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# Takeda Withdraws BLA for Dengue Vaccine
- URL: https://www.fdaweb.com/takeda-withdraws-bla-for-dengue-vaccine/
- Published: 2023-07-11T12:00:00.000Z
- Updated: 2026-09-14T18:43:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154855

Takeda says it has withdrawn a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on “aspects of data collection, which cannot be addressed within the current BLA review cycle.” The vaccine’s future plan in the U.S. will be further evaluated, it says, adding that it is currently approved in multiple endemic and non-endemic countries, with more approvals expected over the coming years.

Takeda says the vaccine’s efficacy and safety profiles have been demonstrated through its clinical trial program, including a 4.5-year [Phase 3 ](https://clinicaltrials.gov/study/NCT02747927?tab=table&ref=fdaweb.com)study of over 20,000 children and adolescents living in eight dengue-endemic areas.

Dengue is a mosquito-borne viral disease that spreads rapidly. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. “Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease, Takeda says.