First Vaccinations against Dengue Mark Historic Moment in Prevention of Infectious Diseases

February 22, 2016

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- Dengvaxia®, the first vaccine approved for the prevention of Dengue, is now being administered by healthcare providers in the Philippines -


Lyon, France - February 22, 2016 - Sanofi Pasteur, the vaccines division of Sanofi, announced today that vaccinations with Dengvaxia® have commenced in the Philippines following official receipt of the first shipment of the vaccine earlier this month.

Dengvaxia®, a tetravalent dengue vaccine, was approved in the Philippines on 22 December 2015 for the prevention of disease caused by all four Dengue types in individuals from 9-45 years of age living in endemic areas. The vaccine is administered in three doses given over a one-year period.

Asia bears 70% of dengue fever burden globally with an estimated 67 million people being sickened by the disease annually. In the Philippines alone, over 110,000 people on average get Dengue every year.  Asian endemic countries spend an estimated 6.5 billion USD annually in both direct medical and indirect costs due to Dengue.

This is truly a great moment in the history of vaccinology,” states Guillaume Leroy, Vice-President of Dengue Vaccine, Sanofi Pasteur. “Dengvaxia®’s availability for administration by healthcare providers in the Philippines, to be followed closely by the initiation of a public sector immunization program in the country is a landmark event for global Dengue prevention and a great achievement for the people of the Philippines.”

Medical Societies in the Philippines held a media event in Manila earlier this month to welcome receipt of the first shipment of Dengvaxia® to the country. In attendance, Dr. Rose Capeding, chief of the Research Institute for Tropical Medicine’s department of microbiology, noted that the Philippines participated in all three phases of the clinical development of the vaccine and that healthcare providers there were delighted to be able to begin vaccinating against dengue, which continues to pose a major public health threat to the nation.
(http://www.gmanetwork.com/news/story/554826/scitech/science/dengue-vaccine-rolls-out-nationwide-in-phl)

Dengue is a growing public health threat in tropical and subtropical countries in Asia and Latin America. Mainly an urban disease found in over 120 countries where half the world’s population live, Dengue typically hits in the form of unpredictable outbreaks capable of paralyzing health care systems and disrupting social and economic activity in these city centers. Sanofi Pasteur is introducing Dengvaxia® first in endemic countries like the Philippines where the vaccine has the greatest potential to reduce dengue burden globally and help these countries to achieve the World Health Organization’s goal to reduce dengue mortality by 50% and morbidity by 25% by 2020 in endemic countries.

Dengvaxia® is also currently approved in Mexico, Brazil and El Salvador, which according to the Pan American Health Organization, collectively bear about 83% of the dengue burden in the Americas.

About Dengvaxia®
In addition to the Philippines, Dengvaxia® is also registered in Mexico, Brazil and El Salvador to date.  Regulatory review processes for Dengvaxia® are continuing in other countries where dengue is a public health priority.

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.

Pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were published in The New England Journal of Medicine on July 27th 2015, affirming the vaccine’s consistent efficacy and longer-term safety profile in study population 9-16 years of age. In the pooled efficacy analysis in this age group, Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases. 

Dengvaxia® is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced at the dedicated production site in France with planned full-scale production capacity of 100 million vaccine doses annually. Official receipt of the shipment of Dengvaxia® in the Philippines was announced earlier this month.

Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at 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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Contacts:

Global Media Relations
Alain Bernal
T. +33-4-37-37-50-38
alain.bernal@sanofipasteur.com
www.sanofipasteur.com


Investor Relations
Sébastien Martel
T. + 33 1 53 77 45 45
ir@sanofi.com


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