BELGIUM—Takeda Pharmaceutical’s dengue vaccine has been authorized for use in the European Union, making it the second approved inoculation against the mosquito-borne disease that causes millions of infections annually.
Importantly, the latest regulatory endorsement paves the way for more approvals across the world.
The vaccine’s European approval could hasten approvals in dengue-affected countries. Officials in endemic countries could choose to leverage the EU nod for their own green lights under a special regulatory pathway.
The vaccine, branded QDENGA, is authorized for use in those aged 4 and older to prevent any of the four so-called serotypes of dengue.
There are no antivirals or specific treatments for the flu-like viral disease.
While the illness is mostly mild, some people can develop life-threatening complications. Between 20,000 and 25,000 people, mostly children, die each year from the virus, according to the World Health Organization.
Dengue fever, which is one of the World Health Organization’s top ten global health threats for 2019, is 30 times more prevalent than it was 50 years ago and is present in over 125 countries. The global incidence has increased eightfold in the last 20 years.
QDENGA follows Sanofi’s Dengvaxia, which became the world’s first approved dengue vaccine in 2015.
Use of the French drugmaker’s vaccine was scaled back considerably after the company disclosed in 2017 that it increased the risk of severe disease in ‘seronegative’ children – those who had no prior dengue exposure when they got the shot.
Takeda’s vaccine is based on a dengue 2 virus, with DNA from the other three serotypes added in. Data from a pivotal trial demonstrated that the vaccine can induce immune responses to a varied degree against all four dengue types.
The vaccine has good evidence of benefit and no evidence of any safety concern, Takeda’s dengue program head Derek Wallace said in an interview.
Although there is no study that directly compares the Sanofi vaccine with QDENGA, EU health officials in October said the Takeda vaccine conferred comparatively wider protection in young children and people older than 45 years old.
The Takeda vaccine has also been approved in Indonesia, while U.S. regulators are reviewing QDENGA on a priority basis.
The vaccine will be made available in some European countries by early 2023, Wallace told Reuters, adding that the company intends on implementing a tiered pricing strategy across geography where launches occur. In such cases, developing countries are typically charged less than richer nations.
Takeda expects its vaccine to generate US$700 million to US$1.6 billion in sales over the course of several years, Gary Dubin, president of Takeda’s global vaccine business, said earlier this year.
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