Brazil recorded 118,037 malaria cases in 2025, with more than 99% in the Amazon region. Anvisa has cleared the first human trial of Vivaxin, a vaccine candidate against malaria caused by Plasmodium vivax. Public funders include Brazil's science ministry, its national science fund, the Finep innovation agency and the Ministry of Health. The trial will test safety and immune response—not whether the vaccine protects people.
Public funding, private partners
CTVacinas at the Federal University of Minas Gerais, the University of São Paulo and laboratory Cristália developed the vaccine. Public institutions are the project’s listed funders. The report offers no development costs, commercial terms, projected price or account of how the developers would divide any future revenue.
Anvisa approved the clinical development dossier and research process in Resolution-RE No. 3,956 of October 6, 2026. CTVacinas at UFMG said the approval appeared in the federal official gazette on Wednesday, October 7. The authorization clears the clinical research process; it doesn't establish that Vivaxin prevents malaria or allow public use as an approved vaccine.
Researchers will enrol 48 healthy volunteers aged 18 to 59 who have never had malaria in the Phase 1 trial. Participants will receive three doses, 28 days apart, and researchers will follow them for 360 days. The developers describe the study as double-blind, randomised and placebo-controlled. It will take place at the clinical research centre of the Hospital das Clínicas of UFMG in Belo Horizonte, the capital of Minas Gerais state.
The disease's toll on work
Ricardo Gazzinelli, CTVacinas’ coordinator, said malaria keeps people from working and has a large socioeconomic effect. The Amazon region accounts for the reported case burden. The article gives no figures for lost wages, treatment costs or the effect on particular workers and communities.
Plasmodium vivax caused about 63% of estimated malaria cases in the Americas in 2024, according to the World Health Organization's World Malaria Report. The WHO-recommended vaccines RTS,S and R21/Matrix-M target Plasmodium falciparum, which dominates in sub-Saharan Africa. The developers say no vaccine against vivax malaria is available to the public anywhere in the world.
Vivaxin combines three variants of a parasite surface protein called PvCSP in one molecule. The vaccine aims to block the parasite before it reaches the liver. Brazilian research reports say the formulation fully prevented infection in some mice, but animal results don't predict people's responses. Vaccines that work in animals can fail in humans.
A first step, not protection
Phase 1 will assess safety, injection reactions and immune response. Researchers intend to use its results to guide later trial phases, which would have to show protection before any public approval. The report gives no start date for volunteer recruitment, no results date and no date for a later trial testing protection.
The vaccine remains years from any possible approval. The report advises people heading to the Amazon to keep following medical advice on malaria prevention. The available account identifies public funders and the institutions developing Vivaxin, but gives no details about manufacturing, future access or price. For now, the trial will establish only how a small group of volunteers responds to the candidate vaccine.