Asunción, Paraguay. November 22, 2016. Sanofi Pasteur, the vaccines global business unit of Sanofi, announced today that its dengue vaccine, Dengvaxia®, is available in Paraguay for the vaccination of individuals aged 9 to 60 years old.
This year, up to October 22nd, the Surveillance System recorded a total of 2,537 confirmed cases, and 69,857 probable cases of dengue. In the total confirmed and probable cases, a dominance of the age group from 20 to 39 years old is observed.1 Cases of dengue are reported from all countries in the Southern Cone region in 2016, where circulation of all four serotypes has been confirmed.2
The Latin American Society of Pediatric Infectious Diseases (SLIPE) has recently published its support to dengue vaccination.3 Other national medical associations of the Philippines, Indonesia, Brazil and Mexico have also recommended vaccination with Dengvaxia®. These recommendations from leading medical associations provide endorsement of the individual protective value of the vaccine. In addition the World Health Organization’s published its position paper on July 29, 2016, recommending countries with a high burden of the disease to consider the introduction of Dengvaxia® as part of an integrated program for dengue management. These recommendations on dengue vaccination from national, regional and international organizations provide important validation of the efficacy, safety, quality and strong public health value of the vaccine.
“The dengue vaccine has been shown to prevent the negative clinical outcomes of dengue. Two large-scale studies concluded that the vaccine reduces individual risk of severe dengue by up to 93% and prevents 8 out of 10 hospitalizations due to dengue in the indicated age population over 9 years of age over a 25 month follow-up period. Based on this published data, the Paraguay health authorities have chosen to approve the vaccine in 9-60 years of age as an addition to the country’s other dengue prevention efforts.” adds Dr. Cesar Mascareñas, Global Head of Medical Affairs for Dengue, Sanofi Pasteur.
About Sanofi Pasteur Dengue Vaccine
Dengvaxia® dengue vaccine has received 13 marketing approvals to date: Mexico, The Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand, Singapore, Bolivia and Cambodia. 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.
A summary of the efficacy documentation on Dengvaxia® for the study population 9 years and older population was published in The New England Journal of Medicine on July 27th 2015. These findings affirm the vaccine’s consistent efficacy in reducing dengue due to all four serotypes in two-thirds of the study participants 9 years and older and also documents the ability of the vaccine to prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases in this age group during the 25 month follow-up phase of the studies.4
An integrated safety analysis was recently published documenting Dengvaxia®’s satisfactory safety profile comparable to placebo in over 26,000 vaccinated people from 15 countries. In the study population 9 years and older, the results of this analysis documented that the vaccine protected against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination when compared to placebo.5
Sanofi Pasteur’s dengue vaccine is the first vaccine licensed for the prevention of dengue in the world. The vaccine is supplied from a dedicated production site in France.
Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at www.dengue.info
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. 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 produces a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. 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.com.py.
2 Organización Panamericana de la Salud, Número de casos informados de dengue y dengue grave en América, por país: Semana Epidemiológica / EW 18 (actualizado el 13 de mayo de 2016), disponible en http://www.paho.org/hq/index.php?option=com_docman&task=doc_download&Itemid=&gid=34589&lang=en, con acceso el 10/08/2016
4 Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206
5 Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: pooled analysis of data from 18 clinical trials.Gailhardou et al PLoS Negl Trop Dis. 2016 Jul 14;10(7):e0004821. doi: 10.1371/journal.pntd.0004821