DENGVAXIA, WORLDS 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 o
f
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 worlds 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 Jos Luis Arredondo Garca, 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.
*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.
Dengue disease burden
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. 3,4
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 USD annually in direct and indirect costs. 5
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.6
About Sanofi Pasteur's dengue vaccine
Sanofi Pasteurs 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 vaccines 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 Pasteurs dengue vaccine is available on the web
at http://www.dengue.info

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on
patients needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs,
consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each
year, making it possible to immunize more than 500 million people across the globe. A world leader in
the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious
diseases. The company's heritage, to create vaccines that protect life, dates back more than a century.
Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests
more than EUR 1 million in research and development. For more information, please
visit:www.sanofipasteur.com or www.sanofipasteur.us
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