USA — In a recent development, Takeda Pharmaceutical has voluntarily withdrawn its application seeking US approval for its dengue vaccine.
The decision came after discussions with the Food and Drug Administration (FDA) regarding data collection issues, which the company believed couldn’t be addressed within the standard review cycle of the regulator.
While Takeda remains committed to progressing regulatory reviews and providing access to the vaccine in dengue-endemic areas, the withdrawal of the US application prompts the company to explore future steps in the country.
Gary Dubin, the head of Takeda’s vaccine business unit, emphasized their dedication to determining the next course of action in the US.
Dengue fever, a viral disease transmitted by mosquitoes, poses a significant global threat, with approximately half of the world’s population at risk.
Commonly found in tropical and subtropical climates, reported cases of dengue have witnessed a substantial increase over the past two decades.
Although many individuals do not experience symptoms or only have mild effects such as fever, headache, and nausea, the disease can be severe and, in rare instances, fatal for some.
Unfortunately, there is currently no specific treatment for dengue, highlighting the urgent need for preventive measures.
Climate change plays a significant role in this surge, as it fosters the growth of mosquito populations and expands the geographical range of vector-borne diseases.
The Aedes mosquitoes, responsible for transmitting dengue, now find breeding grounds beyond the tropics and subtropics due to changing climates.
Travelers venturing into Latin America, Southeast Asia, and the Caribbean face a particularly high risk of contracting dengue fever.
However, the disease has recently spread to unexpected regions, including Croatia, France, Portugal, and southern states in the US. This expansion further underscores the urgent need for an approved dengue vaccine.
Currently, one preventive vaccine from Sanofi is available in some countries, including the US. However, its usage is limited by age, previous infection status, and the geographical prevalence of the disease.
Takeda’s vaccine, sold as Qdenga in the European Union (EU), received approval last year for individuals aged four years and older.
It is also available in the United Kingdom, Brazil, Argentina, Indonesia, and Thailand. The vaccine underwent extensive testing in a 4.5-year clinical trial involving over 20,000 children and adolescents residing in eight dengue-endemic areas.
The results demonstrated its efficacy in protecting against symptomatic dengue and reducing hospitalization rates.
The trial continues to monitor vaccine efficacy one year after booster vaccination, as well as its long-term effectiveness and safety.
The World Health Organization (WHO) estimates that the US witnesses 3.1 million cases of mosquito-borne viral infections, with over 25,000 classified as severe.
Recent occurrences of locally acquired malaria cases in Florida and Texas, the first in the US in two decades, serve as a stark reminder of the impact of mosquito-borne diseases on a global scale.
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