Will Brazil's Dengue Vaccine Come to the USA

After a false start with the Dengvaxia® dengue fever vaccine produced in France, and an unresolved dispute with the U.S. FDA over the authorization of a second-generation QDENGA® vaccine made in Japan, many international travelers are now wondering whether the newly approved quadrivalent vaccine produced in Brazil will become available in the United States.

According to the media release on December 8, 2025, the single-dose Butantan-DV vaccine will be offered exclusively by the Unified Health System in the Brazil, where over 3.6 million dengue cases have been reported in 2025.

The first 1.3 million doses already manufactured will be allocated to primary care professionals in Brazil. 

Anvisa's registration No. 4,863 of the single-dose Butantan-DV vaccine developed by the Butantan Institute formalizes the conclusion of the regulatory process. It has passed all stages of technical and regulatory analysis required by health legislation, guaranteeing its safety, quality, and efficacy, and allows the production and commercialization of the immunizing agent.

The director of the Butantan Institute, Esper Kallás, commented in a previous press release, "The production of the dengue vaccine in São Paulo demonstrates our capacity to lead the development of strategic biotechnologies for the country, reducing dependence on imports and ensuring autonomy in protecting our population."

This third-generation vaccine protects people against the four dengue serotypes, which are transmitted to people by virus-carrying mosquitoes.

The vaccine's approved indication is for people aged 12 to 59 years. This profile may be expanded in the future, depending on further results from clinical studies. Even with the new registration, Butantan will actively monitor its use by the general population.

In the U.S., this innovative vaccine could be offered to residents along Florida's southeast coast, where 61 locally transmitted dengue cases were reported in 2025. Until then, the U.S. CDC advises everyone to avoid mosquito bites.