The Central Drug Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) has approved Bharat Biotech International’s proposal to conduct the phase II clinical trial of the Mycobacterium Tuberculosis (Live Attenuated) Vaccine to assess the safety and immunogenicity in healthy adolescent and adult populations.
According to a release issued by the Company, the MTBVAC is the first vaccine against TB derived from a human source to begin clinical trials in adults in India.
“Studying the safety, immunogenicity, and efficacy of MTBVAC in the most populated country in the world and the one with the highest number of cases of this infectious disease is key to continue advancing in this vaccine. Bharat Biotech International Limited in collaboration with Spanish biotechnology company Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity, and efficacy of MTBVAC in India. MTBVAC is being developed for two purposes - as a more effective and potentially longer-lasting vaccine than BCG for newborn children, and for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine,” the statement said.
