to address the dual challenges of enhancing TB vaccination efficacy and expanding preventive measures to include adults and adolescents.
The ongoing clinical trials aim to evaluate the safety and immunogenicity of Mtbvac, paving the way for a pivotal trial slated to commence in 2025. This trial will encompass comprehensive assessments of safety, immunogenicity, and efficacy, marking a significant stride in the quest for an improved TB vaccine.
Krishna Ella, Executive Chairman of Bharat Biotech, expressed optimism about the potential of Mtbvac, affirming the company’s commitment to developing effective TB vaccines. The trials represent a culmination of rigorous research efforts, with Mtbvac having surpassed critical milestones on its journey towards clinical validation.
Mtbvac’s trajectory towards clinical trials in India follows a series of significant achievements, including the completion of Phase-2 dose finding trials and the initiation of Phase-3 trials involving newborns.
