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FDA approves preservative-free influenza vaccine for pediatric use

SWIFTWATER, PA., Sept. 12, 2002 -- Aventis Pasteur announced that the FDA has approved licensure to market Fluzone 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 6-35 months.

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 hospitalizations.

Due to the current scheduling of the influenza vaccine manufacturing process, Aventis Pasteur can provide only a limited quantity of pediatric Fluzone vaccine for the 2002-2003 season. However, the company has the capacity to produce larger quantities of pediatric Fluzone vaccine for the 2003-2004 season should the ACIP expand its position on pediatric influenza immunization.

For the 2002-2003 influenza season, the available supply of pediatric 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 pediatric Fluzone vaccine will be available for shipment in early to mid-November.

Health care providers can be placed on a wait list for pediatric Fluzone vaccine by calling 1-800-VACCINE (1-800-822-2463).

Source: Aventis pasteur

Posted: September 2002