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India's New Dengue Vaccine Faces Safety Questions
27 Jul
Summary
- India approved its first dengue vaccine, Qdenga, effective against four virus serotypes.
- Clinical trial data show Qdenga may increase DENV-3 infection risk in seronegative children.
- Screening seronegative recipients before vaccination is recommended to prevent risks.

India's drug regulator has approved Qdenga, the nation's first vaccine against dengue, targeting all four DENV serotypes. Manufactured by Takeda, Qdenga has received approval in over 40 countries.
However, data from clinical trials published between 2019 and 2024 have raised concerns regarding the vaccine's efficacy, particularly in seronegative individuals. The vaccine demonstrated an overall efficacy of approximately 80%, but a notable issue emerged: seronegative children vaccinated with Qdenga were 25% more likely to be infected by DENV-3.
This variable efficacy across serotypes, especially the potential for enhancing dengue in those not previously exposed, has led to recommendations for screening. Researchers suggest that screening individuals, particularly children, for prior dengue exposure before administering Qdenga could be a crucial step in ensuring vaccine safety and preventing severe outcomes.