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The World Health Organisation (WHO) marked a significant milestone in the global fight against dengue fever with the prequalification of a new vaccine, TAK-003 on May 10, 2024. Developed by Takeda, this vaccine is now the second to receive WHO's stamp of approval for its efficacy and safety in combating the mosquito-borne disease.

TAK-003 is a live-attenuated vaccine designed to provide immunity against the four serotypes of the dengue virus. This breakthrough offers hope in regions burdened with high dengue transmission rates, particularly for children aged 6–16 years. WHO recommends a two-dose schedule, administered three months apart, to ensure optimal protection.

Dr. Rogerio Gaspar, WHO's Director for Regulation and Prequalification, emphasised the significance of this achievement. “The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies including UNICEF and PAHO,” he stated.

“With only two dengue vaccines to date prequalified, we look forward to more vaccine developers coming forward for assessment, so that we can ensure vaccines reach all communities who need them," Dr. Rogerio added.

This approval joins the CYD-TDV vaccine by Sanofi Pasteur on WHO's prequalification list, reinforcing the arsenal



against dengue fever. Dengue, a mosquito-borne illness, poses a significant public health threat, with severe cases potentially leading to life-threatening complications. Vaccination against dengue not only protects individuals but also contributes to the broader effort of disease prevention and control.

The global burden of dengue is staggering, with estimates ranging from 100 to 400 million cases annually. The majority of these cases occur in Asia, Africa, and the Americas, where 3.8 billion people reside in dengue-endemic regions. In 2023, the WHO Region of the Americas reported a concerning surge, with 4.5 million cases and 2300 deaths recorded.

Climate change and urbanisation further exacerbate the spread of dengue, underscoring the urgent need for effective preventive measures. In addition to TAK-003 and CYD-TDV, WHO's prequalification list serves as a beacon of hope in the ongoing battle against dengue fever. It represents a collective commitment to global health and underscores the importance of collaboration between vaccine developers, regulatory bodies, and international agencies in combating infectious diseases.

As the world continues to grapple with emerging health challenges, the prequalification of TAK-003 stands as a testament to the power of scientific innovation and collective action in safeguarding public health on a global scale.
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