PHARMA COMPANY AWAITS REGULATORY NOD FOR DENGUE VACCINE IN PHILIPPINES

Japan-based Takeda Pharmaceuticals is awaiting approval from the Philippine FDA for its second-generation dengue vaccine, Qdenga, after completing the required submissions.

The company has provided a risk management plan and explanations for the vaccine’s voluntary withdrawal from markets in the US and Singapore.

Qdenga has been approved in 40 countries and distributed over 15 million doses, with a strong safety profile supported by WHO prequalification in May 2024.

The vaccine is recommended for use regardless of prior dengue exposure and does not require serologic screening before vaccination. 

Meanwhile, the Philippine Department of Health requires the final submission of some documents before granting product registration, and has no plans to reintroduce the controversial Dengvaxia vaccine.

Source: PhilNews24 | July 4, 2025

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