Statement by the Dengue Vaccine Initiative on the Philippines Regulatory Approval of Sanofi Pasteur’s Dengue Vaccine, Dengvaxia®
December 22, 2015 — The Philippines yesterday became the first Asian country to approve Sanofi Pasteur’s dengue vaccine, Dengvaxia®, marking the second time in less than one month that a dengue vaccine has been licensed for use in a country. Following the Mexican government’s approval of Dengvaxia® on December 11, the Philippines Food and Drug Administration approved this vaccine for people ages 9 to 45 years in endemic areas.
The Philippines’ approval of Dengvaxia® is a major milestone in the global fight against dengue. Recent Phase III trials suggest that Dengvaxia® may have a significant public health impact in reducing dengue disease burden for people 9 years of age and older in areas with existing high infection rates of dengue. The Asia-Pacific region bears the highest incidence of dengue in the world, accounting for more than 70 percent of the global burden of for the disease. A 2013 study found that from 2000 to 2010, Southeast Asia alone had an average of 2.9 million dengue episodes and 5,906 deaths per year. During the same time period, dengue costs resulted in $950 million per year, or approximately $1.65 per person.
The Dengue Vaccine Initiative (DVI) is encouraged by the growing momentum in global dengue prevention and control strategies. Together with Mexico’s approval of Dengvaxia® and Brazil’s recent authorization for a Phase III study of Instituto Butantan’s dengue vaccine candidate, DVI views the Philippines’ licensure as the latest development in an ongoing effort to deliver innovative, comprehensive dengue prevention and control strategies. The Philippines’ approval of Dengvaxia® also will help answer remaining questions about Dengvaxia®, including duration of protection, price, and impact on overall dengue virus transmission, especially in age groups not vaccinated.
Dengue, also known as “breakbone fever,” is caused by a virus transmitted by Aedes mosquitoes, the same mosquito species that transmits chikungunya and Zika virus. There are approximately 400 million dengue virus infections globally each year. As countries consider vaccine introduction, it will be crucial to improve access to the scientific evidence needed to inform public health decisions.
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 with funding by the Bill & Melinda Gates Foundation.
Related DVI Statements on Sanofi Pasteur’s Dengue Vaccine
- Mexico COFEPRIS regulatory approval of Dengvaxia®
- Efficacy and long-term safety in dengue-endemic regions
- Phase III study in Latin America
- Phase III study in Asia