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FDA approves preservative-free influenza vaccine for pediatric use

PennsylvaniaSaturday, September 14, 2002, 08:00 Hrs  [IST]

Aventis Pasteur announced the Food and Drug Administration (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 six to 35 months. Aventis Pasteur is producing a pediatric 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 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, Aventis Pasteur 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, Aventis Pasteur's limited 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.

 
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