MANILA, Philippines — Takeda Healthcare Philippines revealed on Thursday that its voluntary withdrawal of dengue vaccine applications in the US and Singapore is linked to the local health agencies’ requests for additional data collection. This update provides important context regarding the ongoing approval process for the company’s dengue vaccine, TAK-003, also known as Qdenga.
Takeda, a Japanese pharmaceutical manufacturer, has filed for a certificate of product registration (CPR) with the Philippine Food and Drug Authority (FDA). The company’s decision to pause submissions in other countries highlights challenges in meeting regulatory requirements and reflects the complex nature of vaccine approval worldwide.
Takeda Explains Data Collection Issues
In an official statement, Takeda said, “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 added that it respects each nation’s regulatory process and remains committed to collaborating closely with health authorities globally.
Local leaders noted the importance of the four-word keyphrase early in the discussion, as it underscores the vaccine’s current status and the hurdles faced during approval.
Pending PH Approval and Requirements
During the 2nd Dengue Summit hosted by the Philippine Medical Association, Health Secretary Teodoro Herbosa shared updates on the vaccine’s pending approval. He emphasized that the FDA is awaiting two specific submissions from Takeda before granting approval.
Herbosa explained, “One requirement is a risk management plan in case something happens like what happened with Dengvaxia.” This plan aims to address safety concerns and avoid past controversies. The second requirement is a company explanation about why the vaccine applications were withdrawn in the US and Singapore, which the FDA also needs to review.
Herbosa expressed optimism, stating, “We’re just waiting for that and if they submit that, I think we can give the CPR.” Meanwhile, Takeda confirmed it has already provided all requested information to Philippine authorities and remains dedicated to ensuring TAK-003 undergoes thorough evaluation as part of the nation’s broader dengue prevention efforts.
Dengue Cases and Vaccine Urgency
The Department of Health has reported 123,191 dengue cases nationwide from January 1 to June 7 this year. Notably, infections among children aged 5 to 9 have risen sharply, reaching 27,358 cases. This increase has intensified calls from medical groups urging the government to expedite vaccine approval.
Back in February, medical leaders urged President Ferdinand R. Marcos Jr. to prompt the FDA to fast-track registration of the new vaccine. TAK-003 is one of two dengue vaccines, alongside Dengvaxia, approved by the World Health Organization for use in countries with high dengue prevalence like the Philippines. Additionally, the vaccine is licensed in over 40 countries, including Indonesia, Malaysia, Vietnam, and Thailand.
Clinic-Based Vaccination Approach
Health Secretary Herbosa clarified that once approved, Qdenga will not be distributed through mass immunization campaigns. Instead, vaccinations will be administered in clinics. “It has to be done in your clinics. What we learned in Dengvaxia is that you should know the serologic status of the person you’re giving the dengue vaccine to,” Herbosa said.
This cautious approach stems from past experiences with Dengvaxia, which was administered to about 700,000 children nationwide beginning in 2016. The program faced controversy after some children developed severe symptoms and died, allegedly linked to the vaccine.
Legal Developments on Dengvaxia Cases
The Department of Justice previously dismissed 98 cases of reckless imprudence resulting in homicide against former Health Secretary Janette Garin and two others related to the Dengvaxia controversy. Justice Secretary Jesus Crispin Remulla stated that no causal link could be established between the vaccine and the children’s deaths.
For more news and updates on dengue vaccine approval, visit Filipinokami.com.