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

The Immunization Practices Advisory Committee (ACIP) and the Committee on Infectious Diseases, American Academy of Pediatrics, recommend that children routinely receive a series of five doses of vaccine against diphtheria, tetanus, and pertussis before 7 years of age (1,2). The Food and Drug Administration has approved a diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) prepared by Lederle Laboratories (Pearl River, New York) and distributed as ACEL-IMUNETM *. This vaccine is licensed only for use as the fourth and fifth doses for children 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 fifth doses. DTaP is not licensed for use in children less than 15 months of age or after the seventh birthday. The fourth dose should be given at least 6 months after the third dose of whole-cell DTP and is usually administered to children 15-18 months of age (1,2). A dose of DTaP may be given as the fifth dose in the series for children aged 4-6 years who have received either all four prior doses as whole-cell vaccine or three doses of whole-cell DTP plus one dose of DTaP; this fifth dose should be given before the child enters kindergarten or elementary school. The fifth dose in the vaccination series is not necessary if the fourth dose was given on or after the fourth birthday (1,2).

The following evidence supports the use of ACEL-IMUNETM after the initial three-dose series of whole-cell DTP vaccine in infants:

  1. The immunogenicity of the antigens comprising ACEL-IMUNETM when used for the fourth and fifth doses is comparable to that of whole-cell DTP vaccine (3).

  2. Although not evaluated in a prospective study in which clinicians and investigators were blinded with respect to the vaccination status of the study subjects, the effectiveness against clinical pertussis disease of a DTaP vaccine manufactured and used in Japan (which contained a pertussis vaccine component identical to that in ACEL-IMUNETM) has been demonstrated in children greater than or equal to 2 years of age (4).

  3. The rates of local reactions, fever, and other common systemic symptoms following receipt of ACEL-IMUNETM inoculations are lower than those following whole-cell DTP vaccination (3). A statement from ACIP will be published as an MMWR Recommendations and Reports (5). Reported by: Center for Biologics Evaluation and Research, Food and Drug Administration. National Center for Prevention Svcs, CDC.


  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. Blumberg DA, Mink CM, Cherry JD, et al. Comparison of an acellular pertussis-component diphtheria-tetanus-pertussis (DTP) vaccine with a whole-cell pertussis-component DTP vaccine in 17- to 24-month-old children, with measurement of 69-kilodalton outer membrane protein antibody. J Pediatr 1990;117:46-51.

  4. Mortimer EA, Kimura M, Cherry JD, et al. Protective efficacy of the Takeda acellular pertussis vaccine combined with diphtheria and tetanus toxoids following household exposure of Japanese children. Am J Dis Child 1990;144:899-904.

  5. ACIP. Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use--supplementary Immunization Practices Advisory Committee (ACIP) statement. MMWR (in press).

    • Use of trade names is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

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