Biofabri, a biopharmaceutical company based in Porriño, Galicia, has begun pivotal clinical trials for its tuberculosis vaccine, MTBVAC, in South Africa, Kenya, and Tanzania.

After sixteen years of development, the company expresses optimism about the vaccine's potential to eradicate tuberculosis, which remains the deadliest infectious disease globally.

CEO Esteban Rodríguez projects that Biofabri's production facility will manufacture the majority of the estimated three billion doses required starting in 2029.

The MTBVAC vaccine distinguishes itself from traditional vaccines, such as the widely used Bacillus Calmette-Guérin (BCG), by utilizing a strain of the bacteria that spreads directly between humans rather than from livestock.

This approach aims to provide robust protection for adults and effective coverage for all forms of tuberculosis, including pulmonary and military types.

The design allows for an elevated level of immunity beyond the capabilities of existing vaccines, which have historically focused on infants.

The crucial testing phase was initiated on February 19 with participants in South Africa's Cape Town receiving the first doses.

The IMAGINE project, conducted in partnership with the International AIDS Vaccine Initiative (IAVI), involves the participation of 4,300 individuals with latent tuberculosis infection who will be monitored over a period of two to three years to assess the vaccine's safety and efficacy.

This effort is financially backed by various organizations, including Open Philanthropy, the Bill & Melinda Gates Foundation, and the German government.

The new vaccine, administered in a single intradermal dose, addresses specific limitations presented by BCG, which, while effective in saving lives, has not prevented over 1.25 million tuberculosis-related deaths in 2023 alone.

The initiative is led by Spanish researcher Carlos Martín from the University of Zaragoza and Brigitte Giquel from the Pasteur Institute.

The origins of this vaccine project trace back to the 1990s, during an outbreak of multidrug-resistant tuberculosis among HIV patients that resulted in numerous fatalities in Spain.

Early research focused on identifying a transcription factor that increased the virulence of the bacterium, ultimately leading to the development of an attenuated vaccine—an essential safety consideration for Biofabri.

Prior to the current phase, MTBVAC underwent two Phase 2 clinical trials in both adults and newborns, demonstrating favorable immunogenicity and safety profiles compared to BCG.

Additional studies are planned, including a Phase 3 trial in newborns across South Africa, Madagascar, and Senegal, along with a Phase 2a trial beginning in January 2024, focusing on individuals with and without HIV.

Esteban Rodríguez indicates that upon successful testing, the aim is to market the vaccine by 2029. The project's funders emphasize the importance of making the vaccine globally distributed, affordable, and ethically produced.

Currently, the funding for clinical trials exceeds $70 million.

To facilitate large-scale production, Biofabri has established partnerships in India and Brazil, preparing to produce the vaccine rapidly once all necessary approvals are secured.

The target is to provide vaccinations for a population of three billion individuals aged 12 to 45, necessitating the production of three billion doses in a time frame of three to five years.

This ambitious project positions Galicia as a central production hub for a potentially pivotal global health intervention against tuberculosis.