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.
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
