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) 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 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 is the second acellular pertussis-containing vaccine to be licensed for use in infants in the United States.