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Sanofi Pasteur Responds to Nation's Need for Hib Vaccine With Increased Supply

Posted on: Thursday, 25 June 2009, 13:08 CDT

- The CDC Reinstates Booster Dose of Hib Vaccine -

SWIFTWATER, Pa., June 25 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the company has been able to increase the supply of its Hib-containing vaccines to enable the return to a full series of vaccinations for U.S. children. Based on the increased supply, on July 1, the U.S. Centers for Disease Control and Prevention (CDC) will reinstate its recommendation that children receive a booster dose of Haemophilus influenzae type b (Hib) vaccine after 12 months of age. The CDC also provided guidance on a phased approach to immunize children whose booster dose was previously deferred at their next regularly scheduled medical visit. The CDC had recommended a temporary deferral of the booster dose of Hib vaccine in 2007 due to supply constraints caused by another manufacturer's withdrawal of Hib vaccine from the market. Since that time, Sanofi Pasteur has been, and continues to be, the sole supplier of Hib vaccine to the U.S. market.

Sanofi Pasteur is able to meet the nation's need for Hib vaccination through the use of its two Hib-containing vaccines: Pentacel(R) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) and ActHIB(R) (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]).

"Sanofi Pasteur has accelerated production and reallocated excess global supplies so that health-care providers can stop deferring the booster dose and return to protecting children with the full Hib vaccine series," said Wayne Pisano, president and CEO of Sanofi Pasteur. "We are proud that we are able to fulfill this important national need. In recent years, Sanofi Pasteur has supplied approximately half the Hib vaccine in the U.S. each year, but we have been able to substantially increase supply in 2009 to help make up for the shortfall created by the other manufacturer's continued absence."

"The reinstatement of the booster dose of Hib vaccine is important due to recent epidemiologic trends," said Dr. Gary Overturf, professor of pediatrics and pathology at the University of New Mexico. "The deferral of the booster dose was always meant to be a temporary situation, but now that nearly 18 months have passed, we have seen several cases of Hib disease primarily among unimmunized and partially immunized children. This could represent an increase of Hib carriage and transmission from older non-symptomatic children to those children whose parents refused vaccination or are too young to have received their full primary series. While this is a hypothesis, it's reassuring to know we won't have to put it to the test, and can begin immunizing with the full schedule again."

The CDC recommends that children receive a primary series of Hib vaccinations during infancy and a booster dose at 12-15 months of age. Sanofi Pasteur has been working closely with the CDC since December of 2007 to meet the country's Hib immunization needs, and maximize the availability of the vaccine to the greatest number of children. As is the case with many vaccines, Hib vaccine manufacturing is a complex biological process with lengthy production cycles.

To maintain adequate supplies of Hib vaccine throughout the reinstatement period, the CDC is encouraging all health-care providers to administer the booster dose of Hib vaccine to children older than 12 months of age who were previously deferred, at the next regularly-scheduled medical encounter. This practice will help ensure a steady stream of available supply, which remains constrained in the short term.

About Hib Disease

Haemophilus influenzae type b, or Hib, is a bacterium that resides in the upper respiratory tract of humans and is usually transmitted by coughing or sneezing. Invasive Hib disease can be very severe, and can cause hospitalization or even death. Before Hib vaccines were available, Hib was the most common cause of bacterial meningitis in the United States. According to the CDC, about 12,000 children each year, most of whom were younger than 5 years of age, got Hib meningitis. Hib can also cause serious respiratory symptoms that make breathing and swallowing difficult, including epiglottitis (infection in the throat) and pneumonia (infection in the lungs). Hib can also cause blood, bone, or joint infections. Despite the success of Hib vaccine, Hib disease still exists and can be carried in the noses and throats of people who do not demonstrate symptoms. Carriers can spread the bacteria to infants and children who are not immunized or who are incompletely immunized. Vaccinating infants fully and on time helps protect them when they are most vulnerable. If vaccination levels were to drop too low, Hib disease could make a comeback.

Sanofi Pasteur manufactures two Hib-containing vaccines -- ActHIB and Pentacel -- which can be used by physicians to fulfill CDC immunization recommendations. ActHIB vaccine has been available in the United States since 1987. Last year, in June 2008, the U.S. Food and Drug Administration (FDA) licensed Sanofi Pasteur's Pentacel vaccine, a pediatric combination vaccine for active immunization against five serious childhood diseases: diphtheria, tetanus, pertussis, poliomyelitis and Hib. This new vaccine added another option to meet Hib vaccine demand.

About Pentacel Vaccine

Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).

The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.

The decision to give Pentacel vaccine should be based on the potential benefits and risks; if Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel vaccine may not protect all individuals. Before administering Pentacel vaccine, please see full Prescribing Information. The full Prescribing Information for Pentacel vaccine is available with the product and on www.pentacel.com and www.vaccineshoppe.com.

About ActHIB Vaccine

ActHIB vaccine is indicated for the active immunization of infants and children 2 through 18 months of age for prevention of invasive Haemophilus influenzae type b disease. The most common local and systemic adverse reactions to ActHIB vaccine include injection site erythema, swelling, and tenderness; fever irritability, drowsiness, and anorexia. Other adverse reactions may occur. ActHIB vaccine is contraindicated in persons with known hypersensitivity to any component of the vaccine. The decision to give ActHIB vaccine should be based on the potential benefits and risks; if Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of tetanus toxoid-containing vaccine. Vaccination with ActHIB vaccine may not protect all individuals. Before administering ActHIB vaccine, please see full Prescribing Information. The full Prescribing Information for ActHIB vaccine is available with the product and on www.vaccineshoppe.com.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2008, 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 financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, 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-aventis' 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-aventis, 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 those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi Pasteur

Source: PR Newswire

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