Jakarta, Indonesia – 13 September, 2016 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that Indonesia’s National Agency for Drug and Food Control has approved Sanofi Pasteur’s tetravalent dengue vaccine, to protect individuals living in endemic areas against all four serotypes of dengue.
The approval in Indonesia is the second registration of the dengue vaccine in Asia, and the seventh in the world. Sanofi Pasteur’s dengue vaccine has already been approved in Mexico, Brazil, El Salvador, Costa Rica, the Philippines and Paraguay.
“We welcome the timely approval of the dengue vaccine in Indonesia,” said Professor Dr. Sri Rezeki S. Hadinegoro, Chairman of ITAGI (Indonesian Technical Advisory Group on Immunization), “The dengue disease is hyper-endemic in our country and already in April 2016, more than 80,000 dengue cases were recorded which is a 39%ii spike vis-à-vis levels in 2015. Indonesia has one of the world’s highest dengue burden costing us more than USD323 million annually,iii and approval of the dengue vaccine gives us access to this innovative prevention tool to curb further spread of this debilitating disease and strengthen Indonesia’s dengue control strategy for the future.”
The WHO published its position paper on dengue vaccine use on 29 July 2016 in which it recommended endemic countries to consider the introduction of Sanofi Pasteur’s dengue vaccine as part of integrated disease prevention including vector control and community mobilization.iv The WHO has set the objectives of reducing mortality by dengue by 50% and morbidity by 25% by 2020 in the endemic countries.v
“Dengue represents a growing and serious public health issue in many parts of Asia with significant associated human and economic burden,” according to Dr. Anh Wartel, Medical Affairs, Sanofi Pasteur Asia & Japan Pacific. “This latest approval in Indonesia, the second in Asia, is testament to the speed which we are moving to make dengue a vaccine-preventable disease in countries where the disease burden is the highest. This is important as 70% of the world’s population at risk of dengue lives in Asia, and healthcare providers in Indonesia now have access to the first clinical preventive tool which allows them to better protect their people against this public health threat.”
Severe dengue, or dengue haemorrhagic fever, was first recognized in Indonesia in the cities of Jakarta and Surabaya in 1968. Between 2004 and 2010, Indonesia reported the second highest number of dengue cases in the world behind Brazil according to the World Health Organization, with an average of 129,000 cases per year.vi Nevertheless, dengue reporting in the country is acknowledged to be incomplete and the efficacy of reporting procedures varies widely among the provinces. A 2013 cartographical modelling study estimated that as many as 7.6 million dengue infections may have occurred in the country in 2010 with the vast majority going unreported.vii In 2015, the number of reported cases rose to just over 100,000 and 907 deaths were attributed to dengue.viii
The global burden of dengue
According to the WHO, dengue is currently the fastest-growing mosquito-transmitted disease in the world, causing around 400 million infections every year. Over the last 50 years, dengue has spread; initially present in a handful of countries, it is now endemic in 128, inhabited by around 4 billion people. Also, the incidence of this disease has increased 30 times in this same period.ix
Even though dengue affects people of all ages and lifestyles, the greatest number of dengue cases worldwide occurs in individuals 9 years of age and older, who represent a highly mobile and social segment of the community capable of contributing significantly to spread of the disease.xxi
About Sanofi Pasteur’s dengue vaccine
In addition to Indonesia, Sanofi Pasteur Dengue Vaccine is also registered in Mexico, Brazil, El Salvador, Costa Rica, The Philippines and Paraguay to date. Regulatory review processes for Dengue Vaccine are continuing in other countries where dengue is a public health priority.
Sanofi Pasteur’s dengue vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in over 15 countries around the world. More than 40,000 volunteers participated in the dengue vaccine clinical study program (phase I, II and III), of whom 29,000 volunteers received the vaccine.xii
A summary of the efficacy documentation on Dengvaxia® for the study population 9 years and older population was published in The New England Journal of Medicine on July 27th 2015. These findings affirm the vaccine’s consistent efficacy in reducing dengue due to all four serotypes in two thirds of the study participants 9 years and older and also documents the ability of the vaccine to prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases in this age group during the 25 month follow-up phase of the studies.xiii
An integrated safety analysis was recently published documenting Dengvaxia®’s satisfactory safety profile comparable to placebo during the late stage clinical study program involving around 30,000 participants from 15 countries. In addition, the results of this analysis documented that the vaccine provided beneficial protection against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination compared to placebo in the study population 9 years and older.xiv
Sanofi Pasteur Dengue Vaccine is the first vaccine licensed for the prevention of dengue in the world. The vaccine is supplied from a dedicated production site in France.
Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at www.dengue.info.