#addition #emotional #support #tuberculosis #vaccine #requires #economic #support
The other day, Esteban Rodríguez, CEO of Biofabri, said that the tuberculosis vaccine was going to be a global milestone similar to that of the Balmis expedition, which promoted mass smallpox vaccination. Do you think so too?
So asked… All of us who are working on it think that it is a very ambitious project. When we started, there were very few of us at the university, then Biofabri joined in 2008, which has a large team. Now, if we have the American teams, all the people involved in the clinical trials, both in babies, more than a thousand mothers who have given permission to vaccinate their babies; and the study that begins in adolescents studies… and if safety is demonstrated in adults as has been shown in animal models and babies. And we still lack the protection marker, because if the vaccine protects against tuberculosis, it is a very important milestone.
It seems incredible that there is still no vaccine against the disease.
In September there was a meeting at the UN where tuberculosis was discussed and there, Mark Hatherill, director of the South African Tuberculosis Vaccine Initiative, explained that if on January 1 of this year we had had a disease that was going to cause us 1 .3 million dead and 10 million new cases, surely global society would begin, as it did for covid, to fight the disease. But tuberculosis has been killing two million people for years, it goes down with Covid or HIV and then it goes up again. It is a disease that we see from afar, because in Zaragoza, in Europe, we have a treatment. As it is cured we do not give it importance. If here we have ten cases per hundred thousand, in South Africa, in 2012, one or two children out of every 100 children develop the disease and if that baby is not treated, it dies in 50% of cases. It seems to be associated with poverty, but it is because if people improved their diet, tuberculosis would decrease.
Have you found the perfect partner in Biofabri?
Esteban Rodríguez is excited about the vaccine. He set up a production company for vaccines, which was later used for Covid, because in Spain there was no vaccine factory for humans. In 2008 they opted for MTBVac, and he built a factory because, as he says, we are not going to go with a bottle that says it is produced in veterinary medicine. He now has a factory in Galicia, another in Portugal and is in talks with India to produce the vaccine. What we have learned with the covid ones is that first it has to work well in this phase three, but to be authorized you have to demonstrate that you can produce as many vaccines as are needed. And only in babies, 200 million doses are needed after one year of BCG (the current vaccine). If we vaccinate adults-adolescents, much more would have to be produced and they are preparing by making investments. In fact, he already has an acceleration system at the EMA, which has only been achieved for four other vaccines. So everything is prepared so that the moment we know that it works, we can ask for authorization to produce, because if it doesn’t work, everything is over. The impact can be brutal. Because if you have 60, 70 or 50% protection, this population will no longer have to be treated, the rest of the population will have to be diagnosed and treated. But with a vaccine and giving the diagnosis and treatment we can think about eradicating the disease
And it is a 100% Spanish project.
That’s right, created by the University of Zaragoza, which has developed a company with European aid, but for the baby phase there is still a lack of money. We would like it to be Spanish financing.
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«In Europe or in Spain, how it is cured, we do not give importance to tuberculosis»
He has been in the project for 25 years now. What led to him?
I carry more. It was in the 80s when we began to spread the genetics of Mycobacteria in France, in 87, until 92, which was when I returned to Zaragoza, when there was an epidemic of multidrug-resistant tuberculosis that we study here. And what we saw was that the genes were reactivated and what we did from there was try to deactivate them. That’s when we started working at the university; and in 2008 we looked for a company to produce the vaccine. Nobody in Europe wanted to produce it because it is a pathogen; and an attenuated strain of human tuberculosis had never been tested in humans.
So, it can be a milestone, like the Balmis Expedition.
It was very important because it leaves the port of La Coruña with the 22 children who are transmitting the strain and more than half a million people were vaccinated. It was the beginning of mass vaccination and the eradication of the disease. But when they returned to Spain it was the French invasion and it went unnoticed. That’s why if this vaccine worked and we were able to vaccinate en masse… When I was studying medicine, in ’82, tuberculosis was going to be eradicated in the year 2000, and we are in 2024 and we are talking about 2050 or more. It is a very complex disease.
Because?
We have inactivated the tuberculosis bacillus, but we do not eliminate it, what we seek is to produce a mild infection; that the individual recognizes that bacteria and with it fights against the pathogenic form of the disease. This is important because a quarter of the world’s population, that is, 2 billion people, are or have been infected and only one in 10 or 20 will develop the disease. What we want with MTBVAC is that they never develop a disease and protect themselves like those infected because we know very little about tuberculosis; has no toxin; But it infects the person and when they stop eating, when they have HIV or when they get very old and the immunity does not work, that is when pulmonary tuberculosis develops and it is transmitted.
Let’s talk about financing.
In the US, a foundation that vaccinates against AIDS is going to receive funding of 55 million for trials in adolescents-adults of MTBVac, therefore it has an international projection that is very important. The meeting the other day with the president of Aragón is what we wanted to convey to him, and that we also want it to be recognized at the national level, which is a Spanish vaccine. Biofabri agreed to make it accessible and universal, so we need it.
You as a researcher will be used to it, but the deadlines are very long. The evaluation in babies will be done until 2028.
It’s like this, the normal thing is 15 or 20 years, we are between 20 and 25, but by classic methods because it was only accelerated with the covid because the American government gave the six candidates 2,000 million to start developing it. In the end three worked. We are talking about the fact that in tuberculosis vaccines the investment can be 100 times less. But the money has to be public because the companies know they are not going to win. Furthermore, in the covid vaccines it was seen that the protection was for two months, ours for two years, so we have to wait two years to evaluate. Biofabri is a totally credible partner and they also let us investigate.
What else is being investigated with MTBVac?
We have Nacho Aguiló, who is a senior researcher, still with a non-fixed contract, who is working on cancer and on MTBVac. BCG (the current tuberculosis vaccine) is the current non-invasive bladder cancer treatment. It has some mouse models and several researchers working with it and seeing that in the mouse model when BCG does not work, MTBvac works. He is also working on other types of cancer, asthma, because BCG and MTB Vac are live attenuated vaccines that give an immune response that is very powerful. There is also Jesús Gonzalo, another senior researcher, who has done all the genomics, proteomics, and lipidomics studies, that is, MTBVac is one of the vaccines worldwide that has the most complete studies. We save those nerves while waiting by continuing to investigate.
He said that if its effectiveness was not demonstrated, everything would stop. Are you considering it?
In 2008, Biofabri invested in a human vaccine factory and if it were not for it it would not have been able to produce covid vaccines, because there were none in Spain and that is an aberration because when there is a health emergency, priority will be given to the countries that they produce them. We are not used to betting on long-term projects like this in Spain, but in the US we are. Some work and others fail, but the one that works will move the others. In our case, we have reached this point, phase 2, which is a great achievement. We are in phase 3, we have demonstrated safety in very few numbers, safety and immunity in phase 2 in many numbers and in phase 3. In addition, we have the factory.
In Spain it has to be now.
Here it was not customary to do phase 1 or phase 2, phase 3 yes, against cancer that are tested in Spanish hospitals. It’s great to start from the beginning. In fact, we are in South Africa in the place where the Oxford vaccine did not work in 2012. You learn from what works and what doesn’t work, that’s how it is. In the US they see it very well and in other European countries, but not in Spain, everything has to be in four-year periods, which is the electoral period. We are very happy that everyone supports us, from the beginning, emotionally, but now we don’t want emotionally, now we want nationally. This is the Spanish vaccine and we ask for support, although it may not work. It is a longer term project of four years. We have received support from everyone but we need to move from that emotional support to economic support.
