New England Journal of Medicine Publishes New Analyses Confirming that Sanofi Pasteur's Vaccine Candidate Safely Protects Pre-Adolescents to Adults Against Dengue
(Thomson Reuters ONE) -
New England Journal of Medicine Publishes New Analyses Confirming that Sanofi
Pasteur's Vaccine Candidate Safely Protects
Pre-Adolescents to Adults Against Dengue
- The highest burden of dengue disease globally in endemic countries is in pre-
adolescent to adults age group[1],[2],[3] -
* In a new pooled analysis, dengue vaccine candidate protected two out of
three volunteers aged 9 years and older against all four dengue
serotypes
* Protection against severe dengue reached 93% and prevention of
hospitalizations due to dengue 80% in this age group
- Based on this clinical profile in 9 years of age and older, the dengue vaccine
candidate has the potential to significantly reduce disease burden in endemic
countries -
Lyon, France, - July 27, 2015 - Sanofi Pasteur, the vaccines division of Sanofi,
announced today that new data analyses published in the New England Journal of
Medicine (NEJM) provide a comprehensive picture of the potential public health
impact of vaccinating endemic populations from pre-adolescence to adulthood
against dengue. Not only is this the largest population at risk of dengue
globally, but individuals 9 years of age and older also represent a highly
mobile group capable of spreading disease more broadly during outbreaks and also
contributing substantially to the economic burden of dengue, for example in
number of lost school and work days due to the disease.
The NEJM article reported results from a new pooled efficacy analysis of
individuals 9 years of age and older at vaccination from the two Phase III
studies of Sanofi Pasteur's dengue vaccine. The new analysis documented that the
vaccine protects two-thirds of these individuals (66%) against dengue, providing
even greater protection against two clinically-relevant manifestations of
dengue, namely severe dengue (93%) and prevention of hospitalizations due to
dengue (80%) that account for the greatest human and economic burden of dengue
in endemic countries. In addition, the dengue vaccine candidate protected
volunteers 9 years of age and older who were previously exposed to dengue (82%),
as well as those who were naïve to dengue (52.5%) prior to vaccination.
The clinical development program for the vaccine candidate includes studies with
four-year, long-term follow-up phases, in line with WHO guidelines for dengue
vaccine development. Results from first 25 months of the two Phase III efficacy
studies were published in 2014.[4],[5] Interim data from the third year of these
studies and interim data from the third and fourth years of the Phase II
extension study in Thailand published in the new NEJM article confirm the
continuing reduction of hospitalized dengue in the vaccinated population 9 years
of age and older.
The third-year interim data from the Asian Phase III study identified the need
for further long-term surveillance in children under 9 years of age to assess
the impact of the dengue vaccine candidate in these younger children.
"It is not unusual to require additional data on a new vaccine to determine its
value in a specific age group, particularly young children, whose immune
response to the vaccine and the disease itself may differ significantly from
that of older children and adults," notes Professor Tim Endy, MD., MPH, Upstate
University Hospital, New York. "It is reassuring to have confirmation of the
safe protection that this vaccine offers against dengue in the endemic
preadolescent to adult population, particularly coupled with its consistent
efficacy and safety profile reported last year from the PIII studies across
diverse geographic regions, ethnic study populations and dengue epidemiology
covered."
Dr. Maria Rosario Capeding from the Research Institute for Tropical Medicine in
the Philippines, who is a lead author on the NEJM article, points out the
potential public health benefit of having a first dengue vaccine available to
protect individuals 9 years of age and older. "This large, at-risk population
includes the most dynamic members of the community who have the potential to
spread disease widely and also contribute most to dengue's heavy societal impact
in terms of school absences and lost work productivity. Certainly, individuals
9 years of age and older represent a compelling target group for an immunization
program against dengue aimed at significantly reducing overall disease burden."
Dengue is the world's fastest growing vector-borne disease, endemic in over 100
countries where almost half the world's population resides. Dengue poses
considerable economic and human burden in these endemic countries as it is prone
to unpredictable outbreaks and spreads readily in densely populated urban areas,
often paralyzing local healthcare systems and requiring cost-intensive
intervention efforts. Today, no specific treatment or prevention for dengue is
available.
The WHO has set objectives to reduce mortality due to dengue by 50% and
morbidity by 25% by 2020. Introduction of an effective and safe dengue vaccine
as an integral part of dengue prevention efforts will be critical to achieving
this goal.
Based on the totality of the safety and efficacy data for its dengue vaccine
candidate, Sanofi Pasteur has decided to recommend a targeted age indication for
the vaccine of 9 years of age and older in endemic countries, where the
combination of disease burden and the vaccine's proven impact profile in this
age group point to the greatest potential for reduction of dengue disease burden
in these countries.
[1] L'Azou M, Moureau A, Sarti E, et al. Incidence of symptomatic pediatric
dengue in ten Asian and Latin American countries. . N Engl J Med 2015;
Manuscript resubmitted.
[2] L'Azou M, Taurel AF, Flamand C, Quenel P. Recent epidemiological trends of
dengue in the French territories of the Americas (2000-2012): a systematic
literature review. PLoS Negl Trop Dis 2014;8:e3235.
[3] 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.
[4 ]Capeding M.R. et.al, Clinical efficacy and safety of a novel tetravalent
dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-
masked, placebo-controlled trial ; Volume 384, Issue 9951, 11-17 October 2014,
Pages 1358-1365
[5] Villar L, Dayan GH, Arredondo-Garcia JL, Rivera DM, Cunha R, Deseda C et
al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N
Engl J Med. 2015
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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www.sanofipasteur.com
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Datum: 27.07.2015 - 18:01 Uhr
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