New Dengue Vaccine Resolves Old Dilemma

Qdenga TAK003 vaccine gains FDA priority review
Dengue vaccinations
by Bojan Vuksanovic
Osaka (Vax Before Travel)

One of the worlds leading mosquito-borne viruses has increased globally over the past two decades and is endemic in more than 125 countries.

The good news is dengue has had a U.S. Food and Drug Administration (FDA) approved vaccine available for a few years.

However, deploying the Dengvaxia vaccine comes with very specific requirements to prevent dengue infections.

Dengue is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. 

But the 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.

To address this clinical need, the FDA confirmed on November 22, 2022, it had accepted and granted priority review of the Biologics License Application (BLA) for TAK-003 (QDENGA®), Takeda (TSE:4502/NYSE:TAK) investigational dengue vaccine candidate.

In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age.

TAK-003 is based on a live-attenuated, tetravalent dengue serotype two virus, which provides the genetic "backbone" for all four dengue serotypes. 

The active substance contains live attenuated dengue viruses, which replicate locally and elicit humoral and cellular immune responses against the four dengue virus serotypes.

"If approved, we believe TAK-003 has the potential to become an important dengue prevention option for healthcare providers, and we continue to be encouraged by our discussions with the FDA," said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda, in a related press release.

"This year, of the 888 dengue infections in the U.S., 96% were a result of travel to dengue endemic areas."

"Of the 316 dengue infections in U.S. endemic territories, 97% were locally transmitted."

Additionally, the state of Florida experienced a dengue outbreak in the Miami area during the summer of 2022.

Dengue is a mosquito-borne virus endemic in more than 125 countries, including the U.S. territories of Puerto Rico, the U.S. Virgin Islands, and American Samoa.

Dengue is a leading cause of fever among travelers returning from Latin America, the Caribbean, and Southeast Asia.

Additional dengue news is posted at

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Article by
Donald Hackett