Brazil’s Minister of Health, Alexandre Padilha, announced this Wednesday (Nov. 26) that the country’s national drug regulator Anvisa has approved the registration of the dengue vaccine (Butantan-DV), produced by the Butantan Institute.

This is the world’s first single-dose dengue vaccine, and it is expected to be offered free of charge through the Brazilian public health network, the SUS, in 2026.

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• Brazil begins human trials to treat spinal muscular atrophy.

The Butantan Institute notes that 1 million units of the dengue vaccine are ready for distribution and estimates having more than 30 million doses available by mid-2026.

“Today is a day of joy - a victory for the vaccine, a victory for science, a victory for the cooperation between the Brazilian SUS and its public institutions spread throughout the country, including the Butantan Institute,” said Padilha.

The approved indication covers people aged 12 to 59. This range may be expanded in the future, depending on new studies to be submitted by the manufacturer.

Dengue worldwide

The vaccine could benefit not only Brazilians but also populations in other countries, according to Renato Kfouri, vice-president of the Brazilian Society of Immunizations (SBIm).

He warns that the disease is rapidly expanding worldwide, especially in tropical countries.

“Today, more than half of the world’s population lives in areas at risk for the disease.”

The disease vector, the mosquito, expands as temperatures rise. Climate change and shifting rainfall patterns favor its proliferation.

“Dengue and other arboviruses are expanding diseases, and vaccines are essential for controlling them, especially in tropical countries,” the doctor emphasizes.

Butantan-DV

The vaccine, called Butantan-DV, was developed through a partnership between the Ministry of Health and the Chinese company WuXi Vaccines.

The new vaccine uses live attenuated virus technology, which is safe and already applied in other immunizations used in Brazil and worldwide, such as the MMR, yellow fever, polio, and some influenza vaccines.

According to the technical evaluation by Anvisa, Butantan-DV showed an overall efficacy of 74.7 percent against symptomatic dengue in the population aged 12 to 59 years. This means that in 74 percent of cases the disease was prevented thanks to the vaccine.

It also demonstrated 89 percent protection against severe forms and those with warning signs, as published in The Lancet Infectious Diseases.

Brazil’s drug authority Anvisa has authorized the research foundation Fiocruz to begin clinical trials in humans with GB221, an advanced gene therapy product for the treatment of type-1 spinal muscular atrophy (SMA1), the most severe form of the disease.

Quickly approved by Anvisa under priority review, the study positions Brazil at the forefront of the field in Latin America. 

The GB221 therapy was developed by the US company Gemma Biotherapeutics, Inc. In addition to participating in the clinical development of the therapy, Fiocruz signed a technology transfer agreement with the company, paving the way for the unprecedented Brazilian production of a gene therapy.

The foundation’s strategy for advanced therapies aims to ensure that the country has the scientific and technological foundations to offer products to the Brazilian public health care network, the SUS.

With this initiative, the Brazilian Ministry of Health is increasing national support for research and development of gene therapies, one of the most innovative frontiers in precision public health care, with a focus on the SUS.

The project led by Fiocruz has received investments of BRL 122 million from the Ministry of Health. The strategy also has financial support from the Brazilian Innovation Agency (Finep), which has invested BRL 50 million in infrastructure for the production of advanced therapies.

Type-1 SMA

Considered rare and manifesting in the first months of life, type-1 SMA is caused by a mutation in the SMN1 gene, which is responsible for producing a protein essential for the functioning of motor neurons. 

The absence of this protein causes progressive muscle weakness and can compromise the survival of children in the first years of life.