SWIFTWATER, Pa., April 25, 2018 /PRNewswire/ -- The U.S. Food and
Drug Administration has accepted for review a supplemental
Biologics License Application to expand the age indication of the
0.5 mL dose of Sanofi Pasteur's Fluzone® Quadrivalent
(Influenza Vaccine) to include children 6 through 35 months of age.
Per the Prescription Drug User Fee Act, the target action date is
January 28, 2019. If approved, physicians will be able to
reserve the vaccine for young children for the 2019–2020 flu
season.
The application is supported by clinical data from a Phase IV
safety and immunogenicity study conducted in nearly 2,000 children.
Detailed results from the Phase IV, randomized, observer-blinded,
controlled, multicenter study will be presented at medical meetings
later this year.
"We are dedicated to helping
protect patients of all ages against the flu, which can be
especially severe and life threatening for more vulnerable groups
such as younger children," said Dr. David
P. Greenberg, Associate Vice President and Regional Medical
Head of North America, Sanofi
Pasteur. "We are one step closer to potentially offering clinicians
the option to use 0.5 mL dose of Fluzone Quadrivalent vaccine with
all of their eligible pediatric patients 6 months of age and
older."
Fluzone Quadrivalent vaccine is designed to help protect people
6 months of age and older against the four flu viruses that cause
the most disease: two influenza A subtypes, A(H1N1) and A(H3N2),
and two influenza B lineages, Victoria and Yamagata. A 0.25-mL dose of
Fluzone Quadrivalent vaccine is currently approved for use in
children 6 through 35 months of age; a 0.5-mL dose is approved for
people 36 months of age and older.
About Influenza
Influenza is a leading cause of vaccine-preventable deaths among
children in the United States.
Children of all ages can get the flu, including those who are
otherwise healthy. Each year, young children are admitted to the
hospital because of the flu more often than for any other
vaccine-preventable disease – including approximately 20,000
children younger than 5 years of age.
Important Safety Information for Fluzone Quadrivalent
Vaccine
Fluzone Quadrivalent vaccine should not be administered to
anyone who has had a severe allergic reaction (e.g., anaphylaxis)
to any vaccine component, including egg protein or thimerosal (the
multidose vial is the only presentation containing thimerosal), or
to a previous dose of any influenza vaccine.
If Guillain-Barré syndrome has occurred within 6 weeks following
previous influenza vaccination, the decision to give Fluzone
Quadrivalent vaccine should be based on careful consideration of
the potential benefits and risks.
The most common local adverse reactions to Fluzone Quadrivalent
vaccine include pain at the injection site (all ages) and erythema
and swelling at the injection site (in children). The most common
systemic reactions include myalgia, malaise, and headache
(irritability, abnormal crying, drowsiness, appetite loss,
vomiting, and fever in young children). Other adverse reactions may
occur. Vaccination with Fluzone Quadrivalent vaccine may not
protect all individuals.
Please see full U.S. Prescribing Information.
About Sanofi
Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Media Relations Contact
Ashleigh Koss
Tel.: +1 908 981 8745
Ashleigh.Koss@sanofi.com
Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
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press release contains forward-looking statements as defined in the
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Forward-looking statements are statements that are not historical
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things, the uncertainties inherent in research and development,
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or future litigation and the ultimate outcome of such
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Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2017. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
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