Dengvaxia, World’s First Dengue Vaccine, Approved in Mexico

Dengvaxia, World’s First Dengue Vaccine, Approved in Mexico
December 9, 2015
– First marketing authorization of Dengvaxia® is a historic milestone paving the way to significantly impact dengue burden in endemic countries –

Lyon, France – December 9, 2015 – 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,” said Olivier Brandicourt, MD, Chief Executive Officer, Sanofi. “Today, with this first marketing authorization of Dengvaxia®, 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,” asserts 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% and morbidity by 25% 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% in five years.1 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…

About Sanofi Pasteur’s dengue vaccine
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.7, 8

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.9
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.
Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at http://www.dengue.info

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Statement by the Dengue Vaccine Initiative on Mexico’s Regulatory Approval of Sanofi Pasteur’s Dengue Vaccine, Dengvaxia
Cross-posted by Sabin Vaccine Institute and International Vaccine Access Center
On December 9 2015, 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 virus causes 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.

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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.