Abstract

Concerns about the safety of whole-cell pertussis vaccines prompted development of acellular vaccines that are less likely to provoke adverse events because they contain purified antigenic components of Bordetella pertussis. Two diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines -- ACEL-IMUNE{Registered} * and Tripedia{Registered} ** -- have been licensed for several years, but (until recently) only for administration of the fourth and fifth doses in the series to children aged 15 months-6 years who previously had received three or more doses of diphtheria and tetanus toxoids and whole-cell pertussis (DTP) vaccine. Published reports indicate that, when administered to infants aged 2, 4, and 6 months, acellular pertussis vaccines are effective in preventing pertussis disease and associated with fewer local, systemic, and certain more serious adverse events than whole-cell pertussis vaccines. On the basis of these data, the Food and Drug Administration (FDA) has licensed three DTaP vaccines for use among children aged 6 weeks-6 years. Tripedia{Registered} is now licensed for the initial four doses, and ACEL-IMUNE{Registered} for all five doses of the diphtheria, tetanus and pertussis vaccination series. A third DTaP vaccine (Infanrix TM) *** was licensed in January 1997 for the initial four doses of the series. Tripedia{Registered}, ACEL-IMUNE{Registered}, and Infanrix TM are now recommended for routine vaccination of infants and young children, although whole-cell pertussis vaccines remain acceptable alternatives. Tripedia{Registered}, ACEL-IMUNE{Registered}, and Infanrix TM are recommended for all remaining doses in the schedule for children who have started the vaccination series with one, two, three, or four doses of whole-cell pertussis vaccines. In September 1996, FDA licensed the use of TriHIBit TM (ActHIB{Registered} reconstituted with Tripedia{Registered}) **** for the fourth dose in the series of vaccinations against diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease.
This statement a) provides general information regarding whole-cell pertussis vaccines currently licensed in the United States; b) summarizes results of recent studies of the immunogenicity, efficacy, and safety of acellular pertussis vaccines administered to infants and young children; c) presents recommendations for the use of Tripedia{Registered}, TriHIBit TM, ACEL-IMUNE{Registered}, and Infanrix TM vaccines; and d) supplements previous recommendations on pertussis vaccination.

Recommendation Americas United States of America