FDA Approves Preservative-Free Influenza Vaccine for Paediatric Use
SWIFTWATER, PA -- September 12, 2002 -- Aventis Pasteur today announced the Food and Drug Administration (FDA) has approved licensure to market FluzoneŽ Preservative-free: Pediatric Dose, Influenza Virus Vaccine.
For the first time, physicians have the option of offering a preservative-free formulation of influenza vaccine to infants aged six to 35 months.
Aventis Pasteur is producing a paediatric Fluzone vaccine to ensure continued public confidence in influenza vaccine for young children. The new vaccine will enable physicians to immunize infants, especially those considered high-risk, with a preservative-free influenza vaccine. In the near future, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) plans to consider strengthening its current encouragement to annually immunize healthy children aged six to 23 months. Children in this age group are at a substantially increased risk for influenza-related hospitalisations.
Due to the current scheduling of the influenza vaccine manufacturing process, Aventis Pasteur can provide only a limited quantity of paediatric Fluzone vaccine for the 2002-2003 season. However, Aventis Pasteur has the capacity to produce larger quantities of paediatric Fluzone vaccine for the 2003-2004 season should the ACIP expand its position on paediatric influenza immunization.
"Aventis Pasteur is pleased to provide physicians with the option of a preservative-free formulation of Fluzone vaccine to immunize infants aged six to 23 months," said Philip Hosbach, vice president, new products and immunization policy at Aventis Pasteur.
For the 2002-2003 influenza season, Aventis Pasteur's limited supply of paediatric Fluzone vaccine will be specially packaged for infants in pre-filled syringes (in a 0.25 mL presentation). Current production schedules anticipate that a limited quantity of paediatric Fluzone vaccine will be available for shipment in early to mid-November. Health care providers can be placed on a wait list for paediatric Fluzone vaccine by calling 1-800-VACCINE (1-800-822-2463).
"Due to paediatricians' increased awareness of the incidence of influenza virus infections in the first years of life, the ACIP and the American Academy of Pediatrics have encouraged the use of influenza vaccine for children aged six to 23 months," said Samuel L. Katz, Wilburt C. Davison professor of paediatrics and chairman emeritus of the paediatric department, Duke University Medical Center. "The availability of preservative-free influenza vaccine provides an alternative to parents and health care providers."
FluzoneŽ Preservative-free: Pediatric Dose, Influenza Virus Vaccine is produced and marketed by Aventis Pasteur Inc., which is located in Swiftwater, Pennsylvania, and is a subsidiary of Aventis Pasteur SA. Aventis Pasteur Inc. provides the broadest range of human vaccines and biologicals commercially available from any single U.S. vaccine company. It is a leading supplier of vaccines to protect against influenza, diphtheria, tetanus, pertussis, polio, Japanese encephalitis, yellow fever, Haemophilus influenzae type b disease, meningitis, rabies, and typhoid fever.
Aventis Pasteur, a world leader in vaccines with the broadest range of products, produces more than one billion doses of vaccines every year to immunize 400 million people around the world. Aventis Pasteur, headquartered in Lyon, France, is a subsidiary of Aventis SA.
Aventis is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of 17.7 billion euros ($15.5 billion), invested approximately 3 billion euros ($2.6 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.
SOURCE: Aventis Pasteur
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