The Oswaldo Cruz Foundation (Fiocruz) will conclude in the coming months the production process of the Schistovac vaccine against schistosomiasis, which should be available to the Unified Health System (SUS) at the end of 2025. This is the world’s first vaccine against this parasitic disease which is considered neglected. The name is derived from Schistosoma mansoni, the worm that causes schistosomiasis in Latin America and Africa. The vaccine is an old Fiocruz project that is reaching the final stage this year, highlighted, this Monday (12) in an interview with Agência Brasil, researcher at Fiocruz’s Oswaldo Cruz Institute (IOC) Miriam Tendler. The unprecedented vaccine is being developed and will be patented by the IOC/Fiocruz. The project entered the clinical phase between 2010 and 2011. So far, five major clinical trials have been carried out. Phases 1 and 2 were carried out in Brazil in a non-endemic area, after a regulatory process at the National Health Surveillance Agency (Anvisa). Afterwards, the phase 2 clinical tests started to be carried out in a structure in Senegal, linked to the Pasteur Institute in Lille, in France, and located in an endemic area of that African country. The tests were performed first on adults and then on children. Now, with the field part closed, data processing is being carried out. Researcher Miriam Tendler says that the vaccine against schistosomiasis is an old Fiocruz project, which is now reaching the final stage – Gutemberg Brito/IOC/Fiocruz Tendler. As with covid-19, which started with two doses of the vaccine and then reached five doses, it may be necessary to adjust the number of doses and the interval between them later. “We proposed it, and the Senegalese Ministry of Health agreed. We adopted an alternative protocol that is the same as for covid and other diseases, which are two doses, with an interval of one month between them, and then four months for the third dose”. According to the researcher, this protocol induces a better response. Progress A new batch (Sm14) was used, produced from a master cell bank in the United States. “There was a great advance in the production process. From the cells of that bank, we produced a new lot at the North American University of Nebraska and then we did this last phase 2 test, in Senegal, which went very well, just like the others”, said Miriam. The process was delayed by a few months due to the most acute period of the new coronavirus pandemic. “The great gain in this period, in the last two years, was the scaling up of the large-scale production process”, she pointed out. From this process, a new batch was produced, which was validated. According to Miriam, all this is adding value to the technology, which is all from Brazil. “Now, we are preparing phase 3 in a number that reaches, in total, 2 thousand people, for safety reasons, in order to be able to pass the pre-qualification screening of the World Health Organization [OMS]. This will be done by the end of this year. In eight months, we finish it ”, she assured. Phase 2 was completed on vaccination and safety assessment in February 2023, but the report has not yet been released. “The evaluation of immunogenicity is being awaited. It is a complex process.” The individuals’ lymphocyte cells have to come to Brazil and this analysis of the immune response that reflects the immunogenicity of the vaccine is already being done – a part in Senegal, related to antibodies, and the other part, the cells, in Fiocruz , with technology transferred to the foundation recently. The cells are currently being transported to Brazil. Humanitarian vaccine Schistosomiasis is an endemic disease in 74 countries in Africa. Miriam Tendler stated that, with the production of the vaccine against the disease by Fiocruz, for the first time, Brazil enters as a supplier of cutting-edge technology. Normally, the country produces the vaccine, but buys technology. “And this time it will be a technology supplier. This reverses the paradigm of people buying from the Northern Hemisphere or Asia, as was the case with covid. We will be trained through Bio-Manguinhos.” The transfer of technology to the National Institute of Immunobiologicals (Bio-Manguinhos), another Fiocruz unit, is already being worked on. She highlighted that Fiocruz took full command of the final stage, including the vaccine production stage. This should occur in the context of a humanitarian vaccine, which combines the format and product technology stipulated by the United Nations (UN). Products aimed at low-income populations are preferably marketed within very strict criteria. They will not be donated. According to the researcher, for African countries, the vaccine will be distributed by Fiocruz, “in the context of a humanitarian vaccine” and “this is of great importance”. One of the gains in this most recent period was the scaling up of the Sm14 production process , which resulted in a very low-cost, high-yield process. With this, Fiocruz will be able to work on the horizon of a humanitarian vaccine and distribute it to African countries, she highlighted. These data are very important politically, because, now, the office Brazilian diplomat in Geneva, called Permanent Mission of Brazil to the UN, is supporting Fiocruz in the elaboration of a work together with African countries, to create a financing fund that will make it possible to supply Schistovac as a humanitarian vaccine, with its introduction in the immunization schedule of endemic countries Risk Currently, 800 million people live in risk areas, subject to schistosomiasis. The disease does not have a high mortality rate, but it has a very high impact, especially on the populations of countries that need their young population to develop. Although data for Brazil are incomplete, Miriam Tendler estimates that 2% of the population is affected by schistosomiasis, with greater occurrences in the Northeast Region and in the south of Minas Gerais. There are, however, outbreaks spreading to the South and Southeast of the country, in regions without basic sanitation. “It is a disease that is expanding”, said the researcher. Also known as water belly, schistosomiasis is linked to poor sanitary conditions and lack of basic sanitation. “Access to clean water and basic sanitation is an unquestionable human issue,” she said. Miriam Tendler assessed that, based on Fiocruz technology, there is no reason not to produce vaccines for other parasitic diseases. “The biggest issue is that, today, we have the technology to make a vaccine. So, there is no reason not to make a vaccine for all parasitic diseases. We are opening a door and I hope that behind us will come vaccines for other parasitic diseases.” Fiocruz is engaged in an antiparasitic vaccine platform. Although leprosy vaccines [hanseníase] and leishmaniasis are being developed with non-Brazilian technology, the researcher emphasized that the important thing is that Fiocruz is also involved.
Agência Brasil
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