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news.The Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM) has approved Takeda’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).
Qdenga has been approved to prevent dengue disease in people aged six years to 45 years. Credit: José R Valverde from Pixabay.
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The vaccine has been approved for preventing dengue disease in people aged six years to 45 years.
Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.
It is designed for providing protection against any of the four serotypes.
Qdenga is claimed to be the only dengue vaccine that has been approved in Indonesia for use in people without the need for pre-vaccination testing and with previous dengue exposure.
The company stated that the vaccine needs to be utilised as per the official recommendations.
Takeda Vaccine Business Unit president Gary Dubin said: “Dengue can affect anyone living in or traveling to endemic areas – regardless of age, health and socio-economic circumstances.
“Developing this innovative dengue vaccine has been an exciting challenge, and its approval in Indonesia is an important achievement for Takeda and for public health.
“We’re proud to introduce Qdenga as a new dengue prevention tool to the people of Indonesia, and we will continue to work with additional regulatory agencies to make Qdenga available globally.”
The regulatory approval is based on data obtained three years after vaccination from the ongoing Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.
In the study, more than 20,000 healthy children and adolescents aged four to 16 years who are living in dengue-endemic areas in Asia and Latin America were enrolled.
Qdenga showed continued overall protection against dengue disease and hospitalisation three years following vaccination and was also well tolerated.
