Anvisa authorizes the start of human trials of a 100% Brazilian vaccine against malaria
Quick Look
- Anvisa authorized the start of human testing of a malaria vaccine developed by UFMG in partnership with USP and the Cristália laboratory.
- The vaccine, called Vivaxin, targets Plasmodium vivax and will be tested on 48 volunteers in Belo Horizonte, with the expectation of availability in health centers in five to seven years.
AI-generated summary
Why It Matters
Malaria caused by Plasmodium vivax is predominant in Brazil, especially in the Amazon region, with 118 thousand cases registered in 2026. The Vivaxin vaccine was developed in the laboratory by UFMG in partnership with USP and Cristália after 15 years of research.
Anvisa authorized the start of human trials of a malaria vaccine. The 100% Brazilian vaccine was developed by the Federal University of Minas Gerais.
The laboratory study has been carried out for 15 years. Scientists from UFMG, in partnership with researchers from USP and the pharmaceutical laboratory Cristália, created the immunizer Vivaxin.
"It has a difference: it encodes pieces of the different variants of the parasite. So, it is not a vaccine against a single variant. What we did in the laboratory gave 100%. Now, this has to be tested in humans", explains Ricardo Gazzinelli, coordinator of CTVacinas/UFMG.
Forty-eight volunteers - aged 18 to 59 - will participate in the tests. This phase, in humans, will evaluate the safety and immunological response to the vaccine. Volunteers will be divided into two groups. One will receive three doses; the other, just for control, will receive a placebo, which is a substance without the active ingredient. The volunteers will be monitored for a year at the UFMG Hospital das Clínicas, in Belo Horizonte.
The next two phases of the research, with more than 300 volunteers, will be in the Amazon. If everything goes well with the immunological response, it is necessary to request registration with Anvisa to begin large-scale production. Scientists expect the new malaria vaccine to be in health centers in five to seven years.
Anvisa authorizes the start of human trials of a 100% Brazilian vaccine against malaria — Photo: Jornal Nacional/ Reproduction
In 2026, Brazil had 118 thousand cases of malaria, almost all in the Amazon region. The disease in Brazil is mainly caused by the Plasmodium vivax parasite. It is for this type that the pioneering vaccine is being developed.
Symptoms are fever, tiredness, nausea, headaches and body aches, loss of appetite and yellowing of the eyes and skin. If treatment is delayed, the severe form of the disease can cause changes in consciousness, anemia and compromise organs, such as the liver and spleen.
Anvisa's CEO, Leandro Safatle, stated that the Brazilian vaccine can help eradicate malaria on all continents:
"This malaria affected 9.9 million people in the world last year. It is the malaria, from this vaccine, it is the malaria that is affecting the entire region of the Americas. It is the first vaccine in the world being developed for this type of malaria. It is a very important advance. We are talking here about a very important global public health impact."
What to Watch
AI outlook — possibilities, not facts
The vaccine will be available in Brazilian health centers in five to seven years, if clinical trials are successful.
Likely · Within years
The next phases of testing will be carried out in the Amazon with more than 300 volunteers.
Very likely · Within months
Open Questions
- What will the cost of the vaccine be when available?
- What will the distribution be like in endemic regions?
- Will there be international partnerships for scale production?
