Dengue Vaccine Availability in 2025: A Global Update

Estimated reading time: 8 minutes

The fight against dengue fever, a mosquito-borne illness affecting millions worldwide, has seen significant advancements with the development of effective vaccines. However, the path to widespread protection is not without its challenges. The availability of these vaccines, their specific recommendations for use, and their regulatory approvals differ dramatically depending on geographic location and the specific vaccine in question. This disparity arises from a combination of factors, including vaccine efficacy, safety profiles, and logistical considerations.

Qdenga, developed by Takeda, represents a significant leap forward in dengue vaccine technology. This live-attenuated vaccine targets all four dengue virus serotypes (DENV1-4), offering broader protection than its predecessor. Its key advantage lies in its applicability to individuals regardless of prior dengue infection. This eliminates the need for pre-vaccination serological testing, simplifying the vaccination process and potentially accelerating widespread rollout. The two-dose regimen, administered three months apart, with protection beginning as early as 14 days post-first dose, makes it an attractive option for public health initiatives.

The World Health Organization (WHO) prequalified Qdenga in May 2024, a crucial step that facilitates its procurement by UN agencies such as UNICEF and PAHO for use in endemic regions. The WHO currently recommends Qdenga for children aged 6–16 years in areas with high dengue transmission intensity. However, the WHO’s recommendation does not extend to children under 6 years due to observed lower efficacy in that age group and also cautions against programmatic use in low to moderate transmission settings until further data on the efficacy-risk profile, especially concerning DENV3 and DENV4 in seronegative individuals, is available.

As of September 2025, Qdenga has received authorization in 40 countries and is commercially available in 27, including key markets in Asia (Indonesia, Thailand, Malaysia), Latin America (Brazil, Argentina, Colombia), and Europe (United Kingdom, Germany, France, Spain, and others). Brazil’s integration of Qdenga into its public health system in 2023 highlights the vaccine’s growing global acceptance. The absence of Qdenga in the U.S. market, following Takeda’s withdrawal of its application in July 2023 due to FDA disagreements regarding data collection requirements, presents a significant limitation in one of the world’s largest markets. There is currently no set timeline for its availability in the United States.

Dengvaxia, manufactured by Sanofi Pasteur, was the first dengue vaccine to receive regulatory approval. This tetravalent, live-attenuated vaccine also targets all four dengue serotypes. However, its use is strictly limited to individuals with laboratory-confirmed prior dengue infection. This “Screen & Vaccinate” approach, while crucial for safety, presents significant logistical challenges. In individuals without prior dengue infection, Dengvaxia has been shown to increase the risk of severe dengue during subsequent infections.

Initially approved in Mexico, the Philippines, and Brazil in December 2015, Dengvaxia subsequently gained approval in other Asian and Latin American countries, as well as the European Union and the United States. In the U.S., its approval in 2019 was restricted to individuals aged 9–16 years with confirmed prior dengue infection residing in endemic areas. However, due to the complexities of implementing the “Screen & Vaccinate” strategy and the resulting low uptake, Sanofi announced the discontinuation of Dengvaxia in the third quarter of 2026. Its discontinuation in Brazil, announced in February 2025, further illustrates the challenges faced by this vaccine. While still technically approved in the U.S., it’s practically unavailable outside Puerto Rico due to Sanofi’s discontinuation efforts.

The landscape of dengue vaccine development is far from static. Several promising candidates are in various stages of clinical trials, offering the potential for improved efficacy, safety profiles, and ease of administration. These include live-attenuated, inactivated, DNA, and subunit vaccines.

For example, Merck’s MOBILIZE-1 Phase 3 trial evaluates V181, a live-attenuated quadrivalent dengue vaccine candidate that could potentially be administered regardless of prior dengue exposure. Indian Immunologicals Limited (IIL) aims to launch a dengue vaccine commercially by 2026, based on positive early-stage trial results showing no significant adverse effects. Panacea Biotec, in collaboration with the Indian Council of Medical Research (ICMR), is also actively developing a tetravalent dengue vaccine (TV003/TV005) and launched a Phase 3 clinical trial in India in August 2024.

Navigating the complexities of dengue fever vaccine availability requires a nuanced understanding of the available options and their respective limitations. For businesses operating in dengue-endemic regions, this necessitates:

The global landscape of dengue fever vaccine availability remains dynamic and presents both opportunities and challenges. While Qdenga offers a promising new approach, the discontinuation of Dengvaxia underscores the complexities involved in vaccine rollout and acceptance. The ongoing development of new vaccine candidates offers hope for improved protection in the years to come. Staying informed about the latest developments and adapting strategies accordingly are essential for effective dengue fever prevention and control.

Call to Action: Want to stay ahead of the curve in understanding dengue fever vaccine availability and its implications for your business? Contact us today to discuss your specific needs and explore how our expertise can help you navigate this evolving landscape.