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WHO Prequalifies New Dengue Vaccine

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World Health Organization (WHO) has officially prequalified a new vaccine designed to combat the mosquito-borne viral disease; dengue fever.

The WHO announced a news release, that the new vaccine for dengue has received prequalification by its organization on Friday, May 10.

The newly prequalified vaccine, TAK-003 is developed by a multinational pharmaceutical company, Takeda as the second dengue vaccine to be prequalified by WHO.

According to WHO, TAK-003 is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue.

Dr. Rogerio Gaspar, director for Regulation and Prequalification for Dengue, WHO,  emphasized the vaccine’s potential to save lives and reduce the burden on healthcare systems in dengue-endemic areas.

“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,” Dr. Gaspar said.

“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.” Dr. Gaspar added

The WHO prequalification list also includes the CYD-TDV vaccine against dengue developed by Sanofi Pasteur.

Both vaccines are tetravalent live-attenuated vaccines but differ in the extent of chimerization and the genome backbone, as well as in efficacy and safety.

Also, the CYD-TDV vaccine schedule consists of 3 doses administered 6 months apart, with an indication for individuals aged 9–45 years or 9–60 years (depending on the country-specific regulatory approvals) living in dengue-endemic countries or areas while the TAK-003 vaccine schedule consists of 2 doses administered subcutaneously with an interval of 3 months between doses.

The WHO further recommended the use of TAK-003 in children aged 6–16 years in settings with high dengue burden and transmission intensity noting that the vaccine should be administered in a 2-dose schedule with a 3-month interval between doses.

Dengue fever, a viral infection caused by the dengue virus (DENV) is a potentially deadly vector-borne disease transmitted by the bite of an infected mosquito; Aedes mosquitoes. It poses a significant public health threat in many tropical and subtropical regions, affecting millions of people each year, with severe cases leading to potentially lethal complications developing from dengue infections.

According to the news release, the WHO estimates over 100-400 million cases of dengue worldwide each year with 3.8 billion people living in dengue-endemic countries, most of which are in Asia, Africa, and the Americas.

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 urbanization.

According to the Nigerian Centre for Disease Control and Prevention (NCDC) in December 2023, a total of 71 suspected cases, 13 confirmed cases, and zero deaths have been reported in Sokoto state with the state being the only one with reported confirmed cases so far.

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