Sanofi Pasteur Ships First of its 2016-2017 Seasonal Influenza Vaccine Doses in United States

SWIFTWATER, Pa., July 26, 2016 /PRNewswire/ — Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its initial doses of Fluzone^® (Influenza Vaccine) for the 2016-2017 influenza (“flu”) season have actually been released by the U.S. Meals and Drug Administration (FDA) for shipment. This represents the initial of Much more compared to 6five million total doses of seasonal influenza vaccine manufactured by Sanofi Pasteur that will certainly be delivered to U.S. health care providers and pharmacies beginning in July and continuing throughout the remainder of the year. Sanofi Pasteur plans to increase its supply to respond to the shifting pediatric public health needs.

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Seasonal influenza activity typically occurs between October and May and peaks between December and February. However, influenza activity peaked noticeably late last season occurring in early March 2016.¹ Influenza seasons are constantly unpredictable as Brand-new influenza strains emerge and strain activity fluctuates throughout the year, making timely vaccination more necessary to assistance protect versus the virus, especially for seniors, young youngsters and infants 6 months of age and older.

The Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for everyone 6 months of age and older, along with rare exception, and recommends receiving the vaccine when it is available to assistance along with prevention even prior to the season begins. In the 2015-2016 influenza season, 50 percent of seniors that were vaccinated received Fluzone High-Dose vaccine, and this number is expected to rise to 60 percent in the coming season.

“There is general awareness of influenza among the public provided its widespread prevalence,” said David P. Greenberg, M.D., Associate Vice President and Regional Medical Head North America, Sanofi Pasteur. “Just what is not populared is that influenza can easily be life-threatening and have actually a lasting health impact, especially for the most vulnerable populations. In the 2014-201five season, the CDC estimated 40 million flu illnesses, 19 million flu-associated medical visits and almost 1 million flu-associated hospitalizations.”²

As the single largest provider of influenza vaccine to the United States, Sanofi Pasteur provides a wide range of influenza vaccine options. The Fluzone vaccine portfolio meets immunization calls for across the entire lifespan, from youngsters as young as 6 months of age through adults 6five years of age and older, and includes the following products:

Fluzone High-Dose vaccine, the initial influenza vaccine designed specifically for people 6five years of age and older, is an inactivated influenza vaccine.³ Fluzone High-Dose vaccine is the only influenza vaccine for seniors that the U.S. Meals and Drug Administration (FDA) has actually approved as having demonstrated superior efficacy versus influenza compared along with Fluzone vaccine. It contains four times the antigen content of Fluzone vaccine to assistance promote a stronger immune response to influenza.⁴ Clinical data published in The New England Diary of Medicine demonstrated that Fluzone High-Dose vaccine was 24.2 percent Much more effective compared to Fluzone vaccine in preventing laboratory-confirmed influenza caused by any influenza viral type or subtype in association along with influenza-like illness, in adults 6five years of age and older.⁴ A secondary endpoint demonstrated Fluzone High-Dose vaccine was 51.1 percent Much more effective compared to Fluzone vaccine versus influenza caused by viral strains antigenically similar to those contained in the vaccine using a modified CDC influenza-like illness definition.⁴

Fluzone Quadrivalent vaccine helps protect versus four influenza strains (two A strains and two B strains). The influenza B strain is associated along with substantial hospitalization and mortality, especially in youngsters and young adults. In fact, on average, over multiple recent seasons, 34 percent of influenza-related deaths in youngsters up to 18 years of age were because of influenza B.⁵ Fluzone Quadrivalent vaccine is the initial four-strain influenza vaccine licensed for use in people 6 months of age and older.

Fluzone Intradermal Quadrivalent vaccine was licensed by the U.S. Meals and Drug Administration (FDA) in 2014 for adults 18 through 64 years of age. Fluzone Intradermal Quadrivalent vaccine is administered directly in to the skin using a 90 percent smaller, 1.five mm microneedle and offers four-strain protection that is convenient, efficient, and easy to use, allowing for streamlined administration by health care providers.

“Sanofi Pasteur is at the forefront of influenza vaccine innovation,” said Dr. Greenberg. “Our legacy for researching and manufacturing influenza vaccines has actually existed for nearly 70 years at our Swiftwater-based facility, demonstrating our experience and commitment to this necessary public health need. We are dedicated to continuously enhancing our influenza vaccine selections to ultimately assistance protect versus influenza strains, including drifted strains that may occur in the future.”

To address insight by the Advisory Committee on Immunization Practices (ACIP), Sanofi Pasteur has actually increased production of Fluzone Quadrivalent vaccine where possible. Sanofi Pasteur is the sole provider of injectable influenza vaccine for pediatric patients 6 months through 3five months of age.

Health care providers that placed reservations along with Sanofi Pasteur must expect to receive very first shipments between late July and early August to support fall immunization campaigns. Health care providers wishing to reserve vaccine can easily do so by visiting http://ift.tt/1o6e08s or by calling 1-800-VACCINE (1-800-822-2463). Members of the public seeking a personal vaccine option, such as Fluzone High-Dose vaccine, Fluzone Intradermal Quadrivalent vaccine, or Fluzone Quadrivalent vaccine, can easily search for local providers at www.Fluzone.com.

About Sanofi Pasteur Influenza Vaccine Manufacturing
As the globe leader in the research, development and manufacturing of seasonal influenza vaccines, Sanofi Pasteur uses the most innovative technology and processes. For Much more guide Regarding 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 in to the Sanofi Pasteur production facilities.

About Influenza
Influenza is a serious respiratory illness that is easily spread and can easily lead to severe complications, even death. Each year, one from every 5 Americans gets the flu and, on average, Much more compared to 200,000 people are hospitalized from influenza-related complications.⁶ Influenza seasons are unpredictable along with flu-related deaths ranging from 3000 to as Higher as 49,000 people.⁷ Combined along with pneumonia, influenza is one of the top ten leading induces of death in the United States.⁸ Vaccination is safe and effective and the very best means to assistance Stay clear of influenza and its complications.

Children 6 months through eight years of age may require two doses of vaccine for the 2016-2017 influenza season. Parents must consult their health care provider Regarding the number of doses of influenza vaccine their kid must receive.

Individuals that are not immunized early in the season will certainly still have actually time do so as the influenza vaccination is valuable throughout the season, even in to the spring, as long as influenza viruses are still in circulation.⁹

About Fluzone Vaccines

Indication
Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose vaccines are provided to assistance Stay clear of influenza disease caused by influenza A and B strains contained in each vaccine.

Fluzone Quadrivalent vaccine is provided to people 6 months of age and older. Fluzone Intradermal Quadrivalent vaccine is provided to people 18 through 64 years of age. Fluzone High-Dose vaccine is provided to people 6five years of age and older.

Safety Information
adverse effects to Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose vaccines include pain and swelling at the injection site (additionally itching in adults receiving Fluzone Intradermal Quadrivalent vaccine); muscle aches, fatigue, headache, and fever (additionally irritability, abnormal crying, drowsiness, appetite loss, and vomiting in young youngsters receiving Fluzone Quadrivalent vaccine). Itching, redness, swelling, and firmness at the injection site occurred Much more frequently along with Fluzone Intradermal vaccine (containing 3 influenza strains) compared to along with Fluzone vaccine. Various other adverse effects may occur.

Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose, vaccines must not be administered to anyone along with a severe allergic reaction (e.g., 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 kid has actually ever suffered Guillain-Barré syndrome (severe muscle weakness) after a previous dose of influenza vaccine. If you notice any Various other troubles or symptoms following vaccination, please contact your health care professional immediately. Vaccination along with Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine may not protect all individuals.

For Much more guide Regarding Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine, talk to your health care professional and see finish Patient Information.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has actually core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in Brand-new York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides Much more compared to 1 billion doses of vaccine each year, making it feasible to immunize Much more compared to 500 million people across the globe. A globe leader in the vaccine industry, Sanofi Pasteur produces a portfolio of Higher quality vaccines that suits its areas of expertise and meets public-health demand. The company’s heritage, to make vaccines that protect life, dates spine Much more compared to a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests Much more compared to EUR 1 million in research and development. For Much more information, please visit: http://ift.tt/134OR0e 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 about plans, objectives, intentions and expectations along with respect to future financial results, events, operations, services, product development and potential, and statements about future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Even though Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking guide and statements are subject to various risks and uncertainties, numerous 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 guide and statements. These risks and uncertainties include among Various other things, the uncertainties inherent in research and development, future clinical data and analysis, including information marketing, decisions by regulatory authorities, such as the FDA or the EMA, about whether and once to approve any drug, device or biological application that might be filed for any such product candidates as well as their decisions about labelling and Various other matters that could affect the availability or commercial potential of such product candidates, the absence of make sure that the product candidates if approved will certainly be commercially successful, the future approval and commercial triumph of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the standard number of shares outstanding as well as those discussed or identified in the public filings along with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement about Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2015. Various other compared to as called for by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking guide or statements.

¹ Centers for Disease Control and Prevention (CDC). Just what You must Know for the 2015-2016 Influenza Season. http://ift.tt/1P0BXIX. Accessed May 9, 2016.
² CDC. Just what You must Know for the 2014-201five Influenza Season. http://ift.tt/29YGyl5. Accessed May 12, 2016.
³ Fluzone High-Dose vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2015.
⁴ DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014;371:635-645.
⁵ Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccine. Hum Vaccin Immunother. 2012; 8:81-88
⁶ CDC. Seasonal Influenza-Associated Hospitalizations in the United States. http://ift.tt/13jEhnw. Accessed May 12, 2016.
⁷ CDC. Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu. http://ift.tt/WGLBTO. Accessed May 12, 2016.
⁸ Bastian AB, Kochanek DK, Murphy SL, et al. National Important Statistics Reports. Pg 1. http://ift.tt/18uXkTw. Accessed May 12, 2016.
⁹ CDC. Key Facts Regarding Seasonal Flu Vaccine. http://ift.tt/QLFLCD. Accessed May 12, 2016.