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Development of Tuberculosis Vaccine ‘Mtbvac’ Expected by 2028: Global Director of Operations at IAVI Highlights Urgent Need

The tuberculosis vaccine “is possible” and, furthermore, “very necessary”, given that the disease “is not controlled.” One of them, called Mtbvac, could be available in 2028.

This was stated this Thursday by the global director of Operations at IAVI, the Spanish Ana Céspedes, in an interview with Servimedia in which she reviewed some of the projects that this non-profit scientific research organization is developing. vaccines and antibodies for HIV, tuberculosis and emerging infectious diseases, and advanced that “we are very close” to obtaining said vaccine.

After pointing out that every year 1.3 million people die from tuberculosis and 10 million are infected by a disease that is “so old” and that “it is somehow neglected,” he stressed that “there is very little research. There are only 12 vaccines in development and there is a Spanish vaccine that is about to enter efficacy studies this year,” and recalled that it is being developed in two indications, one in neonates and children and the other in adults.

In the first case, he stressed that what is being “measured” is “whether it is going to be 50% more effective” than the BCG vaccine, which, he warned, “never followed the normal regulatory process, was approved 100 years ago and which , since then, it has been used.” “The effectiveness is unknown to some extent, but it is known that it is effective in protecting children from tuberculosis, only children up to the age of seven or eight,” he added.

CHILDREN AND ADULTS

In this context, he emphasized that the development of Mtbvac is being done “both in children, to see if it will be more effective than BCG, and in adults, where there is no vaccine,” and taking into account that the “majority ” of the population that becomes infected, up to 90%, are young people and adults.

“Clinical development begins now and, at the earliest, this vaccine will be available in 2028, if we obtain all the necessary financing so that this study is the only one we need,” he added, to indicate that, for the moment, in the case of For adults, the project only has funding to carry out the study on 7,000 people.

In this regard, he pointed out that the trial in neonates and children is “fully funded” and “positive results” are expected and that the study for which “partial” funding is available is the study in adults, the results of which will also be ready. in 2028.

“There are two clinical developments in parallel and, furthermore, it is a very nice project, because it is an international collaboration project,” he added, to explain that, in the case of the study in children and neonates, IAVI is working with Edctp, a coalition between Africa and Europe and with agents such as the pharmaceutical company Biofabri or the University of Zaragoza and, in the area of ​​adults, with the Indian Government, the NIH or the Bill and Melinda Gates Foundation.

JOINING RESOURCES

In this sense, Céspedes defended the importance of “uniting resources” of “many” agents to “manage to advance in the two indications in parallel”, to indicate that, “in reality”, this vaccine “has been developed since 1999” .

It was then that, through genetic engineering, Mycobacterium tuberculosis was isolated, “two genes were removed, which are what cause Mycobacterium tuberculosis to become infected and produce the disease and this is the attenuated tuberculosis bacillus, that is, it is still alive, but it does not cause the disease.”

“The Mtbvac vaccine began in 1999. In that year, Mycobacterium tuberculosis was isolated and two genes were removed, which are what make this bacillus pathogenic in humans. A gene is removed that causes it to replicate very quickly, another gene is removed that causes it to hide inside our body, and then, by eliminating these genes, the bacillus becomes a live attenuated vaccine, that is, it does not It produces the disease, but it can produce an immunogenic response with all the potential it has,” he explained.

The expert lamented that, “unfortunately,” the development of the vaccine “has been very slow, because funding is very scarce and, when funding is scarce, you take very short steps.”

“We have been doing studies in the laboratory since then and, later, in the clinical phase, but we are in the last stage, in the efficacy studies,” he insisted, to highlight that there have been “25 years of public collaboration.” private worldwide”, with the participation of Europe, the United States and Africa, “which is already in the last phase”, which is to “demonstrate effectiveness”.

TUBERCULOSIS IN SPAIN

Asked about the situation of the disease in Spain, Céspedes assessed that, “fortunately, we do not have a tuberculosis epidemic,” although “cases of highly resistant tuberculosis are growing,” cases that are also “occurring” “with the movements migratory”, which join those of health professionals displaced to “risk” areas who “come and bring the bacillus.”

In this sense, he considered it “very important” to take into account that infectious diseases “require a global approach.” “An infectious disease is not eradicated until you eradicate it everywhere or until you control it, because it is very difficult to completely eradicate diseases,” he asserted.

“We have eradicated two and what we have to do is control them, because tuberculosis is not controlled,” he added, to warn that cases of highly resistant tuberculosis “grow every year” and treatment can last up to seven years, while Non-resistant tuberculosis requires a treatment of around six months in which the patient “has to stop working”, to which is added the “impact” it has on their lungs and quality of life.

2024-04-11 16:04:00
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