While Takeda's dengue fever vaccine Qdenga isn't the biopharma industry's first immunization against the deadly infection, the drugmaker is hoping its launch can avoid the pitfalls of an earlier rollout.
Last month, after more than a decade of research, Takeda’s dengue fever vaccine finally nabbed its long-awaited first approval. Authorities in Indonesia blessed the vaccine in people 6 to 45 years of age after years of testing in Asia and Latin America.
Before the company can distribute the shot, there are a "few steps" yet to be completed, program head Derek Wallace recently told Fierce Pharma. Takeda’s contract manufacturer in Germany has an inventory ready for launch, he said. All that’s needed now is labeling and packaging of the product, including some label details specific to the Indonesian language.
Takeda expects other approvals soon. The company has a “very ambitious” regulatory strategy and is seeking parallel approvals in multiple endemic countries, Wallace said. At the same time, officials with the European Medicines Agency are also reviewing the shot.
Despite the best efforts of health authorities across the globe, dengue fever remains a serious concern. Back in 2019, the World Health Organization named it one of the top ten public health threats, a list that included HIV and climate change. According to Wallace, who has spent 14 years working on the Takeda program, the disease is now about 30 times more prevalent than it was 50 years ago.
Dengue has made its way to 120 countries and is one of the primary causes of hospitalization in children in “much of the world,” Wallace said.
Much like COVID-19, an epidemic like dengue can be a big problem for governments, not just individuals. Mass hospitalizations can trigger a collapse of the hospital system, causing other aspects of healthcare to deteriorate. Takeda sees Indonesia as “a great place to start" with its launch, Wallace said, as it has a significant dengue burden. About half of the dengue burden in Southeast Asia is in Indonesia, he noted.
With its launch, Takeda is following in the footsteps of French big pharma Sanofi. Previously, Sanofi's dengue vaccine launch ended in disaster when it was revealed that the shot could cause more serious dengue cases if given to patients without a previous infection
Knowing this, Takeda's dengue team worked to generate “a lot of data” and design a study that included participants without a prior dengue infection, Wallace said. The study, called Tides, ended up being the largest that Takeda has ever conducted. It enrolled 20,000 children in eight different countries and generated four and a half years of data. After participants received two doses of the vaccine, the team contacted every child, or their parents, every week during that span.
Making that clinical trial investment “reflects the quality of the data” provided to regulatory agencies, Wallace said.
“We had to be thorough, and I think that thoroughness has been rewarded with our first license,” Wallace said.
Wallace is confident that this approval is the first of many.
“We recognize the public health challenge that dengue represents, and I think that the vaccine is a key component of meeting that challenge,” Wallace said. “I think we’re about to start a new chapter where we learn how best to use this vaccine with the existing dengue control mechanisms that countries are implementing. It’s a watershed moment in a sense of where we moved from developing a dengue vaccine in a pre-licensure setting to learning how to best use that vaccine to have the maximum impact on public health.”