In May 2024 WHO announced the prequalification of Takeda’s dengue vaccine TAK-003, the second dengue vaccine prequalified by WHO. The vaccine is a live-attenuated vaccine comprising the four serotypes of the virus that cause dengue. It is hoped that this update will broaden global access to dengue vaccines, particularly as 2024 to date has seen “over five million” cases and “over 2,000” dengue-related deaths globally.
Two prequalified vaccines
The latest prequalification adds TAK-003 to the current vaccine: CYD-TDV by Sanofi Pasteur. TAK-003 is recommended for use by WHO in children aged 6-16 in settings with “high dengue burden and transmission intensity”, administered in a 2-dose schedule with a 3- month interval between doses.
Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification, described the prequalification as an “important step” in the “expansion of global access to dengue vaccines”. It is now eligible for procurement by UN agencies such as UNICEF.
“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 it.”
Dengue concerns
WHO estimates that there are over 100-400 million cases of dengue worldwide each year, with 3.8 billion people living in dengue endemic countries. Most of these countries are in Asia, Africa, and the Americas.
“Dengue cases are likely to increase and expand geographically due to climate change and urbanisation.”
PAHO’s latest dengue situation report identifies a total of 6,769,140 suspected cases between epidemiological weeks 1 and 16 of 2024. This is a cumulative incidence of 717 per 100,000 population and represents an increase of 206% compared to the same period in 2023. It is a further 387% increase on the average of the last 5 years. Out of the reported cases, 3,027,582 cases were confirmed by laboratory, and 6,456 cases were classified as “severe dengue”. 2,844 deaths have been registered.
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