TOKYO (AFP): Japanese pharma firm Takeda is voluntarily withdrawing its application for approval of a dengue vaccine candidate in the United States, citing “data collection” issues.
The decision, announced by the company in the United States on Tuesday evening, comes despite the shot winning European Union approval late last year.
The company said it took the decision after talks with the US Food and Drug Administration on “aspects of data collection, which cannot be addressed within the current…review cycle”.
It did not specify when it might seek to reapply for authorisation.
Takeda said there remained a need for its vaccine, known as TAK-003 or Qdenga.
“The future plan for TAK-003 in the US will be further evaluated given the need for travellers and those living in dengue-endemic areas of the US, such as Puerto Rico,” it said.
Takeda stressed that the vaccine has already been “approved in multiple endemic and non-endemic countries, with more approvals expected over the coming years”.
In December, it received regulatory approval from the EU.
Only one other dengue vaccine, Dengvaxia, is approved in the United States and EU, but only for those with a previously confirmed infection.
Dengvaxia became the subject of controversy in 2019 when the Philippines banned it over safety concerns.
Dengue can cause hemorrhagic fever and infects an estimated 100 to 400 million people a year, although over 80 percent of cases are mild or asymptomatic, according to the World Health Organization.