Brazil Launches First Single-Dose Dengue Vaccine for Remote Areas

A groundbreaking single-dose vaccine for the dengue virus, known as Butantan-DV, has received approval for use in Brazil, offering significant benefits for isolated populations, particularly in the Amazon region. Approved by Brazil’s national drug regulator on November 26, 2024, the vaccine is the first to target all four serotypes of the dengue virus with a single administration. This development follows Brazil’s largest dengue epidemic, which saw 6.4 million cases and 5,972 deaths reported in 2024, according to the Ministry of Health.

The Butantan Institute, a public research center that developed the vaccine, reported that it demonstrated an overall efficacy of 74.7% during late-stage human trials, with an impressive 91.6% efficacy against severe forms of the disease. The vaccine is expected to be incorporated into Brazil’s national immunization program by early 2026, with over 1 million doses already prepared for distribution.

Access for Remote Communities

Experts emphasize the unique advantages of this one-dose vaccine for hard-to-reach communities. Traditional vaccines, such as TAK-003 or Qdenga, require two doses spaced three months apart, creating significant barriers for remote populations. Jesem Orellana, an epidemiologist from the Oswaldo Cruz Foundation (Fiocruz), noted that the new vaccine allows indigenous communities to receive complete vaccination in a single visit to a health clinic.

“It is much more difficult and expensive to apply a two-dose vaccine in remote regions, such as the Amazon, which are often challenging to access,” Orellana stated. The vaccination strategy and priority groups will be determined by specialists from Brazil’s National Immunization Program in the coming weeks.

Production and Future Distribution

The Butantan Institute has partnered with WuXi Vaccines, a Chinese company, to produce 60 million doses of the vaccine over the next two years. Approximately half of these doses are anticipated to be delivered before the end of 2026. Although the vaccine has not yet been authorized for pregnant women, immunocompromised individuals, or older adults, Brazil’s health regulatory agency, Anvisa, is currently analyzing evidence of its efficacy in these groups.

Renato Kfouri, vice president of the Brazilian Society of Immunizations, remarked, “With this, Brazil becomes a strategic player in international vaccine production and will soon be able to supply other Latin American countries affected by the disease, such as Argentina, Peru, and Colombia.”

As of 2024, the World Health Organization reported over 14 million dengue cases worldwide, with 12.6 million occurring in Latin America, leading to more than 8,000 fatalities. The Butantan Institute confirmed its intention to provide the new vaccine to neighboring countries, although specific timelines remain undisclosed.

Decade of Research and Efficacy

The Butantan-DV vaccine is a live, attenuated vaccine, employing weakened viruses to stimulate immunity without causing the disease. It has been evaluated for nearly a decade, involving trials with 16,000 volunteers across Brazil. Previous studies, documented in the New England Journal of Medicine and The Lancet Infectious Diseases, showcased its efficacy, with the latest data indicating 100% efficacy against hospitalizations. A spokesperson for Butantan stated that these findings will soon be published in the journal Nature Medicine.

Unlike earlier vaccines, which limited use to individuals with prior dengue infections, Butantan-DV can be administered to both previously infected individuals and those encountering the virus for the first time. This feature enhances its potential integration into Brazil’s public health system, as noted by physician and virologist Maurício Nogueira from the Faculty of Medicine of São José do Rio Preto.

Continued Need for Control Measures

Despite the promise of the new vaccine, experts warn that it will not eliminate dengue entirely. They stress the importance of continuing mosquito control measures to combat the Aedes aegypti mosquito, the primary vector of the disease.

“The vaccine is important, but it doesn’t mean we should neglect mosquito control,” Orellana cautioned, highlighting the risks associated with other mosquito-borne diseases, such as chikungunya and yellow fever. “Control remains essential, surveillance is fundamental, and investments are necessary to reduce the vector’s reproductive capacity.”

The approval and anticipated rollout of the Butantan-DV vaccine mark a significant milestone in Brazil’s public health efforts, particularly for communities vulnerable to the impacts of dengue fever.