Following the recent news in which the US FDA approved Sanofi’s first-in-class dengue vaccines, Dengvaxia,
Arafa Salam, PhD, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the FDA approval for the first ever vaccine for dengue virus:
“The approval for Dengvaxia offers little commercial upside for Sanofi due to the vaccine being only approved for individuals aged 9-16 living in parts of the United States where the dengue virus is endemic. Because dengue is predominantly found only in Puerto Rico and a few other US offshore territories, the market uptake for Dengvaxia will be severely hindered. Barring any efforts to expand its label via additional clinical studies, which GlobalData does not foresee Sanofi pursuing, Dengvaxia will continue to struggle generating uptake and revenue.
”The highly restricted approval comes after post-market research identifying that the vaccine should not be given to dengue virus (DENV)-naïve individuals as it associated with a heightened risk of severe infection. Therefore, the approval is only for individuals that have already been infected with one previous DENV serotype.
”A potential competitor to Dengvaxia is Takeda’s TAK-003, an investigational live attenuated tetravalent vaccine which showed positive efficacy and safety results in its pivotal Phase III trial in both DENV-exposed DENV-naïve individuals between four to 16 years old. This vaccine, when approved can overtake Dengvaxia due to its anticipated ability to be administered to DENV-naïve children in endemic settings.”