Dengue Vaccine Candidate Gets FDA's Priority Review
The FDA has set a Prescription Drug User Fee Action date of May 1 for the vaccine.
A Biologics License Application for Sanofi Pasteur's dengue vaccine, Dengvaxia (CYD-TDV), has been granted priority review by the Food and Drug Administration (FDA). If approved, it would become the first prevention tool against dengue to be available in the US.
Two Phase 3 trials conducted in Asia and Latin America assessed the efficacy of the vaccine in >35,000 individuals aged 2 to 16 years. Results showed that in the year following the primary series, overall efficacy against confirmed dengue was 59.2%; efficacy against severe dengue was 79.1%.
According to the Centers for Disease Control and Prevention, most cases of dengue in US citizens result due to transmission in US territories with tropical climates, such as Puerto Rico. In 2016, there was a state of emergency declared in Hawaii due to 250 confirmed cases during a 4 month period.
The FDA has set a Prescription Drug User Fee Action date of May 1 2019 for the vaccine.
For more information visit Sanofi.us.