The WHO prequalifies a single-dose dengue vaccine effective against all four serotypes, a critical tool as global dengue cases hit record levels.
The World Health Organization has prequalified a new single-dose dengue vaccine effective against all four serotypes of the dengue virus, providing a crucial public health tool as global cases surge to record levels. The vaccine, developed by the Butantan Institute in Brazil, demonstrated 79% efficacy in preventing symptomatic dengue infection in a Phase III trial involving 16,000 participants across endemic regions.
Dengue fever has become the fastest-spreading mosquito-borne disease in the world, with cases increasing eightfold over the past two decades. In 2025, an estimated 12 million symptomatic cases and 8,000 deaths were recorded, with outbreaks spreading to previously unaffected regions in southern Europe, the southern United States, and Australia due to climate change expanding the habitat of Aedes mosquitoes.
The Butantan-DV vaccine represents a significant advance over existing dengue vaccines. Unlike Dengvaxia, which requires testing for prior dengue exposure before administration, the Butantan vaccine is safe and effective regardless of previous infection status. This eliminates a major logistical barrier that has limited the uptake of dengue vaccination in endemic regions.
The single-dose regimen is another advantage. Previous dengue vaccines required two or three doses administered months apart, leading to high dropout rates in the regions most affected by the disease. A one-dose vaccine dramatically simplifies delivery through mass vaccination campaigns and routine immunization programs.
Brazil has already begun incorporating the vaccine into its national immunization schedule, targeting the 100 million people living in high-transmission areas. India, Indonesia, the Philippines, and Thailand have announced plans to begin vaccine procurement through WHO mechanisms, with rollout expected to begin later this year.
The vaccine's development at the Butantan Institute represents an important milestone in South-South health cooperation and demonstrates the capacity of research institutions in endemic countries to develop solutions for diseases that disproportionately affect their populations. The institute has committed to making the vaccine available at a cost of $2 per dose for low- and middle-income countries.
Public health experts emphasize that vaccination alone will not eliminate dengue. Integrated vector management, including community-based mosquito control, improved urban sanitation, and environmental management, remains essential. However, an effective single-dose vaccine adds a powerful new tool to the dengue control arsenal.