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Sanofi Pasteur Announces the Availability of Quadracel™ DTaP-IPV Vaccine for Children 4 Through 6 Years of Age in the U.S.

Jan 31, 2017

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.

SOURCE Sanofi Pasteur

For further information: U.S. /Country Media Relations, Marisol Peron, Tel. + 1 570 957 0717, mediaus@sanofipasteur.com