After an analysis showed that Sanofi's highly touted dengue vaccine could lead to more serious infections if used in the wrong setting, the company is requesting a label change that will likely lead to fewer eligible recipients. With the development, Sanofi is taking a €100 million ($119 million) charge in the fourth quarter.
A new data analysis has concluded that if Dengvaxia is given to individuals who haven't been exposed to dengue, they could get more serious infections when they encounter the virus naturally. Dengue is different than most infectious diseases because a person's second infection is typically much more serious than the first.
Before the current analysis, a research team last year found that the vaccine—if given to dengue-naïve individuals—"acts very much like a natural infection but without making recipients sick." So, when a person encounters dengue naturally after a previous vaccination, their immune system could process it as a second infection that’s much more severe, according to the team from Imperial College London, Johns Hopkins Bloomberg School of Public Health and the University of Florida.
Still, the vaccine can provide worthwhile protection for those who have already been exposed to the virus, and so Sanofi is asking regulators to change the vaccine's label based on the findings. The WHO has already taken the dynamic into effect has recommends the vaccine—along with other countermeasures—in areas where dengue is prevalent.
For the requested label change, Sanofi is asking doctors to consider whether it's likely an individual has been exposed to dengue, and if they haven't, to hold off. The company says vaccination should "only be recommended when the potential benefits outweigh the potential risks," such as where the disease burden is high.
With the change, Sanofi is recording a charge of about €100 million after tax in its fourth-quarter results, reflecting inventory depreciation and accelerated depreciation of assets, according to a release. The change doesn't affect its 2017 guidance.
Sanofi's dengue vaccine—which took 20 years and $1.5 billion to develop—has come far short of initial blockbuster sales ambitions. Last year, it generated just €55 million in sales compared to the €200 million execs had anticipated. The company said political and economic turmoil had an effect on the launch.
More recently, the company turned in €4 million in Dengvaxia sales in the third quarter of 2017, bringing its total haul for the year to €22 million. The company said the indicated population for the vaccine, people 9 to 45 years old, are tougher to vaccinate as part of large programs than younger children or elderly people. Further, a "very low" incidence this year in Brazil and Mexico is "is contributing to a lack of sense of urgency," a representative said.
Meanwhile, Takeda is pressing ahead with its vaccine that could give Dengvaxia a run for its money. In a phase 2 study, the vaccine recently showed antibody responses against all four serotypes, "regardless of previous dengue exposure," lasted at least 18 months. Last year, the company said it's building a $106 million plant in Germany for the shot. The vaccine is also in a much larger phase 3 trial.