Dengvaxia® First Dengue Vaccine Approved in Brazil
(Thomson Reuters ONE) -
Dengvaxia(®) First Dengue Vaccine Approved in Brazil
- Global introduction of the first Dengue Vaccine gains further momentum with
this third approval in a row in an endemic country -
- With 1.4 million dengue cases reported this year, Brazil stands to gain
tremendous value from this new dengue prevention
tool -
Lyon, France - December 28, 2015 - Sanofi Pasteur, the vaccines division of
Sanofi, announced today that Brazil has granted regulatory approval to
Dengvaxia(®), representing the third successful licensure of the dengue vaccine,
which was also approved in Mexico and the Philippines earlier this month.
The Brazilian regulatory authorities ANVISA 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.
Dengue continues to hit hard in Brazil with over 1.4 million Brazilians directly
affected by the disease during this year's outbreak season alone. Up to 70% of
dengue cases in Brazil are reported in individuals 9 years and older, a highly
mobile and socially active segment of the population who contributes to the
spread of the disease within communities.
Dengvaxia(® )was shown to reduce dengue due to all four serotypes in two-thirds
of the participants and prevent 8 out of 10 hospitalizations due to dengue and
up to 93% of severe dengue cases.[1]
"This new Approval of Dengvaxia(® )by the ANVISA, a well-recognized and World
Health Organization (WHO) certified regulatory authority is an important
milestone for Sanofi Pasteur," says Guillaume Leroy, Vice President of Dengue
Vaccine, Sanofi Pasteur. "Dengvaxia(®) has the potential to significantly reduce
the dengue disease burden and to help Brazil reach the WHO's 2020 dengue
reduction objectives."
Approval of the first dengue vaccine is an important public health breakthrough
with critical importance to our country, which bears the greatest dengue burden
in Latin America," says Joao Bosco Siqueira Junior of the Department of
Community Health, Institute of Tropical Pathology and Public Health, Federal
University of Goias, Goiania, Brazil. "The 2015 dengue outbreak is still very
present in the minds of Brazilians so Dengvaxia's approval is a most welcome
addition to our ongoing dengue prevention efforts."
Dengue is a major public health priority in tropical and subtropical countries
in Latin America and Asia. Sanofi Pasteur is introducing Dengvaxia(®) first in
these countries where the vaccine has the greatest potential to reduce dengue
burden globally and help to achieve the WHO's goal to reduce dengue mortality by
50% and morbidity by 25% by 2020 in endemic countries. Sanofi Pasteur enrolled
over 40,000 participants in extensive safety and clinical efficacy studies
conducted mainly in endemic countries and built a dedicated vaccine production
facility in France to secure adequate quality and quantity supply of the vaccine
to meet endemic country demand upon introduction.
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.[2] 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]
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.[5]
Dengue disease burden in Brazil
This year, over 1.4 million Brazilian citizens were reportedly sickened by the
virus.[6] On top of this considerable human suffering, the cost of dengue is
substantial in terms of direct medical costs, as well as indirect losses such as
lowered work productivity. Estimated spending on dengue disease for Brazil is
$1.2 billion USD every year; an average of $448 USD per hospitalized case and
$173 USD per ambulatory case[7].
About Dengvaxia(®)
Besides Brazil, Dengvaxia(®) is also registered in Mexico and in The
Philippines. 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.
Brazil participated in a global phase III efficacy studies including more than
30,000 volunteers from 10 different countries which was successfully completed
in 2014.
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 27(th) 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.[8]
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 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:
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Alain Bernal Eleonora Leone
T. +33-4-37-37-50-38 T. +52 55 39 93 48 47
alain.bernal(at)sanofipasteur.com eleonora.leone(at)sanofipasteur.com
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Sébastien Martel
T. + 33 1 53 77 45 45
ir(at)sanofi.com
--------------------------------------------------------------------------------
[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] http://www.who.int/mediacentre/factsheets/fs117/en/
[3] Ibid.
[4] http://www.who.int/csr/disease/dengue/impact/en/
[5] 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.
[6] Secretaria de Vigilância em Saúde - Ministério da Saúde. Epidemiological
Bulletin - Volume 46 - No. 24-2015 - Monitoring of cases of dengue fever and
chikungunya. Epidemiological Week 36, 2015. Available at:
http://portalsaude.saude.gov.br/images/pdf/2015/outubro/15/svsbe-denchikzik-v46-
n31.pdf. Accessed 21 October 2015.
[7] Martelli CM, et al. Economic Impact of Dengue: Multicenter Study across
Four Brazilian Regions. PLoS Negl Trop Dis. 2015 Sep 24;9(9):e0004042. doi:
10.1371/journal.pntd.0004042.
[8] 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.
Press release :
http://hugin.info/152918/R/1975899/723110.PDF
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Datum: 28.12.2015 - 11:31 Uhr
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