Sanofi Pasteur Starts Shipping Influenza Vaccine for the 2011-2012 Season
Early shipments of Fluzone and Fluzone High-Dose vaccines support health-care providers in immunization planning and provide additional opportunities to increase immunization rates
SWIFTWATER, Pa., July 18, 2011 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that it began shipping its 2011-2012 Fluzone® Influenza Virus Vaccine in the U.S. This shipment represents the first of approximately 70 million doses of seasonal influenza vaccine the company plans to deliver to the U.S. in the upcoming season.
"As the largest producer of influenza vaccine in the U.S., supplying more than 40 percent of the nation's influenza vaccine, our goal is to continue supporting the fight against influenza by consistently delivering a reliable supply of influenza vaccine to U.S. health-care providers," said Damian Braga, Senior Vice President, Commercial Operations, Sanofi Pasteur. "With the licensure of Fluzone Intradermal vaccine earlier this year and Fluzone High-Dose vaccine at the end of 2009, for the first time this season, Sanofi Pasteur will be offering four influenza vaccine options to help address the unique immunization needs of all age groups in support of public health recommendations for everyone 6 months of age and older to receive an annual influenza immunization."
Fluzone vaccine, which health-care providers have relied upon for more than 40 years, will again be provided this season in two formulations: 0.25 mL pediatric dose for children 6 months through 35 months of age and 0.5 mL dose for children and adults 36 months and older.
Fluzone High-Dose vaccine, which was a new vaccine available in limited quantities last season following licensure at the end of 2009, will be widely available this season for adults 65 years of age and older. Adults in this age group suffer disproportionately from influenza and its complications. Due to weaker immune systems, people 65 years of age and older often do not produce as much antibody as younger people following influenza immunization. Fluzone High-Dose vaccine is specifically formulated to increase the antibody response in those 65 years of age and older.
Fluzone Intradermal vaccine, licensed for the first time in the U.S. in May 2011, is the first influenza vaccine licensed in the U.S. that uses a novel microinjection system for intradermal delivery. Fluzone Intradermal vaccine features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine. Fluzone Intradermal vaccine is anticipated to be an attractive immunization option for adults 18 through 64 years of age, an age group that has among the lowest rates of immunization.
The first shipments consist of Fluzone and Fluzone High-Dose vaccines. Regular shipments to health-care providers and their distributors will be ongoing with all health-care providers who have placed reservations receiving initial shipments by August and completed orders by early October. Due to the more recent licensure of Fluzone Intradermal vaccine, doses of this vaccine will be limited for the 2011-2012 season and are anticipated to ship in late September through October. Sanofi Pasteur is still accepting orders for all formulations of Fluzone vaccine. 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).
Heath-care providers are anticipated to begin immunization in the next few weeks. The U.S. Centers for Disease Control and Prevention (CDC) recommends that health-care providers begin offering influenza vaccine as soon as the vaccine becomes available and continue vaccination efforts throughout the entire influenza season. Influenza disease activity most often peaks in the winter during February; so, individuals who are not immunized early in the season still have time to do so prior to the peak of influenza season. Influenza vaccination is of value in December and January, or even into the spring, as long as influenza viruses are in circulation.
Influenza is a serious respiratory illness that is easily spread and can lead to severe complications, even death. Each year in the U.S., 5 to 20 percent of the population gets the flu and an estimated 226,000 people are hospitalized from influenza-related complications. Influenza seasons are unpredictable and can be severe. Depending on virus severity during the influenza season, annual deaths can range from a low of 3,000 to a high of about 49,000 people. Combined with pneumonia, influenza is the nation's eighth leading cause of death. Vaccination is safe and effective and the best way to help prevent influenza and its complications.
About Fluzone Vaccines
Fluzone, Fluzone High-Dose, and Fluzone Intradermal vaccines are indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccines.
Fluzone vaccine is intended for persons 6 months of age and older. Fluzone High-Dose vaccine is intended for persons 65 years of age and older. The indication for Fluzone High-Dose vaccine is based on the superior immune response elicited by Fluzone High-Dose vaccine relative to Fluzone vaccine. Data demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone vaccine are not available. Fluzone Intradermal vaccine is approved for use in persons 18 through 64 years of age.
The most common local and systemic adverse reactions to Fluzone and Fluzone High-Dose vaccines include soreness, pain, and swelling at the vaccination site; fever, headache, malaise, and myalgia. The most common local and systemic adverse reactions to Fluzone Intradermal vaccine include erythema, induration, swelling, pain, and pruritus at the vaccination site; headache, myalgia, and malaise. Other adverse reactions may occur.
Fluzone, Fluzone Intradermal, and Fluzone High-Dose vaccines should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multi-dose vial of Fluzone vaccine is the only presentation that contains thimerosal), or to a previous dose of any influenza vaccine. The decision to give Fluzone, Fluzone Intradermal, or Fluzone High-Dose vaccine should be based on the potential benefits and risks, especially if Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine. The prefilled syringe tip caps of Fluzone and Fluzone High-Dose vaccines may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. Vaccination with Fluzone, Fluzone Intradermal, or Fluzone High-Dose vaccines may not protect all individuals.
Sanofi, a global and diversified health-care leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of health-care with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. 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 offers the broadest range of vaccines protecting against 20 infectious diseases. 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 labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities 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, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
SOURCE Sanofi Pasteur
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