SWIFTWATER, Pa., Jan. 31, 2017 /PRNewswire/ -- Sanofi
Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE:
SNY), announced today the availability of Quadracel™
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
and Inactivated Poliovirus; DTaP-IPV) vaccine in the United States. Quadracel is approved by
the U.S. Food and Drug Administration (FDA) for active immunization
against diphtheria, tetanus, pertussis and poliomyelitis in
children 4 through 6 years of age.
"Far too many children remain undervaccinated against serious
diseases like pertussis, polio and Haemophilus
influenzae type b (Hib) disease," said David P. Greenberg, M.D., Associate Vice
President and Regional Medical Head North America, Sanofi Pasteur.
"We are committed to helping protect more children by making
vaccination as easy and convenient as possible for parents and
healthcare providers. The availability of Quadracel is a step in
this direction. When Quadracel is used in children who started
their immunization series with Pentacel® (DTaP-IPV/Hib),
it can save an extra shot and may help improve vaccination coverage
for children through 6 years of age."
A 2015 report from the Centers for Disease Control (CDC) showed
an 11 percent vaccination coverage drop-off from the third to
fourth dose of DTaP, and a 12 percent drop-off from the primary to
full series of Haemophilus influenzae type b
(Hib).1
To protect infants and children from life-threatening diseases,
the CDC recommends children 4 through 6 years of age receive the
fifth dose of the DTaP vaccine and the fourth dose of inactivated
poliovirus (IPV) vaccine.2 Quadracel vaccine provides
these two vaccines in a single shot.
"Reducing the number of vaccine injections in a multi-dose
series can mean more than just convenience," said Michael J. Smith MD, MSCE, Associate Professor
of Pediatrics, University of Louisville
School of Medicine. "According to the CDC, it can also lead to
stocking fewer vaccines – which helps facilitate process
standardization – increased staff efficiency and prevention of
administration errors."
About Quadracel and Pentacel
Vaccines
Indication
Pentacel vaccine is given as
a 4-dose series to children 6 weeks through 4 years of age (prior
to fifth birthday) to help prevent diphtheria, tetanus (lockjaw),
pertussis (whooping cough), poliomyelitis, and infections caused by
Haemophilus influenzae type b (e.g., meningitis).
Quadracel vaccine is given for active immunization against
diphtheria, tetanus, pertussis, and poliomyelitis.
A single dose of Quadracel vaccine is approved for use in
children 4 through 6 years of age as a fifth dose in the
diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a
fourth or fifth dose in the inactivated poliovirus vaccination
(IPV) series, in children who have received 4 doses of Pentacel
and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and
Acellular Pertussis Vaccine Adsorbed).
For more information about Pentacel or Quadracel vaccine, talk
to your healthcare professional.
Safety Information
There is a small risk of allergic
reactions. Some signs of allergic reactions are hives, swelling of
the throat, low blood pressure, difficulty breathing, and shock. If
your child begins experiencing any of these signs seek treatment
right away. These reactions are rare and usually occur before
leaving the doctor's office. If you notice any other problems or
symptoms following vaccination, please contact your child's
healthcare professional promptly.
Tell the doctor if your child has ever experienced a severe
brain disorder, such as encephalopathy (altered consciousness),
Guillain-Barré syndrome (severe muscle weakness), or if side
effects occurred following a previous dose of pertussis-containing
vaccine.
Breathing problems following vaccine administered into the
muscle have been seen in some babies born prematurely.
Side effects to Pentacel vaccine include redness, swelling, and
tenderness at the injection site; fever, fussiness, and abnormal
crying. Other side effects may occur.
Side effects of Quadracel vaccine include pain, redness, and
swelling at the injection site; muscle pain, fatigue, and headache.
Other side effects may occur.
Vaccination with Pentacel or Quadracel vaccine may not protect
all people receiving the vaccine.
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 or www.sanofipasteur.us.
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, 2015.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
http:///www.sanofipasteur.us
References:
1. Centers for Disease Control and Prevention (CDC). Vaccination
Coverage Among Children Aged 19–35 Months — United States, 2015.
https://www.cdc.gov/mmwr/volumes/65/wr/mm6539a4.htm. Accessed
December 14, 2016.
2. Centers for Disease Control and Prevention (CDC). 2016
Recommended Immunizations for Children from Birth Through 6 Years
Old.
http://www.cdc.gov/vaccines/parents/downloads/parent-ver-sch-0-6yrs.pdf.
Accessed December 14, 2016.
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SOURCE Sanofi Pasteur