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Food and Drug Administration Approval of a Second Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine

The Advisory Committee for Immunization Practices (ACIP) and the Committee on Infectious Diseases, American Academy of Pediatrics (AAP), recommend that children routinely receive a series of five doses of vaccine against diphtheria, tetanus, and pertussis before age 7 years (1,2). On December 17, 1991, the Food and Drug Administration (FDA) approved a diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) prepared and distributed by Lederle Laboratories (Pearl River, New York) as ACEL-IMUNE\T * (3). On February 7, 1992, ACIP issued a supplementary statement on the use of DTaP (4), and the AAP did so on April 15 (5).

On August 21, 1992, the FDA approved licensure of a second DTaP product, prepared and distributed as Tripedia\T by Connaught Laboratories, Inc. (Swiftwater, Pennsylvania). As with ACEL-IMUNE\T, Tripedia\T is licensed only for use as the fourth and/or fifth dose(s) for children aged 15 months through 6 years (i.e., before the seventh birthday) who have previously been vaccinated against diphtheria, tetanus, and pertussis with three doses of whole-cell diphtheria and tetanus toxoids and pertussis vaccine (DTP) and is not licensed for the initial three-dose series in infants and children; whole-cell DTP should continue to be used for these initial doses. Whole-cell DTP continues to be an acceptable alternative for the fourth and/or fifth dose(s).

The following evidence supports the use of Tripedia\T after the initial three-dose series of whole-cell DTP in infants:

  1. The immunogenicity of the antigens that make up Tripedia\T

when used for the fourth and fifth doses is comparable to that of whole-cell DTP (unpublished manufacturer's data).

2. A randomized, placebo-controlled clinical efficacy trial in Sweden in 1985-1987 demonstrated efficacy when two doses of a pertussis vaccine similar to the formulation in Tripedia\T were given to children starting at ages 5-11 months (an age older than that recommended for initiating whole-cell DTP vaccination in the United States) (6).

3. The rates of local reactions, fever, and other common systemic symptoms following receipt of Tripedia\T inoculations when used for the fourth and fifth doses are lower than those following whole-cell DTP vaccination (unpublished manufacturer's data). An updated statement from ACIP will be issued as an MMWR Recommendations and Reports (7).

Reported by: Center for Biologics Evaluation and Research, Food and Drug Administration. National Center for Prevention Svcs, CDC.

References

  1. ACIP. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures -- recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-10).

  2. American Academy of Pediatrics. Report of the Committee on Infectious Diseases. Elk Grove Village, Illinois: American Academy of Pediatrics, Committee on Infectious Diseases, 1991.

  3. CDC. Food and Drug Administration approval of use of diphtheria and tetanus toxoids and acellular pertussis vaccine. MMWR 1991;40:881-2.

  4. ACIP. Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use -- supplementary ACIP statement: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1992;41(no. RR-1).

  5. Committee on Infectious Diseases, American Academy of Pediatrics. Acellular pertussis vaccines: recommendations for use as the fourth and fifth doses. Pediatrics 1992;90:121-3.

  6. Ad Hoc Group for the Study of Pertussis Vaccines. Placebo-controlled trial of two acellular pertussis vaccines in Sweden -- protective efficacy and adverse events. Lancet 1988;1:955-60.

  7. ACIP. Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series -- update to supplementary ACIP statement: recommendations of the Advisory Committee for Immunization Practices (ACIP). MMWR 1992 (in press).

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