Aventis Pasteur Receives FDA Approval for Tripedia Vaccine for Fifth Consecutive Dose

Strategic Insights -

The U.S. Food and Drug Administration (FDA) has approved Tripedia, a diphtheria and tetanus toxoids and acellular pertussis vaccine, for the fifth consecutive dose in the childhood immunization series against diphtheria, tetanus, and pertussis. This approval enables the pediatric healthcare community to use the leading acellular pertussis vaccine for the entire DTP immunization series, providing convenience and boosting vaccination coverage for infants and young children in the U.S.

Key Takeaways:

  • Tripedia, an acellular pertussis vaccine, has received FDA approval for the fifth consecutive dose in the childhood immunization series against diphtheria, tetanus, and pertussis.
  • This approval follows a product license application filed in 1999 with new data on five consecutive doses of Tripedia.
  • The clinical data showed that the safety profile of Tripedia was better than historical safety profiles of whole-cell DTP vaccines.
  • Over 40 million doses of Tripedia have been distributed in the United States since its licensure in August 1992.
  • Tripedia is the only acellular DTP vaccine 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.
  • Aventis Pasteur, a world leader in vaccines, produces more than one billion doses of vaccines every year to immunize 400 million people around the world.

Statistics:

  • Since its licensure in August 1992, over 40 million doses of Tripedia have been distributed in the United States.
  • Tripedia is the first acellular pertussis vaccine to be licensed for use in infants in the U.S.
  • The FDA approved Tripedia for the third dose of the immunization series in July 1996.
  • The fifth consecutive dose indication for Tripedia will enable the pediatric healthcare community to use the leading acellular pertussis vaccine for the entire DTP immunization series.

Sources:

  • Aventis Pasteur Inc. press release, "Aventis Pasteur Receives FDA Approval to Market Tripedia(R) for Fifth Consecutive Dose", August 28 /PRNewswire/.
  • (1) American Academy of Pediatrics. PedComm; AAP Member Alert. October 4, 1996.
  • (2) Centers for Disease Control and Prevention. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1997; 47(RR-7): 1-25.