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

On July 29, 1998, the Food and Drug Administration (FDA) licensed North American Vaccine, Inc. (Beltsville, Maryland) to distribute a combined diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) (CertivaTM *) ** for the first four doses of the diphtheria and tetanus toxoids and pertussis vaccination series administered to infants and children aged 6 weeks-6 years. CertivaTM is the fourth acellular pertussis vaccine to be licensed for use in infants and young children in the United States (1).

Vaccine doses should be administered at ages 2, 4, 6, and 15-20 months. Data are insufficient to evaluate the use of CertivaTM as a fifth dose among children aged 4-6 years who have received CertivaTM for the previous four doses. Additional information about the immunogenicity and safety of a fifth dose following four previous doses of the same acellular pertussis vaccine is being collected and should be available before these infants are aged 4-6 years and require a fifth dose.

The Advisory Committee on Immunization Practices (ACIP), the Committee on Infectious Diseases, the American Academy of Pediatrics, and the 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 (1,2). 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 CertivaTM for the first four doses of the diphtheria, tetanus, and pertussis vaccination series:

  1. The rates of local reactions, fever, and other common systemic symptoms following receipt of CertivaTM inoculations were significantly lower than those following whole-cell pertussis vaccination (administered as diphtheria and tetanus toxoids and pertussis vaccine {DTP}) for doses one through three in controlled clinical studies (1,3).

  2. Efficacy of three doses of CertivaTM against pertussis disease was assessed in a double-blind, randomized, placebo-controlled trial in Sweden using CertivaTM-EU, a vaccine containing the same amount of pertussis toxoid (40 ug) per dose as CertivaTM but more diphtheria toxoid (25 Lf versus 15 Lf) and more tetanus toxoid (7 Lf versus 6 Lf) (4). Infants were randomly assigned to be vaccinated with either CertivaTM-EU or DT (Diphtheria and Tetanus Toxoids Adsorbed Vaccine, Statens Seruminstitut, Copenhagen, Denmark) at ages 3, 5, and 12 months. The main observation period started 30 days after the third dose of vaccine and lasted a mean of 17 months. In this trial, pertussis was defined according to the World Health Organization case definition (i.e., a paroxysmal cough illness lasting greater than or equal to 21 days and confirmed by culture, serology, or epidemiologic link to a culture-positive household contact). Starting 1 month after the third dose, the vaccine efficacy of CertivaTM-EU against WHO-defined pertussis was 72% (95% confidence interval=62%-78%) (3). Although a serologic correlate of protection for pertussis has not been established, the antibody response to pertussis toxoid in U.S. infants after doses of CertivaTM at 2, 4, 6, and 15-20 months of age was comparable to that achieved in a previous trial among infants in Sweden in whom efficacy was demonstrated after three doses at 3, 5, and 12 months of age. Because of the reduced frequency of adverse reactions and demonstrated efficacy, the ACIP recommends a licensed DTaP for all five doses of the routine diphtheria, tetanus, and pertussis vaccination series and for the remaining doses in the series for children who have started the vaccination series with whole-cell DTP vaccine (1). The ACIP considers the data to be insufficient in terms of safety and efficacy to express a preference between different acellular pertussis vaccine formulations.

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 received previously, any of the licensed DTaP vaccines may be used to complete the vaccination series (1).


  1. CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1997;46(no. RR-7).

  2. American Academy of Pediatrics. Pertussis. In: Peter G, ed. 1997 Red book: report of the Committee on Infectious Diseases. 24th ed. Elk Grove Village, Illinois: American Academy of Pediatrics 1997:394-407.

  3. Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (CertivaTM) {Package insert}. Beltsville, Maryland: North American Vaccine, Inc., 1998.

  4. Trollfors B, Taranger J, Lagergard T, et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995;333:1045-50.

* Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed, CertivaTM, manufactured and distributed by North American Vaccine, Inc., Beltsville, Maryland. Marketed by Ross Products Division, Abbott Laboratories, Inc. The diphtheria and tetanus toxoid components are produced by the Statens Seruminstitut, Copenhagen, Denmark. Final formulation and release of CertivaTM are conducted by North American Vaccine, Inc. 

** Use of trade names and commercial sources is for identification only and does not imply endorsement by CDC or U.S. Department of Health and Human Services.

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