Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Mexican authorities have granted marketing authorization to Dengvaxia®, making it the first vaccine to be licensed in the world for the prevention of dengue.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults, 9 to 45 years of age living in endemicareas.
“When Sanofi set out to develop a dengue vaccine 20 years ago together with local and global public health and scientific communities, it was with the intention of developing an innovative vaccine to tackle this global public health need,” says Olivier Brandicourt, MD, CEO of Sanofi. “Today, with this first marketing authorization ofDengvaxia®, we have achieved our goal of making dengue the next vaccine-preventable disease. This is a historic milestone for our company, for the global public health community and, most importantly, for half the world’s population who lives at risk of dengue.”
The COFEPRIS approval of Dengvaxia® is based on results from an extensive clinical development program involving over 40,000 people of different ages, geographic and epidemiological settings, and ethnic and socio-economic backgrounds living in 15 countries. Dengue-endemic regions of Mexico participated in all three phases of the clinical development program for the vaccine.
“Dengue is a growing health threat in Mexico and many other tropical and subtropical countries in Latin America and Asia. The first vaccine approved to prevent dengue fever is a major innovation and a public health breakthrough. Dengvaxia® will be a critical addition to the integrated dengue prevention and control efforts. It will be an essential tool to boost on-going community efforts to relieve the long-standing suffering that this disease continues to bring to people in endemic countries like ours,” says José Luis Arredondo García, associate director of clinical research in the National Institute of Pediatrics.*
Regulatory review processes for Dengvaxia® are continuing in other endemic countries. Manufacturing of Dengvaxia® has already started at vaccine facilities in France and first doses are already produced. Sanofi Pasteur remains committed to introducing Dengvaxia® first in countries where dengue is a major public health priority.
The World Health Organization (WHO) has called for development of a dengue vaccine as an essential part of the integrated dengue prevention effort needed to significantly lower the dengue burden globally. The WHO has called on endemic countries to reduce dengue mortality by 50 percent and morbidity by 25 percent by 2020. Disease impact modelling results indicate if you vaccinate 20% of the population in the 10 endemic countries that participated in the Phase III efficacy studies for Dengvaxia, in the ages 9 and above indication, you could potentially reduce your dengue burden by 50 percent in five years. Such a significant disease reduction in this large at-risk population would result in a smaller pool of infected individuals in a given country and, therefore, fewer mosquitoes capable of transmitting the disease, potentially leading to an overall lowering of transmission risk for all.
*Pediatrician specialized in infectious diseases and coordinator of the Medical Science Master and PHD programs in the UNAM (National Autonomous University of Mexico), campus National Institute of Pediatrics.
According to the WHO, dengue is the fastest growing mosquito-borne disease in the world today, causing nearly 400 million infections every year.2 Factors such as increased urbanization, mobility of populations and climate changes that increase the range of the dengue mosquito vector have created a perfect storm for dengue expansion. In the last 50 years dengue has spread from being present in a handful of countries to being endemic in 128 countries, where about 4 billion people live, and dengue incidence has likewise increased 30-fold in this time period.
The mosquito that transmits dengue feeds mainly at dawn and dusk and can breed in very small amounts of standing water, making it a formidable foe for public-health workers and endemic community residents alike. Dengue is a painful disease that is also known as ‘break bone’ fever due to the terrible bone and joint pain it causes. In addition to this human suffering, dengue also has the ability to break the back of local healthcare systems during outbreaks. Globally, dengue is estimated to cost $9 billion annually in direct and indirect costs.
Although dengue affects people from all ages and walks of life, the greatest number of dengue cases worldwide occurs in the highly mobile and social segment of the population that includes preadolescent to adult ages.
Sanofi Pasteur’s vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine. Dengvaxia® successfully completed phase III clinical studies in 2014 to evaluate the primary objective of vaccine efficacy.
Long-term follow-up studies of the vaccine, recommended by WHO for all dengue vaccines in development, are currently ongoing. Additional pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were recently published in The New England Journal of Medicine reconfirming the vaccine’s consistent efficacy and longer-term safety profile in populations 9 years of age and older. In a pooled efficacy analysis in volunteers aged 9-16 who participated in the two Phase III 25-month efficacy studies, Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants. Furthermore, this pooled efficacy analysis showed that Dengvaxia® prevented 9 out of 10 cases of severe dengue and 8 out 10 hospitalizations due to dengue in this age group.
Dengvaxia® is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced and full scale production capacity will be reaching 100 million vaccine doses annually.
Source: Sanofi Pasteur