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Manila Bulletin devider Philippines devider National devider Takeda Philippines explains dengue vaccine application withdrawals in US, Singapore

Takeda Philippines explains dengue vaccine application withdrawals in US, Singapore

Published Jul 3, 2025 02:05 pm
(PHOTO: PIXABAY)
(PHOTO: PIXABAY)
Takeda Healthcare Philippines, Inc. on Thursday, July 3, clarified that its decision to voluntarily withdraw applications for its dengue vaccine TAK-003 in the United States (US) and Singapore was due to data collection requirements from local regulators, not because of safety or efficacy concerns.
Currently, Takeda is applying for Food and Drugs Administration (FDA) approval in the Philippines for its dengue vaccine, TAK-003.
“The voluntary withdrawal of our applications in the US and Singapore for our dengue vaccine, TAK-003, was related to aspects of data collection requested by the local health agencies,” the company said in a statement.
“Takeda respects the regulatory processes of each country and remains committed to working closely with health authorities globally,” it added.
Despite the withdrawals, the company said TAK-003 has been validated through regulatory approvals in 40 countries across Europe, South America, and Asia.
More than 15 million doses have been distributed globally under public and private immunization programs, it added.
“The vaccine’s real-world safety profile has been consistent with the data from clinical trials,” Takeda said.
The company noted that the World Health Organization (WHO) in May 2024 recommended and prequalified the vaccine for use in countries with high dengue burden.
Takeda said TAK-003 can be given regardless of prior dengue exposure and does not require serologic screening before vaccination.
In the Philippines, the company said it has submitted all necessary documents to local regulators and is cooperating with health authorities.
“In the Philippines, 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 stated.
“We share the government’s vision of reducing the dengue burden and protecting Filipino communities from this ongoing health threat,” it added.
In February 2025, the Philippine Medical Association (PMA) called on President Marcos to fast-track the approval of a next-generation dengue vaccine amid rising cases.
The PMA, in a letter addressed to the Chief Executive, urged the prompt approval of TAK-003, the dengue vaccine created by Japan-based pharmaceutical company Takeda.
Earlier, the Department of Health (DOH) emphasized that the FDA must complete its full evaluation before any new vaccine can be approved.
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