Statement by the Dengue Vaccine Initiative on Mexico’s Regulatory Approval of Sanofi Pasteur’s Dengue Vaccine, Dengvaxia®
10 DECEMBER 2015— Yesterday, Mexico approved Sanofi Pasteur’s dengue vaccine marking the first time a dengue vaccine has been licensed for use in a country. Called Dengvaxia® and developed by the French pharmaceutical company, Sanofi Pasteur, the vaccine was approved for people aged 9 to 45 years in areas that are highly endemic, with a dengue seroprevalence of more than 60 percent.
The Dengue Vaccine Initiative (DVI) views Mexico’s licensure of Dengvaxia® as an important milestone in the fight against dengue. Recent studies have demonstrated that in children and adolescents aged 9 years and above, Dengvaxia® reduces dengue cases overall by approximately 65 percent; dengue cases requiring hospitalization by 81 percent; and severe dengue cases by 93 percent. The vaccine’s efficacy was most apparent in individuals with evidence of prior dengue virus exposure. In children below the age of 9 years and in those with no evidence of prior dengue, the vaccine’s efficacy was substantially lower. There was also an increased risk of cases requiring hospitalization during the third year after vaccine initiation in children under 9.
These results suggest that Dengvaxia® may have significant public health impact in reducing dengue disease burden for people 9 years of age and older, especially in areas with existing high infection rates of dengue. Questions remain regarding Dengvaxia®, including duration of protection, price, and impact on overall dengue virus transmission given that the youngest age groups will not be vaccinated. These and other issues will have to be closely followed in order to ascertain the ultimate impact of this vaccine.
Dengue, also known as “breakbone fever,” is caused by a virus transmitted by Aedes mosquitoes, the same mosquitoes that can transmit chikungunya and Zika virus. Dengue viruscauses approximately 400 million infections globally each year. In the Americas alone, dengue’s economic burden has been estimated to cost $2.1 billion dollars a year.
DVI believes that this first vaccine licensure in a dengue-endemic country may pave the way for other countries considering new technologies to fight dengue, but stresses that the decision to introduce a dengue vaccine should follow scientific evidence. Following registration, ministries of health will still face important decisions about whether and how to introduce the vaccine into national programs. These decisions may vary according to the specific demographic characteristics, dengue epidemiology and the capacity of public health systems of each country. Therefore, DVI continues to strongly support increasing efforts to improve endemic countries’ access to the evidence needed to inform vaccine introduction decisions.
DVI also welcomes the decision by Mexico as an opportunity to increase our understanding of the questions raised above, as well as the effectiveness of the vaccine in field conditions. DVI recognizes the importance of effective integration of dengue prevention and control strategies,notably vaccination and vector-control approaches, to comprehensively reduce dengue. DVI also encourages the global health community to facilitate and support mechanisms for regional knowledge transfers and information sharing among endemic countries to collectively fight dengue and other vector-borne diseases that are also on the rise. We hope this development spurs other vaccine candidates currently in clinical development to continue to progress in the pipeline.
About the Dengue Vaccine Initiative
The Dengue Vaccine Initiative is an international consortium of the International Vaccine Institute, the World Health Organization Initiative for Vaccine Research, the International Vaccine Access Center at the Johns Hopkins University Bloomberg School of Public Health and the Sabin Vaccine Institute that specializes in research, health economics, policy and advocacy to equip countries with objective information and scientific evidence to fight dengue fever. The Initiative is supported by the Bill & Melinda Gates Foundation.
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