A New Hope Against a Lethal Disease

For more than 25 years, Dr. Carlos Martín and veterinarian Esteban Rodríguez have dedicated their careers to developing a vaccine that could revolutionize the treatment of tuberculosis (TB), the world’s most lethal infectious disease. The current, century-old BCG vaccine may soon have a competitor. The Spanish vaccine, MTBVAC, has demonstrated promising results and could potentially replace it by 2028.

MTBVAC: A Spanish Commitment

MTBVAC began its growth in the 1990s, spurred by a multi-resistant tuberculosis outbreak in Malaga. Dr. Martín,a microbiologist trained at the Pasteur Institute,gained crucial insights during this period.Clinical trials are now in their final stages, including phase three trials for newborns and phase two B trials for adults. MTBVAC is emerging as a leading candidate among the few vaccines in advanced efficacy studies worldwide to replace the BCG (Calmette and Guérin bacillus) vaccine, which has been in use since 1920.

The Limitations of BCG

The primary limitation of the BCG vaccine is that it only protects infants from disseminated TB, the most severe form of the disease. It is ineffective in adolescents and adults, who are more prone to developing respiratory or pulmonary tuberculosis, the most common and transmissible form.

Clinical Trial Progress

Since 2022, clinical trials have been underway in South Africa, Senegal, and Madagascar, vaccinating over 4,000 newborns with MTBVAC. the goal is to reach 7,500 participants, requiring an estimated two more years of vaccination followed by two years of follow-up. Another trial involving 4,200 adolescents and adults in South Africa, Kenya, and Tanzania has also been conducted.While the results are yet to be published,Dr. Martín stated that the vaccine is safe and immunogenic in previously infected with tuberculosis and not infected.

Future Prospects

Phase three trials are set to begin in India, involving approximately 30,000 adults and adolescents. Rodríguez anticipates that if everything goes well, the vaccine will complete all regulatory procedures by 2028,potentially allowing for commercialization from 2029.

Affordability and Accessibility

Developing a vaccine requires significant investment, typically around $1 billion. While the adolescent and adult studies for MTBVAC are fully funded, the newborn trials still require approximately 22 million euros. Rodríguez noted that although a baby vaccine was vrey effective, the result is seen in 20 years, which makes its social impact so strong and, therefore, does not attract financing.

The University of Zaragoza is committed to ensuring that the vaccine is accessible and affordable in endemic and impoverished countries. The plan is to produce and supply the vaccine through centers in Spain, India, and South America. Biofabri will also authorize its manufacture in countries with a high burden of the disease through licensing agreements.