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| |  FDA Approves Vaccine Tripedia For Fifth Consecutive Dose For Pediatric Immunizations SWIFTWATER, PA -- August 28, 2000 -- Aventis Pasteur Inc. said that it received U.S. Food and Drug Administration (FDA) approval to market Tripedia® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) for the fifth consecutive dose in the currently recommended childhood immunization series against diphtheria, tetanus, and pertussis (whooping cough). Tripedia is already licensed for the three doses of the primary series followed by one booster and for the completion of the five-dose diphtheria, tetanus, pertussis (DTP) series for any child who has received one or more doses of whole-cell pertussis DTP vaccine. The fifth consecutive dose indication for Tripedia will enable the pediatric healthcare community to use the leading acellular pertussis vaccine product for the entire DTP immunization series. "This is a welcome milestone in the company's long history of research and development in preventing pertussis. The FDA's approval is important so that children who began their immunization with Tripedia can now complete the series with the same vaccine. The convenience of using one acellular pertussis product with established safety and effectiveness for the entire DTP series will help to boost vaccination coverage for infants and young children in the U.S.," said Michel DeWilde, Deputy Executive Vice President, Research & Development, Aventis Pasteur. Tripedia was the first acellular pertussis (DTaP) vaccine recommended over whole-cell DTP for infants by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), and the American Academy of Pediatrics (AAP).(1)(2) This acellular vaccine has a safety profile with significantly milder and less frequent adverse events than its whole-cell counterpart. The current U.S. childhood immunization schedule recommends five doses of a DTP vaccine before school entry to adequately protect children. The suggested ages of administration are: FDA approval follows a product license application (PLA) filed in 1999 with new data on five consecutive doses of Tripedia. The information included evaluations on the safety of Tripedia following the administration of a fifth consecutive dose to children four to six years of age from studies conducted in the U.S. and Germany. Findings from both studies showed that the safety profile of Tripedia was better than historical safety profiles of whole-cell DTP vaccines. In August 1992, Tripedia was licensed in the U.S. for the fourth and fifth dose of the series for those who previously received three doses of a whole-cell DTP vaccine. Thereafter, in July 1996, Tripedia received FDA approval for its use in the primary three-dose immunization series for infants and the fourth consecutive dose, making it the first acellular pertussis vaccine to be licensed for use in infants in the U.S. From 1992 until now, over 40 million doses have been distributed in the United States. Tripedia is the only acellular DTP vaccine that has been approved by the FDA to be combined with a specific Haemophilus influenzae type b (Hib) conjugate vaccine by reconstitution for administration in a single injection at 15 to 18 months of age for the fourth dose. In September 1996, TriHIBit™ (ActHIB® Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate] reconstituted with Tripedia (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) was licensed as the first and only vaccine of its kind for the fourth doses in both the childhood DTP and Hib immunization series. References: 1. American Academy of Pediatrics. PedComm; AAP Member Alert. October 4, 1996. Related Link: Tripedia (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).
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