The Brazilian Health Regulatory Agency (Anvisa) has authorized the start of human trials for the world's first vaccine against malaria caused by Plasmodium vivax, the parasite responsible for the majority of cases of the disease in the country. The immunizer is produced with 100% domestic technology.
In a statement, the Ministry of Health detailed that the dose, called Vivaxin, is the result of research conducted by the Vaccine Technology Center (CTVacinas) at the Federal University of Minas Gerais (UFMG). The technology has planned funding of R$ 12 million from the ministry for phase I, II and III clinical trials.
According to the ministry, the phase I clinical study will evaluate the vaccine's safety, possible reactions to the application, and its ability to stimulate an immune response in a total of 48 participants without prior infection, aged between 18 and 59. Clinical follow-up will be conducted for 360 days.
"The advancement of this technology's research represents a milestone and opens the possibility of a new form of prevention against a disease that, in 2025, recorded 118,037 cases nationwide," the ministry stated in the announcement.
The two malaria vaccines currently recommended by health authorities were developed for another species of malaria-causing parasite, Plasmodium falciparum, which is predominant in Africa — not against Plasmodium vivax, which predominates in the Americas and Asia.
The disease
Malaria is an infectious disease caused by a parasite of the genus Plasmodium, transmitted to humans through the bite of infected female Anopheles mosquitoes, which are most abundant at twilight, at dusk and at dawn.
"It is not a contagious disease, meaning a sick person cannot transmit malaria directly to another person," the ministry emphasized.
Also known as paludism, marsh fever, intermittent fever, benign tertian fever, or malignant tertian fever, malaria also goes by popular names such as maleita, sezão, tremedeira, batedeira, or simply fever.
"Anyone can contract malaria. Individuals who have had multiple episodes of malaria may reach a state of partial immunity, showing few or even no symptoms. However, a sterilizing immunity, which confers complete clinical protection, has not been observed to date," the ministry highlighted.
The ministry also warns that, if not properly treated, a malaria patient can be a source of infection for months or even years, depending on the parasite species involved.
In Brazil, the majority of cases of the disease are concentrated in the Amazon region, made up of the following states: Acre, Amapá, Amazonas, Maranhão, Mato Grosso, Pará, Rondônia, Roraima, and Tocantins.
"In the extra-Amazonian region, made up of the remaining states, despite the few notifications, the disease cannot be neglected, as the lethality in this region is higher than in the Amazon region," the ministry concluded.