SWITZERLAND—TAK-003 has been prequalified as the new dengue vaccine by the World Health Organization (WHO), making it the second dengue vaccine to receive this mark of approval.

TAK-003, developed by the Japanese pharmaceutical company Takeda, is a live-attenuated vaccine comprising weakened forms of the four viral serotypes that cause dengue (DENV-1, DENV-2, DENV-3, and DENV-4).

This vaccine has been recommended for children aged 6 to 16 in regions with a high dengue burden and transmission intensity.

It will be given in two doses, with a three-month interval between them, protecting against all four serotypes of dengue currently circulating in the Americas and some nations.

According to different studies, Takeda’s vaccine has been shown to be  approximately 84% efficient in preventing dengue hospitalization and around 61% effective in treating symptoms.

Speaking at the prequalification event, Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, noted that the prequalification of TAK-003 is an important step in expanding global access to dengue vaccines, as it is now eligible for procurement by UN agencies including UNICEF and PAHO.

Dr. Gaspar went on to underline that with only two dengue vaccines prequalified to date, they look forward to new vaccine producers coming forward for evaluation, ensuring vaccines reach all populations in need.

Sanofi Pasteur’s CYD-TDV dengue vaccine is also on the WHO’s pre-qualification list.

Sanofi Pasteur developed the first WHO-approved vaccine, which later proved to raise the risk of severe dengue in people who had never been infected with the disease.

There is no specific treatment for dengue, which is a primary cause of serious illness and death in approximately 120 Latin American and Asian nations.

While approximately 80 percent of dengue infections are mild, severe cases can cause internal bleeding, organ failure, and even death.

Dengue is a vector-borne disease spread through the bite of an infected mosquito. Severe dengue is a potentially deadly consequence of dengue infections.

The vector mosquito for dengue, Aedes aegypti, is widely dispersed throughout the Americas. Only Canada and continental Chile are free of dengue and its vector. Uruguay has no dengue cases, however, it does have Aedes aegypti.

It is estimated that there are about 100–400 million cases of dengue globally each year, with 3.8 billion people living in dengue-endemic nations, the majority of which are in Asia, Africa, and the Americas.

The WHO Region of the Americas recorded the most dengue cases in 2023, with 4,565,911 cases, including 7,653 (0.17%) severe cases and 2,340 deaths (case fatality rate of 0.051%).

Dengue incidences are expected to rise and spread geographically as a result of climate change, urbanization, and the expanding range of dengue-carrying mosquitoes.

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