The World Health Organization (WHO) on Wednesday announced that it has prequalified new dengue vaccine. According to WHO, the vaccine, developed by Takeda Pharmaceuticals, received prequalification on 10 May 2024.
The vaccine, TAK-003, is the second dengue vaccine to be prequalified by WHO. WHO recommends the use of TAK-003 in children aged 6–16 years in settings with high dengue burden and transmission intensity. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses.
“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,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. “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.”
Interestingly, the WHO prequalification list also includes CYD-TDV vaccine against dengue developed by Sanofi Pasteur.
What is TAK-003?
TAK-003 vaccine is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue. According to a 2023 study published in the Journal of Travel Medicine, the vaccine is based on a “mix of a DENV-2 backbone with three recombinant DENV-2 strains expressing surface proteins for DENV-1, DENV-3 and DENV-4.”
In September 2023, WHO SAGE recommended that TAK-003 be introduced for children aged 6 to 16 years in sub-national settings with high dengue transmission intensity. The vaccine was also approved in Europe in late 2022 for all persons >4 yr (with no upper age limit) but indications and ages for use are to be according to individual national recommendations.
The UK, Brazil, Argentina, Indonesia and Thailand have also approved TAK-003. However an application for US FDA approval was unexpectedly withdrawn in July 2023.
Reportedly, the vaccine is intended to be an improvement on Sanofi’s Dengvaxia.
Dengue is a vector-borne disease transmitted by the bite of an infected mosquito. Severe dengue is a potentially lethal complication which can develop from dengue infections.
It is estimated that there are over 100-400 million cases of dengue worldwide each year and 3.8 billion people living in dengue-endemic countries, most of which are in Asia, Africa, and the Americas.
According to WHO, dengue cases are likely to increase and expand geographically due to climate change and urbanisation.
