Sanofi: Dengue Immunization Public Program in Paraná State of Brazil Set To Achieve WHO 2020 Ambition
(Thomson Reuters ONE) -
Dengue Immunization Public Program in Paraná State of Brazil Set To Achieve WHO
2020 Ambition
- First dengue immunization public program in the Americas starts today
targeting broad age range of individuals at highest risk of disease consistent
with recent WHO position
- Paraná state will lead Dengue prevention in Brazil launching benchmark public
program to immunize 500,000 individuals with Dengvaxia(®) dengue vaccine over
next three weeks -
Paris, France - August 13th, 2016 - Sanofi and its vaccines global business unit
Sanofi Pasteur announced that 500,000 doses of Dengvaxia(®) have been received
in Paraná to support a large-scale public dengue immunization program initiated
today in the State's 30 most highly endemic municipalities.
Paraná State, home to 10 million people, has seen a steep 3-fold increase in
both dengue incidence and deaths in recent years. In the last year, there have
been 55,000 cases reported, costing the State an estimated R$ 330 million (~91 M
Euro) in related healthcare expenses.
"For the public immunization program being launched today, we have used our
extensive dengue surveillance data to ensure that we are targeting people at
highest risk of disease. We will vaccinate all individuals 15-27 years of age in
28 municipalities and 9-44 years of age in the two municipalities with the top
dengue burden in our State over the next three weeks," said Michele Caputo Neto,
Paraná Health Secretary.
"Paraná has a good track record in vaccination coverage in general and
successful implementation of this dengue immunization strategy could result in
74% reduction in disease burden in these highly impacted municipalities within
5 years, according to a dengue vaccine impact study published in the Brazilian
Journal of Health Economics[1]," Secretary Neto noted.
Dr. Stephen J. Thomas, a physician-scientist at the Walter Reed Army Institute
of Research in Silver Spring, Maryland who is an international dengue expert
commented on the public immunization program initiated by Paraná State today.
"Dengue remains one of the world's most important mosquito transmitted diseases
causing significant human suffering and financial cost. The strategic deployment
of a safe and effective dengue vaccine offers the best hope of reducing dengue's
burden, especially in highly endemic countries like Brazil."
Dengvaxia's safety and efficacy have been documented in a large clinical study
program involving more than 40,000 people in studies conducted in 15 countries
around the world including Brazil which participated in both phases II and III
of the clinical development of the vaccine. The safety, efficacy and public
health value of the dengue vaccine has been independently endorsed by the World
Health Organization (WHO) in position paper on Dengvaxia published on 29(th)
July 2016 [2], which is consistent with the earlier positive recommendation on
the dengue vaccine issued by the WHO's Strategic Advisory Group of Experts on
Immunization last April.
Guillaume Leroy, of Sanofi Pasteur, added "Introduction of the dengue vaccine
first in endemic countries like Brazil has always been Sanofi Pasteur's priority
because this is where the vaccine can have the greatest impact on disease burden
globally. Furthermore, successful implementation of Dengvaxia in a large-scale
public program in Paraná will serve as a benchmark for dengue prevention efforts
elsewhere in the country and in the world."
Sanofi Pasteur will continue to address all supply demands coming from all
clinics in Brazil, both public and private, as well as any additional requests
from other countries supported by company's ample dengue vaccine supply capacity
from its production facility in France.
About Sanofi Pasteur commitment to public health in Brazil
Sanofi Pasteur is a leading vaccine provider in Brazil and a committed and
longtime partner for public health in the country. Going back to 1974 the
company produced and delivered 90 million doses of meningitis vaccine in record
time to respond to an outbreak in Brazil. Sanofi Pasteur has partnered with the
Butantan Institute in Brazil since 1999 to deliver seasonal influenza vaccines
to the Brazilian population. In 2009 this partnership was instrumental in
providing the pandemic A/H1N1 flu vaccine to the Brazilian government. In 2008,
Sanofi Pasteur responded to a yellow fever outbreak in Brazil by delivering four
million doses of yellow fever vaccine at the request of local health authorities
and United Nation agencies. Since 2011, Brazilian infants have been receiving
inactivated poliomyelitis vaccine provided via an agreement between Sanofi
Pasteur and FIOCRUZ/ Biomanguinhos.
About Sanofi Pasteur Dengue Vaccine
In addition to Brazil, Sanofi Pasteur Dengue Vaccine is also registered in
Mexico, Philippines, El Salvador and Costa Rica to date. Regulatory review
processes for Dengue Vaccine 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 27(th) 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.[3]
An integrated safety analysis was recently documenting Dengvaxia's satisfactory
safety profile comparable to placebo during the late stage clinical study
program involving around 30,000 participants from 15 countries. In addition, the
results of this analysis documented that the vaccine provided beneficial
protection against hospitalization due to dengue and severe dengue for up to 4
years post dose 1 of vaccination compared to placebo in the study population 9
years and older.[4]
Sanofi Pasteur 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.
About Sanofi
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
Sanofi Forward-Looking Statements
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Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
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--------------------------------------------------------------------------------
Contacts:
Global Media Relations Investor Relations
Jack Cox George Grofik
Tel: +33 (0)1 53 77 46 46 Tel: +33 (0)1 53 77 45 45
mr(at)sanofi.com ir(at)sanofi.com
Global Sanofi Pasteur Communications Brazil Media Relations
Alain Bernal Juliane Zaché
Tel: +33 (0)4 37 37 50 38 Tel: +55 11 99 4035095
alain.bernal(at)sanofipasteur.com Juliane.zache(at)sanofi-pasteur.com
www.sanofipasteur.com www.sanofipasteur.com.br
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[1] Denizar V A, et al. Jornal Brasileiro de Economia da Saúde Brazilian Journal
of Health Economics ABRIL 2016, VOLUME 8, NÚMERO 1 | APRIL 2016, VOLUME 8,
NUMBER 1
[2] (http://www.who.int/wer/2016/wer9130.pdf?ua=1)
[3] Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206
[4] 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
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Datum: 13.08.2016 - 13:00 Uhr
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