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World TB Day: Trial on new TB vaccine begins in India. Breakthrough in TB Fight: India Set to Launch Trials of New Vaccine | . News

There is a need for a new vaccine and better medicines to treat millions of patients in less time. Today on World Tuberculosis Day (24 March), there is some good news for India. Clinical trials of a promising new vaccine developed by Spain have been announced.

Bharat Biotech, the Hyderabad-based vaccine manufacturer, will conduct the trials in collaboration with Biofabri. MTBVAC, the Spanish tuberculosis vaccine, is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from humans. BCG (Bacillus Calmette and Guerin) is a weakened version of the bovine TB pathogen. It is over a hundred years old and has very limited effect on pulmonary tuberculosis, which is responsible for the spread of the disease.

Researchers have been trying to develop a new vaccine against TB for decades as TB affects millions of people worldwide and causes more than 1.6 million deaths each year. It is a debilitating disease that can affect the productivity of the individual and also affect the economy of the family, especially because the disease is more prevalent among the poor.

MTBVAC is the first vaccine against TB that is derived from a human source. It is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG for newborns, and for the prevention of TB disease in adults and adolescents for whom there is currently no vaccine. There is no effective vaccine.

Experts say the success of trials in India, now the world’s most populous country and the country with the most cases of the infectious disease, is critical to advancing the vaccine.

Biofabri is part of the Gendal Group, a group of Spanish pharmaceutical companies specializing in human and animal health. After more than three decades of research, the vaccine has been developed through public-private, national and international collaboration.

Dr. According to Esteban Rodríguez, Biofabri’s CEO, “This is a major step forward for testing in adults and adolescents in a country that accounts for 28% of the world’s TB cases.” He felt that more effort and money was needed to tackle TB, which remains one of the world’s leading infectious causes of death, especially in India. The trials are conducted by Bharat Biotech in close collaboration with Biofabri. Evaluation of safety, immunogenicity and efficacy testing of MTBVAC is planned to begin in 2025.

TB vaccine status TB vaccine status
The MTBVAC vaccine has passed several stages before entering clinical trials in India. This is a good example of public-private cooperation. The first phase was the dose determination phase which has been completed recently. After this, a double-blind, controlled Phase 3 clinical trial has been started in 2023 to test the effectiveness of the vaccine on newborns. In this trial, MTBVAC will be compared with the existing BCG vaccine.

A target has been set to vaccinate 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal. More than 1,900 children have been vaccinated so far. The objective of this trial is to assess the immunogenicity and efficacy of MTBVAC. This vaccine is given under the skin to babies on the first day of birth.

There was a brief pause in the fight against TB globally. Restrictions imposed during the COVID-19 pandemic have led to an increase in TB infections and a decline in diagnosis and treatment. As a result, the number of annual deaths due to TB has exceeded 1.6 million.

TB vaccine development TB vaccine development MTBVAC is the only vaccine against tuberculosis that is in clinical trials. It is based on a genetically modified form of a pathogen called Mycobacterium tuberculosis isolated from the human body. Unlike BCG, it contains all the antigens that are present in strains that infect humans.

This vaccine was developed in the laboratory of the University of Zaragoza. It has been created in collaboration with Dr. Brigitte Gickel at the Pasteur Institute in Paris. Biofabri is the industrial partner of the University of Zaragoza. Established in 2008, Biofabri is engaged in the research, development and manufacturing of human vaccines.

Daily Global Times
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