The World Health Organization (WHO) has prequalified a second dengue vaccine, TAK-003, providing international procurement agencies another option against the disease that affects millions of people each year.
The prequalification comes amidst a surge in mosquito-borne viral infections across Asia, Africa, and the Americas, including new spread into previously unaffected areas.
According to the WHO, 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.
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.
The WHO in a statement issued on Wednesday said Dengue cases are likely to increase and expand geographically due to climate change and urbanization.
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 vaccine
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.
Developed by Takeda, TAK-003 vaccine is given in two doses over a three-month interval, protects against four serotypes of the dengue virus. It was cleared by WHO for use in children aged 6 to 16 in areas with high infection rates.
The prequalification makes it eligible for procurement by United Nations agencies like UNICEF and Pan American Health Organization.
“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.”
The goal of WHO vaccine prequalification is to ensure that vaccines used in immunization programmes are safe and effective.
In prequalifying vaccines, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe and effective.