Spanish biotechnology leads the global fight against tuberculosis

In 2022, more than 1.3 million people died from tuberculosis worldwide, according to the latest figures from the World Health Organization (WHO). Tuberculosis, caused by the tubercle bacillus (a bacterium that usually affects the lungs), stands as the second deadliest infectious disease, after Covid-19 and ahead of HIV/AIDS. WHO estimates that around 10.6 million people fell ill with tuberculosis in the same year.

WHO emphasizes that global activities since 2000 to combat tuberculosis have saved the lives of more than 75 million people. A significant advance in public health, but $13 billion annually is needed for the prevention, diagnosis, treatment, and care of tuberculosis worldwide to meet the global target agreed upon at the United Nations High-Level Meeting on Tuberculosis in 2018. It is worth noting that ending the tuberculosis epidemic by 2030 is one of the goals set in the Sustainable Development Goals (SDGs) related to health.

Drug-resistant and multidrug-resistant tuberculosis (DR/MDR TB) is becoming an increasingly significant threat. In 2022 alone, 410,000 cases were recorded. The treatment of DR/MDR TB is lengthy, costly, often has side effects, and does not always succeed. Tuberculosis is treated with antibiotics, and treatment is recommended for both tuberculosis infection and the disease itself. In some countries, the Bacillus Calmette-Guérin (BCG) vaccine is administered to infants and young children. This vaccine prevents tuberculosis outside the lungs but not within them.

For this reason, a vaccine that prevents tuberculosis would play a crucial role in reducing the incidence of DR/MDR TB by decreasing its transmission, reducing the use of anti-tuberculosis drugs, and the emergence of drug-resistant strains. This is a challenge that biotechnology is making significant strides in. On the occasion of World Tuberculosis Day, celebrated on March 24, we focus on the work of Biofabri (a subsidiary of the Zendal Group), a biopharmaceutical company created in 2008 with the aim of researching, developing, and manufacturing vaccines for humans, through the MTBVAC candidate vaccine.

"MTBVAC is an attenuated vaccine like the current BCG vaccine, which is 100 years old. The main difference is that MTBVAC, derived from a strain isolated from humans with tuberculosis and BCG from a strain isolated from tuberculosis-infected cows, contains a higher number of antigens, including those lost in BCG due to its attenuation," Biofabri shares.

MTBVAC is being developed with two objectives: as a more effective and potentially longer-lasting vaccine than BCG for newborns and for the prevention of tuberculosis in adults and adolescents, for whom there is currently no effective vaccine. As reported by Biofabri, two Phase II trials have been completed, one supported by the European & Developing Countries Clinical Trials Partnership (EDCTP) and sponsored by Biofabri in South African babies, and another sponsored by IAVI (a non-profit scientific research organization based in the USA with locations in Europe, Africa, and India that develops vaccines and antibodies) and supported by the National Institutes of Health and the Department of Defense, both of the USA, through the Congressionally Directed Medical Research Program.

"The results are yet to be published, but both the Phase 2 in babies and the Phase 2 in adults have shown that MTBVAC is as safe as BCG and more immunogenic, and have allowed the selection of the MTBVAC dose for the ongoing Phase 3 studies in newborn babies in Africa and Phase 2b in adolescent adults, in the preparation phase," Biofabri explains.

At the end of December 2023, the Bill & Melinda Gates Foundation awarded IAVI $55 million to conduct a Phase IIb trial to evaluate the safety and efficacy of the MTBVAC vaccine, a candidate against tuberculosis. "It is expected to start in the fall of 2024 to demonstrate efficacy in adults in South Africa, Kenya, and Tanzania."

"Our commitment to the MTBVAC vaccine is to have global access through future agreements with manufacturing partners in Asia, Africa, and America. On the other hand, Biofabri would be the producer for the USA, Canada, Japan, and Australia. Our goal is to contribute to the fight against tuberculosis described in Sustainable Development Goal 3 to end the global tuberculosis epidemic by ensuring the availability of at least one new tuberculosis vaccine that is safe and effective. It is important to remember that every year 10 million people are infected, and 1,600 die from this disease," they conclude.