Takeda's dengue shot scores crucial EU nod, opening the door to wider global use

Just a few months after Takeda’s dengue fever vaccine, Qdenga, scored its first global approval in Indonesia, the vaccine has been cleared for use in Europe. Importantly, the latest regulatory endorsement paves the way for more approvals across the world.

Thursday, the European Commission endorsed Takeda's Qdenga to protect against dengue in people aged 4 and older as a two-dose series. The decision comes after a committee of the European Medicines Agency recommended the nod back in October.

The vaccine’s European approval could speed up more approvals in dengue-affected countries. Under a special regulatory pathway, officials in endemic countries could choose to leverage the EU nod for their own green lights.

“We are one step closer to achieving our aspiration to help reduce the global burden of dengue,” Gary Dubin, M.D., president of Takeda’s global vaccine business, said in the company’s statement.

Dengue, which is one of the World Health Organization’s 2019 top 10 threats to global health, is 30 times more prevalent than it was 50 years ago and is present in over 125 countries. In just the past 20 years, the worldwide incidence has risen eightfold.

In clinical trials, Qdenga prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases over four-and-a-half years of follow-up. The vaccine protects against all four dengue serotypes.

The company is continuing with its regulatory filings in other dengue-endemic countries in Asia and Latin America, Takeda said. Just a few weeks ago, Takeda's vaccine application received a priority review designation from the FDA. 

Takeda's launch comes after Sanofi's rollout of an earlier dengue vaccine, Dengvaxia, faltered over safety concerns. The French pharma giant had started its rollout, but its effort was derailed after it became apparent the vaccine caused more serious infections if given to people who hadn't been previously exposed to the virus.