Takeda has scored a landmark approval for its dengue vaccine, the first step in helping tackle what the WHO has defined as a top 10 health problem and cracking open a potential blockbuster market.
Indonesia approved the vaccine, formerly known as TAK-003 and now branded Qdenga, for the prevention of dengue disease regardless of prior dengue exposure.
The broad label is key, because while Sanofi lays claim to the world’s first dengue vaccine, the rollout of its shot, Dengvaxia, imploded amid a public health scandal. In late 2017, after the Philippines already purchased $70 million worth of Dengvaxia and began a mass vaccination campaign, it emerged that the vaccine actually carried a life-threatening risk for those who have never had a dengue infection. The Filipino government suspended the campaign and sued Sanofi, which eventually conceded the risks.
Although Dengvaxia did go on to earn an FDA approval, it was limited to young people who’ve had laboratory-confirmed dengue disease.
Under that cloud, Takeda has been carefully collecting data on both seropositive — previously infected — and seronegative populations, breaking down the numbers every step of the way to ensure that its vaccine wouldn’t repeat the same mistake.
On their recent quarterly call, execs noted that follow-up data out to 4.5 years suggest the vaccine still holds up.
“While mortality from dengue is relatively low, severe dengue infection can be devastating for patients, sometimes leading to hospitalization,” R&D chief Andy Plump said on the call, adding:
Gary Dubin
For regions that experience a dengue epidemic, hospitals can become overrun with patients, requiring supportive care. And so, the secondary consequences for patients with other diseases can be substantial, not unlike what we have seen with COVID. There is an incredible unmet medical need, and we are ready to meet that need with a really good vaccine. Our 4.5-year data continued to support sustained efficacy. What we show here with patients at baseline who are seropositive or seronegative is an incredible 84% reduction in hospitalization. Hospitalization is an indicator of severe forms of dengue.
And the Indonesia OK is just a start, with an EU decision expected later this year.
“Dengue can affect anyone living in or traveling to endemic areas – regardless of age, health and socio-economic circumstances,” said Gary Dubin, president of Takeda’s vaccine business unit.