The World Health Organization prequalified Takeda’s new dengue vaccine on Wednesday, a year after the company withdrew its FDA application for the candidate — though the company now says it will soon “re-engage” with the FDA.
The WHO wrote in a statement that the vaccine, known as TAK-003 or Qdenga, is recommended for children 6 to 16 years old in areas with a burden and transmission of dengue, adding that the vaccine should be administered in a two-dose schedule with a three-month interval between doses.
“With only two dengue vaccines to date prequalified, we look forward to more vaccine developers coming forward for assessment, so that we can ensure vaccines reach all communities who need it,” WHO Director for Regulation and Prequalification Rogerio Gaspar wrote in a statement.
Dengue is transmitted by infected mosquitoes, and can lead to death in severe cases. According to the WHO, it’s estimated that over 100 to 400 million cases of dengue occur worldwide each year. The WHO uses its Prequalification of Medicines Programme “to assess the quality, safety and efficacy of medicinal products” in order to increase access to treatments, though it doesn’t replace approvals or denials by national or state regulatory authorities, according to the organization.
Takeda won priority review status and filed a biologics license application (BLA) in 2022, but voluntarily pulled the application the following year after regulators wanted more data “not captured within the TAK-003 clinical trial protocol.”
A representative for Takeda told Endpoints News that the company is “excited about the WHO PQ and what it could mean for public vaccination programs and supranational procurement.” The representative added that the IND application in the US is still open and that Takeda plans “to re-engage with the FDA in the next several months.”
Takeda based its BLA on data from the Phase 3 TIDES trial, which hit its primary endpoint of preventing 80.2% of symptomatic dengue cases at 12 months. A follow-up after four years showed that Qdenga had 84% efficacy against dengue hospitalization and 61% efficacy against symptomatic cases.
The vaccine has already been approved elsewhere — it scored its first approval in 2022 in Indonesia, and has since been given the green light in the EU, United Kingdom, Brazil, Argentina, and Thailand.