We have never sought economic benefit. The condition of the University of Zaragoza and the Galician company Biofabri is that the MTBVAC be universal, affordable and easy to distribute to the whole world. It will be a historical milestone that can eradicate a disease that is the worst scourge in history, the one that has caused the most deaths. More than a billion are estimated.
One hundred percent Spanish vaccine.
It is a Spanish university that has built it and the industrial and clinical development is carried out with the help of another Spanish company. If we now obtain Spanish financing, apart from the European one, it will be a vaccine built, produced and developed throughout the process with Spanish funds.
And you are the leader.
The dad (hehehehe). We started working in 1987, when I arrived at the Pasteur Institute in Paris. Then I returned to Zaragoza in 1992 and we began to work on multiresistant tuberculosis. From there we described the virulence genes and built a human-derived vaccine strain.
What phase is it in?
At the end of last year we started phase 3 of efficacy in babies, which is the last step, in several centers in South Africa, Madagascar and Senegal. Phase 1 was from 2012 to 2015 in Switzerland, with volunteers between 18 and 45 years old. And from 2015 it was tested in South Africa, in adults and newborns. Phase 2 was in South Africa, Madagascar and Senegal, also with a European project, and from there the efficacy dose was selected, which is the one being used in phase 3, which is the last.
When will it go on the market?
The program is designed so that 5 years of vaccination and 2 of follow-up pass, except if the tuberculosis figures, which is what we think has happened, have increased with the covid where the vaccine is being tested. If so, the study may be resolved sooner.
How is it different from the existing vaccine?
BCG was developed in 1921 and is a variant of tuberculosis in cows that does not work against respiratory forms in humans, which is what we want to achieve with MTBVAC. It is the most used in the world, except in Europe, America and Australia, where there is little incidence and it is preferred to treat the disease. Of the 7,100 babies who will be vaccinated in phase 3, 3,500 will be with BCG.
Tell us about the financing.
The start of the clinical trial has been funded by the EDCTP, which is the European project for clinical developments in Africa. What we are looking for now is to finance phase 3 and we have created a non-profit foundation T.END, (Tuberculosis Fin), which we are presenting this Friday. A way to give visibility to organizations, groups and private companies that want to collaborate in this Spain brand vaccine.
What treatments are currently available.
Of the 10 million new cases of tuberculosis that exist in the world, half a million are resistant to antibiotics. Therefore, the new resistant global pandemic could be tuberculosis. Hence the importance of the new vaccine. In India and South Africa, these multi-resistant strains are appearing that can attack us at any moment.
The motto of today’s event is ‘Yes, we can put an end to tuberculosis’.
Exact. You have to diagnose, you have to treat, but without a vaccine tuberculosis cannot be eradicated. The WHO goal is to eradicate it by 2050.
How do you define tuberculosis?
It is a cellular immunity from which the mechanism by which it is protected is unknown. It is a disease of poverty, with a very high mortality.
The AIDS Vaccine Initiative is also collaborating on the vaccine. How is it related to AIDS?
AIDS decreases cellular immunity, which is what tuberculosis needs, which co-infects and kills people. It is said that in Africa they live with AIDS and die of tuberculosis.