Sanofi Pasteur’s Fluzone High-Dose Vaccine Significantly More Effective Than Standard Dose Fluzone Vaccine in Preventing

PR Newswire/Les Echos/ 
Sanofi Pasteur's Fluzone High-Dose Vaccine Significantly More Effective Than
Standard Dose Fluzone Vaccine in Preventing Influenza in Adults 65 Years of Age 
                                 and Older  
 - Efficacy trial in more than 30,000 older adults meets primary endpoint for 
                             superior efficacy -  
Lyon, France - August 26, 2013 - Sanofi Pasteur, the vaccines division of Sanofi
(EURONEXT: SAN and NYSE: SNY), today announced topline results of a large-scale,
multi-center efficacy trial in people 65 years of age and older showing a
superior clinical benefit of Fluzone(r) High-Dose (Influenza Virus Vaccine)
relative to the standard dose of Fluzone vaccine in preventing influenza. 
Today's announcement reflects the positive findings related to the primary
endpoint for the study population. Further data analyses of secondary endpoints
are ongoing, including an evaluation of the relative efficacy based on the match
of the vaccine strains to circulating influenza virus strains. Sanofi Pasteur
anticipates submitting the full clinical study report to the FDA for review by
early 2014 and will seek a modification to the label for Fluzone High-Dose
vaccine reflecting the superior efficacy data in adults 65 years of age and
"We are pleased that this study demonstrates the superior relative efficacy of
Fluzone High-Dose vaccine compared to Fluzone vaccine in preventing influenza in
older adults," said David P. Greenberg, M.D., Vice President, U.S. Scientific
and Medical Affairs, Sanofi Pasteur. "This efficacy trial complements the
previous evidence of superior immune responses for Fluzone High-Dose vaccine
compared to Fluzone vaccine and reaffirms the Phase III safety data in this
population that were the basis for FDA licensure of Fluzone High-Dose vaccine in
In the study, Fluzone High-Dose vaccine was 24.2 percent more effective in
preventing influenza in adults 65 years of age and older than Fluzone vaccine.
The results met the pre-specified primary objective of the study, demonstrating
statistically superior efficacy for Fluzone High-Dose vaccine. Additionally, the
study results suggested consistent clinical benefit across the study years,
influenza virus types, clinical illness definitions, and laboratory methods of
influenza confirmation. This large, multi-year trial also reaffirmed the safety
of Fluzone High-Dose vaccine as demonstrated in previous studies. 
"Influenza vaccines have been shown to offer public health benefits in
preventing influenza and its complications in all age groups; however, older
adults still have the highest rates of influenza-related hospitalization and
death despite having high immunization rates," said John Shiver, Senior Vice
President, Research and Development, Sanofi Pasteur. "This led Sanofi Pasteur to
develop Fluzone High-Dose vaccine, which this trial has confirmed provides
better protection against influenza compared to Fluzone vaccine in people 65
years of age and older."  
Fluzone High-Dose vaccine was licensed in the United States by the Food and Drug
Administration (FDA) in December 2009 based on the vaccine's safety profile and
superior immunogenicity compared to Fluzone vaccine. Immunogenicity (the ability
of a vaccine to trigger the body to produce antibodies against an infectious
agent) is commonly used to evaluate vaccines in clinical trials. Fluzone
High-Dose vaccine contains 60 mcg of hemagglutinin antigen per strain of
influenza virus in the vaccine as compared to 15 mcg of influenza virus
hemagglutinin antigen per strain of influenza virus in standard dose Fluzone
vaccine. Fluzone High-Dose vaccine was licensed by the FDA under an accelerated
approval process to address the medical need in older adults. As a requirement
of the accelerated approval pathway, Sanofi Pasteur embarked on this
large-scale, two-season, confirmatory efficacy trial, involving more than 30,000
participants 65 years of age and older, to evaluate the clinical benefit of
Fluzone High-Dose vaccine compared to Fluzone vaccine in the prevention of
influenza disease.  
About Influenza Disease in People 65+ Years of Age 
Research has shown that the immune system weakens as people age. Older adults
are not only more susceptible to infections, but also less responsive to
vaccination. When infected with the influenza virus, they are less able to mount
an effective immune response to neutralize the attack. Compared to younger
adults, people 65 years of age and older suffer disproportionately from seasonal
influenza disease and its complications, including severe illness leading to
hospitalization and death. Although this group comprises only 15 percent of the
U.S. population, on average it accounts for 65 percent of the estimated 226,000
hospitalizations and 90 percent of the 3,000 to 49,000 deaths attributed to
seasonal influenza and its complications each year. The first baby boomers began
to turn 65 in 2011 and, by the year 2030, the number of adults 65 years of age
and older is anticipated to double and surpass 70 million people, comprising 20
percent of the U.S. population. Thus, better prevention of influenza in older
adults can have a significant impact on public health, quality of life, and
healthcare costs.  
About Fluzone High-Dose Vaccine 
Indication Fluzone High-Dose vaccine is an inactivated influenza virus vaccine
given for active immunization in persons 65 years of age and older against
influenza disease caused by influenza virus subtypes A and type B contained in
the vaccine. Approval of Fluzone High-Dose vaccine is based on superior immune
response relative to Fluzone vaccine. Data demonstrating a decrease in influenza
disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone
vaccine have not yet been reviewed by FDA. 
Safety Information 
The most common side effects to Fluzone High-Dose vaccine include pain,
swelling, and redness at the injection site; fever, headache, fatigue, and
muscle aches. Other side effects may occur. Fluzone High-Dose vaccine should not
be given to anyone with a severe allergic reaction to any vaccine component,
including eggs or egg products, or to a previous dose of any influenza vaccine. 
The decision to give Fluzone or Fluzone High-Dose vaccine should be based on the
potential benefits and risks if Guillain-Barré syndrome has occurred within six
weeks of receipt of a prior influenza vaccine. Vaccination with Fluzone or
Fluzone High-Dose vaccine may not protect all individuals. 
Before administering Fluzone Quadrivalent vaccine or Fluzone vaccine, please see
full Prescribing Information available at or  
About Sanofi 
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of health care with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new 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 the broadest 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: or  
Forward Looking Statements 
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-0- Aug/26/2013 07:04 GMT
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