According to the Ministry, the MTBVAC vaccine is in the final phase of efficacy studies in clinical trials; phase 3 in babies and phase 2b in adults. In 2022, a study was initiated in sub-Saharan Africa that expects the participation of 7,500 newborns. By March 2025, 3,914 babies had already been vaccinated as part of this trial.
The study compares the efficacy of MTBVAC with that of BCG – the only vaccine currently authorized against tuberculosis – and is expected to conclude in 2028. This trial aims to demonstrate an efficacy 50 percent higher than the BCG vaccine in newborns.
The development of MTBVAC is the result of a public-private collaboration that combines 25 years of research and development (R&D) by the University of Zaragoza and 17 years of industrial and clinical development by Biofabri, belonging to Zendal, a Spanish biopharmaceutical group. The event was attended by its developer, the Aragonese scientist Carlos Martín, and Esteban Rodriguez, CEO of Biofabri.
The production and global supply of MTBVAC is planned to be carried out through production centers in Spain, India, and South America, to ensure «equitable access,» as pointed out by the Ministry. Through licensing agreements, the biopharmaceutical company Biofabri will authorize international partners to produce and distribute the vaccine in countries with a high burden of tuberculosis, which will «expand access globally,» the Ministry adds.
At this point, the Ministry explains that a licensing agreement is a common formula to scale up the production of a medicine or vaccine while ensuring control over the quality of processes and the final product. «In the case of the Spanish vaccine, these agreements allow companies in other countries to manufacture and distribute the vaccine in their regions. In this way, the vaccine can reach more people, especially in countries with a high burden of tuberculosis, guaranteeing both quality standards and proper use,» details the Ministry.
Thus, it ensures that this is a «key tool» in international health cooperation, allowing the expansion of access to the medicine without giving up scientific supervision or the business sustainability model.
THE CURRENT TUBERCULOSIS VACCINE IS OVER A HUNDRED YEARS OLD
The ‘Global Tuberculosis Report 2024,’ published by the World Health Organization (WHO), reveals that tuberculosis (TB) returned to the top spot among the most deadly infectious diseases in the world in 2023. According to the report, 10.8 million people fell ill with tuberculosis that year, and approximately 1.25 million died from this preventable and curable disease.
This increase in cases represents the highest figure recorded since the WHO began global tuberculosis monitoring in 1995. The most affected countries are India, Indonesia, China, the Philippines, and Pakistan, which together account for more than 50 percent of global cases.
The BCG vaccine (Bacillus Calmette-Guérin), used for over a century, is currently the only vaccine authorized against tuberculosis. Health authorities emphasize that, although it provides reasonable protection in babies and young children against the most severe forms of the disease, such as tuberculous meningitis, its efficacy decreases significantly in adolescents and adults, «precisely the groups where pulmonary tuberculosis, the most common and transmissible form, is more frequent.»
Additionally, they point out that the protection provided by this vaccine tends to lose effectiveness over time, does not prevent a person from getting infected, and does not effectively stop the transmission of the disease.
Currently, there are three tuberculosis vaccines in phase 3 clinical trials worldwide: MTBVAC, M72/AS01E, and VPM1002. Each follows a different strategy to improve disease prevention. However, health authorities assure that MTBVAC is currently the best positioned.
«MTBVAC has the potential to replace the century-old BCG and offer more comprehensive protection in both newborns and adults,» concludes the Ministry.