SWIFTWATER, Pa., Sept. 19, 2011 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that it began shipping the new Fluzone® Intradermal (Influenza Virus Vaccine) in the U.S. Sanofi Pasteur's other Fluzone vaccines for children, adults and seniors 65 years of age and older began shipping in July. Approximately 60 million doses of Fluzone influenza vaccines will have been shipped by the end of September.
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Fluzone Intradermal vaccine, licensed by the U.S. Food and Drug Administration (FDA) in May 2011, is the first influenza vaccine in the U.S. that uses a microinjection system for intradermal delivery. Fluzone Intradermal vaccine, indicated for active immunization of adults 18 through 64 years of age against influenza, features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine.
"Adults 18 through 64 years of age have some of the lowest influenza immunization rates in the U.S. despite public health recommendations for everyone 6 months of age and older to receive an annual influenza immunization," said Damian Braga, Senior Vice President, Commercial Operations, Sanofi Pasteur. "Our commitment to introducing new technologies, such as Fluzone Intradermal vaccine, reflects Sanofi Pasteur's expertise in developing innovative immunization options that can help foster greater vaccine acceptance among adults."
Fluzone Intradermal vaccine is anticipated to be an attractive new immunization option for adults 18 through 64 years of age, a population that is often overlooked, but still at risk of contracting influenza. Sanofi Pasteur has already introduced similar influenza vaccines using the intradermal microinjection system in more than 40 countries including Australia, Canada and countries in Europe.
Due to the mid-year licensure of Fluzone Intradermal vaccine, shipping of this new vaccine is starting later than other influenza vaccines and supplies will be limited for the 2011-2012 season. However, distribution is planned across the country through all types of immunization providers. In addition to private physicians, the vaccine is being offered at select locations of retail pharmacy chains nationwide.
Sanofi Pasteur is still accepting orders for all formulations of Fluzone vaccines including Fluzone vaccine pediatric dose for children 6 months through 35 months of age, Fluzone vaccine for people 36 months of age and older and Fluzone High-Dose vaccine for adults 65 years of age and older, as well as the new Fluzone Intradermal vaccine. Health-care providers seeking information on Fluzone vaccines should visit www.vaccineshoppe.com or call 1-800-VACCINE (1-800-822-2463).
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.
About Fluzone Intradermal Vaccine
Fluzone Intradermal vaccine incorporates a new, easy-to-use, prefilled microinjection system designed to consistently deposit vaccine antigens into the dermal layer of the skin of adults. The dermal layer contains a high concentration of specialized cells known as dendritic cells, which play a key role in generating an immune response. In clinical trials, Fluzone Intradermal vaccine produced an immune response similar to Fluzone vaccine administered intramuscularly.
Typically, adult influenza vaccines are administered into the muscle utilizing a needle 1 inch to 1.5 inches (25 mm to 38 mm) in length. Fluzone Intradermal vaccine features an ultra-fine needle that is 0.06 inches (1.5 mm) in length. Fluzone vaccine contains 15 mcg of hemagglutinin per strain of influenza in a 0.5 mL dose. Fluzone Intradermal vaccine contains 9 mcg of hemagglutinin per strain of influenza in a 0.1 mL dose.
Fluzone Intradermal Vaccine Immunogenicity and Safety
Clinical trials were conducted to evaluate the safety and immunogenicity of Fluzone Intradermal vaccine. Fluzone Intradermal vaccine was licensed based on data from a Phase III clinical trial in 4,276 adults 18 through 64 years of age (2,855 participants received Fluzone Intradermal vaccine and 1,421 participants received Fluzone vaccine via intramuscular administration). The study, which assessed the safety and immunogenicity of Fluzone Intradermal vaccine in comparison to Fluzone vaccine, was presented in October 2010 at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia. In the Phase III trial, Fluzone Intradermal vaccine was found to induce immunologic responses similar to licensed Fluzone vaccine.
Systemic reactogenicity of Fluzone Intradermal vaccine was comparable to that of intramuscular administration of Fluzone vaccine in the study. Intradermal microinjection deposits influenza vaccine near the surface of the skin; therefore, local reactions are more easily visible. The most common solicited injection-site reactions reported in participants given the intradermal vaccine were erythema (redness) (>75%), swelling (>50%), induration (hardness) (>50%), pain (>50%) and pruritus (itching) (>40%). The injection-site and systemic reactions with intradermal administration were transient, resolving in three to seven days without sequelae. The injection-site reactions were more frequent with participants given the intradermal vaccine compared to the intramuscular vaccine, with the exception of pain, which was similar.
About Influenza
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 flu-related complications. Flu 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.
The Centers for Disease Control and Prevention recommends annual influenza vaccination for everyone 6 months of age and older to help protect against influenza and its complications. Adults younger than 65 years of age are among those with the lowest rates of immunization against influenza. Fluzone Intradermal vaccine, which is licensed for adults 18 through 64 years of age, is anticipated to provide an attractive immunization option for this age group.
Important Safety Information
Fluzone Intradermal vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
The most common local and systemic adverse reactions to Fluzone Intradermal vaccine include erythema (redness), induration (firmness), swelling, pain, and pruritus (itching) at the vaccination site; headache, myalgia (muscle ache), and malaise. Other adverse reactions may occur. Fluzone Intradermal vaccine should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, or to a previous dose of any influenza vaccine. The decision to give Fluzone Intradermal 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. Vaccination with Fluzone Intradermal vaccine may not protect all individuals.
Before administering Fluzone Intradermal vaccine or Fluzone vaccine, please see full Prescribing Information available at www.sanofipasteur.us or www.vaccineshoppe.com
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare 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.
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Global Media Relations | U.S. Media Relations | |
Pascal Barollier | Donna Cary | |
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SOURCE Sanofi Pasteur