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Notice to Readers FDA Approval of a Second Acellular Pertussis Vaccine for Use Among Infants and Young Children

On December 30, 1996, the Food and Drug Administration (FDA) licensed Wyeth-Lederle Vaccines and Pediatrics to distribute a combined diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (ACEL-IMUNE{Registered} *) ** for all five doses of the diphtheria, tetanus, and pertussis vaccination series administered to infants and children aged 6 weeks-6 years (before the seventh birthday). Since December 1991, ACEL-IMUNE{Registered} has been licensed for use as the fourth and fifth doses of the vaccination series among children aged 15 months-6 years who previously received three or four doses of diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine (DTP). ACEL-IMUNE{Registered} is the second acellular pertussis-containing vaccine to be licensed for use in infants in the United States (1).

The Advisory Committee on Immunization Practices (ACIP); Committee on Infectious Diseases, American Academy of Pediatrics; and American Academy of Family Physicians recommend that children routinely receive a series of five doses of vaccine against diphtheria, tetanus, and pertussis before age 7 years (2-5). The first four doses should be administered at ages 2, 4, 6, and 15-18 months and the fifth dose at age 4-6 years.

The following evidence supports the use of ACEL-IMUNE{Registered} for the diphtheria, tetanus, and pertussis vaccination series:

  1. The rates of local reactions, fever, and other common systemic symptoms following receipt of ACEL-IMUNE{Registered} inoculations were lower than those following whole-cell pertussis vaccination (administered as DTP) for doses one through four in controlled clinical studies. The rates of these reactions following the fifth dose of ACEL-IMUNE{Registered} were no greater than the rates described for historical controls who received a fifth dose of DTP after four previous doses of DTP (6, package insert).

  2. Efficacy of ACEL-IMUNE{Registered} was assessed in a prospective study in Erlangen, Germany. Infants were randomly assigned to groups that were administered either ACEL-IMUNE{Registered} or DTP (distributed by Wyeth-Lederle Vaccines and Pediatrics) at mean ages 3, 5, 7, and 17 months. A third group of infants (not selected randomly) received DT at ages 3, 5, and 17 months. In this trial, pertussis was defined as cough illness lasting 21 days with at least one pertussis-associated symptom (paroxysms, whoop, or post-tussive vomiting) confirmed by culture, serology, or epidemiologic link to a culture-positive household contact. The adjusted vaccine efficacy after three doses and before receipt of the fourth dose was 73% (95% confidence interval {CI}=51%-86%) for ACEL-IMUNE{Registered} and 83% (95% CI=65%-92%) for DTP. The adjusted efficacy after four doses of ACEL-IMUNE{Registered} was 85% (95% CI=76%-90%). Adjusted efficacy of four doses of DTP was 94% (95% CI=89%-97%). Considering all observation time, (i.e., including after the third dose until the fourth dose {approximately 40% of follow-up time} and after the fourth dose until the end of the study {approximately 60% of follow-up time}), the adjusted efficacy estimated for ACEL-IMUNE{Registered} was 81% (95% CI=73%-87%) compared with 91% for DTP (95% CI=85%-95%) (package insert).

Because of the reduced frequency of adverse reactions and high efficacy, the ACIP recommends DTaP (either ACEL-IMUNE{Registered} or Tripedia{Registered} {Connaught Laboratories, Inc., Swiftwater, Pennsylvania}) for all doses of the routine diphtheria, tetanus, and pertussis vaccination series (1). DTaP also is recommended for all remaining doses in the schedule for children who have started the vaccination series with one, two, three, or four doses of DTP. During the transition period from use of whole-cell DTP to DTaP, vaccines containing a whole-cell pertussis component continue to be an acceptable alternative for all doses in the pertussis vaccination series.

Whenever feasible, the same DTaP vaccine should be used throughout the entire vaccination series. No data exist on the safety, immunogenicity, or efficacy of different DTaP vaccines when administered interchangeably in the primary or booster vaccination of a child. However, if the vaccine provider does not know or have available the type of DTaP vaccine the child to be vaccinated had previously received, any of the licensed DTaP vaccines may be used to complete the vaccination series. ACIP is developing recommendations for use of DTaP among infants.


  1. CDC. Food and Drug Administration approval of an acellular pertussis vaccine for the initial four doses of the diphtheria, tetanus, and pertussis vaccination series. MMWR 1996;45:676-7.

  2. CDC. 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).

  3. American Academy of Pediatrics. Pertussis. In: Peter G, ed. 1994 Red book: report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, Illinois: American Academy of Pediatrics, Committee on Infectious Diseases, 1994:355-67.

  4. CDC. 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. CDC. Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series: update to the supplementary ACIP statement: recommendations of the Advisory Committee on Immunization Practices. MMWR 1992;41(no. RR-15).

  6. Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics 1995;96(suppl):557-66.

* Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, ACEL-IMUNE{Registered}, manufactured by Lederle Laboratories and distributed by Wyeth-Lederle Vaccines and Pediatrics (Pearl River, New York). The acellular pertussis vaccine component is produced by Takeda Chemical Industries, Ltd. (Osaka, Japan), and is combined with diphtheria and tetanus toxoids manufactured by Lederle Laboratories. 

** Use of trade names and commercial sources 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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