The Aragonese vaccine against tuberculosis could reach the market in 2027 or 2028

Designed by the University of Zaragoza, with the professor of Microbiology and researcher at the IIS Aragón Carlos Martín at the helm, and developed by the Galician biopharmaceutical company Biofabri (of the Zendal group), phase 2B will begin in the middle of the year in adolescents and adults in Africa to immunize 4.200 people.

Every day more than 4.100 people die from tuberculosis in the world, and in 2022, more than 1,3 million died from this disease. Hence the importance of the development of the vAragonese cradle against tuberculosis, MTBVAC, designed by the University of Zaragoza and developed by the Galician biopharmaceutical company Biofabri (of the Zendal group), which could reach the market in 2027-2028, after three decades of research and between 800 and 1.000 million of private investment.

El President of the Government of Aragon, Jorge Azcón, led this Monday a institutional visit to the Faculty of Medicine, where the laboratories of the Mycobacteria Genetics Group, founded in 1992 and led by Professor of Microbiology Carlos Martín. Also participating in the event were Esteban Rodríguez, CEO of the company Biofabri, producer of the vaccine and industrial partner with Unizar; the Ministers of Education and Health, Claudia Pérez Forniés and José Luis Bancalero, respectively; the vice-rector for Scientific Policy, Rosa Bolea; and the dean of Medicine, Javier Lanuza, among others.

The president of Aragón has highlighted that the University of Zaragoza is a «social and economic engine» of the Community and has highlighted its contribution to "generating talent" and "scientific advances". He has described this vaccine as “one of the most important advances that can be carried out in the world.” In fact, "it can prevent millions of deaths": "We are talking about the fact that after Covid, tuberculosis is the most important epidemic in history." "For this reason," she said, "it is essential that this vaccine finally sees the light of day. For the University of Zaragoza and for the Community it's a pride» as well as an «incentive»: «Investing in science, in innovation, is extraordinarily profitable.» 

Regarding investment in R&D per inhabitant between autonomous communities, he said, in the case of Aragon, The Community invests 331 euros per inhabitant, 18% less than the Spanish average (€402), occupying sixth position below Castilla y León. Therefore, the challenge, he said, is for Aragon to be situated "at least" in the national average, although "even so it would not be enough because Spain is well below the average of European countries": "We come with "Many years of delay in investing in research and development and it is evident that the focus is now on successful research like this one on tuberculosis."

The vice-rector for Scientific Policy, Rosa Bolea, recalled that “currently There are a total of 17 tuberculosis vaccine candidates in clinical development and MTBVAC, the one designed at the University of Zaragoza, is one of them. 

The Zaragoza scientist Carlos Martín has explained that, "after many years of research", the Aragonese vaccine against tuberculosis is in phase 3 in babies to see its effectiveness, after having demonstrated that it is "safe." The Aragonese MTBVAC candidate began in the second quarter of 2022 phase 3 efficacy trials in around 7.200 newborns in tuberculosis-endemic regions in sub-Saharan Africa: Senegal, South Africa and Madagascar. The vaccination of these babies is scheduled to continue until 2026 and in the following two years, until 2028, their monitoring and evaluation will be carried out.

In addition, it is expected that In mid-2024, phase 2B begins in adolescents and adults in several African countries to reach 4.200 people who have been previously vaccinated with BCG and have been in contact with the tuberculosis bacillus.

Esteban Rodríguez, CEO of the Biofabri company, has confirmed that "the vaccine is scheduled to reach the market in 2027-2028" and has stated that "It will be the most important international health event after the Balmis Expedition", which was launched to distribute the smallpox vaccine. «We are in the final stages of effectiveness. We hope, added Martín, to have results in four more years. "It is important that the vaccine works," he mentioned, but then we must "be able to produce as many vaccines as needed." 

In this sense, the CEO of Biofabri has highlighted that private investment is around 20 million in these 15 years: "But clinical tests are worth a lot." In total, the cost, he has said, can reach 800 or 1.000 million "to have the vaccine available." 

To this amount we will have to add the cost of manufacturing millions of doses. As anticipated, the company's factory has capacity to produce around one hundred million doses per year, which is "totally insufficient." "The one we have planned for the coming years will produce around 800 million doses," plus those made in India and Brazil, where Biofabri has partners to whom it will transfer technology.

Along these lines, he has announced that the intention of the World Health Organization (WHO), if MTBVAC is proven effective, is to "carry out a mass vaccination" in people between 12 and 44 years old "to stop the appearance of pulmonary tuberculosis." . 

«One of the commitments that we signed with the University of Zaragoza, 15 years ago, indicated Esteban Rodríguez, is that we committed to making the vaccine globally accessible and affordable» and «the conversations with the WHO suggest that the price of a doses for adults would not exceed 5 euros", while in the case of children "around 2 or 2,50 euros".

He has highlighted the importance of obtaining a vaccine against tuberculosis, due to its great impact on mortality and also the economic burden of the disease: "It represents between 4 and 8 months of antibiotic treatment, not to mention resistant tuberculosis, which forces people to be isolated." Added to this, he added, is that it affects endemic countries, "where the workforce between the ages of 14 and 40 is the one most infected with tuberculosis." 

«The WHO is trying to get a vaccine that is effective for adults, there has not been one in 120 years no one capable of placing a vaccine in phase 3 that is effective in adults«, he specified: «All the scientists who are experts in tuberculosis are behind this vaccine, because it is the one that so far has shown the greatest possibilities and we have full confidence that it will be effective in adults, especially in children, and it means cutting off the route of infection. 

In mid-2022, an agreement was reached between Biofabri and Bharat Biotech, one of the largest vaccine manufacturing companies in the world, which will guarantee global production in the supply of the future vaccine in more than 70 countries with high incidence of tuberculosis as is the case of India, a country with the highest burden of tuberculosis in the world, 25% of the total.

A Spanish public-private project with global reach

The scientist Carlos Martín has highlighted that «The current vaccine (Bacillus Calmette-Guérin BCG) is 100 years old, but it does not protect against respiratory forms of the disease, and in fact tuberculosis continues to be the communicable disease that causes the most deaths worldwide. Only two years was it surpassed by covid, in 2020 and 2021.

Tuberculosis is a highly contagious disease in which vaccines are the best solution to prevent the disease, reduce transmission and combat multi-resistant strains. 

MTBVAC is the only live attenuated vaccine against Mycobacterium tuberculosis in development. Currently, it is being developed for two purposes: as a more effective and potentially longer lasting vaccine than BCG for newborns and, on the other hand, for the prevention of tuberculosis disease in adults and adolescents, for whom there is currently no effective vaccine.

Source: Herald of Aragon

Pictures: José Miguel Marco