Acellular Pertussis Vaccines: Recommendations for Use as the Fourth and Fifth Doses

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Abstract
In December 1991, the US Food and Drug Administration (FDA) licensed the first diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) for administration to children as the fourth and fifth doses of diphtheria, tetanus, and pertussis immunization. The product consists of an acellular pertussis vaccine produced by Japan's Takeda Chemicals and diphtheria and tetanus components produced by Lederle Laboratories, Division of American Cyanamid. It is expected that one or more additional acellular pertussis vaccine(s) will be licensed in the future. The American Academy of Pediatrics (AAP) recommends that children routinely receive a series of five doses of vaccine against diphtheria, tetanus, and pertussis before 7 years of age.1,2 The FDA-approved DTaP vaccine (ACEL-IMUNE) is licensed for use only as the fourth and fifth doses for children who have been immunized previously with at least three doses of diphtheria and tetanus toxoids and whole-cell pertussis (DTP) vaccine. It is not licensed for the initial series of three doses in infants and children or for use in children younger than 15 months of age or after the seventh birthday. The following recommendations supplement previous AAP guidelines for use of whole-cell pertussis vaccines as the fourth and fifth doses and provide a follow-up to a previous AAP statement on acellular pertussis vaccines,3 which contains more complete background information. BACKGROUND The whole-cell pertussis vaccines currently used in the United States are prepared from inactivated cells of Bordetella pertussis and contain multiple antigens (Table 1). In contrast, the acellular vaccines contain one or more immunogens derived from the B pertussis organism.

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