Spain is poised to launch a new and more effective vaccine against tuberculosis, the world’s deadliest infectious disease, which kills more than one million people annually. Research initiated 25 years ago by Carlos Martín, a microbiologist and professor at the University of Zaragoza, will culminate in 2028 with the results of clinical trials on infants and adults. If these latest studies confirm the efficacy of the MTBVAC vaccine, it could pave the way for all administrative and legal procedures to negotiate and approve licensing agreements, allowing other laboratories in countries with high tuberculosis burdens to manufacture and distribute the vaccine. Esteban Rodríguez, CEO of Biofabri, the Spanish biopharmaceutical company that has spearheaded industrial and clinical development for the past 17 years, is optimistic that the vaccine can be commercialized in 2029. It will not be available over the counter, but will be manufactured with the support of donors in laboratories in Spain, India, and Brazil and distributed at affordable prices in low- and middle-income countries. However, to achieve this scientific milestone in Spain, an additional €20 million in funding is needed to develop the vaccine for infants.
Martín and Rodríguez are confident that the new vaccine is more effective than BCG, the only approved injection to prevent tuberculosis, which has been used for over 100 years and is based on a strain that causes the disease in cattle, not humans. This information was shared this week with national and regional authorities, collaborating agencies, and other interested parties invited by the Ministry of Health to the meeting of the Multisectoral Governance Group for the Tuberculosis Plan. An exchange on progress and challenges was also held with representatives of three media outlets, including EL PAÍS.
The goal is for MTBVAC to be at least 50% more effective than BCG in preventing vaccinated individuals from contracting the disease and thus becoming carriers of the bacteria. The vaccine is administered in a single dose and can be transported under normal refrigeration, facilitating logistics in hard-to-reach areas.
However, both have also acknowledged a financial gap of over €20 million for the development of the vaccine for infants. “Organizations focus on funding where there is greater social impact by interrupting the route of infection, since 90% of cases occur in adults. Therefore, there have been no problems funding the development of the vaccine for adolescents and adults, whereas there are difficulties for infants,” explains Rodríguez. “Although the vaccine can be very effective, the results will not be visible for about 20 years.”
The project already receives funding from various organizations, including the European Union, the Gates Foundation, Open Philanthropy, the US National Institutes of Health (NIH), the German development bank KfW, and the NGO IAVI, but funds are still needed for the final push. “The EU is financing 50 percent of the baby project; the other 50 percent is still pending,” says the researcher from the University of Zaragoza. “Developing a pharmaceutical product is so costly that you either need a for-profit company or, if you don’t want to make a profit, rely on altruistic foundations or community funds,” he adds.
Martín and Rodríguez are working to secure this funding. One of the goals of meetings like the one held at the Ministry of Health is to educate potential investors about the process and pharmaceutical development. “It’s not an over-the-counter vaccine, so there’s no speculation or added value. That’s why organizations are encouraged to contribute to its development,” emphasizes Rodríguez.
Tuberculosis has always been the world’s deadliest infectious disease, losing this status only for three years due to COVID-19. However, a year ago, the WHO warned that tuberculosis was once again the leading cause of death from infectious pathogens. In 2023, 10.8 million people contracted tuberculosis, of whom 1.25 million died – equivalent to the crash of 10 A350 aircraft every day with no survivors.
Vulnerable populations are particularly affected. The Global Fund for HIV, Malaria and Tuberculosis even called it a “pandemic of the poor.” In 2023, for example, two-thirds of new cases were concentrated in countries such as Bangladesh, China, the Philippines, India, Indonesia, and the Philippines.
