Anvisa authorizes research for the first Brazilian malaria vaccine

Clinical study will evaluate the potential for immunizing people in endemic areas

The Brazilian Health Regulatory Agency (Anvisa) has approved the start of clinical research for a malaria vaccine developed in Brazil. This marks the first phase of human testing. The clinical study follows a double-blind, placebo-controlled model to assess the safety and immunogenicity of the vaccine, known as Vivaxin (PvCSP-All protein).

Prioritized by Anvisa’s Innovation Committee, the vaccine’s development is being carried out by the Vaccine Technology Center (CTVacinas) at the Federal University of Minas Gerais (UFMG), with support from the Brazilian Funding Authority for Studies and Projects (Finep), the Ministry of Science, Technology and Innovation, and the Ministry of Health .

In this first phase, the study focuses on defining the vaccine’s safety profile. This involves evaluating reactions during the first 14 and 28 days following the intramuscular administration of Vivaxin, as well as throughout the entire duration of the study. If the results are positive, the vaccine may proceed to phases 2 and 3, with the potential for registration applications to be submitted to Anvisa and other regulatory agencies worldwide.

The Clinical Research Center (CPC) at the University Hospital of the Federal University of Minas Gerais is responsible for recruiting participants. The plan includes 48 healthy volunteers, aged 18 to 59, with no prior malaria infection.

Anvisa’s authorization was published last Wednesday (October 7).

Vivaxin Technology

The vaccine consists of a recombinant chimeric protein called "PvCSP-All epitopes" and includes an adjuvant (CTVad3) to enhance the immune response. Vivaxin is supplied as a lyophilized (freeze-dried) active substance, which is reconstituted with the CTVad3 adjuvant at the time of use for intramuscular administration.

Malaria

The disease is caused by parasites of the Plasmodium species, which are transmitted through the bite of an Anopheles mosquito in tropical regions.

According to the World Health Organization (WHO), 9.9 million cases of Plasmodium vivax malaria were recorded in 2024. In the Americas, this species accounted for 63.1% of the estimated cases of the disease that year.

In Brazil, 118,037 cases of malaria contracted within the national territory were recorded in 2025, according to the Ministry of Health.