Takeda Pharmaceutical, a leading Japanese pharmaceutical company listed on the NYSE (NYSE: TAK), is reportedly preparing to submit its dengue fever vaccine for regulatory approval in the United States, according to the Nikkei Asian Review. At this juncture, specifics regarding the timing of the filing or the anticipated decision date have not been disclosed.
Takeda’s vaccine, QDENGA (TAK-003), is formulated around a live-attenuated dengue serotype 2 virus. It serves as the genetic foundation for all four dengue virus serotypes, offering protection against each. Initially approved in Argentina in 2022, the vaccine has since gained regulatory approvals in Indonesia, Thailand, Brazil, and the European Union. It has also received the World Health Organization (WHO) pre-qualification for administration to children aged 6 to 16 in regions with elevated infection rates.
Dengue fever, transmitted primarily by the Aedes aegypti mosquito, is recognized as one of the world’s most rapidly spreading viral diseases and is classified by the WHO as a top-10 threat to global health. As of July 2024, the US Center for Disease Control and Prevention (CDC) documented 2,559 cases of dengue fever within the United States, with a significant concentration of these cases in Florida.- Flcube.com