SWIFTWATER, Pa., July 17, 2017 /PRNewswire/ -- Sanofi
Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE:
SNY), announced today that its first doses of the
Fluzone® (Influenza Vaccine) portfolio for the 2017-2018
influenza ("flu") season have been released by the U.S. Food and
Drug Administration (FDA). Sanofi Pasteur has begun distributing
initial shipments, representing the first of nearly 70 million
total doses of seasonal influenza vaccine manufactured by the
company for this upcoming influenza season. Widespread shipment of
Fluzone Quadrivalent, Fluzone High-Dose and Fluzone Intradermal
Quadrivalent vaccine to health care provider offices, pharmacies
and other immunizers will begin in early August to support fall
immunization campaigns.
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"As we enter the Swiftwater
site's 120th year, it reminds us of our innovation and
growth as we came to understand the science of influenza and its
impact on human health," said David P.
Greenberg, M.D., Associate Vice President and Regional
Medical Head North America, Sanofi Pasteur. "Influenza can be
especially severe for the most vulnerable populations, including
the elderly, young children and those with compromised immune
systems; however, it can also have a serious health impact on
otherwise healthy individuals. Sanofi Pasteur is and always has
been deeply committed to improving public health by continuously
striving to develop new vaccines and on improving existing
ones."
According to the U.S. Centers for Disease Control and Prevention
(CDC), the single best way to prevent the flu is to get an annual
flu vaccination, which is recommended for everyone six months of
age and older, with rare exception. The CDC recommends receiving
the vaccine as soon as it is available to help with prevention even
before the season begins.
As the single largest provider of influenza vaccine to
the United States, Sanofi Pasteur
provides a wide range of influenza vaccines. The Fluzone vaccine
portfolio meets immunization needs across the lifespan, from
children as young as six months of age through adults 65 years of
age and older, and includes the following products:
- Fluzone High-Dose vaccine, the first influenza vaccine
designed specifically for people 65 years of age and older, is the
only influenza vaccine approved by the U.S. Food and Drug
Administration (FDA) that has been shown in clinical trials to have
superior efficacy compared to Fluzone vaccine, its standard-dose
comparator, in helping to protect against the flu. During the
2016-2017 season, about 60 percent of adults 65 years of age and
older who were vaccinated in the United
States received Fluzone High-Dose vaccine, helping to
protect this vulnerable population. Since its introduction in 2010,
more than 70 million doses of Fluzone High-Dose vaccine have been
distributed in the United
States.
In two observational, comparative effectiveness studies conducted
by the CDC, Centers for Medicare and Medicaid Services (CMS) and
the FDA of 6 million seniors, Fluzone High-Dose vaccine reduced
influenza-associated medical visits and hospitalizations by 22
percent and, during an H3N2-predominated season (2012-2013),
reduced post-influenza death by 36 percent compared to
standard-dose influenza vaccines. During an H1N1-predominated
season (2013-2014), there was a 13 percent reduction in influenza
hospitalizations and no significant reduction (2.5 percent) in
death.
- Fluzone Quadrivalent vaccine helps protect against four
influenza strains (two A strains and two B strains) and is the
first four-strain influenza vaccine licensed for use in people six
months of age and older.
-
- There is also a 0.25-mL prefilled syringe (pediatric dose),
that has been available for influenza immunization of children six
months through 35 months of age since its launch in 2004 and
maintains a record of safety and immunogenicity.
- Fluzone Intradermal Quadrivalent vaccine, the first
intradermal influenza vaccine for adults 18-64 years of age, offers
four-strain protection using a 90 percent smaller, 1.5 mm
microneedle.
"Last season, our influenza vaccine represented nearly 50
percent of the U.S. influenza vaccine supply, and we anticipate our
global supply of Fluzone High-Dose vaccine will increase
significantly over the next few years," said Franck Chassant,
Vice President Vaccines Industrial Affairs U.S. and Site Head,
Sanofi Pasteur U.S. "Recently, Sanofi has been making
significant capital investments at our Swiftwater site. Just this spring, we also
opened our new Quality building, which is testament to our focus
and commitment to quality, which runs through everything we do
within Sanofi Pasteur."
For the 2017-2018 influenza season, Sanofi Pasteur production
plans are again accounting for providers choosing not to use live
attenuated influenza vaccine (LAIV) during the upcoming flu season.
Health care providers wishing to reserve vaccine can do so by
visiting www.vaccineshoppe.com or by calling 1-800-VACCINE
(1-800-822-2463). Members of the public seeking a specific vaccine
option, such as Fluzone High-Dose vaccine, Fluzone Intradermal
Quadrivalent vaccine, or Fluzone Quadrivalent vaccine, can search
for local providers at www.Fluzone.com.
About Fluzone Vaccines
Indication
Fluzone Quadrivalent, Fluzone Intradermal
Quadrivalent, and Fluzone High-Dose vaccines are given to help
prevent influenza disease caused by influenza A and B strains
contained in each vaccine. Fluzone Quadrivalent vaccine is given to
people 6 months of age and older. Fluzone Intradermal Quadrivalent
vaccine is given to people 18 through 64 years of age. Fluzone
High-Dose vaccine is given to people 65 years of age and older.
For more information about Fluzone Quadrivalent, Fluzone
Intradermal Quadrivalent, or Fluzone High-Dose vaccine, talk to
your health care professional and see complete Patient
Information.
Safety Information
Fluzone Quadrivalent, Fluzone
Intradermal Quadrivalent, and Fluzone High-Dose vaccines should not
be administered to anyone with a severe allergic reaction (eg,
anaphylaxis) to any vaccine component, including eggs, egg
products, or thimerosal (the multidose vial is the only
presentation containing thimerosal), or to a previous dose of any
influenza vaccine.
Tell the doctor if you/your child has ever experienced
Guillain-Barré syndrome (severe muscle weakness) after a previous
dose of influenza vaccine. If you notice any other problems or
symptoms following vaccination, please contact your health care
professional immediately.
Side effects to Fluzone Quadrivalent, Fluzone Intradermal
Quadrivalent, and Fluzone High-Dose vaccines include pain and
swelling at the injection site (also itching at the injection site
and shivering in adults receiving Fluzone Intradermal Quadrivalent
vaccine); muscle aches, fatigue, and headache (also irritability,
abnormal crying, drowsiness, appetite loss, vomiting, and fever in
young children receiving Fluzone Quadrivalent vaccine). Itching,
redness, swelling, and firmness at the injection site have occurred
more frequently with vaccine administered into the skin compared to
vaccine administered into the muscle. Other side effects may occur.
Vaccination with Fluzone Quadrivalent, Fluzone Intradermal
Quadrivalent, or Fluzone High-Dose vaccine may not protect all
individuals.
About Sanofi Pasteur Influenza Vaccine Manufacturing
As the world leader in the research, development and manufacturing
of seasonal influenza vaccines, Sanofi Pasteur uses the most
innovative technology and processes. For more information about
Sanofi Pasteur's influenza vaccine manufacturing process, please
view the following infographic ("Production Process for the United
States Infographic") and watch a video that provides a glimpse into
the Sanofi Pasteur production facilities.
About Influenza
Influenza is a serious respiratory
illness that is easily spread and can lead to severe complications,
even death. Each year, 5-20 percent of U.S. residents acquire
influenza, and many will seek medical care in outpatient settings
such as physician's offices and urgent-care clinics. Influenza
seasons are unpredictable. In the 2015-2016 influenza season, the
CDC estimated 25 million flu illnesses, 11 million flu-associated
medical visits and more than 300,000 flu-associated
hospitalizations. Adults 65 years of age and older typically
account for 50 to 70 percent of flu-related hospitalizations and 70
to 90 percent of flu-related deaths. In fact, last season's
cumulative hospitalization rate for adults 65 years of age and
older was three times higher than that of younger persons. Among
young children, influenza causes more hospitalizations than any
other vaccine-preventable disease.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global
business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare. 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 produces a portfolio
of high quality vaccines that matches its areas of expertise and
meets public-health demand. 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
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic
conditions, the impact of cost containment initiatives and
subsequent changes thereto, the average number of shares
outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi, including those
listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2016.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
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SOURCE Sanofi Pasteur