Brazil’s health regulator Anvisa has approved the first human trial of Vivaxin, authorizing a study of 48 healthy volunteers but leaving one basic question unanswered: whether the vaccine protects people from malaria. The approval appeared in the federal official gazette on Wednesday, October 7, 2026. It permits research, not public use.
Who Controls the Next Step
Anvisa approved the clinical development dossier and clinical research process in Resolution-RE No. 3,956 of October 6, 2026. The trial will run at the clinical research centre of the Hospital das Clínicas of UFMG in Belo Horizonte, the capital of Minas Gerais state. Researchers will assess safety, reactions to the injection and immune response. They won't find out whether Vivaxin prevents infection in people.
The Phase 1 study will enroll 48 healthy volunteers aged 18 to 59 who have never had malaria. Participants will get three doses, 28 days apart, and researchers will follow them for 360 days. The source gives no recruitment start date, results date or date for a later trial to test protection. Volunteers shoulder the immediate burden of a study whose findings are meant to guide later phases.
The developers describe the trial as double-blind, randomised and placebo-controlled. Those procedures shape how researchers compare outcomes, but they don't change the first phase's limited purpose: assessing safety and immune response, not proving protection.
A Vaccine Still Years From Public Use
CTVACINAS centre at the Federal University of Minas Gerais (UFMG), the University of São Paulo (USP) and laboratory Cristália developed Vivaxin. The vaccine combines three variants of a parasite surface protein called PvCSP in one molecule and aims to stop the parasite before it reaches the liver.
Brazilian research reports say the formulation fully prevented infection in some mice. But mouse results don't show how people will respond, and vaccines that work in animals can fail in humans. Later trials would have to demonstrate protection before any public approval; the article says the vaccine is years from any possible approval.
The World Health Organization-recommended vaccines RTS,S and R21/Matrix-M target Plasmodium falciparum, which dominates in sub-Saharan Africa. Plasmodium vivax caused about 63% of estimated malaria cases in the Americas in 2024, according to the WHO’s World Malaria Report. The developers say no vaccine against vivax malaria is available to the public anywhere in the world.
Brazil recorded 118,037 malaria cases in 2025, with more than 99% in the Amazon region, according to the CTVacinas centre. Ricardo Gazzinelli, who coordinates CTVacinas, said the disease keeps people from working and has a large socioeconomic effect. People living with the disease bear those costs as the research moves through institutional approvals and trial phases.
Public Money, No Grassroots Response Described
Public funders include Brazil’s science ministry, its national science fund, the Finep innovation agency and the Ministry of Health. The article names those funders but gives no funding amounts or account of community-led organizing around the research. It describes no mutual-aid or direct-action response, either.
For people heading to the Amazon, the report advises continuing to follow medical advice on malaria prevention. Anvisa has cleared a first test, and researchers have a path to more trials. Protection remains unproven.