The World Health Organisation has prequalified TAK-003 as a new vaccine for dengue (break-bone fever).
This was according to a press statement released by the WHO on Wednesday, on its website.
WHO defined dengue as a viral infection transmitted to humans through the bite of infected mosquitoes. About half of the world’s population is at risk of dengue with an estimated 100–400 million infections occurring each year.
The largest number of dengue cases reported was in 2023 with the WHO Region of the Americas reporting 4.5 million cases and 2300 deaths. Dengue cases are likely to increase and expand geographically due to climate change and urbanisation.
Dengue is found in tropical and sub-tropical climates worldwide, mostly in urban and semi-urban areas. While many dengue infections are asymptomatic or produce only mild illness, the virus can occasionally cause more severe cases and even death.
The global health organisation noted that the new dengue vaccine was prequalified on May 10, 2024.
TAK-003 is the second dengue vaccine to be prequalified by WHO. The first dengue vaccine, Dengvaxia (CYD-TDV) by Sanofi Pasteur, was first licensed in December 2015, in Mexico.
TAK-003 was developed by Takeda. It is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue.
The goal of WHO vaccine prequalification is to ensure that vaccines used in immunisation programmes are safe and effective. In prequalifying vaccines, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe and effective.
WHO recommends the use of TAK-003 in children aged six to 16 years in settings with high dengue burden and transmission intensity. The vaccine should be administered in a 2-dose schedule with a three-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 the WHO Director for Regulation and Prequalification, Dr Rogerio Gaspar.
“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.”
