– Dengvaxia® introduced in private immunization clinics throughout the country –
– In the past 15 years dengue cases in Peru have been increasing more than 3 times, 2011 and 2015 dengue outbreaks reached up to 40.000 annual cases1 –
Lima, Peru – November 21, 2016- Sanofi Pasteur, the vaccines global business unit of Sanofi, announced today that the Dengvaxia® dengue vaccine is now available in private healthcare clinics of Peru for vaccination of individuals from 9 to 45 years of age.
From 2010 to 2015, Peru presented an average incidence of dengue cases of 85 per 100,000 inhabitants and reached 129 per 100,000 inhabitants in outbreak years in 2011 and in 2015 with up to 40,000 people sickened by dengue. For hiperendemic regions such as Piura, in the past 4 years the average incidence was 362 per 100.000 inhabitants and in 2015, in an outbreak period the average incidence was 1,115 per 100,000 inhabitants.2
“Having the dengue vaccine available in our country is an historical moment given the epidemiological situation in regions such as Piura, Amazones and Tumbes and the need for new alternatives to dengue prevention that support the Integrated Management Strategy (IMS)”, affirmed Dr. Ciro Manguiña, Infectious Diseases Expert and Vice Dean of the Medical School of Peru. “The impact of vector control efforts on dengue burden in Peru has been limited, so having access to this new prevention tool against dengue is an important addition to our fight against this growing disease burden.”
Peru is an endemic country, specially with high incidence in 3 Northern regions: Piura, Lambayeque and Tumbes; and 5 Eastern regions, Amazonas, Loreto, Madre de Dios, Ucayali and La Libertad. The burden of the disease in Peru is considered high in most regions of the country. Moreover, 176 fatal dengue cases were registered in the past 5 years. From 2010 to 2015, all serotypes were cocirculating (Denv-1, Denv-2, Denv-3, Denv 4).3
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 vaccines 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.us
1 Centro Nacional de Epidemiología, prevención y control de enfermedades Minsa. SE 18 de 2016
2 Centro Nacional de Epidemiología, prevención y control de enfermedades Minsa. SE 18 de 2016
3 Equipo de vigilancia en salud pública. Situación del dengue en el Perú, 2016 (a la SE 30); 25 (30): 644 – 646.
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