India to launch trials on new TB vaccine; Hyderabad firm Bharat Biotech takes lead

A sustained war armed with a new and more potent vaccine and multi-drug therapy, which are affordable to the poor, are imperative to tame this disease which has been raging in most of the poor and largely populated nations in the world. For India, it’s a must and needed at the earliest.

TB or Tuberculosis, the once dreaded disease, continues to remain a top killer in India. BCG, the only available vaccine is over a hundred years old. The multi-drug therapy, though quite effective still remains long drawn.

The need for a new vaccine and better drugs with shorter treatment regime have been a crying need for millions of patients. On this World TB Day today (March 24), there is some good news to cheer, especially for Indians with the announcement that clinical trials will be started of a promising new vaccine developed by Spain.

The Hyderabad-based vaccine maker, Bharat Biotech will carry out the trials with Biofabri. MTBVAC, the Spanish tuberculosis vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human.

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The BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine TB pathogen. It is more than a hundred years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease.

The vaccine challenge

For decades, researchers have been trying to develop a new vaccine as TB continues to affect millions across the world with more than 1.6 million deaths annually. It is a debilitating disease that can impact the productivity of the person and also affect the economy of the family, especially since the disease is predominantly 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 effective vaccine.

The success of the trials in India, now 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, say experts.

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

According to Esteban Rodriguez, CEO of Biofabri, “It is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate.”

He felt that more effort and funding is needed to combat TB, which remains one of the world’s leading infectious causes of death, especially in India. The trials are carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety, immunogenicity and efficacy trial of MTBVAC has been planned to start in 2025.

Dr Krishna Ella, Executive Chairman Bharat Biotech says, “Our quest for a more effective vaccine against Tuberculosis to prevent disease in adults and adolescents received a big boost today, with clinical trials in India. The partnership with BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to reinvent TB vaccines will go a long way.”

Status of the vaccine

A long process, an example of public-private collaboration the MTBVAC vaccine has passed several milestones before entering clinical trials in India. The first is that after the recent completion of a Phase2 dose finding trial, a double-blind, controlled Phase3 clinical trial in newborns has started in 2023, comparing the vaccine with the current BCG vaccine.

A target of 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated in due course. To date, more than 1,900 babies have been vaccinated, according to a statement from the collaborators.

The aim is to assess the immunogenicity and efficacy of MTBVAC which is administered intradermally to infants on the first day of life.

The vaccination drive began at a time of setback in the global fight against TB. Health restrictions imposed during the COVID-19 pandemic led to an increase in infections and a decrease in diagnosis and treatment. As a result, annual TB deaths have risen to over 1.6 million.

Vaccine development & TB

MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis which, unlike BCG, contains all the antigens present in strains that infect humans.

This vaccine was developed in the laboratory of the University of Zaragoza, which has been part of CIBERES since its creation, in collaboration with Dr Brigitte Gicquel of the Pasteur Institute in Paris. Bio fabric is the industrial partner of the University of Zaragoza. Founded in 2008, Biofabri is into research, development and manufacture of human vaccines.

Tuberculosis, which is transmitted through the respiratory tract, kills more than 1.6 million people and infects another 10 million worldwide each year. In 90% of infections, the immune system recognises and controls the bacteria without causing disease. However, in 5-10%, the bacteria develop tuberculosis, which is fatal in half of patients without treatment with several drugs over 6 months.

If the TB is in the lungs, it can find a free path to progress, multiply and spread the disease. Although there are antibiotics that can kill the bacilli at a higher rate than they reproduce, TB bacteria have a coat that protects them from the immune system and makes it difficult for many of these drugs to penetrate, and multidrug-resistant strains have emerged in recent decades.

India has been waging a long battle against TB. Its National TB control programme covers all the states and districts. It has elaborate detection and supplying of the multi-drug therapy drugs to the poor. It has made progress, but the burden continues to be substantive with its own impact on productivity of the individual and family.

A sustained war armed with a new and more potent vaccine and multi-drug therapy, which are affordable to the poor, are imperative to tame this disease which has been raging in most of the poor and largely populated nations in the world. For India, it’s a must and needed at the earliest.

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