Dengvaxia® Approved in El Salvador
- El Salvador becomes fourth country in two months to approve the world’s first vaccine for Dengue - 

Lyon, France – February 5, 2016 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that El Salvador has granted regulatory approval to Dengvaxia®, representing the fourth successful licensure of the dengue vaccine in two months. Dengvaxia® was approved in Mexico, the Philippines and Brazil in December of last year.        

The regulatory authorities in El Salvador approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas.

Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the study participants 9 years and older and to prevent 8 out of 10 hospitalizations due to dengue and up to 93% of severe dengue cases in this age group.1

“Approval of the much-needed Dengue vaccine is welcome news for our country,” said Dr. Lourdes Dueñas de Chicas, Infectious Disease Specialist at the Hospital del Niño Benjamín Bloom in El Salvador and President of the Infectious Disease Association from El Salvador “Our dengue burden has grown every year for the last decade. Severe cases have increased as well as hospitalizations, which cause serious public health problems. Access to this vaccine is essential to boost and strengthen our other dengue prevention efforts in El Salvador and bring down our disease burden here. We believe that this approval has been timely and precise.”

“This latest approval of Dengvaxia® in El Salvador shows the speed with which we are moving to make dengue a vaccine-preventable disease in countries where the disease burden is the highest,” says Dr. Cesar Mascareñas, Head of Global Medical Affairs, Sanofi Pasteur. “This is great news for the people of El Salvador and it is great news for the value of this new public health approach to bring an innovative vaccine first to people living with the highest disease risk where the vaccine can, in fact, have the greatest impact.”

The annual incidence of reported dengue in El Salvador has ranged between 90/100,000 (2008) and 845/100,000 (2014) in the past 10 years.2 All four types of dengue are found in the country and dengue incidence increased precipitously in the last two reporting years, reaching 49,396 reported cases in 2015.3,4

Up to 60% of dengue cases in El Salvador are reported in individuals over 9 years of age, a highly mobile and socially-active segment of the population who contributes to the spread of the disease within communities and across regions.5

The Pan American Health Organization (PAHO) reported 2,317,354 cases of dengue in the Americas in 2015; 1,917,997 or almost 83% of the total reported cases occurred in the countries where the Dengue vaccine is currently approved: Brazil, Mexico and El Salvador.6

Dengue disease burden globally

According to the WHO, dengue is the fastest growing mosquito-borne disease in the world today, causing nearly 400 million infections every year.7 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. 8,9

Although dengue affects people from all ages and socio-economic backgrounds, the greatest number of dengue cases worldwide occurs in the highly mobile and social segment of endemic populations that include preadolescents to adult ages of 9 years and older.10


About Dengvaxia®

In addition to El Salvador, Dengvaxia® is also registered in Mexico, The Philippines and Brazil 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.11

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.

Additional information about Sanofi Pasteur’s dengue vaccine is available on the web atwww.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.


Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.



1 Hadinegoro, Sri Rezeki S., et al. Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease Integrated Analysis of Efficacy and Interim Long-Term Safety Data for a Dengue Vaccine in Endemic Regions. July 27, 2015DOI: 10.1056/NEJMoa1506223.

2 PAHO, available at http://www.paho.org/hq/index.php?option=com_topics&view=readall&cid=3273...

3 (Ministry of Health, available athttp://www.salud.gob.sv/archivos/vigi_epide2015/edad_consolidado522015.pdf

http://www.paho.org/hq/index.php?option=com_topics&view=rdmore&cid=6290&...

5 Ibid.

http://www.paho.org/hq/index.php?option=com_topics&view=rdmore&cid=6290&...

http://www.who.int/mediacentre/factsheets/fs117/en/

8 Ibid.

http://www.who.int/csr/disease/dengue/impact/en/

10 Joseph R. Egger, Paul G. Coleman. Age and Clinical Dengue Illness. Emerg Infect Dis. 2007 June; 13(6): 924–927.

San Martin JL, Brathwaite O, Zambrano B, et al. The epidemiology of dengue in the americas over the last three decades: a worrisome reality. Am J Trop Med Hyg 2010;82:128-35.

11 Hadinegoro, Sri Rezeki S., et al. Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease Integrated Analysis of Efficacy and Interim Long-Term Safety Data for a Dengue Vaccine in Endemic Regions. July 27, 2015DOI: 10.1056/NEJMoa1506223.