Dengue vaccine nears FDA approval in the Philippines

National

IT’S not a done deal just yet—but Takeda’s Qdenga vaccine may soon get the official sting of approval in the Philippines, pending final regulatory clearance.

Japanese drugmaker Takeda says it has completed all submission requirements for its dengue vaccine, Qdenga (TAK-003), and is now waiting for the Philippine Food and Drug Administration (FDA) to complete its review.

In a statement, the company said it has turned over the necessary documents, including a risk management plan and a detailed explanation of the vaccine’s voluntary withdrawal from certain international markets. “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,” it said.

Takeda clarified that its decision to withdraw Qdenga from the United States and Singapore was based on data collection requests from local health agencies. It emphasized that these actions did not reflect concerns about the vaccine’s safety or effectiveness, and added that it respects each country’s regulatory processes.

Globally, Qdenga has received approval in 40 countries across Europe, South America, and Asia. Over 15 million doses have been administered in both public and private immunization programs. According to Takeda, post-approval safety data has remained consistent with clinical trial results. The World Health Organization (WHO) also prequalified the vaccine in May 2024 for use in countries with high dengue burdens. Unlike the first dengue vaccine, Qdenga does not require prior screening for dengue exposure.

In the Philippines, the Department of Health (DOH) confirmed that Qdenga’s application is still under review. Health Secretary Ted Herbosa said final approval from the FDA is contingent on the submission of two remaining items: a complete risk management plan and a formal explanation regarding the vaccine’s market withdrawal in other countries. “Takeda should submit a risk management plan in case something happens, just like what happened in Dengvaxia,” Herbosa stated in a Philstar report.

Qdenga is the second dengue vaccine to receive WHO prequalification, following Sanofi Pasteur’s Dengvaxia in 2020. However, Dengvaxia faced public backlash and legal scrutiny in the Philippines after being linked to the deaths of several children, prompting the DOH to discontinue its use. The department has since reiterated that it has no plans to reintroduce Dengvaxia into its immunization programs.