MANILA, Philippines — Japan-based Takeda Pharmaceuticals, manufacturer of the second-generation dengue vaccine Qdenga, said it is just waiting for approval of its product application following the completion of the requirements set by the Food and Drug Administration (FDA).
“Takeda has submitted all information requested by relevant agencies and remains committed to working with health authorities to ensure TAK-003 can be thoroughly evaluated for approval as part of the Philippines’ broader dengue prevention efforts,” Takeda said in a statement.
Takeda said a risk management plan as well as an explanation of why Qdenga was pulled out from FDA markets in other countries have already been submitted to the Philippine FDA.
“The voluntary withdrawal of our applications in the US and Singapore for our dengue vaccine, TAK-003 (Qdenga), was related to aspects of data collection requested by the local health agencies,” Takeda said. “Takeda respects the regulatory processes of each country and remains committed to working closely with health authorities globally.”
The pharmaceutical firm said Qdenga has been validated through approvals in 40 countries across Europe, South America and Asia, with over 15 million doses distributed globally in both private and public programs.
“The vaccine’s real-world safety profile has been consistent with the data from clinical trials. The World Health Organization (WHO) recommendation and prequalification of Takeda’s dengue vaccine in May 2024 for introduction in high dengue burden areas, further reinforces the vaccine as part of an integrated approach to dengue management,” said Takeda.
It also stressed that?the vaccine is indicated for use regardless of previous dengue exposure and does not require serologic screening before vaccination.
Earlier, the Department of Health said Qdenga is still lacking two requirements before it can be issued a certificate of product registration by the FDA.
Health Secretary Ted Herbosa said Takeda should submit a risk management plan “in case something happens, just like what happened in Dengvaxia” and to explain why it pulled Qdenga out of other FDA markets such as the US and Singapore.
Qdenga is the second dengue vaccine to be prequalified by the WHO, following Sanofi’s Dengvaxia in 2020. Dengvaxia, however, was surrounded by controversies after being linked to the deaths of Filipino children.
The DOH said it has no plans to reintroduce the use of Dengvaxia.