PARIS, Nov. 4, 2019
/PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has
approved a supplemental Biologics License Application for
Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for
use in adults 65 years of age and older.
Fluzone® High-Dose (Influenza Vaccine) was approved
by the FDA in 2009 as a trivalent influenza vaccine, including two
influenza A strains and one influenza B strain. Fluzone High-Dose
Quadrivalent contains an additional influenza B strain. Fluzone
High-Dose Quadrivalent is given to people 65 years of age and
older to help prevent influenza disease caused by influenza A and B
strains contained in the vaccine.
"Increasing protection and
delivering improved influenza vaccines are critical to public
health," said David Loew, Sanofi
Executive Vice President and head of Sanofi Pasteur. "We are
excited to build upon the success of trivalent Fluzone High-Dose
with this FDA approval to expand protection for an additional B
strain. We have submitted filings with additional regulatory bodies
outside the U.S. and anticipate approval in the European Union next
spring."
This approval is the final step toward the company's complete
transition to quadrivalent influenza vaccines in the U.S. Fluzone
High-Dose Quadrivalent will be made available for immunization
efforts during the 2020-2021 influenza season. Sanofi Pasteur will
continue to deliver and offer the trivalent formulation of Fluzone
High-Dose through the end of the 2019-2020 influenza season.
"Influenza is a serious threat,
especially for older adults who are more vulnerable to serious
complications and even death. For the past 10 years, Fluzone
High-Dose has helped protect millions of people 65 years of age and
older from seasonal influenza," said John
Shiver, PhD, Senior Vice President, Global Research and
Development, Sanofi Pasteur. "We are committed to helping protect
as many people as possible from influenza and look forward to
introducing this new formulation."
FDA approval was based on data from a Phase 3 immunogenicity and
safety study, in which Fluzone High-Dose Quadrivalent achieved the
primary endpoint of non-inferior immunogenicity compared to two
trivalent formulations of Fluzone High-Dose, each containing one of
the two influenza B strains recommended for inclusion in the
vaccine for the 2017-2018 influenza season. In a secondary endpoint
of the trial, each B strain in Fluzone High-Dose Quadrivalent
induced a superior immune response compared to the trivalent
formulation not containing the corresponding B strain.
Rates of local and systemic reactions that occurred following
immunization with Fluzone High-Dose Quadrivalent were similar to
those induced by trivalent formulations of Fluzone High-Dose. The
most common reactions occurring after administration were
injection-site pain (41.3 percent), myalgia (22.7 percent),
headache (14.4 percent), and malaise (13.2 percent). Onset usually
occurred within the first three days after vaccination, and the
majority of solicited reactions were resolved within three days of
vaccination. Results from the study were published in Vaccine
in September 2019.
Fluzone High-Dose is the first and only influenza vaccine proven
to provide superior efficacy compared to Fluzone®
(Influenza Vaccine) in adults 65 years of age and older, based on
results in a randomized controlled trial.i
This study evaluated nearly 32,000 adults 65 years of age and older
over two influenza seasons in the U.S. and Canada. Results
showed that Fluzone High-Dose prevented 24 percent more cases of
influenza caused by any circulating influenza strain and 51 percent
more cases of influenza caused by strains similar to those
contained in the vaccine compared to Fluzone. Based on data from
Fluzone High-Dose, solicited injection site reactions and systemic
adverse reactions were slightly more frequent after vaccination
with Fluzone High-Dose compared to a standard-dose
vaccine.i
As of the end of the 2018-2019 influenza season, over 112
million doses of Fluzone High-Dose have been distributed in the
U.S. In the 2018-2019 influenza season, nearly two-thirds of U.S.
adults 65 years of age and older who received an influenza vaccine
received Fluzone High-Dose.ii
About Fluzone High-Dose Quadrivalent in the
U.S.
Fluzone High-Dose Quadrivalent is given to people 65
years of age and older to help prevent influenza disease caused by
influenza A and B strains contained in the vaccine.
Important Safety Information for Fluzone High-Dose
Quadrivalent (Influenza Vaccine) in the U.S.
Fluzone
High-Dose Quadrivalent should not be given to anyone who has had a
severe allergic reaction to any component of the vaccine, including
eggs or egg products, or after previous dose of any influenza
vaccine.
Tell your health care provider if you have ever had
Guillain-Barré syndrome (severe muscle weakness) after a previous
influenza vaccination.
If Fluzone High-Dose Quadrivalent is given to people with a
compromised immune system, including those receiving therapies that
suppress the immune system, the immune response may be lower than
expected.
Vaccination with Fluzone High-Dose Quadrivalent may not protect
all people who receive the vaccine.
For Fluzone High-Dose Quadrivalent, in adults 65 years of age
and older, the most common side effects were pain, redness, and/or
swelling where you got the shot; muscle ache, headache, and general
discomfort. Other side effects may occur.
Please see the full Prescribing Information, including
Patient Information.
Vaccineshoppe.com/fluzonehighdosequadrivalent
About Sanofi
Sanofi 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
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Contact
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Nicolas
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George
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+1 (732)
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Tel.: +33 (0)1 53 77
45 45
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Nicolas.Kressmann@sanofi.com
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ir@sanofi.com
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Forward-looking statements are statements that are not historical
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Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2018. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
i Fluzone High-Dose Quadrivalent [Prescribing
Information]. Swiftwater, PA:
Sanofi Pasteur Inc.
ii Sanofi Pasteur Inc. Data on file (Sanofi Pasteur
Fluzone High-Dose vaccine doses sold).
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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