Mexico Approves Qdenga Dengue Vaccine for Use in High-Risk Areas

Mexico City — Mexico’s Federal Commission for Protection against Health Risks (Cofepris) has approved Qdenga (TAK-003), a new dengue vaccine developed by Takeda Pharmaceuticals, marking a significant shift in the country’s dengue prevention strategy amid rising case numbers across endemic regions.

Qdenga is a live-attenuated tetravalent vaccine designed to protect against all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). It is administered in a two-dose schedule spaced three months apart and is approved in Mexico for use in children aged 6 to 16 living in high-transmission areas.

The World Health Organization (WHO) issued a recommendation in 2023 supporting Qdenga’s use in countries with moderate to high dengue transmission. Unlike Dengvaxia — the earlier dengue vaccine developed by Sanofi, which is recommended only for individuals with prior dengue infection — Qdenga can be administered regardless of previous exposure, simplifying deployment in endemic regions.

Clinical trials involving more than 20,000 participants across Asia and Latin America demonstrated overall vaccine efficacy of approximately 61–80% against symptomatic dengue and higher protection against hospitalization, depending on serotype and follow-up period. Protection has been shown to persist for at least four and a half years after vaccination.

Cofepris noted that Qdenga is already authorized in more than 40 countries, including Argentina, Brazil, Colombia, Indonesia, Thailand, and members of the European Union. Several Latin American nations have incorporated it into public vaccination campaigns in high-incidence zones.

Mexico has experienced cyclical dengue outbreaks in recent years, particularly in southern and coastal states such as Quintana Roo, Yucatán, Veracruz, and Chiapas. According to Mexico’s Ministry of Health, dengue cases increased significantly in 2023 and 2024, reflecting broader regional trends linked to climate variability, urbanization, and mosquito habitat expansion.

While pricing varies internationally — generally between $40 and $115 USD per dose — some countries have subsidized or publicly funded vaccination in priority regions.

The approval represents a policy reversal from 2021, when Cofepris declined to grant registration to Qdenga. With dengue incidence climbing across Mexico and Latin America, the new authorization signals a strengthened federal response to a mosquito-borne disease that continues to pose a growing public health challenge.