PR Newswire/Les Echos/
Sanofi Pasteur Press Release
FDA Licenses New Influenza Vaccine Designed Specifically for People 65 Years of
Age and Older
- Fluzone(r) High-Dose (Influenza Virus Vaccine) strengthens immune response in
the 65+ population, an age group that suffers disproportionately from influenza
and its complications -
Lyon, France and Swiftwater, Pa - December 23, 2009 - Sanofi Pasteur, the
vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY),
announced today that the U.S. Food and Drug Administration (FDA) has approved
the company's supplemental biologics license application (sBLA) for licensure of
Fluzone(r) High-Dose (Influenza Virus Vaccine). The new vaccine, for adults 65
years of age and older, will be available to health-care providers for
immunizations administered this fall in preparation for the upcoming 2010-2011
influenza season.
"This new addition to Sanofi Pasteur's vaccine portfolio reflects our
long-standing commitment to public health and to research and development of new
vaccines for enhanced prevention of influenza," said Wayne Pisano, President and
Chief Executive Officer of Sanofi Pasteur. "In 2011 the first baby boomers will
turn 65 and, by the year 2030, the number of adults over age 65 is anticipated
to double and surpass 70 million people, or 20 percent of the U.S. population.
We are excited to introduce Fluzone High-Dose vaccine which will provide
health-care pro fessionals with a new vaccine to help prevent influenza in their
patients over the age of 65."
Fluzone High-Dose vaccine was specifically designed to generate a more robust
immune response in people 65 years of age and older. This age group typically
does not respond as well to the standard dose of influenza virus vaccines as
younger individuals because they have weakened immune systems.
About Influenza Disease in People 65+ Years of Age
Influenza vaccines have been shown to offer public health benefits in reducing
influenza-related morbidity and mortality in older adults. However, as people
age, research has shown that the immune system weakens. 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 and its
complications, including severe illness leading to hospitalization and
death.Although this group comprises only 15 percent of the U.S. population, it
accounts for 65 percent of the estimated 226,000 hospitalizations and 90 percent
of the 36,000 deaths attributed to seasonal influenza and its complications on
average each year.
About Fluzone High-Dose Vaccine
Fluzone High-Dose vaccine is an inactivated influenza virus vaccine indicated
for active immunization of people 65 years of age and older against influenza
disease caused by influenza virus subtypes A and type B contained in the
vaccine.
This indication is based on the immune response elicited by Fluzone High-Dose
vaccine and there have been no controlled clinical studies demonstrating a
decrease in influenza disease after vaccination with Fluzone High-Dose
vaccine.
Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin per strain of
influenza virus in the vaccine as compared to 15 mcg of influenza virus
hemagglutinin per strain of influenza virus in standard-dose Fluzone vaccine.
Fluzone High-Dose vaccine is produced in the same production facility as Fluzone
vaccine. Fluzone HighDose vaccine is supplied as a single-dose, no preservative,
prefilled syringe.
In a clinical study of 3,876 adults 65 years of age and older, Fluzone High-Dose
vaccine was compared with the standard-dose Fluzone vaccine. The key finding was
that the new high-dose vaccine induced statistically significant increases in
immune responses compared to standard-dose Fluzone vaccine in the study
population. After 28 days following immunization, investigators assessed serum
hemagglutination inhibition (HAI) titers in study participants, a standard
measurement of the immune response to influenza vaccination. Higher HAI titers
were reported in those who received the high-dose vaccine compared with those
who received the standard-dose vaccine. Immunogenicity results met pre-defined
criteria for superiority of the high-dose vaccine. The primary endpoint of the
study was the statistical superiority of immune responses to at least two of the
strains contained in the vaccines when comparing Fluzone HighDose vaccine to
standard-dose Fluzone vaccine. Pre-defined criteria for overall superiority in
the Phase III study were based on geometric mean titers (GMT) and
seroconversion, which is defined as either a rise in HAI titer from <1:10 to
>=1:40 post-vaccination or a >=4-fold increase in HAI titer post-vaccination
from a prevaccination titer >=1:10.There are no data demonstrating clinically
relevant prevention of culture confirmed influenza or its complications after
vaccination with Fluzone High-Dose vaccine compared to standard- dose Fluzone
in adults 65 years of age and older.
In the clinical trial, Fluzone High-Dose vaccine was shown to have a clinically
comparable safety profile to Fluzone vaccine. Rates of unsolicited and serious
adverse events were similar between those who received Fluzone High-Dose vaccine
and those who received Fluzone vaccine. Solicited local (injection site) adverse
events and solicited systemic adverse events were more frequent after
vaccination with Fluzone High-Dose vaccine compared to standard-dose Fluzone
vaccine. More frequent mild to moderate local reactions were observed at the
injection site as would be expected with increased antigen. The most common
injection site reactions (>=10 percent) were injection site pain and redness.
The most common systemic adverse events (>=10 percent) were malaise (feeling
unwell), headache and myalgia (body aches).
Safety Information for Fluzone Vaccine and Fluzone High-Dose Vaccine
Side effects to Fluzone vaccines are soreness, pain and swelling at the
injection site; fever, fatigue, headache and muscular pain. Other side effects
may occur. Fluzone vaccines should not be administered to anyone with a history
of serious allergic reaction to any vaccine component, including eggs, egg
products, or thimerosal (the only Fluzone vaccine product containing thimerosal
is the multi-dose vial), or to persons who have been previously diagnosed with
Guillain-Barré syndrome (GBS). If you notice any other problems or symptoms
following vaccination, please contact your health-care professional immediately.
Vaccination with Fluzone vaccine or Fluzone High-Dose vaccine may not protect
all individuals.
Before administering Fluzone High-Dose vaccine or Fluzone vaccine, please see
full Prescribing Information at www.vaccineplace.com/products.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and
distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
For more information, please visit: www.sanofi-aventis.com
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, provided more
than 1.6 billion doses of vaccine in 2008, 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:
www.sanofipasteur.com or www.sanofipasteur.us.
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Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. These statements include financial
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expressions. Although sanofiaventis' management believes that the expectations
reflected in such forward-looking statements are reasonable, investors are
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developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These risks and
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the SEC and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofiaventis' annual report on Form 20-F for the year ended December 31, 2008.
Other than as required by applicable law, sanofi-aventis does not undertake any
obligation to update or revise any forward-looking information or statements.
Contacts
Global Media Relations US Media Relations
Pascal Barollier Donna Cary
T. +33-(0)4-37-37-50-38 T. + 1-570-957-0717
pascal.barollier@sanofipasteur.com donna.cary@sanofipasteur.com
www.sanofipasteur.com www.sanofipasteur.us
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