On May 10, the World Health Organization (WHO) preclassified a new vaccine against dengue, TAK-003, developed by Takeda. It is the second vaccine to receive this preclassification by the WHO and the announcement by this organization has occurred in the midst of a dengue outbreak in Latin America that has caused a significant increase in cases in the region.
TAK-003 – marketed under the name Qdenga – is a live attenuated vaccine that contains weakened versions of the four serotypes of the virus that cause dengue and was approved by the European Commission in December 2022. The WHO recommends its use in children and adolescents between 6 and 16 years old in areas with a high dengue burden and high intensity of transmission. The vaccine should be administered in a two-dose schedule with a three-month interval between each dose.
Dengue is a disease that is transmitted through the bite of an infected mosquito, and although patients usually experience mild symptoms, severe dengue is a life-threatening complication that can develop from dengue infections. TAK-003 is the second dengue vaccine included in the WHO preclassification list, after the CYD-TDV (Dengvaxia) vaccine developed by the French pharmaceutical company Sanofi Pasteur.
“The prequalification of TAK-003 is an important step in expanding global access to dengue vaccines, as it is now eligible for procurement by UN agencies, including UNICEF and PAHO,” said Dr. Rogerio Gaspar, director of Regulation and Prequalification of the WHO. “With only two dengue vaccines prequalified to date, we hope that more vaccine developers will come forward for evaluation so that we can ensure that vaccines reach all communities that need them,” he added.
Climate change contributes to the spread of dengue
The WHO has warned that the incidence of dengue has increased considerably worldwide over the last two decades, and constitutes a major public health problem. According to this organization, between 2000 and 2019, the number of cases reported worldwide had multiplied by 10, going from 500,000 to 5.2 million. In 2019, an unprecedented peak was reached and cases were recorded in 129 countries.
There are an estimated 100 to 400 million cases of dengue worldwide each year, and 3.8 billion people live in endemic countries, mostly in Asia, Africa and the Americas. The highest number of reported dengue cases was in 2023, with the WHO Americas Region recording 4.5 million cases and 2,300 deaths. The WHO considers it likely that dengue cases will increase and expand geographically due to climate change – an increase in temperatures and high levels of precipitation and humidity – and urbanization.
“The prequalification of TAK-003 is an important step in expanding global access to dengue vaccines”
Currently, Latin America is immersed in another epidemic outbreak. In February, the Pan American Health Organization (PAHO) issued an epidemiological alert to report on the increase in cases of this disease in several countries in the Region of the Americas, and on March 29, it carried out an epidemiological update in which indicates that during 2024 and until epidemiological week 12, 3,578,414 cases of dengue were reported to the Health Information Platform for the Americas (PLISA), of which 2,888 were classified as severe dengue and 1,039 deaths occurred.
PAHO highlighted in its update that “the total number of cases reported through PLISA in 2024 represents an increase of more than three times compared to the same period in 2023 in the Region of the Americas.” The incidence since then has continued to increase and in the Americas there have already been more than seven million cases of dengue so far this year.
Source: World Health Organization (WHO)
